ISO8 3600m3/H Modular Clean Room Steel GMP USP Turnkey Project

ISO8 Steel Modular clean room turnkey project

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 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, ISO 9 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; 10,000; 1,000; 100; 10; 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 It was withdrawn in 2001, but it is still widely used.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 regional standards. For example, EU GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies.

ISO 8 CLEANROOM (CLASS 100,000 CLEANROOM)

Let’s assume that an unclassified space (office or lab) is ISO 9. In this case, you can directly enter an ISO 8 cleanroom, without an airlock. Depending on the production process inside the cleanroom, however, you may have to add a gowning room.

• ISO 8 zone | 15–25 air changes per hour

Non-unidirectional air flow