Systems, methods and apparatus for producing and packaging fluids

Abstract

A system for producing and packaging fluids may include a water distillation device. The system may also include a mixing circuit connected to an output of the water distillation device and including a concentrate source. The mixing circuit may include a plurality of flow controllers configured to adjust the flow of the fluid through the mixing circuit to generate a preset fluid. The system may also include a housing including a front chamber and a packaging compartment. The system may also include a reservoir dispenser in the packaging compartment, the reservoir dispenser having a feed plate and a housing block. The reservoir dispenser may include a biasing member to push the feed plate toward the housing block. The system may also include a filling station in the packaging compartment, the filling station including a filling nozzle connected to the mixing circuit. The system may also include a sealing station in the packaging compartment, the sealing station having a push rod and a sealing member dispenser. The system may also include a quarantine storage in the packaging compartment, the quarantine storage having a plurality of reservoir holders. The system may also include a labeler in the packaging compartment. The system may also include an output chute from the packaging compartment to the outside of the housing.

Description

[0001] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] This invention was made with Government support under Agreement HHSO100201900017C awarded by HHS. The Government has certain rights in this invention. Technical Field

[0003] The present disclosure relates to medical fluids. More particularly, the present disclosure relates to the generation and packaging of medical fluids. Background Art

[0004] Nearly every hospitalized patient is administered saline or a saline-based solution. As a result, the amount of saline solution consumed is very large. In the United States alone, more than 1 billion bags of saline are used each year. Despite this demand, there are only a few different saline manufacturers that provide this solution to the U.S. market. Unfortunately, manufacturing challenges that limit production to one manufacturer can and do lead to saline shortages in the United States. Compounding the problem is that these manufacturers have varying market shares for all bagged saline products. For example, 50% of saline bags of 250 ml or less are provided by a single manufacturer. Therefore, when such a manufacturer faces production issues, the impact on the availability of that particular type of bag is much greater.

[0005] Recently, media attention has been focused on the delays caused in the aftermath of Hurricane Maria, which has resulted in a shortage of small-volume saline bags. According to the American Society of Health-System Pharmacists, there is also a shortage of large-volume bags and saline bags for irrigation purposes. An alternative way to produce medical fluid bags that can be located in the facility where the bags are used may be desirable. Summary of the invention

[0006] According to an embodiment of the present disclosure, a sealing member dispenser may include a dispenser body, the dispenser body including: at least one groove, the at least one groove being configured to receive a plurality of sealing members; and an outlet port, the outlet port extending from the groove to the outer face of the dispenser body. The outlet port may have a guide portion adjacent to the outer face of the dispenser body. The sealing member dispenser may also include a blocking element, the blocking element blocking the passage of the sealing member through the outlet port. The sealing member dispenser may also include a cover, the cover is coupled to the dispenser body and suspended on the groove. The cover may include an orifice in line with the outlet port. The orifice may have an opening, the opening being too small for a sealing member in the plurality of sealing members to pass through.

[0007] In some embodiments, the groove may extend along a spiral path. In some embodiments, the dispenser body may be a drum. In some embodiments, the guide portion may include a funnel-shaped profile. In some embodiments, the guide portion may be a chamfered edge. In some embodiments, the guide portion may be a rounded edge. In some embodiments, the blocking element may be displaceable. In some embodiments, the blocking element may be an outlet cover coupled to a handle. The displacement of the handle may cause the outlet cover to shift away from the blocking position. In some embodiments, the blocking element may include a brake member protruding into the outlet port. In some embodiments, the brake member may be a spherical brake. In some embodiments, the sealing member dispenser may further include a follower and a biasing member coupled to a portion of the follower and the dispenser body. In some embodiments, the biasing member may be a constant force spring. In some embodiments, the dispenser body may further include a receiving slit sized to receive the follower. In some embodiments, the sealing member dispenser may further include a magnetic body. In some embodiments, the sealing member dispenser may further include: a rotor coupled to a shaft; and a biasing assembly configured to apply a biasing force to the shaft to drive the shaft to rotate. In some embodiments, the sealing member dispenser may include a rotor coupled to the shaft. In some embodiments, the sealing member dispenser may include a rotor drive assembly configured to automatically index the rotor until the sealing member is displaced along the groove to the exit point. In some embodiments, the rotational displacement for indexing the rotor may vary as the sealing member of the sealing member dispenser is depleted.

[0008] According to another embodiment of the present disclosure, the reservoir feeding device may include a housing block including at least one channel extending through the housing block. The reservoir feeding device may also include a set of retaining pins associated with each of the at least one channel. The reservoir feeding device may also include a set of guides associated with each of the at least one channel. A groove may be defined between the guides in each set of guides. The reservoir feeding device may also 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 device may also include an elongated member extending from the housing block through the feed plate. The biasing member may push the feed plate to shift along the elongated member toward the stop surface of the housing block. The biasing member may also be configured to push the follower protrusion to contact the port of the reservoir arranged in the guide.

[0009] In some embodiments, each retaining pin may be biased to an extended state by a retaining pin biasing member, in which the retaining pin extends into a channel associated therewith. In some embodiments, the retaining pins in each group of retaining pins may be arranged on opposite sides of a channel associated with the group of retaining pins. In some embodiments, each retaining pin may be biased to an extended state by a retaining pin biasing member, and when in the extended state, the ends of the retaining pins in a group of retaining pins are spaced apart from each other by a distance that is less than the diameter of the port of the reservoir. In some embodiments, each retaining pin may be configured to move out of a blocking position when a grabber is introduced to collect the reservoir from the reservoir feeder. In some embodiments, the biasing member may be a constant force spring. In some embodiments, the length of the follower protrusion is at least equal to the distance from the stop face to the retaining pin. In some embodiments, the reservoir feeding device may further include a feed plate retainer for retaining the feed plate in a loading orientation. The feed plate retainer may be coupled to the housing block via at least one support member. In some embodiments, the feed plate retainer may include a spring-biased latch member. In some embodiments, the feed plate retainer may include a magnet, and the feed plate includes a metal body.

[0010] According to another embodiment of the present disclosure, a reservoir feeding device may include a housing block including at least one channel extending through the housing block. The reservoir feeding device may also include a set of retaining pins associated with each of the at least one channel. The reservoir feeding device may also include a reservoir box connected to the housing block. The reservoir feeding device may also include a feed plate connected to the housing block by at least one biasing member. The feed plate may include at least one follower protrusion. The reservoir feeding device may also include an elongated member extending from the housing block through the feed plate. The biasing member may push the feed plate to shift along the elongated member toward the stop surface of the housing block. The biasing member may also push the follower protrusion to shift through the reservoir box toward the housing block.

[0011] In some embodiments, each retaining pin may be biased to an extended state by a retaining pin biasing member, in which the retaining pin extends into a channel associated therewith. In some embodiments, the retaining pins in each group of retaining pins may be arranged on opposite sides of a channel associated with the group of retaining pins. In some embodiments, each retaining pin may be biased to an extended state by a retaining pin biasing member, and when in the extended state, the ends of the retaining pins in a group of retaining pins are spaced apart from each other by a distance that is less than the diameter of the port of the reservoir. In some embodiments, each retaining pin may be configured to move out of a blocking position when a grabber is introduced to collect the reservoir from the reservoir feeder. In some embodiments, the biasing member may be a constant force spring. In some embodiments, the length of the follower protrusion may be at least equal to the distance from the stop face to the retaining pin. In some embodiments, the reservoir feeding device may further include a feed plate retainer for retaining the feed plate in a loading orientation. The feed plate retainer may be coupled to the housing block via at least one support member. In some embodiments, the feed plate retainer may include a spring-biased latch member. In some embodiments, the feed plate retainer may include a magnet, and the feed plate may include a metal body.

[0012] According to another embodiment of the present disclosure, the bag sealing device includes a push rod, which can be displaced along the displacement axis by a push rod actuator. The bag sealing device may also include a sealing member dispenser container, which is used to receive the sealing member dispenser. The bag sealing device may also include a sealing member dispenser sensor, which is configured to output a first signal, and the first signal indicates the presence of the sealing member dispenser in the container. The bag sealing device may also include a reservoir guide, which includes a first part and a second part, and has a gap between the first part and the second part. When the reservoir is arranged in the gap, the reservoir guide guides the port of the reservoir to align with the displacement axis. At least one of the first part and the second part of the reservoir guide may include a gripper docking surface.

[0013] In some embodiments, the bag sealing device may be a plugging device. In some embodiments, the sealing member container may be arranged between the push rod and the reservoir guide. In some embodiments, the sealing member dispenser sensor may be a magnetic sensor. In some embodiments, the sealing member dispenser sensor is a Hall effect sensor. In some embodiments, the bag sealing device may further include a reservoir detection sensor configured to output a second signal indicating the presence of the reservoir in the reservoir guide. In some embodiments, the bag sealing device may further include a controller. The controller may be configured to prevent actuation by the push rod actuator in the absence of at least one of the first signal and the second signal. In some embodiments, the bag sealing device may further include an optical port detection sensor configured to output a second signal based on the reflected intensity of light emitted from the sensor, the second signal indicating the presence of a port aligned with the displacement axis. In some embodiments, the bag sealing device may further include a controller configured to prevent actuation by the push rod actuator in the absence of the first signal.

[0014] According to an embodiment of the present disclosure, a device for packaging fluid may include a filling catheter dispenser having a reel portion containing a certain length of filling catheter. The device may also include a feeder assembly, which includes an actuator coupled to at least one feeding member. The device may also include a tube holder, which has a first portion coupled to a slider and a cam follower. The tube holder may have a second portion coupled to a substrate. The tube holder may include a container for a section of filling catheter and a port of a bag. The device may also include a slider actuator. The device may also include an occluder assembly, which has an occluder actuator, which is coupled to a carriage mounted to the occluder. The device may also include a cutter assembly, which includes a cutter actuator coupled to a cutting element and a cam surface. The cam surface and the cutting element may be configured to shift in unison with each other. The device may also include a guide, which is coupled to the first portion of the tube holder, the occluder assembly, and the cutter assembly. The device may also include a biasing member that pushes the cam follower against the cam surface. The device may also include a controller configured to govern the operation of the slider actuator, the occluder actuator, and the cutter actuator to occlude, cut, and engage the section of filling conduit and port.

[0015] In some embodiments, the first and second parts of the tube holder can be separated by a first gap. In some embodiments, the occluder may include a first occluder part and a second occluder part separated by a second gap. In some embodiments, the first gap and the second gap are arranged in the same plane, and the first gap and the second gap are sized to receive a cutting element therein. In some embodiments, the occluder includes a first occluder part and a second occluder part, and the first occluder part is mounted on a guide rail and can rotate relative to the carriage. In some embodiments, the occluder may include a first occluder part coupled to a first retainer part by a first pin, and the occluder may include a second occluder part coupled to a second retainer part by a second pin. In some embodiments, the occluder may include a first occluder part and a second occluder part. The first occluder part may be mounted on the guide rail and coupled to the first retainer part by a pin, wherein the pin couples the first occluder part and the first retainer part, so that the actuation of the slider actuator to the slider causes the first occluder part to shift along the guide rail. In some embodiments, the displacement of the cam follower along the cam surface can change the size of the gap. In some embodiments, the cam surface may be shaped so that the gap is maximum when the cutting element is arranged in the gap, and the gap decreases as the cutting element is retracted. In some embodiments, the occluder may include a first portion and a second portion. The first portion may be capable of rotating relative to the carriage and connected to the first retainer portion via a connecting rod. A biasing member may connect the first portion of the occluder to the carriage. In some embodiments, the cutting element may include a metal plate and a coating. In some embodiments, the coating may be ceramic. In some embodiments, the cutter assembly may include at least one heating element. In some embodiments, the device may also include a tube sealing assembly having relative jaws, each having a heating element and a low thermal conductivity cutting insert in each jaw. The tube sealing assembly may have a sealing actuator configured to displace the jaws toward and away from each other. In some embodiments, the controller may be configured to govern the operation of the sealing actuator so that the jaws are displaced against the port for a period of time, and the jaws heat the port until the cutting insert is squeezed through the port. In some embodiments, the device may also include a counterweight coupled to the slider. The counterweight may be configured to keep the cam follower against the cam surface.

[0016] According to another embodiment of the present disclosure, the reservoir filling kit may include a carrier including a plurality of compartments. The reservoir filling kit may also include a plurality of packaging packages, each packaging package accommodating a flexible reservoir, which is attached to the liquid administration kit and the filling line. The reservoir filling kit may also include an adapter, which includes a plurality of retainer recesses, each retainer recess having an end of one of the filling lines arranged therein. The retainer recess may constrain the end of the filling line to extend straight along the axis of the retainer recess. The reservoir filling kit may also include a plurality of sealing members. A sealing member among the plurality of sealing members may be included in each end of the filling line.

[0017] In some embodiments, the administration kit may include at least one blocking member associated therewith. The blocking member may be in a blocking state in which flow through at least a portion of the administration kit is inhibited. In some embodiments, the blocking member may be a roller clamp. In some embodiments, the blocking member may be a sliding clamp. In some embodiments, the blocking member may be a thumb clamp. In some embodiments, the carrier may include a handle. In some embodiments, each packaging package may include a pocket and a wing, wherein a flexible reservoir is arranged in the pocket, and the wing holds the administration kit in the packaging package in a closed position. In some embodiments, the flexible reservoir accommodated by each packaging package may be an IV bag. In some embodiments, the multiple sealing members may be diaphragms. In some embodiments, the retainer recesses may be spaced apart from each other at preset angle increments. The angle increment may be selected to align with the spike in the spike port of the filling device.

[0018] According to another embodiment of the present disclosure, a system for packaging fluid may include a fluid source. The system may also include a spike port, the spike port including a plurality of spikes. The system may also include an inline heater. The system may also include at least one pump. The system may also include a plurality of valves. The system may also include a controller configured to: in a first mode, supply power to the heater to heat the fluid to a predetermined temperature set point, and govern the operation of the at least one pump and the plurality of valves to recirculate the fluid through the spike port for a predetermined period of time to sterilize the spike port; and in a second mode, govern the operation of the at least one pump and the plurality of valves to direct the fluid from the fluid source to the spike of the spike port.

[0019] In some embodiments, the tip port may include a recess in which the tip is disposed, and the tip port includes a recirculation port. In some embodiments, the tip port may be configured to receive a tip adapter, including a plurality of fluid lines in a retaining recess of the tip adapter. The tips of the tip port may be spaced apart to align with the retaining recess of the tip adapter. In some embodiments, the tip port may include at least one alignment guide configured to cooperate with an alignment element of the tip adapter. In some embodiments, the system may further include a passive manifold that bifurcates fluid input from a common point to each tip of the tip port. In some embodiments, the tip port may include a cover and a gasket, the cover being sealed to the gasket when the cover is in a closed orientation. In some embodiments, the predetermined temperature set point may be at least 70°C.

[0020] According to another embodiment of the present disclosure, a method of filling a reservoir may include creating a joint between a filling conduit and a port of the reservoir by heating the filling conduit and the port, cutting the filling conduit and the port, coaxially aligning the filling conduit with the port, and joining the cut end of the port to the cut end of the filling conduit. The method may also include conveying a fluid through the filling conduit through the joint and into the reservoir via the port. The method may also include actuating the jaws against a portion of the port and heating the jaws until a non-thermally conductive insert in each jaw is squeezed through the port.

[0021] In some embodiments, cutting the filling conduit and the port may include driving a heated blade into a gap in a retainer in which the filling conduit and the port are arranged. In some embodiments, aligning the filling conduit coaxially with the port may include actuating a slide to displace a movable portion of the retainer relative to a fixed portion of the retainer so that the cut end of the port and the cut end of the filling conduit slide over the opposite surfaces of the heated blade. In some embodiments, coupling the cut end of the port to the cut end of the filling conduit may include biasing the movable portion of the retainer toward the fixed portion of the retainer and displacing the cam surface in unison with the heated blade relative to the cam follower coupled to the movable portion of the retainer when the heated blade is withdrawn from the retainer. In some embodiments, the method may also include actuating a slide along a path orthogonal to a plane substantially parallel to the joint. In some embodiments, the method may also include forming a seal in the port that separates an aliquot of the liquid in the port from the fluid in the reservoir. In some embodiments, the reservoir may be a bag.

[0022] According to another embodiment of the present disclosure, a method of filling a reservoir may include forming a joint between a filling conduit and a port of a reservoir by cutting the filling conduit and the port with a heated cutting element, sliding the cut end of the port and the cut end of the filling conduit over opposing surfaces of the cutting element to position the filling conduit in coaxial alignment with the port, and joining the cut end of the port to the cut end of the filling conduit when the cutting element is retracted. The method may also include conveying a fluid through the filling conduit through the joint and into the reservoir via the port. The method may also include actuating the jaws against a portion of the port and heating the jaws until a non-thermally conductive insert in each jaw is squeezed through the port.

[0023] In some embodiments, cutting the filling conduit and the port may include driving the cutting element into a gap in a retainer in which the filling conduit and the port are arranged. In some embodiments, aligning the filling conduit coaxially with the port may include actuating a slide to displace the movable portion of the retainer relative to the fixed portion of the retainer. In some embodiments, coupling the cutting end of the port to the cutting end of the filling conduit may include biasing the movable portion of the retainer toward the fixed portion of the retainer and displacing the cam surface in unison with the cutting element relative to the cam follower connected to the movable portion of the retainer when the cutting element is withdrawn from the retainer. In some embodiments, the method may also include actuating a slide along a path substantially parallel to a plane of the joint. In some embodiments, the method may also include forming a seal in the port that separates an aliquot of the liquid in the port from the fluid in the reservoir. In some embodiments, the reservoir may be a bag. In some embodiments, the method may also include sensing the presence of at least one of the filling conduit and the port in the tube retainer with at least one sensor.

[0024] According to another embodiment of the present disclosure, a system for producing and packaging fluids may include a water distillation device. The system may also include a mixing circuit, which is connected to the output of the water distillation device and includes a concentrate source. The mixing circuit may include a plurality of flow controllers configured to adjust the flow of the fluid through the mixing circuit, thereby generating a preset fluid. The system may also include a housing, which includes a front chamber and a packaging compartment. The system may also include a reservoir dispenser in the packaging compartment, the reservoir dispenser having a feed plate and a housing block. The reservoir dispenser may include a biasing member that pushes the feed plate toward the housing block. The system may also include a filling station in the packaging compartment, the filling station including a filling nozzle connected to the mixing circuit. The system may also include a sealing station in the packaging compartment, the sealing station having a push rod and a sealing member dispenser. The system may also include a quarantine storage in the packaging compartment, the quarantine storage having a plurality of reservoir brackets. The system may also include a labeling machine in the packaging compartment. The system may also include an output chute from the packaging compartment to the outside of the housing.

[0025] In some embodiments, the system may also include at least one of a reverse osmosis unit and an ultrafilter. In some embodiments, the concentrate source may be a reservoir of a crystal concentrate 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 front chamber may include a flexible sterile barrier. In some embodiments, the flexible sterile barrier may include at least one glove interface. In some embodiments, the front chamber and the packaging compartment may be separated by a partition. In some embodiments, the partition may include a door with a sample container holder. In some embodiments, the system may also include a pyrogen tester. In some embodiments, the system may also include a robot arm including a gripper. In some embodiments, the system may also include a control system configured to displace the robot arm and actuate the gripper to collect the reservoir from the reservoir dispenser, displace the reservoir to the filling station, command the reservoir to be filled, displace the reservoir to the sealing station, and command the actuation of the push rod to drive the sealing member from the sealing member to the port of the reservoir. In some embodiments, the filling station may further include a set of reservoir characteristic sensors, and the system may further include a control system configured to analyze data received from the reservoir characteristic sensors and determine the capacity of a reservoir in place at the filling station. In some embodiments, the control system may be configured to govern the operation of the flow controller based on the capacity of the reservoir, wherein the capacity of the reservoir is determined based on the data from the reservoir characteristic sensors. In some embodiments, the control system may be configured to govern the operation of the flow controller to deliver an amount of concentrate to the reservoir, and subsequently deliver an amount of purified water to the reservoir to achieve a fill amount selected based on the capacity of the reservoir.

[0026] According to another embodiment of the present disclosure, a system for producing and packaging fluids may include a water distillation device. The system may also include a mixing circuit, which is connected to the output of the water distillation device and includes a concentrate source. The mixing circuit may be configured to adjust the flow of the fluid through the mixing circuit, thereby generating a fluid with a predetermined component. The system may also include a housing, which includes a front chamber and a packaging compartment. The system may also include a reservoir dispenser at least partially in the packaging compartment, the reservoir dispenser having a reservoir box and an outlet end. The reservoir dispenser may include an actuator configured to drive a follower of the reservoir box toward the outlet end of the reservoir dispenser. The system may also include a filling station in the packaging compartment, the filling station including a filling nozzle and a reservoir volume sensing assembly connected to the mixing circuit. The system may also include a sealing station in the packaging compartment. The system may also include a storage library in the packaging compartment, the storage library having a plurality of reservoir racks. The system may also include a labeling machine in the packaging compartment. The system may also include an output chute from the packaging compartment to the outside of the housing.

[0027] In some embodiments, the system may also include at least one of a reverse osmosis unit and an ultrafilter. In some embodiments, the concentrate source may be a reservoir of a crystal concentrate having a purified water inlet and a fluid concentrate outlet. In some embodiments, the front chamber may include a flexible sterile barrier. In some embodiments, the flexible sterile barrier may include at least one glove interface. In some embodiments, the front chamber and the packaging compartment may be separated by a partition. In some embodiments, the partition may include a door with a sample container holder. In some embodiments, the system may also include a pyrogen tester. In some embodiments, the system may also include a robot arm including a gripper. In some embodiments, the system may also include a control system configured to displace the robot arm and actuate the gripper to collect the 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 the reservoir to be filled with a fluid amount not greater than the volume of the reservoir, displace the reservoir to a sealing station, and command the sealed reservoir. In some embodiments, the reservoir volume sensing assembly may include a set of reservoir characteristic sensors, and the system may further include a control system configured to analyze data received from the reservoir characteristic sensors, and the control system is configured to determine the capacity of a reservoir in place at a filling station. In some embodiments, the control system may be configured to govern the operation of at least one flow controller based on the reservoir capacity, wherein the capacity of the reservoir is determined based on the data from the reservoir characteristic sensors. In some embodiments, the control system may be configured to govern the operation of the at least one flow controller to deliver an amount of concentrate to the reservoir, and subsequently deliver an amount of purified water to the reservoir to achieve a fill amount selected based on the capacity of the reservoir.

[0028] According to another embodiment of the present disclosure, a system for producing and packaging fluids may include a water purification device. The system may also include a mixing circuit, which is connected to the output of the water purification device and includes a concentrate source. The mixing circuit may be configured to generate a fluid with a predetermined component. The system may also include a housing, which includes a front chamber and a packaging compartment. The system may also include a reservoir dispenser, which extends from the front chamber to the packaging compartment and has a reservoir box and an outlet end. The reservoir dispenser may include a driver configured to displace the follower of the reservoir box toward the outlet end of the reservoir dispenser. The system may also include a filling station in the packaging compartment, which includes a filling nozzle and a reservoir volume sensing assembly connected to the mixing circuit. The system may also include a sealing station in the packaging compartment. The system may also include at least one reservoir hanger in the packaging compartment. The system may also include a labeler in the packaging compartment. The system may also include an output chute from the packaging compartment to the outside of the housing.

[0029] In some embodiments, the system may also include at least one of a reverse osmosis unit and an ultrafilter. In some embodiments, the concentrate source may be a reservoir of a crystal salt concentrate. In some embodiments, the front chamber may include at least one glove interface. In some embodiments, the front chamber may include at least one flexible barrier element. In some embodiments, the front chamber and the packaging compartment may be separated by a partition including at least one door between the front chamber and the packaging compartment. In some embodiments, the system may also include a robotic arm including a gripper. In some embodiments, the system may also include a robotic manipulator and a control system configured to displace the robotic manipulator to collect a reservoir from a reservoir dispenser, displace the reservoir to a filling station, determine the volume of the container via data from a reservoir volume sensing assembly, command to fill the reservoir with a fluid amount not greater than the volume of the reservoir, displace the reservoir to a sealing station, and command to seal the reservoir. In some embodiments, the reservoir volume sensing assembly may include a set of reservoir characteristic sensors. In some embodiments, the control system may be configured to govern the operation of at least one flow controller based on the capacity of the reservoir, wherein the capacity of the reservoir is determined based on data from a reservoir characteristic sensor. In some embodiments, the control system can be configured to govern operation of the at least one flow controller to deliver an amount of concentrate to the reservoir and subsequently deliver an amount of purified water to the reservoir to achieve a fill amount selected based on a capacity of the reservoir, wherein the capacity of the reservoir is determined based on data from a reservoir characteristic sensor.

[0030] 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 also include a plurality of filters, the plurality of filters including at least one of a reverse osmosis filter and a carbon filter. The system may also include a mixing loop, the mixing loop including a purified water flow path and a concentrate flow path including a concentrate source. A flow controller and an ultrafilter may be provided on each of the purified water flow path and the concentrate flow path. The system may also include a sensor set including a total organic carbon sensor, a bioburden sensor, a particle monitor, a plurality of ultrapure water conductivity sensors, and a concentrate conductivity sensor. The system may also include a controller configured to govern the operation of the flow controller to distribute a predetermined amount of fluid in a first stage and a second stage, the first stage at least mainly conveying fluid from the concentrate flow path, and the second stage at least mainly conveying fluid from the purified water flow path, the controller proportioning fluid in the first stage and the second stage based on data from the concentrate conductivity sensor, a predetermined desired fluid component, and a predetermined amount.

[0031] In some embodiments, the water distillation device may be a water vapor compression distillation device. In some embodiments, the system may further include at least one of a sediment filter, a water softener, and a temperature regulator. In some embodiments, the controller may be configured to analyze data from each sensor of the sensor set and generate an error when the data indicates that the fluid quality characteristic exceeds a threshold value. In some embodiments, the concentrate source is a container of crystallized concentrate, which includes a purified water inlet and a concentrated solution outlet. In some embodiments, the concentrate source may include a crystallized component dispenser. In some embodiments, the purified water may be water of injection grade water quality. In some embodiments, the system may further include at least one manual sampling port. In some embodiments, the particle counter may be arranged downstream of the ultrafilter. In some embodiments, the controller may command only the delivery of fluid from the concentrate flow path during the first stage. In some embodiments, the controller may command only the delivery of fluid from the purified water flow path in the second stage. In some embodiments, a condensed water reservoir may be included in the water distillation device. In some embodiments, the water distillation device may be configured to generate purified water in a first temperature range and a second temperature range. In some embodiments, the first temperature range may be lower than 40°C, and the second temperature range may be higher than 60°C. In some embodiments, the controller can be configured to govern operation of the flow controller during a disinfection phase, in which the controller governs operation of the flow controller to direct water through the system, to the nozzle, and into the discharge outlet at a temperature within a second temperature range.

[0032] According to another embodiment of the present disclosure, a method for filling a bag with a medical fluid may include placing a first filling nozzle in a first port of the bag that is connected to a first compartment of the bag and placing a second filling nozzle in a second port of the bag that is connected to a second compartment of the bag. The first filling nozzle and the second filling nozzle are connected to a fluid source via a common flow channel. The method may also include delivering fluid to the first compartment and the second compartment of the bag. The method may also include stopping the delivery of fluid to the smaller compartment with an unpowered valve when the smaller compartment of the first compartment and the second compartment of the bag is completely filled. The method may also include stopping the delivery of fluid to the larger compartment when the larger compartment of the first compartment and the second compartment of the bag is completely filled. The method may also include 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. The method may also include accessing the smaller compartment to collect a fluid sample for testing.

[0033] 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 a physiological saline solution. In some embodiments, the method can also include testing the sample for endotoxins and discarding the larger compartment when the endotoxin test indicates the presence of endotoxins greater than a predetermined level.

[0034] According to another embodiment of the present disclosure, a bag for containing medical fluids and separable sampling aliquots may include a first compartment having a first filling port and a delivery port. The bag may also include a second compartment having a second filling port. The bag may also include a seal separating the first compartment and the second compartment. The bag may also include a perforation extending along the length of the seal.

[0035] In some embodiments, the first compartment may have a greater capacity than the second compartment.In some embodiments, the seal may extend along the length of the bag from a first end of the bag to a second end of the bag.

[0036] According to an embodiment of the present disclosure, a reservoir for holding a fluid may include a first material sheet and a second material sheet, which are sealed to each other at a peripheral seal to define an internal volume of the reservoir. The reservoir may also include at least one port that is coupled to the peripheral seal and provides a fluid path into the internal volume. The reservoir may also include an internal seal extending from the peripheral seal. The internal seal may define a partition portion of the internal volume and a main portion of the internal volume. The partition portion may be in fluid communication with the main volume via a gap in the internal seal.

[0037] In some embodiments, the gap can be configured to be sealed after the reservoir is filled to separate the partition portion from the main volume. In some embodiments, the at least one port can include a filling port and a dosing port. In some embodiments, the volume capacity of the partition portion can be less than the volume capacity 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 arranged at a certain angle, when the reservoir is suspended for gravity-based dosing of the fluid contained therein, the angle directs the fluid to the at least one port. In some embodiments, the reservoir can be a bag.

[0038] According to another embodiment of the present disclosure, a reservoir for holding a fluid may include a first material sheet and a second material sheet, which are sealed to each other at a peripheral seal to define the internal volume of the reservoir. The reservoir may also include at least one port, which is coupled to the peripheral seal and provides a fluid path into the internal volume. The peripheral seal may have an expanded area, and the at least one port is located in the expanded area. The reservoir may also include a sampling reservoir defined in the expanded area. The sampling reservoir may extend from a flow path through the expanded area, and the flow path connects the port of the at least one port to the internal volume of the reservoir. In some embodiments, the sampling reservoir may be connected to the flow path via a branch path included in the expanded area. In some embodiments, the branch path may be configured to be sealed after the reservoir is filled to separate the sampling reservoir from the internal volume. In some embodiments, the reservoir is a bag. In some embodiments, the at least one port may include a filling port and a liquid feeding port. In some embodiments, the filling port is connected to the internal volume by the flow path of the expanded area connected to the sampling reservoir.

[0039] According to another embodiment of the present disclosure, a method of encapsulating a fluid in a reservoir may include introducing a filling nozzle into a filling port of the reservoir. The method may also include delivering a predetermined amount of fluid into the reservoir via the filling nozzle. The method may also include removing the filling nozzle. The method may also include sealing a port of the reservoir. The method may also include forming a seal in the reservoir. The seal may create an internal aliquot of the fluid within the reservoir that is isolated from the rest of the reservoir.

[0040] In some embodiments, the reservoir can be a bag. In some embodiments, forming a seal includes sealing a gap within a portion of a wall included in the reservoir, the portion of the wall defining the main internal volume of the reservoir and the partitioned internal volume of the reservoir. When unsealed, the gap can provide fluid communication between the main volume and the partitioned internal volume. In some embodiments, the reservoir can be composed of a first material sheet and a portion of a material sheet, which are engaged with each other at a peripheral seal defining the internal volume of the reservoir, and forming a seal can include sealing a portion of a flow path defined in an expanded portion of the peripheral seal. In some embodiments, the portion of the flow path defined in the expanded portion of the peripheral seal can separate the sampling reservoir defined in the expanded portion of the peripheral seal from the internal volume of the reservoir. In some embodiments, the method can also include collecting a sample from an internal aliquot and testing the sample.

[0041] According to another embodiment of the present disclosure, a filling and sampling nozzle may include a first portion including a single lumen. The sampling portion may also include a second portion including a filling lumen and a sampling lumen. The filling lumen may be continuous with the single lumen of the first portion. The filling lumen and the single lumen may define a continuous flow path from the first portion to the outlet of the nozzle. The sampling lumen may have an opening at the outlet of the nozzle and may be in fluid communication with a sample flow path coupled to a sidewall of the nozzle.

[0042] According to another embodiment of the present disclosure, a method of encapsulating a fluid in a reservoir may include introducing a nozzle into a port of the reservoir. The method may also include delivering a first fluid amount through a continuous flow path extending from a first portion of the nozzle through a second portion of the nozzle and into the reservoir. The method may also include delivering a second fluid amount into the reservoir through the continuous flow path. The second fluid amount may exceed the capacity of the reservoir. The method may also include directing overflow through a sampling lumen of the nozzle into a sampling conduit coupled to the nozzle during delivery of the second fluid amount.

[0043] In some embodiments, the method may further include providing the overflow to the sensing assembly. In some embodiments, the method may further include providing the overflow to the vial. In some embodiments, the first fluid amount may be equal to the capacity of the reservoir. In some embodiments, the reservoir may be a bag. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1 Depicted are illustrative example embodiments of systems for producing and packaging medical fluids;

[0045] Figure 2A Depicted are illustrative example embodiments of systems for producing and packaging medical fluids;

[0046] Figure 2B Depicted are illustrative example embodiments of systems for producing and packaging medical fluids;

[0047] Figure 3 Depicted are illustrative example embodiments of systems for producing and packaging medical fluids;

[0048] Figure 4A Another illustrative example embodiment of a system for producing and packaging medical fluids is depicted;

[0049] Figure 4B Depicted are illustrative example embodiments of systems for producing and packaging medical fluids;

[0050] Figure 5A Depicted are illustrative example embodiments of systems for producing and packaging medical fluids;

[0051] Figure 5B Depicted are illustrative example embodiments of systems for producing and packaging medical fluids;

[0052] Figure 6 depicts a top view of a multi-compartment bag containing a concentrate;

[0053] Figure 7 An exemplary bag having a partial barrier wall within its interior volume is depicted;

[0054] Figure 8 depicts an exemplary bag having an isolated aliquot of a fluid separated from its main volume by a seal;

[0055] Fig. 9 depicts a flow chart detailing a number of example actions that may be performed to enclose a fluid within a bag;

[0056] Fig.10 Another example bag having a sample reservoir disposed in an open area of ​​a peripheral seal thereof is depicted;

[0057] Fig.11 depicts the example bag of FIG. 4 , wherein the sampling reservoir is isolated from and not in fluid communication with the remainder of the bag;

[0058] Fig.12 An exemplary bag having a first compartment and a second compartment is depicted;

[0059] Fig.13 An exemplary bag having a seal with perforations therein is depicted;

[0060] Fig.14 depicts another flow chart detailing a number of example actions that may be performed to enclose a fluid within a bag;

[0061] Fig.15 An example filling nozzle is depicted;

[0062] Fig.16 depicts an example multi-lumen filling nozzle that may be used to fill a bag and collect an aliquot of fluid for sampling;

[0063] Fig.17 depicts another flow chart detailing a number of example actions that may be performed to enclose a fluid within a bag;

[0064] Fig.18 An illustrated example of filling a receiving kit is depicted;

[0065] Fig.19A depicts an exploded view of an example bag with a dosing set;

[0066] Fig.19B depicts a top view of an example bag with a dosing set;

[0067] Fig. 20 depicts a top view of another example bag;

[0068] Fig.21 depicts a top view of another example bag;

[0069] FIG. 22A to FIG. 22F depicts views of a bag including a dosing set and a fill line in various stages of sealed closure;

[0070] Fig.23 depicts a top view of another example bag;

[0071] Fig.24 depicts a top view of yet another example bag;

[0072] FIG. 25A to FIG. 25C A view of an example manifold is shown;

[0073] Fig.26 depicts a view of an example fill receiving kit including another example manifold;

[0074] Fig. 27 depicts a perspective view of an example filled receiving kit;

[0075] Fig.28 depicts a cross-sectional view of an example fill receiving kit;

[0076] Fig.29 depicts a cross-sectional view of another example fill receiving kit;

[0077] Fig.30 depicts a cross-sectional view of an example fill receiving set bag filled with fluid;

[0078] Fig.31 depicts a cross-sectional view of an example fill receiving set having a filled bag that has been sealed from fluid communication with the fill receiving set;

[0079] Fig.32 depicts a cross-sectional view of an example fill receiving set wherein a bag has been cut from the fill receiving set;

[0080] Fig.33 depicts a cross-sectional view of an example fill receiving set wherein a bag of the fill receiving set is filled with a fluid;

[0081] Fig.34 depicts a cross-sectional view of an example fill receiving kit;

[0082] Fig.35 depicts a cross-sectional view of an example fill receiving kit;

[0083] Fig.36 A schematic diagram depicting an example populated receiving kit;

[0084] Fig.37 depicting a top view of an example manifold of an example fill receiving kit;

[0085] Fig.38 depicts a cross-sectional view of an example manifold of an example fill receiving kit;

[0086] FIG. 39A to FIG. 39C depicts a progression of valve actuation of an example manifold that may be used to fill bags of an example fill receiving set;

[0087] Fig.40 depicts an actuation block for a manifold of an example fill receiving kit;

[0088] FIG. 41A to FIG. 41F depicts a progression of valve actuations that may be performed to pump fluid from a concentrate supply inlet through an example manifold;

[0089] Fig.42 depicts the amount of fluid transferred to the bag through an example manifold;

[0090] Fig.43 depicts a diagrammatic example of another exemplary fill receiving kit;

[0091] Fig.44 Another illustrative example of an exemplary fill receiving kit is depicted;

[0092] Fig.45 depicts a plurality of material layers that may be used to construct a fill receiving set;

[0093] Fig.46 depicts an access element of a fill receiving set positioned between layers of fill receiving set material;

[0094] Fig.47 depicts a seal formed between layers of material defining an example fill receiving set;

[0095] Fig.48 An example filled receiver kit is depicted;

[0096] Fig.49 depicts an example fill receiving set having steam supplied to a portion of the fill receiving set;

[0097] Fig.50 depicts a bag filled by an example filling receiving kit;

[0098] Fig.51An example fill receiving kit is depicted wherein a first bag of the kit is filled and severed from the kit and a second bag of the kit is filled with a fluid;

[0099] Fig.52 An example fill receiving kit is depicted wherein a first bag and a second bag of the kit are filled and severed from the kit, and a third bag of the kit is filled with a fluid;

[0100] Fig.53 depicts a block diagram of an example fill receiving kit production and filling system;

[0101] Fig.54 depicts a perspective view of an example system for producing and packaging medical fluids;

[0102] Fig.55 Depicted Fig.54 A perspective view of an example system in which portions of the housing are shown as transparent to reveal various internal components of the system;

[0103] Fig.56 depicts a top view of another example system for producing and packaging medical fluids;

[0104] Fig.57 Depicted Fig.56 A side view of the example system shown in ;

[0105] Fig.58 Depicted Fig.56 Another side view of the example system shown in;

[0106] Fig.59 depicts a perspective view of an example bag feeder;

[0107] Fig.60 depicts a perspective view of an example bag feeder fully loaded with bags;

[0108] Fig.61 depicts a perspective view of an example bag feeder with a feed plate released from a loading position;

[0109] Fig.62 depicts a perspective view of an example bag feeder wherein a feed plate of the bag feeder is biased against a port of a bag installed in the bag feeder;

[0110] Fig.63 depicts a bottom front perspective view of an example bag feeder having retaining pins that hold bags in place within the bag feeder;

[0111] Fig.64 depicts a bottom view of an example bag feeder and an example gripper that has been advanced into the bag feeder to retract the bag feeder's retaining pins and collect the bag;

[0112] Fig.65 depicts a perspective view of an example bag feeder and an example gripper that holds bags collected from the bag feeder;

[0113] Fig.66 depicts a perspective view of an exemplary bag filling station;

[0114] Fig.67 depicts a perspective view of an exemplary bag filling station, wherein an unfilled bag is docked at the filling station;

[0115] Fig.68 depicts a perspective view of an exemplary bag filling station with a filled bag docked at the filling station;

[0116] Fig.69 depicts a perspective view of an exemplary bag filling station and an exemplary gripper that has been advanced into the filling station to collect filled bags from the filling station;

[0117] Fig.70 depicts a perspective view of an example gripper holding a filled bag and a filling station having a pivoting discharge inlet aligned with a filling nozzle of the filling station;

[0118] FIG. 71A to FIG. 71B depicts a top view of a portion of a filling station having an offset discharge inlet;

[0119] Fig.72 depicts a perspective view of an example sealing station with a plug dispenser installed therein;

[0120] Fig.73 depicts a perspective view of an example sealing station having an example follower assembly disposed in a retracted position;

[0121] FIG. 74A to FIG. 74B depicts a perspective view of an example plug dispenser;

[0122] FIG. 25 depicts a perspective view of an example sealing station having an example follower assembly biased into contact with a plug in an example plug box;

[0123] Fig.76 depicts a perspective view of an example sealing station having an example plug dispenser installed therein, wherein a cover of the dispenser is displaced to expose an outlet port of the plug dispenser;

[0124] Fig.77A depicts a perspective view of an example sealing station having an example plug dispenser installed in a dispenser receptacle of the sealing station;

[0125] Fig.77B Depicted Fig.77ADetailed view of the indicated area;

[0126] Fig.78 depicts a perspective view of an example sealing station with an example push rod of the sealing station advanced into an example plug dispenser to drive a plug from the dispenser into a port of a bag in place at the sealing station;

[0127] Fig.79 depicts a perspective view of an example sealing station with an example push rod of the sealing station in a retracted position and a plug advanced via an example follower assembly into alignment with an outlet port of an example plug dispenser;

[0128] Fig.80 depicts a perspective view of an example sealing station and an example gripper having collected a sealed bag from the sealing station;

[0129] Fig.81A depicts a perspective view of an example plug dispenser having an outlet port with a beveled port opening;

[0130] Fig.81B Depicted Fig.81A a detailed view of the illustrated portion of;

[0131] Fig.81C Depicts a cross-sectional view of an example sealing station with FIG. 81A to FIG. 81B The invention relates to a plug dispenser with the port of the bag being partially advanced over a portion of the plug retained in the dispenser.

[0132] Figures 82A to 82C depicts a view of another example plug dispenser having an outlet port with a chamfered port opening and an outlet port stopper member;

[0133] Fig.83 depicts a perspective view of another example plug dispenser, wherein a cover plate of the example plug dispenser is removed;

[0134] Fig.84 depicts a top view of an example plug dispenser filled with plugs;

[0135] Fig.85 depicts a top view of an example plug dispenser having been partially emptied of plugs;

[0136] Fig.86 A top view of an example plug dispenser depicting emptying the plugs;

[0137] Fig.87 depicts an exploded view of another example plug dispenser;

[0138] Fig.88 depicts a top view of an example plug dispenser filled with plugs;

[0139] Fig.89 depicts a top view of an example plug dispenser with a plug dispensed in line with an outlet port of the dispenser;

[0140] Fig.90 Depicted is a top view of an example plug dispenser that has been rotated under the force of a biasing member to urge a plug into alignment with an outlet port of the dispenser.

[0141] Fig.91 A top view of an example plug dispenser depicting a partially emptied plug;

[0142] Fig.92 depicts a top view of an example plug dispenser with a plug dispensed in line with an outlet port of the dispenser;

[0143] Fig.93 depicts a top view of an example plug dispenser that has been indexed to advance the next available plug into alignment with the outlet port of the dispenser under the force of a biasing member;

[0144] Fig.94 depicts an exploded view of another example plug dispenser;

[0145] Fig.95 depicts a top view of an example plug dispenser with a plug dispensed in line with an outlet of the dispenser;

[0146] Fig.96 depicts a top view of an example plug dispenser, wherein the plug is urged into alignment with an outlet port of the dispenser via a biasing force applied to an example follower block of the dispenser;

[0147] Fig.97 depicts a perspective view of an example plug dispenser and an example speed loader;

[0148] Fig.98 depicts a perspective view of an example plug dispenser and an example speed loader;

[0149] Fig.99 depicts a perspective view of an example plug dispenser having been populated with plugs by an example speed loader;

[0150] Fig.100 A stereogram of an example quarantine repository is depicted;

[0151] Fig.101 depicts a perspective view of an example scaffold that may be included in a quarantine repository;

[0152] Fig.102depicting a perspective view of an example quarantine storage vault that has been filled to capacity with bags;

[0153] Fig.103 depicts a perspective view of an example sampling fixture with a vial mounted therein;

[0154] Fig.104 depicts a perspective view of an example vial access door and an example sampling fixture with a vial installed in the sampling fixture;

[0155] Fig.105 depicts a side view of an example labeling assembly and a bag being displaced to the labeling assembly by a robotic gripper;

[0156] Fig.106 depicts a side view of an example labeling assembly wherein a bag is in the process of being labeled;

[0157] Fig.107 depicts a side view of an example labeling assembly wherein a gripper holds a bag that has been labeled at the labeling assembly;

[0158] Fig.108 depicts a perspective view of an example output chute that may be included in the system;

[0159] Fig.109 depicts a perspective view of bags stored in an example output chute;

[0160] Fig.110 depicts a perspective view of a bag exiting an example output chute;

[0161] Fig.111 depicts a perspective view of another example system for producing and packaging medical fluids;

[0162] Fig.112 Depicted Fig.111 Another perspective view of a system for producing and packaging medical fluids, wherein a portion of the housing of the system is shown as transparent;

[0163] Fig.113 depicts a front view of an example package assembly;

[0164] FIG. 114A to FIG. 114B depicts a top view of an example bag holder;

[0165] Fig.115 depicts a front view of an example packaging assembly wherein a gripper grasps a bag docked at an example bag holder of the packaging assembly;

[0166] Fig.116depicts a front view of an example packaging assembly wherein a gripper holds a bag that has been released from an example bag holder of the packaging assembly;

[0167] Fig.117 depicts a front view of an example packaging assembly with an example robotic manipulator advancing a bag held by a gripper of the robotic manipulator into alignment with an example filling nozzle of the packaging assembly;

[0168] Fig.118A depicts a front view of an example packaging assembly with an example filling nozzle of the packaging assembly positioned in a port of a bag;

[0169] Fig.118B depicts an exploded view of an example fill nozzle and biasing assembly;

[0170] Fig.119 depicts a front view of an example packaging assembly wherein a filled bag is held by an example gripper of an example robotic manipulator of the packaging assembly;

[0171] Fig.120 depicts a front view of an example packaging assembly wherein a filled bag is shifted to an example sealing station of the packaging assembly;

[0172] Fig.121 depicts a front view of an example packaging assembly wherein a filled bag is shifted to an example sealing station of the packaging assembly;

[0173] Fig.122 depicts a front view of an example packaging assembly wherein a filled bag is displaced to insert a port of the bag into an example support bracket of an example sealing station of the packaging assembly;

[0174] Fig.123 depicts a perspective view of an example support bracket;

[0175] Fig.124 depicts a front view of an example packaging assembly wherein an example push rod of an example sealing station is actuated to drive a plug into a port of a bag disposed within an example support bracket of the packaging assembly;

[0176] Fig.125 depicts a front view of an example packaging assembly wherein a filled and sealed bag is held by an example gripper of an example robotic manipulator of the packaging assembly;

[0177] Fig.126 depicts a front view of an exemplary packaging assembly having a guide slide;

[0178] Fig.127 depicts a perspective view of an example carrier that may include packaging packages each holding at least one bag and an administration set;

[0179] Fig.128 depicts a perspective view of an example carrier with an example package removed from a compartment of the carrier;

[0180] Fig.129 depicts a perspective view of an example carrier with an example package removed from a compartment of the carrier, the package having an open cover flap;

[0181] Fig.130 depicts a perspective view of an example carrier with an example bag and an example administration kit removed from a packaging package;

[0182] Fig.131 depicts a perspective view of a plurality of example packages that may be placed within a compartment of a carrier;

[0183] Fig.132 depicts a perspective view of a pointed adapter that may be included in a carrier;

[0184] Fig.133A depicts a block diagram of an example filling station;

[0185] Fig.133B A block diagram depicting another example filling station

[0186] Fig.134 depicts a perspective view of an example filling station;

[0187] Fig.135 depicts another perspective view of an example filling station;

[0188] Fig.136 depicts another perspective view of an example filling station;

[0189] Fig.137 depicts a top view of an example spike port that may be included in a filling station;

[0190] Fig.138 depicts a block diagram of an example fluid circuit that may be included in an example system for producing and packaging medical fluids;

[0191] Fig.139 depicts a flow chart detailing a number of example actions that may be performed to generate a desired fluid;

[0192] Fig.140 depicts a portion of an example mixing circuit including an example crystallization component dispenser;

[0193] Fig.141 depicts a metering manifold that may be included in an example mixing circuit;

[0194] Fig.142 depicts a perspective view of an example crystallization component dispenser;

[0195] Fig.143 Depicted Fig.142 An example crystallization ingredient dispenser of, wherein a portion is cut away to show internal components of the crystallization ingredient dispenser;

[0196] Fig.144 depicts a perspective view of an example crystallization component dispenser;

[0197] Fig.145 Depicted Fig.144 An example crystallization ingredient dispenser of, wherein a portion is cut away to show internal components of the crystallization ingredient dispenser;

[0198] Fig.146 depicts a perspective view of an exemplary paddle wheel that may be included in an exemplary crystallization ingredient dispenser;

[0199] Fig.147 depicts a perspective view of an example crystallization component dispenser;

[0200] Fig.148 Depicted Fig.147 An example crystallization ingredient dispenser of, wherein a portion is cut away to show internal components of the crystallization ingredient dispenser;

[0201] Fig.149 depicts a side view of an example dispensing assembly that may be included in an example crystallization ingredient dispenser;

[0202] Fig.150 Depicted Fig.149 a cross-sectional view of an example dispensing assembly;

[0203] Fig.151 depicts a perspective view of an example dispensing tray that may be included within an example dispensing assembly of an example crystallization ingredient dispenser;

[0204] Fig.152A depicts a perspective view of an example dispensing assembly that may be included in an example crystallization ingredient dispenser;

[0205] Fig.152B Depicted Fig.152A An exploded view of an example dispensing assembly shown in;

[0206] Fig.153A depicts a front view of another example crystallization component dispenser;

[0207] Fig.153B Depicted Fig.153A a perspective view of an example crystalline component dispenser with certain components removed;

[0208] Fig.154depicts a perspective view of an example port of a dosing manifold having an example outlet that may be included in a crystallization ingredient dispenser docked thereto;

[0209] Fig.155 Depicted Fig.154 A cross-sectional view of an example port and an example outlet is shown;

[0210] Fig.156 depicts a side view of another example dispensing assembly that may be included in a crystallization ingredient dispenser;

[0211] Fig.157 depicts a side view of an example dispensing assembly that may be included in a crystallization ingredient dispenser;

[0212] Fig.158 depicts a side view of an example dispensing assembly that may be included in a crystallization ingredient dispenser;

[0213] Fig.159 depicts a perspective view of an example tube weld assembly;

[0214] Fig.160 depicts another perspective view of an example tube welding assembly;

[0215] Fig.161 depicts a perspective view of an example conduit distributor that may be included in a tube welding assembly;

[0216] Fig.162 depicts an exploded view of an example conduit distributor;

[0217] Fig.163 depicts an exploded view of an example conduit feed assembly that may be included in a tube welding assembly;

[0218] Fig.164 depicts a perspective view of components of an example tube welding assembly;

[0219] Fig.165 depicts a perspective view of components of an example tube welding assembly;

[0220] Fig.166 depicts a perspective view of an example occluder assembly that may be included in an example tube welding assembly;

[0221] Fig.167 depicts a top view of an example occluder assembly that may be included in an example tube welding assembly;

[0222] Fig.168 depicts a perspective view of an example occluder assembly that may be included in an example tube welding assembly;

[0223] Fig.169depicts a perspective view of an example cutter assembly that may be included in an example tube welding assembly;

[0224] Fig.170 depicts a cross-sectional view of a section of a tube occluded by an example occluder assembly and an example cutter assembly;

[0225] Fig.171 depicts a perspective view of components of an example tube welding assembly;

[0226] Fig.172 depicts a perspective view of an example bag sealing assembly that may be included in a tube welding assembly;

[0227] Fig.173 depicts an exploded view of an example jaw of an example bag sealing assembly;

[0228] Fig.174 depicts a front view of an example bag having a fill port with sample aliquots separated by a bag seal assembly; and

[0229] Fig.175 Depicted is a front view of an example bag with a sample aliquot sealed within the bag's fill port.

[0230] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure with reference to the accompanying drawings, in which: DETAILED DESCRIPTION

[0231] Reference now Figure 1 , a system 10 for producing and packaging medical fluids is shown. The system 10 includes a housing 12. The housing 12 can be a clean room of any suitable certification level. The housing 12 can also be a shell that can be placed inside a clean room. In such an embodiment, the housing 12 or its compartments can be configured to meet a higher certification level than the surrounding environment. In addition, there may be compartments within the housing 12 that meet different clean room grade standards.

[0232] Within the housing 12, a plurality of system 10 components may be housed. For example, a medical water production device 14 may be included within the housing 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 (the distillation device may also serve as a degassing 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 the distillation device described in U.S. Patent No. 9,308,467, entitled “Water Vapor Distillation Apparatus, Method, and System”, issued on April 12, 2016 (Attorney Docket No. K97), the entire contents of which are incorporated herein by reference. Alternatively, the medical water production apparatus 14 can be a distillation apparatus, such as the distillation apparatus described in application No. 16 / 370,038, entitled "Water Distillation Apparatus, Method, and System" filed on March 29, 2019 (Agent Case No. Z37), the entire contents of which are incorporated herein by reference. The medical water production apparatus 14 can generate water that meets various pharmacopoeia specifications or can generate water that meets some non-pharmacopoeia specifications. The medical water production apparatus 14 can, for example, produce USP (or other pharmacopoeia) water for injection (WFI), high purity water, low pyrogen water, etc.

[0233] In an alternative embodiment, the medical water production device 14 may not be included in the housing 12. Instead, the medical water production device 14 may be located in a separate housing within a clean room, or in some embodiments may be located in a non-clean room environment or a lower certified clean room environment than the rest of the system 10. The output of the medical water production device 14 can be connected to the rest of the system 10 from the outlet pipe of the medical water production device 14. The medical water production device 14 can receive input water from any suitable water source 16. In some examples, the water source 16 can be a municipal water supply line. In an alternative embodiment, the water source 16 can be a reservoir of pre-treated (e.g., by filtration, UV, softening) water, wherein the medical water production device 14 extracts pre-treated water from the reservoir. In some embodiments, the water source 16 can be a large container or an air bag. In the case where the system 10 produces a pharmacopoeia fluid, the water source 16 can meet any requirements specified for an acceptable water source that can be used to generate the pharmacopoeia fluid. For example, the water source can be drinking water acceptable to the EPA.

[0234] Since the medical water production device 14 generates purified water, the water can be output to the outlet line 18 after undergoing various quality tests. If any output water fails the quality test, the output water can be transferred to a discard location or recycled to the input of the medical water production device 14 for further purification. The output line 18 of the system 10 can be connected to a manifold 20. The manifold 20 may include a fluid channel and one or more valves or actuators that selectively split or direct the purified water input flow to a plurality of separate outlet fluid channels. In some embodiments, the manifold 20 may not have a valve, but passively bifurcates the incoming purified water. The manifold 20 may include a plurality of connectors. These connectors may be connected to a manifold interface element 22 of a filling receiving kit 24. The filling receiving kit 24 may include at least one IV bag 26 and a fluid administration kit 28. In some embodiments, the manifold interface element 22 may be a Luer fitting. In an alternative embodiment, the manifold interface element 22 may be a quick-connect fitting. In some embodiments, the administration set 28 may be bonded or fixedly attached to the manifold 20 (which may include port protrusions extending from the manifold 20). The manifold 20 may also include barbed fittings to which the administration set 28 tubes are secured.

[0235] exist Figure 1 In the exemplary embodiment shown, the filling receiving set 24 includes a plurality of IV bags 26 and a fluid administration set 28. In such an embodiment, the plurality of IV bags 26 and the fluid administration set 28 can be bundled in a package or enclosure 30, which facilitates their installation into the system 10. In some embodiments, the enclosure 30 can be used as a distributor, for example, it allows the topmost bag 26 and the fluid administration set 28 to be collected by the robot gripper of the system 10. Each filling receiving set 24 can include up to or more than 50-100 bag 26 fluid administration set 28 pairs (but it can also be 1-50 pairs or any number greater than 100 pairs). The length of the fluid administration set 28 can be selected so as to be clinically useful, but in the case where the bag 26 is filled via the fluid administration set 28 attached thereto, its length is not enough to present excessive impedance problems when filling. In some embodiments, the fluid administration set 28 can be about 0.75-2.5 meters (e.g., one meter). The manifold interface element 22 can be a connector that can interface with the attachment tube set and the coupling element on the manifold 20. Such accessory tubing sets may include extension lines, multi-way connectors such as Y-sets, V-sets, and T-sets, or potentially various access ports.

[0236] As purified water is produced by the medical water production device 14, water can be delivered to each IV bag 26 of the filling receiving set 24 via the manifold 20. Each IV bag 26 can be filled to capacity (or a desired, preset or specified amount below capacity) and then removed from the system 10. The administration set 28 attached to each bag 26 can be left in a perfused state by the system 10 (e.g., by filling the bag 26 with the administration set 28). In some embodiments, the manifold interface element 22 can be detached from the manifold 20 and covered by the system 10 via a multi-axis robot manipulator. In some embodiments, a clamp can be applied to the administration set 28 or shifted to an actuation position on the set 28 before or during the detachment operation. Alternatively, a seal can be generated in the administration set 28 tube or other filling conduit, and the tube can be cut off from the manifold 20. This seal can be generated via heat, dielectric or RF welding or any other suitable process. In such an embodiment, the administration set 28 can include a branch upstream of the sealing position to allow access to the contents in the bag 26. In an alternative embodiment, the user may manually disconnect 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, which includes one or more controllers. The control system 15 can govern the operation of the manifold actuators or valves, the medical water production device 14, any robotic grippers and manipulators, and can use sensor data to fill the bags 26 to their desired volumes. The controllers that can be used in the control system 15 may include microprocessors, FPGAs, PLCs, etc. The control system 15 can communicate data (wired or wireless) with the various sensors, manipulators, and other hardware of the system 10.

[0238] Reference now Figure 2A In some embodiments, the system 10 can be configured to generate bags 26 with various types of solutions. The solution can be a colloidal solution or a crystal solution. The solution produced can be isotonic, hypotonic or hypertonic relative to physiological standards. For example, the solution can include various saline solutions, such as saline, semi-normal saline or saline of any other concentration. The solution can also include Ringer's solution, Hartmann's solution, sugar solution (e.g., D5W), sugar salt solution (e.g., D5NS, 2 / 3 D5W and 1 / 3NS), Jialeshi, dextran, hydroxyethyl starch, albumin, Ionosteril, SterofundinISO, Plasma-lyte, etc. In such an embodiment, the system 10 can include a container for one or more large cartridges or reservoirs 40, 42 for concentrates or crystal precursors. These large cartridges 40, 42 can be connected to fluid lines leading to pumps 38, 36. Pumps 38, 36 can meter a specific amount of concentrate into the output of the medical water production device 14.

[0239] The output stream of the medical water production device 14 may also be pumped by a pump 46 to monitor the amount of fluid mixed with any concentrate introduced from the one or more 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 the solution can be produced at a faster rate than the output rate of the medical water production device 14 when commanded. In certain embodiments, this accumulator volume may be maintained within the medical water production device 14.

[0240] A mixing volume 34 can be included in the system 10 to ensure that any concentrate and water are evenly mixed before entering the fill receiving kit 24. The mixing volume 34 can 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 can also include a section of pipe that can present a long and / or tortuous path that promotes even mixing. A check valve 32 can also be included on the output line 18 from the medical water production device 14 to prevent the mixed solution from flowing back into the medical water production device 14. The control of the various valves 36, 38, 46 and pumps of the system 10 can be coordinated via the control system 15.

[0241] In some embodiments, and as Figure 2B As shown, the medical water production device 14 can have an output that can be connected to a large cartridge 40, 42 containing a crystalline form concentrate. The output of the medical water production device 14 can pass through the large cartridges 40, 42 and be discharged as a saturated or nearly saturated solution. A pump 45 can be provided to help convey the output flow of the medical water production device 14 through the large cartridges 40, 42. The fluid leaving the large cartridges 40, 42 can be subjected to composition monitoring (e.g., conductivity sensing, temperature sensing, optical rotation sensing, etc.), which can inform the control system 15 to determine the downstream mixing ratio affected by the pumps 38, 36.

[0242] Reference now Figure 3 , shows a system 10 for producing and packaging medical fluids. The system 10 is configured to fill individual bags 26, rather than filling the receiving set 24. Figure 3 The medical water production device 14 in the system 10 generates purified water, so the water can be output to the outlet pipeline 18 after undergoing various quality tests. The output pipeline 18 of the system 10 can be connected to a filling nozzle or dispenser 1420. The dispenser 1420 can include a tapered outlet that can be introduced into the inlet of the bag 26 or other target container. Alternatively, the dispenser 1420 can include a fitting (e.g., Luer lock, quick connect, etc.) that cooperates with the fitting on the target container.

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

[0244] In some embodiments, the bag 26 can be disposed in an outer package 60, which in some embodiments can be a sealed bag, a pocket, or a blister pack. The outer package 60 can be cleaned (e.g., with 70% isopropyl alcohol or other suitable agents) and introduced into the housing 12. The individual bags 26 can then be removed from the outer package 60 manually or in an automated manner (via a robotic manipulator 1422) and installed in a box 1430 included in the system 10. One or more pre-loaded boxes 1430 filled with bags 26 can also be disposed in the outer package 60. The pre-loaded boxes 30 can be removed from the outer package 60 as needed and installed in the bag feeder 128.

[0245] In some embodiments, various protective covers or films may be included on some components of the bag 26. For example, a film or cover may be included on a port of the bag 26. This may help establish a sterile connection if the bag 26 needs to be manipulated after being removed from the outer packaging 60 to install the bag 26 into the system 10. The cover or film may be removed shortly before connecting or installing into the system 10. Alternatively, the film or cover may be pierced during filling.

[0246] As purified water is produced by the medical water production device 14, the water may be output to each IV bag 26 via a dispenser 1420. A robotic manipulator 1422 may collect the bags 26 from the bag feeder 128 and displace them to the dispenser 1420 for filling. Each IV bag 26 may be filled to capacity or some other desired volume and then removed from the system 10 or placed in a quarantine area 1424 while various tests of the fluid output from the dispenser 20 are completed. In some embodiments, a seal may be created in the fill conduit leading to the bag 26. Such a seal may be created via heat, dielectric or RF welding, installation of a plug or other sealing member, or any other suitable process.

[0247] Reference now Figure 4A , another system 10 for producing and packaging medical fluids is shown. Figure 3As depicted, the system 10 is configured to fill the individual bags 26 rather than by filling the receiving set 24 . Figure 4A The example system 10 in FIG. 1 is configured to generate bags 26 having various types of solutions. Figure 4A The system 10 includes the following Figure 2A The components described are used to complete the mixing operation to produce a solution. Figure 4B Another system 10 for producing and packaging a medical fluid is depicted, the medical fluid being configured to fill individual bags 26. The system 10 includes the Figure 2B The components described are used to generate various types of solutions to fill the bag 26.

[0248] In other embodiments and now referring to Figure 5A and Figure 5B , large reservoirs 40, 42 may not be used. Instead, the bag 26 may enclose an appropriate amount of concentrate (shown as a stippled pattern in each bag 26). The concentrate may be pre-packaged into the bag 26. As the fluid from the medical water production device 14 flows into the bag 26, the amount of concentrate may be sufficient to generate the desired final solution concentration. In some embodiments, the concentrate may be provided in the form of a liquid. In alternative embodiments, the concentrate may be a powder or a lyophilized drug. In yet other embodiments, the concentrate may be included in an ampoule or similar structure disposed in each bag 26. In the case of using an ampoule, the ampoule may be disconnectable or fragile to allow access to the material contained in the ampoule. In some embodiments, the ampoule may be mechanically destroyed by the system 10 or crushed by ultrasound produced by the system 10. If possible, a lighter and / or smaller form of concentrate may be used. For example, a crystalline solid may be used instead of a saturated solution, but both are possible.

[0249] Now also refer to Figure 6In some embodiments, the 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, wherein the concentrate chamber contains a liquid, lyophilized, crystallized or other powdered concentrate (depicted as a stippled pattern in the chamber 54). The chambers 50, 54 can be separated and connected to each other via a seal 52 or multiple seals 52. The seal 52 can be user or machine disconnectable. For example, the seal 52 can include a frangible or the seal 52 can be peelable. Depending on the embodiment, the seal 52 between the chambers 50, 54 may be broken by the user or by the system 10 during the production of the bag 26. In some examples, the seal 52 can be maintained after the production of the bag 26 until the point of use of the bag 26 is closer in time. For example, this can be done in the case where the mixed solution has a relatively short shelf life. In the event that the seal 52 is broken by a component of the system 10, the seal 54 can be broken before or after filling the bag 26 with water from the medical water production device 14. The system 10 may include a vibrator, oscillator, mechanical agitator, or other component that helps mix the concentrate with any water introduced into the bag 26. In some embodiments, the entry port to the bag 26 may include a structure that causes a vortex or turbulence of water entering the bag 26 to mix any concentrate included in the bag 26. In the case where the seal is peelable, it can be generated by changing process characteristics during the formation of the seal. For example, a peelable seal can be made using lower heat, power, welding time, etc. than used to form the peripheral seal of the bag 26. In some examples, the system 10 may include a set of rollers or similar pressure applicators that can be operated on the bag 26 to interrupt any peelable seal.

[0250] In the case where some form of concentrate is provided in the bag 26, the bag 26 may be coded so as to be easily identifiable by a person, a machine, or both. For example, the bag 26 may be color coded (color A = saline, color B = Ringer's solution, color C = sugar solution, etc.). The color coding may 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 areas. The location of the color coding or the shape of the color coded area may also be different between bags 26. The bag 26 may also include machine readable markings, such as bar codes, data matrices, wireless interrogation identifiers, etc. In some embodiments, the bag 26 may also be color coded by volume or color coded by various kit features. For example, a dosing kit 28 having a burette, an injection port, etc. may have a different color coding than a dosing kit without these.

[0251] In some embodiments, the bags 26 can be distinguished based on human or machine observable characteristics other than color. For example, in some embodiments, the bags 26 or portions thereof can additionally or alternatively have different geometric shapes, such as an elongated shape, a square shape, a cylindrical shape, etc. Any shape having a circular or polygonal cross-section can be used. The location of the compartments within the bag 26 can also be different in a visually distinguishable manner, and the compartment location can depend on the concentrate held therein. For example, a first concentrate can be located in a corner compartment or bag 26. The seal defining such a compartment can extend from one side of the bag 26 to the other side of the bag 26, the other side extending at an angle substantially perpendicular thereto. A second concentrate can be stored in a compartment 54 that extends along a side of the bag 26 defined by a seal 52, wherein the seal 52 extends the length or width of the bag 26 parallel to the edge of the bag 26 (e.g., see Figure 6 Any bag 26 of the type described in U.S. Application No. 16 / 384,082, filed on April 15, 2019, entitled “Medical Treatment System and Methods Using a Plurality of Fluid Line” (Attorney Docket No. Z55), the entire contents of which are incorporated herein by reference, may be used.

[0252] Reference now Figure 7 , depicting an exemplary bag 26. The bag 26 can be filled with any fluid described herein by any system 10 described herein. Any of a variety of medical fluids can be contained within the bag 26. Although the exemplary bag 26 can be used in any of a variety of scenarios, Figure 7 The bag 26 shown in the embodiment includes features that can be well suited for applications where the fluid contained in the bag 26 is mixed and packaged on site at or near the intended point of use. For example, the bag 26 can be filled by the system 10 in a hospital, clinic, dialysis clinic, surgery center, or other medical practice that will use the solution. Alternatively, the bag 26 can be filled by the system 10 at a military field hospital or disaster relief operation site. The example bag 26 includes features that can allow aliquots of the fluid to be separated from a certain amount of fluid filled into the bag 26 to be delivered to the patient. The aliquots can be generated by or represent the fluid filled into the bag 26. Such a bag 26 can be used in an embodiment where the system 10 fills the bag 26 separately. Alternatively, such a bag 26 can be included in the filling receiving kit 24.

[0253] Since the aliquots associated with the bag 26 are separated from all other fluids filled into the bag 26, the aliquots can be approached discretely without approaching the main volume that may be filled with the fluid intended to be administered to the patient. This can allow a fluid sample that represents the fluid in the main volume in terms of composition to be extracted from the separated aliquots for testing. The amount of main fluid filled into the bag 26 can remain uninterrupted by the sampling performed on the aliquots. Therefore, the aliquots can allow the fluid in the bag 26 to be sampled without destroying or discarding the entire bag 26. As a result, each bag 26 can be tested before the bag 26 is cleaned for use. In addition, this can allow certain tests that are difficult or impossible to perform when the bag 26 is filled to be performed after the bag 26 is filled. For example, a test that requires an incubation or waiting period can be performed on the fluid sampled from the aliquots separated in the bag 26. After filling, the bag 26 can be kept in a quarantine area until the test is completed. Once the test shows that the fluid in the bag 26 meets a predetermined acceptable standard, the bag 26 can be released for use.

[0254] like Figure 7 As shown, the example bag 26 includes two ports 392. These ports 392 can be sealed into the peripheral seal 1200 that defines the interior volume of the bag 26. The ports 392 can provide fluid communication in and out of the bag 26 for filling and delivering the fluid in the bag 26. For example, one port can be a filling inlet that is sealed after filling. The other port can be a delivery port that can be pierced to access the fluid in the bag 26 when it is needed to deliver it to the patient. In the case where the bag 26 is included as part of the filling receiving kit 24, the filling port 392 can be connected to the manifold 20.

[0255] As shown, the bag 26 includes a partial barrier wall 1202. The partial barrier wall 1202 can substantially isolate a portion 1203 of the interior volume of the bag 26 from the remainder of the interior volume or main volume 1205 of the bag 26. However, the partial barrier wall 1202 can be disrupted by at least one gap or interruption area 1204. The gap area 1204 can provide a fluid passage between the partitioned portion 1203 of the bag 26 and the remainder of the interior volume 1205 of the bag 26. As the bag 26 is filled, both the main volume 1205 and the partitioned portion 1203 of the bag 26 can receive fluid. Because the gap area 1204 maintains the partitioned portion 1203 in fluid communication with the main volume 1205, the fluid filled into the partitioned portion 1203 and the main volume 1205 should be identical in composition.

[0256] Now also refer to Figure 8, once the bag 26 has been filled, a seal can be formed in any gap areas 1204 that disrupt the portion of the barrier wall 1202. This can create a complete barrier wall 1206 that completely separates the main volume 1205 of the bag 26 from the partition portion 1203. This can be achieved by heat sealing (or otherwise sealing) the bag 26 materials together at at least one gap area 1204. Thus, an aliquot of fluid can be cut off from the main volume 1205 of the bag 26. Because the aliquot is generated from the same initial internal volume of the bag 26 as the main volume 1205, the aliquot can be referred to as an internal aliquot.

[0257] The partial barrier wall 1202 can be generated within the bag 26 so that when the bag 26 is filled and the at least one interruption or gap area 1204 is sealed, the inner aliquot will have a desired nominal amount of fluid contained therein. Likewise, the partial barrier wall 1202 can be arranged so that when the bag 26 is filled and the gap area 1204 is sealed, the main volume 1205 within the bag 26 has a nominal containment volume. The size of the inner aliquot can be designed to contain an amount of fluid sufficient for any intended sampling.

[0258] like Figure 8 392. As shown, the complete barrier wall 1206 can be positioned and shaped to encourage fluid contained in the main volume 1205 of the bag 26 to be directed to the port 392 when the fluid in the bag 26 is delivered. In this example, the barrier portion 1203 of the bag 26 is located at the corner of the bag 26 on the side of the bag 26 near the port 392. The complete barrier wall 1206 includes an inclined section 1208 that is inclined toward the port 392. Therefore, when the bag 26 is suspended (e.g., for gravity-fed delivery), fluid can be inhibited from being trapped or bagged along the area of ​​the complete barrier wall 1206. This can help ensure that all of the fluid filled 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 complete barrier wall 1206 can include rounded features that help direct the fluid to the port 392. In alternative embodiments, the inner aliquot may be created on a side of the bag 26 opposite the side including the port 392 or in a corner of the bag 26 away from a corner adjacent to the port 392 .

[0259] Reference now Fig. 9, flowchart 1240 depicts a plurality of example actions that may be performed to encapsulate fluid within bag 26. In box 1242, a filling nozzle may be introduced into port 392 of bag 26. In box 1244, fluid may be delivered to the interior volume of bag 26 through the filling nozzle. Bag 26 may be filled until a desired amount of fluid has been transferred into the interior of bag 26. In box 1246, the nozzle may be removed from port 392 and port 392 may be sealed. In the case where bag 26 is included as part of a filling receiving kit 24, a nozzle may not be used. Instead, port 392 of bag 26 may receive fluid from manifold 20. When the desired amount has been filled into bag 26, port 392 may be sealed and bag 26 may be provided from the manifold, as described elsewhere herein.

[0260] In block 1248, a seal can be created within the bag 26. The seal can create an internal aliquot within the interior volume of the bag 26 that is isolated from the main volume of the bag 26. In block 1250, a fluid sample from the internal aliquot can be collected and tested. In the case where the bag 26 is included as part of the fill receiving kit 24, a nozzle may not be used. Instead, the port 392 of the bag 26 can be filled 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 provided from the manifold, as described elsewhere herein.

[0261] Reference now Fig.10 , depicts another exemplary bag 26. As shown, the bag 26 includes two ports 392. These ports 392 can be sealed into the peripheral seal 1200 that defines the interior volume of the bag 26. In the example embodiment, the peripheral seal 1200 includes an expanded portion 1210, wherein the ports 392 are coupled in the bag 26. The expanded portion 1210 can have a greater width than the rest of the peripheral seal 1200 and can have one or more features defined therein. These features can be defined by leaving selected areas open or unsealed when forming the expanded portion 1210 of the peripheral seal 1200.

[0262] In an example embodiment, the port 392 may not extend all the way through the expanded portion 1210. As shown, the port 392 extends partially into the expanded portion 1210 and is aligned with the channel 1212. The channel 1212 may be an unsealed area defined during the formation of the expanded portion 1210 of the peripheral seal 1200. The channel 1212 may extend from the end of the port 392 to the interior volume of the bag 26. Therefore, the port 392 combined with their corresponding channel 1212 can provide fluid communication in and out of the bag 26 for filling and delivery of the fluid in the bag 26. For example, a pair of ports and channels can be a filling inlet that is sealed after filling and receiving fluid from the filling nozzle 1420 or the manifold 20. Another pair of ports and channels can be a delivery flow path, for example, when delivery to a patient is required, the delivery flow path can be punctured to access the fluid in the bag 26.

[0263] As shown, one of the channels 1212 includes a branch 1214. The branch 1214 can extend to a sampling reservoir 1216 that is included within the expanded portion 1210 of the peripheral seal 1200. The sampling reservoir 1216 and the branch 1214 can also be defined as open areas during the formation of the expanded portion 1210 of the peripheral seal. When the bag 26 is filled, the branch 1214 and the sampling reservoir 1216 can communicate with the interior volume of the bag 26. Therefore, when the bag 26 has been filled, the fluid within the sampling reservoir 1216 and the interior volume of the bag 26 can communicate and should be identical in composition. Once the bag 26 is filled, and now referring to Fig.11 , the sampling reservoir 1216 can be isolated from the interior volume of the bag 26. In some examples, this can be achieved by heat sealing (or otherwise sealing) the branch 1214 or a portion of its closure. Thus, as described above, the internal aliquot of the fluid can be isolated within the bag 26.

[0264] Reference now Fig.12, depicts another exemplary bag 26. As shown, the bag 26 includes three ports 392. These ports 392 can be sealed into the peripheral seal 1200 of the bag 26. The bag 26 can also include an inner seal 1220. The inner seal 1220 together with the peripheral seal 1200 can define a first internal compartment 1222 and a second internal compartment 1224. The compartments 1222, 1224 can have different volume capacities. The inner seal 1220 can extend between the two ports 392 so that one of the compartments 1222, 1224 can be approached via a single port 392, and the other of the compartments 1222, 1224 can be approached via the remaining two ports 392. The compartments 1222, 1224 that can only be approached via one port 392 can be, but not necessarily, the smaller of the compartments 1222, 1224. In the exemplary embodiment, the second compartment 1224 has a smaller capacity than the first compartment 1222.

[0265] The compartment 1224 of smaller volume can be filled by port 392. Then, the port 392 leading to the small volume compartment 1224 can be sealed. Therefore, the smaller compartment 1224 can be filled to contain the sample aliquots separated from it that can be taken out to carry out various tests. The larger compartment 1222 can contain the medical fluid preparation intended to be delivered to the patient. The larger compartment 1222 can be filled by one of the ports 392, and then the port is sealed. Another port 392 communicated with the larger compartment 1222 can be used for conveying fluid. Since the sampling aliquot in the small compartment is filled in the compartment separated from the fluid to be delivered to the patient, the aliquot can be called an external aliquot. Two compartments 1222, 1224 can be filled simultaneously from the filling pipeline of the branch. Therefore, the fluid in the external aliquot should represent the fluid in the larger compartment 1222 in composition.

[0266] The inner seal 1220 can be positioned and shaped to inhibit fluid contained in the larger compartment 1222 of the bag 26 from being bagged away from the port 392 when the fluid in the larger compartment 1222 is fed via gravity feed. In this example, the inner seal 1220 is a vertical seal that extends along the length of the bag 26 in a direction substantially parallel to the axis of the port 392. In alternative embodiments, the inner seal 1220 may include a seal that is similar to the seal of FIG. Figure 8 A similar angled portion of the inner seal is shown. A rounded profile that helps direct fluid to port 392 may also be used in other embodiments.

[0267] In some examples, and now mainly with reference to Fig.13, the inner seal 1220 can be constructed with perforations 1221 therein. The perforations 1221 can extend along the entire length of the inner seal 1220 and are all used to separate the outer aliquot filled into the bag 26 from the bag 26 after filling. In a bag 26 with perforations, 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 any identifier described herein. This can allow any testing performed on the outer aliquot separated from the bag 26 to be associated with the remaining but now separated portion of the bag 26. Perforations 1221 that allow the separated aliquot to be separated from the bag 26 can be included in other bag 26 embodiments. For example, with respect to Figure 7 and Figure 8 The depicted partial barrier wall 1202 may include perforations 1221. Additionally, the seal created when the interstitial region 1204 in the partial barrier wall 1202 is filled to create the complete barrier wall 1206 may include perforations 1221. This may allow the interior aliquot to be isolated from the rest of the bag 26.

[0268] Reference now Fig.14 , a flowchart 1260 is shown, which details a plurality of example actions that can be performed to encapsulate a fluid within a bag 26. In box 1262, a nozzle can be introduced into a first port 392 of a bag 26, which can be in communication with a first compartment in the bag 26. In box 1262, a second nozzle can also be introduced into a second port 392 of a bag 26, which can be in communication with another compartment of the bag 26. In box 1264, a fluid can be delivered to the bag 26 until the compartments of the bag 26 are filled to a desired amount. In box 1266, the nozzle can be removed from the first port and the second port 392, and the first port and the second port of the bag 26 can be sealed. This can produce a first compartment, which can be in communication with a third port, through which the contents of the first compartment can be dosed. This can also produce an external aliquot of fluid in a second compartment (e.g., a smaller compartment) that can be used for testing. In box 1268, a sample from the external aliquot can be collected and tested. Where the bag 26 is included as part of the fill receiving set 24, the nozzle may not be used. Instead, the port 392 of the bag 26 may receive fluid 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 provided from the manifold 20, as described elsewhere herein.

[0269] Now also refer to Fig.15, depicts an example filling device 1290. As shown, the filling device 1290 includes a first filling nozzle 1292 and a second filling nozzle 1294. Such a filling device 1290 can be used to fill, for example, Fig.12 The bag 26 shown. The filling device 1290 includes a common line 1296 and a fork 1298, which branches the fluid flowing in the common line 1296 to each of the first nozzle 1292 and the second nozzle 1294. Each of these nozzles 1292, 1294 can deliver fluid to a separate compartment included in the bag 26. The second nozzle 1294 can be associated with an unpowered valve that stops the flow into the associated compartment when the compartment reaches capacity. In the exemplary embodiment, a check valve 1299 is shown. Since the compartments of the bag 26 can have different sizes, one compartment can be completely filled before the large compartment. Once the smaller compartment is filled, the pressure in the compartment can begin to build up (the associated seal in the bag 26 can be constructed to be strong enough to withstand the pressure). Then, the check valve 1299 can be actuated after it is filled to capacity and prevent further flow into the smaller compartment.

[0270] Reference now Fig.16 In some embodiments, fill nozzle 1230 may include features that may allow an aliquot of fluid to be separated from the fluid being filled into bag 26. The aliquot may be created as the fluid is filled into bag 26. In some examples, the aliquot may be collected by overfilling bag 26 and collecting fluid that flows out of bag 26 after bag 26 has been filled to its capacity during a filling operation.

[0271] As shown, the filling nozzle 1230 can be inserted into the port 392 of the bag 26. The filling nozzle 1230 may include a first inner cavity 1232 and a second inner cavity 1234. The first inner cavity 1232 may be fluidly connected to a fluid source and may receive a fluid pumped or otherwise delivered from the fluid source. The fluid from the fluid source may leave the first inner cavity 1232 and fill the bag 26. The second inner cavity 1234 may extend out of the filling nozzle 1230 and may be connected to the aliquot collection reservoir. When the fluid exceeding the capacity of the bag 26 is discharged from the first inner cavity 1234, this overfilling may cause the fluid in the bag 26 to be pushed out through the second inner cavity 1234. The fluid pushed out of the bag 26 through the second inner cavity 1234 should be the same in composition as the rest of the fluid in the bag 26. Therefore, the fluid flowing to the aliquot collection reservoir during the overfilling period may represent 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 the first of the ports 392, and the second of the ports 392 may be communicated with the aliquot collection reservoir. After the bag 26 is filled to its capacity, additional fluid may cause the fluid within the bag 26 to be forced out of the bag 26 through the second port 392 and into the aliquot collection reservoir. The aliquot collection reservoir may be separated from the bag 26 and the second port 392 may be closed with a pierceable inlet or diaphragm. The filling nozzle may be removed from the first port 392 and the first port 392 may be sealed. When the fluid pushed into the aliquot collection reservoir is displaced from the internal volume of the bag 26, the fluid should be identical in composition to the rest of the fluid in the bag 26, and the test performed on the sample from the aliquot should represent the contents of the bag 26.

[0273] Reference now Fig.17 , a flow chart 1270 is shown, which details a number of exemplary steps that may be performed to encapsulate a fluid within a bag 26. As shown, in box 1272, a nozzle 1230 may be introduced into the port 392 of the bag 26. In box 1274, the fluid may be delivered to the bag 26 by filling the first lumen 1232 of the nozzle 1230 until the bag is filled to the desired amount. In box 1276, an additional amount of fluid may be delivered to the bag 26 by the first lumen 1232 of the nozzle 1230. In box 1278, overflow from the bag 26 may be collected in an aliquot collection reservoir by a second lumen 1234 in the nozzle 1230. In box 1280, the nozzle 1230 may be removed from the port 392 and the port 392 may be sealed closed. In box 1282, the fluid from the overflow aliquot may be tested.

[0274] Reference now Fig.18, depicting an example filling receiving kit 24. As shown, the filling receiving kit 24 includes a plurality of bags 26 and a liquid administration kit 28. The manifold interface element 22 of each liquid administration kit 28 is attached to the manifold 20, which is included as a part of the filling receiving kit 24. Before the bag 26, the liquid administration kit 28 and the manifold 20 are placed in the outer packaging 60, this attachment can be performed in a controlled aseptic environment. In certain embodiments, the outer packaging 60 can be a sealed bag or a blister packaging package. It is possible that after the bag 26, the liquid administration kit 28 and the manifold 20 are packaged in the outer packaging 60, they can all be sterilized via an appropriate method. For example, gamma ray sterilization, ethylene oxide and / or electron beam sterilization can be used. The outer packaging 60 can maintain a sterile environment, which protects the filling receiving kit 24 from contamination during storage. Any filling receiving kit 24 described herein can be sterilized as described above. Embodiments of the individually filled bag 26 may also receive the bag 26 and possibly a dispenser (e.g., a bag box) within an outer package 60 that is sterilized as described above. The plug dispensers described elsewhere herein may be similarly sterilized and provided in the outer package 60. Any other consumables described herein that are replaced during operation of the system 10 may be provided sterilized in the outer package 60.

[0275] In some embodiments, various protective covers or films may be included on some of the components of the filling receiving set 24. For example, a film or cover may be included on any connector on the manifold 20 that is not pre-connected to another component. This may facilitate the establishment of a sterile connection if the bag 26 and administration set 28 after removal from the outer packaging 60 need to be manipulated to install the filling receiving set 24 into the system 10. The cover or film may be removed shortly before connection or installation into the system 10.

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

[0277] In the embodiment that system 10 is connected in an automated manner, each of manifold interface elements 22 may include a cover that can be removed by system 10. In such an embodiment, system 10 may include a drivable slide thereon, on which manifold interface element 22 may be mounted. A second slide may also be included, which includes a cover retainer or a gripper. The second slide may be displaced toward the first slide to be coupled with the cover. Then, the second slide may be displaced from the first slide to remove the cover from administration kit 28. Then, the second slide may be withdrawn outside the displacement path of the first slide. The first slide may advance toward manifold 20 to place manifold interface element 22 on the coupler of manifold 20. In some embodiments, administration kit 28 or another filling conduit may include a pierceable septum that maintains a sterile barrier for the internal volume of the associated bag 26 and administration kit 28. In such an embodiment, the manifold 20 coupler may include a piercing member, such as a spike or needle, and action of the first slider may cause the piercing member to be driven through and into sealing engagement with the pierceable septum to facilitate filling.

[0278] Manifold 20 can also include a coupler 62 for establishing fluid communication with the output of medical water production device 14. In some embodiments, the coupler 62 can include a cover and can be driven to a piercing member (e.g., a spike or needle) that is communicated with the output from medical water production device 14 in the manner described above. In other embodiments, the coupler 62 can be a Luer fitting. By providing a manifold interface element 22 pre-connected to manifold 20 for the manifold 20 in the outer packaging 60, only a single connection can be made to place the bag 26 and the administration kit 28 to be communicated with the output flow of the medical water production device 14. This eliminates the need for many aseptic connections. This may be particularly desirable in embodiments where the filling receiving kit 24 includes a large number of bags 26 and administration kits 28.

[0279] In certain embodiments, each bag 26 can be a bag 26 of the same volume. However, if necessary, the bag 26 can be filled to a volume less than the capacity. This can allow uniformity and simplicity in the system 10. There is no need to store many different filling receiving kits 24 (mini bags, 250ml, 500ml, 1 liter, etc.). In certain embodiments, there can be two types of kits 24. A type of kit 24 can include a bag 26, which is the bag with the largest volume in the bag 26, which is intended to be used for a relatively small amount of fluid. These bags can accommodate any filling amount, from a very small amount to some first maximum amount (e.g., 500ml). Other maximum capacity cutoffs can be used. Another type of kit 24 can include a bag of large volume size, which can accommodate any filling amount in the range of a large amount of preparations up to a second maximum amount larger than the first maximum amount. As a bag 26 is filled, the volume in a particular bag 26 can be determined by at least one of a scale, a flow meter, and / or a fluid transfer monitoring system, such as the system described in U.S. Application No. 16 / 384,082, filed on April 15, 2019, entitled “Medical Treatment System and Methods Using a Plurality of Fluid Lines” (Attorney Docket No. Z55), the entire contents of which are incorporated herein by reference.

[0280] In some embodiments, the system 10 may include a printer or labeling component that can provide an indication of the fill level of the bag 26 directly on the bag 26 or the administration set 28. Alternatively, where the bag 26 may include a unique identifier, the system 10 may communicate with a database that associates the fill level with the unique identifier. Through the communication network, the unique identifier may be looked up (e.g., via a barcode or data matrix scanner) to query the database for the fill level of the bag 26. Where a printer or labeling component is included, the printer or labeler may also record any information that may be required by law or regulation on the bag 26.

[0281] In some cases, bag 26 may be filled to a specific amount that is less than the expected total amount of fluid to be administered. One situation in which this may be done is when a certain amount of medication is expected to be injected into bag 26. In this case, bag 26 may be filled to contain an appropriate amount of diluent to generate a solution of the concentration of the fluid to be administered. For example, if a patient is prescribed a one-liter drug formulation of a certain concentration, bag 26 may be intentionally less filled with an amount equal to the volume of the concentrated medication to be injected in order to generate a solution of the correct concentration for the patient. System 10 may be in communication with a physician order entry system, and control system 15 may determine the appropriate fill volume based on the prescription for which bag 26 is generated.

[0282] The filling receiving set 24 can also be used for certain types of drugs. For example, the filling receiving set 24 is composed of or equipped for light-sensitive drugs (e.g., amphotericin B, nitroglycerin, etc.). In such an embodiment, the liquid administration set 28 and the bag 26 can be made of a light-shielding material or can be equipped with a light-shielding cover or sleeve. In some cases, the material used to form the pipeline or bag 26 can include a light-blocking layer (e.g., an amber or green material).

[0283] In some examples, multiple fill receiving kits 24 having different characteristics (e.g., bag sizes) may be installed simultaneously in the system 10. Depending on the order being fulfilled by the system 10, the system 10 may fill the bag 26 from the appropriately sized fill receiving kit 24. In such an embodiment, the fill receiving kit 24 may include indicia (e.g., barcode, data matrix, RFID, etc.) that may be read by the system 10 to allow the system 10 to determine the type of kit 24 installed.

[0284] Reference now FIG. 19A to FIG. 19B , the bag 26 and the administration kit 28 included in the fill receiving kit 24 can be integrated with each other. This may be desirable because it can allow the administration kit 28 to be pre-filled in certain embodiments. In addition, this will remove the need to puncture the bag 26. Since a typical bag 26 can be difficult to hold and puncture, the integrated kit can make the bag 26 more user-friendly and remove the sterile connection procedure performed during setup. The administration kit 28 can be integrated into the bag 26 in a manner similar to that used to incorporate a spike port, injection port, etc. into the peripheral seal of an IV bag.

[0285] For example, the bag 26 can be made of two separate flexible material sheets 84A, 84B. The sheets 84A, 84B can be joined at their peripheries via any suitable type of sealing method (including solvent bonding, RF welding, heat sealing, adhesives, ultrasonic welding, etc.). The sheets 84A, 84B can be made of any suitable material or laminate. The tube 82 can be constructed similarly. The laminate layers can be selected and ordered to achieve the desired goals. For example, steam or gas impermeable layers or other barrier layers, adhesive layers, solution compatible layers and reinforcement or durability increasing layers can be included. The selected materials can inform the following information: the expected sterilization method, weight, optical clarity, hardness, flexibility, heat resistance, lubricity, elastic modulus, required material thickness, ease of molding (e.g., molded fittings at the ends of the tube), strength, kink tendency, light blocking ability, dielectric / polarity, etc. The materials that can be used to construct the bag and tube are as follows:

[0286] Table 1 provides:

[0287]

[0288]

[0289] In the case where the sheets 84A, 84B have a multilayer structure, they can be formed, for example, in an extrusion lamination or co-extrusion process. The tube 82 of the dosing kit 28 can be manufactured as a multilayer structure of different materials (e.g., extrusion). In the case of using different materials, an adhesive layer can be present in some embodiments. The outer layer of the tube 82 can have a lower melting point range than at least the inner layer of the tube 82. The melting point range of the outer layer of the tube 82 can overlap with the melting point range of the bag 26 material. During construction, the tube 82 can be compressed between the sheets 84A, 84B and heated during the welding process. The outer layer of the tube 82 can be bonded to the bag 26, and the inner layer can maintain an unobstructed inner cavity that allows flow into and out of the bag 26, such as Fig.19B As shown. In an alternative embodiment, the bag 26 can be blow molded. In such an embodiment, the tube 82 can be attached to the periphery with a similar welding process.

[0290] Fig. 20 Another example bag 26 is depicted. Fig. 20 The exemplary bag in includes a dosing kit 28. The bag 26 also includes an exemplary fill port 90. The exemplary fill port 90 can interface with the manifold 20 or can interface directly with the output of the medical water production device 14. The fill port 90 can be integrated into the bag 26 as described above for the tube 82 and can include a self-sealing septum, plug, cover, or similar sealing device. The sealing member can be installed after the filling process is completed. Alternatively, a sealing member may not be used and a welded seal may be formed. The fill port 90 can also be used as an injection port that allows medication to be added to the bag 26 as needed. In other embodiments, the fill port 90 can be located on a side of the bag 26 to which the dosing kit 28 is not attached. As Fig.21 As shown, 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 .

[0291] Fig.22A Describe the bag 26 design of replacement, wherein, administration set 28 is integrated into bag 26, as discussed elsewhere herein, but with separate filling line 140.Similar to administration set 28, filling line 140 can be integrated into bag 26.Filling line 140 can include coupling 142, and this coupling interfaces with system 10 to receive fluid flow during filling.Couple 142 can be located on a part of filling line 140 that is sacrificed and removed after filling.In some embodiments, coupler 142 can be molded into this part of pipeline and form a part of this part.In some examples, coupler 142 can be Luer fitting.In other embodiments, can include pierceable septum as described above.

[0292] like FIG. 22B to FIG. 22D As shown, after filling bag 26 through fill line 140, system 10 can create a seal 146 (by Fig.22D This may be produced via RF welding or a similar process, or a tube sealer assembly 906 (such as described with respect to Fig.172 146 can be formed via the RF welding die / rod 144 of the system 10. In some embodiments, a roller or scraper assembly 145 can be used prior to introducing the welding die 144. Fig. 22C As shown, a roller or scraper assembly 145 can be pressed against the fill line 140, and a pair or more rollers or scrapers of the assembly 145 can be displaced in opposite directions to push the liquid out of the weld area 145. Then, a welding die 144 can be introduced to form a seal in the fill line 140. The roller or scraper assembly 145 can remain present or absent while the seal is being created. Once the seal 146 has been formed, a cutting element 148 (see Fig.22E ) can separate the sacrificial end of fill line 140 from the remainder of fill line 140. This can result in a sealed portion of fill line 140 extending from bag 26, such as Fig.22F Preferably, the sealed portion of the fill line 140 can be kept to a minimum length in order to limit the amount of fluid that may be separated from the administration set 28 when the bag is emptied. In some examples, the seal 146 can extend to the peripheral edge of the bag 26.

[0293] Reference now Fig.23, depicts the design of another bag 26. As shown, bag 26 includes a feeding kit 28 integrated into bag 26, as described elsewhere in this article. Feeding kit 28 includes a drip chamber 190, a roller clamp 192 (but may also include another type of clamp or not include a clamp) and a Y site 194 (or other types of bifurcations). Bag 26 can be filled by a filling port 196 attached to Y site 194. Once bag 26 has been filled, the part of the branch leading to filling port 196 from Y site 194 can be sealed (e.g., by high frequency welding), and filling port 196 can cut off feeding kit 28, as described elsewhere in this article. During feeding, the remaining branches of Y site 194 may include a feeding port 198, which is included in the inner cavity that remains unobstructed after sealing and removing other branches of Y site 194. The feeding port 198 can be connected to a cannula line, etc. to feed the contents of the liquid bag 26. In such an embodiment, the cannula line may include a check valve to prevent backflow. In some embodiments, the ports 196, 198 may include Luer fittings. This type of bag 26 and administration set 28 may be pre-primed. Prior to use, the user may hold the bag 26 and set 28 so that the administration set 28 is vertically above the bag 26. The drip chamber 190 may be squeezed as needed to displace the fluid in the drip chamber 190 into the bag 26. Then, when the drip chamber 190 returns to its normal shape, the air within the bag 26 may be sucked into the drip chamber 190. This may create air space in the drip chamber 190 for operating the drip chamber 190 and visualizing droplet formation during flow rate setting.

[0294] Reference now Fig.24 , another example bag 26 and administration set 28 are shown. As shown, the bag 26 and administration set 28 do not include a Y site 194 (e.g., see Fig.23 ). Instead, the administration kit 28 includes an administration port 198. The drip chamber 190 is attached to a frangible or breakable barrier 200 that can be broken by the user prior to administration so that the user can fill the administration kit 28. The bag 26 may include a fill inlet 202 on another portion of the bag 26 that interfaces with the output of the medical water production device 14 or manifold 20. Once filled, the inlet may be welded closed and a portion of it may be cut away from the bag 26. This process may be similar to FIG. 22A to FIG. 22F Alternatively, the filling inlet 202 may be provided at a Y-site 194 disposed upstream of the drip chamber 190 (see, for example, Fig.23 ) in the form of. In some embodiments, an injection port may also be included in the bag 26. Such an injection port may be included on a side panel of the bag 26 or may be attached to an edge of the bag 26 (e.g., adjacent to an attachment point of the administration set 28).

[0295] Reference now FIG. 25A to FIG. 25C , an exemplary manifold 20 is shown. The manifold 20 included in the fill receiving kit 24 can be a disposable component. Alternatively, the manifold 20 can be returned to the manufacturer or taken to another location after use and cleaned to allow it to be used in another fill receiving kit 24. In embodiments where 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 of an injection molded block 68 of material that includes a plurality of flow paths 74. These flow paths 74 can be open on one side. As shown in FIG. Fig.25C As best shown, one or more plates 70, 72 may then be attached to the block 68 to cover any open portions of the flow paths 74. The plates may be attached in any suitable manner, including via heating, solvent bonding, welding, fasteners (and possibly gaskets), adhesives, etc. In certain embodiments, the plates 70, 72 may be laser welded to the block 68, and the block 68 may be made of a material selected at least in part for its ability to absorb the laser welding wavelength (e.g., may be black). The plates 70, 72 in this embodiment may be transparent to allow the laser to pass through the block 68. The laser weld may seal around the periphery of any flow paths 74 included in the manifold 20. Although described as plates 70, 72, in some examples, it is also contemplated that a flexible film cover may be used in place of at least one of the plates 70, 72.

[0296] Reference is primarily made to the opposite side of block 68 of the exemplary manifold 20. Fig.25A and Fig.25B , the block 68 may include a plurality of passages 76A-76C in communication with the fluid path 74. The block 68 may also include a plurality of fittings or couplers 78, 80. In some example embodiments, the couplers 78, 80 may be Luer fittings. If desired, the plates 70, 72 may include apertures through which the couplers 78, 80 may extend (e.g., see Fig.25C). In other embodiments, the plates 70, 72 may include couplers 78, 80. The coupler 78 may be used to form a connection with the output of the medical water production device 14. The coupler 78 may surround a passage 76A leading to the opposite side of the block 68. The passage 76A associated with the coupler 78 may be in fluid communication with a plurality of flow path 74 segments on the opposite side of the block 68. These flow path 74 segments may each extend to their own passage 76B. In this example, the flow path 74 extends radially from the passage 76A. In alternative embodiments, any desired routing scheme may be used. The passages 76B each extend through the block 68 to the flow path 74 segments on one side of the block including the coupler 78. These flow path segments 74 further extend to another passage 76C extending through the block 68. Each passage 76C extends to a coupler 80 on the opposite side of the block 68. Each coupler 80 may be connected to the manifold interface element 22 of the administration kit 28 included in the filling receiving kit 24. Alternatively, any of the manifold interface elements 22 described herein may be included on another fill inlet, such as Fig.24 Fill import 202 or FIG. 22A to FIG. 22F The filling pipeline 140 is provided.

[0297] Fig.26 Another example filling receiving kit 24 including manifold 20 is depicted. Manifold 20 may include block 310. Block 310 may include flow channel 312 passing therethrough. Block 310 may also include connector interface 314 for coupling inlet 324 of manifold 20 with a dispenser (e.g., output or mixing volume 34 of medical water production device 14) for medical water or medical fluid mixture. Flow channel 312 may include multiple branches 316 extending from wall 318 of fluid channel 312 to port 326 on the face of block 310. A displaceable seal may be included in fluid channel 312. In some examples, displaceable rod 320 may be disposed in fluid channel 312. Displaceable rod 320 may include sealing portion 322, which may be made of or coated with compliant material (rubber, silicon, various elastomers, etc.). Alternatively, sealing portion 322 may include one or more O-rings or raised compliant portions. The sealing portion 322 can be pressed against the wall 318 of the fluid channel and form a seal between the wall 318 and the displaceable rod 320 so that fluid on one side of the sealing portion 322 does not travel to the other side of the sealing portion 322. In some embodiments, the displaceable rod 320 can be a plunger 330 (e.g., see Fig. 27 In various examples, the displaceable rod 320 may also be a threaded rod or lead screw 332 (see, for example, Fig.29 ). The actuator used to govern the displacement of the displaceable rod 320 may be selected based on the type of displaceable rod 320 used.

[0298] The displaceable rod 320 can be actuated along the extent of the flow channel 312 to place the various branches 316 in communication with the inlet 324. This can allow the bags 26 to be filled sequentially (one, two, or three at a time, etc.). Fig.26 In the example shown, the bag 26 is in fluid communication with the inlet 324 so that fluid entering the manifold 20 can be directed to that bag 26. The sealing portion 322 of the displaceable rod 320 prevents the incoming fluid from flowing to any other bag 26 coupled to the port 326 of the manifold 20. After the first bag 26 has been filled, the bag 26 can be sealed from the fluid passage 312 and removed from the manifold 20. This can be accomplished by FIG. 22A to FIG. 22F The manifold 20 is then completed with a similar welding die 144 and possibly a roller or scraper assembly 145 as described. The displaceable rod 320 can then be displaced along the fluid passage 312 to place the next bag 26 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 can be included on the manifold 20.

[0299] Additionally, in certain embodiments, the manifold 20 may include a plurality of flow channels 312, each associated with a displaceable rod 320 (e.g., all extending parallel or substantially parallel to one another). This may allow bags 26 communicating with different flow channels 312 to be filled in parallel or independently of one another. In the case of filling bags 26 associated with different flow channels 312 in parallel, the displaceable rods 320 of the various flow channels 312 may be coupled so as to move in a coordinated manner with one another (e.g., perhaps in a 1:1 ratio). The system 10 may also fill bags 26 of multiple manifolds 20, wherein multiple manifolds 20 may be installed in the system 10 at the same time.

[0300] refer to Fig. 27 and Fig.28 , an example manifold 20 is shown. In the example manifold 20, the displaceable rod 320 is depicted as a plunger 330. The plunger 330 includes a plunger rod 334 and a plunger head 336 serving as a sealing portion 336. Fig.29An example is shown that includes a lead screw 332 as a displaceable rod 320. The lead screw 332 may also include a sealing head portion 338 at its end, which is arranged in the manifold 20. Although not shown, the bag 26 associated with the port 326 of the manifold 20 may include various inlets. In addition to the lines extending from each bag 26 to the manifold 20, each bag 26 may also include one or more of a dosing kit 28, a spike port, an injection port, or any other inlet shown herein. Although this may be the case in some examples, not all bags 26 attached to the manifold 20 need to be the same. For example, some bags 26 may include different inlets or have different maximum fill volumes. In the case where a variety of different manifolds 20 can be used with the system 10, the manifold 20 may include an identifier that includes information about the type of manifold 20 being installed or about the bag 26 included on the manifold 20. The identifier may be machine-readable (such as a barcode, data matrix, RFID) or any other suitable identifier. The control system 15 may use information gathered from the identifier in order to control the filling of the bags 26 included on the manifold 20 .

[0301] Reference now Figure 30 to Figure 33 , depicting an exemplary filling sequence. Although the illustrated manifold 20 includes a plunger 330, other displaceable rods 320 (e.g., a lead screw, a plunger with a rack and pinion arrangement) may be similarly displaced through such a filling sequence. The plunger 330 may be provided with its plunger head 336 disposed within the interior of the flow channel 312 of the manifold 20. The plunger 330 may be initialized at a position against or near the inlet 324 of the manifold 20 (e.g., see Fig.28 ). Manifold 20 can be coupled to distributor 340 to place flow channel 312 in fluid communication with a medical fluid supply. Coupling can be performed aseptically and via threaded fittings (such as Luer locks), barbed fittings, quick connects, magnetic couplings, or any other suitable method. In some embodiments, steam can be sprayed to clean connector interface 314 before coupling occurs.

[0302] An actuator (not shown) can retract the plunger 330 a distance from the fluid passage 312. By moving the plunger 330 away from the inlet 324, the port 326 or a selected plurality of ports 326 can be placed in communication with the inlet 324. Fig.30 In the example shown, only a single port 326 is placed in communication with the inlet 324. The fluid can then be transferred through the flow channel 312 to the bag 26 that is in communication with one or more ports 326. Fig.30 The dots in the figure are used to represent the image. Fig.31 As shown, once the bag 26 or bags 26 have been filled to the desired amount, the fluid transfer may be stopped.

[0303] As shown, each bag 26 can be connected to a port 326 via a flow path. The port 326 in this example includes a protruding fitting (e.g., a barbed fitting) to which a tube providing a flow path is coupled. The flow path may include a sealable area, for example, which may be welded to close the flow path to fluid flow. Thus, a seal 342 may be generated at the sealable area to isolate the bag 26 from the rest of the manifold 20. The seal 342 may be generated as described elsewhere herein (e.g., see FIG. 22A to FIG. 22F ). The displacement of the plunger 330 can be tracked by a sensing device to ensure that the correct port 326 or multiple ports 326 are in communication with the inlet 324 at a given time. The sensing device may include a linear potentiometer, an encoder, an array of Hall effect sensors that monitor the position of a magnet on the plunger 330, or a combination thereof, etc. The fill level of each bag 26 can be monitored via a scale on which the bag 26 rests.

[0304] After the seal 342 has been created, the filled bag 26 may be removed from the manifold 20. Fig.32 As shown, the bag 26 has been removed from the manifold 20. A portion of the seal 342 can be used to close the port 326 from which the bag 26 was removed. Fig.32 As shown, the plunger 330 can be retracted to a position further away from the inlet 324 to place an additional bag 26 or multiple bags 26 in communication with the inlet 324. Fluid can be transferred to fill the bag 26 or multiple bags 26 until the desired amount is filled and a seal 342 can be formed, such as Fig.33 This can be repeated until each bag 26 on the manifold 20 is filled and removed from the manifold 20.

[0305] Reference now Fig.34 , a filling receiving set 24 is shown including another manifold 20. The manifold 20 is similar to the manifold 20 of Figure 28 to Figure 33 The manifold 326 is depicted and described, however, the bags 26 are coupled to the manifold 20 in an alternative manner. As shown, the port 326 does not include a fitting or protrusion extending away from the manifold 20 to which the flow path to each bag 26 is coupled. Instead, the fluid line 344 that provides the flow path for the bag 26 is inserted into an aperture in the block 310 that forms the port 326. The fluid line 344 may be retained in the port 326 via solvent bonding, adhesives, threaded coupling, or via any other suitable means.

[0306] In other embodiments, the flow path between the manifold 20 and each bag 26 may include Fig.35The disconnect fitting 346 is shown. The disconnect fitting 346 can allow the bag 26 to be removed from the filling receiving set 24 without 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 thereon have been filled. This can allow the manifold 20 to be reused.

[0307] Reference now Figure 36 to Figure 38 , showing aspects of another example filling receiving kit 24. Fig.36 As shown, the fill receiving set 24 may include a manifold 20 that is pre-connected to a plurality of administration sets 28 that have been integrated into respective bags 26. As with other embodiments described herein, other filling conduits may be coupled to the manifold 20 in place of the illustrative administration set 28. The manifold 20 in the example embodiment may be a cassette 150 that is installed into the system 10. The cassette 150 may include a fluid introduction port 152 that may be connected to a fluid output stream from the medical water production device 14. The cassette 150 may also include a plurality of couplers 154 (e.g., Luer fittings) that may be coupled to the manifold interface element 22 (or fill line 140, inlet 202, or other fill conduits) on each set 28.

[0308] like Fig.38As best shown in the cross section of the depicted box 150, the box 150 may include a rigid body 156, which in some examples may be injection molded. The rigid body 156 may include a plurality of valve stations 158A-158I, which may be covered by a flexible membrane 160. In alternative embodiments, a plurality of flexible membranes may be included. For example, each valve station 158A-158I may be covered by a dedicated flexible membrane. The flexible membrane 160 shown may be actuated (usually pneumatic, but mechanical or hydraulic is also feasible) against and away from the valve seat 162 of each valve station 158A-158I to open and close the valve 158A-158I. In the example illustration, all valve stations 158A-158I are shown as being in a closed configuration. The box 150 also includes a fluid busbar 164 located on the opposite side of the intermediate body 166 of the box 150. The fluid busbar 164 is communicated with the fluid introduction port 152 through a passage 172 in the side wall of the box 150. The second flexible membrane 168 is included on this side of the box 150 to seal the fluid busbar 166. The second flexible membrane 168 can be replaced by a plate (such as a laser welding plate described elsewhere in this article). By displacing the valve seat 162 of the first flexible membrane 160 away from the desired valve station 158A-158I, the fluid busbar 164 can be placed to communicate with the desired valve station 158A-158I. As shown, each valve station includes a passage 174 leading to the fluid busbar 164 from the valve station 158A-158I. This can establish a flow path from the fluid busbar 164 to the valve station 158A-158I. The valve station 158A-158I can also include an opening to the coupler 154 of the box 150, to allow fluid to flow from the fluid busbar 164 through the valve station 158A-158I and outflow from the box 150 to the bag 26 and the fluid administration kit 28 attached to the associated coupler 154. This may allow bags 26 to be filled one by one (or two by two, etc.). In some embodiments, each valve station 158A-158I may be associated with more than one coupler 154. This may be desirable in situations where multiple bags 26 are to be filled at one time.

[0309] FIG. 39A to FIG. 39CThe progress of valve actuation is shown, which can be used to fill the bag 26 attached to the box 150. The bag 26 can be filled in any order, but is shown here as being filled in sequence by opening the valve stations 158A-158I in a left-to-right manner. As shown, the leftmost valve station 158A can be opened to fill the associated bag 26. Once filled, the bag 26 can be removed from the box 150, as described elsewhere herein. Then, the valve station 158A can be closed. Then, the adjacent valve station 158B can be opened to fill the bag 26 attached to it. The bag 26 and the attached administration kit 28 (or other filling inlet) can be removed from the box 150 (e.g., sealed and cut, disengaged from the cooperative quick connector, etc.). Then, the valve station 158B can be closed. Then, the next valve station 158C can be opened, and its associated bag 26 can be filled and removed. This process can continue until all bags 26 are filled. The number of bags 26 being filled, and therefore the number of valve stations 158A-158I that are open at a given time, can 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. For example, if the system 10 fills fifty bags 26 at a time at a low flow output, there will be a certain amount of downtime before bags 26 become available. By filling bags 26 one by one (or filling some appropriate number of multiple bags at a time), the system 10 can provide a steady output of bags 26 at the same flow output.

[0310] like Fig.40 As shown, the box 150 can interface with the actuation block 180 included in the system 10. The actuation block 180 can be made of metal (or other strong, dimensionally stable, thermally stable and / or non-porous materials) and is subjected to hot steam or exhaust flow from the medical water production device 14 before the box 150 is placed against the actuation block 180. The flexible membrane 160 on the box 150 can be covered by a covering layer, which keeps the surface of the flexible membrane 160 sterile before being applied to the actuation block 180. The covering layer can be removed by the system 10 or an operator. In some embodiments, the box 150 can be pressed against the actuation block 180 by closing and latching the door of the system 10. In other embodiments, a piston or plate can be pressed against one side of the box 150 including the fluid busbar 164 to force the box 150 against the actuation block 180 and ensure that a good seal is achieved by the flexible membrane 160 around the valve stations 158A-158I. This can be accomplished via inflation of an air bag, rotation of a leadscrew or cam, actuation of a scissor jack, a linear actuator, or any other actuator that can apply sufficient force.

[0311] As shown, the actuator block 180 includes a plurality of pressure passages. These pressure passages can be independently placed to selectively communicate with a positive pressure source 182 or a negative pressure source 184 (e.g., pneumatic) to open and close the valve stations 158A-158I of the box 150. Through the operation of the valve 188 associated with each control chamber 186, each control chamber 186 can be selectively placed to communicate with a positive pressure source 182 or a negative pressure source 184 fluid. In an exemplary embodiment, each control chamber 186 is associated with a valve control application of a positive pressure and a valve control application of a negative pressure. In an alternative embodiment, a single valve can be used to switch between a positive pressure application and a negative pressure application. In such an embodiment, the valve can be designed to apply a positive pressure in a failed state. The positive pressure source 182 and the negative pressure source 184 can be a reservoir maintained at a specific pressure set point by a pump (not shown). The pressure sources 182, 184 can be monitored by one or more pressure sensors 191, which can notify the pump to maintain the pressure source 191 at the pressure set point. In some embodiments, each control chamber 188 can also be in fluid communication with a pressure sensor 192. The pressure sensor 192 can be monitored to check whether the pressure is applied to the valve chambers 158A-158I of the box 150 as expected. In some embodiments, the medical water production device 14 can output the product at a pressure higher than the environment. In such an embodiment, negative pressure may not be used. Instead, the pressure of the product water can be used to displace the flexible member 160 to open the valve stations 158A-158I. The positive pressure used to close the valve stations 158A-158I can be selected to be sufficiently higher than the output pressure of the medical water production device 14, thereby maintaining the robust closure of the valve stations 158A-158I.

[0312] Once the bag 26 has been filled, the bag can be removed from the box 150 (or any other manifold 20) in a variety of ways. For example, a weld seal can be made on the tube of the administration set 28 (or the filling port 140 or the inlet 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 the above description of FIG. 22A to FIG. 22F As described. Alternatively, the tube of the administration kit 28 can be clamped or otherwise blocked, and the administration kit 28 is disengaged from the box 150. Then, the administration kit 28 can be plugged by a cover or similar element. In some examples, each administration kit 28 can include a sliding clamp. When installed in the system 10, the sliding clamp can be interfaced with an actuator, and once the bag 26 attached to the administration kit 28 has been filled to the appropriate amount, the actuator is commanded to shift. The displacement of the actuator can drive the narrow portion of the sliding clamp toward the tube so that the narrow portion of the sliding clamp blocks the tube of the administration kit 28.

[0313] Where the system 10 is configured to mix various fluids, and reference is now made to FIG. 41A to FIG. 42, the cassette 150 may include a plurality of valved pumping stations 270A-270C. Small amounts of fluid may be pumped through the cassette 150 via coordinated actuation of the valved pumping stations 270A-270C. FIG. 41A to FIG. 41F As the process progresses, the three valved pumping stations 270A-270C of the cartridge 150 can be actuated to pump fluid in small amounts from a concentrate supply inlet 272 included in the cartridge 150. Although the three valved pumping stations 270A-270C are shown adjacent to one another, this is done to provide a streamlined example. Other configurations with additional and / or non-adjacent valved pumping stations 270A-270C can be constructed.

[0314] like Fig.41B As shown, the first valve station 270A and the second valve station 270B can be opened to perform the filling operation of the valve pump station. These valve stations 270A-270B can be opened sequentially or substantially simultaneously. This may cause a fluid flow 278 to enter these valve stations 270A-270B from the concentrate supply inlet 272. Once the valve filling is completed, the filled valve station 270B can be isolated by closing the first valve station 270A, such as Fig.41C Thus, the second valve station 270B can be used as an intermediate holding volume during valve-based fluid pumping.

[0315] Then, the third valve station 270C may be opened to establish fluid communication between the second valve station 270B and the third valve station 270C, such as Fig.41D Then, the valve pump stroke can be performed by closing the second valve station 270B, as shown. Fig.41E This will transfer the valve pump stroke volume from the intermediate holding volume to the third valve station 270C. The third valve station 270C can then be closed, as shown in FIG. Fig.41F As shown, the valve pump stroke volume is pumped toward the valve station 158A-158N associated with the bag 26 attached to the box 150. Alternatively, the third valve station 270C can be omitted and the fluid can be transferred to the desired valve station 158A-158N when the second valve station is closed. This can be repeated as needed until the target amount of concentrate has been transferred. By utilizing multiple valve stations as intermediate holding volumes, a larger volume per valve pumping sequence can be achieved. Further description of such a 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 on April 15, 2019, the entire contents of which are incorporated herein by reference.

[0316] Once the desired amount of concentrate has been transferred via the valve-based pumping stroke, and now primarily referenced Fig.42 , a certain amount of water can be transferred to the bag 26 to dilute the concentrate to the final concentration. The final concentration can be the concentration ready for administration to the patient. The final concentration can also be defined to allow a certain amount of another drug to be added to make a final drug preparation, which is then administered to the patient. In an exemplary embodiment, a water inlet valve station 274 is included at the very end of the box 150. The water inlet valve station 274 can be in communication with the water inlet port 276, and when opened, a flow path can be established from the water inlet port 276 through the fluid bus 164 to the desired valve station 158A-158N and the associated bag 26. By positioning the water inlet valve station 274 at the end of the box 150, the water flow through the bus 164 can also be used to flush any concentrate remaining in the bus 164 to the desired bag 26. In some embodiments, any valve station that is not dedicated to a specific concentrate (e.g., an intermediate holding volume station) can perform multiple valve pumping strokes using water to flush these stations.

[0317] When concentrate is pumped into the bag 26 via the valve pump stroke, the amount of concentrate to be flushed from the valve station and / or fluid bus 164 may be considered in any volumetric goals. Thus, the entire amount of concentrate defined for a particular bag 26 may not be transferred to that bag 26 until after the flush is complete.

[0318] Fig.43 Another alternative filling receiving kit 24 is depicted. As shown, there is a main line 204 that can interface with the output of the medical water production device 14. The bag 26 can be branched from the main line 204 in series via a plurality of pipelines 206. In some embodiments, the pipeline 206 can be attached to the main line 204 at a T-joint. Alternatively, the main line 204 can include a plurality of coupling fittings, and the cooperative elements of the pipeline 206 can be connected to these coupling fittings. The filling receiving kit 24 can be arranged to be used as a manifold 20. The pipeline 206 to the bag 26 can be kept closed by an occluder device acting on the pipeline. Alternatively, the main line 204 can be blocked upstream of each branch point to the pipeline 206 leading to one of the bags 26. In some examples, the pipeline 206 can be closed via a pinch clamp 302, which can be mechanically actuated under the command of the control system 15. The bags 26 may be filled one by one and cut from the main line 204 after sealing, as described elsewhere herein (e.g., see FIG. 22A to FIG. 22F). Once a bag 26 has been filled and cut off from the fill receiving set 24, the pinch point 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 fill receiving set 24 have been filled and cut off from the main line 204. In some embodiments, more than one bag 26 may be filled at a time. The line 206 to the bag 26 may be constructed in the same manner as any of the lines or inlets described above, and may include any of the features described elsewhere herein. For example, the bag 26 may include a FIG. 22A to FIG. 22F Similar additional liquid supply lines (not shown) or with Fig.23 A similar Y site may also be included. In the Fig.43 In the example shown, line 206 is included as a fill line, and bag 26 includes additional attached access to its interior volume, such as administration set 28 and injection port 203 .

[0319] In some embodiments, and now mainly with reference to Fig.44 , the pinch point clamp 302 may not be used. Instead, each line 206 extending from the main line 204 may have a sliding clamp 300 that, when installed in the system 10, is located in a blocking position on the line 206 or upstream of the point at which each line 206 branches from the main line 204. The sliding clamp 300 may be displaced to a flow-permitting position on the line to allow filling of each bag 26. In some embodiments, the sliding clamp 300 may remain stationary in the block, and the line 206 may be displaced instead to bring the line 206 into the flow-permitting section of the sliding clamp 300. After filling, the line 206 may then be blocked by displacing the line 206 or the sliding clamp 300 to bring the line 206 into the flow-inhibiting section of the sliding clamp 300. The same process may be used with the sliding clamp 300 in place on the main line 204. Once the bag 26 has been filled to the desired amount, the line 206 may be disconnected from the main line 204 and capped or sealed.

[0320] Reference now Fig.45 In some embodiments, the fill receiving kit 24 can be composed of two layers of material. For example, the fill receiving kit 24 can be composed of an adhesive sheet 220 or a material sheet. In the case where multiple sheets 220 are used, they can be stacked on top of each other. In the case where a single sheet 220 is used, the sheet 220 can be a continuous sheet of material that is folded upon itself to create multiple layers of starting material. Fig.46As shown, the access elements 226, 228 can be placed at regular intervals between the sheets 220 or between the layers of the folded sheets 220. For example, the access element 226 can be an injection port and the access element 228 can be a fluid administration set 28. In the example embodiment, only four sets (pairs in this example) of access elements are shown, however, the number of sets of access elements 226, 228 can be selected to match the number of bags 26 in the fill receiving set 24. In some embodiments, each set of access elements 226, 228 can include more than two access elements. In other embodiments, each bag 26 can include only a single access element.

[0321] Reference now Fig.47 , a seal 230 can be formed to attach the sheet 220 or the portion of the folded sheet 220 to each other and form the filling receiving kit 24. This can be done via a welding process (such as an RF welding process). The material selected for each sheet may include an RF weldable material and may be a polar plastic, such as PVC. For example, the layers of the sheet 220 or the layers of the folded sheet 220 adjacent to each other before welding may be made of such a material. During the construction of the filling receiving kit 24, a plurality of sheets 220 or a portion of the sheet 220 may be welded and the sheet material may be transferred to the next portion of the sheet 220. The portion may be welded and transferred, and so on. The number of bags 26 formed in each welding operation may be less than the total number of bags 26 in the filling receiving kit 24. In some embodiments, 1-4 or more bags 26 may be formed at a time. Preferably, the number of bags 26 in the filling receiving kit 24 is an even multiple of the number of bags 26 formed per welding operation. As shown, the seal 230 can also be formed to create a flow path 232 in the busbar portion 234 of the fill receiving set 24. The interior volume of each bag 26 can be in fluid communication with the busbar portion 234 via a branch 238 from the flow path 232 to each bag 26. In this example, the branches 238 all extend away from the busbar portion 234 in the same direction. In some embodiments, the branches 238 can extend from opposite sides of the busbar portion 234 so that the bags 26 are arranged on each side of the busbar portion 234.

[0322] When formed, the bag 26, busbar portion 234, and branch 238 can all be flat, with substantially little or no internal volume. During filling, the sheet material can be displaced to allow the bag 26 to fill and provide an internal cavity at the busbar portion 234 and branch 238. As a result, there should be no entrapped volume of air in the busbar portion 234 and 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.

[0323] The welding and indexing process can be repeated until the entire sheet 220 has been welded to form the filler receiving sleeve 24. As the sheet or sheets 220 are indexed, the welding die can be extended over at least a portion of the overlap area in the previously created weld. This can ensure that the seal 230 is formed airtightly over the entire length of the filler receiving sleeve 24. In some embodiments, each time an indexing occurs, a pair of access elements 226, 228 can be introduced between the sheet 220 or sheets 220. Fig.47 As shown, the pockets 26 may be formed close to one another to minimize waste of sheet 220 material.

[0324] After indexing from the welding station, the sheet 220 or sheets 220 may be Fig.48 As shown, the bag 26 is cut at the cutting station. A portion of the sheet 220 or multiple sheets 220 can be cut while welding another portion. The cutting station may include a cutting die that is pushed into the folded sheet 220 or multiple sheets 220 to cut out the bag 26. Excess material can be separated from the filling receiving kit 24. Port 236 may be included in the end of the filling receiving kit 24. A branch 240 from the flow path 232 may extend to the environment through the port 236. The port 236 may be located near the inlet opening 249 of the flow path 232 in the fluid busbar 234. In some embodiments, a fitting may be coupled to the opening 249 to facilitate connection to the dispensing member.

[0325] Reference now Fig.49 , when installed in the system 10, the dispensing member 250 can be received in the opening 249 or a fitting secured thereto. This can be accomplished by user manipulation of the busbar portion 234 of the fill receiving kit 24, although such coupling can also be performed in an automated manner. In the case of manual user manipulation, the interaction between the user and the fill receiving kit 24 can occur through a glove box device. In addition, the occluder 252 can close the flow path 232 upstream of the first branch 238, where the first branch 238 leads to the bag 26. The dispensing member 250 can initially output a steam flow into the flow path 232. This can clean the flow path. The steam can be provided by exhausting steam (e.g., purified but uncondensed water vapor, which may be pharmacopoeial steam, such as pure steam) from the medical water production device 14, where the medical water production device 14 is a distillation device. The steam can leave the flow path 232 through the branch 240 leading to the port 236. After an appropriate amount of steam cleaning, the port 236 can be sealed, for example, by an RF seal 254, such as Fig.50 As shown.

[0326] like Fig.50As shown, the distribution member 250 (or in some embodiments, a second distribution member that has been connected to the opening 249 after the steam distributor is removed) can output the medical water flow to the flow path 232 of the busbar portion 234. In the case of providing a fluid mixture to the bag 26, the mixture can be output by the distribution member 250. The occluder 252 can be advanced downstream of the first branch 238 to the bag 26. This can place the internal volume of at least one bag 26 in fluid communication with the opening 249. In some embodiments, as Fig.50 As shown, the occluder 252 can be displaced to a position on the flow path 232, which is located at an intermediate position between the first branch and the second branch 238 to the bag 26. In other embodiments, the occluder 252 can be displaced to place multiple bags 26 in fluid communication with the opening 249. The output of the 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 displacement sensing device) and the dispensing can be stopped. The amount dispensed to a given bag 26 can be order-specific and is selected based on the amount of diluent required for a specific medication order. This can be calculated by the control system 15, which can communicate with the pharmacy order entry system and receive orders from there.

[0327] like Fig.51 As shown, a seal 254 may be created to close the branch 238 to any filled bag 26 and the filled bag 26 may be cut from the busbar portion 234. The seal may be created via RF welding and the sealing process may be performed in a manner such as FIG. 22A to FIG. 22F as described in or in relation to Figures 159 to 175 The occluder 252 may be advanced to place the interior volume of the additional bag 26 or bags 26 in fluid communication with the opening 249. The dispensing member 250 may then output the medical water or medical fluid mixture to fill the bag 26 or bags 26 as described above. Fig.52 As shown, this can continue until all bags 26 included in the fill receiving set 24 have been filled. As described elsewhere herein, the fill receiving set 24 can include dozens of bags 26 (eg, 50-100).

[0328] Now also refer to Fig.53In some embodiments, the welding, cutting and filling of the bag 26 can be a continuous process on the production line 280. In such an example, the sheet or tablet 220 can be pulled from the tablet source 282 in a continuous manner. The tablet source 282 can be a large roll, a reel, a carton, etc. The tablet 220 can first be pulled into the bag / busbar former component 284 of the production line 280. As mentioned elsewhere, the bag / busbar former 284 can be a plastic welding machine, such as an RF welding machine. The tablet 220 can be indexed by the bag / busbar former 284 so that one or more bags are formed in the tablet 220 at a time. The formed portions of the bag 26 and the busbar 234 can be cut from the tablet 220 at the cutting station 286 of the production line 280. As mentioned elsewhere, the cutting station can include a die cutter. With the unformed portions of any downstream bags 26 and tablets 220 blocked by the blocker 288 of the production line 280, the filling station 290 can fill one or more cut bags 26. The filled bag 26 can be sealed with the busbar 234 at the sealing station 292 of the production line 280. The sealing station 292 can include an RF welding machine and can include rollers or scrapers as mentioned elsewhere herein. After the bag 26 is sealed with the busbar 234, the bag 26 can be cut from the busbar 234 by the bag cutting station 294 of the production line 280.

[0329] In an alternative example, the production line 280 can form and cut bags 26 and busbars 234 from a certain amount of pressed sheets 220. However, the production line 280 may not fill the bags 26 and cut them from the busbars 234. In such an example, the unfilled bags 26 still attached to the busbars 234 can be provided as a filling receiving kit 24 to an institution or medical facility with filling, blocking, sealing and bag cutting components. This may help minimize the amount of floor space required for the medical facility. In such an embodiment, the production line 280 may include a packaging station that applies an outer packaging around the filling receiving kit 24.

[0330] Reference now Figure 54 to Figure 55 , an example system 10 for producing and packaging medical fluids is shown. As shown, the system 10 is placed in a clean room environment. The system 10 includes a housing 12. In the example embodiment, the housing is divided into a first portion 96 and a second portion 98. Fig.55 Best shown (which depicts Fig.54In a system 10 in which some portions of the housing 12 are transparent), the first portion 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 pipe connected to the clean room. In an exemplary embodiment, the medical water production device 14 is shown as a distillation device that receives water that has been pre-treated by multiple filters 100 (e.g., carbon filters and / or reverse osmosis filters). The first portion 96 may include a partition 102 that is used to divide the first portion into a hot compartment and a cold compartment. The walls of the first portion 96 of the housing 12 and the partition 102 may appropriately include insulators to prevent electronic devices and surfaces elsewhere in the system 10 from being subjected to high temperatures during distillation. The top of the first portion 96 may also have a work surface 104 designed to be easy to clean. For example, Fig.54 The work surface shown has rounded corners, which can minimize the possibility of missing areas during cleaning. The work surface 104 can be used to open the packaging of the filling receiving kit 24 or each bag 26, and manipulate them as needed to prepare them to be installed in the system 10 for filling. The first part 96 of the shell 12 can also include a user interface 106, such as a touch screen GUI. The user interface 106 can be used to interact with the medical water production device 14. The user interface 106 can also provide visual guidance in the form of a tutorial (for example, for wiping and cleaning the work surface 104 or other system 10 parts or for preparing to fill the receiving kit 24). The user interface 106 can also be used to interact with the medical water production device 14, and allows to change settings and / or display notifications, alarms, warnings and other messages related to the operation of the medical water production device 14.

[0331] The second portion 98 of the housing also includes a user interface 108. In an exemplary embodiment, the user interface 108 is included on an articulated cantilever 110. The cantilever 110 may include a plurality of joints that may allow the user interface 108 to be displaced to a convenient position by a user. A bezel 112 of the user interface 108 may include an easy-to-grasp handle that may facilitate displacement of the user interface 108. The user interface 108 may be, for example, a touch screen GUI.

[0332] The user interfaces 106, 108 can be used to interact with components of the system 10 that fill the filling receiving kit 24, or in the illustrated example, fill the individual bags 26. The user interfaces 106, 108 can also be used to interact with various medical systems of a hospital, an urgent care center, a surgery center, or a similar institution. Such a system 10 can include a physician order entry system, a pharmacy order entry system, a medical record system, a continuous quality improvement system, a medication error reduction system, an inventory system, a laboratory system, a medication regulatory library, etc. Certain example medical systems that can interact with the system 10 are further described in detail in U.S. Application No. 14 / 137,421, entitled "Computer-Implemented Method, System, and Apparatus for Electronic Patient Care" filed on December 20, 2013, the entire contents of which are incorporated herein by reference. Such a system can track the use of the system 10 for producing and packaging medical fluids and manage orders sent to the system 10. These other medical systems can also monitor the production of the system 10 and perform analysis for the actual bag 26 usage in the institution (bag storage time, solution usage in the nursing area, daily needs in the week, etc.). The bag 26 can include a unique identifier or be associated with a unique identifier to facilitate data collection for this purpose. These identifiers can be read before or during the administration of the fluid to indicate that the fluid has been used and where the fluid may be used in the institution. This can allow better inventory management and minimize storage costs and storage space requirements. This may help allow the system 10 to operate as part of a "just in time" inventory management system. In addition, this may allow additional checks to ensure that the fluid used is the correct fluid for a specific patient (correct amount, concentration, dosage, no contraindications, etc.). Software updates for the system 10 can also be provided via these other medical systems.

[0333] In some cases, the user interface 108 can be used for user authentication; thereby ensuring that only trained or qualified users can operate the system 10 to produce and package medical fluids. This can be done via biometric identification, facial recognition, password entry, etc., which is checked against a database of approved users or passwords. In the case of using biometrics, the user interface 106, 108 or another part of the system 10 can be equipped with appropriate sensors (e.g., cameras, fingerprint scanners, etc.)

[0334] like Fig.55As best shown, the second portion 98 of the housing 12 may include a storage space or repository 120. The repository 120 may house at least one bag feeder 128 ready to be filled. In an exemplary embodiment, two bag feeders 128 are stored within the repository 120. The bag feeders 128 are mounted to the system 10 via a rolling cart 122. The bag feeders 128 may include an offset platform 124. The bags 26 may be placed on the platform 124 in a stack. In an alternative embodiment, the bags 26 may include a fill receiving kit 24 and may be filled via a manifold 20 such as described elsewhere herein. The bag feeder 128 may also include a top surface 126, which may include an orifice through which the bag 26 may be pushed. When the bag 26 is removed from the stack (e.g., by a robotic manipulator, a robotic flipper, or a vacuum gripper), the offset platform may be pushed toward the top surface of the bag feeder 128. This may ensure that another bag 26 is available for removal from the stack until the bag feeder 128 has been completely exhausted. As shown, the biasing member of the platform 124 is depicted as a spring, however, pneumatic, hydraulic, or other means of displacing the platform 124 may be used in alternative embodiments.

[0335] In an exemplary embodiment, a vacuum gripper 130 is included to pick up bags 26 and displace them to a filling station or dispenser. In other embodiments, a filling nozzle assembly can be displaced to the topmost bag 26 and connected to the filling port on the bag 26. In the embodiment where the bag 26 is filled by the liquid administration kit 28, the filling nozzle can be connected to the inlet included in the liquid administration kit 28. The bag 26 can be transferred to the filling compartment 132 of the system 10 for filling. In other embodiments, particularly those embodiments where the liquid administration kit 28 or other conduits are integrated into the bag 26, a flipper can be used. The flipper can include a paddle member, which is below the path of the liquid administration kit 28 tube or other conduit to easily enter the bag 26 below and separate the bag 26 from the adjacent bag 26. Then, the flipper can transport the bag 26 to the filling station. Any suitable visual or sensing system can be used additionally or alternatively to help collect and transport the bag 26 away from the stacking piece.

[0336] When the connection between the filling nozzle and the bag 26 or the administration set 28 is completed, the coupling member can be cleaned. For example, the exhaust port of the distillation device used as the medical water production device 14 can be positioned to spray hot steam on the coupling portion on the coupling surface. Alternatively, the exhausted hot steam can pass through the filling nozzle and spray at the coupling portion of the bag 26 or the set 28.

[0337] In the case where it is desired to fill the bag 26 with a pharmacopoeial fluid (such as WFI), the fluid can be provided from the medical water production device 14. In an embodiment where the system 10 is arranged to fill the bag 26 with a mixed fluid (if necessary), the system 10 may include large reservoirs 40, 42. For the purpose of example, the large reservoirs 40, 42 are marked as 5% glucose and 30% saline, respectively. Any other suitable large reservoirs 40, 42 can be utilized and the contents of the reservoirs 40, 42 will depend on the solution that one wishes to produce. In the case where the solution is a multi-component solution (e.g., Ringer's solution), large reservoirs 40, 42 for the various components of the solution can be used. Alternatively, a single large reservoir 40, 42 containing a concentrate of a mixture of all the necessary components of the solution can be used. The system 10 may include a pumping device 134 that meters the fluid to be sent to the bag 26. The fluid can be metered so that the desired final fluid concentration is achieved in a given bag 26. In some examples, the pumping device 134 may be a box-based pumping device. One such example device is described in U.S. Application No. 16 / 384,082 (Agent Docket No. Z55), filed on April 15, 2019, entitled “Medical Treatment System and Methods Using a Plurality of Fluid Line,” the entire contents of which are incorporated herein by reference. In the case where the system 10 fills the bag 26 with a mixed fluid, the system 10 may include a sensing manifold. The sensing manifold may include conductivity and temperature probes for monitoring the components. Other types of component sensors may also be used. For example, the system 10 may include a spectrometer, a turbidity meter, a pH probe, a sensor such as a polarimeter for monitoring the chiral properties of the 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 monitor the output from the medical water production device 14 or be integrated therein. 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 with a predetermined acceptable limit or threshold for a given fluid type. Such a sensor may also be used as a redundant check in addition to the water quality testing 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 obtain a quality reading prior to consuming the concentrate into the fluid stream from the medical water production device 14. The sensor described above or a sensor in another sensing manifold may check the quality of the WFI water output from the medical water production device 14.

[0338] Once the bag 26 has been filled, it can be sealed and then leave the filling compartment 132 to travel to a barrel 136 or similar holder, which places the bag 26 on a conveyor assembly 138. The conveyor assembly 138 can make the bag 26 travel to a cabinet or similar storage location that can be used to keep the bag 26 until they are needed for dosing. Alternatively, the conveyor assembly 138 can transport the bag 26 to a composite area, where additional medicines are introduced into the bag 26 automatically or manually. In some embodiments, the conveyor assembly 138 can make the bag 26 travel to one or more automated and / or manual inspection stations. In certain embodiments, the bag 26 can be transported to a quarantine station where they reside until cleaned for use.

[0339] In some examples, a sensing component may be included to monitor the bags 26 produced by the system 10. The sensing component may include, for example, a visual sensor that images the bags 26. The processor may perform image analysis and screen out bags 26 that may be defective. For example, the processor may flag bags 26 that have visible particles, have an incorrect color, leak, have excess air, and other issues of concern.

[0340] Reference now Fig.56 , shows a top view of another example system 10 for producing and packaging medical fluids. The system 10 may include a medical water production device 14, such as any of the devices described herein. The system 10 may also include a mixing circuit 348 and a sensor assembly 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 assembly 350 may include any number of different types of water quality sensors. Any of the water quality sensors described herein may be included. The mixing circuit 348 and the sensor assembly 350 may be about Fig.138 An example mixing circuit 348 and sensor package 350 are depicted.

[0341] System 10 also includes housing 12. Housing 12 can provide a clean room environment for the components of system 10 contained therein. Housing 12 itself can also be contained in a clean room environment. In such an embodiment, housing 12 can be maintained at a higher clean room standard than the clean room in which it is located. In some embodiments, housing 12 can be moved by a blower system ( Fig.5610 (not shown). In the exemplary embodiment, the housing 12 is divided into a first portion 96 and a second portion 98. Each of these portions can be maintained at a slightly different positive pressure. For example, the first portion 96 can be maintained at a first pressure that is positive relative to the surrounding environment. The second portion 98 can be maintained at a pressure higher than the first pressure. The filling of the bag 26 can occur in the most strictly controlled environment of the system 10. Various filters (such as HEPA filters) can be included to help ensure that any air blown into the housing 12 to maintain the positive pressure is clean.

[0342] The first portion 96 may be a front chamber that may be used to prepare various consumables for use by the system 10. For example, an inventory of bags 26 or cartridges 30 preloaded with bags 26 may be maintained in the front chamber during use. Fig.74A ) can also be stored in the front chamber. Sample vial 532 (see, for example, Fig.103 ) can also be kept stored in the front chamber. This can help minimize the need to access the interior of the housing 12 during operation of the system 10. Various racks, shelves, hangers, compartments or brackets can be included to help organize the component inventory. The first part 96 can also include certain test equipment that can be used to verify that the bag 26 has been filled according to a predetermined standard. For example, the first part 96 can include an endotoxin or pyrogen tester, such as the Endosafe nexgen-PTS available from Charles River Laboratories, Inc. in Wilmington, Massachusetts. In addition, any sampling port in the fluid circuit can be accessed via the front chamber. The first part 96 can be configured as a glove box and include at least one pair of glove interfaces 352, which can be used to interact with the components in the front chamber.

[0343] The second portion 98 may include a bag feeder 354, a filling station 356, and a sealing station 358. The bags 26 may be loaded into the bag feeder 354 by a user via the glove interface 352. Alternatively, a filling receiving kit 24 may be used. In the example shown, a large container or box of individual bags 26 or a preloaded bag dispenser (e.g., a box) may be held in the front chamber and the bags 26 may be individually mounted in the bag feeder 354. In certain embodiments, a plurality of bag feeders 354 may be included, each holding a different type of bag 26 with a different fill capacity. A robotic arm 360 including a gripper may collect the bags 26 from the bag feeder 354 and shift the bags 26 to the filling station 356. A fluid may be dispensed into the bags 26 at the filling station 356. The fluid may be purified water (such as WFI water) or a mixture of purified water and water in a manner similar to that described herein. Figure 2A and Figure 2BThe fluid mixture generated at the mixing subsystem is similar to those described above. For example, the bag 26 can also include FIG. 5A to FIG. 6 The robotic arm 360 can move the filled bag 26 from the filling station 356 to the sealing station 358. The entrance to the interior volume of the bag 26 can be sealed closed at the sealing station 358 (eg, via a plug, RF welding, etc.).

[0344] Bag 26 can be moved from sealing station 358 to quarantine storage 362 included in second part 98 of housing 12. When bags 26 are filled and sealed, they can be kept in quarantine storage 362 for a period of time. For example, before first bag 26 is stored in quarantine storage 362, sampling vial 364 can be brought to filling station 356. A certain amount of fluid can be distributed in vial 364. Then, vial 364 can be brought to tester, such as pyrogen (e.g., endotoxin) tester described above. Once quarantine storage 362 is full or after a certain number of bags 26 have been placed in quarantine storage 362, another fluid vial 364 can be collected at filling station 356 and can be tested for the second time at tester. In order to allow control system 15 to release bag 26 from quarantine storage 362, both pre-quarantine test and post-quarantine test may be required.

[0345] Once the bag 26 has been released from the quarantine area, the bag 26 can be labeled. In an exemplary embodiment, the second portion 98 of the housing 12 includes a labeler 366. The labeler 366 can be any suitable labeler 366, such as a thermal printer. In some embodiments, a thermal ribbon transfer printer may be particularly desirable. The labeler 366 can generate labels and facilitate the application of labels to each bag 26 produced by the system 10. The label can be adhered to the bag 26 via an adhesive backing. The label can include information required by any relevant statute or regulation as well as identification characteristics, tracking information, computer readable markings, corresponding patient information, instructions for use, etc. The bag 26 can then be discharged from the housing 12 through an output portion 368, which may include a chute with a door or a door inlet and outlet. The bag 26 can leave the housing 12 through the output portion and be discharged to a container or conveyor ( Fig.56 are not shown in the figure).

[0346] Reference now Fig.57 , showing Fig.561. A side view of the housing 12 depicted in FIG. As shown, the side panel 370 of the first portion 96 of the housing 12 is depicted as transparent to allow viewing of the interior of the front chamber. As shown, the side panel 370 may include a port 372. A glove interface 352 may be mounted in the port 372 in a fluid-tight manner. The glove interface 352 may be mounted at a comfortable height for an average standing or sitting user. The glove interface 352 may provide a sterile barrier through which a user may manipulate various components of the system 10 within the housing 12.

[0347] Now also refer to Fig.58, showing a side view of an example housing with the side panel 370 and glove interface 352 removed. A plurality of access openings may be included from the first portion 96 to the second portion 98 of the housing 12. 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 may allow access to a portion of the bag feeder 354 to allow the bag feeder 354 to be opened so that bags 26 or pre-loaded dispensers of bags 26 (such as a cassette 354) may be loaded into the bag feeder 354. The bag feeder door 374 may be opened to allow bags 26 to travel from the first portion 96 to the second portion 98 of the housing 12 as they are loaded into the bag feeder 354. The sealing station port 378 may provide an opening through which a cassette (e.g., a supply containing plugs) may be installed in the sealing station 358. The vial access door 380 can allow the vial to be introduced into and removed from the second portion 98 of the housing 12 for sample collection and testing. All interactions with these components can be performed via the glove interface 352. Any door can include a hinge 382 suitable for a clean room. In some embodiments, the hinge 382 can be a brake hinge that tends to keep the attached door in a specified position and resists accidental displacement from the specified position. Once the door has been rotated within the range of the specified position, such a hinge can also help the attached door reach the specified position. For example, a brake hinge that tends to keep the attached door closed can be used. Any door can be paired with at least one corresponding position sensor 384. The position sensor 384 can detect whether the door is in an open state or a closed state. Any suitable type of sensor can be used, however, in some embodiments, an inductive or magnetic sensor 384 may be preferred. A front chamber door 386 can also be provided and it can include a lockable latch mechanism 388 that can be used to keep the front chamber door 386 in a closed position. The front chamber door 386 can be paired with at least one position sensor 384 similar to that described above. The control system 15 of the system 10 can monitor the output from the door position sensor 384 and can generate a user interface notification when the door is open. The control system 15 can also prohibit certain actions if the door is open. For example, the filling of the bag 26 can be prohibited if the door is open.

[0348] Reference now Fig.59, depicting an example embodiment of a reservoir dispenser. The reservoir dispenser in the example embodiment is depicted as a bag feeder 354. As shown, the bag feeder 354 can include a box portion 399 and a housing block 398, which can be from the outlet end of the bag feeder 354. In some embodiments, the box portion 399 can be separated from the housing block 398. In such an embodiment, the box portion 399 can be set in a pre-loaded state and connected to the housing block 398 to be ready for use by the bag feeder 354. In an example embodiment, the box portion 399 is integrated with the housing block 398 and fixed to the housing block 398. The box portion 399 can be opened by a user and loaded with a bag 26, and the bag 26 can be pushed through the bag feeder 354 when the system 10 consumes the bag 26. In some embodiments, a stripping clamp or a box loader can be provided to facilitate the loading of the box portion 399. In the case of using a pre-loaded box portion 399 or peel clip, these items can be made clean and sterile within the outer packaging 60, which is removed once the box or peel clip has entered the front chamber and is ready for use.

[0349] In an exemplary embodiment, the box portion 399 includes a plurality of guides 390. The guides 390 may be sized to receive a tube or port 392 extending from the bag 26. In an exemplary embodiment, one of the ports 392 includes a fin 394 that may rest on top of one of the guides 390 to allow the bag to be suspended from the guide 390. In this example, the guides 390 are configured as a pair of rails extending parallel to each other. A slot may exist between the rails that make up each guide 390 and may have a width sufficient to receive the port 392 of the bag 26. The exemplary guides 390 extend from a housing block 398. The housing block 398 may include a passage 400 for passing the port 392 through when the bag 26 is fed from the front chamber into the second portion 98 of the housing 12.

[0350] In some embodiments, the blocking plate 405 (see Fig.64 390. This can help prevent a user from incorrectly loading a bag 26 into the bag feeder 354 by preventing the port 392 from shifting into the space between the guides 390. In some embodiments, a straightener member 407 (see Fig.64 ). The straightener member 407 can extend parallel to the guide 390 and be positioned to prevent the bag 26 from being suspended in the guide 390 in a curved orientation. The straightener member 407 can be spaced apart from the guide 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.

[0351] The box 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 biased by a biasing member 401 ( Fig.64 398) is coupled to the housing block 398, the biasing member 401 urging the feed plate 396 toward the housing block 398. In various examples, the biasing member 401 can be a constant force spring. Any other suitable actuator that drives the feed plate 396 toward the housing block 398 can be used. A pair of standoffs 402 can also extend from the housing block 398. The standoffs 402 can be coupled to the feed plate retainer 403. In an exemplary embodiment, a latch plate 404 is shown that can include a latch 406. The feed plate 396 can be coupled to a plunger 408 that can be pulled via the glove interface 352 to retract the feed plate 396. The latch 406 can interface with the feed plate 396 to hold the feed plate 396 in its retracted position spaced a distance from the guide 390. This can allow a user to load the bag 26 into the box portion 399. In an alternative embodiment, a similar arrangement to that described with respect to Fig.73 A magnetic latching device is described to replace latch 406.

[0352] In some embodiments, the latch 406 can be biased toward a latched position (e.g., via a torsion spring). As the feed plate 396 is retracted via the plunger 408, the latch 406 can be pushed open and automatically shifted into latching engagement with the feed plate 396 when the feed plate 396 has been retracted to a predetermined open position. The latch 406 can include an inclined surface or ramp 410 (e.g., see Fig.61 ), when the feed plate 396 is retracted to make contact with the latch 406, the inclined surface or ramp can promote the latch 406 to move out of the obstruction orientation. The latch 406 can also include a recessed portion 412, which can facilitate the operation of the latch 406 through the glove interface 352.

[0353] Reference now Fig.60 , Fig.59 The exemplary bag feeder 354 is shown fully loaded with bags 26. In the exemplary embodiment, the bag feeder 354 has a capacity of sixteen bags 26, however, in alternative embodiments, a greater or lesser number of bags 26 may be installed. Once filled, and now also referred 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 moved away from engagement with the feed plate 396 by the biasing member 401 (in Fig.64 354) is displaced into contact with the last bag 26 in the bag feeder 354 under the action of the force applied by the bag feeder 354 (best shown in FIG. 35).

[0354] Reference now Fig.62, the feed plate 396 is shown in position against the last bag 26 installed in the bag feeder 354. As shown, the feed plate 396 can slide along two slender members 414. At least one of the slender members 414 can also serve as a rod forming a guide 390. The feed plate 396 can also include protrusions 416, which can be spaced apart so as to press against the port 392 of the bag 26. This can help ensure that the bag 26 is retained in the bag feeder 354 in a compact and space-efficient manner. The protrusions 416 can be sized to fit within the slots of each guide 390. In addition, the protrusions 416 can ensure that when the feed plate 396 is displaced along the slender members 414 to the end of its displacement range, the last bag 26 loaded into the box portion 399 can be pushed through the channel 400 in the housing block 398 The appropriate distance. When the feed plate 396 is pulled up against the stop surface 397 (see Fig.59 ), the feed plate can be at the end of its displacement range. In some examples, the protrusion 416 can extend a distance at least equal to the distance from the stop face 397 to the retaining pin 420. In other examples, the protrusion 416 can extend a distance equal to the distance from the stop face 397 to the retaining pin 420 minus a percentage of the diameter of the port 392.

[0355] Main references Fig.63 , attached to the robotic arm 360 of the system 10 (not shown for illustration, see, e.g., Fig.56 ) can collect bags 26 from the bag feeder 354 as needed. As shown, each guide 390 can be associated with one or more retaining pins 420. The retaining pins 420 can retain the front-most bag 26 in the bag feeder 354 to resist the force applied by the feed plate 396. In an exemplary embodiment, two retaining pins 420 are included on opposite sides of each channel 400. The exemplary retaining pins 420 can be arranged to protrude into the path of the channel 400 of the bag 26 transported through the housing block 398 and obstruct the access to the port 392 attached to each bag 26. In some embodiments, the retaining pins 420 can be arranged at an angle of 10-20° (e.g., 15°) relative to the axis of the guide 390.

[0356] The retaining pin 420 may be biased to a blocking position, but may be displaceable to a retracted position in which the retaining pin 420 is at least partially depressed into the housing block 398 and does not interfere with the transport path of the bag 26. In certain embodiments, and as Fig.64As shown, the gripper 418 can be configured so that, when opened, the jaws 422A, 422B of the gripper 418 can be appropriately spaced apart so as to actuate the retaining pin 420 from the obstructing position to the retracted position when the gripper 418 is advanced toward the bag feeder 354. When the gripper 418 is displaced to the bag feeder 354, the jaws 422A, 422B can press the retaining pin 420 into the retracted state. The jaws 422A, 422B can support the fins 394 of the port 392 on the bag 26 so that the bag 26 does not fall out when the retaining pin 420 is retracted. The force applied by the feed plate 396 can help push the frontmost bag 26 into the jaws A, B of the gripper 418. The coefficient of friction between the gripper 418 material and the port 392 under the force applied by the feed plate 396 may be sufficient to hold the bag 26 in place before the jaws 422A, 422B are closed. Similar retaining pins 420 may be incorporated into the Figure 54 to Figure 55 In the bag feeder 28 described.

[0357] The gripper 418 may include a drive 419 including one or more actuators for displacing the jaws 422A, 422B. In addition, a jaw position sensor 423 may be included. The jaw position sensor 423 may monitor the position of the jaws 422A, 422B via a magnetic field-based sensor (such as an inductive or Hall effect sensor). The control system 15 of the system 10 may check the output of the jaw position sensor 423 to determine whether the bag 26 has been properly grasped by the gripper 418. In some embodiments, the control system 15 may compare the position output of the jaw position sensor 423 with a predetermined range of acceptable positions. In the event that the jaws 422A, 422B are displaced to the limit of their displacement range (e.g., fully closed), the control system 15 may infer that the gripper 418 has missed the bag 26. If the jaws 422A, 422B are displaced outside of the predetermined range, but not to the limit of the displacement range, the control system 15 may infer that the gripper has grasped incorrectly (e.g., only partially grasped a section of the port 392, rather than the entire port 392). Fig.65 392 is shown closed around port 392). When the control system 15 determines that the position output of the jaw position sensor 423 is outside a predetermined range, the control system 15 can command the gripper 418 to retry. There may be an upper limit to the number of retries allowed before the control system 15 may generate an error. Although the jaw position sensor 423 can be monitored when a bag 26 is removed from the bag feeder 354, the control system 15 can also perform this check at any other time when a bag 26 is gripped 418 within the system 10.

[0358] Now the main reference Fig.65Once the jaws 422A, 422B are closed around the port 392, the frontmost bag 26 can be removed from the bag feeder 354 and moved 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 attached to the housing block 398 by the biasing member 401 (in Fig.64 In addition, when the gripper 418 is displaced away from the bag feeder 354, the retaining pin 420 can be pushed back to the blocking position. Therefore, the next bag 26 in the bag feeder 354 can be advanced and ready to be collected by the gripper 418.

[0359] Reference now Fig.66 , depicting an exemplary filling station 356. As shown, the filling station 356 may include a filling nozzle 430, which may be connected to a fluid input line 432. The fluid input line 432 may carry purified water or a mixed fluid (e.g., saline) that has traveled through the sensor set 350 and is considered acceptable. The filling nozzle 430 may be arranged above the discharge port 434 and aligned with the discharge port. The discharge inlet 434 may include a tapered funnel-shaped opening leading to a discharge conduit 436. As shown, the discharge conduit 436 has a larger diameter than the fluid input line 432. In this example, the diameter of the discharge conduit 436 may be three times that of the fluid input line 432. This can help ensure that the discharge conduit 436 has the ability to carry undesired flows or drops from the filling nozzle 430.

[0360] 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 a plurality of mounting points for bag characteristic sensors 444A, 444B, 444C. The bag characteristic sensors 444A-444C may be any suitable sensor capable of collecting data regarding distinguishing characteristics of various bags that may be used with the system 10. The bag characteristic sensors 444A-444C may sense the presence, material, color, shape, size, etc. of the bag 26. Preferably, the bag characteristic sensors 444A-444C are at least sufficient to identify the volume of the bag 26 in place at the filling station 356. Thus, in some examples, the bag characteristic sensors 444A, 444B, 444C may form a reservoir volume sensing assembly.

[0361] In an exemplary embodiment, bag property sensors 444A-444C are positioned to collect information sufficient to determine the type of bag 26 docked at the filling station 356. Exemplary bag property sensors 444A-444C may be, for example, sensors based on beam interruption or reflection that may determine the presence or absence of bag material in its vicinity. In an exemplary embodiment, a bag presence detector 444B is included and may determine whether a bag 26 has been docked in the filling station 354. The bag presence detector 444B may be mounted on the back plate 442 at a location that may detect any of the various types of bags 26 that may be used in the system 10 (e.g., from mini bags to bags of one liter or greater capacity). In the event that the bag presence detector 444B does not detect that a bag 26 is in place at the filling station 356, the filling station 356 may be prohibited from dispensing liquid via the control system 15. A bag width detector 444A may be included and mounted on the back plate 442 at a location that may detect whether the width of the bag 26 is greater than a certain value. The width detector 444A can be placed closer to the filling nozzle 430 to ensure that any bag 26 with a width greater than a threshold width value (regardless of its length) will be picked up by the width detector 444A. The bag length detector 444C can be mounted on the back plate 442 at a position where it can detect whether the bag 26 is longer than a specific value. The bag length detector 444C can be arranged at the farthest side of the filling nozzle 430. Based on the data collected by the bag characteristic sensors 444A-444C, the control system 15 can determine the type of bag 26 docked in the filling station 356. For example, the control system 15 can determine the expected filling amount of the bag 26 based on the data collected from the bag characteristic sensors 444A-444C, and ensure that the bag 26 is not overfilled. A lookup table or the like can be used to determine the expected filling amount of the bag 26 based on the output of each of the bag characteristic sensors 444A-444C. Other embodiments may include additional bag characteristic sensors 444A-444C. For example, some embodiments may include additional width detectors 444A or length detectors 444C to provide additional data related to the size of bag 26. In some embodiments, each bag characteristic sensor 444A-444C may be accompanied by a redundant sensor.

[0362] In an example embodiment, the discharge inlet 434 and the attached discharge conduit 436 may be pivotally or otherwise displaceably coupled to the filling station housing block 438. When the bag 26 is introduced into the filling station 356 with the gripper 418, the jaws 422A, 422B of the gripper 418 may drive the discharge inlet 434 and the discharge conduit 436 to the retracted position. Fig.67 As shown, the filling station 356 may include a filling station gripper 440. The filling station gripper 440 may be opened by a gripper drive 446 to receive the port 392 of the bag 26 and once the robotic arm 360 (e.g., see Fig.56) is shifted to the pre-programmed bag 26 docking coordinates and is then driven closed. The coordination of the filling station gripper 440 and the robot arm 360 can be formulated by the control system 15.

[0363] like Fig.68 As shown, during the filling of the bag 26, the robot arm 360 (see, for example, Fig.56 ) can be displaced away from the filling station 356. When the bag 26 docked on the filling station 356 is filled, the gripper 418 can be used to perform other operations within the housing 12. For example, when the bag 26 is filled at the filling station 356, the gripper 418 can be used to remove, mark and distribute the completed bag 26 from the quarantine storage 362. Once the bag 26 has been filled to the desired amount (e.g., as indicated by one or more flow meters in the sensor kit 350), the gripper 418 can return to the filling station 354 and collect the filled bag 26 from the filling station 354. Fig.69 As shown, the jaws 422A, 422B of the gripper 418 can be actuated closed around the port 392 of the filled bag 26, and the filling station gripper 440 can be driven open by the gripper drive 446. In some embodiments, the robotic arm 360 may not be displaced away from the filling station 356 in various situations. For example, in the case of a small 100mL bag 26 to be filled, the robotic arm 360 can remain in place because the filling time of the bag 26 should be very short. In the case of filling a large bag 26 (e.g., several liters), the gripper 418 can be displaced away from the filling station 356 because the filling time can have a duration that allows the robotic arm 360 to complete one or more other tasks.

[0364] Reference now Fig.70 , the gripper 418 can remove the filled bag 26 from the filling station 356. The filled bag 26 can be taken to the sealing station 358 after being removed from the filling station 356. As shown, when the bag 26 is collected from the filling station 356, the discharge inlet 434 can automatically return to align with the filling nozzle 430. A biasing member (e.g., see Fig.71B A biasing member 454 is provided to facilitate the automatic return of the discharge inlet 434 to the aligned position.

[0365] Now also refer to Fig.71A and Fig.71B, the discharge inlet 434 can be attached to a flange 448, which can pivotally mount the discharge inlet 434 to the filling station housing block 438. The flange 448 may include a track 450, in which a pin 452 extending from the filling station housing block 438 is arranged. Because the pin 452 within the track 450 is attached to the filling station housing block 438, the pin 452 can remain stationary. At least one biasing member 454 can be coupled to the pin 452 and to a mounting pin 456 included on the flange 448. The mounting pin 456 can be displaced with the flange 448 and the discharge inlet 434. In this example, one biasing member 454 is depicted and shown as a tension spring, but other types of biasing members 454 can be used in alternative embodiments. As shown, when the discharge inlet 434 is displaced, the track 450 can travel along the fixed pin 452. The distance between the mounting pin 456 and the fixed pin 452 can increase and the biasing member 454 can extend (for example, see Fig.71B ). As the biasing member 454 recovers (e.g., after the bag 26 has been filled and removed), the track 450 can travel along the pin 452 until the distance between the two pins 452, 456 is minimized or the biasing member 454 returns to the rest state. As shown, this can automatically pivot the discharge inlet 434 back into alignment with respect to the filling nozzle 430 (e.g., see Fig.71A ).

[0366] As shown, the filling station 356 may include a discharge inlet sensor 437. The discharge inlet sensor 437 may monitor the position of the discharge inlet 434. The discharge inlet sensor 437 may be any suitable sensor, such as a magnetic field sensor, such as an inductive sensor or a Hall effect sensor. In some embodiments, the discharge inlet 434 or the flange may include a magnetic or metal body monitored by the discharge inlet sensor 437. Alternatively, the discharge inlet sensor 437 may be an optical sensor. The control system 15 may receive an output signal from the discharge inlet sensor 437 and ensure that the discharge inlet 434 is arranged in an expected position. For example, after the bag 26 has been filled and removed, the control system 15 may verify that the discharge inlet 434 returns to an aligned state relative to the filling nozzle 430. In addition, the control system 15 may check the output of the discharge inlet sensor 437 to ensure that the discharge inlet 434 is in an aligned state below the filling nozzle 430 before commanding the filling nozzle 430 to be flushed or the fluid circuit to be sterilized. During sterilization, hot purified water may be delivered through the fluid circuit and discharged into the discharge inlet 434 through the filling nozzle 430.

[0367] Reference now Fig.72, an example embodiment of a sealing station 358 is shown. As shown, the sealing station 358 can include a base plate 460. A push rod driver 462 can be mounted to the base plate 460. The push rod driver 462 can achieve the displacement of a push rod 464, which can drive the plug into the port 392 of the bag 26. In some embodiments, the push rod driver 464 is capable of applying at least 100 pounds of force to the plug 476 during the stop of the bag 26. A support 463 can be attached to the base plate 460. During the sealing of the bag 26, the gripper 418 holding the bag 26 can be docked on the docking surface (e.g., the top surface) of the support 463 to support the gripper 418 against the force applied by the push rod driver 462. In the example embodiment, the support 463 is depicted as a metal frame, but any suitable material can also be used. In this example, two supports 463 are shown. The support 463 can also be used as a guide. As shown, the two seats 463 can be separated by a gap that can allow the bag 26 to be positioned between the seats 463. The bag 26 can be displaced into the gap to help position the bag 26 port 392 to align with the displacement axis of the push rod 464.

[0368] A plug dispenser, depicted in the example embodiment as a plug cartridge 466, is also included in the example sealing station 358. The plug cartridge 466 can dock into a cartridge receiver 468 in the sealing station 358. The plug cartridge 466 can include an opening 472 that aligns and is sized to allow passage of the push rod 464 when the plug cartridge 466 is in place at the cartridge receiver 468. A follower assembly 470 can be included to automatically advance the plug through the plug cartridge 466 when the plug is dispensed.

[0369] Reference now Fig.73 In an exemplary embodiment, the plug box 466 can be provided in a preloaded state. The plug box 466 can be cleanly and sterilely packaged in an outer package 60, which is opened in the front chamber of the system 10. In an exemplary embodiment, the plug box 466 has a capacity of 22 plugs 476, however, in other embodiments, the capacity of the plug box 466 can be smaller or larger. In an exemplary embodiment, the cover plate 474 (e.g., see Fig.72 ) has been removed to show the plug 476. After the plug box 466 is removed from its outer packaging 60, the plug box 466 can be docked onto the box receiver 472. In some embodiments, the box receiver 472 can accommodate a variety of different plug boxes 466 varieties. For example, some embodiments can have a box receiver 472 that can accommodate any plug box 466 shown and described herein. This can allow the user to use plug boxes 466 of different capacities as needed. In some embodiments, the plug box 466 may not be a removable box. Instead, a fixed box can be included, which is loaded manually by an operator of the system 10 or loaded in an appropriate position on the base plate 460 with the help of a speed loader.

[0370] To load the example plug cartridge 466 into the sealing station 358, the user can retract the follower assembly 470. 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 to the loaded state via the glove interface 352. In some embodiments, a similar Fig.59 The latch is shown 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 plug cartridge 466 in place on the cartridge receiver 472.

[0371] The handle 478 can be coupled to a follower block 480. The follower block 480 can include a follower 482. The follower block 480 can be coupled to the cartridge receiver 472 via a biasing member 484. In the example embodiment, the biasing member 484 is depicted as a constant force spring, however, in other embodiments, other types of biasing members 484 can be used. The biasing member 484 can apply a force to the follower block 480, which keeps the follower 482 in close contact with the last one or more plugs 476 in the plug box 466. The follower block 480 can be displaced along one or more follower guides 502, which limits the movement of the follower 482 along a prescribed path. In the example embodiment, an end block 504 is included on the end of the guide 502 that is farthest from the cartridge receiver 472. The end block can include a magnet 500. The magnet 500 may interact with a metal portion of the follower block 480 to hold the follower assembly 470 in an open position as loading of the plug cartridge 466 occurs.

[0372] The example plug box 466 is shown as a multi-column box. The follower 482 includes staggered protrusions 486 extending from the plug contact portion of the follower 482. The staggered protrusions 486 can help ensure orderly feeding of the plugs 476 as the plug box 466 is depleted. The staggered protrusions 486 can cause the plugs 476 in one column to be offset from the plugs 476 in the adjacent column. This can help prevent jamming and facilitate movement of a single plug 466 from the multiple columns to the opening 472 in the plug box 466 (see, for example, Fig.72 ).

[0373] Now also refer to Fig.74A and Fig.74B, a view of an example plug box 466 is shown. As shown, the plug box 466 may include a box body 508. The box body 508 may include a plurality of plug grooves 510 recessed therein. The partition wall 488 may separate and partially define each groove 510. The plug box 466 may also include a ridge 490 located on the side of each groove 510. Any partition wall 488 and ridge 490 may be at the same height as each other. In some examples, the plug 476 may include portions of different diameters. The ridge 490 and the partition wall 488 may have a height that is selected so that a step area 512 on the plug 476 can run along the top surface of the ridge 490 and the partition wall 488, where the plug 476 transitions to a larger diameter. As shown, the plug box 466 may also include a slit 492. The slot 492 may allow a portion of the follower assembly 470 , including the follower 482 , to travel into and be displaced within the plug box 466 .

[0374] In an example embodiment, the plug box 466 includes mating features that can facilitate mounting the plug box 466 onto the cartridge receiver 472. In an example embodiment, two mounting or mating pins 494 are included in the plug box 466. These mating pins 494 can be received in alignment holes within the cartridge receiver 472. In some embodiments, the mating pins 494, a portion of the alignment holes, or both can be magnetic. This can allow the plug box 466 to be magnetically coupled to the cartridge receiver 472 in place. The cartridge receiver 472 can also include a cartridge sensor 473 (e.g., see Fig.77B ). In some examples, a Hall effect sensor or inductive sensor can be used that can record the correct fit of the plug box 466 in the box receiver 472. Other types of sensors (such as micro switches, optical sensors, button-type sensors, etc.) can also be used to monitor whether the plug box 466 is installed in the box receiver 472. In some embodiments, a magnetic body for sensing by the magnetic box sensor 473 can be included elsewhere in the plug box 466. In some embodiments, the control system 15 of the system 10 may not allow displacement of the push rod 464 unless the box sensor 473 indicates that the plug box 466 is installed in the box receiver 472.

[0375] Now also refer to Figures 75 to 77B , the plug box 466 may include a blocking element that prevents the plug 476 from being released prematurely from the plug box 466. The example plug box 466 includes a displaceable handle 496. The displaceable handle 496 may include a ring, a flange, or a 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 outlet cover 498 (e.g., see Fig.74AThe outlet cover 498 can prevent the plug 476 from leaving the plug box 466. The displaceable handle 496 can be integral with the outlet cover 498 (in Fig.74B 4) or may be coupled to the outlet cover via a connecting rod. When a user displaces the displaceable handle 496, the outlet cover 498 may be displaced or retracted from the blocking position, thereby allowing the plug 476 to be removed from the plug box 466. The displaceable handle 496 may be moved along a guide slot 506 included in a body 508 of the plug box 466. In some embodiments, the displaceable handle 496 may be completely removed from the plug box 466 before use.

[0376] In operation, and as Fig.75 As shown, before actuating the outlet cover 498 to the retracted state, the user can position the follower 482 against the plug 476 in the plug box 466. Figures 76 to 77A When displaced as depicted, a plug 476 from the plug box 466 aligned with the outlet port 514 can be frictionally retained within the plug box 466 by the force applied by the follower 482 via the biasing member 484. Only the head of the plug 476 can be frictionally held in place against the plug box 466. The stem of the plug 476 may not be in contact with the plug box 466. With the follower 482 deployed against the plug 476 and the outlet cover 498 retracted, the sealing station 358 can be considered to be in a ready state.

[0377] Reference now Fig.78, when the sealing station 358 is in the ready state, the robotic arm 360 can displace the bag 26 to the sealing station 358 via the gripper 418. The gripper 410 can align the port 392 of the bag 26 to be sealed under the outlet port 514 of the plug box 466. The control system 15 can command the push rod driver 462 to displace the push rod 464 through the opening 472 of the plug box 466. The push rod 464 can contact the head of the plug 476, and the plug 476 can begin to displace with the push rod 464. In an example embodiment, when the driven plug 476 is displaced toward the port 392 of the bag 26, the driven plug can travel along the guide portion 516 of the plug box 466. The guide portion 516 can ensure that the plug 476 is displaced substantially in line with the axis of the port 392. The shaft or smaller diameter portion of the plug 476 may enter the port 392 of the bag 26 before the plug 476 is displaced beyond the guide portion 516 of the plug box 466. The push rod 464 may continue to be driven by the push rod driver 462 until the step 512 of the plug 476 abuts the top of the port 392. In certain embodiments, the push rod 464 may be displaced until at least a threshold amount of the shaft or smaller diameter portion of the plug 476 is within the port 392. For example, the plug 476 may be driven until at least 75% of the shaft is within the port 392. The control system 15 may monitor position feedback from the push rod driver 462 to determine the travel distance of the shaft portion of the plug 476 into the port 392.

[0378] As mentioned above, in some examples, unless the cartridge sensor 473 (e.g., see Fig.77B ) records that the plug box 466 is correctly loaded into the sealing station 358, otherwise the control system 15 can prohibit the displacement of the push rod 464. In some embodiments, the control system 15 can also monitor data from the bag detection sensor. In some embodiments, for example, a port detection sensor 475 that monitors the presence of the port 392 of the bag 26 can be used. The port detection sensor 475 can be an optical sensor, such as a reflectivity-based sensor. Such a sensor can, for example, monitor the reflected intensity of light emitted from the sensor. The port detection sensor 475 can detect whether the port 392 of the bag 26 is in the appropriate position for the stopper. Unless the port detection sensor 475 indicates that the port 392 is in the appropriate position, the control system 15 can prohibit the displacement of the push rod 464.

[0379] Reference now Fig.79 Once the plug 476 is in sealing engagement with the port 392, the push rod 464 can be retracted. The control system 15 can command the push rod driver 462 to retract the push rod 464, and the follower assembly 470 can automatically advance the plug 476 in the plug box 466 so that the next plug 476 in the plug box 466 is aligned with the outlet port 514 of the plug box 466. Fig.80As shown, the sealed bag 26 can then be moved from the sealing station 358 to the quarantine storage 362.

[0380] Reference now FIG. 81A to FIG. 81B In some embodiments, the sealing station 358 can accept different plug boxes 466 or can be designed to accept various plug boxes 466 with different styles, capacities, or containing different plug 476 types and sizes. For example, a single-row box, a drum box, or any other suitable type of plug box 466 can be used. FIG. 81A to FIG. 81B Depicted in Fig.74A and Fig.74B . As shown, the outlet port 514 of the plug box 466 is an elongated shape that extends all the way to the front end of the plug box 466. The elongated shape can allow for greater alignment tolerance when the plug 476 is moved out of the outlet port 514. In addition, the wall of the outlet port 514 may include a guide portion that is disposed at a portion of the outlet port 514 wall that is adjacent to the exterior face of the box body 506. In some embodiments, the guide portion may include a chamfer 477 or fillet that is applied to the edge where the outlet port 514 and the exterior face of the box body 506 intersect. Such a chamfered outlet port 514 may be included on any of the plug boxes 466 described herein.

[0381] Reference now Fig.81C In some embodiments, the port 392 of the bag 26 can be displaced into the outlet port 514 of the plug box 466 before sealing the port 392. The chamfer 477 on the outlet port 514 of the plug box 466 can be designed to facilitate this action. Fig.81C As shown, the push rod 464 can be driven into the plug box 466 until the push rod 464 contacts the plug 476 in line with the outlet port 514. The push rod 464 can be stopped in this position and the gripper 418 can lift the bag 26 so that the plug 476 is partially installed (e.g., no more than 25%-35%) into the port 392. When this happens, the push rod 464 can prevent the plug 476 from being pushed upward. The chamfer 477 on the outlet port 514 of the plug box 466 can guide or guide the port 392 of the bag 26 to align with the stem or smaller diameter portion of the plug 476. Once the plug 476 is partially installed in the port 392, the push rod 464 can be actuated by the push rod driver 462 to complete the installation of the plug 476 into the port 392 to seal the bag 26.

[0382] Reference now Figures 82A to 82C , shows a view of another exemplary plug box 466. As shown, the exemplary plug box 466 includes an outlet port 514 with a chamfer 477. As described above, the chamfer 477 can convey or guide the port 392 of the bag 26 to align with the stem or smaller diameter portion of the plug 476. In addition, as shown in FIG. Fig.82C As best shown, a stopper member 479 can be included in the wall of the outlet port 514. Such a stopper member 479 can be included in any of the plug boxes 466 described herein. The stopper member 479 in the example embodiment includes a spherical stopper. In alternative embodiments, the stopper member 479 can be a barb, a bump, or other protrusion. The stopper member 479 can protrude into the outlet path of the plug 476 traveling through the outlet port 514. The step area 512 of the plug 476 can catch on the stopper member 479, helping to retain the plug 476 within the plug box 466. As shown in FIG. Fig.82A As best shown, embodiments including the brake member 479 may omit the coupling to the outlet cover 498 (see, e.g., Fig.74B ) of the displaceable handle 496 and the accompanying guide rail 506 (see, for example, Fig.74B ).

[0383] Reference now Fig.83 , depicting an exemplary roller-type plug box 466. The plug box 466 may include a roller body 630. The roller body 630 may include a spiral groove or track 632, which may have a depth sufficient to receive the plug 476 therein. The plug box 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 placed behind the last plug 476 in the plug box 466. The plug box 466 may also include a removable cover member (not shown) that may be placed on the plug box 466 to enclose the plug 476 within the plug box 466. The exemplary roller-type plug box 466 has a capacity of 64 plugs 476. In other embodiments, the capacity may be higher (e.g., up to 100 or more) or lower (e.g., 50 or less).

[0384] Reference now Figure 84 to Figure 86 , as the plug box 466 is exhausted, the constant force spring 634 can pull the follower 636 along the spiral path 632 in the drum body 630. This in turn can advance the remaining plugs 476 in the plug box 466. As shown, the spiral path 632 can include a groove portion 640. The groove portion 640 can receive the rod or small diameter portion of each plug 476. Therefore, when the plug is displaced along the spiral path 632, the groove portion can serve as a guide for the plug 476. In some embodiments, the size of the follower 636 can be designed to travel along the groove 640, and therefore the groove portion 640 can also serve as a follower guide during operation. The groove portion can be flanked on each side by a ledge 642, and the step area 512 of the plug 476 can rest on this ledge.

[0385] Plug box 466 Fig.864. As shown in the figure, the size of the outlet port 638 of the plug 476 can be designed to substantially match the size of the head or larger diameter portion of the plug 476. In addition, the outlet port 638 can be at least partially surrounded by a guide wall 644. The guide wall 644 can be positioned in front of the outlet port 638 to prevent the constant force spring 634 from pushing the plug 476 beyond the outlet portion 638. The guide wall 644 can also have a guide surface 646 having a curvature that helps position the head of the plug 476 to align with the outlet port 638.

[0386] although Fig.86 , but may include a mating pin 492 (see, e.g., Fig.74A ). The mating pin 492 can help install the plug box 466 in the cartridge receiver 472. The mating pin 492 can also allow the cartridge sensor 473 to detect the presence of the plug box 466 at the cartridge receiver 472.

[0387] Reference now Fig.87 , depicts an exploded view of another example plug box 466. As shown in the figure, Fig.87 The plug box 466 in the example is a drum type box. The plug box 466 may include a drum body 650 having a spiral groove or track 654 formed therein. A rotor element 656 may also be included and may include a plurality of grooves 658 extending therethrough. The grooves 658 may be sized to receive the plug 476 therein. A biasing assembly 652 may also be included in the example plug box 466. In the example embodiment, the biasing assembly 652 may include a torsion spring or a wrap spring 660 as in the example embodiment. A portion of the wrap spring 660 may be attached to a spindle 662 included in the biasing assembly 652 that extends through the drum body 650 and the rotor 656. Typically, the wrap spring 660 may be included in the example Fig.87 660 is shown within a housing not depicted in the figure to better illustrate the wrap spring 660. The spindle 662 may include a keyed segment 664 that interfaces with the rotor 656. In an example embodiment, the keyed segment 664 is "D" shaped and may ensure that the rotor 656 rotates in cooperation with the spindle 662. In other embodiments, the keyed segment 664 may have a different cross-sectional shape, such as a square or a star. In operation, a user may grasp a knob 666 attached to the spindle to rotate the spindle 662. This may cause the wrap spring 660 to store energy, which may be used to turn the rotor 656 and advance the plug 476 along the spiral track 654. The plug box 466 may also include a removable cover member (not shown) that may be placed on the plug box 466 to enclose the plug 476 and the rotor 656 within the plug box 466. As in other plug box 466 embodiments, a mating pin 492 may be included (e.g., see Fig.74B) to facilitate installation and detection of the plug box 466 in the box receiver 473.

[0388] Reference now Fig.88 , depicting Fig.87 4. A top view of an example plug box 466 is shown. As shown, the plug box 466 is fully loaded with plugs 476. In the example embodiment, the example plug box 466 has a capacity of 108 plugs 476, but as with other plug boxes 466 described herein, this capacity may be less or more depending on the embodiment. As shown, the grooves 658 have different lengths and extend from the periphery of the rotor 656 toward the center of the rotor 656. Such different length grooves 658 can increase the space efficiency of the plug box 466 and allow a large number of plugs 476 to be loaded into the plug box 466.

[0389] Still reference Fig.88 , the plug 476 is depicted at the outlet port 668 of the plug box 466. The edge of the groove 658 in which the plug 476 is disposed can press against the head of the plug 476. Since the biasing assembly 652 of the plug box 466 can be preloaded when the plug box 466 is operated, the groove 658 can apply a force to the plug 476 that is sufficient to frictionally hold the plug 476 against the wall of the outlet 668. In addition, the plug 476 at the outlet port 668 may interfere with the wall of the groove 658, which can prevent the rotor 656 from shifting under the force of the biasing assembly 652. When the plug 476 is driven out of the plug box 466 by the push rod 464 or the like (see Fig.89 ), the interference can be removed and the rotor 656 can rotate freely. Fig.90 As shown, the rotor 656 can push the plug 476 to shift along the spiral track 654 of the drum body 650. This can push the next plug 476 into the outlet port 668, which may again interfere with the further displacement of the rotor 656.

[0390] Reference now Fig.91 As the plug box 466 is depleted, the smaller recesses 658 of the rotor 656 can be emptied of plugs 476. The exemplary plug box 466 is arranged to automatically index to the next available plug 476 and will automatically skip any empty recesses 658. Fig.91 In the example shown, the plug 476 at the outlet port 668 is separated from the next available plug 476 by two empty grooves 658. Fig.92 ) is discharged, the rotor 656 can advance freely until the next plug 476 is aligned with the outlet port 668 and interferes with further movement of the rotor 656, such as Fig.9366. Thus, even though the required rotational shift is variable, the plug box 466 can be automatically indexed to the next plug 476. 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 shifting assembly can be included in place of the biasing assembly 652. In such an example, the control system 15 can track the number of plugs 476 dispensed from the box 466 and use this count to ensure that the motorized shifting assembly drives the rotor 656 an amount sufficient to advance the next plug 476 to the outlet port 668.

[0391] Reference now Fig.94 , shows an exploded view of another plug box 466. As shown, the plug box 466 can include a box body 670. The box body 670 can include a groove 672. The groove 672 can receive the stem or smaller diameter portion of each plug 476. Thus, when the plug 476 is directed toward the outlet port 690 of the plug box 466 (see, for example, Fig.95 ) when the plug box 466 is displaced, the groove portion 672 can serve as a guide for these plugs 476. The groove portion 672 can be flanked on each side by a ledge 676, and the step area 512 of the plug 476 can rest on the ledge. In an example embodiment, the plug box 466 can also include two plates 674, which can be attached to the box body 670 on opposite sides of the groove 672. The plates 674 can be partially suspended on the groove 672. The suspended portions of these plates 674 can ensure that the plugs 476 do not fall out of the plug box 466 during shipping or when handling the plug box 466. In addition, the outlet port 690 can be at least partially surrounded by a guide wall 678. The guide wall 678 can be positioned in front of the outlet port 690 to prevent the plug 476 from advancing beyond the outlet port 690. The guide wall 64 may also have a guide surface 680 having a curvature that helps position the head of the plug 476 in alignment with the outlet port 690 .

[0392] Now also refer to Fig.95 and Fig.96 , the plug box 466 may also include a follower assembly 682. The follower assembly 682 may include a follower block 684, which includes a follower 686. The follower 686 may include a plug contact surface having an arcuate shape that supports the head or larger diameter portion of the plug 476. A biasing member 688 may also be included in the follower assembly 682. In the example embodiment, the biasing member 688 is shown as a constant force spring mounted to a mounting block 692, where the mounting block is attached to the follower block 684. As shown in FIG. Fig.94 As best shown, the box body 670 may include a routing channel 694 that allows the end of the constant force spring to be fed through the box body 670 to a mounting point on the exterior face of the guide wall 678. For example, Fig.95 As shown, the end of the constant force spring can be connected to the outer face of the guide wall via a fastener 696. When the plug 476 is dispensed from the outlet port 690 of the box body 670, the biasing member 688 can exert a force on the follower block 684, which causes the follower block 684, the follower 686 and any remaining plugs 476 in the plug box 466 to shift toward the outlet port 690. This can advance the next plug 476 to align with the outlet port 690. The follower assembly 682 in the example embodiment also includes two guide rails 698. The guide rails 698 can extend parallel to each other on opposite sides of the groove portion 672. These guide rails 698 can extend through the follower block 684 and guide the displacement of the follower block 684 when dispensing the plug 476 from the plug box 466. As in other plug box 466 embodiments, a mating pin 492 can be included to facilitate installation and detection of the plug box 466 in the box receiver 473.

[0393] Reference now Figure 97 to Figure 99 , depicts another exemplary plug box 466. As shown, the plug box 466 is similar to Fig.74A The plug box shown, however, includes slots 700 extending through the bottom of each plug groove 510. These slots 700 can allow the plug box 466 to be loaded with a quick loader 702. The quick loader 702 can include a plate 704 having a plug rack 706 that can hold a plurality of plugs 476. The plug rack 706 can define the spacing of the plugs 476 on the quick loader 702. In an exemplary embodiment, when the plugs 476 are placed into the plug rack 706, the plugs 476 can be arranged in a staggered double-column configuration suitable for the plug box 466. The quick loader 702 can provide cleanliness and sterility within the outer packaging. The user can keep an inventory of the quick loader 702 in the front chamber of the system 10, and the plug box 466 can remain in place or can be integrated into the sealing station 358. The speed loader 702 may be opened and used to refill the plug cartridge 466 during the bag 26 sealing operation, as desired.

[0394] Now the main reference Figure 98 to Figure 99 To load the plug 476 into the plug box 466, the speed loader 702 may be positioned to align with the opening in the plug box 466 and introduced into the plug box 466. Fig.74AAs shown, the box may include a divider wall 488 that may separate and partially define each groove 510. The plug box 466 may also include a ridge 490 flanking each groove 510. The divider wall 488 and the ridge 490 may be at the same height as each other. The height may be selected so that the step area 512 on the plug 476 may allow the plug 476 to snap onto the top surface of the ridge 490 and the divider wall 488, thereby allowing each plug 476 to be suspended in its corresponding plug groove 510. The plate 704 of the speed loader 702 may include a slit 708 that may allow the divider 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 top surface of the divider wall 488 may begin to support the plug 476. At this time, the plate 704 may be displaced relative to the plug 476. The plate 704 can continue to be lowered until the plug housing 706 portion of the plate 704 passes through the slot 700 in the plug channel 510 and the plug 476 is completely separated from the housing 706. The plate 704 can then be discarded and the follower assembly (e.g., Fig.72 The follower assembly 470 of the plug box 466 is displaced to come into contact with the plug 476, thereby allowing the plug 476 in the plug box 466 to be automatically advanced when the plug is dispensed from the plug box 466.

[0395] Reference now Fig.100 , depicting an exemplary quarantine storage vault 362. As shown, the quarantine storage vault 362 may include a plurality of racks 518. In the exemplary embodiment, two racks 518 are shown. In other embodiments, a greater number of racks 518 or only a single rack 518 may be included. Each rack 518 may include a plurality of racks 520 that may support filled and sealed bags 26. The racks may be storage hangers that may suspend filled bags 26. Fig.100 Only one bag 26 is depicted in place on a bracket 520. In the exemplary embodiment, 17 brackets 520 are included on each rack 518. Other embodiments may include a fewer number of brackets 520 on each rack 520, or may include a greater number of brackets on each rack 520.

[0396] Fig.101An example bracket 520 is depicted. The bracket 520 can include a set of arms 522. Each arm 522 can be substantially a mirror image of the other. As shown, the arms 522 each include a ledge 524 that is recessed relative to the top surface 526 of the arm 522. As shown, each ledge 524 also includes a set of recesses 528. The recesses 528 can be spaced apart from each other by a distance that is equal to the spacing of the ports 392 of the bag 26. Each arm 522 also includes a ramp 530 at the end of the arm 522, which is farthest from the mounting portion of the arm 522 to the rack 518. The ramp 530 can be used as a guide that helps guide the bag 26 into the small gap that may exist between each arm 522. The robotic arm 360 can advance the bag 26 to each bracket 520. As the bag 26 is displaced into the bracket 520, the two arms 522 can be elastically opened to help receive the bag 26. The bag 26 can be guided into the bracket 520 so that the port 392 rests in a recess 528 in each arm 522. Since the diameter of the port 392 is larger than the gap between the arms 522, the bag 26 may not be able to slide through the bracket 520. Therefore, 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 contacting any sharp surfaces.

[0397] Reference now Fig.102 In some embodiments, the quarantine storage 362 can be completely filled with bags 26. In other embodiments, the quarantine storage 362 can store bags 26 in a manner that depends on the type of bag 26 used. For example, when bags 26 filled to a volume greater than a certain predetermined volume are being generated, the control system 15 can command the robotic arm 360 to place bags 26 every other rack 520. This can alleviate the possibility of the quarantine storage becoming overcrowded and making it problematic to suspend additional bags 26. In the case of generating bags 26 filled to a volume less than a predetermined volume, each rack 520 can be filled with a filled bag 26.

[0398] Now also refer to Fig.103 and Fig.104, when one or more tests are completed, the bag 26 can remain in the quarantine storage 362. In some embodiments, a test for monitoring pyrogens can be performed before the bag 26 is released from the quarantine storage 362. For example, the control system 15 can generate a notification of the test expiration on its user interface. The user can place the vial 532 in the sampling fixture 534, and then the sampling fixture 534 can be advanced to the second part 98 of the housing 12 via the vial access door 380. The vial 532 can be processed in a depyrogenation oven before use and can be set in an outer package 60 that is opened only in the front chamber of the housing 12. The sampling fixture 534 may include a cup-shaped portion 536, in which the vial 532 can be placed. In order to introduce the vial 532 into the second part 98 of the housing 12, the vial access door 380 can be opened so that the user can access the receptacle 542 attached to the vial access door 380 on one side of the second part 98 facing the housing 12. The sampling fixture 534 may dock into the receptacle 542 and the vial access door 380 may be closed again.

[0399] The sampling fixture 534 can have a branch 538 that includes an expanded portion 540. The expanded portion 540 can be shaped to mimic the size of the port 392 of the bag 26. This can allow the gripper 418 on the robotic arm 360 to collect the sampling fixture 534 and shift it around the second portion 98 of the housing 12. The robotic arm 360 can shift the sampling fixture 534 and the vial 532 to the filling station 356, and the control system 15 can command an aliquot of the fluid to be dispensed into the vial 532. The robotic arm 360 can then return the sampling fixture 534 and the vial 532 to the receptacle 542 of the vial access door 380. The vial access door 380 can be opened again by the user and the vial 532 can be removed and installed in a pyrogen testing device (such as an endotoxin monitor).

[0400] Typically, the bags 26 can remain in the quarantine repository 362 until at least the first pyrogen test and the second pyrogen test are completed and indicate that the pyrogen content is below a predetermined amount (e.g., some predetermined EU / mL threshold). The first pyrogen test can be a pyrogen test for a fluid sample collected before any bag 26 currently located in the quarantine repository 362 has been filled. The second test can be a pyrogen test for a fluid sample collected after all bags 26 in the quarantine repository 362 have been filled. In some embodiments, this second test can double as the first test for the next set of bags 26 to be filled by the system 10. In some embodiments, additional pyrogen tests can be performed.

[0401] In an alternative embodiment, a pyrogen test may be performed after each rack 518 of the quarantine repository 362 is filled to capacity. This may be desirable because a pyrogen test may take some time (e.g., about 15 minutes) to complete. This may allow the system 10 to continue filling bags 26 while the pyrogen test is completed. One rack 518 may be tested while a second rack 518 is being filled. By the time the second rack 518 is filled with bags 26, the pyrogen test of the first rack 518 may have been completed and the bags 26 may be ready for labeling and distribution from the system 10. This can help improve the efficiency of the system 10 because there may be no downtime when completing the pyrogen test, in which the filling of bags 26 must be stopped to free up space in the quarantine repository 362.

[0402] Reference now Figures 105 to 107 Before the bags 26 are dispensed from the system 10 , the bags 26 may be labeled. Fig.105 An example labeler 366 is depicted. The labeler 366 can generate labels that can be adhered to each bag 26 by an adhesive. In some embodiments, the labeler 366 can be a thermal transfer ribbon type labeler. As shown, the labeler 366 can include a housing 550 that can enclose a supply of blank labels and various printing components of the labeler 366. The labeler 366 can also include one or more rollers 552. The robotic arm 360 (for ease of illustration, not shown in FIG. 5 ) can be used to move the labeler 366 to a desired location. Fig.105 The bag 26 may be moved to the labeling machine 366, for example, where many bags 26 in the quarantine storage 362 have been tested. The bag 26 may be pulled over a plate 554 that includes a feed slot through which the label 556 extends. The label 556 may be adhered to the surface of the bag 26 and the bag 26 may be pulled over the rollers 552. As the bag 26 is moved over the rollers 552, the weight of the bag 26 and its contents may help securely couple the label 556 to the bag 26.

[0403] A tag sensor 557 may be included (see Fig.56 ) to monitor the presence of the label 556. The control system 15 can receive the output signal from the label sensor 557 and analyze the signal to determine whether the label 556 is applied to the bag 26. In addition, the control system 15 can analyze the signal to ensure that the label 556 is present before the bag 26 is shifted to the labeling machine 336 to apply the label 556. Therefore, the control system 15 can analyze the label sensor 557 to determine whether the label supply in the labeling machine 366 is empty or if there is an error condition. The control system 15 can generate a notification that the label supply is empty or a labeling error based on the data received from the label sensor 557.

[0404] Once labeled, and now referred to Figures 108 to 110, the robotic arm 360 can move the bag 26 to the outlet of the housing 12. Figures 108 to 110 In the example shown, the exit is shown as a chute 560. The chute 560 may include a top opening covered by a door wing 562. In addition, the chute 560 may include a funnel arm 564 that can help guide the bag 26 into the chute 560 when the bag 26 is lowered by the gripper 418 of the robotic arm 360. When the bag 26 falls into the chute 560, the door wing 562 can be rotated away by the weight of the bag 26. A biasing member (such as a torsion spring) may be included to return the door wing 562 to a closed orientation. Fig.109 and Fig.110 As best shown, the door wing 562 can be attached to the sensing protrusion. As the door wing 562 shifts, the sensing protrusion 566 can shift to allow 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 interruption sensor or a reflection-based sensor. The door sensor 568 can alternatively be a magnetic-based sensor, such as a Hall effect sensor. In such an embodiment, the door wing 562 can include a magnet. In some examples, a microswitch or button can also be used, which is mechanically actuated by the displacement of the sensing protrusion 566 when the door wing 562 shifts. An encoder can monitor the displacement of the pivot pin on which the door wing 562 is mounted. Other types of sensing devices are also possible. As the bag 26 travels along the chute 560, the bag 26 can push open the exit wing 570 as it is transported out of the housing 12. As shown Fig.110 As shown, the outlet flap 570 may be a rigid hinged door or may be a flexible sheet of material.

[0405] The control system 15 of the system 10 can 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 the bag 26 into the chute 360, the control system 15 can check to ensure that the door sensor 568 records that the door wing 562 has been opened. The control system 15 can also check to ensure that the door sensor 568 indicates that the door wing 562 has returned to a closed state. In the event that the door sensor 568 does not indicate that the door wing 562 has been opened when the bag 26 is released, the control system 15 can generate a notification or alarm on the user interface of the system 10. The control system 15 can also generate a notification if the door wing 562 is not closed. For example, the notification can instruct the user to check if there are any items blocking the exit wing 570 and to back up the bag 26 in the chute 560.

[0406] In the event that the bag 26 is deemed unacceptable, the bag 26 may be dispensed from the housing 12 without the label 556. For example, in the event that the bag 26 is in the quarantine storage 362, the bag 26 may be removed from the quarantine storage 362 and dispensed without the label 556. During the filling of the bag 26 at the filling station 356, when the composition sensor indicates that the fluid filled into the bag 26 does not meet the predetermined target composition range, the bag 26 may be sealed and dispensed from the housing 12 outlet. The label 556 may not be applied. In an alternative embodiment, a label 556 may be generated from the bag 26 that clearly indicates that the bag 26 is not to be used. For example, a label 556 labeled "Not for Human Use" or the like may be generated and applied to the bag 26 prior to dispensing.

[0407] Reference now Fig.111 , depicts another exemplary system 10 for producing and packaging medical fluids. As shown, the system 10 may include a medical water production device 14, such as any of those described herein. The system 10 may also include a mixing circuit 348 for generating a specified solution (e.g., 0.9% saline). The system 10 may include a sensor kit 350 that can monitor the quality of purified water produced by the medical water production device 14 and can monitor the solution generated by the mixing circuit 348. The sensor kit 350 may include any number of different types of water quality sensors. Any water quality sensor described herein may be included. Example mixing circuit 348 and example sensor kit 350 will be described later in the specification.

[0408] The system 10 also includes an enclosure 12. The enclosure 12 can provide a clean room environment for the components of the system 10 contained therein. The enclosure 12 itself can also be contained in a clean room environment. In such an embodiment, the enclosure 12 can be maintained at a higher clean room standard than the room in which it is located. In some embodiments, the enclosure 12 can be maintained under positive pressure by a blower system 600.

[0409] In an exemplary embodiment, the housing 12 is divided into a first portion 96 and a second portion 98. Each of these portions can be maintained at a slightly different positive pressure. For example, the first portion 96 can be maintained at a first pressure that is positive relative to the surrounding environment. The second portion 98 can be maintained at a pressure higher than the first pressure. The filling of the bag 26 can occur in the most strictly controlled environment of the system 10. Various filters, such as HEPA filters, can be included to help ensure that any air blown into the housing 12 to maintain the positive pressure is clean.

[0410] Now also refer to Fig.112, the first portion 96 may be a front chamber that may be used to prepare various consumables for use by the system 10. For example, a batch of bags 26 may be placed in the front chamber. A plug box 466 (such as any box described herein) may also be stored in the front chamber. A sampling vial 532 (e.g., see Fig.103 ) can also be kept stored in the front chamber. This can help minimize the need to access the interior of the housing 12 during operation of the system 10. The first portion 96 can also include some testing equipment that can be used to verify that the bag 26 has been filled according to predetermined standards. Sampling ports in the fluid circuit can also be accessed via the front chamber.

[0411] The second portion 98 can be constructed as a glove box type enclosure with a glove interface 352, which can be used to manipulate certain components of the system 10 within the enclosure 12. The second portion 98 may include a filling subsystem 610 of the system. The filling subsystem 610 may include a bag holder 602, a filling station 356, and a sealing station 358. The bag 26 can be collected from the front chamber via the glove interface 352 through a door 604 between the first portion 96 and the second portion 98 of the enclosure 12. The bag 26 can be placed at the bag holder 602. A robotic manipulator 606 including a gripper can collect the bag 26 from the bag holder 602 and move the bag 26 to the filling station 356. A fluid can be dispensed into the bag 26 at the filling station 356. The fluid can be purified water (e.g., WFI water), or in a manner similar to that described with respect to Figure 2A and Figure 2B The fluid mixture generated at the mixing subsystems described above. For example, the bag 26 may also include the above FIG. 5A to FIG. 6 The robotic manipulator 606 can move the filled bag 26 from the filling station 356 to the sealing station 358. The entrance to the interior volume of the bag 26 can be sealed closed at the sealing station 358 (e.g., via a plug, RF welding, etc.).

[0412] As shown, the exemplary embodiment includes a bag holder 602 that can hold a single bag 26 at a time. In an alternative embodiment, the bag holder 602 can be made of a bag similar to that described above with respect to Figure 59 to Figure 65 The bag feeder 354 described above is replaced. Similarly, Fig.58 The bag feeder 354 shown in the example system 10 of FIG. 1 may be replaced by a bag holder 602. The bag holder 602 may be useful in embodiments of the system 10 where only a small number of bags 26 need to be produced or where a smaller footprint may be desired. The bag holder 602 may further be useful in situations where the type of bags 26 filled by the system 10 changes frequently.

[0413] Reference now Figures 113 to 114B, the bag holder 602 may include a buckle 612 pivotally attached to a base plate 614. The buckle 612 may be opened and the user may hold the bag 26 in place at the bag holder 302 via the glove interface 352. The buckle 612 may then be closed against the base plate 614. The buckle 612 may frictionally hold the port 392 of the bag 26. In some embodiments, the buckle 612, the base plate 614, or both the buckle 612 and the base plate 614 may include a receptacle 616 that receives a member 618 included on the port 392 to help hold the bag 26 in place in the bag holder 602. When in the closed position, the buckle 612 may latch in place. Such latching may be achieved via a mechanical latch, or may be achieved via a magnet in one of the base plate 614 and the buckle 612 and a metal and / or magnetic body in the other of the base plate 614 and the buckle 612. The bag holder 602 can also help locate the port 392 of the bag 26 through which the bag 26 will be filled in a fixed and known position. As shown, the bag holder includes a locating pin 615 (see also Fig.116 ). The bag 26 can be loaded into the bag holder 602 so that the locating pin 615 is in place 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 position before the bag 26 is removed.

[0414] Reference now Fig.115 , with the bag 26 in place in the bag holder 602, the control system 15 of the system 10 can displace the robotic manipulator 606 to the bag holder 602. In an example embodiment, the robotic manipulator 606 is capable of displacing about multiple axes. In an example embodiment, a first rail 622 is included, wherein the first rail 622 defines a first axis along which the robotic manipulator 606 can be displaced. The robotic manipulator 606 can include a gripper 620 that can be closed around the port 392 of the bag 26 to grasp the bag 26. The gripper 620 can be included on a second rail 624, wherein the second rail 624 defines a second axis along which the gripper 620 of the robotic manipulator 606 can be displaced. In an example embodiment, the second axis is substantially perpendicular to the first axis.

[0415] like Fig.116 As shown, once the bag 26 has been grasped, the robotic manipulator 606 can move the gripper 620 downward along the second guide rail 624 to pull the bag 26 away from the bag holder 602. In some embodiments, the downward force applied by the robotic manipulator 606 causes the buckle 612 of the bag holder 602 to open. In other embodiments, the force may not open the buckle 612, but is sufficient to overcome any friction holding the bag 26 in place within the bag holder 602. Fig.117As shown, the robotic manipulator 606 may then be displaced along the first rail 622 to move the bag 26 toward the filling station 356 .

[0416] Reference now Fig.118A Once the robotic manipulator 606 has displaced the bag 26 so that the port 392 of the bag 26 is aligned with the filling nozzle 430, the control system 15 can command the robotic manipulator 606 to raise the gripper 620 toward the filling station 356. In the example shown, the filling nozzle 430 is also displaceable, and the filling nozzle 430 can be displaced toward the port 392 while the gripper 620 of the robotic manipulator 606 is raised. Fig.118A As shown, the filling nozzle 430 can be tapered to help the filling nozzle 430 enter the port 392 of the bag 26. Once the filling nozzle 430 is located in the port 392, the control system 15 can command the filling station 356 to dispense fluid into the bag 26. Fig.118A 356 may include a set of bag characteristic sensors 444A-444C, such as Fig.66 As described elsewhere herein, control system 15 may determine the fill level of bag 26 based on data collected from bag characteristic sensors 444A-444C.

[0417] Reference now Fig.118B , the filling nozzle 430 can be included in a biasing assembly 611 that includes a biasing member 613 that applies a force to the filling nozzle 430 that tends to press the filling nozzle 430 firmly into the port 392 of the bag 26. The biasing assembly 611 can also be included in other filling stations 356 described herein, such as those described with respect to Fig.66 The filling station shown and described. As shown, the filling nozzle 430 is coupled to the inlet fitting 617 (in this example, integrally). In this example, a portion of a conduit 619 connects the inlet fitting 617 and the filling nozzle 430. The conduit 619 may include a flange 621. A housing 623 including a body 627 and an end cap 625 is also shown (see Fig.118A). The end cap 625 may include a passage that allows the filling nozzle 430 to protrude but is too small for the flange 621 to pass through. When the conduit 619 and the biasing member 613 are contained within the housing 623, the biasing member 613 may be loaded between the inner surface of the housing 623 and the flange 621. The port 392 of the bag 26 may press the filling nozzle 430 into the housing 623 against the force applied by the biasing member 613 during filling. The restoring force of the biasing member 613 may thus push the filling nozzle 430 robustly into the port 392. In this example, the biasing member 613 is shown as a compression spring. In alternative embodiments, any suitable biasing member 613 may be used.

[0418] Reference now Figures 119 to 122 , once the bag 26 has been filled, the bag 26 can be lowered away from the filling nozzle 430 by displacing the gripper 620 along the second rail 624. The filling nozzle 430 can also be raised. The robotic manipulator 606 can be displaced along the first rail 622 toward the sealing station 358. The sealing station 358 may include a support bracket 626. The support bracket 626 can help position and hold the port 392 of the bag 26 during the sealing operation. In the example embodiment, the robotic manipulator 606 is displaced so that the bag 26 is slightly moved past the position where the port 392 to be sealed will be aligned with the push rod 464 ( Fig.120 The gripper 620 may be displaced along the second guide rail 624 to raise the bag 26 toward the sealing station 358 ( Fig.121 ). The robotic manipulator 606 can then be shifted to back along the guide rail 622 and bring the port 392 into the support bracket 626. This can guide the port 392 into alignment with the push rod 464.

[0419] Reference now Fig.123 , depicting an example support bracket 626. As shown, the support bracket 626 may include a groove 760. The groove 760 may include a first portion 762A and a second portion 762B. The first portion 762A of the groove 760 may extend to a funnel-shaped opening 764 in the top surface 766 of the support bracket 626. The funnel-shaped opening 764 may help guide the plug 476 into the groove and align it with the axis of the port 392 of the bag 26 to be sealed. The first portion 762A may also be referred to as the plug guide portion of the groove 760 and its size may be designed to surround a majority of the plug 476 so as to guide the plug 476 as the push rod 464 translates the plug 476 into the port 392. The second portion 762B of the groove 760 may position the port 392 during the sealing process. As shown in FIG. Fig.122As shown, the port 392 can be displaced into the groove 760 in a direction substantially perpendicular to the axis of the groove 760. The second portion 762B of the groove 760 can be flanked by a wavy wall 768. When this vertical displacement occurs, the wavy wall 768 can help guide the port 392 into the second portion 762B of the groove 760. The groove 760 of the example support bracket 626 can also include a ledge 770. The ledge 770 can form a stop surface that can catch on the step 516 of the plug 476 when the plug 476 is displaced into the port 392 of the bag 26. Two removal notches 772 flanking the groove 760 above the ledge 770 are also recessed into the support bracket 626. Once the plug 476 is in place in the port 392, these notches 772 can allow the port 392 to be easily displaced out of the support bracket 626.

[0420] Now also refer to Fig.124 To seal the port 392, the control system 15 can command the push rod driver 462 of the sealing station 358 to advance the push rod 464 toward the port 392 of the bag 26 to be sealed. The push rod 464 can drive the plug 476 from the plug box 466 into the port 392 to seal the port 392. As mentioned above, the funnel-shaped opening 764 and the plug guide portion 762A of the support bracket 626 can help ensure that the plug 476 enters the port 392 cleanly. Then, the control system 15 can command the push rod driver 462 to retract the push rod 464 and can actuate the robotic manipulator 606 to remove the bag 26 from the sealing station 358. Fig.125 As shown, the control system 15 may then move the robotic manipulator 606 to a drop position for the bag 26 .

[0421] Reference now Fig.126 , the filling subsystem 610 can include a guide chute 628 that helps guide the bag 26 once the bag is released from the gripper 620. The robotic manipulator 606 can also include a guide plate 630. The guide plate 630 can ensure that the bag 26 is guided onto the guide chute 628 when the bag 26 is released from the gripper 620. Once the bag 26 reaches the bottom of the guide chute 628, the bag 26 can be manually labeled via the glove interface 352 or placed in the quarantine storage 362 while various tests (e.g., the endotoxin test described above) are completed.

[0422] Reference now Figure 127 to Figure 128In some embodiments, the system 10 can fill multiple bags 26 in parallel at the same time. These bags 26 can be arranged in a package 1082 within the carrier 1080. The carrier 1080 may include a plurality of compartments 1084 in which the package 1082 can be kept. In an exemplary embodiment, the carrier 1080 includes six compartments 1084 and holds six packages 1082. In other embodiments, the number of compartments 1084 may be different. Preferably, the number of compartments 1084 may be selected so that the user can comfortably transport the carrier 1080 when all bags 26 in the carrier are filled. Different carriers 1080 for bags 26 of different volumes may be provided with a carrier 1080 for smaller volume bags 26 with a greater number of compartments 1084. The carrier 1080 may be composed, for example, of a plastic sheet or a medical grade wax paper product. Such a material may be preferred, wherein the carrier or package 1082 may be filled within the housing 12, such as those described elsewhere herein. In other embodiments, card stock may be used. The carrier 1080 may include a handle 1087 that may facilitate carrying by a user or grasping by the gripper 418 of the robotic arm 360 .

[0423] Now the main reference Fig.129 and Fig.130 , each packaging package 1082 may include a cover wing 1086. The cover wing 1086 may include a passage 1088 through which the fill line 1090 may extend. The cover wing 1086 may be secured to a pocket portion 1092 of the packaging package 1082. The bag portion 26 may be disposed in the pocket portion 1092. The pocket portion 1092 may be expandable to accommodate the increase in volume of the bag 26 as the bag 26 is filled. For example, the sidewalls of the pocket portion may include a bellows feature. Fig.130 , the packaging package 1082 is removed to reveal the exemplary bag 26. In the exemplary embodiment, when the cover flap 1086 is in the closed position, a portion of the hook and loop strap 1096 can be used to couple the cover flap 1086 to the pocket portion 1092. Any other suitable coupling can be used. When held to the pocket portion 1092, the cover flap 1086 can hold the dosing kit 1094 attached to the bag 26 in place with the packaging package 1082. The sliding clamp 1098, roller clamp 1100, other blocking devices can be placed on the pipeline of the dosing kit 1094 in a blocked state to prevent fluid from flowing through the dosing kit 1094 when the bag 26 is filled. Alternatively, the dosing kit 1094 can include a frangible that prevents fluid from flowing through the frangible until it is 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.

[0424] Reference now Fig.131 and Fig.132 Each fill line 1090 extending from the packaging package 1082 can be coupled to a pointed adapter 1102. Fig.132 As best shown, the pointed adapter 1102 may include a plurality of radial recesses 1104. These recesses 1104 may be recessed into the outer sidewall of the pointed adapter 1102. The number of recesses 1104 may be equal to the number of packages 1082 held by the carrier 1080. The size of the recesses 1104 may be designed to receive and hold the ends of the filling lines 1090 leading to each bag 26. The size of the opening of the recess may be designed to be smaller than the outer diameter of the filling lines 1090. Therefore, the filling lines 1090 may be deformed when they are inserted into the recesses 1104 and once contained therein, they may resist accidental removal. The pointed adapter 1102 may also include a plurality of protrusions 1106. These protrusions 1106 may facilitate grasping by a robot gripper 418 or by a user's hand. These recesses 1104 are spaced apart from each other at regular angular intervals on each side of the protrusions 1106. As shown, the ends of the filling lines 1090 may include sealing members 1108. Sealing member 1108 can be a septum that can be pierced to access the lumen of fill line 1090 and can self-seal once the piercing member is withdrawn. As shown, radial recess 1104 of pointed adapter 1102 can ensure that fill line 1090 is straight immediately upstream of sealing member 1108.

[0425] Reference now Fig.133A and Figures 134 to 136 , depicts multiple views of an example filling station 1110 that can receive a pointed adapter 1102 to fill a bag 26. Fig.133A 11. An illustrated example of a filling station 1110 is shown in FIG. As shown, the filling station 1110 may include a source 1112. The source 1112 may be in communication with a recirculation valve 1114 and an inlet valve 1116. The inlet valve 1116 may gate a flow to a fluid pump 1118, which may be a diaphragm pump in some examples. The fluid pump 1118 may deliver fluid from the source to a heater 1120, which may be an in-line heater. An air pump 1122 may also be piped into a line from the fluid pump 1118 to the heater 1120. A check valve 1123 may be included to ensure that the liquid does not flow back into the air pump 1122. The fluid may flow from the heater 1120 to a manifold 1124. The manifold 1124 may divide the flow into many different flow paths leading to a spike port 1126. The spike port 1126 may also be connected to the recirculation valve 1114.

[0426] Fluid flowing out of source 1112 can be routed to tip port 1126 to be delivered to fill line 1090 of bag 26 disposed in tip adapter 1102. After completing the filling operation, cover 1130 of tip port 1126 can be sealed closed and fluid entering filling station 1110 can be recirculated while being heated by heater 1120. Heater 1120 can maintain the temperature of the recirculating fluid within a predetermined temperature set point range. Control system 15 of system 10 can continue to recirculate water within filling station 1110 for a period of time sufficient to cause disinfection at a predetermined temperature set point. The water can then be transferred to discharge destination 1128 through inlet valve 1116. In some embodiments, heater 1120 can maintain the fluid at a temperature of 75-80°C or higher during disinfection. Therefore, each time a connection is made to tip port 1126, tip port 1126 may have been freshly disinfected.

[0427] In an alternative embodiment, reference is now made to Fig.133B , the example filling station 1110 may include a source 1112 that is in direct communication with an inlet valve 1116 that may double as a recirculation valve. The spike port 1126 may include a connection that may allow the fluid to recirculate through the spike port 1126 as described above, or may allow the fluid to flow through a drain port 1128. During sterilization, the fluid may be directed through a heater 1120 and heated to a range of temperature set points. The water may travel to a drain port 1128 via a drain valve 1115 without being recirculated.

[0428] Now also refer to Fig.137, depicts a top view of an example spike port 1126. As shown, the spike port 1126 can include a cup-shaped 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 spike adapter 1102. As shown, the spike port 1126 can include an alignment channel 1136. The alignment channel 1136 can receive the protrusion 1106 of the spike adapter 1102. The protrusion 1106 on the spike adapter 1102 can be positioned so that when they are within the alignment channel 1136, the sealing member 1108 of the fill line 1090 can be aligned with the corresponding spike 1134 in the recess 1132. Other keying elements can also be used to help ensure proper alignment. Pressing the pointed adapter 1102 into the recess 1132 can cause each spike 1134 to penetrate the corresponding sealing member 1108 so that fluid can be delivered to the bag 26 through the filling line 1090. Since the radial recess 1104 of the pointed adapter 1102 ensures that the filling line 1090 immediately upstream of each sealing member 1108 is straight, the spike 1134 can be prevented from piercing the side wall of the filling line 1090. Before pressing the pointed adapter 1102 into the recess 1132, the pointed adapter 1102 and the sealing member 1108 can be wiped with a disinfectant. For example, 70% isopropyl alcohol can be used. In addition, the cover 1130 of the spike port 1126 can remain closed until just before the connection is made. The cover 1130 can also be cleaned with a disinfectant before opening. The materials used to construct fill conduit 1090 , sealing member 1108 , tip adapter 1102 , and tip port 1126 may be selected to be suitable for the sterilant used and the temperatures present during sterilization of fill station 1110 .

[0429] As shown, the spike port 1126 may include a gasket member 1136 surrounding the recess 1132. The gasket member 1136 may form a seal against the lid 1130 when the lid 1130 is in a closed position over the recess 1132. In some embodiments, a latch (not shown) may be included to maintain the lid 1130 in a closed orientation and ensure that a small amount of pressure is applied between the lid 1130 and the gasket member 1136 and prevent the spike port 1126 from accidentally opening. Fig.137 1130. The recirculation port 1138 can allow fluid pumped into the recess 1132 via the tip 1134 to be removed from the tip port 1126 and circulated back through the heater 1120 when the cap 1130 is closed. This can help ensure that the fluid in the tip port 1126 remains at a desired temperature during the sterilization process. In some embodiments, both the recirculation port 1138 and a drain port (not shown) can be included in the tip port 1126.

[0430] Reference now Fig.138 , depicts a schematic diagram of an example fluid circuit 710 that can be used with any of the systems 10 described herein. The mixing circuit 348 and the sensor assembly 350 (e.g., Fig.56 and Fig.111 Those mentioned) can be included in the fluid circuit 710. As shown, the fluid circuit 710 can extract water from the water source 16. The water source 16 can be any water source described herein. In certain embodiments, the fluid from the water source 16 can be subjected to any of a variety of pre-treatment operations. For example, filtering or chemical treatment can be performed before the water travels to the medical water production device 14. In the example fluid circuit 710, the fluid from the water source 16 can pass through a softener 712. After passing through the softener 712, the fluid can be filtered by one or more carbon filters 714 (for example, two identical carbon filters in series). In some examples, a coarse filter or a sediment filter can be included in the upstream of the carbon filter 714. The filtered water flowing out of the one or more carbon filters 714 can then be filtered by a reverse osmosis assembly 716. Depending on the water source 16, one or more of the softener 712, the carbon filter 714 and the reverse osmosis assembly 716 can be optional or can be omitted.

[0431] In the example fluid loop 710, the fluid can travel from the reverse osmosis component 716 to the temperature regulator 718. The temperature regulator 718 may include at least one of a cooler and a heater. For some applications, the temperature regulator 718 can be omitted. In the case where a temperature sensor (not shown) upstream of the temperature regulator 718 indicates that the inlet water temperature is higher than a predetermined threshold, the temperature regulator 718 can reduce the temperature of the inlet water or can operate to reduce the temperature of the inlet water. In some examples, when the inlet water temperature is lower than a predetermined threshold, the temperature regulator 718 can be bypassed. The inlet water can then flow to the medical water production device 14. The medical water production device 14 can be any of those described herein. For example, the medical water production device 14 can be a vapor compression distillation device, which is some example.

[0432] In an 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 loop. As shown, the fluid traveling from the medical water production device 14 can be tested for one or more characteristics of concern. In an exemplary embodiment, two conductivity sensors 722A, 722B 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, 722B to ensure that the water is suitable for the intended application. For example, the control system 15 can check to ensure that the conductivity of the water is within the allowable range of injection grade water (WFI). The acceptability threshold of the conductivity sensors 722A, 722B (or other sensors in the fluid circuit 710) can be defined in pharmacopoeia standards or water monographs. In some examples, the conductivity sensors 722A, 722B can be selected to have high resolution, accuracy and reliability under low conductivity values. In certain embodiments, an ultrapure water conductivity sensor optimized for sensing low conductivity fluids may be used. Fluid circuit 710 may also include a total organic carbon (TOC) monitor 724. In the example embodiment, TOC monitor 724 is shown as receiving a slipstream of fluid that then flows to drain 726. In other embodiments, the TOC monitor may be on-line and may not be on the slipstream.

[0433] After the initial sensing, the fluid can travel to the inlet pressure sensor 728. The inlet pressure sensor 728 may include at least one pressure sensor that can sense the pressure of the incoming water. In some embodiments, the inlet pressure sensor 728 can be paired with a sampling port or diaphragm, from which fluid can be extracted from the fluid circuit 710 for testing. Water can flow from the inlet pressure sensor 728 to the transfer manifold 730. In the case where the water production at the medical water production device 14 exceeds the current system 10 demand, the transfer manifold 730 can allow the system 10 to transfer water to the discharge port 726. In addition, the transfer manifold 730 can allow the measured water exceeding the predefined sensing threshold to be directed to the discharge port 726. The water leaving the transfer manifold 730 can flow to the pump 732, which can be operated to adjust the pressure of the water if necessary. 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 whether the inlet pressure is a positive pressure or a positive pressure exceeding a certain threshold before running the pump 732. This can ensure that the pump 732 has water to pump before power is supplied to the pump 732. The water can proceed from the pump 732 to the inlet manifold 734. In some embodiments, the pump 732 can include a bypass that allows fluid to be recirculated to the pump 732 if the pressure downstream of the pump 732 is at a desired value. The inlet manifold 734 can include an additional conductivity sensor 736 that can again check whether the conductivity of the water is within predetermined limits. A pressure sensor 738 can also be included in the inlet manifold 734 and can 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 a diaphragm.

[0434] Water can travel from the inlet manifold 734 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 supports generating. In certain embodiments, a flow path can be included for each component 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.

[0435] With regard to the saline flow path, in an example embodiment, the mixing circuit 348 may include a crystal component container 740. The crystal component container 740 may be filled with sodium chloride. Other crystal components (e.g., sugars for producing D5NS or dialysate) may be used in other embodiments. The fluid may enter the crystal component container and pass through the sodium chloride contained therein to dissolve a certain amount of sodium chloride. In various examples, the fluid leaving the crystal component container 740 may be saturated or nearly saturated. In some embodiments, the crystal component container may also be used as a reservoir 740, which may hold a certain amount of solution therein. This may allow the system 10 to easily adapt to periods of high fluid demand. The fluid leaving the crystal component container 740 may then pass through at least one filter. For example, a coarse filter may be included to help ensure that granular components do not leave the crystal component container 740. In this example, an ultrafilter 742 is also shown downstream of the crystal component container 740. At least one conductivity sensor 744 may collect data on the concentration of sodium chloride in the fluid leaving the ultrafilter 742.

[0436] As shown, fluid exiting the inlet manifold 734 may also flow along Fig.138 The second WFI water flow path in the saline flow path can flow. The second path can include a second ultrafilter 746. The saline and water from the second path can be combined in a mixing manifold 748. In order to generate a solution of appropriate concentration, flow controllers 750A, 750B can be included in the fluid circuit 710. Flow controllers 750A, 750B can measure the amount 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 that can be executed via commands to the flow controllers 750A, 750B. Therefore, the control system 15 can combine 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 mixing manifold 748 can be replaced by a mixing tank that can maintain a certain amount of fluid to help accommodate periods of increased demand.

[0437] The fluid may exit the mixing manifold 748 and travel along a tortuous and / or relatively long flow path to promote mixing. The fluid may then pass through a set of redundant conductivity sensors 752A, 752B. These conductivity sensors 752A, 752B may collect data about the conductivity of the solution exiting the mixing loop 348, and the control system 15 may ensure that the conductivity is the same as expected for the solution being generated by the system 10. The solution may travel from the conductivity sensors 752A, 752B to the particle sensor 754 and the dispensing nozzle 756. Fig.138, the particle sensor 754 is shown as being fed from the slipstream, however, in other embodiments, the particular sensor 754 may be in-line and upstream of the dispensing nozzle 756. The control system 15 may monitor the data from the particle counter to check whether the fluid being generated complies with predetermined particle limits. The fluid exiting the particle counter may travel to the discharge port 726. If the fluid is deemed acceptable, the fluid may travel to the dispensing nozzle 756 and may be used to fill the bag 26. Alternatively, if the fluid is found to be unacceptable, the fluid may be dispensed from the dispensing nozzle 756 to the discharge port (e.g., see Fig.71A The discharge inlet 434) may then be followed by a flushing amount of solution.

[0438] Reference now Fig.139 , a flowchart 1300 is shown that details a number of example 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 mass of an ingredient (e.g., sodium chloride) to dispense for the bag 26. The mass may be the mass required to generate a solution with a desired percentage of the ingredient per unit volume (e.g., 0.9% saline). In block 1304, a set of bag characteristic sensors 444A-444C (e.g., see Fig.66 ) collect bag 26 information. In box 1306, the first dispensing stage can be started. In this stage, the fluid delivered to the bag 26 can be completely or mainly ingredient concentrate. The mass of the ingredient dispensed into the bag 26 can be tracked by the degree from at least one conductivity sensor and a flow meter or flow controller. Once the required mass of the ingredient is dispensed into the bag 26 in box 1308, the second dispensing stage can be started in box 1310. In the second stage, WFI can be dispensed into the bag 26. The amount of WFI dispensed can be tracked by a flow meter or flow controller. Once the amount of WFI required to generate the desired solution has been dispensed in box 1312, the dispensing can be stopped in box 1314. Also in box 1314, the bag 26 can be collected from the filling station 356. By delivering the ingredient in the first stage, the second stage can be used as a flush of the pipeline leading to the filling nozzle. This can ensure that substantially all of the ingredient concentrate in the pipeline is dispensed into the bag 26. Thus, the control system 15 may not have to consider the holdup in the line when attempting to pump the ingredient concentrate to produce a fluid having a desired concentration. In addition, after a bag 26 has been filled, a subsequent bag 26 may be filled with a different type of solution or may be filled with a solution of a different concentration. This may be accomplished without waste and ingredient concentrate in the fluid purge in the line between bags 26.

[0439] Reference now Fig.140In some embodiments, a crystallization component container 740 through which fluid flows may not be included. Instead, a crystallization component distributor 780 may be used. As shown, the fluid may leave the inlet manifold 734 and travel to a metering manifold 784. The metering manifold 784 may also be in communication with the crystallization component distributor 780. The crystallization component distributor 780 may distribute the crystallization component into the metering manifold 784 via a distribution assembly 787. A motor 785 may be included to drive the distribution assembly 878. The fluid may flow from the metering manifold 784 to the concentrate reservoir 782. In the case of including a concentrate reservoir 782, at least one conductivity sensor (e.g., conductivity sensor 744) of the component flow path of the mixing circuit 348 may be included in the interior volume of the concentrate reservoir 782 or communicated with the interior volume of the concentrate reservoir.

[0440] Now also refer to Fig.141 , depicting Fig.140784 . As shown, the dosing manifold 784 may include an internal cavity 786. The internal cavity 786 may be communicated with the inlet manifold 734 via a first port 788. The crystal component distributor 780 may be communicated with the internal cavity 786 via a second port 790. The axis of the second port 790 may be arranged to allow the component to be gravity fed from the crystal component distributor 780 into the internal cavity 786. The internal cavity 786 may be configured to generate a specific flow pattern, which may help promote vigorous mixing in the dosing manifold 784. In an example embodiment, the internal cavity 786 includes a baffle 792, which is in line with the axis of the first port 788. The baffle 792 may cause turbulence directly upstream of the second port 790, thereby promoting rapid mixing and dissolution of the crystal component when introduced. The baffle 792 may 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 generate a venturi effect, which can cause the flow of the second port 790 to the internal cavity 786 to be faster than the flow of other places in the internal cavity 786. Therefore, when the ingredients enter the metering manifold 784, it can be suppressed to accumulate at the entry point. In other embodiments, the internal cavity 786 may include a plurality of baffles 792. The internal cavity 786 may also include a funnel area 796 directly located upstream of the outlet 794. The funnel area 796 can promote the generation of eddy currents in the internal cavity 786, which can further help to dissolve the crystalline ingredients distributed from the crystalline ingredient distributor 780. In an exemplary embodiment, a turbulence generator 798 is also arranged in the outflow conduit 800 from the metering manifold 784. The turbulence generator 798 can provide additional assistance, which may help dissolve the crystalline ingredients. In an exemplary embodiment, the turbulence generator 798 is an insert with a spiral route (helicoid flighting), but any insert that can promote mixing can be used. In an alternative embodiment, the outflow conduit 800 from the metering manifold 784 may be a coil of tubing that increases the transit time of the fluid in the outflow conduit 800 as it travels to downstream components in the fluid circuit 710 (eg, the conductivity sensor 744 ).

[0441] Reference now Fig.142 and Fig.143 , depicts an example crystallization component dispenser 780. Fig.143, a portion of the crystallization ingredient dispenser 780 is broken to reveal components of the dispensing assembly 787. As shown, the crystallization ingredient dispenser 780 may include an ingredient storage compartment 802. The storage compartment 802 may have an outlet 804 that can feed into the dispensing assembly 787. In an exemplary embodiment, the dispensing assembly 787 includes a hole 806 in which an auger 808 is arranged. The auger 808 can be attached to a drive shaft 810. The drive shaft 810 can extend to the motor 785, which can be operated to cause the rotation of the auger 808. As the auger 808 rotates, the ingredient can be pushed through the hole 806 toward the outlet 812 of the dispensing assembly 787. The outlet can be connected to the internal volume of the dosing manifold 784 via a second port 790 of the dosing manifold 784. The control system 15 can be based on the conductivity sensor (e.g., Fig.138 Data collected by the conductivity sensor 744) commands the rotation of the auger 808 to produce a solution of the desired concentration.

[0442] Reference now Figures 144 to 146 , depicts another embodiment of an example crystallization component dispenser 780. Again, in Fig.145 , a portion of the crystallization ingredient dispenser 780 is broken to reveal components of the dispensing assembly 787. As shown, the crystallization ingredient dispenser 780 may include an ingredient storage compartment 802. The storage compartment 802 may have an outlet 804 that may be fed into the dispensing assembly 787. In an exemplary embodiment, the dispensing assembly 787 includes an internal void 814 in which a paddle wheel 816 is disposed. The paddle wheel 816 may be attached to a drive shaft 810 that may extend to a motor 785 that may be operated to cause rotation of the paddle wheel 816. The rotation of the paddle wheel 816 may cause a certain amount of ingredient to be propelled from the storage compartment 802 to the outlet 812 of the dispensing assembly 787. The outlet may be connected to the internal volume of the dosing manifold 784 via a second port 790 of the dosing manifold 784. The control system 15 may be based on a flow rate from a conductivity sensor (e.g., Fig.138 Data collected by conductivity sensor 744) commands the rotation of paddle wheel 816 to produce a solution of desired concentration.

[0443] Specific reference Fig.146 , an exemplary paddle wheel 816 is shown separately. As shown, the paddle wheel 816 includes a plurality of circular members 818 arranged orthogonally to each other. Fig.146 Two circular members 818 are shown in FIG. 8 , but other embodiments may include a greater number. In the exemplary embodiment, the two circular members 818 are arranged substantially perpendicular to each other.

[0444] Reference now Fig.147 and Fig.148 , depicts another example allocation component 787. Again, in Fig.148 787. In the embodiment, a portion of the housing 1018 of the assembly 787 is broken to reveal the components of the distribution assembly 787. Although not shown, the distribution assembly 787 can generally be attached to a component storage compartment 802, such as those shown and described above. The storage compartment 802 can be fed into the inlet 1010 of the distribution assembly 787. In an exemplary embodiment, the distribution assembly 787 includes an internal passage 1016, in which the impeller 1012 is arranged. The size of the passage 1016 can be designed so that the impeller 1012 prevents the component from shifting through the passage 1016 when the impeller 1012 does not rotate. The impeller 1012 can be attached to a drive shaft 810, which can extend to the motor 785, which can be operated to cause the rotation of the impeller 1012. The rotation of the impeller 1012 can cause a certain amount of the component to be advanced from the storage compartment 802 to the outlet 1014 of the distribution assembly 787. The outlet 1014 may be in communication with the interior volume of the dosing manifold 784 via the second port 790 of the dosing manifold 784. The control system 15 may be based on the conductivity sensor (e.g., Fig.138 Data collected by conductivity sensor 744) commands the rotation of impeller 1012 to produce a solution of the desired concentration.

[0445] Reference now Fig.149 and Fig.150 In some embodiments, a disk 1020 having a plurality of spaced-apart recesses 1022 may be used in place of the impeller 1012. The recesses 1022 may be evenly spaced around the disk 1020. In an example embodiment, the recesses 1022 are spaced at even angular increments of 72°. The recesses 1022 may be of the same shape. In this example, the recesses 1022 are bowl-shaped. In other embodiments, the recesses 1022 may be oblong (see Fig.151 ) or any other desired shape. When the disk 1020 rotates (the disk 1020 can be coupled to a drive shaft 810 driven by a motor 785, such as similar to Fig.147 ), the recess 1022 can be aligned with the inlet 1024 of the dispensing assembly 787. The ingredient can fill the recess 1022. As the disc 1020 rotates further, the recess 1022 can pass through the inlet 1024 and communicate with the outlet 1026 of the dispensing assembly 787. The ingredient can fall from the recess 1022. The outlet 1014 can communicate with the internal volume of the dosing manifold 784 via the second port 790 of the dosing manifold 784. When aligned above the inlet 1024...

Claims

1. A system for producing and packaging medical fluids near a point of use, comprising: Source input unit; at least one processing device for producing water conforming to a predetermined standard from a fluid received from the source input; a mixing circuit in communication with an output of the at least one processing device and comprising a concentrate source, the mixing circuit being configured to regulate a flow of a fluid through the mixing circuit to produce a fluid having a predetermined composition; a housing comprising a packaging compartment; a reservoir feeder in the housing, the reservoir feeder having a supply of reservoirs to be filled, the reservoir feeder being configured to feed reservoirs in the supply of reservoirs through the reservoir feeder to an outlet portion of the reservoir feeder; a filling station in the packaging compartment, the filling station comprising a filling nozzle coupled to the mixing circuit, and the filling station comprising a reservoir volume sensing assembly and a filling output for dispensing a fluid of the predetermined composition; a discharge port coupled to the conduit, the discharge port being displaceable from a storage position to a receiving position, the fluid dispensed from the fill output being dispensed into the discharge port when the discharge port is in the receiving position; a sealing station in said packaging compartment; a reservoir labeler assembly in said packaging compartment; as well as A reservoir in the packaging compartment has a plurality of reservoir holders configured to hold filled reservoirs in the packaging compartment.

2. The system according to claim 1, wherein: The at least one treatment device includes at least one of a reverse osmosis unit, a plurality of carbon filters, and an ultrafilter.

3. The system according to claim 1, wherein: The concentrate source is a reservoir of crystalline solid concentrate having an inlet in communication with an output of the at least one processing apparatus and having a fluid concentrate outlet.

4. The system according to claim 1, wherein: The housing includes a chamber having at least one glove interface, and the reservoir feeder extends from the chamber to the packaging compartment.

5. The system according to claim 1, wherein: The source input is configured to be coupled to a drinking water supply.

6. The system according to claim 1, wherein: The predetermined standard is a pharmacopoeia standard.

7. The system according to claim 1, wherein: The sealing station is a plugging station including a push rod and a plug dispenser, the sealing station also including a bracket including a plug guide and a portion configured to receive a port of a reservoir.

8. The system according to claim 1, wherein: The system also includes a pyrogen tester.

9. The system according to claim 1, wherein: The system also includes a robotic assembly including a gripper.

10. The system according to claim 9, wherein: The system further includes a control system configured to: displace at least a portion of the robotic assembly and actuate the gripper to collect a reservoir from the supply of reservoirs in the reservoir feeder; displace the reservoir to the filling station; determining a capacity of the reservoir via data from the reservoir volume sensing assembly; commanding filling of the reservoir with an amount of fluid no greater than the capacity of the reservoir; shifting the reservoir to the sealing station; and commanding sealing of said reservoir.

11. The system according to claim 1, wherein: The reservoir volume sensing assembly 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 the control system is configured to determine the capacity of a reservoir in place at the filling station.

12. The system according to claim 11, wherein: The control system is configured to govern the operation of at least one flow controller to deliver a quantity of concentrated fluid containing a concentrate to the reservoir positioned at the filling station, and subsequently deliver a quantity of water meeting the predetermined criteria to the reservoir positioned at the filling station to achieve a fill quantity selected based on the capacity of the reservoir.

13. The system of claim 1, wherein: The system also includes a sensor package including a total organic carbon sensor, a bioburden sensor, a particle monitor, a plurality of ultrapure water conductivity sensors, and a concentrate conductivity sensor.

14. A system for producing and packaging a medical fluid, comprising: Source water input; a water treatment assembly including a water distillation device configured to produce water meeting predetermined quality specifications using water received via the source water input; a mixing circuit coupled to an output of the water treatment assembly and comprising a concentrate source, the mixing circuit comprising a plurality of flow controllers configured to regulate the flow of a fluid through the mixing circuit to produce a fluid having a predetermined composition; a housing comprising a packaging compartment; a reservoir dispenser at least partially within the packaging compartment and configured to receive a plurality of reservoirs; a filling station in the packaging compartment, the filling station comprising an outlet in fluid communication with the mixing circuit; a sealing station in the packaging compartment, the sealing station having a push rod and a sealing member dispenser; a filled reservoir repository in the packaging compartment, the repository having a plurality of reservoir holders; a discharge port coupled to the conduit, the discharge port being displaceable from a storage position to a receiving position, into which fluid dispensed from an outlet of the filling station is dispensed when the discharge port is in the receiving position; as well as A container labeler in said packaging compartment.

15. The system of claim 14, wherein: The water treatment assembly also includes at least one of a reverse osmosis unit, a plurality of carbon filters, an electrodeionization unit, and an ultrafilter.

16. The system of claim 14, wherein: The system also includes a sensor package including a total organic carbon sensor, a bioburden sensor, a particle monitor, a plurality of ultrapure water conductivity sensors, and a concentrate conductivity sensor.

17. The system of claim 14, wherein: The concentrate source is a reservoir of crystal concentrate having an inlet and a fluid concentrate outlet.

18. The system of claim 14, wherein: The source water input is connected to the municipal water supply.

19. The system of claim 14, wherein: The housing further comprises a front chamber, the front chamber and the packaging compartment being separated by a partition, the partition comprising at least one door from the front chamber to the packaging compartment.

20. The system of claim 14, wherein: The system also includes a robotic arm including a gripper.

21. The system of claim 20, wherein: The system also includes a control system configured to: actuate the robotic arm and actuate the gripper to collect a reservoir from a plurality of reservoirs of the reservoir dispenser; shifting the reservoir to the filling station; commanding filling of said reservoir; shifting the reservoir to the sealing station; commanding actuation of the pushrod to drive a sealing member from the sealing member into a port of the reservoir; and translating the reservoir to the labelling machine, and the control system being configured to coordinate application of labels to the reservoir via commands to the labelling machine and the robotic arm.

22. The system of claim 14, wherein: The filling station also includes a set of reservoir characteristic sensors, and the system also includes a control system, which is configured to analyze data received from the reservoir characteristic sensors, and the control system is configured to determine the capacity of the reservoir in place at the filling station based at least in part on the data from the reservoir characteristic sensors.

23. The system of claim 22, wherein: The control system is configured to govern operation of a flow controller of the mixing circuit based on the capacity of the reservoir.

24. The system of claim 23, wherein: The system also includes a robotic arm including a gripper configured to displace the discharge port between the receiving position and the storage position.

25. A system for producing and packaging a fluid, comprising: Source water input; a water treatment assembly, the water treatment assembly comprising a plurality of medical water production devices; a mixing circuit coupled to a product output of the water treatment assembly and including a concentrate source, the mixing circuit having at least one flow controller configured to generate a fluid having a predetermined composition; a housing comprising at least a first portion and a packaging compartment; a reservoir feed assembly extending from the first portion to the packaging compartment and configured to receive a reservoir cassette; a filling station in the packaging compartment, the filling station including a filling nozzle coupled to the mixing circuit and including a reservoir volume sensing assembly, the filling station receiving the fluid having a predetermined composition from the mixing circuit; a discharge port coupled to the conduit, the discharge port being displaceable from a storage position to a receiving position, the fluid dispensed from the filling station being dispensed into the discharge port when the discharge port is in the receiving position; a sealing station in said packaging compartment; a container labeler in said packaging compartment; as well as A plurality of filling reservoir racks are provided for holding filled reservoirs.

26. The system of claim 25, wherein: The medical water production device includes at least an endotoxin removal filter, a water distillation device and a set of redundant carbon filters.

27. The system of claim 25, wherein: The concentrate source is a reservoir of crystalline salt concentrate.

28. The system of claim 25, wherein: The system also includes a sensor package including a total organic carbon sensor, a bioburden sensor, a particle monitor, a plurality of ultrapure water conductivity sensors, and a concentrate conductivity sensor.

29. The system of claim 25, wherein: The first portion of the housing and the packaging compartment are separated by a partition comprising at least one door between the first portion and the packaging compartment.

30. The system of claim 29, wherein: The system also includes a robotic manipulator and a control system configured to: govern actuation of the robotic manipulator to collect a reservoir from the reservoir feed assembly; shift the reservoir to the filling station; determine the capacity of the reservoir via data from the reservoir volume sensing assembly; commanding filling of the reservoir with an amount of fluid no greater than the capacity of the reservoir; shifting the reservoir to the sealing station; and coordinating the sealing of the reservoir.

31. The system of claim 30, wherein: The reservoir volume sensing assembly includes a set of reservoir characteristic sensors, and the control system is configured to govern operation of at least one flow controller based on a capacity of the reservoir, wherein the capacity of the reservoir is determined based on data from the reservoir characteristic sensors.

32. The system of claim 31, wherein: The control system is configured to govern operation of the at least one flow controller to deliver an amount of concentrate to the reservoir via the filling station and subsequently deliver an amount of purified water to the reservoir to achieve a fill amount selected based on a capacity of the reservoir, wherein the capacity of the reservoir is determined based on data from the reservoir characteristic sensor.

33. The system of claim 25, wherein: At least one of the medical water production devices includes a distillation device configured to produce water in a sterilization temperature range and a reservoir fill temperature range.

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