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Control over crystallization plays a very important part in the process development of Active Pharmaceutical Ingredients (APIs). The use of Process Analytical Technology (PAT) tools such as Focused Beam Reflectance Measurement (FBRM) and Particle Vision and Measurement (PVM) allows an in-line analysis of on-going crystallizations and evaluate in real-time the crystals size and morphology. These latter properties are fundamental to achieve a good filtration, ensuring displacement of solvents and impurities, for shorter drying times and for formulation (grinding, milling, etc).

The principles of these two technologies will be summarized and case study examples will be presented showcasing the application of FBRM and PVM probes in the development of crystallization processes at Hovione. The use of these technologies has become a standard of best practices in our process development and inserted in our workflow of Excellent Development and Manufacturing (EDaM).

Key Learning Objectives:

• Principles and Applications of FBRM and PVM
• Crystallization development using FBRM Lasentec
• Optimization of a seeding procedure
• FBRM and PVM analysis in parallel

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