Extended sterilizations cycles are becoming more and more common as manufacturers are incorporating complex materials and designs into medical devices. It can be very difficult for the sterilant to penetrate a narrow path or throughout a very dense or heavy load with traditional sterilization cycle times so increased sterilization cycles are something manufacturers are dictating more and more. Certainly longer cycles are intended to allow for fewer positive biological indicators, but are all biological indicators designed to provide accurate results in extended cycles?
For self-contained biological indicators, as the spores are exposed to an extended insult, the recovery/growth media is exposed as well. In many instances, this added exposure will start to caramelize pH indicator color within the growth media and the media itself will appear altered post-sterilization. A logical question to ask is “Can this media still sustain growth for a low number of injured spores?”
Mesa has performed a study on its ProSpore Ampoule self-contained biological indicator to address this topic specifically by exposing ampoules to a typical 20 minute cycle in addition to an extended 120 minute cycle, looking at the color change of the media post-sterilization in addition to the media’s effectiveness throughout the incubation process. The results of this study can be seen here.
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