![]() For these reasons, filters should be tested both before use but after sterilisation and again after use.” The performance of a filter can improve with use, as particles begin to block individual pathways and remove larger pathways that smaller particles could successfully navigate. For example, high temperatures during the process may cause the filter to distort, potentially leading to fluid pathways that allow the passage of particles greater than 0.2 µm in size. However, European regulators started enforcing pre-use testing, PUPSIT, in 2007 because of a debatable Q&A document 8 that speculatively states: “ The filter-sterilisation process may be physically stressful for the filter. Pre-use testing, without specifying whether pre- or post-sterilization, is listed as a proposal and is not even mentioned in some of the guidance, as the complexity is understood by these organizations. Consequently, most regulatory authorities mandate post-use testing of the integrity of a sterilizing grade filter. ![]() ![]() Exceptionally rare are integrity tests pre-use/post-sterilization, as such tests would require downstream sterile filtrate side manipulation and therefore can be considered precarious as they are accompanied with higher process complexity and increased risks. Some filter users test the integrity before the filtration process and before the filter is sterilized. The integrity test of sterilizing grade filters must be done and is most commonly performed after the filtration process, or post-use. This article reviews the potential benefits and downfalls of PUPSIT, as well as the recommendation to utilize risk assessment evaluation instead of the generic enforcement of the test. The necessity of this test is debatable because its implementation and accompanying increase in process design and handling complexities cause concerns. It has been part of the EU Annex 1, Manufacture of Sterile Medicinal Products, guideline since inception, but sporadic enforcement only started happening around 2007 and solidified with the newest version of Annex 1.5. However, the Pre-use Post Sterilization Integrity Test (PUPSIT) of final sterilizing grade filters has been a topic of discussion in recent years. The mandatory integrity test is typically performed post-use. Yet, to routinely confirm that the sterilizing grade filter is flawless, nondestructive integrity tests like bubble point, diffusive flow, or pressure decay have been used successfully since the first regulatory requests in the mid-'70s. 1, 2, 3 The process validation is not just limited to the retentivity performance of the filter but also the stability during steam and/or gamma sterilization, pressure pulsations, packaging, transportation, etc. The reliability of this aseptic processing step increased with filter and membrane stability improvements, advanced integrity tests of filters, and essential process validation activities, which evaluate the performance of a particular sterilizing grade filter under process conditions utilizing the actual fluid. Sterilizing grade filtration has been used for decades with reliability and assurance and has become the more prevalent sterilization method with biologics. Jornitz, principal consultant, BioProcess Resources LLC Script-O-Rama afterwards - because reading is good for your noodle. At least you'll have some Flawless quotes (or even a monologue or two) to annoy your coworkers with in the meantime, right? I know, I know, I still need to get the cast names in there and all that jazz, so if you have any corrections, feel free toĭrop me a line. Transcribed using the screenplay and/or viewings of the movie to get the dialogue. This puppy is a transcript that was painstakingly Voila! Finally, the Flawless script is here for all you fans of the Michael Caine and Demi Moore movie. Flawless Script - transcript from the screenplay and/or Michael Caine and Demi Moore movie Flawless Script - Dialogue Transcript
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