Process Analytical Technology
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Process Analytical Technology For The Food Industry
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Author : Colm P. O'Donnell
language : en
Publisher: Springer
Release Date : 2014-11-03
Process Analytical Technology For The Food Industry written by Colm P. O'Donnell and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-03 with Technology & Engineering categories.
The Process Analytical Technology (PAT) initiative aims to move from a paradigm of ‘testing quality in’ to ‘building quality in by design’. It can be defined as the optimal application of process analytical technologies, feedback process control strategies, information management tools, and/or product–process optimization strategies. Recently, there have been significant advances in process sensors and in model-based monitoring and control methodologies, leading to enormous opportunities for improved performance of food manufacturing processes and for the quality of food products with the adoption of PAT. Improvements in process efficiency, reduced product variability, enhanced traceability, process understanding, and decreased risk of contamination are some of the benefits arising from the introduction of a PAT strategy in the food industry. Process Analytical Technology for the Food Industry reviews established and emerging PAT tools with potential application within the food processing industry. The book will also serve as a reference for industry, researchers, educators, and students by providing a comprehensive insight into the objectives, challenges, and benefits of adopting a Process Analytical Technology strategy in the food industry.
Process Analytical Technology
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Author : Katherine A. Bakeev
language : en
Publisher: John Wiley & Sons
Release Date : 2010-04-01
Process Analytical Technology written by Katherine A. Bakeev and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-04-01 with Science categories.
Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analytical chemist. In this new edition all of the original chapters have been updated and revised, and new chapters covering the important topics of sampling, NMR, fluorescence, and acoustic chemometrics have been added. Coverage includes: Implementation of Process Analytical Technologies UV-Visible Spectroscopy for On-line Analysis Infrared Spectroscopy for Process Analytical Applications Process Raman Spectroscopy Process NMR Spectrscopy: Technology and On-line Applications Fluorescent Sensing and Process Analytical Applications Chemometrics in Process Analytical Technology (PAT) On-Line PAT Applications of Spectroscopy in the Pharmaceutical Industry Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing NIR Chemical Imaging This volume is an important starting point for anyone wanting to implement PAT and is intended not only to assist a newcomer to the field but also to provide up-to-date information for those who practice process analytical chemistry and PAT. It is relevant for chemists, chemical and process engineers, and analytical chemists working on process development, scale-up and production in the pharmaceutical, fine and specialty chemicals industries, as well as for academic chemistry, chemical engineering, chemometrics and pharmaceutical science research groups focussing on PAT. Review from the First Edition “The book provides an excellent first port of call for anyone seeking material and discussions to understand the area better. It deserves to be found in every library that serves those who are active in the field of Process Analytical Technology.”—Current Engineering Practice
Continuous Pharmaceutical Processing And Process Analytical Technology
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Author : Ajit S. Narang
language : en
Publisher: CRC Press
Release Date : 2023-03-01
Continuous Pharmaceutical Processing And Process Analytical Technology written by Ajit S. Narang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-01 with Medical categories.
Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability. Features: Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized Addresses economic and practical considerations, unlike many other technical books Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies
Pat Applied In Biopharmaceutical Process Development And Manufacturing
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Author : Cenk Undey
language : en
Publisher: CRC Press
Release Date : 2011-12-07
Pat Applied In Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-12-07 with Medical categories.
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
Process Analytical Technology Pat
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Author : Gerard Blokdyk
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-10-07
Process Analytical Technology Pat written by Gerard Blokdyk and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-10-07 with categories.
What is our formula for success in Process Analytical Technology PAT ? Who are the Process Analytical Technology PAT improvement team members, including Management Leads and Coaches? How do we keep improving Process Analytical Technology PAT? Does Process Analytical Technology PAT analysis isolate the fundamental causes of problems? What potential environmental factors impact the Process Analytical Technology PAT effort? This best-selling Process Analytical Technology PAT self-assessment will make you the assured Process Analytical Technology PAT domain leader by revealing just what you need to know to be fluent and ready for any Process Analytical Technology PAT challenge. How do I reduce the effort in the Process Analytical Technology PAT work to be done to get problems solved? How can I ensure that plans of action include every Process Analytical Technology PAT task and that every Process Analytical Technology PAT outcome is in place? How will I save time investigating strategic and tactical options and ensuring Process Analytical Technology PAT opportunity costs are low? How can I deliver tailored Process Analytical Technology PAT advise instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all Process Analytical Technology PAT essentials are covered, from every angle: the Process Analytical Technology PAT self-assessment shows succinctly and clearly that what needs to be clarified to organize the business/project activities and processes so that Process Analytical Technology PAT outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced Process Analytical Technology PAT practitioners. Their mastery, combined with the uncommon elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in Process Analytical Technology PAT are maximized with professional results. Your purchase includes access to the $249 value Process Analytical Technology PAT self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. Your exclusive instant access details can be found in your book.
New Directions In Bioprocess Modeling And Control
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Author : Michael A. Boudreau
language : en
Publisher: ISA
Release Date : 2007
New Directions In Bioprocess Modeling And Control written by Michael A. Boudreau and has been published by ISA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Science categories.
Models offer benefits even before they are put on line. Based on years of experience, the authors reveal in New Directions in Bioprocess Modeling and Control that significant improvements can result from the process knowledge and insight that are gained when building experimental and first-principle models for process monitoring and control. Doing modeling in the process development and early commercialization phases is advantageous because it increases process efficiency and provides ongoing opportunities for improving process control. This technology is important for maximizing benefits from analyzers and control tool investments. If you are a process design, quality control, information systems, or automation engineer in the biopharmaceutical, brewing, or bio-fuel industry, this handy resource will help you define, develop, and apply a virtual plant, model predictive control, first-principle models, neural networks, and multivariate statistical process control. The synergistic knowledge discovery on bench top or pilot plant scale can be ported to industrial scale processes. This learning process is consistent with the intent in the Process Analyzer and Process Control Tools sections of the FDA_s Guidance for Industry PAT _ A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. It states in the Process Analyzer section of the FDA_s guidance: _For certain applications, sensor-based measurements can provide a useful process signature that may be related to the underlying process steps or transformations. Based on the level of process understanding these signatures may also be useful for the process monitoring, control, and end point determination when these patterns or signatures relate to product and process quality._
Optofluidics
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Author : Dominik G. Rabus
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2018-12-03
Optofluidics written by Dominik G. Rabus and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-03 with Science categories.
This introduction into the multidisciplinary area of optofluidics offers the necessary foundations in photonics, polymer physics and process analytics to students, engineers and researchers to enter the field. All basic ingredients of a polymer-based platform as a foundation for quick and compact solutions for chemical, biological and medical sensing and manipulation are developed.
Micro Instrumentation
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Author : Melvin V. Koch
language : en
Publisher: John Wiley & Sons
Release Date : 2007-04-09
Micro Instrumentation written by Melvin V. Koch and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-04-09 with Science categories.
This first comprehensive treatment of the intertwined roles of micro-instrumentation, high throughput experimentation and process intensification as valuable tools for process analytical technology covers both industrial as well as academic aspects. First class editors and authors from top companies and universities provide interdisciplinary coverage ranging from chemistry and analytics to process design and engineering, supported throughout by case studies and ample analytical data.
Process Analytical Chemistry
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Author : F. McLennan
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Process Analytical Chemistry written by F. McLennan and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Science categories.
Process analytical chemistry (PAC) can be defined as the technology of obtaining quantitative and qualitative information about a chemical process in order to control or optimise its performance. This highly practical book provides an up-to-date introduction to the field with a special emphasis placed on industrial processes. Edited by representatives from one of the world's leading chemical companies and centres of excellence for research into the subject, the book is written by a transatlantic team of authors who provide a global perspective.
Pharmaceutical Quality By Design
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Author : Walkiria S. Schlindwein
language : en
Publisher: John Wiley & Sons
Release Date : 2018-01-05
Pharmaceutical Quality By Design written by Walkiria S. Schlindwein and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-05 with Science categories.
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.