Dose mapping for radiation sterilization

We provide comprehensive dose mapping and dosimetric validation services for radiation sterilization processes at gamma, e-beam and X-ray facilities, supporting process validation, qualification and routine control.

Dosimetric validation for Installation and Operational Qualification (IQ/OQ) is performed in accordance with EN/ISO 11137-1 and includes measurement and characterization of fundamental facility parameters and irradiation conditions for both e-beam and gamma facilities. For Performance Qualification (PQ), we measure dose distributions in products and product loads to verify that all parts of the product are irradiated within the specified dose limits.

Dose mapping is a critical element in demonstrating that the specified absorbed dose is delivered reproducibly and within defined limits throughout the product load, in compliance with EN/ISO 11137 and applicable ISO/ASTM dosimetry standards.

All measurements are performed using traceable dosimetry systems (e.g. alanine and Risø B3 film) under our ISO-17025 accredited quality system, with documented uncertainty budgets and full traceability.

Our services cover the full-qualified lifecycle:

• Installation Qualification (IQ) – Documentation and characterization of the installed irradiation facility

   

• Operational Qualification (OQ) – measurement of process parameters and establishment of dose relationships over the operating range

   

• Performance Qualification (PQ) – measurement of dose distributions in products and product loads to ensure that all parts of the product are irradiated within the specified dose limits

   

• Modelling of dose distributions – supporting process design, optimization and interpretation of experimental results