Validation and Process Control for Electron Beam Sterilization (course)

 

15 – 19 June 2020 Cancelled due to corona virus
7 – 11 September 2020

This course gives the background for understanding and implementing the requirements of the radiation sterilization standard EN ISO 11137 with focus on the dosimetric aspects of electron beam sterilization as required in IQ, OQ, PQ and Routine Monitoring and Process Control

Participants will
- calibrate dosimeters to be used in the exercises,
- carry out IQ/OQ measurements on the 10 MeV electron accelerator,
- perform PQ dose mapping on products irradiated at the 10 MeV accelerator,
- make routine dosimetric process control.

Methods for selecting or substantiating a sterilization dose are covered by lectures and exercises. Effects of Radiation on Polymers as well as Biocompatibility are also discussed.