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3M™ Attest™ Rapid Readout Biological Indicator 1295
Product Description
The 3M™ Attest™ Rapid Readout Biological Indicator
1295 (pink cap, referred to hereinafter as the 1295 BI) is
a self‑contained biological indicator specifically
designed for rapid and reliable routine monitoring of
vaporized hydrogen peroxide sterilization processes
when used in conjunction with the 3M™ Attest™
Auto‑reader 490H or the 3M™ Attest™ Auto‑reader
490 having software version 4.0.0 or greater
(hereinafter referred to as the 490H Auto‑reader or
490 Auto‑reader having software version 4.0.0 or
greater). The 1295 BI is a single‑use device.
A schematic
illustrating the
design of the
1295 BI is provided
in Figure 1. The
self‑contained
design includes a
carrier with spores
of Geobacillus
stearothermophilus
and a media
ampoule
containing
bacteriological
GROWTH CHAMBER
growth medium
which meets the
requirements for
growth promoting
ability specified
in ISO 11138‑1:
2017. The spore
carrier and media ampoule are contained in a plastic vial
topped with a pink cap. A chemical process indicator
printed with stripes which change in color from blue
towards pink upon exposure to vaporized hydrogen
peroxide is located on the top of the cap.
PROCESS
INDICATOR
BI CAP
WITH LABEL
VIAL
MEDIA
AMPOULE
AMPOULE
CRUSHER
SPORE
CARRIER
Figure 1: Design of the
3M™ Attest™ Rapid Readout
Biological Indicator 1295
The 1295 BI utilizes the ‑glucosidase enzyme system,
which is generated naturally within growing cells of
Geobacillus stearothermophilus. The ‑glucosidase
in its active state is detected by measuring the
fluorescence produced by the enzymatic hydrolysis
of a non‑fluorescent substrate, 4‑methylumbelliferyl‑
‑D‑glucoside (MUG). The resultant fluorescent
by‑product, 4‑methylumbelliferone (MU), is detected
in the Auto‑reader. The presence of fluorescence within
the specified incubation time for the 1295 BI in the
Auto‑reader indicates a sterilization process failure.
The 1295 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 sterilization
process failure. Use of this indication method is optional
and is typically restricted to special studies.
Readout Time
The rapid readout result has been correlated with a
7‑day visual pH color change result following the FDA's
Reduced Incubation Time protocol. The time to result
is determined by the software version programmed on
the Auto‑reader.
24‑minute Fluorescent Result
1295 BIs incubated in a 490H or 490 Auto‑reader
having software version 4.0.0 or greater have a
24 minute reduced incubation time result that
correlates to the 7 day (168 hours) visual readout
result ≥ 97% of the time.
4‑hour Fluorescent Result
1295 BIs incubated in a 490H Auto‑reader having
software versions less than 4.0.0 have a 4‑hour
reduced incubation time result that correlates to
the 7 day (168 hours) visual readout result ≥ 97% of
the time.
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