We worked on validation of sterilization process when we replaced the steam sterilizer in our hospital. During performance qualification process, we used Self-Contained Biological Indicators (BIs) populated with 105, which we usually use.
For minimum-load testing, we set the sterilization time for one min, and we found those BIs were killed completely, then we measured F-value with Data Logger. According to half cycle method, we calculated the sterilization time to accomplish more than 12D, and it turned out to be 4 min and 5 sec.
For maximum-load testing, we used Type 4 Chemical Indicators (CIs, Stated Value:135°C, 6 min and 30 sec), and Helix-PCD test sets to determine the actual sterilization time, considering sterilization effectiveness and steam penetration of instruments in the sterilization containers, which we assume to be the most difficult to be sterilized.
Then, we finally set the sterilization time for 6 min, which is enough for Type 4CIs to react, to avoid human errors during routine monitoring.
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