01/12/2008Latest advances in the control of freeze-drying processes at the ISPE Conference on Applying a Science and Risk-based Approach.

Within the framework of the ISPE Conference on Applying a Science and Risk-based Approach, experts in freeze-drying will analyze the latest advances in technologies and procedures in this technique applied to the pharmaceutical industry. This debate will take place during the work sessions that, organized under the guidance of Miquel Galán, R&D Manager of Telstar and Seminar Leader of this worshop, will be held the 3^rd and 4^th of December, 2008, at the Juan Carlos I Hotel, in Barcelona.

During these sessions, representatives from different industries (suppliers and manufacturers) will present the latest novelties applied in freeze-drying processes.  Besides Telstar, representatives from AgroParisTech/inra (France), FDA (USA), Politecnico di Torino (Italy), Reig Jofré Group (Spain), BIOCORP (Francia), MP5 Laboratory (France), Sanofi Pasteur (France) and SPEC Conseils (France) will also be participating.

On the part of Telstar, Miquel Galán will be presenting the latest advances in monitoring and control of the freeze-drying process in the manufacturing environment based on the QbD (Quality by Design) model.  In the framework of the traditional quality control system based on QdT (Quality by Testing), Miquel Galán will approach the new proposal, developed in conjunction with the University of Torino, which allows for the incorporation of the quality control during the manufacturing process, ensuring this way, that the final product complies with the safety and quality requisites and contributes towards the efficiency and effectiveness of internal manufacturing processes.

Miquel Galán is the Innovation and R&D Manager of TELSTAR.  Expert in pharmaceutical engineering, vacuum technology and leak detection and director of process engineering, Miquel Galán has a degree in Chemical Engineering by the Chemical Institute of Sarrià (IQS) and a degree in Industrial Engineering by the Ramon Llull University. He is an active member of the ISPE (International Society of Pharmaceutical Engineering), PDA (Parenteral Drug Association), and the ISL-FD (International Society of Lyophilization - Freeze Drying), as well as of the ASME (American Society of Mechanical Engineers), PHSS (The Pharmaceutical and Healthcare Sciences Society), and the AAPS (American Association of Pharmaceutical Scientists).

To consult the session program:

Lyophilisation: Scientific Issues of the Process and Introduction to Risk-based Approach -  3/4 December 2008 - Barcelona, Spain.

http://www.ispe.org/cs/2008_barcelona_conference/lyophilisation_