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THE WBF BOOK SERIES--ISA 88 and ISA 95 in the Life Science Industries

Book Description

THE WBF BOOK SERIES--ISA 88 and ISA 95 In Life Science Industries is a guide book to the ISA 88 and ISA 95 Manufacturing Protocols. The book features: -- How to set up a pharmaceutical module library using ISA 88 and how to implement ISA 88 across life Science Development Operations -- Understanding Product life cycle batches -- Case Studies on Risk-based engineering assessment and qualifications, a SCADA upgrade project, and more. The ISA (International Society of Automation) standards 88 and 95 are manufacturing standards established in the late 1990s and periodically updated by the governing bodies responsible for them -- the ISA and the WBF (World Batch Forum). The two standards set up protocols and uniform specifications for batch control systems, including types of control equipment, design of control systems and interpretation of batch control data. In Volume 1, ISA 88 and 95 are explained in the context of the pharmaceutical and medical industries. Examples of such batch processing procedures as fermentation, separation, and refinement are discussed and how the two standards affect the design of facilities and systems for performing these procedures. The ISA 88 and 95 standards have been around (and periodically updated) for nearly 20 years now, but little really helpful has been published on how to put those standards into use, particularly from a pragmatic, real-life experience point of view. The four books in this new series will do exactly that: explain to the manufacturing engineer, the controls engineers, and the industrial planner and manager alike how these standards translate into improved batch and continuous process operations -- and ultimately how those operations can be integrated and automated into general business operations (accounting, inventory, customer relations, product development) of the manufacturing concern.

Table of Contents

  1. Cover Page
  2. Title Page
  3. Copyright
  4. Contents
  5. List of Figures
  6. List of Tables
  7. WBF Foreword
  8. Foreword by Walt Boyes
  9. Preface
  10. 1 ISA-88 Provides a Framework for a Pharmaceutical Process Module Library
  11. 2 ISA-88 Design and Implementation Case Study for a Complex Bulk Pharmaceutical Batch Process
  12. 3 Managing Complex Equipment Status in a GMP Environment
  13. 4 Impact of Batch Software Upgrades on Validated Batch Applications
  14. 5 Is It Possible to Build a Pharmaceutical Plant in 18 Months or Less Using ISA-88?
  15. 6 Batch On-line Analytics: A Solution Beyond Six Sigma
  16. 7 Implementing ISA-88 across Life Science Development Operations
  17. 8 Process Definition Management: Using ISA-88 and BatchML as a Basis for Process Definitions and Recipe Normalization
  18. 9 ISA-88 Design and Implementation Case Study for a Pharmaceutical Batch Process
  19. 10 Product Life-cycle Stages Linked Using ISA-88 and ISA-95
  20. 11 Jazz Up Your Batch Projects
  21. 12 The Challenge of Integrating Multiple Batch Systems to Global Business Systems
  22. 13 The Road to Full MES Integration: Practical Experience from the Pharmaceutical Industry
  23. 14 MES Roll-out in a Regulated Environment: Reducing the Costs of Validation Based on Risk Assessment
  24. 15 Fast and Efficient Configuration and Integration of Automation Solutions from a Global Perspective: A Practical Approach
  25. 16 Risk-based Engineering Assessment and Qualification: A Case Study
  26. 17 Lean Computer Validation through a Risk-based Approach: A Case Study
  27. 18 Multiple Products in a Monoclonal Antibody ISA-88.01 Batch Plant
  28. 19 Considerations for Managing Global Recipe Development
  29. 20 General Recipes as Contracts with Manufacturing
  30. 21 Using General Recipes for Standardized Multiple Plant Manufacturing Science
  31. 22 Manufacturing Science Model Extensions to Address Lean Manufacturing and Supply Chain Optimization
  32. 23 Manufacturing Science Model Extensions to Address Product and Process Sustainability
  33. 24 Manufacturing Science Model Extensions to Address Quality by Design and Risk Assessments
  34. 25 Batch Release and Material Use Reporting: A Case Study
  35. Index