Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services


This website contains a number of documents written by Destin A. LeBlanc that are critical of certain aspects of and statements in the Risk-MaPP document. Note that Mr. LeBlanc’s main issue is not with setting limits for highly hazardous actives based on a toxicological evaluation, but rather statements in Risk-MaPP that conventional methods, such as 0.001 of a dose, are not science-based and are arbitrary when used for any actives, including those that are not highly hazardous.


To view pdf files of documents by Mr. LeBlanc critiquing Risk-MaPP, click on the links below. Note also included are documents related to EMA’s PDE version of health-based limits. The documents are listed in chronological order except for item #11.


1. Slides from Webinar “Are We Setting Limits Correctly?”, August 19, 2008. Note that this is actually a critique of a presentation by Andy Walsh, a Risk-MaPP author, on his presentation at a June 2008 ISPE meeting, which was before Risk-MaPP was officially released in September 2010.

2. Cleaning Memo of October 2008 entitled “Are We Setting Limits Correctly?” This is similar to the webinar critique.

3. Cleaning Memo of May 2009, entitled “The Science Behind Limits” discusses what we mean when we say something is “scientific”. This is relevant because one of the main assertions in Risk-MaPP about conventional ways of setting limits is that those conventional ways are “not scientifically justified”.

4. Cleaning Memo of November 2010, entitled “A Critique of Cleaning Validation Issues in ISPE’s Risk-MaPP”. This was based on my attendance at the Risk-MaPP launch meeting in Washington, DC in September 2010.

5. Cleaning Memo of February 2011 entitled “More on ISPE’s Risk-MaPP”.

6. News Release by Cleaning Validation Technologies of March 28, 2011, entitled “Cleaning Validation Expert Challenges ISPE Risk-MaPP Report”.

7. Cleaning Memo Addendum of June 2011, entitled “Where Risk-MaPP Got it Wrong”.

8. Cleaning Memo of December 2011, entitled “The Good, Bad and Inexplicable of Risk-MaPP”.

9. Cleaning Memo of March 2012, entitled "How Are ADE’s Determined for Non-Highly Hazardous Actives?"

10. Cleaning Memo Addendum of October 2012, entitled “Another Critique of Risk-MaPP”
11. PharmaWeb exchange in 2002 between Destin LeBlanc and Andy Walsh on the question of limits: This sheds some light on the possible origin of certain concepts in Risk-MaPP. This also includes a reply made by Destin LeBlanc that was made outside the PharmWeb site.

12. Cleaning Memo of February 2013, “Does Risk-MaPP Offer More Patient Protection?”

13. Cleaning Memo of June 2013, “Are Health-Based Limits Enough?”

14. Cleaning Memo of November 2013, “Comments on the EMA Guideline on Dedicated Facilities”.

15. Cleaning Memo of December 2013, “A Way Forward for “Health-based” Limits”.

16. Cleaning Memo of January 2014, “Setting Limits for Cleaning Agents

17. Cleaning Memo of May 2014-Addendum - "Shortcomings of ADE/PDE Values for Cleaning Validation"

18. Cleaning Memo of March 2015, “EMA on Limits for Shared Facilities-Part 1”

19. Cleaning Memo of April 2015, “EMA on Limits for Shared Facilities-Part 2”

20. Cleaning Memo of May 2015, “EMA on Limits for Shared Facilities-Part 3”

21. Cleaning Memo of August 2015, “Route Specific Health-based Limit Values”

22. Cleaning Memo of September 2015, “Duration Specific Health-based Limit Values”

23. Cleaning Memo of March 2016, “Meeting EMA Requirements for Existing Products”

24. Cleaning Memo of July 2016, “Should 10 PPM be Used for Limits”
25. Cleaning Memo of July 2017, “EMA’s Q&A Clarification: Part 1”
27. Cleaning Memo of August 2017, “EMA’s Q&A Clarification: Part 2”

28. Cleaning Memo of December 2017, “What’s at Stake with HBELs”

29. Cleaning Memo of January 2018, “A Look at the Revised Risk-MaPP”
30. Cleaning Memo of February 2018, “Does a High ‘Margin of Safety’ Protect

31. Cleaning Memo of June 2018, “The EMA Q&A “Clarification” on Limits”

32. Cleaning Memo of January 2020, “EMA vs. ISPE on Cleaning Limits?”