Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

CURRICULUM VITAE



Destin A. LeBlanc

Cleaning Validation Technologies

2932 Dayton Drive

Winter Haven, FL 33884

Phone: 863-662-5315

Email: destin@cleaningvalidation.com

Destin LeBlanc has over thirty-five years of Technical Service and Product Development experience in specialty chemicals and medical technologies, the last twenty-five years of which have been involved with various aspects of cleaning and cleaning validation in pharmaceutical and medical device manufacturing. These include years with STERIS Corporation at their Cleaning and Microbial Control Technology Center in St. Louis, and with Calgon Vestal as part of Merck & Co., Inc. and then as part of Bristol-Myers Squibb. At the end of 2000 he went into full time consulting as Cleaning Validation Technologies.

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.

He was co-chair of a PDA task force to prepare Technical Report #49, “Points to Consider for Biotechnology Cleaning Validation” and was the chair of a PDA task force to revise and update Technical Report #29, “Points to Consider for Cleaning Validation”

Awards

  • 2006 PDA Distinguished Editor/Author Award
  • 2013 Kenneth G. Chapman Lifetime Achievement Award from the Institute of Validation Technology.

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


WORK EXPERIENCE

1/01 to present

Cleaning Validation Technologies Winter Haven, FL
Provide consulting service on cleaning and cleaning validation.

8/80 to 12/00

STERIS / Calgon Vestal St. Louis, MO
This was actually one continuous work experience, except that at various times STERIS, Bristol-Myers Squibb, Merck, Chemed, and W.R. Grace owned the company I worked for. Various titles and responsibilities were:

  • Vice President, Scientific Technical Support (9/97 to 12/00) -- Provide overall leadership for four technical support groups (cleaning and microbial control, gamma contract sterilization, ethylene oxide contract sterilization, and sterilization products) for pharmaceutical and medical device industries. Provide leadership for company in technical expertise in cleaning technologies and cleaning validation for pharmaceutical manufacturing.
  • Vice President, Quality, Regulatory and Technical Support (4/97 to 8/97) -- Provided leadership of various departments in business unit transition to new ownership.
  • Director of Technology (4/95 to 3/97) -- Provided technical service, technology licensing, and R&D liaison for the Contamination Control Group.
  • Director, Business Development and Strategic Planning (6/93 to 3/95) -- Developed plans and licensing opportunities to move company into dermatological markets.
  • Director, Technical Services (1/93 to 5/93) -- Directed technical services in Healthcare and Contamination Control markets during company reorganization.
  • Technical Director, Chemical Technologies Group (6/90 to 12/92) -- Directed new product development and technical service for business group, including Contamination Control.
  • Manager, Healthcare Technology (8/87 to 5/90) -- Directed new product development and technical service for Healthcare Group
  • Manager, Product Development (6/87 to 7/87) -- Directed new product development for Calgon Vestal Laboratories for both Healthcare and Chemical Technologies groups.
  • Director, Product Development (8/80 to 5/87) -- Directed new product development for Vestal Laboratories in areas of infection control and maintenance specialties.
3/77 to 8/80

Harshaw Chemical Company Beachwood, OH

  • Group Leader, Textile and Paper Applications -- Directed applications development of inorganic antimony chemicals for flame-retardant applications.
1/72 to 3/77

LeBlanc Research Corp. East Greenwich, RI

  • Laboratory Supervisor -- Directed applied research and development on flame retardant textile finishes. Supervised environmental and routine clinical analyses.


EDUCATION

1965-1969

University of Michigan 
Department of Chemistry
B.S. with High Distinction (1969)

1969-1972

University of Iowa 
Department of Communications
M.A. in Radio, TV, Film (1972)


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