Pharmaceutical Microbiology

Best Practices, Validation, Quality Assurance

Inbunden, Engelska, 2025

AvMichael Rieth,Germany) Rieth, Michael (University of Gottingen

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All-in-one guide to monitoring and maintaining microbiological safety in the manufacturing of pharmaceuticals, diagnostics, and cosmetics Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, Pharmaceutical Microbiology covers methods and technologies required by regulatory authorities throughout the world, with all methods and protocols rated in terms of their compliance with current (2023) EU legislation. Written by the former head of biological quality assurance for one of Europe’s biggest pharmaceutical and diagnostics companies, Pharmaceutical Microbiology covers sample topics including: General conditions for the operation of microbiological laboratories, calibration and qualification of devices, and type culture maintenanceIndustrial hygiene, ambient monitoring, quality control, process validation, microbiological water examination, and rapid microbiological methodsAutomation in the microbiology laboratory, quality assurance, identification of microorganisms, cleaning, sterilization, decontamination, and disposal, and contract testingPharmacopoeial and non-pharmacopoeial methods for the identification and quantification of microorganisms, including cell culture and selected animal testsPharmaceutical Microbiology is an essential practice-oriented all-in-one reference for engineers, researchers, and professionals involved in setting up and running a microbiological quality control unit in the pharmaceuticals, diagnostics, and cosmetics industries.

Produktinformation

Utgivningsdatum2025-04-02
Mått170 x 244 x 15 mm
Vikt680 g
FormatInbunden
SpråkEngelska
Antal sidor432
FörlagWiley-VCH Verlag GmbH
ISBN9783527354252

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Kemi inom Naturvetenskap och teknik
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Michael Rieth received his biology doctorate from the Institute of Microbiology University of Gottingen. He entered into the pharmaceutical industry in 1988. From 1999 to 2014 he was Head of Biological Quality Assurance at Merck KGaA, Darmstadt. He then worked in the field of Global Regulatory Affairs until his retirement in 2020. He has written four books, including Pharmaceutical Microbiology in the German language, which was awarded the Wallhausser Prize in 2013.

Preface to the English Edition xviiPreface to the First German Edition xixList of Abbreviations xxiGlossary xxvii1 Introduction to Microbiology 11.1 Historical 11.2 Importance 21.3 World of Microorganisms 31.4 The Bacterial Cell 91.5 Taxonomy of Microorganisms 181.6 Medical Microbiology 22References 26Further Reading 272 General Conditions for the Operation of Microbiological Laboratories 292.1 Laws and Technical Regulations 292.2 Medical Care for Employees 332.3 Operating Description for Microbiological Laboratories 362.4 Establishment of Microbiological Laboratories 372.4.1 Required Devices/Equipment 372.5 Nutrient Media 392.6 Media Preparation 47References 783 Calibration and Qualification of the Devices 813.1 Calibration Error 833.2 Calibration 833.3 Balance 843.4 pH Meter 853.5 Piston Pipettes 853.6 Stopwatch 863.7 Devices for Achieving Specific Temperatures 873.8 Clean Bench 903.9 Air Sampler 933.10 Particle Counter 953.11 Measuring Device for Determining the Water Activity 963.12 Photometer/Reader 963.13 Tube Reader for Endotoxin Determinations 983.14 Fluorescence Reader for Endotoxin Determinations 98References 984 Stock Collection 1014.1 Reference 1014.2 Shipping 1054.3 Storage 1054.4 Cultivation 106References 1075 Industrial Hygiene 1095.1 Hygiene 1095.2 Microbiological Basics for Hygiene 1125.3 Hygiene Measures 1155.4 Sterilization, Disinfection, and Aseptic Production 1275.5 Hygiene Protocol for Microbiological Laboratories 1365.6 Pest Control 1375.7 Hygiene Officer 1405.8 Implementation of Hygiene Training Courses 140References 1436 Environmental Monitoring 1456.1 Methods 1456.2 Microbiological Monitoring in the Sterility Test Isolator 1506.3 Physical Monitoring in Sterile Production 1546.4 Physical Operation 1556.5 Evaluation of the Microorganisms 1586.6 Register of Microorganisms 159References 170Further Reading 1727 Quality Control 1737.1 Pharmacopeial Methods (Compendial Methods) 1737.2 Non-Compendial Methods 2147.3 Tests Using Animal Models 2287.4 Cell Culture Methods 2317.5 Validation of Pharmacopeial Methods 235References 263Further Reading 2668 Process Validations 2678.1 Media Fill 2678.2 Depyrogenation 2748.3 Validation of Sterilization with Dry Heat 2768.4 Validation of Sterilization Using Moist Heat (Autoclave) 2788.5 Validation of Sterile Filtration 2798.6 Container Closure Integrity Test 2828.7 Cleaning Validation 286References 289Further Reading 2909 Microbiological Examination of Water 2919.1 Sampling 2939.2 Specimen Transport 2949.3 Use of the Different Water Qualities (Table 9.6) 2979.4 Purified Water 2979.5 Highly Purified Water 3019.6 Water for Injection 3019.7 Water for Diluting Concentrated Hemodialysis Solutions 3029.8 Water for the Preparation of Extracts 3029.9 Drinking Water 3039.10 Legionella 305References 30810 Rapid Microbiological Methods 30910.1 Determination via ATP Content 30910.2 Determination Via the Incorporation of Fluorescent Markers 31310.3 Flow Cytometry 315References 316Further Reading 31711 Automation in the Microbiology Laboratory 31911.1 Automatic Dyeing Machines 31911.2 Devices for Counting Colonies 32011.3 Automatic Nutrient Media Filling Machine 32011.4 Automation of the Endotoxin Test 321References 32212 Quality Assurance 32312.1 Structure of an SOP System 32312.2 Training 32412.3 Audits and Inspections 32612.4 Procedure for OOS and OOE Results 330References 33713 Microorganism Identification 33913.1 Growth Curve 33913.2 Generation Time 34013.3 Preparation of Pure Cultures 34013.4 Sensory and Macroscopic Characteristics 34013.5 Microscopic Examination 34113.6 Staining 34713.7 Principle of the “Colored Row” 34913.8 Immunological Procedures 35113.9 Polymerase Chain Reaction 35113.10 Gas Chromatography (FAME) 35213.11 FT-IR Spectroscopy 35213.12 Maldi-tof 353References 35314 Cleaning, Sterilization, Decontamination, and Disposal 35514.1 Cleaning 35514.2 Sterilization 35514.3 Laboratory Cleaning and Disinfection 36014.4 Disposal of Infectious Waste 36214.5 Disinfection Measures in Case of Accidents 363References 36315 Contract Testing (Outsourcing) 365References 366Further Reading 36616 Microbiological Networks 36716.1 CPM 36716.2 VAAM Expert Group Quality Management 36716.3 Subcommittee Microbiology in the VfA 36816.4 DGHM 368References 36917 Addresses 371Literature 379Index 389