Abstract
Especially for the production of active pharmaceutical ingredients, the use of process analytical technology (PAT) is highly encouraged by the U.S. Food and Drug Administration. In crystallization and granulation processes, in situ particle characterization is the most important PAT. The technique of Focused Beam Reflectance Measurement (FBRM) is very well-suited for in situ particle characterization. A large community of users successfully applies FBRM technology for monitoring, fault detection, and quality control of dynamic processes. However, FBRM measurements are not easy to interpret, because the measured chord-length distribution (CLD) is different from any type of particle size distribution (PSD). For monitoring purposes, moments of the PSD are usually correlated empirically to moments of the CLD. Alternatively, process phenomena such as secondary nucleation and particle growth can be attributed to the time evolution of the number of chords detected in a length interval. To the authors’ knowledge,...
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