The use of X-rays as an alternative modality to either gamma irradiation or electron beam irradiation for the sterilization of medical devices has become a topical subject over the last two or three years. The drivers are the improved capability of modern-day X-ray generation systems and a desire to develop a range of competitive and sustainable sterilization technologies. The Panel on Gamma and Electron Irradiation has compiled a short guidance document on the steps required when switching radiation sterilization technology, for example, from gamma or electron beam to X-ray. The guidance clarifies the requirements of ISO EN 11137-1 (Sterilization of health care products - Radiation: Requirements for development, validation, and routine control of a sterilization process for medical devices), the primary standard relevant to the radiation sterilization of medical devices. This standard addresses both the technological aspects of delivering the correct dose and the microbiological aspects of ensuring sterility of the treated product. When considering a switch to X-ray sterilization, the main challenge to be addressed is transferring the two key product-based irradiation parameters, namely the sterilization dose (required to achieve the desired sterility assurance level) and the maximum acceptable dose (that the product is qualified to withstand). The guidance document outlining the points to be considered and how to achieve them is available for free download from the Panel website, at https://www.irradiationpanel.org/guides/
The Panel has active Working Groups in the areas of Dosimetry, Microbiology, and X-ray. The Microbiology Working Group has also recently published a comparison of the 2018 and 2006 versions of the ISO EN 11737 standard (Microbiological Methods – Determination of a population of microorganisms on products). This comparison highlights the significant differences in the updated version of the standard in terms of quality management system elements, selection of products for testing, and testing methods. A similar document on the differences between the 2017 and 2006 versions of ISO 11137-3 (Sterilization of health care products – Radiation: Guidance on dosimetric aspects of development, validation and routine control) has been published by the Dosimetry Working Group. This guidance is highly relevant to all those actively involved in ensuring that their sterilization processes, and the product sterility assurance levels that those processes deliver, satisfy the requirements of ISO EN 11137. These documents are available for free download from the Panel website via the link highlighted above.
Over recent years the Irradiation Panel has also developed a number of other advice and guidance documents that will be of interest to those involved with the technological and microbiological aspects of radiation sterilization. These are all visible via the link to the Panel publications https://www.irradiationpanel.org/guides/.
The panel is a technology-neutral industry body focused on radiation sterilization processes, their applications and control. It was established more than 50 years ago and meets regularly to discuss issues and developments within the radiation processing industry and contributes to the developments of standards and guidance that apply to these processes. For further information about the panel, please visit our website https://www.irradiationpanel.org
The panel’s membership is composed of major medical device and equipment manufacturers, service providers, reference laboratories, notified bodies, academics, and knowledgeable individuals all directly involved in the field of irradiation processing. For information about joining the panel and the ability to learn from and contribute to its working groups, please contact us at [email protected]