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ISA-88 and ISA-95 in the Life Science Industries

ISA-88 and ISA-95 in the Life Science Industries

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Published by Momentum Press
The life science industries make products that directly affect the health of people. They are regulated by government agencies to assure that products are safe and effective, and that manufacturing processes will not vary in ways that affect product quality. Many of the chapters in this book address that very same verification and validation of products and processes. Other chapters describe ways to shorten new product development time—from identification of a need for a new process to actual production of products. In addition, case studies and implementation experiences further describe ways to get the most from the ISA standards in the book’s title.
The life science industries make products that directly affect the health of people. They are regulated by government agencies to assure that products are safe and effective, and that manufacturing processes will not vary in ways that affect product quality. Many of the chapters in this book address that very same verification and validation of products and processes. Other chapters describe ways to shorten new product development time—from identification of a need for a new process to actual production of products. In addition, case studies and implementation experiences further describe ways to get the most from the ISA standards in the book’s title.

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Categories:Types, Research, Science
Published by: Momentum Press on Jan 26, 2011
Copyright:Traditional Copyright: All rights reserved

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11/29/2012

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v
Contents
List of Figures viiList of Tables xvWBF Foreword xviiForeword by Walt Boyes xixPreface xxi 1 ISA-88 Provides a Framework for aPharmaceutical Process Module Library 12 ISA-88 Design and Implementation Case Study fora Complex Bulk Pharmaceutical Batch Process 133 Managing Complex Equipment Status in a GMP Environment 294 Impact of Batch Software Upgrades on Validated Batch Applications 395 Is It Possible to Build a PharmaceuticalPlant in 18 Months or Less Using ISA-88? 476 Batch On-line Analytics: A Solution Beyond Six Sigma 577 Implementing ISA-88 across Life Science Development Operations 718 Process De
nition Management: Using ISA-88 and BatchMLas a Basis for Process De
nitions and Recipe Normalization 859 ISA-88 Design and Implementation Case Studyfor a Pharmaceutical Batch Process 9510 Product Life-cycle Stages Linked Using ISA-88 and ISA-95 11311 Jazz Up Your Batch Projects 129
 
vi
 
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CONTENTS
12 The Challenge of Integrating MultipleBatch Systems to Global Business Systems 14313 The Road to Full MES Integration:Practical Experience from the Pharmaceutical Industry 15514 MES Roll-out in a Regulated Environment:Reducing the Costs of Validation Based on Risk Assessment 17315 Fast and Ef 
cient Con
guration and Integration of AutomationSolutions from a Global Perspective: A Practical Approach 18316 Risk-based Engineering Assessment and Quali
cation: A Case Study 19917 Lean Computer Validation through a Risk-based Approach: A Case Study 20918 Multiple Products in a Monoclonal Antibody ISA-88.01 Batch Plant 22119 Considerations for Managing Global Recipe Development 23120 General Recipes as Contracts with Manufacturing 24121 Using General Recipes for StandardizedMultiple Plant Manufacturing Science 25122 Manufacturing Science Model Extensions to AddressLean Manufacturing and Supply Chain Optimization 26123 Manufacturing Science Model Extensions toAddress Product and Process Sustainability 27324 Manufacturing Science Model Extensions toAddress Quality by Design and Risk Assessments 29325 Batch Release and Material Use Reporting: A Case Study 315Index 323
 
vii
Figures
ow. 2 1.2 GR library. 3 1.3 Harvest vessel P&ID. 5 1.4 Mechanical features of the harvest vessel. 6 1.5 Harvest unit EMs. 7 1.6 EM library with expansion of “Clean Air Supply.” 8 1.7 Transfer unit example. 9 1.8 Harvest vessel unit process operations. 11 1.9 The process module library, with units for Product Alpha. 122.1 Example process model diagram. 152.2 Example physical model drawing. 172.3 Example requirements outline. 182.4 Example procedural model database. 192.5 Example of radio channels for coordination control. 232.6 Example batch reporting strategy. 263.1 Equipment model. 323.2 Equipment status architecture. 365.1 The construction period. 495.2 Parallel project phases in a construction period. 495.3 Preassembled facilities. 50

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