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Informationen zum Autor 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. Klappentext 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. Zusammenfassung 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. Inhaltsverzeichnis List of Tables xi List of Figures xiii Items on the Web Accompanying This Book xv Acknowledgements xvii Preface xix 1 INTRODUCTION 1 1.1 Bioprocess Engineering Information Transfer and Management Practices 3 1.2 The Need for Bioprocess Safety Management Systems 7 1.2.2 Bioprocessing Incidents and Releases 8 1.3 Our Target Audience 14 1.4 How to use this Guideline 15 2 AN OVERVIEW OF THE BIOPROCESSING INDUSTRY 17 2.1 Bioprocessing's History 17 2.1.1 Bioprocessing's Historical Advancement 18 2.1.1.1 Microbiological Advancements 18 2.1.1.2 Food Science and Food Process Technology Advancements 19 2.1.1.3 Genetic Advancements 19 2.1.1.4 Future Bioprocessing Developments 20 2.2 Industrial Applications 20 2.2.1 Processes 21 2.2.2 Products 21 2.3 The Bioprocess Lifecycle 22 2.3.1 Discovery 23 2.3.2 Development Phase: Laboratory and Pilot Plant 23 2.3.3 Scale-up Phase 24 2.3.4 Upstream Operations and Downstream Operations 26 2.3.4.1 Inoculation / Seed and Production Biosafety Containment and Production Risk 27 2.3.4.2 Fermentation / Cell Culture 31 2.3.4.3 Scale of Manufacturing 36 2.3.5 General Biosafety Recommendations for Large Scale Work 38 2.3.5.1 Facility Design 39 2.3.5.2 Equipment Design 39 2.3.5.3 Cleaning, Inactivation, and Sterilization 41 2.3.5.4 Maintenance 42 2.3.5.5 Air and Gas Emissions 42 2.3.5.6 Waste Handling 42 2.3.5.7 Accidental Release 43 2.3.6 Product Safety Information 43 2.3.6.1 Product Handling 44 2.3.6.2 Material Disposal 44 2.3.63 Disposable Process Technology 44 2.3.7 Outsourced Manufacturing Concerns 45 3 BIOPROCESSING SAFETY MANAGEMENT PRACTICES 47 3.1 Sample Approach 48 3.1.2 Develop and Document a System to Manage Bioprocess Safety Hazards 50 3.1.3 Appoint a Biological Safety Officer 50 3.1.4 Collect Bioprocess Hazard Information 51 3.1.5 Identify Bioprocess Safety Hazards 51 3.1.5.1 Point of Decision 51 3.1.6 Assess Bioprocess Safety Risks and Assign Bioprocess Safety Hazard Level 52 3.1.7 Identify Bioprocess Controls and Risk Management Options 52
