Enhancing the capabilities of fluid bed granulation through process automation and digitalisation

Developers, Data Scientists and Data Engineers (Dukart, et al., 2020). Drug manufacturing processes This paper describes a PAT-enabled, digitalised, and automated fluid bed granulation system. A multichannel Near-Infrared (NIR) spectrophotometer and a direct imaging particle size and shape analyser in constant dialogue with the SmartX no-code/low-code platform provide a ground-breaking process automation toolset now located at the Bernal Institute in the University of Limerick. Two sets of results are presented for this study, from two iterations of the Advance Dynamic Process Control (ADPC) controller application. The results demonstrate the direct measurement and control of the product’s critical quality attributes through digitality enabled feedback control of processing setpoints and parameters. The platform controlled the particle size more tightly compared to non-automated control and a more accurate measurement-driven process endpoint for moisture content was achieved. Implementing a digitally enabled control approach can significantly reduce batch to batch variation and greatly improve process performance and product consistency.