Impact of X‐ray irradiation as an equivalent alternative to gamma for sterilization of single‐use bioprocessing polymers

摘要

Abstract Irradiation sterilization of polymeric pharmaceutical processing systems and medical devices, an essential healthcare technology, is facing critical business continuity challenges, driving the need to qualify equivalent alternative irradiation technologies, such as X‐ray. Whereas the underlying there is a paucity of cross‐industry published data evaluating X‐ray irradiation effects on plastics as compared to gamma irradiation. That leads to regulatory uncertainty in the levels of costly validation data regulators will require and overall apprehension in the rate of X‐ray irradiation adoption. The present study evaluates the impact of X‐ray versus gamma irradiation on a wide range of polymers with more than 36 single‐use (SU) components, using a comprehensive set of industry aligned methods for characterization of bioprocess polymers. Whereas many of these techniques readily demonstrate changes in polymer properties following irradiation, all of the polymers evaluated demonstrated that the impact of X‐ray irradiation was to the same degree or less as compared to gamma. Increased publication of studies evaluating the impact to polymers of X‐ray versus gamma irradiation is critical to leveraging extensive, existing validation packages on bioprocess systems and medical devices obtained following gamma irradiation, and essential in qualifying X‐ray irradiation as an equivalent technology (i.e., materials are impacted to the same extent or less than gamma) that can overcome business continuity challenges to ensure continued availability of critical patient therapies.