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PAT - Articles and news items
IFPAC 2013, 22-25 January 2013, Baltimore Marriott Waterfront, Baltimore, Maryland, USA
Process analytics experiences in biopharmaceutical manufacturing.
Correlation between powder rheology data and processability in solid dosage form manufacturing.
Expert industry users of process analytical technologies for pharmaceuticals pose questions for leading vendor experts of process analytical technology.
PHARMA•ID™ is a palm-sized, easy to use Raman spectrometer identifies and validates excipients and active pharmaceutical ingredients (API) wherever testing is needed.
Thursday 17 May 2012, The Royal Society of Chemistry, London
Webinars / 9 February 2012 / HACH LANGE
View presentations from experts in the fields of monitoring and compliance and pharmaceutical water and cleanroom facility standards…
Issue 6 2011, PAT & QbD, Supplements / 15 December 2011 / Terry McMahon (PAI Partners), Dr. Marianna Machin, Dr. Lorenz Liesum, Dr. Antonio Peinado (Novartis Pharma AG), Ravindra Dhumal, Tim Gough (Centre for Pharmaceutical Engineering Science, University of Bradford)
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.
Issue 3 2011 / 20 June 2011 / 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 Services Frankfurt Chemistry, Sanofi.
Expo Technologies and Umetrics Inc. announce the release of Expo’s NovaMath 5.0…
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 is to gain a deep understanding of manufacturing processes and to learn how to control them1. When processes are understood, opportunities for continuous improvement (quality and efficiency), cycle time reduction, cost reduction and QC lab test replacement arise. In this article, the strategy of Johnson & Johnson Pharmaceutical Research & Development (J&J PRD) towards the implementation of PAT in Pharmaceutical Process Development is explained and elucidated by case studies.
Issue 4 2010, PAT & QbD / 19 August 2010 / 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. In this roundtable, three leading pharmaceutical PAT companies offer their opinions on why PAT is becoming more and more essential to the pharmaceutical industry.
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 to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorisation.
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 will be discussed. Secondly, the applicability of Raman spectroscopy for in-process monitoring of drug product production processes will be highlighted. In addition, the tendency within the pharmaceutical industry to move from batch processing towards continuous manufacturing will be envisaged.
ABB Analytical Measurement Analytik Jena AG Aptalis Pharmaceutical Technologies ASM - Aerosl-Service AG Azbil BioVigilant, Inc. B&W Tek, Inc. bioMérieux BioTrends – Archilex SA BMG LABTECH GmbH Bruker Daltonik GmbH CAMO Software AS Catalent Pharma Solutions Chemspec Europe Ltd CI Precision Dow Chemical Company Ltd EUROGENTEC FOSS NIRSystems, Inc. GE Analytical Instruments Gerresheimer Group HAMAMATSU PHOTONICS EUROPE I Holland Limited IDBS IONIMED Analytik GmbH LI-COR Biosciences Lonza Natoli Engineering Company, Inc. Pall Life Sciences PANalytical B.V. Patheon Inc PhyNexus, Inc. ReAgent Roche Sirius Analytical Instruments Ltd Vala Sciences Veltek Associates Inc.