Industrial Pharmaceutical Microbiology: Standards & Controls

  • ID: 2570348
  • Book
  • Region: Global
  • 600 Pages
  • Euromed Communications
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Industrial Pharmaceutical Microbiology: Standards and Controls
Edited by Geoff Hanlon and Tim Sandle

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.

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Industrial Pharmaceutical Microbiology: Standards and Control 2015 Edition
Editors – Geoff Hanlon and Tim Sandle

Preface Geoff Hanlon and Tim Sandle

Part A: The Role of the Microbiologist and the Microbiology Laboratory

1. Safety in Microbiology
Nigel Silman

2. Best Practices in Microbiology Laboratory Training
Tim Sandle

3. The Use of Culture Media in Pharmaceutical Microbiology
Tim Sandle

4. Rapid Microbiological Methods and Process Analytical Technology (PAT) Jeanne Moldenhauer

5. Microbial Risk Assessments for Operational Cleanrooms
Tim Eaton

6. The Role of the Qualified Person in Microbiological Quality Assurance
John Dolman

7. Auditing the Pharmaceutical Microbiology Department
Andy Martin

Part B: Microbiological Control and Industrial Processes

8. Microbiological Environmental Monitoring
Rosamund M Baird

9. Selection and Use of Cleaning and Disinfection Agents in Pharmaceutical Manufacturing
Tim Sandle

10 Microbiology of Pharmaceutical Grade Water
Tim Sandle

11. Biofilm Contamination in Pharmaceutical Facilities
Alex P Blanchard

12. Cleanrooms, Isolators and Rabs: Basic Principles, Design, Testing, Operation and Regulatory Aspects
John Neiger

13. Aseptic Process Simulations/Media Fills
Marco Budini and Francesco Boschi

14. Filtration
Claire Jarmey-Swan

15. Sterilisation Technologies
Eric Dewhurst and Eamonn Hoxey

16. Biological Indicators
Tim Sandle

17. Endotoxins and Dehydrogenation
Karen Zinc McCullough

18. Containment System Integrity: Microbial Challenges for Sterile Products
Tim Sandle

19. Challenges of Bacteriophage Therapy
Alexander Sulakvelidze

Part C: Regulatory Aspects of Industrial Pharmaceutical Microbiology

20. Microbiological Quality and Regulatory Requirements for Biotherapeutics
Daniel Galbraith

21. The Microbiological Quality and Regulatory Requirements for Natural and Nutraceutical Products
Martin Dennison

22. The Regulatory Control and Quality Assurance of Immunological products
Tim Sandle

23. Regulatory Guidelines (Microbiology) for Veterinary Medicinal Antimicrobial Products
Klaus Hellmann and Peter Silley

24. Regulatory Expectations for Non-Sterile Manufacture of Pharmaceutical Dose Forms
Edel Fitzmaurice

25. The Pharmacopoeias and Microbiology
V Fenton-May

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- "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 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. 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 Containment Review Issue 21, January 2015

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