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.
AseptiCap® VK-γ capsule filters incorporate a specially designed combination of validated sterilizing grade hydrophobic PVDF as well as hydrophilic Polyethersulfone (PES) membrane to facilitate passage of both gas and liquid a single filter device and provide unique performance advantages in pre-use integrity testing of aseptic filtration systems. AseptiCap® VK-γ capsule filters help carry out critical functions such as filter wetting and integrity testing while maintaining the sterility downstream of the aseptic filtration system.
Advantages of AseptiCap® VK-γ:
- Acts as a sterile barrier against inadvertent contamination
- Adequate flushing for filter wetting and minimizing extractables
- Helps prevent false integrity test result
- Allows retesting of in-place post-use integrity testing
- Allows drying of product filters
- Minimizes drug product loss during aseptic filtration
- User-friendly simplified PUPSIT assembly design.
To know more about AseptiCap® VK-γ capsule filters, click here