Industrial Pharmaceutical Microbiology Standards & Controls 6th Edition

Jan 2023
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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 700-page edition a team of 20 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.

The new 6th edition of 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.

Table of Contents

Table of Contents:

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. Validation approaches for microbiological methods

    Amy Marflitt and Joanna Wolodkowicz

  4. The Use of Culture Media in Pharmaceutical Microbiology

    Tim Sandle

  5. Rapid Microbiological Methods and Process Analytical

    Technology (PAT)

    Jeanne Moldenhauer

  6. Microbial Risk Assessments for Operational Cleanrooms

    Tim Eaton

  7. Product release and microbiological quality assurance

    John Dolman and Tim Sandle

  8. Auditing the Pharmaceutical Microbiology Department

    Andy Martin

    Part B: Microbiological Control and Industrial Processes

  9. Microbiological Environmental Monitoring

    Rosamund M Baird

  10. Selection and use of Cleaning and Disinfection Agents in

    Pharmaceutical Manufacturing

    Tim Sandle

  11. Microbiology of Pharmaceutical Grade Water

    Tim Sandle

  12. Biofilm Contamination in Pharmaceutical Facilities

    Alex P Blanchard

  13. Microbial Identification Strategy for Pharmaceutical


    Tim Sandle

  14. Cleanrooms, Isolators and RABS: Basic Principles, Design,

    Testing, Operation and Regulatory Aspects

    John Neiger

  15. Aseptic Process Simulations/Media Fills

    Francesco Boschi

  16. Filtration

    Claire Jarmey-Swan

  17. Sterilisation Technologies

    Eric Dewhurst and Eamonn Hoxey

  18. Biological Indicators

    Tim Sandle

  19. Endotoxins and Depyrogenation

    Karen Zink McCullough

  20. Containment System Integrity: Microbial Challenges for

    Sterile Products

    Tim Sandle

  21. Microbiological controls around ATMPs

    Tim Sandle

    Part C: Regulatory Aspects of Industrial Pharmaceutical Microbiology

  22. Microbiological Quality and Regulatory Requirements for


    Daniel Galbraith

  23. Regulatory Microbial Expectations for Non-Sterile Manufacture

    of Pharmaceutical Dose Forms

    Edel Fitzmaurice

  24. The Pharmacopoeias and Microbiology

    Barbara Gebala

  25. Challenges of Bacteriophage Therapy

Alexander Sulakvelidze

About the Authors