Sterilization Validation Guidelines - CPAC RapidCyde RapidHeat RH-Pro11 Operation Manual

Blower temperature sensor failed
Air temperature sensor failed
Return air temperature sensor failed
Chamber too hot 406.4°F
Return air too hot 402.8°F
Return air did not heat to set point
Blower overheat 185.0°F
A/D read failure
Chamber did not heat to set point
7.0 STERILIZATION CYCLE VALIDATION GUIDELINES
The American Dental Association, United States Air Force, Joint Commission
of Accreditation of Hospitals, and the Centers for Disease Control
recommend biological indicator tests to monitor and verify the sterilizer's
performance. State or local requirements (public health departments) for
biological testing may also apply.
CPAC Equipment, Inc. recommends that a test be performed every 25 cycles,
or at least once a week, to test the effectiveness of the RH-Pro11.
7.1 Recommended Chemical and Biological Indicators
Biological indicators (i.e. spore test strips) containing Bacillus atrophaeus
should be used along with the appropriate dry heat chemical indicators to
reliably monitor the effectiveness of the RH-Pro-11. Spore test strips and
chemical indicators, as well as test services are widely available. CPAC
Equipment, Inc. recommends using the following:
 Chemical indicators, supplied by SteriSURE, part. no. 400635
 Spore test strips (Bacillus atrophaeus), supplied by SteriSURE, part no.
400634
7.2 Microbial Efficacy Test Protocols
Periodic and routine microbial kill efficacy tests are conducted for the sole
purpose of verifying operating performance. All operating parameters for
these tests shall be recorded as detailed below and retained in the Biological
Test Data Manual. Biological Indicator testing is a Risk Management function
and as such, strict adherence to the sterilizer's operating instructions is
essential, including the retrieval of the biological indicator immediately upon
completion of the sterilization cycle.
1. Prepare a sample test load. The test load should be typical of a
normal full load (4 or 6 trays) consisting of instruments normally
sterilized during the day.
2. Conduct a pre-check prior to initiation of sterilization cycle (see
Appendix I).
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