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3M™ Attest™ Super Rapid 5 Steam-Plus
a
Challenge Pack 41482V
Product Description
The 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V is specifically designed to qualify
and monitor dynamic-air-removal steam sterilization processes at 270°F (132°C) and 275°F (135°C) in
healthcare facilities. The challenge pack consists of multiple layers of medical index cards, some of which
are die-cut to contain the monitoring products. The stacked cards are wrapped with a sterilization wrap.
Each challenge pack has a process indicator on the pack label that changes from yellow to brown or
darker when exposed to steam. This convenient disposable challenge pack presents a challenge to the
sterilization process equivalent to the user-assembled biological indicator (BI) challenge test pack (towel
PCD) recommended by the Association for the Advancement of Medical Instrumentation (AAMI). The
challenge pack is a single use device.
Each challenge pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V (brown
cap, hereinafter referred to as a 1492V BI), a 3M™ Attest™ Steam Chemical Integrator, and a record
keeping sheet. AAMI recommends that steam sterilization loads containing an implant be monitored
with a process challenge device (PCD) containing a biological indicator and an integrating indicator.
3M™ Attest™ Steam Chemical Integrators are Type 5 (Category i5) Integrating Indicators as categorized
by ISO 11140-1:2014. 3M™ Attest™ Steam Chemical Integrators are single-use chemical indicators
consisting of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/
film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The
migration is visible through a green window marked ACCEPT or a red window marked REJECT; the extent
of migration depends on steam, time, and temperature.
The 1492V BI is a self-contained dual readout biological indicator specifically designed for rapid and
reliable monitoring of the steam sterilization process when used in conjunction with the 3M™ Attest™
Auto-reader 490, hereinafter referred to as the 490 Auto-reader or a 3M™ Attest™ Auto-reader 490H
having software version 4.0.0 or greater (hereinafter referred to as the 490H Auto-reader). When steam
processed, the process indicator on the top of the 1492V BI cap changes color from pink to light brown or
darker. 3M™ Attest™ 1492V biological indicator controls are provided with the challenge packs.
The 1492V BI utilizes the α-glucosidase enzyme system, which is generated naturally within
growing cells of Geobacillus stearothermophilus. The α-glucosidase in its active state is detected by
measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate,
4-methylumbelliferyl-α-D-glucoside (MUG). The resultant fluorescent by-product, 4-methylumbelliferone
(MU), is detected in the 490 Auto-reader. The presence of fluorescence within the specified incubation
time of the 1492V BI in the 490 or 490H Auto-reader indicates a steam sterilization process failure.
The 1492V BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color
change reaction. Biochemical activity of the G. stearothermophilus organism produces metabolic
by-products that cause the media to change color from purple to yellow which also indicates a steam
sterilization process failure. Use of this indication method is optional and is typically restricted to
special studies.
1492V BIs meet ISO 11138-1:2017 and ISO 11138-3:2017.
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