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Optimization and scale-up of crystallization and precipitation to produce a product that consistently meets purity, yield, form and particle size specifications can be one of the biggest challenges of process development. The use of Process Analytical Technology (PAT) tools for real-time monitoring of the crystal distribution and population (using FBRM® and PVM®) and the supersaturation driving force (with ReactIR™) have simplified the understanding, optimization and control of crystallization. The integration of PAT tools with synthesis workstations ensures the precise monitoring and control of critical process variables and a more accurate determination of the acceptable and optimal design space for the crystallization step.
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