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Assembly Processes - Clean Room Assembly
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For medical device manufacturing, semi-conductors, micro-fluidic devices and any particle sensitive assembly process, the manufacturing may need to be carried out in a controlled, clean room environment to prevent any contamination that may cause the device to fail. Clean rooms are classified according to an international standard. The class of clean room required will depend on the sensitivity of the device to particles.
Cleanliness Classes
The contamination control industry currently uses an international ISO specification to provide a qualified and standardized method for measuring how clean the air is in a cleanroom. Six classes have been established to designate cleanroom cleanliness.
The class number refers to the maximum number of particles bigger than 0.1 of a micron that would be allowed in one cubic meter of cleanroom air.
The US system is slightly different in that the standard refers to the maximum number of particles bigger than half a micron in a cubic foot of air. For example, a US class 100 clean room would not contain more than 100 particles bigger than half a micron in a cubic foot of air.
The ISO Classes are:
ISO 1: A cleanroom where particle count is not to exceed a total of 10 particles, 0.1 of a micron in size in a cubic meter of air.
ISO 2: A cleanroom where particle count is not to exceed a total of 100 particles, 0.1 of a micron in size in a cubic meter of air.
ISO 3 (US Class 1): A cleanroom where particle count is not to exceed a total of 1,000 particles, 0.1 of a micron in size in a cubic meter of air.
ISO 4 (US Class 10): A cleanroom where particle count is not to exceed a total of 10,000 particles, 0.1 of a micron in size in a cubic meter of air.
ISO 5 (US Class 100): A cleanroom where particle count is not to exceed a total of 100,000 particles, 0.1 of a micron in size in a cubic meter of air.
ISO 6 (US Class 1,000): A cleanroom where particle count is not to exceed a total of 1,000,000 particles, 0.1 of a micron in size in a cubic meter of air.
ISO 7 (US Class 10,000): A cleanroom where particle count is not to exceed a total of 352,000 particles, 0.5 of a micron in size in a cubic meter of air.
ISO 8 (US Class 100,000): A cleanroom where particle count is not to exceed a total of 3,520,000 particles, 0.5 of a micron in size in a cubic meter of air.
ISO 9: A cleanroom where particle count is not to exceed a total of 35,200,000 particles, 0.5 of a micron in size in a cubic meter of air.
The cleanliness of the air in a clean room is often controlled by a high efficiency particulate air (HEPA) filtration system.
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