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 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 device (10) and method for aseptically or non-aseptically accessing a fluid in a container (210) using an existing container opening (211). The device (10) includes a sanitary fitting (12) for attaching the device to the container over the existing container opening, and a sample coupling (14) associated with the sanitary fitting. The sanitary fitting (12) includes a first port (32), and the sample coupling (14) includes at least two second ports (52). The sample coupling (14) is rotatable relative to the sanitary fitting (12) in one direction to cause the first port (32) to successively align with each of the second ports (52), and thereby allows access to the fluid through the aligned first and second ports (32,52).

Abstract: A system (10) and method for substantially automatically aseptically or non-aseptically filling a container with a fluid. The transfer of fluid occurs via a movable nozzle mechanism (20) substantially automatically inserted into a side opening (32) in a connector (12) attached to the container. More specifically, the side opening (32) in the connector (12) is exposed, the nozzle mechanism (20) is moved into the side opening (32), the fluid is transferred into the container via the nozzle mechanism (20) and the connector (12), the nozzle mechanism (20) is removed from the side opening (32) in the connector (12), and the side opening (32) in the connector (12) is closed. The aseptic transfer of fluid includes a substantially automatic sterilization procedure accomplished by both spray and contact components (54,56).

Abstract: A device (10) for clamping and separating a length of tubing. The device (10) comprises first and second subassemblies (12,14) for, in their closed positions, clamping the tubing at first and second locations, respectively, and at least weakening the tubing for subsequent separation. The subassemblies (12,14) face each other and are connected by a breakable connection. Each subassembly (12,14) includes clamping elements (26,34) for clamping the tubing, a perforating or cutting element (28) for perforating or otherwise weakening or cutting the tubing, and locking elements (24,32) for locking the subassembly (12,14) in the closed position. The perforating element (28) may be at least one hard plastic or metal spike. Once each subassembly (12,14) is locked in the closed position, the breakable connection is broken to result in respective lengths of clamped tubing.

Abstract: A system (10) and method for substantially automatically aseptically or non-aseptically filling a container with a fluid. The transfer of fluid occurs via a movable nozzle mechanism (20) substantially automatically inserted into a side opening (32) in a connector (12) attached to the container. More specifically, the side opening (32) in the connector (12) is exposed, the nozzle mechanism (20) is moved into the side opening (32), the fluid is transferred into the container via the nozzle mechanism (20) and the connector (12), the nozzle mechanism (20) is removed from the side opening (32) in the connector (12), and the side opening (32) in the connector (12) is closed. The aseptic transfer of fluid includes a substantially automatic sterilization procedure accomplished by both spray and contact components (54,56).