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Clean Room Classifications (ISO 8, ISO 7, ISO 6, ISO 5)

Author: Jesse

Aug. 13, 2024

258 0

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 -1.

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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 by ISO--1. It was withdrawn in , but it is still widely used.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.

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You might also like this article '>How Classification Impacts your Cleanroom Design

Want to learn more about Clean Rooms? '>What is a Clean room?

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ISO 8 Class Cleanroom Requirements

ISO 8 or Class 100,000 Cleanrooms and CNC (Controlled Non-Classified) clean spaces common classifications of cleanrooms across a variety of industries and application types.  ISO 8 Cleanrooms are utilized in biotechnology, pharmaceutical, electronic assembly, and various cleantech manufacturing applications such as ion lithium battery, solar, surgical kit assembly, packaging, nutraceuticals, and certain packages foods.  

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