Determining Critical Process Parameters and Process Robustness in Preparative Chromatography - A Model-Based Approach
This paper presents a model-based method to aid in the process validation for the purification of pharmaceutical drugs. The critical process parameters are identified by simulating process disturbances, and this information is then used to determine if the process control space is robust. Simulations are chosen to analyze the entire control space to also find nonlinearities and interaction effects