Self-Contained Biological Indicators (SCBIs) for monitoring Steam processes consist of: a polycarbonate vial and a polypropylene cap, a crushable media ampoule which contains modified Tryptic Soy Broth (TSB) with a pH indicator and an inoculated carrier (disc) of Geobacillus stearothermophilus Cell Line 7953 with a population level of 106. The modified TSB will transition from the initial Purple color to Yellow and/or demonstrate turbidity in the presence of bacterial growth.
Population: ≥1.0 x 106 per disc.
Compliant with USP, ISO 11138-1 and ISO 11138-3.