Powder Handling and Characterization for Design of Pharmaceutical Manufacturing Processes
Yifan Wang, Ph.D.
Wednesday October 12 2016 @ 1:30PM EST
While powder handling and processing is common in pharmaceutical manufacturing, multiple challenges, for example jamming of hoppers, sub-standard blending performance, weight variability of final products, and process scale-up failures, are encountered during production due to lack of fundamental understanding of powder behavior. Powder characterization techniques have a central role in both product and process development. By characterizing materials using a substantial number of flow property techniques, a material library has been established. Methodologies based on principal component analysis are provided to classify materials so that process performance of a new material can be predicted based on knowledge of exiting materials in the library. The material property knowledge is integrated with multivariate analysis and process analytical technology tools to enable predictive capabilities for process and product development. In a quality-by-design approach, information extracted from the material library has been used to develop data-driven models to predict process performance. A case study using material characterization methods and data analysis tools to predict powder flow in feeders will be discussed.