Biosafety in Industrial Biotechnology

Front Cover
P. Hambleton, T. Salusbury
Springer Science & Business Media, Sep 30, 1994 - Science - 302 pages
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As an industry, biotechnology may be likened to the Hymn Book, being both ancient and modern. Whereas activities such as baking, brewing, the fermenting of foods date from our earliest attempts to control and utilise the environment, the application of recombinant DNA technology is recognised as being at the forefront of novel industrial development. Perhaps because of its association with processing foodstuffs together with the benefits derived from applications in the early organic chemistry and pharmaceutical industries, biotechnology has been regarded as being inherently safe. Yet unlike other modern industries, such as chemical and nuclear, where regulation has followed from incidents or accidents, modern biotechnology has been subject to close scrutiny and regulation almost from its inception. The process of regulation itself is somewhat unusual in that it was initially self-imposed by the very scientists who developed the fundamental techniques of recombinant DNA technology. They recognised the signific ance of their development but were concerned of the effects on humans and the environment of uncontrolled application of the new, powerful technology. Concern about the possible consequences of genetic manipula tion has undoubtedly been the driving force behind the regulations that are now in place in many parts of the world and which are the subject of this book. Safety issues in the biotechnology industry can be categorised under three headings: worker, environmental and consumer (product) safety.
 

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Contents

The development of European legislation on genetically modified organisms
1
13 The EC Directives on genetic modification
2
131 Directive 90219EEC Contained use of geneticallymodified microorganisms
3
132 Directive 9012201EEC Deliberate release of geneticallymodified organisms
5
14 The situation in the twelve Member States as of February 1993
8
143 Netherlands
9
144 France
10
146 Belgium
11
84 Safety cabinets
133
841 Classification
134
843 Class I cabinets
135
844 Class II cabinets
136
846 Laminar flow work stations
137
849 Other processes
139
8410 Flexible film isolators
143
85 Design engineering for secondary containment
144

16 Europe vs the USA
12
Disclaimer
13
Occupational and environmental safety the UK legislative framework
14
221 The UK approach
15
23 Occupational health and safety legislation
16
24 The Health and Safety at Work Act
18
242 Duties of employees
19
244 Duties of manufacturers and suppliers
20
25 The Environmental Protection Act
21
262 Genetically Modified Organisms Contained Use Regulations 1992 and Genetically Modified Organisms Contained Use Regulations 1993
22
263 Pressure Systems and Transportable Gas Containers Regulations 1989
23
264 Electricity at Work Regulations 1989
24
271 Guidelines
25
272 Local involvement
26
281 Aims of inspection
27
283 Enforcement
28
29 The way forward
29
Regulation of biotechnology in the United States Canada and Latin America
32
321 Federal regulatory structure
33
322 Food and Drug Administration
36
323 Environmental Protection Agency
43
324 Department of Agriculture
49
325 Coda
51
33 Canada
52
331 Veterinary biologies
53
332 Genetically modified plants and microorganisms
54
The legal and regulatory framework for biotechnology in Japan
57
43 The government bodies involved in biotechnology
58
431 Laboratoryscale experiments
59
44 Industrialscale applications of rDNA Technology
61
442 Guidance for the use of rDNA technology in the pharmaceutical sector
62
45 Agricultural applications of rDNA technology
63
46 Foods and food additives
64
47 Deliberate release of geneticallymodified microorganisms
65
Acknowledgements
66
Biotechnology and industrial microbiology regulations in Russia and the former Soviet republics
67
52 Regulations governing work with microorganisms containing recombinant DNA
68
522 The current guidelines
70
523 Regulatory authorities
74
53 Regulations governing labour safety in biotechnology research institutes and the microbiological industry
77
532 Rules governing the release of microorganisms into the workplace
78
533 Regulations governing the release of microorganisms into the environment
79
54 Adherence to regulations governing the containment and safe use of microorganisms
80
541 The environment
81
542 Waste water
83
543 Industrial personnel
84
55 Conclusions
86
References
87
Physical aspects of the uncontrolled release of material in biotechnology operations
90
62 The generation of aerosols
92
63 Persistence of aerosols in a closed space
95
64 Persistence of aerosols in the atmosphere
98
65 Retention clearance and absorption in the respiratory tract
99
66 The biological behaviour of airborne particles
100
662 Particle size
101
664 Oxygen
102
666 Protecting agents
103
68 Conclusions
104
References
105
Health hazards in biotechnology
109
72 Health hazards
110
721 Laboratoryassociated infection
111
722 Allergic reactions
112
723 Endotoxin reactions
116
724 Toxic reactions to products or byproducts
118
725 Hazards posed by genetic modification
119
726 Hazards posed by animal cell culture
120
727 Hazards posed by plant cell culture
121
73 Hazards of bioprocessing equipment
122
734 Filtration
123
737 Prevention
124
References
125
Containment of unit processes
129
82 Unit processes in biotechnology
130
83 Categories of containment
131
852 Other processes
145
86 The cost of containment
146
References
147
Containment in downstream processing
149
92 Regulations and guidelines
151
93 Cell separation
152
932 Centrifugation
154
94 Cell disruption
166
942 Nonphysical techniques
172
95 Fluid handling
173
96 Discussion and conclusions
174
97 Recommendations
175
References
176
Freezedrying of biohazardous products
178
1022 Prefreezing
179
1025 Stoppering and removal
180
103 Risk assessment
181
1033 Liquid and particulate aerosols
182
104 Hazards associated with product dispensing and handling finished materials
183
1043 Filling reservoirs
184
1046 Vials
185
1048 Spillages
186
10412 Product storage
187
10414 Leak testing of sealed vials and ampoules
188
1052 Prefreezing
189
1055 Container breakage and miscellaneous consequences of product freezing
190
1057 Comparison of protection during aerosolation or freezedrying
191
1063 Ablation and spillage
192
1071 Freezedrier design
193
1072 Freezedrier fabrication
194
1074 Protective devices
195
1077 Filtration
196
1079 Decontamination of the interior of the freezedrier
199
10711 Sterilisation by gaseous biocides
200
10712 Dry heat
204
10715 Integrated approach to safe freezedrying of biohazardous materials
206
10717 Dispensing product
207
Acknowledgement
209
Interpretation of regulatory requirements to large scale biosafety the role of the Industrial Biosafety Project
213
113 Risk assessment
214
114 Human health and safety
215
1142 Elaboration of containment principles
217
1143 Equipment containment design principles
218
1144 Measuring and monitoring containment
228
1145 Maintenance and training
232
116 Conclusions
235
Acknowledgements
236
Managing the effluent from bioindustrial processes
240
122 Regulatory background
241
124 Categories of waste
242
126 Choice of treatment method
244
1271 Multiplicity of containment devices
245
1272 Dead legs and crevice avoidance
246
1274 Standard operating procedures SOPs and process records
247
1275 Planned preventative maintenance PPM schedule
248
1282 Disinfection using chemical agents
249
1283 Heat treatment using steam
250
129 Testing effluent for sterility
251
1210 Design and qualification of a heat treatment effluent plant
252
12102 Qualification of effluent treatment plant
256
1211 The approach to effluent treatment at CAMR
257
References
266
Sampling methods for testing and monitoring biosafety of biotechnology equipment and activities
268
132 Sampling microbial aerosols
269
133 Sampling methods
270
134 Air sampling devices
272
1341 Inertial collectors
273
1342 Air centrifuges
280
1343 Filtration
284
135 Sample assessment
286
136 Practical applications of sampling techniques
288
References
291
Index
293
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