Sterilisation Validation in pharmaceutical manufacturing is the comprehensive process of proving and documenting that a sterilisation method or process effectively achieves a specified level of microbial reduction or inactivation, ensuring product sterility, safety, and compliance with regulatory standards. This involves determining and validating appropriate sterilisation parameters, conducting thorough validation studies and performing microbiological testing to confirm the process’s lethality against target microorganisms and biological indicators. The purpose of sterilisation validation is to guarantee the efficacy and reliability of sterilisation methods in eradicating microbial contaminants, thus safeguarding against product contamination and ensuring the sterility assurance of pharmaceutical products, containers, and packaging materials.
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