Sterile filtration is one of the most important process steps in the aseptic production of sterile pharmaceutical products from heat-sensitive raw materials.
In contrast to other sterilization methods, particles, i.e. living and non-living microorganisms, are not inactivated or killed, but removed from liquids or gases. Important aspects in connection with sterile filtration are the qualification of the filter, the validation of the filtration process and the performance of filter integrity tests.
This is the subject of the technical article (German language) by gempex:
Raimund Brett, pharmind 10-2024: "Sterile Filtration"
The technical article is an excerpt from the GMP-BERATER, Chapter 12 Sterile Production (12.E Aseptic Production), GMP-Verlag Peither AG. pharmind has taken up the topic and published the subject of sterile filtration separately.
The article explains technically relevant issues relating to sterile filtration with regard to GMP / GxP issues and refers to Annex 1 of the EU GMP guidelines. Individual aspects are qualification and validation of sterile filters, validation of sterile filtration, sterilization of filters, filter integrity tests and reuse of filters.
The technical article is available in German language for download at www.gempex.de/GMP-Knowledge .
Raimund Brett, Principal Consultant gempex GmbH, will be happy to answer questions to the topic of qualification and validation in pharmaceutical sterile production via contact@gempex.com .