 Peter Strain Sterigenics VP Technology EMEAA Visit Website |
Peter Strain has more than 25 years’ experience in the field of sterilisation in the medical device industry in the United Kingdom. He joined contract sterilisation company Sterigenics (then called Griffith Micro Science) in 1993 as Quality Assurance Manager at its UK ethylene oxide sterilisation facility. He was responsible for management of all validation activities, and his activities involved the co-ordination, management, technical review and documentation of numerous customer and product-specific validation projects that included the implementation of parametric release. Since then, the company ownership changed and, in 2001, Strain was appointed General Manager for Sterigenics' UK business. In 2004, Strain was appointed Vice President Technology EMEAA, responsible for technical development, validation management and laboratory services at the company’s ethylene oxide, gamma and electron beam contract sterilisation facilities in Belgium, China, Denmark, France, Germany, Holland, Thailand and the United Kingdom. Recent projects include overseeing installation qualification, operational qualification and performance qualification of the new electron beam and ethylene oxide sterilisation facilities in Shanghai, China. Strain was secretary of ABHI (Association of British Healthcare Industries) Sterilisation and Microbiology Working Group 1998-2002. He represents the United Kingdom as a National Expert on ISO / TC 198 Working Group I "Ethylene Oxide Sterilization," which has recently issued ISO 11135-1:2007 'Sterilization healthcare products – Requirements for the development, validation and routine control of a sterilization process for medical devices - Ethylene Oxide sterilization' and ISO/TS 11135-2:2008 'Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the Application of ISO 11135-1.' |
Sterilisation Q&A
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What is the best way to demonstrate the appropriateness of the biological indicator (BI), as required in ISO 11135-1:2007?Answered May 12th, 2009 by Expert:It is a good idea to gather experimental data to verify that the BI provides a greater challenge than the natural product bioburden. This is achieved first by characterising the product bioburden in accordance with ISO 11737-1 using a validated method. Products are then selected that have representative bioburden and are packaged as normal. These products are placed alongside process-challenge devices that contain BIs. Both types of products are subjected to a validation cycle that is designed to be sublethal for the BI but lethal for the product bioburden. (Note: Historical validation data should be reviewed to determine the gas dwell exposure time necessary to achieve this outcome.) After exposure to the validation cycle, the BIs are subjected to an endpoint sterility test by direct inoculation, and the product bioburden samples are sterility tested in accordance with ISO 11737-2. If a fraction or all of the BIs test positive, and the product bioburden sterility tests are negative, this demonstrates the appropriateness of the BI relative to the natural product bioburden. It is then necessary to ensure the product bioburden is controlled and monitored in accordance with ISO 11737-1.