 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
-
What is the effect of E-beam sterilisation (54-75 kGy) and accelerated aging (1 year at 55°C) on the physical property of PVC tubing?Answered August 11th, 2009 by Expert:PVC likely will show severe discolouring at the doses that you mention, both immediately after irradiation and after accelerated aging. Also, PVC has a tendency to crosslink. This will slightly stiffen the tube. If these phenomena do occur and are unacceptable to you, you could try to find a radiation-stabilised grade of PVC.
General information about a material’s compatibility with a sterilisation process can be found in AAMI TIR17:2008. Please note, however, that ISO 11137-1:2006 requires the setting of a maximum acceptable product dose. This means that a formal test programme, including product irradiations and subsequent real-time ageing, should be set up to determine the highest absorbed dose at which the product will continue to meet all of its specifications (functional and biocompatibility) during its defined shelf life.