Compared to other industries, the production performance of pharmaceutical plants is relatively low according to Duennibier, Riehle and Tups. The introduction of analytical technologies and sensors has been considered over the past fifteen years to bring greater understanding and control to pharmaceutical processes. The introduction of such technologies was termed Process Analytical Technology by the Food and Drug Administration (FDA) in 2004. PAT is a system for designing, analysing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. Central to PAT is improving final product quality through knowledge of the fundamental scientific principles behind it, and continuous online control of a process. The hypothesis behind PAT is that the quality of the products can and should be incorporated by process design and not by postproduction quality testing.
In pharmaceutical processes particles and granules play a key role in process efficacy and final product quality. The pharmaceutical manufacturing platform of fluid bed granulation is widely used, whereby powders are fluidized and a binder solution or suspension is sprayed onto the fluidized particles, creating liquid bridges which form agglomerates from the powder. However, the adoption of PAT to monitor and control this process is difficult, due to its dynamic nature. These physical and chemical variables can have a significant effect on final product behaviour such as blend homogeneity, drug absorption rates, product robustness, etc and thus overall product quality. Addressing these problems delivers a drug product that meets quality, safety and efficacy requirements and therefore improves patient safety. A right first time approach to manufacturing will ensure the production of high quality medications and also reduce the cost of medicines for the worlds seven billion people.
Overall Objectives
The overall objective was to develop and commercialise the world’s first Self-Guided Fluidised Bed Granulation Solution. The SMART-GRAN solution incorporates a suite of PAT analysers for the in-process monitoring and closed loop control of the Critical Process Parameters coupled with soft-sensoring, for obtaining consistent product quality and safety. The ability of the system to confirm cleaning process success between batches will reduce equipment downtime, increase product throughput and lead to increased productivity. Through a cloud-based data management platform, the SMART-GRAN solution enables historical data to be available for interrogation. This enables intelligence-based manufacturing (IbM) concepts which focus on harnessing the complementary power of data, modelling, engineering and IT infrastructure by transforming data into knowledge and ultimately intelligence, to equip industry to move to proactive manufacturing strategies that deliver predictable manufacturing performance.
