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Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety
| Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-AIChE, 2011 |
| Descrizione fisica | 1 online resource (248 p.) |
| Disciplina |
338.476606
660.6028/9 |
| Soggetto topico | Biochemical engineering - Safety measures |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-118-00900-2
1-282-94392-8 9786612943928 0-470-94914-7 1-61583-628-4 0-470-94913-9 |
| Classificazione | TEC009010 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Guidelines for Process Safety in Bioprocess Manufacturing Facilities; CONTENTS; List of Tables; List of Figures; Items on the Web Accompanying This Book; Acknowledgements; Preface; 1 INTRODUCTION; 1.1 Bioprocess Engineering Information Transfer and Management Practices; 1.2 The Need for Bioprocess Safely Management Systems; 1.2.2 Bioprocessing Incidents and Releases; 1.3 Our Target Audience; 1.4 How to use this Guideline; 2 AN OVERVIEW OF THE BIOPROCESSING INDUSTRY; 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 Advancements2.1.1.3 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 Design2.3.5.2 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; 2.3.6.3 Disposable Process Technology; 2.3.7 Outsourced Manufacturing Concerns; 3 BIOPROCESSING SAFETY MANAGEMENT PRACTICES; 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 Hazards3.1.5.1 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 System3.3.1 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 IDENTIFYING BIOPROCESS HAZARDS 4.1 Key Considerations for Assessing Risk to Manage Bioprocess Safety |
| Record Nr. | UNINA-9910141041303321 |
| Hoboken, N.J., : Wiley-AIChE, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety
| Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-AIChE, 2011 |
| Descrizione fisica | 1 online resource (248 p.) |
| Disciplina |
338.476606
660.6028/9 |
| Soggetto topico | Biochemical engineering - Safety measures |
| ISBN |
1-118-00900-2
1-282-94392-8 9786612943928 0-470-94914-7 1-61583-628-4 0-470-94913-9 |
| Classificazione | TEC009010 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Guidelines for Process Safety in Bioprocess Manufacturing Facilities; CONTENTS; List of Tables; List of Figures; Items on the Web Accompanying This Book; Acknowledgements; Preface; 1 INTRODUCTION; 1.1 Bioprocess Engineering Information Transfer and Management Practices; 1.2 The Need for Bioprocess Safely Management Systems; 1.2.2 Bioprocessing Incidents and Releases; 1.3 Our Target Audience; 1.4 How to use this Guideline; 2 AN OVERVIEW OF THE BIOPROCESSING INDUSTRY; 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 Advancements2.1.1.3 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 Design2.3.5.2 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; 2.3.6.3 Disposable Process Technology; 2.3.7 Outsourced Manufacturing Concerns; 3 BIOPROCESSING SAFETY MANAGEMENT PRACTICES; 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 Hazards3.1.5.1 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 System3.3.1 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 IDENTIFYING BIOPROCESS HAZARDS 4.1 Key Considerations for Assessing Risk to Manage Bioprocess Safety |
| Record Nr. | UNINA-9910830128403321 |
| Hoboken, N.J., : Wiley-AIChE, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety
| Guidelines for process safety in bioprocess manufacturing facilities [[electronic resource] /] / Center for Chemical Process Safety |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-AIChE, 2011 |
| Descrizione fisica | 1 online resource (248 p.) |
| Disciplina |
338.476606
660.6028/9 |
| Soggetto topico | Biochemical engineering - Safety measures |
| ISBN |
1-118-00900-2
1-282-94392-8 9786612943928 0-470-94914-7 1-61583-628-4 0-470-94913-9 |
| Classificazione | TEC009010 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Guidelines for Process Safety in Bioprocess Manufacturing Facilities; CONTENTS; List of Tables; List of Figures; Items on the Web Accompanying This Book; Acknowledgements; Preface; 1 INTRODUCTION; 1.1 Bioprocess Engineering Information Transfer and Management Practices; 1.2 The Need for Bioprocess Safely Management Systems; 1.2.2 Bioprocessing Incidents and Releases; 1.3 Our Target Audience; 1.4 How to use this Guideline; 2 AN OVERVIEW OF THE BIOPROCESSING INDUSTRY; 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 Advancements2.1.1.3 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 Design2.3.5.2 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; 2.3.6.3 Disposable Process Technology; 2.3.7 Outsourced Manufacturing Concerns; 3 BIOPROCESSING SAFETY MANAGEMENT PRACTICES; 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 Hazards3.1.5.1 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 System3.3.1 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 IDENTIFYING BIOPROCESS HAZARDS 4.1 Key Considerations for Assessing Risk to Manage Bioprocess Safety |
| Record Nr. | UNINA-9910840626503321 |
| Hoboken, N.J., : Wiley-AIChE, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||