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Cleanroom Standards Guide Contamination Control on the Ground and in the Stars

Open Comment on ISO Cleanroom Standard Invited at ESTECH 2004

New York, Feb 03, 2004

Contamination control may conjure images of HAZ/MAT teams in hermetic suits or lab coat-clad scientists working in pristine sealed rooms, but its origins actually date back hundreds of years. Swiss watchmakers performed contamination control measures to prevent dust from falling on their sensitive timepieces when they were not being worked on by covering them with a small bell jar. From that simple solution to today’s sophisticated cleanrooms, contamination control has allowed for safe research and manufacturing in aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, food, and industries. By adhering to international standards, today’s cleanrooms and associated controlled environments provide for the control of airborne particulate contamination to levels appropriate for accomplishing contamination-sensitive activities.

ISO 14644-1, Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness, is part of a series of International Standards concerned with cleanrooms and associated subjects. The document is one of nine international cleanroom standard documents at various stages of development by ISO Technical Committee 209 (ISO/TC 209), Cleanrooms and associated controlled environments, and was issued as a standard in 1999. ISO 14644-1 supercedes Federal Standard 209E, Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones, which was canceled in November 2001. The ISO/TC 209 family of International Standards governs all aspects of the cleanroom community - from design inception to daily operations. ISO 14644-1 covers the classification of air cleanliness in cleanrooms and associated controlled environments. Classification in accordance with this standard is specified and accomplished exclusively in terms of concentration of airborne particles.

In the history of the cleanroom, the development of the High Efficiency Particulate Air (HEPA) filter after World War II was groundbreaking because it allowed nuclear particles that would have been deadly to personnel to be isolated in process areas with HEPA filters while allowing air to circulate in them. ANSI member NASA employs cleanrooms for many of its missions, including the Hubble Telescope project. The Hubble cleanroom, formally known as the Spacecraft Systems Development and Integration Facility (SSDIF), is an 86,000 square-foot building used to integrate and test space hardware. Located at Goddard Space Flight Center in Greenbelt, MD, the building is the largest of its kind. The Hubble cleanroom is 1,000 times cleaner than a hospital operating room, and one entire wall is made up of HEPA filters that remove particles smaller than a red blood cell.

The Institute Of Environmental Sciences And Technology (IEST), an ANSI member and accredited standards developer, has issued an invitation to users of ISO 14644-1 to voice their comments and recommendations for improving the international standard. A public session is scheduled for Monday, April 26, during ESTECH 2004, the 50th annual meeting and exposition of IEST, as part of the Systematic Review process for ISO 14644-1. ESTECH 2004 will be held April 25-28, 2004, in Las Vegas, NV.

At this forum, participants can provide input to a panel representing the national standards bodies responsible for developing and maintaining the document. These comments will be reviewed by the U.S. Technical Advisory Group (TAG) to ISO/TC 209 and may be incorporated into the U.S. vote on the document. The purpose of the ISO Systematic Review is to ensure standards remain current and valid. ISO 14644-2, Specifications for testing and monitoring to prove continued compliance with ISO 14644-1, will come up for Systematic Review next year.

Founded in 1953, IEST is a multidisciplinary, international not-for-profit society whose members are recognized for their contributions to the environmental sciences in the areas of contamination control in electronics manufacturing and pharmaceutical processes; design, test, and evaluation of commercial and military equipment; and product reliability issues associated with commercial and military systems.

For more information about ESTECH 2004, visit or contact IEST at (847) 255-1561.

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