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.
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