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theses

The priority in pharmaceutical industry is the manufacturing of high quality drug products that meet predefined specifications mandated by regulator. With the advances in continuous manufacturing for solid drug products, there are technical challenges and regulatory requirements that must be investigated and solutions that must be satisfied. Powder feeding is a critical first step in the continuous direct compression of tablets. The ability to model feeding performance will allow for better process understanding and control of the initial unit operations in the line.
With continuous manufacturing strategy growing in use, there is also a need for all regulatory requirements to be met to maximize benefits of continuous manufacturing. One area that needs attention is material traceability for continuous manufacturing. For patient safety and regulatory compliance, the history of each drug product should be known and traceable. It requires the current guidelines to be applied to a continuous manufacturing line, through the application of residence time distribution (RTD) of each component in the formulation. This allows for raw material batch numbers to be traced to the outlet and documented appropriately for release. Continuous manufacturing in the pharmaceutical industry currently lacks the implementation framework and software to utilize material traceability in its novel solid dose continuous manufacturing processes. A systematic framework is necessary for material traceability to ensure that this methodology is implemented properly. Because material traceability is not able to be verified during production, there must be certainty that all considerations and factors that influence the accuracy and implementation are understood.
The goal of this work is two-fold. First, to develop a control relevant model for powder feeding of K-Tron feeder and implement and investigate the control system performance. Second, to develop and implement a systematic material traceability framework for the continuous pharmaceutical tablet manufacturing process. We were able to achieve an accurate model to explore and simulate realistic disturbances and evaluate feeder control performance in these scenarios. And with a focus on regulation, we successfully designed and deployed prototype software for material traceability in the continuous line.

ETD_9126

doi:10.7282/T37P930T

M.S.

Includes bibliographical references

by Matthew William Billups

ETD graduate

The author owns the copyright to this work.