Validation and Process Control for Electron Beam Sterilization (course)

Course on Validation and Process Control for Electron Beam Sterilization

22-26 May & 11-15 September 2023

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 emphasis of this course is on high energy (10 MeV) electron beam sterilization, but aspects of low energy (100-200 keV) electron beam and of gamma sterilization 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 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
    - Rdiochromic 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)
    - 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:
    - radiation effects on the properties of plastics.
    - biocompatibility and testing for toxicity and pyrogenicity (EN ISO 10993)

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

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