부산대학교 도서관

A near-infrared (NIR) calibration is developed using an efficient offline approach to enable a quantitative partial least-squares (PLS) chemometric model to measure and monitor the concentration of active pharmaceutical ingredients (API) in powder blends in the feed frame (FF) of a tablet press.The design of experiment (DOE) for the calibration is established by an initial risk assessment and included anticipated variability from factors related to formulation, process, environment, and instrumentation.The real-time monitoring enabled by the offline calibration approach can be useful as a key component of the control strategy for continuous manufacturing processes for drug products.