ABSTRACT
Biological Indicators (BIs) are preparations of specific microorganisms that are resistant to a specified sterilization process [1]. To be utilized as a BI, the preparation should be characterized and ‘‘calibrated,’’ i.e., the reaction of the organism to the sterilization process should be known and consistent. BIs are used for a variety of purposes, e.g., qualification of sterilizers, qualification of Steam-in-Place systems, monitoring cycle performance, and so forth. In the United States, the regulatory guidance documents for requesting approval tomarket drug products require that microbiological challenge studies be performed for the Performance Qualification of the sterilization process [2]. Furthermore, there is an expectation that the pharmaceutical manufacturers verify the accuracy of the thermal death time (D-value) and the organism control counts [2]. Due to a lack of sterilization requirements harmonization this expectation is not shared globally [3]. Some typical performance standards for BIs, e.g., verification of organisms suspension counts and survival kill time studies, are relatively easy to perform and do not require
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specialized equipment. Other tests, e.g., thermal death time (D-value) analysis, or z-value analysis, may require a greater level of expertise and specialized equipment. This chapter discusses the BI performance standards and provides useful information on resolving conflicts in verifying whether these standards have been met. It also discusses some of the advances in rapid microbiology that may be used for BI testing.
