FAQs

FAQ

Grupo de productos: Productos Life Science

What are special characteristics of BIO-CERT® products?

BIO-CERT® products are made of pure granular materials. They are sterile, free of endotoxins, DNA, RNase and ATP.

All lots are tested for sterility and endotoxins and monitored for DNA-, RNase- and ATP-concentration. BIO-CERT® products are sterilized according to ISO 11137 and AAMI guidelines with β-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.

The endotoxin concentration is tested by a gel-clotting Limulus Amoebocyte Lysate test. The detection limit is 0.01 EU/ml providing documented endotoxin level of less than 1 x 10-12 g/item. The concentrations of DNA, DNase, RNase and ATP are monitored regularly.

All BIO-CERT® products are supplied with a Certificate of Analysis.
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