Greiner Bio-One products are:

 

Free of DNase, RNase and human DNA DNases and RNases are essential and ubiquitous enzymes which protect the living organism against the invasion of foreign DNA and RNA. DNases are cell components which also occur in body fluids. Because of the great potential for transmission (e.g. skin, hair etc.) overalls, gloves and hairnets are worn in all production areas. The most sensitive method available, the PCR method, is used to check for contamination with DNase, RNase or human DNA. DNase, RNase and human DNA free products are labelled in our catalogue.

Free of endotoxins Endotoxins are complex lipopolysaccharides which are components of the outer membrane of gram-negative bacteria. These substances are the most widespread and effective members of a group of so-called pyrogens that cause fever in humans. The LAL assay (Limulus Amoebocyte Lysate) used to test for freedom from endotoxins complies with the FDA guidelines for medical products (12/87). Greiner Bio-One works with the sensitive detection limit of <= 0.06 EU/ml. Endotoxin-free products are labelled in our catalogue.

Sterile Sterilisation by irradiation is required for the application of many of our products. The validation of the necessary radiation dose is conducted in accordance with EN 552, ISO 11137 and ANSI/AAMI ST31/ST32. On the basis of this standard, the so-called bioburden (germ level) is established for each product and the necessary radiation dose is determined. This determination is repeated at regular intervals. The sterility of the sterilised products is monitored. We guarantee a sterilisation dose of SAL 10-3 and a shelf life of 5 years for sterilised products.

Binding properties of all immunological products The binding properties of all immunological products are tested with a competitive ELISA (enzyme-linked immunosorbent assay). The CV (coefficient of variation) limits of our products are as follows: MICROLON® CV<5%; FLUOTRAC™ and LUMITRAC™ CV<10%. We guarantee a shelf life of 4 years for the immunological pre-treatment of these products.

Testing of cell culture products All cell culture products are physically surface-treated and are tested with different cell lines. Morphology, cell growth and cell vitality are monitored in the process. A broad spectrum of cells, ranging form primary cells, mammalian cells and human cells to insects cells, enable comprehensive testing. We guarantee 4 years' stability on the surface treatment of all cell culture products.

Free of cytotoxicity In many experiments toxic effects on cells or tissue cultures play an important role particularly in the field of In-vitro diagnostics. The relevant culture vessels and all objects that come into direct contact with the cells and tissues must therefore be free of cytotoxic substances. All cell-culture-relevant end products are checked for freedom of cytotoxicity. The detection of cytotoxicity is evaluated with mammalian cells according to EN ISO 10993.

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