Model Based Process Development and Operation of a Fluid Bed Granulation Unit to Manufacture Pharmaceutical Tablets

A hybrid model for the fluid bed granulation operation was built. The deterministic component focuses on the mass and energy balances representing the water ingress and egress from the powder bed. The empirical one does on granule growth. Estimability techniques were used to determine which parameters to regress from the available data. A partial least squares approach was used to better understand the impact of the model parameters onto key model responses and sensitivity plots were made to aid operational decisions and support pharmaceutical development.