Products from Greiner Bio-One provide one or more of the following feature
Free of detectable DNase, RNase and human DNAFor reliable and accurate results in molecular biology applications, e.g. sequencing and amplification, the applied products should not contain any DNase, RNase or human DNA. Therefore protective gear, like overalls, gloves and hairnets, is a prerequisite in all production areas. Furthermore, a routine monitoring of DNase, RNase and human DNA is performed. Products are washed with an appropriate volume of a 0.5% Tween 20 solution to detach adherent nucleases and nucleotides. DNase, RNase and human DNA present in the washing solution are detected by quantitative Real-Time PCR. The detection limits related to the applied PCR methods are 1.3 x 10-8 Kunitz units for DNase, 5 x 10-11 Kunitz units for RNase and 5 pg for human DNA. All products that meet the above mentioned features are identified in our catalogue with the respective label. |
Free of detectable endotoxinsEndotoxins are complex lipopolysaccharides and part of the outer membrane of gram-negative bacteria. These substances are the most widespread and effective species of a group of so-called pyrogens that can cause fever. The US Pharmacopoeia guidelines stipulate that eluates from Medical Devices (e.g. washing fluids from disposables) do not exceed endotoxin levels of more than 0.5 EU/ml. Consumables that are in contact with cerebrospinal fluid require endotoxin levels of 0.06 EU/ml. The testing of endotoxins is conducted in a kinetic turbidimetric LAL assay (Limulus Amoebocyte Lysate) with a detection limit of < 0.06 EU/ml. This test procedure complies with the FDA guidelines for medical products (Rev. 12/87). All products that meet the above mentioned feature are identified in our catalogue with the respective label..jpg) |
SterilityThe validation of our products is conducted in accordance with ISO 11137. Related to this standard, the so-called bioburden (germ level) is established for each product and repeated in regular intervals. Based on this data the necessary radiation dose is determined. Products labelled as sterile are routinely monitored. Except for In Vitro Diagnostic and Medical Devices with an SAL level of |
Binding properties of immunological productsThe binding properties of all our immunological products are tested with an ELISA. The limits of the coefficient of variation (CV) of our products are as follows: MICROLON® CV < 5 %; FLUOTRAC™ and LUMITRAC™ CV < 10 %. We provide these products with a shelf life of 4 years for the binding characteristics. |
Cell compatibility of cell culture productsThe quality of cell culture products is tested with a large variety of different cell lines. Relevant parameters like morphology, cell growth and cell vitality are monitored. A wide set of cells enables comprehensive testing. For more detailed information about the self life of our cell culture products, please visit the product area of our website. |
Free of cytotoxic substancesCell culture products used in cell-based applications and in the field of In-Vitro Diagnostics should not contain any cytotoxic substances. Therefore all relevant cell culture end products are analysed for cytotoxicity. The detection of cytotoxicity is evaluated with mammalian cells according to EN ISO 10993. All products that meet the above mentioned feature are identified in our catalogue with the respective label. |
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