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Jean-Sébastien Simard - Articles and news items
Issue 2 2014, PAT & QbD / 15 April 2014 / Jose Montenegro-Alvarado, Bradley Diehl, Jean-Maxime Guay, Steve Hammond, Hiwot Isaac, Ben Lyons, Conor McSweeney, Seamus O’Neill, Jean-Sébastien Simard and Joep Timmermans, Pfizer Inc.
This article reviews some emerging applications of Process Analytical Technologies (PAT) for packaging quality testing. Specifically, four commercially-available packaging applications are explored in further detail: Raman spectroscopy for rapid material identification testing of polymeric packaging materials; vision-based elastic deformation for non-destructive blister integrity testing; X-ray monitoring for inline blister fill inspection; and thermal imaging for inline verification of bottle foil seal integrity. For each application, a brief review is provided stating technology capabilities and principles of measurement as well as sharing example(s), other relevant remarks covering some practical aspects and comments on considerations for building a business case for these technologies.
Process analytical technology (PAT) initiatives are now an integral part of developmental efforts in the pharmaceutical industry. Many technical and scientific papers and even dedicated sections appear regularly in several pharmaceutical manufacturing publications. They may be part of a quality by design (QbD) project to better identify and understand critical process parameters. The need and plus value of PAT is usually well-recognised and understood through establishment of the design space of a unit process. However, monitoring and control methodology and PAT protocols are still undefined, and there is no global consensus yet. It is on these grounds that ASTM started working groups focusing on the elaboration of standards in model building and process monitoring with PAT.
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