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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 particulates. [6]
A cleanroom or clean room is an engineered space that maintains a very low concentration of airborne particulates. It is well isolated, well controlled from contamination , and actively cleansed. Such rooms are commonly needed for scientific research and in industrial production for all nanoscale processes, such as semiconductor manufacturing.
ISO 14698-1 was first written in 2003. ISO 14698-1 describes the principles and basic methodology for a formal system to assess and control biocontamination, where cleanroom technology is applied, in order that biocontamination in zones at risk can be monitored in a reproducible way and appropriate control measures can be selected.
The aim of cleanroom suitability tests is to determine the suitability of machines and operating utilities (air conditioning, venting, etc.) for use in cleanrooms. The tests must be carried out using measurement techniques as particle emission behavior cannot be adequately assessed by the naked eye or similar means.
FED-STD-209 E Airborne Particulate Cleanliness Classes in Cleanrooms and Cleanzones was a federal standard concerning classification of air cleanliness, intended for use in environments like cleanrooms. The standard based its classifications on the measurement of airborne particles. [1]
Cleanrooms have defined particle count limits. Aerosol particle counters are used to test and classify a cleanroom to ensure its performance is up to a specific cleanroom classification standard. Several standards exist for cleanroom classification. The most frequently referred to classification is from the United States.
Air showers are typically placed between a gowning area and cleanroom; after workers don appropriate garb and personal protective equipment, they enter the shower so that the pressurized air nozzles remove any residual particles from coveralls. Once the program cycle is complete, users exit through a second door into the cleanroom.
A biosafety cabinet (BSC)—also called a biological safety cabinet or microbiological safety cabinet—is an enclosed, ventilated laboratory workspace for safely working with materials contaminated with (or potentially contaminated with) pathogens requiring a defined biosafety level.
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