Filtration and Drying Operations: Experimental and Modeling Techniques to Preserve Particle Properties Upon Scale-up to Agitated Filter Driers (AFD’s).

Agitated Filter Driers (AFD’s) are commonly used in pharmaceutical manufacturing for performing both filtration and drying operations. Common challenges for scale-up include balling and agglomeration, avoiding grinding or attrition of particles during agitation, preserving the desired crystalline form such as a hydrate, as well as managing the drying time. Preserving particle attributes of the API is required for a robust process and to ensure batch-to-batch quality of the product is consistently met. Laboratory tools and techniques are employed to characterize propensity for agglomeration and attrition. Modeling tools are employed to understand drying times and to develop optimal process conditions including design of an effective stirring protocol. The focus of this presentation will be to describe our laboratory predictive tools, process modeling, and scale-up.