Radiation sterilisation and tissue banking

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EDITORIAL

Radiation sterilisation and tissue banking Peter Myint

Published online: 22 June 2018 Ó Springer Nature B.V. 2018

This Special Edition is dedicated to Professor Gly O Phillips for his contribution towards tissue banking from the aspect of radiation sterilisation. Radiation sterilisation is an integral part of tissue banking, especially in musculoskeletal tissue banking. Professor Phillips is an imminent radiation chemist who has published over 700 research items in journals and books in various subjects, mainly in food science and tissue banking. His vision and strategy of using radiation as a means to sterilise tissues has made a great contribution to the expansion of tissue banking worldwide, particularly in developing countries, and his achievements remain relevant to this day since his involvement started in the 1970s. Radiation is the only terminal sterilisation method with unique properties—(1) it can sterilise products or items in final packaging, (2) it does not require a postirradiation sterility test and (3) cost effectiveness; for these reasons irradiation is widely used in sterilisation of medical and pharmaceutical products. As a radiation chemist, Professor Phillips instantly recognised the benefits that radiation technology could bring to tissue banking and how this could benefit the developing countries where imported surgical implants are expensive and beyond the reach of many patients. Together with the International Atomic Energy P. Myint (&) Wrexham, UK e-mail: [email protected]

Agency (IAEA), the organisation which promotes the peaceful use of nuclear energy, regional programmes were set out to support setting up of tissue banks around the world. Over the span of a half a century, the course of tissue sterilisation by irradiation has evolved as much as tissue banking has developed. For a long time, the sterilisation dose for tissues was adopted at 25 kGy (known as 2.5 Mrad) as in pharmaceutical products. This dose is derived from Bacillus Pumilus, a bacteria which is the most resistant organism to radiation, however, this organism is never found in tissues. Unlike medical products, tissues are sensitive to radiation due to their biological nature, and some tissue establishments, mainly in the USA, in the late 90s and early 2000s started to opt for aseptic processing without sterilisation, or using much lower radiation dose for decontamination purpose prior to processing. Unfortunately, this led to some incidents of transmission of bacteria and fungi from tissues to recipients. This led to the return of radiation sterilisation, albeit a new approach in relation to the dose applied. A meeting was held in 2004 in Wrexham, United Kingdom, gathering experts from tissue banking as well as from the radiation industry to address the role of radiation sterilisation for tissues. Tissue bankers started to adopt what was happening in the pharmaceutical industry where dose setting based on ‘‘bioburden’’ was increasingly adopted rather than the

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standard 25 kGy dose. ISO11137 dose