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In Destin LeBlanc's Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Vol. 3 pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation.
Volume 3, a complement to Destin's two earlier books on the same subject, presents modifications and updates of his monthly Cleaning Memos originally published from January 2009 through December 2012. Each Cleaning Memo is presented as a chapter, with the chapters then organized by common topics. For example, topics related to setting limits are in one section, those related to sampling in another section, and so forth. An appendix with a list of acronyms is included as well.
Book wrote in 2013.
Table of Contents:
Click here to download >>>Detailed Table of Contents
1. The Changing Paradigm for Cleaning Validations
2. Differences between Cleaning and Process Validation
3. "Design Space" for Cleaning Processes
4. Understanding the Cleaning Process in 2010 (and Beyond)
5. "Continued" vs. "Continuous" Process Verification
6. Revisiting "Cleaning Verification"
7. How to Completely Avoid Doing Cleaning Validation
8. Significance of Water Activity for Cleaning Validation
9. Issues in Cleaning Validation for Parts Washers
10. Manual Cleaning Issues — Part 1
11. Manual Cleaning Issues — Part 2
12. More on Campaign Length
13. Use of Alkali/Acid Cleaning Agents in Biotech
14. Revisiting Limits Based on Process Capability
15. Differing Ways to Express Limits
16. My Revised Shorthand for Expressing Limits
17. Limits Below the LOD in Rinse Solutions — Part 1
18. Limits Below the LOD in Rinse Solutions — Part 2
19. Limits Below the LOD in Rinse Solutions — Part 3
20. Limits for Rinse "Grab" Samples
21. Another Alternative for Rinse Sampling Limits?
22. Basics of "Stratified Sampling"
23. More on "Stratified Sampling"
24. Final Notes on "Stratified Sampling"
25. A Conundrum Regarding Limits
26. The Science Behind Limits
27. A Critique of Cleaning Validation Issues in ISPE's RiskMaPP
28. More on ISPE's RiskMaPP
29. Where Risk-MaPP Got it Wrong
30. The Good, the Bad and the Inexplicable of Risk-MaPP
31. How are ADEs Determined for Non-Highly Hazardous Actives?
32. Another Critique of Risk-MaPP
33. Visually Clean and Visual Limits
34. More Uses for Visual Limit Determination
35. Statistics for Visual Limits
36. What's an "Equivalent" Swab?
37. Use of Multiple Swabs for Sampling
38. The Rationale for Rinse Sampling for Cleaning Agents
39. Revisiting Linearity of Swab Recovery Results
40. Swab Sampling Recovery as a Function of Residue Level
41. Acceptable Variability for Sampling Recovery Studies
42. An Alternative Swab Recovery Procedure
43. More on an Alternative Swab Recovery Procedure
44. Grouping for Surfaces for Swab Recovery Studies?
45. What's Happening to Worst-case Process Conditions?
46. What does the FDA Process Validation Guidance say about the Number of Qualification Runs
47. Selecting the Number of Validation Runs for Equipment Grouping
48. Hold Time Issues
49. Regulatory Guidances I'd Like to See Changed — Part 1
50. Regulatory Guidances I'd Like to See Changed — Part 2
Acronyms Used in
About the Author
Destin LeBlanc is a consultant at Cleaning Validation Technologies. He has extensive experience in product development and technical services for cleaning and antimicrobial applications. He is an international lecturer on contamination control and has written widely on cleaning validation topics including four volumes in the Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing series published by PDA and DHI. He is a member of PDA and ISPE and trains FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.