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Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. 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. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques.
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
11.12 Non-sterilising processes
11.13 Conclusion
Chapter 12: Depyrogenation and endotoxin
Abstract:
12.1 Introduction
12.2 Different types of depyrogenation
12.3 Case study 1: Dry heat depyrogenation
12.4 Case study 2: Removal of endotoxin through rinsing
12.5 Conclusion
Chapter 13: Cleanrooms, isolators and cleanroom technology
Abstract:
13.1 Introduction
13.2 Cleanrooms and contamination control
13.3 Cleanroom classification
13.4 Cleanroom operating conditions
13.5 Measuring the physical operation of cleanrooms
13.6 Clean air devices and isolators
13.7 Ongoing monitoring
13.8 Conclusion
Chapter 14: Aseptic processing filling
Abstract:
14.1 Introduction
14.2 Selecting aseptic manufacture in place of terminal sterilisation
14.3 Regulatory aspects
14.4 Aseptic processing risks and sources of contamination
14.5 Contamination control
14.6 Types of aseptic filling
14.7 Single-use sterile disposable items
14.8 Conclusion
Chapter 15: Media simulation trials
Abstract:
15.1 Introduction
15.2 Defining a media simulation trial
15.3 Objectives of a media simulation trial
15.4 The media trial protocol
15.5 Conducting media simulation trials
15.6 Frequency of media simulation trials
15.7 Media fill failures
15.8 Media fill invalidation
15.9 Conclusion
Chapter 16: Cleaning disinfection of sterile processing facilities
Abstract:
16.1 Introduction
16.2 Cleaning
16.3 Disinfection
16.3.3 Factors affecting disinfectant efficacy
16.4 Cleaning and disinfection in practice
16.5 Environmental monitoring
16.6 Validation of disinfectants
16.7 Conclusion
Chapter 17: Biological indicators
Abstract:
17.1 Introduction
17.2 Application of biological indicators
17.3 Characteristics of biological indicators
17.4 Use of biological indicators
17.5 Areas of concern and testing errors
17.6 Conclusion
Chapter 18: The Sterility Test
Abstract:
18.1 Introduction
18.2 Sterility Test methods
18.3 Pharmacopeia Sterility Test
18.4 Test environment
18.5 Sterility Test media
18.6 Sterility Test method validation
18.7 Stasis Test
18.8 GMP requirements
18.9 Can the Sterility Test really confirm product sterility?
18.10 Rapid microbiological methods
18.11 Conclusion
Chapter 19: Investigating sterility test failures
Abstract:
19.1 Introduction
19.2 Failure investigations
19.3 Sterility Test and process area link
19.4 Re-testing
19.5 Concluding Sterility Test failure investigations
19.6 Conclusion
Chapter 20: Auditing sterilisation processes facilities
Abstract:
20.1 Introduction
20.2 The audit process
20.3 Scope of audits
20.4 Key focal points for auditing sterile manufacturing facilities
20.5 Conclusion
Conclusion
Index
