Sterilisation of biomaterials and medical devices

347 Pages·2012·5.204 MB·English

by  Sophie Lerouge, Anne Simmons

Sterilisation of biomaterials and medical devices
© Woodhead Publishing Limited, 2012
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© Woodhead Publishing Limited, 2012
Woodhead Publishing Series in Biomaterials: Number 46
Sterilisation of
biomaterials and
medical devices
Edited by
Sophie Lerouge and
Anne Simmons
Oxford Cambridge Philadelphia New Delhi
© Woodhead Publishing Limited, 2012
Published by Woodhead Publishing Limited,
80 High Street, Sawston, Cambridge CB22 3HJ, UK
www.woodheadpublishing.com
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Library of Congress Control Number: 2012945021
ISBN 978-1-84569-932-1 (print)
ISBN 978-0-85709-626-5 (online)
ISSN 2049-9485 Woodhead Publishing Series in Biomaterials (print)
ISSN 2049-9493 Woodhead Publishing Series in Biomaterials (online)
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Contents
Contributor contact details xi
Woodhead Publishing Series in Biomaterials xiii
1 Introduction to sterilization: defi nitions
and challenges 1
S. LEROUGE, École de technologie supérieure,
Canada
1.1 Introduction 1
1.2 Defi nitions of sterilization in the context of biomaterials 2
1.3 Validation, monitoring and safety of sterilization methods 5
1.4 Challenges and constraints of sterilization methods 9
1.5 Ideal versus actual sterilization methods 13
1.6 Conclusions 14
1.7 References 17
2 Steam and dry heat sterilization of biomaterials
and medical devices 20
W. J. ROGERS, Independent Healthcare Consultant, USA
2.1 Introduction 20
2.2 Steam sterilization 21
2.3 Different methods of steam sterilization 27
2.4 Test methods for the effectiveness of steam sterilization 33
2.5 Dry heat sterilization 41
2.6 Testing and validating dry heat sterilization 48
2.7 Conclusions 50
2.8 Sources of further information 52
2.9 References 53
v
© Woodhead Publishing Limited, 2012
vi Contents
3 Sterilisation of healthcare products by
ionising radiation: principles and standards 56
B. J. PARSONS, Leeds Metropolitan University, UK
3.1 Introduction 56
3.2 Interaction of ionising radiation with matter 57
3.3 Sources of ionising radiation 61
3.4 Validation and international standards of
sterilisation by ionising radiation 63
3.5 Conclusions and future trends 69
3.6 Sources of further information and advice 69
3.7 References 69
4 Ethylene oxide (EO) sterilization of healthcare products 71
G. C. MENDES, T. R. S. BRANDÃO and C. L. M. SILVA,
Universidade Católica Portuguesa, Portugal
4.1 Introduction 71
4.2 Advantages of ethylene oxide (EO) sterilization 72
4.3 Disadvantages of ethylene oxide (EO) sterilization 73
4.4 Sterilization process characterization 79
4.5 Process defi nition 84
4.6 Process optimization and the process challenge device 88
4.7 Qualifi cation of ethylene oxide (EO) sterilization 90
4.8 Contract sterilization 93
4.9 Acknowledgments 93
4.10 References 93
5 Non-traditional sterilization techniques for
biomaterials and medical devices 97
S. LEROUGE, École de technologie supérieure, Canada
5.1 Introduction 97
5.2 Non-traditional sterilization methods 99
5.3 Novel non-traditional sterilization methods 110
5.4 Conclusions 113
5.5 References 113
6 Sterilization and decontamination of surfaces
by plasma discharges 117
F. ROSSI, European Commission – Joint Research Centre,
Italy and O. KYLIÁN, Charles University, Czech Republic
6.1 Introduction 117
6.2 Overview of plasma generation 119
© Woodhead Publishing Limited, 2012
Contents vii
6.3 Plasma generation at low and atmospheric pressures 121
6.4 Interaction of plasma with biological pathogens: bacteria and
bacterial spores 129
6.5 Interaction of plasma with biological pathogens:
pyrogens and proteins 134
6.6 Further issues with the use of plasma for
sterilization purposes 141
6.7 Conclusions and future trends 144
6.8 References 145
7 Sterilisation techniques for polymers 151
W. J. ROGERS, Independent Healthcare Consultant, USA
7.1 Introduction 151
7.2 Dry-heat sterilisation 152
7.3 Steam (moist heat) sterilisation 163
7.4 Ethylene oxide (EO) sterilisation 168
7.5 Low-temperature hydrogen peroxide with plasma 173
7.6 Ozone sterilisation 175
7.7 Radiation sterilisation 179
7.8 Sterilisation and polymer effi ciency 186
7.9 Comparative effi ciencies of sterilisation techniques
for different polymers 188
7.10 Post-implantation effects 192
7.11 Dry heat sterilisation of silicones 194
7.12 Ethylene oxide (EO) sterilisation of polymers 196
7.13 Sterilisation issues relating to biodegradable
polymers and coatings 200
7.14 Biocompatibility testing 202
7.15 Conclusions 206
7.16 Sources of further information 209
7.17 References 210
8 Sterilisation of healthcare products by ionising
radiation: sterilisation of drug-device products
and tissue allografts 212
B. J. PARSONS, Leeds Metropolitan University, UK
8.1 Introduction 212
8.2 The effect of radiation on aqueous systems 215
8.3 Sterilisation of aqueous solutions of proteins and enzymes:
reactions of free radicals with proteins 217
© Woodhead Publishing Limited, 2012
viii Contents
8.4 The sterilisation of proteins in aqueous solution 220
8.5 Sterilisation of drugs using radiation 224
8.6 Sterilisation of drug-delivery systems using radiation 227
8.7 Sterilisation of tissue allografts using radiation 230
8.8 Conclusions and future trends 232
8.9 Sources of further information and advice 233
8.10 References 234
9 Antimicrobial coatings for ‘self-sterilisation’ 240
C. W. DUNNILL and I. P. PARKIN, University College
London, UK
9.1 Introduction 240
9.2 Self-sterilising surfaces 243
9.3 Antimicrobial metal surfaces 246
9.4 Light-activated antimicrobial surfaces 247
9.5 Conclusions 255
9.6 Future trends 257
9.7 Sources of further information 257
9.8 References 257
10 Prions and endotoxins: reprocessing strategies
for reusable medical devices 261
L. M. SEHULSTER, Centers for Disease Control
and Prevention, USA
10.1 Introduction: prion disease epidemiology 261
10.2 Prion resistance to inactivation: early research 263
10.3 Current recommendations for instrument reprocessing 267
10.4 Factors that impact the decision to use
prion-inactivating methods 273
10.5 Important issues associated with cleaning/decontamination 279
10.6 Research developments towards a validated
reprocessing strategy 289
10.7 Bacterial endotoxins 293
10.8 Device reprocessing strategies for endotoxin 295
10.9 References 299
11 Future trends for the sterilisation of biomaterials
and medical devices 310
A. SIMMONS, University of New South Wales, Australia
11.1 Introduction 310
11.2 Common sterilisation techniques 311
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Contents ix
11.3 Future trends 314
11.4 Conclusions 317
11.5 References 318
Index 321
© Woodhead Publishing Limited, 2012