Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

PUBLICATIONS


Publications of Destin LeBlanc related to cleaning and cleaning validation.

Books and book chapters

  • D A LeBlanc, Validated Cleaning Technologies for Pharmaceutical Manufacturing. Interpharm Press, Englewood, CO (2000). Order book from Amazon.com.
  • D A LeBlanc, "Equipment Cleaning", in Encyclopedia of Pharmaceutical Technology, Second Edition, Marcel Dekker, New York, 2002, pp. 1102-1114.
  • D A LeBlanc, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, PDA, Bethesda, MD (2006). Order book from PDA
    Mr. LeBlanc was given the 2006 PDA Distinguished Editor/Author Award for this book.
  • D A LeBlanc, "Cleaning Validation Basics", Chapter 2 in Cleaning and Cleaning Validation: Volume I (P L Pluta editor), PDA, Bethesda, MD (2009).
  • D A LeBlanc, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 2, PDA, Bethesda, MD (2010). Order book from PDA.
  • D A LeBlanc, "Miscellaneous Equipment Cleaning Topics", Chapter 5 in Cleaning and Cleaning Validation: Volume 2 (P L Pluta editor), PDA, Bethesda, MD (2013).
  • D A LeBlanc, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 3, PDA, Bethesda, MD (2013).
  • 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).

Articles in journals and proceedings

  • 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).
  • 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 (May2011).
  • D A LeBlanc, "Microbiological Issues in Process Equipment Cleaning Validation Part II: Clean Hold Times", PMF Newsletter 15:12, pp. 7-11 (December 2009).
  • D A LeBlanc, "Microbiological Issues in Process Equipment Cleaning Validation Part I: Basic Issues", PMF Newsletter 15:10, pp. 2-9 (October 2009).
  • D A LeBlanc, "PDA Survey Results: Cleaning Validation Sampling Recovery Practices", PDA Letter 45:7, pp. 9-15 (Jul-Aug 2009).
  • D A LeBlanc, "Issues in Setting Limits for Actives in Bulk Biotech Manufacture", Journal of Validation Technology 15:1, 71-76 (Winter 2009).
  • D A LeBlanc, "PDA Survey Results: Cleaning Validation Sampling Practices", PDA Letter 44:10, pp. 10-15 (Nov-Dec 2008).
  • 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).
  • D A LeBlanc, "PDA Survey on Analytical Methods for Cleaning Validation", PDA Letter 43:10, pp. 16-18 (Nov-Dec 2007).
  • D A LeBlanc, "PDA Survey Sheds Light on Current Practices in Setting Residue Limits", PDA Letter 43:5, pp. 11-14 (May 2007).
  • D A LeBlanc, Analytical Methods and Acceptance Criteria for Cleaning Validation Protocols for Medical Devices. Journal of ASTM International 3:3 (May2006).
  • D A LeBlanc, Dispelling Cleaning Validation Myths: Part II. Pharmaceutical Technology Europe 17:12, pp. 45-47 (December 2005).
  • D A LeBlanc, Dispelling Cleaning Validation Myths: Part I. Pharmaceutical Technology Europe 17:11, pp. 30-34 (November 2005).
  • D A LeBlanc, Equipment Cleaning Validation: Microbial Control Issues. Journal of Validation Technology 8:4, 40-46 (August 2002).
  • 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).
  • D A LeBlanc, Establishing Scientifically Justified Acceptance Criteria for the Cleaning Validation of APIs. Pharmaceutical Technology 24:10, 160-168 (October 2000).
  • 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).
  • 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).
  • 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).
  • D A LeBlanc, Rinse Sampling for Cleaning Validation Studies. Pharmaceutical Technology 22:5, 66-74 (May 1998).
  • 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, May1999]
  • D A LeBlanc, D D Danforth and J M Smith. Cleaning Technology for Pharmaceutical Manufacturing. Pharmaceutical Technology 20:7, 84-92 (July 1996).
  • 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.
  • D A LeBlanc. Cleaning Manufacturing Equipment in Pharmaceutical Cleanroom Facilities. Microcontamination 11:5, 37-40 (1993).
  • 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).
  • 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 (May1993).
  • 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.
  • 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).
  • 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).