July 12, 2023 – Arlington, VA – The Bio-Process Systems Alliance (BPSA) announces the release of its latest guide, “X-Ray Sterilization of Single-Use Bioprocessing Equipment, Part 2: Representative Qualification Data”, which serves to follow up on BPSA’s 2021 white paper, “X-Ray Sterilization of Single-Use Bioprocess Equipment, Part 1: Industry Need, Requirements & Risk Evaluation.”
Supply challenges and availability of gamma irradiation for sterilization have continued to increase, leading many single-use component and system suppliers to implement X-ray irradiation as an alternative to gamma irradiation. To support the risk assessments needed for such implementation, BPSA has generated supporting data evaluating the performance levels of X-ray sterilization and gamma-ray sterilization on certain single-use materials.
“There is a lot of concern about whether gamma contract irradiation capacity will be sufficient to meet the increasing demand from the bioprocessing industry,” said James Hathcock of Cytiva, Co-Chair of the BPSA X-ray Committee. “This research and accompanying white paper is a critical initiative for BPSA and the entire single-use industry.”
The resulting data in the new BPSA guide demonstrates the equivalent impact of X-ray irradiation of single-use materials as gamma. It also includes examples of data comparing X-ray and gamma irradiated components, generated by multiple component manufacturers for different types of single-use components and materials. “We are very pleased the examples verify the science-based understanding that X-ray and gamma impacts on single-use systems are equivalent,” said Samuel Dorey of Sartorius, BPSA X-ray Committee Co-Chair.
“I want to thank the BPSA X-ray Committee and its Co-Chairs, James Hathcock of Cytiva and Samuel Dorey of Sartorius, for their leadership of this initiative,” said BPSA Chair Mark Petrich, PhD, Krystal Biotech. “The results presented in this white paper are very good news, not only for single-use suppliers, but for customers and patients around the world who rely on our products. Advancing X-ray as a mode of sterilization is critical, for BPSA members and the broader bioprocessing industry.”
The 63-page guide results from a multi-year project, produced by BPSA members, industry stakeholders and subject-matter experts. The project team met with FDA’s Center for Drug Evaluation & Research Emerging Technologies Team, the European Medicines Agency Quality Innovation Group, and the Japan Pharmaceuticals and Medical Devices Agency to advance the adoption of X-ray technology for sterilization.
The Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. www.bpsalliance.org.