Abstract

Mimicking the human decision-making process is challenging. Especially, many process control situations during the manufacturing of pharmaceuticals are based on visual observations and related experience-based actions. The aim of the present work was to investigate the use of image analysis to classify the quality of coated tablets. Tablets with an increasing amount of coating solution were imaged by fast scanning using a conventional office scanner. A segmentation routine was implemented to the images, allowing the extraction of numeric image-based information from individual tablets. The image preprocessing was performed prior to utilization of four different classification techniques for the individual tablet images. The support vector machine (SVM) technique performed superior compared to a convolutional neural network (CNN) in relation to computational time, and this approach was also slightly better at classifying the tablets correctly. The fastest multivariate method was partial least squares (PLS) regression, but this method was hampered by the inferior classification accuracy of the tablets. Finally, it was possible to create a numerical threshold classification model with an accuracy comparable to the SVM approach, so it is evident that there exist multiple valid options for classifying coated tablets.

Highlights

  • Visual observation is still a commonly used method for the characterization of pharmaceutical systems

  • An experienced pharmaceutical scientist and/or process operator can identify these defects with a plain eye and important decision-making for process control purposes can be performed based on these visual observations

  • The numerical threshold classification (NTC) method was performed in MATLAB® (Natick, MA, USA) on the 50 times downsampled images by performing an intensity summation over the spatial pixel positions for the single tablet images

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Summary

Introduction

Visual observation is still a commonly used method for the characterization of pharmaceutical systems. One example of this is the expression ‘cake appearance’ that is commonly used to describe freeze-dried products [1]. An experienced pharmaceutical scientist and/or process operator can identify these defects with a plain eye and important decision-making for process control purposes can be performed based on these visual observations. This is challenging to document and missing an experienced person with key product/process understanding can be detrimental. Robust algorithms and computational methods [2,3] capable of mimicking human decision-making processes will be especially important considering the fast development of imaging tools

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