Validation and Process Control
for Low Energy Electron Beam Irradiation
19-21 March, 2012
Risø High Dose Reference Laboratory
Risø – DTU, 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, and 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
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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.
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Practical dosimetry exercises
will be carried out by irradiation on Risø’s 100 keV 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
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Microbiological aspects
For radiation sterilization it is necessary to determine a required minimum dose for an effective sterilization process. Methods for selecting or substantiating a sterilization dose for medical devices are described in EN ISO 11137, part 2. These methods and their applicability at low energy electron irradiation will be 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 and Jakob Helt-Hansen
Risø High Dose Reference Laboratory.
Who should attend?
Persons responsible for quality control at low energy electron beam facilities.
Manufacturers and suppliers of low energy electron beam facilities.
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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 Risø - DTU near Roskilde, Denmark, approximately 30 km west of Copenhagen. www.risoe.dtu.dk/
Cost
The cost for one participant is DKK 14.000. This includes:
- course compendium
- refreshments and lunches
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
Registration forms
Payment
An invoice will be forwarded 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 Risø 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.
Risø 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. Risø will not be responsible for discount airfare penalties or other costs incurred due to a course cancellation.
Accommodation
We have made provisional reservations at Hotel Prindsen, Roskilde.
Hotel Prindsen, Roskilde
http://www.hotelprindsen.dk/
5 km from the Laboratory, 15 min. by bus.
Rooms with bath/shower, TV, phone, internet.
Good restaurant.
Single room: DKK 825 per night (by reservation through Risø).
If you have other hotel preferences, e.g. staying in Copenhagen, this is also possible. There are frequent train connections with a travel time of approximately 30 min. from Copenhagen to Roskilde. Let us know if we can assist you.
For further information please contact:
Arne Miller
High Dose Reference Laboratory
Risø – DTU, Radiation Research Division
P.O.B. 49, Frederiksborgvej 399
DK 4000 Roskilde
Denmark
Phone: +45 4677 4224
Fax: +45 4677 4959
e-mail: armi@risoe.dtu.dk
http://hdrl.risoe.dk /
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