Sterilization standardization moves into new areas

ISO TC 198 – Sterilization of health care products – starts two significant new projects

ISO TC 198, Sterilization of health care products, met in Minneapolis in the last week of April. As well as progressing with a number of new editions of standards in its portfolio, such as those for moist heat, ethylene oxide and radiation sterilization, the Committee initiated work in two new areas.

The first of these is to prepare a standard for the validation and routine control of sterilization using vapourized hydrogen peroxide. The application of this method of sterilization has increased over the last few years and so it is timely that a specific standard laying down procedures for validation and routine control is prepared. A new Working Group will be set up to undertake this work.

The second area of standardization is for sterilizing equipment. Up until now, work on sterilizers has been done at regional level in Europe and nationally in other parts of the world. Existing standards for sterilizing equipment have been developed individually, process by process. Different standards do not always deal with common aspects of sterilizer construction or performance in a consistent manner. These inconsistencies present problems for manufacturers, test engineers and users. ISO TC 198 has agreed to start a project to define common aspects of sterilizers. These common elements will be internationally-agreed requirements and apply across a range of sterilizing technologies. The existing Working Group 11, General criteria for sterilization, will be reactivated to undertake this project and a call for nomination for experts to join this group is being issued.

The ISO sterilization committee works in cooperation with two European Standardization committees for sterilizing equipment (CEN TC 102) and sterilization (CEN TC 204). Therefore, the standards resulting from this new work will be candidates for adoption in Europe. Manufacturers and users of sterilization technology should watch out for these standards as they are developed. In the UK, input will be provided by BSI Committee CH/198, Sterilization and associated equipment and processes.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.