The 3M™ Attest™ Rapid Readout Biological Indicator 1292E (brown cap) is a dual readout biological indicator system specifically designed for rapid and reliable monitoring for 121-123°C Gravity and 132-135°C Vacuum-Assisted steam sterilization processes when used in conjunction with the 3M™ Attest™ Auto‑reader 290 or the 3M™ Attest™ Auto‑reader 390.
Biological indicators provide the best assurance of sterility by challenging the sterilizer with quantifiable, highly resistant Geobacillus stearothermophilus 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 121-123°C gravity displacement and 132-135°C vaccum assisted cycles consisting of a Geobacillus stearothermophilus spore strip; sealed glass ampule with growth medium and dual indicator system; brown color-coded cap with holes for sterilant penetration and a filter as a bacterial barrier and a chemical indicator on the label that changes from rose to brown 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™ 290/390 Series Auto-reader for a fluorescent reading. The 3M™ Attest™ 1292E Rapid Readout Biological Indicator detects the presence of Geobacillus stearothermophilus by detecting the activity of alpha‑glucosidase, an enzyme present within the organism. The presence of the enzyme is detected by reading fluorescence produced by the enzymatic breakdown of a non‑fluorescent substrate. This creates a fluorescence change, which is detected by the auto‑reader. A fluorescence change indicates a steam sterilization process failure.The Attest™ 1292E Rapid Readout Biological Indicator also detects the presence of G. stearothermophilus organisms by a visual color change reaction. Biochemical activity of the G. stearothermophilus organism produces acid by‑products that cause the media to change color from purple to yellow. A visual pH color change also indicates a steam sterilization process failure. Due to the high sensitivity of the 3‑hour fluorescent results, however, there is no advantage to incubating the BI for 48 hours.