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Guidelines for process safety in bioprocess manufacturing facilities /

"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 guide...

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Bibliographic Details
Corporate Author: American Institute of Chemical Engineers. Center for Chemical Process Safety
Format: Book
Language:English
Published: Hoboken, New Jersey : John Wiley & Sons, Inc., [2011]
Subjects:
Biochemical engineering > Safety measures.
TECHNOLOGY & ENGINEERING > Chemical & Biochemical.
Table of Contents:
  • Machine generated contents note: 1.1. Bioprocess Engineering Information Transfer and Management Practices
  • 1.2. The Need for Bioprocess Safety Management Systems
  • 1.2.2. Bioprocessing Incidents and Releases
  • 1.3. Our Target Audience
  • 1.4. How to use this Guideline
  • 2.1. Bioprocessing's History
  • 2.1.1. Bioprocessing's Historical Advancement
  • 2.1.1.1. Microbiological Advancements
  • 2.1.1.2. Food Science and Food Process Technology Advancements
  • 2.1.1.3. Genetic Advancements
  • 2.1.1.4. Future Bioprocessing Developments
  • 2.2. Industrial Applications
  • 2.2.1. Processes
  • 2.2.2. Products
  • 2.3. The Bioprocess Lifecycle
  • 2.3.1. Discovery
  • 2.3.2. Development Phase: Laboratory and Pilot Plant
  • 2.3.3. Scale-up Phase
  • 2.3.4. Upstream Operations and Downstream. Operations
  • 2.3.4.1. Inoculation/Seed and Production Biosafety Containment and Production Risk
  • 2.3.4.2. Fermentation/Cell Culture
  • 2.3.4.3. Scale of Manufacturing
  • 2.3.5. General Biosafety Recommendations for Large Scale Work
  • 2.3.5.1. Facility Design
  • 2.3.5.2. Equipment Design
  • 2.3.5.3. Cleaning, Inactivation, and Sterilization
  • 2.3.5.4. Maintenance
  • 2.3.5.5. Air and Gas Emissions
  • 2.3.5.6. Waste Handling
  • 2.3.5.7. Accidental Release
  • 2.3.6. Product Safety Information
  • 2.3.6.1. Product Handling
  • 2.3.6.2. Material Disposal
  • 2.3.4.3. Disposable Process Technology
  • 2.3.7. Outsourced Manufacturing Concerns
  • 3.1. Sample Approach
  • 3.1.2. Develop and Document a System to Manage Bioprocess Safety Hazards
  • 3.1.3. Appoint a Biological Safety Officer
  • 3.1.4. Collect Bioprocess Hazard Information
  • 3.1.5. Identify Bioprocess Safety Hazards
  • 3.1.5.1. Point of Decision
  • 3.1.6. Assess Bioprocess Safety Risks and Assign Bioprocess Safety Hazard Level
  • 3.1.7. Identify Bioprocess Controls and Risk Management Options
  • 3.1.8. Document Bioprocess Safety Hazard Risks and Management Decisions
  • 3.1.9. Communicate and Train on Bioprocess Safety Hazards
  • 3.1.10. Investigate & Learn from Bioprocess Incidents
  • 3.1.11. Review, Audit, Manage Change, and Improve Hazard Management Practices and Program
  • 3.2. Existing Management Systems
  • 3.2.1. Product Stewardship for Bioproducts
  • 3.3. Establishing a Bioprocess Safety Management System
  • 3.3.1. Select a Management System Model Based Upon Your Needs
  • 3.3.2. Identifying the Elements that Apply to Your Operations
  • 3.3.3. Establish a Review and Approval Cycle for the Documents
  • 3.3.4. Rolling Out the Management System to the Users
  • 3.4. Biosafety Training for the Workforce
  • 3.5. Investigating Incidents
  • 3.5.1. A Generic Procedure for Initial Biohazard Incident Response
  • 3.6. Managing Change
  • 3.7. Reviewing and Auditing for Continuous Improvement
  • 3.8. Applying Behavior-Based Safety to Bioprocesses
  • 4.1. Key Considerations for Assessing Risk to Manage Bioprocess Safety
  • 4.1.1. Testing for Bioactivity
  • 4.1.2. Non-biological Hazards
  • 4.2. Bioprocess Risk Assessment
  • 4.2.1. Three Types of Assessment
  • 4.2.2. Agent Considerations
  • 4.2.3. Process Considerations
  • 4.2.4. Environmental Considerations
  • 4.2.5. Microorganisms
  • 4.3. Recombinant Organisms
  • 4.4. Cell Culture
  • 5.1. Physical Plant Design
  • 5.1.1. Architectural Aspects
  • 5.1.1.1. Finishes and Materials
  • 5.1.1.2. Layout Strategies
  • 5.1.1.3. People and Material Flow
  • 5.1.1.4. Non-biological Hazards
  • 5.1.1.5. Seismic and Building Loads
  • 5.1.1.6. Hardened Construction
  • 5.1.1.7. Equipment Mezzanines and Subfloors
  • 5.1.1.8. Heating, Ventilation, and Air Conditioning Aspects
  • a. Supply and Exhaust Systems
  • b. Special Exhaust Stream Mitigation
  • c. HVAC Issues from a Biosafety Perspective
  • d. Microenvironments
  • e. Cascading Pressure Differentials
  • f. Containment versus Clean Room Environments
  • 5.1.1.9. Waste and Waste Treatment
  • 5.1.1.10. Process Support Systems: High Purity Water
  • 5.1.1.11. Process Support Systems: Hand Washing Sinks and Personnel showers
  • 5.1.2. Plant Sitting Issues
  • 5.1.2.1. Zoning & Permitting
  • 5.1.2.2. Regional Environmental Agencies and Environmental Impact Reports
  • 5.1.2.3. Building and Site Security
  • 5.2. Bioprocess Unit Operations
  • 5.2.1. General Equipment Design Considerations
  • 5.2.2. Closed-System Design
  • 5.2.2.2. Impact on Operations
  • 5.2.3. Upstream Equipment and Facility Design
  • 5.2.3.1. Additional Upstream Design Considerations
  • 5.2.3.2. Equipment and Facility Integration
  • 5.2.3.3. Production Segregation and Flows
  • 5.2.3.4. Segregation from a Biosafety Perspective
  • 5.2.3.5. Cleaning the Equipment
  • 5.2.4.1. Harvest and Recovery
  • 5.2.4.2. Centrifugation
  • 5.2.4.3. Filtration
  • 5.2.4.4. Chromatography
  • 5.2.5. Facility Support Issues
  • 5.2.6. Biosafety for Personnel: SOP, Protocols, and PPE
  • 6.1. Researching and Staying Informed
  • 6.1.1. Biopharmaceutical
  • 6.1.1.1. Drug Discovery and Development
  • 6.1.1.2. Gene-based Pharmaceuticals
  • 6.1.1.3. Drug Delivery Research
  • 6.1.2. Renewable-resources
  • 6.1.3. Environmental
  • 6.1.3.1. Bioprocessing and Waste Management
  • 6.2. Communicating the Impacts of New Technology.