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.
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:
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 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.