Cleanroom - FDA and EU classifications

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.

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Pharma and Life Science

 

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.

Cleanroom - FDA og EU klassifikationer

See here for more detailed comparison of cleanroom classification

Explore the broad range of products

Cleanroom Computers & HMIs

Cleanroom Computers & HMIs

Gain higher productivity and user satisfaction with Blue Line's Cleanroom Computers & HMIs. Designed to avoid the typical challenges in the life science, biotech, and pharmaceutical industries
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Cleanroom Tablet

Cleanroom Tablet

GMP Tablets for biotech and pharmaceutical environments. Easy to clean resisting all detergents. Operable with gloves. Slim and low weight.
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