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BI Evaluation and Counts |
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BACKGROUND:
Biological indicators (BI) are used to validate and monitor steam sterilization cycles, ethylene oxide and hydrogen peroxide sterilization cycles. In
These are tested in accordance with USP <55> Biological Indicators – Resistance Performance Tests or manufacturer’s instructions.
PRINCIPLE OF TESTS:
Viable spores of B. subtilis, B. atrophaeus or G. stearothermophilus are used to validate sterilization cycles. A count ensures the count recovered meets manufacturer’s claims of the Bacillus population inoculated on the carrier. Counts are performed by resuscitation of the Bacillus, serial dilution and pour plate method.
BI growth evaluation determines the viability of Bacillus spores after exposure to the sterilization process. This method is performed by placing spore strips or inoculated process control devices (PCD) into sterile broth; or in the case of BI’s contained with their own medium system, the medium is released to contact the BI. All results are compared against an untreated spore strip or BI control.
SAMPLE REQUIREMENTS:
Viable BI sent for verification counting are recommended to be sent in triplicate. BI and PCD should be sent in contained vessels.
Glass vials should be wrapped to prevent cracking.
Untreated BI to be sent and tested in conjunction with sample as a control
TEST PROTOCOLS:
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