Heat resistance of Bacillus coagulans spores suspended in various parenteral solutions

Bacillus coagulans, ATCC 51232 (formerly referred to as FRR B666), was previously reported to be a potentially excellent biological indicator. The organism was grown on a relatively simple sporulation media and the spores were evaluated for moist heat resistance in various parenteral solutions. Resistance was determined using the survivor curve method. For those solutions which appeared to be inhibitory to the outgrowth of Bacillus coagulans, ATCC 51232, further investigations were performed to evaluate the inhibitory effect. The results obtained demonstrated that the organism had the highest resistance in Calcium Gluconate Injection; USP (100 mg/mL) at 120 degrees C.