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:
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
Biography
David M. Carlberg
