The Self-Contained Biological Indicators (SCBIs) may be utilized to monitor Ethylen Oxide (EO) sterilization efficacy through equipment and process validation and routine monitoring. The SCBIs are labeled for laboratory/industrial use only.
SCBIs for monitoring EO processes consist of: a polypropylene 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 Bacillus atrophaeus Cell Line 9372 with a population level of 106. The modified TSB will transition from the initial Green 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 11138-2.