Steam sterilization biological indicators

Biological indicators to evaluate the effectiveness of the steam 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 steam sterilization appear as:

  • Strips, discs, threads, rods, etc. inoculated with the spores.
  • Self-contained devices containing the strip with the spores and the ampoule with the culture broth.
  • Glass ampoules containing spores suspended in culture broth.
  • Vials of spores in aqueous suspension.

 

Spores used:

  • Geobacillus stearothermophilus 7953
  • Bacillus subtilis 35021

  

They are regulated by:

  • ISO 11138-1:2017 Sterilization of health care products — Biological indicators Part 1: General requirements
  • ISO 11138-3:2017 Sterilization of health care products — Biological indicators Part 3: Biological indicators for moist heat sterilization processes
  • ISO 11138-5:2017 Sterilization of health care products — Biological indicators Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
  • EP and USP
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