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  • Devices consisting of a biological sterilization process indicator contained within packaging that functions as a barrier to penetration of the sterilizing agent. Biological process challenge packs may be supplied commercially or prepared at the healthcare facility. Biological process challenge pack packaging is typically designed to provide a challenge to sterilizing agent penetration equal to or greater than the challenge posed by the most difficult item routinely processed at the facility. Some biological sterilization process challenge packs contain a chemical sterilization process indicator in addition to the biological indicator.
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