Edited by Tim Sandle
ISBN 978-0-9956666-7-2 (Hb)
The contamination control of pharmaceutical and healthcare environments and processes, together with pre-clinical drug development labs, requires a far more holistic approach than simply choosing technologies and disinfectants. Today the microbiologist is expected to understand industrial processes and cleanrooms, and how to effectively evaluate microbial risks to products from personnel and processes.
To meet the latest regulatory expectations, the role of the microbiologist is essential. In addition there is important input requirement from quality assurance personnel, engineers, and process specialists. Whilst there is a continuing need for monitoring of the environment and conducting standardised laboratory tests, industrial pharmaceutical microbiology has moved on a great deal in the past decade. It now has to embrace microbiological audits; rapid microbiological methods; conducting risk assessments, both proactive in terms of minimising contamination, and reactive in terms of addressing microbial data deviations; and also ensuring that processes meet ‘quality by design’ principles. In this new 600 page book a team of 24 international authorities will assist you in all your questions.
Industrial Pharmaceutical Microbiology: Standards and Control covers the entire spectrum of industrial pharmaceutical microbiology, as applicable to pharmaceuticals and healthcare. Connect instantly with regulations and current best practices on everything from disinfectants to sterility testing; environmental monitoring to hazard analysis; and from pharmaceutical processes to biological indicators. All of this is developed from an international perspective, where different regulations are compared and contrasted together with insightful commentary as to best practices.
Industrial Pharmaceutical Microbiology: Standards and Controls provides clear, practical and up-to-date guidance for handling virtually every compliance and operational challenge associated with pharmaceutical microbiology.
"This new second edition is an excellent reference work for those working in industrial pharmaceutical microbiology. It covers all aspects of this complex subject with contributions from many leading figures in the field and is highly recommended."
European Journal of Parenteral and Pharmaceutical Sciences, Vol 19 No 4
"This book is not simply about the science of microbiology for it takes the science into to the industrial setting and offers invaluable advice on how to apply it to the manufacture of pharmaceutical and healthcare products, and for keeping such products within microbial control. A further strength with the book is its topicality, in having the most recent regulations and standards featured. The book features 25 chapters covering environmental monitoring, water systems, vaccines, safety, biological indicators and microbiology laboratory management. Picking the stand-out chapters is difficult, because there are so many good ones. … In summary this book is essential for every pharmaceutical laboratory: scientific, topical and practical"
Pharmig, January 2015
"The 2015 edition of Industrial Pharmaceutical Microbiology is a first-rate reference resource for any professional microbiologist, covering a wide range of topics of relevance to the whole industry. The book starts with the role of the microbiologist and the microbiology laboratory, before moving on to specific microbiological and industry controls. It closes with the issues facing some specialised areas of the industry with their own particular microbiological challenges. … Overall a very useful, well-edited book that will be an invaluable reference to anyone involved in pharmaceutical microbiology."
Clean Air and Technology Review Issue 21, January 2015