Industrial Pharmaceutical Microbiology: Standards and Controls 6th Edition

Edited by Tim Sandle

ISBN: 978-1-9196417-6-8 eBook; 706pp, £240
ISBN: 978-1-9196417-5-1 Hardback; 706pp, £270

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 book 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.

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 of previous editions

"This 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

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

1. Safety in Microbiology

Nigel J Silman 1.1–1.42

2 Best Practices in Microbiology Laboratory Training

Tim Sandle 2.1–2.24

3 Validation and Qualification Approaches for Microbiological

Methods

Amy Marflitt, Joanna Wolodkowicz and Tim Sandle 3.1–3.16

4 The Use of Culture Media in Pharmaceutical Microbiology

Tim Sandle 4.1–4.26

5 Rapid Microbiological Methods and Process Analytical

Technology (PAT)

Jeanne Moldenhauer 5.1–4.42

6 Microbial Risk Assessments for Operational Cleanrooms

Tim Eaton 6.1–6.18

7 Product Release and Microbiological Quality Assurance

John Dolman and Tim Sandle 7.1–7.14

8 Auditing the Pharmaceutical Microbiology Department

Andy Martin 8.1–8.23

Part B: Microbiological Control and Industrial Processes

9 Microbiological Environmental Monitoring

Rosamund M Baird and Tim Sandle 9.1–9.30

10 Selection and use of Cleaning and Disinfection Agents in

Pharmaceutical Manufacturing

Tim Sandle 10.1–10.32

11 Microbiology of Pharmaceutical Grade Water

Tim Sandle 11.1–11.20

12 Biofilm Contamination in Pharmaceutical Facilities

Alex P Blanchard 12.1–12.36

13 Strategies and Approaches for Microbial Identification

Tim Sandle 13.1–13.20

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

Testing, Operation and Regulatory Aspects

John Neiger 14.1–14.74

15 Aseptic Process Simulations/Media Fills

Francesco Boschi 15.1–15.34

16 Filtration

Claire Jarmey-Swan 16.1–16.18

17 Sterilisation Technologies

Eric Dewhurst and Eamonn Hoxey 17.1–17.45

18 Biological Indicators

Tim Sandle 18.1–18.27

19 Endotoxins and Depyrogenation

Karen Zink McCullough 19.1–19.26

20 Containment System Integrity: Microbial Challenges for

Sterile Products

Tim Sandle 20.1–20.16

21 Advanced Therapy Medicinal Products: A contamination

control perspective

Tim Sandle 21.1–21.21

Part C: Regulatory Aspects of Industrial Pharmaceutical Microbiology

22 Microbiological Quality and Regulatory Requirements for

Biotherapeutics

Daniel Galbraith 22.1–22.13

23 Regulatory Microbial Expectations for Non-Sterile Manufacture

of Pharmaceutical Dose Forms

Edel Fitzmaurice 23.1–23.9

24 The Pharmacopoeias and Microbiology

Barbara Gebala 24.1–24.15

25 Challenges of Bacteriophage Therapy

Alexander Sulakvelidze 25.1–25.16