MTU Cork Library Catalogue

Syndetics cover image
Image from Syndetics

Guidelines for process safety in bioprocess manufacturing facilities / Center for Chemical Process Safety of the American Institute of Chemical Engineers.

Contributor(s): American Institute of Chemical Engineers. Center for Chemical Process Safety.
Material type: materialTypeLabelBookPublisher: Hoboken, N.J. : John Wiley & Sons, Inc., [2011]Copyright date: ©2011Description: xix, 225 pages : illustrations ; 24 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 9780470251492 (hardback).Subject(s): Biochemical engineering -- Safety measuresAdditional physical formats: Electronic version:.: Guidelines for process safety in bioprocess manufacturing facilities.DDC classification: 660.60289 Also available in electronic formSummary: "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.

Enhanced descriptions from Syndetics:

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.

Includes bibliographical references and index.

"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.

CIT Module OCCH6001- Supplementary reading.

Also available in electronic form

Table of contents provided by Syndetics

  • List of Tables (p. xi)
  • List of Figures (p. xiii)
  • Items on the Web Accompanying This Book (p. xv)
  • Acknowledgements (p. xvii)
  • Preface (p. xix)
  • 1 Introduction (p. 1)
  • 1.1 Bioprocess Engineering Information Transfer and Management Practices (p. 3)
  • 1.2 The Need for Bioprocess Safety Management Systems (p. 7)
  • 1.2.2 Bioprocessing Incidents and Releases (p. 8)
  • 1.3 Our Target Audience (p. 14)
  • 1.4 How to use this Guideline (p. 15)
  • 2 An Overview of the Bioprocessing Industry (p. 17)
  • 2.1 Bioprocessing's History (p. 17)
  • 2.1.1 Bioprocessing's Historical Advancement (p. 18)
  • 2.1.1.1 Microbiological Advancements (p. 18)
  • 2.1.1.2 Food Science and Food Process Technology Advancements (p. 19)
  • 2.1.1.3 Genetic Advancements (p. 19)
  • 2.1.1.4 Future Bioprocessing Developments (p. 20)
  • 2.2 Industrial Applications (p. 20)
  • 2.2.1 Processes (p. 21)
  • 2.2.2 Products (p. 21)
  • 2.3 The Bioprocess Lifecycle (p. 22)
  • 2.3.1 Discovery (p. 23)
  • 2.3.2 Development Phase: Laboratory and Pilot Plant (p. 23)
  • 2.3.3 Scale-up Phase (p. 24)
  • 2.3.4 Upstream Operations and Downstream Operations (p. 26)
  • 2.3.4.1 Inoculation / Seed and Production Biosafety Containment and Production Risk (p. 27)
  • 2.3.4.2 Fermentation / Cell Culture (p. 31)
  • 2.3.4.3 Scale of Manufacturing (p. 36)
  • 2.3.5 General Biosafety Recommendations for Large Scale Work (p. 38)
  • 2.3.5.1 Facility Design (p. 39)
  • 2.3.5.2 Equipment Design (p. 39)
  • 2.3.5.3 Cleaning, Inactivation, and Sterilization (p. 41)
  • 2.3.5.4 Maintenance (p. 42)
  • 2.3.5.5 Air and Gas Emissions (p. 42)
  • 2.3.5.6 Waste Handling (p. 42)
  • 2.3.5.7 Accidental Release (p. 43)
  • 2.3.6 Product Safety Information (p. 43)
  • 2.3.6.1 Product Handling (p. 44)
  • 2.3.6.2 Material Disposal (p. 44)
  • 2.3.6.3 Disposable Process Technology (p. 44)
  • 2.3.7 Outsourced Manufacturing Concerns (p. 45)
  • 3 Bioprocessing Safety Management Practices (p. 47)
  • 3.1 Sample Approach (p. 48)
  • 3.1.2 Develop and Document a System to Manage Bioprocess Safety Hazards (p. 50)
  • 3.1.3 Appoint a Biological Safety Officer (p. 50)
  • 3.1.4 Collect Bioprocess Hazard Information (p. 51)
  • 3.1.5 Identify Bioprocess Safety Hazards (p. 51)
  • 3.1.5.1 Point of Decision (p. 51)
  • 3.1.6 Assess Bioprocess Safety Risks and Assign Bioprocess Safety Hazard Level (p. 52)
  • 3.1.7 Identify Bioprocess Controls and Risk Management Options (p. 52)
  • 3.1.8 Document Bioprocess Safety Hazard Risks and Management Decisions (p. 53)
  • 3.1.9 Communicate and Train on Bioprocess Safety Hazards (p. 53)
  • 3.1.10 Investigate & Learn from Bioprocess Incidents (p. 53)
  • 3.1.11 Review, Audit, Manage Change, and Improve Hazard Management Practices and Program (p. 54)
  • 3.2 Existing Management Systems (p. 54)
  • 3.2.1 Product Stewardship for Bioproducts (p. 61)
  • 3.3 Establishing a Bioprocess Safety Management System (p. 62)
  • 3.3.1 Select a Management System Model Based Upon Your Needs (p. 63)
  • 3.3.2 Identifying the Elements that Apply to Your Operations (p. 64)
  • 3.3.3 Establish a Review and Approval Cycle for the Documents (p. 65)
  • 3.3.4 Rolling Out the Management System to the Users (p. 66)
  • 3.4 Biosafety Training for the Workforce (p. 67)
  • 3.5 Investigating Incidents (p. 69)
  • 3.5.1 A Generic Procedure for Initial Biohazard Incident Response (p. 71)
  • 3.6 Managing Change (p. 75)
  • 3.7 Reviewing and Auditing for Continuous Improvement (p. 76)
  • 3.8 Applying Behavior-Based Safety to Bioprocesses (p. 76)
  • 4 Identifying Bioprocess Hazards (p. 79)
  • 4.1 Key Considerations for Assessing Risk to Manage Bioprocess Safety (p. 79)
  • 4.1.1 Testing for Bioactivity (p. 79)
  • 4.1.2 Non-biological Hazards (p. 80)
  • 4.2 Bioprocess Risk Assessment (p. 80)
  • 4.2.1 Three Types of Assessment (p. 80)
  • 4.2.2 Agent Considerations (p. 80)
  • 4.2.3 Process Considerations (p. 81)
  • 4.2.4 Environmental Considerations (p. 82)
  • 4.2.5 Microorganisms (p. 83)
  • 4.3 Recombinant Organisms (p. 85)
  • 4.4 Cell Culture (p. 86)
  • 5 Bioprocess Design Considerations and Unit Operations (p. 89)
  • 5.1 Physical Plant Design (p. 89)
  • 5.1.1 Architectural Aspects (p. 90)
  • 5.1.1.1 Finishes and Materials (p. 90)
  • 5.1.1.2 Layout Strategies (p. 91)
  • 5.1.1.3 People and Material Flow (p. 94)
  • 5.1.1.4 Non-biological Hazards (p. 94)
  • 5.1.1.5 Seismic and Building Loads (p. 96)
  • 5.1.1.6 Hardened Construction (p. 97)
  • 5.1.1.7 Equipment Mezzanines and Subfloors (p. 97)
  • 5.1.1.8 Heating, Ventilation, and Air Conditioning Aspects (p. 98)
  • (a) Supply and Exhaust Systems (p. 98)
  • (b) Special Exhaust Stream Mitigation (p. 100)
  • (c) HVAC Issues from a Biosafety Perspective (p. 101)
  • (d) Microenvironments (p. 103)
  • (e) Cascading Pressure Differentials (p. 105)
  • (f) Containment versus Clean Room Environments (p. 107)
  • 5.1.1.9 Waste and Waste Treatment (p. 109)
  • 5.1.1.10 Process Support Systems: High Purity Water (p. 112)
  • 5.1.1.11 Process Support Systems: Hand Washing Sinks and Personnel showers (p. 112)
  • 5.1.2 Plant Siting Issues (p. 113)
  • 5.1.2.1 Zoning & Permitting (p. 113)
  • 5.1.2.2 Regional Environmental Agencies and Environmental Impact Reports (p. 113)
  • 5.1.2.3 Building and Site Security (p. 114)
  • 5.2 Bioprocess Unit Operations (p. 116)
  • 5.2.1 General Equipment Design Considerations (p. 117)
  • 5.2.2 Closed-System Design (p. 118)
  • 5.2.2.2 Impact on Operations (p. 123)
  • 5.2.3 Upstream Equipment and Facility Design (p. 124)
  • 5.2.3.1 Additional Upstream Design Considerations (p. 124)
  • 5.2.3.2 Equipment and Facility Integration (p. 127)
  • 5.2.3.3 Production Segregation and Flows (p. 127)
  • 5.2.3.4 Segregation from a Biosafety Perspective (p. 129)
  • 5.2.3.5 Cleaning the Equipment (p. 130)
  • 5.2.4.1 Harvest and Recovery (p. 134)
  • 5.2.4.2 Centrifugation (p. 134)
  • 5.2.4.3 Filtration (p. 135)
  • 5.2.4.4 Chromatography (p. 137)
  • 5.2.5 Facility Support Issues (p. 139)
  • 5.2.6 Biosafety for Personnel: SOP, Protocols, and PPE (p. 140)
  • 6 The Effects of Emerging Technology on Bioprocessing Risk Management (p. 143)
  • 6.1 Researching and Staying Informed (p. 143)
  • 6.1.1 Biopharmaceutical (p. 144)
  • 6.1.1.1 Drug Discovery and Development (p. 144)
  • 6.1.1.2 Gene-based Pharmaceuticals (p. 144)
  • 6.1.1.3 Drug Delivery Research (p. 146)
  • 6.1.2 Renewable-resources (p. 147)
  • 6.1.3 Environmental (p. 148)
  • 6.1.3.1 Bioprocessing and Waste Management (p. 148)
  • 6.2 Communicating the Impacts of New Technology (p. 149)
  • 6.2.1 Industry (Communication at Your Site) (p. 150)

Author notes provided by Syndetics

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.

Powered by Koha