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Rapid automated process development of a continuous capsule-filling process.

Bernhard Wagner1, Thomas Brinz2, Stephanie Otterbach2

  • 1Robert Bosch Packaging Technology GmbH, Waiblingen, Germany; Institute for Particle and Process Engineering, Graz University of Technology, Graz, Austria.

International Journal of Pharmaceutics
|May 9, 2018
PubMed
Summary

This study presents a rapid automated process development for continuous capsule filling, creating a statistical model in just two days. This accelerates the optimization and manufacturing of pharmaceutical dosage forms.

Keywords:
Automated capsule fillingContinuous capsule fillingDesign of experimentsOptimized processProcess modelingRapid automated process development

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Process Automation

Background:

  • Continuous manufacturing offers advantages in pharmaceutical production.
  • Rapid process development is crucial for efficient implementation of continuous platforms.
  • Optimizing capsule-filling processes requires understanding material attributes and critical process parameters.

Purpose of the Study:

  • To introduce a rapid automated process-development approach for continuous capsule filling.
  • To generate a statistical process model quickly for continuous manufacturing.
  • To validate the developed model for predicting capsule fill weight and variability.

Main Methods:

  • Varied material compositions (ascorbic acid, lactose, magnesium stearate) and critical process parameters (speed, pressure, immersion depth, powder bed height).
  • Developed a statistical process model within two days.
  • Validated the model by predicting mean fill weight and relative standard deviation at different set points.

Main Results:

  • A statistical process model was generated with unprecedented speed (2 days).
  • Model predictions for mean fill weight and relative standard deviation showed high accuracy.
  • The approach successfully validated the system's behavior at various set points.

Conclusions:

  • The rapid automated process development approach is effective for continuous capsule filling.
  • This method enables faster development and operation of continuous pharmaceutical manufacturing platforms.
  • It establishes a new strategy for developing and manufacturing pharmaceutical dosage forms.