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ISA-88 and ISA-95 in the life science industries / by WBF ; edited by William Hawkins, Dennis Brandl, Walt Boyes.
- Format:
- Book
- Author/Creator:
- World Batch Forum Staff, Corporate Author.
- Series:
- WBF book series ; v. 4.
- WBF book series ; v. 4
- Language:
- English
- Subjects (All):
- Process control--Standards.
- Process control.
- Production control--Standards.
- Production control.
- Pharmaceutical industry.
- Biotechnology industries.
- Physical Description:
- 1 online resource (362 p.)
- Edition:
- 1st ed.
- Place of Publication:
- [New York, N.Y.] (222 East 46th Street, New York, NY 10017) : Momentum Press, 2011.
- Language Note:
- English
- Summary:
- The twenty-five chapters in this book are concerned with processes and systems that operate in a government-regulated environment. What is quite all right in the petrochemical industries is inadequate in the life science industries.
- Contents:
- List of figures
- List of tables
- WBF foreword
- Foreword by Walt Boyes
- Preface
- 1. ISA-88 provides a framework for a pharmaceutical process module library
- 2. ISA-88 design and implementation case study for a complex bulk pharmaceutical batch process
- 3. Managing complex equipment status in a GMP environment
- 4. Impact of batch software upgrades on validated batch applications
- 5. Is it possible to build a pharmaceutical plant in 18 months or less using ISA-88?
- 6. Batch on-line analytics: a solution beyond six sigma
- 7. Implementing ISA-88 across life science development operations
- 8. Process definition management: using ISA-88 and BatchML as a basis for process definitions and recipe normalization
- 9. ISA-88 design and implementation case study for a pharmaceutical batch process
- 10. Product life-cycle stages linked using ISA-88 and ISA-95
- 11. Jazz up your batch projects
- 12. The challenge of integrating multiple batch systems to global business systems
- 13. The road to full MES integration: practical experience from the pharmaceutical industry
- 14. MES roll-out in a regulated environment: reducing the costs of validation based on risk assessment
- 15. Fast and efficient configuration and integration of automation solutions from a global perspective: a practical approach
- 16. Risk-based engineering assessment and qualification: a case study
- 17. Lean computer validation through a risk-based approach: a case study
- 18. Multiple products in a monoclonal antibody ISA-88.01 batch plant
- 19. Considerations for managing global recipe development
- 20. General recipes as contracts with manufacturing
- 21. Using general recipes for standardized multiple plant manufacturing science
- 22. Manufacturing science model extensions to address lean manufacturing and supply chain optimization
- 23. Manufacturing science model extensions to address product and process sustainability
- 24. Manufacturing science model extensions to address quality by design and risk assessments
- 25. Batch release and material use reporting: a case study
- Index.
- Notes:
- Description based upon print version of record.
- Includes bibliographical references and index.
- Title from PDF t.p. (viewed on January 26, 2011).
- ISBN:
- 1-283-89549-8
- 1-60650-205-0
- OCLC:
- 819592940
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