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首页> 外文期刊>Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis >Continuous blending monitored and feedback controlled by machine vision-based PAT tool
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Continuous blending monitored and feedback controlled by machine vision-based PAT tool

机译：连续混合监控和由机器视觉的PAT工具控制的反馈

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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% using a 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 great accuracy 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, the technique was applied in real-time feedback control of a continuous powder blending process. Machine vision based direct or indirect API concentration determination is a promising and fast method with a great potential for monitoring and control of continuous pharmaceutical processes. (C) 2021 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license
机译：在连续粉末混合过程中，机器视觉被用作过程分析技术（PAT）工具。虽然近红外（NIR）和拉曼光谱是该领域的可靠方法，但当浓度低于2 w/w%时，测量变得具有挑战性。然而，通过数码相机记录的图像，具有强烈颜色的活性药物成分（API）的定量可能更低。核黄素（RI）被用作橙色的模型API，通过基于图像像素值的校准，其检测限为0.015 w/w%，定量限为0.046 w/w%。在0.2-0.45 w/w的范围内制备了RI浓度在线测量的校准，用UV/VIS光谱法验证显示了较高的准确性，相对误差为2.53%。然后利用所开发的方法进行停留时间分布（RTD）测量，以表征共混过程的动力学。最后，将该技术应用于粉末连续混合过程的实时反馈控制。基于机器视觉的直接或间接原料药浓度测定是一种有前途的快速方法，在连续制药过程的监测和控制方面具有巨大潜力。（c）作者2021。由爱思唯尔B.V.出版。这是一篇基于CC by license的开放获取文章

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