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Process Analytical Technology (PAT) in Quality Assurance: A Detailed Review
International Journal of Pharmaceutical Sciences and Nanotechnology, 2022Process Analytical Technology (PAT) is a proactive initiative published by the Food and Drug Administration so as to overcome the conventional way of batch testing. As per the documented guideline it can be stated as a system for designing, analyzing, and controlling pharmaceutical manufacturing through the timely measurement of critical quality ...
Esha Bhavin Shah, Anuradha Gajjar
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Process Analytical Technologies (PAT) in freeze-drying of parenteral products
Pharmaceutical Development and Technology, 2009Quality by Design (QbD), aims at assuring quality by proper design and control, utilizing appropriate Process Analytical Technologies (PAT) to monitor critical process parameters during processing to ensure that the product meets the desired quality attributes.
Sajal Manubhai, Patel, Michael, Pikal
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Spectroscopy for Process Analytical Technology (PAT)
2010Spectroscopic sensors play a key role in process analytical technology. Such sensors can be interfaced to almost any type of manufacturing process, and by rapid, precise, and nondestructive spectroscopic analysis, it is possible to predict analyte concentration, quantify physical parameters, or fingerprint process streams and raw materials.
Skibsted, Erik, Engelsen, Søren Balling
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CHEMOMETRIC PROCESS ANALYTICAL TECHNOLOGY (PAT) APPLICATIONS IN BIOPROCESS ENGINEERING
IFAC Proceedings Volumes, 2005Abstract The production process of an active pharmaceutical ingredient (API) by fermentation in an industrial environment was analysed using process analytical technologies. The Food and Drug Administration's (FDA) process analytical technology (PAT) initiative is intended to be a collaborative effort with industry to promote the integration of new ...
João A. Lopes +2 more
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Chemometrics in bioprocess engineering: process analytical technology (PAT) applications
Chemometrics and Intelligent Laboratory Systems, 2004Abstract The production process of an active pharmaceutical ingredient (API) by fermentation in an industrial environment was analysed using process analytical technologies.The Food and Drug Administration's (FDA) process analytical technology (PAT) initiative is intended to be a collaborative effort with industry to promote the integration of new ...
João A. Lopes +3 more
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Biotechnology and Bioengineering, 2009
AbstractImplementing real‐time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: “variability is managed by the process” and “product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other ...
E K, Read +5 more
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AbstractImplementing real‐time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: “variability is managed by the process” and “product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other ...
E K, Read +5 more
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Assessment of Recent Process Analytical Technology (PAT) Trends: A Multiauthor Review
Organic Process Research & Development, 2015This multiauthor review article aims to bring readers up to date with some of the current trends in the field of process analytical technology (PAT) by summarizing each aspect of the subject (sensor development, PAT based process monitoring and control methods) and presenting applications both in industrial laboratories and in manufacture e.g.
Levente L. Simon +45 more
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PAT – PROCESS ANALYTICAL TECHNOLOGY IN CULTIVATION PROCESSES WITH RECOMBINANT ESCHERICHIA COLI
IFAC Proceedings Volumes, 2007Abstract An extensive monitoring system is build up to fully automate and scan production processes of recombinant Escherichia coli for optimal process performance. It is based on in-line, on-line and at-line measurements for substrates and products.
C. Kaiser +4 more
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Process Analytical Technologies (PAT)—the impact for Process Systems Engineering
2008Abstract With the increasing take-up of Process Analytical Technologies (PAT) by the pharmachem, bio-pharma, specialty chemicals and materials manufacturing industries there is a critical need for robust data verification, particularly as this information is being included in real-time control or at least advisory feedback applications. In particular
Chen ZP, Lovett D, Morris J
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Development of Process Analytical Technology (PAT) methods for controlled release pellet coating
European Journal of Pharmaceutics and Biopharmaceutics, 2014This work focused on the control of the manufacturing process for a controlled release (CR) pellet product, within a Quality by Design (QbD) framework. The manufacturing process was Wurster coating: firstly layering active pharmaceutical ingredient (API) onto sugar pellet cores and secondly a controlled release (CR) coating. For each of these two steps,
P, Avalle +6 more
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