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Practical Pharmaceutical Engineering

Practical Pharmaceutical Engineering

Autorzy
Wydawnictwo Wiley & Sons
Data wydania
Liczba stron 576
Forma publikacji książka w twardej oprawie
Język angielski
ISBN 9780470410325
Kategorie Inżynieria biochemiczna
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Opis książki

A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and designEngineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience--until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing.Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings.* Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire* Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry* Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering* Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineeringPractical Pharmaceutical Engineering is an indispensable "tool of the trade" for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.

Practical Pharmaceutical Engineering

Spis treści

Preface xiii1 US Regulations for the Pharmaceutical Industries 11.1 Introduction 11.2 The FDA: Formation of a Regulatory Agency 21.3 FDA's Seven Program Centers and Their Responsibility 61.3.1 Center for Biologics Evaluation and Research 61.3.2 Center for Drug Evaluation and Research 61.3.3 Center for Devices and Radiological Health 61.3.4 Center for Food Safety and Applied Nutrition 61.3.5 Center for Veterinary Medicine 61.3.6 Office of Combinational Products 61.3.7 Office of Regulatory Affairs 71.4 New Drug Development 71.4.1 Discovery 71.4.2 Investigational New Drug Application 81.4.3 Preclinical Studies (Animal) 91.4.4 Clinical Studies 101.5 Commercializing the New Drug 161.5.1 New Drug Application 171.6 Harmonization 231.6.1 Common Technical Document 231.7 Review Process of US NDA 251.8 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs 271.8.1 Organization and Personnel 271.8.2 Building and Facilities 281.8.3 Equipment 281.8.4 Control of Components and Drug Product Containers and Closures 291.8.5 Production and Process Controls 291.8.6 Packaging and Labeling Control 301.8.7 Holding and Distribution 311.8.8 Laboratory Controls 311.8.9 Records and Reports 321.8.10 Returned and Salvaged Drug Products 331.8.11 Other 331.9 Compliance 341.9.1 Quality System 351.9.2 Facilities and Equipment System 351.9.3 Materials System 361.9.4 Production System 361.9.5 Packaging and Labeling System 361.9.6 Laboratory Control System 361.10 Electronic Records and Electronic Signatures 371.10.1 Electronic Records 371.10.2 Electronic Signatures 381.11 Employee Safety 381.11.1 Process Safety Information 391.11.2 Process Hazard Analysis 401.11.3 Operating Procedures 411.11.4 Training 411.11.5 New Facility Startup 411.11.6 Mechanical Integrity 421.11.7 Hot Work Permit 421.11.8 Management of Change 421.11.9 Incident Investigation 431.11.10 Emergency Planning and Response 431.11.11 Compliance Audits 431.12 US EPA 431.12.1 Clean Air Act 441.12.2 Safe Drinking Water Act 451.12.3 Resource Conservation and Recovery Act 461.12.4 Emergency Planning and Community Right-to-Know Act 471.12.5 Clean Water Act 481.13 Process Analytical Technology 491.13.1 Process Understanding 491.13.2 Principles and Tools 501.13.3 Strategy for Implementation 511.14 Conclusion 51References 51Further Reading 522 Pharmaceutical Water Systems 532.1 Pharmaceutical Water Systems Basics 532.1.1 Fundamentals of Fluid Mechanics for Pharmaceutical Water Systems 582.2 Pharmaceutical Water Equipment 772.2.1 Centrifugal Pumps 772.2.2 Centrifugal Pump Installation Considerations 812.3 Thermodynamics Interlude 822.4 Heat Transfer for Pharmaceutical Water Production 902.5 Evaporation 1092.6 Ion Exchange Systems 1152.7 Reverse Osmosis 1162.7.1 Principles of Reverse Osmosis 1182.7.2 Reverse Osmosis Installation and Operational Costs 1212.7.3 Reverse Osmosis Design Hint 1222.8 cGMP Design and Facility Maintenance Considerations for Pharmaceutical Water Systems 122References 128Further Reading 1293 Heating, Ventilating, and Air Conditioning 1313.1 Fundamentals of HVAC Electrical Systems 1323.1.1 Electric Motors 1333.1.2 Motor Plate and Associated Data 1343.2 Design Considerations 1403.2.1 Weather Data 1433.2.2 Temperature and Humidity 1433.2.3 Ventilation 1473.2.4 Air Filtration 1493.2.5 Internal Loads 1503.2.6 Air Distribution 1503.2.7 Room Pressurization 1513.2.8 Sound and Acoustic Criteria 1523.2.9 Building Control Systems 1583.3 Cleanrooms 1583.3.1 Cleanroom Design Fundamentals 1583.3.2 Cleanroom Monitoring, Maintenance, and Design Considerations for USP and USP Facilities 169References 172Further Reading 1724 Pressure Vessels, Reactors, and Fermentors 1754.1 Introduction 1754.1.1 Pressure Vessels 1754.1.2 Basics of Pressure Vessel Design and Specifications 1784.1.3 Pharmaceutical Reactors 1884.1.4 Kinetics and Reactor Fundamentals 1884.1.5 Bioreactor Principles 1974.1.6 Fermentor Principles 2094.1.7 Heat Transfer Aspects of Fermentors 2114.1.8 Bioreactor and Fermentor Design, Maintenance, Operating, and cGMP Considerations 2144.2 Safety Relief Valves and Rupture Discs 2194.2.1 Safety Relief Devices, Definition of Terms 2194.2.2 Relief Valve Design and Specifications 2234.2.3 Requirements and Capacity 223References 237Further Reading 2385 Reliability, Availability, and Maintainability 2395.1 Introduction to RAM 2395.2 The Role of Reliability 2405.3 The Role of Maintainability 2475.4 The Preventive Maintenance Program 2525.4.1 System Replacement Considerations 2535.5 Human Factors 2545.6 The Role of Availability 2595.7 Basic Mathematics for Reliability, Availability, and Maintainability 2595.8 Series and Parallel Configurations 2715.9 Spares and Replacement Parts 271References 276Further Reading 2776 Parenteral Operations 2796.1 Introduction 2796.2 Parenteral Definitions, Regulations, and Guidelines 2806.2.1 Nomenclature and Definitions 2806.3 Lyophilization 2826.3.1 Background 2826.3.2 Lyophilization Glossary 2836.3.3 Lyophilizer Design and Operation 2846.4 Lyophilizer Maintenance Issues 2946.4.1 Maintenance Systems Analysis 294References 296Further Reading 2967 Tableting Technology 2997.1 Introduction 2997.2 The Role of the FDA in the Manufacturing, Processing, Packing, and Holding of Drugs: The Relationship Between Regulations and Pharmaceutical Engineering 3007.3 Tablet Blending Operations 3047.3.1 Dry Granulation 3057.3.2 Wet Granulation 3207.4 Tableting Operations 3227.4.1 Tablet Manufacturing 3247.4.2 Tablet Press Maintenance 3297.5 Coating 3307.5.1 Tablet Coating 3307.5.2 Tablet Coater Maintenance 3317.6 Capsules 3337.6.1 Capsule Fundamentals 3347.6.2 Capsule Materials and Manufacturing 334References 337Further Reading 3388 Corrosion and Passivation in Pharmaceutical Operations 3398.1 Corrosion 3398.2 Corrosion and Corrosion Protection in Pharmaceutical Operations 3398.2.1 Definition of Corrosion 3438.2.2 Corrosion Fundamentals 3438.3 General Corrosion Protection in Pharmaceutical Operations 3448.3.1 Electrochemical Action 3448.3.2 Environmental Characteristics and Corrosion 3498.3.3 Properties of Metals that Influence Corrosion 3508.3.4 Effects of Fabrication and Assembly on Corrosion 3508.3.5 Protective Films and Corrosion 3528.3.6 Corrosion Activity in Solutions 3528.3.7 Types of Corrosion 3548.4 Corrosion- Resistant Metals and Alloys 3658.4.1 Iron Alloys 3668.4.2 Aluminum and Aluminum Alloys 3678.5 Passivation and Rouging 3688.5.1 Passivation 3688.5.2 Rouging 3698.6 General Corrosion Protective Measures 3708.6.1 General Design Considerations for Corrosion Prevention 3708.7 Pourbaix Diagrams 374References 377Further Reading 3789 Pharmaceutical Materials of Construction 3799.1 Introduction 3799.2 Materials Selection and Performance Requirements 3799.2.1 Introduction of Polymeric Materials for Single Use Systems 3809.3 Advantages and Disadvantages of Stainless Steels and Polymers for cGMP and Non-cGMP Pharmaceutical Applications 3819.4 Disposal of Single Use Components 3829.5 Performance Considerations for Pharmaceutical Materials of Construction 3929.5.1 Stainless Steels 3929.5.2 Copper and Copper Alloys 3949.5.3 Carbon Steels and Alloy Steels 3969.5.4 Polymeric Materials: Overview 3999.5.5 Preventing Pharmaceutical Materials Component Materials Failures 4029.6 Practical Piping Calculations 403References 408Further Reading 40910 Commissioning and Validation 41110.1 Introduction to Commissioning and Validation 41110.1.1 Introduction to Construction Specifications 41110.2 Commissioning 41610.2.1 Description of Tasks 41910.2.2 Commissioning Costs 42510.3 Validation 42510.4 Process Validation 45910.5 Electronic Records and Electronic Signatures 48410.5.1 Application of Risk Assessment Methods to Outsourcing 49110.5.2 Validation Costs 49210.6 Comparison Between Commissioning and Validation 493References 493Further Reading 49311 Topics and Concepts Relating to Pharmaceutical Engineering 49511.1 Preliminary Concepts 49511.1.1 Basic Statistical Concepts and Computational Techniques 49511.2 Introduction to Six Sigma 50811.2.1 Six Sigma Organization and Background 50811.2.2 DMAIC: The Basic Six Sigma Acronym 51411.2.3 Define 51411.2.4 Measure 51611.2.5 Analyze 51911.2.6 Improve 52011.2.7 Control 52311.2.8 Lean Six Sigma 52411.3 Process Analytical Technology 53011.4 Quality by Design 537References 540Further Reading 540Index 543

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