Abstract: An aseptic connector assembly includes a body portion having a receptacle configured to receive a corresponding fill connector. A pivot portion is movably coupled to the body portion, the pivot portion having a channel formed therein. A conduit portion is slidably disposed within the channel formed in the pivot portion. The pivot portion has a ready position and an operative position, the pivot portion being adjustable from the ready position to the operative position via relative movement with respect to the body portion.

Abstract: A mixing system includes a container having a support plate and a mixing assembly supported on the support plate. The mixing assembly includes a pliable enclosure containing a fluid and a mixing device. A portion of the mixing device extends from the pliable enclosure and is adapted to be detachably coupled to a drive mechanism. A first plate is detachably secured to the rigid container. The pliable enclosure is disposed between the first plate and the support plate. A mixing arrangement includes a docking station having a drive cradle and a drive mechanism. The mixing system is removably positioned within the drive cradle so that the drive mechanism is removably coupled to the mixing device.

Abstract: A bag assembly includes a first panel secured to a second panel by a seam so that a cavity is formed between the first panel and the second panel, the seam encircling the cavity. A first seal couples together the first panel and the second panel at a location spaced apart from the seam so that the cavity encircles the first seal. In one embodiment, the first seal can be circular. A first port communicates with the cavity.

Abstract: A mixing system includes a container having a support plate and a mixing assembly supported on the support plate. The mixing assembly includes a pliable enclosure containing a fluid and a mixing device. A portion of the mixing device extends from the pliable enclosure and is adapted to be detachably coupled to a drive mechanism. A first plate is detachably secured to the rigid container. The pliable enclosure is disposed between the first plate and the support plate. A mixing arrangement includes a docking station having a drive cradle and a drive mechanism. The mixing system is removably positioned within the drive cradle so that the drive mechanism is removably coupled to the mixing device.

Abstract: A mixing system includes a tank assembly and a container positioned within the tank assembly, the container bounding a compartment. A mixer is disposed within the compartment of the container. A shaft has a first end secured to the mixer and an opposing second end disposed outside of the container. An actuation mechanism is coupled with the second end of the shaft outside of the container and reciprocally moves the shaft and the mixer a stroke length, the stroke length being adjusted based on a pre-programmed protocol or signals from a sensor.

Abstract: A bag assembly includes a pliable housing having a first panel secured to a second panel by a seam so that a cavity is formed between the first panel and the second panel, the seam encircling the cavity. A first tufting couples together the first panel and the second panel at a location spaced apart from the seam so that the cavity encircles the first tufting. In one embodiment the first tufting can circular. A first port is coupled with the pliable housing and communicating with the cavity.

Abstract: A method for forming an aseptic connection includes inserting an end of a sealed fill connector into a receptacle of an aseptic connector assembly; moving a pivot portion of the aseptic connector assembly relative to a body portion of the aseptic connector assembly so as to sever a portion of the fill connector, the pivot portion being at least partially disposed within the body portion; and advancing a conduit portion of the aseptic connector assembly into the fill connector so as to form an aseptic connection therebetween, the conduit portion being at least partially disposed within the pivot portion or the body portion of the aseptic connector assembly after advancing.

Abstract: A freezer bag, a storage system, and a method of freezing are provided. The freezer bag includes a pliable housing having opposing sides and bounding a cavity at least partially disposed between the opposing sides, each opposing side having an interior surface communicating with the cavity and an opposing exterior surface that is openly exposed, the pliable housing including a first panel and a seam. A first tufting couples together the opposing sides of the pliable housing at a distance spaced apart from the seam so that the cavity encircles the first tufting. A first port is connected to the pliable housing and communicates with the cavity.

Abstract: A mixing system and mixing method are provided. The mixing system includes a tank assembly, a container positioned within the tank assembly, a mixer disposed within a compartment of the container, a linear motor, and a shaft having a first end secured to the mixer and an opposing second end secured to the linear motor. The linear motor provides a variable stroke length for the shaft. The mixing method includes providing a tank assembly having a linear motor, positioning a mixing assembly including a mixing bag in the tank assembly, combining two or more components in a compartment of the mixing bag, attaching a mixing shaft extending from a mixer disposed within the mixing bag to the linear motor, and raising and lowering the mixing shaft to mix the two or more components. A stroke length of the mixing shaft during the raising and lowering is varied.

Abstract: A mixing system and mixing arrangement are provided. The mixing system includes a rigid container including an integral support plate; a mixing assembly supported on the integral support plate, the mixing assembly including a pliable enclosure containing a fluid and a mixing device, a portion of the mixing device extending from the pliable enclosure and adapted to be detachably coupled to a drive mechanism; and a first plate detachably secured to the rigid container. The pliable enclosure is in compression between the first plate and the integral support plate. The mixing arrangement includes a docking station including a drive cradle and a drive mechanism, a rigid container removably positioned within the drive cradle, a mixing assembly positioned within the rigid container, and a first plate configured to be detachably secured to the rigid container.

Abstract: A plunge-mixing bag arrangement includes a flexible mixing bag defining a mixing region, and a shaft extending from outside of the flexible mixing bag into the mixing region, the shaft comprising a sparger within the mixing region. The sparger comprises an interior channel and ports extending from the interior channel. The shaft is capable of axial movement within the bag to fracture gas bubbles being released from the interior channel through the ports. A plunge-mixing system includes a mechanism for raising and lowering the shaft.

Abstract: A portable test device and related method are disclosed for conducting integrity testing of flexible containers. The test is particularly useful for testing aseptic flexible film bags in a manner that maintains the sterile nature of the container and removes crinkles by inflating the containers to remove crinkles and establish an inflation set point. The decay in pressure is measured over a predetermined period of time; if pressure loss does not exceed a predetermined threshold the integrity of the bag is confirmed and it can be filled without further manipulation of the container that may result in introducing flaws.

Abstract: A pressure decay testing system including a testing device for determining the reliability of connectors is provided and includes a pneumatic cylinder that raises and lowers a sealing member that closes a second end of a connector inserted in the device. A base member is adjacent pneumatic cylinder and includes a receiving surface having at least one receiving member for holding the connector. A channel is disposed therethrough though the receiving surface of the base member and aligns with an inner bore of the connector inserted in the testing device. An air line is attached to base member fluidly connecting inner bore of the connector with decay tester. Decay tester introduces a pressure differential through the channel to reach a predetermined set point pressure when the connector is closed by the testing device. Decay tester is configured to measure a change in pressure over time with respect to the predetermined set point.

Abstract: A portable test device and related method are disclosed for conducting integrity testing of flexible containers. The test is particularly useful for testing aseptic flexible film bags in a manner that maintains the sterile nature of the container and removes crinkles by inflating the containers to remove crinkles and establish an inflation set point. The decay in pressure is measured over a predetermined period of time; if pressure loss does not exceed a predetermined threshold the integrity of the bag is confirmed and it can be filled without further manipulation of the container that may result in introducing flaws.

Abstract: A portable flexible container integrity test device for conducting integrity testing of flexible containers is disclosed. The test device is particularly useful for testing aseptic flexible film bags in a manner that maintains the sterile nature of the container and removes crinkles by inflating the containers to remove crinkles and establish an inflation set point. The test device includes a programmable logic controller (PLC), a pressure transducer in electronic communication with the PLC, a power source configured to provide electrical power to the PLC, a blower in electronic communication with the PLC, a gas delivery pathway in selective fluid communication with the blower, and a human/machine interface in electronic communication with the PLC. The device is portable and configured to fluidly connect to a flexible container via the gas delivery pathway.

Abstract: An aseptic connector assembly and a method of aseptically transferring fluid are provided. The aseptic connector assembly includes a body portion, the body portion having a receptacle configured to receive a corresponding fill connector; a pivot portion adjustably disposed within and extending partially from the body portion, the pivot portion having a channel formed therein; and a conduit portion axially slidably disposed within the channel formed in the pivot portion. The pivot portion comprises a ready position and an operative position, the pivot portion being adjustable from the ready position to the operative position via relative movement with respect to the body portion. The method includes providing an aseptic connector in a ready position, coupling a flexible tubing and a fill connector to the aseptic connector, moving a pivot portion to an operative position, axially sliding the conduit portion into the fill connector, and transferring a fluid through the connector.

Abstract: A mixing system and mixing method are provided. The mixing system includes a tank assembly, a container positioned within the tank assembly, a mixer disposed within a compartment of the container, a linear motor, and a shaft having a first end secured to the mixer and an opposing second end secured to the linear motor. The linear motor provides a variable stroke length for the shaft. The mixing method includes providing a tank assembly having a linear motor, positioning a mixing assembly including a mixing bag in the tank assembly, combining two or more components in a compartment of the mixing bag, attaching a mixing shaft extending from a mixer disposed within the mixing bag to the linear motor, and raising and lowering the mixing shaft to mix the two or more components. A stroke length of the mixing shaft during the raising and lowering is varied.

Abstract: A freezer bag, a storage system, and a method of freezing are provided. The freezer bag includes a pliable housing including at least one panel and a seam, the at least one panel and the seam defining a cavity within the pliable housing, a port extending from the pliable housing, and a tufting coupling opposing sides of the pliable housing, the tufting dividing the cavity into a plurality of regions.

Abstract: A mixing system and mixing arrangement are provided. The mixing system includes a rigid container including an integral support plate; a mixing assembly supported on the integral support plate, the mixing assembly including a pliable enclosure containing a fluid and a mixing device, a portion of the mixing device extending from the pliable enclosure and adapted to be detachably coupled to a drive mechanism; and a first plate detachably secured to the rigid container. The pliable enclosure is in compression between the first plate and the integral support plate. The mixing arrangement includes a docking station including a drive cradle and a drive mechanism, a rigid container removably positioned within the drive cradle, a mixing assembly positioned within the rigid container, and a first plate configured to be detachably secured to the rigid container.

Abstract: A portable flexible container integrity test device for conducting integrity testing of flexible containers is disclosed. The test device is particularly useful for testing aseptic flexible film bags in a manner that maintains the sterile nature of the container and removes crinkles by inflating the containers to remove crinkles and establish an inflation set point. The test device includes a programmable logic controller (PLC), a pressure transducer in electronic communication with the PLC, a power source configured to provide electrical power to the PLC, a blower in electronic communication with the PLC, a gas delivery pathway in selective fluid communication with the blower, and a human/machine interface in electronic communication with the PLC. The device is portable and configured to fluidly connect to a flexible container via the gas delivery pathway.