Real-time monitoring of crystallization is shown to provide benefits leading to improved methods for process development, optimization and scale-up. This white paper reviews case studies examining many of these benefits for:
- Providing process knowledge that enables real improvements in yield, throughput and profitability of production scale crystallization
- Eliminating downstream bottlenecks by improving filtration/dryer performance
- Accelerating the characterization of critical operating parameters for increased productivity
- Enabling the design of more robust processes to assure batch-to-batch repeatability and consistent meeting of crystal specifications
- Identifying undesired events in real time to help ensure product quality
Scale-up of crystallization is notoriously complicated and companies are under pressure to develop scalable crystallization processes faster - at lower costs and with higher quality. Companies must control crystallization conditions to improve cycle times and optimize product quality. With the incorporation of Process Analytical Technology (PAT), real-time monitoring of crystallization can be achieved without pulling samples. In situ Process Analytical Technology (PAT) tools can track critical parameters such as the crystal size and shape, the crystal form, and even the level of supersaturation.