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A study of a visual inspection technique for in-process monitoring of coating of pharmaceutical pellets

机译:目视检查技术对药丸包衣过程的监测研究

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A systemic approach to development of process analytical technology (PAT) tools for monitoring the critical quality and performance attributes of the manufacturing process is of great importance in ensuring final product quality in the pharmaceutical industry. The aim of this study was to examine the possibilities for a visual inspection technique as a PAT tool for in-process and on-line monitoring of the coating process of pharmaceutical pellets. The in-process conditions of the Wurster coating system were studied and an experimental visual imaging system that mimics these conditions was set up. Image analysis methods were developed that allow the determination of pellets' coating thickness estimation from the images acquired during the coating process. The results of the proposed visual imaging method were evaluated through comparison with a reference method and a good agreement of the coating thickness estimations by the two methods was found.
机译:用于监测制造过程的临界质量和性能属性的过程分析技术(PAT)工具的开发系统方法在制药行业中最终产品质量方面具有重要意义。本研究的目的是研究视觉检查技术的可能性作为用于制作用于药物颗粒的涂层过程的工艺和在线监测。研究了Wurster涂层系统的工艺条件,并建立了模仿这些条件的实验性视觉成像系统。显影图像分析方法,其允许从涂覆过程中获取的图像确定颗粒涂层厚度估计。通过与参考方法的比较来评估所提出的视觉成像方法的结果,并发现了两种方法的涂层厚度估计的良好一致性。

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