Validation and Process Control for Low Energy Electron Beam Irradiation


New dates: 6-8 October 2020

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 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 requirements 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 with focus on the dosimet­ric aspects as used in 

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