Morning Conference Session - October 27, 2005

Session: Process Analytical Technology (PAT)

Session Chairperson: Ivette Novoa, M. Sc.

9:00 - 9:25 - PAT (Process Analytical Technology) Guidance. Impact on lyophilization processes.
Miguel Galán/Telstar Industrial-Spain
9:35 - 9:40 Discussion

9:40 - 10:15 - Assessment of Risk Factors of the Container-Closure system for PAT Guidelines
Thomas A. Jennings, Ph. D/Phase Technologies, Inc.-USA
10:15 - 10:30 Discussion

10:30 - 10:45               Morning Coffee break

Session: Materials and Equipments

Session Chairperson: Miguel Galán

10:45 - 11:20 - High Precision, Automatic Head Space Gas Analysis Machines.
Jean-Philippe Descloux, Dipl. Ing./WILCO AG-Switzerland
11:20 - 11:25 Discussion

11:25 - 11:55 Stopper Considerations for Lyophilized Drugs
Thaís Perotti/West Pharmaceutical Services-Brazil
11:55 - 12:00 Discussion

12:00 - 12:30 Freeze Dryers and Automatic Loading System
Ernesto Renzi/Edwards, BOC-USA
12:30 - 12:35 Discussion

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