Main description:

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