Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

<p>Dedication</p> <p>List of figures and tables</p> <p>Preface</p> <p>About the author</p> <p>Introduction</p> <p>Chapter 1: Sterility, sterilisation and microorganisms</p> <p>Abstract:</p> <p>1.1 Introduction</p> <p>1.2 Sterility</p> <p>1.3 Sterility Assurance and the Sterility Assurance Level (SAL)</p> <p>1.4 Sterility testing</p> <p>1.5 Parametric release</p> <p>1.6 Sterile products</p> <p>1.7 Sterilisation</p> <p>1.8 Factors affecting sterilisation</p> <p>1.9 Risk assessment</p> <p>1.10 Conclusion</p> <p>Chapter 2: Pyrogenicity bacterial endotoxin</p> <p>Abstract:</p> <p>2.1 Introduction</p> <p>2.2 Pyrogenicity</p> <p>2.3 Endotoxin</p> <p>2.4 The LAL test</p> <p>2.5 Alternative assays</p> <p>2.6 Water: the source of endotoxins in pharmaceutical manufacturing</p> <p>2.7 Conclusion</p> <p>Chapter 3: Regulatory requirements and Good Manufacturing Practices (GMP)</p> <p>Abstract</p> <p>3.1 Introduction</p> <p>3.2 A brief history of compliance</p> <p>3.3 Key terminology</p> <p>3.4 Current regulatory requirements</p> <p>3.5 Federal Drug Administration (FDA)</p> <p>3.6 European Good Manufacturing Practices</p> <p>3.7 Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme)</p> <p>3.8 World Health Organisation</p> <p>3.9 ISO</p> <p>3.10 ICH</p> <p>3.11 Pharmacopoeias</p> <p>3.12 National standards</p> <p>3.13 Other sources of guidance</p> <p>3.14 Regulatory inspections</p> <p>3.15 Conclusion</p> <p>Chapter 4: Gamma radiation</p> <p>Abstract:</p> <p>4.1 Introduction</p> <p>4.2 Application of gamma radiation</p> <p>4.3 Sterilisation method</p> <p>4.4 Process requirements</p> <p>4.5 Regulatory aspects</p> <p>4.6 Conclusion</p> <p>Chapter 5: Electron beam processing</p> <p>Abstract:</p> <p>5.1 Introduction</p> <p>5.2 Application of e-beam radiation</p> <p>5.3 Sterilisation method</p> <p>5.4 Microbial destruction</p> <p>5.5 Process requirements</p> <p>5.6 Advantages of e-beam radiation</p> <p>5.7 Disadvantages of e-beam radiation</p> <p>5.8 Conclusion</p> <p>Chapter 6: Dry heat sterilisation</p> <p>Abstract:</p> <p>6.1 Introduction</p> <p>6.2 Microbial kill and endotoxin inactivation</p> <p>6.3 Application of dry heat sterilisation</p> <p>6.4 Validation of dry heat devices</p> <p>6.5 Advantages and disadvantages of dry heat sterilisation</p> <p>6.6 Conclusion</p> <p>Chapter 7: Steam sterilisation</p> <p>Abstract:</p> <p>7.1 Introduction</p> <p>7.2 Microbial destruction</p> <p>7.3 Steam sterilisation devices</p> <p>7.4 Applications of steam sterilisation</p> <p>7.5 Cycle development</p> <p>7.6 Validation of steam sterilisation cycles</p> <p>7.7 In-use evaluation</p> <p>7.8 Flash sterilisation</p> <p>7.9 Advantages and disadvantages of steam sterilisation</p> <p>7.10 Conclusion</p> <p>Chapter 8: Gaseous sterilisation</p> <p>Abstract:</p> <p>8.1 Introduction</p> <p>8.2 Applications</p> <p>8.3 Ethylene oxide</p> <p>8.4 Ozone</p> <p>8.5 Chlorine dioxide gas</p> <p>8.6 Summary</p> <p>Chapter 9: Hydrogen peroxide vapour sterilisation</p> <p>Abstract:</p> <p>9.1 Introduction</p> <p>9.2 Chemical composition</p> <p>9.3 Antimicrobial effectiveness</p> <p>9.4 Barrier devices and isolators</p> <p>9.5 HVP cycles</p> <p>9.6 Validating VHP cycles</p> <p>9.7 Cycle failures</p> <p>9.8 Conclusion</p> <p>Chapter 10: Sterilisation by filtration</p> <p>Abstract:</p> <p>10.1 Introduction</p> <p>10.2 Sterilising grade filters</p> <p>10.3 Application of sterilising grade filters</p> <p>10.4 Filter testing</p> <p>10.5 Filter failures</p> <p>10.6 Selection of sterilising grade filters</p> <p>10.7 Validation of sterilising grade filters</p> <p>10.8 Conclusion</p> <p>Chapter 11: Other methods of sterilisation</p> <p>Abstract:</p> <p>11.1 Introduction</p> <p>11.2 Ultraviolet light</p> <p>11.3 Pulsed light</p> <p>11.4 Microwaves</p> <p>11.5 Infrared radiation</p> <p>11.6 Ultrasonics</p> <p>11.7 Supercritical gases</p> <p>11.8 Formaldehyde steam</p> <p>11.9 X-rays</p> <p>11.10 Plasma</p> <p>11.11 Nitrogen dioxide</p> <p>11.12 Non-sterilising processes</p> <p>11.13 Conclusion</p> <p>Chapter 12: Depyrogenation and endotoxin</p> <p>Abstract:</p> <p>12.1 Introduction</p> <p>12.2 Different types of depyrogenation</p> <p>12.3 Case study 1: Dry heat depyrogenation</p> <p>12.4 Case study 2: Removal of endotoxin through rinsing</p> <p>12.5 Conclusion</p> <p>Chapter 13: Cleanrooms, isolators and cleanroom technology</p> <p>Abstract:</p> <p>13.1 Introduction</p> <p>13.2 Cleanrooms and contamination control</p> <p>13.3 Cleanroom classification</p> <p>13.4 Cleanroom operating conditions</p> <p>13.5 Measuring the physical operation of cleanrooms</p> <p>13.6 Clean air devices and isolators</p> <p>13.7 Ongoing monitoring</p> <p>13.8 Conclusion</p> <p>Chapter 14: Aseptic processing filling</p> <p>Abstract:</p> <p>14.1 Introduction</p> <p>14.2 Selecting aseptic manufacture in place of terminal sterilisation</p> <p>14.3 Regulatory aspects</p> <p>14.4 Aseptic processing risks and sources of contamination</p> <p>14.5 Contamination control</p> <p>14.6 Types of aseptic filling</p> <p>14.7 Single-use sterile disposable items</p> <p>14.8 Conclusion</p> <p>Chapter 15: Media simulation trials</p> <p>Abstract:</p> <p>15.1 Introduction</p> <p>15.2 Defining a media simulation trial</p> <p>15.3 Objectives of a media simulation trial</p> <p>15.4 The media trial protocol</p> <p>15.5 Conducting media simulation trials</p> <p>15.6 Frequency of media simulation trials</p> <p>15.7 Media fill failures</p> <p>15.8 Media fill invalidation</p> <p>15.9 Conclusion</p> <p>Chapter 16: Cleaning disinfection of sterile processing facilities</p> <p>Abstract:</p> <p>16.1 Introduction</p> <p>16.2 Cleaning</p> <p>16.3 Disinfection</p> <p>16.3.3 Factors affecting disinfectant efficacy</p> <p>16.4 Cleaning and disinfection in practice</p> <p>16.5 Environmental monitoring</p> <p>16.6 Validation of disinfectants</p> <p>16.7 Conclusion</p> <p>Chapter 17: Biological indicators</p> <p>Abstract:</p> <p>17.1 Introduction</p> <p>17.2 Application of biological indicators</p> <p>17.3 Characteristics of biological indicators</p> <p>17.4 Use of biological indicators</p> <p>17.5 Areas of concern and testing errors</p> <p>17.6 Conclusion</p> <p>Chapter 18: The Sterility Test</p> <p>Abstract:</p> <p>18.1 Introduction</p> <p>18.2 Sterility Test methods</p> <p>18.3 Pharmacopeia Sterility Test</p> <p>18.4 Test environment</p> <p>18.5 Sterility Test media</p> <p>18.6 Sterility Test method validation</p> <p>18.7 Stasis Test</p> <p>18.8 GMP requirements</p> <p>18.9 Can the Sterility Test really confirm product sterility?</p> <p>18.10 Rapid microbiological methods</p> <p>18.11 Conclusion</p> <p>Chapter 19: Investigating sterility test failures</p> <p>Abstract:</p> <p>19.1 Introduction</p> <p>19.2 Failure investigations</p> <p>19.3 Sterility Test and process area link</p> <p>19.4 Re-testing</p> <p>19.5 Concluding Sterility Test failure investigations</p> <p>19.6 Conclusion</p> <p>Chapter 20: Auditing sterilisation processes facilities</p> <p>Abstract:</p> <p>20.1 Introduction</p> <p>20.2 The audit process</p> <p>20.3 Scope of audits</p> <p>20.4 Key focal points for auditing sterile manufacturing facilities</p> <p>20.5 Conclusion</p> <p>Conclusion</p> <p>Index</p>