(385c) Crystallization Process and Product Development, Optimization, and Scale-up By Digital Twin and Knowledge Map

Crystallization process development, scale-up, and tech-transfer from lab to manufacturing is a challenging task and sensitive and expensive activity. The underlying physics and transport phenomena are scale depended and mixing and heat and mass transfer could have significant impact on the CQA (such as purity and form, PSD) of product, and performance of equipment, and also on downstream (such as filtration). The synchronized multiscale, multidomain, and multiphsyics simulations (based on first-principle analysis) can be utilized for rapid scale-up and equipment characterization, to avoid manufacturing scale trial and error DoE approach.

At this presentation, some scale-up issues for crystallization will be discussed with case studies. A detailed scale-up case study for an industrial cooling batch crystallization (from 0.1 to 1500 litter) will be demonstrated with workflow and stages of activities, validation data, challenges and befits of adopting a model-based process development approach.