Validation and Process Control for Low Energy Electron Beam Irradiation

Irradiation with electron beams in the energy range lower than 300 keV is used in the polymer industry for curing and crosslinking. Lately these beams have also been used in the pharmaceutical and medical device industries for sterilization of surfaces. This application emphasizes the need for validation of low energy electron beam processes.

The international standard EN ISO 11137 gives validation requirements primarily for medical device sterilization, but the validation principles 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

The course also addresses issues of documenting the microbiological effectiveness, as well as radiation effects on polymers and material selection


Low energy electron beam course information

Low energy electron beam course time plan

Low energy electron beam course registration form

Page updated by   18.11.2008

Arne Miller
Professor
Radiation Research (NUK)
Dir tel+45 4677 4224

Jakob Helt-Hansen
Senior scientist
Radiation Research (NUK)
Dir tel+45 4677 4908