Cleanroom Cleanroom classification

Cleanrooms are designed to provide this by meeting purity classes of various degrees based on
ISO and cGMP standards, as directed by the given applications at rest conditions

A cleanroom is an environment, typically used in also designed to produce a minimum of particles and to be 3
Air Particle Count Maximum allowable particle count per M
manufacturing or scientific research, that has a low easy to clean.
US
level of environmental pollutants such as dust, airborne Common materials such as paper, pencils, and fabrics made
ISO a) Fedral Standard > 0.1 um > 0.2 um > 0.3 um > 0.5 um > 1.0 um > 5.0 um
14644-1 a)
microbes, aerosol particles and chemical vapors. More from natural fibers are often excluded; however, alternatives
209 Si
accurately, a cleanroom has a controlled level of are available. Cleanrooms are not sterile (i.e., free of
ISO
10 2
Class 1
contamination that is specified by the number of uncontrolled microbes) and more attention is given to
particles per cubic meter at a specified particle size. To airborne particles. Particle levels are usually tested using a
ISO
100 24 10 4
Class 2
give perspective, the ambient air outside in a typical particle counter.
urban environment might contain as many as ISO M1.5
1000 237 102 35 8
Some cleanrooms are kept at a positive pressure so that if Class 3 (1) b)
35,000,000 particles per cubic meter, 0.5 µm and 1240 265 106 35
larger in diameter, corresponding to an ISO 9 there are any leaks, air leaks out of the chamber instead of ISO M2.5
(10) b) 10000 2370 1020 352 83
cleanroom. unfiltered air coming in. Class 4 12400 2650 1060 353

Some cleanroom HVAC systems control the humidity to ISO M3.5 3520
Overview Class 5 (100)
b) 100000 23700 10200 3530 832 29
relatively low levels, such that extra precautions are 26500 10600 3500 0
Cleanrooms can be very large. Entire manufacturing necessary to prevent electrostatic discharge (ESD) ISO M4.5 1000000 237000 102000 35200 8320 293
facilities can be contained within a cleanroom with problems. These ESD controls ("ionizers") are also used in Class 6 (1000)
b)
35200 247
factory floors covering thousands of square meters. rooms where ESD sensitive products are produced or
ISO M5.5 352000 2930
They are used extensively in semiconductor handled. (10000)
b) 353000 83200 2470
Class 7
manufacturing, biotechnology, the life sciences and 350000 2000
Low-level cleanrooms may only require special shoes, ones
other fields that are very sensitive to environmental ISO M6.5 3520000
832000
29300
with completely smooth soles that do not track in dust or dirt. Class 8 (100000)
b)
3530000 24700
contamination. 3500000 20000
However, shoe bottoms must not create slipping hazards
ISO
The air entering a cleanroom from outside is filtered to (safety always takes precedence). Entering a cleanroom Class 9 35200000 8320000 293000
exclude dust, and the air inside is constantly usually requires wearing a cleanroom suit.
recirculated through high efficiency particulate air a) At rest conditions b) Class division in cubic feet
In cheaper cleanrooms, in which the standards of air
(HEPA) and/or ultra low penetration air (ULPA) filters to
contamination are less rigorous, the entrance to the
remove internally generated contaminants.
cleanroom may not have an air shower. There is an anteroom,
For Guidance
Staff enter and leave through airlocks (sometimes in which the special suits must be put on, but then a person Class 1 and 10 (the highest specification) are generally used for integrated circuit and semi-conductor manufacture.
including an air shower stage), and wear protective can walk in directly to the room .
clothing such as hats, face masks, gloves, boots and Class 100 (BS. 5295 equivalent classifications E and F) are often used by the electronics industry along with some applications
Some manufacturing facilities do not use fully classified within pharmaceutical facilities.
cover alls.
cleanrooms, but use some cleanroom practices together to
Equipment inside the cleanroom is designed to maintain their cleanliness requirements. Class 1,000 to 10,000 are used by manufacturers of the highest specification fibre optics, precision engineering, sterile
generate minimal air contamination. There are even packaging and pharmaceutical manufacturing.
specialised mops and buckets. Cleanroom furniture is Class 100,000 is adequate for general component assembly and packaging.

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