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A Unique Dimension in Biological Purity

Eppendorf AG Introduction With Eppendorf Biopur products, Eppendorf has created a unique standard of purity for consumables. Pipette tips, Safe-Lock/Flex Tube Microcentrifuge Tubes and Combitips bearing the Eppendorf Biopur seal are produced with extensive automation of all steps in the production process. Contamination with nucleic acids, proteins or microorganisms by human contact or through other sources is excluded. Eppendorf certifies the purity of all Biopur products! This certificate* lists the limits for sterility, pyrogens (endotoxins), DNA, RNase and ATP. *Eppendorf Biopur products are tested independently and certified by ACILA GMN mbH, Laboratory Dr. P. Weidner All Eppendorf Biopur articles are guaranteed:
  • Sterile (high energy electron radiation, sterility assurance level (SAL) of 106 )
  • pyrogen-free (<0.002 EU/ml, kinetic turbidimetric LAL-test, FDA guideline)
  • RNase-free (<3.4 x 1011 Kunitz units)
  • DNA-free (<5 x 1011 mg)
  • ATP-free (<5.5 x 1012 mg)

The Eppendorf Biopur seal stands not only for reliability, but also for a saving of time and work, as these articles are ready for use.

In accordance with an initiative of the European Confederation of Medical Suppliers Associations (EUCOMED), a contamination probability with viable microorganisms of 106 after a sterilization process was specified for reliable sterilization. This is equivalent to an SAL of 106, which means: 1 microorganism surviving in a sample of 106 or 1 non-sterile item after sterilization of a batch of 106 items.

For Eppendorf Biopur products, sterility with an SAL of 106 is achieved by beta-radiation. Combitips are sterilized using a minimum dose of 12.9 kGy (= 12.9 Joule per kilogram or 0.129 Megarad). The choice of the sterilization dose is based on experimental determinations of the bioburden and on sterility tests and reflects the actual quality of the production process.

According to table B1 of the ISO/DIS 11137.2, a SAL of 106 is achieved when a dose of 12.9 kGY is used for an average bioburden of 0.39 microorganisms per item. After validation of the sterility process and product sterility with suitable bacterial indicators (Bacillus pumilus), further control of the process is made with dosimeters. This is in accordance with the USP XXII (United States Pharmacopoeia), DAB 10 (Deutsches Apothekerbuch) and Ph. Eur. (European Pharmacopoeia). Eppendorf Biopur products are not sterilized in an ethylene oxide (EtO) process because EtO is absorbed at a rate of several thousand parts per million by plastic consumables. The absorbed EtO and its reaction products are not easily removed from these articles. The levels of residues of EtO and its reaction product ethylene chlorohydrin that can be tolerated have to be very low, but even the smallest trace in plastic consumables might affect very sensitive cells or enzymes. Inactivation of Bacillus Pumilus in Relationship to Ionizing Radiation
D10 for bacillus pumilus = 1.75 kGy (dose required to reduce the bioburden by one order of magnitude), cfu = colony-forming unit Pyrogens Pyrogens form a class of substances that cause fever when given parenterally (from Greek: pyr, pyros = fire; genes: to arise). Endotoxins as the most important class of pyrogens are monitored in Eppendorf Biopur products by a kinetic-turbidimetric LAL-Test. LAL is the abbreviation for Limulus Amoebocyte Lysate. This lysate of blood cells from Limulus polyphemus (horseshoe crab) reacts very sensitively with very small amounts of the lipopolysaccaride fraction of bacterial cell envelopes of Gram-negative bacteria (bacterial endotoxins). The addition of a solution containing endotoxins to a solution of the lysate produces turbidity, precipitation or gelation of the mixture. Horseshoe crabs are used as blood donors for the collection of amoebocytes. Fortunately, the crabs do not have to be killed for this process. Since 1987 and 1988 the Ph. Eur. and the FDA (Federal Drug Administration, USA), respectively, have set guidelines for the use of gel tests and kinetic-turbidimetric tests with LAL.

The LAL-Test for Eppendorf Biopur products is carried out with endotoxin standards (ie, WHO-Standard 84/650 or Endotoxin BRS) or control standard endotoxins.

North American horseshoe crab Limulus polyphemus ATP ATP can be used as a general indicator for the presence of a microbiological bioburden, as it is a common substance in all kind of cells. Eppendorf Biopur products are ATP-free and therefore are optimally suited for use with ATP quantification kits. These kits commonly use the enzyme luciferase from firefly organs that catalyze the formation and oxidation of adenyl-luciferin with emission of light. The bioluminescence is used as an indicator for metabolic activities or the presence of biological material. DNA and RNase Contaminating nucleic acids and enzymes that cleave DNA or RNA are the most critical substances that can very much influence experimental work in molecular biology, eg, the Polymerase Chain Reaction (PCR*) or other amplification techniques. The contamination of plastic consumables throughout production processes with DNA and RNases is mostly due to human contact and air-borne contamination, which is excluded for the entire Biopur production process. (DNase is too unstable to be listed here as a contaminant.) *Practice of the patented polymerase chain reaction (PCR) process requires a license.



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