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8 November 2017

Whitepaper – A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products

The White Paper is being jointly published by GIPA and iia.

The purpose of the White Paper is to describe the role and importance of the key industrial sterilization methods to the healthcare industry and the means by which each technology ensures that products are safe and ready for their intended use. This paper focusses on the major sterilization modalities, including both radiation based (gamma, e-beam and x-ray) and gas based (Ethylene Oxide), comparing and contrasting them to provide the reader with a greater understanding of the way they work and their capabilities. This paper further highlights the advantages of each technology and describes their limitations.

This White Paper was collaborated upon and written by a significant number of technical experts from companies that constitute the Gamma Industry Processing Alliance (GIPA) and was subsequently reviewed and refined with input from the International Irradiation Association (iia). The authors and reviewers included members of global medical device and pharmaceutical industry as well as technology experts. The experience of the participants spans many decades and incorporates practical operational experience of all of the sterilization technologies described in this document.

We believe that this is the most comprehensive single document available to those who wish to understand the relative strengths and weaknesses of the key sterilization modalities.  The White Paper has been prepared as a result of collaboration and is endorsed by leading technology users and suppliers.