While there are books on cleanrooms available, these focus almost entirely on the physical and rarely address microbiological risks. Similarly, there are various books on microbiology (even a few about pharmaceutical microbiology), yet these books rarely mention cleanrooms, or, where they do, give controlled environments limited coverage.
To the authors of Cleanroom Microbiology, these two domains, normally separated by different functions, are inseparable. This book is about cleanrooms and controlled environments in relation to the pharmaceutical and healthcare sectors and is applicable to both the sterile and non-sterile pharmaceutical sectors with its focus on cleanroom microbiology.
Book written in November, 2014
Table of Contents:
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- Introduction to Cleanroom Microbiology
- Cleanrooms, Clean Zones and Cleanroom Technology
- Global Standards for Cleanrooms and cGMPs
- Microbiological Environmental Monitoring of Cleanrooms: Part 1: Contamination Sources and Methods
- Microbiological Environmental Monitoring of Cleanrooms: Part 2: Constructing an Environmental Monitoring Program
- Cleanroom Microflora
- Characterization and Identification of Cleanroom Microflora
- Evaluation and Interpretation of Environmental Monitoring Data
- The Human Microbiome Project and the Implications for Cleanroom Microbiology
- Implications of Pharmaceutical Microbial Contamination
- Contamination Control in Cleanrooms: Part 1: Disinfection Practices in Pharmaceutical Cleanrooms
- Contamination Control in Cleanrooms: Part 2: Cleanroom Design Factors
- Contamination Control in Cleanrooms: Part 3: The Personnel Factor
- Contamination Control in Cleanrooms: Part 4: Media Simulation Trials
- Auditing Cleanrooms for the Contamination Control Perspective
- Cleanrooms and Microbiology: The Importance of Risk Assessment
About the Authors
Tim Sandle has over twenty-five years of experience in pharmaceutical microbiology. Tim is the site microbiologist at the Bio Products Laboratory and he is a visiting tutor at the University of Manchester, where he teaches pharmaceutical microbiology. In addition, Tim is a longstanding committee member of the Pharmaceutical Microbiology Interest Group (Pharmig). Tim has worked on a number of different microbiological projects including developments in the testing of bacterial endotoxins and pyrogens; validation of culture media; establishing the environmental monitoring regime for a network of over two hundred clean rooms; qualifying several water systems; and validating a sterility testing isolator system. Tim has authored over three-hundred papers, articles and book chapters in relation to microbiology; and he has written or edited ten books.
Dr. R. Vijayakumar is an Assistant Professor of Microbiology in the College of Science, Zulfi, Majmaah University in the Kingdom of Saudi Arabia. He has over twelve years' experience in the field of Pharmaceutical and Clinical Microbiology. He has a doctorate in Microbiology from Bharathidasan University, India. His past experience in the sterile pharmaceutical industry includes (Aurolab, India) as Microbiology Manager where he was involved in QC and QA activities. He has written one book and published more than 12 research articles in peer-reviewed national and international journals relating to microbiology. He has also delivered papers to over 20 national conferences and is an eminent infection control auditor in an ophthalmic hospital.