In-house Biological Indicator Evaluator Resistometer (BIER) units and sterilizers can be utilized to determine/verify the resistance of a biological indicator. By exposing biological indicators to a known dose of sterilant for a range of times, the indicator’s D-value (time required to reduce a population by 1 log, or 90%) and z-value (change in temperature required for a 1 log change in D-value) can be determined. Survivor/kill times can also be similarly determined. This information can be utilized to confirm a biological indicator manufacturer’s label claim or certify a biological indicator’s performance. The information can be further used in cycle development to calculate the sterilization time required to provide a desired safety factor. Determination/verification of a biological indicator population consists of effectively removing the organisms from their substrate (i.e. maceration of paper carriers) and plating appropriate dilutions to enumerate the resistant population of the indicator organism.
All testing is performed according ANSI/AAMI/ISO/EN 11138 and United States Pharmacopeia (USP) Chapter 1229.5 guidelines or utilizing client or biological indicator manufacturer-specific procedures.
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