An overview of sterility testing

Sterility testing is a crucial process in the manufacture of sterile products, ensuring they are free from harmful microorganisms. Two primary methods are used: membrane filtration and direct inoculation, each with challenges such as long wait times and the risk of false positives. Insourcing versus outsourcing sterility testing presents various advantages and disadvantages. The industry is increasingly adopting isolators to minimize contamination risks, supported by regulatory guidelines like EU GMP Annex 1. Isolators offer benefits in reducing false positives and operating costs. The future of sterility testing focuses on developing rapid testing methods to enhance efficiency and reduce wait times, especially vital for products with short shelf lives, such as cell therapies.

https://www.ecv.de/beitrag/Cleanroom-and-Processes/An_overview_of_sterility_testing

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