Cleaning Validation : Practical Compliance Approaches for Pharmaceutical Manufacturing book cover
1st Edition

Cleaning Validation
Practical Compliance Approaches for Pharmaceutical Manufacturing

  • Available for pre-order on November 29, 2022. Item will ship after December 20, 2022
ISBN 9781032430836
December 20, 2022 Forthcoming by CRC Press
216 Pages

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Book Description

Pharmaceutical manufacturers and upper management are encouraged to meet the

challenges of the science-based and risk-based approaches to cleaning validation.

Using some of the principles and practices in this volume will help in designing a

more effective and efficient cleaning validation program.


• Timely coverage of cleaning validation for the pharmaceutical industry,

a dynamic area in terms of health-based limits.

• The author encourages pharmaceutical manufacturers, and particularly

upper management, to meet the challenges of the science-based and riskbased

approaches to cleaning validation.

• Draws on the author’s vast experience in the field of cleaning validation

and hazardous materials.

• Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for

highly hazardous products in shared facilities.

• A diverse list of topics from protocol limits for yeasts and molds to

cleaning validation for homeopathic drug products.

Table of Contents


  1. Use of the Term "Product"
  2. Use of the Terms Grouping and Matrixing
  3. Deviations and Nonconformances
  4. Clarifying Terms: Blanks vs. Controls
  5. Meaning of "Dedicated"?
  6. Words (Again??)
  7. Health-based Limits

  8. What's at Stake with HBELs
  9. A Look at the Revised Risk-MaPP
  10. EMA's Q&A Clarification: Part 1
  11. EMA's Q&A Clarification: Part 2
  12. The EMA Q&A "Clarification" on Limits
  13. The EMA Q&A on Routine Analytical Testing
  14. Other Issues in EMA's Q&A
  15. Highly Hazardous Products in Shared Facilities
  16.  Limits - General

  17. EMA vs. ISPE on Cleaning Limits?
  18. Does a High "Margin of Safety" Protect Patients?
  19. What If the Next Product is the Same Product?
  20. Limits for "Product A to Product A"
  21. Surfaces Areas in Carryover Calculations
  22. Carryover Calculation Errors to Avoid
  23. Protocol Limits for Yeasts/Molds?
  24. Cleaning Validation for Homeopathic Drug Products
  25. A Possible Approach for Biotech Limits
  26. Establishing Clearance for Degraded Protein Actives
  27.  Visually Clean

  28. Avoiding "Visually Dirty" Observations
  29. What's a Visual Limit?
  30. Visual Residue Limits – Part 1
  31. Visual Residue Limits – Part 2
  32. Analytical and Sampling Methods

  33. Two More Nails in the Coffin?
  34. More Swab Sampling Issues
  35. Timing for Swab Sampling in a Protocol?
  36. Pass/Fail Analytical Test Methods
  37. Product Grouping

  38. Issues in Product Grouping
  39. Toxicity as a Worst-Case Grouping Factor
  40. Another "Worst Case" Product Grouping Idea
  41. Protocols and Procedures

  42. Issues in Rinsing - Part 1
  43. Issues in Rinsing - Part 2
  44. Routine Monitoring for Highly Hazardous Products
  45. "Concurrent Release" for Cleaning Validation
  46. Dirty and Clean Hold Time Protocols
  47. API Manufacture

  48. A Critique of the APIC Guideline
  49. Another Issue for API Synthesis
  50. Contaminants in API Manufacture
  51. Miscellaneous

  52. Significant Figures: Back to Basics
  53. The Value of a Protocol Worksheet for Manual Cleaning
  54. Dealing with Used and New Equipment
  55. Solving Cleaning Validation Problems by Analogy
  56. Causing Cleaning Validation Problems by Analogy


Appendix A: Acronyms Used in this Volume

Appendix B: Shorthand Notations for Expressing Limits


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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 has trained FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.