Technical Information

Sterility

The sterility of most of our products is fully validated and qualified to be in compliance with ISO 11137-1 regularoty requirements that includes the routine control of sterilization process.
Randomized selection, examination and monitoring ensures the overall process and products, labeled as sterile, are within the predetermined limits with an Sterility Assurance Level of 10^-6.

Non-cytotoxic

The cytotoxicity of our products is routinely tested according to the principles of the MEM Elution, described by the FDA guidelines. 

Non-pyrogenic

The endotoxin level of our products is tested according to the principles of the Limulus Amoebocyte Lysate Test, described in the FDA guidelines for medical products, and certified to be non-pyrogenic with a documented endotoxin level of less than 0.01 EU/ml.

DNase / RNase / DNA-free

Our products are routinely tested according to a Standard Operating Procedure, and certified to be less than 1 x 10^-8 Kunitz units for DNase, 1 x 10^-9 Kunitz units for RNase and 0.1 pg for DNA.

Dlux / Flux

DLux material has a modified plastic surface for enhanced cell attachment, with minimal autofluorescence and high chemical resistance.
Flux material has a modified plastic film surface for enhanced cell attachment, optimal for confocal microscopy. 

Surface Treatment

Surfaces of our "Surface Treatment" products are treated physically and not chemically.