Microbiology And Sterility Assurance In Pharmaceuticals And Medical Devices – New Book Released

Oct. 12, 2010 - PRLog -- BUSINESS HORIZONS
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FOR IMMEDIATE RELEASE


Microbiology And Sterility Assurance In Pharmaceuticals And Medical Devices – New Book Released


Top International Experts Come Together to Offer the Latest Contemporary Knowledge on Microbiological Aspects of Sterility Assurance for Pharmaceuticals, Biotechnology and Medical Devices in this new book.

Hardbound 996 pages, ISBN: 9788190646741


Injectable product manufacturing is booming because of the growth of new biopharmaceuticals and small molecule anticancer drugs. The requirements for contamination control will become even more stringent than today. Isolators or blow-fill-seal equipment have already replaced the conventional clean rooms and LAF-hoods in many production facilities. Conventional microbiological monitoring methods, requiring 3 to 5 days of incubation will become inappropriate. Equipment is already available allowing real time, simultaneous viable and non-viable counting. Sterile manufacturing facilities especially, require state-of-the-art skills to ensure sterility and compliance at all times. With a view to provide such cutting-edge information within reach of even the SMB pharma sector, this book – Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices – has been launched. This book therefore represents an unparalleled and unprecedented text in the field of pharmaceutical and medical device microbiology. This book not only covers subject matter and technical content which is established as best practices, but also includes content regarded as possible, future and emerging technology or processes.

The book is edited by three people; Madhu Raju Saghee (from India), Tim Sandle (from UK) and Edward C. Tidswell (from USA). Experts from top pharmaceutical companies like Baxter, Johnson and Johnson, Amgen, Pfizer, Patheon, Sartorious, Gador, Catalent, British NHS, GE Healthcare and many more top experts from industry and academics have come together to create this collection of knowledge. The list of authors includes chair and members of USP expert committee on Microbiology and Sterility Assurance, president and senior experts in Parenteral Drug Association, ISPE and ASTM. Foreword by Hans van Doorne, Chair of EDQM, Committee on Microbiology.

The text is organized into four distinct sections each with a number of chapters exclusively dedicated to specific subject matter. In each chapter the style and detail varies to reflect the individual expertise and experience of the contributing author, yet maintaining a consistently high caliber of content permitting a superior learning experience for the reader. The book aims to both inform and assist the reader by balancing theoretical understanding with practical application.

The results of 45 years of scientific and technological development are laid down in these 33 chapters. These chapters, all written by international experts, give a vivid picture of today's pharmaceutical microbiology. The high standard of the chapters makes it an essential reference guide that should be on the shelf of everyone who is involved or interested in this field.

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