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E-grāmata: Guidelines for Process Safety in Bioprocess Manufacturing Facilities

  • Formāts: EPUB+DRM
  • Izdošanas datums: 28-Dec-2011
  • Izdevniecība: Wiley-AIChE
  • Valoda: eng
  • ISBN-13: 9781118009000
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Guidelines for Process Safety in Bioprocess Manufacturing FacilitiesPalielināt
  • Formāts: EPUB+DRM
  • Izdošanas datums: 28-Dec-2011
  • Izdevniecība: Wiley-AIChE
  • Valoda: eng
  • ISBN-13: 9781118009000
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"This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities"--

Provided by publisher.



This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities.
List of Tables xi
List of Figures xiii
Items on the Web Accompanying This Book xv
Acknowledgements xvii
Preface xix
1 Introduction 1(16)
1.1 Bioprocess Engineering Information Transfer and Management Practices
3(4)
1.2 The Need for Bioprocess Safety Management Systems
7(7)
1.2.2 Bioprocessing Incidents and Releases
8(6)
1.3 Our Target Audience
14(1)
1.4 How to use this Guideline
15(2)
2 An Overview Of The Bioprocessing Industry 17(30)
2.1 Bioprocessing's History
17(3)
2.1.1 Bioprocessing's Historical Advancement
18(2)
2.1.1.1 Microbiological Advancements
18(1)
2.1.1.2 Food Science and Food Process Technology Advancements
19(1)
2.1.1.3 Genetic Advancements
19(1)
2.1.1.4 Future Bioprocessing Developments
20(1)
2.2 Industrial Applications
20(2)
2.2.1 Processes
21(1)
2.2.2 Products
21(1)
2.3 The Bioprocess Lifecycle
22(25)
2.3.1 Discovery
23(1)
2.3.2 Development Phase: Laboratory and Pilot Plant
23(1)
2.3.3 Scale-up Phase
24(2)
2.3.4 Upstream Operations and Downstream. Operations
26(12)
2.3.4.1 Inoculation/Seed and Production Biosafety Containment and Production Risk
27(4)
2.3.4.2 Fermentation/Cell Culture
31(5)
2.3.4.3 Scale of Manufacturing
36(2)
2.3.5 General Biosafety Recommendations for Large Scale Work
38(5)
2.3.5.1 Facility Design
39(1)
2.3.5.2 Equipment Design
39(2)
2.3.5.3 Cleaning, Inactivation, and Sterilization
41(1)
2.3.5.4 Maintenance
42(1)
2.3.5.5 Air and Gas Emissions
42(1)
2.3.5.6 Waste Handling
42(1)
2.3.5.7 Accidental Release
43(1)
2.3.6 Product Safety Information
43(2)
2.3.6.1 Product Handling
44(1)
2.3.6.2 Material Disposal
44(1)
2.3.4.3 Disposable Process Technology
44(1)
2.3.7 Outsourced Manufacturing Concerns
45(2)
3 Bioprocessing Safety Management Practices 47(32)
3.1 Sample Approach
48(6)
3.1.2 Develop and Document a System to Manage Bioprocess Safety Hazards
50(1)
3.1.3 Appoint a Biological Safety Officer
50(1)
3.1.4 Collect Bioprocess Hazard Information
51(1)
3.1.5 Identify Bioprocess Safety Hazards
51(1)
3.1.5.1 Point of Decision
51(1)
3.1.6 Assess Bioprocess Safety Risks and Assign Bioprocess Safety Hazard Level
52(1)
3.1.7 Identify Bioprocess Controls and Risk Management Options
52(1)
3.1.8 Document Bioprocess Safety Hazard Risks and Management Decisions
53(1)
3.1.9 Communicate and Train on Bioprocess Safety Hazards
53(1)
3.1.10 Investigate & Learn from Bioprocess Incidents
53(1)
3.1.11 Review, Audit, Manage Change, and Improve Hazard Management Practices and Program
54(1)
3.2 Existing Management Systems
54(8)
3.2.1 Product Stewardship for Bioproducts
61(1)
3.3 Establishing a Bioprocess Safety Management System
62(5)
3.3.1 Select a Management System Model Based Upon Your Needs
63(1)
3.3.2 Identifying the Elements that Apply to Your Operations
64(1)
3.3.3 Establish a Review and Approval Cycle for the Documents
65(1)
3.3.4 Rolling Out the Management System to the Users
66(1)
3.4 Biosafety Training for the Workforce
67(2)
3.5 Investigating Incidents
69(6)
3.5.1 A Generic Procedure for Initial Biohazard Incident Response
71(4)
3.6 Managing Change
75(1)
3.7 Reviewing and Auditing for Continuous Improvement
76(1)
3.8 Applying Behavior-Based Safety to Bioprocesses
76(3)
4 Identifying Bioprocess Hazards 79(10)
4.1 Key Considerations for Assessing Risk to Manage Bioprocess Safety
79(1)
4.1.1 Testing for Bioactivity
79(1)
4.1.2 Non-biological Hazards
80(1)
4.2 Bioprocess Risk Assessment
80(5)
4.2.1 Three Types of Assessment
80(1)
4.2.2 Agent Considerations
80(1)
4.2.3 Process Considerations
81(1)
4.2.4 Environmental Considerations
82(1)
4.2.5 Microorganisms
83(2)
4.3 Recombinant Organisms
85(1)
4.4 Cell Culture
86(3)
5 Bioprocess Design Considerations And Unit Operations 89(54)
5.1 Physical Plant Design
89(27)
5.1.1 Architectural Aspects
90(23)
5.1.1.1 Finishes and Materials
90(1)
5.1.1.2 Layout Strategies
91(3)
5.1.1.3 People and Material Flow
94(1)
5.1.1.4 Non-biological Hazards
94(2)
5.1.1.5 Seismic and Building Loads
96(1)
5.1.1.6 Hardened Construction
97(1)
5.1.1.7 Equipment Mezzanines and Subfloors
97(1)
5.1.1.8 Heating, Ventilation, and Air Conditioning Aspects
98(11)
a Supply and Exhaust Systems
98(2)
b Special Exhaust Stream Mitigation
100(1)
c HVAC Issues from a Biosafety Perspective
101(2)
d Microenvironments
103(2)
e Cascading Pressure Differentials
105(2)
f Containment versus Clean Room Environments
107(2)
5.1.1.9 Waste and Waste Treatment
109(3)
5.1.1.10 Process Support Systems: High Purity Water
112(1)
5.1.1.11 Process Support Systems: Hand Washing Sinks and Personnel showers
112(1)
5.1.2 Plant Sitting Issues
113(3)
5.1.2.1 Zoning & Permitting
113(1)
5.1.2.2 Regional Environmental Agencies and Environmental Impact Reports
113(1)
5.1.2.3 Building and Site Security
114(2)
5.2 Bioprocess Unit Operations
116(27)
5.2.1 General Equipment Design Considerations
117(1)
5.2.2 Closed-System Design
118(6)
5.2.2.2 Impact on Operations
123(1)
5.2.3 Upstream Equipment and Facility Design
124(15)
5.2.3.1 Additional Upstream Design Considerations
124(3)
5.2.3.2 Equipment and Facility Integration
127(1)
5.2.3.3 Production Segregation and Flows
127(2)
5.2.3.4 Segregation from a Biosafety Perspective
129(1)
5.2.3.5 Cleaning the Equipment
130(4)
5.2.4.1 Harvest and Recovery
134(1)
5.2.4.2 Centrifugation
134(1)
5.2.4.3 Filtration
135(2)
5.2.4.4 Chromatography
137(2)
5.2.5 Facility Support Issues
139(1)
5.2.6 Biosafety for Personnel: SOP, Protocols, and PPE
140(3)
6 The Effects Of Emerging Technology On Bioprocessing Risk Management 143
6.1 Researching and Staying Informed
143(6)
6.1.1 Biopharmaceutical
144(3)
6.1.1.1 Drug Discovery and Development
144(1)
6.1.1.2 Gene-based Pharmaceuticals
144(2)
6.1.1.3 Drug Delivery Research
146(1)
6.1.2 Renewable-resources
147(1)
6.1.3 Environmental
148(1)
6.1.3.1 Bioprocessing and Waste Management
148(1)
6.2 Communicating the Impacts of New Technology
149
6.2.1 Industry (Communication at Your Site)
150
Since 1985, the Center for Chemical Process Safety (CCPS) has been the world leader in developing and disseminating information on process safety management and technology. CCPS, an industry technology alliance of the American Institute of Chemical Engineers (AIChE), has published over 80 books in its process safety guidelines and process safety concepts series, and over 100 training modules through its Safety in Chemical Engineering Education (SACHE) series.
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