Comparison Study of the Growth Promotion Capabilities of Self Contained Biological Indicator Culture Medium in Extended Steam Sterilization Cycles

摘要

Self Contained Biological Indicators (SCBIs) from four different manufacturers were subjected to extended steam sterilization cycles and tested per United States Pharmacopeia (USP) for growth promotion capabilities. Testing consisted of inoculating the processed SCBIs with less than 100 G. stearothermophilus bacterial endospores in order to determine if the culture medium could support growth of a low number of spores after exposure to extended cycle times. All SCBI test samples were processed, activated and incubated per their manufacturers' instructions. This study demonstrates the validity of commercially available SCBIs for use in commonly used extended steam sterilization cycles. Testing was conducted independently by three separate laboratories utilizing different lots of SCBIs in order to statistically verify results.