Validation and Process Control for Electron Beam Sterilization (course)

17-21 June  -  9-13 September, 2019 

Risø High Dose Reference Laboratory
DTU Nutech
Technical University of Denmark
DK 4000 Roskilde, Denmark

This Risø course gives background for understanding and fulfilling the requirements of the radiation sterilization standard EN ISO 11137.

The course is an updated version of the course that has been organized by Risø High Dose Reference Laboratory approximately 60 times with a total close to 500 participants.

Participants will carry out

-       dosimeter calibration by irradiation at a 10 MeV electron accelerator,

-       measurements for Operational Qualification and

-       dose mapping for Performance Qualification.

Methods for sterilization dose setting and substantiation according to EN ISO 11137-2 will be discussed, as well as Effects of radiation on polymers.

The emphasis of this course is on high energy (10 MeV) electron beam sterilization, but aspects of low energy (100 keV) electron beam and of gamma sterilization will also be discussed.