Consulting service
Consultancy for ISO 11137 compliant radiation sterilization, supported by optional dose modelling
We provide expert consultancy for the validation of radiation sterilization processes, supporting customers in achieving and demonstrating compliance with ISO 11137. Our consultancy covers the planning, execution and interpretation of validation activities, including dose mapping, process qualification and regulatory documentation, supported by traceable dosimetric measurements.
Where beneficial, Monte Carlo dose modelling can be applied as a supporting tool for IQ, OQ and PQ dose mapping, for example to characterize irradiation geometries, process parameters and product configurations, and to support interpretation of experimental dose mapping measurements, including those performed with Risø B3 film. Modelling may also be used to support irradiation testing of electrical and electronic components for space and other high-reliability applications.
By combining standards-based consultancy with ISO/IEC 17025 accredited dosimetry and optional modelling, we provide robust, audit-ready support for complex radiation sterilization and irradiation test programs.
For more information contact:
Arne Miller Specialist Consultant Department of Health Technology Phone: +45 46774224 Mobile: 2132 5613 armi@dtu.dk
Christina Ankjærgaard Head of Dosimetry, senior researcher Department of Health Technology Mobile: +45 61656929 cank@dtu.dk