Systems, methods, and apparatus for producing and packaging fluids

Abstract

To provide a system for producing and packaging a fluid.SOLUTION: A system for producing and packaging a fluid may include a water distillation device. The system may further include a mixing circuit coupled to an output of the water distillation device and including a source of concentrate. The mixing circuit may include a plurality of flow controllers configured to regulate the flow of fluid through the mixing circuit, the plurality of flow controllers being adapted to generate a preset fluid. The system can further include an enclosure including an antechamber and a packaging compartment.SELECTED DRAWING: Figure 56

Description

[Technical Field]

[0001] STATEMENT OF FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT This invention was made with Government support under Contract HHSO100201900017C awarded by HHS. The Government has certain rights in this invention.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to medical fluids. More particularly, the present disclosure relates to the generation and packaging of medical fluids. [Background technology]

[0003] Nearly all hospitalized patients receive saline or saline-based solutions. As a result, the amount of saline solution consumed is enormous. In the United States alone, more than 1 billion bags of saline solution are used annually. Despite this demand, there are only a few different saline solution manufacturers offering this solution for the U.S. market. Unfortunately, manufacturing challenges that limit production from any one manufacturer can and have caused saline solution shortages in the U.S. Compounding the problem, these manufacturers have uneven market shares for all bagged saline products. For example, 50% of saline solution bags under 250 ml are provided by a single manufacturer. As a result, when such a manufacturer experiences production issues, the impact on the availability of that particular bag type is greater.

[0004] Most recently, the media spotlight has been on the delays caused in the aftermath of Hurricane Maria, which led to a shortage of small-volume saline bags. According to the American Society of Health-System Pharmacists, shortages also currently exist for large-volume bags and bags of saline for cleaning purposes. Alternative means of producing medical fluid bags, possibly locatable within the institutions that use the bags, would be desirable. Summary of the Invention

[0005] According to an embodiment of the present disclosure, a sealing member dispenser may include a dispenser body including at least one trough and an exit port, the trough configured to receive a plurality of sealing members, and the exit port extending from the trough to an exterior surface of the dispenser body. The exit port may have a guide portion adjacent to the exterior surface of the dispenser body. The sealing member dispenser may further include a blocking element that obstructs passage of the sealing member through the exit port. The sealing member dispenser may further include a cover, the cover coupled to the dispenser body and overhanging the trough. The cover may include an orifice aligned with the exit port. The orifice may present an opening too small to allow passage of one of the plurality of sealing members.

[0006] In some embodiments, the trough can extend along a helical path. In some embodiments, the dispenser body can be a drum. In some embodiments, the guide portion can include a funnel-shaped profile. In some embodiments, the guide portion can include a chamfered edge. In some embodiments, the guide portion can include a filleted edge. In some embodiments, the blocking element can be displaceable. In some embodiments, the blocking element can be an outlet cover coupled to the handle. Displacement of the handle can result in displacement of the outlet cover from the obstructing position. In some embodiments, the blocking element can include a detent member that protrudes into the exit port. In some embodiments, the detent member can be a ball detent. In some embodiments, the sealing member dispenser can further include a follower and a biasing member, the biasing member coupled to the follower and a portion of the dispenser body. In some embodiments, the biasing member can be a constant force spring. In some embodiments, the dispenser body can further include a receiving slit sized to receive the follower. In some embodiments, the sealing material dispenser can further include a magnetic material. In some embodiments, the sealing material dispenser can further include a rotor coupled to the shaft and a biasing assembly configured to exert a biasing force on the shaft urging the shaft to rotate. In some embodiments, the sealing material dispenser can include a rotor coupled to the shaft. In some embodiments, the sealing material dispenser can include a rotor drive assembly configured to automatically index the rotor until the sealing material is displaced along the trough to the exit point.In some embodiments, the rotational displacement for indexing the rotor can change when the sealing material dispenser is depleted of sealing material.

[0007] According to another embodiment of the present disclosure, a reservoir feeding device can include a housing block including at least one channel, the at least one channel extending through the housing block. The reservoir feeding apparatus may further include a set of retention pins associated with each of the at least one channel. The reservoir feeding apparatus may further include a set of guides associated with each of the at least one channel. There may be slots defined between the guides of each set of guides. The reservoir feeding apparatus may further include a feed plate coupled to the housing block by at least one biasing member. The feed plate may include at least one follower protrusion. The reservoir feeding apparatus may further include an elongated member extending from the housing block through the feed plate. The biasing member may urge the feed plate to be displaced along the elongated member toward the stop surface of the housing block. The biasing member may also be configured to urge the follower protrusion into contact with a port of a reservoir disposed in the guide.

[0008] In some embodiments, each retention pin can be biased to an expanded state by a retention pin biasing member, wherein the retention pin extends into its associated channel. In some embodiments, the retention pins of each set of retention pins can be disposed on opposite sides of the channel with which the set of retention pins is associated. In some embodiments, each retention pin can be biased to an expanded state by a retention pin biasing member, wherein the ends of the retention pins of a set are spaced apart from one another by a distance less than the diameter of the port of the reservoir when in the expanded state. In some embodiments, each retention pin can be configured to be displaced from the obstructing position upon introduction of a grasper to collect reservoirs from the reservoir feeder. In some embodiments, the biasing member can be a constant force spring. In some embodiments, the length of the follower protrusion is at least equal to the distance from the stop surface to the retention pin. In some embodiments, the reservoir feeding apparatus can further include a feed plate retainer for holding the feed plate in the loading orientation. The feed plate retainer can be coupled to the housing block via at least one standoff. In some embodiments, the feed plate retainer can include a spring-biased latch member. In some embodiments, the feed plate retainer can include a magnet, and the feed plate includes a metal body.

[0009] According to another embodiment of the present disclosure, a reservoir feeding device can include a housing block including at least one channel, the at least one channel extending through the housing block. The reservoir feeding apparatus may further include a set of retention pins associated with each of the at least one channel. The reservoir feeding apparatus may further include a reservoir magazine coupled to the housing block. The reservoir feeding apparatus may further include a feed plate coupled to the housing block by at least one biasing member. The feed plate may include at least one follower protrusion. The reservoir feeding apparatus may further include an elongated member extending from the housing block through the feed plate. The biasing member may urge the feed plate to be displaced along the elongated member toward the stop surface of the housing block. The biasing member may urge the follower protrusion to be displaced through the reservoir magazine toward the housing block.

[0010] In some embodiments, each retention pin can be biased to an expanded state by a retention pin biasing member, wherein the retention pin extends into its associated channel. In some embodiments, the retention pins of each set of retention pins can be disposed on opposite sides of the channel with which the set of retention pins is associated. In some embodiments, each retention pin can be biased to an expanded state by a retention pin biasing member, wherein the ends of the retention pins of a set are spaced apart from one another by a distance less than the diameter of the port of the reservoir in the expanded state. In some embodiments, each retention pin can be configured to be displaced from the obstructing position upon introduction of a grasper to collect reservoirs from the reservoir feeder. In some embodiments, the biasing member can be a constant force spring. In some embodiments, the length of the follower protrusion can be at least equal to the distance from the stop surface to the retention pin. In some embodiments, the reservoir feeding apparatus can further include a feed plate retainer for holding the feed plate in the loading orientation. The feed plate retainer can be coupled to the housing block via at least one standoff. In some embodiments, the feed plate retainer can include a spring-biased latch member. In some embodiments, the feed plate retainer can include a magnet, and the feed plate can include a metal body.

[0011] According to another embodiment of the present disclosure, a bag sealing device includes a ram displaceable along a displacement axis by a ram actuator. The bag sealing device may further include a sealing material dispenser receiver for receiving a sealing material dispenser. The bag sealing device may further include a sealing material dispenser sensor configured to output a first signal indicating the presence of the sealing material dispenser in the receiver. The bag sealing device may further include a reservoir guide including a first portion and a second portion, the first portion and the second portion having a gap therebetween. The reservoir guide guides a port of the reservoir into alignment with the displacement axis when the reservoir is disposed in the gap. At least one of the first and second portions of the reservoir guide may include a grasper docking surface.

[0012] In some embodiments, the bag sealing device can be a stoppering apparatus. In some embodiments, the sealing member receiver can be disposed intermediate the ram and the reservoir guide. In some embodiments, the sealing member dispenser sensor can be a magnetic sensor. In some embodiments, the sealing member dispenser sensor is a Hall Effect sensor. In some embodiments, the bag sealing device can further include a reservoir detection sensor configured to output a second signal indicative of the presence of a reservoir in the reservoir guide. In some embodiments, the bag sealing device can further include a controller. The controller can be configured to prevent actuation by the ram actuator when at least one of the first and second signals is absent. In some embodiments, the bag sealing device can further include an optical port detection sensor configured to output a second signal indicative of the presence of a port in alignment with the axis of displacement based on an intensity of reflection of light emitted from the sensor. In some embodiments, the bag sealing apparatus may further include a controller, the controller configured to prevent actuation by the ram actuator in the absence of the first signal.

[0013] According to an embodiment of the present disclosure, an apparatus for packaging fluid may include a fill conduit dispenser having a reel portion containing a length of fill conduit. The apparatus may further include a feeder assembly including an actuator coupled to at least one feeding member. The apparatus may further include a tubing retainer having a first portion coupled to a sled and a cam follower. The tubing retainer may have a second portion coupled to the base plate. The tubing retainer may include a receptacle for a fill conduit segment and a bag port. The apparatus may further include a sled actuator. The apparatus may include an occluder assembly having an occluder actuator coupled to a carriage mounted to the occluder. The apparatus may further include a cutter assembly including a cutter actuator coupled to a cutting element and a cam surface. The cam surface and the cutting element may be configured to displace in unison with one another. The apparatus can further include a guide coupled to the first portion of the tubing retainer, the occluder assembly, and the cutter assembly. The apparatus can further include a biasing member that presses the cam follower against the cam surface. The apparatus can further include a controller configured to manage operation of the sled actuator, the occluder actuator, and the cutter actuator to occlude, cut, and join segments of the fill conduit and port.

[0014] In some embodiments, the first and second portions of the tubing retainer can be separated by a first gap. In some embodiments, the occluder can include a first occluder portion and a second occluder portion separated by a second gap. In some embodiments, the first and second gaps are disposed in the same plane, and the first and second gaps are sized to receive a cutting element therein. In some embodiments, the occluder includes a first occluder portion and a second occluder portion, and the first occluder portion is mounted on a rail and rotatable relative to the carriage. In some embodiments, the occluder can include a first occluder portion coupled to the first retainer portion by a first pin, and the occluder can include a second occluder portion coupled to the second retainer portion by a second pin. In some embodiments, the occluder can include first and second occluder portions. The first occluder portion can be mounted on the rail and coupled to the first retainer portion by a pin linking the first occluder portion and the first retainer portion, such that actuation of the sled by the sled actuator results in displacement of the first occluder portion along the rail. In some embodiments, displacement of the cam follower along the cam surface can vary the size of the gap. In some embodiments, the cam surface can be shaped so that the gap is maximized when the cutting element is disposed in the gap and decreases when the cutting element is withdrawn. In some embodiments, the occluder can include a first portion and a second portion. The first portion can be rotatable relative to the carriage and coupled to the first retainer portion via a linkage. A biasing member can couple the first portion of the occluder to the carriage.In some embodiments, the cutting element can include a metal plate and a coating. In some embodiments, the coating can be ceramic. In some embodiments, the cutter assembly can include at least one heating element. In some embodiments, the apparatus can further include a tube sealing assembly having opposed jaws, the jaws each having a heating element and a low thermal conductivity cutting insert therein. The tube sealing assembly can include a sealing actuator configured to displace the jaws toward and away from each other. In some embodiments, the controller can be configured to manage operation of the sealing actuator to displace the jaws against the port over a predetermined period of time, the jaws heating the port until the cutting insert presses through the port. In some embodiments, the apparatus can further include a counterweight coupled to the sled. The counterweight can be configured to hold the cam follower against the cam surface.

[0015] According to another embodiment of the present disclosure, the reservoir filling set can include a carrier including multiple compartments. The reservoir filling set can further include multiple packets each containing a flexible reservoir to be attached to the administration set and the filling line. The reservoir filling set can further include an adapter including multiple retainer recesses, each having an end of one of the filling lines disposed therein. The retainer recesses can restrain the ends of the filling lines so that they extend straight along the axis of the retainer recesses. The reservoir filling set can further include multiple sealing members. A sealing member of the multiple sealing members can be included in each end of the filling line.

[0016] In some embodiments, the administration set can include at least one occlusion member associated therewith. The occlusion member can be in an occluded state, where flow through at least a portion of the administration set is restricted. In some embodiments, the occlusion member can be a roller clamp. In some embodiments, the occlusion member can be a slide clamp. In some embodiments, the occlusion member can be a thumb clamp. In some embodiments, the carrier can include a handle. In some embodiments, each packet can include a pocket and a flap, with a flexible reservoir disposed in the pocket and the flap, in the closed position, retaining the administration set within the packet. In some embodiments, the flexible reservoir contained by each packet can be an IV bag. In some embodiments, the multiple sealing members can be septa. In some embodiments, the retainer recesses can be spaced apart from each other at preset angular increments. The angular increments can be selected to align with spikes in the spike port of the filling device.

[0017] According to another embodiment of the present disclosure, a system for packaging fluid may include a fluid source. The system may further include a spike port including a plurality of spikes. The system may further include an in-line heater. The system may further include at least one pump. The system may further include a plurality of valves. The system may further include a controller configured to, in a first mode, power the heater to heat the fluid to a predefined temperature setpoint and manage operation of the at least one pump and the plurality of valves to recirculate the fluid through the spike port for a predefined period of time to sanitize the spike port, and to, in a second mode, manage operation of the at least one pump and the plurality of valves to route the fluid from the source to the spikes of the spike port.

[0018] In some embodiments, the spike port can include a recess, the spike disposed within the recess, and the spike includes a recirculation port. In some embodiments, the spike port can be configured to receive a spiking adapter, the spiking adapter having multiple fluid lines contained within a retaining recess of the spiking adapter. The spikes of the spike port can be spaced apart to align with the retaining recess of the spiking adapter. In some embodiments, the spike port can include at least one alignment guide configured to cooperate with an alignment element of the spiking adapter. In some embodiments, the system can further include a passive manifold, the passive manifold bifurcating a fluid input from a common point to each of the spikes of the spike port. In some embodiments, the spike port can include a cap and a gasket, the cap abutting and sealing against the gasket when the cap is in a closed orientation. In some embodiments, the predefined temperature set point can be at least 70°C.

[0019] According to another embodiment of the present disclosure, a method of filling a reservoir can include creating a junction between the fill conduit and the port of the reservoir by heating the fill conduit and the port, cutting the fill conduit and the port, bringing the fill conduit into coaxial alignment with the port, and connecting the cut end of the port to the cut end of the fill conduit. The method can further include delivering fluid through the fill conduit, across the junction, through the port, and into the reservoir. The method can further include actuating jaws against a portion of the port and heating the jaws until a non-thermally conductive insert in each jaw is pressed through the port.

[0020] In some embodiments, cutting the fill conduit and port can include forcing a heated blade into a gap in the retainer in which the fill conduit and port are disposed. In some embodiments, bringing the fill conduit into coaxial alignment with the port can include actuating a sled to displace a movable portion of the retainer relative to a stationary portion of the retainer, such that the cut ends of the port and fill conduit slide across opposing surfaces of the heated blade. In some embodiments, coupling the cut end of the port to the cut end of the fill conduit can include biasing a movable portion of the retainer toward the stationary portion of the retainer and displacing a cam surface, in unison with the heated blade, relative to a cam follower coupled to the movable portion of the retainer as the heated blade is retracted away from the retainer. In some embodiments, the method can further include actuating a sled along a path generally parallel to the plane of the joint. In some embodiments, the method can further include forming a seal in the port that separates the aliquot of liquid in the port from the fluid in the reservoir. In some embodiments, the reservoir can be a bag.

[0021] According to another embodiment of the present disclosure, a method of filling a reservoir can include cutting a fill conduit and a port with a heated cutting element, sliding the cut ends of the port and fill conduit across opposing surfaces of the cutting element to position the fill conduit in coaxial alignment with the port, and mating the cut end of the port with the cut end of the fill conduit as the cutting element is withdrawn, thereby creating a junction between the fill conduit and the port of the reservoir. The method can further include delivering fluid through the fill conduit, across the junction, and through the port into the reservoir. The method can further include actuating jaws against a portion of the port and heating the jaws until a non-thermally conductive insert in each jaw is pressed through the port.

[0022] In some embodiments, cutting the fill conduit and the port can include forcing a cutting element into a gap in the retainer in which the fill conduit and the port are disposed. In some embodiments, bringing the fill conduit into coaxial alignment with the port can include actuating a sled to displace a movable portion of the retainer relative to a stationary portion of the retainer. In some embodiments, coupling the cut end of the port to the cut end of the fill conduit can include biasing a movable portion of the retainer toward the stationary portion of the retainer and displacing a cam surface, together with the cutting element, on a cam follower coupled to the movable portion of the retainer as the cutting element is withdrawn from the retainer. In some embodiments, the method can further include actuating the sled along a path generally parallel to the plane of the interface. In some embodiments, the method can further include forming a seal in the port that isolates an aliquot of liquid in the port from fluid in the reservoir. In some embodiments, the reservoir can be a bag. In some embodiments, the method can further include sensing, with at least one sensor, the presence of at least one of the fill conduit and the port in the tubing retainer.

[0023] According to another embodiment of the present disclosure, a system for producing and packaging a fluid may include a water distillation device. The system may further include a mixing circuit, the mixing circuit coupled to the output of the water distillation device and including a source of concentrate. The mixing circuit may include a plurality of flow controllers configured to regulate the flow of fluid through the mixing circuit to generate a preset fluid. The system may further include an enclosure including an antechamber and a packaging compartment. The system may further include a reservoir dispenser in the packaging compartment having a feed plate and a housing block. The reservoir dispenser may include a biasing member, which urges the feed plate toward the housing block. The system may further include a filling station in the packaging compartment including a filling nozzle coupled to the mixing circuit. The system may further include a sealing station in the packaging compartment having a ram and a sealing member dispenser. The system may further include a quarantine repository in the packaging compartment having a plurality of reservoir holders. The system may further include a labeler in the packaging compartment. The system may further include an output chute from the packaging compartment to an exterior of the enclosure.

[0024] In some embodiments, the system may further include at least one of a reverse osmosis unit and an ultrafilter. In some embodiments, the concentrate source may be a crystal concentrate reservoir having a purified water inlet and a fluid concentrate outlet. In some embodiments, the concentrate source may include a crystal component dispenser. In some embodiments, the antechamber may include a flexible sterile barrier. In some embodiments, the flexible sterile barrier may include at least one gloved interface. In some embodiments, the antechamber and the packaging compartment may be separated by a divider. In some embodiments, the divider may include a door having a sample container holder. In some embodiments, the system may further include a pyrogen tester. In some embodiments, the system may further include a robotic arm including a gripper. In some embodiments, the system can further include a control system configured to displace the robotic arm, activate the gripper to collect the reservoir from the reservoir dispenser, displace the reservoir to the filling station, command the filling of the reservoir, and command the actuation of the ram to displace the reservoir to the sealing station and drive the sealing member from the sealing member into the port of the reservoir. In some embodiments, the filling station can further include a set of reservoir characteristic sensors, and the system can further include a control system configured to analyze data received from the reservoir characteristic sensors and determine the volume of the reservoir in place at the filling station. In some embodiments, the control system can be configured to manage operation of the flow controller based on the volume of the reservoir determined based on data from the reservoir characteristic sensors. In some embodiments, the control system can be configured to manage operation of at least one flow controller to deliver a volume of concentrate to the reservoir and a subsequent volume of purified water to the reservoir to achieve a fill volume selected based on the capacity of the reservoir.

[0025] According to another embodiment of the present disclosure, a system for producing and packaging a fluid may include a water distillation device. The system may further include a mixing circuit, the mixing circuit coupled to the output of the water distillation device and including a source of concentrate. The mixing circuit may be configured to regulate the flow of fluid through the mixing circuit to generate a fluid of a predefined composition. The system may further include an enclosure including an antechamber and a packaging compartment. The system may further include a reservoir dispenser at least partially within the packaging compartment, having a reservoir magazine and an outlet end. The reservoir dispenser may include an actuator, the actuator configured to drive a follower of the reservoir magazine toward the outlet end of the reservoir dispenser. The system may further include a filling nozzle coupled to the mixing circuit and a filling station within the packaging compartment including a reservoir volume sensing assembly. The system may further include a sealing station within the packaging compartment. The system may further include a repository within the packaging compartment having a plurality of reservoir holders. The system may further include a labeler within the packaging compartment. The system may further include an output chute from the packaging compartment to an exterior of the enclosure.

[0026] In some embodiments, the system may further include at least one of a reverse osmosis unit and an ultrafilter. In some embodiments, the concentrate source may be a crystal concentrate reservoir having a purified water inlet and a fluid concentrate outlet. In some embodiments, the antechamber may include a flexible sterile barrier. In some embodiments, the flexible sterile barrier may include at least one gloved interface. In some embodiments, the antechamber and the packaging compartment may be separated by a divider. In some embodiments, the divider may include a door having a sample container holder. In some embodiments, the system may further include a pyrogen tester. In some embodiments, the system may further include a robotic arm including a gripper. In some embodiments, the system can further include a control system configured to displace the robotic arm and actuate the gripper to collect the reservoir from the reservoir dispenser, displace the reservoir to the filling station, determine the volume of the reservoir via data from the reservoir volume sensing assembly, command filling the reservoir with a volume of fluid equal to or less than the volume of the reservoir, and displace the reservoir to the sealing station and command sealing the reservoir. In some embodiments, the reservoir volume sensing assembly can include a set of reservoir characteristic sensors, and the system can further include a control system configured to analyze data received from the reservoir characteristic sensors and determine the volume of the reservoir in an appropriate location at the filling station. In some embodiments, the control system can be configured to manage operation of at least one flow controller based on the volume of the reservoir determined based on data from the reservoir characteristic sensors.In some embodiments, the control system can be configured to manage operation of at least one flow controller to deliver a volume of concentrate to the reservoir and a subsequent volume of purified water to the reservoir to achieve a fill volume selected based on the capacity of the reservoir.

[0027] According to another embodiment of the present disclosure, a system for producing and packaging a fluid may include a water purification device. The system may further include a mixing circuit, the mixing circuit coupled to an output of the water purification device and including a source of concentrate. The mixing circuit may be configured to generate a fluid of a predefined composition. The system may further include an enclosure including an antechamber and a packaging compartment. The system may further include a reservoir dispenser extending from the antechamber to the packaging compartment, the reservoir dispenser having a reservoir magazine and an outlet end. The reservoir dispenser may include a drive, the drive configured to displace a follower of the reservoir magazine toward the outlet end of the reservoir dispenser. The system may further include a filling station in the packaging compartment including a filling nozzle coupled to the mixing circuit and a reservoir volume sensing assembly. The system may further include a sealing station in the packaging compartment. The system may further include at least one reservoir hanger within the packaging compartment. The system may further include a labeler within the packaging compartment. The system may further include an output chute from the packaging compartment to an exterior of the enclosure.

[0028] In some embodiments, the system may further include at least one of a reverse osmosis unit and an ultrafilter. In some embodiments, the concentrate source may be a reservoir of crystalline salt concentrate. In some embodiments, the antechamber may include at least one gloved interface. In some embodiments, the antechamber may include at least one flexible barrier element. In some embodiments, the antechamber and the packaging compartment may be separated by a partition, the partition including at least one door between the antechamber and the packaging compartment. In some embodiments, the system may further include a robotic arm including a gripper. In some embodiments, the system can further include a robotic manipulator and a control system configured to displace the robotic manipulator to collect a reservoir from the reservoir dispenser, displace the reservoir to a filling station, determine the volume of the reservoir via data from the reservoir volume sensing assembly, command filling the reservoir with a volume of fluid equal to or less than the volume of the reservoir, and displace the reservoir to a sealing station and command sealing the reservoir. In some embodiments, the reservoir volume sensing assembly can include a set of reservoir characteristic sensors. In some embodiments, the control system can be configured to manage operation of at least one flow controller based on the volume of the reservoir determined based on data from the reservoir characteristic sensors. In some embodiments, the control system can be configured to manage operation of the at least one flow controller to deliver a volume of concentrate to the reservoir and a subsequent volume of purified water to the reservoir to achieve a fill volume selected based on the volume of the reservoir determined based on data from the reservoir characteristic sensors.

[0029] According to another embodiment of the present disclosure, a fluid production system for a medical fluid packaging system may include a water distillation device. The system may further include a plurality of filters, including at least one of a reverse osmosis filter and a carbon filter. The system may further include a mixing circuit including a purified water flow path and a concentrate flow path, the concentrate flow path including a concentrate source. A flow controller and an ultrafilter may be present for each of the purified water flow path and the concentrate flow path. The system may further include a sensor suite, including a total organic carbon sensor, a bioburden sensor, a particulate monitor, a plurality of ultrapure water conductivity sensors, and a concentrate conductivity sensor. The system may further include a controller configured to manage operation of the flow controller to dispense predetermined volumes of fluid in a first stage and a second stage, the first stage delivering fluid at least primarily from the concentrate flow path and the second stage delivering fluid at least primarily from the purified water flow path, the controller apportioning the fluid among the first and second stages based on data from the concentrate conductivity sensor, a predefined desired fluid composition, and the predetermined volumes.

[0030] In some embodiments, the water distillation device can be a vapor compression distillation device. In some embodiments, the system can further include at least one of a sediment filter, a water softener, and a temperature regulator. In some embodiments, the controller can be configured to analyze data from each sensor in the sensor suite and generate an error when the data indicates that a fluid quality attribute exceeds a threshold. In some embodiments, the concentrate source is a crystal concentrate container including a purified water inlet and a concentrated solution outlet. In some embodiments, the concentrate source can include a crystal component dispenser. In some embodiments, the purified water can be water for injection quality water. In some embodiments, the system can further include at least one manual sampling port. In some embodiments, a particulate counter can be disposed downstream of the ultrafilter. In some embodiments, the controller can direct the delivery of fluid from only the concentrate flow path during the first stage. In some embodiments, the controller can direct the delivery of fluid from only the purified water flow path during the second stage. In some embodiments, the water distillation device can include a condensate reservoir therein. In some embodiments, the water distillation device can be configured to generate purified water in a first temperature range and a second temperature range. In some embodiments, the first temperature range can be below 40°C, and the second temperature range can be above 60°C. In some embodiments, the controller can be configured to manage the operation of the flow controller during a disinfection stage, wherein the controller manages the operation of the flow controller to route water at a temperature within the second temperature range through the system, to the nozzle, and into the drain.

[0031] According to another embodiment of the present disclosure, a method of filling a bag with a medical fluid can include installing a first fill nozzle into a first port of the bag communicating with a first compartment of the bag and installing a second fill nozzle into a second port of the bag communicating with a second compartment of the bag. The first and second fill nozzles communicate with a fluid source via a common flow channel. The method can further include delivering fluid into the first and second compartments of the bag. The method can further include stopping delivery of fluid into a smaller one of the first and second compartments of the bag when the smaller compartment is fully filled with a non-powered valve. The method can further include stopping delivery of fluid into a larger one of the first and second compartments of the bag when the larger compartment is fully filled. The method may further include separating a first compartment of the bag from a second compartment of the bag at a perforation in a seal extending between the first and second compartments. The method may further include accessing the smaller compartment and collecting a sample of the fluid for testing.

[0032] In some embodiments, the fluid can be a mixture of water for injection and at least one concentrate. In some embodiments, the fluid can be saline. In some embodiments, the method can further include performing an endotoxin test on the sample and discarding the larger compartment when the endotoxin test indicates the presence of endotoxin greater than a predefined level.

[0033] According to another embodiment of the present disclosure, a bag for containing a medical fluid and separable sampling aliquots can include a first compartment having a first fill port and a delivery port. The bag can further include a second compartment having a second fill port. The bag can further include a seal separating the first and second compartments. The bag can further include a perforation extending along the length of the seal.

[0034] In some embodiments, the first compartment can have a larger capacity than the second compartment. In some embodiments, the seal can extend along the length of the bag from the first end of the bag to the second end of the bag.

[0035] According to embodiments of the present disclosure, a reservoir for holding a fluid can include first and second sheets of material sealed together at a peripheral seal to define an interior volume of the reservoir. The reservoir can further include at least one port joined at the peripheral seal and providing a fluid path into the interior volume. The reservoir can further include an interior seal extending from the peripheral seal. The interior seal can define a partitioned portion of the interior volume and a main section of the interior volume. The partitioned portion can be in fluid communication with the main volume through a gap in the interior seal.

[0036] In some embodiments, the gap can be configured to be sealed after the reservoir is filled to isolate the compartmented portion from the main volume. In some embodiments, the at least one port can include a fill port and an administration port. In some embodiments, the compartmented portion can have a volumetric capacity smaller than that of the main volume. In some embodiments, each of the at least one port can be in direct fluid communication with the main volume. In some embodiments, the internal seal can be disposed at an angle to direct fluid toward the at least one port when the reservoir is suspended for gravity-based administration of the fluid contained therein. In some embodiments, the reservoir can be a bag.

[0037] According to another embodiment of the present disclosure, a reservoir for holding a fluid can include first and second sheets of material sealed together at a peripheral seal to define an interior volume of the reservoir. The reservoir can further include at least one port joined at the peripheral seal and providing a fluid path into the interior volume. The peripheral seal can have an enlarged region, with the at least one port positioned within the enlarged region. The reservoir can further include a sampling reservoir defined within the enlarged region. The sampling reservoir can extend from a flow path through the enlarged region connecting one of the at least one port to the interior volume of the reservoir. In some embodiments, the sampling reservoir can be in communication with the flow path through a branch pathway contained within the enlarged region. In some embodiments, the branch pathway can be configured to be sealed after the reservoir is filled, isolating the sampling reservoir from the interior volume. In some embodiments, the reservoir is a bag. In some embodiments, the at least one port can include a fill port and an administration port. In some embodiments, a flow path through the enlarged region that is connected to a sampling reservoir connects the fill port to the interior volume.

[0038] According to another embodiment of the present disclosure, a method of packaging a fluid in a reservoir can include introducing a fill nozzle into a fill port of the reservoir. The method may further include delivering a predefined amount of fluid into the reservoir through the fill nozzle. The method may further include removing the fill nozzle. The method may further include sealing a port in the reservoir. The method may further include forming a seal in the reservoir. The seal may create an internal aliquot of fluid in the reservoir that is isolated from the remainder of the reservoir.

[0039] In some embodiments, the reservoir can be a bag. In some embodiments, forming a seal can include sealing a gap within a partial wall contained within the reservoir, which defines a main interior volume of the reservoir and a partitioned interior volume of the reservoir. The gap, when unsealed, can provide fluid communication between the main volume and the partitioned interior volume. In some embodiments, the reservoir can be constructed from first and second sheets of material joined together at a peripheral seal that defines the interior volume of the reservoir, and forming a seal can include sealing a section of a flow path defined within the enlarged portion of the peripheral seal. In some embodiments, sealing a section of a flow path defined within the enlarged portion of the peripheral seal can isolate a sampling reservoir defined within the enlarged portion of the peripheral seal from the interior volume of the reservoir. In some embodiments, the method can further include collecting a sample from the internal aliquot and testing the sample.

[0040] According to another embodiment of the present disclosure, the filling and sampling nozzle can include a first portion including a single lumen. The sampling portion can further include a second portion including a filling lumen and a sampling lumen. The filling lumen can be continuous with the single lumen of the first portion. The filling lumen and the single lumen can define a continuous flow path from the first portion to an outlet portion of the nozzle. The sampling lumen can have an opening at the outlet portion of the nozzle and can be in fluid communication with a sample flow path connected to a sidewall portion of the nozzle.

[0041] According to another embodiment of the present disclosure, a method of packaging a fluid in a reservoir can include introducing a nozzle into a port of the reservoir, and the method can further include delivering a first volume of fluid into the reservoir through a continuous flow path extending from a first portion of the nozzle through a second portion of the nozzle. The method can further include delivering a second volume of fluid into the reservoir through the continuous flow path. The second volume of fluid can exceed the capacity of the reservoir. The method can further include directing overflow during delivery of the second volume through a sampling lumen of the nozzle and into a sampling conduit coupled to the nozzle.

[0042] In some embodiments, the method can further include providing the overflow to a sensing assembly. In some embodiments, the method can further include providing the overflow to a vial. In some embodiments, the first volume of fluid can be equal to the capacity of the reservoir. In some embodiments, the reservoir can be a bag. [Brief explanation of the drawings]

[0043] [Figure 1]1 illustrates a schematic exemplary embodiment of a system for producing and packaging medical fluids.

[0044] [Figure 2A] 1 illustrates a schematic exemplary embodiment of a system for producing and packaging medical fluids.

[0045] [Figure 2B] 1 illustrates a schematic exemplary embodiment of a system for producing and packaging medical fluids.

[0046] [Figure 3] 1 illustrates a schematic exemplary embodiment of a system for producing and packaging medical fluids.

[0047] [Figure 4A] FIG. 1 illustrates another schematic exemplary embodiment of a system for producing and packaging medical fluids.

[0048] [Figure 4B] 1 illustrates a schematic exemplary embodiment of a system for producing and packaging medical fluids.

[0049] [Figure 5A] 1 illustrates a schematic exemplary embodiment of a system for producing and packaging medical fluids.

[0050] [Figure 5B] 1 illustrates a schematic exemplary embodiment of a system for producing and packaging medical fluids.

[0051] [Figure 6] A top-down view of a multi-compartment bag containing a concentrate contained therein.

[0052] [Figure 7] 1A-1C illustrate an exemplary bag having a partial barrier wall within its interior volume.

[0053] [Figure 8] FIG. 1 shows an exemplary bag having an isolated aliquot of fluid separated from its main volume by a seal.

[0054] [Figure 9] 1 is a flowchart detailing several exemplary actions that may be performed to package a fluid in a bag.

[0055] [Figure 10] FIG. 10 shows another exemplary bag having a sampling reservoir disposed within the open area of ​​its peripheral seal.

[0056] [Figure 11] FIG. 5 illustrates the exemplary bag of FIG. 4 with the sampling reservoir isolated from fluid communication with the rest of the bag.

[0057] [Figure 12] 1 illustrates an exemplary bag with a first compartment and a second compartment.

[0058] [Figure 13] FIG. 1 illustrates an exemplary bag with a seal having perforations therein.

[0059] [Figure 14] 10 is another flowchart detailing several exemplary actions that may be performed to package a fluid in a bag.

[0060] [Figure 15] FIG. 1 illustrates an exemplary fill nozzle.

[0061] [Figure 16] FIG. 1 illustrates an exemplary multi-lumen filling nozzle that can be used to fill bags and to collect aliquots of fluid for sampling.

[0062] [Figure 17] 10 is another flowchart detailing several exemplary actions that may be performed to package a fluid in a bag.

[0063] [Figure 18] FIG. 1 shows a schematic example of a filling receiving set.

[0064] [Figure 19A] FIG. 1 is an exploded view of an exemplary bag with an administration set.

[0065] [Figure 19B] FIG. 1 is a top-down view of an exemplary bag with an administration set.

[0066] [Figure 20] FIG. 10 is a top down view of another exemplary bag.

[0067] [Figure 21] FIG. 10 is a top down view of another exemplary bag.

[0068] [Figure 22A-F] 1 is a diagram of a bag containing an administration set and a filling line at one stage of being sealed closed;

[0069] [Figure 23] FIG. 10 is a top down view of another exemplary bag.

[0070] [Figure 24] FIG. 10 is a top down view of yet another exemplary bag.

[0071] [Figure 25A-C]FIG. 1 is a diagram of an exemplary manifold.

[0072] [Figure 26] FIG. 10 is a diagram of an exemplary charge receiving set including another exemplary manifold.

[0073] [Figure 27] FIG. 1 is a perspective view of an exemplary filler receiving set.

[0074] [Figure 28] FIG. 1 is a cross-sectional view of an exemplary packing receiving set.

[0075] [Figure 29] FIG. 10 is a cross-sectional view of another exemplary packing receiving set.

[0076] [Figure 30] 1 is a cross-sectional view of a bag of an exemplary filler receiving set being filled with fluid.

[0077] [Figure 31] 1 is a cross-sectional view of an exemplary filler receiving set with a filled bag sealed out of fluid communication with the filler receiving set. FIG.

[0078] [Figure 32] 1 is a cross-sectional view of an exemplary filler receiving set with a bag cut from the filler receiving set.

[0079] [Figure 33] 1 is a cross-sectional view of an exemplary filler receiving set with a bag of the filler receiving set filled with fluid.

[0080] [Figure 34] FIG. 1 is a cross-sectional view of an exemplary packing receiving set.

[0081] [Figure 35]FIG. 1 is a cross-sectional view of an exemplary packing receiving set.

[0082] [Figure 36] FIG. 1 is a schematic diagram of an exemplary packing receiving set.

[0083] [Figure 37] FIG. 10 is a top-down view of an exemplary manifold of an exemplary packing receiving set.

[0084] [Figure 38] 1 is a cross-sectional view of an exemplary manifold of an exemplary packing receiving set.

[0085] [Figure 39A-C] 10A-10C illustrate the progression of valve actuation of an exemplary manifold that may be used to fill bags of an exemplary fill receiving set.

[0086] [Figure 40] FIG. 10 illustrates actuation blocks for the manifold of an exemplary filler receiving set.

[0087] [Figure 41A-F] FIG. 10 illustrates a progression of valve actuations that may be performed to pump fluid from a concentrate supply inlet through an exemplary manifold.

[0088] [Figure 42] FIG. 10 illustrates a volume of fluid being transferred through an exemplary manifold to a bag.

[0089] [Figure 43] FIG. 10 shows a schematic example of another exemplary filler receiving set.

[0090] [Figure 44] FIG. 10 illustrates another schematic example of an exemplary filler receiving set.

[0091] [Figure 45] FIG. 1 illustrates multiple layers of material that may be used to construct a packing receiving set.

[0092] [Figure 46] FIG. 10 shows a packing receiving set access element installed between layers of packing receiving set material.

[0093] [Figure 47] 10A-10C illustrate seals formed between layers of material defining an exemplary packing receiving set.

[0094] [Figure 48] FIG. 1 illustrates an exemplary filler receiving set.

[0095] [Figure 49] FIG. 1 illustrates an exemplary charge receiving set with steam being supplied to a portion of the charge receiving set.

[0096] [Figure 50] FIG. 10 illustrates a bag being filled through an exemplary filler receiving set.

[0097] [Figure 51] FIG. 1 illustrates an exemplary fill receiving set with a first bag of the set filled and disconnected from the set and a second bag of the set filled with fluid.

[0098] [Figure 52] FIG. 1 illustrates an exemplary fill receiving set with the first and second bags of the set filled and disconnected from the set, and the third bag of the set filled with fluid.

[0099] [Figure 53] FIG. 1 is a block diagram of an exemplary filler receiving set production and filling system.

[0100] [Figure 54] 1 is a perspective view of an exemplary system for producing and packaging medical fluids.

[0101] [Figure 55] FIG. 55 is a perspective view of the exemplary system of FIG. 54 with portions of the enclosure shown transparent to reveal various internal components of the system.

[0102] [Figure 56] FIG. 2 is a top-down view of another exemplary system for producing and packaging medical fluids.

[0103] [Figure 57] FIG. 57 is a side view of the exemplary system shown in FIG. 56.

[0104] [Figure 58] FIG. 57 is another side view of the exemplary system shown in FIG. 56.

[0105] [Figure 59] FIG. 1 is a perspective view of an exemplary bag feeder.

[0106] [Figure 60] FIG. 1 is a perspective view of an exemplary bag feeder fully loaded with bags.

[0107] [Figure 61] FIG. 1 is a perspective view of an exemplary bag feeder with the feed plate released from the loading position.

[0108] [Figure 62] FIG. 1 is a perspective view of an exemplary bag feeder with the feed plate of the bag feeder biased against the port of a bag mounted in the bag feeder.

[0109] [Figure 63] FIG. 1 is a bottom front perspective view of an exemplary bag feeder having retention pins that hold bags in place within the bag feeder.

[0110] [Figure 64] FIG. 1 is a bottom-up view of an exemplary bag feeder and an exemplary grasper, the exemplary grasper advancing into the bag feeder to retract a retention pin of the bag feeder and to collect a bag.

[0111] [Figure 65] FIG. 1 is a perspective view of an exemplary bag feeder and an exemplary grasper, the exemplary grasper holding bags collected from the bag feeder.

[0112] [Figure 66] FIG. 1 is a perspective view of an exemplary bag filling station.

[0113] [Figure 67] FIG. 1 is a perspective view of an exemplary bag filling station with an unfilled bag docked at the filling station.

[0114] [Figure 68] FIG. 1 is a perspective view of an exemplary bag filling station with filled bags docked at the filling station.

[0115] [Figure 69] FIG. 1 is a perspective view of an exemplary bag filling station and an exemplary grasper, the exemplary grasper being advanced into the filling station to collect filled bags from the filling station.

[0116] [Figure 70]FIG. 1 is a perspective view of a filling station with an exemplary grasper holding a filled bag and a pivoting drain inlet aligned with the filling nozzle of the filling station.

[0117] [Figure 71A-B] FIG. 10 is a top down view of a portion of a filling station having an energized drain inlet.

[0118] [Figure 72] FIG. 1 is a perspective view of an exemplary sealing station having a stopper dispenser installed therein.

[0119] [Figure 73] FIG. 1 is a perspective view of an exemplary sealing station having an exemplary follower assembly disposed in a retracted position.

[0120] [Fig. 74A-B] FIG. 1 is a perspective view of an exemplary stopper dispenser.

[0121] [Figure 75] FIG. 1 is a perspective view of an exemplary sealing station having an exemplary follower assembly biased into contact with a stopper in an exemplary stopper magazine.

[0122] [Figure 76] FIG. 1 is a perspective view of an exemplary sealing station having an exemplary stopper dispenser installed therein, with the dispenser cover displaced to expose the stopper dispenser exit port.

[0123] [Figure 77A] FIG. 1 is a perspective view of an exemplary sealing station having an exemplary stopper dispenser mounted in a dispenser receptacle of the sealing station.

[0124] [Figure 77B] FIG. 77B is a detailed view of the indicated area of ​​FIG. 77A.

[0125] [Figure 78] FIG. 1 is a perspective view of an exemplary sealing station with an exemplary ram of the sealing station advanced into an exemplary stopper dispenser to force a stopper from the dispenser into a port of a bag in place at the sealing station.

[0126] [Figure 79] FIG. 10 is a perspective view of an exemplary sealing station with an exemplary ram of the sealing station in a retracted position and a stopper advanced via an exemplary follower assembly into alignment with an exit port of an exemplary stopper dispenser.

[0127] [Figure 80] FIG. 1 is a perspective view of an exemplary sealing station and an exemplary grasper, the exemplary grasper collecting a sealed bag from the sealing station.

[0128] [Figure 81A] FIG. 1 is a perspective view of an exemplary stopper dispenser having an exit port with a chamfered port opening.

[0129] [Figure 81B] FIG. 81B is a detailed view of the indicated portion of FIG. 81A.

[0130] [Figure 81C] 81A-81B is a cross-sectional view of an exemplary sealing station with the stopper dispenser of FIGS. 81A-81B installed therein and with the port of the bag partially advanced over a portion of the stopper held in the dispenser.

[0131] [Figure 82A-C] FIG. 10 is a diagram of another exemplary stopper dispenser having an exit port with a chamfered port opening and an exit port detent member.

[0132] [Figure 83] FIG. 10 is a perspective view of another exemplary stopper dispenser with the cover plate of the exemplary stopper dispenser removed.

[0133] [Figure 84] FIG. 1 is a top-down view of an exemplary stopper dispenser being filled with stoppers.

[0134] [Figure 85] FIG. 1 is a top-down view of an exemplary stopper dispenser with the stoppers partially emptied.

[0135] [Figure 86] FIG. 1 is a top-down view of an exemplary stopper dispenser being emptied of stoppers.

[0136] [Figure 87] FIG. 10 is an exploded view of another exemplary stopper dispenser.

[0137] [Figure 88] FIG. 1 is a top-down view of an exemplary stopper dispenser being filled with stoppers.

[0138] [Figure 89] FIG. 1 is a top-down view of an exemplary stopper dispenser with a dispensed stopper aligned with the exit port of the dispenser.

[0139] [Figure 90]FIG. 1 is a top-down view of an exemplary stopper dispenser rotated under the force of a biasing member to advance the stopper into alignment with the exit port of the dispenser.

[0140] [Figure 91] FIG. 1 is a top-down view of an exemplary stopper dispenser in which the stoppers have been partially emptied.

[0141] [Figure 92] FIG. 1 is a top-down view of an exemplary stopper dispenser with a dispensed stopper aligned with the exit port of the dispenser.

[0142] [Figure 93] FIG. 1 is a top-down view of an exemplary stopper dispenser indexed to advance the next available stopper into alignment with the dispenser's exit port under the force of a biasing member.

[0143] [Figure 94] FIG. 10 is an exploded view of another exemplary stopper dispenser.

[0144] [Figure 95] FIG. 1 is a top-down view of an exemplary stopper dispenser with a dispensed stopper aligned with the exit port of the dispenser.

[0145] [Figure 96] FIG. 10 is a top-down view of an exemplary stopper dispenser with the stopper advanced into alignment with the exit port of the dispenser via a biasing force exerted against an exemplary follower block of the dispenser.

[0146] [Figure 97] FIG. 1 is a perspective view of an exemplary stopper dispenser and an exemplary speed loader.

[0147] [Figure 98] FIG. 1 is a perspective view of an exemplary stopper dispenser and an exemplary speed loader.

[0148] [Figure 99] FIG. 1 is a perspective view of an exemplary stopper dispenser filled with stoppers by an exemplary speed loader.

[0149] [Figure 100] FIG. 1 is a perspective view of an exemplary quarantine repository.

[0150] [Figure 101] 1 is a perspective view of an exemplary holder that may be included in a quarantine repository.

[0151] [Figure 102] FIG. 1 is a perspective view of an exemplary quarantine repository filled to capacity with bags.

[0152] [Figure 103] FIG. 1 is a perspective view of an exemplary sampling fixture with a vial mounted therein.

[0153] [Figure 104] FIG. 1 is a perspective view of an exemplary vial access door and an exemplary sampling fixture with a vial installed therein.

[0154] [Figure 105] FIG. 1 is a side view of an exemplary labeling assembly and a bag being displaced into the labeling assembly by a robotic grasper.

[0155] [Figure 106] FIG. 1 is a side view of an exemplary labeling assembly in the process of a bag being labeled.

[0156] [Figure 107] FIG. 1 is a side view of an exemplary labeling assembly with a grasper holding a labeled bag in the labeling assembly.

[0157] [Figure 108] FIG. 10 is a perspective view of an exemplary output chute that may be included in the system.

[0158] [Figure 109] FIG. 1 is a perspective view of a bag being placed in an exemplary output chute.

[0159] [Figure 110] FIG. 1 is a perspective view of a bag exiting an exemplary output chute.

[0160] [Figure 111] FIG. 1 is a perspective view of another exemplary system for producing and packaging medical fluids.

[0161] [Figure 112] 112 is another perspective view of the system for producing and packaging medical fluids of FIG. 111, with a portion of the system's enclosure shown transparent.

[0162] [Figure 113] FIG. 1 is a front view of an exemplary packaging assembly.

[0163] [Fig. 114A-B] FIG. 1 is a top-down view of an exemplary bag retainer.

[0164] [Figure 115] FIG. 1 is a front view of an exemplary packaging assembly with graspers gripping a bag docked in an exemplary bag retainer of the packaging assembly.

[0165] [Figure 116] FIG. 1 is a front view of an exemplary packaging assembly with a grasper holding a bag that has been released from an exemplary bag retainer of the packaging assembly.

[0166] [Figure 117] A front view of an exemplary packaging assembly with an exemplary robotic manipulator advancing a bag held by the robotic manipulator's grasper into alignment with an exemplary filling nozzle of the packaging assembly.

[0167] [Figure 118A] FIG. 1 is a front view of an exemplary packaging assembly with an exemplary filling nozzle of the packing assembly in a port of the bag.

[0168] [Figure 118B] FIG. 1 is an exploded view of an exemplary fill nozzle and biasing assembly.

[0169] [Figure 119] FIG. 1 is a front view of an exemplary packaging assembly with a filled bag held by an exemplary grasper of an exemplary robotic manipulator of the packaging assembly.

[0170] [Figure 120] FIG. 1 is a front view of an exemplary packaging assembly with a filled bag displaced into an exemplary sealing station of the packaging assembly.

[0171] [Figure 121] FIG. 1 is a front view of an exemplary packaging assembly with a filled bag displaced into an exemplary sealing station of the packaging assembly.

[0172] [Figure 122] A front view of an exemplary packaging assembly with a filled bag displaced to insert the bag's port into an exemplary support cradle of an exemplary sealing station of the packaging assembly.

[0173] [Figure 123] FIG. 1 is a perspective view of an exemplary support cradle.

[0174] [Figure 124] FIG. 10 is a front view of an exemplary packaging assembly with an exemplary ram of an exemplary sealing station actuated to push a stopper into a port of a bag disposed in an exemplary support cradle of the packaging assembly.

[0175] [Figure 125] FIG. 1 is a front view of an exemplary packaging assembly with a filled and sealed bag held by an exemplary grasper of an exemplary robotic manipulator of the packaging assembly.

[0176] [Figure 126] FIG. 1 is a front view of an exemplary packaging assembly with a directing chute.

[0177] [Figure 127] FIG. 1 is a perspective view of an exemplary carrier that can contain packets that each hold at least one bag and an administration set.

[0178] [Figure 128] FIG. 1 is a perspective view of an exemplary carrier with an exemplary packet removed from a compartment of the carrier.

[0179] [Figure 129]FIG. 1 is a perspective view of an exemplary carrier with an exemplary packet removed from a compartment of the carrier, the packet having its cover flap open.

[0180] [Figure 130] FIG. 1 is a perspective view of an exemplary carrier with an exemplary bag and an exemplary administration set removed from the packet.

[0181] [Figure 131] 1 is a perspective view of a number of exemplary packets that may be placed in a compartment of a carrier.

[0182] [Figure 132] FIG. 1 is a perspective view of a spiking adapter that may be included with the carrier.

[0183] [Figure 133A] FIG. 2 is a block diagram of an exemplary filling station.

[0184] [Figure 133B] FIG. 2 is a block diagram of another exemplary filling station.

[0185] [Figure 134] FIG. 1 is a perspective view of an exemplary filling station.

[0186] [Figure 135] FIG. 2 is another perspective view of an exemplary filling station.

[0187] [Figure 136] FIG. 2 is another perspective view of an exemplary filling station.

[0188] [Figure 137] FIG. 1 is a top-down view of an exemplary spike port that may be included within a filling station.

[0189] [Figure 138]FIG. 1 is a block diagram of an exemplary fluid circuit that may be included in an exemplary system for producing and packaging medical fluids.

[0190] [Figure 139] 1 is a flowchart detailing several exemplary actions that may be performed to generate a desired fluid.

[0191] [Figure 140] FIG. 1 illustrates a portion of an exemplary mixing circuit including an exemplary crystal component dispenser.

[0192] [Figure 141] FIG. 1 illustrates a dosing manifold that may be included in an exemplary mixing circuit.

[0193] [Figure 142] FIG. 1 is a perspective view of an exemplary crystal component dispenser.

[0194] [Figure 143] 143 illustrates the exemplary crystal component dispenser of FIG. 142 with portions removed to show the internal components of the crystal component dispenser.

[0195] [Figure 144] FIG. 1 is a perspective view of an exemplary crystal component dispenser.

[0196] [Figure 145] 145 illustrates the exemplary crystal component dispenser of FIG. 144 with portions removed to show the internal components of the crystal component dispenser.

[0197] [Figure 146] FIG. 1 is a perspective view of an exemplary paddle wheel that may be included in an exemplary crystal component dispenser.

[0198] [Figure 147] FIG. 1 is a perspective view of an exemplary crystal component dispenser.

[0199] [Figure 148] 148 illustrates the exemplary crystal component dispenser of FIG. 147 with portions removed to show the internal components of the crystal component dispenser.

[0200] [Figure 149] FIG. 1 is a side view of an exemplary dispensing assembly that may be included in an exemplary crystal component dispenser.

[0201] [Figure 150] FIG. 149 is a cross-sectional view of the exemplary dispensing assembly of FIG.

[0202] [Figure 151] 1 is a perspective view of an exemplary dispensing disk that may be included in an exemplary dispensing assembly of an exemplary crystal component dispenser.

[0203] [Figure 152A] FIG. 1 is a perspective view of an exemplary dispensing assembly that may be included in an exemplary crystal component dispenser.

[0204] [Figure 152B] FIG. 152B is an exploded view of the exemplary dispensing assembly shown in FIG. 152A.

[0205] [Figure 153A] FIG. 10 is a front view of another exemplary crystal component dispenser.

[0206] [Figure 153B] 153B is a perspective view of the exemplary crystal component dispenser of FIG. 153A with certain components removed.

[0207]

[0208] [Fig. 154] FIG. 1 is a perspective view of an exemplary port of a dosing manifold with an exemplary outlet portion docked thereon that may be included in a crystal component dispenser.

[0209] [Figure 155] FIG. 155 is a cross-sectional view of the exemplary port and exemplary outlet shown in FIG. 154.

[0210] [Figure 156] FIG. 10 is a side view of another exemplary dispensing assembly that may be included in the crystal component dispenser.

[0211] [Figure 157] FIG. 1 is a side view of an exemplary dispensing assembly that may be included in a crystal component dispenser.

[0212] [Figure 158] FIG. 1 is a side view of an exemplary dispensing assembly that may be included in a crystal component dispenser.

[0213] [Figure 159] FIG. 1 is a perspective view of an exemplary tube welding assembly.

[0214] [Figure 160] FIG. 2 is another perspective view of an exemplary tube welding assembly.

[0215] [Figure 161] FIG. 1 is a perspective view of an exemplary conduit dispenser that may be included in a tube welding assembly.

[0216] [Figure 162] FIG. 1 is an exploded view of an exemplary conduit dispenser.

[0217] [Figure 163]FIG. 1 is an exploded view of an exemplary conduit feed assembly that may be included in a tube welding assembly.

[0218] [Fig. 164] FIG. 1 is a perspective view of components of an exemplary tube welding assembly.

[0219] [Figure 165] FIG. 1 is a perspective view of components of an exemplary tube welding assembly.

[0220] [Figure 166] FIG. 1 is a perspective view of an exemplary occluder assembly that may be included within an exemplary tube welding assembly.

[0221] [Figure 167] FIG. 1 is a top-down view of an exemplary occluder assembly that may be included within an exemplary tube welding assembly.

[0222] [Figure 168] FIG. 1 is a perspective view of an exemplary occluder assembly that may be included within an exemplary tube welding assembly.

[0223] [Figure 169] FIG. 1 is a perspective view of an exemplary cutter assembly that may be included in an exemplary tube welding assembly.

[0224] [Figure 170] FIG. 1 is a cross-sectional view of a piece of tubing being occluded by an exemplary occluder assembly and an exemplary cutter assembly.

[0225] [Figure 171] FIG. 1 is a perspective view of components of an exemplary tube welding assembly.

[0226] [Fig. 172]FIG. 1 is a perspective view of an exemplary bag sealing assembly that may be included in a tube welding assembly.

[0227] [Figure 173] FIG. 1 is an exploded view of an exemplary jaw of an exemplary bag sealing assembly.

[0228] [Fig. 174] FIG. 1 is a front view of an exemplary bag having a fill port in which a sample aliquot is isolated by a bag sealing assembly.

[0229] [Figure 175] FIG. 1 is a front view of an exemplary bag with a sample aliquot sealed within the fill port of the bag. DETAILED DESCRIPTION OF THE INVENTION

[0230] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure, taken in conjunction with the drawings.

[0231] Referring now to FIG. 1, a system 10 for producing and packaging medical fluids is shown. The system 10 includes an enclosure 12. The enclosure 12 can be a clean room of any appropriate certification level. Alternatively, the enclosure 12 can be a housing that can be installed inside a clean room. In such an embodiment, the enclosure 12 or a compartment thereof can be constructed to meet a higher certification level than the surrounding environment. Additionally, there can be compartments within the enclosure 12 that meet different clean room level standards.

[0232] Within the enclosure 12, multiple system 10 components may be housed. For example, a medical water production device 14 may be included within the enclosure 12 of the system 10. The medical water production device 14 may be or include any suitable water production device, such as a filtration device (charcoal, ultrafilter, endotoxin removal filter, reverse osmosis, microfilter, depth filter, etc.), a distillation device, a degassing device (which may also serve as a distillation device), a UV light source, a chemical treatment device, an exchange resin, an electrodeionization unit, etc., or a combination thereof. In certain embodiments, the medical water production device 14 may be a distillation device such as that described in U.S. Patent No. 9,308,467 (Attorney Docket No. K97), entitled "Water Vapor Distillation Apparatus, Method, and System," issued April 12, 2016, which is incorporated herein by reference in its entirety. Alternatively, the medical water production device 14 can be a distillation device such as that described in Application No. 16 / 370,038 (Attorney Docket No. Z37), entitled "Water Distillation Apparatus, Method, and System," filed March 29, 2019, which is incorporated herein by reference in its entirety. The medical water production device 14 can generate water that meets various official specifications or adheres to some non-official specification. The medical water production device 14 can produce, for example, USP (or another pharmacopoeia) water for injection (WFI), high-purity water, low-pyrogenic water, etc.

[0233] In alternative embodiments, the medical water production device 14 may not be contained within the enclosure 12. Instead, the medical water production device 14 may be in a separate enclosure within a clean room, or in some embodiments, may be located in a non-clean room environment or in a less certified clean room environment than the rest of the system 10. The output of the medical water production device 14 may be plumbed from an outlet of the medical water production device 14 to the rest of the system 10. The medical water production device 14 may receive input water from any suitable source 16. In some examples, the source 16 can be a municipal water supply line. In alternative embodiments, the source 16 can be a reservoir of pre-treated (e.g., via filtration, UV, softening) water from which the medical water production device 14 draws. In some embodiments, the source 16 can be a large container or bladder. If the system 10 produces an official fluid, the source 16 can meet any requirements specified regarding acceptable sources that can be used to generate official fluids. For example, the source can be EPA-acceptable drinking water.

[0234] When the medical water production device 14 generates purified water, the water may be subjected to various quality tests before being output to the outlet line 18. If any of the output water fails a quality test, the output water may be diverted to waste or recycled to the input of the medical water production device 14 for further purification. The output line 18 of the system 10 may be connected to a manifold 20. The manifold 20 may include fluid channels and one or more valves or actuators that selectively split or direct the purified water input flow into multiple separate outlet fluid channels. In some embodiments, the manifold 20 may lack valves and instead passively bifurcate the incoming purified water. The manifold 20 may include multiple couplings. These couplings may be connected to the manifold interface element 22 of the fill receiving set 24. The fill receiving set 24 may include at least one IV bag 26 and an administration set 28. In some embodiments, the manifold interface element 22 can be a Luer fitting. In alternative embodiments, the manifold interface element 22 can be a quick connect fitting. In some embodiments, the administration set 28 can be coupled to or fixedly attached to the manifold 20, which can include port protrusions extending from the manifold 20. The manifold 20 can also include a barbed fitting, and the administration set 28 tubing is secured via the barbed fitting.

[0235] In the exemplary embodiment shown in FIG. 1 , the filler receiving set 24 includes multiple IV bags 26 and administration sets 28. In such an embodiment, multiple IV bags 26 and administration sets 28 may be bundled together in a bundle or package 30, which facilitates their installation into the system 10. In some embodiments, the package 30 may act as a dispenser, allowing, for example, the top bag 26 and administration set 28 to be collected by a robotic grasper of the system 10. Each filler receiving set 24 may include up to 50-100 or more bag 26-administration set 28 pairs (although 1-50 pairs or greater than 100 pairs are also possible). The administration set 28 length may be selected to be clinically useful but not so long as to present excessive impedance problems when filling a bag 26 when filled through its attached administration set 28. In some embodiments, administration set 28 can be approximately 0.75 to 2.5 meters (e.g., 1 meter). Manifold interface element 22 can be a connector that can interface with coupling elements on an accessory tubing set, similar to manifold 20. Such an accessory tubing set can include extension lines, multi-way connectors (e.g., Y-sets, V-sets, and T-sets), or potentially various access ports.

[0236] As purified water is produced by the medical water producing device 14, the water can be routed through the manifold 20 to each IV bag 26 of the fill receiving set 24. Each IV bag 26 can be filled to capacity (or a desired volume, a preset volume, or a predetermined amount below capacity) and then removed from the system 10. The administration set 28 attached to each bag 26 can be left primed by the system 10 (e.g., if the bag 26 is being filled through the administration set 28). In certain embodiments, the manifold interface element 22 can be disconnected from the manifold 20 and capped by the system 10 via a multi-axis robotic manipulator. In some embodiments, a clamp can be applied to the administration set 28 or displaced into an operative position on the set 28 prior to or during the disconnection operation. Alternatively, a seal can be generated in the administration set 28 tubing or other fill conduit, and the tubing can be disconnected from the manifold 20. The seal may be created via heat, dielectric or RF welding, or any other suitable process. In such an embodiment, the administration set 28 may include a branch upstream of the seal location to allow access to the contents within the bag 26. In an alternative embodiment, the user may manually separate the bag 26 and administration set 28 from the remainder of the fill receiving set 24.

[0237] The system 10 may also include a control system 15 including one or more controllers. The control system 15 may manage the operation of the manifold actuators or valves, the medical water production device 14, any robotic graspers and manipulators, and may use sensor data to fill the bag 26 to its desired volume. Controllers that may be used in the control system 15 may include microprocessors, FPGAs, PLCs, etc. The control system 15 may be in data communication (wired or wireless) with the various sensors, manipulators, and other hardware of the system 10.

[0238] Referring now to FIG. 2A, in some embodiments, the system 10 can be configured to produce a bag 26 containing various types of solutions. The solutions can be colloidal or crystalloid solutions. The solutions produced can be isotonic, hypotonic, or hypertonic with respect to physiological norms. For example, the solutions can include various salt solutions, such as normal saline, semi-normal saline, or any other concentration of saline. The solutions can also include Ringer's solution, Hartmann's solution, sugar solutions (e.g., D5W), sugar saline solutions (e.g., D5NS, 2 / 3 D5W, and 1 / 3 NS), gelofusine, dextran, hetastarch, albumin, ionosterol, sterofundin ISO, plasma-lyte, etc. In such embodiments, the system 10 can include a receiver for one or more bulk cartridges or reservoirs 40, 42 of concentrate or crystalline precursor. These bulk cartridges 40, 42 may be in communication with fluid lines leading to pumps 38, 36. The pumps 38, 36 may meter a specific volume of concentrate into the output of the medical water producing device 14.

[0239] Additionally, the output stream of the medical water production device 14 may be monitored for the amount of fluid being pumped by the pump 46 and mixed with any concentrate introduced from the bulk reservoirs 40, 42. In some examples, an accumulator or storage volume (not shown) may be included to maintain a supply of medical-grade water so that, if commanded, solution may be produced at a rate faster than the output rate of the medical water production device 14. This accumulator volume may be maintained within the medical water production device 14 in certain embodiments.

[0240] A mixing volume 34 may be included in the system 10 to ensure any concentrate and water are uniformly mixed before proceeding to the fill receiving set 24. The mixing volume 34 may have an interior that includes various baffles or obstacles that disrupt the incoming flow and promote mixing of the fluids within the mixing volume 34. The mixing volume 34 may also include a stretch of tubing that can present a long and / or tortuous path that promotes uniform mixing. A check valve 32 may also be included on the output line 18 from the medical water production device 14 to prevent any backflow of the mixed solution into the medical water production device 14. Control of the various valves 36, 38, 46 and pumps of the system 10 may be directed via the control system 15.

[0241] In some embodiments, and as shown in FIG. 2B , the medical water production device 14 can have an output that can communicate with bulk cartridges 40, 42 containing the concentrate in crystalline form. The output of the medical water production device 14 can pass through the bulk cartridges 40, 42 and exit as a saturated or nearly saturated solution. A pump 45 can be provided to assist in delivering the output stream of the medical water production device 14 through the bulk cartridges 40, 42. The fluid exiting the bulk cartridges 40, 42 can undergo compositional monitoring (e.g., conductivity sensing, temperature sensing, polarization sensing, etc.), which can inform the control system 15 of the determined downstream mixing ratio achieved by the pumps 38, 36.

[0242] Referring now to FIG. 3, a system 10 for producing and packaging medical fluids is shown. The system 10 is configured to fill individual bags 26, as opposed to filling through a fill receiving set 24. When the medical water production device 14 of FIG. 3 generates purified water, the water may undergo various quality tests before being output to an outlet line 18. The output line 18 of the system 10 may be connected to a filling nozzle or dispenser 1420. The dispenser 1420 may include a tapered outlet portion that may be introduced into an inlet portion of the bag 26 or other destination container. Alternatively, the dispenser 1420 may include a fitting (e.g., a luer lock, a quick connect, etc.) that mates with a fitting on the destination container.

[0243] In the exemplary embodiment shown in FIG. 3 , the system 10 includes a plurality of IV bags 26 that may be contained within a bag feeder 128. In such an embodiment, the plurality of IV bags 26 may be contained within a cartridge or dispenser (e.g., magazine 1430) that facilitates their installation into the system 10. In some embodiments, the magazine 1430 may act as a dispenser, allowing, for example, the frontmost bag 26 to be collected by the robotic manipulator 1422 of the system 10. Any suitable robotic manipulator 1422 may be included, for example, one or more multi-axis robotic arms. Each magazine 1430 may hold, for example, 10 to 50 bags 26, although magazines 1430 having a capacity for a greater or lesser number of bags 26 may also be used.

[0244] In some embodiments, the bags 26 may be provided in an overpack 60, which in certain embodiments may be a sealed bag, pouch, or blister pack. The overpack 60 may be cleaned (e.g., with 70% isopropyl alcohol or another suitable agent) and introduced into the enclosure 12. Individual bags 26 may then be manually or automatedly extracted from the overpack 60 (via a robotic manipulator 1422) and placed into a magazine 1430 included in the system 10. One or more pre-loaded magazines 1430 full of bags 26 may also be provided in the overpack 60. The pre-loaded magazines 1430 may be removed from the overpack 60 and placed into the bag feeder 128 as needed.

[0245] In some embodiments, various protective caps or films may be included over some components of bag 26. For example, films or caps may be included over ports of bag 26. This can facilitate the establishment of a sterile connection if manipulation of bag 26 after removal from overpack 60 is required to install bag 26 into system 10. The caps or films may be removed immediately prior to connection or installation into system 10. Alternatively, the films or caps may be perforated during filling.

[0246] As purified water is produced by the medical water production device 14, the water may be output by the dispenser 1420 into each IV bag 26. A robotic manipulator 1422 can collect the bags 26 from the bag feeder 128 and displace them to the dispenser 1420 for filling. Each IV bag 26 is filled to capacity or some other desired volume and then removed from the system 10 or placed in a quarantine section 1424 while various tests are completed on the fluid output from the dispenser 1420. In some embodiments, a seal may be created in the fill conduit leading to the bag 26. This seal may be created via heat, dielectric or RF welding, installation of a stopper or other sealing member, or any other suitable process.

[0247] Referring now to FIG. 4A, another system 10 for producing and packaging medical fluids is shown. As described with respect to FIG. 3, the system 10 is configured to fill individual bags 26, as opposed to filling through a filler receiving set 24. The exemplary system 10 of FIG. 4A is configured to produce bags 26 with various types of solutions. The system 10 of FIG. 4A includes the components described with respect to FIG. 2A to achieve a mixing operation to generate the solutions. FIG. 4B shows another system 10 for producing and packaging medical fluids configured to fill individual bags 26. This system 10 includes the components described above with respect to FIG. 2B to generate various types of solutions for filling the bags 26.

[0248] In other embodiments, and now referring to FIGS. 5A and 5B , the bulk reservoirs 40, 42 may not be used. Instead, the bags 26 can enclose an appropriate amount of concentrate (shown as a stippled pattern within each bag 26). This concentrate can be pre-packaged within the bags 26. When fluid from the medical water producing device 14 flows into the bags 26, the amount of concentrate can be sufficient to generate the desired final solution concentration. The concentrate, in some embodiments, can be provided in liquid form. In alternative embodiments, the concentrate can be a powder or lyophilized drug. In yet other embodiments, the concentrate can be contained within an ampule or similar structure provided within each bag 26. If an ampule is used, the ampule can be breakable or frangible to allow access to the material contained within the ampule. The ampule, in some embodiments, can be mechanically breakable by the system 10 or can be shattered by ultrasound waves generated by the system 10. When possible, lighter and / or less bulky concentrate forms can be used. For example, instead of a saturated solution, a crystalline solid can be used, although both are possible.

[0249] Referring now to FIG. 6 , in certain embodiments, bag 26 can be a multi-chamber bag 26. One chamber 50 can be empty and can be adjacent to at least one concentrate chamber 54 containing a liquid concentrate, lyophilized concentrate, crystalline concentrate, or other powdered concentrate (shown as a stippled pattern within chamber 54). Chambers 50, 54 can be separated from communication with one another via one or more seals 52. Seal 52 can be interruptible by a user or machine. For example, seal 52 can include a frangible, or seal 52 can be peelable. Depending on the embodiment, seal 52 between chamber 50 and chamber 54 can be broken by a user or by system 10 during production of bag 26. In some instances, seal 52 can be maintained after production of bag 26 until closer in time to use of bag 26. This can be done, for example, if the mixed solution has a relatively short shelf life. If the seal 52 is broken by a component of the system 10, the seal 54 may be broken before or after filling the bag 26 with water from the medical water production device 14. The system 10 may include a shaker, vibrator, mechanical agitator, or other component to assist in mixing any water and concentrate introduced into the bag 26. In some embodiments, the entry port to the bag 26 may include structure that encourages the water entering the bag 26 to swirl or turbulently mix any concentrate contained therein. If the seal is peelable, this may be achieved by altering the process characteristics during seal formation. For example, lower heat, power, welding time, etc. may be used to create a peelable seal than those used to form the peripheral seal of the bag 26. In certain examples, the system 10 may include a set of rollers or similar pressure applicators that may act on the bag 26 to break any peelable seals.

[0250] If the bag 26 contains some form of concentrate, the bag 26 may be coded to be easily identifiable by humans, machines, or both. The bag 26 may be color-coded, for example (color A = saline, color B = Ringer's solution, color C = sugar solution, etc.). The color-coding need not be applied to the entire bag 26. The seams of the bag 26 may be color-coded, or the bag 26 may include color-coded stripes, blocks, or zones. The location of the color-coding or the shape of the color-coded zones may also vary throughout the bag 26. The bag 26 may also include machine-readable indicia, such as a bar code, data matrix, radio frequency interrogable tag, etc. In some embodiments, the bag 26 may also be color-coded by volume or by various set characteristics. For example, administration sets 28 that have burets, injection ports, etc. may have different color coding than those that do not.

[0251] In some embodiments, bags 26 may be differentiated based on human- or machine-observable characteristics other than color. For example, in some embodiments, bags 26 or portions thereof may additionally or instead have different geometric shapes (e.g., elongated, square, cylindrical, etc.). Any shape having a round or polygonal cross-section may be used. Also, the locations of compartments within bags 26 may differ in a visually distinguishable manner, and the compartment locations may depend on the concentrate held therein. For example, a first concentrate may be located in a corner compartment or bag 26. The seal defining such a compartment may run from a side of bag 26 and extend to another side of bag 26 at a substantially perpendicular angle thereto. A second concentrate may be stored in compartment 54, which runs along the side of bag 26 defined by seal 52 extending the length or width of bag 26 parallel to the edge of bag 26 (see, e.g., FIG. 6 ). Any bag 26 of the type described in U.S. Application No. 16 / 384,082 (Attorney Docket No. Z55), entitled "Medical Treatment System and Methods Using a Plurality of Fluid Line," filed April 15, 2019, which is incorporated herein by reference in its entirety, may be used.

[0252] Referring now to FIG. 7 , an exemplary bag 26 is shown. The bag 26 may be filled with any of the fluids described herein by any of the systems 10 described herein. Any of a wide variety of medical fluids may be contained within the bag 26. While the exemplary bag 26 may be used in any of a variety of scenarios, the bag 26 shown in FIG. 7 includes features that may make it well-suited for applications in which the fluid contained within the bag 26 is mixed and packaged on-site or near the intended point of use. For example, the bag 26 may be filled by the system 10 within a hospital, clinic, dialysis clinic, surgery center, or other medical service facility where the solution will be used. Alternatively, the bag 26 may be filled by the system 10 within a military field hospital or at the site of a disaster relief operation. The exemplary bag 26 includes features that may allow an aliquot of fluid to be isolated therein from a predetermined volume of fluid filled into the bag 26 for delivery to a patient. This aliquot may be generated from or representative of the fluid filled into the bag 26. Such bags 26 may be used in embodiments in which the system 10 individually fills the bags 26. Alternatively, such bags 26 may be included in the fill receiving set 24.

[0253] Because the aliquot associated with a bag 26 is isolated from all other fluids filled into the bag 26, the aliquot can be accessed individually without also accessing the main volume, which may be filled with fluid intended for administration to a patient. This can allow a sample of fluid that is compositionally representative of the fluid in the main volume to be extracted from the isolated aliquot for testing. The main volume of fluid filled into the bag 26 can remain undisturbed by the sampling performed on the aliquot. Thus, the aliquot can allow sampling of the fluid in the bag 26 without the entire bag 26 having to be damaged or discarded. As a result, it may be possible to test each bag 26 before the bag 26 is removed for use. Additionally, this can allow certain tests that are difficult or impossible to perform when the bag 26 is being filled to be performed after the bag 26 is filled. For example, tests requiring an incubation or waiting period can be performed on the fluid sampled from the aliquot isolated in the bag 26. After filling, the bag 26 can be held in a quarantine area until the testing is completed. Once the test indicates that the fluid in the bag 26 meets the predefined pass criteria, the bag 26 may be released for use.

[0254] As shown in FIG. 7 , the exemplary bag 26 includes two ports 392. These ports 392 may be sealed into a peripheral seal 1200 that defines the interior volume of the bag 26. The ports 392 may provide fluid communication into and out of the bag 26 for filling and delivery of the fluid therein. One may be, for example, a fill access that is sealed after filling. The other may be a delivery port that may be spiked to access the fluid in the bag 26 when it is needed for delivery to a patient. If the bag 26 is included as part of a fill receiving set 24, the fill port 392 may be connected to the manifold 20.

[0255] As shown, the bag 26 includes a partial barrier wall 1202. The partial barrier wall 1202 may substantially separate a portion 1203 of the interior volume of the bag 26 from a remainder of the interior volume, or main volume 1205, of the bag 26. However, the partial barrier wall 1202 may be interrupted by at least one gap or interruption region 1204. The gap region 1204 may provide a fluid path between the separated portion 1203 of the bag 26 and the remainder of the interior volume 1205 of the bag 26. When the bag 26 is filled, both the main volume 1205 and the separated portion 1203 of the bag 26 are capable of receiving fluid. Because the gap region 1204 maintains the separated portion 1203 in fluid communication with the main volume 1205, the fluid filled into the separated portion 1203 and the main volume 1205 should be compositionally the same.

[0256] 8, once the bag 26 is filled, a seal may be created in any gap region 1204 that eliminates the partial barrier wall 1202. This may result in a complete barrier wall 1206 that completely isolates the main volume 1205 of the bag 26 from the compartmented portion 1203. This may be accomplished by heat-sealing (or otherwise sealing) the bag 26 material together in at least one gap region 1204. Thus, an aliquot of fluid may be separated from the main volume 1205 of the bag 26. Because this aliquot is generated from the same initial internal volume of the bag 26 as the main volume 1205, the aliquot may be referred to as an internal aliquot.

[0257] The partial barrier wall 1202 may be generated within the bag 26 such that when the bag 26 is filled and at least one interruption or gap region 1204 is sealed, the internal aliquot has a desired nominal volume of fluid contained therein. Similarly, the partial barrier wall 1202 may be arranged such that when the bag 26 is filled and the gap region 1204 is sealed, the main volume 1205 within the bag 26 has a nominal volumetric volume. The internal aliquot may be sized to contain a predetermined volume of fluid sufficient for any intended sampling.

[0258] As shown in FIG. 8, the completed barrier wall 1206 can be positioned and shaped to encourage the fluid contained within the main volume 1205 of the bag 26 to be directed toward the port 392 when the fluid in the bag 26 is delivered. In the example, the segmented portion 1203 of the bag 26 is positioned at a corner of the bag 26, on the side of the bag 26 proximate the port 392. The completed barrier wall 1206 includes a sloped segment 1208 that slopes toward the port 392. Thus, when the bag 26 is suspended (e.g., for gravity-feed-based delivery), fluid can be inhibited from becoming trapped or pocketed along the area of ​​the complete barrier wall 1206. This can help ensure that all of the fluid loaded into the main volume 1205 of the bag 26 can be delivered without requiring user intervention to reposition the bag 26. In other embodiments, the completed barrier wall 1206 can include rounded features that help direct the fluid toward the port 392. In alternative embodiments, the internal aliquot can be generated on the side of the bag 26 opposite that containing the port 392 or at a corner of the bag 26 distal to that adjacent the port 392.

[0259] 9 , a flowchart 1240 is shown illustrating several exemplary actions that may be performed to package a fluid in a bag 26. At block 1242, a fill nozzle may be introduced into a port 392 of the bag 26. Fluid may be delivered into the interior volume of the bag 26 through the fill nozzle at block 1244. The bag 26 may be filled until a desired volume of fluid has been transferred into the interior of the bag 26. At block 1246, the nozzle may be removed from the port 392, and the port 392 may be sealed. If the bag 26 is included as part of the fill receiving set 24, a nozzle may not be used. Instead, the port 392 of the bag 26 may receive fluid from the manifold 20. When the desired amount has been filled into the bag 26, the port 392 may be sealed, and the bag 26 may be dispensed from the manifold as described elsewhere herein.

[0260] At block 1248, a seal may be generated in the bag 26. This seal may create an internal aliquot in an internal volume of the bag 26 that is isolated from the main volume of the bag 26. At block 1250, a sample of fluid from the internal aliquot may be collected and tested. If the bag 26 is included as part of the fill receiving set 24, a nozzle may not be used. Instead, the port 392 of the bag 26 may be filled through the manifold 20. When the desired amount has been filled into the bag 26, the port 392 may be sealed, and the bag 26 may be dispensed from the manifold as described elsewhere herein.

[0261] 10 , another exemplary bag 26 is shown. As shown, the bag 26 includes two ports 392. These ports 392 may be sealed into a peripheral seal 1200 that defines the interior volume of the bag 26. In the exemplary embodiment, the peripheral seal 1200 includes an enlarged section 1210 where the ports 392 are coupled into the bag 26. The enlarged section 1210 may have a width greater than the remainder of the peripheral seal 1200 and may have one or more features defined therein. These features may be defined by leaving selected areas open or unsealed when the enlarged section 1210 of the perimeter seal 1200 is formed.

[0262] In an exemplary embodiment, the ports 392 do not have to extend through the enlarged section 1210. As shown, the ports 392 extend partially into the enlarged section 1210 and are aligned with the channels 1212. The channels 1212 can be unsealed areas defined during the formation of the enlarged portion 1210 of the peripheral seal 1200. The channels 1212 can extend from the terminal ends of the ports 392 into the interior volume of the bag 26. Thus, the ports 392, in combination with their respective channels 1212, can provide fluid communication into and out of the bag 26 for filling and delivery of fluid therein. One pair can be, for example, a fill access that is sealed after filling and receives fluid from the fill nozzle 1420 or the manifold 20. The other can be a delivery channel that can be spiked, for example, to access the fluid in the bag 26 when it is needed for delivery to a patient.

[0263] As shown, one of the channels 1212 includes a branch 1214. The branch 1214 can extend to a sampling reservoir 1216, which is contained within the enlarged portion 1210 of the peripheral seal 1200. The sampling reservoir 1216 and the branch 1214 can again be defined as open areas during the formation of the enlarged portion 1210 of the peripheral seal. When the bag 26 is filled, the branch 1214 and the sampling reservoir 1216 can be in communication with the interior volume of the bag 26. Thus, when the bag 26 is filled, the fluids in the sampling reservoir 1216 and the interior volume of the bag 26 can be in communication and should be compositionally similar. When the bag 26 is full, and now referring to FIG. 11 , the sampling reservoir 1216 can be isolated from the interior volume of the bag 26. In certain instances, this may be accomplished by heat sealing (or otherwise sealing) branch 1214, or a portion thereof, so that an internal aliquot of fluid may be separated within bag 26, as described above.

[0264] 12 , another exemplary bag 26 is shown. As shown, the bag 26 includes three ports 392. These ports 392 may be sealed into a peripheral seal 1200 of the bag 26. The bag 26 may also include an internal seal 1220. The internal seal 1220 may cooperate with the peripheral seal 1200 to define a first internal compartment 1222 and a second internal compartment 1224. The compartments 1222, 1224 may have different volume capacities. The internal seal 1220 may extend between two of the ports 392, such that one of the compartments 1222, 1224 is accessible through a single port 392 and the other of the compartments 1222, 1224 is accessible through the remaining two ports 392. The compartment 1222, 1224 accessible through only one port 392 can be, but is not necessarily, the smaller of the compartments 1222, 1224. In an exemplary embodiment, the second compartment 1224 can have a smaller capacity than the first compartment 1222.

[0265] The smaller volume compartment 1224 can be filled through port 392 . The port 392 leading to the smaller compartment 1224 can then be sealed. The smaller compartment 1224 can then be filled to contain a segregated sample aliquot from which various tests can be performed. The larger compartment 1222 can contain a medical fluid preparation intended for delivery to a patient. The larger compartment 1222 can be filled through one of the ports 392, which is then sealed. The other port 392, which communicates with the larger compartment 1222, can be used for fluid delivery. Because the sampling aliquot in the smaller compartment is filled into a compartment that is fluidically isolated from the fluid to be delivered to the patient, that aliquot can be referred to as the external aliquot. Both compartments 1222, 1224 can be filled simultaneously from a branching fill line. The fluid in the external aliquot should therefore be compositionally representative of the fluid in the larger compartment 1222.

[0266] Internal seal 1220 may be positioned and shaped to inhibit fluid contained in larger compartment 1222 of bag 26 from pocketing away from port 392 when the fluid in larger compartment 1222 is administered via gravity feed. In an example, internal seal 1220 is a vertical seal that extends along the length of bag 26 in a direction substantially parallel to the axis of port 392. In an alternative embodiment, internal seal 1220 may include an angled portion similar to that shown in FIG. 8 . Also, rounded contours that assist in directing fluid toward port 392 may be used in other embodiments.

[0267] In a particular example, and referring primarily now to FIG. 13 , the internal seal 1220 can be constructed with perforations 1221 therein. The perforations 1221 can extend along the entire length of the internal seal 1220, all for the purpose of separating the outer aliquot filled into the bag 26 from the bag 26 after filling. In bags 26 with perforations present, each compartment 1222, 1224 of the bag 26 can include a corresponding (e.g., matching) unique identifier, which can be machine- and / or human-readable. Any suitable identifier can be used, such as, for example, any of those described herein. This can allow any tests performed on the outer aliquot separated from the bag 26 to be associated with the remaining (but now separate) portion of the bag 26. The perforations 1221, which allow the isolated aliquot to be separated from the bag 26, can be included in other bag 26 embodiments. 7 and 8 can include perforations 1221. Additionally, the seal generated when gap region 1204 in partial barrier wall 1202 is filled to generate complete barrier wall 1206 can include perforations 1221. This can allow the interior aliquot to be separated from the remainder of bag 26 for isolation.

[0268] 14 , a flowchart 1260 is shown detailing exemplary actions that may be performed to package a fluid in a bag 26. At block 1262, a nozzle may be introduced into a first port 392 of the bag 26, which may be in communication with a first compartment in the bag 26. At block 1262, a second nozzle may be introduced into a second port 392 of the bag 26, which may be in communication with another compartment of the bag 26. At block 1264, fluid may be delivered into the bag 26 until the bag 26 compartment is filled to a desired amount. At block 1266, the nozzles may be removed from the first and second ports 392, and the first and second ports of the bag 26 may be sealed. This can create a first compartment, which can be in communication with a third port, through which the contents of the first compartment can be administered. This can also create an external aliquot of fluid in a second compartment (e.g., a smaller compartment) that can be used for testing. At block 1268, a sample from the external aliquot can be collected and tested. If the bag 26 is included as part of the fill receiving set 24, a nozzle need not be used. Instead, a port 392 on the bag 26 can receive fluid through the manifold 20. When the desired amount has been filled into the bag 26, the port 392 can be sealed, and the bag 26 can be dispensed from the manifold 20 as described elsewhere herein.

[0269] Referring now also to FIG. 15 , an exemplary filling tool 1290 is shown. As shown, the filling tool 1290 includes a first filling nozzle 1292 and a second filling nozzle 1294. Such a filling tool 1290 may be utilized to fill a bag 26 (such as that shown in FIG. 12 ). The filling tool 1290 includes a common line 1296 and a branch 1298 that branches fluid flowing through the common line 1296 to each of the first and second nozzles 1292, 1294. Each of these nozzles 1292, 1294 is capable of delivering fluid into a separate compartment contained within the bag 26. The second nozzle 1294 may be associated with a non-powered valve that stops flow into the associated compartment when the compartment reaches capacity. A check valve 1299 is shown in the exemplary embodiment. Because the compartments of bag 26 can be of different sizes, one compartment may fill completely before a larger compartment. As the smaller of the compartments fills, pressure may begin to build within that compartment (the associated seal within bag 26 may be constructed sufficiently sound to withstand this pressure). Then, after the smaller compartment is filled to capacity, check valve 1299 may operate, preventing further flow into the smaller compartment.

[0270] 16 , in some embodiments, the fill nozzle 1230 can include features that can allow an aliquot of fluid to be isolated from the fluid being filled into the bag 26. This aliquot can be generated as the fluid is filled into the bag 26. In certain instances, the aliquot can be collected by overfilling the bag 26 and collecting the fluid that flows out of the bag 26 after the bag 26 has been filled to its capacity during the fill operation.

[0271] As shown, the fill nozzle 1230 may be inserted into the port 392 of the bag 26. The fill nozzle 1230 may include a first lumen 1232 and a second lumen 1234. The first lumen 1232 may be in fluid communication with a fluid source and may receive fluid pumped or otherwise delivered from the fluid source. Fluid from the fluid source may exit the first lumen 1232 and fill the bag 26. The second lumen 1234 may extend out from the fill nozzle 1230 and may be in communication with an aliquot collection reservoir. When more fluid than the capacity of the bag 26 is released from the first lumen 1234, this overfill may cause fluid in the bag 26 to be forced out through the second lumen 1234. The fluid forced out of the bag 26 through the second lumen 1234 should be compositionally the same as the remainder of the fluid in the bag 26. Thus, the fluid passing to the aliquot collection reservoir during the overfill period can be representative of the contents of the bag 26 when tested.

[0272] In an alternative embodiment, the bag 26 may include two ports 392. The bag 26 may be overfilled through a first of the ports 392, and the second of the ports 392 may be in communication with an aliquot collection reservoir. After the bag 26 is filled to its capacity, additional fluid can push the fluid in the bag 26 out of the bag 26 through the second port 392 and into the aliquot collection reservoir. The aliquot collection reservoir can be isolated from the bag 26, and the second port 392 can be closed by a spikeable access or a septum. The fill nozzle can be removed from the first port 392, and the first port 392 can be sealed. Because the fluid pushed into the aliquot collection reservoir has been displaced from the internal volume of the bag 26, the fluid should be compositionally identical to the remainder of the fluid in the bag 26, and tests performed on samples from the aliquot should be representative of the contents of the bag 26.

[0273] 17 , a flowchart 1270 is shown detailing exemplary steps that may be performed to package a fluid in a bag 26. As shown, in block 1272, a nozzle 1230 may be introduced into the port 392 of the bag 26. In block 1274, fluid may be delivered into the bag 26 through the first lumen 1232 of the fill nozzle 1230 until the bag is filled to a desired volume. In block 1276, an additional volume of fluid may be delivered to the bag 26 through the first lumen 1232 of the nozzle 1230. In block 1278, overflow from the bag 26 may be collected in an aliquot collection reservoir through the second lumen 1234 in the nozzle 1230. In block 1280, the nozzle 1230 may be removed from the port 392, and the port 392 may be sealed closed. In block 1282, the fluid from the overflow aliquot may be tested.

[0274] Referring now to FIG. 18 , an exemplary filler receiving set 24 is shown. As shown, the filler receiving set 24 includes a plurality of bags 26 and administration sets 28. The manifold interface element 22 of each administration set 28 is attached to the manifold 20 included as part of the filler receiving set 24. This attachment may be performed in a controlled, sterile environment prior to placing the bags 26, administration sets 28, and manifold 20 into an overpack 60. The overpack 60, in certain embodiments, may be a sealed bag or blister pack. The entire bag 26, administration set 28, and manifold 20 may all be sterilized via a suitable method, possibly after packaging within the overpack 60. For example, gamma sterilization, ethylene oxide, and / or electron beam sterilization may be used. The overpack 60 is capable of maintaining a sterile environment that protects the filler receiving set 24 from contamination during storage. Any of the filler receiving sets 24 described herein may be sterilized as outlined above. Also, embodiments in which bags 26 are individually filled can receive bags 26 and possibly dispensers (e.g., bag magazines) in an overpack 60 that is sterilized as described above. Stopper dispensers described elsewhere herein can be similarly sterilized and provided in overpack 60. Any other consumables described herein that are replaced during operation of system 10 can be provided sterilized in overpack 60.

[0275] In some embodiments, various protective caps or films may be included on some components of the fill receiving set 24. For example, films or caps may be included on any couplers to the manifold 20 that are not pre-connected to another component. This can facilitate the establishment of a sterile connection if manipulation of the bag 26 and administration set 28 after removal from the overpack 60 is required to install the fill receiving set 24 into the system 10. The caps or films may be removed immediately prior to connection or installation into the system 10.

[0276] In some embodiments, the manifold interface element 22 of the administration set 28 may not be pre-connected to the manifold 20. The system 10 is capable of making any necessary connections in an automated manner. This may be accomplished as described in U.S. Application No. 16 / 384,082 (Attorney Docket No. Z55), entitled "Medical Treatment System and Methods Using a Plurality of Fluid Line," filed April 15, 2019, which is incorporated herein by reference in its entirety.

[0277] In embodiments in which the system 10 performs the connection in an automated manner, each of the manifold interface elements 22 can include a cap that can be removed by the system 10. In such embodiments, the system 10 can include an actuatable sled, and the manifold interface elements 22 can be mounted on the actuatable sled. A second sled including a cap retainer or grasper can also be included. The second sled can be displaced toward the first sled and engage with the cap. The second sled can then be displaced from the first sled to remove the cap from the administration set 28. The second sled can then be retracted from the displacement path of the first sled. The first sled can be advanced toward the manifold 20 to seat the manifold interface elements 22 on the couplers of the manifold 20. In some embodiments, the administration set 28 or another filling conduit can include a pierceable septum that maintains a sterile barrier for the interior volume of the associated bag 26 and administration set 28. In such embodiments, the manifold 20 coupler can include a piercing member (e.g., a spike or needle, etc.), and the action of the first thread can result in the piercing member being forced through the pierceable septum and into sealing engagement with the pierceable septum to facilitate filling.

[0278] The manifold 20 can also include a coupler 62 for establishing fluid communication with the output of the medical water production device 14. In some embodiments, the coupler 62 can include a cap and can be driven into a piercing member (e.g., a spike or needle) that communicates with the output from the medical water production device 14 in the manner described above. In other embodiments, the coupler 62 can be a Luer fitting. By providing the manifold 20 in the overpack 60 with the manifold interface element 22 pre-connected to the manifold 20, only a single connection can be made to place the bag 26 and administration set 28 in communication with the output stream of the medical water production device 14. This eliminates the need to make multiple sterile connections. This can be particularly desirable in embodiments in which the fill receiving set 24 includes a large volume of bags 26 and administration sets 28.

[0279] In certain embodiments, each of the bags 26 can be the same volume. However, the bags 26 can be filled to a volume less than their capacity if desired. This can allow for uniformity and simplicity within the system 10. There is no need to stock many different fill receiving sets 24 (e.g., mini-bags, 250 ml, 500 ml, and 1 liter). In some embodiments, there can be two types of sets 24. One type of set 24 can include bags 26 that are the largest volume size among bags 26 intended for use with relatively small fluid volumes. These bags can accommodate any fill volume from very small volumes up to some first maximum volume (e.g., 500 ml). Other maximum volume cutoffs can be used. The other type of set 24 can include larger volume size bags that can accommodate any fill volume ranging from a high-volume preparation up to a second maximum volume higher than the first maximum volume. The volume within a particular bag 26 when the bag 26 is filled may be determined by at least one of a scale, a flow meter, and / or a fluid transfer monitoring system, such as those described in U.S. Application No. 16 / 384,082 (Attorney Docket No. Z55), entitled "Medical Treatment System and Methods Using a Plurality of Fluid Line," filed April 15, 2019, which is incorporated herein by reference in its entirety.

[0280] In some embodiments, system 10 can include a printer or labeling component that can provide an indication of the fill volume of bag 26 directly on bag 26 or administration set 28. Alternatively, if bag 26 can include a unique identifier, system 10 can communicate with a database that associates fill volumes with the unique identifier. Through the communications network, the unique identifier can be looked up (e.g., via a barcode or data matrix scanner) and the database can be queried regarding the fill volume of bag 26. If a printer or labeling component is included, the printer or labeler can also document on bag 26 any information that may be required by law or regulation.

[0281] Bag 26 may, in certain cases, be filled to a specific amount less than the intended total dose volume. One time this may be done is when there is an intention to infuse a predetermined volume of medication into bag 26. In such a case, bag 26 may be filled to contain an appropriate amount of diluent to generate a solution at the dosage strength. For example, if a patient is prescribed one liter of a drug preparation at a specific strength, bag 26 may be intentionally underfilled by an amount equal to the volume of concentrated drug that would be infused to generate the correct strength solution for that patient. System 10 may communicate with a physician order entry system, allowing control system 15 to determine the appropriate fill volume based on the prescription for which bag 26 is being generated.

[0282] Also, a filler receiving set 24 may exist for a particular type of drug. For example, the filler receiving set 24 may be constructed with or equipped for use with a light-sensitive drug (e.g., amphotericin B, nitroglycerin, etc.). In such embodiments, the administration set 28 and bag 26 may be made from a light-blocking material or may be fitted with a light-blocking cover or sleeve. In some cases, the material used to form the line or bag 26 may include a light-blocking layer (e.g., of an amber or green material).

[0283] In certain examples, multiple filler receiving sets 24 having different characteristics (e.g., bag size) may be installed simultaneously within system 10. System 10 may fill bags 26 from appropriately sized filler receiving sets 24 depending on the order being fulfilled by system 10. In such embodiments, filler receiving sets 24 may include indicia (e.g., bar codes, data matrix, RFID, etc.) that may be read by system 10, enabling system 10 to determine the type of set 24 installed.

[0284] 19A-19B, the bag 26 and administration set 28 contained within the filler receiving set 24 may be integrated with one another. This may be desirable in certain embodiments, as it may allow the administration set 28 to be provided in a pre-primed state. Additionally, it may eliminate the need to spike the bag 26. Because a typical bag 26 may be difficult to hold and spike, an integrated set may make the bag 26 easier to use and eliminate the need for a sterile connection step during setup. The administration set 28 may be integrated into the bag 26 in a manner similar to that used to incorporate spike ports, infusion ports, etc. into the peripheral seal of an IV bag.

[0285] The bag 26 may be constructed, for example, from two separate sheets 84A, B of flexible material. The sheets 84A, B may be joined at their perimeters via any suitable type of sealing method, including solvent bonding, RF welding, heat sealing, adhesives, ultrasonic welding, etc. The sheets 84A, B may be made from any suitable material or laminate of materials. The tubing 82 may be constructed similarly. The layers of the laminate may be selected and ordered to achieve a desired purpose. For example, vapor- or gas-impermeable or other barrier layers, bonding layers, solution-compatible layers, and reinforcing or durability-enhancing layers may be included. The materials selected may be informed by the intended sterilization method, weight, optical clarity, durometer, flexibility, heat resistance, lubricity, modulus of elasticity, required material thickness, ease of forming (e.g., forming fittings onto the ends of the tubing), strength, kink tendency, light-blocking ability, dielectric / polarity properties, etc. Materials that may be used to construct the bag and tubing are provided in Table 1 below. [Table 1]

[0286] When sheets 84A, B are of a multilayer construction, they can be formed, for example, in an extrusion lamination process or a coextrusion process. The tubing 82 of the administration set 28 can be fabricated as a multilayer construction (e.g., extrusion) of different materials. When dissimilar materials are used, an adhesive layer can be present in certain embodiments. The outer layer of the tubing 82 can have a lower melting point range than at least the inner layer of the tubing 82. The melting point range of the outer layer of the tubing 82 can overlap that of the bag 26 material. During construction, the tubing 82 can be compressed between sheets 84A and 84B and heated in a welding process. The outer layer of the tubing 82 can be bonded to the bag 26, and the inner layer can maintain an open lumen that allows inflow and outflow into the bag 26, as shown in FIG. 19B. In an alternative embodiment, the bag 26 can be blow molded. In such an embodiment, the tubing 82 can be attached at its periphery in a similar welding process.

[0287] FIG. 20 illustrates another exemplary bag 26. The exemplary bag 26 of FIG. 20 includes an administration set 28. The bag 26 also includes an exemplary fill port 90. The exemplary fill port 90 can either interface with the manifold 20 or directly interface with the output of the medical water production device 14. The fill port 90 can be integrated into the bag 26, as described above with respect to the tubing 82, and can include a self-sealing septum, plug, cap, or similar sealing structure. This sealing member can be installed after the filling process is completed. Alternatively, a sealing member may not be used, and instead a welded seal may be formed. The fill port 90 can also be used as an injection port, which can allow medication to be added to the bag 26 as desired. In other embodiments, the fill port 90 can be located on a side of the bag 26 that does not have an administration set 28 attached. The fill port 90 may also be included in the face of one of the panels that are joined together to form the bag 26, as shown in FIG.

[0288] FIG. 22A shows an alternative bag 26 design in which an administration set 28 is integrated into the bag 26, as discussed elsewhere herein, but with a separate fill line 140. The fill line 140 may be integrated into the bag 26, similar to the administration set 28. The fill line 140 may include a coupler 142, which interfaces with the system 10 and receives the fluid stream during fill. The coupler 142 may be positioned on a portion of the fill line 140 that is sacrificial and removed after fill. In some embodiments, the coupler 142 may be molded into or form part of this portion of the line. The coupler 142 may be a Luer fitting in some instances. In other embodiments, a pierceable septum, as described above, may be included.

[0289] As shown in FIGS. 22B-22D, after filling the bags 26 through the fill line 140, the system 10 can generate a seal 146 (shown by shading in FIG. 22D) in a segment of the fill line 140. This can be produced via an RF welding or similar process, or a tube sealer assembly 906 (such as that shown and described in connection with FIG. 172) can be used. The seal 146 can be formed via an RF welding die / bar 144 of the system 10. In some embodiments, a roller or squeegee assembly 145 can be used prior to the introduction of the welding die 144. The roller or squeegee assembly 145 can be pressed against the fill line 140, and the pair of assemblies 145 or rollers or squeegees can be displaced in opposite directions, as shown in FIG. 22C, to force liquid out of the weld area 145. The welding die 144 can then be introduced to form the seal in the fill line 140. The roller or squeegee assembly 145 may or may not remain present when the seal is generated. Once the seal 146 is formed, a cutting element 148 (see FIG. 22E) may separate the sacrificial end of the fill line 140 from the remainder of the fill line 140. This may result in a sealed portion of the fill line 140 extending from the bag 26, as shown in FIG. 22F. Preferably, the sealed portion of the fill line 140 may be maintained to a minimum length to limit the volume of fluid that may become isolated from the administration set 28 when the bag is emptied. In certain instances, the seal 146 may extend to the peripheral edge of the bag 26.

[0290] Referring now to FIG. 23 , an alternative bag 26 design is shown. As shown, the bag 26 includes an administration set 28, which is integrated into the bag 26 as described elsewhere herein. The administration set 28 includes a drip chamber 190, a roller clamp 192 (although another type of clamp or no clamp may be included), and a Y-site 194 (or other type of branch). The bag 26 can be filled through a fill port 196 attached to the Y-site 194. Once the bag 26 is filled, the portion of the branch from the Y-site 194 that leads to the fill port 196 can be sealed (e.g., by radio frequency welding), and the fill port 196 can be cut from the administration set 28 as described elsewhere herein. During administration, the remaining branch of the Y-site 194 can include an administration port 198, which includes a lumen that remains open after the other branch is sealed and removed from the Y-site 194. The administration port 198 can be connected to a cannula line or the like to administer the contents of the bag 26. In such embodiments, the cannula line can include a check valve to prevent backflow. In some embodiments, the ports 196, 198 can include Luer fittings. This type of bag 26 and administration set 28 can be provided pre-primed. Prior to use, the user can hold the bag 26 and set 28 so that the administration set 28 is vertically above the bag 26. The drip chamber 190 can be squeezed as needed to displace the fluid in the drip chamber 190 into the bag 26. Air in the bag 26 can then be sucked into the drip chamber 190 as the drip chamber 190 returns to its normal shape. This can create an air space in the drip chamber 190, which can be used to operate the drip chamber 190 and visualize droplet formation during flow rate setting.

[0291] Referring now to FIG. 24, another exemplary bag 26 and administration set 28 are shown. As shown, this bag 26 and administration set 28 do not include a Y-site 194 (see, e.g., FIG. 23). Instead, the administration set 28 includes an administration port 198. The drip chamber 190 is attached to a frangible or destructible barrier 200 that can be destructed by the user prior to administration so that the user can prime the administration set 28. The bag 26 can include a fill access 202 on another portion of the bag 26, which interfaces with the output or manifold 20 of the medical water production device 14. Once filled, this access can be welded closed, and a portion thereof can be cut from the bag 26. This process can be similar to that shown with respect to the bag 26 shown in FIGS. 22A-22F. Alternatively, the filling access 202 may be provided in the form of a Y-site 194 (see, e.g., FIG. 23 ) disposed upstream of the drip chamber 190. In some embodiments, an injection port may also be included in the bag 26. Such an injection port may be included in a side panel of the bag 26 or may be attached to an edge of the bag 26 (e.g., adjacent an attachment point for the administration set 28).

[0292] 25A-25C, an exemplary manifold 20 is shown. The manifold 20 included in the packing receiving set 24 can be a disposable component. Alternatively, the manifold 20 can be returned to the manufacturer after use or taken to another location and cleaned to allow it to be used in another packing receiving set 24. In embodiments in which the manifold 20 is a disposable component, it can be designed to be simple to manufacture and not unnecessarily expensive. For example, the manifold 20 can be constructed from an injection-molded block 68 of material containing multiple flow channels 74. These flow channels 74 may be open on one side. As best shown in FIG. 25C , one or more plates 70, 72 can then be attached to the block 68 to cover any open portions of the flow channels 74. The plates can be attached in any suitable manner, including via heat, solvent bonding, welding, fasteners (and possibly gaskets), adhesives, etc. In certain embodiments, plates 70, 72 may be laser welded onto block 68, which may be made from a material selected at least in part for its ability to absorb the laser welding wavelength (e.g., it may be black). In this embodiment, plates 70, 72 may be transparent to allow the laser to pass through block 68. The laser weld may seal around the periphery of any flow channels 74 contained within manifold 20. Although described as plates 70, 72, the use of a flexible film cover in place of at least one of plates 70, 72 is also contemplated in some instances.

[0293] Referring primarily to FIGS. 25A and 25B, which show opposing sides of the block 68 of the exemplary manifold 20, the block 68 can include multiple passages 76A-76C that communicate with the fluid pathway 74. The block 68 can also include multiple fittings or couplers 78, 80. In some exemplary embodiments, the couplers 78, 80 can be Luer fittings. If desired, the plates 70, 72 can include orifices, and the couplers 78, 80 can extend through the orifices (see, for example, FIG. 25C). In other embodiments, the plates 70, 72 can include the couplers 78, 80. The coupler 78 can be used to form a connection to the output of the medical water production device 14. The coupler 78 can surround the passage 76A, which connects to the opposite side of the block 68. The passage 76A associated with the coupler 78 can be in fluid communication with multiple flow path 74 segments on the opposite side of the block 68. These flow path 74 segments can each extend to their own passage 76B. In the example, the flow paths 74 extend radially from the passage 76A. Any desired routing scheme can be used in alternative embodiments. The passages 76B each extend through the block 68 to a flow path 74 segment on the side of the block containing the coupler 78. These flow path segments 74 then extend to another passage 76C, which in turn extends through the block 68. Each passage 76C extends to a coupler 80 on the opposite side of the block 68. Each of the couplers 80 can be coupled to a manifold interface element 22 of an administration set 28 included in the fill receiving set 24. Alternatively, any of the manifold interface elements 22 described herein may be included on another fill access, such as, for example, fill access 202 of FIG. 24 or fill line 140 of FIGS. 22A-22F.

[0294] A filler receiving set 24 including another example of a manifold 20 is shown in FIG. 26 . The manifold 20 can include a block 310. The block 310 can include a flow channel 312 therethrough. The block 310 can also include a connector interface 314 for coupling an inlet 324 of the manifold 20 with a dispenser for medical water or a medical fluid mixture (e.g., the output of the medical water producing device 14 or the mixing volume 34). The flow channel 312 can include multiple branches 316 extending from a wall 318 of the fluid channel 312 to a port 326 on the face of the block 310. A displaceable seal can be included in the fluid channel 312. In certain examples, a displaceable rod 320 can be provided in the fluid channel 312. The displaceable rod 320 can include a sealing section 322, which can be made of or coated with a flexible material (such as rubber, silicone, various elastomers, etc.). Alternatively, the sealing section 322 can include one or more O-rings or a raised flexible section. The sealing section 322 can press against the fluid channel wall 318 to form a seal between the wall 318 and the displaceable rod 320, preventing fluid on one side of the sealing section 322 from passing to the other side of the sealing section 322. In some embodiments, the displaceable rod 320 can be a plunger 330 (see, e.g., FIG. 27). The displaceable rod 320 can also be a threaded rod or lead screw 332 (see, e.g., FIG. 29) in various examples. The actuator used to manage the displacement of the displaceable rod 320 can be selected based on the type of displaceable rod 320 used.

[0295] The displaceable rod 320 can be actuated along the length of the flow channel 312 to position the various branches 316 in communication with the inlets 324 . This can allow bags 26 to be filled sequentially (e.g., one, two, or three at a time). In the example shown in FIG. 26 , the bags 26 are in fluid communication with the inlet 324, so that fluid entering the manifold 20 can be directed toward the bags 26. The sealing section 322 of the displaceable rod 320 prevents the flow of the incoming fluid to any other bags 26 coupled to ports 326 of the manifold 20. After the first bag 26 is filled, the bag 26 can be sealed from the fluid channel 312 and removed from the manifold 20. This can be accomplished with a welding die 144 and possibly a roller or squeegee assembly 145, similar to that described with respect to FIGS. 22A-22F. The displaceable rod 320 can then be displaced along the fluid channel 312 to align the next bag or bags 26 in fluid communication with the inlet 324 for filling, and the process can be repeated. Although only three bags are shown, any number of bags 26 may be included on one manifold 20 .

[0296] Additionally, in certain embodiments, the manifold 20 can include multiple flow channels 312 (e.g., all extending parallel or generally parallel to one another) each associated with a displaceable rod 320. This can allow bags 26 communicating with different flow channels 312 to be filled in a parallel manner or independently of one another. When bags 26 associated with different flow channels 312 are filled in parallel, the displaceable rods 320 of the various flow channels 312 can be coupled to move in a cooperative manner with one another (e.g., perhaps in a 1:1 ratio). The system 10 can also fill bags 26 of multiple manifolds 20, where multiple manifolds 20 can be installed in the system 10 simultaneously.

[0297] 27 and 28, an exemplary manifold 20 is shown. In the exemplary manifold 20, the displaceable rod 320 is shown as a plunger 330. The plunger 330 includes a plunger stem 334 and a plunger head 336, which acts as a sealing section 336. An example of the displaceable rod 320 including a lead screw 332 is shown in FIG. 29. The lead screw 332 can also include a sealing head section 338 at its terminal end disposed within the manifold 20. Although not shown, the bags 26 associated with the ports 326 of the manifold 20 can include various accesses. In addition to the lines extending from each bag 26 to the manifold 20, each bag 26 can also include one or more of an administration set 28, a spike port, an injection port, or any other access shown herein. Although this may be the case in some instances, not all bags 26 attached to the manifold 20 need be identical. Some bags 26 may include different accesses or, for example, may have different maximum fill volumes. Where a variety of different manifolds 20 may be used with the system 10, the manifold 20 may include an identifier that includes information about the type of manifold 20 installed or about the bags 26 contained on the manifold 20. This identifier may be machine-readable, such as a barcode, data matrix, RFID, or any other suitable identifier. Information gathered from this identifier may be used by the control system 15 to control the filling of the bags 26 contained on the manifold 20.

[0298] Referring now to the progression of Figures 30-33, an exemplary filling sequence is shown. While the illustrated manifold 20 includes a plunger 330, other displaceable rods 320 (e.g., plungers with lead screws or rack-and-pinion arrangements) can be similarly displaced through such a filling sequence. The plunger 330 can be provided with its plunger head 336 disposed within the flow channel 312 of the manifold 20. The plunger 330 can be initialized against or proximal to the inlet 324 of the manifold 20 (see, for example, FIG. 28 ). The manifold 20 can be coupled to a dispenser 340 to place the flow channel 312 in fluid communication with a medical fluid supply. The coupling can be made aseptically and via a threaded fitting (e.g., a Luer lock), a barbed fitting, a quick connect, a magnetic coupling, or any other suitable method. In some embodiments, steam can be released to clean the connector interface 314 before coupling.

[0299] An actuator (not shown) can withdraw plunger 330 a predetermined distance out of fluid channel 312. By displacing plunger 330 away from inlet 324, a port 326 or selected ports 326 can be brought into communication with inlet 324. In the example shown in FIG. 30 , only a single port 326 is brought into communication with inlet 324. Fluid can then be transferred through flow channel 312 into bags 26 in communication with one or more ports 326. This is shown representatively via stippling in FIG. 30 . Fluid transfer can be stopped once one or more bags 26 have been filled to a desired volume, as shown in FIG. 31 .

[0300] As shown, each bag 26 can be connected to a port 326 via a fluid path. The port 326 in this example includes a protruding fitting (e.g., a barbed fitting) onto which tubing providing the fluid path is coupled. The fluid path can include a sealable region, which can be welded, for example, to close the fluid path to fluid flow. Thus, a seal 342 can be generated in the sealable region to isolate the bag 26 from the rest of the manifold 20. The seal 342 can be generated as described elsewhere herein (e.g., see FIGS. 22A-22F). The displacement of the plunger 330 can be tracked by a sensing arrangement to ensure that the correct port or ports 326 are in communication with the inlet 324 at a given time. The sensing arrangement can include a linear potentiometer, an encoder, a Hall-effect sensor array monitoring the location of a magnet on the plunger 330, or a combination thereof. The fill level of each bag 26 can be monitored via a scale on which the bag 26 rests.

[0301] The filled bag 26 can be removed from the manifold 20 after the seal 342 is created. As shown in FIG. 32 , the bag 26 has been removed from the manifold 20. A portion of the seal 342 can serve to close the port 326 from which the bag 26 was removed. As shown in FIG. 32 , the plunger 330 can be withdrawn to a location more distal to the inlet 324, placing an additional bag or bags 26 in communication with the inlet 324. Fluid can be transferred to fill one or more bags 26 until the desired amount is filled, and a seal 342 can be formed as shown in FIG. 33 . This can be repeated until each bag 26 on the manifold 20 has been filled and removed from the manifold 20.

[0302] Referring now to FIG. 34, a filler receiving set 24 is shown that includes another manifold 20. The manifold 20 is similar to that shown and described in connection with FIGS. 28-33, however, the bags 26 may be coupled to the manifold 20 in an alternative manner. As shown, the ports 326 do not include fittings or protrusions extending away from the manifold 20 to which the fluid paths to the respective bags 26 are connected. Instead, the fluid lines 344 that provide the fluid paths to the bags 26 are inserted into orifices in the block 310 that form the ports 326. The fluid lines 344 may be secured within the ports 326 via solvent bonding, adhesives, threaded couplings, or any other suitable manner.

[0303] In other embodiments, the flow path between the manifold 20 and each bag 26 can include a disconnect fitting 346, as shown in FIG. 35. The disconnect fitting 346 can allow the bag 26 to be removed from the fill receiving set 24 without the need for a separate sealing operation. In some embodiments, a self-sealing sterile disconnect fitting can be used. In such an embodiment, the fitting can be selected to allow the manifold 20 to be sterilized after all bags 26 on the manifold 20 have been filled. This can allow the manifold 20 to be reused.

[0304] 36-38 , another exemplary embodiment of the fill receiving set 24 is shown. As shown in FIG. 36 , the fill receiving set 24 can include a manifold 20 pre-connected to multiple administration sets 28 integrated into individual bags 26. As with other embodiments described herein, other fill conduits can be coupled to the manifold 20 in place of the illustrative administration sets 28. In the exemplary embodiment, the manifold 20 can be a cassette 150, which is installed into the system 10. The cassette 150 can include a fluid introduction port 152 that can be connected to a fluid output stream from the medical water production device 14. The cassette 150 can also include multiple couplers 154 (e.g., Luer fittings) that can be connected to the manifold interface elements 22 for each of the sets 28 (or fill lines 140, access 202, or other fill conduits).

[0305] As best seen in the cross-section of cassette 150 shown in FIG. 38 , cassette 150 can include a rigid body portion 156, which in certain instances may be injection molded. Rigid body portion 156 can include multiple valve stations 158A-I, which may be covered by a flexible membrane 160. In alternative embodiments, multiple flexible membranes may be included. For example, each valve station 158A-I may be covered by its own dedicated flexible membrane. The illustrated flexible membrane 160 may be actuated (typically pneumatically, although this could also be accomplished mechanically or hydraulically) against and away from a valve seat 162 of each valve station 158A-I to open or close the valve 158A-I. In the exemplary illustration, all of valve stations 158A-I are shown in a closed configuration. The cassette 150 also includes a fluid bus 164 on the opposite side of the cassette 150 mid-body portion 166. The fluid bus 164 communicates with the fluid introduction port 152 through a passage 172 in the sidewall of the cassette 150. A second flexible membrane 168 is included on this side of the cassette 150 to seal the fluid bus 166. This second flexible membrane 168 may be replaced by a plate (e.g., a laser-welded plate as described elsewhere herein). The fluid bus 164 may be placed in communication with a desired valve station 158A-I by displacing the first flexible membrane 160 away from the valve seat 162 of the desired valve station 158A-I. As shown, each valve station includes a passage 174 leading from the valve station 158A-I to the fluid bus 164. This allows for establishing a flow path from fluid bus 164 to valve stations 158A-I.Valve stations 158A-I may also include openings to couplers 154 of cassette 150, allowing fluid to flow from fluid bus 164 through valve stations 158A-I and out of cassette 150 to bags 26 and administration sets 28 attached to the associated couplers 154. This may allow bags 26 to be filled one at a time (or two at a time, etc.). In some embodiments, each valve station 158A-I may be associated with two or more couplers 154, which may be desirable if multiple bags 26 are to be filled at one time.

[0306] 39A-39C illustrate a progression of valve actuation that may be used to fill bags 26 attached to cassette 150. The bags 26 may be filled in any order, but are shown here as being filled sequentially by opening valve stations 158A-I in a left-to-right fashion. As shown, the leftmost valve station 158A may be opened to fill the associated bag 26. Once full, the bag 26 may be removed from cassette 150 as described elsewhere herein. Valve station 158A may then be closed. The adjacent valve station 158B may then be opened to fill its attached bag 26. That bag 26 and attached administration set 28 (or other fill access) may be removed from cassette 150 (e.g., sealed and cut, detached from a cooperating quick-connect, etc.). Valve station 158B may then be closed. The next valve station 158C may then be opened, and its associated bag 26 may be filled and removed. This process may continue until all bags 26 are filled. The number of bags 26 filled, and therefore the number of valve stations 158A-I open at a given time, may be determined by the flow output of the medical water production device 14. It may be desirable for the system 10 to output a certain number of bags per unit time. If the system 10 fills, for example, 50 bags 26 at a low flow output, there will be a certain amount of downtime before the bags 26 become available. By filling the bags 26 one at a time (or some suitable number at a time), the system 10 can provide a constant output of bags 26 at the same flow output.

[0307] As shown in FIG. 40 , the cassette 150 can interface with an actuation block 180 included in the system 10. The actuation block 180 can be made of metal (or another robust, dimensionally stable, thermally stable, and / or non-porous material) and can be exposed to high-temperature steam or a venting stream from the medical water production device 14 before the cassette 150 is seated against the actuation block 180. The flexible membrane 160 on the cassette 150 can be covered by an overlay that maintains a sterile surface of the flexible membrane 160 before application to the actuation block 180. This overlay can be removed by the system 10 or an operator. In some embodiments, the cassette 150 can be pressed against the actuation block 180 by closing and latching a door of the system 10. In other embodiments, a piston or plate can press against the side of cassette 150 containing fluid bus 164, forcing cassette 150 against actuation block 180 and ensuring a good seal is made by flexible membrane 160 around valve stations 158A-I. This can be done through the inflation of a bladder, the rotation of a lead screw or cam, the actuation of a scissor jack, a linear actuator, or any other actuator capable of applying sufficient force.

[0308] As shown, actuation block 180 includes multiple pressure paths. These pressure paths can be individually placed in selective communication with either a (e.g., pneumatic) positive pressure source 182 or a negative pressure source 184 to open or close valve stations 158A-I of cassette 150. Each control chamber 186 can be selectively placed in fluid communication with either the positive pressure source 182 or the negative pressure source 184 by operation of a valve 188 associated with the respective control chamber 186. In the exemplary embodiment, each control chamber 186 is associated with a valve that controls the application of positive pressure and a valve that controls the application of negative pressure. In an alternative embodiment, a single valve can be utilized to switch between applying positive and negative pressure. In such an embodiment, the valve can be designed to apply positive pressure in a fault condition. Positive pressure source 182 and negative pressure source 184 can be reservoirs maintained at specific pressure set points by pumps (not shown). The pressure sources 182, 184 may be monitored by one or more pressure sensors 191, which may signal the operation of a pump to maintain the pressure sources 182, 184 at a pressure setpoint. In some embodiments, each control chamber 186 may also be in fluid communication with a pressure sensor 192. This pressure sensor 192 may be monitored to check that the expected pressure is being applied to the valve chambers 158A-I of the cassette 150. In some embodiments, the medical water producing device 14 is capable of outputting product at a pressure above ambient pressure. In such embodiments, negative pressure may not be used. Instead, the product water pressure may be used to displace the flexible member 160 to open the valve stations 158A-I. The positive pressure used to close the valve stations 158A-I may be chosen to be sufficiently higher than the output pressure of the medical water producing device 14 to maintain a robust closure of the valve stations 158A-I.

[0309] Once the bag 26 is filled, it can be removed from the cassette 150 (or any other manifold 20) in a variety of ways. For example, a welded seal can be made on the tubing of the administration set 28 (or the fill port 140 or access 202). The bag 26 and a portion of the administration set 28 can then be cut from the manifold 20. This can be similar to what is described above in connection with FIGS. 22A-22F. Alternatively, the tubing of the administration set 28 can be pinched or otherwise occluded, and the administration set 28 can be disconnected from the cassette 150. The administration set 28 can then be capped with a cap or similar element. In some examples, each administration set 28 can include a slide clamp. When installed in the system 10, the slide clamp can interface with an actuator, which is commanded to displace when the bag 26 attached to the administration set 28 is filled to the appropriate amount. Displacement of the actuator can drive the narrow section of the slide clamp toward the tubing such that the narrow section of the slide clamp occludes the tubing of the administration set 28 .

[0310] Where system 10 is configured to mix various fluids, and now referring to FIGS. 41A-42, cassette 150 can include multiple valve-type pumping stations 270A-C. Through the cooperative actuation of valve-type pumping stations 270A-C, small volumes of fluid can be pumped through cassette 150. Referring to the progression of FIGS. 41A-41F, three valve-type pumping stations 270A-C of cassette 150 can be actuated to pump small volumes of fluid from a concentrate supply inlet 272 contained within cassette 150. While the three valve-type pumping stations 270A-C are shown adjacent to one another, this is done to provide a streamlined example. Other configurations may be constructed with additional and / or non-adjacent valve-type pumping stations 270A-C.

[0311] As shown in FIG. 41B, first and second valve stations 270A and 270B can be opened to perform a valve-type pumping station fill operation. These valve stations 270A-B can be opened sequentially or substantially simultaneously, resulting in fluid flow 278 from the concentrate supply inlet 272 into these valve stations 270A-B. Once valve fill is complete, the filled valve station 270B can be isolated by closing the first valve station 270A, as shown in FIG. 41C. Thus, the second valve station 270B can serve as an intermediate hold-up volume during valve-based fluid pumping.

[0312] The third valve station 270C can then be opened to establish fluid communication between the second valve station 270B and the third valve station 270C, as shown in FIG. 41D. A valve pump stroke can then be performed by closing the second valve station 270B, as shown in FIG. 41E. This transfers the valve pump stroke volume from the intermediate hold volume to the third valve station 270C. The third valve station 270C can then be closed to pump the valve pump stroke volume toward the valve stations 158A-N associated with the bag 26 attached to the cassette 150, as shown in FIG. 41F. Alternatively, the third valve station 270C can be omitted, and fluid can be transferred to the desired valve station 158A-N when the second valve station is closed. This can be repeated as desired until the target volume of concentrate has been transferred. Larger volumes per valve pumping sequence can be achieved by utilizing multiple valve stations as intermediate hold volumes. Further description of such arrangements is provided in U.S. Application No. 16 / 384,082 (Attorney Docket No. Z55), entitled "Medical Treatment System and Methods Using a Plurality of Fluid Line," filed April 15, 2019, which is incorporated herein by reference in its entirety.

[0313] Once the desired volume of concentrate has been transferred via the valve-based pumping stroke, and now, referring primarily to FIG. 42 , a volume of water may be transferred to bag 26 to dilute the concentrate to a final concentration. The final concentration may be the concentration ready to be administered to a patient. Alternatively, the final concentration may be defined so that the addition of a predetermined volume of another medication creates the final drug preparation, which is then administered to the patient. In an exemplary embodiment, a water inlet valve station 274 is included at the extreme end of cassette 150. Water inlet valve station 274 may communicate with water inlet 276 and, when open, may establish a flow path from water inlet 276 through fluid bus 164 to the desired valve station 158A-N and associated bag 26. By positioning water inlet valve station 274 at the end of cassette 150, water flow through bus 164 may also serve to flush any concentrate remaining in bus 164 into the desired bag 26. In some embodiments, multiple valve pumping strokes using water may be performed with any valve stations not specialized for a particular concentrate (e.g., intermediate hold volume stations) to flush these stations.

[0314] The volume of concentrate to be flushed from the valve station and / or fluid bus 164 may be considered in any volume target when pumping the concentrate into the bag 26 via the valve pump stroke. Thus, the entire volume of concentrate defined for a particular bag 26 may not be transferred into the bag 26 until after the flush is complete.

[0315] FIG. 43 illustrates another alternative filler receiving set 24. As shown, a main line 204 is present and can interface with the output of the medical water production device 14. The bags 26 can branch off from the main line 204 in series via multiple lines 206. In some embodiments, the lines 206 can be attached to the main line 204 at a T-junction. Alternatively, the main line 204 can include multiple coupler fittings, and cooperating elements on the lines 206 can connect to the multiple coupler fittings. The filler receiving set 24 can be configured to act as a manifold 20. The lines 206 to the bags 26 can be kept closed by occluder structures acting on the lines. Alternatively, the main line 204 can be occluded upstream of each branch point to the lines 206 leading to one of the bags 26. In certain examples, the line 206 may be closed via a pinch clamp 302, which may be mechanically actuated upon command of the control system 15. The bags 26 may be filled one at a time, sealed, and then disconnected from the main line 204 as described elsewhere herein (see, e.g., FIGS. 22A-22F). Once a bag 26 is filled and disconnected from the filler receiving set 24, the pinch clamp 302 on another bag 26 (e.g., an adjacent bag) may be opened to allow that bag 26 to be filled. This may be repeated until all bags 26 in the filler receiving set 24 have been filled and disconnected from the main line 204. In some embodiments, two or more bags 26 may be filled at once. The line 206 to the bag 26 may be constructed in the same manner as any of the lines or accesses described above and may include any of the features described elsewhere herein. For example, bag 26 may include an additional administration line (not shown) similar to that of Figures 22A-22F and 24 or a Y-site similar to that of Figure 23. Also, a drip chamber 190 may be included.In the example shown in FIG. 43, line 206 is included as a fill line, and bags 26 include additional attached access to their internal volumes (e.g., administration set 28 and injection port 203).

[0316] In some embodiments, and referring primarily to FIG. 44 , pinch clamps 302 may not be used. Instead, each line 206 extending from main line 204 may have a slide clamp 300 that, when installed in system 10, is in an occluding position on line 206 or upstream of the point where each line 206 branches off from main line 204. Slide clamps 300 may be displaced to a flow-permissive position on the line to allow filling of each bag 26. In some embodiments, slide clamps 300 may be held stationary in a block, and line 206 may instead be displaced, bringing line 206 into the flow-permissive segment of slide clamp 300. After filling, line 206 may then be occluded by displacing either line 206 or slide clamp 300 to bring line 206 into the flow-prohibiting portion of slide clamp 300 to occlude line 206. The same process can be used when slide clamp 300 is in place on main line 204. Once bag 26 is filled to the desired volume, line 206 can be disconnected from main line 204 and capped or sealed.

[0317] Referring now to FIG. 45 , in certain embodiments, the filler receiving set 24 may be constructed from two layers of material. For example, the filler receiving set 24 may be constructed from bonded sheets 220 or sheets of material. If multiple sheets 220 are used, they may be placed on top of each other. If a single sheet 220 is used, the sheet 220 may be a continuous sheet of material folded over itself to create a multi-layer starting material. As shown in FIG. 46 , access elements 226, 228 may be placed at regular intervals between the sheets 220 or between layers of the folded sheet 220. For example, the access elements 226 may be injection ports, and the access elements 228 may be administration sets 28. In the exemplary embodiment, there are only four sets (in this example, pairs) of access elements shown; however, the number of sets of access elements 226, 228 may be selected to match the number of bags 26 in the filler receiving set 24. In some embodiments, each set of access elements 226, 228 may include three or more access elements, while in other embodiments, only a single access element may be included for each bag 26.

[0318] Referring now to FIG. 47 , seals 230 may be formed to attach portions of sheets 220 or folded sheets 220 to one another to form the filler-receiving set 24. This may be done via a welding process (e.g., an RF welding process, etc.). The material selected for each sheet may include an RF-weldable material, such as a polar plastic, such as PVC. For example, the layers of sheets 220 or folded sheets 220 that are adjacent to one another before welding may be made from such a material. During construction of the filler-receiving set 24, a portion of the sheet 220 or sheets 220 may be welded, and the sheet material may be indexed to the next portion of the sheet 220. This portion may be welded, indexed, etc. The number of bags 26 formed in each welding operation may be fewer than the total number of bags 26 in the filler-receiving set 24. In some embodiments, one to four or more bags 26 may be formed at a time. It may be preferable that the number of bags 26 in the filler-receiving set 24 be an even multiple of the number of bags 26 formed per welding operation. As shown, the seal 230 may be similarly formed to create a flow path 232 within a bus portion 234 of the filler receiving set 24. The interior volume of each bag 26 may be in fluid communication with the bus portion 234 via a side branch 238 from the flow path 232 to each bag 26. In examples, the side branches 238 all extend in the same direction from the bus portion 234. In some embodiments, the side branches 238 may extend from opposite sides of the bus portion 234, such that a bag 26 is disposed on each side of the bus portion 234.

[0319] When formed, the bag 26, bus section 234, and side branch 238 can all be flat and have substantially little or no internal volume. During filling, the sheet material can displace to allow the bag 26 to be filled and to provide lumens in the bus section 234 and side branch 238. As a result, a hold-up volume of air should not be present in the bus section 234 and side branch 238 and therefore will not be transferred into the bag 26 during filling. In some embodiments, a vacuum can be drawn on the flow path to ensure that a minimal amount of air is present within the features formed by the seal 230.

[0320] The welding and indexing process can be repeated until the entire sheet 220 is welded to form the packing-receiving set 24. As one or more sheets 220 are indexed, the welding die can extend over at least a portion of the overlap area in the previously created weld. This can ensure that a seal 230 is hermetically formed along the entire length of the packing-receiving set 24. In some embodiments, a pair of access elements 226, 228 can be introduced between one or more sheets 220 after each indexing. As shown in FIG. 47, the bags 26 can be formed close together to minimize wasted sheet 220 material.

[0321] After being indexed from the welding station, one or more sheets 220 may be cut at a cutting station, as shown in FIG. Sections of one or more sheets 220 can be cut simultaneously as other sections are welded. The cutting station can include a cutting die that is advanced into the folded one or more sheets 220 to cut out bags 26. Excess material can be separated from the filler receiving set 24. A port 236 can be included at the terminal end of the filler receiving set 24. A side branch 240 from the flow path 232 can extend to the environment through the port 236. The port 236 can be positioned adjacent to an inlet opening 249 to the flow path 232 in the fluid bus 234. In certain embodiments, a fitting can be coupled to the opening 249 to facilitate connection to a dispensing member.

[0322] 49 , when installed in the system 10, the dispensing member 250 can be received in the opening 249 or a fitting attached thereto. This can be done by user operation of the bus portion 234 of the filler receiving set 24, but this connection can also be made in an automated manner. If manual user operation is utilized, interaction between the user and the filler receiving set 24 can be through a glove box configuration. Additionally, an occluder 252 can close the flow path 232 upstream of the first side branch 238 to the bag 26. The dispensing member 250 can first output a steam stream into the flow path 232. This can clean the flow path. Steam can be provided by venting a stream (e.g., purified but not yet condensed water vapor, perhaps a standard vapor, such as pure steam) from the medical water producing device 14 if the medical water producing device 14 is a distillation device. The steam can exit the flow path 232 through a side branch 240 that leads through port 236. After an appropriate amount of steam purging, port 236 can be sealed, for example, with an RF seal 254, as shown in FIG.

[0323] As shown in FIG. 50 , the dispensing member 250 (or, in some embodiments, a second dispensing member coupled to the opening 249 after removal of the vapor dispenser) can output a medical water flow to the flow path 232 of the bath portion 234. When a mixture of fluids is provided to the bag 26, the mixture can be output by the dispensing member 250. The occluder 252 can be advanced downstream of the first side branch 238 to the bag 26. This can place the interior volume of at least one bag 26 in fluid communication with the opening 249. In some embodiments, the occluder 252 can be displaced to a location on the flow path 232 intermediate the first and second side branches 238 to the bag 26, as shown in FIG. 50 . In other embodiments, the occluder 252 can be displaced to place multiple bags 26 in fluid communication with the opening 249. The output of medical water or mixture from the dispensing member 250 can fill the bag 26 to the appropriate amount (e.g., as sensed by a scale or volume displacement sensing arrangement) and dispensing can be stopped. The volume dispensed into a given bag 26 can be order-specific and can be chosen based on the amount of diluent needed for a particular pharmaceutical order. This can be computed by the control system 15, which can be in communication with and receive orders from a pharmacy order entry system.

[0324] As shown in FIG. 51 , a seal 254 can be generated to close the side branch 238 to any filled bag 26, and the filled bag 26 can be cut from the bath portion 234. The seal can be created via RF welding, and the sealing process can be performed, for example, as described in FIGS. 22A-22F or similarly as described with respect to FIGS. 159-175. The occluder 252 can be advanced to place the interior volumes of one or more additional bags 26 in fluid communication with the opening 249. The dispensing member 250 can then output the medical water or medical fluid mixture, as described above, to fill one or more bags 26. As shown in FIG. 52 , this can continue until all bags 26 contained in the filler receiving set 24 are filled. As described elsewhere herein, the filler receiving set 24 can include dozens of bags 26 (e.g., 50-100).

[0325] Referring now also to FIG. 53 , the welding, cutting, and filling of bags 26 can, in certain embodiments, be a continuous process on production line 280. In such an example, sheet or sheeting 220 can be drawn in a continuous manner from sheeting supply 282. Sheeting supply 282 can be a large roll, spool, carton, or the like. Sheeting 220 can initially be drawn into bag / bath former component 284 of production line 280. As described elsewhere, bag / bath former 284 can be a plastic welder (e.g., an RF welder, etc.). Sheeting 220 can be indexed through bag / bath former 284 such that one or more bags are formed into sheeting 220 at a time. Formed portions of bags 26 and baths 234 can be cut from sheeting 220 at cutter station 286 of production line 280. As described elsewhere, this cutter station can include a die cutter. A filling station 290 can fill one or more of the cut-out bags 26, with the occluder 288 of the production line 280 blocking any downstream bags 26 and unformed sections of the sheeting 220. The filled bags 26 can be sealed from the bus 234 at a sealing station 292 of the production line 280. The sealing station 292 can include an RF welder and, as described elsewhere herein, can include a roller or squeegee. After sealing the bags 26 from the bus 234, the bags 26 can be cut from the bus 234 by a bag cutting station 294 of the production line 280.

[0326] In an alternative example, production line 280 may form and cut bags 26 and busses 234 from a quantity of sheeting 220. However, production line 280 may not fill bags 26 and cut them from busses 234. In such an example, unfilled bags 26, still attached to busses 234, may be provided as filler receiving sets 24 to an institution or medical facility that has filling, closure, sealing, and bag-cutting components. This may help minimize the amount of floor space required at the medical facility. In such an embodiment, production line 280 may include a packaging station that applies an overpack around the filler receiving sets 24.

[0327] Referring now to FIGS. 54-55 , an exemplary system 10 for producing and packaging medical fluids is shown. As shown, the system 10 is installed in a clean room environment. The system 10 includes an enclosure 12. In the exemplary embodiment, the enclosure is divided into a first section 96 and a second section 98. As best shown in FIG. 55 (which shows the system 10 of FIG. 54 with a portion of the enclosure 12 transparent), the first section 96 can house the medical water production device 14. In an alternative embodiment, the medical water production device 14 can be in a non-clean room (or less stringent clean room) environment, with its output plumbed to a clean room. In the exemplary embodiment, the medical water production device 14 is shown as a distillation device that receives water that has been pretreated by a plurality of filters 100 (e.g., charcoal filters and / or reverse osmosis filters). The first section 96 may include a divider 102 that divides the first section into a hot compartment and a cold compartment. The divider 102 and walls of the first section 96 of the enclosure 12 may include insulation, if necessary, to protect electronics and surfaces elsewhere in the system 10 from exposure to high temperatures during distillation. The first section 96 may also include a work surface 104 on top that is designed for easy cleaning. For example, the work surface shown in FIG. 54 has rounded corners that minimize the chance of an area being overlooked during cleaning. The work surface 104 may be used to open the packaging of the fill receiving sets 24 or individual bags 26 and, if necessary, manipulate them to prepare them for installation into the system 10 for filling. The first section 96 of the enclosure 12 may also include a user interface 106 (e.g., a touchscreen GUI).The user interface 106 may be used to interact with the medical water production device 14 and may provide visual guidance in the form of tutorials (e.g., for wiping and cleaning the work surface 104 or other system 10 components or for preparing the fill receiving set 24). The user interface 106 may also be used to interact with the medical water production device 14 and may allow for changes to settings and / or the display of notifications, warnings, alarms, and other messages related to the operation of the medical water production device 14.

[0328] The second portion 98 of the enclosure also includes a user interface 108. In an exemplary embodiment, the user interface 108 is included on an articulating boom 110. The boom 110 can include multiple joints that can allow the user interface 108 to be displaced by a user to a convenient location. A bezel 112 of the user interface 108 can include an easily graspable handle that can facilitate displacement of the user interface 108. The user interface 108 can be, for example, a touch screen GUI.

[0329] The user interfaces 106, 108 may be used to interact with components of the system 10 that fill the fill receiving set 24 or (in the illustrated example) the individual bags 26. The user interfaces 106, 108 may also be used to interact with various medical systems in a hospital, urgent care center, surgery center, or similar institution. Such systems 10 may include physician order entry systems, pharmacy order entry systems, medical record systems, continuous quality improvement systems, medication error reduction systems, inventory systems, laboratory systems, medication administration libraries, and the like. Certain exemplary medical systems that may interface with the system 10 are described in further detail in U.S. Application No. 14 / 137,421, filed December 20, 2013, entitled "Computer-Implemented Method, System, and Apparatus for Electronic Patient Care," which is incorporated herein by reference in its entirety. Such systems may track the use of the system 10 to produce and package medical fluids and manage orders sent to the system 10. These other healthcare systems can also monitor production from system 10 and perform analytics on actual bag 26 usage within the institution (bag storage time, solution usage by care area, demand by day of the week, etc.). Bags 26 can include or be associated with unique identifiers to facilitate data collection for this purpose. These identifiers can be read before or during administration to indicate that fluid has been used and perhaps where within the institution the fluid is being used. This can allow for better inventory management and minimize storage costs and storage space demands. It can help enable system 10 to be implemented as part of a “just-in-time” inventory management system.Additionally, it allows for additional checks to be made to ensure that the fluid being used is the correct fluid for the particular patient (correct volume, concentration, dose, no contraindications, etc.). Software updates for the system 10 may be provided via these other medical systems as well.

[0330] In some cases, the user interface 108 may be used for user credentialing to ensure that only trained or qualified users are able to operate the system 10 for producing and packaging medical fluids. This may be accomplished via biometrics, facial recognition, pass code entry, etc., checked against a database of authorized users or pass codes. If biometrics are used, the user interfaces 106, 108 or another portion of the system 10 may be equipped with a suitable sensor (e.g., a camera, fingerprint scanner, etc.).

[0331] As best shown in FIG. 55 , the second portion 98 of the enclosure 12 can include a storage volume or bay 120. The storage bay 120 can house at least one bag feeder 128, which is ready to be filled. In an exemplary embodiment, two bag feeders 128 are housed within the bay 120. The bag feeders 128 are mounted within the system 10 via a roll cart 122. The bag feeder 128 can include a biased platform 124. The bags 26 can be stacked and positioned on the platform 124. In an alternative embodiment, the bags 26 can be included in a fill receiving set 24 and filled via a manifold 20, such as those described elsewhere herein. The bag feeder 128 can also include an upper surface 126, which can include an orifice through which the bags 26 can be pushed. When a bag 26 is removed from the stack (e.g., by a robotic manipulator, robotic flipper, or vacuum grasper), the biased platform can advance toward the top of the bag feeder 128. This can ensure that another bag 26 is available for removal from the stack until the bag feeder 128 is completely depleted. As shown, the biasing member for the platform 124 is shown as a spring, however, pneumatic, hydraulic, or other means of displacing the platform 124 can be used in alternative embodiments.

[0332] In the exemplary embodiment, a vacuum grasper 130 is included to pick up the bags 26 and displace them to a filling station or dispenser. In other embodiments, a fill nozzle assembly can be displaced to the top bag 26 and coupled to a fill port on the bag 26. In embodiments in which the bags 26 are filled through an administration set 28, the fill nozzle can be coupled to an access included on the administration set 28. The bag 26 can be transported to the filling compartment 132 of the system 10 for filling. In other embodiments, particularly those in which the administration set 28 or other conduit is integrated into the bag 26, a flipper can be used. The flipper can include a paddle member that follows the path of the administration set 28 tubing or other conduit to easily get under the bag 26 and separate it from adjacent bags 26. The flipper can then transport the bag 26 to the filling station. Any suitable vision or sensing system can additionally or alternatively be used to assist in the collection and transport of the bags 26 from the stack.

[0333] The coupling members can be cleaned when the connection between the fill nozzle and the bag 26 or administration set 28 is made. For example, a venting port from a distillation device serving as the medical water producing device 14 can be positioned to release hot steam onto the coupling surface. Alternatively, the vented hot steam can pass through the fill nozzle and be released at the coupling of the bag 26 or administration set 28.

[0334] If it is desired to fill the bag 26 with a standard fluid, such as WFI, the fluid may be provided from the medical water production device 14. In embodiments in which the system 10 is configured to fill the bag 26 with a mixed fluid, the system 10 may include bulk reservoirs 40, 42 (if desired). For illustrative purposes, the bulk reservoirs 40, 42 are labeled as 5% dextrose and 30% saline, respectively. Any other suitable bulk reservoirs 40, 42 may be utilized, and the contents of the reservoirs 40, 42 will depend on the solution desired to be produced. If the solution is a multi-component solution (e.g., Ringer's solution), bulk reservoirs 40, 42 for various components of the solution may be used. Alternatively, a single bulk reservoir 40, 42 containing a concentrate of a mixture of all of the components required for that solution may be used. The system 10 may include a pumping device 134 that meters the fluid to be delivered to the bag 26. The fluid can be metered to achieve a desired final concentration of fluid in a given bag 26. In a particular example, the pumping device 134 can be a cassette-based pumping device. One such exemplary device is provided in U.S. Application No. 16 / 384,082 (Attorney Docket No. Z55), entitled "Medical Treatment System and Methods Using a Plurality of Fluid Line," filed April 15, 2019, which is incorporated herein by reference in its entirety. When the system 10 fills the bag 26 with a mixed fluid, the system 10 can include a sensing manifold. The sensing manifold can include conductivity and temperature probes for monitoring composition. Other types of composition sensors can also be used. For example, the system 10 can include sensors such as a spectrometer, a turbidity meter, a pH probe, a polarimeter for monitoring the chiral properties of fluid components, a dissolved ion sensor, a dissolved oxygen sensor, an oxidation-reduction potential sensor, a refractometer, a TOC sensor, and the like.Similar sensors may also be capable of monitoring the output from or integrated into the medical water production device 14. Other sensors, such as bioburden sensors, may also be included. Data from any mixture quality sensor may be sent to the control system 15 of the system 10 for analysis. The data may be compared to predetermined tolerance limits or thresholds for a given fluid type. Such sensors may also be used as a redundant check in addition to the water quality tests performed by the medical water production device 14. In embodiments where the system 10 is equipped to mix various fluids, it may be desirable to take a quality reading before consuming concentrate into the fluid stream from the medical water production device 14. The sensors described above, or sensors in a separate sensing manifold, can check the quality of the WFI water output from the medical water producing device 14.

[0335] Once the bag 26 is filled, it is sealed and may then exit the filling compartment 132 and be handed off to a bucket 136 or similar holder, which places the bag 26 on a conveyor assembly 138. The conveyor assembly 138 may deliver the bag 26 to a bin or similar storage location, which may serve to hold the bag 26 until it is needed for administration. Alternatively, the conveyor assembly 138 may transport the bag 26 to a compounding area, where additional medication is introduced into the bag 26 in an automated or manual manner. In some embodiments, the conveyor assembly 138 may deliver the bag 26 to one or more automated and / or human inspection stations. The bag 26 may, in certain embodiments, be transported to a quarantine station, where it resides until it is cleared for use.

[0336] In some examples, a sensing assembly can be included to monitor the bags 26 produced by the system 10. This sensing assembly can include, for example, a visual sensor that images the bags 26. A processor can perform image analysis to screen out bags 26 that may have defects. For example, the processor can flag bags 26 that have visible particles, are the wrong color, leaks, excessive air, and other concerns of concern.

[0337] Referring now to FIG. 56 , a top-down view of another exemplary system 10 for producing and packaging medical fluids is shown. The system 10 can include a medical water production device 14, such as any of those described herein. The system 10 can also include a mixing circuit 348 and a sensor suite 350, which can monitor the quality of the purified water produced by the medical water production device 14 and the mixed fluid generated in the mixing circuit 348. The sensor suite 350 can include any number of different types of water quality sensors. Any of the water quality sensors described herein can be included. The mixing circuit 348 and sensor suite 350 can be the exemplary mixing circuit 348 and sensor suite 350 described in connection with FIG. 138 .

[0338] System 10 also includes an enclosure 12. Enclosure 12 can provide a clean room environment for the components of system 10 contained therein. Enclosure 12 itself can also be contained within a clean room environment. In such embodiments, enclosure 12 can be maintained at a higher clean room standard than the room in which it is located. In some embodiments, enclosure 12 can be maintained at a positive pressure by a blower system (not shown in FIG. 56 ). In an exemplary embodiment, enclosure 12 is divided into a first section 96 and a second section 98. Each of these sections can be maintained at a slightly different positive pressure. For example, first section 96 can be maintained at a first pressure that is positive relative to the surrounding environment. Second section 98 can be maintained at a pressure higher than the first pressure. Filling of bag 26 can occur within the most tightly controlled environment of system 10. Various filters, such as a HEPA filter, may be included to help ensure that any air blown into the enclosure 12 is clean in order to maintain a positive pressure.

[0339] The first section 96 can be an antechamber, which can be utilized to prepare various consumables used by the system 10. For example, a stock of bags 26 or a magazine 30 pre-loaded with bags 26 can be maintained in the antechamber during use. Also, a stopper magazine 466 (see, e.g., FIG. 74A) can be maintained in the antechamber. Also, sampling vials 532 (see, e.g., FIG. 103) can be maintained in stock in the antechamber. This can help minimize the need to access the interior of the enclosure 12 during operation of the system 10. Various racks, shelves, hangers, compartments, or holders may be included to help organize component inventory. The first section 96 may also include specific testing equipment that can be used to verify that the bags 26 have been filled according to predefined criteria. For example, the first section 96 may include an endotoxin or pyrogen tester, such as the Endosafe nexgen-PTS, available from Charles River Laboratories, Inc., Wilmington, Massachusetts. Additionally, any sampling ports in the fluid circuit may be accessible via the ante-chamber. The first section 96 may be constructed as a glove box and may include at least one pair of glove interfaces 352 that can be used to interact with components in the ante-chamber.

[0340] The second section 98 can include a bag feeder 354, a filling station 356, and a sealing station 358. Bags 26 can be loaded into the bag feeder 354 by a user via a gloved interface 352. Alternatively, a filler receiving set 24 can be used. In the example shown, bulk containers or cartridges of individual bags 26, or pre-loaded bag dispensers (e.g., magazines) can be held in the antechamber, and the bags 26 can be individually installed in the bag feeder 354. In certain embodiments, multiple bag feeders 354 can be included, each holding a different bag 26 type with a different fill capacity. A robotic arm 360 including a grasper can collect the bags 26 from the bag feeder 354 and displace the bags 26 to the filling station 356. Fluid can be dispensed into the bags 26 at the filling station 356. The fluid can be purified water (e.g., WFI water, etc.) or can be a mixture of fluids generated in a mixing subsystem similar to that described in connection with Figures 2A and 2B. Bag 26 can also contain a concentrate, for example, as described above in connection with Figures 5A-6. From filling station 356, robotic arm 360 can displace filled bag 26 to sealing station 358. Access to the interior volume of bag 26 can be sealed closed at sealing station 358 (e.g., via a stopper ring, RF welding, etc.).

[0341] From the sealing station 358, the bag 26 may be moved to a quarantine repository 362 contained within the second section 98 of the enclosure 12. When the bag 26 is filled and sealed, it may remain in the quarantine repository 362 for some period of time. For example, before a first bag 26 is stored in the quarantine repository 362, a sampling vial 364 may be brought to the filling station 356. A volume of fluid may be dispensed into the vial 364. The vial 364 may then be taken to a tester, such as the pyrogen (e.g., endotoxin) tester described above. Once the quarantine repository 362 is full, or after a certain number of bags 26 have been placed in the quarantine repository 362, another vial 364 of fluid may be collected at the filling station 356, and a second test may be performed in the tester. Both pre-quarantine and post-quarantine tests may be required to be passed in order for the control system 15 to allow the release of the bag 26 from the quarantine repository 362 .

[0342] Once the bags 26 are released from the quarantine section, they may be labeled. In an exemplary embodiment, the second section 98 of the enclosure 12 includes a labeler 366. The labeler 366 may be any suitable labeler 366, such as a thermal printer. A thermal ribbon transfer-type printer may be particularly desirable in certain embodiments. The labeler 366 may effect and facilitate the application of a label to each of the bags 26 produced by the system 10. The label may be adhered to the bag 26 via an adhesive backing. The label may include information required by any relevant statute or regulation, as well as identifying characteristics, tracking information, computer-readable indicia, corresponding patient information, instructions for use, etc. The bags 26 may then be discharged from the enclosure 12 through an output 368, which may include a chute with a gated or doored access. The bags 26 can exit the enclosure 12 through the output and can be discharged into a container or conveyor (neither of which are shown in FIG. 56) disposed at the exit of the output 368.

[0343] Referring now to FIG. 57, a side view of the enclosure 12 shown in FIG. 56 is shown. As shown, the side panel 370 of the first section 96 of the enclosure 12 is shown as being transparent to allow viewing of the interior of the ante-chamber. As shown, the side panel 370 can include a port 372. A glove interface 352 can be fitted into the port 372 in a fluid-tight manner. The glove interface 352 can be fitted at a height that is comfortable for an average standing or seated user. The glove interface 352 can provide a sterile barrier through which a user can operate various components of the system 10 within the enclosure 12.

[0344] Referring now also to FIG. 58 , a side view of the exemplary enclosure is shown with the side panel 370 and glove interface 352 removed. Multiple access openings from the first section 96 to the second section 98 of the housing 12 may be included. These access openings may include a bag loading door 374, a bag feeder port 376, a sealing station port 378, and a vial access door 380. The bag feeder port 376 provides access to a portion of the bag feeder 354 and may allow the bag feeder 354 to be opened so that bags 26 or pre-loaded dispensers (e.g., magazines, etc.) of bags 26 can be loaded into the bag feeder 354. The bag feeder door 374 may be opened to allow the bags 26 to be passed from the first section 96 to the second section 98 of the enclosure 12 as the bags 26 are loaded into the bag feeder 354. The sealing station port 378 can provide an opening through which a magazine (e.g., containing a supply of stoppers) can be installed into the sealing station 358. A vial access door 380 can allow vials to be introduced into and withdrawn from the second section 98 of the enclosure 12 for sample collection and testing. All interaction with these components can be through the glove interface 352. Any door can include a clean room-appropriate hinge 382. In certain embodiments, the hinge 382 can be a detent hinge that holds the attached door in place and resists inadvertent displacement therefrom. Such a hinge can also assist the attached door in reaching a predetermined position once the door is rotated within the predetermined position. For example, a detent hinge can be used that holds the attached door closed.Any door may be paired with at least one respective position sensor 384. The position sensor 384 may detect whether the door is open or closed. Any suitable type of sensor may be used, however, an inductive or magnetic sensor 384 may be preferred in certain embodiments. An antichamber door 386 may also be provided, which may include a lockable latch mechanism 388 that may be used to hold the antichamber door 386 in a closed position. The antichamber door 386 may be paired with at least one position sensor 384 similar to those described above. The control system 15 of the system 10 may monitor the output from the door position sensor 384 and generate a user interface notification when the door is open. The control system 15 may also prohibit certain actions if the door is open. For example, filling of the bag 26 may be prohibited if the door is left open.

[0345] Referring now to FIG. 59 , an exemplary embodiment of a reservoir dispenser is shown. In the exemplary embodiment, the reservoir dispenser is shown as a bag feeder 354. As shown, the bag feeder 354 can include a magazine portion 399 and a housing block 398, where the housing block 398 can form the outlet end of the bag feeder 354. In some embodiments, the magazine portion 399 can be separable from the housing block 398. In such embodiments, the magazine portion 399 can be provided pre-loaded and coupled to the housing block 398 to prepare the bag feeder 354 for use. In the exemplary embodiment, the magazine portion 399 is integral with and secured to the housing block 398. The magazine portion 399 can be opened and loaded with bags 26 by a user and can advance the bags 26 through the bag feeder 354 as the system 10 consumes the bags 26. In some embodiments, a stripper clip or magazine charger may be provided to facilitate loading of the magazine section 399. If pre-loaded magazine sections 399 or stripper clips are used, these items can be provided clean and sterile in the overpack 60, which is removed once the magazine or stripper clip has entered the ante-chamber and is ready for use.

[0346] In the exemplary embodiment, the magazine portion 399 includes a plurality of guides 390. The guides 390 may be sized to receive tubing or ports 392 extending from the bags 26. In the exemplary embodiment, one of the ports 392 includes a fin 394 that can rest on one of the guides 390, allowing the bag to hang from the guide 390. In the example, the guides 390 are constructed as a pair of rails extending parallel to one another. A slot may be present between the rails that make up each of the guides 390 and may be wide enough to receive the ports 392 of the bags 26. The exemplary guides 390 extend from a housing block 398. The housing block 398 may include a channel 400 through which the ports 392 pass as the bags 26 are fed from the antechamber into the second section 98 of the enclosure 12.

[0347] In some embodiments, a blocking plate 405 (see embodiment in FIG. 64) may be included between the guides 390. This can help prevent the user from accidentally loading a bag 26 into the bag feeder 354 by preventing the port 392 from being displaced into the space between the guides 390. Also, in some embodiments, a straightener member 407 (see embodiment in FIG. 64) may be included. The straightener member 407 may extend parallel to the guides 390 and may be positioned to prevent the bag 26 from hanging in the guides 390 in a distorted orientation. The straightener member 407 may be spaced from the guides 390 by a distance at least equal to the distance from the port 392 of the bag 26 to the nearest side edge of the bag 26.

[0348]

[0349] The magazine portion 399 of the bag feeder 354 may also include a follower, which in the exemplary embodiment is shown as a feed plate 396. The feed plate 396 may be coupled to a housing block 398 via a biasing member 401 (best shown in FIG. 64 ), which urges the feed plate 396 toward the housing block 398. The biasing member 401 may be a constant force spring in various examples. Any other suitable actuator may be used to drive the feed plate 396 toward the housing block 398. A pair of standoffs 402 may also extend from the housing block 398. The standoffs 402 may be coupled to a feed plate retainer 403. In the exemplary embodiment, a latch plate 404 is shown, which may include a latch 406. The feed plate 396 can be coupled to a plunger 408, which can be pulled through the glove interface 352 to retract the feed plate 396. A latch 406 can interface with the feed plate 396 and hold the feed plate 396 in a retracted position where the feed plate 396 is positioned a distance from the guide 390. This can allow a user to load a bag 26 into the magazine portion 399. In an alternative embodiment, a magnetic latching arrangement similar to that described in connection with FIG. 73 can be used in place of the latch 406.

[0350] In some embodiments, the latch 406 can be biased toward the latching position (e.g., via a torsion spring). When the feed plate 396 is withdrawn via the plunger 408, the latch 406 can be pushed out of the way and automatically displaced into latching engagement with the feed plate 396 when the feed plate 396 is withdrawn to a predefined open position. The latch 406 can include a sloped or beveled surface 410 (see, e.g., FIG. 61 ), which can facilitate movement of the latch 406 out of the obstructing orientation when the feed plate 396 is withdrawn into contact with the latch 406. The latch 406 can also include a recess 412, which can assist in movement of the latch 406 through the grove interface 352.

[0351] Referring now to FIG. 60, the exemplary bag feeder 354 of FIG. 59 is shown fully loaded with bags 26. In the exemplary embodiment, the bag feeder 354 has a capacity of 16 bags 26, however, in alternative embodiments, a greater or lesser number of bags 26 could be installed. Once full, and now also referring to FIG. 61, the latch 406 can be displaced out of engagement with the feed plate 396. The exemplary feed plate 396 can then be displaced into contact with the last bag 26 in the bag feeder 354 under a force exerted by a biasing member 401 (best shown in FIG. 64) connecting the feed plate 396 to the housing block 398.

[0352] Referring now to FIG. 62 , a feed plate 396 is shown in position relative to the last bag 26 installed in the bag feeder 354. As shown, the feed plate 396 can slide along two elongated members 414, and at least one of the elongated members 414 can act as one of the rods forming one of the guides 390. The feed plate 396 can also include protrusions 416, which can be spaced apart to bear against the ports 392 of the bag 26. This can help ensure that the bag 26 is retained in the bag feeder 354 in a compact, space-efficient manner. The protrusions 416 can be sized to fit within the slots of the respective guides 390. Additionally, the protrusions 416 can ensure that the last bag 26 loaded in the magazine section 399 can advance an appropriate distance through the channel 400 in the housing block 398 when the feed plate 396 is displaced along the elongated member 414 to the end of its displacement range. The feed plate 396 can be at the end of its displacement range when it is drawn against a stop surface 397 (see FIG. 59 ) of the housing block 398. In some examples, the protrusions 416 can extend a distance at least equal to the distance from the stop surface 397 to the retention pin 420. In other examples, the protrusions 416 can extend a distance equal to the distance from the stop surface 397 to the retention pin 420 minus a predetermined percentage of the diameter of the port 392.

[0353] Referring primarily to FIG. 63 , a gripper or grasper 418 attached to the robotic arm 360 (not shown for illustrative purposes; see, e.g., FIG. 56 ) of the system 10 can collect bags 26 from the bag feeder 354 as needed. As shown, each of the guides 390 can be associated with one or more retention pins 420. The retention pins 420 can hold the front-most bag 26 in the bag feeder 354 against the force exerted by the feed plate 396. In an exemplary embodiment, two retention pins 420 are included on opposite sides of each channel 400. The exemplary retention pins 420 can be positioned to protrude into the path of the bags 26 traveling through the channels 400 of the housing block 398 and obstruct passage of the ports 392 attached to the respective bags 26. In some embodiments, the retention pins 420 can be positioned at an angle of 10° to 20° (e.g., 15°) relative to the axis of the guide 390.

[0354] The retention pin 420 may be biased to an obstructing position but may be displaceable to an extended position in which the retention pin 420 is at least partially pressed into the housing block 398 and out of the way of the bag 26. In certain embodiments, and as shown in FIG. 64 , the grasper 418 may be configured such that when open, the jaws 422A, B of the grasper 418 may be appropriately spaced to actuate the retention pin 420 from the obstructing position to the extended position as the grasper 418 is advanced toward the bag feeder 354. As the grasper 418 is displaced toward the bag feeder 354, the jaws 422A, B may urge the retention pin 420 toward a retracted state. The jaws 422A, B may support the fins 394 of the port 392 on the bag 26 to prevent the bag 26 from falling out when the retention pin 420 is retracted. The force exerted by the feed plate 396 can help push the front-most bag 26 into the grasper 418 jaws A, B. The coefficient of friction of the grasper 418 material and port 392 under the force exerted by the feed plate 396 can be sufficient to hold the bag 26 in place prior to closure of the jaws 422 A, B. A similar retention pin 420 can be incorporated into the bag feeder 28 described in connection with Figures 54-55.

[0355] The grasper 418 can include a driver 419, which includes one or more actuators for displacing the jaws 422A, B. Additionally, a jaw position sensor 423 can be included. The jaw position sensor 423 can monitor the location of the jaws 422A, B via a magnetic field-based sensor (e.g., an inductive sensor or a Hall Effect sensor). The control system 15 of the system 10 can check the output of the jaw position sensor 423 to determine whether the bag 26 has been properly grasped by the grasper 418. In some embodiments, the control system 15 can compare the position output of the jaw position sensor 423 with a predefined range of acceptable positions. If the jaws 422A, B are displaced to the extremes of their displacement range (e.g., fully closed), the control system 15 can infer that the grasper 418 has missed the bag 26. If the jaws 422A,B are displaced outside the predefined range but not to the extreme end of the displacement range, the control system 15 can infer that the grasper has improperly grasped (e.g., only partially grasped a segment of the port 392 as opposed to encircling and closing the port 392 as shown in FIG. 65). When the control system 15 determines that the position output of the jaw position sensor 423 is outside the predefined range, the control system 15 can instruct the grasper 418 to retry. There can be an upper limit on the number of retries allowed before the control system 15 can generate an error. The jaw position sensor 423 can be monitored when a bag 26 is removed from the bag feeder 354, although the control system 15 can also perform this check at any other time a bag 26 is grasped 418 in the system 10.

[0356] Referring now primarily to FIG. 65, once the jaws 422A, B are closed around the port 392, the front-most bag 26 can be removed from the bag feeder 354 and displaced by the robotic arm 360 (for ease of illustration, only the gripper 418 of the robotic arm 360 is shown) to, for example, the filling station 356. The feed plate 396 can be advanced under the force of a biasing member 401 (best shown in FIG. 64) that attaches it to the housing block 398. Additionally, as the gripper 418 is displaced away from the bag feeder 354, the retention pin 420 can be urged back to the blocking position. Thus, the next bag 26 in the bag feeder 354 can be advanced and ready for collection by the gripper 418.

[0357] Referring now to FIG. 66 , an exemplary fill station 356 is shown. As shown, the fill station 356 can include a fill nozzle 430, which can be connected to a fluid input line 432. The fluid input line 432 can carry purified water or a mixed fluid (e.g., saline) that has been passed through the sensor suite 350 and deemed acceptable. The fill nozzle 430 can be disposed above and aligned with a drain 434. The drain inlet 434 can include a tapered, funnel-like opening that leads to a drain conduit 436. As shown, the drain conduit 436 has a larger diameter than the fluid input line 432. In an example, the diameter of the drain conduit 436 can be three times the diameter of the fluid input line 432. This can help ensure that the drain conduit 436 has the capacity to carry any unwanted flow or drip from the fill nozzle 430.

[0358] The filling station 354 may also include a back plate 442 extending from the filling station housing block 438. The back plate 442 may include multiple mounting points for bag characteristic sensors 444A, B, C. The bag characteristic sensors 444A-C may be any suitable sensors capable of collecting data about differentiating characteristics of various bags that may be utilized with the system 10. The bag characteristic sensors 444A-C may sense the presence or absence, color, shape, size, etc., of the bag 26 material. Preferably, the bag characteristic sensors 444A-C are sufficient to identify at least the volume of the bag 26 in place at the filling station 356. Thus, the bag characteristic sensors 444A, B, C may form a reservoir volume sensing assembly in some examples.

[0359] In an exemplary embodiment, bag characteristic sensors 444A-C are positioned to collect sufficient information to determine the type of bag 26 docked on the filling station 356. The exemplary bag characteristic sensors 444A-C can be, for example, beam-break or reflectance-based sensors, which can determine the presence or absence of bag material in their vicinity. In an exemplary embodiment, a bag presence detector 444B is included to determine whether a bag 26 has been docked in the filling station 354. The bag presence detector 444B can be mounted on the back plate 442 in a location that can detect any of the various types of bags 26 that can be used in the system 10 (e.g., from mini bags to bags with a capacity of one liter or more). If the bag presence detector 444B does not detect that the bag 26 is in the proper location at the filling station 356, the filling station 356 can be inhibited from dispensing liquid via the control system 15. A bag width detector 444A can be included and mounted on the back plate 442 in a location that can detect whether the width of the bag 26 is greater than a specified value. Width detector 444A may be located more proximal to fill nozzle 430 to ensure that any bag 26 having a width greater than a threshold width value (regardless of its length) will be picked up by width detector 444A. Bag length detector 444C may be mounted on back plate 442 at a location that can detect whether a bag 26 is longer than a certain value. Bag length detector 444C may be disposed most distally of fill nozzle 430. Based on the data collected by bag characteristic sensors 444A-C, control system 15 can determine the type of bag 26 to be docked into fill station 356. Control system 15 can, for example, determine the intended fill volume of a bag 26 based on the data collected from bag characteristic sensors 444A-C to ensure that the bag 26 is not overfilled.A lookup table or the like may be used to determine the intended bag 26 fill volume based on the output of each of the bag characteristic sensors 444A-C. Other embodiments may include additional bag characteristic sensors 444A-C. For example, certain embodiments may include additional width or length detectors 444A, C to provide additional data related to bag 26 dimensions. In some embodiments, each bag characteristic sensor 444A-C may be accompanied by a redundant sensor.

[0360] In an exemplary embodiment, the drain inlet 434 and attached drain conduit 436 may be pivotally or otherwise displaceably coupled to a fill station housing block 438. When a bag 26 is introduced into the fill station 356 by the grasper 418, jaws 422A, B of the grasper 418 may drive the drain inlet 434 and drain conduit 436 to a retracted position. As shown in FIG. 67, the fill station 356 may include a fill station grasper 440. The fill station grasper 440 may be opened by a grasper driver 446 to receive the port 392 of the bag 26 and may be driven closed when the robotic arm 360 (see, for example, FIG. 56) is displaced to preprogrammed bag 26 docking coordinates. Cooperation between the fill station grasper 440 and the robotic arm 360 may be directed by the control system 15.

[0361] As shown in FIG. 68 , the grasper 418, which is attached to the robotic arm 360 (see, e.g., FIG. 56 ), can be displaced away from the filling station 356 during the filling of the bag 26. The grasper 418 can be used to perform other operations within the enclosure 12 while the bag 26 docked on the filling station 356 is being filled. For example, the grasper 418 can be used to retrieve, label, and dispense the completed bag 26 from the quarantine repository 362 while the bag 26 is being filled at the filling station 356. Once the bag 26 is filled to a desired volume (e.g., as indicated by one or more flow meters in the sensor suite 350), the grasper 418 can return and collect the filled bag 26 from the filling station 354. As shown in FIG. 69 , the jaws 422A, B of the grasper 418 can be actuated to close around the port 392 of the filled bag 26, and the fill station grasper 440 can be driven open by the grasper driver 446. In certain embodiments, the robotic arm 360 may not be displaced away from the fill station 356 under various circumstances. For example, if a small 100 mL bag 26 is to be filled, the fill time of the bag 26 should be minimal, so the robotic arm 360 can remain in place. If a large bag 26 (e.g., several liters) is to be filled, the fill time may have a duration that will allow the robotic arm 360 to complete one or more other tasks, so the grasper 418 can be displaced away from the fill station 356.

[0362] 70, the grasper 418 can remove the filled bag 26 from the filling station 356. After removal from the filling station 356, the filled bag 26 can be taken to the sealing station 358. As shown, the drain inlet 434 can automatically return to alignment with the fill nozzle 430 when the bag 26 is collected from the filling station 356. A biasing member (see, for example, biasing member 454 in FIG. 71B) can be included to facilitate this automatic return of the drain inlet 434 to the aligned position.

[0363] 71A and 71B, the drain inlet portion 434 can be attached to a flange 448, which can pivotally mount the drain inlet portion 434 to the fill station housing block 438. The flange 448 can include a track 450, and a pin 452 extending from the fill station housing block 438 is disposed in the track 450. The pin 452 can remain stationary when the pin 452 in the track 450 is attached to the fill station housing block 438. At least one biasing member 454 can be coupled to the pin 452 as well as to a mounting pin 456 included on the flange 448. The mounting pin 456 can be displaceable along with the flange 448 and the drain inlet portion 434. In the example, one biasing member 454 is depicted and is shown as a tension spring, but other types of biasing members 454 can be used in alternative embodiments. As shown, when the drain inlet portion 434 is displaced, the track 450 can advance along the stationary pin 452. The distance between the mounting pin 456 and the stationary pin 452 can be increased, and the biasing member 454 can be extended (see, e.g., FIG. 71B). When the biasing member 454 restores (e.g., after the bag 26 has been filled and removed), the track 450 can advance along the pin 452 until the distance between the two pins 452, 456 is minimized or the biasing member 454 returns to its rest state. As shown, this can automatically pivot the drain inlet portion 434 back into alignment with the fill nozzle 430 (see, e.g., FIG. 71A).

[0364] As shown, the filling station 356 may include a drain inlet sensor 437. The drain inlet sensor 437 may monitor the location of the drain inlet 434. The drain inlet sensor 437 may be any suitable sensor, for example, a magnetic field sensor (e.g., an inductive sensor or a Hall Effect sensor, etc.). In some embodiments, the drain inlet 434 or flange may include a magnetic or metallic object that may be monitored by the drain inlet sensor 437. The drain inlet sensor 437 may alternatively be an optical sensor. The control system 15 may receive an output signal from the drain inlet sensor 437 and ensure that the drain inlet 434 is disposed in an expected position. For example, the control system 15 may verify that the drain inlet 434 returns to alignment with the fill nozzle 430 after the bag 26 is filled and removed. Additionally, control system 15 may check the output of drain inlet sensor 437 to ensure that drain inlet 434 is aligned below fill nozzle 430 before commanding a flush of fill nozzle 430 or sanitizing of the fluid circuit. During sanitizing, hot purified water may be delivered through the fluid circuit and dumped through fill nozzle 430 into drain inlet 434.

[0365] Referring now to FIG. 72 , an exemplary embodiment of the sealing station 358 is shown. As shown, the sealing station 358 can include a base plate 460. A ram driver 462 can be mounted to the base plate 460. The ram driver 462 can provide displacement of a ram 464 that can drive the stopper into the port 392 of the bag 26. In some embodiments, the ram driver 464 can be capable of exerting a force of at least 100 lbs against the stopper 476 during stoppering of the bag 26. A rest 463 can be attached to the base plate 460. A grasper 418 that holds the bag 26 can be docked onto a docking surface (e.g., an upper surface) of the rest 463 during sealing of the bag 26, so as to butt the grasper 418 against the force exerted by the ram driver 462. In the exemplary embodiment, the rest 463 is shown as a metal shelf, but any suitable material can be used. In the example, two rests 463 are shown. The rests 463 can also act as guides. As shown, two rests 463 can be spaced apart by a gap that can allow the bag 26 to be positioned between the rests 463. The bag 26 can be displaced into this gap to help position the bag 26 port 392 in alignment with the axis of displacement of the ram 464.

[0366] Also included within the exemplary sealing station 358 is a stopper dispenser, shown in the exemplary embodiment as a stopper magazine 466. The stopper magazine 466 can be docked into a magazine receiver 468 within the sealing station 358. The stopper magazine 466 can include an opening 472 that is aligned and sized to allow passage of the ram 464 when the stopper magazine 466 is in place in the magazine receiver 468. A follower assembly 470 can be included to automatically advance the stoppers through the stopper magazine 466 as they are dispensed.

[0367] Referring now to FIG. 73 , in an exemplary embodiment, the stopper magazine 466 may be provided in a pre-loaded state. The stopper magazine 466 may be packaged clean and sterile within the overpack 60, which may be opened in the ante-chamber of the system 10. In the exemplary embodiment, the stopper magazine 466 has a capacity of 22 stoppers 476; however, in other embodiments, the capacity of the stopper magazine 466 may be less or greater. In the exemplary embodiment, the cover plate 474 (see, e.g., FIG. 72 ) has been removed to reveal the stoppers 476. After removing the stopper magazine 466 from its overpack 60, the stopper magazine 466 may be docked onto the magazine receiver 472. In certain embodiments, the magazine receiver 472 is capable of accepting a variety of different stopper magazine 466 types. For example, certain embodiments may include a magazine receiver 472 that can accept any of the stopper magazines 466 shown and described herein. This may allow a user to use stopper magazines 466 of different capacities as desired. In some embodiments, the stopper magazine 466 may not be a removable magazine. Instead, a fixed magazine may be included that is manually loaded by an operator of the system 10 while in place on the base plate 460, or loaded with the assistance of a speed loader.

[0368] To load the exemplary stopper magazine 466 into the sealing station 358, the follower assembly 470 can be retracted by the user. As shown, the follower assembly 470 can include a handle 478. The handle 478 can allow the user to easily pull the follower 482 of the follower assembly 470 into the loaded state through the gloved interface 352. In some embodiments, a latch similar to that shown in FIG. 59 can be included to hold the follower assembly 470 in the open state. When the follower assembly 470 is in the loaded state, the follower 482 can be displaced to a point where there is sufficient clearance to fit the stopper magazine 466 in the appropriate location on the magazine receiver 472.

[0369] The handle 478 may be coupled to a follower block 480. The follower block 480 may include a follower 482. The follower block 480 may be coupled to the magazine receiver 472 via a biasing member 484. In the exemplary embodiment, the biasing member 484 is shown as a constant force spring, however, in other embodiments, other types of biasing members 484 may be used. The biasing member 484 may exert a force on the follower block 480, which maintains the follower 482 in intimate contact with the last stopper or stops 476 in the stopper magazine 466. The follower block 480 may be displaceable along one or more follower guides 502, which constrain the movement of the follower 482 along a predetermined path. In the exemplary embodiment, an end block 504 is included on the end of the guide 502 that is most distal to the magazine receiver 472. The end block may include a magnet 500. The magnet 500 is capable of interacting with a metallic portion of the follower block 480 to hold the follower assembly 470 in an open position while the stopper magazine 466 is being loaded.

[0370] The exemplary stopper magazine 466 is shown as a multi-column magazine. The follower 482 includes staggering projections 486 extending from the stopper-contacting portions of the follower 482. The staggering projections 486 can help ensure orderly feeding of the stoppers 476 as the stopper magazine 466 is depleted. The staggering projections 486 can encourage the stoppers 476 in one column to be offset from the stoppers 476 in an adjacent column. This can help prevent clogging and facilitate movement of a single stopper 466 from multiple columns into an opening 472 (see, e.g., FIG. 72 ) in the stopper magazine 466.

[0371] 74A and 74B, a diagram of an exemplary stopper magazine 466 is shown. As shown, the stopper magazine 466 can include a magazine body 508. The magazine body 508 can include a plurality of stopper troughs 510 recessed therein. Divider walls 488 can separate and partially define each trough 510. The stopper magazine 466 can also include ridges 490 flanking each trough 510. Any divider walls 488 and ridges 490 can be of equal height. In some examples, the stopper 476 can include sections of varying diameter. The ridges 490 and dividing walls 488 can have heights selected such that a step region 512 on the stopper 476, where the stopper 476 transitions to a larger diameter, can run along the top surface of the ridges 490 and dividing walls 488. Also, as shown, the stopper magazine 466 can include a slit 492. The slit 492 can allow passage of a portion of the follower assembly 470, including the follower 482, into and displacement within the stopper magazine 466.

[0372] In the exemplary embodiment, the stopper magazine 466 includes a mating feature that can facilitate installation of the stopper magazine 466 onto the magazine receptacle 472. In the exemplary embodiment, two mounting or mating pins 494 are included in the stopper magazine 466. These mating pins 494 can be received in alignment holes in the magazine receptacle 472. In certain embodiments, the mating pins 494, a portion of the alignment holes, or both, can be magnetic. This can allow the stopper magazine 466 to be magnetically coupled to the appropriate location in the magazine receptacle 472. The magazine receptacle 472 can also include a magazine sensor 473 (see, for example, FIG. 77B ). A Hall effect or inductive sensor capable of registering proper engagement of the stopper magazine 466 into the magazine receptacle 472 may be used in some examples. Other types of sensors (e.g., microswitches, optical sensors, button-type sensors, etc.) may also be used to monitor whether the stopper magazine 466 is installed in the magazine receptacle 472. In some embodiments, a magnetic material may be included elsewhere in the stopper magazine 466 for sensing by a magnetic magazine sensor 473. In some embodiments, the control system 15 of the system 10 may not allow displacement of the ram 464 unless the magazine sensor 473 indicates that the stopper magazine 466 is installed in the magazine receptacle 472.

[0373] 75-77B, the stopper magazine 466 can include a blocking element that inhibits premature release of the stoppers 476 from the stopper magazine 466. An exemplary stopper magazine 466 includes a displaceable handle 496. The displaceable handle 496 can include a loop, flange, or similar feature that allows a user to easily pull the displaceable handle 496 through the glove interface 352 of the system 10. The displaceable handle 496 can be coupled to an exit cover 498 (see, for example, FIG. 74A). The exit cover 498 can prevent the exit of the stoppers 476 from the stopper magazine 466. The displaceable handle 496 can be integral with the exit cover 498 (best shown in FIG. 74B) or can be coupled thereto via a linkage. When a user displaces the displaceable handle 496, the outlet cover 498 can be displaced or pulled away from the blocking position to allow passage of the stoppers 476 out of the stopper magazine 466. The displaceable handle 496 can be displaced along guide slots 506 contained within a body portion 508 of the stopper magazine 466. In some embodiments, the displaceable handle 496 can be completely removed from the stopper magazine 466 prior to use.

[0374] In operation, and as shown in FIG. 75 , a user can position the follower 482 against the stopper 476 in the stopper magazine 466 prior to actuation of the outlet cover 498 to the extended position. Thus, when the outlet cover 498 and displaceable handle 496 are displaced as shown in FIGS. 76-77A , the stopper 476, aligned with the exit port 514 from the stopper magazine 466, can be frictionally held within the stopper magazine 466 through the application of force exerted through the follower 482 via the biasing member 484. Only the head portion of the stopper 476 can be frictionally held in place against the stopper magazine 466. The stem portion of the stopper 476 can be out of contact with the stopper magazine 466. With the follower 482 deployed against the stopper 476 and the outlet cover 498 extended, the sealing station 358 can be considered in a ready state.

[0375] 78 , when the sealing station 358 is in a ready state, the robot arm 360 can displace a bag 26 to the sealing station 358 via the gripper 410. The gripper 410 can align the port 392 of the bag 26 to be sealed under the exit port 514 of the stopper magazine 466. The control system 15 can command the ram driver 462 to displace the ram 464 through the opening 472 of the stopper magazine 466. The ram 464 can contact the head portion of the stopper 476, and the stopper 476 can begin to displace with the ram 464. In an exemplary embodiment, the actuated stopper 476 can travel along a guide portion 516 of the stopper magazine 466 as it is displaced toward the port 392 of the bag 26. The guide portion 516 can ensure that the stopper 476 is displaced substantially in line with the axis of the port 392. The stem or smaller diameter portion of the stopper 476 may enter the port 392 of the bag 26 before the stopper 476 is displaced past the guide portion 516 of the stopper magazine 466. The ram 464 may continue to be driven by the ram driver 462 until the step 512 of the stopper 476 abuts the top of the port 392. In certain embodiments, the ram 464 may be displaced until at least a threshold amount of the stem or smaller diameter portion of the stopper 476 is within the port 392. For example, the stopper 476 may be driven until at least 75% of the stem is within the port 392. The control system 15 monitors position feedback from the ram driver 462 to determine the travel distance of the stem portion of the stopper 476 into the port 392.

[0376] As mentioned above, in some examples, the control system 15 can inhibit displacement of the ram 464 unless the magazine sensor 473 (see, e.g., FIG. 77B ) registers that the stopper magazine 466 is properly loaded into the sealing station 358. In certain embodiments, the control system 15 can also monitor data from a bag detection sensor. In some embodiments, a port detection sensor 475 can be used that monitors, for example, for the presence of a port 392 in the bag 26. The port detection sensor 475 can be an optical sensor, such as a reflectance-based sensor. Such a sensor can monitor, for example, the intensity of the reflection of light emitted from the sensor. The port detection sensor 475 can detect whether the port 392 in the bag 26 is in the proper location for stoppering. The control system 15 can inhibit displacement of the ram 464 unless the port detection sensor 475 indicates that the port 392 is in the proper position.

[0377] 79, once the stopper 476 is in sealing engagement with the port 392, the ram 464 may be withdrawn. The control system 15 may command the ram driver 462 to withdraw the ram 464, and the follower assembly 470 may automatically advance the stopper 476 in the stopper magazine 466 such that the next stopper 476 in the stopper magazine 466 is aligned with the exit port 514 of the stopper magazine 466. As shown in FIG. 80, the sealed bag 26 may then be displaced from the sealing station 358 to the quarantine repository 362.

[0378] 81A-81B, in some embodiments, the sealing station 358 can accept different stopper magazines 466 or can be designed to accept a variety of stopper magazines 466 having different styles, capacities, or containing different stopper 476 types and sizes. For example, a single-column magazine, a drum-type magazine, or any other suitable type of stopper magazine 466 can be used. A modified version of the stopper magazine 466 shown in FIGS. 74A and 74B is shown in FIGS. 81A-81B. As shown, the exit port 514 of the stopper magazine 466 is elongated and extends all the way to the forward end of the stopper magazine 466. The elongated shape can allow for greater alignment tolerances when the stoppers 476 are displaced out of the exit port 514. Additionally, the wall of the exit port 514 can include a guide portion disposed in a portion of the wall of the exit port 514 adjacent the exterior surface of the magazine body 506. The guide portion, in some embodiments, can include a chamfer 477 or fillet applied to the edge where the exterior surfaces of the exit port 514 and the magazine body 506 meet. Such a chamfered exit port 514 can be included with any of the stopper magazines 466 described herein.

[0379] Referring now to FIG. 81C , in certain embodiments, the port 392 of the bag 26 can be displaced into the exit port 514 of the stopper magazine 466 prior to sealing of the port 392. A chamfer 477 on the exit port 514 of the stopper magazine 466 can be designed to facilitate this action. As shown in FIG. 81C , the ram 464 can be driven into the stopper magazine 466 until it contacts the stopper 476 that is aligned with the exit port 514. The ram 464 can be parked in this position, and the grasper 418 can raise the bag 26 so that the stopper 476 is seated partially (e.g., 25-35% or less) into the port 392. The ram 464 can prevent the stopper 476 from being pushed upward as this occurs. A chamfer 477 on the exit port 514 of the stopper magazine 466 can funnel or direct the port 392 of the bag 26 into alignment with the stem or smaller diameter section of the stopper 476. Once the stopper 476 is partially seated within the port 392, the ram 464 can then be actuated by the ram driver 462 to complete the seating of the stopper 476 within the port 392 and seal the bag 26.

[0380] Referring now to FIGS. 82A-82C, views of another exemplary stopper magazine 466 are shown. As shown, the exemplary stopper magazine 466 includes an exit port 514 with a chamfer 477. As described above, the chamfer 477 can funnel or direct the port 392 of the bag 26 into alignment with the stem or smaller diameter section of the stopper 476. Additionally, as best shown in FIG. 82C, a detent member 479 can be included in the wall of the exit port 514. Such a detent member 479 can be included in any of the stopper magazines 466 described herein. In an exemplary embodiment, the detent member 479 includes a ball-type detent. In alternative embodiments, the detent member 479 can be a barb, bump, or other protrusion. The detent member 479 can protrude into the exit path of the stopper 476 traveling through the exit port 514. A step region 512 of the stopper 476 can catch on the detent member 479 and help retain the stopper 476 in the stopper magazine 466. As best shown in FIG. 82A, an embodiment including the detent member 479 can omit the displaceable handle 496 (see, e.g., FIG. 74B) and attached guide track 506 (see, e.g., FIG. 74B) coupled to the outlet cover 498.

[0381] Referring now to FIG. 83 , an exemplary drum-type stopper magazine 466 is shown. The stopper magazine 466 may include a drum body 630. The drum body 630 may include a spiral trough or track 632, which may be deep enough to receive the stoppers 476 therein. The stopper magazine 466 may also include a biasing member, such as a constant force spring 634. The constant force spring 634 may be connected to a follower 636, which may be positioned behind the last stopper 476 in the stopper magazine 466. The stopper magazine 466 may also include a removable cover member (not shown), which may be positioned over the stopper magazine 466 and enclose the stoppers 476 within the stopper magazine 466. The exemplary drum-type stopper magazine 466 has a capacity of 64 stoppers 476. In other embodiments, the capacity may be higher (eg, up to 100 or more) or lower (eg, 50 or less).

[0382] 84-86 , when the stopper magazine 466 is depleted, the constant force spring 634 can pull the follower 636 along the helical path 632 of the drum body 630. This can then advance the remaining stoppers 476 in the stopper magazine 466. As shown, the helical path 632 can include a trough portion 640. The trough portion 640 can receive the stem or reduced diameter section of each of the stoppers 476. Thus, the trough portion 640 can act as a guide for the stoppers 476 as they are displaced along the helical path 632. In certain embodiments, the follower 636 can be sized to follow the trough 640, and thus the trough portion 640 can act as a follower guide during operation. The trough portion 640 may be flanked on each side by a ledge portion 642 upon which the step region 512 of the stopper 476 may rest.

[0383] The stopper magazine 466 is shown empty in FIG. 86 . As shown, the exit port 638 for the stopper 476 can be sized to substantially match the dimensions of the head or larger diameter portion of the stopper 476. Additionally, the exit port 638 can be at least partially surrounded by a guide wall 644. The guide wall 644 can be positioned in front of the exit port 638 to prevent the constant force spring 634 from advancing the stopper 476 beyond the exit portion 638. The guide wall 644 can also have a guide surface 646 with a curvature that helps position the head portion of the stopper 476 in alignment with the exit port 638.

[0384] Although not shown in FIG. 86, a mating pin 492 (see, for example, FIG. 74A) may be included. The mating pin 492 may aid in the placement of the stopper magazine 466 in the magazine receptacle 472. The mating pin 492 may also enable the magazine sensor 473 to detect the presence of the stopper magazine 466 in the magazine receptacle 472.

[0385] Referring now to FIG. 87 , an exploded view of another exemplary stopper magazine 466 is shown. As shown, the stopper magazine 466 of FIG. 87 is a drum-type magazine. The stopper magazine 466 can include a drum body 650 having a helical trough or track 654 formed therein. A rotor element 656 can also be included, which can include a plurality of flutes 658 extending therethrough. The flutes 658 can be sized to receive the stoppers 476 therein. A biasing assembly 652 can also be included within the exemplary stopper magazine 466. In the exemplary embodiment, the biasing assembly 652 can include a torsion or wound spring 660, similar to the exemplary embodiment. A portion of the wound spring 660 can be attached to a spindle 662 included within the biasing assembly 652, which extends through the drum body 650 and the rotor 656. Typically, the wound spring 660 may be contained within a housing, which is not shown in FIG. 87 to better illustrate the wound spring 660. The spindle 662 may include a keyed segment 664 that interfaces with the rotor 656. In an exemplary embodiment, the keyed segment 664 may be "D" shaped to ensure that the rotor 656 rotates in unison with the spindle 662. In other embodiments, the keyed segment 664 may have a different cross-sectional shape, such as a square or star shape. In operation, a user may grasp the knob 666 attached to the spindle and rotate the spindle 662. This may cause the wound spring 660 to store energy, which may be used to turn the rotor 656 and advance the stopper 476 along the helical track 654.The stopper magazine 466 can also include a removable cover member (not shown) that can be placed over the stopper magazine 466 to enclose the stopper 476 and rotor 656 within the stopper magazine 466. As with the other stopper magazine 466 embodiments, a mating pin 492 (see, for example, FIG. 74B) can be included to aid in the placement and detection of the stopper magazine 466 within the magazine receptacle 473.

[0386] Referring now to FIG. 88 , a top-down view of the exemplary stopper magazine 466 of FIG. 87 is shown. As shown, the stopper magazine 466 is fully loaded with stoppers 476. The exemplary stopper magazine 466 has a capacity of 108 stoppers 476 in the exemplary embodiment, although, as with the other stopper magazines 466 described herein, the capacity may be lower or higher depending on the embodiment. As shown, the flutes 658 are of different lengths and extend from the periphery of the rotor 656 toward the center of the rotor 656. This variety of different length flutes 658 can increase the space efficiency of the stopper magazine 466 and allow a large number of stoppers 476 to be loaded into the stopper magazine 466.

[0387] Still referring to FIG. 88 , a stopper 476 is shown in the exit port 668 of the stopper magazine 466. The edges of the flutes 658 in which the stopper 476 is disposed can press against the head of the stopper 476. The biasing assembly 652 of the stopper magazine 466 can be preloaded as the stopper magazine 466 is operated, so that the flutes 658 can exert sufficient force against the stopper 476 to frictionally hold the stopper 476 against the walls of the exit port 668. Additionally, the stopper 476 in the exit port 668 can present an interference against the walls of the flutes 658, which prevents the rotor 656 from displacing under the force of the biasing assembly 652. When the stopper 476 is driven out of the stopper magazine 466, such as by the ram 464 (see FIG. 89 ), the interference can be removed and the rotor 656 can rotate freely. The rotor 656 can be displaced along the spiral track 654 of the drum body 650, pushing against the stopper 476, as shown in FIG. 90. This can advance the next stopper 476 into the exit port 668, again presenting an interference to further displacement of the rotor 656.

[0388] 91, when the stopper magazine 466 is depleted, the smaller flutes 658 of the rotor 656 may be emptied of stoppers 476. The exemplary stopper magazine 466 is arranged to automatically index to the next available stopper 476, automatically skipping any empty flutes 658. In the example shown in FIG. 91, the stopper 476 at the exit port 668 is separated from the next available stopper 476 by two empty flutes 658. As stoppers 476 are dispensed from the exit port 668 (see FIG. 92 ), the rotor 656 is free to advance until the next stopper 476 comes into alignment with the exit port 668 and presents an interference to further movement of the rotor 656, as shown in FIG. 93 . Thus, the stopper magazine 466 can automatically index to the next stopper 476, even when the required rotational displacement is variable. It should be noted that in other embodiments, other rotor drive assemblies can be utilized in addition to the biasing assembly 652 shown. For example, a motorized displacement assembly can be included in place of the biasing assembly 652. In such an example, the control system 15 can track the number of stoppers 476 dispensed from the magazine 466 and use this count to ensure that the motorized displacement assembly drives the rotor 656 the appropriate amount to advance the next stopper 476 to the exit port 668.

[0389] Referring now to FIG. 94 , an exploded view of another stopper magazine 466 is shown. As shown, the stopper magazine 466 can include a magazine body portion 670. The magazine body portion 670 can include a trough 672. The trough 672 can receive the stem or smaller diameter section of each of the stoppers 476. Thus, the trough portion 672 can act as a guide for the stoppers 476 as they are displaced toward the exit port 690 (see, for example, FIG. 95 ) of the stopper magazine 466. The trough portion 672 can be flanked on each side by a ledge portion 676, upon which the step region 512 of the stopper 476 rests. Also, in the illustrative embodiment, the stopper magazine 466 can include two plates 674 that can be attached to the magazine body portion 670 on opposite sides of the trough 672. The plates 674 can partially overhang the troughs 672. These overhanging portions of the plates 674 can ensure that the stoppers 476 do not fall out of the stopper magazine 466 during shipping or when the stopper magazine 466 is being handled. Additionally, the exit port 690 can be at least partially surrounded by a guide wall 678. The guide wall 678 can be positioned in front of the exit port 690 to prevent the stoppers 476 from advancing beyond the exit port 690. The guide wall 644 can also have a guide surface 680 with a curvature that helps position the head of the stopper 476 in alignment with the exit port 690.

[0390] 95 and 96, the stopper magazine 466 can also include a follower assembly 682. The follower assembly 682 can include a follower block 684 that includes a follower 686. The follower 686 can include a stopper contact surface having an arcuate shape that embraces the head or larger diameter portion of the stopper 476. A biasing member 688 can also be included in the follower assembly 682. In the exemplary embodiment, the biasing member 688 is shown as a constant force spring that is mounted to a mounting block 692 that is attached to the follower block 684. As best shown in FIG. 94, the magazine body 670 can include a routing channel 694 that allows an end of the constant force spring to be fed through the magazine body 670 to a mounting point on the exterior surface of the guide wall 678. As shown in FIG. 95 , for example, the end of a constant force spring can be coupled to the outer surface of the guide wall via a fastener 696. When a stopper 476 is dispensed from the exit port 690 of the magazine body 670, the biasing member 688 can exert a force on the follower block 684, which displaces the follower block 684, the follower 686, and any remaining stoppers 476 in the stopper magazine 466 toward the exit port 690. This can advance the next stopper 476 into alignment with the exit port 690. Also, in the exemplary embodiment, the follower assembly 682 includes two guide rails 698. The guide rails 698 can extend parallel to each other on opposite sides of the trough portion 672. These guide rails 698 extend through the follower block 684 and can guide the displacement of the follower block 684 as the stoppers 476 are dispensed from the stopper magazine 466 .As with the other stopper magazine 466 embodiments, a mating pin 492 may be included to aid in the placement and detection of the stopper magazine 466 within the magazine receptacle 473 .

[0391] 97-99, yet another exemplary stopper magazine 466 is shown. As shown, the stopper magazine 466 is similar to that shown in FIG. 74A, however, the stopper magazine 466 includes slots 700 that extend through the bottom of each of the stopper troughs 510. These slots 700 can allow the stopper magazine 466 to be loaded with a speed loader 702. The speed loader 702 can include a plate 704 having a stopper rack 706 that can hold a plurality of stoppers 476. The stopper rack 706 can define the spacing of the stoppers 476 on the speed loader 702. In the exemplary embodiment, when the stoppers 476 are installed in the stopper rack 706, the stoppers 476 can be arranged in a staggered double-column type configuration suitable for the stopper magazine 466. The speed loader 702 may be provided clean and sterile in an overpack. The user may maintain a stock of speed loaders 702 in the ante-chamber of the system 10, and the stopper magazine 466 may remain in place or may be integrated into the sealing station 358. If necessary, the speed loader 702 may be opened and used to refill the stopper magazine 466 during a bag 26 sealing operation.

[0392] 98 and 99, to load stoppers 476 into the stopper magazine 466, the speed loader 702 may be positioned in alignment with an opening in the stopper magazine 466 and introduced into the stopper magazine 466. Similar to FIG. 74A, the magazine may include divider walls 488 that separate and partially define respective troughs 510. The stopper magazine 466 may also include ridges 490 located on the sides of each trough 510. The divider walls 488 and the ridges 490 may be of equal height. The heights may be selected so that step regions 512 on the stoppers 476 can hook onto the upper surfaces of the ridges 490 and the dividing walls 488, allowing each stopper 476 to hang down in its respective stopper trough 510. The plate 704 of the speed loader 702 may include a slit 708 that may allow the dividing wall 488 to pass through the plate 704 when the speed loader 702 is lowered. As the plate 704 is lowered, the ridge 490 and the upper surface of the dividing wall 488 may begin to support the stopper 476. At this point, the plate 704 may be displaced relative to the stopper 476. The plate 704 may continue to be lowered until the stopper rack 706 portion of the plate 704 passes through the slot 700 in the stopper trough 510 and the stopper 476 is completely separated from the rack 706. Plate 704 can then be discarded and the follower assembly (e.g., follower assembly 470 of FIG. 72) can be displaced into contact with the stops 476, allowing the stops 476 in stopper magazine 466 to automatically advance as they are dispensed from stopper magazine 466.

[0393] Referring now to FIG. 100, there is shown an exemplary quarantine repository 362. As shown, the quarantine repository 362 may include multiple racks 518. In the exemplary embodiment, two racks 518 are shown. Other embodiments may include more racks 518 or only a single rack 518. Each rack 518 may include multiple holders 520, which may support filled and sealed bags 26. The holders may be reservoir hangers from which filled bags 26 may hang. In FIG. 100, only one bag 26 is shown in place on the holder 520. In the exemplary embodiment, seventeen holders 520 are included on each rack 518. Other embodiments may include fewer holders 520 on each rack 520 or may include a greater number of holders on each rack 520.

[0394] FIG. 101 illustrates an exemplary holder 520. The holder 520 can include a set of arms 522. Each of the arms 522 can be substantially a mirror image of the other. As shown, each arm 522 includes a ledge 524 that is recessed relative to the top surface 526 of the arm 522. Also shown, each of the ledges 524 includes a set of indentations 528. The indentations 528 can be spaced apart a distance equal to the spacing between the ports 392 of the bags 26. Each arm 522 also includes a sloped surface 530 at the distal end of the arm 522 that is most distal to the attachment of the arm 522 to the rack 518. The sloped surface 530 can act as a guide to help orient the bag 26 into small gaps that may exist between the arms 522. The robotic arm 360 can advance the bag 26 into each of the holders 520. When the bag 26 is displaced into the holder 520, the two arms 522 can elastically spread apart to help receive the bag 26. The bag 26 can be guided into the holder 520 such that the ports 392 are positioned within the recesses 528 in each arm 522. Because the ports 392 have a diameter larger than the gap between the arms 522, the bag 26 may not slide off the holder 520. Thus, the two arms 522 can form a cradle for the bag 26. As shown, the edges of the ledge 524 and the recess 528 can be rounded to prevent the bag 26 from coming into contact with any sharp surfaces.

[0395] 102, the quarantine repository 362 may be completely filled with bags 26 in certain embodiments. In other embodiments, the quarantine repository 362 may be stocked with bags 26 in a manner that depends on the type of bag 26 being used. For example, when bags 26 filled to more than some predetermined volume are being produced, the control system 15 may instruct the robotic arm 360 to place a bag 26 in every other holder 520. This may mitigate the possibility of the quarantine repository becoming overcrowded and making the hanging of additional bags 26 problematic. When bags 26 filled to less than the predetermined volume are being produced, all holders 520 may be filled with bags 26.

[0396] 103 and 104, the bag 26 can remain in the quarantine repository 362 while one or more tests are completed. In certain embodiments, a test monitoring for pyrogens can be performed prior to the release of the bag 26 from the quarantine repository 362. For example, the control system 15 can generate a notification on its user interface that a test is scheduled. A user can place a vial 532 in the sampling fixture 534, which can then be passed into the second section 98 of the enclosure 12 via the vial access door 380. The vial 532 can be processed in a depyrogenation oven before use and can be provided in an overpack 60, which can only be opened in the antechamber of the enclosure 12. The sampling fixture 534 can include a cup-shaped portion 536, and the vial 532 can be placed in the cup-shaped portion 536. To introduce vial 532 into second section 98 of enclosure 12, vial access door 380 can be opened, allowing a user to access receptacle 542 attached to the side of vial access door 380 facing second section 98 of enclosure 12. Sampling fixture 534 can be docked into receptacle 542, and vial access door 380 can be closed again.

[0397] The sampling fixture 534 can have a side branch 538 that includes an enlarged segment 540. The enlarged segment 540 can be shaped to mimic the dimensions of the port 392 of the bag 26. This can allow the grasper 418 on the robotic arm 360 to collect the sampling fixture 534 and displace it around the second section 98 of the enclosure 12. The robotic arm 360 can displace the sampling fixture 534 and vial 532 to the filling station 356, and the control system 15 can command an aliquot of fluid to be dispensed into the vial 532. The robotic arm 360 can then return the sampling fixture 534 and vial 532 to the receptacle 542 of the vial access door 380. Vial access door 380 can be reopened by the user and vial 532 can be removed and installed in a pyrogen testing device such as an endotoxin monitor.

[0398] Typically, bags 26 may be retained in quarantine repository 362 until at least first and second pyrogen tests have been completed and indicate a pyrogen content below a predefined amount (e.g., some predefined EU / mL threshold). The first pyrogen test may be a pyrogen test on a fluid sample collected before any bags 26 currently in quarantine repository 362 are filled. The second test may be a pyrogen test on a fluid sample collected after all of the bags 26 in quarantine repository 362 have been filled. In some embodiments, this second test may double as the first test for the next group of bags 26 to be filled by system 10. In some embodiments, additional pyrogen tests may be performed.

[0399] In an alternative embodiment, pyrogen testing may be performed after each rack 518 of the quarantine repository 362 is filled to capacity. This may be desirable because pyrogen testing may take some time (e.g., 15 minutes) to complete. This may allow the system 10 to continue filling bags 26 as the pyrogen testing is completed. One rack 518 may be tested while a second rack 518 is being filled. By the time the second rack 518 is full of bags 26, the pyrogen testing for the first rack 518 may be complete, and the bags 26 may be ready for labeling and dispensing from the system 10. This may help increase the efficiency of the system 10 because there may be no downtime while the pyrogen testing (where filling of bags 26 must be stopped to free up space in the quarantine repository 362) is completed.

[0400] 105-107, the bags 26 may be labeled before they are dispensed from the system 10. FIG. 105 illustrates an exemplary labeler 366. The labeler 366 may produce labels, which may be adhered to each bag 26 via adhesive. The labeler 366, in certain embodiments, may be a thermal transfer ribbon-type labeler. As shown, the labeler 366 may include a housing 550 that may enclose a supply of blank labels and various printing components of the labeler 366. The labeler 366 may also include one or more rollers 552. For example, once a number of bags 26 in the quarantine repository 362 have passed testing, the robotic arm 360 (for ease of illustration, only the gripper 418 of the robotic arm 360 is shown in FIG. 105) may displace the bags 26 to the labeler 366. The bag 26 may be pulled across a plate 554 that includes a feed slot, with the label 556 extending through the feed slot. The label 556 may be adhered to a surface of the bag 26, and the bag 26 may be pulled across rollers 552. The weight of the bag 26 and its contents may help securely couple the label 556 to the bag 26 as the bag 26 is displaced over the rollers 552.

[0401] A label sensor 557 (see FIG. 56) may be included to monitor for the presence of a label 556. The control system 15 may receive an output signal from the label sensor 557 and analyze the signal to determine whether the label 556 has been applied to the bag 26. Additionally, the control system 15 may analyze the signal to ensure that the label 556 is present before displacing the bag 26 into the labeler 336 for application of the label 556. Thus, the control system 15 may analyze the label sensor 557 to determine whether the label supply in the labeler 336 is empty or whether an error condition exists. The control system 15 may generate an empty label supply notification or a labeling error based on the data received from the label sensor 557.

[0402] As labeled, and now referring to FIGS. 108-110 , the robotic arm 360 can displace the bag 26 to an exit portion of the enclosure 12. In the example shown in FIGS. 108-110 , the exit portion is shown as a chute 560. The chute 560 can include an upper opening covered by a door flap 562. Additionally, the chute 560 can include a funnel arm 564 that can help direct the bag 26 into the chute 560 as it is dropped by the grasper 418 of the robotic arm 360. When the bag 26 is dropped into the chute 560, the door flap 562 can be rotated out of the way by the weight of the bag 26. A biasing member, such as a torsion spring, can be included to return the door flap 562 to a closed orientation. As best shown in FIGS. 109 and 110 , the door flap 562 can be attached to a sensing protrusion. When the door flap 562 is displaced, the sensing protrusion 566 can be displaced, allowing the door sensor 568 to pick up the movement of the door. Any suitable sensor can be used. For example, the door sensor 568 can be an optical sensor, such as a beam break sensor or a reflective-based sensor. Alternatively, the door sensor 568 can be a magnetic-based sensor, such as a Hall-effect sensor. In such an embodiment, the door flap 562 can include a magnet. A microswitch or button that is mechanically activated by the displacement of the sensing protrusion 566 when the door flap 562 is displaced can also be used in certain instances. An encoder can monitor the displacement of a pivot pin on which the door flap 562 is mounted. Other types of sensing configurations are also possible. As the bag 26 travels along the chute 560 , the bag 26 can push open the exit flap 570 as it is delivered out of the enclosure 12 .The exit flap 570 can be a rigid hinged door or can be a flexible piece of material as shown in FIG.

[0403] The control system 15 of the system 10 may monitor the door sensor 568 to ensure that the system 10 is operating as expected. For example, when the control system 15 commands the robotic arm 360 to release a bag 26 into the chute 360, the control system 15 may check to ensure that the door sensor 568 registers that the door flap 562 has opened. The control system 15 may also check to ensure that the door sensor 568 indicates that the door flap 562 has returned to a closed state. If the door sensor 568 does not indicate that the door flap 562 has opened when the bag 26 is released, the control system 15 may generate a notification or alert on the user interface of the system 10. The control system 15 may also generate a notification if the door flap 562 does not close. The notification may indicate to the user to check that there are no items blocking the exit flap 570 and that there are no items present that would, for example, cause the bag 26 to climb backwards in the chute 560.

[0404] If the bag 26 is deemed unacceptable, the bag 26 may be dispensed from the enclosure 12 without the label 556. For example, if the bag 26 is in the quarantine repository 362, the bag 26 may be removed from the quarantine repository 362 and dispensed without the label 556. If, during filling of the bag 26 at the filling station 356, a composition sensor indicates that the fluid filled into the bag 26 does not conform to a predefined target composition range, the bag 26 may be sealed and dispensed from the enclosure 12 outlet. The label 556 may not be applied. In an alternative embodiment, a label 556 may be produced on the bag 26 that prominently indicates that the bag 26 should not be used. For example, a label 556 that reads, for example, "NOT FOR HUMAN USE," may be produced and applied to the bag 26 prior to dispensing.

[0405] Referring now to FIG. 111 , another exemplary system 10 for producing and packaging medical fluids is shown. As shown, the system 10 can include a medical water production device 14, such as any of those shown herein. The system 10 can also include a mixing circuit 348 for generating a specific solution (e.g., 0.9% saline). The system 10 can also include a sensor suite 350, which can monitor the quality of the purified water produced by the medical water production device 14 and can also monitor the solution generated by the mixing circuit 348. The sensor suite 350 can include any number of different types of water quality sensors. Any of the water quality sensors described herein can be included. The exemplary mixing circuit 348 and exemplary sensor suite 350 are described later in this specification.

[0406] System 10 also includes enclosure 12. Enclosure 12 is capable of providing a clean room environment for the components of system 10 contained therein. Enclosure 12 itself may also be contained within a clean room environment. In such embodiments, enclosure 12 may be maintained at a higher clean room standard than the room in which it is located. In some embodiments, enclosure 12 may be maintained at a positive pressure by blower system 600.

[0407] In the exemplary embodiment, the enclosure 12 is divided into a first section 96 and a second section 98. Each of these sections may be maintained at a slightly different positive pressure. For example, the first section 96 may be maintained at a first pressure that is positive relative to the surrounding environment. The second section 98 may be maintained at a pressure higher than the first pressure. The filling of the bag 26 may occur in the most tightly controlled environment of the system 10. Various filters, such as HEPA filters, may be included to help ensure that any air blown into the enclosure 12 to maintain the positive pressure is clean.

[0408] 112, the first section 96 can be an antechamber, which can be utilized to prepare various consumables used by the system 10. For example, a stock of bags 26 can be placed in the antechamber. Also, a stopper magazine 466 (such as any of those described herein) can be stocked in the antechamber. Sampling vials 532 (see, for example, FIG. 103) may also be maintained in stock within the antechamber. This can help minimize the need to access the interior of the enclosure 12 during operation of the system 10. The first section 96 may also include specific test equipment that can be used to verify that the bags 26 have been filled according to predefined criteria. Sampling ports within the fluid circuit may likewise be accessible via the antechamber.

[0409] The second section 98 may be constructed as a glove box-type enclosure with a gloved interface 352 that may be used to manipulate certain components of the system 10 within the enclosure 12. The second section 98 may include a filling subsystem 610 of the system. The filling subsystem 610 may include a bag retainer 602, a filling station 356, and a sealing station 358. A bag 26 may be collected from the ante-chamber through a door 604 between the first section 96 and the second section 98 of the enclosure 12 via the gloved interface 352. The bag 26 may be placed in the bag retainer 602. A robotic manipulator 606 including a grasper may collect the bag 26 from the bag retainer 602 and displace the bag 26 to the filling station 356. Fluid may be dispensed into the bag 26 at the filling station 356. The fluid can be purified water (e.g., WFI water) or a mixture of fluids generated in a mixing subsystem similar to that described in connection with Figures 2A and 2B. The bag 26 can also contain a concentrate, for example, as described above in connection with Figures 5A-6. From the filling station 356, the robotic manipulator 606 can displace the filled bag 26 to the sealing station 358. Access to the interior volume of the bag 26 can be sealed closed at the sealing station 358 (e.g., via a stopper ring, RF welding, etc.).

[0410] As shown, the exemplary embodiment includes a bag retainer 602 capable of holding a single bag 26 at a time. In alternative embodiments, the bag retainer 602 may be replaced by a bag feeder 354 similar to that described above in connection with, for example, FIGS. 59-65 . Similarly, the bag feeder 354 shown in the exemplary system 10 of FIG. 58 may be replaced by the bag retainer 602. The bag retainer 602 may be useful in implementations requiring only small quantities of bags 26 to be produced or in implementations where a system 10 having a smaller footprint may be desired. The bag retainer 602 may be even more useful in scenarios where the types of bags 26 filled by the system 10 are changed frequently.

[0411] 113-114B, the bag retainer 602 can include a catch 612, which can be pivotally attached to a base plate 614. The catch 612 can be opened, allowing a user to hold the bag 26 in place in the bag retainer 602 via the gloved interface 352. The catch 612 can then be closed against the base plate 614. The catch 612 can frictionally hold the port 392 of the bag 26 in place. In some embodiments, the catch 612, the base plate 614, or both the catch 612 and the base plate 614 can include a receiver 616 that receives a member 618 included on the port 392 to help hold the bag 26 in place within the bag retainer 602. The catch 612 can latch into place when in the closed position. This latching can be achieved via a mechanical latch or via a magnet in one of the base plate 614 and the fastener 612 and a metallic and / or magnetic material in the other of the base plate 614 and the fastener 612. The bag retainer 602 can also help position the bag 26 port 392, through which the bag 26 is to be filled, in a fixed, known location. As shown, the bag retainer includes a locating pin 615 (see also FIG. 116). The bag 26 can be loaded into the bag retainer 602 such that the locating pin 615 is seated in the fill port 392. Because the locating pin 615 is fixed, the locating pin 615 can ensure that the fill port 392 is in a known location prior to removal of the bag 26.

[0412] 115, with the bag 26 in place within the bag retainer 602, the control system 15 of the system 10 can displace the robotic manipulator 606 into the bag retainer 602. In an exemplary embodiment, the robotic manipulator 606 can be displaceable about multiple axes. In an exemplary embodiment, a first rail 622 can be included that defines a first axis along which the robotic manipulator 606 can be displaced. The robotic manipulator 606 can include a grasper 620 that can close around the port 392 of the bag 26 to grasp the bag 26. The grasper 620 can be included on a second rail 624 that defines a second axis along which the grasper 620 of the robotic manipulator 606 can be displaced. In an exemplary embodiment, the second axis is substantially perpendicular to the first axis.

[0413] As shown in FIG. 116 , once the bag 26 is grasped, the robotic manipulator 606 can displace the grasper 620 downward along the second rail 624, pulling the bag 26 free from the bag retainer 602. In some embodiments, the downward force exerted by the robotic manipulator 606 can open the catch 612 of the bag retainer 602. In other embodiments, the force may not open the catch 612, but may be sufficient to overcome any frictional forces holding the bag 26 in place within the bag retainer 602. The robotic manipulator 606 can then displace along the first rail 622 and move the bag 26 toward the filling station 356, as shown in FIG. 117 .

[0414] 118A , once the robotic manipulator 606 displaces the bag 26 so that the port 392 of the bag 26 is aligned with the fill nozzle 430, the control system 15 can command the robotic manipulator 606 to raise the grasper 620 toward the filling station 356. In the example shown, the fill nozzle 430 is also displaceable, such that the fill nozzle 430 can be displaced toward the port 392 while the grasper 620 of the robotic manipulator 606 is raised. The fill nozzle 430 can be tapered to aid in the entry of the fill nozzle 430 into the port 392 of the bag 26, as shown in FIG. 118A . Once the fill nozzle 430 is positioned in the port 392, the control system 15 can command the filling station 356 to dispense fluid into the bag 26. Although not shown in Fig. 118A, in some embodiments, the filling station 356 can include a set of bag characteristic sensors 444A-C, such as those shown and described in connection with Fig. 66. As described elsewhere herein, the control system 15 can determine a fill volume for the bag 26 based on data collected from the bag characteristic sensors 444A-C.

[0415] 118B, the fill nozzle 430 may be included in a biasing assembly 611 including a biasing member 613 that exerts a force on the fill nozzle 430 tending to firmly press the fill nozzle 430 into the port 392 of the bag 26. The biasing assembly 611 may also be included in the other fill stations 356 described herein, such as the one shown and described in connection with FIG. 66. As shown, the fill nozzle 430 is coupled to (and, in the example, integral with) an inlet fitting 617. In the example, a section of conduit 619 connects the inlet fitting 617 and the fill nozzle 430. The conduit 619 may include a flange 621. Also shown is a housing 623 (see FIG. 118A) including a main body portion 627 and an end cap 625. The end cap 625 may include a passageway through which the fill nozzle 430 can protrude but is too small for the flange 621 to pass. When the conduit 619 and biasing member 613 are housed within the housing 623, the biasing member 613 may be mounted between the inner surface of the housing 623 and the flange 621. The port 392 of the bag 26 may urge the fill nozzle 430 into the housing 623 against the force exerted by the biasing member 613 during filling. The restoring force of the biasing member 613 may then robustly press the fill nozzle 430 into the port 392. In the example, the biasing member 613 is shown as a compression spring. In alternative embodiments, any suitable biasing member 613 may be used.

[0416] 119-122, once the bag 26 is filled, it can be lowered away from the fill nozzle 430 by displacing the grasper 620 along the second rail 624, and the fill nozzle 430 can be raised. The robotic manipulator 606 can be displaced along the first rail 622 toward the sealing station 358. The sealing station 358 can include a support cradle 626. The support cradle 626 can help position and hold the port 392 of the bag 26 during the sealing operation. In an exemplary embodiment, the robotic manipulator 606 is displaced such that the bag 26 is moved slightly past the position where the port 392 to be sealed will be aligned with the ram 464 (FIG. 120). The grasper 620 can be displaced along the second rail 624 to raise the bag 26 toward the sealing station 358 (FIG. 121). The robotic manipulator 606 can then be displaced back along the track rail 622 to bring the port 392 into the support cradle 626. This can guide the port 392 into alignment with the ram 464.

[0417] 123 , an exemplary support cradle 626 is shown. As shown, the support cradle 626 can include a trough 760. The trough 760 can include a first portion 762A and a second portion 762B. The first portion 762A of the trough 760 can extend to a funnel-shaped opening 764 in a top surface 766 of the support cradle 626. The funnel-shaped opening 764 can help direct the stopper 476 into the trough and align it with the axis of the port 392 of the bag 26 to be sealed. The first portion 762A, which may also be referred to as the stopper guide portion of the trough 760, can be sized to surround a majority of the stopper 476 and guide the stopper 476 as the ram 464 translationally displaces the stopper 476 into the port 392. The second portion 762B of the trough 760 can position the port 392 during the sealing process. As shown in FIG. 122 , the port 392 can be displaced into the trough 760 in a direction generally perpendicular to the axis of the trough 760. The second portion 762B of the trough 760 can be flanked by a contoured wall 768. The contoured wall 768 can help guide the port 392 into the second portion 762B of the trough 760 as this vertical displacement occurs. The trough 760 of the example support cradle 626 can also include a ledge portion 770. The ledge portion 770 can form a stop surface that can engage the step 516 of the stopper 476 as the stopper 476 is displaced into the port 392 of the bag 26. Additionally, two removal notches 772 located on the sides of the trough 760 above the ledge portion 770 are recessed into the support cradle 626. These notches 772 can allow the port 392 to be easily displaced out of the support cradle 626 once the stopper 476 is in place within the port 392.

[0418] Referring now also to FIG. 124 , to seal the port 392, the control system 15 can command the ram driver 462 of the sealing station 358 to advance the ram 464 toward the port 392 of the bag 26 to be sealed. The ram 464 can drive a stopper 476 from the stopper magazine 466 into the port 392 to seal the port 392. As described above, the funnel-shaped opening 764 and stopper guide portion 762A of the support cradle 626 can help ensure that the stopper 476 enters the port 392 cleanly. The control system 15 can then command the ram driver 462 to retract the ram 464, and the robotic manipulator 606 can be operated to remove the bag 26 from the sealing station 358. The control system 15 can then displace the robotic manipulator 606 to a drop location for the bag 26, as shown in FIG. 125 .

[0419] 126, the filling subsystem 610 can include an orientation chute 628 that helps orient the bag 26 upon release from the grasper 620. The robotic manipulator 606 also includes a guide plate 630 that can ensure that the bag 26 is oriented on the orientation chute 628 upon release from the grasper 620. Once the bag 26 reaches the bottom of the orientation chute 628, the bag 26 can be manually labeled via the gloved interface 352 or placed into the quarantine repository 362 while various tests (e.g., the endotoxin tests described above) are completed.

[0420] 127-128 , in certain embodiments, the system 10 is capable of simultaneously filling multiple bags 26 in parallel. The bags 26 may be provided in packets 1082 within a carrier 1080. The carrier 1080 may include multiple compartments 1084, and the packets 1082 may be held within the multiple compartments 1084. In an exemplary embodiment, the carrier 1080 includes six compartments 1084 and holds six packets 1082. In other embodiments, the number of compartments 1084 may be different. Preferably, the number of compartments 1084 may be selected so that a user can comfortably transport the carrier 1080 when all of the bags 26 within the carrier are full. Different carriers 1080 for bags 26 of different volumes may be provided, with a carrier 1080 for smaller volume bags 26 having a greater number of compartments 1084. The carrier 1080 may be constructed from, for example, plastic sheeting or a medical-grade wax paper product. Such materials may be preferred when the carrier or packet 1082 is to be filled into an enclosure 12 (such as those described elsewhere herein). In other embodiments, card stock may be used. The carrier 1080 may include a handle 1087, which may facilitate carrying by a user or gripping by the grasper 418 of the robotic arm 360.

[0421] 129 and 130 , each packet 1082 can include a cover flap 1086. The cover flap 1086 can include a passageway 1088, and the fill line 1090 can extend through the passageway 1088. The cover flap 1086 can be secured to a pouch portion 1092 of the packet 1082. The bag 26 can be provided within the pouch portion 1092. The pouch portion 1092 can be expandable to accommodate an increase in the volume of the bag 26 as it is filled. For example, the sidewalls of the pouch portion can include a bellows feature. The packet 1082 has been removed in FIG. 130 to reveal the exemplary bag 26. In the exemplary embodiment, a section of hook-and-loop fastener 1096 can be used to connect the cover flap 1086 to the pouch portion 1092 when the cover flap 1086 is in the closed position. Any other suitable coupling may be used. When retained in the pouch portion 1092, the cover flap 1086 may hold the administration set 1094 attached to the bag 26 in place within the packet 1082. A slide clamp 1098, roller clamp 1100, or other occlusion structure may be placed in an occlusive state over the line of the administration set 1094 to prevent flow through the administration set 1094 when the bag 26 is filled. Alternatively, the administration set 1094 can include a frangible, which prevents flow therethrough until broken by the user. The administration set 1094 can be any desired administration set 1094 and can include one or more of a drip chamber, a burette, a bifurcation (Y-site, T-site, etc.), a luer lock, a septum, etc.

[0422] 131 and 132, each of the fill lines 1090 extending from the packet 1082 can be coupled to a spiking adapter 1102. As best shown in FIG. 132, the spiking adapter 1102 can include a plurality of radial recesses 1104. The recesses 1104 can be recessed into the exterior sidewall of the spiking adapter 1102. The number of recesses 1104 can equal the number of packets 1082 held by the carrier 1080. The recesses 1104 can be sized to receive and retain the terminal ends of the fill lines 1090 leading to the respective bags 26. The openings of the recesses can be sized to be smaller than the outer diameter of the fill lines 1090. Thus, the fill lines 1090 are deformed when inserted into the recesses 1104 and, once contained therein, can resist inadvertent removal. The spiking adapter 1102 can also include a plurality of protrusions 1106. The protrusions 1106 can facilitate grasping by the robotic grasper 418 or by a user's hand. The recesses 1104 are spaced apart at regular angular intervals from one another on each side of the protrusions 1106. As shown, the terminal end of the fill line 1090 can include a sealing member 1108. The sealing member 1108 can be a septum that can be pierced to gain access to the lumen of the fill line 1090 and can self-seal when the piercing member is withdrawn. As shown, the radial recesses 1104 of the spiking adapter 1102 can ensure that the fill line 1090 is straight just upstream of the sealing member 1108.

[0423] 133A and 134-136, multiple views of an exemplary filling station 1110 capable of accepting a spiking adapter 1102 for filling the bag 26 are shown. A schematic example of the filling station 1110 is shown in FIG. 133A. As shown, the filling station 1110 can include a supply source 1112. The supply source 1112 can be in communication with a recirculation valve 1114 and an inlet valve 1116. The inlet valve 1116 can gate flow to a fluid pump 1118, which can be a diaphragm pump in certain examples. The fluid pump 1118 can deliver fluid from the supply to a heater 1120, which can be an in-line heater. Additionally, an air pump 1122 can be plumbed into the line leading from the fluid pump 1118 to the heater 1120. A check valve 1123 may be included to ensure that liquid does not backflow into the air pump 1122. From the heater 1120, the fluid may flow to a manifold 1124. The manifold 1124 may split the flow into several different flow paths that lead to a spike port 1126. The spike port 1126 may also be connected to a recirculation valve 1114.

[0424] Fluid flowing from the source 1112 may be routed to a spike port 1126 for delivery into the fill line 1090 of the bag 26 disposed within the spiking adapter 1102. After the fill operation is completed, a cap 1130 on the spike port 1126 may be sealed closed, and the fluid entering the fill station 1110 may be recirculated while being heated by the heater 1120. The heater 1120 may maintain the temperature of the recirculating fluid within a predefined temperature setpoint. The control system 15 of the system 10 may continue to recirculate the water within the fill station 1110 for a sufficient period of time to provide disinfection at the predefined temperature setpoint. This water may then be diverted to a drain destination 1128 through the inlet valve 1116. In certain embodiments, the heater 1120 may maintain the fluid at a temperature of 75-80°C or higher during disinfection. Thus, each time a connection is made to the spike port 1126, the spike port 1126 can be freshly sterilized.

[0425] In an alternative embodiment, and now referring to FIG. 133B , an exemplary filling station 1110 can include a supply 1112 that is in direct communication with an inlet valve 1116, which can double as a recirculation valve. A spike port 1126 can include a connection that can allow fluid to be recirculated through the spike port 1126, as described above, or can allow the fluid to flow through to a drain 1128. During disinfection, fluid can be directed through a heater 1120 and heated to within a temperature setpoint. This water can be passed to the drain 1128 through a drain valve 1115 without recirculation.

[0426] Referring now also to FIG. 137 , a top-down view of an exemplary spike port 1126 is shown. As shown, the spike port 1126 can include a cup-like recess 1132. The recess 1132 can include a plurality of spikes 1134. Each of the spikes 1134 can be in communication with a line extending from the manifold 1124. The recess 1132 can be sized to receive the spiking adapter 1102. As shown, the spike port 1126 can include alignment channels 1136. The alignment channels 1136 can receive the protrusions 1106 of the spiking adapter 1102. The protrusions 1106 on the spiking adapter 1102 can be positioned such that, when they are in the alignment channels 1136, the sealing members 1108 of the fill line 1090 can align with the respective spikes 1134 in the recesses 1132. Other keying elements may also be used to help ensure proper alignment. Pressing the spiking adapter 1102 into the recesses 1132 allows each of the spikes 1134 to pierce a respective sealing member 1108, allowing fluid to be delivered through the fill line 1090 and into the bag 26. The radial recesses 1104 of the spiking adapter 1102 ensure that the fill line 1090 immediately upstream of each sealing member 1108 is straight, preventing the spikes 1134 from perforating the sidewall of the fill line 1090. The spiking adapter 1102 and sealing member 1108 may be wiped with a disinfectant prior to pressing the spiking adapter 1102 into the recesses 1132. For example, 70% isopropyl alcohol may be used. Additionally, the cap 1130 of the spike port 1126 may be kept closed until just prior to forming the connection. The cap 1130 may also be cleaned with a disinfectant before opening.The materials used to construct the fill conduit 1090, sealing member 1108, spiking adapter 1102, and spike port 1126 may be selected to be appropriate for the sterilizing agent used and the temperatures present during sterilization of the fill station 1110.

[0427] As shown, the spike port 1126 can include a gasket member 1136 surrounding the recess 1132. The gasket member 1136 can form a seal against the cap 1130 when the cap 1130 is in a closed position over the recess 1132. In some embodiments, a latch (not shown) can be included to maintain the cap 1130 in a closed orientation, to ensure that a small amount of pressure is exerted between the cap 1130 and the gasket member 1136, and to inhibit inadvertent opening of the spike port 1126. Also shown in FIG. 137 is a recirculation port 1138. With the cap 1130 closed, the recirculation port 1138 can allow fluid pumped into the recess 1132 via the spike 1134 to be removed from the spike port 1126 and circulated back through the heater 1120. This can help ensure that the fluid in the spike port 1126 is maintained at a desired temperature during the disinfection process. In certain embodiments, both a recirculation port 1138 and a drain port (not shown) may be included within the spike port 1126.

[0428] Referring now to FIG. 138, a schematic diagram of an exemplary fluid circuit 710 that may be utilized with any of the systems 10 shown herein is shown. A mixing circuit 348 and a sensor suite 350 (e.g., as described with respect to FIGS. 56 and 111) may be included within the fluid circuit 710. As shown, the fluid circuit 710 may draw water from a water source 16. The water source 16 may be any of the water sources described herein. The fluid from the source 16 may, in certain embodiments, be subjected to any of a variety of pretreatment operations. For example, filtration or chemical treatment may be performed before the water passes to the medical water production device 14. In the exemplary fluid circuit 710, the fluid from the water source 16 may pass through a water softener 712. After passing through the water softener 712, the fluid may be filtered through one or more carbon filters 714 (e.g., two identical carbon filters in series). In some examples, a coarse filter or sediment filter may be included upstream of the carbon filter 714. The filtered water that has passed through the one or more carbon filters 714 may then be filtered through a reverse osmosis assembly 716. Depending on the water source 16, one or more of the water softener 712, carbon filter 714, and reverse osmosis assembly 716 may be optional or may be omitted.

[0429] In the exemplary fluid circuit 710, the fluid can pass from the reverse osmosis assembly 716 to a temperature regulator 718. The temperature regulator 718 can include at least one of a chiller and a heater. For certain applications, the temperature regulator 718 can be omitted. The temperature regulator 718 can reduce the temperature of the incoming water or can be operated to reduce the temperature of the incoming water when a temperature sensor (not shown) upstream of the temperature regulator 718 indicates that the temperature of the incoming water is above a predefined threshold. In some examples, the temperature regulator 718 can be bypassed when the temperature of the incoming water falls below the predefined threshold. The incoming water can then flow to the medical water producing device 14. The medical water producing device 14 can be any of those described herein. For example, the medical water producing device 14 can be a vapor compression distillation device in certain examples.

[0430] In the exemplary embodiment, the output of the medical water production device 14 can include a quick-connect fitting 720, which can be used to connect to the rest of the flow circuit. As shown, the fluid passing from the medical water production device 14 can be tested for one or more properties of interest. In the exemplary embodiment, two conductivity sensors 722A, B can be used to collect redundant measurements of the conductivity of the water produced by the medical water production device 14. The control system 15 of the system 10 can monitor the output of the conductivity sensors 722A, B to ensure that the water is appropriate for its intended use. For example, the control system 15 can check to ensure that the water has a conductivity within the range accepted for water-for-injection (WFI) quality water. Acceptable thresholds for the conductivity sensors 722A, B (or other sensors in the fluid circuit 710) can be defined in an official standard or water monograph. In certain examples, the conductivity sensors 722A, B may be selected to have high resolution, accuracy, and reliability at low conductivity values. In certain embodiments, an ultrapure water conductivity sensor optimized for sensing low-conductivity fluids may be used. The fluid circuit 710 may also include a total organic carbon (TOC) monitor 724. In the illustrative embodiment, the TOC monitor 724 is shown as receiving a slipstream of the fluid, which then flows to a drain 726. In other embodiments, the TOC monitor may be in-line and not positioned on the slipstream.

[0431] After the initial sensing, the fluid is allowed to pass to the inlet pressure sensor 728 . The inlet pressure sensor 728 can include at least one pressure sensor capable of sensing the pressure of the incoming water. In some embodiments, the inlet pressure sensor 728 can be paired with a sampling port or septum, from which fluid can be extracted from the fluid circuit 710 for testing. From the inlet pressure sensor 728, water can flow to a diverter manifold 730. The diverter manifold 730 can enable the system 10 to divert water to a drain 726 if water production in the medical water producing device 14 exceeds the current system 10 demand. Additionally, the diverter manifold 730 can enable water measured to be outside a predefined sensing threshold to be directed to the drain 726. Water exiting the diverter manifold 730 can flow to a pump 732, which can be operated to adjust the water pressure if needed. The control system 15 can check the reading from the inlet pressure sensor 728 before running the pump 732. For example, the control system 15 can verify that the inlet pressure is positive or has become positive above some threshold before running the pump 732. This can ensure that the pump 732 has water to pump before powering the pump 732. From the pump 732, the water can proceed to the inlet manifold 734. In some embodiments, the pump 732 can include a bypass that allows fluid to recirculate to the pump 732 when the pressure downstream of the pump 732 is at a desired value. The inlet manifold 734 can include an additional conductivity sensor 736, which can again check that the conductivity of the water is within predefined limits. A pressure sensor 738 can also be included in the inlet manifold 734 to provide feedback for a control loop used by the control system 15 to inform the operation of the pump 732. In some examples, the inlet manifold 734 can include a sampling port or septum.

[0432] From the inlet manifold 734, the water can pass to the mixing circuit 348 of the fluid circuit 710. The mixing circuit 348 can include multiple flow paths. For example, the mixing circuit 348 can include a WFI water path and at least one component path. The number of flow paths in the mixing circuit 348 can depend on the type of solution being mixed or the type of solution that the system 10 helps generate. In certain embodiments, a flow path may be included for each constituent component of the solution. The exemplary system 10 is shown as a saline generation circuit and includes a saline flow path and a WFI water flow path.

[0433] With respect to the saline flow path, in an exemplary embodiment, the mixing circuit 348 can include a crystal component container 740. The crystal component container 740 can be filled with sodium chloride. Other crystal components can be used in other embodiments (e.g., D5NS or, in the case of dialysate production, sugar). Fluid can enter the crystal component container and pass through the sodium chloride contained therein, dissolving a certain amount of the sodium chloride. In various examples, the fluid leaving the crystal component container 740 can be saturated or nearly saturated. Also, in some embodiments, the crystal component container can act as a reservoir 740, which can maintain a volume of solution therein. This can allow the system 10 to easily handle periods of high fluid demand. The fluid exiting the crystal component container 740 can then pass through at least one filter. For example, a coarse filter can be included to help ensure that particulate components do not exit the crystal component container 740. In the example, an ultrafilter 742 is also shown downstream of the crystal component container 740. At least one conductivity sensor 744 is capable of collecting data about the concentration of sodium chloride in the fluid leaving the ultrafilter 742.

[0434] As shown, fluid leaving the inlet manifold 734 can also flow along a second WFI water flow path in FIG. 138. The second path can include a second ultrafilter 746. The saline fluid and water from the second path can be mixed together in a mixing manifold 748. To generate a solution of the appropriate concentration, flow controllers 750A, B can be included in the fluid circuit 710. The flow controllers 750A, B can meter the volume of fluid and control the flow rate of the fluid passing therethrough. The control system 15 of the system 10 can use data from the conductivity sensor 744 in the saline flow path to determine a mixing ratio, which can be implemented via commands to the flow controllers 750A, B. Thus, the control system 15 can mix fluids from the saline flow path and the WFI water flow path to achieve a solution of a target concentration, such as 0.9% saline. In some embodiments, the mix manifold 748 may be replaced by a mix tank, which can maintain a volume of fluid to help handle periods of increased demand.

[0435] The fluid exits the mixing manifold 748 and may travel along a tortuous and / or relatively long flow path to facilitate mixing. The fluid may then pass through a set of redundant conductivity sensors 752A, 752B. These conductivity sensors 752A, B may collect data about the conductivity of the solution leaving the mixing circuit 348, and the control system 15 may ensure that the conductivity is as expected for the solution being generated by the system 10. From the conductivity sensors 752A, B, the solution may pass to a particle sensor 754 and a dispensing nozzle 756. The particle sensor 754 is shown as feeding from a slipstream in FIG. 138, however, in other embodiments, the particle sensor 754 may be in-line and upstream of the dispensing nozzle 756. The control system 15 may monitor data from the particle counter to check that the generated fluid meets predefined particle limits. Fluid leaving the particle counter can pass to drain 726. If the fluid is deemed acceptable, it can pass to dispensing nozzle 756 and can be used to fill bag 26. Alternatively, if the fluid is found to be unacceptable, the fluid can be dispensed from the dispensing nozzle 756 into a drain (see, for example, drain inlet 434 in FIG. 71A) followed by a flush volume of solution.

[0436] Referring now to FIG. 139, a flowchart 1300 is shown detailing several exemplary actions that may be performed to generate and package a desired fluid. As shown, in block 1302, the control system 15 of the system 10 may receive a request to fill a bag 26. The control system 15 may determine a component mass (e.g., sodium chloride) to dispense for that bag 26. This mass may be the mass needed to generate a desired percentage of component solution by weight per unit volume (e.g., 0.9% saline). In block 1304, bag 26 information may be collected from a set of bag characteristic sensors 444A-C (see, e.g., FIG. 66). In block 1306, a first dispensing phase may begin. In this phase, the fluid delivered to the bag 26 may be entirely or primarily a component concentrate. The component mass dispensed into the bag 26 may be tracked by readings from at least one conductivity sensor and a flow meter or flow controller. Once the desired component mass has been dispensed into the bag 26 in block 1308, a second dispensing phase may begin in block 1310. In a second stage, WFI may be dispensed into bag 26. The volume of dispensed WFI may be tracked by a flow meter or flow controller. Once the volume of WFI needed to generate the desired solution has been dispensed in block 1312, dispensing may stop in block 1314. Also in block 1314, bag 26 may be collected from fill station 356. By delivering components in the first stage, the second stage may serve as a flush of the lines leading to the fill nozzle. This may ensure that substantially all of the component concentrate in the lines is dispensed into bag 26. Thus, control system 15 may not need to consider hold-up volume in the lines when attempting to pump component concentrate to generate a fluid having a desired concentration.Additionally, after a bag 26 is filled, subsequent bags 26 can be filled with a different type of solution or with a different concentration of solution, without having waste and component concentrates in the purging of fluid in the lines between bags 26.

[0437] Referring now to FIG. 140 , in certain embodiments, a crystal component container 740 through which fluid flows may not be included. Instead, a crystal component dispenser 780 may be used. As shown, fluid may exit an inlet manifold 734 and pass to a dosing manifold 784. The dosing manifold 784 may also be in communication with the crystal component dispenser 780. The crystal component dispenser 780 may dispense the crystal component into the dosing manifold 784 via a dispensing assembly 787. A motor 785 may be included to drive the dispensing assembly 787. From the dosing manifold 784, the fluid may flow to a concentrate reservoir 782. If a concentrate reservoir 782 is included, at least one conductivity sensor (e.g., conductivity sensor 744) of a component flow path of the mixing circuit 348 may be contained within or in communication with the internal volume of the concentrate reservoir 782.

[0438] Referring now also to FIG. 141 , a cross-sectional view of the exemplary dosing manifold 784 of FIG. 140 is shown. As shown, the dosing manifold 784 can include an internal cavity 786. The internal cavity 786 can be in communication with the inlet manifold 734 via a first port 788. The crystal component dispenser 780 can be in communication with the internal cavity 786 via a second port 790. The axis of the second port 790 can be positioned to allow gravity feed of components from the crystal component dispenser 780 into the internal cavity 786. The internal cavity 786 can be constructed to generate a particular flow pattern that can help promote vigorous mixing within the dosing manifold 784. In the exemplary embodiment, the internal cavity 786 includes a baffle 792, which is aligned with the axis of the first port 788. The baffle 792 can induce turbulence immediately upstream of the second port 790, encouraging rapid mixing and dissolution of the crystalline components upon introduction. The baffle 792 can also narrow the cross-section of the flow path from the first port 788 to the outlet 794 of the dosing manifold 784. This can create a Venturi effect, which can cause the flow to be more rapid where the second port 790 opens into the internal cavity 786 than elsewhere within the internal cavity 786. Thus, as the components enter the dosing manifold 784, they can be prevented from piling up at the entry point. In other embodiments, the internal cavity 786 can include multiple baffles 792. The internal cavity 786 can also include a funnel region 796 immediately upstream of the outlet 794. The funnel region 796 can facilitate the creation of a vortex within the interior cavity 786, which can further assist in dissolving the crystal components dispensed from the crystal component dispenser 780.Also in the exemplary embodiment, a turbulator 798 is disposed in the outlet conduit 800 from the dosing manifold 784. The turbulator 798 can provide additional assistance that can help dissolve the crystalline components. In the exemplary embodiment, the turbulator 798 is an insert with helicoid flighting, although any insert that can promote mixing can be used. In an alternative embodiment, the outlet conduit 800 from the dosing manifold 784 can be a coil of tubing, which increases the transit time of the fluid in the outlet conduit 800 as it travels to a downstream component in the fluid circuit 710 (e.g., the conductivity sensor 744).

[0439] 142 and 143 , an exemplary crystal component dispenser 780 is shown. A portion of the crystal component dispenser 780 has been removed in FIG. 143 to reveal the components of a dispensing assembly 787. As shown, the crystal component dispenser 780 can include a component storage compartment 802. The storage compartment 802 can have an outlet 804, which can feed into the dispensing assembly 787. In the exemplary embodiment, the dispensing assembly 787 includes a bore 806 with an auger 808 disposed within the bore 806. The auger 808 can be attached to a drive shaft 810. The drive shaft 810 can extend to a motor 785, which can be operated to cause rotation of the auger 808. As the auger 808 rotates, components may be advanced through the bore 806 toward an outlet 812 of the dispensing assembly 787. The outlet may communicate with the interior volume of the dosing manifold 784 via a second port 790 of the dosing manifold 784. The control system 15 may command the rotation of the auger 808 based on data collected from a conductivity sensor (e.g., conductivity sensor 744 of FIG. 138) to generate a solution of a desired concentration.

[0440] 144-146, another embodiment of an exemplary crystal component dispenser 780 is shown. Again, in FIG. 145, a portion of the crystal component dispenser 780 has been removed to reveal the components of a dispensing assembly 787. As shown, the crystal component dispenser 780 can include a component storage compartment 802. The storage compartment 802 can have an outlet 804, which can feed into the dispensing assembly 787. In the exemplary embodiment, the dispensing assembly 787 includes an internal void 814, with a paddle wheel 816 disposed within the internal void 814. The paddle wheel 816 can be attached to a drive shaft 810, which can extend to a motor 785, which can be operated to cause rotation of the paddle wheel 816. Rotation of the paddle wheel 816 can advance a volume of component from the storage compartment 802 to the outlet 812 of the dispensing assembly 787. The outlet can communicate with the interior volume of the dosing manifold 784 via a second port 790 of the dosing manifold 784. The control system 15 can command the rotation of the paddle wheel 816 based on data collected from a conductivity sensor (e.g., conductivity sensor 744 of FIG. 138) to generate a solution of a desired concentration.

[0441] Referring specifically to FIG. 146, an exemplary paddle wheel 816 is shown in isolation. As shown, the paddle wheel 816 includes a plurality of circular members 818 disposed orthogonally to one another. While two circular members 818 are shown in FIG. 146, other embodiments may include a greater number. In the exemplary embodiment, the two circular members 818 are disposed substantially perpendicular to one another.

[0442] 147 and 148, another exemplary dispensing assembly 787 is shown. Again, in FIG. 148, a portion of the housing 1018 of the assembly 787 has been removed to reveal the components of the dispensing assembly 787. Although not shown, the dispensing assembly 787 may typically be attached to a component storage compartment 802 (such as those shown and described above). The storage compartment 802 may feed into the inlet portion 1010 of the dispensing assembly 787. In the exemplary embodiment, the dispensing assembly 787 includes an internal passageway 1016, with an impeller 1012 disposed within the internal passageway 1016. The passageway 1016 may be sized such that the impeller 1012 prevents components from being displaced therethrough without rotation of the impeller 1012. The impeller 1012 can be attached to a drive shaft 810, which can extend to a motor 785, which can be operated to cause rotation of the impeller 1012. Rotation of the impeller 1012 can advance a volume of component from the storage compartment 802 to an outlet 1014 of the dispensing assembly 787. The outlet 1014 can communicate with the interior volume of the dosing manifold 784 via a second port 790 of the dosing manifold 784. The control system 15 can command the rotation of the impeller 1012 based on data collected from a conductivity sensor (e.g., conductivity sensor 744 of FIG. 138) to generate a solution of a desired concentration.

[0443] 149 and 150, in some embodiments, a disk 1020 with a plurality of spaced-apart depressions 1022 may be used in place of the impeller 1012. The depressions 1022 may be uniformly spaced around the disk 1020. In an exemplary embodiment, the depressions 1022 may be spaced at uniform angular increments of 72°. The depressions 1022 may be uniformly shaped. In an example, the depressions 1022 are bowl-like. In other embodiments, the depressions 1022 may be oblong (see FIG. 151) or any other desired shape. When the disk...

Claims

1. 1. A system for producing and packaging a fluid, comprising: a water distillation device; a mixing circuit coupled to an output of the water distillation device and including a source of concentrate, the mixing circuit configured to regulate a flow of fluid through the mixing circuit to generate a fluid of a predefined composition; an enclosure including an ante-chamber and a packaging compartment; a reservoir dispenser at least partially within the packaging compartment, the reservoir dispenser having a reservoir magazine and an outlet end, the reservoir dispenser including an actuator configured to drive a follower of the reservoir magazine toward the outlet end of the reservoir dispenser; a filling station in the packaging compartment including a filling nozzle connected to the mixing circuit and a reservoir volume sensing assembly; a sealing station within said packaging compartment; a repository in the packaging compartment having a plurality of reservoir holders; a labeler assembly within said packaging compartment; an output chute from said packaging compartment to the exterior of said enclosure; Including, the system.

2. The system of claim 1 , wherein the system further comprises at least one of a reverse osmosis unit and an ultrafilter.

3. 10. The system of claim 1, wherein the concentrate source is a crystal concentrate reservoir having a purified water inlet and a fluid concentrate outlet.

4. The system of claim 1 , wherein the antechamber comprises a flexible sterile barrier.

5. 5. The system of claim 4, wherein the flexible sterile barrier includes at least one gloved interface.

6. 2. The system of claim 1, wherein the sealing station is a stoppering station including a ram and a stopper dispenser, and the sealing station further includes a cradle, the cradle including a stopper guide and a portion configured to receive a port of a reservoir.

7. 10. The system of claim 1, wherein the antechamber and the packaging compartment are separated by a partition, the partition including a door having a sample container holder.

8. The system of claim 1 , further comprising a pyrogen tester.

9. The system of claim 1 , wherein the system further comprises a robotic arm including a gripper.

10. 10. The system of claim 9, further comprising a control system configured to displace the robotic arm and actuate the gripper to collect a reservoir from the reservoir dispenser, displace the reservoir to the filling station, determine the volume of the reservoir via data from the reservoir volume sensing assembly, command filling the reservoir with a volume of fluid less than or equal to the volume of the reservoir, displace the reservoir to the sealing station, and command sealing the reservoir.

11. 10. The system of claim 1, wherein the reservoir volume sensing assembly includes a set of reservoir characteristic sensors, the system further including a control system configured to analyze data received from the reservoir characteristic sensors and to determine the volume of a reservoir in place at the filling station.

12. 12. The system of claim 11, wherein the control system is configured to manage operation of at least one flow controller based on the volume of the reservoir determined based on the data from the reservoir property sensor.

13. 13. The system of claim 12, wherein the control system is configured to manage operation of the at least one flow controller to deliver a volume of concentrate to the reservoir and a subsequent volume of purified water to the reservoir to achieve a fill volume selected based on the capacity of the reservoir.

14. 1. A system for producing and packaging a fluid, comprising: a water distillation device; a mixing circuit coupled to the output of the water distillation device and including a source of concentrate, the mixing circuit including a plurality of flow controllers configured to regulate the flow of fluid through the mixing circuit to generate a fluid of a predefined composition; an enclosure including an ante-chamber and a packaging compartment; a reservoir dispenser having a portion within the packaging compartment, the reservoir dispenser having a feed plate and a housing block, the reservoir dispenser including a biasing member, the biasing member urging the feed plate toward the housing block; a filling station in the packaging compartment including a filling nozzle connected to the mixing circuit; a sealing station in the packaging compartment having a ram and a sealing material dispenser; a repository in the packaging compartment having a plurality of reservoir holders; a labeler within said packaging compartment; an output chute from said packaging compartment to the exterior of said enclosure; Including, the system.

15. 15. The system of claim 14, wherein the system further comprises at least one of a reverse osmosis unit and an ultrafilter.

16. 15. The system of claim 14, wherein the concentrate source is a crystal concentrate reservoir having a purified water inlet and a fluid concentrate outlet.

17. 15. The system of claim 14, wherein the antechamber includes at least one gloved interface.

18. 15. The system of claim 14, wherein the antechamber and packaging compartment are separated by a partition, the partition including at least one door from the antechamber to the packaging compartment.

19. The system of claim 14 , wherein the system further comprises a robotic arm including a gripper.

20. 20. The system of claim 19, further comprising a control system configured to command actuation of the ram to displace the robotic arm, actuate the gripper to collect a reservoir from the reservoir dispenser, displace the reservoir to the filling station, command filling of the reservoir, displace the reservoir to the sealing station, and drive a sealing member from the sealing member into a port of the reservoir.

21. 15. The system of claim 14, wherein the filling station further includes a set of reservoir characteristic sensors, and the system further includes a control system configured to analyze data received from the reservoir characteristic sensors and to determine the volume of a reservoir in place at the filling station.

22. 22. The system of claim 21, wherein the control system is configured to manage operation of the flow controller based on the volume of the reservoir determined based on the data from the reservoir property sensor.

23. 1. A system for producing and packaging a fluid, comprising: a water purification device; a mixing circuit coupled to an output of the water purification device and including a source of concentrate, the mixing circuit configured to generate a fluid of a predefined composition; an enclosure including an ante-chamber and a packaging compartment; a reservoir dispenser extending from the antechamber to the packaging compartment, the reservoir dispenser having a reservoir magazine and an outlet end, the reservoir dispenser including a drive configured to displace a follower of the reservoir magazine toward the outlet end of the reservoir dispenser; a filling station in the packaging compartment including a filling nozzle connected to the mixing circuit and a reservoir volume sensing assembly; a sealing station within said packaging compartment; at least one reservoir hanger within said packaging compartment; a labeler within said packaging compartment; an output chute from said packaging compartment to the exterior of said enclosure; Including, the system.

24. 24. The system of claim 23, wherein the system further comprises at least one of a reverse osmosis unit and an ultrafilter.

25. 24. The system of claim 23, wherein the concentrate source is a reservoir of crystalline salt concentrate.

26. 24. The system of claim 23, wherein the antechamber includes at least one gloved interface.

27. 24. The system of claim 23, wherein the antechamber and packaging compartment are separated by a partition, the partition including at least one door between the antechamber and the packaging compartment.

28. 24. The system of claim 23, wherein the system further comprises a robotic arm including a gripper.

29. 29. The system of claim 28, further comprising a robotic manipulator and a control system configured to displace the robotic manipulator to collect a reservoir from the reservoir dispenser, displace the reservoir to the filling station, determine the volume of the reservoir via data from the reservoir volume sensing assembly, command filling the reservoir with a volume of fluid less than or equal to the volume of the reservoir, and command displace the reservoir to the sealing station and seal the reservoir.

30. 24. The system of claim 23, wherein the reservoir volume sensing assembly includes a set of reservoir characteristic sensors.

31. 31. The system of claim 30, wherein the control system is configured to manage operation of at least one flow controller based on a volume of the reservoir determined based on the data from the reservoir property sensor.

32. 31. The system of claim 30, wherein the control system is configured to manage operation of the at least one flow controller to deliver a volume of concentrate to the reservoir and a subsequent volume of purified water to the reservoir to achieve a fill volume selected based on a capacity of the reservoir determined based on the data from the reservoir characteristic sensor.

33. 1. A sealing material dispenser comprising: a dispenser body including at least one trough and an exit port, the trough configured to receive a plurality of sealing members, the exit port extending from the trough to an exterior surface of the dispenser body, the exit port having a guide portion adjacent the exterior surface of the dispenser body; a blocking element that obstructs passage of a sealing member through the exit port; a cover coupled to the dispenser body and overhanging the trough, the cover including an orifice that coincides with the exit port, the orifice presenting an opening that is too small to allow passage of a sealing member of the plurality of sealing members; A sealing material dispenser comprising:

34. 34. The sealing member dispenser according to claim 33, wherein the trough extends along a helical path.

35. 34. The sealing material dispenser of claim 33, wherein the dispenser body is a drum.

36. 34. The sealing member dispenser of claim 33, wherein the guide portion includes a funnel-shaped profile.

37. 34. The sealing material dispenser according to claim 33, wherein the guide portion is a chamfered edge.

38. 34. The sealing member dispenser according to claim 33, wherein the blocking element is displaceable.

39. 34. The sealing material dispenser of claim 33, wherein the blocking element is an outlet cover coupled to a handle, wherein displacement of the handle results in displacement of the outlet cover from a blocking position.

40. 34. The sealing material dispenser according to claim 33, wherein the blocking element includes a detent member that protrudes into the exit port.

41. 41. The sealing material dispenser of claim 40, wherein the detent member is a ball detent.

42. 34. The sealing material dispenser of claim 33, further comprising a follower and a biasing member, the biasing member coupled to the follower and a portion of the dispenser body.

43. 43. The sealing member dispenser of claim 42, wherein the biasing member is a constant force spring.

44. 34. The sealing material dispenser according to claim 33, wherein the dispenser body further includes a receiving slit sized to receive a follower.

45. 34. The sealing member dispenser of claim 33, wherein the sealing member dispenser further comprises a magnetic material.

46. 34. The sealing material dispenser of claim 33, further comprising a rotor coupled to the shaft and a biasing assembly configured to exert a biasing force on the shaft urging the shaft to rotate.

47. 34. The sealing material dispenser of claim 33, comprising a rotor coupled to a shaft and a rotor drive assembly configured to automatically index the rotor until the sealing material is displaced along the trough to the exit point.

48. 48. The sealing material dispenser of claim 47, wherein a rotational displacement for indexing the rotor varies when the sealing material dispenser is depleted of sealing material.

49. a housing block including at least one channel extending through the housing block; a set of retention pins associated with each of the at least one channel; a set of guides associated with each of the at least one channel, a slot being defined between the guides of each set of guides; a feed plate coupled to the housing block by at least one biasing member, the feed plate including at least one follower projection; an elongated member extending from the housing block through the feed plate, the biasing member urging the feed plate to be displaced along the elongated member toward a stop surface of the housing block, the biasing member configured to urge the follower protrusion into contact with a port of a reservoir disposed in the guide; A reservoir feeding device comprising:

50. 50. The reservoir feeding device of claim 49, wherein each retention pin is biased by a retention pin biasing member to an expanded state in which the retention pin extends into the channel with which it is associated.

51. 50. A reservoir feeding device as claimed in claim 49, wherein the retention pins of each set of retention pins are disposed on opposite sides of the channel with which the set of retention pins is associated.

52. 50. The reservoir feeding device of claim 49, wherein each retention pin is biased to an expanded state by a retention pin biasing member, and wherein the ends of the retention pins of a set are spaced apart from one another by a distance less than the diameter of the port of the reservoir when in the expanded state.

53. 50. The reservoir feeding apparatus of claim 49, wherein each retention pin is configured to be displaced from the obstructing position upon introduction of a grasper to collect reservoirs from the reservoir feeder.

54. 50. The reservoir feeding device of claim 49, wherein the biasing member is a constant force spring.

55. 50. A reservoir feeding device as defined in claim 49, wherein the length of said follower projection is at least equal to the distance from said stop surface to said retention pin.

56. 50. The reservoir feeding apparatus of claim 49, further comprising a feed plate retainer for holding the feed plate in a loading orientation, the feed plate retainer being coupled to the housing block via at least one standoff.

57. 57. The reservoir feeding apparatus of claim 56, wherein the feed plate retainer includes a spring-biased latch member.

58. 57. The reservoir feeding apparatus of claim 56, wherein the feed plate retainer includes a magnet and the feed plate includes a metal body.

59. a housing block including at least one channel extending through the housing block; a set of retention pins associated with each of the at least one channel; a reservoir magazine coupled to the housing block; a feed plate coupled to the housing block by at least one biasing member, the feed plate including at least one follower projection; an elongated member extending from the housing block through the feed plate, the biasing member urging the feed plate to be displaced along the elongated member toward a stop surface of the housing block and the follower projection to be displaced through the reservoir magazine toward the housing block; A reservoir feeding device comprising:

60. 60. A reservoir feeding device as described in claim 59, wherein each retention pin is biased by a retention pin biasing member to an expanded state in which the retention pin extends into the channel with which it is associated.

61. 60. A reservoir feeding device as claimed in claim 59, wherein the retention pins of each set of retention pins are disposed on opposite sides of the channel with which the set of retention pins is associated.

62. 60. The reservoir feeding device of claim 59, wherein each retention pin is biased to an expanded state by a retention pin biasing member, and wherein the ends of the retention pins of a set are spaced apart from each other by a distance less than the diameter of the port of the reservoir when in the expanded state.

63. 60. The reservoir feeding apparatus of claim 59, wherein each retention pin is configured to be displaced from the obstructing position upon introduction of a grasper to collect reservoirs from the reservoir feeder.

64. 60. The reservoir feeding device of claim 59, wherein the biasing member is a constant force spring.

65. 60. A reservoir feeding device as set forth in claim 59, wherein the length of said follower projection is at least equal to the distance from said stop surface to said retention pin.

66. 60. The reservoir feeding apparatus of claim 59, further comprising a feed plate retainer for holding the feed plate in a loading orientation, the feed plate retainer being coupled to the housing block via at least one standoff.

67. 67. The reservoir feeding apparatus of claim 66, wherein the feed plate retainer includes a spring-biased latch member.

68. 67. The reservoir feeding apparatus of claim 66, wherein the feed plate retainer includes a magnet and the feed plate includes a metal body.

69. a ram displaceable along a displacement axis by a ram actuator; a sealing material dispenser receiver for receiving a sealing material dispenser; a sealing material dispenser sensor configured to output a first signal indicative of the presence of a sealing material dispenser in the receptacle; a reservoir guide including a first portion and a second portion, the first portion and the second portion having a gap therebetween, the reservoir guide configured to guide a port of a reservoir into alignment with the displacement axis when the reservoir is disposed in the gap, and at least one of the first and second portions of the reservoir guide including a grasper docking surface; 1. A bag sealing device comprising:

70. 70. The bag sealing device of claim 69, wherein the bag sealing device is a stoppering device.

71. 70. The bag sealing apparatus of claim 69, wherein the sealing member receiving portion is disposed intermediate the ram and the reservoir guide.

72. 70. The bag sealing apparatus of claim 69, wherein the sealing material dispenser sensor is a magnetic sensor.

73. 73. The bag sealing apparatus of claim 72, wherein the sealing material dispenser sensor is a Hall Effect sensor.

74. 70. The bag sealing device of claim 69, wherein said bag sealing device further comprises a reservoir detection sensor configured to output a second signal indicative of the presence of a reservoir in said reservoir guide.

75. 75. The bag sealing apparatus of claim 74, further comprising a controller, the controller configured to prevent actuation by the ram actuator in the absence of at least one of the first and second signals.

76. 70. The bag sealing apparatus of claim 69, wherein the bag sealing apparatus further includes an optical port detection sensor configured to output a second signal indicative of the presence of a port in alignment with the axis of displacement based on the intensity of reflection of light emitted from the sensor.

77. 70. The bag sealing apparatus of claim 69, further comprising a controller, the controller configured to prevent actuation by the ram actuator in the absence of the first signal.

78. 1. An apparatus for packaging fluids, said apparatus comprising: a fill conduit dispenser having a reel portion containing a length of fill conduit; a feeder assembly including an actuator coupled to at least one feeding member; a tubing retainer having a first portion connected to the sled and cam follower, said tubing retainer having a second portion connected to a base plate, said tubing retainer including receptacles for the segments of the fill conduit and the ports of the bag; a sled actuator; an occluder assembly having an occluder actuator, the occluder actuator coupled to a carriage mounted on the occluder; a cutter assembly including a cutter actuator coupled to a cutting element and a cam surface, the cam surface and the cutting element configured to displace in unison with one another; a guide coupled to the first portion of the tubing retainer, the occluder assembly, and the cutter assembly; a biasing member urging the cam follower against the cam surface; a controller configured to manage operation of the sled actuator, the occluder actuator, and the cutter actuator to occlude, cut, and join the segments and ports of the fill conduit; 1. An apparatus comprising:

79. 79. The apparatus of claim 78, wherein the first and second portions of the tubing retainer are separated by a first gap.

80. 80. The apparatus of claim 79, wherein the occluder includes a first occluder portion and a second occluder portion separated by a second gap.

81. 81. The apparatus of claim 80, wherein the first and second gaps are disposed in the same plane, and the first and second gaps are sized to receive the cutting element therein.

82. 79. The apparatus of claim 78, wherein the occluder includes a first occluder portion and a second occluder portion, the first occluder portion being mounted on a rail and rotatable relative to the carriage.

83. 79. The apparatus of claim 78, wherein the occluder includes a first occluder portion connected to the first retainer portion by a first pin, and the occluder includes a second occluder portion connected to the second retainer portion by a second pin.

84. 79. The apparatus of claim 78, wherein the occluder includes first and second occluder portions, the first occluder portion mounted on a rail and connected to the first retainer portion by a pin linking the first occluder portion and a first retainer portion, such that actuation of the sled by the sled actuator results in displacement of the first occluder portion along the rail.

85. 79. The apparatus of claim 78, wherein displacement of the cam follower along the cam surface changes the size of the gap.

86. 86. The apparatus of claim 85, wherein the cam surface is shaped so that the gap is greatest when the cutting element is disposed in the gap and the gap decreases when the cutting element is withdrawn.

87. 79. The apparatus of claim 78, wherein the occluder includes a first portion and a second portion, the first portion being rotatable relative to the carriage and connected to the first retainer portion via a linkage, and the biasing member connecting the first portion of the occluder to the carriage.

88. 79. The apparatus of claim 78, wherein the cutting element comprises a metal plate and a coating.

89. 89. The device of claim 88, wherein the coating is ceramic.

90. 79. The apparatus of claim 78, wherein the cutter assembly includes at least one heating element.

91. 79. The apparatus of claim 78, further comprising a tube sealing assembly having opposed jaws, the jaws each having a heating element and a low thermal conductivity cutting insert therein, the tube sealing assembly having a sealing actuator configured to displace the jaws toward and away from each other.

92. 92. The apparatus of claim 91, wherein the controller is configured to manage operation of the sealing actuator to displace the jaw against the port over a period of time, the jaw heating the port until the cutting insert is pressed through the port.

93. 79. The apparatus of claim 78, further comprising a counterweight coupled to the sled, the counterweight configured to hold the cam follower against the cam surface.

94. a carrier including multiple compartments; a plurality of packets each containing a flexible reservoir that is attached to an administration set and a fill line; an adapter including a plurality of retainer recesses, each having an end of one of the fill lines disposed therein, the retainer recesses restraining the ends of the fill lines so that the ends extend straight along the axis of the retainer recess in which they are disposed; a plurality of sealing members, a sealing member of the plurality of sealing members being included within each end of the filling line; Includes reservoir filling set.

95. 95. The reservoir filling set of claim 94, wherein the administration set includes at least one occlusion member associated therewith, the occlusion member being in an occluded state, wherein in the occluded state, flow through at least a portion of the administration set is restricted.

96. 96. The reservoir filling set of claim 95, wherein the occlusion member is a roller clamp.

97. 96. The reservoir filling set of claim 95, wherein the closure member is a slide clamp.

98. 96. The reservoir filling set of claim 95, wherein the occlusion member is a thumb clamp.

99. 95. The reservoir filling set of claim 94, wherein the carrier includes a handle.

100. 95. The reservoir filling set of claim 94, wherein each packet includes a pocket and a flap, the flexible reservoir disposed in the pocket, and the flap, in a closed position, retains the administration set within the packet.

101. 95. The reservoir filling set of claim 94, wherein the flexible reservoir contained by each packet is an IV bag.

102. 95. The reservoir filling set of claim 94, wherein the plurality of sealing members are septa.

103. 95. The reservoir filling set of claim 94, wherein the retainer recesses are spaced apart from one another at preset angular increments, the angular increments selected to align with spikes in a spike port of a filling device.

104. 1. A system for packaging fluids, comprising: a fluid source; a spike port including a plurality of spikes; In-line heater and; at least one pump; a plurality of valves; a controller configured to, in a first mode, power the heater to heat fluid to a predefined temperature setpoint and manage operation of the at least one pump and a plurality of valves to recirculate fluid through the spike port for a predetermined period of time to sanitize the spike port, and to, in a second mode, manage operation of the at least one pump and a plurality of valves to route fluid from the source to the spike of the spike port; Including, the system.

105. 105. The system of claim 104, wherein the spike port includes a recess, the spike is disposed within the recess, and includes a recirculation port.

106. 106. The system of claim 105, wherein the spike port is configured to receive a spiking adapter, the spiking adapter having a plurality of fluid lines contained within a retaining recess of the spiking adapter, and the spikes of the spike port are spaced apart to align with the retaining recess of the spiking adapter.

107. 107. The system of claim 106, wherein the spike port includes at least one alignment guide configured to cooperate with an alignment element of the spiking adapter.

108. 105. The system of claim 104, further comprising a passive manifold that branches fluid input from a common point to each of the spikes of the spike port.

109. 105. The system of claim 104, wherein the spike port includes a cap and a gasket, the cap sealingly abutting the gasket when the cap is in a closed orientation.

110. 105. The system of claim 104, wherein the predefined temperature set point is at least 70 degrees Celsius.

111. 1. A method of filling a reservoir, comprising: creating a joint between the fill conduit and the port of the reservoir by heating the fill conduit and port, cutting the fill conduit and port, bringing the fill conduit into coaxial alignment with the port, and joining the cut end of the port to the cut end of the fill conduit; delivering fluid through the fill conduit, across the junction, and into the reservoir through the port; actuating jaws against a portion of the port and heating the jaws until a non-thermally conductive insert in each jaw is pressed through the port; A method comprising:

112. 112. The method of claim 111, wherein cutting the fill conduit and port comprises forcing a heated blade into a gap in a retainer in which the fill conduit and port are disposed.

113. 113. The method of claim 112, wherein the step of bringing the fill conduit into coaxial alignment with the port includes actuating a sled to displace a movable portion of the retainer relative to a stationary portion of the retainer, such that the port and the cut ends of the fill conduit are slid across opposing surfaces of the heated blade.

114. 114. The method of claim 113, wherein the step of coupling the cut end of the port to the cut end of the filling conduit includes the steps of: biasing the movable portion of the retainer toward the stationary portion of the retainer; and displacing a cam surface, integral with the heated blade, on a cam follower coupled to the movable portion of the retainer when the heated blade is retracted away from the retainer.

115. 113. The method of claim 112, further comprising actuating the sled along a path generally parallel to a plane of the joint.

116. 112. The method of claim 111, further comprising forming a seal in the port that isolates an aliquot of liquid in the port from fluid in the reservoir.

117. 112. The method of claim 111, wherein the reservoir is a bag.

118. 112. The method of claim 111, further comprising sensing the presence of at least one of the fill conduit and port in a tubing retainer with at least one sensor.

119. 1. A method of filling a reservoir, comprising: cutting a fill conduit and a port with a heated cutting element, sliding the cut ends of the port and fill conduit across opposing surfaces of the cutting element to position the fill conduit in coaxial alignment with the port, and joining the cut end of the port to the cut end of the fill conduit as the cutting element is withdrawn, thereby creating a joint between the fill conduit and the reservoir port; delivering fluid through the fill conduit, across the junction, and into the reservoir through the port; actuating jaws against a portion of the port and heating the jaws until a non-thermally conductive insert in each jaw is pressed through the port; A method comprising:

120. 120. The method of claim 119, wherein cutting the fill conduit and port comprises forcing the cutting element into a gap in a retainer in which the fill conduit and port are disposed.

121. 121. The method of claim 120, wherein bringing the fill conduit into coaxial alignment with the port comprises actuating a sled to displace a movable portion of the retainer relative to a stationary portion of the retainer.

122. 122. The method of claim 121, wherein the step of coupling the cut end of the port to the cut end of the fill conduit includes the steps of: biasing the movable portion of the retainer toward the stationary portion of the retainer; and displacing a cam surface integral with the cutting element relative to a cam follower coupled to the movable portion of the retainer when the cutting element is withdrawn from the retainer.

123. 121. The method of claim 120, further comprising actuating the sled along a path generally parallel to a plane of the joint.

124. 120. The method of claim 119, further comprising forming a seal in the port that isolates an aliquot of liquid in the port from fluid in the reservoir.

125. 120. The method of claim 119, wherein the reservoir is a bag.

126. 120. The method of claim 119, further comprising sensing the presence of at least one of the fill conduit and port in a tubing retainer with at least one sensor.

127. 1. A fluid production system for a medical fluid packaging system, comprising: a water distillation device; a plurality of filters including at least one of a reverse osmosis filter and a carbon filter; a mixing circuit including a purified water flow path and a concentrate flow path, the concentrate flow path including a concentrate source, and a flow controller and an ultrafilter present on each of the purified water flow path and the concentrate flow path; a sensor suite including a total organic carbon sensor, a bioburden sensor, a particulate monitor, a plurality of ultrapure water conductivity sensors, and a concentrate conductivity sensor; a controller configured to manage operation of the flow controller to dispense predetermined volumes of fluid in a first stage and a second stage, the first stage delivering fluid at least primarily from the concentrate flow path and the second stage delivering fluid at least primarily from the purified water flow path, the controller apportioning fluid among the first and second stages based on data from the concentrate conductivity sensor, a predefined desired fluid composition, and the predetermined volumes; 1. A fluid production system comprising:

128. 128. The system of claim 127, wherein the water distillation device is a water vapor compression distillation device.

129. 128. The system of claim 127, wherein the system further includes at least one of a sediment filter, a water softener, and a temperature regulator.

130. 128. The system of claim 127, wherein the controller is configured to analyze data from each sensor in the sensor suite and to generate an error when the data indicates that the fluid quality attribute violates a threshold.

131. 128. The system of claim 127, wherein the concentrate source is a crystal concentrate container comprising a purified water inlet and a concentrated solution outlet.

132. 128. The system of claim 127, wherein the purified water is water of injection quality.

133. 128. The system of claim 127, wherein the system further comprises at least one manual sampling port.

134. 128. The system of claim 127, wherein the particulate counter is disposed downstream of the ultrafilter.

135. 128. The system of claim 127, wherein the controller commands delivery of fluid from only the concentrate flow path during the first stage.

136. 128. The system of claim 127, wherein the controller commands fluid delivery from only the purified water flow path during the second stage.

137. 128. The system of claim 127, wherein the water distillation device includes a condensed water reservoir therein.

138. 128. The system of claim 127, wherein the water distillation device is configured to generate purified water in a first temperature range and a second temperature range.

139. 139. The system of claim 138, wherein the first temperature range is below 40°C and the second temperature range is above 60°C.

140. 139. The system of claim 138, wherein the controller is configured to manage operation of the flow controller during a disinfection phase, wherein during the disinfection phase, the controller manages operation of the flow controller to route water at a temperature within the second temperature range through the system, to a nozzle, and into a drain.

141. 1. A method of filling a bag with a medical fluid, comprising: placing a first fill nozzle into a first port of the bag communicating with a first compartment of the bag and a second fill nozzle into a second port of the bag communicating with a second compartment of the bag, the first and second fill nozzles communicating with a fluid source via a common flow channel; delivering a fluid into the first and second compartments of the bag; stopping the delivery of fluid in the smaller of the first and second compartments of the bag when the smaller compartment is completely filled with a non-powered valve; ceasing delivery of fluid into the larger of the first and second compartments of the bag when that compartment is completely filled; separating the first compartment of the bag from the second compartment of the bag at a perforation in a seal extending between the first compartment and the second compartment; accessing the smaller compartment and collecting a sample of fluid for testing; A method comprising:

142. 142. The method of claim 141, wherein the fluid is a mixture of water for injection and at least one concentrate.

143. 142. The method of claim 141, wherein the fluid is a saline solution.

144. 142. The method of claim 141, further comprising the steps of performing an endotoxin test on the sample and discarding the larger compartment when the endotoxin test indicates that the presence of endotoxin is greater than a predefined level.

145. 1. A bag for containing a medical fluid and a separable sampling aliquot, comprising: a first compartment having a first fill port and a delivery port; a second compartment having a second fill port; a seal separating the first compartment and the second compartment; a perforation extending along the length of the seal; Including the bag.

146. 146. The bag of claim 145, wherein the first compartment has a larger capacity than the second compartment.

147. 146. The bag of claim 145, wherein the seal extends along the length of the bag from a first end of the bag to a second end of the bag.

148. A reservoir for holding a fluid, comprising: first and second sheets of material sealed together at a peripheral seal to define an interior volume of the reservoir; at least one port coupled at the peripheral seal and providing a fluid path into the interior volume; an internal seal extending from the peripheral seal, the internal seal defining a partitioned portion of the internal volume and a main section of the internal volume, the partitioned portion being in fluid communication with the main volume through a gap in the internal seal; , a reservoir.

149. 149. The reservoir of claim 148, wherein the gap is configured to be sealed after the reservoir is filled to isolate the compartmented portion from the main volume.

150. 149. The reservoir of claim 148, wherein the at least one port includes a fill port and an administration port.

151. 149. The reservoir of claim 148, wherein the divided portion has a volume capacity smaller than the volume capacity of the main volume.

152. 149. The reservoir of claim 148, wherein each of the at least one port is in direct fluid communication with the main volume.

153. 149. The reservoir of claim 148, wherein the internal seal is disposed at an angle to direct fluid toward the at least one port when the reservoir is suspended for gravity-based administration of fluid contained within the reservoir.

154. 149. The reservoir of claim 148, wherein the reservoir is a bag.

155. A reservoir for holding a fluid, comprising: first and second sheets of material sealed together at a peripheral seal to define an interior volume of the reservoir; at least one port coupled at the peripheral seal and providing a fluid path into the interior volume, the peripheral seal having an enlarged area, the at least one port being positioned within the enlarged area; a sampling reservoir defined within the enlarged region, the sampling reservoir extending from a flow path through the enlarged region connecting one of the at least one port to the interior volume of the reservoir; and , a reservoir.

156. 156. A reservoir as described in claim 155, wherein the sampling reservoir is in communication with the flow path via a branch path contained within the enlarged region.

157. 157. The reservoir of claim 156, wherein the branch pathway is configured to be sealed after the reservoir is filled, isolating the sampling reservoir from the internal volume.

158. 156. The reservoir of claim 155, wherein the reservoir is a bag.

159. 156. The reservoir of claim 155, wherein the at least one port includes a fill port and an administration port.

160. 160. The reservoir of claim 159, wherein the flow path through the enlarged region connected to the sampling reservoir connects the fill port to the internal volume.

161. 1. A method of packaging a fluid in a reservoir, comprising: introducing a fill nozzle into a fill port of the reservoir; delivering a predefined amount of fluid into the reservoir through the fill nozzle; removing the fill nozzle; sealing the port of the reservoir; forming a seal in the reservoir, the seal creating an internal aliquot of fluid in the reservoir that is isolated from the remainder of the reservoir; A method comprising:

162. 162. The method of claim 161, wherein the reservoir is a bag.

163. 162. The method of claim 161, wherein the step of forming the seal includes sealing a gap in a partial wall portion contained within the reservoir that defines a main internal volume of the reservoir and a partitioned internal volume of the reservoir, the gap providing fluid communication between the main volume and the partitioned internal volume.

164. 162. The method of claim 161, wherein the reservoir is constructed from first and second sheets of material joined together at a peripheral seal that defines an interior volume of the reservoir, and wherein forming the seal includes sealing and closing a section of a flow path defined within an enlarged portion of the peripheral seal.

165. 165. The method of claim 164, wherein sealing and closing the section of the flow path defined within the enlarged portion of the peripheral seal isolates a sampling reservoir defined within the enlarged portion of the peripheral seal from the internal volume of the reservoir.

166. 162. The method of claim 161, wherein the method further comprises the steps of collecting a sample from the internal aliquot and testing the sample.

167. a first portion including a single lumen; a second portion including a fill lumen and a sampling lumen, the fill lumen being continuous with the single lumen of the first portion, the fill lumen and the single lumen defining a continuous flow path from the first portion to an outlet of the nozzle, the sampling lumen having an opening at the outlet of the nozzle and in fluid communication with a sample flow path connected to a sidewall of the nozzle; a filling and sampling nozzle,

168. 1. A method of packaging a fluid in a reservoir, comprising: introducing a nozzle into a port of the reservoir; delivering a first volume of fluid into the reservoir through a continuous flow path extending from a first portion of the nozzle through a second portion of the nozzle; delivering a second volume of fluid into the reservoir through the continuous flow path, the second volume of fluid exceeding the capacity of the reservoir; directing overflow during delivery of the second volume through a sampling lumen of the nozzle and into a sampling conduit coupled to the nozzle; A method comprising:

169. 169. The method of claim 168, wherein the method further comprises providing the overflow to a sensing assembly.

170. 169. The method of claim 168, wherein the method further comprises providing the overflow to a vial.

171. 169. The method of claim 168, wherein the first volume of fluid is equal to the capacity of the reservoir.

172. 169. The method of claim 168, wherein the reservoir is a bag.

173. The system, method, and apparatus as herein shown and described.

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