FDA Emerging Technologies team meeting September 2022 – Update on adoption of X-Ray

Samuel Dorey from Sartorius and James Hathcock from PALL Corporation presents an ‘Executive Summary’ of the meeting on September 8th, 2022, between members of BioPhorum and BPSA, BARDA, and subject matter experts who met with the FDA/CDER/Emerging Technologies Team (ETT), including observers from CBER and EMA. The purpose of the meeting was a) to socialize and advocate for the positions published in the 2021 BPSA white paper on X-ray* and b) to address concerns expressed by regulators during a prior, December 2021 Type C meeting with the ETT. The team was there to express the urgency to qualify X-ray as a complementary alternative technology to Gamma for the delivery of the method of sterilization for single-use systems (SUSs), that being ionizing electromagnetic irradiation. The team wanted to show the industry was working on clear alignment among suppliers, pharmaceutical manufacturers, and regulators on expectations for transition & commercial implementation.In the presentation, the Document & Data package shared with the FDA is discussed

The package included:

• The follow-up Type C meeting request identified key questions on which agency feedback was desired
• The May 2021 BPSA whitepaper
• A recently finished and to-be-published technical paper demonstrating the comparability of X-ray and Gamma irradiation physics {reference to now published paper by Thomas Kroc}
• The December 2021 CDER/ETT Type C meeting minutes
• A report consisting of 3 primary examples of post-approval changes and additional supporting rationale for the BPSA-recommended approach to extractables & leachables verification testing
• A general letter of support for the risk-based approach to assessment, verification, and notification of changes from BioPhorum.

{*Bioprocess Systems Alliance (BPSA), “X-ray Sterilization of Single-Use Bioprocess Equipment. Part I – Industry Need, Requirements, and Risk Evaluation,” 2021}