Published Date: June 29, 2022
Examples will be presented for radiation sterilization of RTU SVPP as well as terminal sterilization of fill/finished items.
A critical aspect in validation of the irradiation processes is the Process Definition step, where there is considerable benefit to not default to a specification of 25 kGy to 40 kGy. Methods and practices for widening the specification will be discussed.
Learn more about the presenter below.
Technical Director Irradiation EMEAA – Sterigenics
Dr. Bart Croonenborghs received his PhD in nuclear and solid-state physics, at the University of Leuven (Belgium) in 2004. He joined Sterigenics International in 2005 and currently serves as Technical Director Irradiation. Throughout his career with Sterigenics, Dr. Croonenborghs has performed IQ/OQ validation of gamma and electron beam irradiators, designed and executed Process Definition programs (establishing of sterilization and maximum acceptable dose), as well as PQ dose mapping for Sterigenics’ customers – specifically those in the field of pharmaceuticals and biologics. Dr. Croonenborghs is actively involved in industry committees, task forces, and working groups. As a working group member, he represents Belgium on ISO TC 198 WG 2 Radiation Sterilization (since 2009). He is also a member of ASTM E61 and past secretary of the Irradiation Panel.
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