PT  - JOURNAL ARTICLE
AU  - Veillon, Romain
AU  - Shabushnig, John
AU  - Aabye-Hansen, Lars
AU  - Duvinage, Matthieu
AU  - Eckstein, Christian
AU  - Li, Zheng
AU  - Sardella, Andrea
AU  - Soto, Manuel
AU  - Torres, Jorge Delgado
AU  - Turnquist, Brian
TI  - Applying Machine Learning to the Visual Inspection of Filled Injectable Drug Products
AID  - 10.5731/pdajpst.2022.012796
DP  - 2023 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 376--401
VI  - 77
IP  - 5
4099  - http://journal.pda.org/content/77/5/376.short
4100  - http://journal.pda.org/content/77/5/376.full
SO  - PDA J Pharm Sci Technol2023 Sep 01; 77
AB  - 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.