BACKGROUND AND SCOPE

This 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 〈1229.1〉

• Moist Heat Sterilization of Aqueous Liquids 〈1229.2〉

• Monitoring of Bioburden 〈1229.3〉

• Sterilizing Filtration of Liquids 〈1229.4〉

• Biological Indicators for Sterilization 〈1229.5〉

• Liquid Phase Sterilization 〈1229.6〉

• Gaseous Sterilization 〈1229.7〉

• Dry Heat Sterilization 〈1229.8〉

• Physicochemical Integrators and Indicators for Sterilization 〈1229.9〉

• Radiation Sterilization 〈1229.10〉

• Vapor Phase Sterilization 〈1229.11〉