(568c) Applying CFD Towards Defining Crystallisation Scale up Strategy

Efficient scale up of a crystallisation is an objective that presents significant challenges for pharmaceutical industry. It is critical that particle characteristics remain robust throughout scale up from laboratory to plant.

Within this presentation, an examination of the use of novel technologies such as Computational Fluid Dynamics (CFD) in aiding the design of an experimental scale up strategy will be outlined. The standard approach within industry uses established engineering calculations in conjunction with experimental data obtained during lab scale experiments to determine scale up effects. This presentation will assess this strategy for a model API system across different scales and describe use of CFD as a complimentary tool. The use of CFD will be discussed in terms of the qualitative and quantitative aspects to the model outputs, such as directional velocities, torque and shear values, as well as its ability to predict or explain any impact to crystallisation output. The role of CFD in the design of investigative scale up experiments will be highlighted as well as the potential CFD offers to test vessel configurations before being implemented on plant.