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The Complete Guide to Pharmaceutical Sterility Testing

Illustration of a hand holding a syringe with a needle, representing medical injections or vaccinations.
Credit: iStock

Sterility testing is a critical quality control measure that ensures pharmaceutical products and medical devices are free from microbial contamination before being released to patients. 


However, traditional testing methods present significant challenges including 14-day incubation periods, potential false negative results with antimicrobial products and closed-system sampling difficulties.


This comprehensive eBook explores best practices, validation strategies and innovative technologies for sterility testing, from traditional membrane filtration techniques to cutting-edge PCR-based rapid detection methods for advanced therapy medicinal products (ATMPs).


Download this eBook to learn:

  • Essential techniques for reliable sterility testing across different pharmaceutical applications
  • How to test products with antimicrobial properties
  • Rapid sterility testing methods for short shelf-life cell and gene therapy products

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