(422c) Crystallization Process Understanding and Optimization Using FBRM and Raman As PAT Tools

The presentation features the application of process analytical technology (PAT) for understanding the crystallization process in process chemistry development and scale-up. PAT tools such as FBRM, PVM and Raman can be applied as efficient process-monitoring tools to provide real time profile and reliable information much faster than off-line testing. Two challenging case studies will be presented as examples; where PAT tools helped us understand crystallization mechanisms, such as seeding point, nucleation, crystal growth and polymorphic form. This understanding enabled us improve filtration time on scale up by controlling the particle size distribution (PSD) and also optimizing solvent selection for correct polymorphic form. Such information is important for designing science-based process control strategies.