Tim Sandle

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals (eBook, ePUB)

Technology, Validation and Current Regulations

• Format: ePub

Produktbeschreibung

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.

• Covers the main sterilisation methods of physical removal, physical alteration and inactivation
• Includes discussion of medical devices, aseptically filled products and terminally sterilised products
• Describes bacterial, pyrogenic, and endotoxin risks to devices and products

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Produktdetails

• Verlag: Elsevier Science & Techn.
• Seitenzahl: 362
• Erscheinungstermin: 31. Oktober 2013
• Englisch
• ISBN-13: 9781908818638
• Artikelnr.: 40159184

Autorenporträt

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.

Inhaltsangabe

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