Description:

A prospective assessment of the contract gamma-irradiation used for sterilization of bioprocess single-use systems, highlights increasing capacity constraints that may impact delivery and business continuity for a rapidly growing single use market by 2022. X-ray sterilization, now considered a mature technology, is positioned as a highly similar alternative to gamma, and contract irradiators are planning much of the future irradiation sterilization capacity in the form of X-ray. Qualification of alternate sterilization modalities such as X-ray, in addition to addressing industry capacity constraints, offers increased flexibility to accommodate disruptions or demand spikes and may result in less unwanted effects on plastics. Technical similarities and differences between X-ray and gamma are reviewed herein, as well as a risk-based testing strategy for evaluation of x-ray sterilization of single-use systems. The consensus testing strategy indicates the types of data that may be generated by single-use suppliers on representative single-use materials and is expected to confirm that existing gamma-irradiation validation packages can be considered applicable to X-ray.