Safety in Industrial Microbiology and Biotechnology (eBook)

Front Cover 1
Safety in Industrial Microbiology and Biotechnology 4
Copyright Page 5
Table of Contents 6
Preface 8
Contributors 10
Chapter 1. Safety in microbiology: an overview 12
1. Introduction 12
2. Laboratory-associated infections 12
3. Industry-associated infections 14
4. Conclusions 15
References 15
Chapter 2. Current legislation and regulatory frameworks 17
1. Introduction 17
2. United Kingdom legislation 18
3. European Community Directives and their effect in the UK 24
4. Current European national laws 26
5. The Organization for Economic Cooperation and Development (OECD) 27
6. USA 28
7. Japan 29
8. Sources of information 30
10. Conclusions 32
References 32
Chapter 3. Hazard groups and containment categories in microbiology and biotechnology 34
1. Introduction 34
2. Systems for classifying microorganisms on the basis of hazard 34
3. Lists of microorganisms in the various classes and groups 37
4. Containment categories 38
5. Equation of risk classes/hazard groups with containment levels 42
6. Conclusions 43
References 43
Chapter 4. Assessment of risk 45
1. Introduction 45
2. Large-scale industrial processes (GILSP level) 47
3. Fermentations under higher levels of containment 64
4. Risks by accidents (breakage and leakage) 68
5. Biomass 77
6. Open fermentations 78
Acknowledgements 82
References 83
Chapter 5. Pathogenicity testing 86
1. Features of microbial pathogenicity 86
2. Problems of pathogenicity testing 88
3. Methods of pathogenicity testing 89
4. Biotechnology and pathogenicity 97
5. Recombinant DNA – technology and pathogenicity 99
Acknowledgements 100
References 101
Chapter 6. Recombinant plasmids 104
1. Introduction 104
2. Recombinant plasmids 104
3. Uses of recombinant plasmids 110
4. Safety considerations 112
5. Optimizing production from recombinant plasmids 123
6. Conclusion 138
Acknowledgements 139
References 139
Chapter 7. Safe handling of mammalian cells on an industrial scale 164
1. Introduction 164
2. Microbial contamination from external sources 164
3. Contamination by viruses derived from cells 166
4. Viruses for production 167
5. Therapeutic proteins and antibodies 167
6. Cell banks 167
7. Conclusions 168
8. Precautions for staff 169
References 170
Chapter 8. Recombinant DNA techniques in production 172
1. Introduction 172
2. Processes used in production with recombinant organisms 173
3. Secondary containment, monitoring and environmental impact 182
4. Conclusions 185
References 185
Chapter 9. Engineering for safe bioprocessing 187
1. Introduction 187
2. Good industrial large-scale practice (GILSP) 188
3. Containment features 188
4. Design for safety: facility design 191
5. Design for safety: bioreactors 193
6. Design for safety: process engineering 196
7. Assessment and measurement of containment 198
8. Conclusions 198
References 198
Chapter 10. Containment in the development and manufacture of recombinant DNA-derived products 201
1. Introduction 201
2. Classification of microorganisms on the basis of risk 201
3. Safety precautions and containment categories 202
4. Good industrial large-scale practice 203
5. General principles: primary and secondary containment 207
6. Containment Category 1 210
7. Containment Category 2 213
8. Containment Category 3 222
Acknowledgement 224
References 224
Chapter 11. Monitoring and validation in biotechnological processes 225
1. Introduction 225
2. Definitions 225
3. Importance of detection of air and surface contamination 229
4. Influence of good microbiological technique during laboratory and pilot plant work 234
5. Monitoring large-scale operations 238
6. Results of monitoring pilot plant operations 240
7. Controlling improvements in containment 242
8. Validation of air filters 244
9. Critical places in the laboratory, pilot plant and production equipment and processes 247
10. Conclusions 248
Acknowledgement 248
References 248
Chapter 12. Occupational health implications of industrial biotechnology 250
1. Introduction 250
2. Exposure to microorganisms 250
3. Exposure to physiologically active products 251
4. Medical surveillance 252
5. Experience in Scandinavia 252
6. Conclusions 253
References 253
Appendix A: Glossary of acronyms 254
Appendix B: The Safety in Biotechnology Working Party of the European Federation of Biotechnology 256
Membership and organization 256
Activities 257
Publications 257
References 257
Appendix C: British Coordinating Committee for Biotechnology 258
References 263
Index 264