ABSTRACT
The installation qualification sequence for an E-beam facility is outlined in American National Standards Institute/Advancement of Medical Instrumentation/International Organization for Standardization 11137 and consists of four separate elements: equipment documentation, equipment testing, equipment calibration and irradiator dose mapping. The essential documentation is the Design History Record for the system and the documentation associated with the installation qualification cycle. All subsystems that comprise the radiation processing facility should be tested to demonstrate their compliance with the Design History Record, and the results should be documented and archived. Safety systems are associated with electrical and mechanical hazards, radiation, ozone production and access to the process chamber. Protection at mechanical pinch points shall be provided, and audible and visual alarms associated with the automatic start-up of moving equipment should be demonstrated. The principal parameters that ensure system integrity of the delivered dose are the average beam current, beam energy and process conveyor speed.
