Biological Indicator – Sterility Testing

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Biological Indicators (BIs) are widely used to monitor the efficacy of sterilization processes. BIs provide a high level of sterility assurance and are ideal monitors of the sterilization process. The BI Sterility test is performed on exposed BIs after completion of a sterilization load through either a validation or routine lot release monitoring. The test is qualitative which yields results of either growth or no growth of the appropriate indicator organism.

The test is performed on BIs subjected to different types of sterilization such as ethylene oxide, steam, dry heat, vapor phase hydrogen peroxide and ozone, as well as other novel processes. Both traditional BIs and self-contained BIs may be tested. This test is typically performed during validation as well as during routine production as a LOT release test.

BI testing and sample requirements are in numerous standards including USP <55>, the ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 14161, and ANSI/AMMI/ISO 11138 series.

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