PT  - JOURNAL ARTICLE
AU  - Patrick McCormick
AU  - Catherine Finocchario
AU  - Robert Manchester
AU  - Louis Glasgow
AU  - Stephen Costanzo
TI  - Qualification of a Rapid Readout Biological Indicator with Moist Heat Sterilization
DP  - 2003 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 25--31
VI  - 57
IP  - 1
4099  - http://journal.pda.org/content/57/1/25.short
4100  - http://journal.pda.org/content/57/1/25.full
SO  - PDA J Pharm Sci Technol2003 Jan 01; 57
AB  - Biological indicators are recognized as an important component in the validation and routine monitoring of moist heat (steam) sterilization processes (1,2). 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” (3).