{"product_id":"process-understanding-for-scale-up-and-manufacture-of-active-ingredients-9783527325849","title":"Process Understanding: For Scale-Up and Manufacture of Active Ingredients","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eProcess 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. \u003cbr\u003e \u003cbr\u003e 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. \u003cbr\u003e \u003cbr\u003e 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.\u003cbr\u003e \u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e“Who should read this book? I would recommend everyone to read it, especially the parts that are not from your own discipline. If you are a development chemist, you should find much important learning in the engineering sections! Why not learn how impurities affect crystal growth or how the Kolmogorov space helps us understand mixing, or why not learn how to make ruby crystals by the Czochralski method and much, much more;and it is all in one book! Get your own copy now!.”  (\u003ci\u003eOrg. Process Res. Dev\u003c\/i\u003e, 1 August 2013)\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003ePreface\u003cbr\u003e \u003cbr\u003e QUALIT Y BY DESIGN\u003cbr\u003e History\u003cbr\u003e Defining Product Design Requirements and Critical Quality Attributes\u003cbr\u003e The Role of Quality Risk Management in QbD\u003cbr\u003e Design Space and Control Strategy\u003cbr\u003e Quality Systems\u003cbr\u003e \u003cbr\u003e ROUTE AND PROCESS SELECTION\u003cbr\u003e Introduction\u003cbr\u003e Route Evaluation\u003cbr\u003e Factors to Consider\u003cbr\u003e Route Selection\u003cbr\u003e Process Selection\u003cbr\u003e Summary\u003cbr\u003e \u003cbr\u003e CRITICAL STAGES OF SAFETY ASSESSMENT IN PROCESS DESIGN AND SCALE-UP\u003cbr\u003e Reaction Safety Concepts\u003cbr\u003e Pre-Laboratory Safety Studies\u003cbr\u003e The Synergies of Safety and Optimization -\u003cbr\u003e Together\u003cbr\u003e Establishing a Reliable Basis of Safety for Scale-Up\u003cbr\u003e Flammability Hazards\u003cbr\u003e Summary\u003cbr\u003e \u003cbr\u003e UNDERSTANDING THE REACTION\u003cbr\u003e Introduction\u003cbr\u003e Process Complexity\u003cbr\u003e Topics for Data Acquisition\u003cbr\u003e Reaction Profiles\u003cbr\u003e Reaction Pictures\u003cbr\u003e Ionic Equilibria and Reaction Selectivity\u003cbr\u003e Kinetics\u003cbr\u003e Catalyzed Processes\u003cbr\u003e The Rate-Determining Step\u003cbr\u003e Mixing in Chemical Reactors\u003cbr\u003e Mixing Theory\u003cbr\u003e Multiphase Processes\u003cbr\u003e Mass Transfer Theory\u003cbr\u003e Mass Transfer and Mixing Requirements in Multiphase Systems\u003cbr\u003e Concepts of Structure and Scale for Equipment Selection\u003cbr\u003e Conclusion\u003cbr\u003e \u003cbr\u003e USE OF MODELS TO ENHANCE PROCESS UNDERSTANDING\u003cbr\u003e Introduction\u003cbr\u003e The Process Characterization Elements of a Chemical Reaction\u003cbr\u003e The Impact of Modeling\u003cbr\u003e Understanding the Chemistry\u003cbr\u003e Physical Rates (The Elements of Mass Transfer)\u003cbr\u003e Summary and Outlook\u003cbr\u003e \u003cbr\u003e SCALE-UP OF CHEMICAL REACTIONS\u003cbr\u003e Introduction\u003cbr\u003e Case Study -\u003cbr\u003e Batch Hydrogenation\u003cbr\u003e Scale-Up of Stirred Tank Reactors (STRs)\u003cbr\u003e Stirred Tank Scale-Up\u003cbr\u003e Chemistry Effects in Scale-Up\u003cbr\u003e Achieving Process Understanding for Reactor Scale-Up\u003cbr\u003e Reactor Selection\u003cbr\u003e Exploiting Process Understanding in Scale-Up\u003cbr\u003e Conclusions\u003cbr\u003e \u003cbr\u003e PROCESS UNDERSTANDING -\u003cbr\u003e CRYSTALLIZATION\u003cbr\u003e Introduction\u003cbr\u003e Crystallization Processes\u003cbr\u003e Batch Crystallization Techniques\u003cbr\u003e Process Control of Crystallization\u003cbr\u003e Analytical Techniques for Product Characterization\u003cbr\u003e Conclusions\u003cbr\u003e \u003cbr\u003e KEY TECHNOLOGIES AND OPPORTUNITIES FOR INNOVATION AT THE DRUG SUBSTANCE -\u003cbr\u003e DRUG PRODUCT INTERFACE\u003cbr\u003e Introduction\u003cbr\u003e Opportunities for Innovation\u003cbr\u003e Crystallization\u003cbr\u003e Selected Manufacturing Technologies at the Drug Substance -\u003cbr\u003e Drug Product Interface\u003cbr\u003e Analytical Techniques\u003cbr\u003e Conclusions\u003cbr\u003e \u003cbr\u003e PROCESS UNDERSTANDING REQUIREMENTS IN ESTABLISHED MANUFACTURE\u003cbr\u003e Introduction\u003cbr\u003e The Status Quo\u003cbr\u003e Risk and Reward\u003cbr\u003e Terms and Definitions\u003cbr\u003e Process Understanding Requirements\u003cbr\u003e Method Development and Installation\u003cbr\u003e Statistical Process Control\u003cbr\u003e Automation\u003cbr\u003e Conclusion\u003cbr\u003e \u003cbr\u003e PLANT DESIGN\u003cbr\u003e Introduction\u003cbr\u003e Developing Process Concept to Plant Concept\u003cbr\u003e Regulations\u003cbr\u003e Infrastructure Design\u003cbr\u003e Portfolio Analysis and Asset Planning\u003cbr\u003e \u003cbr\u003e CONTRACT MANUFACTURE\u003cbr\u003e Introduction\u003cbr\u003e Why Contract?\u003cbr\u003e The Contractor\u003cbr\u003e The Client\u003cbr\u003e Technology Transfer\u003cbr\u003e What Makes a Good Technical Package?\u003cbr\u003e Client Process Understanding\u003cbr\u003e Case Studies\u003cbr\u003e Winning and Delivering the Project\u003cbr\u003e Project Timing\u003cbr\u003e Challenges of Multiproduct Plant Scheduling against an Uncertain Background\u003cbr\u003e Conclusion\u003cbr\u003e \u003cbr\u003e WHOLE PROCESS DESIGN\u003cbr\u003e Process Understanding for Whole Process Design\u003cbr\u003e Process Outcomes\u003cbr\u003e Organization of the Design Activity\u003cbr\u003e Risk and Uncertainty in WPD\u003cbr\u003e Whole Process Representations\u003cbr\u003e Decision Making in WPD\u003cbr\u003e Summary\u003cbr\u003e","brand":"Wiley-VCH Verlag GmbH","offers":[{"title":"Default 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