Sterility Testing Best Practices
Authors: Dr. Eric Clement Arakel and Marius Iseke | Last updated: May 2024
In the pharmaceutical industry Sterility Testing is a key compendial final release regulatory requirement and is designed to confirm that sterile products, such as sterile pharmaceuticals and medical devices, do not contain contaminating viable microorganisms, according to EP2.6.1, USP 71, JP 4.06 and ICH Q4B Annex 8. This essential test is part of the strategy to assess if a manufactured batch of a sterile product is suitable for release.In this video, we guide you through how best to perform your membrane filtration based sterility testing.
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