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This Lyophilization Workshop will be give prior to the Delaware Valley Local Chapter meeting of the International Society of Lyophilization - Freeze Drying, Inc. (Society). The Society and Phase Techologies, Inc. (Phase) have entered into an Dontation Agreement whereby, Phase will donate $2000.00 to the Society upond completion of the workshop. By attanding this workshop you will also be supporting the Society. The workshop will be held at the following location:
Holiday Inn
100 Independence Way
Princeton, New Jersey 08540
Telephone 609-520-1200The interactive workshop is different than a seminar or lectures on a subject in that there is active attendee participation. The workshop leader will provide some background information and define the topic under consideration. It is then the attendees express their views; ask questions or give examples with respect to the topic at hand. Sometimes the topic will come up again even during a coffee break or lunch. Each attendee will also receive a personal copy of the PowerPoint presentation on a CD-ROM disk. Deadline for Seminar registration is September 1, 2007
| Time | Workshop Schedule |
| 08:30-09:00 | Registration + Coffee |
| 09:00-10:15 | General Topic: Why is this process still
being treated as an art instead of science and what is needed to make the
change? Historical Background - Where did the art concept come from? Formulation - What role does the formulation play in the lyophilization process? What impact does the have on manufacturing and equipment costs? How can we develop better formulations in the future? |
| 10:15-10:30 | Morning refreshment break |
| 10:30-12:00 | Formulation (continued) - What are the key thermal properties of the formulation? What are the affects of these thermal properties lyophilization process? How do we measure such thermal properties today? What are the challenges are there to applying PAT to determining the thermal properties? |
| 12:00-13:30 | Lunch break |
| 13:30-15:00 | Development of a Lyophilization Process - How do you select the initial shelf temperature? How to determine the proper rate of freezing? What chamber pressure and temperature do I use to determine the primary drying process? How can I tell the primary drying is complete? |
| 15:00-15:15 | Afternoon break |
| 15:15-16:30 | Properties of the Final Product. What can I learn from an examination of the cosmetic properties of the cake? Methods for determining the residual moisture in the cake. What should I look when reconstituting the cake? Problems associated with stability testing. |
| Time | Workshop Schedule |
| 08:30-09:00 | Review of previous sessions |
| 09:00-10:15 | General Topic: The impact that instrumentation
and freeze dryer hardware can play in the lyophilization process Vacuum Technology Issues involved in the selection and using pressure gauges. Basic concepts of vacuum technology |
| 10:15-10:30 | Morning refreshment break |
| 10:30-12:00 | Key issues regarding freeze dryers; materials, design, SIP, CIP and data collection. |
| 12:00-13:30 | Lunch break |
| 13:30-15:00 | General Topic: PAT and it impact and
application on lyophilization today and tomorrow. What is PAT and how did it come about. What impact will in have on the pharmaceutical industry? How will it impact our QC procedures such as QC of incoming materials, formulation, filling and loading operation, impact on the lyophilization process and freeze drying equipment. |
| 15:00-15:15 | Afternoon break |
| 15:15-16:30 | The
effect of PAT on the IQ and OQ of freeze dryers Current efforts to implement PAT Fill-Volume using NMR Tune laser for detection of oxygen and water vapor in the headspace Surface contact area Moisture in Closures |
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.
Workshop Fees
The fees for this workshop will include all coffee breaks, and lunches. Each attendee will also receive a personal copy of the PowerPoint presentation on a CD-ROM disk. The fees for this workshop will be $995.00 US Dollars. To register for this workshop by Credit Card please go to Workshop Registration..
You can also register by Company Check (US residence only). Make the check payable to Phase Technologies, Inc. and mail it on or before September 1, 2008 to the following address:
Phase Technologies, Inc.
112 A Bala Ave.
Bala Cynwyd, PA 19004
Pre-Registration Form
You can reserve a place at the workshop by completion the following form. Your reservation will only be held until August 14, 2008 by which time you must complete your registration at Workshop Registration.