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(586u) Design of An Interface for Integrating PAT Tools in Continuous Manufacturing for in-Line Real Time Sensing

Sahay, A., Rutgers University
Jayjock, E., Rutgers University
Sanchez, E., Janssen Pharmaseuticals
Muzzio, F. J., Rutgers, the State University of New Jersey
Romañach, R. J., University of Puerto Rico at Mayaguez

Currently, pharmaceutical manufacturing is a batch driven process with unit operations such as granulation, milling, coating etc. This approach has a number of disadvantages such as big footprint of equipment, higher costs and lower product quality. There is a push within the industry to adopt continuous manufacturing with inline testing and control. Such systems will have much smaller equipment requirements such that the whole line could be built in one space. They will be modular so as to be able to incorporate different processes, such as wet/dry granulation with relative ease. Also, the incorporation of inline testing will lead to better product quality and reduced wastage.

Under the PAT(Process Analytical Technology) framework proposed by the FDA there is a strong push to developing sensing techniques to make the manufacturing process more robust and incorporate Quality by Design. A majority of the commercially available analytical instruments are bench top in nature and need to be adapted for real time sensing. One of the challenges lies in building the methodology for real time sensing and sampling Here we describe the design and selection  of a chute for attachment of NIR instruments to a continuous manufacturing line. This setup can be used for in line detection of blend uniformity. Furthermore it can be used as a control variable for closed loop control and process optimization.