Product inoculation with biological indicators (BI) The BI strips are removed from the product and sent to the STERIS to test for presence/absense of the microorganisms within the BI. The BIs can also be placed in during routine monitoring for product release.Since such spores are usually challenging to sterilize, their presence/absence in the final sample validates the method or lot and determines sterility assurance levels (SALs).Process Challenge Devices (PCDs) are often also used in this aspect of the validation. The BIs are placed during validation to assess the challenge of the product bioburden to the sterilant and establish relationships between such and the BIs.The product, with indicators attached, is subjected to the Customer’s preferred sterilization method.General requirements for BIs can be found in ISO11138-1, with the specific requirements for EO and Steam in ISO11138-2 and ISO11138-3, respectively.Bacillus atrophaeus spores for EO, Geobacillus stearothermophilus for Steam. BIs are filter strips impregnated with a known microorganism that represents the reference organism for that technology.The biological indicator testing process is as follows: Our laboratory experts are equipped to provide product inoculation with biological indicator strips for a range of sterilization methods including steam and Ethylene Oxide (EO). ![]() Testing of Biological Indicators (BIs) BIs are tested in support of sterilization validations and routine product release for various sterilization technologies. ![]()
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