Embedded NIR Spectroscopy for Rotary Tablet Press

The Near Infrared Spectroscopy (NIRS) was employed for control and monitoring of the tableting process during a continuous manufacturing process. The tableting production is key step in the production of solid dosage forms. Two spectrometers were embedded in the press and controlled by the press automation without any additional computer in order to have a fast and robust measurement. 72 batches were produced to calibrate and to validate the NIRS models at the BU and the CU position. A precise calibration (API content in %) have been obtained and a full speed acquisition was possible. The embedded spectroscopy for the control and the monitoring of the tableting process was demonstrated. The proposed strategy is an adequate Process Analytical Technology tool for continuous manufacturing and will enable opportunities for Real Time Release.