RT Journal Article
SR Electronic
T1 Qualification of a Rapid Readout Biological Indicator with Moist Heat Sterilization
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 25
OP 31
VO 57
IS 1
A1 Patrick McCormick
A1 Catherine Finocchario
A1 Robert Manchester
A1 Louis Glasgow
A1 Stephen Costanzo
YR 2003
UL http://journal.pda.org/content/57/1/25.abstract
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).