New Guide for Standard Guide for Operational Qualification of Accelerator-Based Electron Beam Irradiators
1. Scope
1.1 This document provides guidance on operational qualification tests for accelerator-based electron beam irradiators. The tests are not requirements but may help the user gain an increased understanding of operational aspects of their irradiator. Based on facility-specific assessments for routine operation, certain tests listed in this document may be deemed unnecessary and omitted.
1.2 Requirements for Operational Qualification are dependent on the application of the irradiation process and may be in addition to what is in the scope of this document. For example, requirements for OQ when sterilizing healthcare product can be found in ISO 11137-1 as well as ISO/ASTM 51649.
1.3 This standard provides guidance for assessing a change to the irradiator as part of the change control process. Qualification testing completed as part of the change control should be assessed to determine the impact, if any, of the change.
1.4 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and provides guidance for achieving compliance with the requirements of ISO/ASTM 52628 “Practice for Dosimetry in Radiation Processing” related to the evaluation and documentation of the uncertainties associated with measurements made with a dosimetry system. It is intended to be read in conjunction with ISO/ASTM 52628 and ISO/ASTM 51261.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use, including activation of irradiator components due to the energy of the electron beam. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
There is no standardized approach for operational qualification testing of an e-beam irradiator. This will be used to support the requirements for radiation processing requirements as defined in ISO/ASTM 51649 as well as ISO 11137-1.
