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Bernhard Wagner1,2, Shea Fen Cheong3, Thomas Brinz1

  • 1a Packaging Technology , Robert Bosch Packaging Technology GmbH , Waiblingen , Germany.

Drug Development and Industrial Pharmacy
|June 20, 2019
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This study optimized continuous capsule filling weight control by deriving controller settings from process models. Rapid Automated Process Development (RAPD) enabled efficient optimization for pharmaceutical excipients.

Keywords:
Control strategycontinuous capsule fillingcontrol challengesderiving control settingsfeedback controlfeedforward controlmean fill weightprocess modelingrapid automated process development

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Control Engineering
  • Automation and Robotics

Background:

  • Continuous manufacturing is crucial for modern pharmaceutical production.
  • Controlling mean fill weight in capsule filling presents challenges due to material variability.
  • Existing controller parameter settings often require extensive manual optimization.

Purpose of the Study:

  • To investigate the feasibility of deriving controller settings for continuous capsule filling from process models.
  • To develop and validate a method for optimizing mean fill weight control in automated capsule fillers.
  • To assess the impact of process variations on active pharmaceutical ingredient (API) content and excipient quality.

Main Methods:

  • Utilized a fully automated capsule filler integrated with an online gravimetric scale.
  • Investigated both feedback control and combined feedback/feedforward control strategies.
  • Developed a novel method using Rapid Automated Process Development (RAPD) to determine optimal control parameters based on process models.

Main Results:

  • Successfully derived and applied controller parameters using the RAPD method for optimized weight control.
  • Demonstrated the method's effectiveness across three different pharmaceutical excipients.
  • Verified the feasibility of the proposed approach through experimental validation and system dynamics analysis.

Conclusions:

  • Process model-derived controller settings offer an effective and rapid solution for optimizing continuous capsule filling weight control.
  • The RAPD method provides a fast and efficient approach to determine optimal control parameters, addressing a key industry challenge.
  • This work lays the foundation for integrating advanced control strategies into continuous pharmaceutical manufacturing systems.