Pyrogen-free consumables are consumables without exogenous endotoxin, including pyrogen-free pipette tips (tip box), pyrogen-free test tubes or called endotoxin free glass tubes, pyrogen-free glass ampoules, endotoxin-free 96-well microplates, and endotoxin-free water (depyrogenated water use in the bacterial endotoxin test ), endotoxin free buffer and etc. Among them, the water for bacterial endotoxintest by gel clot method and quantitative endotoxin test assay in the all related Pharmacopoeia editions (USP, EP, BP, JP and China Pharmaceutica) . 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. Even the highest standard is less than 0.001EU/ml is able to be produced and supplied by Bioendo.
Related key words of endotoxins, and endotoxin free consumables, pyrogen and heat sources are two completely different concepts: 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 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 Pyrogen free consumables are necessary in the endotoxin test assay, both gel clot endotoxin test assay and quantitative endotoxin test assay?
Yes, pyrogen-free consumables are essential for performing the endotoxin test assay accurately and reliably.The presence of pyrogens, which are fever-inducing substances often derived from bacterial endotoxins, can interfere with the results of the test and lead to false readings.The endotoxin test, commonly known as the Limulus amebocyte lysate (LAL) test or called Lyophilized amebocyte lysate (LAL) test, is used to detect and quantify the presence of bacterial endotoxins in pharmaceuticals, medical devices, and other products. The LAL test relies on the reaction between the LAL reagent and endotoxins to produce a clotting or chromogenic response.To ensure accurate results, it is crucial to use consumables that are free from pyrogens. Pyrogens can contaminate various laboratory materials, including glassware, pipette tips, tubes, and sample containers. If pyrogen-contaminated consumables come into contact with the LAL reagent or test samples, they can trigger false-positive reactions, leading to erroneous conclusions about the presence or concentration of endotoxins.Pyrogen-free consumables are manufactured and tested specifically to minimize or eliminate the presence of pyrogens. They undergo rigorous quality control processes to ensure that they meet the required standards for endotoxin testing. Using these specialized consumables helps maintain the integrity and accuracy of the endotoxin test assay, ensuring reliable results and promoting patient safety in pharmaceutical and biomedical applications.
Post time: Nov-07-2022