Wednesday November 09, 2022 from 13:30 to 17:00
Performance qualification dose mapping – a review
1DTU Health Technology, Technical University of Denmark, Roskilde, Denmark
Performance Qualification – PQ – Dose mapping is an important step of the validation of a radiation sterilization process. Several requirements must be fulfilled, and choices must be made and justified for the PQ dose map results to be considered valid for establishing the sterilization process parameters. The new PQ dose map report by The Irradiation Panel provides the basis for understanding the requirements and for making sound and justifiable choices where needed.
The Panel report complements the international standards from ISO (1) and ASTM (2) on PQ dose mapping, but it is written in a more narrative style leading the reader through the PQ process.
The report content comprises:
- description of radiation processing facilities, including low and high energy electron beam and X-ray, as well as gamma facilities,
- dosimetry systems, their advantages and limitations as well as their calibration requirements,
- where and how to measure,
- establishing process parameters
- potential, and limitations, of calculation methods (Monte Carlo)
The Irradiation Panel PQ dose mapping report is useful tool for anyone who wishes to understand and use the international standards on dose mapping as part of the validation of radiation sterilization and other radiation processes.
(1) ISO 2006: ISO 11137-1. Sterilization of health care products – Radiation – Part 1: Requirement for development, validation and routine control of a sterilization process. ISO, Geneva, Switzerland
(2) ISO ASTM, 52303. (2015) Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities, ASTM International, 100 Barr Harbor Drive, West Conshohocken PA 19428, USA