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Informationen zum Autor Tim Sandle is Head of Microbiology at the Bio Products Laboratory, Elstree, UK and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, Manchester University, UK. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. Zusammenfassung Sterility! sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat! radiation and filtration.
List of contents
Dedication
List of figures and tables
Preface
About the author
Introduction
Chapter 1: Sterility, sterilisation and microorganisms
Abstract:
1.1 Introduction
1.2 Sterility
1.3 Sterility Assurance and the Sterility Assurance Level (SAL)
1.4 Sterility testing
1.5 Parametric release
1.6 Sterile products
1.7 Sterilisation
1.8 Factors affecting sterilisation
1.9 Risk assessment
1.10 Conclusion
Chapter 2: Pyrogenicity bacterial endotoxin
Abstract:
2.1 Introduction
2.2 Pyrogenicity
2.3 Endotoxin
2.4 The LAL test
2.5 Alternative assays
2.6 Water: the source of endotoxins in pharmaceutical manufacturing
2.7 Conclusion
Chapter 3: Regulatory requirements and Good Manufacturing Practices (GMP)
Abstract
3.1 Introduction
3.2 A brief history of compliance
3.3 Key terminology
3.4 Current regulatory requirements
3.5 Federal Drug Administration (FDA)
3.6 European Good Manufacturing Practices
3.7 Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme)
3.8 World Health Organisation
3.9 ISO
3.10 ICH
3.11 Pharmacopoeias
3.12 National standards
3.13 Other sources of guidance
3.14 Regulatory inspections
3.15 Conclusion
Chapter 4: Gamma radiation
Abstract:
4.1 Introduction
4.2 Application of gamma radiation
4.3 Sterilisation method
4.4 Process requirements
4.5 Regulatory aspects
4.6 Conclusion
Chapter 5: Electron beam processing
Abstract:
5.1 Introduction
5.2 Application of e-beam radiation
5.3 Sterilisation method
5.4 Microbial destruction
5.5 Process requirements
5.6 Advantages of e-beam radiation
5.7 Disadvantages of e-beam radiation
5.8 Conclusion
Chapter 6: Dry heat sterilisation
Abstract:
6.1 Introduction
6.2 Microbial kill and endotoxin inactivation
6.3 Application of dry heat sterilisation
6.4 Validation of dry heat devices
6.5 Advantages and disadvantages of dry heat sterilisation
6.6 Conclusion
Chapter 7: Steam sterilisation
Abstract:
7.1 Introduction
7.2 Microbial destruction
7.3 Steam sterilisation devices
7.4 Applications of steam sterilisation
7.5 Cycle development
7.6 Validation of steam sterilisation cycles
7.7 In-use evaluation
7.8 Flash sterilisation
7.9 Advantages and disadvantages of steam sterilisation
7.10 Conclusion
Chapter 8: Gaseous sterilisation
Abstract:
8.1 Introduction
8.2 Applications
8.3 Ethylene oxide
8.4 Ozone
8.5 Chlorine dioxide gas
8.6 Summary
Chapter 9: Hydrogen peroxide vapour sterilisation
Abstract:
9.1 Introduction
9.2 Chemical composition
9.3 Antimicrobial effectiveness
9.4 Barrier devices and isolators
9.5 HVP cycles
9.6 Validating VHP cycles
9.7 Cycle failures
9.8 Conclusion
Chapter 10: Sterilisation by filtration
Abstract:
10.1 Introduction
10.2 Sterilising grade filters
10.3 Application of sterilising grade filters
10.4 Filter testing
10.5 Filter failures
10.6 Selection of sterilising grade filters
10.7 Validation of sterilising grade filters
10.8 Conclusion
Chapter 11: Other methods of sterilisation
Abstract:
11.1 Introduction
11.2 Ultraviolet light
11.3 Pulsed light
11.4 Microwaves
11.5 Infrared radiation
11.6 Ultrasonics
11.7 Supercritical gases
11.8 Formaldehyde steam
11.9 X-rays
11.10 Plasma
11.11 Nitrogen dioxide
