The Chromatography Forum

of Delaware Valley

Delivering the Analytical Lab to the Manufacturing Floor: Online Chromatography for Advanced Process Understanding and Control

Acquiring analytical data in near real-time to monitor process performance has challenged analytical chemists to operate at the interfaces of chemical engineering, pharmaceutical and biopharmaceutical science. Processes utilizing connected unit operations, flow chemistry, process intensification, and continuous manufacturing demand higher resolution analytical data and have renewed interest in integrating higher-resolution instruments (HPLC, GC, LC-MS) to manufacturing processes. Several factors need to be considered when integrating higher resolution instruments to a process including flexibility, portability, and ease of data transfer to distributed control systems, process models, and data historians. The sampling interface to a process is also critical to ensure a representative sample is acquired and that the process is not disturbed during sampling. In this talk we will share our experiences coupling online HPLC to synthetic processes, highlighting case studies where online HPLC has provided improved process understanding and real-time decision making to ensure product quality and process control. Strategies for transferring and visualizing data to distributed control systems, process models, and data historians will also be presented.