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Process Understanding : For Scale-Up and Manufacture of Active Ingredients - Ian Houson

Process Understanding

For Scale-Up and Manufacture of Active Ingredients

By: Ian Houson

eText | 8 April 2011 | Edition Number 1

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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.

Industry Reviews

"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 moreand it is all in one book! Get your own copy now!." (Org. Process Res. Dev, 1 August 2013)

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Non-FictionScienceChemistryEngineering & TechnologyIndustrial Chemistry & Manufacturing TechnologiesIndustrial ChemistryBiochemical Engineering

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