{"product_id":"process-architecture-in-biomanufacturing-facility-design-9781118833674","title":"Process Architecture in Biomanufacturing Facility","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eContributors xv\u003c\/p\u003e \u003cp\u003eForeword xvii\u003c\/p\u003e \u003cp\u003ePreface xix\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction to Biomanufacturing \u003c\/b\u003e\u003cb\u003e1\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eMark F. Witcher\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 The Basics Constituents of Biopharmaceuticals 2\u003c\/p\u003e \u003cp\u003e1.2.1 Proteins 3\u003c\/p\u003e \u003cp\u003e1.2.2 Nucleic Acids (DNA and RNA) 5\u003c\/p\u003e \u003cp\u003e1.2.3 Cells 6\u003c\/p\u003e \u003cp\u003e1.3 Enterprise Element #1—Manufacturing Processes 8\u003c\/p\u003e \u003cp\u003e1.3.1 Process—Unit Operations 8\u003c\/p\u003e \u003cp\u003e1.3.2 Upstream Processes—Inoculum through Production Bioreactor 9\u003c\/p\u003e \u003cp\u003e1.3.3 Upstream Processes—Harvest and Recovery 12\u003c\/p\u003e \u003cp\u003e1.3.3.1 Normal Filtration 12\u003c\/p\u003e \u003cp\u003e1.3.3.2 Centrifuge 13\u003c\/p\u003e \u003cp\u003e1.3.3.3 Cell Disruption 13\u003c\/p\u003e \u003cp\u003e1.3.4 Downstream Processes 13\u003c\/p\u003e \u003cp\u003e1.3.4.1 Viral Clearance 14\u003c\/p\u003e \u003cp\u003e1.3.4.2 Tangential Flow Filtration 15\u003c\/p\u003e \u003cp\u003e1.3.4.3 Chromatography 16\u003c\/p\u003e \u003cp\u003e1.3.5 Process Performance and Control 19\u003c\/p\u003e \u003cp\u003e1.3.6 Process—Equipment 22\u003c\/p\u003e \u003cp\u003e1.3.7 Process—Materials 23\u003c\/p\u003e \u003cp\u003e1.4 Enterprise Element #2—Manufacturing Facility 23\u003c\/p\u003e \u003cp\u003e1.4.1 Facility—Layout 23\u003c\/p\u003e \u003cp\u003e1.4.2 Facility—Environment 25\u003c\/p\u003e \u003cp\u003e1.4.3 Clean Rooms\/CNC Spaces 25\u003c\/p\u003e \u003cp\u003e1.4.4 HVAC—Heating Ventilation and Air-Conditioning 26\u003c\/p\u003e \u003cp\u003e1.4.5 Surfaces 30\u003c\/p\u003e \u003cp\u003e1.4.6 Facility—Utilities Systems 30\u003c\/p\u003e \u003cp\u003e1.4.7 Facility—Control Systems 31\u003c\/p\u003e \u003cp\u003e1.5 Enterprise Element #3—Manufacturing Infrastructure 31\u003c\/p\u003e \u003cp\u003e1.5.1 Infrastructure—People (Operating Staff) 32\u003c\/p\u003e \u003cp\u003e1.5.2 Infrastructure—Enterprise Practices and Procedures 32\u003c\/p\u003e \u003cp\u003e1.6 Controlling the Manufacturing Enterprise 33\u003c\/p\u003e \u003cp\u003e1.7 Summary 35\u003c\/p\u003e \u003cp\u003eReferences 36\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Product–Process–Facility Relationship \u003c\/b\u003e\u003cb\u003e39\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJeffery Odum\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 39\u003c\/p\u003e \u003cp\u003e2.2 The Characteristics of Biological Therapeutic Products 40\u003c\/p\u003e \u003cp\u003e2.3 Understanding the Attributes 42\u003c\/p\u003e \u003cp\u003e2.3.1 Product Quality Attributes 44\u003c\/p\u003e \u003cp\u003e2.3.2 Process Parameters 44\u003c\/p\u003e \u003cp\u003e2.3.3 Facility Attributes 45\u003c\/p\u003e \u003cp\u003e2.4 Factors that Impact Facility Design 46\u003c\/p\u003e \u003cp\u003e2.4.1 Facility Types 47\u003c\/p\u003e \u003cp\u003e2.4.1.1 Product Development Facilities 47\u003c\/p\u003e \u003cp\u003e2.4.1.2 Pilot\/Clinical 49\u003c\/p\u003e \u003cp\u003e2.4.1.3 Commercial Manufacturing 54\u003c\/p\u003e \u003cp\u003e2.4.2 Comparisons of the Facility Types 54\u003c\/p\u003e \u003cp\u003eReferences 54\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Regulatory Considerations of Biomanufacturing Facilities \u003c\/b\u003e\u003cb\u003e55\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eKip Priesmeyer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 55\u003c\/p\u003e \u003cp\u003e3.2 Regulatory “Uncertainty,” A Two-Way Street 56\u003c\/p\u003e \u003cp\u003e3.3 Design with the Patient in Mind: Assess the Patient, Product, Process, and Plant 58\u003c\/p\u003e \u003cp\u003e3.4 Laws, Regulations, and Guidelines: Historical Background 60\u003c\/p\u003e \u003cp\u003e3.5 Global Guidance Documents 64\u003c\/p\u003e \u003cp\u003e3.6 Quality Systems and Risk Management 66\u003c\/p\u003e \u003cp\u003e3.7 Product Changeover and Regulatory Assessment of Cleaning Validation 70\u003c\/p\u003e \u003cp\u003e3.8 Control Strategy 74\u003c\/p\u003e \u003cp\u003e3.9 Contract Manufacturing Organizations 77\u003c\/p\u003e \u003cp\u003e3.10 FDA Inspections of Biopharm Facilities and Regulators’ Priorities 80\u003c\/p\u003e \u003cp\u003e3.11 Regulatory Meetings 84\u003c\/p\u003e \u003cp\u003e3.12 Conclusion 85\u003c\/p\u003e \u003cp\u003eReferences 88\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Biopharmaceutical Facility Design and Validation \u003c\/b\u003e\u003cb\u003e91\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJeffery Odum\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 91\u003c\/p\u003e \u003cp\u003e4.2 Designing for Compliance 92\u003c\/p\u003e \u003cp\u003e4.2.1 Facility Considerations 93\u003c\/p\u003e \u003cp\u003e4.2.2 Product–Process–Facility Integration 94\u003c\/p\u003e \u003cp\u003e4.2.3 The Role of Quality by Design 94\u003c\/p\u003e \u003cp\u003e4.3 Risk Management 102\u003c\/p\u003e \u003cp\u003e4.4 Qualification\/Verification 105\u003c\/p\u003e \u003cp\u003e4.5 Process Validation 110\u003c\/p\u003e \u003cp\u003e4.6 List of Abbreviations 113\u003c\/p\u003e \u003cp\u003eReferences 115\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Closed Systems in Bioprocessing \u003c\/b\u003e\u003cb\u003e117\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJeffery Odum\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 117\u003c\/p\u003e \u003cp\u003e5.2 Definition of Closed Systems 117\u003c\/p\u003e \u003cp\u003e5.3 Closed System Design 119\u003c\/p\u003e \u003cp\u003e5.4 Impact on Facility Design 121\u003c\/p\u003e \u003cp\u003e5.5 Impact on Operations 123\u003c\/p\u003e \u003cp\u003e5.6 Summary 127\u003c\/p\u003e \u003cp\u003eReferences 127\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Aseptic Manufacturing Considerations for Biomanufacturing Facility Design \u003c\/b\u003e\u003cb\u003e129\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJeffery Odum, Hartmut Schaz, and Larry Pressley\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 129\u003c\/p\u003e \u003cp\u003e6.2 The Relationship to Biological Products 130\u003c\/p\u003e \u003cp\u003e6.3 Process Attributes—Product Protection 130\u003c\/p\u003e \u003cp\u003e6.3.1 System Closure 131\u003c\/p\u003e \u003cp\u003e6.3.2 Segregation Strategy 133\u003c\/p\u003e \u003cp\u003e6.4 Facility Design 134\u003c\/p\u003e \u003cp\u003e6.5 Critical Area 137\u003c\/p\u003e \u003cp\u003eReferences 141\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Facility Control of Microorganisms: Containment and Contamination \u003c\/b\u003e\u003cb\u003e143\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJonathan Crane\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 143\u003c\/p\u003e \u003cp\u003e7.2 Design Principles for Controlling Microorganisms 144\u003c\/p\u003e \u003cp\u003e7.2.1 Planning Concepts 145\u003c\/p\u003e \u003cp\u003e7.2.2 Physical Barriers 145\u003c\/p\u003e \u003cp\u003e7.2.3 Engineering Systems 146\u003c\/p\u003e \u003cp\u003e7.2.4 Containment and Isolation Equipment 150\u003c\/p\u003e \u003cp\u003e7.2.5 Design to Support Operational Protocols 151\u003c\/p\u003e \u003cp\u003e7.3 Controlling Viable Environmental Particulates 151\u003c\/p\u003e \u003cp\u003e7.4 Reducing the Transport of Mold into the Bioprocess Facility 153\u003c\/p\u003e \u003cp\u003e7.4.1 Environmental Zoning 153\u003c\/p\u003e \u003cp\u003e7.4.2 Filtration of Molds and Mold Spores from Incoming Air 155\u003c\/p\u003e \u003cp\u003e7.5 Reducing Mold Sources within the Bioprocess Facility 156\u003c\/p\u003e \u003cp\u003e7.5.1 Cleaning and Decontamination 157\u003c\/p\u003e \u003cp\u003e7.6 Biocontainment: An Overlay to Process Design 157\u003c\/p\u003e \u003cp\u003e7.7 The Biocontainment Regulatory Environment 159\u003c\/p\u003e \u003cp\u003e7.7.1 Laboratory-Scale Use and Use in Animal Models of Disease 160\u003c\/p\u003e \u003cp\u003e7.7.2 Large-Scale Use of Pathogens 161\u003c\/p\u003e \u003cp\u003e7.7.3 Animal and Plant Pathogens 162\u003c\/p\u003e \u003cp\u003e7.7.4 Genetically Modified Organisms (GMO) and Synthesized Organisms 163\u003c\/p\u003e \u003cp\u003e7.7.5 Toxins 163\u003c\/p\u003e \u003cp\u003e7.7.6 Allergens and Biologically Active Products 164\u003c\/p\u003e \u003cp\u003e7.7.7 Biosecurity 164\u003c\/p\u003e \u003cp\u003e7.8 Principles of Biosafety 165\u003c\/p\u003e \u003cp\u003e7.8.1 Risk Groups 165\u003c\/p\u003e \u003cp\u003e7.8.2 Biosafety Levels 165\u003c\/p\u003e \u003cp\u003e7.9 Principles of Biocontainment Facility Design 167\u003c\/p\u003e \u003cp\u003e7.9.1 Risk Assessment 168\u003c\/p\u003e \u003cp\u003e7.9.2 Primary Containment 168\u003c\/p\u003e \u003cp\u003e7.9.3 Secondary Containment 169\u003c\/p\u003e \u003cp\u003e7.9.4 Impact of Scale and Process 170\u003c\/p\u003e \u003cp\u003e7.10 Design for the Entire Process 171\u003c\/p\u003e \u003cp\u003e7.10.1 Upstream Process Facilities 172\u003c\/p\u003e \u003cp\u003e7.10.2 Downstream Process Facilities 173\u003c\/p\u003e \u003cp\u003e7.10.3 Fill and Finish Facilities 173\u003c\/p\u003e \u003cp\u003e7.10.4 Quality Control Laboratory Facilities 173\u003c\/p\u003e \u003cp\u003e7.10.5 Cross-contamination “Live” to “Nonlive” 173\u003c\/p\u003e \u003cp\u003e7.11 Conclusion 173\u003c\/p\u003e \u003cp\u003eReferences 174\u003c\/p\u003e \u003cp\u003eFurther Reading 176\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Process-Based Laboratory Design \u003c\/b\u003e\u003cb\u003e177\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eHenriette Schubert and Flemming K. Nielsen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 177\u003c\/p\u003e \u003cp\u003e8.2 Areas of Application\/Scope 177\u003c\/p\u003e \u003cp\u003e8.3 Translation of Process Elements into Laboratory Architecture 179\u003c\/p\u003e \u003cp\u003e8.4 Key Steps in Planning Approach and Methodology 180\u003c\/p\u003e \u003cp\u003e8.4.1 Laboratory Planning Process 180\u003c\/p\u003e \u003cp\u003e8.4.1.1 Project Initiation (Analyze Data) 181\u003c\/p\u003e \u003cp\u003e8.4.1.2 Conceptual Design (Develop Concepts) 181\u003c\/p\u003e \u003cp\u003e8.4.1.3 Basic Design and Detailed Design (Develop Solutions) 181\u003c\/p\u003e \u003cp\u003e8.4.2 Creating an Informed Basis for Design 182\u003c\/p\u003e \u003cp\u003e8.4.2.1 Mapping of Design Drivers and Project Targets 183\u003c\/p\u003e \u003cp\u003e8.4.2.2 Designing for the Desired Laboratory Work Culture 185\u003c\/p\u003e \u003cp\u003e8.4.2.3 Risk Assessment (GMP, Biocontainment\/High Potent Product Containment) 188\u003c\/p\u003e \u003cp\u003e8.4.2.4 Operational Workflow Mapping and Visual Planning 193\u003c\/p\u003e \u003cp\u003e8.4.2.5 Functional Adjacency Analysis (Function\/Relation) 195\u003c\/p\u003e \u003cp\u003e8.4.2.6 Laboratory Typologies as a Planning Tool 197\u003c\/p\u003e \u003cp\u003e8.5 Laboratory Concept Development 200\u003c\/p\u003e \u003cp\u003e8.5.1 Planning Considerations for Laboratory Concepts 200\u003c\/p\u003e \u003cp\u003e8.5.1.1 Area Distribution 200\u003c\/p\u003e \u003cp\u003e8.5.1.2 Laboratory Concepts 201\u003c\/p\u003e \u003cp\u003e8.5.1.3 Capacity Considerations 201\u003c\/p\u003e \u003cp\u003e8.5.1.4 Translating Strategic Project Drivers into Laboratory Concepts 202\u003c\/p\u003e \u003cp\u003e8.5.1.5 Generic Versus Tailor-Made\/Specialized Laboratory Concepts 203\u003c\/p\u003e \u003cp\u003e8.5.1.6 Typical Objectives for Laboratory Types (R\u0026amp;D, QC) 204\u003c\/p\u003e \u003cp\u003e8.5.1.7 Laboratory Planning Modules and Floor Height 206\u003c\/p\u003e \u003cp\u003e8.5.2 Mechanical Considerations 208\u003c\/p\u003e \u003cp\u003e8.6 SHE Considerations 209\u003c\/p\u003e \u003cp\u003e8.7 Glossary 210\u003c\/p\u003e \u003cp\u003e8.8 List of Abbreviations 210\u003c\/p\u003e \u003cp\u003eReferences 211\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Case Study: Pharmaceutical Pilot Plant Design and Operation \u003c\/b\u003e\u003cb\u003e213\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eBeth H. Junker\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 213\u003c\/p\u003e \u003cp\u003e9.2 Operational Concepts and Processing Requirements 215\u003c\/p\u003e \u003cp\u003e9.3 Design 217\u003c\/p\u003e \u003cp\u003e9.3.1 Process Equipment 219\u003c\/p\u003e \u003cp\u003e9.3.2 Utilities 223\u003c\/p\u003e \u003cp\u003e9.3.2.1 Product Contact 224\u003c\/p\u003e \u003cp\u003e9.3.2.2 Nonproduct Contact 227\u003c\/p\u003e \u003cp\u003e9.3.2.3 HVAC 228\u003c\/p\u003e \u003cp\u003e9.3.3 Containment 230\u003c\/p\u003e \u003cp\u003e9.3.3.1 Product Protection 231\u003c\/p\u003e \u003cp\u003e9.3.3.2 Environmental Protection 231\u003c\/p\u003e \u003cp\u003e9.3.3.3 Personnel Protection 232\u003c\/p\u003e \u003cp\u003e9.3.4 Instrumentation 232\u003c\/p\u003e \u003cp\u003e9.3.5 Automation and Control 233\u003c\/p\u003e \u003cp\u003e9.3.6 Data Acquisition and Archiving 235\u003c\/p\u003e \u003cp\u003e9.3.7 Warehousing 236\u003c\/p\u003e \u003cp\u003e9.3.8 Back-Up Systems\/Redundancy 237\u003c\/p\u003e \u003cp\u003e9.3.9 Future Expansion\/Modification 237\u003c\/p\u003e \u003cp\u003e9.4 Operation 238\u003c\/p\u003e \u003cp\u003e9.4.1 Maintenance 238\u003c\/p\u003e \u003cp\u003e9.4.1.1 Preventative 238\u003c\/p\u003e \u003cp\u003e9.4.1.2 Ongoing 240\u003c\/p\u003e \u003cp\u003e9.4.1.3 Calibrations 240\u003c\/p\u003e \u003cp\u003e9.4.1.4 Modifications\/Change Control 241\u003c\/p\u003e \u003cp\u003e9.4.2 Staffing 242\u003c\/p\u003e \u003cp\u003e9.4.3 Laboratory Support 243\u003c\/p\u003e \u003cp\u003e9.4.4 Standard Operating Procedures (SOPs) 243\u003c\/p\u003e \u003cp\u003e9.4.5 Safety 247\u003c\/p\u003e \u003cp\u003e9.4.6 Training 249\u003c\/p\u003e \u003cp\u003e9.4.7 Validation 250\u003c\/p\u003e \u003cp\u003e9.4.8 Facility Records and Manufacturing Execution Systems (MES) 251\u003c\/p\u003e \u003cp\u003eReferences 253\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Addressing Sustainability in Biomanufacturing Facility Design \u003c\/b\u003e\u003cb\u003e259\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJosh Capparella, Samuel Colucci, Daniel Conner, Robert Dick, and Amanda Weko\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 259\u003c\/p\u003e \u003cp\u003e10.1.1 Economics of Sustainability 261\u003c\/p\u003e \u003cp\u003e10.1.2 Energy Benchmarking in the Biopharmaceutical Industry 261\u003c\/p\u003e \u003cp\u003e10.1.3 Integrating Sustainability into the Design Process 261\u003c\/p\u003e \u003cp\u003e10.1.3.1 Building Sustainability into the Process Early 261\u003c\/p\u003e \u003cp\u003e10.1.3.2 Building Information Modeling 262\u003c\/p\u003e \u003cp\u003e10.1.3.3 Integrated Utilities Approach 262\u003c\/p\u003e \u003cp\u003e10.1.4 Sustainable Building Benchmarking 263\u003c\/p\u003e \u003cp\u003e10.1.4.1 Commercial Building Benchmarking 263\u003c\/p\u003e \u003cp\u003e10.1.4.2 Biopharmaceutical Building Benchmarking 265\u003c\/p\u003e \u003cp\u003e10.1.4.3 Variations in Benchmarking Data 266\u003c\/p\u003e \u003cp\u003e10.1.4.4 Making a Meaningful Impact to Facility Energy Reductions 267\u003c\/p\u003e \u003cp\u003e10.1.4.5 Energy Efficiency: Current Trends 268\u003c\/p\u003e \u003cp\u003e10.1.5 Cost of Utilities 269\u003c\/p\u003e \u003cp\u003e10.1.6 Is Net Zero a Possibility? 271\u003c\/p\u003e \u003cp\u003e10.1.7 Process Drives the Design 272\u003c\/p\u003e \u003cp\u003e10.1.8 Risk-Based Approach to Sustainability 272\u003c\/p\u003e \u003cp\u003e10.1.9 Risk in a Closed Process 273\u003c\/p\u003e \u003cp\u003e10.2 Process Architecture 273\u003c\/p\u003e \u003cp\u003e10.2.1 Process Technology Impact on Footprint 273\u003c\/p\u003e \u003cp\u003e10.2.2 Tech Transfer and Scale Up 274\u003c\/p\u003e \u003cp\u003e10.2.3 Water 276\u003c\/p\u003e \u003cp\u003e10.3 Water and Water Treatment 276\u003c\/p\u003e \u003cp\u003e10.3.1 Incoming City Water 277\u003c\/p\u003e \u003cp\u003e10.3.2 Filtration and Softening 277\u003c\/p\u003e \u003cp\u003e10.3.3 Deionization and Reverse Osmosis 278\u003c\/p\u003e \u003cp\u003e10.3.4 Water for Injection (WFI) 279\u003c\/p\u003e \u003cp\u003e10.3.4.1 Ambient, Intermediate, and Hot WFI Requirements 279\u003c\/p\u003e \u003cp\u003e10.3.5 Clean Steam 279\u003c\/p\u003e \u003cp\u003e10.3.6 Black Utilities 280\u003c\/p\u003e \u003cp\u003e10.3.7 Wastewater Treatment 280\u003c\/p\u003e \u003cp\u003e10.4 Energy Efficiency 281\u003c\/p\u003e \u003cp\u003e10.4.1 Building Envelope and Materials 281\u003c\/p\u003e \u003cp\u003e10.4.2 Heating, Ventilation, and Air Conditioning (HVAC) 282\u003c\/p\u003e \u003cp\u003e10.4.2.1 Once-Through HVAC Versus Recirculation 283\u003c\/p\u003e \u003cp\u003e10.4.2.2 Filtration 283\u003c\/p\u003e \u003cp\u003e10.4.2.3 Primary–Secondary Air 283\u003c\/p\u003e \u003cp\u003e10.4.2.4 Setback Strategies 283\u003c\/p\u003e \u003cp\u003e10.4.3 Chilled Water 285\u003c\/p\u003e \u003cp\u003e10.4.3.1 Chilled Water and the HVAC System 286\u003c\/p\u003e \u003cp\u003e10.4.3.2 Chilled Water Generation 286\u003c\/p\u003e \u003cp\u003e10.4.3.3 Chilled Water Analysis and Design 286\u003c\/p\u003e \u003cp\u003e10.4.3.4 Free Cooling Opportunities 288\u003c\/p\u003e \u003cp\u003e10.4.3.5 Cooling Tower Design 289\u003c\/p\u003e \u003cp\u003e10.4.4 Steam 289\u003c\/p\u003e \u003cp\u003e10.4.4.1 Steam Optimization 289\u003c\/p\u003e \u003cp\u003e10.4.5 Compressed Air 291\u003c\/p\u003e \u003cp\u003e10.4.5.1 Air- and Water-Cooled Air Compressors 293\u003c\/p\u003e \u003cp\u003e10.4.5.2 Drier Technology 293\u003c\/p\u003e \u003cp\u003e10.4.6 Nitrogen 294\u003c\/p\u003e \u003cp\u003e10.4.7 Retro Commissioning 294\u003c\/p\u003e \u003cp\u003e10.4.8 Maintenance and Operations Best Practices 297\u003c\/p\u003e \u003cp\u003e10.5 Conclusion 300\u003c\/p\u003e \u003cp\u003eAcknowledgments 301\u003c\/p\u003e \u003cp\u003eReferences 301\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Technology’s Impact on the Biomanufacturing Facility of the Future \u003c\/b\u003e\u003cb\u003e305\u003cbr\u003e\u003c\/b\u003e\u003ci\u003eJeffery Odum and Mark F. Witcher\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 305\u003c\/p\u003e \u003cp\u003e11.2 The Enabling Technologies 307\u003c\/p\u003e \u003cp\u003e11.2.1 Process Platform Improvements 307\u003c\/p\u003e \u003cp\u003e11.2.2 Single-Use Technology 308\u003c\/p\u003e \u003cp\u003e11.2.3 Process Automation 311\u003c\/p\u003e \u003cp\u003e11.3 Elements of a Biomanufacturing Enterprise 311\u003c\/p\u003e \u003cp\u003e11.4 Evolution of the Facility of the Future 313\u003c\/p\u003e \u003cp\u003e11.5 The Future—Summary and Conclusions 320\u003c\/p\u003e \u003cp\u003eReferences 321\u003c\/p\u003e \u003cp\u003eGlossary 323\u003c\/p\u003e \u003cp\u003eIndex 329\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49406931009879,"sku":"9781118833674","price":131.1,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781118833674.jpg?v=1730497596","url":"https:\/\/bookcurl.com\/products\/process-architecture-in-biomanufacturing-facility-design-9781118833674","provider":"Book Curl","version":"1.0","type":"link"}