USP〈1229〉 STERILIZATION OF COMPENDIAL ARTICLES

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.1 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〉

Liuid-Phase Sterilization 〈1229.6〉

Gaeous 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〉

▲New Sterilization Methods 〈1229.12〉

Sterilization-in-Place 〈1229.13〉

Sterilization Cycle Development 〈1229.14〉

Sterilizing Filtration of Gases 〈1229.15〉

Prion Inactivation 〈1229.16〉

Mycoplasma Sterilization 〈1229.17〉

Viral Clearance 〈1229.18〉▲ (USP 1-May-2021)

In the strictest definition of sterility, a specimen is deemed sterile only when there is a complete absence of viable microorganisms (bacteria, yeasts, and molds), but sterility cannot be demonstrated with respect to compendial articles and other items because of the inherent limitations of the current test (see Sterility Tests 〈71〉). Sterility, therefore, is defined in probabilistic terms that establish an acceptable level of risk. Sterility can be accomplished only by the use of a validated sterilization process under appropriate current good manufacturing practices and cannot be demonstrated by reliance on sterility testing alone. The basic principles for control of sterilization processes, including method development, validation, and ongoing assurance, are as follows:

Sterilization process development that includes evaluation of the stability and compatibility of materials, container integrity, expected presterilization bioburden, equipment method control parameters, etc.

Identification of sterilization process parameters that preserve the inherent properties of the materials yet inactivate or remove microorganisms.

Demonstration that the sterilization process and equipment are capable of operating within the prescribed parameters and corresponding to independent measurements of the critical parameters.

Performance of replicate studies that represent the operational range of the equipment and employ actual or simulated product. The use of biological indicators for correlation between the measured physical parameters, and the expected lethality is recommended wherever possible.

Maintenance and monitoring of the validated process during routine operation.

Assurance that the bioburden (number and type) of the materials is acceptable and is maintained within predetermined limits during routine operation.

Source from USP and Please refer to USP for details:

https://online.uspnf.com/uspnf/document/2_GUID-ECD53800-853C-40EB-9E08-F125CF4C999B_10101_en-US?

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