Descrição
Contents:
SECTION ONE: Cleaning Validation Basics and Expectations
1. Process Validation Basics by Paul L. Pluta
2. Cleaning Validation Basics by Destin A. LeBlanc
3. Cleaning Validation Application in the Laboratory by Cindy Green
4. The Cleaning Validation Policy and the Cleaning Validation Plan by Miguel Montalvo
5. Global Regulatory Inspection Standards for Cleaning Validation by Clive G. Blatchford
6. Quality by Design for Cleaning Validation by Rizwan Sharnez and Martin Van Trieste
SECTION TWO: General Technical Principles Cleaning Chemistry and Engineering
7. Cleaning Agents and Cleaning Chemistry by George Verghese and Nancy Kaiser
8. Cleaning Engineering and Equipment Design by George Verghese and Paul Lopolito
SECTION THREE:General Technical Principles Residues
9. Residues and Cleaning Chemistry by William R. Porter
10. Microbial and Endotoxin Residues Product Contact Surfaces by Jeanne Moldenhauer
11. Cleaning of Non-Product Contact Surfaces by Anne Marie Dixon
12. Residue Pharmacology and Toxicology Considerations by William H. Houser
13. Residue Grouping Strategies by William E. Hall
14. A Scientific Approach to the Selection of Cleaning Validation Worst-Case Soils for Biopharmaceutical Manufacturing by Rod J. Azadan and Alfredo J. Canhoto
15. Visual Cleanliness by Richard J. Forsyth
16. Personnel Training Visual Inspection of Cleaned Equipment by Paul L. Pluta
SECTION FOUR:Specific Residues for Cleaning Part 1
17. Biotech Residues and Cleaning by Jennifer Carlson
18. Case Study Cleaning Process Optimization for a Manufacturing Process Change by Soren Damkjaer and Pernille L. Johansen
19. Manual Cleaning Processes and Procedures by Valerie Welter
