The USP is proposing a significant change to the way in which the chapters on sterilization are organized. This was featured on this blog earlier this year. Now the latest edition of the Pharmacopeial Forum has details on the numbering and ordering of the new chapters (this appeared in Volume 38, Issue 2 dated February 2012).
USP chapter 1211 “Sterilization and Sterility Assurance of Compendial Articles” is being revised. The chapter will change its focus and consider general concepts for sterility assurance only (the goal being sterilisation at a more basic level with more instruction and with less standardisation). The changes will include removal of any description of the sterility test (instead UPS 71 will be referred to). There will also be some tidying up of the chapter, such as the removal of out dated irradiation sterilisation references.
With USP 1211 slimmed down a new chapter: 1229; is proposed. This chapter will be entitled “General Concepts for Sterilization”. The chapter will consist of a series of sub-chapters, see below.
The details are:
Sterilisation of Compendial Articles (1229)
(Revision proposal target, USP36-NF31 1st Supplement)
The USP general information chapter Sterilisation and Sterility Assurance of Compendial Articles 1211 is to be split into several individual chapters (see Stimuli to the revision process for further information regarding the change).
The proposed new chapter, 1229 will address general principles of sterilisation of compendial articles.
List of proposed new chapters:
- Steam Sterilisation by Direct Contact 1229.1 (see comments below)
- Steam Sterilisation of Aqueous Liquids 1229.2
- Monitoring of Bioburden 1229.3
- Sterilising Filtration of Liquids 1229.4
- Biological Indicators for Sterilisation 1229.5
- Chemical Sterilisation 1229.6
- Gaseous Sterilisation 1229.7
- Dry Heat Sterilisation 1229.8
- Physicochemical Integrators and Indicators for Sterilisation 1229.9
- Radiation Sterilisation 1229.10
- Vapour Sterilisation 1229.11
(Revision proposal target, USP36-NF31 1st Supplement)
This new chapter 1229 will address steam sterilisation by direct contact.
STIMULI TO THE REVISION PROCESS
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