Sterilization by gamma irradiation is a standardized process for some healthcare devices. Many worldwide industrial sites offer gamma irradiation as a means of sterilization, and in the last decade, new irradiation technology such as X-rays or electron-beam raises. All irradiation technologies are reliable and reproducible processes and ensure sterility over time by avoiding any possible risk of contamination. It will thus reflect on post-pandemic world solutions to build capacity with high flexibility while looking forward to anticipating future increases in sterilization demand without negative implications/repercussions in all industries where sterilization is needed. This radiation processing also presents the disadvantages of inducing modifications for exposed materials. While X-ray industrial units are beginning to emerge, the question of a comparative study between the effects of different types of radiation and their health impact on the materials/products studied still arises. This previous lack of data represented a hurdle for medical device and biopharmaceutical manufacturers desiring to transition from gamma-ray sterilization modalities to X-ray or electron-beam. Communicating to the industry our approach and polymer effects results can support medical device and biopharmaceutical manufacturers to perform their own risk assessment when piloting the transition to alternative irradiation modalities. To help fill these data gaps previously enounced, physicochemical testing, mechanical testing, extractable testing, etc., were performed on products, including their polymer components previously irradiated by the different radiation technologies (gamma and X-ray).
This presentation will provide an updated status of where the industry is regarding the implementation of X-ray as a sterilization method, as well as identify what are the timelines, risks and regulatory perspective.