Control and safety of production processes in pharmaceutical
Code 090II
Credits 6
Learning outcomes
The course’s programme is designed to provide students with knowledge and understanding of the main unit operations required for active pharmaceutical ingredient (API) and drug product manufacturing, focusing for each unit on the main operating parameters to be controlled to ensure the product quality and process safety. The unit operations include API synthesis in batch or continuous reactors, isolation and crystallization, filtration and drying. Introduces students to measuring instruments to monitor and control the main process parameters (temperature, pressure, flow, level, concentration) and to pressure relieving systems (safety valves, rupture discs and blow-down line). The course covers the basics of reactor scale-up (from kilo-lab to industrial scale) and the scale influence on transport phenomena, including mass, heat, and momentum transfer. The course provides also an overview of utilities in the pharmaceutical industry including electrical systems, potable water, utility steam, compressed air and gas, fuel oil/natural gas systems, process gases (e.g., nitrogen, hydrogen), pure steam and process water (pure, ultrapure and for injection), temperature control fluids.