Pharmaceutical Freeze Drying - GEA Pharma Systems

2008 PDA
Pharmaceutical
Freeze Drying
Technology
23-24 September,
Brussels/Wavre, Belgium
Conference, Exhibition: 23-24 September
Training Course: 25 September
See the complete program at:
www.pda.org/europe
Register by
23 July 2008
and SAVE!

2008 PDA Pharmaceutical Freeze Drying Technology
Overview
Freeze drying is a standard process in the pharmaceutical industry to stabilize drug
products. An increasing number of molecules, particularly of biotech, are not stable
in liquid water, and the way to increase stability and shelf life is freeze-drying. It is very
important to develop a robust freeze-drying cycle and, be conscious of the challenges
of up-scaling to stabilize production. The conference focuses on the practical
aspects of freeze drying. The sessions and workshops will cover aspects of freeze
drying in development, production, and special challenges like freeze drying of potent
and temperature-sensitive drugs. A special session will deal with hydrogen peroxide
sterilisation of freeze dryers. There will be plenty of time for discussion and Q & A.
The conference will have an exhibition, followed by a one day training course.
Who Should Attend
Specialty Areas
API Development & Production | Pharmaceutical
Development | Pharmaceutical Production | Process
Engineering | Process Development | QC & QA
Departments
Development | Quality Assurance | Manufacturing |
Engineering
Job Function
Development | Quality | Manufacturing | Engineering
Planning Committee
Harald Stahl, PhD, Chair of Conference,
GEA Pharma Systems
Wolfgang Friess, Prof, PhD, University of Munich,
Department of Pharmacy
Georg Frinke, OPTIMA GROUP pharma GmbH
Yves Mayeresse, Glaxo Smith Kline
Edward Trappler, Lyophilization Technology, Inc.
Frederike Graeper, PDA Europe
Georg Roessling, PhD, PDA Europe
Venue
Leonardo Hotel Wavre
Rue de la Wastine 45
B-1301 Wavre
Tel: +32 (0) 10 – 41 13 63
Fax: +32 (0) 10 – 41 19 22
Email: info.wavre@leonardo-hotels.com
www.leonardo-hotels.com
Contacts
For conference information, please contact:
PDA Europe gGmbH
Adalbertstr. 9
16548 Glienicke/ Berlin, Germany
Tel: +49 (0) 33056- 23 77 10
Fax: +49 (0) 33056- 23 77 77
info-europe@pda.org
Training Course
25 September 2008, 08:00 - 17:00
Development of a Freeze Drying Process - From Formulation
to a Robust Process
For more information please see page 4.
Exhibition
Exhibition and Sponsorship Opportunities are
available. PDA meetings and conferences are a
great opportunity for your company to gain on-site
exposure in front of highly-qualified, upper-level
professionals in the pharmaceutical and biopharmaceutical
industry. Exhibit at PDA events and
let your company’s products or services become a
valuable tool or resource for our attendees.
For more information, please contact:
Katharina Keisers-Engstfeld
Event Manager, PDA Europe
Tel: +49 (0) 33056-237714
Email: keisers@pda.org
For more details: www.pda.org/europe

Program-at-a-Glance
Tuesday, 23 September 2008
Overview and Basics of Freeze Drying
Moderator: Harald Stahl
9:00 Welcome Remarks
Georg Roessling, PDA Europe
Harald Stahl, Niro Pharma Systems
09:15 Formulation of Lyophilized Protein Products
Cornelius Pompe, Ludwig-Maximilians Universitaet
Muenchen
10:00 Characteristics and Behavior of Mixed Solvent Sytsems
During Freezing and Freeze Drying
Edward Trappler, Lyophilization Technology, Inc
10:45 Exhibition and Coffee Break
11:15 Models for Freeze-Drying Process
Yves Mayeresse, GlaxoSmithKline
12:00 Controlling the Critical System Components
-Preventive Maintenance for Lyophilizers
Hans Hoermann, Boehringer Ingelheim
12:45 Fast Track Project Related to a Lyo Suite
Sergio Steffanoni, Patheon
13:30 Lunch
Parallel Workshops
Workshop 1: Development
14:30 Moderator: Georg Frinke
Nearby Infrared Read Process Analytical Technology
and the Freeze-Drying Process
Cor van Ingen, NVI Netherlands Vaccin Instituut
Parameters Characterization of a
Lyophilization Cycle
Enric Jó Cardoso, Reig Jofré Group
Workshop 2: Production
14:30 Moderator: Yves Mayeresse
New Generation Isolators for Freeze Dryed Products
With ATEX Compliance Approach
Franck Pavan, Pierre Fabre
LYOSEAL:
One Step Class A Freeze Drying and Capping
Philippe Legall, Biocorp Inc. USA
Rational Freeze-Drying Process Transfer
-From lab to Production Scale
Michael Siedler, Abbott
Workshop 3: Special Challenges: POTENT AND
OR TEMPERATURE SENSITIVE DRUGS
14:30 Moderator: Edward Trappler
Industrial Case Studies
Bernd Sennhenn, Abbott
16:00 Exhibition and Coffee Break
16:30 Results of Workshops
Workshop Hosts
17:30 End of Conference Day One
2008 PDA
Visual Inspection
Forum
14-15 October 2008
Berlin, Germany
Conference and Exhibition: 14-15 October
Training Courses: 16-17 October
See the complete program at:
www.pda.org/europe

Wednesday, 24 September 2008
Special Issues:
VHP to Sterile Freeze Dryers
Moderator: Edward Trappler
09:00 H 2
O 2
- Gas Plant Sterilization Under Vacuum Conditions
Ralph Groß, GEA Lyophil GmbH
09:45 Microbiological Validation of a H 2
O 2
Sterilisation Process
Berthold Düthorn, Bosch Crailsheim
10:30 Exhibition and Coffee Break
11:00 Regulatory Issues
Speaker invited
11:45 Case Study: Selection of Freeze Dryer With VHP
Sterilization for a Small Scale/Clinical Trials Facility
Tim Nicholls, Exmoor UK
Panel Discussion
with Representatives from GlaxoSmithKline
13:30 - Tech Transfer
- Best Practice
- Challenges “What can & What goes wrong”
Jean-Luc Lambert, Engineering
Laurent Jeanmart, Devices
Bob Darius, QA Global
Bertrand Gerard, Validation
Yves Mayeresse, Head of Freeze Drying
Industrialisation
16:30 Closing Remarks
16:45 End of Conference
12:30 Lunch
Training Course: Development of a Freeze Drying Process - From Formulation to a
Robust Process
Thursday, 25 September 2008, 09:00 - 17:00
Scope:
Hear about the essentials to develop an efficient
freeze-drying cycle. Learn the techniques to determine
the physical parameters which are needed to
measure glass transition temperature/critical ice temperature
of formulations. Analyse experimental data
and discuss the results. Use the results to outline the
parameters for a freeze-dry cycle.
Goal is to have a very practical course, look at real
data and derive from this. Participants should be
able at the end of the traning course to develop their
own freeze-dry cycle and know how to optimize
existing freeze-dry cycles.
09:00 - Welcome & Overview
- Short Theoretical Background
- Formulation/Saccharose/Mannitol Solution:
Determine Tg/Critical Ice Temperature,
Use Eutektik Monitor
- Analyze and Interpret Data
- Discussion of Results
- Q&A
12:00 Lunch Break
13:00 - Develop a Proposal for a Freeze-Drying cycle
Based on the Data Determined
- Perform the Freeze Drying (Handling steps, IPCs)
- Present and Discuss the Different IPC Methods
- Analyze the data of the Whole Freeze-Dry Cycle
- Discuss Data and Optimizing Potential
- Discuss GMP Compliance/Regulatory Issues:
Freeze Dryer, Processing, Capping
(Introduce New Techniques)
- Analyze the Freeze Dried Product: Appearance,
Water Content (KF), Headspace
- Discussion of the Results
- Q&A
17:00 Close of the Training Course

Registration
Form
2008 Pharmaceutical
Freeze Drying Technology
23-24 September 2008, Brussels/Wavre, Belgium
2 Ways to register FAX: +49 33056 23 77 77
MAIL: PDA Europe, Adalbertstr. 9, 16548 Glienicke/Berlin, Germany
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PDA Member 1095 1295 Training Course
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to a Robust Process
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requests must be in writing and faxed to PDA at +49 (33056) 23 77 77 (emails are not accepted). If your written request is received on or before 9 September 2008, you will receive a full
refund minus a € 150 handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration
fee at the on-site registration rate if your cancellation has not been received in writing on or before 26 August 2008. On-site registrants are not guaranteed to receive conference materials until all
advanced registered attendees receive them. Refund for Courses: If your written request is received by 4 September 2008, you will receive a full refund less a € 150 processing fee. After that time,
no refund or credit requests will be approved. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be
canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details,
contact PDA at info-europe@pda.org or fax to +49 (33056) 23 77 77.
Date
Mandatory Signature

PDA Europe Conference & Event Calendar
2008/2009
QbD – Practical Applications in Development and
Manufacturing of Pharmaceutical Products
Conference/Exhibition: 7 - 8 October – Frankfurt, Germany
Training Course: 6 October
Contact: info-europe@pda.org
2008 PDA Visual Inspection Forum
Conference/Exhibition: 14 - 15 October – Berlin, Germany
Training Courses: 16 - 17 October
Contact: info-europe@pda.org
Pharmaceutical Cold Chain Management
Conference/Exhibition: 4 - 5 November – Berlin, Germany
Training Courses: 6 - 7 November
Contact: info-europe@pda.org
PDA/ISPE Workshop with PIC/S
Workshop: 13 - 14 November – Geneva, Switzerland
Contact: info-europe@pda.org
Sterilisation Technologies in Development
and Manufacturing of Parenterals
Conference/Exhibition: 19 - 20 November 2008 – Milan, Italy
Training Course: 17 - 18 November
Contact: info-europe@pda.org
For latest info: www.pda.org/europe
Subject to change
2009 Preview of Conferences and Events
2009 PDA Inter-Chapter Conference on Endotoxin
Conference/Exhibition: 21 - 22 January – Paris, France
2009 PDA Inter-Chapter Conference on IMPs
Conference/Exhibition: 28 - 29 January – Rome, Italy
Training Course: 27 January
Microbiology: Implementation of RMM
Conference/Exhibition: 3 - 4 February – Berlin, Germany
Training Courses: 5 - 6 February
PDA Workshop on Mycoplasma
Workshop/Exhibition: 5 February – Berlin, Germany
April
2009 PDA Compendial Forum, Date and Location TBA
May
QbD ICH Q8 Date TBA – Frankfurt, Germany
June
2009 Biopharmaceutical, Date TBA – Munich, Germany
2009 Pharmaceutical Freeze Drying Technology
Conference/Exhibition: 29 - 30 September – Milan, Italy
Modern Aseptic Production
Conference/Exhibition: 1 - 2 October – Milan, Italy
October
2009 Pharmaceutical Cold Chain Management Date TBA – Berlin, Germany
Universe of Pre-filled Syringes Date and Location TBA
2008 PDA
Pharmaceutical
Cold Chain Management
4-5 November 2008
Berlin, Germany
Conference and Exhibition: 4-5 November
Training Courses: 6-7 November
See the complete program at:
www.pda.org/europe
Register by
4 September
2008
and SAVE!