A “controlled environment” typically refers to a separate space where temperature, humidity, air flow, lighting, or access are controlled to meet a specific need such as manufacturing, testing, research, or material storage. They do not require a specific particle count per volume or filtration. To certify a controlled environment, the temperature and humidity are measured and logged to ensure the environment is meeting required specification.
A “cleanroom” refers to a space which meets ISO14644-1 or FED Std 209E cleanroom classification standard. The ISO cleanroom standard includes particles per cubic meter and air changes per hour. The FED cleanroom standard includes particle per cubic foot and air changes per hour. The standards are roughly equivalent but use different units. To certify a cleanroom, the room is particle tested to ensure the designed cleanroom classification is being achieved, air pressure is measured continuously via magnehelic gauges, and filtration is working properly to achieve the required air changes per hour. In pharmaceutical and medical device cleanrooms, it common to use settling plates to measure “viable” contamination.
Cleanrooms can be thought of as “controlled environments” with added requirement of filtration / particle control.
|Clase||Máximo de Partículas/ft³||ISO Equivalente|
|>0.1 um||>0.2 um||>0.3 um||>0.5 um||>1 um||>5 um|
|ISO 3||1,000||237||102||35||8||Class 1|
|ISO 4||10,000||2,370||1,020||352||83||Class 10|
|ISO 5||100,000||23,700||10,200||3,520||832||29||Class 100|
|ISO 6||1,000,000||237,000||102,000||35,200||8,320||293||Class 1,000|
|ISO 7||352,000||83,200||2,930||Class 10,000|
|ISO 8||3,520,000||832,000||29,300||Class 100,000|
|Criterio||Clase 10 ISO4||Clase 100 ISO5||Clase 1000 ISO6||Clase 10,000 ISO7||Clase 100,000 ISO8|
|Cambios de Aire por HR / Min||500-600 / 8 to 10||300 to 480 / 5 to 8||180 / 3||60 /1||20 /0.33|
|% de Cobertura por Filtros||90 – 100||60 – 70||20 – 30||7 – 15||4 – 5|
|CFM por pie Cuadrado||85 – 90||36 – 65||18 – 32||9 – 16||4 – 8|
|Eficiencia de Filtro||99.9997% ULPAs||99.997% HEPAs||99.997% HEPAs||99.997% HEPAs||99.97% HEPAs|
Common Applications for Controlled Environments:
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