The U.S. Pharmacopeial Convention publishes a compilation of drug-related information, once a year, for the United States of America. This publication is known as the USP (U.S. Pharmacopeia). While designed to provide information on drugs or drug ingredients, as well as setting standards for dietary supplements and food ingredients, the USP also provides guidance (procedures, tests, analytical methods, etc.) for the manufacture of biological indicators.
With the release of the most recent revision, biological indicator manufacturers are required to comply with two specific chapters. Included in these chapters are specific requirements for various sterilization methods, along with which spore species to use:
- <55> Biological Indicators – Resistance Performance Tests
- <1229> Sterilization of Compendial Articles
- <1229.1> Steam Sterilization by Direct Contact
- <1229.2> Moist Heat Sterilization of Aqueous Liquids
- <1229.3> Monitoring of Bioburden
- <1229.4> Sterilizing Filtration of Liquids
- <1229.5> Biological Indicators for Sterilization
- <1229.6> Liquid-Phase Sterilization
- <1229.7> Gaseous Sterilization
- <1229.8> Dry Heat Sterilization
- <1229.9> Physicochemical Integrators and Indicators for Sterilization
- <1229.10> Radiation Sterilization
- <1229.11> Vapor Phase Sterilization
- <1229.12> New Sterilization Methods
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