The Risø Course on Validation and Process Control for Low Energy Electron Beam Processing

13 - 15 May 2024

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

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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 require that delivered doses are traceable to national standards and that the low energy electron beam processes are validated. 

This Risø course provides the background for understanding the validation requirements for low energy electron beam processing with focus on the dosimetric aspects as used in:

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

 
The dose measurements must be traceable to national standards, and for low energy electrons this can be difficult. The penetration of the electron beam 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 presented.

Practical dosimetry exercises
will be carried out by irradiation on Risø HDRL’s low energy electron accelerator.

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.

For more information, see the Course Info document

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