Sunday, 14 June 2015

Industrial Pharmaceutical Microbiology: Standards and Controls

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

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.

The chapter list is:

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

1. Safety in Microbiology by Nigel Silman and John V Daniels

2. Best Practices in Microbiology Laboratory Training by Tim Sandle

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

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

5. Microbial Risk Assessments for Operational Cleanrooms by Tim Eaton

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

7. Auditing the Pharmaceutical Microbiology Department by Andy Martin

Part B: Microbiological Control and Industrial Processes
8. Microbiological Environmental Monitoring by Rosamund M Baird

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

10 Microbiology of Pharmaceutical Grade Water by Tim Sandle

11. Biofilm Contamination in Pharmaceutical Facilities by Alex P Blanchard

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

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

14. Filtration by Claire Jarmey-Swan

15. Sterilisation Technologies by Eric Dewhurst and Eamonn Hoxey

16. Biological Indicators by Tim Sandle

17. Endotoxins and Depyrogenation by Karen Zinc McCullough

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

19. Challenges of Bacteriophage Therapy by Alexander Sulakvelidze

Part C: Regulatory Aspects of Industrial Pharmaceutical Microbiology

20. Microbiological Quality and Regulatory Requirements for Biotherapeutics by Daniel Galbraith

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

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

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

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

25. The Pharmacopoeias and Microbiology by V Fenton-May

For details and to order a copy, see: Euromed Communications: Industrial Pharmaceutical Microbiology: Standards & Controls - 2015 Edition
Posted by Tim Sandle