Ardmac Pharma Solutions Bi-Monthly Newsletter Sept …

What is a cleanroom?

A cleanroom is a controlled environment where provisions are made to reduce particulate contamination (along with other environmental parameters such as temperature, humidity, and pressure) to levels appropriate for accomplishing contamination- sensitive activities. A cleanroom environment is typically specified in industries such as aerospace, microelectronics, optics, nuclear and life sciences (pharmaceuticals, medical devices, food and healthcare).

ISO Standards determine the controlled level of contamination based on the number of particles per cubic meter at a specified particle size. An ISO Level 3 cleanroom, or Class 1 cleanroom, contains the least number of particles per cubic meter and the smallest specified particle size going down to 0.1 micron. At ISO Level 9, the environment is equivalent to normal room air with no control over the particle count or size. The tablebelowshows thevarious ISOlevelsand their corresponding cleanroom classification.

iso 14644-1 cleanroom standards

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