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Technical Resources

Post Date:
8/25/2006

Entry type:
Articles and White Papers

Topics:
Life Science/Biotech , Pharmaceutical, Semiconductors and Electronics

Tags: Critical Environment

 

Cleanrooms

General Information About Cleanrooms

A cleanroom is an area free of impurities, where contamination, air velocity, pressure, temperature, and humidity are controlled under rigid specifications. Things to be considered when planning a cleanroom:

  • Rate of personal emission
  • Amount of physical movement
  • Hot and cold environments create different rates of particulate generation
  • Type of undergarments worn
  • Contamination from the tools used
  • FDA regulations
Airborne Particulate Cleanliness Classes and ISO Standards

A cleanroom class is determined by the number of particles present per unit volume. A class is met if the measured concentration is within the limits of a specified particle size. Use this table to convert from English to metric classes and the equivalent ISO standard.

Class name Particle count
limit*
English SI ISO standard
Class 1 M 1.5 ISO 3 1
Class 10 M 2.5 ISO 4 10
Class 100 M 3.5 ISO 5 100
Class 1000 M 4.5 ISO 6 1000
Class 10,000 M 5.5 ISO 7 10,000
Class 100,000 M 6.5 ISO 8 100,000
                         *Particles 0.5 microns or larger in a cubic foot of air.
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