Validation and Process Control for Low Energy Electron Beam Irradiation

Validation and Process Control
for Low Energy Electron Beam Irradiation

19-21 March, 2012



Irradiation with electron beams in the energy range lower than 300 keV is used in the polymer industry for curing and crosslinking. These beams are also used now in the pharmaceutical and medical device industries for sterilization of surfaces, emphasizing the need for validation of low energy electron beam processes.

The international standard ISO 11137 is written primarily for medical device sterilization, but the validation principles in this standard apply equally well for the sterilization of, for example, packaging for pharmaceutical products, and in fact for all processes employing low energy electron beams.

This Risø course on “Validation and process control for low energy electron beam irradiation” provides the background for understanding the validation requirements of the radiation sterilization standards with focus on the dosimetric aspects as used in

  • IQ/OQ, Installation / Operational Qualification 
  • PQ, Performance Qualification 
  • Routine monitoring and Process Control


Low energy electron beam course information

Low energy electron beam course time plan

Low energy electron beam course registration form

Page updated  by   19.12.2011


Arne Miller
Professor
Radiation Research (NUK)
Dir tel+45 46774224


Jakob Helt-Hansen
Senior scientist
Radiation Research (NUK)
Dir tel+45 46774908