Preface to the English Edition -- Preface to the First German Edition -- List of Abbreviations -- Glossary -- 1 Introduction to Microbiology -- 1.1 Historical -- 1.2 Importance -- 1.3 World of Microorganisms -- 1.4 The Bacterial Cell -- 1.5 Taxonomy of Microorganisms -- 1.6 Medical Microbiology -- References -- Further Reading -- 2 General Conditions for the Operation of Microbiological Laboratories -- 2.1 Laws and Technical Regulations -- 2.2 Medical Care for Employees -- 2.3 Operating Description for Microbiological Laboratories -- 2.4 Establishment of Microbiological Laboratories -- 2.5 Nutrient Media -- 2.6 Media Preparation -- References -- 3 Calibration and Qualification of the Devices -- 3.1 Calibration Error -- 3.2 Calibration -- 3.3 Balance -- 3.4 pH Meter -- 3.5 Piston Pipettes -- 3.6 Stopwatch -- 3.7 Devices for Achieving Specific Temperatures -- 3.8 Clean Bench -- 3.8.1 Principle -- 3.9 Air Sampler -- 3.10 Particle Counter -- 3.11 Measuring Device for Determining the Water Activity -- 3.12 Photometer/Reader -- 3.13 Tube Reader for Endotoxin Determinations -- 3.14 Fluorescence Reader for Endotoxin Determinations -- References -- 4 Stock Collection -- 4.1 Reference -- 4.2 Shipping -- 4.3 Storage -- 4.4 Cultivation -- References -- 5 Industrial Hygiene -- 5.1 Hygiene -- 5.2 Microbiological Basics for Hygiene -- 5.3 Hygiene Measures -- 5.4 Sterilization, Disinfection, and Aseptic Production -- 5.5 Hygiene Protocol for Microbiological Laboratories -- 5.6 Pest Control -- 5.7 Hygiene Officer -- 5.8 Implementation of Hygiene Training Courses -- References -- 6 Environmental Monitoring -- 6.1 Methods -- 6.2 Microbiological Monitoring in the Sterility Test Isolator -- 6.2.1 Example of an Isolator -- 6.3 Physical Monitoring in Sterile Production -- 6.4 Physical Operation -- 6.5 Evaluation of the Microorganisms -- 6.6 Register of Microorganisms -- References -- Further Reading -- 7 Quality Control -- 7.1 Pharmacopeial Methods (Compendial Methods) -- 7.2 Non-Compendial Methods -- 7.3 Tests Using Animal Models -- 7.4 Cell Culture Methods -- 7.5 Validation of Pharmacopeial Methods -- References -- Further Reading -- 8 Process Validations -- 8.1 Media Fill -- 8.2 Depyrogenation -- 8.3 Validation of Sterilization with Dry Heat -- 8.4 Validation of Sterilization Using Moist Heat (Autoclave) -- 8.5 Validation of Sterile Filtration -- 8.6 Container Closure Integrity Test -- 8.7 Cleaning Validation -- References -- Further Reading -- 9 Microbiological Examination of Water -- 9.1 Sampling -- 9.2 Specimen Transport -- 9.3 Use of the Different Water Qualities (Table 9.6) -- 9.4 Purified Water -- 9.5 Highly Purified Water -- 9.6 Water for Injection -- 9.7 Water for Diluting Concentrated Hemodialysis Solutions -- 9.8 Water for the Preparation of Extracts -- 9.9 Drinking Water -- 9.10 Legionella -- References -- 10 Rapid Microbiological Methods -- 10.1 Determination via ATP Content -- 10.2 Determination Via the Incorporation of Fluorescent Markers -- 10.3 Flow Cytometry -- References -- Further Reading -- 11 Automation in the Microbiology Laboratory -- 11.1 Automatic Dyeing Machines -- 11.2 Devices for Counting Colonies -- 11.3 Automatic Nutrient Media Filling Machine -- 11.4 Automation of the Endotoxin Test -- References -- 12 Quality Assurance -- 12.1 Structure of an SOP System -- 12.2 Training -- 12.3 Audits and Inspections -- 12.4 Procedure for OOS and OOE Results -- References -- 13 Microorganism Identification -- 13.1 Growth Curve -- 13.2 Generation Time -- 13.3 Preparation of Pure Cultures -- 13.4 Sensory and Macroscopic Characteristics -- 13.5 Microscopic Examination -- 13.6 Staining -- 13.7 Principle of the "Colored Row" -- 13.8 Immunological Procedures -- 13.9 Polymerase Chain Reaction -- 13.10 Gas Chromatography (FAME) -- 13.11 FT-IR Spectroscopy -- 13.12 Maldi-tof -- References -- 14 Cleaning, Sterilization, Decontamination, and Disposal -- 14.1 Cleaning -- 14.2 Sterilization -- 14.3 Laboratory Cleaning and Disinfection -- 14.4 Disposal of Infectious Waste -- 14.5 Disinfection Measures in Case of Accidents -- References -- 15 Contract Testing (Outsourcing) -- References -- Further Reading -- 16 Microbiological Networks -- 16.1 Cpm -- 16.2 VAAM Expert Group Quality Management -- 16.3 Subcommittee Microbiology in the VfA -- 16.4 Dghm -- References -- 17 Addresses -- Literature -- Index.