Integration is a challenging task and requires an interdisciplinary approach. In our laboratory, we developed a fully continuous manufacturing line by integrating blending, twin-screw granulation, fluidized bed drying and milling. The truly continuous operation of the devices makes this system suitable for robust and stable continuous granule production. By connecting to tableting, the most preferred final dosage form with consistent quality can be produced from the starting powder materials to final formulation in one complete system. For this purpose, a holistic approach is required towards process development, including real-time and in-line monitoring of material properties, process scale-up, residence time distribution modeling, process modeling and simulations for accurate prediction and control.
