Dry Heat sterilization biological indicators
Biological indicators to evaluate the effectiveness of the dry heat sterilization process
The biological indicators are made up of standardized bacterial spores inoculated on different types of support which, in addition to allowing their appropriate use, emulate the process that leads to the reduction of the microbial load.
Biological indicators for dry heat sterilization appear as:
- Strips inoculated with spores.
- Vials of spores in aqueous suspension.
Spores used:
- Bacillus atrophaeus 9372
They are regulated by:
- ISO 11138-1:2017 Sterilization of health care products — Biological indicators Part 1: General requirements
- ISO 11138-4:2017 Sterilization of health care products — Biological indicators Part 4: Biological indicators for dry heat sterilization processes
- EP and USP