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STERILIZATION OF COMPENDIAL ARTICLES

Printed on: Mon Mar 30 2020, 16:40:49 pmPrinted by: Deborah NishikawaOfficial Status: Currently Official on 30-Mar-2020 Official Date: Official as of 1-Aug-2013 Document Type: GENERAL CHAPTERDocId: 1_GUID-ECD53800-853C-40EB-9E08-F125CF4C9 99B_1_en-USPrinted from: 2020 USPC 1229 STERILIZATION OF COMPENDIAL ARTICLES BACKGROUND AND SCOPEThis general information chapter provides an overview of the concepts and principles involved in STERILIZATION (by various modes) of COMPENDIAL ARTICLES that must be sterile. It includes information about supportive STERILIZATION processes utilized in their preparation. More detailed recommendations are presented in specific information chapters for each STERILIZATION mode: steam STERILIZATION by Direct Contact Moist Heat STERILIZATION of Aqueous Liquids Monitoring of Bioburden Sterilizing Filtration of Liquids Biological Indicators for STERILIZATION Liquid Phase STERILIZATION Gaseous STERILIZATION

For steam and dry heat, the D-value is a function of temperature. In gas sterilization (ethylene oxide, ClO , or O ), D-values are a function of the chemical concentration, relative humidity, and temperature. Similarly, for liquid chemical sterilization the D-value is a function of the temperature and sterilant concentration.

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