What kind of standard pipette tips is Endotoxin-free level ?

Pyrogen-free consumables are consumables without exogenous endotoxin, including pyrogen-free pipette tips (tip boxes), pyrogen-free test tubes or called endotoxin free tubes, pyrogen-free glass ampoules, endotoxin-free 96-well microplates, and endotoxin-free water (depyrogenated water use in the bacterial endotoxin test ), and etc. Among them, the water for bacterial endotoxintest by gel clot method in the Pharmacopoeia 05 edition refers to sterile water for injection with endotoxin content less than 0.015EU/ml. Now the latest version of Pharmacopoeia, the BET water is less than 0.005EU/ml.

Pyrogen: Also called pyrogen or exothermic factor. substances that can cause an increase in body temperature.
Heat Source: An object that emits heat. Such as burning matches, charcoal, etc.
The above two are two completely different concepts.

The so-called “non-pyrogenic consumables” and “pyrogenic response” of some manufacturers and merchants are actually very unprofessional and misleading names. The correct ones should be “Pyrogen-free” and “Pyrogen Response”.

Why endotoxin test assay need pipette tips by depyrogenation treatment?

Endotoxin test assays, such as the Limulus Amebocyte Lysate (LAL) assay, require pipette tips that have undergone depyrogenation treatment to prevent the introduction of endotoxins into the assay. Endotoxins are toxic components of the cell wall of Gram-negative bacteria, and they can interfere with the accuracy of endotoxin test results, leading to false positives or false negatives.

Depyrogenation is a process that removes or inactivates endotoxins from surfaces or materials, including pipette tips. This process typically involves heating the material at a high temperature, such as 250°C, for a period of time, typically 2-4 hours. This effectively destroys any endotoxins that may be present on the surface of the pipette tip.

Since pipette tips come in contact with the sample and the reagents used in the endotoxin test assay, they must be free of endotoxins to ensure the accuracy of the test results. Using depyrogenated pipette tips helps to prevent contamination and ensure that the endotoxin test assay results are reliable and accurate.

Laboratory Environmental Conditions for Endotoxin free experiment:

The BET can be performed in most modern laboratories under controlled conditions.

Appropriate aseptic technique is important when preparing and diluting standards and handling samples. Gowning practice outside of normal laboratory personal protective equipment (PPE) requirements is not a concern unless the product under test demands specific analyst safety considerations due to toxicity or infectiousness. Gloves should be TALC-free, as the TALC may contain significant levels of endotoxins. Plate readers, water baths, and dry heat blocks (dry heat incubator) used for sample incubation should be on a laboratory bench away from heating, ventilation, and air conditioning (HVAC) ducts, significant vibration, and laboratory traffic that could affect the test results. Sample hold times and conditions should be determined and subsequently documented, if necessary, to ensure that accurate test results can be generated in the qualified time.

For example, if the laboratory receives a Water for Injection (WFI) or in-process sample, must it be refrigerated or can it remain at room temperature, and for how long? Prior to testing, it is recommended that the primary sample container(s) be adequately mixed before removing the test aliquot(s) for either direct testing or subsequent dilution.

Tianjin Ruikang Supplied those pipette tips which is passing the inspection of endotoxin-free level. Pipette tips through the depyrogenation processing, then ensure the quality of the endotoxin free pipette tips. That is very necessary for the no interference for the endotoxin detection. Especially endotoxin free consumables are requires in the quantitative endotoxin test experiment.