PAT and the Crystallization Toolkit

By Des O’Grady, Mark Barrett, Eoin Casey, and Brian Glennon, School of Chemical and Bioprocess Engineering, Center for Synthesis and Chemical Biology, University College Dublin
PharmaManufacturing.com
Process Analytical Technology, CFD and microscopy can help ensure that crystallization scale-up is “right the first time.”

Crystallization is a key unit operation within the pharmaceutical industry, and over 80% of drug products involve at least one crystallization step. Yet, despite its obvious importance, crystallization is still a relatively poorly understood process. Typical problems associated with crystallization include unsuitable final particle size distribution, impurity issues (including incorrect polymorph) and poor or inconsistent yield. There are also stringent regulatory commitments to which all pharmaceutical companies must adhere to ensure that the crystallization process is robust and repeatable.
However, the crystallization step offers a unique opportunity to control the size, shape, purity and yield of the final crystal product. This can be greatly facilitated by measurement of important crystallization characteristics such as the crystal size and the liquid phase concentration over the course of a batch. Ideally, these measurements should be made in situ so as to avoid the inherent difficulties associated with sampling.

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