78
3M
™
Steri‑Vac
™
Sterilizer / Aerator GSX Series
– Operator’s Manual
14.2. Biological Indicators and Process Challenge Devices
CAUTION: To reduce patient risks associated with exposure to potentially non‑sterile devices or inadequate sterilization procedures,
always use chemical indicators and biological indicators for monitoring the performance of sterilization cycles as described in this manual Always use chemical indicators and biological
indicators per the device manufacturer’s instructions for use (IFU)
Biological indicators (BIs) consist of viable spores in or on a carrier, sometimes (as in the case of self‑contained BIs) accompanied by incubation media BIs provide the only direct measure of
the lethality of the sterilization process BIs must be incubated for various periods of time (depending on the specific product) until it is determined whether the microorganisms grow (ie they
survived the sterilization process) or fail to grow (ie they were killed by the sterilization process)
For routine monitoring of the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series EO sterilization process, use 3M™ Attest™ Biological Indicators for EO which contain spores of Bacillus atrophaeus
or a biological indicator defined by the user
3M Attest Biological indicators for EO:
•
comply with applicable clauses of ISO 11138‑2
•
should be placed within an appropriate process challenge device (PCD)
The appropriateness of the BI PCD used for process definition, validation or routine monitoring and control should be defined and determined by the user Additional information for defining the
appropriateness of a PCD can be found in ISO 11135
A minimum of three (3) appropriate PCDs with BIs should be used in every load The BI PCDs should be placed in the worst case location to achieve sterilization conditions inside the chamber
and load
BIs should be used in accordance with the biological indicator manufacturer’s instructions
Use a positive control each day a BI is processed This helps ensure:
•
Correct incubation temperatures are met
•
Viability of the spores has not been altered due to improper storage temperature, humidity, or proximity to chemicals
•
Capability of media to promote growth
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Proper functioning of the BI incubator
Failure of the positive control test may invalidate the processed indicator results Refer to the instructions for use for BIs for additional information
