Validation and process control for electron beam sterilization

The radiation sterilization process must be validated, and the dose measurements must be traceable to national standards as required by the international standard EN ISO 11137-1, “Sterilization of Health Care Products – Radiation – Requirements for Development, Validation and Routine Control of a sterilization Process for Medical Devices”.

This Risø course gives background for understanding and implementing the requirements of EN ISO 11137. The standard was recently revised, and the new ISO 11137-1:2025 will be reviewed and the impact of the differences from the old version will be highlighted.

The emphasis of this course is on high energy (10 MeV) electron beam sterilization, but aspects of gamma sterilization and of low energy (100-200 keV) electron beam irradiation will also be addressed. 

26 – 30 April, 2027
6 - 10 September, 2027

1. Calibration of dosimetry systems.
2. Determination and use of measurement uncertainty.
3. Dose measurements as required and used in: 
     - IQ/OQ, Installation / Operational Qualification
     - PQ, Performance Qualification
     - Routine monitoring and Process Control
4. Establishing the sterilization dose using the methods in EN ISO 11137-2 and EN ISO 13004.
5. Establishing maximum acceptable dose by investigating effect of dose on product.
   
    

During the dosimetry part of the course, the participants will:

• Calibrate dosimeters to be used in IQ/OQ and PQ exercises.
• Carry out IQ/OQ measurements on a 10 MeV electron accelerator.
• Perform PQ dose mapping studies on products.
• Make routine dosimetric process control.

Different dosimetry systems are used during the course:

• Calorimeters
• Radiochromic film dosimeters
• Alanine / EPR dosimeters

Methods for establishing the sterilization dose for medical devices using the methods described in EN ISO 11137-2 and EN ISO 13004 are covered by lectures and exercises based on simulated data.
The discussion of the dose setting methods comprises:

• Sterilizing dose selection - Methods 1 and 2, Methods VDmax25 and VDmax15
• Sterilizing dose audit
• Bioburden estimation (ISO 11737-1)
• Testing for sterility (ISO 11737-2)
  

Material effects
The basis for selecting materials for products to be radiation sterilized, and for establishing a maximum acceptable dose for products will be reviewed and discussed.
The discussion will include:

• Effects of irradiation  on the properties of plastics
• Biocompatibility and testing for toxicity and pyrogenicity (EN ISO 10993)

Lecturers:
Arne Miller, Risø High Dose Reference Laboratory
Mark Bailey, Risø High Dose Reference Laboratory
Christina Ankjærgaard, Risø High Dose Reference Laboratory
Eamon Hoxey, E.V.Hoxey, UK
Frederik Steenstrup, Technological Institute, Denmark
Andy Makin, Andrew Makin Preclinical Consulting, Denmark 

Registration
Please fill in the Registration form and send it to: armi@dtu.dk