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Guidelines for Process Safety in Bioprocess Manufacturing Facilities

Guidelines for Process Safety in Bioprocess Manufacturing Facilities

CCPS (Center for Chemical Process Safety)

ISBN: 978-0-470-94914-6

Nov 2010

248 pages


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.

List of Figures.

Items on the Web Accompanying This Book.



1. Introduction.

1.1 Bioprocess Engineering Information Transfer and Management Practices.

1.2 The Need for Bioprocess Safety Management Systems.

1.3 Our Target Audience.

1.4 How to use this Guideline.

2. An Overview of the Bioprocessing Industry.

2.1 Bioprocessing?s History.

2.2 Industrial Applications.

2.3 The Bioprocess Lifecycle.

3. Bioprocessing Safety Management Practices.

3.1 Sample Approach.

3.2 Existing Management Systems.

3.3 Establishing a Bioprocess Safety Management System.

3.4 Biosafety Training for the Workforce.

3.5 Investigating Incidents.

3.6 Managing Change.

3.7 Reviewing and Auditing for Continuous Improvement.

3.8 Applying Behavior-Based Safety to Bioprocesses.

4. Identifying Bioprocess Hazards.

4.1 Key Considerations for Assessing Risk to Manage Bioprocess Safety.

4.2 Bioprocess Risk Assessment.

4.3 Recombinant Organisms.

4.4 Cell Culture.

5. Bioprocess Design Considerations and Unit Operations.

5.1 Physical Plant Design.

5.2 Bioprocess Unit Operations.

6. The Effects of Emerging Technology on Bioprocessing Risk Management.

6.1 Researching and Staying Informed.

6.2 Communicating the Impacts of New Technology.

Appendix A ? References & Selected Regulations.

Appendix B ? Large Scale Biosafety Guidelines.

Appendix C ? A Generic Laboratory/Large Scale Biosafety Checklist.

Appendix D ? Biological Assessment Questionnaire & Bioprocess safety Checklist.

Appendix E ? Bioprocess Facility Audit Checklist.

Appendix F ? Directive 2000/54/EC of the European Parliament and of the Council.

Appendix G ? Comparison of Good Large Scale Practice (GLSP) and Biosafety Level (BL) ? Large Scale (LS) Practice.


Acronyms and Abbreviations.