PAT Implementation

M. Gams, M. Ožek, J. Krivec, T. Tušar

PAT Implementation project

Short description, main aims and objectives of the project:

Process Analytical Technology (PAT) is a system for designing, analyzing and controlling manufacturing through timely measurements of critical quality and performance attributes of materials and processes, with the goal of ensuring final product quality. The goal for the PAT Implementation project for the Slovene pharmaceutical company Lek (part of Sandoz) was to achieve higher flexibility, better understanding and efficient control of the tablet-manufacturing process. For this purpose we designed and implemented a new method for process analysis as well as an application for process visualization and modeling. This contributed to a better understanding of the manufacturing process and achieving a higher quality for the produced tablets.