Validation and Process Control for Low Energy Electron Beam Irradiation

10 - 12 October, 2023

Risø High Dose Reference Laboratory
DTU Health Tech, Technical University of Denmark
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 may require that delivered doses are traceable to national standards and that the low energy electron beam processes is validated.

The Risø course on “Validation and process control for low energy electron beam irradiation” provides the background for understanding the validation requirements of the radiation sterilization standards with focus on the dosimet¬ric 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 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.

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

Who should attend?
Persons responsible for quality control at low energy electron beam facilities. 
Manufacturers and suppliers of low energy electron beam facilities.

Because of the emphasis on gaining practical dosimetric experience during the course, the number of participants is limited to 9, who will work in 3 groups.

Certificate
Each participant will receive a certificate to witness participation.

Location
The course will be held at DTU Health Tech near Roskilde, Denmark, approximately 30 km west of Copenhagen, see:
https://www.dtu.dk/english/about/campuses/dtu-risoe-campus

Cost
The cost for one participant is DKK 19.250.  This includes:
- course compendium
- refreshments and lunches 
- one dinner

Multiple attendees’ discount:  Two or more participants from the same company location attending the same course together are eligible for a 10% discount on the total course fee.

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

Payment
An invoice will be sent after receipt of registration.
Payment should be made no later than one month before the start of the course.
Final registration of participants will be made in order of their payments.

The small print
Fees are refunded in full if DTU Health Tech receives notification of a participant's cancellation at least one month before the start of the course. No refund is made for cancellations made later, or for not attending the course (no-shows).  Cancellation notification must be made in writing or by fax or e-mail.  Substitute participants are welcome, without prior notice, should the registrant be unable to attend the course.

DTU Health Tech reserves the right to modify course material, substitute speakers without notice, or to cancel the course.  If the course must be canceled, an extremely rare occurrence due to circumstances beyond our control (e.g. melting of the polar ice cap, lecturer being hospitalized, coup d'etat, etc.), registrants will be notified as soon as is possible and will receive a full refund of fees paid.  DTU Health Tech will not be responsible for discount airfare penalties or other costs incurred due to a course cancellation.

Accommodation
List of hotels in Roskilde:
Zleep Hotel Prindsen, https://www.zleep.com/en/hotel/roskilde/
Scandic Scandic Roskilde Park
Comwell https://comwell.com/

There are plenty of hotels in and around Copenhagen, but transportation time to/from DTU Risø is longer.
Contact us if you want assistance. 

For further information please contact:

Arne Miller
High Dose Reference Laboratory
DTU Health Tech, Bldg. 201
Technical University of Denmark, Risø Campus
Frederiksborgvej 399
DK 4000 Roskilde
Denmark

Phone: +45 4677 4224
Fax: +45 4677 4959
e-mail: armi@dtu.dk
Risø High Dose Reference Laboratory - HDRL - DTU Sundhedsteknologi