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BIO-CERT® products are made from dye-free materials and are manufactured without soft lubricants or other additives.
All lots are tested for sterility and pyrogens (endotoxins) and monitored for DNA-, RNase- and ATP concentration.
All products are supplied with a Certificate of Analysis.
PLASTIBRAND® BIO-CERT® products are certified to be:
Free of DNA and RNase:
BIO-CERT® products are DNA-free (< 4 x 10-12 g/item), to prevent false positive signals during PCR* applications. These products are free of RNases (< 8,6 x 10-15 g/item), to prevent degradation of RNA during purification processes.
Sterile:
BIO-CERT® products are sterilized according to ISO 11137 and AAMI guidelines with ß-radiation, using a minimum radiation dose of 12.1 kGy. This gives a SAL (sterility assurance level) of 10-6. The sterility meets USP 29 and Ph. Eur. requirements for sterility.
Free of ATP:
All products are supplied with a Certificate of Analysis which guarantees an ATP concentration less than 1 x 10-15 g/item. Therefore, BIO-CERT® products are suitable for ATP detection using bioluminescence-systems.
Free of endotoxins:
The endotoxin concentration in BIO-CERT® products are tested by a gel-clotting Limulus Amoebocyte Lysate test. The detection limit is 0.01 I.U./ml providing documented endotoxin level of less than 1,1 x 10-12 g/item.
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