Lyophilization Conference 2002 Timetable

I. NEW LYOPHILIZATION SEMINAR PROGRAM

by DR. THOMAS A. JENNINGS

Attendance limited to 25 persons! - Fees $1995.00 (US Dollars)

The seminar has been revised and up-dated. It will be presented using Microsoft PowerPoint and each attendee to the seminar will receive complete set of the course notes, a copy of the book Lyophilization- Introduction and Basic Principles and their personal copy of the PowerPoint presentation on a CD-ROM disk.

          Seminar Objectives

           Learning Objectives

1st Day Program (October 19, 2002)

Time Event Responsible Person
 08:30-09:00  Registration + Coffee Mrs. Conny van Schendel
 09:00-10:15  Introduction, historical review and product formulation  Dr. T. A. Jennings
Professional Background
10:15-10:30   Morning refreshment break  
 10:30-12:00  Role of water, review of phase changes   Dr. T. A. Jennings
 12:00-13:30   Lunch break  
 13:30-15:00  Thermal analysis, differential thermal analysis (DTA)   Dr. T. A. Jennings
 15:00-15:15   Afternoon break   
 15:15-16:30  Electrothermal analysis   Dr. T. A. Jennings

2nd Day Program (October 20, 2002)

Time Event Responsible Person
 08:30-09:00  Review of previous sessions  Dr. T. A. Jennings
 09:00-10:15  Freezing process  Dr. T. A. Jennings
10:15-10:30   Morning refreshment break  
 10:30-12:00 Primary drying process   Dr. T. A. Jennings
 12:00-13:30   Lunch break  
 13:30-15:00  Secondary Drying   Dr. T. A. Jennings
 15:00-15:15   Afternoon break   
 15:15-16:30 Product Properties   Dr. T. A. Jennings

3rd Day Program (October 21, 2002)

Time Event Responsible Person
 08:30-09:00  Review of previous sessions  Dr. T. A. Jennings
 09:00-10:15 Principles of vacuum technology  Dr. T. A. Jennings
10:15-10:30   Morning refreshment break  
 10:30-12:00 Container-Closure system   Dr. T. A. Jennings
 12:00-13:30   Lunch break  
 13:30-15:00 Vacuum Freeze Dryer - Instrumentation   Dr. T. A. Jennings
 15:00-15:15   Afternoon break   
 15:15-16:30 Final Review   Dr. T. A. Jennings

Who should attend

For those just entering the field of lyophilization it will provide a broad overview of the entire process and the interrelationship between the formulation, the lyophilization and the drying equipment and instrumentation. For individuals with more experience in the field of lyophilization it will broaden their depth of understanding and grasp of this very complex and often puzzling field of science. The seminar is particularly directed at those individuals responsible for developing lyophilized formulations, QA and QC personnel responsible for the lyophilized products, production personnel and members of the managerial staff.

II. HALF DAY WORKSHOPS (21/10/02)

Each workshop is limited to 25 persons

Workshop A (Abstract): Lyophilizers Commissioning & Validation -Telstar- $450.00 (US Dollars) Room A

Time Event Responsible Person(s)
08:00-08:30 Registration + Coffee Mrs. Conny van Schendel
08:30-10:30 Part 1:Qualification and validation of a freeze dryer Miquel Galan (Background)
Jordi Puig
10:30-10:45 Morning refreshment break  
10:45-12:00 Part 2: Interactive session same topic as above Miquel Galan, Jordi Puig

Workshop B (Abstract): Minilyophilizer Reports, Graphic Display  $450.00 (US Dollars)   Cancelled

Time Event Responsible Person(s)
13:00-13:30 Registration Mrs. Conny van Schendel
13:30-15:30 Part 1: Lab-scale freeze drying demo: presentation of equipment, setting recipe parameters, demo cycle, monitoring and analysis of data. Arnaud Serfass (Background)Christophe de Saint LEGER (Background), Olivier Gechter (USIFROID)
15:30-15:45 Coffee break  
15:45-17:00 Part 2: Lab-scale freeze drying demo: presentation of equipment, setting recipe parameters, demo cycle, monitoring and analysis of data. A. Serfass, Christophe de Saint LEGER, Olivier Gechter (USIFROID)

Workshop C (Abstract) : Lyophilizers Sterilization- VHP, Freeze Dryer - Thermodynamic Control  $450.00 (US Dollars)  Room B  -  Cancelled

Time Event Responsible Person(s)
 08:00-08:30  Registration + Coffee Mrs. Conny van Schendel
 08:30-10:30 Part 1: VHP - Alternative way to steam sterilization of a freeze dryer Peter Haseley (Background)
10:30-10:45   Morning refreshment break  
10:45-12:00 Part 2: Thermodynamic control of a freeze drying process Peter Haseley

Workshop D (Abstract): Freeze Dryer Maintenance -  $450.00 (US Dollars)  Room B

Time Event Responsible Person(s)
13:00-13:30 Registration Mrs. Conny van Schendel
13:30-15:30 Part 1: Freeze Dryer - Maintenance Lawrence Ulfik (Virtis)(Background)
15:30-15:45 Coffee break
15:45-17:00 Part 2 - Freeze Dryer - Maintenance L. Ulfik

INTERNATIONAL LYOPHILIZATION CONFERENCE - $1495.00 (US Dollars)

1st Day Of The Conference (October 22, 2002)

Time Events and Presentations Session Chairperson
08:00-09:00 Registration + Coffee+ Tabletops and Exhibits Mrs. Conny van Schendel
09:00-09:15 Opening ISL-FD Conference
Goals of the conference
Yossi Shapira
Dr. A. Tambunan
09:15-10:00 Key Note Address - Some leading edge prospects in Freeze Drying by Prof. L. Rey - (Abstract) Dr. T. A. Jennings
10:00-10:30 Coffee break & Tabletops and Exhibits
10:30-11:15 Prof. Y. Sagara Advances in Transport Phenomena During Freeze-Drying of Food Materials: Fundamentals and Applications. - (Abstract) Dr. A. Tambunan
11:15-11:45 M. Hernist - Restoration Of Flooded Documents: Past And Future Of The Activity At Liege, Belgium - (Abstract) Yossi Shapira
11:45-12:15 P. D. Sayaboc Effects of Freeze Dried Bacterial Cells and Bacterial Suspension on Lesser Grain Borer, Rhizopertha dominica (F) (Coleoptera: ostrychidae). (Abstract) Yossi Shapira
12:15-13:30 Lunch Break.
13:30-14:15  P. Haseley & Dr. G. W. Oetjen - Freeze Drying Pilot Plant : Minimum Amount Of Product, Reproducible Cycles, Documented Data For Transfer To a Production Unit. (Abstract) Yossi Shapira
14:15-14:45 I. Bakaltcheva - Lyophilization of Blood Cells. (Abstract) Yossi Shapira
14:45-15:15 Coffee break + Tabletops + Exhibits
15:15-16:00 A. Serfass and C.S. Leger - Automatic Loading System In View To Dangerous Materials (Abstract) Yossi Shapira
16:00-16:30 ISL-FD Annual Meeting Dr. T. A. Jennings
16:30-17:30 Lyophilizer Demonstration - Usifroid
19:00 - 21:00 ISL-FD Reception (Music and Refreshments)*** ISL-FD BoD

***Dress Code: Suites for Gentlemen and Cocktail Dresses for Ladies - or Appropriate Country Attire

2nd Day of the Conference (October 23, 2002)
A visit to BOC Edwards

Time Events and Presentations Session Chairperson
07:30-08:00 Boarding on the busses Mrs. Conny van Schendel
08:00-10:00 Travelling to Dongen- BOC
10:00-10:30 Registration
10:00-10:30 Welcome and Introduction to Edwards BOC
10:45-12:30 BOC Edwards - Technology Overview BOC Dr. Paul Stewar
12:30-13:30 Lunch Break.
13:30-15:15 Factory Tour: Demonstration on Several Freeze Dryer and Loading Systems BOC
15:15-15:30 Discussion & Questions
15:30-16:00 Refreshments & Socializing
16:00-18:00 Bus Trip Back To The Hotel

3rd Day of the Conference (October 24, 2002)

Time Events and Presentations Session Chairperson
08:00-08:30 Coffee+ Tabletops and Exhibits
08:30-09:15 A. Serfass and C.S. Leger - Compliance of FD control systems to CFR 21 part 11 (Abstract) Yossi Shapira
09:15-10:00 Dr. J. May - Residual Moisture In Freeze Dried Vaccines And Biological Products: Specifications and Measurement. (Abstract) Yossi Shapira
10:00-10:30 Coffee break & Tabletops and Exhibits
10:30-11:00 A.M.I.B. Ayrosa, B.L. Faintuch, R.N.M. Pitombo Critical Steps In Freeze-Drying Process Of Radiopharmaceutical Kits Labeled With Tc-99m. (Abstract) Yossi Shapira
11:30-12:00 H. Willemer - Comparisons Between Measurements of Electrical Resistance and Cryomicroscope Visualizations of Pharmaceutical Products to be Freeze-Dried (Abstract) Yossi Shapira
12:00-12:30 M. Galan (Background) - Specifying GMP Lyophilizer (Abstract) Yossi Shapira
12:30 -13:30 Lunch Break.
13:30-14:15 M. Janssen - The Art of floral Freeze Drying (Abstract) Yossi Shapira
14:15-14:45 Jos Corver - Thermosyphoning, Temperature Driven Airflow With Cold Shelf Loading (Abstract) Yossi Shapira
14:45-15:15 Coffee break + Tabletops + Exhibits
15:15-16:00 O. Caparino - Characteristics And Quality Of Freeze-Dried Mango Powder Pre-Frozen At Different Temperatures. (Abstract) Yossi Shapira
16:00-16:30 Dr. A. Tambunan - Heating Characteristics During Freeze-Drying Process Of “Jamu” Ingredients. (Abstract) Yossi Shapira
16:30 - 18:00 Tabletops + Exhibits
20:00 - 22:00 ISL-FD Banquet (Awards and Entertainment)* Yossi Shapira
Dr. A.Tambunan

***Dress Code: Suites for Gentlemen and Cocktail Dresses for Ladies - or Appropriate Country Attire

4th Day of the Conference (October 25, 2002)

Time Events and Presentations Session Chairperson
08:00-08:30   Coffee+ Tabletops and Exhibits
08:30-09:15 T. Fischer - The System Qualification Procedure (SQP) for Lyophilizers at Aventis Behring Gmbh (Abstract) Yossi Shapira
09:15-10:00 J.M. Pardo, Padar S., Suess F., Niranjan K. à Modelling The Relationship Between Freezing Kinetics and Sublimation Kinetics of Coffee Brews. (Abstract) Yossi Shapira
10:00-10:30 Coffee break & Tabletops and Exhibits
10:30-11:00 Lu Xiaozhou, Fei Liu, and Dr. Z. Luo - Lyophilization of Technetium-99. (Abstract) Yossi Shapira
11:30-12:00 P. Matejtschuk, M. Andersen, P Phillips - Investigations Into Anomalies Arising During The Freeze Drying Of Biologicals In Ampoules. (Abstract) Yossi Shapira
12:00-12:30 Closing of Conference Dr. A.Tambuna
Yossi Shapira
12:30 -13:30 Light Snack Bar & Rooms Check Out.

All technical papers presented at the Conferences will appear in an issue of the American Pharmaceutical Review or on its web site at www.americanpharmaceuticalreview.com. The American Pharmaceutical Review will serve as the Official Publication for the Society

Radisson Hotel    The seminar, workshops and conference will be held at the Radisson SAS Hotel Amsterdam Airport. Click on the picture for    more information about the hotel and making hotel reservations.

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