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

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9783527325849: Process Understanding: For Scale-Up and Manufacture of Active Ingredients

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.

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About the Author:

Ian Houson gained a 1st class BSc. Hons in Chemistry and Oceanography from the University of Southampton, he completed his doctorate at the University of Oxford with Prof. John Brown FRS in organic chemistry. Ian then joined Zeneca, which became Avecia and finally NPIL Pharma where he was Chemical Process R&D Manager for the site. His main roles were invention of new routes, scale-up and manufacturing support for the contract manufacturing of agrochemicals and pharmaceuticals at the kg`s to 10`s tonnes scale. Moving to Britest Ltd. in 2007 as a senior innovation specialist, Ian was involved in developing new tools and methodologies
for innovative process development and manufacturing, facilitating manufacturing process improvement studies and collaborative research in a number of European projects. In March 2011 Ian joined Giltech Ltd, Ayr, Scotland as a Senior Scientist involved in development of novel biodegradable and slow release technologies across a wide range of chemicals and medical device applications. His responsibilities include product development, supporting joint development projects and intellectual property aspects.

Review:

“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!.”  (Org. Process Res. Dev, 1 August 2013)

 

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