The Risø Course on Validation and Process Control for Electron Beam Sterilization

15-19 April & 9-13 September 2024

Risø High Dose Reference Laboratory
DTU Health Tech
Technical University of Denmark, Risø Campus
DK 4000 Roskilde, Denmark

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A 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 is under revision, and a new ISO 11137-1 is expected to be published in mid-2024. 

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. 

The focus points of the course are:

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

 
During 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 selecting or substantiating a sterilization dose for medical devices 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)
• test of 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:

• radiation effects on the properties of plastics
• biocompatibility and testing for toxicity and pyrogenicity (EN ISO 10993)

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