3M™ Attest™ Biological Indictor for Ethylene Oxide 1264-S

The ISO 11138-1:2017 and ISO 11138-2:2017 compliant 3M™ Attest™ Ethylene Oxide Biological Indicator, 1264-S, can be used for industrial ethylene oxide (EO, EtO) sterilization (Life Science) applications when verified by the end user. The self-contained biological indicator (BI) consists of a Bacillus atrophaeus spore strip and a sealed glass ampoule with growth media and bromothymol blue pH indicator dye system. The spore strip and media ampoule are contained in a plastic vial topped with a green color-coded cap. The label includes a chemical process indicator. The BI is packaged in a foil pouch designed to protect the product from humidity excursions.

After the ethylene oxide sterilization process, the BI is activated to join the growth media with the processed spore strip. The BI is incubated for a final visual color change readout in 48 hours. A color change from green to yellow indicates bacterial growth and a positive result. When processed, the chemical process indicator turns from reddish-brown to green.