About CMA

Anne Marie Dixon

Career Summary

Owner and President of Cleanroom Management Associates, Inc., a consulting firm based in Carson City, NV that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management.

Actively engaged in the field of contamination control for over 35 years with extensive experience in the areas of cleanroom operations, training, technical writing, strategic consulting, facility start-up, construction protocols, and process optimization. Has trained over 850,000 cleanroom technicians and managers.

Major Accomplishments

• 1978   Developed and tested cleanroom sanitization protocols
• 1979   Developed initial clean build protocols for the cleanroom industry
• 1980   Developed the first Cleanroom Management Training and Manuals
• 1983   Chairman of Institute of Environmental Sciences – Recommended Practice on Cleanroom Housekeeping and Sanitization Procedures, testing and equipment. In this committee the techniques and testing of 1978 were incorporated and proven.
• 1983-present – Developed aseptic gowning techniques
• 1984-present – Developed equipment move-in procedures
• 1985   Developed undergraduate course in Cleanroom maintenance and equipment installation techniques – used today at 5 major universities in the USA.
• 1986   Chairman of Institute of Environmental Sciences – Recommended Practice on Cleanroom Operations. In this committee the techniques for equipment move-in were incorporated and proven.
• 1988   Developed and expanded clean build protocols to include 3/5 and 8 phases
• 1990   Chairman of conference on Particle Detection Methodology and Control
• 1991-1992 President of the Institute of Environmental Sciences
• 1992   Chairman of conference on Mini-environments and Isolators
• 1993-present – Chairman of the United States Technical Advisory Group to ISO Technical Committee 209
• 1993-present – Head of the United States Delegation to ISO Technical Committee 209 on Cleanrooms and Associated Controlled Environments
• 1995   Chairman Biocontamination Control Symposium – IEST
• 1998   Chairman of Symposium on Cleanrooms for the Healthcare Industry (PDA and IEST)
• 1998   Headed research to develop new techniques for sanitization and cleaning of walls and floors in cleanrooms and controlled environments
• 1999   Chairman of PDA Special Scientific Forum on Environmental Monitoring
• 2000   Keynote address – PDA Training Conference
• 2001   Keynote address – Barnett International – conference on Environmental Monitoring
• 2001   Updated Institute of Environmental Sciences Recommended Practice on Housekeeping and Sanitization Procedures. Included new techniques and methods as developed in 1998-2000
• 2002/2019   Updated IEST Recommended Practice on Cleanroom Operations
• 2007/2019   Updated IEST Recommended Practice on Housekeeping and Sanitization
• 2008-2018   Chair of ISO TC 209 – Nanotechnology Cleanroom and Controlled Environment – WG-10
• 2011-2017   Chairman RP on Controlled Environments
• 2019   Chairman RP on Cleanroom Robotics

Awards

• 1993   James P. Agalloco – “Excellence in Education”
• 1997   Diploma in Validation – Pharmaceutical Association of Mexico
• 1998   Fellow of the Institute of Environmental Sciences
• 2007   Fred Hermann Award
• 2010   First recipient – Woman of the Year in Contamination Control
• 2012   Monroe Seligman Award – Contamination Control Educational Programs
• 2014   IEST President Award

Publications

Books

• Cleanroom Management Manual – 1980, revised 1988
• Guidelines for Cleanroom Management and discipline chapter 4 – Noyes publication, Handbook of Contamination Control in the Microelectronics Industry – 1988 – isbn# 0-81551151-5
• Cleaning and Sanitization of Cleanrooms and Materials – Marcel Dekker publication, Validation of Pharmaceutical Processes – 1999 chapter 22 – isbn#0-8247-9384-6
• How to Write A Training Manual –Micron Video International – 1999 Personnel Training – A cleanroom must – Interpharm Press – Sterilization of Medical Devices – 1999
• 2007 – Editor – Environmental Monitoring for Cleanrooms and Controlled Environments – Informa USA isbn# 10-0-8247-2359-7
• 2007 – Confronting Variability, editor R. Prince, chapter 2 – “People, Training and Variability”, DHI International.isbn# 1-933722-04-5
• 2011 – Aerosol Measurement – Principles, Techniques and Applications, editor – Pramod Kulkari, Paul Al. Baron, Klaus Willeke – John Wiley&Sons Publication, isbn# 978-0-470-38741-2chapter 36 – Aerosol Measurement in Cleanrooms, David S. Ensor and Anne Marie Dixon
• 2010 – Cleaning and Cleaning Validation – Informa USA – 2009 – Paul Pluta editor – chapter 11 – “Cleaning of Non-Product Contact Surfaces” isbn# 1-933722-37-1
• Contamination Control in Healthcare Product Manufacturing, Volume 1 – Russell Madsen and Jeanne Moldenhauer Editors, DH Publishing, 2013, ISBN# 1-933722-71-1 – Chapter 5 – Facility Design and Control: Personnel; Chapter 6 – Facility Design and Control: Cleaning and Sanitization

Professional Organization Memberships

• PDA
• ISPE
• IEST
• ASQ
• AMA