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

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.

Effects of Gamma-Ray Irradiation of Bacteria Colonies in Animal Feeds and on Growth and Gut Health of Weaning Piglets

“…γ-ray irradiation has been widely applied in various fields, including food sterilization [40], healthcare [41], and the packaging materials sector [42]. On the other hand, the cost of using γ-ray irradiation for sterilization falls within an acceptable range.…”

The Structure and Properties of Medical Disposable Protective Clothing Materials with Different Packaging and Models under γ Irradiation

“…In order to improve the sterilization capacity, the use of γ‐rays to irradiate medical supplies is getting more and more attention [5] . During the sterilization process of medical disposable protective clothing by γ irradiation, the changes in molecular structure caused by the irradiation can result in free radical‐induced after‐effects, [6–8] which lead to material property deterioration and cannot meet the usage requirements [9] . The main material of medical disposable protective clothing is polypropylene, [10] its radiation mainly involves β degradation [11] .…”

The Effect of Sterilization on the Accuracy and Fit of 3D-Printed Surgical Guides

“…X-ray sterilization or bremsstrahlung is chemical-free and radioactivity-free and can be used efficiently for large loads with low-density packages. However, studies have shown a negative impact of this method on the properties of polymer materials [24]. Gamma radiation sterilization has the advantage of high penetrability, low reactivity, no toxic residues and time and cost effectiveness.…”