 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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Is it possible to sterilise disposable medical devices containing a primary battery (a lithium or silver oxide cell, for example) using ethylene oxide? Are there any experiences or design requirements that must be considered?Answered August 4th, 2009 by Expert:Ethylene oxide sterilisation is not recommended for medical devices that contain any form of stored energy (i.e., electrical, chemical, pressurised gas) because this energy may be a potential source of ignition.
In extreme cases, however, where no other method is available to sterilise medical devices that contain batteries, EtO has been used. In my view, to achieve the absolute minimum safety requirements for such procedures, make sure that the following steps have been taken:
1. A full review of design of device has been performed by senior Safety Management executives, including a review of subcomponent circuit diagrams to assess energy storage and discharge characteristics
2. Several layers of safety have been designed into the device to prevent accidental discharge when it is in the sterilisation chamber
3. The sterilisation cycle has been designed to be significantly below the flammability curve for ethylene oxide
4. Effective change control procedures have been put in place for the product design and sterilisation cycles to prevent change unless authorised by the relevant safety specialists.
Medical devices containing batteries should not be sterilised by EtO methods unless these criteria have been met and all rationale and decisions have been properly recorded.