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CLEAN ROOM
ISO CLASSIFICATION
Maintaining high cleanliness standards, particularly in Cleanroom Industries like pharmaceuticals, semiconductors, electronics, aerospace, and manufacturing, is essential. These industries rely on environmentally controlled clean rooms that closely monitor airflow, temperature, humidity, and contamination to limit air pollutants. However, each industry has specific qualifications and standards, leading to various clean room classifications. DesignTek Consulting Group, LLC. can assist your company in determining clean room design and construction needs. Cleanrooms are vital for product integrity and high yields, demanding rigorous construction protocols, and our experts offer guidance to determine the appropriate classification for your process.
Cleanrooms are classified by how many particles are in the air, as well as how big those particles are, within one cubic meter of air. The smaller the classification is, then the more sterile the clean room. These standards are used amongst different industries, some requiring a higher level of cleanliness.
ISO 14644-1 addresses the cleanroom classification in regards to cleanliness and particle sizes, ranging from 0.1 µm to 5.0 µm. Prior to introduction of ISO 14644-1 (Nov. 2001), Federal standard 209E (FED STD 209E) was main reference used to classify cleanroom cleanliness. Small numbers refer to ISO 14644-1, which indicates the number of particles 0.1 µm or larger allowed per cubic meter of air.
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To comply with ISO standard, each cleanroom classification requires a different air changes/hour, room velocity and filter coverage, ranging from ISO 3 (class1) having the highest air changes per hour (app.450 air changes/hour) at 100% filter coverage, to ISO 8 (class 100,000) having the lowest air changes per hour (app. 10-12 air changes/hour), at 5-10% filter coverage.
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ISO Class 3 is the highest level of air cleanliness out of all the cleanrooms, with the standard set at only 1,000 particles per cubic meter. These particles must be smaller than 0.1 µm, making it an intensely high standard of cleanliness. For slightly larger particles, such as those that are smaller than 0.2 µm, only 237 particles are allowed per cubic meter. These clean rooms have stringent construction requirements, as they require very low contamination (particles).
ISO Class 3
(Class 1, FED STD 209E)
ISO Class 4
(Class 10, FED STD 209E)
This classification increases to 10,000 particles per cubic meter at 0.1 µm, allowing for slightly more flexibility. It also allows for more variations as particles get larger. For example, particles that are 0.2 µm, up to 2,370 particles can be found in each cubic meter. At 0.3 µm, you can find 1,020 particles, and for 0.5 µm, 352 particles per cubic meter can be allowed.
ISO Class 5
(Class 100, FED STD 209E)
ISO Class 5 increases to 10,000 particles per cubic meter at 0.1 µm, allowing for slightly more flexibility. It also allows for more variations as particles get larger. For example, particles that are 0.2 µm, up to 2,370 particles can be found in each cubic meter. At 0.3 µm, you can find 1,020 particles, and for 0.5 µm, 352 particles per cubic meter can be allowed.
ISO Class 6
(Class 1,000 FED STD 209E)
This classification increases to 10,000 particles per cubic meter at 0.1 µm, allowing for slightly more flexibility. It also allows for more variations as particles get larger. For example, particles that are 0.2 µm, up to 2,370 particles can be found in each cubic meter. At 0.3 µm, you can find 1,020 particles, and for 0.5 µm, 352 particles per cubic meter can be allowed.
ISO Class 7
(Class 10,000 FED STD 209E)
This classification increases to 10,000 particles per cubic meter at 0.1 µm, allowing for slightly more flexibility. It also allows for more variations as particles get larger. For example, particles that are 0.2 µm, up to 2,370 particles can be found in each cubic meter. At 0.3 µm, you can find 1,020 particles, and for 0.5 µm, 352 particles per cubic meter can be allowed.
ISO Class 8
(Class 100,000 FED STD 209E)
Also known as Class 100,000, ISO class 8 provides an environment that is slightly different than room air, allowing 3,520,000 particles that are smaller than 0.5 µm. For particles that are less than 5 µm, the room can have upwards of 29,300.
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ISO Class 8 is also commonly associated with clean rooms that are Grade D. At rest, they are limited to less than 3,500,000 particles that are smaller than 0.5. During operation, this number isn’t specified, but allows for the largest grade differential.
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If your manufacturing, pharmaceutical, semiconductor, or aerospace company is looking to build cleanrooms, the experts at DesignTek Consulting can provide you with the proper guidelines. With more than thirty-five years’ experience in cleanroom design and construction, and with proven records on our past cleanroom projects, we will ensure that your cleanroom specifications and standards are met and exceeds your expectation. For more information about cleanroom classification standards, design and construction, give us a call today, or visit us on the web.