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Pharmaceutical Microbiology de Michael Rieth

Pharmaceutical Microbiology

Autor Michael Rieth
en Limba Engleză Hardback – 2 apr 2025

Observăm că această ediție a lucrării Pharmaceutical Microbiology se concentrează pe alinierea riguroasă la standardele legislative europene din 2023, oferind un cadru de lucru actualizat pentru siguranța microbiologică. Ne-a atras atenția expertiza autorului Michael Rieth, a cărui experiență în conducerea asigurării calității la nivel industrial se traduce într-o abordare extrem de aplicată. Volumul nu se limitează la teorie, ci detaliază protocoale specifice pentru calibrarea dispozitivelor, întreținerea culturilor tip și examinarea microbiologică a apei. Considerăm relevantă includerea metodelor de automatizare și a tehnicilor rapide de identificare a microorganismelor, elemente esențiale pentru eficiența laboratoarelor moderne. Pharmaceutical Microbiology servește drept o alternativă tehnică la Essential Microbiology for Pharmacy and Pharmaceutical Science pentru cursurile de microbiologie aplicată, având avantajul unei orientări stricte către controlul calității și conformitatea reglementară în producția de medicamente și cosmetice. În timp ce alte titluri se concentrează pe bazele teoretice, lucrarea de față analizează în profunzime procesele de validare și decontaminare, oferind soluții pentru provocările operaționale zilnice. Structura textului facilitează navigarea între metodele farmacopeice și cele non-pharmacopeice, incluzând secțiuni dedicate testelor pe culturi celulare. Această abordare integrată transformă volumul într-un instrument de referință pentru inginerii și cercetătorii care configurează unități de control microbiologic, asigurând o punte între cerințele de reglementare și practica de laborator.

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Specificații

ISBN-13: 9783527354252
ISBN-10: 3527354255
Pagini: 432
Dimensiuni: 175 x 244 x 27 mm
Greutate: 0.96 kg
Ediția:1
Editura: Wiley-VCH GmbH

De ce să citești această carte

Recomandăm această carte profesioniștilor din industria farmaceutică și cosmetică deoarece oferă un ghid complet de conformitate cu normele UE din 2023. Cititorul câștigă acces la metodologii verificate pentru monitorizarea igienei industriale și validarea proceselor de sterilizare, fiind un instrument esențial pentru asigurarea calității biologice în unitățile de producție și diagnostic.

Descriere

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 tests Pharmaceutical 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.

Notă biografică

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.

Cuprins

Preface to the English Edition xvii

Preface to the First German Edition xix

List of Abbreviations xxi

Glossary xxvii

1 Introduction to Microbiology 1

1.1 Historical 1

1.2 Importance 2

1.3 World of Microorganisms 3

1.4 The Bacterial Cell 9

1.5 Taxonomy of Microorganisms 18

1.6 Medical Microbiology 22

References 26

Further Reading 27

2 General Conditions for the Operation of Microbiological Laboratories 29

2.1 Laws and Technical Regulations 29

2.2 Medical Care for Employees 33

2.3 Operating Description for Microbiological Laboratories 36

2.4 Establishment of Microbiological Laboratories 37

2.4.1 Required Devices/Equipment 37

2.5 Nutrient Media 39

2.6 Media Preparation 47

References 78

3 Calibration and Qualification of the Devices 81

3.1 Calibration Error 83

3.2 Calibration 83

3.3 Balance 84

3.4 pH Meter 85

3.5 Piston Pipettes 85

3.6 Stopwatch 86

3.7 Devices for Achieving Specific Temperatures 87

3.8 Clean Bench 90

3.9 Air Sampler 93

3.10 Particle Counter 95

3.11 Measuring Device for Determining the Water Activity 96

3.12 Photometer/Reader 96

3.13 Tube Reader for Endotoxin Determinations 98

3.14 Fluorescence Reader for Endotoxin Determinations 98

References 98

4 Stock Collection 101

4.1 Reference 101

4.2 Shipping 105

4.3 Storage 105

4.4 Cultivation 106

References 107

5 Industrial Hygiene 109

5.1 Hygiene 109

5.2 Microbiological Basics for Hygiene 112

5.3 Hygiene Measures 115

5.4 Sterilization, Disinfection, and Aseptic Production 127

5.5 Hygiene Protocol for Microbiological Laboratories 136

5.6 Pest Control 137

5.7 Hygiene Officer 140

5.8 Implementation of Hygiene Training Courses 140

References 143

6 Environmental Monitoring 145

6.1 Methods 145

6.2 Microbiological Monitoring in the Sterility Test Isolator 150

6.3 Physical Monitoring in Sterile Production 154

6.4 Physical Operation 155

6.5 Evaluation of the Microorganisms 158

6.6 Register of Microorganisms 159

References 170

Further Reading 172

7 Quality Control 173

7.1 Pharmacopeial Methods (Compendial Methods) 173

7.2 Non-Compendial Methods 214

7.3 Tests Using Animal Models 228

7.4 Cell Culture Methods 231

7.5 Validation of Pharmacopeial Methods 235

References 263

Further Reading 266

8 Process Validations 267

8.1 Media Fill 267

8.2 Depyrogenation 274

8.3 Validation of Sterilization with Dry Heat 276

8.4 Validation of Sterilization Using Moist Heat (Autoclave) 278

8.5 Validation of Sterile Filtration 279

8.6 Container Closure Integrity Test 282

8.7 Cleaning Validation 286

References 289

Further Reading 290

9 Microbiological Examination of Water 291

9.1 Sampling 293

9.2 Specimen Transport 294

9.3 Use of the Different Water Qualities (Table 9.6) 297

9.4 Purified Water 297

9.5 Highly Purified Water 301

9.6 Water for Injection 301

9.7 Water for Diluting Concentrated Hemodialysis Solutions 302

9.8 Water for the Preparation of Extracts 302

9.9 Drinking Water 303

9.10 Legionella 305

References 308

10 Rapid Microbiological Methods 309

10.1 Determination via ATP Content 309

10.2 Determination Via the Incorporation of Fluorescent Markers 313

10.3 Flow Cytometry 315

References 316

Further Reading 317

11 Automation in the Microbiology Laboratory 319

11.1 Automatic Dyeing Machines 319

11.2 Devices for Counting Colonies 320

11.3 Automatic Nutrient Media Filling Machine 320

11.4 Automation of the Endotoxin Test 321

References 322

12 Quality Assurance 323

12.1 Structure of an SOP System 323

12.2 Training 324

12.3 Audits and Inspections 326

12.4 Procedure for OOS and OOE Results 330

References 337

13 Microorganism Identification 339

13.1 Growth Curve 339

13.2 Generation Time 340

13.3 Preparation of Pure Cultures 340

13.4 Sensory and Macroscopic Characteristics 340

13.5 Microscopic Examination 341

13.6 Staining 347

13.7 Principle of the "Colored Row" 349

13.8 Immunological Procedures 351

13.9 Polymerase Chain Reaction 351

13.10 Gas Chromatography (FAME) 352

13.11 FT-IR Spectroscopy 352

13.12 Maldi-tof 353

References 353

14 Cleaning, Sterilization, Decontamination, and Disposal 355

14.1 Cleaning 355

14.2 Sterilization 355

14.3 Laboratory Cleaning and Disinfection 360

14.4 Disposal of Infectious Waste 362

14.5 Disinfection Measures in Case of Accidents 363

References 363

15 Contract Testing (Outsourcing) 365

References 366

Further Reading 366

16 Microbiological Networks 367

16.1 CPM 367

16.2 VAAM Expert Group Quality Management 367

16.3 Subcommittee Microbiology in the VfA 368

16.4 DGHM 368

References 369

17 Addresses 371

Literature 379

Index 389

Descriere scurtă

Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, this practical guide covers methods and technologies required by regulatory authorities throughout the world. Focused on compliance with the European Pharmacopeia and related regulations, the calibration of laboratory equipment, hygiene procedures, ambient monitoring, and the validation of standard microbiological methods is described in detail, usually with step-by-step protocols.
Pharmacopoieal as well as non-pharmacopoeial methods for the identification and quantification of microorganisms are discussed, including cell culture tests, selected animal test, as well as rapid methods. Dedicated chapters cover microbiological water examination and the potential for automation of standard tests. This practice-oriented refrence is an all-in-one resource for successfully setting up and running a microbiologcal quality control unit in the pharmaceuticals, diagnostics, and cosmetics industry.