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Process Analytical Technology (PAT) Model Lifecycle Management
Spectroscopy, 2023Many applications of process analytical technologies (PAT) use spectroscopic measurements that are based on prediction models. The accuracy of the models can be affected by a number of factors such as aging equipment, slight changes in the active pharmaceutical ingredient (API) or excipients, or previously unidentified process variations.
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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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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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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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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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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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Bioresource Technology, 2013
The use of near infrared spectroscopy was investigated as a process analytical technology to monitor the amino acids concentration profile during hydrolysis process of Cornu Bubali. A protocol was followed, including outlier selection using relationship plot of residuals versus the leverage level, calibration models using interval partial least squares
Zhisheng, Wu +6 more
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The use of near infrared spectroscopy was investigated as a process analytical technology to monitor the amino acids concentration profile during hydrolysis process of Cornu Bubali. A protocol was followed, including outlier selection using relationship plot of residuals versus the leverage level, calibration models using interval partial least squares
Zhisheng, Wu +6 more
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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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Critical Reviews in Analytical Chemistry
The field of Process Analytical Technology (PAT) encompasses the utilization of real-time and in-process analytical tools, the analysis and interpretation of the data, and the utilization of this data to control the process (e.g. product consistency).
Alagappan, Shanmugam +2 more
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The field of Process Analytical Technology (PAT) encompasses the utilization of real-time and in-process analytical tools, the analysis and interpretation of the data, and the utilization of this data to control the process (e.g. product consistency).
Alagappan, Shanmugam +2 more
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Journal of Pharmaceutical Sciences, 2008
Terahertz (THz) spectroscopy and chemometric analysis of resultant absorption spectra in the 30-500 cm(-1) range has been applied to perform quantitative determination of both active ingredient and excipient concentrations of tablets. Tests were performed on a series of tablets composed of various concentrations and processes of theophylline formulated
Huiquan, Wu +3 more
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Terahertz (THz) spectroscopy and chemometric analysis of resultant absorption spectra in the 30-500 cm(-1) range has been applied to perform quantitative determination of both active ingredient and excipient concentrations of tablets. Tests were performed on a series of tablets composed of various concentrations and processes of theophylline formulated
Huiquan, Wu +3 more
openaire +2 more sources