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

Monday, October 17, 2011: 2:35 PM
Conrad A (Hilton Minneapolis)
Mark T. Maloney1, David J. am Ende1, Steven J. Brenek1 and Brent Maranzano2, (1)Chemical R&D, Pfizer, Inc, Groton, CT, (2)Analytical R&D, Pfizer, Inc, Groton, CT

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.

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