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Cleanroom Microbiology for the Non-Microbiologist

SECOND EDITION

David M. Carlben

CRC PRESS
Boca Raton London New York Washington, D.C.

Satellite RNA 3. External Features of Bacterial Cells 3. Molds 2. The Bacterial Interior 4.CONTENTS 1 The Scope of Microbiology Introduction Cells Binomial Nomenclature Morphology Specific Microbial Groups A. Taxonomy of Microorganisms VII. Bacteria 1. Subviral Particles 1. Microscopy A. Viroids 2. Protozoa E. Viruses 1. III. Retroviruses 3. Prions VI. The Gram Stain 2. 1 1 3 3 4 5 5 8 10 14 16 18 18 20 21 22 23 25 27 27 27 28 28 28 28 29 30 31 31 33 XV . Light Microscopy 1. Oncoviruses 4. Bacterial Genetics B. II. Staining 2. The Viral Infection Cycle 2. Algae D. Viruses and Gene Therapy F. Yeasts C. Types of Light Microscopes I. IV. Fungi 1. V.

Determining Bacterial Populations in Cultures 1. Temperature 2. Counting Viruses IV. Heat 1. Growing Other Microorganisms: Fungi. Physical Methods of Control A. Characteristics of Bacterial Populations 3. Filtration Methods 3. Low Temperatures D. Algae. Introduction A. Binary Fission and the Bacterial Growth Curve 1. Nonionizing Radiation 34 37 39 39 40 40 40 43 43 44 47 48 48 49 50 53 54 55 59 59 61 65 66 66 67 67 68 68 70 71 73 73 73 74 74 77 77 81 82 84 84 85 86 . Growth of Bacteria A. Moist Heat 2. and Viruses A. Ionizing Radiation 2. Continuous Growth E. Instrumental Methods F. Fungi B. Viruses 1. Introduction II. Nutritional Requirements B. pH C. Summary Growth of Microorganisms I.Total Cell Counts 4. The Kinetics of Microbial Death B. Radiation 1. Scientific Notation II. Protozoa and Algae C. Microbe Math 2. Dry Heat 3. Aseptic Technique V. Summary Controlling Growth and Activities of Microorganisms I. Protozoa. Atmosphere 3.XVI Cleanroom Microbiology for the Non-Microbiologist B. Microorganisms as Tools III. The Viable Plate Count 2. Safety Issues VI. Electron Microscopy VIII. The Growth Curve D. Sterilizing Large Loads C. Environmental Requirements 1. Definitions III.

Control of Microorganisms in High-Purity Water Systems A. Factors Influencing Antimicrobial Chemical Agents C. Validation of Filtration Sterilization IV. Bioburden Method C. Class III BSCs 4.Contents XVII Filtration 1. VIII. Disinfectants 1. . Biofilms VII. Rotation of Disinfectants D. Clean Zones. BSC Certification B. Overkill Method B. Membrane Filters 3. VI. Definitions B. Class II BSCs 3. IV. Validation of Sterilization Processes D. Validation of Disinfectants 4. Selection of Disinfectants 3. Proper BSC Operation 5. Introduction Certified Cleanrooms Bioclean Facilities — Viable vs. Biological Safety Cabinets 1. Maintaining Sterility V. Characteristics of Specific Agents 2. VII. Ensuring Sterility A. The Need for Pure Water B. Isolators C. Depth Filters 2. Sterilants 1. and Isolators A. Antibiotics VI. Characteristics of Specific Agents E. BSL4 Facilities B. Nonviable Particles Clean Facilities — General Considerations Unidirectional Air Flow HEPA and ULPA Filters Aseptic Fill Areas Barriers. Class I BSCs 2. Summary E. Mechanisms of Filtration 4. III. V. Water Purification Methods C. Positive-Pressure Personnel Suits 113 113 114 115 116 117 120 123 124 124 125 125 128 129 130 131 134 134 137 137 IX. II. Chemical Methods of Control A. 88 89 89 89 91 92 92 93 94 95 96 96 97 99 99 101 102 103 104 104 106 107 107 108 110 Ill Cleanroom Facilities and Personnel Controls I. Clean Benches Biosafety Levels A.

Bacterial Nutrition and Choice of Growth Media B. Bacteria 1. Sampler Efficiencies IV. Fungal Nutrition and Choice of Growth Media X. Frequency of Sampling 4. The Sterility Suite XVI. Microbiological Assessment of Liquids VIII. Testing for Bacteriostasis and Fungistasis XII. Detection of Biofilms XIII. The Slit Sampler 3. Monitoring of Air A.xviii • Cleanroom Microbiology for the Non-Microbiologist Cleanroom Garments A. Sterile Gowning XI. Introduction II. Sterile Media Fill Tests XIV. Transporting Microbiological Samples III. Summary 5 Detection and Enumeration of Microorganisms in t h e Cleanroom I. Validation B. Fallout Methods V. Rapid Methods of Identification XI. Fungi 1. Personal Hygiene XIII. General Considerations 2. Air Samplers 1. Portable Samplers 4. Monitoring Techniques 1. General Personnel Practices XIV. Microbiological Assessment of Solids and Semisolids IX. Touch Plates and Other Personnel Monitoring VII. Liquid Impingers 5. Correct Gowning Procedures B. Alert and Action Levels XV. Disposal of Cultures XVII. Summary X. 137 139 142 142 143 144 145 147 147 147 147 148 148 151 152 152 153 153 153 155 156 159 161 162 163 166 167 168 169 169 169 171 171 172 173 174 175 175 176 176 176 179 183 References Index . Overview of Microbiological Environmental Monitoring A. Surface Monitoring VI. Monitoring for Specific Microorganisms A. The Andersen Sampler 2. Personnel Practices and Training XII. Sampling Sites 3.