Course information

Validation and Process Control for Electron Beam Sterilization

17-21 June - 9-13 September 2019

Risø High Dose Reference Laboratory
DTU Nutech
Technical University of Denmark
DK 4000 Roskilde, Denmark

 Rhodotrone accelerator

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”. 

This Risø course gives background for understanding and implementing the requirements of EN ISO 11137.

The emphasis of this course is on high energy (10 MeV) electron beam sterilization, but aspects of low energy (100-200 keV) electron beam and of gamma sterilization will also be addressed. 

  

The focus points of the course are:

1. Calibration of dosimetry systems

2. Dose measurements 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

4. Establishing maximum acceptable dose by investigation effect of dose on product.

  

   

  

Calorimeter

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.

 Risø B3 film

Different dosimetry systems are used during the course:
Calorimeters
Radiochromic film dosimeters
Alanine / EPR dosimeters

  

 

Methods for selecting or substantiating a sterilization dose for medical devices described in EN ISO 11137-2, 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)   Dose mapping

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)

Lecturers
Arne Miller, Risø High Dose Reference Laboratory
Mark Bailey, Risø High Dose Reference Laboratory
Eamon Hoxey, E.V. Hoxey, Ltd, UK
Frederik Steenstrup, Technological Institute, Denmark
Andy Makin, Scantox / CitoTex Lab, Denmark

Experience
All lecturers have several years of experience as experts in their fields and as teachers at these and other courses.
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 irradiation.

History
The Risø course has been repeated approximately 60 times since we started in 1993. A total of close to 500 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 DTU Nutech near Roskilde, Denmark, approximately 30 km west of Copenhagen. Directions

Cost
The cost for one participant is DKK 21.500. This includes:

  • course compendium 
  • refreshments and lunches 
  • one dinner (Thursday evening).

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-form

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 Nutech 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 Nutech 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 Nutech will not be responsible for discount airfare penalties or other costs incurred due to a course cancellation.

Accommodation
We have made a block reservation at Zleep Hotel Roskilde: 

http://www.zleephotels.com/hotel/roskilde

The price per night - breakfast excluded - is DKK 668.

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  Risø

Arne Miller
High Dose Reference Laboratory
DTU Nutech, Technical University of Denmark 
P.O.B. 49, Frederiksborgvej 399
DK 4000 Roskilde
Denmark

Phone: +45 4677 4224
Fax: +45 4677 4959
e-mail: armi@dtu.dk
www.dtu.dk/nutech-hdrl

 

 

 

http://www.nutech.dtu.dk/english/products-and-services/industrial-dosimetry/hdrl/hdrl_courses/electron_beam/course_information
17 DECEMBER 2018