Wednesday, 5 June 2013

USP General Chapters on Sterilization

Two new proposed sterilisation chapters have appeared in the Pharmacopeial Forum 39 (3) for comments.

These are:

USP - 1229.7 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. Many polymeric materials, especially medical devices, are sterilized in this manner, as is non-pressure-rated process equipment.

As outlined in Sterilization of Compendial Articles 1229, the chapter addresses such processes as ethylene oxide, ozone, and chlorine dioxide. The majority of gas sterilization processes employ ethylene oxide (EtO), and procedures for use with other gases generally are patterned after EtO practices.

The chapter also addresses validation requirements and routine process control.

USP – 1229.8 Dry Heat Sterilization

Dry heat sterilization is a process employed for heat-stable items that are unsuited for steam sterilization because of either an absence of water (nonaqueous liquids and powders) or requirements for absolute dryness following processing (product contact parts for nonaqueous products).

This chapter addresses the sterilisation control cycle, validation requirements, biological indicators and routine process controls.

For further details, see the PF.

Posted by Tim Sandle