Cleaning Validation

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.

Terminology






Use of the Term "Product"



Use of the Terms Grouping and Matrixing



Deviations and Nonconformances



Clarifying Terms: Blanks vs. Controls



Meaning of "Dedicated"?



Words (Again??)

Health-based Limits




What's at Stake with HBELs



A Look at the Revised Risk-MaPP



EMA's Q&A Clarification: Part 1



EMA's Q&A Clarification: Part 2



The EMA Q&A "Clarification" on Limits



The EMA Q&A on Routine Analytical Testing



Other Issues in EMA's Q&A



Highly Hazardous Products in Shared Facilities

Limits - General




EMA vs. ISPE on Cleaning Limits?



Does a High "Margin of Safety" Protect Patients?



What If the Next Product is the Same Product?



Limits for "Product A to Product A"



Surfaces Areas in Carryover Calculations



Carryover Calculation Errors to Avoid



Protocol Limits for Yeasts/Molds?



Cleaning Validation for Homeopathic Drug Products



A Possible Approach for Biotech Limits



Establishing Clearance for Degraded Protein Actives

Visually Clean




Avoiding "Visually Dirty" Observations



What's a Visual Limit?



Visual Residue Limits – Part 1



Visual Residue Limits – Part 2
Analytical and Sampling Methods




Two More Nails in the Coffin?



More Swab Sampling Issues



Timing for Swab Sampling in a Protocol?



Pass/Fail Analytical Test Methods

Product Grouping




Issues in Product Grouping



Toxicity as a Worst-Case Grouping Factor



Another "Worst Case" Product Grouping Idea

Protocols and Procedures




Issues in Rinsing - Part 1



Issues in Rinsing - Part 2



Routine Monitoring for Highly Hazardous Products



"Concurrent Release" for Cleaning Validation



Dirty and Clean Hold Time Protocols

API Manufacture




A Critique of the APIC Guideline



Another Issue for API Synthesis



Contaminants in API Manufacture

Miscellaneous




Significant Figures: Back to Basics



The Value of a Protocol Worksheet for Manual Cleaning



Dealing with Used and New Equipment



Solving Cleaning Validation Problems by Analogy



Causing Cleaning Validation Problems by Analogy

Appendix A: Acronyms Used in this Volume

Appendix B: Shorthand Notations for Expressing Limits

Index