Dry Heat Sterilization - New USP General Chapter <1229.8>

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

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