Cleanroom classifications – FDA and EU
Blue Line complies with all regulatory requirements according to EU GMP classification for cleanroom A-B-C-D, as well as FDA and ISO 14644.
We comply with all regulatory requirements and cleanroom classifications
Blue Line’s products for life science industries are consciously designed with smooth surfaces, slanted sides and rounded edges meaning that products are easy to clean.
Blue Line’s cleanroom products withstand all known cleaning detergents as isopropyl alcohol, non-deionized water, VHP, Spor-Klenz™, Klercide, Actisan, LpH®, Vesphene® and many more.
There are more classification standards to respect and you can find a comparison below.
FDA
FDA classifies cleanrooms from ISO 5 to ISO 8.
EU
EU classifies cleanrooms from grade A to D.
ISO 14644:1
ISO 14644-1 specifies classes of air cleanliness in terms of the number of particles expressed as a concentration in air volume.
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