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Process Analytical Technologies (PAT)

 

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PAT for packaging: review of applications for expeditious, nondestructive quality testing

15 April 2014 | By 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…

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Process systems engineering (PSE) in the pharmaceutical industry: past and future

15 December 2013 | By Christos Georgakis, Department of Chemical and Biological Engineering and Systems Research Institute for Chemical and Biological Processes, Tufts University and Gregory M. Troup, Merck Research Laboratories, Merck & Co., Inc

Process Systems Engineering (PSE) has had a profound impact in the chemical, petroleum and petrochemical industry in the last 30 - 40 years. Even though PSE has already started to make a significant impact on the pharmaceutical industry, there are substantial additional benefits that can be derived. The purpose of…

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PAT supplement 2011

15 December 2011 | By

In this PAT supplement: The historical development of the FDA's PAT initiative and its present course; Implementation of modelling approaches in the QbD framework: Examples from the Novartis experience; Challenges in development and implementation of spectroscopic techniques as PAT Analysers...

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PAT & QbD Supplement (free to view)

20 June 2011 | By Magida Zeaiter - GlaxoSmithKline, Mark Morton - Phoenix Scientific Services, Joachim Ermer - Head of Quality Control Services Frankfurt Chemistry - Sanofi

Featuring articles: "A basis for innovation and continuous improvement of process understanding and control in pharmaceutical product development" by Magida Zeaiter, GlaxoSmithKline, "Flexible processing assures product quality" by Mark Morton, Phoenix Scientific Services and "Quality by design: A lifecycle concept for pharmaceutical analysis" by Joachim Ermer, Head of Quality Control…