One presentation that will be given at the Quality by Design Session at the 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting will be: Optimizing and Controlling High Value Processes Using the Principles of Quality by Design (QbD) Advanced Tools Such as Real-Time In Situ Particle Characterization, In Situ Mid-Infrared Spectrometry and Reaction Calorimetry.
During this presentation, industrial examples will be discussed that demonstrate the importance of the ability to precisely control reactions and processes on a lab scale (10mL-20L) while emulating plant conditions. In addition, Process Analytical Technology (PAT) tools are used to continuously monitor how the process is performing under actual reaction conditions delivers critical insight regarding the process so that modifications may be made to deliver a robust, optimized process. This paper includes highlights of several industrial studies performed at the lab or pilot plant scale. The results of these studies, either scale-up or scale-down, were implemented into actual manufacturing environments and demonstrate the value derived from the appropriate use of Quality by Design (QbD) Principles and Process Analytical Technology (PAT) tools. Examples presented demonstrate application not only for high value chemical processes but also in unit operations such as crystallization, wet milling, and granulation.