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Applications of process analytical technology to crystallization processes
Advanced Drug Delivery Reviews, 2004Crystallizations of pharmaceutical active ingredients, particularly those that posses multiple polymorphic forms, are among the most critical and least understood pharmaceutical manufacturing processes. Many process and product failures can be traced to a poor understanding and control of crystallization processes.
Lawrence X, Yu +5 more
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In an ideally regulated manufacturing industry, when a process is launched, its progress should be easily monitored and controlled until that process is completed. This means that at any given time, the condition and the quality of the product with respect to yield are transparent and known.
Alok Kumar Srivastav, Priyanka Das
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Alok Kumar Srivastav, Priyanka Das
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Trends in process analytical technology
Analytical Methods, 2010Since the promotion of Process Analytical Technology (PAT) by the U.S. Food and Drug Administration (FDA), there has been a flurry of activities happening across related fields. This excitement permeates regulatory agencies, professional societies, academia and industry worldwide.
Wee Chew, Paul Sharratt
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Process analytical technology (PAT) for biopharmaceutical products
Analytical and Bioanalytical Chemistry, 2010The "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk Based Approach" initiative announced by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing facilitated adoption of process analytical technology (PAT) by the pharmaceutical industry.
A S, Rathore, R, Bhambure, V, Ghare
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Process Analytical Technology: An Investment in Process Knowledge
Organic Process Research & Development, 2005Process analytical technology (PAT) is fast becoming an integral part of many active pharmaceutical ingredient (API) production facilities. The incorporation of early PAT devices, such as pH probes for example, was shown to increase process efficiency and safety by acting on data in real time and by eliminating sampling.
Frank Sistare +2 more
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2010
Contributors. Preface. List of Abbreviations. Process Analytical Chemistry: Introduction and Historical Prespective. Dr. Ernest Baughman. Implementation of Process Analytical Technologies. Dr. Gert Thurau & Dr. Robert Guenard. Merck and Co., Inc. Near-Infrared Spectroscopy for Process Analytical Chemistry: Theory, Technology and Implementation.
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Contributors. Preface. List of Abbreviations. Process Analytical Chemistry: Introduction and Historical Prespective. Dr. Ernest Baughman. Implementation of Process Analytical Technologies. Dr. Gert Thurau & Dr. Robert Guenard. Merck and Co., Inc. Near-Infrared Spectroscopy for Process Analytical Chemistry: Theory, Technology and Implementation.
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Process analytical technology for cheese manufacture
International Journal of Food Science & Technology, 2018SummaryRecent research on the development and application of process analytical technology (PAT) for cheese manufacture is reviewed in this article. PAT is a framework for innovative process manufacturing and quality assurance, which has been widely investigated for dairy processing applications, where particular processing challenges arise due to the ...
Bhavya Panikuttira +4 more
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Process Analytical Technology in Continuous Crystallization
2020This chapter discusses the topic of process analytical technology (PAT) in the context of continuous manufacturing and crystallization. The chapter starts with the introduction of the quality by design (QbD) concept, which heavily relies on the application of PAT tools for its implementation.
L. L. Simon, E. Simone
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"Optofluidics : Process Analytical Technology" offers in its 2nd edition a distinctive foundational introduction to the realms of materials, photonics, fluidics, and sensors. The work serves to unify the disparate disciplines, integrating the requisite fundamental knowledge with applied science.
Dominik Gerhard Rabus +2 more
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Dominik Gerhard Rabus +2 more
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Emergent FDA biodefense issues for microarray technology: process analytical technology
Expert Review of Molecular Diagnostics, 2004A successful biodefense strategy relies upon any combination of four approaches. A nation can protect its troops and citizenry first by advanced mass vaccination, second, by responsive ring vaccination, and third, by post-exposure therapeutic treatment (including vaccine therapies).
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