3M Attest 1295 - Page 3

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3M™ Attest™ Rapid Readout Biological Indicator1295 1
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 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.
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.
PROCESS
INDICATOR
BI CAP
WITH LABEL
VIAL
MEDIA
AMPOULE
AMPOULE
CRUSHER
GROWTH CHAMBER
SPORE
CARRIER
Figure 1: Design of the
3M™Attest™ Rapid Readout
Biological Indicator 1295