Introduction

• Reactive crystallization is one of the most critical operations in pharmaceutical manufacturing, where hydrodynamic conditions directly influence crystal size, morphology, and downstream filtration performance. Even when crystallization is completed successfully, excessive agitation can generate high shear forces that promote crystal breakage and the formation of fine particles, leading to poor filterability.
• Traditional process optimization often relies on changing agitator speed and addition time through repeated plant trials, However, without understanding the underlying hydrodynamic mechanisms—such as shear rate and particle collision energy—it is difficult to predict their impact on crystal growth, crystal breakage, and downstream filtration performance.

• This case study demonstrates how VisiMix was used to analyze shear rate and particle collision energy, identify the root cause of slow filtration, and establish an optimized scale-up strategy for a 6 kL commercial reactor, reducing filtration time from 7.5 hours to less than 2 hours.