The Filtration and Separation Blog

Final sterile filtration is the subject of intense regulatory attention in the pharmaceutical and biopharmaceutical industries. According to EU Annex 1 2022 PUPSIT of final sterilizing grade filter is one of the requirements, additionally almost all other regulatory agency insist on using redundant filtration system.

Following these regulatory guidelines makes the filtration and filling process challenging and assembly more complex. While performing PUPSIT, wetting the filters, conducting integrity test, reducing product loss, maximizing product recovery, maintaining sterility of downstream side of the filter, in some specific cases eliminating drug product dilution and drying of filter are challenges. AseptiCap® VK Barrier filters simplify PUPSIT of Redundant filtration assembly by supporting both liquid and air passage.

Sterile drug products produced by aseptic processing involve filtration through sterilizing grade filters. It is critical for the drug manufacturer to ensure that the sterilizing filter is integral during the entire filtration process, resulting in a sterile downstream. Regulatory bodies worldwide have therefore made it mandatory to test filter integrity post use and mitigate risk to patient safety.

However, studies* have shown that in some drug products, filter clogging has an impact on post use integrity test (Bubble Point) values, thereby highlighting the possibility of a non integral filter passing post use integrity test due to masking of pre-use flaws.

All this has resulted in a heightened focus on Pre-Use Post-Sterilization Integrity Testing(PUPSIT) and most of the regulatory bodies have made it mandatory. However, with the ever increasing use of single use systems (SUS) in the manufacture of sterile drug products, PUPSIT has become even more challenging.

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Posts

Barrier filters that simplify PUPSIT by supporting both liquid and air passage

PUPSIT in Single Use Systems: Challenges and Risk Mitigation