Cleanroom Microbiology for the Non-Microbiologist  book cover
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2nd Edition

Cleanroom Microbiology for the Non-Microbiologist




ISBN 9780849319969
Published October 28, 2004 by CRC Press
216 Pages 60 B/W Illustrations

 
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Book Description

Written for the professional who has an immediate need for the information but has little or no training in the subject, Cleanroom Microbiology for the Non-Microbiologist, Second Edition introduces principles of microbiology. It explains the consequences of microbiological contamination, what contamination is all about, how microorganisms grow, and how they can be controlled. The author introduces the vocabulary of microbiology and the types, sources, control, and elimination of organisms encountered in the manufacture of sterile products. Beginning with a discussion of the various types of organisms, the text then covers applications for bacterial detection, avoidance of contamination, cleanroom design considerations, and validation of disinfection methods.

New topics covered include:

  • International cleanroom standards
  • Application of rapid, automated methods for detecting and identifying microbial contaminants
  • In-depth examination of the role of biofilms in pure water systems
  • Increased coverage of production of therapeutic products derived from live tissues and cells
  • Table of Contents

    THE SCOPE OF MICROBIOLOGY
    Introduction
    Cells
    Binomial Nomenclature
    Morphology
    New! Specific Microbial Groups
    New! Taxonomy of Microorganisms
    Microscopy
    Summary
    References

    GROWTH OF MICROORGANISMS
    Introduction
    Growth of Bacteria
    New! Growing Other Microorganisms: Fungi, Protozoa, Algae and Viruses
    Aseptic Technique
    New! Safety Issues
    Summary
    References

    CONTROLLING GROWTH AND ACTIVITIES OF MICROORGANISMS
    Introduction
    New! Definitions
    Physical Methods of Control
    New! Assuring Sterility
    New! Chemical Methods of Control
    Control of Microorganisms in High Purity Water Systems
    Summary
    References

    FACILITIES AND PERSONNEL CONTROLS
    Introduction
    New! Certified Cleanrooms
    New! Bioclean Facilities- Viable vs. Non-Viable Particles
    Clean Facilities - General Considerations
    New! Unidirectional Air Flow
    New! HEPA and ULPA Filters
    New! Aseptic Fill Areas
    New! Barriers, Clean Zones and Isolators
    New! Biosafety Levels
    Cleanroom Garments
    New! Personnel Practices and Training
    New! Personal Hygiene
    General Personnel Practices
    Summary
    References

    DETECTION AND ENUMERATION OF MICROORGANISMS IN THE CLEANROOM
    Introduction
    New! Overview of Microbiological Environmental Monitoring
    New! Monitoring of Air
    Fallout Methods
    Surface Monitoring
    New! Touch Plates and Other Personnel Monitoring
    Microbiological Assessment of Liquids
    Microbiological Assessment of Solids and Semisolids
    New! Monitoring for Specific Microorganisms
    New! Rapid Methods of Identification
    New! Testing for Bacteriostasis and Fungistasis
    New! Detection of Biofilms
    Sterile Media Fill Tests
    Alert and Action Levels
    New! The Sterility Suite
    Disposal of Cultures
    Summary
    References

    ...
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