(120f) Development of Laboratory Methods (“Predictive Tools”) to Preserve Particle Properties of APIs Upon Scale-up to Agitated Filter Driers


Agitated Filter Driers (AFD’s) are commonly used in the pharmaceutical manufacturing for performing both filtration and drying operations.  Successful scale-up from lab to manufacturing AFD equipment requires that the physical properties be met. These properties include product quality such as purity and particle size.  Depending on the API-solvent system and other operational parameters, undesired attrition or agglomeration may occur impacting the desired particle properties.  Of importance is increased understanding and better prediction of scale-up performance.  The focus of this presentation will be to discuss recent advances in laboratory methods and predictive tools to help us better assess the risk of scale-up for agglomeration and attrition potential upon scale-up. In addition progress on enhancing cycle times for difficult to dry materials will also be presented.