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Systematic Framework for Implementation of Material Traceability into Continuous Pharmaceutical Tablet Manufacturing Process

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Abstract

Purpose

With the applications of more advanced manufacturing technologies being applied to the pharmaceutical industry, continuous processes are at the forefront of innovation. One area that is highly desired to be systematically investigated is material traceability in continuous manufacturing systems. By following federal guidelines already in place, the goal was to address the issue of material traceability in a continuous direct compression tablet manufacturing process.

Methods

The residence time distribution (RTD) method has been used for material traceability in continuous pharmaceutical tablet manufacturing process. Utilizing the minimum and maximum residence times for the continuous line pre-production, raw material batch changes that occur during feeder refill can be traced at the outlet of the process. MATLAB programing was used to develop software prototype to trace material components.

Results

Developed framework for implementation of material traceability into continuous manufacturing pilot-plant. To demonstrate the application of this framework, a software prototype was developed, which allows the operator to input residence time attributes for each component in the formulation. Using the minimum and maximum residence time values for that component, the lot number is incremented when the change in material batch is predicted to be present in the tablets at the outlet. The tablet lot number is recorded by the control system in real-time.

Conclusions

Developed framework and corresponding software allows the material traceability to be fully accounted for during a continuous drug product manufacturing process. A proof of concept was created to demonstrate feasibility of such a system, which has a wide range of applications.

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Funding

This work is supported by the Rutgers Research Council, through grant 202342 RC-17-Singh R, and National Science Foundation Engineering Research Center on Structured Organic Particulate Systems, through Grant NSF-ECC 0540855.

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Authors and Affiliations

  1. Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ, 08854, USA

    Matthew Billups & Ravendra Singh

Authors
  1. Matthew Billups
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  2. Ravendra Singh
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Corresponding author

Correspondence to Ravendra Singh.

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Billups, M., Singh, R. Systematic Framework for Implementation of Material Traceability into Continuous Pharmaceutical Tablet Manufacturing Process. J Pharm Innov 15, 51–65 (2020). https://doi.org/10.1007/s12247-018-9362-9

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  • DOI: https://doi.org/10.1007/s12247-018-9362-9

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