The Food and Drug Administration (FDA) requires standard test methods, described by the Association of Official Analytical Chemists (AOAC), to determine the efficacy of a sterilizing agent. These tests employ standardized carriers on which the test organism is deposited. The inoculated carrier is exposed to the sterilizing agent under the exact conditions defined for its routine use (i.e., exposure time, concentration, temperature, etc.). The carriers are then placed into growth media and incubated. No growth on a minimum of 720 carriers (with no failures) is required.
Since the chemical sterilants used on medical devices are considered medical devices, they are regulated by the FDA. The FDA recognizes test data by the AOAC but also requires data for the demonstration of killing spore suspensions in hard water and in the presence of heavy organic soil, such as serum protein, and the calculation of reducing the microbial population by 12 logs (12 D time).
The PA-based sterilant of the system described was subjected to these rigorous tests and was cleared by the FDA. The result of the AOAC testing was that the liquid chemical using PA produces sterility to a degree that meets or exceeds the criteria required. Neither the washing nor the rinsing action of the sterilizer is responsible for the sterilization of the AOAC carriers. Since the sterilizer provides sterile, filtered rinse water, no recontamination of the sterilized AOAC carriers occurred from the rinses or within the fluid pathways of the sterilizer. The sterile water is produced by a verifiable sterile water membrane filter that meets United States Pharmacopeia criteria for sterilization of pharmaceuticals by membrane filtration.
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