About Us

Anne Marie Dixon-Heathman

Career Summary

Owner and President of Cleanroom Management Associates, Inc., a consulting firm based in The Villages, FL, 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 40 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 1,000,000 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-present - 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-present - 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 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 Bio-contamination 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 Update IEST Recommended Practice on Housekeeping and Sanitization
2008-2018 Chair of ISO TC 209 – Nanotechnology Cleanroom and Controlled Environment – WG-10. (Document issued 2018)
2011-2017 Chairman RP on Controlled Environments
2019 Chairman RP on Cleanroom Robotics
2021 Secretary of ISO 14644-5 committee on Cleanroom Operations

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 Ist recipient – Woman of the Year in Contamination Control
2012 Monroe Seligman Award – Contamination Control Educational Programs
2014 IEST President Award
2019 Robert Mielke Award

Publications

Books

Cleanroom Management Manual – 1980, revised 1988, revised 1995
Cleanroom Management chapter – Noyes publication, Handbook of Contamination Control in the Microelectronics Industry - 1988
Cleaning and Sanitization of Cleanrooms and Materials – Marcel Dekker publication, Validation of Pharmaceutical Processes – 1998
How to Write A Training Manual –Micron Video International – 1999
Personnel Training– A cleanroom must – Interpharm Press – Sterilization of Medical Devices – 1999
2000 – Cleaning and Cleaning Validation – DHI, chapter on Cleaning of Non-Product Contact Surfaces
2006 – Environmental Monitoring for Cleanrooms and Controlled Environments – Informa USA, Editor
2007 – Confronting Variability, editor R. Prince, DHI, chapter 2 – “People, Training and Variability”
2009 – Aerosol Science and Technology – Particle chapter
2010 – Cleaning Validation – Informa USA – 11/09
2013 – Facility Design and Control, DHI, chapter on Cleaning and sanitization.
2013 - Contamination Control in Healthcare Product Manufacturing, chapter on Facility Design and Control: Personnel; chapter on Facility Design and Control: Cleaning and Sanitization.
2015 – Microbial Risk and Investigation, DHI, chapter on Investigations for Personnel Monitoring
2017 – Aseptic Sterile Processing, DHI, chapter on Cleaning and Sanitization for Aseptic Processing

Professional Organization Memberships

PDA
ISPE
IEST
ASQ
AMA

About CMA

Anne Marie Dixon-Heathman

Major Accomplishments

Awards

Publications

Professional Organization Memberships

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