Validation and routine process control for low-energy electron accelerators

摘要

Radiation curing may not operate under the same strict legal requirements as, for example, radiation sterilization, but it is essential that dose is not delivered to product outside specifications without the knowledge of the operator. This is obtained though establishing and understanding the relationships between key parameters (energy, beam current, beam width and conveying speed) of an electron accelerator facility and absorbed dose. The relationships are established during dosimetric validation of the facility. Validation is defined as “documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications”, and for irradiation processes the international standard for radiation sterilization EN ISO 11137 can be used as a template for the validation activities. Using the ISO 11137 template, this presentation describes how the steps of validation: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) can be applied for low-energy e-beam polymer processing. Calibration of dosimeters and routine dosimetry process control are also described. Keywords: Low-energy, dosimetry, validation, process control.