We also include filtration line design considerations for implementing barrier filters. Here we describe a robust and versatile approach to PUPSIT using a self-venting, all-in-one sterile barrier membrane filter from EMD Millipore, the life science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the United States and Canada.
Some applications use the downstream hold tank as a sterile boundary. Such methods use a flush bag, catch-can/flush bottle, or filter arrangement to create a sterile boundary on the downstream side of the product filter. A number of methods have been developed for running PUPSIT and performing line conditioning without compromising sterility. Unfortunately, it can be difficult to perform a PUPSIT without breaching system sterility. Because it is perceived to reduce business loss risk, preuse post-sterilization integrity testing (PUPSIT) is a current industry practice especially in manufacturing products that will be marketed in the European Union (EU).
Testing after sterilization limits risk, so it is a practice applied based on risk assessment. Performing a preuse test after sterilization detects damage that may have occurred during the sterilization cycle. Before sterilization, a preuse test will confirm that a filter is installed properly and was not damaged during shipment or handling. Figure 1: Design and layout of Millidisk and Millipak barrier filtersĪ number of regulatory guidelines recommend preuse integrity testing of critical sterilizing liquid filters for aseptic processing ( 1– 3).
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