USP <1229.5> is dedicated specifically to the concept of using biological indicators during sterilization cycles. As discussed in a previous Blog (October 14, 2016), USP provides this definition: “A biological indicator (BI) is a well-characterized preparation of a specific microorganism that has known resistance to a specific sterilization process.”
Since we’ve already discussed what a biological indicator is, I won’t go into those details again. This chapter in USP also addresses these topics:
- Proper Use of Biological Indicators
- BI Manufacturer’s Responsibility – determine the performance characteristics of each biological indicator
- BI User’s Responsibility – establish suitability for use in the specific sterilization process
- User-Prepared Biological Indicators – determine the population and resistance characteristics
- Characterization of Biological Indicators – identify packaging, storage, expiration date, species used, purity and disposal methods
- Types of Biological Indicators – spores added to a carrier then packaged, spore suspensions, self-contained
- Selection for Specific Sterilization Processes – confirm that the BI provides an appropriate challenge to the sterilization cycle
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