Features of Cleanroom Microbiology for the Non-Microbiologist Second Edition:

• Covers growth and detection of microorganisms and discusses methods for controlling bacterial growth
• Provides an easy to use introduction to the basic vocabulary of microbiology
• Includes coverage of facilities and personnel control methods
• Describes the common types of microorganisms encountered in the cleanroom, their roles in human activities, and the techniques used to study them
• Explains the rationales behind many of the regulations and operational procedures associated with biocleanrooms

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 in this edition 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

Contents

The Scope of Microbiology

• Cells
• Binomial Nomenclature
• Morphology
• Specific Microbial Groups
• Taxonomy of Microorganisms Microscopy

Growth of Microorganisms

• Growth of Bacteria
• Growing Other Microorganisms: Fungi, Protozoa, Algae and Viruses
• Aseptic Technique
• Safety Issues

Controlling Growth and Activities of Microorganisms

• Definitions
• Physical Methods of Control
• Assuring Sterility
• Chemical Methods of Control
• Control of Microorganisms in High Purity Water Systems

Facilitied and Personnel Controls

• Certified Cleanrooms
• Bioclean Facilities- Viable vs. Non-Viable Particles
• Clean Facilities - General Considerations
• Unidirectional Air Flow
• HEPA and ULPA Filters
• Aseptic Fill Areas
• Barriers, Clean Zones and Isolators
• Biosafety Levels
• Cleanroom Garments
• Personnel Practices and Training
• Personal Hygiene
• General Personnel Practices

Detection and Enumeration of Microorganisms in the Cleanroom

• Overview of Microbiological Environmental Monitoring
• Monitoring of Air
• Fallout Methods
• Surface Monitoring
• Touch Plates and Other Personnel Monitoring
• Microbiological Assessment of Liquids
• Microbiological Assessment of Solids and Semisolids
• Monitoring for Specific Microorganisms
• Rapid Methods of Identification
• Testing for Bacteriostasis and Fungistasis
• Detection of Biofilms
• Sterile Media Fill Tests
• Alert and Action Levels
• The Sterility Suite
• Disposal of Cultures

Index

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