Technical and regulatory requirements for radiation sterilization facilities using electron beam accelerators

Abstract

Various technical and regulatory considerations must be addressed in order to sterilize disposable medical devices by ionizing radiation. Current practices specific to electron beam-based sterilization events are discussed and include material compatibility testing, dose setting, dose mapping, process validation and process control associated with the accelerator/conveyor system. Projected trends in regulatory guideline development are made relative to the appearance and implementation of reliable high power machine-generated sources of electrons operating in the energy range of 0.3–12 MeV.