Guidelines for Process Safety in Bioprocess Manufacturing Facilities [Hardcover]

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.

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:lX