The Use of Electron Beams and X-rays in Industrial Sterilization

IBA INDUSTRIAL
presents two one-day seminars on:
The Use of Electron Beams and X-rays
in Industrial Sterilization
November 3, 2009
Embassy Suites Raleigh-Durham Research Triangle
Raleigh-Durham, North Carolina
Lecturers:
Joern Meissner,
Meissner Consulting
Benoit Mullier,
IBA Industrial
Glenn Thibault,
BeamOne LLC
Steve Yeadon,
Kinetic Concepts Inc.

2
SEMINAR OUTLINE
This insightful one-day course has been developed for manufacturing and sterilization
professionals in the medical device industry, to learn and discuss about the use of electron
beams and X-rays for sterilization. The program includes technology selection factors,
comparative designs and operations, recent updates on materials and dose settings, regulatory
and safety considerations, industry evolution, and how leading device manufacturers are
successfully implementing electronic sterilization equipment.
PROGRAM OUTLINE
Tuesday, November 3, 2009
7:00-8:00 Breakfast & Registration
8:00-8:15 Introduction
8:15-9:30 Directions In Electronic Sterilization – Glenn Thibault
A brief history of the equipment and use of electrically generated radiation sources for
laboratory and industrial sterilization, leading to an analysis of current users and usage
of these technologies. Trends and future use of electron beams and X-rays, including:
combination drug-device products, in-line isolator systems and surface treatments,
impact of lower SAL’s, development cycles for new-age devices, pharmaceuticals and
cosmetics, computerized dose modeling, and in-house sterilization expertise.
9:30-10:45 Contrasting Electronic Sterilization Systems - Joern Meissner
Matching a sterilization system to company and site needs. This unbiased presentation
discusses the physical characteristics and treatment ranges of today’s systems,
providing key rules of thumb about matching products with equipment type; system
features and capabilities (industry wide); scaling considerations present and future;
turnaround times; throughputs; product conditioning and handling; system power
requirements; maintenance and reliability factors, and the economics of operation.
10:45-11:15 Coffee/Tea/Refreshment Break
LECTURERS
■ Joern Meissner, Meissner Consulting, Munich, Germany
■ Benoit Mullier, IBA Industrial, Louvain-la –Neuve, Belgium
■ Glenn Thibault, BeamOne LLC, Denver, USA
■ Steve Yeadon, Kinetic Concepts Inc., San Antonio, USA
11:15-12:30 Facility Design & Process Controls – Benoit Mullier
Practical matters associated with the design and build of an electron beam or X-ray sterilization
facility. This discussion of facility types covers in-line, end-of-line, in-house, and contract
operations; the elements and features of electronic sterilization facilities (from shipping bays to
beam labyrinths). Highlighting the presentation will be virtual tours of 3 distinct types of irradiation
facilities (item/partial devices, box/case, and full pallet sterilizers) and the comprehensive
approach used to establish each of them (design and planning, production flow, process control,
environmental and worker safety, etc.)
12:30-1:45 Lunch
1:45-3:00 Product Design for Electronic Sterilization – Steve Yeadon
This lecture examines sterilization strategies and considerations for new and existing devices,
with emphasis on materials, packaging, and dose setting. It includes comparisons of irradiation
effects on materials (E-beam, X-ray, and gamma), and biological factors (lethality rates, moisture,
temperature, etc.) as a function of dose rate and energy levels. Discussions will include the
validation protocols of new products and key steps and tests when converting between gamma,
X-rays and electron beams.
3:00-3:15 Coffee Break
3:15-4:30 Regulatory Aspects of Electronic Sterilization - Joern Meissner
This presentation discusses how ISO, FDA, and other regulatory bodies (NRC, etc.) view
electronic sterilization systems, and what unique concerns (if any) they may have. Topics to
include: national and international sterilization standards, local and regional licensing and
permitting, environmental acceptance, and worker safety. The talk will also discuss dosimetric
vs parametric product release, and working with higher voltage X-rays.
4:30-5:30 Panel Discussion - Questions & Answers
Use of Electron Beams and X-rays in Industrial Sterilization Use of Electron Beams and X-rays in Industrial Sterilization 3

November 3, 2009
Embassy Suites Raleigh-Durham Research Triangle
201 Harrison Oaks Blvd, Cary NC 27513
Tel: 1-919-677-1840
Registration Fee
Regular registration: $395.00
Two or more delegates from same
organization: $300.00
Student or Government employee: $150.00
Program fees include breakfast, lunch and coffee breaks.
Cancellation fee after September 15, 2009: $120.00
Venues Accomodations
Registration
Online: at www.iba-sterilization.com
and click on Seminar Registration Form.
Please contact the venue hotel directly to make
your room reservations. A limited number of
venue hotel rooms will be held at discounted
seminar rates (mention IBA Seminar).
Contact Us
Geri Toney - IBA Industrial
151 Heartland Blvd
Edgewood, NY 11717, USA
Tel: +1 631 254 6800 X 101
E-mail: geri.toney@iba-group.com
Christelle Lucchetti - IBA Industrial
3, Chemin du Cyclotron
Louvain-La-Neuve, 1348, Belgium
Tel: +32 10 47 58 92
E-mail: christelle.lucchetti@iba-group.com
By mail: Complete and return your signed registration form and cheque or credit card information to:
IBA Industrial - 151 Heartland Blvd - Edgewood, NY 11717 - USA - ATTN: Seminar
Please make cheque payable to IBA Industrial or provide us with your credit card information.
Name (last, first):
Title:
Company/Organization:
Amount: Card type:
Card number: Expiry date:
Name as it appears on the card: Security code:
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Registrants are responsible for their own hotel reservation. Registrations are transferable. Please notify us of any changes as soon as pos
In case of cancellation by the organizer, the registration fee for the seminar will be entirely reimbursed.
4 Use of Electron Beams and X-rays in Industrial Sterilization