RadSter-3: Product qualification

Tuesday November 08, 2022 from 13:30 to 15:00

Room: Moon

RadSter-3.5 Assessing potential induced radioactivity in materials processed with X-ray energy above 5 MeV

Pierre Reppert, Switzerland

Validation Manager
Radiation Technical Team


Assessing potential induced radioactivity in materials processed with X-ray energy above 5 MeV

Pierre Reppert1, Hervé Michel1, Brian McEvoy2.

1Radiation Technical Team, STERIS Applied Sterilization Technologies, Däniken, Switzerland; 2Global Technology , STERIS Applied Sterilization Technologies, Tullamore, Ireland

In accordance with ISO11137-1 section 5.1.2, ‘the potential for induced radioactivity in product shall be assessed’.

This presentation describes how compliance to this requirement may be achieved using qualified test methods. Materials of consideration are conceptually discussed, and results of testing conducted on products processed with a 7.5 MeV X-ray irradiation process are provided.

Photon-neutron activation is the process in which neutron radiation induces radioactivity in some materials, and occurs when atomic nuclei capture free neutrons, becoming heavier and entering excited states. The excited nucleus decays immediately by emitting particles and gamma rays.

The case studies results presented are based on activation tests carried out by STERIS Daeniken Switzerland on Customer products. Since 2011, more than 130 activation tests have been carried out for a large number of different materials. So far, all products have been declared compatible with X-Ray processing.

As X-ray becomes more widely used in healthcare sterilization, having standard assessment protocols for activation coupled with a shared database of material test results will benefit all healthcare product manufacturers seeking to utilize this innovative technology.

The purpose of this presentation is:

1. To explain the X-Ray activation principle
2. To present the methodology of activation assessment
3. To present case study results
4. To introduce the material test results database
5. To discuss the use of standard assessment protocols for activation

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