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
https://www.usp.org