Validation and process control for low energy electron beam irradiation

Irradiation with electron beams in the energy range lower than 300 keV is used in the polymer industry for curing and crosslinking. These beams are also used in the pharmaceutical and medical device industries for sterilization of surfaces. Both applications can require delivered doses to be traceable to national standards and that the irradiation process is validated.

The Risø course on “Validation and process control for low energy electron beam irradiation” focusses on radiation sterilization, and it provides the background for understanding the validation requirements of the international standards in particular the dosimet­ric aspects of:

• IQ/OQ, Installation / Operational Qualification
• PQ, Performance Qualification
• Routine monitoring and Process Control

The penetration of the electron beam at less than 300 keV is limited, and even thin dosimeters can interfere significantly with the beam to be measured.

These problems will be addressed during the course, and methods for establishing measurement traceability will be reviewed and tested.

24 - 26 May, 2027

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

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Practical dosimetry exercises
Irradiation will be done using Risø HDRL’s low energy electron accelerator EbLab

During these exercises the participants will:

• Calibrate dosimeters to be used in the subsequent exercises,

• Carry out IQ / OQ measurements,

• Make PQ dose mapping studies in products,

• Make routine dosimetric process control.

The dosimeter systems that will be used during the course are:

• Radiochromic film dosimeters
• Alanine / EPR film dosimeters
  
  

Microbiological aspects

For radiation sterilization or decontamination, it is necessary to determine the required minimum dose for an effective process. Methods for selecting or substantiating a sterilization dose for medical devices are described in EN ISO 11137-2. These and other methods and their applicability at low energy electron irradiation will be reviewed and discussed.

Material effects

The effect of irradiation on polymers will be discussed. This forms the basis for determining a maximum acceptable dose for the irradiation process.

Lecturers:

Arne Miller, Risø High Dose Reference Laborato­ry
Mark Bailey, Risø High Dose Reference Laborato­ry
Frederik Steenstrup, Danish Technological Institute

For more information, see the Course Info document

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