Smith, G. (2015) Process Analytical Technology and the Question of Scale. Podium presentation at 7th ISLFD International Conference; 2015 July 06-10; Barcelona, Spain
Outline of the presentation
1. Highlight from the CDER PAT guidance document (2004)
2. Brief overview of scale lengths in terms of pharmaceutical freeze-drying (from the molecular and the mesoscopic to the macroscopic)
3. Features and limitations of existing PAT
4. An overview of through-vial impedance spectroscopy (TVIS)
5. TVIS Applications & Challenges:
Ice formation
Phase behaviour (TEU and TG
Annealing & structural relaxation
Various scales (freeze-drier heterogeneity, ice front shape)