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Clean Room

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What is a Cleanroom?

A cleanroom is an environment, typically used in manufacturing or scientific research, that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. To give perspective, the ambient air outside in a typical urban environment might contain as many as 35,000,000 particles per cubic meter, 0.5 μm and larger in diameter, corresponding to an ISO 9 cleanroom.

Cleanrooms are 10,000 times cleaner than a hospital operating room. It takes an incredible amount of technology to achieve and maintain such cleanliness. Huge air filtration systems completely change the air in cleanrooms about 10 times per minute, reducing the chance that there are airborne particles that might harm the chips. They are used extensively in semiconductor manufacturing, biotechnology, the life sciences and other fields that are very sensitive to environmental contamination.

Cleanroom classifications

Cleanrooms are classified according to the number and size of particles permitted per volume of air. Large numbers like "class 100" or "class 1000" refer to US FED STD 209E, and denote the number of particles of size 0.5 μm or larger permitted per cubic foot of air. The standard also allows interpolation, so it is possible to describe e.g. "class 2000".

Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 μm or larger permitted per cubic metre of air. So, for example, an ISO class 5 cleanroom has at most 105 = 100,000 particles per m³.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, there is no such thing as a "zero" particle concentration. The table locations without entries are N/A ("not applicable") combinations of particle sizes and cleanliness classes, and should not be read as zero.

Because 1 m³ is approximately 35 ft³, the two standards are mostly equivalent when measuring 0.5 μm particles, although the testing standards differ. Ordinary room air is approximately class 1,000,000 or ISO 9.

US FED STD 209E cleanroom standards
Class
maximum particles/ft3
ISO equivalent
> 0.1 μm
> 0.2 μm
> 0.3 μm
> 0.5 μm
> 5 μm
1
35
7
3
1
ISO 3
10
350
75
30
10
ISO 4
100
750
300
100
ISO 5
1,000
1,000
7
ISO 6
10,000
10,000

70

ISO 8
100,000
100,000
700
ISO 9
US FED STD 209E was officially cancelled by the General Services Administration of the US Department of Commerce November 29, 2001, but is still widely used.
ISO 14644-1 cleanroom standards
Class
maximum particles/m3
FED STD 209E equivalent
> 0.1 μm
> 0.2 μm
> 0.3 μm
> 0.5 μm
> 1 μm
> 5 μm
ISO 1
10
2
ISO 2
100
24
10
4
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 1000
ISO 7
352,000
83,200
2,930
Class 10,000
ISO 8
3,520,000
832,000
29,300
Class 100,000
ISO 9
35,200,000
8,320,000
293,000
Room air
BS 5295 cleanroom standards
Class
maximum particles/ft3
> 0.5 μm
> 1 μm
> 5 μm
> 10 μm
> 25 μm
Class 1
3,000
Class 2
300,000
2,000
30
Class 3
1,000,000
20,000
4,000
300
Class 4
200,000
40,000
4,000
BS 5295 Class 1 also requires that the greatest particle present in any sample does not exceed 5μm.
Cleanrooms offers several designs to meet all of customers' needs
Softwall
The Econo-Tent softwall is an economical and practical approach to portable cleanrooms. Room sizes range from as small as 4'x6' to as large as 30'x30' (larger sizes available). Custom design units 20'x20'x20' on casters. 24'x57' on seismic approve projects.
Bioclean (Aluminum)
Newest in our line of modular cleanrooms is the 2nd generation of the popular softwall Bio- Clean (now the Micro-Clean). The Aluminum Bio-Clean was born out of the new requirements of USP 797. Overall performance of both Bio-Clean cleanrooms are identical, but the new Aluminum Bio-Clean has fewer joints, smaller seams and wall panels that are 1/4” thick acrylic
or Lexan. When it comes to a modular cleanroom for your pharmacy or manufacturing area it’s as simple as “ABC”.
Micro-Clean
The Micro-Clean was designed to allow for the medical industries concern for microbial contaminants, as well as airborne particulate matter. The Micro-Clean has been specifically designed as a standard for the IV and home infusion markets. We have installed rooms in pharmacies and hospitals all over the Unites States and in Europe.
Hardwall
The Modular Hardwall cleanroom offers you the best of all worlds, they are easily installed, economically expanded and can be relocated or upgraded as your needs change. Modular Hardwall cleanrooms are considered a more permanent fixed facility and offer a full line of options not normally available on Soft and or Semi-rigid cleanrooms, such as removable walls, clear ceiling spans up to 40’+, walls heights of 20’+, oversized single and double wide doors, high speed roll-up and sliding doors, and load bearing roof desks with A/C mixing plenums.
Modular Hardwall cleanrooms are ideal for any industry requiring a cleanroom, projects sizes have varied from as small as 8’x 8’ to as large as 48’ wide, lengths in the excess of 150’ and finished interior heights of 20’+. Our Modular Hardwall cleanrooms have been installed throughout the Unites States and Europe.
 
 
 
 
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