The measurement, control, and validation of critical parameters in an electron beam sterilization facility

Abstract The delivery and validation of a specified dose to a medical device are key concerns of operators of electron beam irradiation facilities. In an IMPELA-based irradiator 1 , four of the parameters that directly influence the absorbed dose distribution in the product are controllable in real time — the electron energy, average beam current, scanned area, and the product exposure time. The 10 MeV accelerator operates at 50 kW with a stream of 200 μs wide, 100 mA pulses at a repetition rate of 250 Hz. The combination of short-term intra-pulse regulation with long-term pulse-to-pulse stability makes the IMPELA output attractive for the sterilization of medical products. The measurement and closed-loop control techniques used in the IMPELA design with be described with reference to facilitating compliance with medical sterilization standards.