Clean Room Management Associates

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  Clean Room Management Associates

 

Clean Room Management Associates Inc. brings nearly four decades of groundbreaking work in the advancement of clean room technology to the state-of-the-art International Milk Bank facilities.

 

Working closely with the skilled consultants of Clean Room Management Associates, International Milk Bank creates and operates sterile processing facilities that meet the U.S. Food and Drug Administration’s stringent Current Good Manufacturing Practice regulations.

 

Clean Room Management Associates was launched in 1976 to provide benchmarking, training, and auditing of clean rooms and controlled environments, and the company has been in the forefront of the development of clean room sanitation protocols for nearly 40 years. It has worked closely with clients such as the NASA Goddard Space Flight Center, pharmaceutical and biotechnology giants such as Amgen and Genzyme and technology leaders including Bausch & Lomb.

International Milk Bank draws on that experienced expertise of Clean Room Management Associates to ensure that its human milk products meet or exceed the highest standards in the world.

 

Clean Room Management Associates has ensured that the engineering of International Milk Bank’s facilities incorporates state-of-the-art systems to prevent contamination and deliver highly consistent products.

 

The controlled environment filters all incoming air, water and chemicals to meet high standards of purity. Temperature, humidity and pressure are controlled. Personnel practices and housekeeping maintenance are tightly managed.

The consulting firm also has worked with International Milk Bank on operational training of employees, creation of detailed operating manuals and validation procedures for all staff and managers.

 

Anne Marie Dixon, the owner and president of Clean Room Management Associates, serves as lead consultant to International Milk Bank.

During a career that began in 1976, Dixon has written many of the protocols and technical standards for contamination control and clean room operation for healthcare, technology and other sectors. She has written 14 books and more than 400 technical articles, chaired some of the most important committees on contamination-control strategies and spoken to audiences around the world.