The LYO SUMMIT 2013 took place from September 18th to September 20th, 2013 in Rottach-Egern in Upper Bavaria.
We are looking forward to welcoming Professor Mike Pikal from the School of Pharmacy of the University of Connecticut as one of the speakers and discussion session moderators. Use the opportunity for a face to face talk to enrich your knowledge about lyophilization.
- Understand the operation principle of the Temperature Remote Interrogation System TEMPRIS®, a wireless and battery-free temperature measurement solution; a PAT Tool, designed as modular system to accurately measure the Production Temperature (Tp) as the most important parameter in rational development of lyocycles by iQ-mobil sulutions.
- We will get an insight into the PAT-Techniques in Lyophilization and Scale-up.
- A case study will be presented on the planning / execution and qualification of a production lyo equipment including TEMPRIS® to obtain real time product temperature values (Engineering Company requested).
- NNE Pharmaplan`s expert Franz Bosshammer will address issues of automatic loading & unloading systems and the integration of TEMPRIS® sensors.
- Learn during a tour at Recipharm on September 18th, 2013 how they apply TEMPRIS® in a GMP Environment in Commercial Production.
- Nucleation and TEMPRIS®: on this subject IMA life, GILYOS® and Pfizer (requested) will give their learnings and experience.
- The application of PAT-Techniques into Lyocycle Design both from a GMP and a Regulatory view will be presented and discussed. A presentation will be given by a GMP Inspector and there will be a possibility to discuss these issues during Q&A sessions.
- Discuss with all presenters and iQ-mobil solutions staff how to use TEMPRIS® to change the paradigm of registered fixed freeze-drying processes to allow PAT/QbD justified flexible approaches.