Dry Heat Sterilization - New USP General Chapter <1229.8>
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According to a proposal in the Pharmacopeial Forum 39 (3) the USP General Chapter <1211> "Sterilization and Sterility Assurance of Compendial Articles" will be separated in several individual chapters. One of these chapters - <1229.8> - will address "Dry Heat Sterilization".
This chapter will provide an overview of dry heat sterilization and its validation. It describes dry heat sterilization in the range of 160 - 190° C with the objective of sterilization rather than depyrogenation. Topics that will be covered are:
- Sterilization Cycle Control
- Validation of Dry Heat Sterilization
- Equipment Qualification
- Empty Chamber Temperature Distribution
- Component Mapping
- Load Mapping
- Biological Indicators
- Heat Penetration and Microbiological Challenge
- Routine Process Control
The Comment deadline is end of July 2013.
You can find more information at the Pharmacopeial Forum.
Source: USP
http://www.usp.org
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