Description:

Since the publication of Part I of this series on qualification of X-ray sterilization of single-use bioprocess equipment in May 2021, security of supply challenges with availability of irradiation sterilization have continued to increase, leading a number of single-use component and system suppliers to issue change notifications with plans to implement X-ray irradiation between late 2022 and mid-2023. To support the risk assessments needed for implementation, multiple BPSA member companies have been working to generate and share supporting data aligned to the science-based protocol outlined in Part I. This white paper includes representative examples of data comparing X-ray and gamma irradiated components, generated by multiple component manufacturers for different types of single-use components and materials.