(657b) Integrating Sensors for Monitoring Blend Content in a Pharmaceutical Continuous Manufacturing Plant

Panikar, S., Rutgers, the State University of New Jersey
Callegari, G., Rutgers University
Gilliam, S., Kaiser Optical Systems, Inc.
J. Muzzio, F., Rutgers, The State University of New Jersey
Lee, S., U.S. Food and Drug Administration
Li, J., Rutgers University
Rane, V., Rutgers University
In a pharmaceutical manufacturing process, Critical Quality Attributes (CQAs), as defined by the FDA, need to be monitored not only for the final product but also for intermediates. Blend uniformity of powders is one such attribute that needs to be measured to ensure the quality of the final product. In-line sensors, to monitor the blend content of the powders, were implemented within a Direct Compaction (DC) continuous tablet manufacturing line. In most cases, since the primary ingredient of interest is the active pharmaceutical ingredient (API), the amount of the API was monitored/predicted over the course of manufacturing. For the calibration model building process, a unique setup involving dynamic powder spectral acquisition method was used. This setup was aimed at mimicking the powder flow characteristics within the manufacturing line. A Raman probe and a portable NIR were used as sensors and they were placed at the exit of the blending process before the tableting stage. The performance of the two sensors and their respective models were evaluated in terms of accuracy, precision, operating range, measurement frequency, placement, reliability, robustness. Additionally, their performances were validated by off-line traditional analytical measurements.