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(95am) Systems Integration for Dry Granulation Based Continuous Pharmaceutical Tableting

Ganesh, S., Purdue University
Moreno, M., Purdue University
Bommireddy, Y., Purdue University
Su, Q., Purdue University
Gonzalez, M., Purdue University
Nagy, Z. K., Purdue University
Reklaitis, G., Purdue University
Over the past decade, the pharmaceutical industry has seen significant progress in the mechanistic understanding of relevant unit operations, availability of multiple sensor technologies for inline monitoring of critical quality attributes and advances in data analytics to support manufacturing decision-making. These have enabled a systematic realization of continuous manufacturing for pharmaceutical tablets using the direct compaction route. However, the limitations and difficulty in handling of some particulate materials provide the impetus for investigating granulation routes to the continuous manufacturing of tablets.

In this work, the integration of dry granulation into a continuous tableting line is investigated. Specifically, the Process Analytical Technology (PAT) tools required for inline and at-line monitoring of the tableting line, and the semi-mechanistic models for the roller compactor and the tablet press are discussed. While the Kawakita model is used for the tablet press, the roller compaction process model is consisting of an integration of material balance and actuator dynamics from Hsu et. al (2010) with the modified Johanson’s model presented by Liu & Wassgren (2016). The PAT tools, mechanistic equations, and automation system are integrated for measurement validation and data accuracy using data reconciliation in a structured ISA-95 network using DeltaV. The experimental data is presented from the operation of the continuous dry granulation line-based pilot plant at Purdue University.