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http://dx.doi.org/10.5806/AST.2009.22.1.035

Process analytical technology (PAT): field applications and current status in pharmaceutical industries  

Woo, Young-Ah (Korea United Pharm. Inc.)
Kim, Jong-Yun (Korea Atomic Energy Research Institute)
Park, Yong Joon (Korea Atomic Energy Research Institute)
Yeon, Jei-Won (Korea Atomic Energy Research Institute)
Song, Kyuseok (Korea Atomic Energy Research Institute)
Kim, Hyo-Jin (Department of Pharmacy, Dongduk Women's University)
Publication Information
Analytical Science and Technology / v.22, no.1, 2009 , pp. 35-43 More about this Journal
Abstract
The goal of PAT (Process Analytical Technology) is to build quality into products through better understanding and control of manufacturing processes, rather than merely testing the quality of the end product. Pharmaceutical manufacturers are trying to develop and implement new technologies in pharmaceutical production and quality control for real-time measurements of critical product and process parameters. Characterization of manufacturing process through experimental design, for evaluation of the effect of product and process variables, represents an integral part of the PAT framework. However, the publications regarding real PAT application to pharmaceutical process are very limited and the technologies are confidential as well. In this review, the case studies related to PAT are shown with real applications from a pharmaceutical company. Additionally, various applications of PAT on the developing stage are introduced with high analytical technologies for the improvement of quality control on manufacturing process.
Keywords
process analytical technology (PAT); real-time measurements; PAT applications; quality control;
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