Monitoring and Controlling in Continuous Manufacturing Process

There is a strong interest in process control in pharmaceutical continuous production processes. The quality of the active pharmaceutical ingredient (API) content, API mixing uniformity, moisture content, particle coating content, coating performance, etc. in the pharmaceutical product is monitored in real-time for each process such as grinding, mixing, granulation, drying, granulation, tableting, and coating. Appropriate operations are required in each process according to the results. Near Infrared Spectroscopy (NIRS), which enables non-destructive, real-time estimation of API content, is attracting attention as a technology for monitoring quality in real-time. Timely measurement and monitoring of critical quality and performance characteristics of raw materials, intermediate products, and intermediates in each process for appropriate control is called Process Analytical Technology (PAT), which is rapidly being globally used. This chapter provides an overview of this approach.