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New monitoring methods improve compliance, reduce costs
9 February 2012 | By HACH LANGE
This pharma webinar presents experts in the fields of monitoring and compliance and pharmaceutical water and cleanroom facility standards.
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Process Analytical Technologies (PAT)
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PAT supplement 2011
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…
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Market leaders Expo Technologies, Umetrics provide better PAT tool connectivity
18 April 2011 | By Expo Technologies LLC
Expo Technologies and Umetrics Inc. announce the release of Expo’s NovaMath 5.0...
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Applying PAT in pharmaceutical processes
1 November 2010 | By Mario Hellings, Tom Van den Kerkhof, Jeroen Geens and Steve Mehrman, Johnson & Johnson
As cited by the FDA, “Process Analytical Technology (PAT) is a system for designing, analysing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.”1 The main goal of PAT…
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Process Analytical Technology: An industry perspective
19 August 2010 | By Uwe Kirschner, General Manager, Sentronic GmbH, Rick E. Cooley, Market Development Manager - Process Analytics, Dionex Corporation, Rebecca Vangenechten, Business Development, Siemens Headquarters Pharma and Kjell François, Project Leader in PAT
Process Analytical Technology (PAT) is a system for designing, analysing and controlling pharmaceutical manufacturing processes through measurements of critical quality and performance attributes of raw and processed materials to ensure final product quality, the idea of which is to become more efficient while reducing over-processing, enhancing efficiency and minimising waste.…
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Article 3: The implementation of rapid microbiological methods
24 June 2010 | By Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC
This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order…
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Raman spectroscopy for the analysis of drug products and drug manufacturing processes
9 May 2010 | By Prof. Thomas De Beer, Assistant-Professor, Process Analytical Technology, Faculty of Pharmaceutical Sciences, University of Ghent
This article aims at supplying a concise overview on the application of Raman spectroscopic analysis methods within the pharmaceutical drug product manufacturing world. Firstly, there will be a focus on the rapid and nondestructive off-line analysis feasibility of Raman spectroscopy for final drug products. Herewith, several possible sources of error…
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‘Pharmaceutical Industry / University’ R&D collaboration on Process Analytical Technologies
9 May 2010 | By Professor Nicolas Abatzoglou, Chair, PAT in Pharmaceutical Engineering, Department of Chemical and Biotechnological Engineering, Université de Sherbrooke
Process analytical technologies (PAT) are mature and well advanced in the classical chemical industry. Many successful industry/university R&D collaborations are aimed at the development of analytical methods and their application in process control. However, PAT in the pharmaceutical industry is a rather new field. It is precisely this latter reality…
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Contributing to the Sustainability of the UK Chemicals and Pharmaceuticals Industries
22 February 2010 | By
The Centre for Process Analytics and Control Technology (CPACT) is a unique industry-driven multi-disciplinary research and development club that was formed in 1997 by the Departments of Pure and Applied Chemistry at the University of Strathclyde, the Department of Chemical and Process Engineering at the University of Newcastle and the…
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Process Analytical Technology (PAT) in Freeze Drying: Tunable Diode Laser Absorption Spectroscopy as an evolving tool for Cycle Monitoring
12 December 2009 | By Stefan Schneid, Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen-Nuremberg and Dr. Henning Gieseler, Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen-Nuremberg
The most important critical product parameter during a freeze-drying process is the product temperature at the ice sublimation interface, Tp1. Once the product temperature in this area of interest exceeds the critical formulation temperature (typically denoted as "collapse temperature", Tc) during primary drying, a stepwise loss of the cake structure…
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Real-time NIR monitoring of pharmaceutical blending processes with multivariate quantitative models
9 October 2009 | By Dr. Nicolas Abatzoglou, Professor and Chairman of the Department of Chemical & Biotechnological Engineering of the Université de Sherbrooke; Pierre-Philippe Lapointe-Garant, PAT Scientist and Jean-Sébastien Simard, Technical Services, both Wyeth Pharmaceuticals
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…
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Real-time environmental monitoring: PAT solutions using rapid microbiological methods
In these economic times the pharmaceutical industry has expressed a renewed interest to explore ways in which to enhance the efficiency and agility of existing and future manufacturing processes. This is also true for laboratory-based operations that support forward processing and product release decisions. One function that can greatly benefit…
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QbD and PAT: From Science to Compliance
30 July 2009 | By Pedro E. Hernandez-Abad, Associate Director; Jun Huang, Principal PAT Scientist II and Saly Romero-Torres, Principal PAT Scientist, both Wyeth Pharmaceuticals
Boards of health like the Food and Drug Administration and European Medicines Agency and ICH guidelines Q8, Q9 and Q10, provide a framework for Quality by Design (QbD) that fully integrates drug substance and drug product development with the principles of Quality Risk Management (QRM), Process Analytical Technology (PAT) and…
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Applying PAT in Chemical Process Development
29 May 2009 | By
As the time-to-market of pharmaceutical products has elongated, while its prices are under big pressure, cost saving is currently essential in the pharmaceutical industry.
