Description

The 3M™ Attest™ Rapid Readout Biological Indicator 1294 (green cap) is a dual readout biological indicator system specifically designed for rapid and reliable monitoring of the Ethylene Oxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto‑reader 290G or the 3M™ Attest™ Auto‑reader 390G.

Biological indicators provide the best assurance of sterility by challenging the sterilizer with quantifiable, highly resistant Bacillus atrophaeus spores. The system includes Rapid Readout biological indicators, disposable test packs and auto-reader. 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.Self-contained BI for Ethylene Oxide Sterilization cycles consisting of a Bacillus atrophaeus spore strip; sealed glass ampule with growth medium and dual indicator system; green color-coded cap with holes for sterilant penetration and a 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 three hours in the 3M™ Attest™ 290G/390G Series Auto-reader for a fluorescent reading. ‘The Attest™ rapid readout biological indicator detects the activity of a naturally occurring Bacillus atrophaeus enzyme, beta‑glucosidase, which is one of the enzymes involved in spore outgrowth and normal vegetative cell function. The Auto‑reader detects the activity of a B. atrophaeus enzyme by reading a fluorescent product produced by the enzymatic breakdown of a substrate in the media. Detection of the enzyme indicates a sterilization process failure. The final fluorescent readout of a negative indicator result is made after 4 hours of incubation. The 4‑hour fluorescent readout has been validated and is routinely verified at standard ethylene oxide test conditions (54ºC ± 1ºC, 600 ± 30 mg/l ethylene oxide, and 60% ± 10% relative humidity).