Development of Continuous Manufacturing of Pharmaceuticals and Its Monitoring and Control

A novel continuous manufacturing system of pharmaceuticals with its monitoring and control systems was developed. The system consists of several unit operations such as mixing, twin screw granulation and spiral drying system. Performance of each unit operations as a function of each operating parameters was investigated experimentally. Also, a DEM (discrete element method) computer simulation was used to analyze the mechanism of twin screw granulation and a CFD (computational fluid dynamics) was used to analyze the mechanism of spiral drying system. Moisture content of granules in the twin screw granulation and the spiral drying was continuously measured and uniformity of API (Active Pharmaceutical Ingredient) content was also continuously monitored with a developed NIR (Near Infrared) sensor. Performance of the automatic manufacturing with feedback control systems of each unit operations was also investigated.