One of the lessons learned from the COVID-19 pandemic¹ was to ensure business continuity by securing supply chain proactively. To mitigate the potential supply constraint of gamma source, X-ray is being established as an alternative and additional sterilization method for polymeric single use systems (SUS) and components in pharmaceutical and biopharmaceutical manufacturing processes.

ASTM E3051² indicates that end users are responsible for qualifying incoming SUS and components.

This talk will present the approaches for implementation of X-ray sterilized SUS. Since the medicines industry is highly regulated to ensure product quality and patient safety, prudent and specific considerations need to be taken for new drug introduction and existing commercial products when applying a new sterilization technology.

The risk-based approaches, combined with scientific study results on effects of X-ray on polymeric materials and regulatory compliance consideration³, enabled the implementation of X-ray sterilization as a meaningful way to mitigate the potential supply constraint from gamma source.

1. Points to Consider No. 9: Lessons learned from the COVID-19 pandemic, PDA, Jan. 11, 2024
2. ASTM E3051, Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing, ASTM, 2016
3. Questions and Answers on the use of X-ray sterilisation processes for Single Use Systems (SUS) used in pharmaceutical manufacturing, EMA, Oct. 12, 2023