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Destin A. LeBlanc
President, Cleaning Validation Technologies

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Biography

Destin LeBlanc has over thirty-five years of Technical Service and Product Development experience in specialty chemicals and medical technologies, the last twenty five of which have been involved with various aspects of cleaning and cleaning validation in pharmaceutical and medical device manufacturing.

Destin LeBlanc consults in the area of cleaning validation as Cleaning Validation Technologies. Previously, he had been with STERIS/Calgon Vestal for over twenty years, primarily in product development and technical service for cleaning and antimicrobial applications. He has lectured on issues related to contamination control internationally, and has written widely on cleaning validation issues. He is the author of five on cleaning validation.

He maintains the web site www.cleaningvalidation.com as a resource for cleaning validation professionals. He is a member of PDA and ISPE and regularly trains FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa. In 2009 he led a PDA task force to prepare a technical report entitled “Points to Consider for Biotechnology Cleaning Validation”.

Since 1990, he has specialized in pharmaceutical cleaning validation, and has written and lectured internationally on cleaning validation, both as part of technical symposia as well as on-site company training. He has worked with both large and small pharmaceutical companies on various aspects of cleaning and cleaning validation. He brings a unique perspective because of his expertise in effective design of cleaning processes as well as validation of those processes.

In 2009 he led a PDA task force to prepare a technical report entitled “Points to Consider for Biotechnology Cleaning Validation”.

He has assisted companies with:
• Review of cleaning SOPs
• Review of cleaning validation protocols
• Development of cleaning processes
• Establishment of residue limits
• Selection and validation of analytical methods
• Selection of sampling methods
• Troubleshooting cleaning problem
• Selection of maintenance cleaning procedures
• Implementation of derouging and passivation procedures

He has been involved in specific training for clients and for the FDA in the following subjects:
• Cleaning technologies
• Cleaning validation concepts and practice
• Regulatory aspects of cleaning validation
• Cleaning methods
• Analytical and sampling methods
• Monitoring of cleaning
• Derouging of process equipment
• Passivation of process equipment
• Microbial control in cleaning validation

PERSONAL DEVELOPMENT:

• Kepner-Tregoe Problem Solving and Decision Making
• Situational Leadership
• Harvard Negotiations Skills Training
• Merck Advanced Management I, II, and III
• Targeted Selection
• Influence Management
• International Creativity Forum

Books and book chapters:

1. D A LeBlanc, Validated Cleaning Technologies for Pharmaceutical Manufacturing. Interpharm Press, Englewood, CO (2000).
2. D A LeBlanc, "Equipment Cleaning", in Encyclopedia of Pharmaceutical Technology, Second Edition, Marcel Dekker, New York, 2002, pp. 1102-1114.
3. D A LeBlanc, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, PDA, Bethesda, MD (2006). Mr. LeBlanc was given the 2006 PDA Distinguished Editor/Author Award for this book.
4. D A LeBlanc, "Cleaning Validation Basics", Chapter 2 in Cleaning and Cleaning Validation: Volume I (P L Pluta editor), PDA, Bethesda, MD (2009).
5. D A LeBlanc, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 2, PDA, Bethesda, MD (2010).
6. D A LeBlanc, "Miscellaneous Equipment Cleaning Topics", Chapter 5 in Cleaning and Cleaning Validation: Volume 2 (P L Pluta editor), PDA, Bethesda, MD (2013).
7. D A LeBlanc, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 3, PDA, Bethesda, MD (2013).
8. D A LeBlanc, "Equipment Cleaning", in Encyclopedia of Pharmaceutical Technology, Fourth Edition, Taylor and Francis, New York, pp. 1436-1448 (published online 23 August 2013).
9. D A LeBlanc, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 4, PDA, Bethesda, MD (2017).

Articles in journals and proceedings:

1. K Ginsbury and D A LeBlanc, "High Potency Rebuttal: Clarifying the Uncertainty Remaining in the Quest to Define 'Certain' Products". Published online by Contract Pharma as http://www.contractpharma.com/issues/2014-01-01/view_features/high-potency-rebuttal/ (January 22, 2014).
2. A S Rathore and D A LeBlanc, "PDA's New Technical Report for Biotech Cleaning Validation", BioPharm International, Vol. 24, No. 3, pp. 26-34 (May 2011).
3. D A LeBlanc, “Microbiological Issues in Process Equipment Cleaning Validation Part II: Clean Hold Times”, PMF Newsletter 15:12, pp. 7-11 (December 2009).
4. D A LeBlanc, “Microbiological Issues in Process Equipment Cleaning Validation Part I: Basic Issues”, PMF Newsletter 15:10, pp. 2-9 (October 2009).
5. D A LeBlanc, “PDA Survey Results: Cleaning Validation Sampling Recovery Practices”, PDA Letter 45:7, pp. 9-15 (Jul-Aug 2009).
6. D A LeBlanc, “Issues in Setting Limits for Actives in Bulk Biotech Manufacture”, Journal of Validation Technology 15:1, 71-76 (Winter 2009).
7. D A LeBlanc, “PDA Survey Results: Cleaning Validation Sampling Practices”, PDA Letter 44:10, pp. 10-15 (Nov-Dec 2008).
8. D A LeBlanc, Applicability of the “Threshold of Toxicological Concern” Concept to Residue Limits for Cleaning Validation, American Pharmaceutical Review, 5:1, pp 93-97 (Jan-Feb 2008).
9. D A LeBlanc, “PDA Survey on Analytical Methods for Cleaning Validation”, PDA Letter 43:10, pp. 16-18 (Nov-Dec 2007).
10. D A LeBlanc, “PDA Survey Sheds Light on Current Practices in Setting Residue Limits”, PDA Letter 43:5, pp. 11-14 (May 2007).
11. D A LeBlanc, Analytical Methods and Acceptance Criteria for Cleaning Validation Protocols for Medical Devices. Journal of ASTM International 3:3 (March 2006).
12. D A LeBlanc, Dispelling Cleaning Validation Myths: Part II. Pharmaceutical Technology Europe 17:12, pp. 45-47 (December 2005).
13. D A LeBlanc, Dispelling Cleaning Validation Myths: Part I. Pharmaceutical Technology Europe 17:11, pp. 30-34 (November 2005).
14. D A LeBlanc, Equipment Cleaning Validation: Microbial Control Issues. Journal of Validation Technology 8:4, 40-46 (August 2002).
15. D A LeBlanc, “Equipment Cleaning”, in Encyclopedia of Pharmaceutical Technology, Second Edition, Marcel Dekker, New York, 2002, pp. 1102-1114.
16. D A LeBlanc, “Visually Clean” as a Sole Acceptance Criteria for Cleaning Validation Protocols, Journal of Pharmaceutical Science and Technology 56:1, 31-36 (January-February 2002).
17. D A LeBlanc, Establishing Scientifically Justified Acceptance Criteria for the Cleaning Validation of APIs. Pharmaceutical Technology 24:10, 160-168 (October 2000).
18. D A LeBlanc, Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of APIs. Proceedings of 15th ICCCS International Symposium and 31st R3-Nordic Symposium on Contamination Control. Copenhagen, Denmark, May 14-18, 2000 (pp.537-542).
19. H J Kaiser, J F Tirey, and D A LeBlanc, Measurement of Organic and Inorganic Residues Recovered from Surfaces. Journal of Validation Technology 6:1, 424-436 (November 1999).
20. H Kaiser, D Klein, E Kopis, D LeBlanc, G McDonnell, and J F Tirey, Interaction of Disinfectant Residues on Cleanroom Surfaces. Journal of Pharmaceutical Science and Technology 53:4, 177-180 (July-August 1999).
21. D A LeBlanc, Rinse Sampling for Cleaning Validation Studies. Pharmaceutical Technology 22:5, 66-74 (May 1998).
22. D A LeBlanc, Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of Finished Drug Products. Pharmaceutical Technology 19:5, 136-148 (October 1998). [also reprinted in Pharmaceutical Technology Europe 11:3, 18-23, March 1999]
23. D A LeBlanc, D D Danforth and J M Smith. Cleaning Technology for Pharmaceutical Manufacturing. Pharmaceutical Technology 20:7, 84-92 (July 1996).
24. D A LeBlanc. Disinfection Products and Processes for the Pharmaceutical and Medical Device Industries. Proceedings of the 1993 IES/PDA Joint Conference. Las Vegas, NV. May 5-7, 1993. pp. 575-579.
25. D A LeBlanc. Cleaning Manufacturing Equipment in Pharmaceutical Cleanroom Facilities. Microcontamination 11:5, 37-40 (1993).
26. D A LeBlanc. Overview of Handwashing for Personnel in Animal Laboratory Facilities: A Review. Contemporary Topics in Laboratory Animal Science 32:5, 12-14 (September, 1993).
27. J M Smith, D D Danforth, D A LeBlanc, C L Scheetz, J E Adams, R G Anderson, A J Nagy, W S McDonough, and A A Howardell. Control of Glassware Washing Performance- A Case History, Pharmaceutical Technology 17:3, 118-128 (March 1993).
28. D A LeBlanc and J M Smith. New Methods for Cleanroom Surfaces. Proceedings of the PDA/IES Joint Conference on Cleanrooms and Microenvironments. Arlington, VA. February 3-6, 1992. pp. 115-135.
29. D A LeBlanc and D D Danforth. Substrate Compatibility of Animal Cage Wash Products. Contemporary Topics in Laboratory Animal Science 31:3, 13-16 (May 1992).
30. S K Harrison, W J Evans D A LeBlanc and L W Bush. Cleaning and Decontaminating Medical Instruments. Journal of Healthcare Materiel Management 8:1, 36-42 (January 1990).