Cleanrooms

 

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NASA's Glenn Research Center

A cleanroom is defined as “a room in which air filtration, air distribution, utilities, materials of construction, and equipment are maintained in a controlled manner.” Operational procedures are defined and regulated for airborne particle
concentrations to meet appropriate particulate cleanliness classifications. ISO 14644-1 is the international standard of
defining cleanroom contamination levels. A cleanroom has a controlled level of contamination that is specified by the number of particles per cubic foot or meter at a specified particle size.  USP797 states that all pharmacies must now have one for IV and admixture preparation.  Other commercial applications utilizing cleanrooms include all manufacturing and scientific research which require very low levels and sizes of particulates for quality control.

Services

All testing and services are performed to FS 209E standards.  ISO 14644 standards are cross-referenced.

  • Complete room analysis of physical environment, including floors, walls, ceiling, doors, etc., to assure standards are met
  • Calibrated particle count testing at multiple, equidistant locations throughout the room by formula
  • Air flow and pressure gradient testing
  • Can be tested as built, at rest, or operational
  • Summary analysis report with findings and recommendations
 

US Federal Standard 209E

Class maximum particles/ft³ ISO
equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm
1 35 7 3 1   ISO 3
10 350 75 30 10   ISO 4
100   750 300 100   ISO 5
1,000       1,000 7 ISO 6
10,000       10,000 70 ISO 7
100,000       100,000 700 ISO 8

NOTE: US FED STD 209E was canceled November 29, 2001 but is still widely used.

 

 

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