Process analytical technology in continuous manufacturing of a commercial pharmaceutical product

Publication date: 1 March 2018 Source:International Journal of Pharmaceutics, Volume 538, Issues 1–2 Author(s): Jenny M. Vargas, Sarah Nielsen, Vanessa Cárdenas, Anthony Gonzalez, Efrain Y. Aymat, Elvin Almodovar, Gustavo Classe, Yleana Colón, Eric Sanchez, Rodolfo J. Romañach The implementation of process analytical technology and continuous manufacturing at an FDA approved commercial manufacturing site is described. In this direct compaction process the blends produced were monitored with a Near Infrared (NIR) spectroscopic calibration model developed with partial least squares (PLS) regression. The authors understand that this is the first study where the continuous manufacturing (CM) equipment was used as a gravimetric reference method for the calibration model. A principal component analysis (PCA) model was also developed to identify the powder blend, and determine whether it was similar to the calibration blends. An air diagnostic test was developed to assure that powder was present within the interface when the NIR spectra were obtained. The air diagnostic test as well the PCA and PLS calibration model were integrated into an industrial software platform that collects the real time NIR spectra and applies the calibration models. The PCA test successfully detected an equipment malfunction. Variographic analysis was also performed to estimate the sampling analytical errors that affect the results from the NIR spectroscopic method during commercial produc...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research