System for producing and encapsulating a fluid, a sealing member dispenser, a reservoir feeding device, a bag sealing device, a reservoir filling kit, a method of filling a reservoir or a

Abstract

A system for producing and encapsulating a fluid, a sealing member dispenser, a reservoir feeding device, a bag sealing device, a reservoir filling kit, a method of filling a reservoir or a bag, a filling and sampling nozzle. A system for producing and encapsulating a fluid may include a water distillation device. The system may also include a mixing circuit and a concentrate source. The mixing loop may include a plurality of flow controllers. The system may also include a housing having a front chamber and an encapsulation compartment. The system may also include a reservoir dispenser in the packaging compartment having a feed plate and a housing block. The reservoir dispenser may include a biasing member to urge the feed plate toward the housing block. The system may also include a filling station in the packaging compartment. The system may also include a sealing station in the packaging compartment. The system may also include a quarantine repository in the encapsulation compartment. 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 an exterior of the housing.

Description

[0001] This application is a divisional application of International Patent Application No. 202080093312.5, filed on September 25, 2020, with the title "Systems for Producing and Encapsulating Fluids, Seal Member Dispensers, Reservoir Feeding Devices, Bag Sealing Devices, Reservoir Filling Kits, Methods for Filling Reservoirs or Bags, Filling and Sampling Nozzles", which entered the Chinese national phase. Statement Regarding Federally Sponsored Research or Development

[0002] This invention was made with government support under Agreement No. HHSO100201900017C awarded by the HHS. The government has certain rights in this invention. Technical Field

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

[0004] Almost every hospitalized patient is given intravenous saline or saline-based solutions. As a result, the amount of saline solution consumed is very large. In the United States alone, more than one billion bags of saline are used each year. Despite such demand, only a few different saline manufacturers supply this solution to the US market. Unfortunately, the manufacturing challenges that limit the production of one manufacturer can and do lead to saline shortages in the United States. Compounding the problem, these manufacturers have uneven market shares across all bagged saline products. For example, 50% of saline bags of 250 ml or less are supplied by a single manufacturer. Thus, when such a manufacturer faces production problems, the impact on the availability of that particular type of bag is much greater.

[0005] Recently, media attention has been shown on the delays caused after Hurricane Maria, which led to shortages 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. Alternative ways to produce medical fluid bags that can be located in the institutions using the bags may be desirable. Summary of the Invention

[0006] According to an embodiment of the present disclosure, a seal member dispenser may include a dispenser body that includes: at least one groove configured to receive a plurality of seal members; and an outlet port that extends from the groove to an outer face of the dispenser body. The outlet port may have a guiding portion adjacent to the outer face of the dispenser body. The seal member dispenser may further include a blocking element that blocks a passage of the seal members through the outlet port. The seal member dispenser may further include a cover that is coupled to the dispenser body and suspended over the groove. The cover may include an orifice that is in line with the outlet port. The orifice may have an opening that is too small for a seal member of the plurality of seal members to pass through.

[0007] In some embodiments, the groove may extend along a helical path. In some embodiments, the dispenser body may be a drum. In some embodiments, the guiding portion may include a funnel-shaped profile. In some embodiments, the guiding portion may be a chamfered edge. In some embodiments, the guiding 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. Displacement of the handle may cause the outlet cover to be displaced away from a blocking position. In some embodiments, the blocking element may include a brake member that projects into the outlet port. In some embodiments, the brake member may be a spherical brake. In some embodiments, the seal member dispenser may further include a follower and a biasing member that is coupled to the follower and a portion of 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 seal member dispenser may further include a magnetic body. In some embodiments, the seal 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 urge the shaft to rotate. In some embodiments, the seal member dispenser may include a rotor coupled to a shaft. In some embodiments, the seal member dispenser may include a rotor drive assembly configured to automatically index the rotor until a seal member is displaced along the groove to an outlet point. In some embodiments, the rotational indexing for indexing the rotor may vary as the seal members of the seal member dispenser are depleted.

[0008] According to another embodiment of the present disclosure, a reservoir feeding device may include a housing block that includes at least one channel extending through the housing block. The reservoir feeding device may further include a set of retaining pins associated with each of the at least one channel. The reservoir feeding device may further include a set of guides associated with each of the at least one channel. A slot may be defined between the guides in each set of guides. The reservoir feeding device may further include a feed plate coupled to the housing block by at least one biasing member. The feed plate may include at least one follower projection. The reservoir feeding device may further include an elongate member extending from the housing block through the feed plate. The biasing member may urge the feed plate to shift along the elongate member toward a stop surface of the housing block. The biasing member may also be configured to urge the follower projection into contact with a port of a reservoir disposed within 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 the channel associated therewith. In some embodiments, the retaining pins in each set of retaining pins may be disposed on opposite sides of the channel associated with the set 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 set of retaining pins are spaced apart from each other by a distance 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 gripper is introduced to collect a 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 projection is at least equal to the distance from the stop surface to the retaining pin. In some embodiments, the reservoir feeding device may further include a feed plate retainer for holding the feed plate in a loading orientation. The feed plate retainer may be coupled to the housing block via at least one support. 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 that includes at least one channel extending through the housing block. The reservoir feeding device may further include a set of retaining pins associated with each of the at least one channel. The reservoir feeding device may further include a reservoir cartridge coupled to the housing block. The reservoir feeding device may further include a feed plate coupled to the housing block by at least one biasing member. The feed plate may include at least one follower protrusion. The reservoir feeding device may further include an elongate member extending from the housing block through the feed plate. The biasing member may urge the feed plate to shift along the elongate member toward a stop surface of the housing block. The biasing member may also urge the follower protrusion through the reservoir cartridge toward the housing block.

[0011] In some embodiments, each retaining pin may be biased by a retaining pin biasing member to an extended state in which the retaining pin extends into the channel associated therewith. In some embodiments, the retaining pins in each set of retaining pins may be disposed on opposite sides of the channel associated with the set of retaining pins. In some embodiments, each retaining pin may be biased by a retaining pin biasing member to an extended state, and when in the extended state, the ends of the retaining pins in a set of retaining pins are spaced apart from each other by a distance 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 gripper 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 surface to the retaining pin. In some embodiments, the reservoir feeding device may further include a feed plate retainer for holding the feed plate in a loading orientation. The feed plate retainer may be coupled to the housing block via at least one support. 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, a bag sealing device includes a push rod that is displaceable along a displacement axis by a push rod actuator. The bag sealing device may further include a seal member dispenser receptacle for receiving a seal member dispenser. The bag sealing device may further include a seal member dispenser sensor configured to output a first signal indicative of the presence of the seal member dispenser within the receptacle. The bag sealing device may further include a reservoir guide including a first portion and a second portion having a gap therebetween. When a reservoir is disposed within the gap, the reservoir guide guides the port of the reservoir into alignment with the displacement axis. At least one of the first portion and the second portion of the reservoir guide may include a gripper docking surface.

[0013] In some embodiments, the bag sealing device can be a plugging device. In some embodiments, the seal member container can be disposed intermediate the push rod and the reservoir guide. In some embodiments, the seal member dispenser sensor can be a magnetic sensor. In some embodiments, the seal member dispenser sensor is a Hall effect sensor. In some embodiments, the bag sealing device can further include a reservoir detection sensor configured to output a second signal indicative of the presence of the reservoir in the reservoir guide. In some embodiments, the bag sealing device can further include a controller. The controller can be configured to prevent actuation by the 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 can further include an optical port detection sensor configured to output a second signal indicative of the presence of a port aligned with the shift axis based on the reflection intensity of light emitted from the sensor. In some embodiments, the bag sealing device can 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 encapsulating a fluid can include a fill catheter dispenser having a spool portion containing a length of fill catheter. The device can further include a feeder assembly including an actuator coupled to at least one feed member. The device can further include a tube holder having a first portion coupled to a slider and a cam follower. The tube holder can have a second portion coupled to a substrate. The tube holder can include a container for a length of fill catheter and a port of the bag. The device can further include a slider actuator. The device can further include a plugger assembly having a plugger actuator coupled to a carriage mounted to the plugger. The device can further include a cutter assembly including a cutter actuator coupled to a cutting element and a cam surface. The cam surface and the cutting element can be configured to shift in unison with each other. The device can further include a guide coupled to the first portion of the tube holder, the plugger assembly, and the cutter assembly. The device can further include a biasing member that pushes the cam follower against the cam surface. The device can further include a controller configured to govern the operation of the slider actuator, the plugger actuator, and the cutter actuator to plug, cut, and join the length of fill catheter and the port.

[0015] In some embodiments, a first portion and a second portion of the tube retainer may be separated by a first gap. In some embodiments, the occluder may include a first occluder portion and a second occluder portion separated by a second gap. In some embodiments, the first gap and the second gap are disposed 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 portion and a second occluder portion, the first occluder portion being mounted on a rail and being rotatable relative to the carriage. In some embodiments, the occluder may include a first occluder portion coupled to a first retainer portion by a first pin, and the occluder may include a second occluder portion coupled to a second retainer portion by a second pin. In some embodiments, the occluder may include a first occluder portion and a second occluder portion. The first occluder portion may be mounted on a rail and coupled to the first retainer portion by a pin, wherein the pin couples the first occluder portion and the first retainer portion such that actuation of the slider actuator on the slider causes the first occluder portion to displace along the rail. In some embodiments, displacement of the cam follower along the cam surface may change the size of the gap. In some embodiments, the cam surface may be shaped such that the gap is maximized when the cutting element is disposed within 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 rotatable relative to the carriage and coupled to the first retainer portion via a linkage. A biasing member may couple 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 further include a tube sealing assembly having opposing jaws, each jaw having a heating element and a low thermal conductivity cutting insert. The tube sealing assembly may have a seal actuator configured to displace the jaws towards and away from each other. In some embodiments, the controller may be configured to govern the operation of the seal actuator to displace the jaws against the port for a period of time, the jaws heating the port until the cutting insert is pressed through the port. In some embodiments, the device may further include a weight coupled to the slider. The weight may be configured to hold the cam follower against the cam surface.

[0016] According to another embodiment of the present disclosure, a reservoir filling kit may include a carrier that includes a plurality of compartments. The reservoir filling kit may further include a plurality of packages, each package containing a flexible reservoir that is attached to a liquid delivery kit and a filling line. The reservoir filling kit may further include an adapter that includes a plurality of retainer recesses, each retainer recess having an end of one of the filling lines disposed 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 further include a plurality of sealing members. One of the plurality of sealing members may be included at each end of the filling line.

[0017] In some embodiments, the liquid delivery kit may include at least one blocking member associated therewith. The blocking member may be in a blocking state in which the flow through at least a portion of the liquid delivery 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 package may include a pouch and a wing, wherein the flexible reservoir is disposed in the pouch and the wing holds the liquid delivery kit within the package in a closed position. In some embodiments, the flexible reservoir contained in each package may be an IV bag. In some embodiments, the plurality of sealing members may be diaphragms. In some embodiments, the retainer recesses may be spaced apart from each other at a preset angular increment. The angular increment may be selected to align with the spikes in the spike ports of the filling device.

[0018] According to another embodiment of the present disclosure, a system for encapsulating a fluid may include a fluid source. The system may further include a spike port that includes a plurality of spikes. The system may further include a line heater. The system may further include at least one pump. The system may further include a plurality of valves. The system may further include a controller configured to: in a first mode, power the heater to heat the fluid to a 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 disinfect 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 spikes of the spike port.

[0019] In some embodiments, the spike port may include a recess in which the spike is disposed, and the spike port includes a recirculation port. In some embodiments, the spike port may be configured to receive a spike adapter that includes a plurality of fluid lines in a retaining recess of the spike adapter. The spikes of the spike port may be spaced apart to align with the retaining recesses of the spike adapter. In some embodiments, the spike port may include at least one alignment guide configured to cooperate with an alignment element of the spike adapter. In some embodiments, the system may further include a passive manifold that bifurcates fluid input from a common point to each spike of the spike port. In some embodiments, the spike port may include a cap and a gasket, and when the cap is in a closed orientation, the cap is sealed onto the gasket. 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 junction between a fill conduit and a port of the reservoir by heating the fill conduit and the port, cutting the fill conduit and the port, coaxially aligning the fill conduit with the port, and joining the cut end of the port to the cut end of the fill conduit. The method may further include: delivering fluid through the fill conduit past the junction and into the reservoir via the port. The method may further include: actuating jaws against a portion of the port and heating the jaws until non-thermally conductive inserts in each jaw are pressed through the port.

[0021] In some embodiments, cutting the fill conduit and the port may include driving a heated blade into a gap in a retainer in which the fill conduit and the port are disposed. In some embodiments, coaxially aligning the fill conduit with the port may include actuating a slider to displace a movable portion of the retainer relative to a fixed portion of the retainer such that the cut ends of the port and the fill conduit slide past opposite surfaces of the heated blade. In some embodiments, joining the cut end of the port to the cut end of the fill conduit may include biasing the movable portion of the retainer toward the fixed portion of the retainer and displacing a cam surface relative to a cam follower coupled to the movable portion of the retainer in unison with the heated blade as the heated blade retracts from the retainer. In some embodiments, the method may further include actuating the slider along a path orthogonal to a plane generally parallel to the junction. In some embodiments, the method may further include forming a seal in the port that separates an aliquot of liquid within 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 fill conduit and a port of the reservoir by cutting the fill conduit and the port with a heated cutting element and sliding the cut ends of the port and the fill conduit across opposite surfaces of the cutting element to position the fill conduit coaxially aligned with the port and joining the cut end of the port to the cut end of the fill conduit when the cutting element is retracted. The method may further include: conveying a fluid through the fill conduit past the joint and into the reservoir via the port. The method may further include actuating jaws against a portion of the port and heating the jaws until a non-thermally conductive insert in each jaw is pressed through the port.

[0023] In some embodiments, cutting the fill conduit and the port may include driving the cutting element into a gap in a retainer in which the fill conduit and the port are disposed. In some embodiments, coaxially aligning the fill conduit with the port may include actuating a slider to displace a movable portion of the retainer relative to a fixed portion of the retainer. In some embodiments, joining the cut end of the port to the cut end of the fill conduit may include biasing the movable portion of the retainer toward the fixed portion of the retainer and displacing a cam surface relative to a cam follower coupled to the movable portion of the retainer in unison with the cutting element when the cutting element is retracted from the retainer. In some embodiments, the method may further include actuating the slider along a path generally parallel to a plane of the joint. In some embodiments, the method may further include forming a seal in the port that separates an aliquot of liquid within the port from the fluid in the reservoir. In some embodiments, the reservoir may be a bag. In some embodiments, the method may further include sensing the presence of at least one of the fill conduit and the port in a tube retainer with at least one sensor.

[0024] According to another embodiment of the present disclosure, a system for producing and encapsulating a fluid may include a water distillation device. The system may further include a mixing circuit that is coupled to an output of the water distillation device and includes a concentrate source. The mixing circuit may include a plurality of flow controllers configured to regulate the flow of fluid through the mixing circuit to produce a preset fluid. The system may further include a housing that includes a front chamber and an encapsulation compartment. The system may further include a reservoir dispenser in the encapsulation compartment that has 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 further include a filling station in the encapsulation compartment that includes a filling nozzle coupled to the mixing circuit. The system may further include a sealing station in the encapsulation compartment that has a push rod and a seal member dispenser. The system may further include a quarantine repository in the encapsulation compartment that has a plurality of reservoir brackets. The system may further include a labeling machine in the encapsulation compartment. The system may further include an output chute from the encapsulation compartment to the exterior of the housing.

[0025] In some embodiments, the system may further include at least one of a reverse osmosis unit and an ultrafilter. In some embodiments, the concentrate source may be a reservoir for the crystallized concentrate, the reservoir having a purified water inlet and a fluid concentrate outlet. In some embodiments, the concentrate source may include a crystallization 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 encapsulation compartment may be separated by a partition. In some embodiments, the partition may include a door having a sample container holder. In some embodiments, the system may further include a pyrogen tester. In some embodiments, the system may further include a robotic arm that includes a gripper. In some embodiments, the system may further include a control system configured to displace the robotic arm and actuate the gripper to collect a reservoir from a reservoir dispenser, displace the reservoir to a filling station, command the filling of the reservoir, displace the reservoir to a sealing station, and command the actuation of a pusher to drive a sealing member from a sealing member into a 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 the reservoir positioned at the filling station. In some embodiments, the control system may be configured to govern the operation of a flow controller based on the capacity of the reservoir, wherein the capacity of the reservoir is determined based on 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 a quantity of concentrate to the reservoir and subsequently deliver a quantity of purified water to the reservoir to achieve a fill quantity selected based on the capacity of the reservoir.

[0026] According to another embodiment of the present disclosure, a system for producing and encapsulating a fluid may include a water distillation device. The system may further include a mixing circuit that is coupled to an output of the water distillation device and includes a concentrate source. The mixing circuit may be configured to regulate a flow rate of a fluid through the mixing circuit to produce a fluid having a predetermined composition. The system may further include a housing that includes a front chamber and an encapsulation compartment. The system may further include a reservoir dispenser at least partially within the encapsulation compartment, the reservoir dispenser having a reservoir cartridge and an outlet end. The reservoir dispenser may include an actuator configured to drive a follower of the reservoir cartridge toward the outlet end of the reservoir dispenser. The system may further include a filling station within the encapsulation compartment, the filling station including a filling nozzle coupled to the mixing circuit and a reservoir volume sensing assembly. The system may further include a sealing station within the encapsulation compartment. The system may further include a repository within the encapsulation compartment having a plurality of reservoir racks. The system may further include a labeling machine within the encapsulation compartment. The system may further include an output chute from the encapsulation compartment to the exterior of the housing.

[0027] In some embodiments, the system may further include at least one of a reverse osmosis unit and an ultrafilter. In some embodiments, the concentrate source may be a reservoir for the crystallized concentrate, the reservoir 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 encapsulation compartment may be separated by a partition. In some embodiments, the partition may include a door having a sample container holder. In some embodiments, the system may further include a pyrogen tester. In some embodiments, the system may further include a robotic arm that includes a gripper. In some embodiments, the system may further include a control system configured to shift the robotic arm and actuate the gripper to collect a reservoir from a reservoir dispenser, shift the reservoir to a filling station, determine the volume of the reservoir via data from a reservoir volume sensing assembly, command the reservoir to be filled with a fluid amount not greater than the volume of the reservoir, shift the reservoir to a sealing station, and command the reservoir to be sealed. 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 configured to determine the capacity of the reservoir in place at the 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 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 a quantity of concentrate to the reservoir and subsequently deliver a quantity 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 encapsulating a fluid may include a water purification device. The system may further include a mixing circuit coupled to an output of the water purification device and including a concentrate source. The mixing circuit may be configured to generate a fluid having a predetermined composition. The system may further include a housing that includes a front chamber and an encapsulation compartment. The system may further include a reservoir dispenser that extends from the front chamber to the encapsulation compartment and has a reservoir cartridge and an outlet end. The reservoir dispenser may include a drive configured to shift a follower of the reservoir cartridge toward the outlet end of the reservoir dispenser. The system may further include a filling station in the encapsulation compartment that includes a filling nozzle coupled to the mixing circuit and a reservoir volume sensing assembly. The system may further include a sealing station in the encapsulation compartment. The system may further include at least one reservoir hanger in the encapsulation compartment. The system may further include a labeling machine in the encapsulation compartment. The system may further include an output chute from the encapsulation compartment to the exterior of the housing.

[0029] In some embodiments, the system may further include at least one of a reverse osmosis unit and an ultrafilter. In some embodiments, the concentrate source may be a reservoir of crystalline salt concentrate. In some embodiments, the 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 encapsulation compartment may be separated by a partition including at least one door between the front chamber and the encapsulation compartment. In some embodiments, the system may further include a robotic arm including a gripper. In some embodiments, the system may further 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 a container via data from a reservoir volume sensing assembly, command filling the reservoir with a fluid amount not greater than the volume of the reservoir, displace the reservoir to a sealing station, and command sealing 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 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 a quantity of concentrate to the reservoir and subsequently deliver a quantity of purified water to the reservoir to achieve a fill amount selected based on the capacity of the reservoir, wherein the capacity of the reservoir is determined based on data from the reservoir characteristic sensors.

[0030] According to another embodiment of the present disclosure, a fluid production system for a medical fluid encapsulation system may include a water distillation device. The system may further include a plurality of filters including at least one of a reverse osmosis filter and a carbon filter. The system may further include a mixing circuit including a purified water flow path and a concentrate flow path 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 further include a sensor suite including a total organic carbon sensor, a bioburden sensor, a particle monitor, a plurality of ultra-pure water conductivity sensors, and a concentrate conductivity sensor. The system may further include a controller configured to govern the operation of the flow controller to dispense a predetermined fluid quantity in a first phase and a second phase, the first phase delivering fluid at least predominantly from the concentrate flow path and the second phase delivering fluid at least predominantly from the purified water flow path, the controller proportioning the fluid in the first phase and the second phase based on data from the concentrate conductivity sensor, a predetermined desired fluid composition, and a predetermined quantity.

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

[0032] According to another embodiment of the present disclosure, a method of filling a bag with a medical fluid can include: placing a first filling nozzle in a first port of the bag that communicates with a first compartment of the bag and placing a second filling nozzle in a second port of the bag that communicates with a second compartment of the bag. The first filling nozzle and the second filling nozzle communicate with a fluid source via a common flow channel. The method can further include delivering fluid into the first compartment and the second compartment of the bag. The method can further include: stopping the delivery of fluid into the smaller of the first and second compartments of the bag when the smaller compartment is fully filled. The method can further include: stopping the delivery of fluid into the larger of the first and second compartments of the bag when the larger compartment is fully filled. The method can further 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 and second compartments. The method can further 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 saline solution. In some embodiments, the method can further include performing an endotoxin test on the sample and discarding the larger compartment when the endotoxin test indicates the presence of endotoxin above a predetermined level.

[0034] According to another embodiment of the present disclosure, a bag for containing a medical fluid and a separable sampling aliquot can include a first compartment having a first fill port and a delivery port. The bag can further include a second compartment having a second fill port. The bag can further include a seal separating the first compartment and the second compartment. The bag can further include a perforation extending along the length of the seal.

[0035] In some embodiments, the first compartment can have a greater capacity than the second compartment. In some embodiments, the seal can 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 can include a first sheet of material and a second sheet of material that are sealed to each other at a peripheral seal to define an internal volume of the reservoir. The reservoir can further include at least one port that is coupled to the peripheral seal and provides a fluid path into the internal volume. The reservoir can further include an internal seal extending from the peripheral seal. The internal seal can define a partition portion of the internal volume and a main portion of the internal volume. The partition portion can 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 fill port and a liquid supply 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 an angle that directs the fluid to the at least one port when the reservoir is suspended for gravity-fed liquid delivery of the fluid contained therein. 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 sheet of material and a second sheet of material, the first and second sheets of material being sealed to each other at a peripheral seal to define an interior volume of the reservoir. The reservoir may further include at least one port that is coupled to the peripheral seal and provides a fluid path into the interior volume. The peripheral seal may have an enlarged region, and the at least one port may be located within the enlarged region. The reservoir may further include a sampling reservoir defined within the enlarged region. The sampling reservoir may extend from a flow path through the enlarged region that connects the port of the at least one port to the interior volume of the reservoir. In some embodiments, the sampling reservoir may be in communication with the flow path via a branch path included within the enlarged region. In some embodiments, the branch path may be configured to be sealed after the reservoir is filled to isolate the sampling reservoir from the interior volume. In some embodiments, the reservoir is a bag. In some embodiments, the at least one port may include a fill port and a liquid supply port. In some embodiments, the fill port is connected to the interior volume via a flow path through the enlarged region that is connected to the sampling reservoir.

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

[0040] In some embodiments, the reservoir may be a bag. In some embodiments, forming the seal includes sealing a gap included within a portion of the wall of the reservoir that defines a primary interior volume of the reservoir and a partitioned interior volume of the reservoir. When unsealed, the gap may provide fluid communication between the primary volume and the partitioned interior volume. In some embodiments, the reservoir may be constructed of a first sheet of material and a partial sheet of material that are joined to each other at a peripheral seal that defines the interior volume of the reservoir, and forming the seal may include sealing a portion of a flow path that is enclosed within an enlarged portion of the peripheral seal. In some embodiments, sealing the portion of the flow path that is enclosed within the enlarged portion of the peripheral seal may isolate a sampling reservoir defined within the enlarged portion of the peripheral seal from the interior volume of the reservoir. In some embodiments, the method may further include collecting a sample from the 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 that includes a single lumen. The sampling portion may also include a second portion that includes 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 the 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 volume through a continuous flow path that extends 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 volume into the reservoir through the continuous flow path. The second fluid volume may exceed the capacity of the reservoir. The method may also include directing an overflow through the sampling lumen of the nozzle into a sampling conduit coupled to the nozzle during the delivery of the second fluid volume.

[0043] In some embodiments, the method may also include providing the overflow to a sensing assembly. In some embodiments, the method may also include providing the overflow to a vial. In some embodiments, the first fluid volume 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 Illustrative example embodiments of a system for producing and encapsulating a medical fluid are depicted;

[0045] Figure 2A Illustrative example embodiments of a system for producing and encapsulating a medical fluid are depicted;

[0046] Figure 2B Illustrative example embodiments of a system for producing and encapsulating a medical fluid are depicted;

[0047] Figure 3 Illustrative example embodiments of a system for producing and encapsulating a medical fluid are depicted;

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

[0049] Figure 4B Illustrative example embodiments of a system for producing and encapsulating a medical fluid are depicted;

[0050] Figure 5A Illustrative example embodiments of a system for producing and encapsulating a medical fluid are depicted;

[0051] Figure 5B Depicts an illustrative example embodiment of a system for producing and encapsulating a medical fluid;

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

[0053] Figure 7 Depicts an exemplary bag having a partial barrier wall in its internal volume;

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

[0055] Figure 9 Depicts a flowchart detailing a plurality of example actions that can be performed to encapsulate a fluid within a bag;

[0056] Figure 10 Depicts another exemplary bag having a sampling reservoir disposed in an open area of its peripheral seal;

[0057] Figure 11 Depicts the example bag of FIG. 4, wherein the sampling reservoir is separated from the remainder of the bag and is not in fluid communication;

[0058] Figure 12 Depicts an exemplary bag having a first compartment and a second compartment;

[0059] Figure 13 Depicts an exemplary bag having a seal with a perforation therein;

[0060] Figure 14 Depicts another flowchart detailing a plurality of example actions that can be performed to encapsulate a fluid within a bag;

[0061] Figure 15 Depicts an example filling nozzle;

[0062] Figure 16 Depicts an example multi-lumen filling nozzle that can be used to fill a bag and collect an aliquot of fluid for sampling;

[0063] Figure 17 Depicts another flowchart detailing a plurality of example actions that can be performed to encapsulate a fluid within a bag;

[0064] Figure 18 Depicts an illustrative example of a filling receiving kit;

[0065] Figure 19A Depicts an exploded view of an exemplary bag having a fluid supply kit;

[0066] Figure 19B Shows a top view of an example bag with a fluid delivery kit;

[0067] Figure 20 Shows a top view of another example bag;

[0068] Figure 21 Shows a top view of another example bag;

[0069] Figures 22A to 22F Shows a view of a bag including a fluid delivery kit and a filling line in different stages of a sealed enclosure;

[0070] Figure 23 Shows a top view of another example bag;

[0071] Figure 24 Shows a top view of yet another example bag;

[0072] Figures 25A to 25C Shows a view of an example manifold;

[0073] Figure 26 Shows a view of an example filling receiving kit including another example manifold;

[0074] Figure 27 Shows a perspective view of an example filling receiving kit;

[0075] Figure 28 Shows a cross-sectional view of an example filling receiving kit;

[0076] Figure 29 Shows a cross-sectional view of another example filling receiving kit;

[0077] Figure 30 Shows a cross-sectional view of a bag of an example filling receiving kit filled with fluid;

[0078] Figure 31 Shows a cross-sectional view of an example filling receiving kit with a filled bag that has been sealed and is not in fluid communication with the filling receiving kit;

[0079] Figure 32 Shows a cross-sectional view of an example filling receiving kit where the bag has been cut off from the filling receiving kit;

[0080] Figure 33 Shows a cross-sectional view of an example filling receiving kit where the bag of the filling receiving kit is filled with fluid;

[0081] Figure 34 Shows a cross-sectional view of an example filling receiving kit;

[0082] Figure 35 Shows a cross-sectional view of an example filling receiving kit;

[0083] Figure 36 Depicts a schematic diagram of an exemplary fill receiving kit;

[0084] Figure 37 Depicts a top view of an exemplary manifold of an exemplary fill receiving kit;

[0085] Figure 38 Depicts a cross-sectional view of an exemplary manifold of an exemplary fill receiving kit;

[0086] Figures 39A to 39C Depicts the process of valve actuation of an exemplary manifold of a bag that can be used to fill an exemplary fill receiving kit;

[0087] Figure 40 Depicts an actuation block for a manifold of an exemplary fill receiving kit;

[0088] Figures 41A to 41F Depicts the process of valve actuation that can be performed to pump fluid from a concentrate supply inlet through an exemplary manifold;

[0089] Figure 42 Depicts the amount of fluid transferred to a bag through an exemplary manifold;

[0090] Figure 43 Depicts an illustrative example of another exemplary fill receiving kit;

[0091] Figure 44 Depicts another illustrative example of an exemplary fill receiving kit;

[0092] Figure 45 Depicts multiple material layers that can be used to construct a fill receiving kit;

[0093] Figure 46 Depicts a proximity element of a fill receiving kit placed between the material layers of the fill receiving kit;

[0094] Figure 47 Depicts a seal formed between the material layers that defines an exemplary fill receiving kit;

[0095] Figure 48 Depicts an exemplary fill receiving kit;

[0096] Figure 49 Depicts an exemplary fill receiving kit with steam supplied to a portion of the fill receiving kit;

[0097] Figure 50 Depicts a bag filled through an exemplary fill receiving kit;

[0098] Figure 51Depicts an example filled receiving kit, where a first bag of the kit is filled and cut off from the kit, and a second bag of the kit is filled with fluid;

[0099] Figure 52 Depicts an example filled receiving kit, where a first bag and a second bag of the kit are filled and cut off from the kit, and a third bag of the kit is filled with fluid;

[0100] Figure 53 Depicts a block diagram of an example filled receiving kit production and filling system;

[0101] Figure 54 Depicts a perspective view of an example system for producing and encapsulating a medical fluid;

[0102] Figure 55 Depicts Figure 54 a perspective view of the example system in

[0103] Figure 56 where a portion of the outer shell is shown transparent to reveal various internal components of the system;

[0104] Figure 57 Depicts Figure 56 a side view of the example system shown in

[0105] Figure 58 Depicts Figure 56 another side view of the example system shown in

[0106] Figure 59 Depicts a perspective view of an example bag feeder;

[0107] Figure 60 Depicts a perspective view of an example bag feeder fully loaded with bags;

[0108] Figure 61 Depicts a perspective view of an example bag feeder, where the feed plate is released from the loading position;

[0109] Figure 62 Depicts a perspective view of an example bag feeder, where the feed plate of the bag feeder is biased against the port of a bag mounted in the bag feeder;

[0110] Figure 63 Depicts a bottom front perspective view of an example bag feeder having retaining pins for holding a bag in place within the bag feeder;

[0111] Figure 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 retaining pins of the bag feeder and collect the bag;

[0112] Figure 65 Shows a perspective view of an exemplary bag feeder and an exemplary gripper that holds a bag collected from the bag feeder;

[0113] Figure 66 Shows a perspective view of an exemplary bag filling station;

[0114] Figure 67 Shows a perspective view of an exemplary bag filling station where an unfilled bag is docked at the filling station;

[0115] Figure 68 Shows a perspective view of an exemplary bag filling station having a filled bag docked at the filling station;

[0116] Figure 69 Shows a perspective view of an exemplary bag filling station and an exemplary gripper that has been advanced to the filling station to collect a filled bag from the filling station;

[0117] Figure 70 Shows a perspective view of an exemplary gripper that holds a filled bag and a filling station having a pivoting discharge inlet aligned with the filling nozzle of the filling station;

[0118] Figures 71A to 71B Shows a top view of a portion of the filling station having an offset discharge inlet;

[0119] Figure 72 Shows a perspective view of an exemplary sealing station in which a plug dispenser is installed;

[0120] Figure 73 Shows a perspective view of an exemplary sealing station having an exemplary follower assembly disposed in a retracted position;

[0121] Figures 74A to 74B Shows a perspective view of an exemplary plug dispenser;

[0122] Figure 75 Shows a perspective view of an exemplary sealing station having an exemplary follower assembly biased into contact with a plug in an exemplary plug cartridge;

[0123] Figure 76 Shows a perspective view of an exemplary sealing station having an exemplary plug dispenser installed therein, where the cover of the dispenser is displaced to expose the outlet port of the plug dispenser;

[0124] Figure 77A Shows a perspective view of an exemplary sealing station having an exemplary plug dispenser installed in a dispenser receptacle of the sealing station;

[0125] Figure 77B ShowsFigure 77A Detailed view of the indicated area;

[0126] Figure 78 Perspective view depicting an exemplary sealing station, in which an exemplary push rod of the sealing station is advanced into an exemplary plug dispenser to drive a plug from the dispenser into a port of a bag positioned at the sealing station;

[0127] Figure 79 Perspective view depicting an exemplary sealing station, in which the exemplary push rod of the sealing station is in a retracted position and a plug is advanced via an exemplary follower assembly into alignment with an outlet port of an exemplary plug dispenser;

[0128] Figure 80 Perspective view depicting an exemplary sealing station and an exemplary gripper that has collected a sealed bag from the sealing station;

[0129] Figure 81A Perspective view depicting an exemplary plug dispenser having an outlet port with a beveled port opening;

[0130] Figure 81B Depicts Figure 81A Detailed view of the indicated portion of;

[0131] Figure 81C Cross-sectional view depicting an exemplary sealing station in which a plug dispenser of Figures 81A to 81B is installed and a port of a bag is advanced partially over a portion of a plug held in the dispenser.

[0132] Figures 82A to 82C View depicting another exemplary plug dispenser having an outlet port with a beveled port opening and an outlet port brake member;

[0133] Figure 83 Perspective view depicting another exemplary plug dispenser in which a cover plate of the exemplary plug dispenser has been removed;

[0134] Figure 84 Top view depicting an exemplary plug dispenser filled with plugs;

[0135] Figure 85 Top view depicting an exemplary plug dispenser that has been partially emptied of plugs;

[0136] Figure 86 Top view depicting an exemplary plug dispenser emptied of plugs;

[0137] Figure 87 Exploded view depicting another exemplary plug dispenser;

[0138] Figure 88Shows a top view of an exemplary plug dispenser filled with plugs;

[0139] Figure 89 Shows a top view of an exemplary plug dispenser, where a plug aligned with the outlet port of the dispenser has been dispensed;

[0140] Figure 90 Shows a top view of an exemplary plug dispenser that has been rotated under the force of a biasing member to advance a plug into alignment with the outlet port of the dispenser.

[0141] Figure 91 Shows a top view of an exemplary plug dispenser with some plugs emptied;

[0142] Figure 92 Shows a top view of an exemplary plug dispenser, where a plug aligned with the outlet port of the dispenser has been dispensed;

[0143] Figure 93 Shows a top view of an exemplary 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] Figure 94 Shows an exploded view of another exemplary plug dispenser;

[0145] Figure 95 Shows a top view of an exemplary plug dispenser, where a plug aligned with the outlet of the dispenser has been dispensed;

[0146] Figure 96 Shows a top view of an exemplary plug dispenser, where a plug is advanced into alignment with the outlet port of the dispenser via a biasing force applied to an exemplary follower block of the dispenser;

[0147] Figure 97 Shows a perspective view of an exemplary plug dispenser and an exemplary quick loader;

[0148] Figure 98 Shows a perspective view of an exemplary plug dispenser and an exemplary quick loader;

[0149] Figure 99 Shows a perspective view of an exemplary plug dispenser that has been filled with plugs by an exemplary quick loader;

[0150] Figure 100 Shows a perspective view of an exemplary quarantine repository;

[0151] Figure 101 Shows a perspective view of an exemplary bracket that may be included in a quarantine repository;

[0152] Figure 102 A perspective view of an exemplary quarantine repository filled to capacity with bags;

[0153] Figure 103 A perspective view of an exemplary sampling fixture with vials installed therein;

[0154] Figure 104 A perspective view of an exemplary vial access door and an exemplary sampling fixture with vials installed therein;

[0155] Figure 105 A side view of an exemplary labeling assembly and a bag being displaced by a robotic gripper to the labeling assembly;

[0156] Figure 106 A side view of an exemplary labeling assembly with a bag in the process of being labeled;

[0157] Figure 107 A side view of an exemplary labeling assembly with a gripper holding a bag that has been labeled at the labeling assembly;

[0158] Figure 108 A perspective view of an exemplary output chute that may be included in the system;

[0159] Figure 109 A perspective view of a bag stored in the exemplary output chute;

[0160] Figure 110 A perspective view of a bag leaving the exemplary output chute;

[0161] Figure 111 A perspective view of another exemplary system for producing and encapsulating a medical fluid;

[0162] Figure 112 Depicts Figure 111 Another perspective view of the system for producing and encapsulating a medical fluid, wherein a portion of the housing of the system is shown as transparent;

[0163] Figure 113 A front view of an exemplary encapsulation assembly;

[0164] Figures 114A to 114B A top view of an exemplary bag retainer;

[0165] Figure 115 A front view of an exemplary encapsulation assembly with a gripper holding a bag that is docked at the exemplary bag retainer of the encapsulation assembly;

[0166] Figure 116Depicts a front view of an exemplary encapsulation assembly, wherein a gripper holds a bag that has been released from an exemplary bag holder of the encapsulation assembly;

[0167] Figure 117 Depicts a front view of an exemplary encapsulation assembly with an exemplary robotic manipulator that advances a bag held by a gripper of the robotic manipulator into alignment with an exemplary fill nozzle of the encapsulation assembly;

[0168] Figure 118A Depicts a front view of an exemplary encapsulation assembly, wherein an exemplary fill nozzle of the encapsulation assembly is positioned within a port of the bag;

[0169] Figure 118B Depicts an exploded view of an exemplary fill nozzle and biasing assembly;

[0170] Figure 119 Depicts a front view of an exemplary encapsulation assembly, wherein a filled bag is held by an exemplary gripper of an exemplary robotic manipulator of the encapsulation assembly;

[0171] Figure 120 Depicts a front view of an exemplary encapsulation assembly, wherein the filled bag is shifted to an exemplary sealing station of the encapsulation assembly;

[0172] Figure 121 Depicts a front view of an exemplary encapsulation assembly, wherein the filled bag is shifted to an exemplary sealing station of the encapsulation assembly;

[0173] Figure 122 Depicts a front view of an exemplary encapsulation assembly, wherein the filled bag is shifted to insert a port of the bag into an exemplary support bracket of an exemplary sealing station of the encapsulation assembly;

[0174] Figure 123 Depicts a perspective view of an exemplary support bracket;

[0175] Figure 124 Depicts a front view of an exemplary encapsulation assembly, wherein an exemplary push rod of an exemplary sealing station is actuated to drive a plug into a port of a bag disposed within an exemplary support bracket of the encapsulation assembly;

[0176] Figure 125 Depicts a front view of an exemplary encapsulation assembly, wherein a filled and sealed bag is held by an exemplary gripper of an exemplary robotic manipulator of the encapsulation assembly;

[0177] Figure 126 Depicts a front view of an exemplary encapsulation assembly with a guide chute;

[0178] Figure 127 Depicts a perspective view of an exemplary carrier that may contain a package of encapsulation assemblies each holding at least one bag and a liquid supply kit;

[0179] Figure 128 Depicts a perspective view of an exemplary carrier having an exemplary package removed from a compartment of the carrier;

[0180] Figure 129 Depicts a perspective view of an exemplary carrier having an exemplary package removed from a compartment of the carrier, the package having an open cover flap;

[0181] Figure 130 Depicts a perspective view of an exemplary carrier with an exemplary pouch and an exemplary fluid delivery kit removed from the package;

[0182] Figure 131 Depicts a perspective view of a plurality of exemplary packages that can be placed within a compartment of a carrier;

[0183] Figure 132 Depicts a perspective view of a pointed adapter that can be included in a carrier;

[0184] Figure 133A Depicts a block diagram of an exemplary filling station;

[0185] Figure 133B Depicts a block diagram of another exemplary filling station

[0186] Figure 134 Depicts a perspective view of an exemplary filling station;

[0187] Figure 135 Depicts another perspective view of an exemplary filling station;

[0188] Figure 136 Depicts another perspective view of an exemplary filling station;

[0189] Figure 137 Depicts a top view of an exemplary spike port that can be included in a filling station;

[0190] Figure 138 Depicts a block diagram of an exemplary fluid circuit that can be included in an exemplary system for producing and packaging a medical fluid;

[0191] Figure 139 Depicts a flowchart detailing a plurality of exemplary actions that can be performed to generate a desired fluid;

[0192] Figure 140 Depicts a portion of an exemplary mixing circuit including an exemplary crystallization ingredient dispenser;

[0193] Figure 141 Depicts a metering manifold that can be included in an exemplary mixing circuit;

[0194] Figure 142 Depicts a perspective view of an exemplary crystallization ingredient dispenser;

[0195] Figure 143 depicts Figure 142 an exemplary crystal component dispenser, a portion of which is cut away to show the internal components of the crystal component dispenser;

[0196] Figure 144 shows a perspective view of an exemplary crystal component dispenser;

[0197] Figure 145 depicts Figure 144 an exemplary crystal component dispenser, a portion of which is cut away to show the internal components of the crystal component dispenser;

[0198] Figure 146 shows a perspective view of an exemplary paddle wheel that may be included in the exemplary crystal component dispenser;

[0199] Figure 147 shows a perspective view of an exemplary crystal component dispenser;

[0200] Figure 148 depicts Figure 147 an exemplary crystal component dispenser, a portion of which is cut away to show the internal components of the crystal component dispenser;

[0201] Figure 149 shows a side view of an exemplary dispensing assembly that may be included in the exemplary crystal component dispenser;

[0202] Figure 150 depicts Figure 149 a cross-sectional view of an exemplary dispensing assembly;

[0203] Figure 151 shows a perspective view of an exemplary dispensing tray that may be included within the exemplary dispensing assembly of the exemplary crystal component dispenser;

[0204] Figure 152A shows a perspective view of an exemplary dispensing assembly that may be included in the exemplary crystal component dispenser;

[0205] Figure 152B depicts Figure 152A an exploded view of the exemplary dispensing assembly shown in

[0206] Figure 153A shows a front view of another exemplary crystal component dispenser;

[0207] Figure 153B depicts Figure 153A a perspective view of an exemplary crystal component dispenser of , with certain components removed;

[0208] Figure 154A perspective view of an exemplary port of a metering manifold with an exemplary outlet that can be included in a crystallizing ingredient dispenser docked thereon;

[0209] Figure 155 depicts Figure 154 A cross-sectional view of the exemplary port and exemplary outlet shown;

[0210] Figure 156 A side view of another exemplary dispensing assembly that can be included in a crystallizing ingredient dispenser;

[0211] Figure 157 A side view of an exemplary dispensing assembly that can be included in a crystallizing ingredient dispenser;

[0212] Figure 158 A side view of an exemplary dispensing assembly that can be included in a crystallizing ingredient dispenser;

[0213] Figure 159 A perspective view of an exemplary tube welding assembly;

[0214] Figure 160 Another perspective view of an exemplary tube welding assembly;

[0215] Figure 161 A perspective view of an exemplary conduit dispenser that can be included in a tube welding assembly;

[0216] Figure 162 An exploded view of an exemplary conduit dispenser;

[0217] Figure 163 An exploded view of an exemplary conduit feed assembly that can be included in a tube welding assembly;

[0218] Figure 164 A perspective view of the components of an exemplary tube welding assembly;

[0219] Figure 165 A perspective view of the components of an exemplary tube welding assembly;

[0220] Figure 166 A perspective view of an exemplary plugging assembly that can be included in an exemplary tube welding assembly;

[0221] Figure 167 A top view of an exemplary plugging assembly that can be included in an exemplary tube welding assembly;

[0222] Figure 168 A perspective view of an exemplary plugging assembly that can be included in an exemplary tube welding assembly;

[0223] Figure 169Shows a perspective view of an exemplary cutter assembly that may be included in an exemplary tube welding assembly;

[0224] Figure 170 Shows a cross-sectional view of a section of tube blocked by an exemplary plugging assembly and an exemplary cutter assembly;

[0225] Figure 171 Shows a perspective view of components of an exemplary tube welding assembly;

[0226] Figure 172 Shows a perspective view of an exemplary bag sealing assembly that may be included in a tube welding assembly;

[0227] Figure 173 Shows an exploded view of exemplary jaws of an exemplary bag sealing assembly;

[0228] Figure 174 Shows a front view of an exemplary bag having a fill port, wherein sample aliquots are separated by a bag sealing assembly; and

[0229] Figure 175 Shows a front view of an exemplary bag having a sample aliquot sealed within the fill port of the bag.

[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, wherein: Detailed Description

[0231] Now refer to Figure 1 , there is shown a system 10 for producing and encapsulating a medical fluid. The system 10 includes a housing 12. The housing 12 can be any suitable certified-class clean room. The housing 12 can also be a housing 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. Additionally, there may be compartments within the housing 12 that meet different clean room level standards.

[0232] Within the enclosure 12, multiple system 10 components can be accommodated. For example, a medical water production device 14 can be included within the enclosure 12 of the system 10. The medical water production device 14 can be or include any suitable water production device, such as filtration devices (charcoal, ultrafiltration, endotoxin removal filters, reverse osmosis, microfiltration, depth filters, etc.), distillation devices, degassing devices (which a distillation device can also serve as), UV light sources, chemical treatment devices, exchange resins, electrodeionization units, etc. or combinations thereof. In some embodiments, the medical water production device 14 can be a distillation device, such as the distillation device described in U.S. Patent No. 9,308,467, titled "Water Vapor Distillation Apparatus, Method, and System" (Attorney Docket No. K97), authorized on April 12, 2016, the entire content of which is incorporated herein by reference. Alternatively, the medical water production device 14 can be a distillation device, such as the distillation device described in Application No. 16 / 370,038, titled "Water Distillation Apparatus, Method, and System" (Attorney Docket No. Z37), filed on March 29, 2019, the entire content of which is incorporated herein by reference. The medical water production device 14 can generate water that complies with various pharmacopoeial specifications or can generate water that complies with some non-pharmacopoeial specifications. The medical water production device 14 can, for example, produce USP (or other pharmacopoeial) 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 enclosure 12. Instead, the medical water production device 14 can be located in a separate enclosure within a clean room or, in some embodiments, in a non-clean room environment or a lower-certification clean room environment that is lower than the rest of the system 10. The output of the medical water production device 14 can be piped from the outlet of the medical water production device 14 to the rest of the system 10. 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, from which the medical water production device 14 draws the pre-treated water. In some embodiments, the water source 16 can be a large container or bladder. In the case where the system 10 produces a pharmacopoeial fluid, the water source 16 can meet any requirements specified for an acceptable water source that can be used to generate that pharmacopoeial fluid. For example, the water source can be EPA-acceptable drinking water.

[0234] Since the medical water production device 14 generates purified water, the water can be output to the outlet pipeline 18 after undergoing various quality tests. If any of the output water fails the quality test, the output water can be diverted to a discard location or recycled to the input section of the medical water production device 14 for further purification. The output pipeline 18 of the system 10 can be connected to a manifold 20. The manifold 20 can include fluid channels and one or more valves or actuators that selectively split or direct the purified water input flow into multiple separate outlet fluid channels. In some embodiments, the manifold 20 can be without valves and instead passively split the incoming purified water. The manifold 20 can include a plurality of connectors. These connectors can be coupled to the manifold interface element 22 of the fill receiving kit 24. The fill receiving kit 24 can include at least one IV bag 26 and a fluid administration set 28. In some embodiments, the manifold interface element 22 can be a Luer fitting. In alternative embodiments, the manifold interface element 22 can be a quick-connect fitting. In some embodiments, the fluid administration set 28 can be integrally combined with or fixedly attached to the manifold 20 (which can include a port protrusion extending from the manifold 20). The manifold 20 can also include a barb fitting to which the fluid administration set 28 tubing is secured.

[0235] In Figure 1 In the exemplary embodiment shown, the fill receiving kit 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 wrapper or package 30, which facilitates their installation into the system 10. In some embodiments, the package 30 can serve as a dispenser, for example, which allows the topmost bag 26 and the fluid administration set 28 to be picked up by a robotic gripper of the system 10. Each fill receiving kit 24 can include up to or more than 50 - 100 bag 26 and fluid administration set 28 pairs (but can also be any number from 1 - 50 pairs or greater than 100 pairs). The length of the fluid administration set 28 can be selected to be clinically useful, but not so long as to present excessive impedance issues during filling in the case where the bag 26 is filled via the attached fluid administration set 28. 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 capable of interfacing with an accessory tubing kit as well as the coupling elements on the manifold 20. Such an accessory tubing kit can include extension lines, multi-connectors, such as Y-type kits, V-type kits, and T-type kits, or potentially various access ports.

[0236] As purified water is produced by the medical water production device 14, the water can be delivered via the manifold 20 to each IV bag 26 of the fill receiving kit 24. Each IV bag 26 can be filled to capacity (or to 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 primed state (e.g., by filling the bag 26 through the administration set 28) by the system 10. In some embodiments, the manifold interface element 22 can be detached from the manifold 20 and capped by the system 10 via a multi-axis robotic manipulator. In some embodiments, a clamp can be applied to the administration set 28 or shifted to an actuated position on the set 28 before or during the detachment operation. Alternatively, a seal can be created in the administration set 28 tubing or other fill catheter, and the tubing can be cut from the manifold 20. Such a seal can be created via heat, dielectric, or RF welding or any other suitable process. In such embodiments, the administration set 28 can include a branch upstream of the seal location to allow access to the contents of the bag 26. In alternative embodiments, the user can manually detach the bag 26 and the administration set 28 from the remainder of the fill receiving kit 24.

[0237] The system 10 can also include a control system 15 that includes one or more controllers. The control system 15 can govern the operation of the manifold actuator or valve, the medical water production device 14, any robotic grippers and manipulators, and can fill the bags 26 to their desired volumes using sensor data. Controllers that can be used in the control system 15 can include microprocessors, FPGAs, PLCs, etc. The control system 15 can communicate (wired or wirelessly) data with the various sensors, manipulators, and other hardware of the system 10.

[0238] Now referring Figure 2A , in some embodiments, the system 10 can be configured to produce bags 26 with various types of solutions. The solutions can be colloid solutions or crystalloid solutions. The solutions produced can be isotonic, hypotonic, or hypertonic relative to physiological standards, etc. For example, the solutions can include various salt solutions such as normal saline, half-normal saline, or normal saline of any other concentration. The solutions can also include Ringer's solution, Hartmann's solution, sugar solutions (e.g., D5W), sugar-salt solutions (e.g., D5NS, 2 / 3 D5W, and 1 / 3 NS), Gelofusine, dextran, hydroxyethyl starch, albumin, Ionosteril, Sterofundin ISO, Plasma-lyte, etc. In such embodiments, the system 10 can include a receptacle for one or more large cartridges or reservoirs 40, 42 for concentrates or crystallization precursors. These large cartridges 40, 42 can be in fluid communication with fluid lines leading to pumps 38, 36. The pumps 38, 36 can meter specific amounts of concentrate into the output of the medical water production device 14.

[0239] The output stream of the medical water production device 14 can also be pumped by a pump 46 to monitor the amount of fluid mixed with any concentrate introduced from one or more large reservoirs 40, 42. In some examples, an accumulator or storage volume (not shown) may be included to maintain the supply of medical-grade water such that a solution can be produced at a rate faster than the output rate of the medical water production device 14 when commanded. In certain embodiments, the accumulator volume may be maintained within the medical water production device 14.

[0240] The mixing volume 34 can be included in the system 10 to ensure that any concentrate and water are uniformly 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 fluid within the mixing volume 34. The mixing volume 34 can also include a section of tubing that can present a long and / or tortuous path that promotes uniform 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 shown, the medical water production device 14 can have an output that can communicate with large cartridges 40, 42 containing the concentrate in crystalline form. The output of the medical water production device 14 can pass through the large cartridges 40, 42 and be discharged as a saturated or near-saturated solution. A pump 45 can be provided to assist in conveying the output stream 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] Now referring to Figure 3 , a system 10 for producing and encapsulating medical fluids is shown. The system 10 is configured to fill individual bags 26 rather than filling through the fill receiving kit 24. Since Figure 3 the medical water production device 14 in

[0243] produces purified water in Figure 3In the exemplary embodiment shown, 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 system 10. In some embodiments, the cassette 1430 may serve as a dispenser, for example, which allows the frontmost bag 26 to be picked up by the robotic manipulator 1422 of 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 with a capacity for more or fewer numbers of bags 26 may also be used.

[0244] In some embodiments, the bags 26 may be provided in an outer package 60, which in certain embodiments may be a sealed bag, pouch, or blister pack. The outer package 60 may be cleaned (e.g., with 70% isopropyl alcohol or other suitable reagent) and introduced into the housing 12. Then, the individual bags 26 may be removed from the outer package 60 manually or automatically (via the robotic manipulator 1422) and installed in the cassette 1430 included in system 10. One or more pre-loaded cassettes 1430 filled with bags 26 may also be provided in the outer package 60. The pre-loaded cassette 30 may be removed from the outer package 60 and installed in the bag feeder 128 as needed.

[0245] In some embodiments, various protective caps or membranes may be included on some components of the bag 26. For example, a membrane or cap may be included on the ports of the bag 26. This may help establish a sterile connection if the bag 26 needs to be manipulated after removal from the outer package 60 to install the bag 26 into system 10. The cap or membrane may be removed shortly before connection or installation to system 10. Alternatively, the membrane or cap may be pierced during filling.

[0246] As purified water is produced by the medical water production device 14, the water may be output through the dispenser 1420 to each IV bag 26. The robotic manipulator 1422 may pick up the bags 26 from the bag feeder 128 and shift 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 system 10 or placed in the quarantine area 1424 while various tests on the fluid output from the dispenser 20 are completed. In some embodiments, a seal may be created in the fill catheter leading to the bag 26. Such a seal may be created via heat, dielectric, or RF welding, installing a plug, or other sealing member or any other suitable process.

[0247] Now referring Figure 4A , another system 10 for producing and encapsulating medical fluid is shown. As with Figure 3As described, system 10 is configured to fill individual bags 26 rather than filling via receiving kit 24. Figure 4A The example system 10 in Figure 4A is configured to generate bags 26 with various types of solutions. Figure 2A System 10 in Figure 4B includes components described with respect to Figure 2B to complete a mixing operation to generate a solution.

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

[0249] Now also referring to Figure 6, in 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, where the concentrate chamber contains a liquid, freeze-dried, crystalline, or other powdered concentrate (depicted as a stippled pattern in chamber 54). Chambers 50, 54 can be separated and in communication with each other via a seal 52 or a plurality of seals 52. The seal 52 can be user or machine-disconnectable. For example, the seal 52 can include a frangible one or the seal 52 can be peelable. Depending on the embodiment, the seal 52 between chambers 50, 54 may be broken by a 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 a point in time closer to the use of the bag 26. For example, this can be done in cases where the mixed solution has a relatively short shelf life. In the case where 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 can include a vibrator, an oscillator, a mechanical stirrer, or other components that assist in mixing the concentrate with any water introduced into the bag 26. In some embodiments, the inlet port to the bag 26 can include a structure that causes the water entering the bag 26 to vortex or turbulently mix any concentrate included in the bag 26. In the case where the seal is peelable, it can be generated by changing the process characteristics during seal formation. For example, a lower heat, power, welding time, etc. than that used to form the peripheral seal of the bag 26 can be employed to manufacture the peelable seal. In certain examples, the system 10 can include a set of rollers or similar pressure applicators that can operate on the bag 26 to break any peelable seals.

[0250] In the case where some form of concentrate is provided in the bag 26, the bag 26 can be coded so as to be easily recognizable by a person, a machine, or both. For example, the bag 26 can be color-coded (Color A = saline solution, 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 can be color-coded, or the bag 26 can include color-coded stripes, blocks, or regions. The location of the color coding or the shape of the color-coded area can also vary between bags 26. The bag 26 can also include machine-readable markings, such as barcodes, data matrices, wireless interrogation identifiers, etc. In some embodiments, the bag 26 can also be color-coded by volume or by various kit characteristics. For example, a fluid administration kit 28 having a burette, an injection port, etc. can have a different color coding from a fluid administration kit without these.

[0251] In some embodiments, the bag 26 can be differentiated based on human- or machine-observable features other than color. For example, in some embodiments, the bag 26 or a portion thereof can additionally or alternatively have different geometries, such as an elongated shape, a square, a cylindrical shape, etc. Any shape with a circular or polygonal cross-section can be used. The location of the compartments within the bag 26 can also be visually distinguishable and can depend on the concentrate held therein. For example, a first concentrate can be located in a corner compartment or in the 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, which extends at an angle substantially perpendicular thereto. A second concentrate can be stored in the compartment 54, which extends along one side of the bag 26 defined by the seal 52, where 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 Apr. 15, 2019, entitled "Medical Treatment System and Methods Using a Plurality of Fluid Line" (Attorney Docket No. Z55), the entire content of which is incorporated herein by reference, can be used.

[0252] Now referring to Figure 7 , an exemplary bag 26 is depicted. The bag 26 can be filled with any of the fluids described herein by any of the systems 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

[0253] Since the aliquot associated with the bag 26 is separated from all other fluids filled into the bag 26, the aliquot can be accessed discretely without accessing the main volume that may be filled with fluid intended for administration to a patient. This can allow for the extraction of a fluid sample from the separated aliquot that is compositionally representative of the fluid in the main volume for testing. The volume of the main fluid filled into the bag 26 can remain undisturbed by the sampling performed on the aliquot. Thus, the aliquot can allow for sampling of the fluid in the bag 26 without destroying or discarding the entire bag 26. As a result, each bag 26 can be tested before the bag 26 is cleared for use. Additionally, this can allow for the performance of certain tests that are difficult or infeasible to perform when the bag 26 is being filled after the bag 26 is filled. For example, tests that require incubation or a waiting period can be performed on the fluid sampled from the aliquot separated within the bag 26. After filling, the bag 26 can be held in a quarantine area until the test is complete. Once the test indicates that the fluid in the bag 26 meets a predetermined acceptable standard, the bag 26 can be released for use.

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

[0255] As shown, the bag 26 includes a partial barrier wall 1202. The partial barrier wall 1202 can substantially partition a portion 1203 of the internal volume of the bag 26 from the remainder of the internal volume or main volume 1205 of the bag 26. However, the partial barrier wall 1202 can be breached by at least one gap or interruption region 1204. The gap region 1204 can provide a fluid pathway between the partitioned portion 1203 of the bag 26 and the remainder of the internal volume 1205 of the bag 26. As the bag 26 is filled, both the main volume 1205 of the bag 26 and the partitioned portion 1203 can receive fluid. Since the gap region 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 the same compositionally.

[0256] Now also referring to Figure 8, once the bag 26 has been filled, a seal can be formed in any gap region 1204 that breaches the partial 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 material together at at least one gap region 1204. Thus, aliquots of fluid can be severed from the main volume 1205 of the bag 26. Since 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 formed within the bag 26 such that when the bag 26 is filled and at least one break or gap region 1204 is sealed, the internal aliquot will have a desired nominal fluid volume contained therein. Similarly, the partial barrier wall 1202 can be arranged such that when the bag 26 is filled and the gap region 1204 is sealed, the main volume 1205 within the bag 26 has a nominal capacity volume. The size of the internal aliquot can be designed to contain a fluid volume sufficient for any intended sampling.

[0258] As Figure 8 shown, the complete barrier wall 1206 can be positioned and shaped such that when the fluid in the bag 26 is dispensed, the fluid contained in the main volume 1205 of the bag 26 is urged toward the port 392. In this example, the partition portion 1203 of the bag 26 is located at a corner of the bag 26 on the side of the bag 26 that is adjacent to the port 392. The complete barrier wall 1206 includes an inclined section 1208 that is inclined toward the port 392. Thus, when the bag 26 is suspended (e.g., for gravity-fed dispensing), fluid entrapment or bagging along the region of the complete barrier wall 1206 can be inhibited. This can help ensure that all of the fluid filled into the main volume 1205 of the bag 26 can be dispensed without user intervention to reposition the bag 26. In other embodiments, the complete barrier wall 1206 can include rounded features that help direct the fluid toward the port 392. In alternative embodiments, the internal aliquot can be generated on a side of the bag 26 that is opposite the side that includes the port 392 or in a corner of the bag 26 that is remote from the corner adjacent to the port 392.

[0259] Now refer to Figure 9, Flowchart 1240 depicts a number of example actions that can be performed to encapsulate fluid within bag 26. At block 1242, a fill nozzle can be introduced into port 392 of bag 26. At block 1244, fluid can be delivered through the fill nozzle into the internal volume of bag 26. Bag 26 can be filled until a desired amount of fluid has been transferred into the interior of bag 26. At block 1246, the nozzle can be removed from port 392 and port 392 can be sealed. In the case where bag 26 is included as part of fill receptacle kit 24, a nozzle may not be used. Instead, port 392 of bag 26 can receive fluid from manifold 20. When a desired amount has been filled into bag 26, port 392 can be sealed and bag 26 can be provided from the manifold, as described elsewhere herein.

[0260] At block 1248, a seal can be generated within bag 26. This seal can create an internal aliquot within the internal volume of bag 26 that is separated from the main volume of bag 26. At block 1250, a fluid sample can be collected and tested from the internal aliquot. In the case where bag 26 is included as part of fill receptacle kit 24, a nozzle may not be used. Instead, port 392 of bag 26 can be filled through manifold 20. When a desired amount has been filled into bag 26, port 392 can be sealed and bag 26 can be provided from the manifold, as described elsewhere herein.

[0261] Now refer to Figure 10 , another exemplary bag 26 is depicted. As shown, bag 26 includes two ports 392. These ports 392 can be sealed into a peripheral seal 1200 that defines the internal volume of bag 26. In an example embodiment, peripheral seal 1200 includes an enlarged portion 1210 in which ports 392 are coupled within bag 26. Enlarged portion 1210 can have a greater width than the remainder of 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 enlarged portion 1210 of peripheral seal 1200.

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

[0263] As shown, one of the channels 1212 includes a branch 1214. Branch 1214 may extend to a sampling reservoir 1216 that is included within the enlarged portion 1210 of the outer seal 1200. Sampling reservoir 1216 and branch 1214 may likewise be defined as open areas during the formation of the enlarged portion 1210 of the outer seal. When the bag 26 is filled, branch 1214 and sampling reservoir 1216 may be in communication with the interior volume of the bag 26. Thus, when the bag 26 has been filled, the fluid within sampling reservoir 1216 and the interior volume of the bag 26 may be in communication and should be the same in composition. Once the bag 26 is full, and now referring to Figure 11 , the sampling reservoir 1216 may be separated from the interior volume of the bag 26. In some examples, this may be accomplished by heat-sealing (or otherwise sealing) branch 1214 or a closed portion thereof. Thus, as described above, an internal aliquot of the fluid may be isolated within the bag 26.

[0264] Now referring to Figure 12, depicts another exemplary bag 26. As shown, bag 26 includes three ports 392. These ports 392 can be sealed into the peripheral seal 1200 of bag 26. Bag 26 can also include an internal seal 1220. The internal seal 1220 together with the peripheral seal 1200 can define a first internal compartment 1222 and a second internal compartment 1224. Compartments 1222, 1224 can have different volume capacities. The internal seal 1220 can extend between two of the ports 392 such that one of the compartments 1222, 1224 can be accessed via a single port 392 and the other of the compartments 1222, 1224 can be accessed via the remaining two ports 392. The compartment 1222, 1224 that can only be accessed via one port 392 can but need not be 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 smaller volume compartment 1224 can be filled through port 392. Then, the port 392 leading to the small volume compartment 1224 can be sealed. Thus, the smaller compartment 1224 can be filled to contain aliquots of the separated sample that can be removed therefrom for various tests. The larger compartment 1222 can contain a medical fluid preparation intended for delivery to a patient. The larger compartment 1222 can be filled through one of the ports 392 and then that port sealed. The other port 392 in communication with the larger compartment 1222 can be used to deliver fluid. Since the sampling aliquot in the small compartment is filled into a compartment that is fluidly separated from the fluid to be delivered to the patient, the aliquot can be referred to as an external aliquot. The two compartments 1222, 1224 can be filled simultaneously from a branched filling line. Thus, the fluid in the external aliquot should be representative in composition of the fluid in the larger compartment 1222.

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

[0267] In certain examples, and now referring primarily to Figure 13, an internal seal 1220 may be constructed therein with perforations 1221. The perforations 1221 may extend along the entire length of the internal seal 1220 and are all used to separate the external aliquots filled into the bag 26 from the bag 26 after filling. In the bag 26 with perforations, each compartment 1222, 1224 of the bag 26 may include a corresponding (e.g., matching) unique identifier, which may be machine and / or human-readable. Any suitable identifier may be used, such as any identifier described herein. This may allow any tests performed on the external aliquots separated from the bag 26 to be associated with the remaining but now separated portions of the bag 26. The perforations 1221 that allow the separated aliquots to be separated from the bag 26 may be included in other bag 26 embodiments. For example, the partial barrier wall 1202 described with respect to Figure 7 and Figure 8 may include perforations 1221. Additionally, the seal formed when filling the gap region 1204 in the partial barrier wall 1202 to generate the complete barrier wall 1206 may include perforations 1221. This may allow internal aliquots to be separated that are to be separated from the remainder of the bag 26.

[0268] Now referring to Figure 14 , a flowchart 1260 is shown that details a plurality of example actions that may be performed to encapsulate a fluid within the bag 26. In block 1262, a nozzle may be introduced into a first port 392 of the bag 26, which first port may communicate with a first compartment in the bag 26. In block 1262, a second nozzle may also be introduced into a second port 392 of the bag 26, which second port communicates with another compartment of the bag 26. In block 1264, fluid may be delivered into the bag 26 until the compartments of the bag 26 are filled to a desired amount. In block 1266, the nozzles may be removed from the first port and the second port 392, and the first port and the second port of the bag 26 may be sealed. This may create a first compartment that may communicate with a third port through which the contents of the first compartment may be liquid-fed. This may also create an external aliquot fluid in the second compartment (e.g., the smaller compartment) that may be used for testing. In block 1268, samples from the external aliquot may be collected and tested. In the case where the bag 26 is included as part of a filling receptacle kit 24, nozzles may not be used. Instead, the ports 392 of the bag 26 may receive fluid through a manifold 20. When the desired amount has been filled into the bag 26, the ports 392 may be sealed and the bag 26 may be provided from the manifold 20, as described elsewhere herein.

[0269] Now also referring to Figure 15, depicts an exemplary filling apparatus 1290. As shown, the filling apparatus 1290 includes a first filling nozzle 1292 and a second filling nozzle 1294. Such a filling apparatus 1290 can be used to fill bags 26 such as Figure 12 shown in the figure. The filling apparatus 1290 includes a common line 1296 and a bifurcation 1298 that 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 separate compartments included in the bag 26. The second nozzle 1294 can be associated with a non-powered valve that stops the flow of fluid into the associated compartment when that compartment reaches capacity. In an 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 larger compartment. Once the smaller compartment is filled, the pressure in that compartment can begin to build up (the associated seals in the bag 26 can be constructed strong enough to withstand that pressure). Then, the check valve 1299 can be actuated after it is filled to capacity and prevent further flow into the smaller compartment.

[0270] Now referring to Figure 16 , in some embodiments, the filling nozzle 1230 can include features that can allow aliquots of fluid to be separated from the fluid filled into the bag 26. Such aliquots can be generated when the bag 26 is filled with fluid. In certain examples, an aliquot can be collected by overfilling the bag 26 and collecting the fluid that flows out of the bag 26 after the bag 26 has been filled to its capacity during the filling operation.

[0271] As shown, the filling nozzle 1230 can be inserted into the port 392 of the bag 26. The filling nozzle 1230 can include a first lumen 1232 and a second lumen 1234. The first lumen 1232 can be in fluid communication with a fluid source and can receive fluid pumped or otherwise delivered from the fluid source. The fluid from the fluid source can leave the first lumen 1232 and fill the bag 26. The second lumen 1234 can extend out of the filling nozzle 1230 and can be in communication with an aliquot collection reservoir. When fluid in excess of the capacity of the bag 26 is discharged from the first lumen 1234, this overfilling can cause the fluid in the bag 26 to be pushed out through the second lumen 1234. The fluid pushed out of the bag 26 through the second lumen 1234 should be identical in composition to the rest of the fluid in the bag 26. Thus, the fluid flowing to the aliquot collection reservoir during the overfilling period can 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 communicate with an 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 separate from the bag 26 and the second port 392 may be closed with a pierceable inlet or diaphragm. The fill 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 displaces fluid from the interior volume of the bag 26, the fluid should be the same in composition as the remaining fluid within the bag 26, and tests performed on samples from the aliquot should be representative of the contents of the bag 26.

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

[0274] Now referring to Figure 18, depicts an example fill receiving kit 24. As shown, the fill receiving kit 24 includes a plurality of bags 26 and a fluid delivery kit 28. The manifold interface element 22 of each fluid delivery kit 28 is attached to a manifold 20, which is included as part of the fill receiving kit 24. This attachment can be performed in a controlled sterile environment before placing the bags 26, fluid delivery kits 28, and manifold 20 into an outer package 60. In some embodiments, the outer package 60 can be a sealed bag or a blister pack. It is possible that after enclosing the bags 26, fluid delivery kits 28, and manifold 20 within the outer package 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 package 60 can maintain a sterile environment, which protects the fill receiving kit 24 from contamination during storage. Any fill receiving kit 24 described herein can be sterilized as described above. Embodiments of the individual fill bags 26 can also receive the bags 26 and possibly a dispenser (e.g., a bag cassette) within the outer package 60 sterilized as described above. The plug dispensers described elsewhere herein can be similarly sterilized and provided within the outer package 60. Any other consumables described herein that are replaced during operation of the system 10 can be provided within the outer package 60 as sterilized.

[0275] In some embodiments, various protective caps or membranes can be included on some components of the fill receiving kit 24. For example, a membrane or cap can be included on any coupler on the manifold 20 that is not pre-connected to another component. This can facilitate the establishment of a sterile connection if the bags 26 and fluid delivery kits 28, after removal from the outer package 60, require manipulation to install the fill receiving kit 24 into the system 10. The cap or membrane can be removed shortly before connection or installation to the system 10.

[0276] In some embodiments, the manifold interface element 22 of the fluid delivery kit 28 can 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 content of which is incorporated herein by reference.

[0277] In embodiments where the system 10 makes connections in an automated manner, each of the manifold interface elements 22 can include a cap that can be removed by the system 10. In such an embodiment, the system 10 can include a drivable slider thereon, to which the manifold interface elements 22 can be mounted. A second slider can also be included, which includes a cap retainer or gripper. The second slider can be displaced towards the first slider to couple with the cap. Then, the second slider can be displaced from the first slider to remove the cap from the fluid supply kit 28. The second slider can then be retracted out of the displacement path of the first slider. The first slider can be advanced towards the manifold 20 to seat the manifold interface elements 22 on the connectors of the manifold 20. In some embodiments, the fluid supply kit 28 or another fill conduit can include a pierceable diaphragm that maintains a sterile barrier for the interior volume of the associated bag 26 and the fluid supply kit 28. In such an embodiment, the manifold 20 connector can include a piercing member (such as a spike or needle), and the action of the first slider can cause the piercing member to be driven through the pierceable diaphragm and into sealed engagement therewith to facilitate filling.

[0278] The manifold 20 can also include a connector 62 for establishing fluid communication with the output of the medical water production device 14. In some embodiments, the connector 62 can include a cap and can be driven onto a piercing member (e.g., a spike or needle) that communicates with the output from the medical water production device 14 in the manner described above. In other embodiments, the connector 62 can be a luer fitting. By providing the manifold interface elements 22 pre-connected to the manifold 20 within the outer package 60, only a single connection needs to be made to place the bag 26 and the fluid supply kit 28 in fluid communication with the output stream of the medical water production device 14. This eliminates the need to make a number of sterile connections. This can be particularly desirable in embodiments where the fill receiving kit 24 includes a large number of bags 26 and fluid supply kits 28.

[0279] In some embodiments, each bag 26 can be a bag 26 of the same volume. However, if desired, the bag 26 can be filled to a volume less than its capacity. This can allow for uniformity and simplicity in system 10. There is no need to store many different fill-receiving kits 24 (mini-bags, 250 ml, 500 ml, 1 liter, etc.). In some embodiments, there can be two types of kits 24. One type of kit 24 can include a bag 26 that is the largest-volume bag among the bags 26 and is intended for relatively small amounts of fluid. These bags can accommodate any fill volume, from very small amounts to some first maximum amount (e.g., 500 ml). Other maximum capacity cutoffs can be used. Another type of kit 24 can include bags of a large-volume size that can accommodate any fill volume within a range from a large amount of formulation up to a second maximum amount that is greater than the first maximum amount. When the 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, entitled "Medical Treatment System and Methods Using a Plurality of Fluid Line," filed on April 15, 2019 (Attorney Docket No. Z55), the entire content of which is incorporated herein by reference.

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

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

[0282] The fill receptacle kit 24 can also be used with certain types of medications. For example, the fill receptacle kit 24 can be constructed of or equipped for photosensitive medications (e.g., amphotericin B, nitroglycerin, etc.). In such an embodiment, the fluid delivery kit 28 and the bag 26 can be made of a light-blocking material or can be fitted with a light-blocking cover or sleeve. In some cases, the material used to form the tubing or bag 26 can include a light-blocking layer (e.g., amber or green material).

[0283] In certain examples, multiple fill receptacle kits 24 having different characteristics (e.g., bag size) can be installed in the system 10 simultaneously. Depending on the command the system 10 is performing, the system 10 can fill the bag 26 from an appropriately sized fill receptacle kit 24. In such an embodiment, the fill receptacle kit 24 can include a marker (e.g., barcode, data matrix, RFID, etc.) that can be read by the system 10 to allow the system 10 to determine the type of kit 24 installed.

[0284] Now referring Figures 19A to 19B , the bag 26 and the fluid delivery kit 28 included in the fill receptacle kit 24 can be integrated with each other. This may be desirable as it can allow the fluid delivery kit 28 to be pre-filled in certain embodiments. Additionally, this would remove the need to pierce the bag 26. Since typical bags 26 can be difficult to hold and pierce, the integrated kit can make the bag 26 more user-friendly and remove the aseptic connection procedure performed during setup. The fluid delivery kit 28 can be integrated into the bag 26 in a manner similar to that used for peripheral seals that bond spike ports, injection ports, etc. to IV bags.

[0285] For example, the bag 26 can be constructed of two separate flexible material sheets 84A, 84B. The sheets 84A, 84B can be joined at their perimeters via any suitable type of sealing method, including solvent bonding, RF welding, heat sealing, adhesives, ultrasonic welding, etc. The sheets 84A, 84B can be made of any suitable material or laminate. The tubing 82 can be constructed similarly. Laminates can be selected and ordered to achieve desired goals. For example, a vapor or gas impermeable layer or other barrier layer, an adhesive layer, a solution-compatible layer, and a reinforcement or durability-increasing layer can be included. The materials selected can convey the following information: the expected sterilization method, weight, optical transparency, hardness, flexibility, heat resistance, lubricity, modulus of elasticity, the desired material thickness, ease of forming (e.g., forming fittings at the ends of the tubing), strength, tendency to kink, light-blocking ability, dielectric / polarity, etc. Materials that can be used to construct the bags and tubing are provided in Table 1 below:

[0286] Polymer Homopolymer Hydrocarbon copolymer Polyester Polybutadiene Polyamide Styrene Polyvinyl chloride Polyolefin Polypropylene Propylene-ethylene copolymer Polyethylene copolymer LDPE, VLDPE, ULDPE MDPE HDPE Silicone Crosslinked polyethylene Synthetic rubber Thermoplastic rubber Rubber Latex Fluoropolymer Nylon Plastic without phthalate plasticizer or without DEHP Ethylene vinyl acetate Polyether block amide Thermoplastic polyurethane Plastics containing polar molecules RF solderable polyolefins

[0287] In the case where the sheets 84A, 84B have a multi-layer structure, they can be formed, for example, during an extrusion lamination or co-extrusion process. The tube 82 of the fluid supply kit 28 can be manufactured as a multi-layer structure of different materials (e.g., extrusion). In the case of using different materials, an adhesive layer may 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 lumen allowing inflow and outflow to and from the bag 26, as Figure 19B shown. In an alternative embodiment, the bag 26 can be blow molded. In such an embodiment, the tube 82 can be attached peripherally in a similar welding process.

[0288] Figure 20 Another exemplary bag 26 is depicted. Figure 20 The exemplary bag in Figure 21 includes a fluid supply 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 diaphragm, plug, cap, or similar sealing device. The sealing member can be installed after the filling process is completed. Alternatively, a sealing member may not be used, but a welded seal can be formed. The fill port 90 can also be used as an injection port, which can allow drugs to be added to the bag 26 as needed. In other embodiments, the fill port 90 can be located on the side of the bag 26 that does not have the fluid supply kit 28 attached. As

[0289] Figure 22A depicted, the fill port 90 can also be included in the face of one of the panels that are joined together to form the bag 26.

[0290] As Figures 22B to 22DAs shown, after the bag 26 is filled through the fill line 140, the system 10 can generate a seal 146 (represented by the shading in Figure 22D ) in a section of the fill line 140. This can be produced via RF welding or a similar process, or a tube sealer assembly 906 (such as that shown and described with respect to Figure 172 ) can be used. The seal 146 can be formed via the RF welding die / bar 144 of the system 10. In some embodiments, a roller or squeegee assembly 145 can be used prior to introducing the welding die 144. As shown in Figure 22C , the roller or squeegee assembly 145 can be pressed against the fill line 140, and one or more rollers or squeegees of the assembly 145 can be displaced in opposite directions to push the liquid out of the welding area 145. Then, the welding die 144 can be introduced to form a seal in the fill line 140. The roller or squeegee assembly 145 can remain present or absent when the seal is generated. Once the seal 146 has been formed, a cutting element 148 (see Figure 22E ) can separate the sacrificial end of the fill line 140 from the remainder of the fill line 140. This can result in the sealed portion of the fill line 140 extending from the bag 26, as shown in Figure 22F . Preferably, the sealed portion of the fill line 140 can be kept to a minimum length to limit the amount of fluid that can be separated from the fluid supply kit 28 when the bag is emptied. In certain examples, the seal 146 can extend to the peripheral edge of the bag 26.

[0291] Now referring to Figure 23, depicts another design of the bag 26. As shown, the bag 26 includes a liquid delivery kit 28 integrated into the bag 26, as described elsewhere herein. The liquid delivery kit 28 includes a drip chamber 190, a roller clamp 192 (but may also include another type of clamp or no clamp), and a Y-site 194 (or other type of bifurcation). The bag 26 can be filled through a fill port 196 attached to the Y-site 194. Once the bag 26 has been filled, the portion of the branch leading from the Y-site 194 to the fill port 196 can be sealed (e.g., by high-frequency welding), and the fill port 196 can sever the liquid delivery kit 28, as described elsewhere herein. During liquid delivery, the remaining branches of the Y-site 194 can include a liquid delivery port 198, which includes a lumen that remains unobstructed after sealing and removing the other branches of the Y-site 194. This liquid delivery port 198 can be connected to a cannula line or the like to deliver the contents of the bag 26. In such an embodiment, the cannula line can include a check valve to prevent backflow. In some embodiments, the ports 196, 198 can include Luer fittings. This type of bag 26 and liquid delivery kit 28 can be pre-filled. Before use, the user can hold the bag 26 and the kit 28 such that the liquid delivery kit 28 is vertically above the bag 26. The drip chamber 190 can be squeezed as needed to displace the fluid in the drip chamber 190 into the bag 26. Then, when the drip chamber 190 returns to its normal shape, air within the bag 26 can be drawn into the drip chamber 190. This can create an air space within the drip chamber 190 for operating the drip chamber 190 and visualizing droplet formation during flow rate setting.

[0292] Now referring to Figure 24 , another example of the bag 26 and the liquid delivery kit 28 is shown. As shown, the bag 26 and the liquid delivery kit 28 do not include a Y-site 194 (e.g., see Figure 23 ). Instead, the liquid delivery kit 28 includes a liquid delivery port 198. The drip chamber 190 is attached to a frangible or breakable barrier 200, which can be broken by the user before liquid delivery so that the user can fill the liquid delivery kit 28. The bag 26 can include a fill inlet 202 on another part of the bag 26, which interfaces with the output of the medical water production device 14 or the manifold 20. Once filled, the inlet can be welded closed and a portion of it can be cut off from the bag 26. This process can be similar to Figure 22A to Figure 22F shown for the bag 26. Alternatively, providing a fill inlet 202 can be arranged as a Y-site 194 upstream of the drip chamber 190 (e.g., see Figure 23In the form of (). In some embodiments, the injection port may also be included in the bag 26. Such an injection port may be included on the side plate of the bag 26 or may be attached at the edge of the bag 26 (e.g., adjacent to the attachment point of the fluid supply kit 28).

[0293] Now referring to Figures 25A to 25C , an exemplary manifold 20 is shown. The manifold 20 included in the filling receiving kit 24 may be a disposable component. Alternatively, the manifold 20 may be returned to the manufacturer or taken to another location after use and cleaned to allow it to be used in another filling receiving kit 24. In embodiments where the manifold 20 is a single-use component, it may be designed to be simple to manufacture and not unduly expensive. For example, the manifold 20 may be formed of an injection molded block 68 of a material including a plurality of flow paths 74. These flow paths 74 may be open on one side. As Figure 25C 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. These plates may be attached in any suitable manner, including via heating, solvent bonding, welding, fasteners (and possibly washers), 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. Laser welding may seal the periphery of any flow paths 74 included in the manifold 20. Although described as plates 70, 72, in some examples, the use of a flexible film cover in place of at least one of the plates 70, 72 is also contemplated.

[0294] Primarily referring to the opposite faces of the block 68 depicting the exemplary manifold 20 Figure 25A and Figure 25B , the block 68 may include a plurality of passages 76A - 76C in communication with the fluid paths 74. The block 68 may also include a plurality of fittings or connectors 78, 80. In some example embodiments, the connectors 78, 80 may be Luer fittings. If desired, the plates 70, 72 may include apertures through which the connectors 78, 80 may extend (e.g., see Figure 25C). In other embodiments, the plates 70, 72 may include connectors 78, 80. The connector 78 may be used to form a connection with the output of the medical water production device 14. The connector 78 may surround the passageway 76A leading to the opposite side of the block 68. The passageway 76A associated with the connector 78 may be in fluid communication with multiple segments of the flow path 74 on the opposite side of the block 68. These segments of the flow path 74 may each extend to their own passageway 76B. In this example, the flow path 74 extends radially from the passageway 76A. In alternative embodiments, any desired routing scheme may be used. Each passageway 76B extends through the block 68 to a segment of the flow path 74 on the side of the block including the connector 78. These segments 74 of the flow path then extend to another passageway 76C extending through the block 68. Each passageway 76C extends to a connector 80 on the opposite side of the block 68. Each connector 80 may be coupled to a manifold interface element 22 of the liquid supply kit 28 included in the filling receiving kit 24. Alternatively, any manifold interface element 22 described herein may be included on another filling inlet, such as Figure 24 the filling inlet 202 of Figures 22A to 22F the filling line 140.

[0295] Figure 26 Another example filling receiving kit 24 including a manifold 20 is depicted. The manifold 20 may include a block 310. The block 310 may include a flow channel 312 therethrough. The block 310 may also include a connector interface 314 for coupling the inlet 324 of the manifold 20 to a dispenser for medical water or a medical fluid mixture (e.g., the output of the medical water production device 14 or the mixing volume 34). The flow channel 312 may include a plurality of branches 316 that extend from the wall 318 of the fluid channel 312 to ports 326 on the face of the block 310. A displaceable seal may be included within the fluid channel 312. In some examples, a displaceable rod 320 may be disposed within the fluid channel 312. The displaceable rod 320 may include a sealing portion 322 that may be made of a compliant material (rubber, silicone, various elastomers, etc.) or coated with a compliant material. Alternatively, the sealing portion 322 may include one or more O-rings or raised compliant portions. The sealing portion 322 may press against the wall 318 of the fluid channel and form a seal between the wall 318 and the displaceable rod 320 such 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 may be a plunger 330 (e.g., see Figure 27 ). In various examples, the displaceable rod 320 may also be a threaded rod or a lead screw 332 (e.g., see Figure 29 ). An actuator for governing the displacement of the displaceable rod 320 may be selected based on the type of displaceable rod 320 used.

[0296] The shiftable rod 320 can be actuated along the extent of the flow channel 312 to place various branches 316 in communication with the inlet 324. This can allow the bags 26 to be continuously filled (one, two, three, etc. at a time). In Figure 26 the example shown, the bag 26 is in fluid communication with the inlet 324 such that fluid entering the manifold 20 can be directed to the bag 26. The sealing portion 322 of the shiftable rod 320 prevents the entering 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 channel 312 and removed from the manifold 20. This can be accomplished by a welding die 144 similar to that described with respect to Figures 22A to 22F and possibly a roller or squeegee assembly 145. Then, the shiftable rod 320 can be shifted along the fluid channel 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.

[0297] In addition, in some embodiments, the manifold 20 can include a plurality of flow channels 312, each flow channel associated with a shiftable rod 320 (e.g., all extending parallel or generally parallel to each other). This can allow the bags 26 in communication with different flow channels 312 to be filled in parallel or independently of each other. In the case of filling the bags 26 associated with different flow channels 312 in parallel, the shiftable rods 320 of the respective flow channels 312 can be coupled to move in a coordinated manner (e.g., perhaps a 1:1 ratio). The system 10 can also fill the bags 26 of a plurality of manifolds 20, where the plurality of manifolds 20 can be installed in the system 10 simultaneously.

[0298] Reference Figure 27 and Figure 28 show an example manifold 20. In the example manifold 20, the shiftable rod 320 is depicted as a plunger 330. The plunger 330 includes a plunger rod 334 and a plunger head 336 that serves as the sealing portion 336. Figure 29An example is shown that includes a lead screw 332 as a shiftable rod 320. The lead screw 332 may also include a seal head portion 338 at its end, and this seal head portion is disposed within 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 pipelines extending from each bag 26 to the manifold 20, each bag 26 may also include a liquid supply kit 28, a spike port, an injection port, or one or more of any other inlets 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 filling volumes. In cases 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 the manifold 20 being installed or information about the bags 26 included on the manifold 20. This identifier may be machine-readable (such as a barcode, a data matrix, an RFID) or any other suitable identifier. The control system 15 may use the information collected from this identifier to control the filling of the bags 26 included on the manifold 20.

[0299] Now referring to Figures 30 to 33 the progression, an exemplary filling sequence is depicted. Although the shown manifold 20 includes a plunger 330, other shiftable rods 320 (e.g., a lead screw, a plunger with a rack and pinion device) can be similarly shifted by such a filling sequence. The plunger 330 may be provided with its plunger head 336, and this plunger head is disposed inside 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 Figure 28 ). The manifold 20 may be coupled to a dispenser 340 to place the flow channel 312 in fluid communication with a medical fluid supply. The coupling can be performed aseptically and via a threaded fitting (such as a Luer lock), a barb fitting, a quick connection, a magnetic coupling, or any other suitable method. In some embodiments, steam can be ejected to clean the connector interface 314 before the coupling occurs.

[0300] An actuator (not shown) can retract the plunger 330 from the fluid channel 312 by a distance. 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. In Figure 30 the example shown, only a single port 326 is placed in communication with the inlet 324. Then, the fluid can be transferred through the flow channel 312 to the bag 26 in communication with one or more ports 326. This is representatively depicted by the dotted line in Figure 30 . As Figure 31 shown, once the bag 26 or the plurality of bags 26 have been filled to the desired amount, the fluid transfer can be stopped.

[0301] 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 barb fitting) to which a tube providing the flow path is connected. The flow path can include a sealable area. For example, the sealable area can be welded to close the flow path to fluid flow. Thus, a seal 342 can be created at the sealable area to separate the bag 26 from the rest of the manifold 20. The seal 342 can be created as described elsewhere herein (e.g., see Figures 22A to 22F ). The displacement of the plunger 330 can be tracked by a sensing device to ensure that the correct port 326 or ports 326 are in communication with the inlet 324 at a given time. The sensing device can include a linear potentiometer, an encoder, an array of Hall effect sensors monitoring 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.

[0302] After the seal 342 has been created, the filled bag 26 can be removed from the manifold 20. As Figure 32 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. As Figure 32 shown, the plunger 330 can be retracted to a position further away from the inlet 324 to place an additional bag 26 or bags 26 in communication with the inlet 324. Fluid can be transferred to fill the bag 26 or bags 26 until the desired amount is reached and a seal 342 can be formed, as Figure 33 shown. This can be repeated until each bag 26 on the manifold 20 has been filled and removed from the manifold 20.

[0303] Now referring to Figure 34 , a fill receiving kit 24 including another manifold 20 is shown. The manifold 20 is similar to the manifold depicted and described with respect to Figures 28 to 33 , however, the bags 26 are connected 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 connected. Instead, a fluid line 344 providing the flow path for the bag 26 is inserted into an orifice in a block 310 forming the port 326. The fluid line 344 can be held in the port 326 via solvent bonding, an adhesive, a threaded connection, or via any other suitable means.

[0304] In other embodiments, the flow path between the manifold 20 and each bag 26 can include as Figure 35The disconnect fitting 346 shown. The disconnect fitting 346 may allow the bag 26 to be removed from the fill receiving kit 24 without a separate sealing operation. In some embodiments, a self-sealing sterile disconnect fitting may be used. In such embodiments, the fitting may be selected to allow the manifold 20 to be sterilized after all of the bags 26 thereon have been filled. This may allow the manifold 20 to be reused.

[0305] Now referring to Figures 36 to 38 , aspects of another exemplary fill receiving kit 24 are shown. As Figure 36 shown, the fill receiving kit 24 may include a manifold 20 that is pre-connected to a plurality of fluid delivery kits 28 that have been integrated into respective bags 26. As with other embodiments described herein, other fill conduits may be coupled to the manifold 20 in place of the illustrative fluid delivery kits 28. The manifold 20 in the exemplary embodiment may be a box 150 that is mounted to the system 10. The box 150 may include a fluid inlet port 152 that may be connected to a fluid output stream from the medical water production device 14. The box 150 may also include a plurality of connectors 154 (e.g., Luer fittings) that may be coupled to the manifold interface elements 22 (or fill lines 140, inlets 202, or other fill conduits) on each kit 28.

[0306] As Figure 38As best shown in the cross-section of the depicted cartridge 150, the cartridge 150 can include a rigid body 156, which in some examples can be injection molded. The rigid body 156 can include a plurality of valve stations 158A - 158I, which can be covered by a flexible membrane 160. In alternative embodiments, a plurality of flexible membranes can be included. For example, each valve station 158A - 158I can be covered by a dedicated flexible membrane. The shown flexible membrane 160 can be actuated (typically pneumatically, but mechanical or hydraulic is also feasible) against and away from the valve seats 162 of each valve station 158A - 158I to open and close the valves 158A - 158I. In the example illustration, all valve stations 158A - 158I are shown in the closed configuration. The cartridge 150 also includes fluid buses 164 located on opposite sides of the intermediate body 166 of the cartridge 150. The fluid buses 164 communicate with a fluid inlet port 152 through passages 172 in the side walls of the cartridge 150. A second flexible membrane 168 is included on this side of the cartridge 150 to seal the fluid bus 166. This second flexible membrane 168 can be replaced by a plate (such as the laser welded plates described elsewhere herein). By shifting the first flexible membrane 160 away from the valve seat 162 of the desired valve station 158A - 158I, the fluid bus 164 can be placed in communication with the desired valve station 158A - 158I. As shown, each valve station includes a passage 174 leading from the valve station 158A - 158I to the fluid bus 164. This can establish a flow path from the fluid bus 164 to the valve station 158A - 158I. The valve stations 158A - 158I can also include openings leading to the connectors 154 of the cartridge 150 to allow fluid to flow from the fluid bus 164 through the valve stations 158A - 158I and out of the cartridge 150 to the bags 26 and fluid administration sets 28 attached to the associated connectors 154. This can allow the bags 26 to be filled one by one (or two by two, etc.). In some embodiments, each valve station 158A - 158I can be associated with more than one connector 154. This may be desirable in cases where multiple bags 26 are to be filled at once.

[0307] Figures 39A to 39CShows the process of valve actuation, which can be used to fill the bag 26 attached to the cassette 150. The bags 26 can be filled in any order, but are shown here as being filled sequentially by opening the valve stations 158A - 158I in a left - to - right manner. As shown, the left - most valve station 158A can be opened to fill the associated bag 26. Once filled, the bag 26 can be removed from the cassette 150, as described elsewhere herein. Then, the valve station 158A can be closed. Then, the adjacent valve station 158B can be opened to fill its attached bag 26. The bag 26 and the attached fluid supply kit 28 (or other filling inlet) can be removed from the cassette 150 (e.g., sealed and cut, detached from a cooperating 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 thus the number of valve stations 158A - 158I 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 specific number of bags per unit time. For example, if the system 10 outputs fifty bags 26 at a low flow rate in one fill, there will be a certain downtime before the bags 26 become available. By filling the 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.

[0308] As Figure 40 shown, the cassette 150 can interface with the actuation block 180 included in the system 10. The actuation block 180 can be made of metal (or other rigid, dimensionally stable, thermally stable, and / or non - porous material) and be subjected to hot steam or exhaust flow from the medical water production device 14 before the cassette 150 is placed against the actuation block 180. The flexible membrane 160 on the cassette 150 can be covered with a covering layer that 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 the operator. In some embodiments, the cassette 150 can be pressed against the actuation block 180 by the closing and latching of a door of the system 10. In other embodiments, a piston or plate can be pressed against the side of the cassette 150 that includes the fluid bus 164 to force the cassette 150 against the actuation block 180 and ensure a good seal is achieved by the flexible membrane 160 around the valve stations 158A - 158I. This can be done via inflation of an airbag, rotation of a lead screw or cam, actuation of a scissor jack, a linear actuator, or any other actuator that can apply sufficient force.

[0309] As shown, the actuator block 180 includes a plurality of pressure passages. These pressure passages can be independently placed in selective communication 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 cartridge 150. By operation of the valves 188 associated with each control chamber 186, each control chamber 186 can be selectively placed in fluid communication with the positive pressure source 182 or the negative pressure source 184. In an example embodiment, each control chamber 186 is associated with both a positive pressure valve control application and a negative pressure valve control application. In an alternative embodiment, a single valve can be used to switch between positive pressure applications and negative pressure applications. In such an embodiment, the valve can be designed to apply positive pressure in a failure state. The positive pressure source 182 and the negative pressure source 184 can be reservoirs maintained at a particular 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 sources 191 at the pressure set point. In some embodiments, each control chamber 188 can also be in fluid communication with a pressure sensor 192. This pressure sensor 192 can be monitored to check if pressure is being applied to the valve chambers 158A - 158I of the cartridge 150 as expected. In some embodiments, the medical water production device 14 can output product at a pressure above ambient. 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 selected for closing the valve stations 158A - 158I can be sufficiently higher than the output pressure of the medical water production device 14 to maintain a robust closure of the valve stations 158A - 158I.

[0310] Once the bag 26 has been filled, the bag can be removed from the cartridge 150 (or any other manifold 20) in a variety of ways. For example, a weld seal can be made on the tubing (or fill port 140 or inlet 202) of the fluid delivery kit 28. Then, the bag 26 and a portion of the fluid delivery kit 28 can be cut off from the manifold 20. This can be similar to that described above with respect to Figures 22A to 22F Alternatively, the tubing of the fluid delivery kit 28 can be clamped or otherwise blocked, and the fluid delivery kit 28 is disengaged from the cartridge 150. Then, the fluid delivery kit 28 can be plugged with a cap or similar element. In some examples, each fluid delivery kit 28 can include a sliding clamp. When installed in the system 10, the sliding clamp can interface with an actuator that is commanded to shift once the bag 26 attached to the fluid delivery kit 28 has been filled to an appropriate amount. The shift of the actuator can drive the narrow portion of the sliding clamp towards the tubing such that the narrow portion of the sliding clamp blocks the tubing of the fluid delivery kit 28.

[0311] In the case where the system 10 is configured to mix various fluids, and now referring to Figures 41A to 42, the cartridge 150 may include a plurality of valved pumping stations 270A - 270C. Through the coordinated actuation of the valved pumping stations 270A - 270C, a small amount of fluid can be pumped through the cartridge 150. Referring to Figures 41A to 41F the progress, 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 each other, this is done to provide a streamlined example. Other configurations with additional and / or non - adjacent valved pumping stations 270A - 270C can be constructed.

[0312] As Figure 41B shown, the first valve station 270A and the second valve station 270B can be opened to perform a filling operation of the valved pumping 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 complete, the filled valve station 270B can be isolated by closing the first valve station 270A, as Figure 41C shown. Thus, the second valve station 270B can be used as an intermediate holding volume during valve - based fluid pumping.

[0313] Then, the third valve station 270C can be opened to establish fluid communication between the second 270B and the third valve station 270C, as Figure 41D shown. Then, a valve pump stroke can be performed by closing the second valve station 270B, as Figure 41E shown. This transfers the valve pump stroke volume from the intermediate holding volume to the third valve station 270C. Then, the third valve station 270C can be closed, as Figure 41F shown, to pump the valve pump stroke volume towards valve stations 158A - 158N associated with a bag 26 attached to the cartridge 150. Alternatively, the third valve station 270C can be omitted and the fluid can be transferred to the desired valve stations 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 greater volume for each 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 content of which is incorporated herein by reference.

[0314] Once the desired amount of concentrate has been transferred via a valve-based pumping stroke and is now mainly referenced Figure 42 , an amount of water can be transferred to the bag 26 to dilute the concentrate to a final concentration. The final concentration can be the concentration ready to be administered to the patient. The final concentration can also be defined to allow the addition of an amount of another drug to make a final pharmaceutical formulation, which is then administered to the patient. In an example embodiment, the inlet valve station 274 is included at the very end of the box 150. The inlet valve station 274 can communicate with the inlet 276 and, when opened, can establish a flow path from the inlet 276 through the fluid bus 164 to the desired valve stations 158A - 158N and the associated bags 26. By positioning the inlet valve station 274 at the end of the box 150, the flow of water through the bus 164 can also be used to flush any concentrate remaining in the bus 164 into the desired bag 26. In some embodiments, any valve station not dedicated to a particular concentrate (e.g., an intermediate holding volume station) can perform multiple valve pumping strokes with water to flush these stations.

[0315] When pumping the concentrate into the bag 26 via a valve pump stroke, the amount of concentrate to be flushed from the valve station and / or the fluid bus 164 can be taken into account in any volume target. Thus, the entire amount of concentrate defined for a particular bag 26 may not be transferred to that bag 26 until after the flushing is complete.

[0316] Figure 43 Another alternative fill 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 bags 26 can branch in series from the main line 204 via a plurality of lines 206. In some embodiments, the lines 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 to which the cooperating elements of the lines 206 can be coupled. The fill receiving kit 24 can be arranged to act as a manifold 20. The lines 206 to the bags 26 can be kept closed by a plugging device acting on the lines. Alternatively, the main line 204 can be plugged upstream of each branch point to the line 206 leading to one of the bags 26. In certain examples, the lines 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 can be filled one by one and cut off from the main line 204 after sealing, as described elsewhere herein (e.g., see Figures 22A to 22F). Once the bag 26 has been filled and severed from the fill receiving assembly 24, the pinch clamp 302 on another bag 26 (e.g., an adjacent bag) can be opened to allow that bag 26 to be filled. This can be repeated until all of the bags 26 in the fill receiving assembly 24 have been filled and severed from the main line 204. In some embodiments, more than one bag 26 can be filled at a time. The line 206 to the bag 26 can be constructed in the same manner as any of the lines or inlets described above and can include any of the features described elsewhere herein. For example, the bag 26 can include an additional fluid supply line (not shown) similar to Figures 22A to 22F or a Y-site similar to Figure 23 . A drip chamber 190 can also be included. In the Figure 43 example shown, the line 206 is included as a fill line and the bag 26 includes additional attachment inlets to its internal volume, such as a fluid supply kit 28 and an injection port 203.

[0317] In some embodiments, and now referring primarily to Figure 44 , the pinch clamp 302 can be not used. Instead, each line 206 extending from the main line 204 can have a sliding clamp 300 that, when installed in the system 10, is in a blocking position on the line 206 or upstream of the point where each line 206 branches from the main line 204. The sliding clamp 300 can be shifted to a flow-permitting position on the line to allow each bag 26 to be filled. In some embodiments, the sliding clamp 300 can remain stationary in a block and the line 206 can instead be shifted to bring the line 206 into the flow-permitting section of the sliding clamp 300. After filling, the line 206 can then be blocked by shifting the line 206 or the sliding clamp 300 to bring the line 206 into the flow-blocking portion of the sliding clamp 300. In the case where the sliding clamp 300 is in place on the main line 204, the same process can be used. Once the bag 26 has been filled to the desired amount, the line 206 can be detached from the main line 204 and capped or sealed.

[0318] Now referring to Figure 45 , in certain embodiments, the fill receiving assembly 24 can be constructed of two layers of material. For example, the fill receiving assembly 24 can be constructed of an adhesive sheet 220 or a sheet of material. In the case of using multiple sheets 220, they can be stacked on top of each other. In the case of using a single sheet 220, the sheet 220 can be a continuous sheet of material that is folded upon itself to create a multi-layer starting material. As Figure 46As shown, proximity elements 226, 228 can be placed at regular intervals between sheets 220 or between layers of folded sheet 220. For example, proximity element 226 can be an injection port, and proximity element 228 can be a fluid supply kit 28. In the example embodiment, only four sets (in pairs in this example) of proximity elements are shown; however, the number of sets of proximity elements 226, 228 can be chosen to match the number of bags 26 in fill receptacle kit 24. In some embodiments, each set of proximity elements 226, 228 can include more than two proximity elements. In other embodiments, each bag 26 can include only a single proximity element.

[0319] Now referring Figure 47 , a seal 230 can be formed to attach portions of sheet 220 or folded sheet 220 to each other and form fill receptacle kit 24. This can be accomplished via a welding process such as an RF welding process. The material chosen for each sheet can include an RF weldable material and can be a polar plastic such as PVC. For example, the layers of sheet 220 or folded sheet 220 adjacent to each other prior to welding can be made of such a material. During the construction of fill receptacle kit 24, multiple sheets 220 or portions of sheet 220 can be welded and the sheet material can be translocated to the next portion of sheet 220. That portion can be welded and translocated, and so on. The number of bags 26 formed in each welding operation can be less than the total number of bags 26 in fill receptacle kit 24. In some embodiments, 1 - 4 or more bags 26 can be formed at one time. Preferably, the number of bags 26 in fill receptacle kit 24 is an even multiple of the number of bags 26 formed in each welding operation. As shown, seal 230 can also be formed to create a flow path 232 in the bus portion 234 of fill receptacle kit 24. The internal volume of each bag 26 can be in fluid communication with bus portion 234 via a branch 238 from flow path 232 to each bag 26. In this example, the branches 238 all extend away from bus portion 234 in the same direction. In some embodiments, the branches 238 can extend from opposite sides of bus portion 234 such that the bags 26 are arranged on each side of bus portion 234.

[0320] When formed, bags 26, bus portion 234, and branches 238 can all be flat with substantially little or no internal volume. During filling, the sheet material can shift to allow bags 26 to fill and provide internal cavities at bus portion 234 and branches 238. As a result, there should be no trapped air volume in bus portion 234 and branches 238 and thus no transfer to bags 26 during filling. In some embodiments, a vacuum can be drawn on the flow path to ensure a minimal amount of air is present within the features formed by seal 230.

[0321] The welding and indexing processes can be repeated until the entire sheet 220 has been welded to form the fill receiving kit 24. When the sheet or sheets 220 are indexed, the welding die can extend over at least a portion of the overlapping area in the previously created weld seam. This can ensure that the seal 230 is formed airtight along the entire length of the fill receiving kit 24. In some embodiments, a pair of proximity elements 226, 228 can be introduced between the sheet 220 or sheets 220 each time indexing occurs. As Figure 47 shown, the pouches 26 can be formed close to each other to minimize waste of the sheet 220 material.

[0322] After indexing from the welding station, the sheet 220 or sheets 220 can be cut at a cutting station as Figure 48 shown. A portion of the sheet 220 or sheets 220 can be cut while another portion is being welded. The cutting station can include a cutting die that is advanced into the folded sheet 220 or sheets 220 to cut out the pouches 26. The excess material can be separated from the fill receiving kit 24. Ports 236 can be included at the ends of the fill receiving kit 24. A branch 240 from the flow path 232 can extend through the port 236 to the environment. The port 236 can be located near the inlet opening 249 of the flow path 232 leading into the fluid bus 234. In certain embodiments, a fitting can be coupled to the opening 249 to facilitate connection to the dispensing member.

[0323] Now referring to Figure 49 , when installed in the system 10, the dispensing member 250 can be received in the opening 249 or in a fitting secured thereto. This can be done by the user manipulating the bus portion 234 of the fill receiving kit 24, although such coupling can also be done 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 arrangement. Additionally, a plug 252 can close the flow path 232 upstream of the first branch 238 that leads to the pouch 26. The dispensing member 250 can initially output a steam stream into the flow path 232. This can clean the flow path. The steam can be provided by discharging steam (e.g., purified but uncondensed water vapor, possibly pharmacopeial 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, with an RF seal 254 as Figure 50 shown.

[0324] As Figure 50As shown, the dispensing member 250 (or in some embodiments, a second dispensing member that has been coupled to the opening 249 after removal of the steam dispenser) can output a medical water stream to the flow path 232 of the manifold portion 234. In the case of providing a fluid mixture to the bag 26, the mixture can be output by the dispensing member 250. The plug 252 can be advanced downstream of the first branch 238 to the bag 26. This can place the interior volume of at least one bag 26 in fluid communication with the opening 249. In some embodiments, as Figure 50 shown, the plug 252 can be shifted to a position on the flow path 232 that is intermediate between the first branch and the second branch 238 to the bag 26. In other embodiments, the plug 252 can be shifted 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 an appropriate amount (e.g., as sensed by a scale or displacement sensing device) and the dispensing can be stopped. The amount dispensed into a given bag 26 can be order specific and selected based on the amount of diluent required for a particular drug order. This can be calculated by the control system 15, which can communicate with a pharmacy order entry system and receive the order therefrom.

[0325] As Figure 51 shown, a seal 254 can be generated to close the branch 238 to any filled bag 26 and the filled bag 26 can be cut from the manifold portion 234. The seal can be generated via RF welding and the sealing process can be carried out as described, for example, Figures 22A to 22F in, or similar to that described with respect to Figures 159 to 175 The plug 252 can be advanced to place the interior volume of an additional bag 26 or multiple bags 26 in fluid communication with the opening 249. Then, the dispensing member 250 can output the medical water or medical fluid mixture as described above to fill the bag 26 or multiple bags 26. As Figure 52 shown, this can continue until all of the bags 26 included in the fill receptacle kit 24 have been filled. As described elsewhere herein, the fill receptacle kit 24 can include dozens of bags 26 (e.g., 50 - 100).

[0326] Now also referring to Figure 53, in some embodiments, the welding, cutting, and filling of the bags 26 can be a continuous process on a production line 280. In such an example, the sheet or tablet 220 can be pulled from a tablet source 282 in a continuous manner. The tablet source 282 can be a large roll, reel, 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 welder, such as an RF welder. The tablet 220 can be translocated through the bag / busbar former 284 such that one or more bags are formed in the tablet 220 at a time. The formed portions of the bags 26 and the busbars 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 the tablet 220 blocked by the sealer 288 of the production line 280, the filling station 290 can fill one or more of the cut-out bags 26. The filled bags 26 can be sealed to the busbars 234 at the sealing station 292 of the production line 280. The sealing station 292 can include an RF welder and can include rollers or scrapers as mentioned elsewhere herein. After sealing the bags 26 to the busbars 234, the bags 26 can be cut from the busbars 234 at the bag cut-off station 294 of the production line 280.

[0327] In an alternative example, the production line 280 can form and cut the bags 26 and the busbars 234 from a quantity of the tablet 220. However, the production line 280 can 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 to an institution or medical facility having filling, plugging, sealing, and bag cut-off components as a filling receiving kit 24. This can help minimize the amount of floor space required by the medical facility. In such an embodiment, the production line 280 can include a packaging station that applies an outer package around the filling receiving kit 24.

[0328] Now referring to Figures 54 to 55 , an example system 10 for producing and encapsulating a medical fluid is shown. As shown, the system 10 is placed in a cleanroom environment. The system 10 includes a housing 12. In an example embodiment, the housing is partitioned into a first portion 96 and a second portion 98. As Figure 55 best shown (which depicts Figure 54System 10, where some parts of the housing 12 are transparent), the first part 96 can accommodate the medical water production device 14. In an alternative embodiment, the medical water production device 14 can be in a non-cleanroom (or less stringent cleanroom) environment, and its output is piped to the cleanroom. In an exemplary embodiment, the medical water production device 14 is shown as a distillation device that receives water that has been pretreated by a plurality of filters 100 (e.g., carbon filters and / or reverse osmosis filters). The first part 96 can include a partition 102 that is used to divide the first part into a hot compartment and a cold compartment. The walls of the first part 96 of the housing 12 and the partition 102 can suitably include insulators to prevent the electronics and surfaces elsewhere in the system 10 from experiencing high temperatures during distillation. The top of the first part 96 can also have a working surface 104 that is designed to be easily cleaned. For example, Figure 54 the working surface shown has rounded corners, which can minimize the possibility of missed areas during cleaning. The working surface 104 can be used to open the packages of the fill receiving kit 24 or the individual bags 26 and manipulate them as needed to prepare them for installation into the system 10 for filling. The first part 96 of the housing 12 can also include a user interface 106, such as a touchscreen GUI. This 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 (e.g., for wiping and cleaning the working surface 104 or other system 10 components or for preparing the fill receiving kit 24). The user interface 106 can also be used to interact with the medical water production device 14 and allow changing settings and / or displaying notifications, alarms, warnings, and other messages related to the operation of the medical water production device 14.

[0329] The second part 98 of the housing also includes a user interface 108. In an example embodiment, the user interface 108 is included on an articulated cantilever 110. The cantilever 110 can include a plurality of joints that can allow the user interface 108 to be displaced by the user to a convenient position. The border 112 of the user interface 108 can include an easily graspable handle, which can facilitate the displacement of the user interface 108. The user interface 108 can be, for example, a touchscreen GUI.

[0330] User interfaces 106, 108 can be used to interact with components of system 10 that fill receiving kit 24, or in the example shown, individual bags 26. User interfaces 106, 108 can also be used to interact with various medical systems in a hospital, urgent care center, surgical center, or similar institution. Such a system 10 can include an 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 drug regulatory repository, and the like. Certain example medical systems that can interact with system 10 are described in further detail in U.S. Application No. 14 / 137,421, filed Dec. 20, 2013, entitled "Computer-Implemented Method, System, and Apparatus for Electronic Patient Care", the entire contents of which are incorporated herein by reference. Such systems can track the usage of system 10 for producing and packaging medical fluids and manage orders sent to system 10. These other medical systems can also monitor the production of system 10 and perform analyses on the actual bag 26 usage within the institution (bag storage times, solution usage in care areas, demand by day of the week, etc.). Bags 26 can include unique identifiers or be associated with unique identifiers to facilitate data collection for this purpose. These identifiers can be read before or during fluid administration to indicate that the fluid has been used and potentially where within the institution the fluid was used. This can allow for better inventory management and minimize storage costs and storage space requirements. This may help to allow system 10 to operate as part of a "just-in-time" inventory management system. Additionally, this may allow for additional checks to ensure that the fluid being used is the correct fluid for a particular patient (correct volume, concentration, dosage, no contraindications, etc.). Software updates for system 10 can also be provided via these other medical systems.

[0331] In some cases, user interface 108 can be used for user authentication; thus ensuring that only trained or qualified users can operate system 10 to produce and package medical fluids. This can be done via biometric identification, facial recognition, password entry, etc., which are checked against a database of approved users or passwords. In the case of using biometrics, user interfaces 106, 108 or another part of system 10 can be equipped with appropriate sensors (e.g., cameras, fingerprint scanners, etc.)

[0332] As Figure 55As best shown, the second portion 98 of the outer shell 12 may include a storage space or repository 120. The repository 120 may house at least one bag feeder 128 that is to be filled. In an example embodiment, two bag feeders 128 are stored within the repository 120. The bag feeder 128 is mounted to the system 10 via a rolling cart 122. The bag feeder 128 may include a biased platform 124. Bags 26 may be placed on the platform 124 in a stack. In an alternative embodiment, the bag 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 further include a top surface 126 that may include an aperture through which the bag 26 may be pushed. When a bag 26 is removed from the stack (e.g., by a robotic manipulator, robotic flipper, or vacuum gripper), the biased platform may advance 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 depleted. As shown, the biasing member of the platform 124 is depicted as a spring; however, in alternative embodiments, pneumatic, hydraulic, or other means for displacing the platform 124 may be used.

[0333] In an example embodiment, a vacuum gripper 130 is included to pick up the bags 26 and displace them to a fill station or dispenser. In other embodiments, the fill nozzle assembly may be displaced to the topmost bag 26 and coupled to a fill port on the bag 26. In embodiments where the bag 26 is filled via a liquid supply kit 28, the fill nozzle may be coupled to an inlet included on the liquid supply kit 28. The bag 26 may be transferred to a fill compartment 132 of the system 10 for filling. In other embodiments, particularly those where the liquid supply kit 28 or other conduits are integrated into the bag 26, a flipper may be used. The flipper may include a paddle member that is positioned below the path of the liquid supply kit 28 tube or other conduit to easily access beneath the bag 26 and separate the bag 26 from adjacent bags 26. The flipper may then transport the bag 26 to a fill station. Any suitable vision or sensing system may additionally or alternatively be used to assist in gathering and transporting the bags 26 away from the stack.

[0334] When the connection between the fill nozzle and the bag 26 or liquid supply kit 28 is complete, the coupling member may be cleaned. For example, an exhaust port of a distillation unit used as a medical water production device 14 may be positioned to spray hot steam onto the coupling on the coupling surface. Alternatively, the expelled hot steam may pass through the fill nozzle and be sprayed at the coupling of the bag 26 or kit 28.

[0335] In the case where it is desired to fill the bag 26 with a pharmacopoeial fluid such as WFI, fluid can be provided from the medical water production device 14. In embodiments where the system 10 is arranged to fill the bag 26 with a mixed fluid (if desired), the system 10 can include large reservoirs 40, 42. For purposes of example, the large reservoirs 40, 42 are labeled 5% dextrose and 30% normal 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 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 can include pumping equipment 134 that meters the fluid to be sent to the bag 26. The fluid can be metered to achieve a desired final fluid concentration in a given bag 26. In some examples, the pumping equipment 134 can be a cassette-based pumping equipment. One such example device is described in U.S. Application No. 16 / 384,082 (Attorney Docket No. Z55) entitled "Medical Treatment System and Methods Using a Plurality of Fluid Line" filed on April 15, 2019, 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 can include a sensing manifold. The sensing manifold can include conductivity and temperature probes for monitoring the components. Other types of component sensors can also be used. For example, the system 10 can include spectrometers, turbidimeters, pH probes, sensors such as polarimeters for monitoring the chiral properties of fluid components, dissolved ion sensors, dissolved oxygen sensors, redox potential sensors, refractometers, TOC sensors, etc. Similar sensors can also monitor or be integrated in the output from the medical water production device 14. Other sensors such as bioburden sensors can also be included. Data from any mixture quality sensor can be sent to the control system 15 of the system 10 for analysis. The data can be compared with predetermined acceptable limits or thresholds for a given fluid type. Such sensors can also be used as a redundancy check in addition to the water quality tests performed by the medical water production device 14. In embodiments where the system 10 is equipped to mix various fluids, it may be desirable to obtain a quality reading before consuming the concentrate from the medical water production device 14 into the fluid stream. The sensors described above or sensors in another sensing manifold can check the quality of the WFI water output from the medical water production device 14.

[0336] 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 retainer that places the bag 26 onto a conveyor assembly 138. The conveyor assembly 138 can move the bag 26 to a cabinet or similar storage location that can be used to hold the bag 26 until they are needed for fluid administration. Alternatively, the conveyor assembly 138 can transport the bag 26 to a compounding area where additional medications are introduced into the bag 26 either automatically or manually. In some embodiments, the conveyor assembly 138 can move the bag 26 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 they are cleaned for use.

[0337] In some examples, a sensing assembly can be included to monitor the bags 26 produced by the system 10. The sensing assembly can include, for example, a vision sensor that images the bags 26. A processor can perform image analysis and screen out potentially defective bags 26. For example, the processor can flag bags 26 that have visible particles, have incorrect colors, are leaking, have excessive air, and other issues of concern.

[0338] Now referring Figure 56 , a top view of another example system 10 for producing and encapsulating medical fluids is shown. The system 10 can include a medical water production device 14, such as any of the devices described herein. The system 10 can also include a mixing loop 348 and a sensor suite 350 that can monitor the quality of the purified water produced by the medical water production device 14 and the mixed fluid generated in the mixing loop 348. The sensor suite 350 can include any number of different types of water quality sensors. Any of the water quality sensors described herein can be included. The mixing loop 348 and the sensor suite 350 can be the example mixing loop 348 and sensor suite 350 described with respect to Figure 138 the example mixing loop 348 and sensor suite 350 described.

[0339] 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 clean room in which it is located. In some embodiments, the enclosure 12 can be ventilated by a blower system ( Figure 56(not shown in the figure) is maintained under positive pressure. In an exemplary embodiment, the outer shell 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 outer shell 12 to maintain positive pressure is clean.

[0340] The first portion 96 can be a front chamber, which can be used to prepare various consumables used by the system 10. For example, during use, the inventory of the bag 26 or the cartridge 30 pre-loaded with the bag 26 can be held in the front chamber. The stopper cartridge 466 (e.g., see Figure 74A ) can also be stored in the front chamber. The sampling vial 532 (e.g., see Figure 103 ) can also be held stored in the front chamber. This can help minimize the need to access the interior of the outer shell 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 portion 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 portion 96 can include an endotoxin or pyrogen tester, such as the Endosafe nexgen-PTS available from Charles River Laboratories, Inc. in Wilmington, Massachusetts (Charles River Laboratories Limited). In addition, any sampling ports in the fluid circuit can be accessed via the front chamber. The first portion 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.

[0341] The second portion 98 can include a bag feeder 354, a filling station 356, and a sealing station 358. The bag 26 can be loaded into the bag feeder 354 by the user via the glove interface 352. Alternatively, the filling receiving kit 24 can be used. In the illustrated example, a large container or box of individual bags 26 or a pre-loaded bag dispenser (e.g., a cartridge) can be held in the front chamber and the bags 26 can be individually mounted in the bag feeder 354. In certain embodiments, multiple bag feeders 354 can be included, each bag feeder holding a different type of bag 26 having a different filling capacity. A robotic arm 360 including a gripper can collect the bag 26 from the bag feeder 354 and shift the bag 26 to the filling station 356. Fluid can be dispensed into the bag 26 at the filling station 356. The fluid can be purified water (such as WFI water), or it can be in connection with Figure 2A and Figure 2BA fluid mixture generated at those hybrid subsystems described similarly. For example, the bag 26 may also include a concentrate as described above with respect to Figures 5A to 6 described. The robotic arm 360 may shift the filled bag 26 from the filling station 356 to the sealing station 358. The inlet of the internal volume of the bag 26 may be sealed closed (e.g., via a plug, RF welding, etc.) at the sealing station 358.

[0342] The bag 26 may be moved from the sealing station 358 to a quarantine repository 362 included within the second portion 98 of the housing 12. When the bags 26 are filled and sealed, they may be retained in the quarantine repository 362 for a period of time. For example, before the first bag 26 is stored in the quarantine repository 362, the sampling vial 364 may be brought to the filling station 356. A certain amount of fluid may be dispensed into the vial 364. Then, the vial 364 may be brought to a tester, such as the pyrogen (e.g., endotoxin) tester described above. Once the quarantine repository 362 is full or after a certain number of bags 26 have been placed in the quarantine repository 362, another fluid vial 364 may be collected at the filling station 356 and a second test may be performed at the tester. In order for the control system 15 to permit the release of the bag 26 from the quarantine repository 362, it may be necessary to pass both the pre-quarantine test and the post-quarantine test.

[0343] Once the bag 26 has been released from the quarantine area, the bag 26 may be labeled. In an example embodiment, the second portion 98 of the housing 12 includes a labeling machine 366. The labeling machine 366 may be any suitable labeling machine 366, such as a thermal printer. In certain embodiments, a thermal ribbon transfer type printer may be particularly desirable. The labeling machine 366 may generate a label and facilitate the application of the label to each bag 26 produced by the system 10. The label may be adhered to the bag 26 via an adhesive backing. The label may include information required by any relevant statutes or regulations as well as identification characteristics, tracking information, computer-readable markings, corresponding patient information, instructions for use, etc. Then, the bag 26 may be discharged from the housing 12 through the output section 368, which may include a chute with a gated or gated inlet and outlet. The bag 26 may leave the housing 12 through the output section and be discharged into a container or conveyor ( Figure 56 not shown in either

[0344] Now referring to Figure 57 shows Figure 56A side view of the enclosure 12 depicted. As shown, the side panel 370 of the first portion 96 of the enclosure 12 is depicted as transparent to permit viewing of the interior of the front chamber. As shown, the side panel 370 may include a port 372. The glove interface 352 may be mounted in the port 372 in a fluid-tight manner. The glove interface 352 may be mounted at a height that is comfortable for a typical standing or sitting user. The glove interface 352 may provide a sterile barrier through which a user may manipulate the various components of the system 10 within the enclosure 12.

[0345] Now also referring to Figure 58, shows a side view of an example enclosure with the side panel 370 and glove interface 352 removed. There can be a plurality of access openings from a first portion 96 to a second portion 98 of the enclosure 12. These access openings can include a bag loading door 374, a bag feeder port 376, a seal station port 378, and a vial access door 380. The bag feeder port 376 can allow access to a portion of the bag feeder 354 to allow the bag feeder 354 to be opened so that a bag 26 or a pre-loaded dispenser for the bag 26, such as a cassette 354, can be loaded into the bag feeder 354. The bag feeder door 374 can be opened to allow the bags 26 to travel from the first portion 96 to the second portion 98 of the enclosure 12 as they are loaded into the bag feeder 354. The seal station port 378 can provide an opening through which a cassette (e.g., a supply containing stoppers) can be mounted in the seal station 358. The vial access door 380 can allow vials to be introduced into and removed from the second portion 98 of the enclosure 12 for sample collection and testing. All interactions with these components can be 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 hold the attached door in a prescribed position and resist accidental displacement from that prescribed position. Once the door has rotated within the range of the prescribed position, such a hinge can also assist the attached door in reaching the prescribed 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 or 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 can include a lockable latch mechanism 388 that can be used to hold 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 those described above. The control system 15 of the system 10 can monitor the output from the door position sensors 384 and can generate a user interface notification when a door is opened. The control system 15 can also prohibit certain actions when a door is open. For example, filling of the bag 26 can be prohibited when a door is open.

[0346] Now refer to Figure 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 cartridge portion 399 and a housing block 398, which can be from the outlet end of the bag feeder 354. In some embodiments, the cartridge portion 399 can be separate from the housing block 398. In such an embodiment, the cartridge portion 399 can be set in a pre-loaded state and coupled to the housing block 398 to be ready for use by the bag feeder 354. In the example embodiment, the cartridge portion 399 is integrated with and fixed to the housing block 398. The cartridge portion 399 can be opened by the user and loaded with bags 26, and can advance the bags 26 through the bag feeder 354 as the system 10 consumes the bags 26. In some embodiments, a peel clip or a cartridge loader can be provided to facilitate the loading of the cartridge portion 399. In the case of using a pre-loaded cartridge portion 399 or a peel clip, these items can be made clean and disinfected within the outer packaging 60, and the outer packaging is removed once the cartridge or the peel clip enters the front chamber and is ready for use.

[0347] In the example embodiment, the cartridge portion 399 includes a plurality of guides 390. The guides 390 can be sized to receive a tube or port 392 extending from the bag 26. In the example embodiment, one of the ports 392 includes a fin 394, which can 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 pairs of rails that extend parallel to each other. Slots can exist between the rails that make up each guide 390 and can have a width sufficient to receive the port 392 of the bag 26. The exemplary guides 390 extend from the housing block 398. The housing block 398 can include a channel 400 for allowing the port 392 to pass through when the bag 26 is fed from the front chamber into the second portion 98 of the outer shell 12.

[0348] In some embodiments, a stop plate 405 (see the embodiment in Figure 64 ) can be included between the guides 390. This can help prevent the user from misloading the 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 the embodiment in Figure 64 ) can also be included. The straightener member 407 can extend parallel to the guides 390 and be positioned to prevent the bag 26 from being suspended in the guides 390 in a bent orientation. The straightener member 407 can be spaced from the guides 390 by a distance that is at least equal to the distance from the port 392 of the bag 26 to the nearest side edge of the bag 26.

[0349] The cassette portion 399 of the bag feeder 354 may also include a follower, which is shown as a feed plate 396 in the exemplary embodiment. The feed plate 396 may be coupled to the housing block 398 via a biasing member 401 (best shown in Figure 64 ), which biases the feed plate 396 towards the housing block 398. In various examples, the biasing member 401 may be a constant force spring. Any other suitable actuator that drives the feed plate 396 towards the housing block 398 may be used. A pair of supports 402 may also extend from the housing block 398. The supports 402 may be coupled to a feed plate retainer 403. In the exemplary embodiment, a latch plate 404 that may include a latch 406 is shown. The feed plate 396 may be coupled to a plunger 408, which may be pulled via the glove interface 352 to retract the feed plate 396. The latch 406 may interface with the feed plate 396 to hold the feed plate 396 in a retracted position spaced apart from the guide 390 by a distance. This may allow a user to load the bag 26 into the cassette portion 399. In an alternative embodiment, a magnetic latch device similar to that described with respect to Figure 73 may be used in place of the latch 406.

[0350] In some embodiments, the latch 406 may be biased towards the latching position (e.g., via a torsion spring). When the feed plate 396 is retracted via the plunger 408, the latch 406 may be pushed aside and automatically shift into latching engagement with the feed plate 396 when the feed plate 396 has been retracted to a predetermined open position. The latch 406 may include an inclined surface or bevel 410 (e.g., see Figure 61 ), which may facilitate the latch 406 moving out of an obstructive orientation when the feed plate 396 is retracted to contact the latch 406. The latch 406 may also include a recess 412, which may assist in the operation of the latch 406 via the glove interface 352.

[0351] Now referring to Figure 60 , Figure 59 the exemplary bag feeder 354 is shown as being fully loaded with bags 26. In the exemplary embodiment, the bag feeder 354 has a capacity for sixteen bags 26, however, in alternative embodiments, it may be possible to install a greater or lesser number of bags 26. Once full, and now also referring to Figure 61 , the latch 406 may be shifted out of engagement with the feed plate 396. Then, the exemplary feed plate 396 may be shifted under the force applied by the biasing member 401 (best shown in Figure 64 ) that connects the feed plate 396 to the housing block 398 to contact the last bag 26 in the bag feeder 354.

[0352] Now referring to Figure 62, the feed plate 396 is shown positioned against the last bag 26 mounted in the bag feeder 354. As shown, the feed plate 396 can slide along two elongate members 414. At least one of the elongate members 414 can also serve as a rod forming a guide 390. The feed plate 396 can further include protrusions 416 that can be spaced to bear against the ports 392 of the bags 26. This can help ensure that the bags 26 are held within 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. Additionally, the protrusions 416 can ensure that when the feed plate 396 is displaced along the elongate members 414 to the end of its displacement range, the last bag 26 loaded into the cassette portion 399 can be advanced an appropriate distance through the passage 400 in the housing block 398. When the feed plate 396 is pulled against the stop surface 397 of the housing block 398 (see Figure 59 ), the feed plate can be at the end of its displacement range. In some examples, the protrusions 416 can extend a distance at least equal to the distance from the stop surface 397 to the retaining pin 420. In other examples, the protrusions 416 can extend a distance equal to the distance from the stop surface 397 to the retaining pin 420 minus a percentage of the diameter of the port 392.

[0353] Main reference Figure 63 , a gripper or grappler 418 attached to the robotic arm 360 (not shown for illustration purposes; see, for example, Figure 56 ) of the system 10 can collect the 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 hold the foremost bag 26 in the bag feeder 354 against the force exerted by the feed plate 396. In an exemplary embodiment, two retaining pins 420 are included on opposite sides of each passage 400. Exemplary retaining pins 420 can be arranged to project into the path of the bags 26 as they are transported through the passage 400 of the housing block 398 and obstruct the passage of the ports 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.

[0354] The retaining pins 420 can be biased to the obstructing position but can be capable of being displaced to a retracted position in which the retaining pins 420 are at least partially pressed into the housing block 398 and do not interfere with the transport path of the bags 26. In certain embodiments, and as Figure 64As shown, the gripper 418 can be configured such that, when open, 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 shifted 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 such that the bag 26 does not fall when the retaining pin 420 is retracted. The force applied by the feed plate 396 can help to push the foremost bag 26 into the jaws A, B of the gripper 418. The coefficient of friction of the material of the gripper 418 and the port 392 under the action of the force applied by the feed plate 396 may be sufficient to hold the bag 26 in place before the jaws 422A, 422B close. Similar retaining pins 420 can be incorporated into the bag feeder 28 described with respect to Figures 54 to 55 The bag feeder 28 described.

[0355] The gripper 418 can include a driver 419 that includes one or more actuators for shifting the jaws 422A, 422B. In addition, a jaw position sensor 423 can be included. The jaw position sensor 423 can 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 can 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 can compare the position output of the jaw position sensor 423 with a predetermined range of acceptable positions. In the case where the jaws 422A, 422B are shifted to the limits of their shift range (e.g., fully closed), the control system 15 can infer that the gripper 418 has missed the bag 26. If the jaws 422A, 422B are shifted outside the predetermined range but not to the limits of the shift range, the control system 15 can infer that the gripper has grasped incorrectly (e.g., only grasped a section of the port 392, rather than closing around the port 392 as Figure 65 Shown). When the control system 15 determines that the position output of the jaw position sensor 423 is outside the 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 the bag 26 is removed from the bag feeder 354, the control system 15 can also perform this check at any other time when the bag 26 within the system 10 is grasped by the gripper 418.

[0356] Now referring primarily to Figure 65, once the jaws 422A, 422B close around the port 392, the foremost bag 26 can be removed from the bag feeder 354 and displaced, for example, to the filling station 356 by the robotic arm 360 (only the gripper 418 of the robotic arm 360 is shown for ease of illustration). The feed plate 396 can be advanced under the force of a biasing member 401 that attaches it to the housing block 398 (best shown in Figure 64 ). Additionally, when the gripper 418 is displaced away from the bag feeder 354, the retaining pin 420 can be pushed back to the obstructing position. Thus, the next bag 26 in the bag feeder 354 can be advanced and ready to be picked up by the gripper 418.

[0357] Now referring to Figure 66 , an exemplary filling station 356 is depicted. As shown, the filling station 356 can include a filling nozzle 430 that can be connected to a fluid input line 432. The fluid input line 432 can carry purified water or a mixed fluid (e.g., saline solution) that has traveled through the sensor suite 350 and is considered acceptable. The filling nozzle 430 can be arranged above and aligned with the discharge port 434. The discharge inlet 434 can 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 can be three times that of the fluid input line 432. This can help ensure that the discharge conduit 436 has the ability to carry unwanted flow or drips from the filling nozzle 430.

[0358] The filling station 354 can also include a backplate 442 extending from the filling station housing block 438. The backplate 442 can include a plurality of mounting points for bag characteristic sensors 444A, 444B, 444C. The bag characteristic sensors 444A - 444C can be any suitable sensors capable of collecting data on the distinguishing characteristics of the various bags that can be used with the system 10. The bag characteristic sensors 444A - 444C can sense the presence or absence, 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 can form a reservoir volume sensing assembly.

[0359] In an exemplary embodiment, the bag characteristic sensors 444A - 444C are positioned to collect information sufficient to determine the type of the bag 26 docked at the filling station 356. The exemplary bag characteristic sensors 444A - 444C can be, for example, sensors based on beam interruption or reflection, which can determine the presence or absence of the bag material in their vicinity. In an example embodiment, a bag presence detector 444B is included and can determine whether the bag 26 has been docked in the filling station 354. The bag presence detector 444B can be mounted on the backplate 442 at a position where it can detect any of the various types of bags 26 that can be used in the system 10 (e.g., from a mini - bag to a bag with a capacity of one liter or greater). In the case where the bag presence detector 444B does not detect the bag 26 in place at the filling station 356, the filling station 356 can be prohibited from dispensing liquid via the control system 15. A bag width detector 444A can be included and mounted on the backplate 442 at a position where it can detect whether the width of the bag 26 is greater than a specific 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 the threshold width value (regardless of its length) will be picked up by the width detector 444A. A bag length detector 444C can be mounted on the backplate 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 the 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 over - filled. A look - up 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 can include additional bag characteristic sensors 444A - 444C. For example, some embodiments can include additional width detectors 444A or length detectors 444C to provide additional data related to the size of the bag 26. In some embodiments, each bag characteristic sensor 444A - 444C can be accompanied by a redundant sensor.

[0360] In an example embodiment, the discharge inlet 434 and the attached discharge conduit 436 can be pivotally or otherwise displaceably coupled to the filling station housing block 438. When the bag 26 is introduced into the filling station 356 by the gripper 418, the jaws 422A, 422B of the gripper 418 can drive the discharge inlet 434 and the discharge conduit 436 to a retracted position. As Figure 67 shown, the filling station 356 can include a filling station gripper 440. The filling station gripper 440 can be opened by a gripper driver 446 to receive the port 392 of the bag 26, and once the robotic arm 360 (e.g., see Figure 56Upon being shifted to the pre-programmed docking coordinates of the bag 26, it is driven to close. The coordination of the filling station gripper 440 and the robotic arm 360 can be formulated by the control system 15.

[0361] As Figure 68 shown, during the filling of the bag 26, the gripper 418 attached to the robotic arm 360 (e.g., see Figure 56 ) can be shifted away from the filling station 356. When the bag 26 docked on the filling station 356 is being filled, the gripper 418 can be used to perform other operations within the enclosure 12. For example, when the bag 26 is being filled at the filling station 356, the gripper 418 can be used to retrieve, label, and dispense the completed bag 26 from the quarantine repository 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 suite 350), the gripper 418 can return to the filling station 354 and collect the filled bag 26 from the filling station 354. As Figure 69 shown, the jaws 422A, 422B of the gripper 418 can be actuated to close around the port 392 of the filled bag 26, and the filling station gripper 440 can be driven to open by the gripper driver 446. In some embodiments, the robotic arm 360 may not be shifted away from the filling station 356 in various situations. For example, in the case of filling a small 100 mL bag 26, the robotic arm 360 can remain in place because the filling time of the bag 26 should be short. While in the case of filling a large bag 26 (e.g., several liters), the gripper 418 can be shifted 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.

[0362] Now referring to Figure 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 collecting the bag 26 from the filling station 356, the discharge inlet 434 can automatically return to alignment with the filling nozzle 430. A biasing member (e.g., see the biasing member 454 of Figure 71B ) can be included to facilitate the automatic return of the discharge inlet 434 to the alignment position.

[0363] Now also referring to Figure 71A and Figure 71B, the discharge inlet 434 can be attached to a flange 448, which pivotally mounts the discharge inlet 434 to the filling station housing block 438. The flange 448 can include a track 450 within which a pin 452 extending from the filling station housing block 438 is disposed. Since 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 elongate (e.g., see Figure 71B ). As the biasing member 454 returns (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 a resting state. As shown, this can automatically pivot the discharge inlet 434 back to an alignment state relative to the filling nozzle 430 (e.g., see Figure 71A ).

[0364] As shown, the filling station 356 can include a discharge inlet sensor 437. The discharge inlet sensor 437 can monitor the position of the discharge inlet 434. The discharge inlet sensor 437 can 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 can include a magnetic or metallic body that is monitored by the discharge inlet sensor 437. Alternatively, the discharge inlet sensor 437 can be an optical sensor. The control system 15 can receive the output signal from the discharge inlet sensor 437 and ensure that the discharge inlet 434 is disposed in the desired position. For example, after the bag 26 has been filled and removed, the control system 15 can verify that the discharge inlet 434 returns to an alignment state relative to the filling nozzle 430. Additionally, the control system 15 can check the output of the discharge inlet sensor 437 to ensure that the discharge inlet 434 is in alignment below the filling nozzle 430 before commanding a flush of the filling nozzle 430 or a disinfection of the fluid circuit. During disinfection, hot purified water can be conveyed through the fluid circuit and discharged through the filling nozzle 430 into the discharge inlet 434.

[0365] Now refer to Figure 72, an example embodiment of a sealing station 358 is shown. As shown, the sealing station 358 can include a substrate 460. A pusher driver 462 can be mounted to the substrate 460. The pusher driver 462 can effect the displacement of a pusher 464 that can drive a stopper into the port 392 of the bag 26. In some embodiments, the pusher driver 464 is capable of applying at least 100 pounds of force to the stopper 476 during the stoppage of the bag 26. A support 463 can be attached to the substrate 460. During the sealing of the bag 26, a gripper 418 that holds the bag 26 can dock on a docking surface (e.g., the top surface) of the support 463 so as to support the gripper 418 against the force applied by the pusher 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 supports 463 can be spaced apart by a gap that can allow the bag 26 to be positioned therebetween. The bag 26 can be displaced into this gap to help align the port 392 of the bag 26 with the displacement axis of the pusher 464.

[0366] A stopper dispenser, depicted as a stopper cartridge 466 in the example embodiment, is also included in the example sealing station 358. The stopper cartridge 466 can be docked into a cartridge receptacle 468 in the sealing station 358. The stopper cartridge 466 can include an opening 472 that is aligned and sized to allow the pusher 464 to pass therethrough when the stopper cartridge 466 is in place at the cartridge receptacle 468. A follower assembly 470 can be included to automatically advance a stopper through the stopper cartridge 466 when dispensing the stopper.

[0367] Now referring to Figure 73 , in the example embodiment, the stopper cartridge 466 can be set in a pre-loaded state. The stopper cartridge 466 can be cleanly and aseptically encapsulated within an outer package 60 that is opened in the front chamber of the system 10. In the example embodiment, the stopper cartridge 466 has a capacity of 22 stoppers 476. However, in other embodiments, the capacity of the stopper cartridge 466 can be smaller or larger. In the example embodiment, a cover plate 474 (e.g., see Figure 72 ) has been removed to show the stoppers 476. After removing the stopper cartridge 466 from its outer package 60, the stopper cartridge 466 can be docked onto the cartridge receptacle 472. In certain embodiments, the cartridge receptacle 472 can accommodate various different varieties of stopper cartridges 466. For example, certain embodiments can have a cartridge receptacle 472 that is capable of accommodating any of the stopper cartridges 466 shown and described herein. This can allow a user to use stopper cartridges 466 of different capacities as needed. In some embodiments, the stopper cartridge 466 can not be a removable cartridge. Instead, a fixed cartridge can be included that is manually loaded by an operator of the system 10 or loaded in place on the substrate 460 with the help of a quick loader.

[0368] To load the example plug cartridge 466 into the sealing station 358, the user may retract the follower assembly 470. As shown, the follower assembly 470 may include a handle 478. The handle 478 may 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 latch similar to that Figure 59 shown may be included to hold the follower assembly 470 in the open state. When the follower assembly 470 is in the loaded state, the follower 482 may be shifted to a point where there is sufficient clearance to mate the plug cartridge 466 in place on the cartridge receptacle 472.

[0369] The handle 478 may be coupled to a follower block 480. The follower block 480 may include a follower 482. The follower block 480 may be coupled to the cartridge receptacle 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 may be used. The biasing member 484 may exert a force on the follower block 480, which keeps the follower 482 in tight contact with the last one or more plugs 476 in the plug cartridge 466. The follower block 480 may be shifted along one or more follower guides 502, which restrict the movement of the follower 482 along a defined path. In the example embodiment, an end block 504 is included at the end of the guide 502 furthest from the cartridge receptacle 472. The end block may include a magnet 500. The magnet 500 may interact with a metal portion of the follower block 480 in order to hold the follower assembly 470 in the open position when loading of the plug cartridge 466 occurs.

[0370] The example plug cartridge 466 is shown as a multi-column cartridge. The follower 482 includes staggered protrusions 486 extending from a plug contact portion of the follower 482. When the plug cartridge 466 is depleted, the staggered protrusions 486 may help to ensure an orderly feed of the plugs 476. The staggered protrusions 486 may cause the plugs 476 in one column to be offset from the plugs 476 in an adjacent column. This may help to prevent jamming and facilitate the movement of individual plugs 466 from the multi-column to the opening 472 in the plug cartridge 466 (e.g., see Figure 72 ).

[0371] Now also referring to Figure 74A and Figure 74B, showing a view of an exemplary plug cartridge 466. As shown, the plug cartridge 466 can include a cartridge body 508. The cartridge body 508 can include a plurality of plug grooves 510 recessed therein. The partition walls 488 can separate and partially define each groove 510. The plug cartridge 466 can also include ridges 490 located at the sides of each groove 510. Any of the partition walls 488 and ridges 490 can be at the same height as each other. In some examples, the plug 476 can include portions of different diameters. The ridges 490 and partition walls 488 can have a height selected such that a step region 512 on the plug 476 can travel along the top surfaces of the ridges 490 and partition walls 488, where the plug 476 transitions to a larger diameter at the step region. As shown, the plug cartridge 466 can also include slots 492. The slots 492 can allow a portion of the follower assembly 470, including the follower 482, to travel into and shift within the plug cartridge 466.

[0372] In an exemplary embodiment, the plug cartridge 466 includes mating features that can facilitate mounting the plug cartridge 466 onto the cartridge receptacle 472. In an exemplary embodiment, two mounting or mating pins 494 are included in the plug cartridge 466. These mating pins 494 can be received in alignment holes within the cartridge receptacle 472. In certain embodiments, the mating pins 494, a portion of the alignment holes, or both can be magnetic. This can allow the plug cartridge 466 to be magnetically coupled into place within the cartridge receptacle 472. The cartridge receptacle 472 can also include a cartridge sensor 473 (e.g., see Figure 77B ). In some examples, a Hall effect sensor or inductive sensor that can record the proper mating of the plug cartridge 466 within the cartridge receptacle 472 can be used. Other types of sensors (such as microswitches, optical sensors, button-type sensors, etc.) can also be used to monitor whether the plug cartridge 466 is mounted within the cartridge receptacle 472. In some embodiments, a magnetic body for sensing by the magnetic cartridge sensor 473 can be included elsewhere on the plug cartridge 466. In some embodiments, the control system 15 of the system 10 may not allow the shift of the pusher 464 unless the cartridge sensor 473 indicates that the plug cartridge 466 is mounted within the cartridge receptacle 472.

[0373] Now also referring to Figures 75 to 77B , the plug cartridge 466 can include a blocking element that prevents premature release of the plug 476 from the plug cartridge 466. The exemplary plug cartridge 466 includes a shiftable handle 496. The shiftable handle 496 can include a loop, flange, or similar feature that allows a user to easily pull the shiftable handle 496 through the glove interface 352 of the system 10. The shiftable handle 496 can be coupled to an outlet cover 498 (e.g., see Figure 74A). The outlet cover 498 can prevent the plug 476 from leaving the plug cartridge 466. The displaceable handle 496 can be integral with the outlet cover 498 (best shown in Figure 74B ) or can be coupled to the outlet cover via a linkage. When the user displaces the displaceable handle 496, the outlet cover 498 can be displaced or retracted from the blocking position, thereby allowing the plug 476 to move out of the plug cartridge 466. The displaceable handle 496 can move along a guide slot 506 included in the body 508 of the plug cartridge 466. In some embodiments, the displaceable handle 496 can be completely removed from the plug cartridge 466 before use.

[0374] In operation, and as Figure 75 shown, before actuating the outlet cover 498 to the retracted state, the user can position the follower 482 against the plug 476 within the plug cartridge 466. Thus, when the outlet cover 498 and the displaceable handle 496 are displaced as Figures 76 to 77A depicted, the plug 476 aligned with the outlet port 514 from the plug cartridge 466 can be frictionally held within the plug cartridge 466 by the force applied through the follower 482 via the biasing member 484. Only the head of the plug 476 can be frictionally held in place against the plug cartridge 466. The stem of the plug 476 can be not in contact with the plug cartridge 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.

[0375] Now refer to Figure 78, when the sealing station 358 is in a 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 below the outlet port 514 of the plug cartridge 466. The control system 15 can command the pusher driver 462 to displace the pusher 464 through the opening 472 of the plug cartridge 466. The pusher 464 can contact the head of the plug 476, and the plug 476 can begin to displace together with the pusher 464. In an example embodiment, when the follower plug 476 displaces towards the port 392 of the bag 26, the follower plug can travel along the guiding portion 516 of the plug cartridge 466. The guiding portion 516 can ensure that the plug 476 displaces substantially in line with the axis of the port 392. The stem or smaller diameter portion of the plug 476 can enter the port 392 of the bag 26 before the plug 476 displaces beyond the guiding portion 516 of the plug cartridge 466. The pusher 464 can continue to be driven by the pusher driver 462 until the step 512 of the plug 476 abuts against the top of the port 392. In certain embodiments, the pusher 464 can be displaced until at least a threshold amount of the stem or small diameter portion of the plug 476 is within the port 392. For example, the plug 476 can be driven until at least 75% of the stem is within the port 392. The control system 15 can monitor the position feedback from the pusher driver 462 to determine the travel distance of the stem portion of the plug 476 into the port 392.

[0376] As mentioned above, in some examples, unless the cartridge sensor 473 (e.g., see Figure 77B ), records that the plug cartridge 466 is correctly loaded into the sealing station 358, the control system 15 can prohibit the displacement of the pusher 464. In certain 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 reflectance-based sensor. Such a sensor can, for example, monitor the reflection 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 proper position for stopping. Unless the port detection sensor 475 indicates that the port 392 is in the proper position, the control system 15 can prohibit the displacement of the pusher 464.

[0377] Now refer to Figure 79 , once the plug 476 is in sealing engagement with the port 392, the pusher 464 can be retracted. The control system 15 can command the pusher driver 462 to retract the pusher 464, and the follower assembly 470 can automatically advance the plug 476 in the plug cartridge 466 such that the next plug 476 in the plug cartridge 466 is aligned with the outlet port 514 of the plug cartridge 466. As Figure 80As shown, the sealed bag 26 can then be shifted from the sealing station 358 to the quarantine repository 362.

[0378] Now referring to Figures 81A to 81B , in some embodiments, the sealing station 358 can accommodate different plug cartridges 466 or can be designed to accommodate various plug cartridges 466 having different styles, capacities, or containing different types and sizes of plugs 476. For example, single-column cartridges, drum cartridges, or any other suitable type of plug cartridge 466 can be used. Depicted in Figures 81A to 81B are Figure 74A and Figure 74B modified versions of the plug cartridge 466 shown. As shown, the exit port 514 of the plug cartridge 466 is of an elongated shape that extends all the way to the front end of the plug cartridge 466. The elongated shape can allow for greater alignment tolerances when the plug 476 exits the exit port 514. Additionally, the wall of the exit port 514 can include a guiding portion disposed at a portion of the wall of the exit port 514 adjacent to the outer face of the cartridge body 506. In some embodiments, the guiding portion can include a chamfer 477 or a rounded corner that is applied to the edge where the exit port 514 and the outer face of the cartridge body 506 intersect. Such chamfered exit ports 514 can be included on any of the plug cartridges 466 described herein.

[0379] Now referring to Figure 81C , in certain embodiments, the port 392 of the bag 26 can be shifted into the exit port 514 of the plug cartridge 466 before the port 392 is sealed. The chamfer 477 on the exit port 514 of the plug cartridge 466 can be designed to facilitate this action. As Figure 81C shown, the pusher 464 can be driven into the plug cartridge 466 until the pusher 464 contacts the plug 476 that is in line with the exit port 514. The pusher 464 can stop at this position and the gripper 418 can raise the bag 26 such that the plug 476 is partially installed (e.g., not more than 25%-35%) into the port 392. When this occurs, the pusher 464 can prevent the plug 476 from being pushed upward. The chamfer 477 on the exit port 514 of the plug cartridge 466 can cause the port 392 of the bag 26 to be conveyed or guided into alignment with the stem or smaller diameter portion of the plug 476. Once the plug 476 is partially installed in the port 392, the pusher 464 can be actuated by the pusher driver 462 to complete the installation of the plug 476 into the port 392 to seal the bag 26.

[0380] Now referring to Figures 82A to 82C , a view of another exemplary plug cartridge 466 is shown. As shown, the exemplary plug cartridge 466 includes an exit port 514 with a chamfer 477. As described above, the chamfer 477 can convey or guide the port 392 of the bag 26 into alignment with the stem or smaller diameter portion of the plug 476. Additionally, asFigure 82C As best shown, the brake member 479 may be included in the wall of the outlet port 514. Such a brake member 479 may be included in any of the plug cartridges 466 described herein. The brake member 479 in the exemplary embodiment includes a ball brake. In an alternative embodiment, the brake member 479 may be a barb, a bump, or other protrusion. The brake member 479 may project into the exit path of the plug 476 traveling through the outlet port 514. The step region 512 of the plug 476 may catch on the brake member 479, helping to hold the plug 476 within the plug cartridge 466. As Figure 82A best shown, embodiments including the brake member 479 may omit the displaceable handle 496 coupled to the outlet cover 498 (e.g., see Figure 74B ), and the accompanying guide track 506 (e.g., see Figure 74B ).

[0381] Now referring Figure 83 to, an exemplary drum-type plug cartridge 466 is depicted. The plug cartridge 466 may include a drum body 630. The drum body 630 may include a helical groove or track 632, which may have a depth sufficient to receive the plug 476 therein. The plug cartridge 466 may also include a biasing member, such as a constant force spring 634. The constant force spring 634 may be connected to a follower 636, which may be positioned behind the last plug 476 in the plug cartridge 466. The plug cartridge 466 may also include a removable cover member (not shown), which may be placed over the plug cartridge 466 to enclose the plug 476 within the plug cartridge 466. The exemplary drum-type plug cartridge 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).

[0382] Now referring Figures 84 to 86 to, as the plug cartridge 466 is depleted, the constant force spring 634 may pull the follower 636 along the helical path 632 in the drum body 630. This may in turn advance the remaining plugs 476 in the plug cartridge 466. As shown, the helical path 632 may include a groove portion 640. The groove portion 640 may receive the stem or small diameter portion of each plug 476. Thus, when the plug is displaced along the helical path 632, the groove portion may serve as a guide for the plug 476. In certain embodiments, the follower 636 may be sized to travel along the groove 640, and thus the groove portion 640 may also serve as a follower guide during operation. The groove portion may be flanked on each side by a ledge 642, on which the step region 512 of the plug 476 may rest.

[0383] The plug cartridge 466 is at Figure 86Shown as empty. As shown, the size of the outlet port 638 of the plug 476 can be designed to substantially match the size of the head or the larger diameter portion of the plug 476. Additionally, 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 that has a curvature which helps to position the head of the plug 476 in alignment with the outlet port 638.

[0384] Although Figure 86 not shown in, but can include mating pins 492 (e.g., see Figure 74A ). The mating pins 492 can help to mount the plug cartridge 466 in the cartridge receptacle 472. The mating pins 492 can also allow the cartridge sensor 473 to detect the presence of the plug cartridge 466 at the cartridge receptacle 472.

[0385] Now referring to Figure 87 , an exploded view of another example plug cartridge 466 is depicted. As shown, Figure 87 the plug cartridge 466 in is a drum-type cartridge. The plug cartridge 466 can include a drum body 650 in which a helical groove or track 654 is formed. A rotor element 656 can also be included and it can include a plurality of grooves 658 extending therethrough. The grooves 658 can be sized to receive the plugs 476 therein. A biasing assembly 652 can also be included in the example plug cartridge 466. In the example embodiment, the biasing assembly 652 can include a torsion spring or a wound spring 660 as in the example embodiment. A portion of the wound spring 660 can be attached to a mandrel 662 included in the biasing assembly 652, which extends through the drum body 650 and the rotor 656. Generally, the wound spring 660 can be included in a housing not depicted in Figure 87 to better show the wound spring 660. The mandrel 662 can include a bonding section 664 that interfaces with the rotor 656. In the example embodiment, the bonding section 664 is "D"-shaped and can ensure that the rotor 656 rotates in cooperation with the mandrel 662. In other embodiments, the bonding section 664 can have a different cross-sectional shape, such as square or star-shaped. In operation, the user can grasp a knob 666 attached to the mandrel to rotate the mandrel 662. This can cause the wound spring 660 to store energy that can be used to rotate the rotor 656 and advance the plugs 476 along the helical track 654. The plug cartridge 466 can also include a removable cover member (not shown) that can be placed over the plug cartridge 466 to enclose the plugs 476 and the rotor 656 within the plug cartridge 466. As in other plug cartridge 466 embodiments, mating pins 492 can be included (e.g., see Figure 74Bto facilitate the installation and detection of the plug cartridge 466 in the cartridge container 473.

[0386] Now referring to Figure 88 , a top view of an exemplary plug cartridge 466 of Figure 87 is depicted. As shown, the plug cartridge 466 is fully loaded with plugs 476. In the exemplary embodiment, the exemplary plug cartridge 466 has a capacity of 108 plugs 476, but like other plug cartridges 466 described herein, this capacity can 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 towards the center of the rotor 656. Such grooves 658 of different lengths can increase the space efficiency of the plug cartridge 466 and allow a large number of plugs 476 to be loaded into the plug cartridge 466.

[0387] Still referring to Figure 88 , the plug 476 is depicted at the exit port 668 of the plug cartridge 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 cartridge 466 can be pre-loaded when the plug cartridge 466 is operated, the groove 658 can exert a force on the plug 476 that is sufficient to frictionally hold the plug 476 against the wall of the exit 668. Additionally, the plug 476 at the exit port 668 may interfere with the wall of the groove 658, which prevents the rotor 656 from shifting under the force of the biasing assembly 652. When the plug 476 is driven out of the plug cartridge 466 by a push rod 464 or the like (see Figure 89 ), the interference can be removed and the rotor 656 can rotate freely. As Figure 90 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 exit port 668, which may again interfere with the further shifting of the rotor 656.

[0388] Now referring to Figure 91 , as the plug cartridge 466 is depleted, the smaller grooves 658 of the rotor 656 can empty the plugs 476. The exemplary plug cartridge 466 is arranged to automatically index to the next available plug 476 and will automatically skip any empty grooves 658. In the example shown in Figure 91 , the plug 476 at the exit port 668 is separated from the next available plug 476 by two empty grooves 658. When the plug 476 is discharged from the exit port 668 (see Figure 92 ), the rotor 656 can freely advance until the next plug 476 is aligned with the exit port 668 and interferes with the further movement of the rotor 656, as Figure 93As shown. Thus, even if the required rotational displacement is variable, the plug cartridge 466 can be automatically indexed to the next plug 476. It should be noted that in other embodiments, other rotor drive assemblies may be utilized in addition to the biasing assembly 652 shown. For example, a motorized displacement assembly may be included in place of the biasing assembly 652. In such an example, the control system 15 can keep track of the number of plugs 476 dispensed from the cartridge 466 and use that count to ensure that the motorized displacement assembly drives the rotor 656 an amount sufficient to advance the next plug 476 to the exit port 668.

[0389] Now referring to Figure 94 , an exploded view of another plug cartridge 466 is shown. As shown, the plug cartridge 466 can include a cartridge body 670. The cartridge body 670 can include a groove 672. The groove 672 can receive the stem or smaller diameter portion of each plug 476. Thus, as the plugs 476 are displaced toward the exit port 690 of the plug cartridge 466 (e.g., see Figure 95 ), the groove portion 672 can serve as a guide for these plugs 476. The groove portion 672 can be flanked on each side by ledges 676 on which the step regions 512 of the plugs 476 can rest. In an example embodiment, the plug cartridge 466 can also include two plates 674 that can be attached to the cartridge body 670 on opposite sides of the groove 672. The plates 674 can partially overhang the groove 672. The overhanging portions of these plates 674 can ensure that the plugs 476 do not fall out of the plug cartridge 466 during shipping or when handling the plug cartridge 466. Additionally, the exit port 690 can be at least partially surrounded by a guide wall 678. The guide wall 678 can be positioned in front of the exit port 690 to prevent the plugs 476 from being advanced beyond the exit port 690. The guide wall 64 can also have a guide surface 680 that has a curvature that helps to align the heads of the plugs 476 with the exit port 690.

[0390] Now also referring to Figure 95 and Figure 96 , the plug cartridge 466 can also include a follower assembly 682. The follower assembly 682 can include a follower block 684 that includes a follower 686. The follower 686 can include a plug contact surface that has an arcuate shape for supporting the head or larger diameter portion of the plug 476. A biasing member 688 can also be included in the follower assembly 682. In an 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 Figure 94 best shown, the cartridge body 670 can include a routing channel 694 that allows the end of the constant force spring to be fed through the cartridge body 670 to a mounting point on the outer face of the guide wall 678. For example, asFigure 95 As shown, the end of the constant force spring can be coupled 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 cartridge body 670, the biasing member 688 can apply a force on the follower block 684 that displaces the follower block 684, the follower 686, and any remaining plugs 476 in the plug cartridge 466 toward the outlet port 690. This can cause the next plug 476 to be advanced into alignment with the outlet port 690. The follower assembly 682 in the exemplary 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 cartridge 466. As in other plug cartridge 466 embodiments, mating pins 492 can be included to facilitate the installation and detection of the plug cartridge 466 in the cartridge receptacle 473.

[0391] Now referring to Figures 97 to 99 , another exemplary plug cartridge 466 is depicted. As shown, the plug cartridge 466 is similar to the plug cartridge shown in Figure 74A , however, the plug cartridge 466 includes slots 700 that extend through the bottom of each plug groove 510. These slots 700 can allow the plug cartridge 466 to be loaded with a quick loader 702. The quick loader 702 can include a plate 704 that has 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 the 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 cartridge 466. The quick loader 702 can provide cleaning and sterility within the outer packaging. The user can keep the quick loader 702 stocked in the front chamber of the system 10, and the plug cartridge 466 can be held in place or integrated into the sealing station 358. As needed, the quick loader 702 can be opened and used to refill the plug cartridge 466 during the bag 26 sealing operation.

[0392] Now referring primarily to Figures 98 to 99 , to load the plugs 476 into the plug cartridge 466, the quick loader 702 can be positioned in alignment with the opening in the plug cartridge 466 and introduced into the plug cartridge 466. As Figure 74AAs shown, the cartridge may include a dividing wall 488 that may separate and partially define each groove 510. The plug cartridge 466 may also include ridges 490 that laterally engage each groove 510. The dividing wall 488 and the ridges 490 may be at the same height as each other. The height may be selected such that a stepped region 512 on the plug 476 may cause the plug 476 to catch on the top surfaces of the ridges 490 and the dividing wall 488, thereby allowing each plug 476 to be suspended in its respective plug groove 510. The plate 704 of the quick loader 702 may include a slit 708 that may allow the dividing wall 488 to pass through the plate 704 when the quick loader 702 is lowered. As the plate 704 is lowered, the top surfaces of the ridges 490 and the dividing wall 488 may begin to support the plugs 476. At this time, the plate 704 may be displaced relative to the plugs 476. The plate 704 may continue to be lowered until the plug rack 706 portion of the plate 704 passes through the slot 700 in the plug groove 510 and the plugs 476 are completely separated from the rack 706. The plate 704 may then be discarded and the follower assembly (e.g., Figure 72 the follower assembly 470 of

[0393] Now referring to Figure 100 , an exemplary quarantine repository 362 is depicted. As shown, the quarantine repository 362 may include a plurality of racks 518. In the example 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 brackets 520 that may support the filled and sealed bags 26. The brackets may be reservoir hangers that may suspend the filled bags 26. In Figure 100 only one bag 26 is depicted in place on a bracket 520. In the example embodiment, 17 brackets 520 are included on each rack 518. Other embodiments may include a lesser number of brackets 520 on each rack 520, or may include a greater number of brackets on each rack 520.

[0394] Figure 101Depicts an exemplary bracket 520. The bracket 520 can include a set of arms 522. Each arm 522 can be substantially a mirror image of the other. As shown, each arm 522 includes a ledge 524 that is recessed relative to the top surface 526 of the arm 522. 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 equal to the spacing of the ports 392 of the bag 26. Each arm 522 also includes a bevel 530 at the end of the arm 522 that is furthest from the mounting portion of the arm 522 to the frame 518. The bevel 530 can serve as a guide that helps direct the bag 26 into the small gap that may exist between each pair of arms 522. The robotic arm 360 can push the bag 26 into each bracket 520. As the bag 26 is shifted into the bracket 520, the two arms 522 can elastically spread apart to facilitate receiving the bag 26. The bag 26 can be directed into the bracket 520 such that the ports 392 rest in the recesses 528 in each arm 522. Since the diameter of the ports 392 is greater than the gap between the arms 522, the bag 26 may not be able to slide past the bracket 520. Accordingly, the two arms 522 can form a cradle for the bag 26. As shown, the edges of the ledges 524 and the recesses 528 can be rounded to prevent contact of the bag 26 with any sharp surfaces.

[0395] Now refer to Figure 102 , in certain embodiments, the quarantine repository 362 can be completely filled with the bags 26. In other embodiments, the quarantine repository 362 can store the bags 26 in a manner that depends on the type of bag 26 being used. For example, when bags 26 are being generated that are filled to a volume greater than a certain predetermined volume, the control system 15 can command the robotic arm 360 to place the bags 26 every other bracket 520. This can reduce the likelihood of the quarantine repository becoming overcrowded and the problem of suspending additional bags 26. In the case where bags 26 are being generated that are filled to a volume less than the predetermined volume, each bracket 520 can be filled with the filled bags 26.

[0396] Now also refer to Figure 103 and Figure 104, when one or more tests are complete, the bag 26 can remain in the quarantine repository 362. In some embodiments, a test for monitoring pyrogens can be performed before the bag 26 is released from the quarantine repository 362. For example, the control system 15 can generate a notification of 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 into the second portion 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 opens only within the front chamber of the housing 12. The sampling fixture 534 can include a cup-shaped portion 536 within which the vial 532 can be placed. To introduce the vial 532 into the second portion 98 of the housing 12, the vial access door 380 can be opened so that the user can access a receptacle 542 attached to the side of the vial access door 380 facing the second portion 98 of the housing 12. The sampling fixture 534 can be docked into the receptacle 542 and the vial access door 380 can be closed again.

[0397] The sampling fixture 534 can have a branch 538 that includes an enlarged portion 540. The enlarged 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 pick up the sampling fixture 534 and displace it around the second portion 98 of the housing 12. The robotic arm 360 can displace the sampling fixture 534 and the vial 532 to the filling station 356, and the control system 15 can command an aliquot of fluid to be dispensed into the vial 532. Then, the robotic arm 360 can 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 test device such as an endotoxin monitor.

[0398] Generally, the bag 26 can remain in the quarantine repository 362 until at least a first pyrogen test and a second pyrogen test are complete 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 on 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 on a fluid sample collected after all the bags 26 in the quarantine repository 362 have been filled. In some embodiments, this second test can also serve 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.

[0399] In an alternative embodiment, the pyrogen test can be performed after each rack 518 of the quarantine repository 362 is filled to capacity. This may be desirable because the pyrogen test can take some time (e.g., about 15 minutes) to complete. This can allow the system 10 to continue filling the bags 26 while the pyrogen test is being completed. One rack 518 can 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 can be ready to be labeled and dispensed from the system 10. This can help improve the efficiency of the system 10 because there can be no downtime when the pyrogen test is completed, during which the filling of the bags 26 must be stopped to free up space in the quarantine repository 362.

[0400] Now referring to Figures 105 to 107 , before the bag 26 is dispensed from the system 10, the bag 26 can be labeled. Figure 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 (only the gripper 418 of the robotic arm 360 is shown in Figure 105 ) can shift the bag 26 to the labeler 366, e.g., many of the bags 26 in the quarantine repository 362 have passed the test. The bag 26 can be pulled through a plate 554 that includes a feed slot for the label 556 to extend through. The label 556 can be adhered to the surface of the bag 26 and the bag 26 can be pulled through the rollers 552. As the bag 26 is shifted over the rollers 552, the weight of the bag 26 and its contents can help to securely attach the label 556 to the bag 26.

[0401] A label sensor 557 (see Figure 56 ) can be included to monitor the presence of the label 556. The control system 15 can receive an output signal from the label sensor 557 and analyze the signal to determine whether the label 556 has been applied to the bag 26. Additionally, the control system 15 can analyze the signal to ensure that the label 556 is present before shifting the bag 26 to the labeler 336 to apply the label 556. Thus, the control system 15 can analyze the label sensor 557 to determine whether the label supply in the labeler 366 is empty or if there is an error condition. The control system 15 can generate a label supply empty notification or a labeling error based on the data received from the label sensor 557.

[0402] Once labeled, and now referring to Figures 108 to 110, the robotic arm 360 can shift the bag 26 to the outlet of the housing 12. In Figures 108 to 110 the example shown, the outlet is shown as a chute 560. The chute 560 can include a top opening covered by a door flap 562. Additionally, the chute 560 can include a funnel arm 564 that can assist in guiding the bag 26 into the chute 560 when the bag 26 is dropped by the gripper 418 of the robotic arm 360. When the bag 26 falls into the chute 560, the door flap 562 can pivot away by the weight of the bag 26. A biasing member (such as a torsion spring) can be included to return the door flap 562 to the closed orientation. As Figure 109 and Figure 110 best shown, the door flap 562 can be attached to a sensing protrusion. As the door flap 562 shifts, the sensing protrusion 566 can shift to allow the door sensor 568 to obtain the movement of the door. Any suitable sensor can be used. For example, the door sensor 568 can be an optical sensor, such as a beam break sensor or a reflection-based sensor. The door sensor 568 can alternatively be a magnet-based sensor, such as a Hall effect sensor. In such an embodiment, the door flap 562 can include a magnet. A microswitch or button can also be used in some examples, which is mechanically actuated by the shift of the sensing protrusion 566 when the door flap 562 shifts. An encoder can monitor the shift of the pivot pin on which the door flap 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 outlet flap 570 as it is transported out of the housing 12. As Figure 110 shown, the outlet flap 570 can be a rigid hinge door or can be a sheet of flexible material.

[0403] The control system 15 of the system 10 can monitor the door sensor 568 to ensure that the system 10 operates 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 flap 562 has opened. The control system 15 can also check to ensure that the door sensor 568 indicates that the door flap 562 has returned to the closed state. In the case where the door sensor 568 does not indicate that the door flap 562 has opened when the bag 26 is released, the control system 15 can generate a notification or alert on the user interface of the system 10. The control system 15 can also generate a notification when the door flap 562 is not closed. For example, the notification can instruct the user to check if there is an item blocking the outlet flap 570 and to move the bag 26 back in the chute 560.

[0404] In the event that bag 26 is considered unacceptable, bag 26 can be dispensed from housing 12 without label 556. For example, in the case where bag 26 is in quarantine repository 362, bag 26 can be removed from quarantine repository 362 and dispensed without label 556. During filling of bag 26 at filling station 356, when the ingredient sensor indicates that the fluid filled into bag 26 does not meet the predetermined target ingredient range, bag 26 can be sealed and dispensed from the outlet of housing 12. Label 556 shall not be applied. In an alternative embodiment, label 556 can be generated from bag 26 that clearly indicates that bag 26 should not be used. For example, a label 556 marked with "Not for human use" etc. can be generated and applied to bag 26 prior to dispensing.

[0405] Now referring to Figure 111 , another exemplary system 10 for producing and encapsulating a medical fluid is depicted. As shown, system 10 can include a medical water production device 14, such as any of those described herein. System 10 can also include a mixing circuit 348 for generating a specified solution (e.g., 0.9% saline). System 10 can include a sensor suite 350 that can monitor the quality of the purified water produced by medical water production device 14 and can monitor the solution generated by mixing circuit 348. Sensor suite 350 can include any number of different types of water quality sensors. Any of the water quality sensors described herein can be included. Example mixing circuit 348 and example sensor suite 350 will be described later in the specification.

[0406] System 10 further includes a 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 room in which it is located. In some embodiments, housing 12 can be maintained at a positive pressure by a blower system 600.

[0407] In an example embodiment, housing 12 is partitioned 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 that is higher than the first pressure. Filling of bag 26 can occur in the most tightly controlled environment of system 10. Various filters, such as HEPA filters, can be included to help ensure that any air blown into housing 12 to maintain positive pressure is clean.

[0408] Now also referring to Figure 112, the first part 96 can be a front chamber, which can be used to prepare various consumables used by the system 10. For example, a batch of bags 26 can be placed in the front chamber. The plug box 466 (such as any box described herein) can also be stored in the front chamber. The sampling vial 532 (e.g., see Figure 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 the operation of the system 10. The first part 96 can also include certain test equipment, which can be used to verify that the bag 26 has been filled according to a predetermined standard. The sampling ports in the fluid circuit can also be accessed via the front chamber.

[0409] The second part 98 can be configured as a glove box-type housing with a glove interface 352, which can be used to manipulate certain components of the system 10 within the housing 12. The second part 98 can include the filling subsystem 610 of the system. The filling subsystem 610 can 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 part 96 and the second part 98 of the housing 12. The bag 26 can be placed at the bag holder 602. The robotic manipulator 606 including a gripper can collect the bag 26 from the bag holder 602 and shift the bag 26 to the filling station 356. Fluid can be dispensed into the bag 26 at the filling station 356. The fluid can be purified water (e.g., WFI water), or a fluid mixture generated at a mixing subsystem similar to those described with respect to Figure 2A and Figure 2B . For example, the bag 26 can also include a concentrate as described above with respect to Figures 5A to 6 . The robotic manipulator 606 can move the filled bag 26 from the filling station 356 to the sealing station 358. The inlet to the internal volume of the bag 26 can be sealed shut (e.g., via a plug, RF welding, etc.) at the sealing station 358.

[0410] 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 replaced by a bag feeder 354 similar to that described above with respect to Figures 59 to 65 . Similarly, Figure 58 the bag feeder 354 shown in the exemplary system 10 of

[0411] Now refer to Figures 113 to 114B, the bag retainer 602 can include a buckle 612 pivotally attached to a substrate 614. The buckle 612 can be opened and the user can hold the bag 26 in place at the bag retainer 302 via the glove interface 352. Then, the buckle 612 can be closed against the substrate 614. The buckle 612 can frictionally hold the port 392 of the bag 26. In some embodiments, the buckle 612, the substrate 614, or both the buckle 612 and the substrate 614 can include a receptacle 616 that receives a member 618 included on the port 392 to assist in holding the bag 26 in place in the bag retainer 602. When in the closed position, the buckle 612 can be latched in place. Such latching can be achieved via a mechanical latch or can be achieved via a magnet in one of the substrate 614 and the buckle 612 and a metal and / or magnetic body in the other of the substrate 614 and the buckle 612. The bag retainer 602 can also assist in positioning the port 392 of the bag 26 through which the bag 26 will be filled at a fixed and known location. As shown, the bag retainer includes a positioning pin 615 (see also Figure 116 ). The bag 26 can be loaded into the bag retainer 602 such that the positioning pin 615 is positioned in the filling port 392. Since the positioning pin 615 is fixed, the positioning pin 615 can ensure that the filling port 392 is in a known position before the bag 26 is removed.

[0412] Now referring to Figure 115 , with the bag 26 in place in the bag retainer 602, the control system 15 of the system 10 can shift the robotic manipulator 606 to the bag retainer 602. In an example embodiment, the robotic manipulator 606 is capable of shifting about multiple axes. In an example embodiment, a first rail 622 is included, where the first rail 622 defines a first axis along which the robotic manipulator 606 can shift. The robotic manipulator 606 can include a gripper 620 that can close around the port 392 of the bag 26 to grasp the bag 26. The gripper 620 can be included on a second rail 624, where the second rail 624 defines a second axis along which the gripper 620 of the robotic manipulator 606 can shift. In an example embodiment, the second axis is substantially perpendicular to the first axis.

[0413] As Figure 116 shown, once the bag 26 has been grasped, the robotic manipulator 606 can shift the gripper 620 downward along the second rail 624 to pull the bag 26 away from the bag retainer 602. In some embodiments, the downward force applied by the robotic manipulator 606 causes the buckle 612 of the bag retainer 602 to open. In other embodiments, the force may not open the buckle 612 but is sufficient to overcome any frictional forces holding the bag 26 in place within the bag retainer 602. As Figure 117As shown, the robotic manipulator 606 can then be displaced along the first rail 622 to move the bag 26 towards the filling station 356.

[0414] Now referring to Figure 118A , once the robotic manipulator 606 has displaced the bag 26 such 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 towards the filling station 356. In the example shown, the filling nozzle 430 is also displaceable, and the filling nozzle 430 can be displaced towards the port 392 while the gripper 620 of the robotic manipulator 606 is raised. As Figure 118A shown, the filling nozzle 430 can be conical to assist the filling nozzle 430 in entering the port 392 of the bag 26. Once the filling nozzle 430 is within the port 392, the control system 15 can command the filling station 356 to dispense fluid into the bag 26. Although not shown in Figure 118A , in some embodiments, the filling station 356 can include a set of bag characteristic sensors 444A - 444C, such as those shown and described with respect to Figure 66 . As described elsewhere herein, the control system 15 can determine the filling level of the bag 26 based on data collected from the bag characteristic sensors 444A - 444C.

[0415] Now referring to Figure 118B , the filling nozzle 430 can be included in a biasing assembly 611 that includes a biasing member 613 that exerts a force on the filling nozzle 430 that tends to firmly press the filling nozzle 430 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 the filling station shown and described with respect to Figure 66 . As shown, the filling nozzle 430 is coupled (integral in this example) to the inlet fitting 617. In this example, a portion of the conduit 619 connects the inlet fitting 617 and the filling nozzle 430. The conduit 619 can include a flange 621. Also shown is a housing 623 that includes a body 627 and an end cap 625 (see Figure 118A). The end cap 625 may include a passageway 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 received 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 exerted by the biasing member 613 during filling. The restoring force of the biasing member 613 may thus robustly push the filling nozzle 430 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.

[0416] Now referring to Figures 119 to 122 , once the bag 26 has been filled, the bag 26 may be lowered away from the filling nozzle 430 by shifting the gripper 620 along the second rail 624. The filling nozzle 430 may also be raised. The robotic manipulator 606 may be shifted along the first rail 622 toward the sealing station 358. The sealing station 358 may include a support bracket 626. During the sealing operation, the support bracket 626 may assist in positioning and holding the port 392 of the bag 26. In the exemplary embodiment, the robotic manipulator 606 is shifted such 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 ( Figure 120 ). The gripper 620 may be shifted along the second rail 624 to raise the bag 26 toward the sealing station 358 ( Figure 121 ). Then, the robotic manipulator 606 may be shifted to retreat along the rail 622 and bring the port 392 into the support bracket 626. This may align the port 392 with the push rod 464.

[0417] Now referring to Figure 123 , an exemplary support bracket 626 is depicted. 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 into a funnel-shaped opening 764 in the top surface 766 of the support bracket 626. The funnel-shaped opening 764 may assist in guiding the plug 476 into the groove and aligning 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 guiding portion of the groove 760 and its dimensions may be designed to surround most of the plug 476 to guide the plug 476 when 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 Figure 122As shown, port 392 can be displaced into groove 760 in a direction substantially perpendicular to the axis of groove 760. The second portion 762B of groove 760 can be flanked by a corrugated wall 768. When this vertical displacement occurs, the corrugated wall 768 can assist in guiding port 392 into the second portion 762B of groove 760. The groove 760 of exemplary support bracket 626 can also include a ledge 770. The ledge 770 can form a stop surface that can catch on step 516 of plug 476 when plug 476 is displaced into port 392 of bag 26. Two removal notches 772 that flank groove 760 above ledge 770 are also recessed into support bracket 626. Once plug 476 is in place in port 392, these notches 772 can allow port 392 to be easily displaced out of support bracket 626.

[0418] Still referring now to Figure 124 , to seal port 392, control system 15 can command push rod driver 462 of sealing station 358 to advance push rod 464 toward port 392 of bag 26 to be sealed. Push rod 464 can drive plug 476 from plug cartridge 466 into port 392 to seal port 392. As mentioned above, the funnel-shaped opening 764 and plug guiding portion 762A of support bracket 626 can assist in ensuring that plug 476 cleanly enters port 392. Then, control system 15 can command push rod driver 462 to retract push rod 464 and can actuate robotic manipulator 606 to remove bag 26 from sealing station 358. As Figure 125 shown, control system 15 can then displace robotic manipulator 606 to the drop-off location of bag 26.

[0419] Now referring to Figure 126 , filling subsystem 610 can include a guide chute 628 that helps guide bag 26 once the bag is released from gripper 620. Robotic manipulator 606 can also include a guide plate 630. Guide plate 630 can ensure that when bag 26 is released from gripper 620, bag 26 is guided onto guide chute 628. Once bag 26 reaches the bottom of guide chute 628, bag 26 can be manually labeled or placed in quarantine repository 362 via glove interface 352 while various tests (e.g., the endotoxin test described above) are completed.

[0420] Now referring to Figures 127 to 128, in some embodiments, system 10 can simultaneously and parallelly fill multiple bags 26. These bags 26 can be disposed in packages 1082 within a carrier 1080. The carrier 1080 can include a plurality of compartments 1084, and the packages 1082 can be held within the plurality of compartments. In an exemplary embodiment, the carrier 1080 includes six compartments 1084 and holds six packages 1082. In other embodiments, the number of compartments 1084 can be different. Preferably, the number of compartments 1084 can be selected such that the user can comfortably transport the carrier 1080 when all the bags 26 in the carrier are filled. Different carriers 1080 for different volume bags 26 can be provided with carriers 1080 having a greater number of compartments 1084 for smaller volume bags 26. The carrier 1080 can be constructed, for example, from a plastic sheet or a medical grade wax paper product. Such materials may be preferred where the carrier or package 1082 can be filled within the housing 12, such as those described elsewhere herein. In other embodiments, cardstock can be used. The carrier 1080 can include a handle 1087, which can facilitate user carrying or grasping by the gripper 418 of the robotic arm 360.

[0421] Now referring primarily to Figure 129 and Figure 130 , each package 1082 can include a cover flap 1086. The cover flap 1086 can include a passageway 1088 through which a fill line 1090 can extend. The cover flap 1086 can be secured to the pocket portion 1092 of the package 1082. The bag portion 26 can be disposed within the pocket portion 1092. The pocket portion 1092 can be expandable to accommodate the increased volume of the bag 26 when the bag 26 is being filled. For example, the sidewalls of the pocket portion can include bellows features. In Figure 130 , the package 1082 is removed to expose an exemplary bag 26. In an 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 coupler can be used. When secured to the pocket portion 1092, the cover flap 1086 can hold the fluid delivery kit 1094 attached to the bag 26 and the package 1082 in place. A sliding clamp 1098, a roller clamp 1100, or other blocking devices can be placed in a blocking state on the tubing of the fluid delivery kit 1094 to prevent fluid from flowing through the fluid delivery kit 1094 when the bag 26 is being filled. Alternatively, the fluid delivery kit 1094 can include a frangible member that prevents fluid from flowing through the frangible member until it is broken by the user. The fluid delivery kit 1094 can be any desired fluid delivery kit 1094 and can include one or more of a drip chamber, a burette, a bifurcation (Y-site, T-site, etc.), a luer lock, a septum, etc.

[0422] Now referring to Figure 131 andFigure 132 , each filling line 1090 extending from the encapsulation package 1082 can be coupled to the pointed adapter 1102. As Figure 132 best shown, the pointed adapter 1102 can include a plurality of radial recesses 1104. These recesses 1104 can be recessed into the outer sidewall of the pointed adapter 1102. The number of recesses 1104 can be equal to the number of encapsulation packages 1082 held by the carrier 1080. The size of the recesses 1104 can 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 can be designed to be smaller than the outer diameter of the filling line 1090. Thus, the filling lines 1090 can deform when they are inserted into the recesses 1104 and can resist accidental removal once contained therein. The pointed adapter 1102 can also include a plurality of protrusions 1106. These protrusions 1106 can facilitate grasping by the robotic gripper 418 or by the 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 can include a sealing member 1108. The sealing member 1108 can be a diaphragm that can be pierced to access the lumen of the filling line 1090 and can self-seal once the piercing member is retracted. As shown, the radial recesses 1104 of the pointed adapter 1102 can ensure that the filling lines 1090 are straight in the immediate upstream of the sealing member 1108.

[0423] Now refer to Figure 133A and Figures 134 to 136 , a plurality of views of an exemplary filling station 1110 that can receive the pointed adapter 1102 to fill the bag 26 are depicted. In Figure 133A a diagrammatic example of the filling station 1110 is shown. As shown, the filling station 1110 can include a source 1112. The source 1112 can communicate with a recirculation valve 1114 and an inlet valve 1116. The inlet valve 1116 can gate the flow to the fluid pump 1118, which can be a diaphragm pump in some examples. The fluid pump 1118 can deliver fluid from the source to a heater 1120, which can be an in-line heater. An air pump 1122 can also be piped into the line leading from the fluid pump 1118 to the heater 1120. A check valve 1123 can be included to ensure that the liquid does not flow back into the air pump 1122. The fluid can flow from the heater 1120 to a manifold 1124. The manifold 1124 can divide the flow into a number of different flow paths leading to the pointed tip ports 1126. The pointed tip ports 1126 can also be connected to the recirculation valve 1114.

[0424] The fluid flowing out of source 1112 can be routed to the spike port 1126 to be delivered into the fill line 1090 of the bag 26 disposed within the spike adapter 1102. After completion of the filling operation, the cap 1130 of the spike port 1126 can be sealed shut and the fluid entering the fill station 1110 can be recirculated while being heated by the heater 1120. The heater 1120 can maintain the temperature of the recirculating fluid within a range of a predetermined temperature set point. The control system 15 of the system 10 can continue to recirculate water within the fill station 1110 for a period of time sufficient to effect disinfection at the predetermined temperature set point. The water can then be transferred to the discharge destination 1128 through the inlet valve 1116. In certain embodiments, the heater 1120 can maintain the fluid at a temperature of 75 - 80 °C or higher during disinfection. Thus, each time a connection is made to the spike port 1126, the spike port 1126 may have been freshly disinfected.

[0425] In an alternative embodiment, now referring to Figure 133B , an exemplary fill station 1110 can include a source 1112 that is in direct communication with an inlet valve 1116 that can double as a recirculation valve. The spike port 1126 can include a connection that can allow fluid to recirculate through the spike port 1126 as described above, or can allow fluid to flow through the discharge port 1128. During disinfection, the fluid can be directed through the heater 1120 and heated to a range of the temperature set point. The water can travel to the discharge port 1128 via the drain valve 1115 without recirculation.

[0426] Now also referring to Figure 137, depicts a top view of an exemplary 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 size of the recess 1132 can be designed to receive the spike adapter 1102. As shown, the spike port 1126 can include an alignment channel 1136. The alignment channel 1136 can receive a protrusion 1106 of the spike adapter 1102. The protrusions 1106 on the spike adapter 1102 can be positioned such that when they are within the alignment channel 1136, the seal member 1108 of the fill line 1090 can be aligned with the corresponding spike 1134 in the recess 1132. Other bonding elements can also be used to help ensure proper alignment. Pressing the spike adapter 1102 into the recess 1132 can cause each spike 1134 to penetrate the corresponding seal member 1108 such that fluid can be delivered through the fill line 1090 to the bag 26. Since the radial recesses 1104 of the spike adapter 1102 ensure that each seal member 1108 is straight adjacent to the upstream fill line 1090, the spikes 1134 can be prevented from piercing the sidewall of the fill line 1090. Before pressing the spike adapter 1102 into the recess 1132, the spike adapter 1102 and the seal member 1108 can be wiped with a disinfectant. For example, 70% isopropyl alcohol can be used. Additionally, the cover 1130 of the spike port 1126 can remain closed until just prior to the time of forming the connection. The cover 1130 can also be cleaned with a disinfectant before opening. The materials selected for constructing the fill catheter 1090, the seal member 1108, the spike adapter 1102, and the spike port 1126 can be suitable for the disinfectant used during disinfection at the fill station 1110 and the temperatures present.

[0427] As shown, the spike port 1126 can include a gasket member 1136 surrounding the recess 1132. When the cover 1130 is in the closed position above the recess 1132, the gasket member 1136 can form a seal against the cover 1130. In some embodiments, a latch (not shown) can be included to hold the cover 1130 in the closed orientation and ensure a small amount of pressure is applied between the cover 1130 and the gasket member 1136 and prevent the spike port 1126 from accidentally opening. In Figure 137 a recirculation port 1138 is also shown. With the cover 1130 closed, the recirculation port 1138 can allow fluid pumped into the recess 1132 via the spikes 1134 to be removed from the spike port 1126 and recirculated back through the heater 1120. This can help ensure that the fluid in the spike port 1126 remains at a desired temperature during the disinfection process. In certain embodiments, both a recirculation port 1138 and a drain port (not shown) can be included in the spike port 1126.

[0428] Now refer to Figure 138 , which depicts a schematic diagram of an exemplary fluid circuit 710 that can be used with any of the systems 10 shown herein. The mixing circuit 348 and the sensor suite 350 (e.g., those mentioned with respect to Figure 56 and Figure 111 ) can be included in the fluid circuit 710. As shown, the fluid circuit 710 can draw water from a water source 16. The water source 16 can be any of the water sources described herein. In certain embodiments, the fluid from the water source 16 can be subjected to any one of a variety of pretreatment operations. For example, filtration or chemical treatment can be performed before the water travels to the medical water production device 14. In the exemplary fluid circuit 710, the fluid from the water source 16 can pass through a water softener 712. After passing through the water softener 712, the fluid can be filtered through one or more carbon filters 714 (e.g., two identical carbon filters in series). In some examples, a coarse filter or sediment filter can be included upstream of the carbon filters 714. The filtered water flowing out of the one or more carbon filters 714 can then be filtered through a reverse osmosis assembly 716. Depending on the water source 16, one or more of the water softener 712, the carbon filters 714, and the reverse osmosis assembly 716 can be optional or can be omitted.

[0429] In the exemplary fluid circuit 710, the fluid can travel from the reverse osmosis assembly 716 to a temperature regulator 718. The temperature regulator 718 can include at least one of a cooler and a heater. For certain 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 lower the temperature of the inlet water or can operate to lower 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 in certain examples.

[0430] In an example embodiment, the output portion of the medical water production device 14 can include a quick connect fitting 720 that 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 interest. In an example 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 outputs 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 for water for injection (WFI). The acceptability thresholds for the conductivity sensors 722A, 722B (or other sensors in the fluid loop 710) can be defined in pharmacopeia standards or water monographs. In some examples, the conductivity sensors 722A, 722B can be selected to have high resolution, accuracy, and reliability at low conductivity values. In some embodiments, an ultra-pure water conductivity sensor optimized for sensing low conductivity fluids can be used. The fluid loop 710 can also include a total organic carbon (TOC) monitor 724. In an example embodiment, the TOC monitor 724 is shown receiving a slipstream of the fluid, which then flows to the drain 726. In other embodiments, the TOC monitor may be in-line and may not be on a slipstream.

[0431] After initial sensing, the fluid can travel to the inlet pressure sensor 728. The inlet pressure sensor 728 can 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 divert water to the drain 726. Additionally, the transfer manifold 730 can allow water measured to exceed a predefined sensing threshold to be directed to the drain 726. Water leaving the transfer manifold 730 can flow to the pump 732, which can be operated if needed to regulate the pressure of the water. The control system 15 can check the reading from the inlet pressure sensor 728 before operating the pump 732. For example, the control system 15 can verify that the inlet pressure is a positive pressure or a positive pressure exceeding a certain threshold before powering on the pump 732. This can ensure that the pump 732 has water to pump before it is powered. 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 recirculate to the pump 732 in the case where the pressure downstream of the pump 732 is at an expected value. The inlet manifold 734 can include an additional conductivity sensor 736, which can again check whether the conductivity of the water is within a predetermined limit. 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 notify the operation of the pump 732. In some examples, the inlet manifold 734 can include a sampling port or diaphragm.

[0432] 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 ingredient path. The number of flow paths in the mixing circuit 348 can depend on the type of solution being mixed or the types of solutions that the system 10 supports generating. In certain embodiments, a flow path can be included for each ingredient component of the solution. An exemplary system 10 is shown as a saline generation circuit and includes a saline flow path and a WFI water flow path.

[0433] Regarding the saline flow path, in the exemplary embodiment, the mixing circuit 348 may include a crystalloid component container 740. The crystalloid component container 740 may be filled with sodium chloride. Other crystalloid components (e.g., sugars for producing D5NS or dialysate) may be used in other embodiments. Fluid may enter the crystalloid 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 crystalloid component container 740 may be saturated or near-saturated. In some embodiments, the crystalloid component container may also serve as a reservoir 740, which may hold a certain amount of solution therein. This may allow the system 10 to easily accommodate periods of high fluid demand. The fluid leaving the crystalloid component container 740 may then pass through at least one filter. For example, a coarse filter may be included to help ensure that particulate components do not leave the crystalloid component container 740. In this example, an ultrafilter 742 is also shown downstream of the crystalloid component container 740. At least one conductivity sensor 744 may collect data regarding the concentration of sodium chloride in the fluid leaving the ultrafilter 742.

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

[0435] The fluid may leave the mixing manifold 748 and travel along a tortuous and / or relatively long flow path to promote mixing. Then, the fluid may pass through a set of redundant conductivity sensors 752A, 752B. These conductivity sensors 752A, 752B may collect data regarding the conductivity of the solution leaving the mixing circuit 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 a particle sensor 754 and a dispensing nozzle 756. In Figure 138In this case, the particulate sensor 754 is shown as being fed from the slipstream. However, in other embodiments, the particular sensor 754 may be in the pipeline and upstream of the dispensing nozzle 756. The control system 15 may monitor data from the particle counter to check whether the generated fluid meets a predetermined particle limit. The fluid exiting the particle counter may travel to the discharge port 726. If the fluid is considered 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 into the discharge port (e.g., see Figure 71A for the discharge inlet 434), and then a flushing volume of solution may follow.

[0436] Now referring to Figure 139 , a flowchart 1300 is shown, which details a number of example actions that may be performed to generate and encapsulate a desired fluid. As shown, in block 1302, the control system 15 of the system 10 may receive a request to fill the bag 26. The control system 15 may determine the mass of the ingredient (e.g., sodium chloride) to be dispensed for the bag 26. This mass may be the mass required to produce a solution of the percentage of the ingredient needed per unit volume (e.g., 0.9% saline). In block 1304, bag 26 information may be collected from a set of bag characteristic sensors 444A - 444C (e.g., see Figure 66 ). In block 1306, a first dispensing stage may be started. In this stage, the fluid delivered to the bag 26 may be entirely or mainly ingredient concentrate. The mass of the ingredient dispensed into the bag 26 may be tracked by readings from at least one conductivity sensor and a flowmeter or flow controller. Once the required mass of the ingredient has been dispensed into the bag 26 in block 1308, a second dispensing stage may be started in block 1310. In the second stage, WFI may be dispensed into the bag 26. The amount of WFI dispensed may be tracked by a flowmeter or flow controller. Once the amount of WFI required to produce the desired solution has been dispensed in block 1312, dispensing may be stopped in block 1314. Also in block 1314, the bag 26 may be collected from the filling station 356. By delivering the ingredient in the first stage, the second stage may be used as a flush of the pipeline leading to the filling nozzle. This may ensure that substantially all of the ingredient concentrate in the pipeline is dispensed into the bag 26. Thus, when attempting to pump the ingredient concentrate to produce a fluid of the desired concentration, the control system 15 may not have to account for the hold-up volume in the pipeline. Additionally, after the bag 26 has been filled, subsequent bags 26 may be filled with different types of solutions or may be filled with solutions of different concentrations. This may be done without waste and ingredient concentrate in the fluid flush in the pipeline between the bags 26.

[0437] Now referring to Figure 140, in some embodiments, the crystallization component container 740 through which the fluid flows may not be included. Instead, a crystallization component dispenser 780 may be used. As shown, the fluid may leave the inlet manifold 734 and proceed to the metering manifold 784. The metering manifold 784 may also be in communication with the crystallization component dispenser 780. The crystallization component dispenser 780 may dispense the crystallization component into the metering manifold 784 via a dispensing assembly 787. A motor 785 may be included to drive the dispensing assembly 878. The fluid may flow from the metering manifold 784 to the concentrate reservoir 782. In the case where the concentrate reservoir 782 is included, at least one conductivity sensor (e.g., conductivity sensor 744) of the component flow path of the mixing loop 348 may be included within the internal volume of the concentrate reservoir 782 or in communication with the internal volume of the concentrate reservoir.

[0438] Now also referring to Figure 141 , depicts Figure 140Cross-sectional view of the exemplary metering manifold 784. As shown, the metering manifold 784 can include an internal cavity 786. The internal cavity 786 can communicate with the inlet manifold 734 via a first port 788. The crystallization component dispenser 780 can communicate with the internal cavity 786 via a second port 790. The axis of the second port 790 can be arranged to allow the component to gravitationally feed from the crystallization component dispenser 780 into the internal cavity 786. The internal cavity 786 can be configured to generate a specific flow pattern, which can help to promote intense mixing within the metering manifold 784. In an exemplary embodiment, the internal cavity 786 includes a baffle 792 that is in line with the axis of the first port 788. The baffle 792 can cause turbulence directly upstream of the second port 790, thereby promoting rapid mixing and dissolution of the crystallization component upon introduction. The baffle 792 can also narrow the cross-section of the flow path from the first port 788 to the outlet 794 of the metering manifold 784. This can create a Venturi effect, which can cause the flow from the second port 790 into the internal cavity 786 to be faster than the flow elsewhere within the internal cavity 786. Thus, when the component enters the metering manifold 784, its accumulation at the inlet point can be inhibited. In other embodiments, the internal cavity 786 can include a plurality of baffles 792. The internal cavity 786 can also include a funnel region 796 located directly upstream of the outlet 794. The funnel region 796 can facilitate the generation of a vortex within the internal cavity 786, which can further help to dissolve the crystallization component dispensed from the crystallization component dispenser 780. In an exemplary embodiment, a turbulence generator 798 is also disposed within the outflow conduit 800 from the metering manifold 784. The turbulence generator 798 can provide additional assistance that may help to dissolve the crystallization component. In an exemplary embodiment, the turbulence generator 798 is an insert having 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 can be a coil of tubing that increases the transit time of the fluid within the outflow conduit 800 as the fluid travels to a downstream component (e.g., conductivity sensor 744) within the fluid circuit 710.

[0439] Now refer to Figure 142 and Figure 143 , an exemplary crystallization component dispenser 780 is depicted. In Figure 143In [description], a part of the crystallization component dispenser 780 is broken to expose the components of the dispensing assembly 787. As shown, the crystallization component dispenser 780 may include a component storage compartment 802. The storage compartment 802 may have an outlet 804 that may feed into the dispensing assembly 787. In an example embodiment, the dispensing assembly 787 includes an aperture 806 in which an auger 808 is disposed. The auger 808 may be attached to a drive shaft 810. The drive shaft 810 may extend to a motor 785 that may be operated to cause rotation of the auger 808. As the auger 808 rotates, the component may be advanced through the aperture 806 toward the outlet 812 of the dispensing assembly 787. The outlet may communicate with the interior volume of the metering manifold 784 via a second port 790 of the metering manifold 784. The control system 15 may command the rotation of the auger 808 based on data collected from a conductivity sensor (e.g., Figure 138 the conductivity sensor 744) to produce a solution of a desired concentration.

[0440] Now referring to Figures 144 to 146 , another embodiment of an exemplary crystallization component dispenser 780 is depicted. Again, in Figure 145 , a part of the crystallization component dispenser 780 is broken to expose the components of the dispensing assembly 787. As shown, the crystallization component dispenser 780 may include a component storage compartment 802. The storage compartment 802 may have an outlet 804 that may be supplied to the dispensing assembly 787. In an example embodiment, the dispensing assembly 787 includes an internal void 814 within 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. Rotation of the paddle wheel 816 may cause a quantity of the component to be advanced from the storage compartment 802 to the outlet 812 of the dispensing assembly 787. The outlet may communicate with the interior volume of the metering manifold 784 via a second port 790 of the metering manifold 784. The control system 15 may command the rotation of the paddle wheel 816 based on data collected from a conductivity sensor (e.g., Figure 138 the conductivity sensor 744) to produce a solution of a desired concentration.

[0441] Specifically referring to Figure 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. Although two circular members 818 are shown in Figure 146 , other embodiments may include a greater number. In an example embodiment, the two circular members 818 are arranged substantially perpendicular to each other.

[0442] Now referring to Figure 147 and Figure 148 , another example dispensing assembly 787 is depicted. Again, inFigure 148 In [the figure], a portion of the housing 1018 of the dispensing assembly 787 is broken away to expose the components of the dispensing assembly 787. Although not shown, the dispensing assembly 787 can generally be attached to the ingredient storage compartments 802, such as those shown and described above. The storage compartment 802 can be fed into the inlet 1010 of the dispensing assembly 787. In an example embodiment, the dispensing assembly 787 includes an internal passageway 1016 in which an impeller 1012 is disposed. The passageway 1016 can be sized such that the impeller 1012 prevents the ingredient from shifting through the passageway 1016 when the impeller 1012 is not rotating. The impeller 1012 can be attached to a drive shaft 810 that can extend to an electric motor 785 that can be operated to cause rotation of the impeller 1012. Rotation of the impeller 1012 can cause a quantity of the ingredient to be advanced from the storage compartment 802 to the outlet 1014 of the dispensing assembly 787. The outlet 1014 can communicate with the interior volume of the metering manifold 784 via a second port 790 of the metering manifold 784. The control system 15 can command rotation of the impeller 1012 based on data collected from a conductivity sensor (e.g., Figure 138 the conductivity sensor 744) to produce a solution of a desired concentration.

[0443] Now referring to Figure 149 and Figure 150 , in some embodiments, a disk 1020 having a plurality of spaced-apart recesses 1022 can be used in place of the impeller 1012. The recesses 1022 can be evenly spaced around the disk 1020. In an example embodiment, the recesses 1022 are spaced at a uniform angular increment of 72°. The recesses 1022 can be the same shape. In this example, the recesses 1022 are bowl-shaped. In other embodiments, the recesses 1022 can be oblong (see Figure 151 ) or any other desired shape. When the disk 1020 rotates (the disk 1020 can be coupled to a drive shaft 810 driven by an electric motor 785, e.g., similar to ...

Claims

1. A system for local production and encapsulation of medical fluids, comprising: A water source input section; A medical water production device that generates product water meeting predetermined quality specifications using water received from the water source input section, the medical water production device having an output section in fluid communication with an outlet pipeline; A housing that includes an encapsulation compartment; A reservoir dispenser; A plurality of bag reservoirs arranged in the reservoir dispenser, each of the plurality of bag reservoirs being pre-filled with a certain amount of concentrate; At least one robotic bag holder that can be actuated to hold the frontmost bag reservoir among the plurality of bag reservoirs and can be displaced relative to the bag reservoir to remove the frontmost bag reservoir from the dispenser, and the plurality of bag reservoirs are advanced through the dispenser as the frontmost bag reservoir is removed; Respective reservoir filling stations connected to the outlet pipeline, at least one of the at least one robotic bag holders being displaceable relative to the filling station to displace each bag reservoir held by the at least one robotic bag holder to a filling position at the filling station; A reservoir labeling component for applying information to the bag reservoir; And An allocation output section of the housing.

2. The system according to claim 1, wherein the system further includes an undesired fluid container connected to an undesired fluid conduit, the undesired fluid container being displaceable from a storage position to a receiving position, and when the undesired fluid container is in the receiving position, fluid from the filling station is dispensed into the undesired fluid container.

3. The system according to claim 1, wherein the medical water production device includes at least one component selected from the following list: a filtration device, a charcoal filter, an ultrafilter, an endotoxin removal filter, a reverse osmosis unit, a microfilter, a depth filter, a distillation device, a degassing device, a UV light source, a chemical treatment device, an exchange resin, and an electrodeionization unit.

4. The system according to claim 1, wherein the concentrate is a liquid concentrate.

5. The system according to claim 1, wherein the concentrate is a solid concentrate.

6. The system according to claim 1, wherein the concentrate is a crystalline concentrate.

7. The system according to claim 1, wherein the concentrate is selected from the following list: a normal saline concentrate, a Ringer's solution concentrate, a Hartmann's solution concentrate, a sugar solution concentrate, a sugar-salt solution concentrate, and a dialysis fluid concentrate.

8. The system according to claim 1, wherein the concentrate is accommodated in an inner compartment of each of the respective bag reservoirs among the plurality of bag reservoirs, and the inner compartment is separated from the rest of the bag reservoir by a machine-interruptible seal.

9. The system according to claim 1, wherein the plurality of bag reservoirs includes at least 50 bag reservoirs.

10. A system for producing and encapsulating medical fluids in a healthcare environment, comprising: A water source input; A medical water production device that uses water from the water source input to produce output water meeting a predetermined standard, the medical water production device having an output in fluid communication with an outlet pipeline; A water quality sensor set, the water quality sensor set including a plurality of output water quality sensors; A housing that includes an encapsulation compartment; An IV bag dispenser that houses a plurality of IV bags, each of the plurality of IV bags enclosing a certain amount of concentrate; At least one robotic IV bag holder, at least one of the at least one robotic holder being actuable to hold the frontmost IV bag of the plurality of IV bags and being displaceable relative to the IV bag dispenser to remove the frontmost IV bag from the dispenser, the plurality of IV bags advancing through the dispenser as the frontmost IV bag is removed; Respective IV bag filling stations connected to the outlet pipeline, at least one of the at least one robotic IV bag holders being displaceable relative to the filling stations to displace respective IV bags held by the at least one robotic bag holder to a filling position at the filling stations; An IV bag labeling component for applying information to the IV bags; And An output of the housing.

11. The system according to claim 10, wherein the medical water production device includes at least one component selected from the list consisting of: a filtration device, a charcoal filter, an ultrafilter, an endotoxin removal filter, a reverse osmosis unit, a microfilter, a depth filter, a distillation device, a degassing device, a UV light source, a chemical treatment device, an exchange resin, and an electro-deionization unit.

12. The system according to claim 10, wherein the concentrate is selected from the list consisting of: a saline concentrate, a Ringer's solution concentrate, a Hartmann's solution concentrate, a sugar solution concentrate, a sugar-salt solution concentrate, and a dialysis fluid concentrate.

13. The system according to claim 10, wherein the concentrate is housed in respective internal compartments of each of the plurality of IV bags, the respective internal compartments being separated from the remainder of the IV bag by a machine-interruptible seal.

14. The system according to claim 10, wherein the plurality of reservoirs includes at least 50 reservoirs.

15. A system for supplying medical fluids within a care facility, the system comprising: A water source input; A purification device that generates water of injection-grade quality from the water source input; A sensor set that includes a plurality of output water quality sensors; A housing; An IV bag cassette filled with a plurality of IV bags, each of the plurality of IV bags enclosing a certain amount of concentrate; At least one robotic manipulator, at least one of the at least one robotic manipulator being actuable to collect a leading one of the plurality of IV bags and shiftable relative to the cassette to remove the leading IV bag from the cassette, the plurality of IV bags being automatically advanced through the cassette as the leading IV bag is removed; Respective IV bag filling stations, the IV bag filling stations being coupled to an output line of the purification device, at least one of the at least one robotic manipulator being shiftable relative to the filling stations to move respective IV bags held by the at least one robotic manipulator to a filling position; An outlet, the outlet being coupled to a conduit, the outlet being shiftable from a retracted position to a receiving position, and when the outlet is in the receiving position, fluid from the IV bag filling stations is dispensed into the outlet; An IV bag labeling component for applying information to the IV bag; and An output portion of the housing.

16. The system according to claim 15, wherein the purification device includes at least one component selected from the list consisting of: a filtration device, a charcoal filter, an ultrafilter, an endotoxin removal filter, a reverse osmosis unit, a microfilter, a depth filter, a distillation device, a degassing device, a UV light source, a chemical treatment device, an exchange resin, and an electrodeionization unit.

17. The system according to claim 15, wherein the concentrate is selected from the list consisting of: a solid concentrate, a liquid concentrate, a saturated solution, a lyophilized concentrate, a crystalline concentrate, a concentrate ampoule, a saline concentrate, a Ringer's solution concentrate, a Hartmann's solution concentrate, a sugar solution concentrate, a sugar-salt solution concentrate, and a dialysis fluid concentrate.

18. The system according to claim 15, wherein the concentrate is contained in a respective internal compartment of each of the plurality of IV bags, the respective internal compartment being separated from the remainder of the IV bag by a machine-interruptible seal.

19. The system according to claim 15, wherein the plurality of reservoirs includes at least 50 reservoirs.

20. The system according to claim 15, wherein each of the plurality of IV bags includes a first port and a second port.

21. A system for producing and encapsulating a fluid, comprising: A water distillation device; A mixing circuit coupled to an output of the water distillation device and including a concentrate source, the mixing circuit being configured to regulate a flow of fluid through the mixing circuit to produce a fluid having a predetermined composition; A housing including a front chamber and an encapsulation compartment; A reservoir dispenser at least partially within the encapsulation compartment, the reservoir dispenser having a reservoir cassette and an outlet end, the reservoir dispenser including an actuator configured to drive a follower of the reservoir cassette toward the outlet end of the reservoir dispenser; A filling station in the encapsulation compartment, the filling station including a filling nozzle and a reservoir volume sensing assembly coupled to the mixing circuit; A sealing station in the encapsulation compartment; A repository in the encapsulation compartment, the repository having a plurality of reservoir brackets; A labeling machine assembly in the encapsulation compartment; And An output chute from the encapsulation compartment to the exterior of the housing.

22. A system for producing and encapsulating a fluid, comprising: A water distillation device; A mixing circuit coupled to an output of the water distillation device and including a concentrate source, the mixing circuit including a plurality of flow controllers configured to regulate the flow of fluid through the mixing circuit to produce a fluid having a predetermined composition; A housing including a front chamber and an encapsulation compartment; A reservoir dispenser having a portion with a feed plate and a housing block in the encapsulation compartment, the reservoir dispenser including a biasing member that urges the feed plate toward the housing block; A filling station in the encapsulation compartment, the filling station including a filling nozzle coupled to the mixing circuit; A sealing station in the encapsulation compartment having a push rod and a seal member dispenser; A repository in the encapsulation compartment having a plurality of reservoir brackets; A labeling machine in the encapsulation compartment; And An output chute from the encapsulation compartment to the exterior of the housing.

23. A system for producing and encapsulating a fluid, comprising: A water purification device; A mixing circuit coupled to an output of the water purification device and including a concentrate source, the mixing circuit configured to produce a fluid of a predetermined composition; A housing including a front chamber and an encapsulation compartment; A reservoir dispenser extending from the front chamber to the encapsulation compartment and having a reservoir cartridge and an outlet end, the reservoir dispenser including a drive configured to displace a follower of the reservoir cartridge toward the outlet end of the reservoir dispenser; A filling station in the encapsulation compartment, the filling station including a filling nozzle and a reservoir volume sensing assembly coupled to the mixing circuit; A sealing station in the encapsulation compartment; At least one reservoir hanger in the encapsulation compartment; A labeling machine in the encapsulation compartment; And An output chute from the encapsulation compartment to the exterior of the housing.

24. A seal member dispenser, comprising: A dispenser body including at least one groove and an outlet port extending from the groove to an exterior face of the dispenser body, wherein the groove is configured to receive a plurality of seal members and the outlet port has a guide portion adjacent to the exterior face of the dispenser body; A blocking element that impedes passage of the seal through the outlet port; And A cover member, the cover member being coupled to the dispenser body and suspended over the groove, the cover member including an orifice in line with the outlet port, the orifice having an opening that is too small for a seal member of the plurality of seal members to pass through.

25. A reservoir feeding device, comprising: A housing block, the housing block including at least one channel that extends through the housing block; A set of retaining pins, the set of retaining pins being associated with each of the at least one channel; A set of guides, the set of guides being associated with each of the at least one channel, a slot being defined between the guides in each set of guides; A feed plate, the feed plate being coupled to the housing block by at least one biasing member, the feed plate including at least one follower projection; And An elongate member, the elongate member extending from the housing block through the feed plate, the biasing member pushing the feed plate along the elongate member towards a stop surface of the housing block, and the biasing member being configured to push the follower projection into contact with a port of a reservoir disposed within the guides.

26. A reservoir feeding device, comprising: A housing block, the housing block including at least one channel that extends through the housing block; A set of retaining pins, the set of retaining pins being associated with each of the at least one channel; A reservoir cartridge, the reservoir cartridge being coupled to the housing block; A feed plate, the feed plate being coupled to the housing block by at least one biasing member, the feed plate including at least one follower projection; And An elongate member, the elongate member extending from the housing block through the feed plate, the biasing member pushing the feed plate along the elongate member towards a stop surface of the housing block and pushing the follower projection through the reservoir cartridge towards the housing block.

27. A bag sealing device, comprising: A push rod, the push rod being displaceable along a displacement axis by a push rod actuator; A seal member dispenser receptacle for receiving a seal member dispenser; A seal member dispenser sensor configured to output a first signal indicative of the presence of the seal member dispenser within the receptacle; And A reservoir guide including a first portion and a second portion having a gap therebetween, the reservoir guide being configured to align a port of a reservoir with the displacement axis when the reservoir is disposed within the gap, at least one of the first portion and the second portion of the reservoir guide including a gripper docking surface.

28. A device for encapsulating a fluid, comprising: A fill catheter dispenser having a reel portion that contains a length of fill catheter; A feeder assembly including an actuator coupled to at least one feed member; A tube retainer having a first portion and a second portion, wherein the first portion is coupled to a slider and a cam follower, the second portion is coupled to a substrate, and the tube retainer includes a receptacle for a port of a section of filled conduit and a bag; A slider actuator; A stopper assembly having a stopper actuator coupled to a carriage mounted to the stopper; A cutter assembly including a cutter actuator coupled to a cutting element and a cam surface, the cam surface and the cutting element being configured to shift in unison with each other; A guide coupled to the first portion of the tube retainer, the stopper assembly, and the cutter assembly; A biasing member that urges the cam follower against the cam surface; And A controller configured to govern the operation of the slider actuator, the stopper actuator, and the cutter actuator to seal, cut, and join the section of filled conduit and the port.

29. A reservoir filling kit, comprising: A carrier including a plurality of compartments; A plurality of packages, each of the plurality of packages containing a flexible reservoir attached to a liquid delivery kit and a fill line; An adapter including a plurality of retainer recesses, each of the plurality of retainer recesses receiving an end of one of the fill lines therein, the retainer recesses constraining the ends of the fill lines to extend straight along the axis of the retainer recesses in which the ends are received; And A plurality of seal members, the seal members of the plurality of seal members being included at each end of the fill line.

30. A system for encapsulating a fluid, comprising: A fluid source; A spike port including a plurality of spikes; A line heater; At least one pump; A plurality of valves; And A controller configured to: in a first mode, power 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 disinfect 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 spikes of the spike port.

31. A method of filling a reservoir, comprising: Creating a junction between the fill conduit and the port by heating the fill conduit and the port of the reservoir, cutting the fill conduit and the port, coaxially aligning the fill conduit with the port, and joining the cut end of the port to the cut end of the fill conduit; Delivering fluid through the fill conduit, past the junction, and into the reservoir via the port; And Actuating jaws against a portion of the port and heating the jaws until non-thermally conductive inserts in each jaw are pressed through the port.

32. A method of filling a reservoir, comprising: Form a joint between the fill conduit and the port by cutting the ports of the fill conduit and reservoir with a heated cutting element, sliding the cut ends of the ports and the cut ends of the fill conduit across opposite surfaces of the cutting element to position the fill conduit in coaxial alignment with the port and joining the cut end of the port to the cut end of the fill conduit when the cutting element is retracted; Convey fluid through the fill conduit, through the joint, and into the reservoir via the port; and Actuate jaws against a portion of the port and heat the jaws until non-thermal blades in each jaw are pressed through the port.

33. A fluid production system for a medical fluid packaging system, comprising: A water distillation device; A plurality of filters including at least one of a reverse osmosis filter and a carbon filter; A mixing circuit including a purified water flow path and a concentrate flow path including a source of concentrate, each having a flow controller and an ultrafilter on the purified water flow path and the concentrate flow path; A sensor suite including a total organic carbon sensor, a bioburden sensor, a particle monitor, a plurality of ultra-pure water conductivity sensors, and a concentrate conductivity sensor; A controller configured to govern the operation of the flow controllers to dispense a predetermined fluid volume in a first phase and a second phase, the first phase delivering fluid at least primarily from the concentrate flow path, and the second phase delivering fluid at least primarily from the purified water flow path, the controller proportioning the fluid in the first phase and the second phase based on data from the concentrate conductivity sensor, a predetermined desired fluid composition, and the predetermined fluid volume.

34. A method of filling a bag with a medical fluid, comprising: Placing a first fill nozzle in a first port of the bag in communication with a first compartment of the bag and a second fill nozzle in a second port of the bag in communication with a second compartment of the bag, the first fill nozzle and the second fill nozzle being in communication with a fluid source via a common flow channel; Conveying fluid into the first and second compartments of the bag; When the smaller of the first and second compartments of the bag is fully filled, stopping the conveyance of fluid into the smaller compartment with a non-powered valve; When the larger of the first and second compartments of the bag is fully filled, stopping the conveyance of fluid into the larger compartment; Separating the first compartment from the second compartment at a perforation in a seal extending between the first compartment and the second compartment of the bag; and Accessing the smaller compartment to collect a fluid sample for testing.

35. A bag for containing a medical fluid and a separable sampling aliquot, the bag comprising: A first compartment having a first fill port and a delivery port; A second compartment having a second fill port; A seal separating the first compartment and the second compartment; and Perforations that extend along the length of the seal.

36. A reservoir for holding a fluid, comprising: A first sheet of material and a second sheet of material, the first sheet of material and the second sheet of material being sealed to each other at a peripheral seal to define an internal volume of the reservoir; At least one port coupled to the peripheral seal and providing a fluid path into the internal volume; And An internal seal extending from the peripheral seal, the internal seal defining a partition portion of the internal volume and a main portion of the internal volume, the partition portion being in fluid communication with the main volume via a gap in the internal seal.

37. A reservoir for holding a fluid, comprising: A first sheet of material and a second sheet of material, the first sheet of material and the second sheet of material being sealed to each other at a peripheral seal to define an internal volume of the reservoir; At least one port coupled to the peripheral seal and providing a fluid path into the internal volume, the peripheral seal having an enlarged area, the at least one port being located in the enlarged area; And A sampling reservoir defined within the enlarged area, the sampling reservoir extending from a flow path through the enlarged area, the flow path connecting the port of the at least one port to the internal volume of the reservoir.

38. A method of encapsulating a fluid in a reservoir, comprising: Introducing a fill nozzle into a fill port of the reservoir; Delivering a predetermined amount of fluid into the reservoir via the fill nozzle; Removing the fill nozzle; Sealing the port of the reservoir; And Forming a seal within the reservoir that creates an internal aliquot of fluid separated from the remainder of the reservoir.

39. A fill and sampling nozzle, comprising: A first portion including a single lumen; And A second portion including a fill lumen and a sampling lumen, the fill lumen being continuous with the single lumen of the first portion, the fill lumen and the single lumen defining a continuous flow path from the first portion to the outlet of the nozzle, the sampling lumen having an opening at the outlet of the nozzle and being in fluid communication with a sample flow path coupled to the sidewall of the nozzle.

40. A method of encapsulating a fluid in a reservoir, comprising: Introducing a nozzle into a port of the reservoir; Delivering a first fluid volume through a continuous flow path that extends from a first portion of the nozzle through a second portion of the nozzle and into the reservoir; Delivering a second fluid volume into the reservoir through the continuous flow path, the second fluid volume exceeding the capacity of the reservoir; And During delivery of the second fluid volume, directing an overflow through a sampling lumen of the nozzle to a sampling conduit coupled to the nozzle.

41. The systems, methods, and devices as shown and described herein.

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