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The Risø Courses on
Validation and Process Control for Electron Beam Sterilization
21 – 25 May 2012
3 - 7 September 2012
Risø High Dose Reference Laboratory
Risø – DTU, Technical University of Denmark
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”. |
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This Risø course gives background for understanding and implementing the requirements of the standard.
The emphasis of this course is on high energy (10 MeV) electron beam sterilization, but aspects of low energy (100 keV) electron beam and of gamma sterilization will also be discussed.
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The focus of the course is on three aspects:
1. Calibration of dosimetry systems
2. Dosimetry as required and used in
- 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, part 2
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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.
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Different dosimetry systems are used during the course:
Calorimeters
Radiochromic film dosimeters
Alanine / EPR dosimeters
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Methods for selecting or substantiating a sterilization dose for medical devices described in EN ISO 11137, part 2, 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)
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Material effects
In addition to the main aspects, the basis for selecting materials for radiation sterilization, and for establishing a maximum acceptable dose for products will be discussed.
The discussion will include:
- radiation effects on the properties of plastics.
- biocompatibility and testing for toxicity and pyrogenicity (EN ISO 10993)
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Lecturers:
Arne Miller Risø High Dose Reference Laborato¬ry
Jakob Helt-Hansen Risø High Dose Reference Laborato¬ry
Alan Tallentire Manchester, UK
Nick Edwards Scantox, Den¬mark.
Experience
All lecturers have several years of experience as experts in their fields and as teachers at these and other courses. Prof. Alan Tallentire is one of the leading figures in establishing the sterilization standards.
Risø High Dose Reference Laboratory is accredited by Danish Accreditation according to EN ISO 17025:2005.
The course is organized in collaboration with Sterigenics, Espergærde, Denmark, who operates a 10 MeV electron accelerator for ISO-9001 certified service irradia¬tion.
History
This course has been repeated more than 40 times since we started in 1993. A total of more than 300 participants from more 100 companies and institutions have expressed their satisfaction with the unique mixture of theory and practical exercises.
The course is continuously being updated to follow the developments in dosimetry methods and in international standards on radiation sterilization.
Certificate
Each participant will receive a certificate to witness participation.
Who should attend?
Persons working with different aspects of electron beam sterilization
Quality management staff and operators at electron beam facilities
Quality management staff at manufacturers of medical equipment
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.
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 18.300. This includes:
- course compendium
- refreshments and lunches
- one dinner (Thursday night).
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 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 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.
Further information can be obtained from
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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