Verification Testing of Biological Indicators for Moist Heat Sterilization

摘要

As described in ISO 14161:2009, "Biological indicators are utilized to test the effectiveness of a given sterilization process and the equipment used, by assessing microbial lethality according to the concept of sterility assurance level." Although the role of biological indicators (BIs) in sterility assurance is widely recognized, BIs are subject to a number of factors that may affect their performance and influence the outcome of testing. These factors include the handling, transport, and storage of the BI prior to use, the manner in which it is placed within the sterilization load, and the growth medium and incubation conditions used to culture the test organism following sterilization processing. Previous studies of the resistance performance of BIs have noted inconsistent results and poor reproducibility among testing laboratories.