Continuous Manufacturing of Pharmaceuticals

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1119001323
Total Pages : 645 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Continuous Manufacturing of Pharmaceuticals by : Peter Kleinebudde

Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-09-05 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Introduction to Market Access for Pharmaceuticals

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Publisher : CRC Press
ISBN 13 : 1315314584
Total Pages : 310 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis Introduction to Market Access for Pharmaceuticals by : Mondher Toumi

Download or read book Introduction to Market Access for Pharmaceuticals written by Mondher Toumi and published by CRC Press. This book was released on 2017-01-12 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers’ needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University. Key Features: The first guide to market access for pharmaceuticals based on tested teaching materials Addresses both pharmaceutical and vaccine products Includes case studies and scenarios Covers market access consdierations for Western Europe, the USA, Japan and China Explains the impact the changing healthcare market will have on your product

The Future of Pharmaceuticals

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Author :
Publisher : CRC Press
ISBN 13 : 1000458164
Total Pages : 620 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis The Future of Pharmaceuticals by : Sarfaraz K. Niazi

Download or read book The Future of Pharmaceuticals written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2022-03-01 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future. Key Features: Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.

Solid State Characterization of Pharmaceuticals

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Publisher : John Wiley & Sons
ISBN 13 : 1119970172
Total Pages : 557 pages
Book Rating : 4.1/5 (199 download)

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Book Synopsis Solid State Characterization of Pharmaceuticals by : Richard A. Storey

Download or read book Solid State Characterization of Pharmaceuticals written by Richard A. Storey and published by John Wiley & Sons. This book was released on 2011-03-31 with total page 557 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of solid state characterization is central to the pharmaceutical industry, as drug products are, in an overwhelming number of cases, produced as solid materials. Selection of the optimum solid form is a critical aspect of the development of pharmaceutical compounds, due to their ability to exist in more than one form or crystal structure (polymorphism). These polymorphs exhibit different physical properties which can affect their biopharmaceutical properties. This book provides an up-to-date review of the current techniques used to characterize pharmaceutical solids. Ensuring balanced, practical coverage with industrial relevance, it covers a range of key applications in the field. The following topics are included: Physical properties and processes Thermodynamics Intellectual guidance X-ray diffraction Spectroscopy Microscopy Particle sizing Mechanical properties Vapour sorption Thermal analysis & Calorimetry Polymorph prediction Form selection

The Life-Cycle of Pharmaceuticals in the Environment

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Author :
Publisher : Elsevier
ISBN 13 : 190881845X
Total Pages : 272 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis The Life-Cycle of Pharmaceuticals in the Environment by : B.M. Peake

Download or read book The Life-Cycle of Pharmaceuticals in the Environment written by B.M. Peake and published by Elsevier. This book was released on 2015-11-13 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship. - Encompasses the full lifecycle of common pharmaceuticals, from prescription and dispensing practices to their occurrence in a range of different types of natural waters and their environmental impact - Explores the role of the healthcare system and its affect on users - Beneficial for environmental engineers involved in the design and operation of appropriate degradation technologies of the pharmaceutical prescription and disposal practices

The Textbook of Pharmaceutical Medicine

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Publisher : John Wiley & Sons
ISBN 13 : 047098726X
Total Pages : 883 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis The Textbook of Pharmaceutical Medicine by : John P. Griffin

Download or read book The Textbook of Pharmaceutical Medicine written by John P. Griffin and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 883 pages. Available in PDF, EPUB and Kindle. Book excerpt: New edition of succesful standard reference book for thepharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebookfor the Diploma in Pharmaceutical Medicine, and is used as astandard reference throughout the pharmaceutical industry. The newedition includes greater coverage of good clinical practice, acompletely revised statistics chapter, and more on safety. Coversthe course information for the Diploma in PharmaceuticalMedicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe andregulation of therapeutic products in Australia

The Colonial Life of Pharmaceuticals

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Publisher : Cambridge University Press
ISBN 13 : 1108474667
Total Pages : 291 pages
Book Rating : 4.1/5 (84 download)

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Book Synopsis The Colonial Life of Pharmaceuticals by : Laurence Monnais

Download or read book The Colonial Life of Pharmaceuticals written by Laurence Monnais and published by Cambridge University Press. This book was released on 2019-08-22 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative examination of the early globalization of the pharmaceutical industry, arguing that colonialism was crucial to the worldwide diffusion of modern medicines.

Bioanalysis of Pharmaceuticals

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Publisher : John Wiley & Sons
ISBN 13 : 1118716825
Total Pages : 332 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Bioanalysis of Pharmaceuticals by : Steen Honoré Hansen

Download or read book Bioanalysis of Pharmaceuticals written by Steen Honoré Hansen and published by John Wiley & Sons. This book was released on 2015-07-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry is the first student textbook on the separation science and mass spectrometry of pharmaceuticals present in biological fluids with an educational presentation of the principles, concepts and applications. It discusses the chemical structures and properties of low- and high-molecular drug substances; the different types of biological samples and fluids that are used; how to prepare the samples by extraction, and how to perform the appropriate analytical measurements by chromatographic and mass spectrometric methods. Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry: Is an introductory student textbook discussing the different principles and concepts clearly and comprehensively, with many relevant and educational examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents both the basic principles that are regularly taught in universities, along with the practical use of bioanalysis as carried out by researchers in the pharmaceutical industry and in hospital laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The book includes multiple examples to illustrate the theory and application, with many practical aspects including calculations, thus helping the student to learn how to convert the data recorded by instruments into the real concentration of the drug substances within the biological sample.

Pharmaceutical Toxicology

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Publisher :
ISBN 13 :
Total Pages : 284 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Pharmaceutical Toxicology by : Gerard J. Mulder

Download or read book Pharmaceutical Toxicology written by Gerard J. Mulder and published by . This book was released on 2006 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Toxicology studies are carried out on all drug substances to ensure safety. This book provides an overview of the methodology andrequirements of pre-clinical safety assessments of new medicines. with the focus on medicinal drugs - the most important safety issues of drugs are covered, including registration requirements of new drugs and pharmacovigilance. This is an introductory text for students at BSc, MSc and PhD levels,and will be an excellent companion to pharmacology textbooks, combining a broad treatment of the issues relevant for assessing the safety/efficacy balance of a new drug wit

Global Pharmaceuticals

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Publisher : Duke University Press
ISBN 13 : 9780822337416
Total Pages : 314 pages
Book Rating : 4.3/5 (374 download)

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Book Synopsis Global Pharmaceuticals by : Adriana Petryna

Download or read book Global Pharmaceuticals written by Adriana Petryna and published by Duke University Press. This book was released on 2006-03-15 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: DIVAnthropological study of the globalization of pharmaceuticals and its effects on local cultures, health, and economics./div

3D Printing of Pharmaceuticals

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Publisher : Springer
ISBN 13 : 3319907557
Total Pages : 246 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis 3D Printing of Pharmaceuticals by : Abdul W. Basit

Download or read book 3D Printing of Pharmaceuticals written by Abdul W. Basit and published by Springer. This book was released on 2018-08-06 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.

Equitable Access to High-Cost Pharmaceuticals

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Publisher : Academic Press
ISBN 13 : 0128119624
Total Pages : 240 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Equitable Access to High-Cost Pharmaceuticals by : Zaheer-Ud-Din Babar

Download or read book Equitable Access to High-Cost Pharmaceuticals written by Zaheer-Ud-Din Babar and published by Academic Press. This book was released on 2018-02-27 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. - Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs - Incorporates existing guidelines and recommendations by international organizations - Compares and contrasts how different countries fund and police high-cost drug access - Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing - Reviews novel pharmaceuticals of current research interest

Drugs for Life

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Publisher : Duke University Press
ISBN 13 : 0822348713
Total Pages : 277 pages
Book Rating : 4.8/5 (223 download)

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Book Synopsis Drugs for Life by : Joseph Dumit

Download or read book Drugs for Life written by Joseph Dumit and published by Duke University Press. This book was released on 2012-09-03 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Challenges our understanding of health, risks, facts, and clinical trials [Payot]

Principles and Practice of Pharmaceutical Medicine

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Publisher : John Wiley & Sons
ISBN 13 : 9780470093146
Total Pages : 780 pages
Book Rating : 4.0/5 (931 download)

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Book Synopsis Principles and Practice of Pharmaceutical Medicine by : Lionel D. Edwards

Download or read book Principles and Practice of Pharmaceutical Medicine written by Lionel D. Edwards and published by John Wiley & Sons. This book was released on 2007-04-30 with total page 780 pages. Available in PDF, EPUB and Kindle. Book excerpt: The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Raman and SERS Investigations of Pharmaceuticals

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Publisher : Springer Science & Business Media
ISBN 13 : 3540782834
Total Pages : 221 pages
Book Rating : 4.5/5 (47 download)

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Book Synopsis Raman and SERS Investigations of Pharmaceuticals by : Monica Baia

Download or read book Raman and SERS Investigations of Pharmaceuticals written by Monica Baia and published by Springer Science & Business Media. This book was released on 2008-06-11 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last several years it has become apparent to most researchers that interdisciplinary research is the key to success in the sciences’ future. The present book exemplifies such interdisciplinary work. Thus, some new derivatives have been prepared by chemists and consecutively analyzed by physicists in order to better understand their physical-chemical properties for future tests to be performed by pharmacists. The book consists of an introductory section and other eight chapters. First, the fundamentals of infrared, Raman and surface-enhanced Raman spectroscopy and those of the theoretical methods employed for the vibrational prediction modes are highlighted. The SERS investigations illustrated in the following chapters are focused on different kinds of drugs: tranquilizers and sedatives, anti-inflammatory drugs, vitamins, drugs with anti-bacterial properties, etc. Since there is an increased interest in designing highly effective and controllable SERS-active substrates, a few newly developed substrates that could contribute to a deeper understanding and knowledge of the adsorption behavior of various types of molecules of pharmaceutical and medical interest are also presented.

Pharmaceuticals in the Environment

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Publisher : Springer Science & Business Media
ISBN 13 : 3540746641
Total Pages : 531 pages
Book Rating : 4.5/5 (47 download)

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Book Synopsis Pharmaceuticals in the Environment by : Klaus Kümmerer

Download or read book Pharmaceuticals in the Environment written by Klaus Kümmerer and published by Springer Science & Business Media. This book was released on 2008-10-10 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following the success of the first edition, this pioneering study of pharmaceuticals in the environment has been updated and greatly extended. It includes the status of research on pharmaceuticals in soil, with attention to terrestrial and aquatic environments as well as new substance categories such as tetracylines and chinolones and the latest results concerning contamination of the environment and risk reduction.

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

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Publisher : Elsevier
ISBN 13 : 1908818638
Total Pages : 370 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by : Tim Sandle

Download or read book Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products