Testing of Biological Indicators (BIs)

Biological Indicators are tested in support of sterilization validations and routine product release for various sterilization technologies, in particular ethylene oxide (EO) gas.

Our laboratory experts are equipped to provide product inoculation with biological indicator strips for a range of sterilization methods including steam and EO.

The biological indicator testing process is as follows:

  • Biological indicators are filter strips impregnated with Bacillus atrophaeus spores
  • Device manufacturers place the strips on medical product samples to test for population and resistance
  • The product, with indicators attached, is subjected to the Customer’s preferred sterilization method, usually via EO gas
  • The biological indicator strips are removed from the product and sent to the laboratory to test for remaining presence of this spore-borne biological indicator

Since such spores are usually challenging to sterilize, their absence in the final sample validates the method or lot and determines sterility assurance levels

Product inoculation with biological indicators (BI)

STERIS Laboratories can carry out the product inoculation with BI strips for various sterilization methods, including steam and EO, conducted at the Customer’s facility, or at a STERIS sterilization facility.

STERIS Laboratories offers:

  • Integrated biological indicator testing with EO sterilization
  • Product inoculation with biological indicator strips for evaluating sterilization process at Customer’s own site
  • Biological Indicator incubation time reduction

Biological Indicator testing is used for:

  • Medical device sterilization
  • Pharmaceutical sterilization
Available services vary between laboratories. Contact us to learn more about the services offered at each of our locations

Contact our team of experts to find out more about Biological Indicators