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

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
2010 AIChE Annual Meeting
AIChE Annual Meeting
November 9, 2010 - 7:00pm
Quality by Design (QbD) is a concept applied to gain true process understanding utilizing tools such as Design of Experiment (DoE), Risk Management, and Process Analytical Technology (PAT). Utilization of these principles and tools not only allow the chemist, engineer, or formulator to optimize a high value chemical or physical process, but also allows them to determine the robustness of a process. The study of the process robustness not only determines process failure conditions by testing the boundary conditions for operating parameters, but also determines acceptable ranges of operation without impacting the final product quality. Several industrial examples are presented that demonstrate the importance of the ability to precisely control reactions and processes on a lab scale (10mL-20L) while emulating plant conditions. Additionally, appropriate PAT tools are utilized to monitor continuously 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. For the industrial studies presented in this paper, real-time in-situ particle characterization tools, in-situ mid-infrared spectrometry, and reaction calorimetry have been utilized to deliver a deeper understanding of each process. This paper includes highlights of several actual 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 QbD Principles and PAT tools. Examples presented demonstrate application not only for high value chemical processes but also in unit operations such as crystallization, high shear wet milling, and granulation.
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