Gaseous Sterilization - New USP General Chapter <1229.7>
Register now for ECA's GMP Newsletter
According to a proposal in Pharmacopoeial 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, the chapter <1229.7> is going to address "Gaseous Sterilization".
The use of sterilizing gases for the preparation of materials and equipment is in widespread application for items that are susceptible to damage by heat or radiation processes, for instance polymeric materials and medical devices.
The new chapter will provide an overview of gaseous sterilization and its validation.
The majority of gas sterilization processes employ ethylene oxide (EtO), and procedures for use with other gases generally patterned after EtO practices. Other gaseous sterilants used are ozone, mixed oxides of nitrogen, and chlorine dioxide.
The Comment deadline for the new General Chapter <1229.7> is end of July 2013.
You can find more information in the Pharmacopeial Forum.
Source: USP
http://www.usp.org
Related GMP News
07.11.2024Revision of USP <1085> "Guidelines on Endotoxin Test"
24.09.2024USP follows the 3R Principle - Implementation of new Chapter on recombinant Test Methods
28.08.2024The Effectiveness of Disinfectant Agents: An Overview
05.06.2024Handling of Microbiological Deviations and Sterility Testing - FDA publishes Warning Letter
07.05.2024HTS/NGS - Draft Ph.Eur. Chapter "High-Throughput Sequencing for detecting Viral Extraneous Agents"
31.01.2024EMA publishes new questions and answers on Annex 1