Qualification of a rapid readout biological indicator with moist heat sterilization

Biological indicators are recognized as an important component in the validation and routine monitoring of moist heat (steam) sterilization processes. Due to the need to allow for the recovery and outgrowth of test organisms that may have been sub-lethally injured, between 2-5 days of incubation are typically required before the outcome of sterilization processing can be reliably interpreted. Rapid readout biological indicators that incorporate the response of a heat resistant enzyme provide a means for assessing the efficacy of moist heat sterilization within hours of processing. This study describes the qualification of the 3M Attest 1292 Rapid Readout Biological Indicator with moist heat sterilization according to the procedures described in the PDA Technical Report No. 33, "Evaluation, Validation and Implementation of New Microbiological Testing Methods".