{"product_id":"practical-pharmaceutical-engineering-9780470410325","title":"Practical Pharmaceutical Engineering","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThis book provides professionals in the pharmaceutical industries a basic understanding of the key elements of pharmaceutical and biotech manufacturing and design.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface xiii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 US Regulations for the Pharmaceutical Industries 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 The FDA: Formation of a Regulatory Agency 2\u003c\/p\u003e \u003cp\u003e1.3 FDA’s Seven Program Centers and Their Responsibility 6\u003c\/p\u003e \u003cp\u003e1.3.1 Center for Biologics Evaluation and Research 6\u003c\/p\u003e \u003cp\u003e1.3.2 Center for Drug Evaluation and Research 6\u003c\/p\u003e \u003cp\u003e1.3.3 Center for Devices and Radiological Health 6\u003c\/p\u003e \u003cp\u003e1.3.4 Center for Food Safety and Applied Nutrition 6\u003c\/p\u003e \u003cp\u003e1.3.5 Center for Veterinary Medicine 6\u003c\/p\u003e \u003cp\u003e1.3.6 Office of Combinational Products 6\u003c\/p\u003e \u003cp\u003e1.3.7 Office of Regulatory Affairs 7\u003c\/p\u003e \u003cp\u003e1.4 New Drug Development 7\u003c\/p\u003e \u003cp\u003e1.4.1 Discovery 7\u003c\/p\u003e \u003cp\u003e1.4.2 Investigational New Drug Application 8\u003c\/p\u003e \u003cp\u003e1.4.3 Preclinical Studies (Animal) 9\u003c\/p\u003e \u003cp\u003e1.4.4 Clinical Studies 10\u003c\/p\u003e \u003cp\u003e1.5 Commercializing the New Drug 16\u003c\/p\u003e \u003cp\u003e1.5.1 New Drug Application 17\u003c\/p\u003e \u003cp\u003e1.6 Harmonization 23\u003c\/p\u003e \u003cp\u003e1.6.1 Common Technical Document 23\u003c\/p\u003e \u003cp\u003e1.7 Review Process of US NDA 25\u003c\/p\u003e \u003cp\u003e1.8 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs 27\u003c\/p\u003e \u003cp\u003e1.8.1 Organization and Personnel 27\u003c\/p\u003e \u003cp\u003e1.8.2 Building and Facilities 28\u003c\/p\u003e \u003cp\u003e1.8.3 Equipment 28\u003c\/p\u003e \u003cp\u003e1.8.4 Control of Components and Drug Product Containers and Closures 29\u003c\/p\u003e \u003cp\u003e1.8.5 Production and Process Controls 29\u003c\/p\u003e \u003cp\u003e1.8.6 Packaging and Labeling Control 30\u003c\/p\u003e \u003cp\u003e1.8.7 Holding and Distribution 31\u003c\/p\u003e \u003cp\u003e1.8.8 Laboratory Controls 31\u003c\/p\u003e \u003cp\u003e1.8.9 Records and Reports 32\u003c\/p\u003e \u003cp\u003e1.8.10 Returned and Salvaged Drug Products 33\u003c\/p\u003e \u003cp\u003e1.8.11 Other 33\u003c\/p\u003e \u003cp\u003e1.9 Compliance 34\u003c\/p\u003e \u003cp\u003e1.9.1 Quality System 35\u003c\/p\u003e \u003cp\u003e1.9.2 Facilities and Equipment System 35\u003c\/p\u003e \u003cp\u003e1.9.3 Materials System 36\u003c\/p\u003e \u003cp\u003e1.9.4 Production System 36\u003c\/p\u003e \u003cp\u003e1.9.5 Packaging and Labeling System 36\u003c\/p\u003e \u003cp\u003e1.9.6 Laboratory Control System 36\u003c\/p\u003e \u003cp\u003e1.10 Electronic Records and Electronic Signatures 37\u003c\/p\u003e \u003cp\u003e1.10.1 Electronic Records 37\u003c\/p\u003e \u003cp\u003e1.10.2 Electronic Signatures 38\u003c\/p\u003e \u003cp\u003e1.11 Employee Safety 38\u003c\/p\u003e \u003cp\u003e1.11.1 Process Safety Information 39\u003c\/p\u003e \u003cp\u003e1.11.2 Process Hazard Analysis 40\u003c\/p\u003e \u003cp\u003e1.11.3 Operating Procedures 41\u003c\/p\u003e \u003cp\u003e1.11.4 Training 41\u003c\/p\u003e \u003cp\u003e1.11.5 New Facility Startup 41\u003c\/p\u003e \u003cp\u003e1.11.6 Mechanical Integrity 42\u003c\/p\u003e \u003cp\u003e1.11.7 Hot Work Permit 42\u003c\/p\u003e \u003cp\u003e1.11.8 Management of Change 42\u003c\/p\u003e \u003cp\u003e1.11.9 Incident Investigation 43\u003c\/p\u003e \u003cp\u003e1.11.10 Emergency Planning and Response 43\u003c\/p\u003e \u003cp\u003e1.11.11 Compliance Audits 43\u003c\/p\u003e \u003cp\u003e1.12 US EPA 43\u003c\/p\u003e \u003cp\u003e1.12.1 Clean Air Act 44\u003c\/p\u003e \u003cp\u003e1.12.2 Safe Drinking Water Act 45\u003c\/p\u003e \u003cp\u003e1.12.3 Resource Conservation and Recovery Act 46\u003c\/p\u003e \u003cp\u003e1.12.4 Emergency Planning and Community Right‐to‐Know Act 47\u003c\/p\u003e \u003cp\u003e1.12.5 Clean Water Act 48\u003c\/p\u003e \u003cp\u003e1.13 Process Analytical Technology 49\u003c\/p\u003e \u003cp\u003e1.13.1 Process Understanding 49\u003c\/p\u003e \u003cp\u003e1.13.2 Principles and Tools 50\u003c\/p\u003e \u003cp\u003e1.13.3 Strategy for Implementation 51\u003c\/p\u003e \u003cp\u003e1.14 Conclusion 51\u003c\/p\u003e \u003cp\u003eReferences 51\u003c\/p\u003e \u003cp\u003eFurther Reading 52\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Pharmaceutical Water Systems 53\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Pharmaceutical Water Systems Basics 53\u003c\/p\u003e \u003cp\u003e2.1.1 Fundamentals of Fluid Mechanics for Pharmaceutical Water Systems 58\u003c\/p\u003e \u003cp\u003e2.2 Pharmaceutical Water Equipment 77\u003c\/p\u003e \u003cp\u003e2.2.1 Centrifugal Pumps 77\u003c\/p\u003e \u003cp\u003e2.2.2 Centrifugal Pump Installation Considerations 81\u003c\/p\u003e \u003cp\u003e2.3 Thermodynamics Interlude 82\u003c\/p\u003e \u003cp\u003e2.4 Heat Transfer for Pharmaceutical Water Production 90\u003c\/p\u003e \u003cp\u003e2.5 Evaporation 109\u003c\/p\u003e \u003cp\u003e2.6 Ion Exchange Systems 115\u003c\/p\u003e \u003cp\u003e2.7 Reverse Osmosis 116\u003c\/p\u003e \u003cp\u003e2.7.1 Principles of Reverse Osmosis 118\u003c\/p\u003e \u003cp\u003e2.7.2 Reverse Osmosis Installation and Operational Costs 121\u003c\/p\u003e \u003cp\u003e2.7.3 Reverse Osmosis Design Hint 122\u003c\/p\u003e \u003cp\u003e2.8 cGMP Design and Facility Maintenance Considerations for Pharmaceutical Water Systems 122\u003c\/p\u003e \u003cp\u003eReferences 128\u003c\/p\u003e \u003cp\u003eFurther Reading 129\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Heating, Ventilating, and Air Conditioning 131\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Fundamentals of HVAC Electrical Systems 132\u003c\/p\u003e \u003cp\u003e3.1.1 Electric Motors 133\u003c\/p\u003e \u003cp\u003e3.1.2 Motor Plate and Associated Data 134\u003c\/p\u003e \u003cp\u003e3.2 Design Considerations 140\u003c\/p\u003e \u003cp\u003e3.2.1 Weather Data 143\u003c\/p\u003e \u003cp\u003e3.2.2 Temperature and Humidity 143\u003c\/p\u003e \u003cp\u003e3.2.3 Ventilation 147\u003c\/p\u003e \u003cp\u003e3.2.4 Air Filtration 149\u003c\/p\u003e \u003cp\u003e3.2.5 Internal Loads 150\u003c\/p\u003e \u003cp\u003e3.2.6 Air Distribution 150\u003c\/p\u003e \u003cp\u003e3.2.7 Room Pressurization 151\u003c\/p\u003e \u003cp\u003e3.2.8 Sound and Acoustic Criteria 152\u003c\/p\u003e \u003cp\u003e3.2.9 Building Control Systems 158\u003c\/p\u003e \u003cp\u003e3.3 Cleanrooms 158\u003c\/p\u003e \u003cp\u003e3.3.1 Cleanroom Design Fundamentals 158\u003c\/p\u003e \u003cp\u003e3.3.2 Cleanroom Monitoring, Maintenance, and Design Considerations for USP and USP Facilities 169\u003c\/p\u003e \u003cp\u003eReferences 172\u003c\/p\u003e \u003cp\u003eFurther Reading 172\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Pressure Vessels, Reactors, and Fermentors 175\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 175\u003c\/p\u003e \u003cp\u003e4.1.1 Pressure Vessels 175\u003c\/p\u003e \u003cp\u003e4.1.2 Basics of Pressure Vessel Design and Specifications 178\u003c\/p\u003e \u003cp\u003e4.1.3 Pharmaceutical Reactors 188\u003c\/p\u003e \u003cp\u003e4.1.4 Kinetics and Reactor Fundamentals 188\u003c\/p\u003e \u003cp\u003e4.1.5 Bioreactor Principles 197\u003c\/p\u003e \u003cp\u003e4.1.6 Fermentor Principles 209\u003c\/p\u003e \u003cp\u003e4.1.7 Heat Transfer Aspects of Fermentors 211\u003c\/p\u003e \u003cp\u003e4.1.8 Bioreactor and Fermentor Design, Maintenance, Operating, and cGMP Considerations 214\u003c\/p\u003e \u003cp\u003e4.2 Safety Relief Valves and Rupture Discs 219\u003c\/p\u003e \u003cp\u003e4.2.1 Safety Relief Devices, Definition of Terms 219\u003c\/p\u003e \u003cp\u003e4.2.2 Relief Valve Design and Specifications 223\u003c\/p\u003e \u003cp\u003e4.2.3 Requirements and Capacity 223\u003c\/p\u003e \u003cp\u003eReferences 237\u003c\/p\u003e \u003cp\u003eFurther Reading 238\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Reliability, Availability, and Maintainability 239\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction to RAM 239\u003c\/p\u003e \u003cp\u003e5.2 The Role of Reliability 240\u003c\/p\u003e \u003cp\u003e5.3 The Role of Maintainability 247\u003c\/p\u003e \u003cp\u003e5.4 The Preventive Maintenance Program 252\u003c\/p\u003e \u003cp\u003e5.4.1 System Replacement Considerations 253\u003c\/p\u003e \u003cp\u003e5.5 Human Factors 254\u003c\/p\u003e \u003cp\u003e5.6 The Role of Availability 259\u003c\/p\u003e \u003cp\u003e5.7 Basic Mathematics for Reliability, Availability, and Maintainability 259\u003c\/p\u003e \u003cp\u003e5.8 Series and Parallel Configurations 271\u003c\/p\u003e \u003cp\u003e5.9 Spares and Replacement Parts 271\u003c\/p\u003e \u003cp\u003eReferences 276\u003c\/p\u003e \u003cp\u003eFurther Reading 277\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Parenteral Operations 279\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 279\u003c\/p\u003e \u003cp\u003e6.2 Parenteral Definitions, Regulations, and Guidelines 280\u003c\/p\u003e \u003cp\u003e6.2.1 Nomenclature and Definitions 280\u003c\/p\u003e \u003cp\u003e6.3 Lyophilization 282\u003c\/p\u003e \u003cp\u003e6.3.1 Background 282\u003c\/p\u003e \u003cp\u003e6.3.2 Lyophilization Glossary 283\u003c\/p\u003e \u003cp\u003e6.3.3 Lyophilizer Design and Operation 284\u003c\/p\u003e \u003cp\u003e6.4 Lyophilizer Maintenance Issues 294\u003c\/p\u003e \u003cp\u003e6.4.1 Maintenance Systems Analysis 294\u003c\/p\u003e \u003cp\u003eReferences 296\u003c\/p\u003e \u003cp\u003eFurther Reading 296\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Tableting Technology 299\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 299\u003c\/p\u003e \u003cp\u003e7.2 The Role of the FDA in the Manufacturing, Processing, Packing, and Holding of Drugs: The Relationship Between Regulations and Pharmaceutical Engineering 300\u003c\/p\u003e \u003cp\u003e7.3 Tablet Blending Operations 304\u003c\/p\u003e \u003cp\u003e7.3.1 Dry Granulation 305\u003c\/p\u003e \u003cp\u003e7.3.2 Wet Granulation 320\u003c\/p\u003e \u003cp\u003e7.4 Tableting Operations 322\u003c\/p\u003e \u003cp\u003e7.4.1 Tablet Manufacturing 324\u003c\/p\u003e \u003cp\u003e7.4.2 Tablet Press Maintenance 329\u003c\/p\u003e \u003cp\u003e7.5 Coating 330\u003c\/p\u003e \u003cp\u003e7.5.1 Tablet Coating 330\u003c\/p\u003e \u003cp\u003e7.5.2 Tablet Coater Maintenance 331\u003c\/p\u003e \u003cp\u003e7.6 Capsules 333\u003c\/p\u003e \u003cp\u003e7.6.1 Capsule Fundamentals 334\u003c\/p\u003e \u003cp\u003e7.6.2 Capsule Materials and Manufacturing 334\u003c\/p\u003e \u003cp\u003eReferences 337\u003c\/p\u003e \u003cp\u003eFurther Reading 338\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Corrosion and Passivation in Pharmaceutical Operations 339\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Corrosion 339\u003c\/p\u003e \u003cp\u003e8.2 Corrosion and Corrosion Protection in Pharmaceutical Operations 339\u003c\/p\u003e \u003cp\u003e8.2.1 Definition of Corrosion 343\u003c\/p\u003e \u003cp\u003e8.2.2 Corrosion Fundamentals 343\u003c\/p\u003e \u003cp\u003e8.3 General Corrosion Protection in Pharmaceutical Operations 344\u003c\/p\u003e \u003cp\u003e8.3.1 Electrochemical Action 344\u003c\/p\u003e \u003cp\u003e8.3.2 Environmental Characteristics and Corrosion 349\u003c\/p\u003e \u003cp\u003e8.3.3 Properties of Metals that Influence Corrosion 350\u003c\/p\u003e \u003cp\u003e8.3.4 Effects of Fabrication and Assembly on Corrosion 350\u003c\/p\u003e \u003cp\u003e8.3.5 Protective Films and Corrosion 352\u003c\/p\u003e \u003cp\u003e8.3.6 Corrosion Activity in Solutions 352\u003c\/p\u003e \u003cp\u003e8.3.7 Types of Corrosion 354\u003c\/p\u003e \u003cp\u003e8.4 Corrosion‐ Resistant Metals and Alloys 365\u003c\/p\u003e \u003cp\u003e8.4.1 Iron Alloys 366\u003c\/p\u003e \u003cp\u003e8.4.2 Aluminum and Aluminum Alloys 367\u003c\/p\u003e \u003cp\u003e8.5 Passivation and Rouging 368\u003c\/p\u003e \u003cp\u003e8.5.1 Passivation 368\u003c\/p\u003e \u003cp\u003e8.5.2 Rouging 369\u003c\/p\u003e \u003cp\u003e8.6 General Corrosion Protective Measures 370\u003c\/p\u003e \u003cp\u003e8.6.1 General Design Considerations for Corrosion Prevention 370\u003c\/p\u003e \u003cp\u003e8.7 Pourbaix Diagrams 374\u003c\/p\u003e \u003cp\u003eReferences 377\u003c\/p\u003e \u003cp\u003eFurther Reading 378\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Pharmaceutical Materials of Construction 379\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 379\u003c\/p\u003e \u003cp\u003e9.2 Materials Selection and Performance Requirements 379\u003c\/p\u003e \u003cp\u003e9.2.1 Introduction of Polymeric Materials for Single Use Systems 380\u003c\/p\u003e \u003cp\u003e9.3 Advantages and Disadvantages of Stainless Steels and Polymers for cGMP and Non‐cGMP Pharmaceutical Applications 381\u003c\/p\u003e \u003cp\u003e9.4 Disposal of Single Use Components 382\u003c\/p\u003e \u003cp\u003e9.5 Performance Considerations for Pharmaceutical Materials of Construction 392\u003c\/p\u003e \u003cp\u003e9.5.1 Stainless Steels 392\u003c\/p\u003e \u003cp\u003e9.5.2 Copper and Copper Alloys 394\u003c\/p\u003e \u003cp\u003e9.5.3 Carbon Steels and Alloy Steels 396\u003c\/p\u003e \u003cp\u003e9.5.4 Polymeric Materials: Overview 399\u003c\/p\u003e \u003cp\u003e9.5.5 Preventing Pharmaceutical Materials Component Materials Failures 402\u003c\/p\u003e \u003cp\u003e9.6 Practical Piping Calculations 403\u003c\/p\u003e \u003cp\u003eReferences 408\u003c\/p\u003e \u003cp\u003eFurther Reading 409\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Commissioning and Validation 411\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction to Commissioning and Validation 411\u003c\/p\u003e \u003cp\u003e10.1.1 Introduction to Construction Specifications 411\u003c\/p\u003e \u003cp\u003e10.2 Commissioning 416\u003c\/p\u003e \u003cp\u003e10.2.1 Description of Tasks 419\u003c\/p\u003e \u003cp\u003e10.2.2 Commissioning Costs 425\u003c\/p\u003e \u003cp\u003e10.3 Validation 425\u003c\/p\u003e \u003cp\u003e10.4 Process Validation 459\u003c\/p\u003e \u003cp\u003e10.5 Electronic Records and Electronic Signatures 484\u003c\/p\u003e \u003cp\u003e10.5.1 Application of Risk Assessment Methods to Outsourcing 491\u003c\/p\u003e \u003cp\u003e10.5.2 Validation Costs 492\u003c\/p\u003e \u003cp\u003e10.6 Comparison Between Commissioning and Validation 493\u003c\/p\u003e \u003cp\u003eReferences 493\u003c\/p\u003e \u003cp\u003eFurther Reading 493\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Topics and Concepts Relating to Pharmaceutical Engineering 495\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Preliminary Concepts 495\u003c\/p\u003e \u003cp\u003e11.1.1 Basic Statistical Concepts and Computational Techniques 495\u003c\/p\u003e \u003cp\u003e11.2 Introduction to Six Sigma 508\u003c\/p\u003e \u003cp\u003e11.2.1 Six Sigma Organization and Background 508\u003c\/p\u003e \u003cp\u003e11.2.2 DMAIC: The Basic Six Sigma Acronym 514\u003c\/p\u003e \u003cp\u003e11.2.3 Define 514\u003c\/p\u003e \u003cp\u003e11.2.4 Measure 516\u003c\/p\u003e \u003cp\u003e11.2.5 Analyze 519\u003c\/p\u003e \u003cp\u003e11.2.6 Improve 520\u003c\/p\u003e \u003cp\u003e11.2.7 Control 523\u003c\/p\u003e \u003cp\u003e11.2.8 Lean Six Sigma 524\u003c\/p\u003e \u003cp\u003e11.3 Process Analytical Technology 530\u003c\/p\u003e \u003cp\u003e11.4 Quality by Design 537\u003c\/p\u003e \u003cp\u003eReferences 540\u003c\/p\u003e \u003cp\u003eFurther Reading 540\u003c\/p\u003e \u003cp\u003eIndex 543\u003c\/p\u003e","brand":"John Wiley \u0026 Sons 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