Iso Eight Clean Room Standards - China

Clean Room Classifications (ISO 8, ISO 7, ISO 6, ISO 5) Clean rooms are classified according to the cleanliness level of the air inside the controlled environment.

The clean room class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air.

The primary authority in the US and Canada is the ISO classification system ISO 14644-1 - This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9 - ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class.

Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room.

The most common ISO clean room classes are ISO 7 and ISO 8 - The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Class 10, 000 and Class 100 000 - The old Federal Standard 209E ( FS 209E ) includes these clean room classes : Class 100, 000; Class 10, 000; Class 1, 000; Class 100; Class 10; Class 1 - This standard was replaced in 1999 by ISO-14644-1 - It was withdrawn in 2001, but it is still widely used.

Clean rooms must also follow industry-specific and international standards.

For example, EU GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies.

Cleanroom Classifications & Standards In ISO Classes 4-9, air change rates are expressed as the rate per hour the air in the cleanroom is completely refreshed (ACH = air changes per hour).

As cleanroom classifications become more stringent, the air change rate must increase to remove particles and keep the air cleaner.

In Class 5 and below, the strictest cleanroom classifications, the air change rate is so rapid it is expressed instead as airflow velocity, either in meters per second or feet per minute.

These cleanroom environments require air that is extremely clean, so the constant changing of contaminant-free air is vital to maintain classification standards.

When upgrading to a stricter cleanroom classification, an important step is to increase the filtration and air change rate to remove more particles of a smaller size from the air.

For example, ISO Class 7 requires between 60-90 ACH and allows for 352, 000 particles at 0.5 microns per cubic meter.

To move to an ISO Class 6, the facility would need to increase to 150-240 ACH to filter all but 35, 200 particles at 0.5 microns per cubic meter.

The more stringent the classification, the more extreme the standards of cleanliness.

Extremely clean cleanrooms require extensive filtration and powerful HVAC systems to maintain classification standards.

Company Contact:

• Posted By: GUANGZHOU YIZHONG ALUMINUM INDUSTRY CO.,LTD

• Phone: 86-20-81554508

• Address: 8053, 5th Floor, Junfeng Business Center, No. 99 Hualei Road, Liwan District, Guangzhou , Guangdong , China

• Email:

• Website: https://www.yizhongalu.com/

• Business Description: Guangzhou Yizhong Aluminum Industry Co., Ltd. founded in Guangzhou, Guangdong province in 1996 named "SANHE", has been developing for more than 20 years with branches and factories in Foshan, Dongguan, Zhongshan and Taishan.
  
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