Abstract
Bacillus coagulans, FRR B666, was evaluated as a potential biological indicator organism. The organism was grown on two types of sporulation media and the spores were tested for wet heat resistance. Further tests were carried out to determine if replicate spore crops exhibited similar heat resistance characteristics. Survivor curve tests were carried out to determine the behavior of B. coagulans spores when heated in Water for Injection (USP), 0.0153 M Butterfield’s buffer, and three representative parenteral solutions. Large numbers of spores were produced using relatively simple sporulation media. Aliquots of replicate spore crops grown on the same lot of medium had almost identical heat destruction characteristics. The semilogarithmic survivor curves in most solutions were straight lines. The results indicate that B. coagulans, FRR B666, is a stable and reliable biological indicator organism. Reproducibility of survivor curves and the low variability among replicate samples in all solutions tested are characteristics that suggest that B. coagulans has attributes of a potentially excellent biological indicator organism.
- Received September 16, 1980.
- Accepted March 10, 1981.
- Copyright © Parenteral Drug Association. All rights reserved.
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