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1. Process Control of Drug Product Continuous Manufacturing Operations - a Study in Operational Simplification and Continuous Improvement

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   Contributor(s):: Medendorp, Joseph, Shapally, Sreendhar, Vrieze, Derek, Tolton, Kelly

   Purpose The purpose of this manuscript is to demonstrate that implementation of gravimetric measurements provides the same assurance of product quality and process control as spectroscopic measurements (1) for control of drug content in a fixed-dose combination (FDC) tablet and (2) for...

2. Method for characterization of loss-in-weight feeder equipment

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   Contributor(s):: William E. Engisch, Fernando J. Muzzio 

   This paper presents a method for evaluating the steady state performance of loss-in-weight powder feeding equipment and then demonstrates the use of the method in evaluating the performance of a K-Tron KT35 loss-in-weight feeder for three pharmaceutical grade powders. The method describes in...