Monday, 9 February 2015

Industrial Pharmaceutical Microbiology: Standards & Controls (2015)

A new edition of the essential microbiology book “Industrial Pharmaceutical Microbiology: Standards & Controls” has been published.

This publication covers the entire spectrum of industrial pharmaceutical microbiology, as applicable to pharmaceuticals and healthcare and it has been edited by Professor Geoff Hanlon and Dr. 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 Controls 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.

For details and to order a copy, see: Euromed

The chapter list is:

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

1. Safety in Microbiology
Nigel Silman and John V Daniels

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

For details and to order a copy, see: Euromed

Posted by Tim Sandle