The bacterial endotoxin test (BET) is performed in most modern laboratories under controlled conditions as the important factor to avoid interference.
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 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.
Bioendo Bacterial Endotoxin Test, the experiments are including gel clot method endotoxin test assay and quantitative endotoxin test assay, gel clot method endotoxin test assay is qualitative endotoxin detection, these experiment requires the consumables is depyrogenation processing, such as endotoxin free reaction tubes, dilution tubes and pyrogen free tips; quantitative endotoxin detection have kinetic chromogenic endotoxin test, kinetic turbidimetric endotoxin test, these experiment requires consumables have to meet the top level of endotoxins less than 0.005EU/ml ( 0.001EU/ml ), such as endotoxin free tubes, pyrogen free tips, and pyrogen free microplates, even pyrogen free resevoir. By the way, if the samples treatment, the container have to be the endotoxin free sample bottle.
Post time: Dec-01-2022
