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Operation of the Collaborative Composite Manufacturing CCM System
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Continuous blending monitored and feedback controlled by machine vision-based PAT tool.

Dorián László Galata1, Lilla Alexandra Mészáros1, Máté Ficzere1

  • 1Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111, Budapest, Műegyetem rakpart 3, Hungary.

Journal of Pharmaceutical and Biomedical Analysis
|January 24, 2021
PubMed
Summary
This summary is machine-generated.

Machine vision accurately quantifies low concentrations of colored active pharmaceutical ingredients (APIs) in continuous powder blending. This Process Analytical Technology (PAT) tool enables real-time monitoring and control of pharmaceutical manufacturing processes.

Keywords:
API content measurementColored APIContinuous blendingFeedback controlMachine visionPAT

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Area of Science:

  • Pharmaceutical Engineering
  • Process Analytical Technology (PAT)
  • Machine Vision Applications

Background:

  • Traditional methods like NIR and Raman spectroscopy struggle with quantifying active pharmaceutical ingredients (APIs) below 2% concentration.
  • Colored APIs present an opportunity for alternative quantification methods in powder blending.

Purpose of the Study:

  • To develop and validate a machine vision-based method for quantifying colored APIs in continuous powder blending.
  • To assess the application of this method for process characterization and real-time control.

Main Methods:

  • Utilized digital camera imaging as a Process Analytical Technology (PAT) tool.
  • Employed Riboflavin (RI) as a model colored API.
  • Developed image-based calibration and validated with UV/VIS spectrometry.

Main Results:

  • Achieved a Limit of Detection (LOD) of 0.015 w/w% and Limit of Quantification (LOQ) of 0.046 w/w% for Riboflavin.
  • Demonstrated high accuracy with a 2.53% relative error during validation.
  • Successfully applied the method for residence time distribution (RTD) measurement and real-time feedback control.

Conclusions:

  • Machine vision offers a promising, fast, and accurate method for monitoring and controlling continuous pharmaceutical powder blending processes.
  • This technique is particularly effective for quantifying colored APIs at low concentrations.
  • The developed approach has significant potential for enhancing process understanding and control in pharmaceutical manufacturing.