Process Understanding
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Process Understanding
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Author : Ian Houson
language : en
Publisher: John Wiley & Sons
Release Date : 2011-06-09
Process Understanding written by Ian Houson 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 2011-06-09 with Science categories.
Process Understanding is the underpinning knowledge that allows the manufacture of chemical entities to be carried out routinely, robustly and to the required standard of quality. This area has gained in importance over the last few years, particularly due to the recent impetus from the USA`s Food and Drug Administration. This book covers the multidisciplinary aspects required for successful process design, safety, modeling, scale-up, PAT, pilot plant implementation, plant design as well the rapidly expanding area of outsourcing. In discussing what process understanding means to different disciplines and sectors throughout a product`s life cycle, this handbook and ready reference reveals the factors important to the development and manufacture of chemicals. The book focuses on the fundamental scientific understanding necessary. for a smoother technical transfer between the disciplines, leading to more effective and effi cient process development and manufacturing. A range of case studies are used to exemplify and illustrate the main issues raised. As a result, readers will appreciate that process understanding can deliver a real competitive advantage within the pharmaceuticals and fine chemicals industry. This book serves as an aid to meeting the stringent regulations required by the relevant authorities through demonstrable understanding of the underlying science.
Understanding Organization As Process
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Author : Tor Hernes
language : en
Publisher: Routledge
Release Date : 2007-09-27
Understanding Organization As Process written by Tor Hernes and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-09-27 with Business & Economics categories.
Coming to grips with the actual complexity and fluidity of organization and management is a persistent problem for scholars and practitioners alike, which is why process issues have received renewed interest in recent years. This book, aimed at scholars and higher level students, frames some of these issues in novel and instructive ways.
Understanding Process Equipment For Operators And Engineers
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Author : Norman Lieberman
language : en
Publisher: Elsevier
Release Date : 2019-05-16
Understanding Process Equipment For Operators And Engineers written by Norman Lieberman and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-16 with Technology & Engineering categories.
Understanding Process Equipment for Operators and Engineers explains how process equipment functions. As problems often arise in plants that must be solved by unit engineers, this book offers successful solutions and methods for their implementation. The concepts explained are based on Norm Lieberman's personal, hands-on experience. Like you, Norm attended a university and was exposed to technical seminars which did not always provide the needed solutions. In this text, you will learn the functioning of a variety of equipment types, including Fired Heater Draft, Centrifugal Pump Head, Distillation Tray Efficiency, Vacuum Jets, Recip Compressors, Steam Turbines, Thermosyphon Circulation Reboilers and Air Cooler.
The Requirements For Activity Based Management The Value Of Process
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Author : John Bentien
language : en
Publisher: Lulu.com
Release Date : 2011
The Requirements For Activity Based Management The Value Of Process written by John Bentien and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with categories.
Resource Efficiency Of Processing Plants
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Author : Stefan Krämer
language : en
Publisher: John Wiley & Sons
Release Date : 2017-12-14
Resource Efficiency Of Processing Plants written by Stefan Krämer 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 2017-12-14 with Science categories.
This monograph provides foundations, methods, guidelines and examples for monitoring and improving resource efficiency during the operation of processing plants and for improving their design. The measures taken to improve their energy and resource efficiency are strongly influenced by regulations and standards which are covered in Part I of this book. Without changing the actual processing equipment, the way how the processes are operated can have a strong influence on the resource efficiency of the plants and this potential can be exploited with much smaller investments than needed for the introduction of new process technologies. This aspect is the focus of Part II. In Part III we discuss physical changes of the process technology such as heat integration, synthesis and realization of optimal processes, and industrial symbiosis. The last part deals with the people that are needed to make these changes possible and discusses the path towards a resource efficiency culture. Written with industrial solutions in mind, this text will benefit practitioners as well as the academic community.
Unit Manufacturing Processes
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 1995-01-03
Unit Manufacturing Processes written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995-01-03 with Technology & Engineering categories.
Manufacturing, reduced to its simplest form, involves the sequencing of product forms through a number of different processes. Each individual step, known as an unit manufacturing process, can be viewed as the fundamental building block of a nation's manufacturing capability. A committee of the National Research Council has prepared a report to help define national priorities for research in unit processes. It contains an organizing framework for unit process families, criteria for determining the criticality of a process or manufacturing technology, examples of research opportunities, and a prioritized list of enabling technologies that can lead to the manufacture of products of superior quality at competitive costs. The study was performed under the sponsorship of the National Science Foundation and the Defense Department's Manufacturing Technology Program.
Multivariate Analysis In The Pharmaceutical Industry
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Author : Ana Patricia Ferreira
language : en
Publisher: Academic Press
Release Date : 2018-04-24
Multivariate Analysis In The Pharmaceutical Industry written by Ana Patricia Ferreira and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-04-24 with Medical categories.
Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. - Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges - Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications - Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come
Biosimilars
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Author : Hiten J. Gutka
language : en
Publisher: Springer
Release Date : 2018-12-13
Biosimilars written by Hiten J. Gutka and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-13 with Medical categories.
This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Understanding The Policy Process
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Author : Hudson, John
language : en
Publisher: Policy Press
Release Date : 2009-03-26
Understanding The Policy Process written by Hudson, John and has been published by Policy Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-26 with Political Science categories.
This book draws on the latest and best social science to explain how and why social policy change occurs. Focusing on the policy making process as the key to change, it uses core concepts of policy analysis, one in each chapter, to build up a fully worked explanation of social policy change and to equip readers with knowledge that can be applied to any aspect of welfare policy and public and social policy more generally. This second edition of the book updates the bestselling first edition for the post-Blair era with international case studies from numerous countries. Understanding the policy process: · introduces the main themes of the policy analysis literature; · demonstrates the centrality of the policy making process to an understanding of the operational possibilities and limits of social policy; · takes account of macro-, meso- and micro-level approaches to social policy analysis; · uses clear explanations of key concepts, up-to-date illustrative case studies and examples to increase students' understanding of the theory and practice of policy analysis; · uses a comparative approach.
Optimization Of Pharmaceutical Processes
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Author : Antonios Fytopoulos
language : en
Publisher: Springer Nature
Release Date : 2022-04-06
Optimization Of Pharmaceutical Processes written by Antonios Fytopoulos and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-06 with Mathematics categories.
Optimization of Pharmaceutical Processes presents contributions from leading authorities in the fields of optimization and pharmaceutical manufacturing. Formulated within structured frameworks, practical examples and applications are given as guidance to apply optimization techniques to most aspects of pharmaceutical processes from design, to lab and pilot scale, and finally to manufacturing. The increasing demand for better quality, higher yield, more efficient-optimized and green pharmaceutical processes, indicates that optimal conditions for production must be applied to achieve simplicity, lower costs and superior yield. The application of such methods in the pharmaceutical industry is not trivial. Quality of the final product is of major importance to human health and the need for deep knowledge of the process parameters and the optimization of the processes are imperative. The volume, which includes new methods as well as review contributions will benefit a wide readership including engineers in pharmaceuticals, chemical, biological, to name just a few.