Clean Room Classification Iso Vs Eu

To meet requirements of a clean room as defined by federal standard 209e and newer iso standards all clean rooms must not exceed a particulate count as specified in the air cleanliness class.

Clean room classification iso vs eu.

Under the fed ste 209e system there was no equivalent for this level of cleanliness. If you do business in europe and are installing a clean room that deals with the manufacture of sterile medicinal products your clean room must adhere to the most recent set of standards set forth in the revision of the annex to the eu guide to good manufacturing practice manufacture of sterile medicinal products. By comparison a typical office space would be 5 10 times more dirty. Grades a and b correspond with class 100 m 3 5 iso 5.

Whereas cleanliness standards were once defined by the federal standard 209e they have been replaced and simplified by iso with classifications 1 to 9. Clean room classifications can be confusing. Classification 1 is the cleanest. For cleanrooms and clean zones shown in iso 14644 1 2015 cleanroom limits for airborne particulate contamination clean room and clean air device classification in relation to gmp 2008.

The class defines a minimum cleanliness level not a specific design. Grade c with class 10000 m 5 5 iso 7 and grade d with class 100000 m 6 5 iso 8. However class will greatly impact design considerations such as filtration hvac requirements and other design elements. The former applies to clean rooms in general see table below.

Iso 14644 1 and iso 14698 are non governmental standards developed by the international organization for standardization iso. A cleanroom must have less than 35 200 000 particles 0 5 micron per cubic meter and 20 hepa filtered air changes per hour. Maximum permitted number of particles per m 3 equal to or greater than the tabulated size. Iso 8 is the least clean cleanroom classification.

B the guidance given for the maximum permitted number of particles in the at rest condition corresponds approximately to the us federal standard 209e and the iso classifications as follows. The latter to cleanrooms where biocontamination may be an issue. The equivalent fed standard is class 100 000 or 100 000 particles per cubic foot. Iso 14644 1 and older standard fs 209e determine class by the concentration levels of particles.

Ordinary room air is around class 1 000 000 or iso 9. The particles range in size from 1 5 microns µm. Classification 9 is defined as room air. As of november 29th 2001 the federal standard 209e has been replaced with iso 14644 1.