Biological indicators provide the best assurance of sterility by challenging the sterilizer with quantifiable, highly resistant spores. The system includes biological indicators, disposable test packs, incubators and record keeping. Biological indicators are used for load control monitoring which is the process by which a load is monitored and released based on the result of a biological indicator (BI) in a test pack.
3M™ Attest™ 1264 or 1264P Biological Indicators for EO
The self-contained BI for all EO cycles consists of a Bacillus atrophaeus spore strip; sealed glass ampule with growth medium and bromothymol blue pH indicator dye system; green color-coded cap with holes for sterilant penetration and a spunbonded olefin (polyethylene) filter as a bacterial barrier, and a chemical indicator on the label that changes to green when processed. After sterilization, the vial is "crushed" to join the growth media with the processed spore strip. The BI is incubated for 48 hours for a visual color change readout. A color change to yellow indicates surviving spores and a positive result.
3M™ Attest™ 1278 or 1278F EO Test Pack
A pre-assembled, EO plastic disposable test pack with an Attest 1264 biological indicator at the end of a tortuous or winding path. The pack is used to monitor all EO cycles. The pack is designed to present a resistant challenge to the EO sterilization process as is the AMMI routine syringe test pack.