Guidelines for Process Safety in Bioprocess Manufacturing Facilities E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Veröffentlichungsjahr: 2011

Beschreibung

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.

Leseprobe

CONTENTS

Cover

Half Title page

Title page

Copyright page

List of Tables

List of Figures

Files on the Web Accompanying This Book

Acknowledgements

Preface

Chapter 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

Chapter 2: An Overview of the Bioprocessing Industry

2.1 Bioprocessing’s History

2.2 Industrial Applications

2.3 The Bioprocess Lifecycle

Chapter 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

Chapter 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

Chapter 5: Bioprocess Design Considerations and Unit Operations

5.1 Physical Plant Design

5.2 Bioprocess Unit Operations

Chapter 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

Glossary

Acronyms and Abbreviations

Index

Guidelines for Process Safety in Bioprocess Manufacturing Facilities

This book is one in a series of process safety guideline and concept books published by the Center for Chemical Process Safety (CCPS). Please go to www.wiley.com/go/ccps for a full list of titles in this series.

It is sincerely hoped that the information presented in this document will lead to an even more impressive safety record for the entire industry. However, neither the American Institute of Chemical Engineers, its consultants, the CCPS Technical Steering Committee and Subcommittee members, their employers, their employers, officers and directors, nor AntiEntropics, Inc., and its employees warrant or represent, expressly or by implication, the correctness or accuracy of the content of the information presented in this document. As between (1) American Institute of Chemical Engineers, its consultants, CCPS Technical Steering Committee and Subcommittee members, their employers, their employers, officers and directors, and AntiEntropics, Inc., and its employees and (2) the user of this document, the user accepts any legal liability or responsibility whatsoever for the consequences of its use or misuse.

Copyright © 2011 by American Institute of Chemical Engineers, Inc. All rights reserved.

A Joint Publication of the Center for Chemical Process Safety of the American Institute of Chemical Engineers and John Wiley & Sons, Inc.

Published by John Wiley & Sons, Inc., Hoboken, New Jersey.Published simultaneously in Canada.

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Library of Congress Cataloging-in-Publication Data:

Guidelines for process safety in bioprocess manufacturing facilities / Center for Chemical Process Safety of the American Institute of Chemical Engineers.p. cm.Includes index.ISBN 978-0-470-25149-2 (hardback)1. Biochemical engineering—Safety measures. I. American Institute of Chemical Engineers. Center for Chemical Process Safety.TP248.3.G85 2011660.6028′9—dc22

2010036824

oBook ISBN: 978-0470-94914-6ePDF ISBN: 978-0470-94913-9

LIST OF TABLES

TABLE 1-1  Typical Hazards at Bioprocess Manufacturing Sites

TABLE 1-2  Preliminary Design Anticipated Hazards Analysis

TABLE 1-3  Incidents Related to Products of Biologic Origin

TABLE 1-4  Selected International Biosafety Levels and Acronyms

TABLE 2-1  Comparison of Process Parameters and Characteristics of Recombinant Bacterial and Mammalian Cell Lines for Production of Recombinant DNA Protein Products

TABLE 2-2  Components of Typical Growth Media

TABLE 2-3  Examples of Very Large Scale Bioprocessing Products

TABLE 3-1  Comparison of a CEN-Based Biorisk Management System to OSHA PSM, EPA RMP, and CCPS Risk-Based Process Safety (RBPS)

TABLE 3-2  A Five-phase Review and Approval Cycle

TABLE 4-1  WHO Risk Group Classifications

TABLE 5-1  Clean Room Classifications

LIST OF FIGURES

Figure 1-1 The International Biohazard Symbol

Figure 2-1 Typical Process Operations for a Bioprocess

Figure 2-2 Typical Steps to Develop rDNA E. coli

Figure 2-3 Typical Steps to Manufacture Human Insulin

Figure 2-4 Basic Biotech Manufacturing Unit Operations

Figure 2-5 The Cell Culture Scale-Up Process (Staging)

Figure 2-6 A Common Spinner Flask

Figure 2-7 Seed Bioreactors

Figure 2-8 The Cell Growth Lifecycle

Figure 2-9, Stirred-Tank Bioreactor

Figure 2-10 Large Scale Wave Bioreactor (Courtesy of GE Healthcare)

Figure 3-1 Bioprocess Hazard Management Implementation Flowchart

Figure 5-1 Nested Zones

Figure 5-2 People and Material Flow Diagram

Figure 5-3 Vaporized Hydrogen Peroxide (VHP) decontamination unit

Figure 5-4 A Wet Scrubber

Figure 5-5 Image of a Microenvironment

Figure 5-6 A Typical Glove Box

Figure 5-7 HEPA Filter Installation

Figure 5-8 Air Lock Types Pressure Differential Diagram

Figure 5-9 Full Body Positive Pressure Suit

Figure 5-10 Effluent Decontamination System

Figure 5-11 Retinal Scanning Device

Figure 5-12 Closed Disposable Sampling System

Figure 5-13 Traditional Clean Room Approach

Figure 5-14 Gray Space Approach

Figure 5-15 Minimizing Classified Space

Figure 5-16 Flow and Segregation Relationships

Figure 5-17 Clean-in-Place Hard Spots

Figure 5-18 Disk-type Centrifuge

Figure 5-19 Ultrafiltration Skid (Courtesy of Sartorius)

Figure 5-20 Chromatography Column Schematic (Courtesy of Optek)

FILES ON THE WEB ACCOMPANYING THIS BOOK

Biological Assessment Questionnaire

Bioprocess Facility Audit Checklist

You can access these files by going to the site:www.aiche.org/ccps/publications/bioprocess.aspx

To access the files, download the zipped folder and extract all of the files. You will be asked for a password, enter the password:

CCPSBio2010

If you have difficulty accessing the files, contact CCPS at [e-mail] or + 1.646.495.1371

ACKNOWLEDGEMENTS

The American Institute of Chemical Engineers (AIChE) wishes to thank the Center for Chemical Process Safety (CCPS) and those involved in its operation, including its many sponsors whose funding made this project possible, and the members of the Technical Steering Committee, who conceived of and supported this guideline project. The members of the bioprocess safety management subcommittee who worked with AntiEntropics, Inc. to produce this text deserve special recognition for their dedicated efforts, technical contributions, and overall enthusiasm for creating a useful addition to the process safety guideline series. CCPS also wishes to thank the subcommittee members’ respective companies for supporting their involvement in this project as well as the American Biological Safety Association (ABSA) for creating a source for sharing valuable bioprocessing safety information and research.

The chairman of the bioprocess safety management subcommittee was Will Fleming of Bristol-Myers Squibb. The CCPS staff liaison was Dan Sliva. The members of the CCPS guideline subcommittee were:

Buddy Bowman, SyngentaRick Braun, IPSMary Cipriano, Abbott LaboratoriesAaron Duff, Bristol-Myers SquibbBruce Greer, Scientific Protein Laboratories LLCJose Hanquier, Eli Lilly and CompanyJerry Jones, GenentechBeth Junker, Merck & Company, Inc.Chantel Laing, Schering-Plough CorporationDenise Lackey, Amgen, Inc.Richard Medwid, Eli Lilly and CompanyBarbara Owen, Bristol-Myers SquibbAlan Powell, Merck & Company, Inc.Robert Stankovich, Eli Lilly and Company

AntiEntropics, Inc. of New Market, Maryland, was the contractor for this project. Robert J. Walter was the principal co-author and project manager. Sandra A. Baker was co-author and editor. Joseph Kallhoff was a contributing author. In addition. AntiEntropics would like to recognize the following contributors:

Bob Stankovich of Eli Lilly and Company for his co-authorship of Chapter 3Mary Cipriano of Abbott Laboratories for her authorship of Chapter 4David McGlashan of Caris DX and Jeffery Odum of NC BioSource for contributing Chapter 5.

CCPS also gratefully acknowledges the comments submitted by the following peer reviewers:

William Gaylord, AllerganRobert Kiss, GenentechDavid R. Maraldo, Ph.D., Merck & Company, Inc.Chris Meyer, Eli Lilly and CompanyDan Noberini, Bristol-Myers SquibbVenkata Ramana, Reliance Life Sciences Pvt. Ltd,Richard Rebar, GlaxoSmithKlineStephen Sykes, United States Food and Drug AdministrationDan Wozniak, Abbott LaboratoriesTimothy E. Woenker, Chematics, Inc.

Their insights, comments, and suggestions helped ensure a balanced perspective for this guideline.

PREFACE

The American Institute of Chemical Engineers (AIChE) has been closely involved with process safety and loss control issues in the chemical and allied industries for more than four decades. Through its strong ties with process designers, constructors, operators, safety professionals, and members of academia, AIChE has enhanced communications and fostered continuous improvement of the industry’s high safety standards. AIChE publications and symposia have become information resources for those devoted to process safety and environmental protection.

AIChE created the Center for Chemical Process Safety (CCPS) in 1985 after the chemical disasters in Mexico City, Mexico, and Bhopal, India. The CCPS is chartered to develop and disseminate technical information for use in the prevention of major chemical accidents. The center is supported by more than 80 chemical process industries (CPI) sponsors who provide the necessary funding and professional guidance to its technical committees. The major product of CCPS activities has been a series of guidelines to assist those implementing various elements of a process safety and risk management system. This book is part of that series.

AIChE recognized a significant increase in members’ bioprocess related needs in the early 1990s. Some of these members’ processes benefit from traditional process safety techniques, others present different challenges for managing the biological nature of their hazards and associated risks, and still others combine both categories of hazards. Bioprocess safety management meshes the lessons learned from over 24 years of chemical process safety management with the unique approaches demanded by the widening variety of bioprocessing safety challenges. The CCPS Technical Steering Committee initiated the creation of these guidelines to assist bioprocessing facilities in meeting these challenges. This book contains approaches for designing, developing, implementing, and continually improving a bioprocess safety management system. The website accompanying this book contains resource materials and support information.

CHAPTER 1

INTRODUCTION

The following definition sets the scope of our discussion of process safety management in the bioprocess manufacturing industry:

Bioprocess—A process that makes use of microorganisms, cells in culture, or enzymes to manufacture products or complete a chemical transformation.

Humans have been using such processes for baking bread, making cheese and fermenting alcoholic beverages since prehistoric times. Advances in commercializing recombinant DNA technology allow the production of an enormous variety of protein-based therapeutic drugs that is having a profound impact on the quality of life for severely ill patients. Bioprocessing is also essential to several emerging industries and technologies, including the production of biofuels from renewable biomass feedstocks such as ethanol biodiesel, and for the production of polymeric materials. Therapeutic stem cells, gene therapy vectors, and new vaccines are all the results of bioprocessing technology.