Applying Machine Learning to the Visual Inspection of Filled Injectable Drug Products.

Q3 Medicine PDA Journal of Pharmaceutical Science and Technology Pub Date : 2023-09-01 Epub Date: 2023-06-15 DOI:10.5731/pdajpst.2022.012796
Romain Veillon, John Shabushnig, Lars Aabye-Hansen, Matthieu Duvinage, Christian Eckstein, Zheng Li, Andrea Sardella, Manuel Soto, Jorge Delgado Torres, Brian Turnquist
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Abstract

With machine learning (ML), we see the potential to better harness the intelligence and decision-making abilities of human inspectors performing manual visual inspection (MVI) and apply this to automated visual inspection (AVI) with the inherent improvements in throughput and consistency. This article is intended to capture current experience with this new technology and provides points to consider for successful application to AVI of injectable drug products. The technology is available today for such AVI applications. Machine vision companies have integrated ML as an additional visual inspection tool with minimal upgrades to existing hardware. Studies have demonstrated superior results in defect detection and reduction in false rejects, when compared with conventional inspection tools. ML implementation does not require modifications to current AVI qualification strategies. The utilization of this technology for AVI will accelerate recipe development by use of faster computers rather than by direct human configuration and coding of vision tools. By freezing the model developed with artificial intelligence tools and subjecting it to current validation strategies, assurance of reliable performance in the production environment can be achieved.

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将机器学习应用于填充注射药品的视觉检测。
通过机器学习(ML),我们看到了更好地利用人工视觉检查(MVI)的人类检查员的智能和决策能力的潜力,并将其应用于自动化视觉检查(AVI),从而提高吞吐量和一致性。本文旨在获取这项新技术的当前经验,并为成功应用于注射药物产品的AVI提供考虑要点。该技术目前可用于此类AVI应用程序。机器视觉公司已经将ML集成为一种额外的视觉检查工具,对现有硬件的升级最小。研究表明,与传统的检查工具相比,在缺陷检测和减少虚假拒收方面取得了优异的结果。ML实现不需要修改当前的AVI资格策略。将这项技术用于AVI将通过使用更快的计算机而不是通过视觉工具的直接人工配置和编码来加速配方开发。通过冻结使用人工智能工具开发的模型,并对其进行当前的验证策略,可以确保在生产环境中的可靠性能。
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CiteScore
1.90
自引率
0.00%
发文量
34
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