Industrial Pharmaceutical Microbiology 5th Edition

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.

Reviews

"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

Contents

br>

Part A: The Role of the Microbiologist and the Microbiology Laboratory
1 Safety in Microbiology by Nigel J Silman

2 Best Practices in Microbiology Laboratory Trainingby Tim Sandle

3 Validation approaches for microbiological methodsby Amy Marflitt and Joanna Wolodkowicz

4 The Use of Culture Media in Pharmaceutical Microbiology byTim Sandle

5 Rapid Microbiological Methods and Process Analytical Technology (PAT) by Jeanne Moldenhauer

6 Microbial Risk Assessments for Operational Cleanroomsby Tim Eaton

7 The role of the Qualified Person in microbiological quality assurance by John Dolman and Tim Sandle

8 Microbiology laboratory design and the qualification of microbiology laboratory equipment by Hedley Maxwell, Dovile Bingelyte and Patrick Sockett

9 Auditing the Pharmaceutical Microbiology Department by Andy Martin

Part B: Microbiological Control and Industrial Processes

10 Microbiological Environmental Monitoringby Rosamund M Baird

11 Selection and use of Cleaning and Disinfection Agents in Pharmaceutical Manufacturing by Tim Sandle

12 Microbiology of Pharmaceutical Grade Water by Tim Sandle

13 Biofilm Contamination in Pharmaceutical Facilitiesby Alex P Blanchard

14 Microbial Identification Strategy for Pharmaceutical Microbiology by Tim Sandle

15 Cleanrooms, Isolators and RABS: Basic Principles, Design, Testing, Operation and Regulatory Aspectsby John Neiger

16 Aseptic Process Simulations/Media Fillsby Marco Budini and Francesco Boschi

17 Filtration by Claire Jarmey-Swan

18 Sterilisation Technologies by Eric Dewhurst and Eamonn Hoxey

19 Biological Indicators by Tim Sandle

20 Endotoxins and Depyrogenation by Karen Zink McCullough

21 Containment System Integrity: Microbial Challenges for Sterile Products by Tim Sandle

Part C: Regulatory Aspects of Industrial Pharmaceutical Microbiology

22 Microbiological Quality and Regulatory Requirements for Biotherapeutics by Daniel Galbraith

23 Regulatory Microbial Expectations for Non-Sterile Manufacture of Pharmaceutical Dose Forms by Edel Fitzmaurice

24 The Pharmacopoeias and Microbiologyby V Fenton-May and Barbara Gebala

Part D: Microbiological Control and Regulatory Aspects

25 Challenges of Bacteriophage Therapyby Alexander Sulakvelidze

26 The Microbiological Quality and Regulatory Requirements for Natural and Nutraceutical Products

by Martin Dennison

27 The Regulatory Control and Quality Assurance of Immunological Products by Tim Sandle 27.1–27.16

28 Veterinary Medicinal Antimicrobial Products by Klaus Hellmann