Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Technology, Validation and Current Regulations

1st Edition - October 31, 2013

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  • Author: Tim Sandle
  • Hardcover ISBN: 9781907568381
  • eBook ISBN: 9781908818638

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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.

Key Features

  • 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


Pharmaceutical professionals; Quality assurance personnel; Microbiologists

Table of Contents

  • Dedication

    List of figures and tables


    About the author


    Chapter 1: Sterility, sterilisation and microorganisms


    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


    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)


    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


    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


    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


    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


    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


    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


    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


    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


    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


    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


    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


    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


    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


    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


    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


    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


    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


    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



Product details

  • No. of pages: 362
  • Language: English
  • Copyright: © Woodhead Publishing 2013
  • Published: October 31, 2013
  • Imprint: Woodhead Publishing
  • Hardcover ISBN: 9781907568381
  • eBook ISBN: 9781908818638

About the Author

Tim Sandle

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.

Affiliations and Expertise

Bio Products Laboratory, UK

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