Biological Indicators

USP 43 General Chapter <1113> states under BI User's Responsibilities, the when biological indicators (BIs) are purchased, their suitability for use in a specific sterilization process must be established. The BI user should obtain a certificate of analysis for each lot of BI's and verify the manufacturer's label claims for spore population. When a BI is used in accordance with the BI manufacturer's directions the resistance of the BI need not be reconfirmed. While this guidance does not address purity and identification, USP 43 General Chapter <1113> dives into both under the section Characterization of Biological Indicators. It states that purity should be determined through observation of the colonies from the spores on a suitable culture plate (see part one of this series on Population Assay's). Identification is usually deemed necessary when investigating into unusual results.

In this session, we walk through the purity testing process and identification methods for BI's. This include an explanation of some ISO 11138 standards including guidance for sterilization, primary and secondary packaging, and manufacturer audits. Also learn more about Phenotypic Identification and Genotypic Identification and what USP 43 General Chapter <1113> has to say about both methods characteristics.

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