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Continuous blending monitored and feedback controlled by machine vision-based PAT tool

By Lászlo Galata, Dorián; Mészaros, Lilla; Ficzere Máté; Vass, Panna; Nagy, Brigitta; Szabó, Edina; Domokos, András; Farkas, Attila; Csontos, István; Marosi, György; Nagy, Zsombor Kristóf

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Abstract

In a continuous powder blending process machine vision is utilized as a Process Analytical Technology (PAT) tool. While near-infrared (NIR) and Raman spectroscopy are reliable methods in this field, measurements become challenging when concentrations below 2 w/w% are quantified. However, an active pharmaceutical ingredient (API) with an intense color might be quantified in even lower quantities by images recorded with a digital camera. Riboflavin (RI) was used as a model API with orange color, its Limit of Detection was found to be 0.015 w/w% and the Limit of Quantification was 0.046 w/w% usinga calibration based on the pixel value of images. A calibration for in-line measurement of RI concentration was prepared in the range of 0.2−0.45 w/w%, validation with UV/VIS spectrometry showed greataccuracy with a relative error of 2.53 %. The developed method was then utilized for a residence time distribution (RTD) measurement in order to characterize the dynamics of the blending process. Lastly, thetechnique was applied in real-time feedback control of a continuous powder blending process. Machinevision based direct or indirect API concentration determination is a promising and fast method with agreat potential for monitoring and control of continuous pharmaceutical processes.

Journal

Journal of Pharmaceutical and Biomedical Analysis. Volume 196, 2021, `113902

DOI

10.1016/j.jpba.2021.113902

Type of publication

Peer-reviewed journal

Affiliations

  • Budapest University of Technology and Economics

Article Classification

Research article

Classification Areas

  • PAT
  • Oral solid dose

Tags