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Practical Pharmaceutical Engineering

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A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmac... Weiterlesen
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Beschreibung

A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design

Engineers 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 engineering

Practical 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. 



GARY PRAGER has a bachelor's degree in chemical engineering and a master's degree in nuclear engineering from the University of New Mexico. He is a Fellow of the American Institute of Chemical Engineers (AIChE). His pharmaceutical experience includes employment with Wyeth Pharmaceuticals, Fisher Scientific, and Skanska USA. Mr. Prager also has significant nuclear engineering and environmental engineering experience with firms such as PSE&G, the Graver Company, SAIC and Kaiser Engineers. He is also the Director of the Pharmaceutical Engineering Workshop presented at the New Jersey Institute of Technology and AIChE National Meetings in Salt Lake City and Philadelphia.

Autorentext

GARY PRAGER has a bachelor's degree in chemical engineering and a master's degree in nuclear engineering from the University of New Mexico. He is a Fellow of the American Institute of Chemical Engineers (AIChE). His pharmaceutical experience includes employment with Wyeth Pharmaceuticals, Fisher Scientific, and Skanska USA. Mr. Prager also has significant nuclear engineering and environmental engineering experience with firms such as PSE&G, the Graver Company, SAIC and Kaiser Engineers. He is also the Director of the Pharmaceutical Engineering Workshop presented at the New Jersey Institute of Technology and AIChE National Meetings in Salt Lake City and Philadelphia.

Klappentext

A PRACTICAL GUIDE TO ALL KEY THE ELEMENTS OF PHARMACEUTICALS AND BIOTECH MANUFACTURING AND DESIGN

Engineers 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 experienceuntil 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, quality assurance, quality control, and current Good Manufacturing Practices (cGMP) 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 engineering

Practical 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.

Inhalt

Preface xiii

1 US Regulations for the Pharmaceutical Industries 1

1.1 Introduction 1

1.2 The FDA: Formation of a Regulatory Agency 2

1.3 FDA's Seven Program Centers and Their Responsibility 6

1.3.1 Center for Biologics Evaluation and Research 6

1.3.2 Center for Drug Evaluation and Research 6

1.3.3 Center for Devices and Radiological Health 6

1.3.4 Center for Food Safety and Applied Nutrition 6

1.3.5 Center for Veterinary Medicine 6

1.3.6 Office of Combinational Products 6

1.3.7 Office of Regulatory Affairs 7

1.4 New Drug Development 7

1.4.1 Discovery 7

1.4.2 Investigational New Drug Application 8

1.4.3 Preclinical Studies (Animal) 9

1.4.4 Clinical Studies 10

1.5 Commercializing the New Drug 16

1.5.1 New Drug Application 17

1.6 Harmonization 23

1.6.1 Common Technical Document 23

1.7 Review Process of US NDA 25

1.8 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs 27

1.8.1 Organization and Personnel 27

1.8.2 Building and Facilities 28

1.8.3 Equipment 28

1.8.4 Control of Components and Drug Product Containers and Closures 29

1.8.5 Production and Process Controls 29

1.8.6 Packaging and Labeling Control 30

1.8.7 Holding and Distribution 31

1.8.8 Laboratory Controls 31

1.8.9 Records and Reports 32

1.8.10 Returned and Salvaged Drug Products 33

1.8.11 Other 33

1.9 Compliance 34

1.9.1 Quality System 35

1.9.2 Facilities and Equipment System 35

1.9.3 Materials System 36

1.9.4 Production System 36

1.9.5 Packaging and Labeling System 36

1.9.6 Laboratory Control System 36

1.10 Electronic Records and Electronic Signatures 37

1.10.1 Electronic Records 37

1.10.2 Electronic Signatures 38

1.11 Employee Safety 38

1.11.1 Process Safety Information 39

1.11.2 Process Hazard Analysis 40

1.11.3 Operating Procedures 41

1.11.4 Training 41

1.11.5 New Facility Startup 41

1.11.6 Mechanical Integrity 42

1.11.7 Hot Work Permit 42

1.11.8 Management of Change 42

1.11.9 Incident Investigation 43

1.11.10 Emergency Planning and Response 43

1.11.11 Compliance Audits 43

1.12 US EPA 43

1.12.1 Clean Air Act 44

1.12.2 Safe Drinking Water Act 45

1.12.3 Resource Conservation and Recovery Act 46

1.12.4 Emergency Planning and Community RighttoKnow Act 47

1.12.5 Clean Water Act 48

1.13 Process Analytical Technology 49

1.13.1 Process Understanding 49

1.13.2 Principles and Tools 50

1.13.3 Strategy for Implementation 51

1.14 Conclusion 51

References 51

Further Reading 52

2 Pharmaceutical Water Systems 53

2.1 Pharmaceutical Water Systems Basics 53

2.1.1 Fundamentals of Fluid Mechanics for Pharmaceutical Water Systems 58

2.2 Pharmaceutical Water Equipment 77

2.2.1 Centrifugal Pumps 77

2.2.2 Centrifugal Pump Installation Considerations 81

2.3 Thermodynamics Interlude 82

2.4 Heat Transfer for Pharmaceutical Water Production 90

2.5 Evaporation 109

2.6 Ion Exchange Systems 115

2.7 Reverse Osmosis 116

2.7.1 Principles of Reverse Osmosis 118

2.7.2 Reverse Osmosis Installation and Operational Costs 121

2.7.3 Reverse Osmosis Design Hint 122

2.8 cGMP Design and Facility Maintenance Considerations for Pharmaceutical Water Systems 122

References 128

Further Reading 129

3 Heating, Ventilating, and Air Conditioning 131

3.1 Fundamentals of HVAC Electrical Systems 132

3.1.1 Electric Motors 133

3.1.2 M...

Produktinformationen

Titel: Practical Pharmaceutical Engineering
Autor:
EAN: 9781119418849
Digitaler Kopierschutz: Adobe-DRM
Format: E-Book (pdf)
Hersteller: Wiley
Genre: Chemie
Anzahl Seiten: 576
Veröffentlichung: 28.11.2018
Dateigrösse: 7.6 MB