Standard Guide for Operational Qualification of Gamma Irradiators

Importancia y uso:

4.1 Operational qualification (OQ) will be used to demonstrate that the irradiator, as installed, is capable of operating and delivering dose to product being irradiated with defined acceptance criteria by determining dose distribution and magnitude through dose mapping exercises and relating these distributions to process parameters.

4.2 The principle objectives of OQ are to:

4.2.1 Establish the dose distribution and create a baseline PQ grid for mapping actual product,

4.2.2 Establish the relationship for dose uniformity ratio (DUR) as a function of density,

4.2.3 Establish the relationship for cycle time (CT) as a function of density and source activity, and

4.2.4 Establish the relationship for minimum dose (kGy) as a function of density, cycle time and source activity.

4.3 OQ exercises could augment or replace PQ exercises. It is the facility’s responsibility to document the rationale when using OQ data for PQ purposes.

4.4 A design of experiments approach may help rationalize the types of OQ tests needed. For some irradiator changes, the minimum number of densities may be different depending on the degree of anticipated change in dose distribution. These decisions should be covered through a documented change control process. See ASTM 52701.

4.5 This guide is not intended to address OQ requirements in research or experimental irradiators.

4.6 An irradiation facility is able to process different process load configurations. For example, an irradiation container may be designed to accommodate boxes, sacks and drums. It is important to consider OQ studies that characterize the irradiator for different irradiation geometries.

4.7 The bulk density, dimensions and atomic composition are important properties in dose mapping. See Appendix X2 for examples of materials for potential use in OQ studies.

Subcomité:

E61.03

Referida por:

E2303_E2303M-24

Volúmen:

12.02

Número ICS:

17.240 (Radiation measurements)