(382b) The Role of Automatic Process Control In QbD

This seminar will discuss the role of automatic process control in Quality by Design, with a primary emphasis on the crystallization of pharmaceuticals. Successful industrial applications of automatic process control strategies will be reviewed, as well as alternative control strategies that have been proposed for providing different tradeoffs between model fidelity, sensor accuracies, and robust performance. Collectively, the strategies will include feedback controllers based on solution concentration measurement via ATR-FTIR spectroscopy as well as particle measurements based on in-process laser backscattering.