In order to ensure the safety and reliability of blood for clinical use, it is very important whether the various blood transfusion devices in blood collection and supply work meet the requirements of the relevant standards. Pyrogen testing and sterility testing can detect blood contaminated with bacteria or endotoxins in time before blood collection and during blood storage to ensure blood safety and an important means of ensuring blood safety in clinical use. However, over the years, due to the influence of pyrogen testing methods, equipment and other factors, especially due to the complexity of the composition of the blood preservation solution in the blood collection bag, it has caused great interference with the normal pyrogen testing methods, and the pyrogen testing work is not satisfactory. In recent years, with the introduction of various endotoxin detectors with reliable performance and the continuous research of testing reagents and testing methods by various manufacturers, it has become possible to perform pyrogen testing on various blood transfusion devices.
Since the endotoxin molecules with bipolar activity are unevenly distributed in water, the national standard for bacterial endotoxins should be dissolved in water with bacterial endotoxin inspection, and each subsequent dilution should be mixed on a vortex mixer. In order to avoid uneven mixing and affect the accuracy of the results. When testing disposable syringes, empty blood collection bags, etc., endotoxin must be extracted with endotoxin inspection water, and incubated at 37 ± 1◦C for 2 hours, and then the extract is taken for endotoxin testing. Because the endotoxin inspection water does not interfere with the Limulus reagent, the recovery rate is better; if sterile pyrogen-free physiological saline is used as the extraction solution, the interference experiment should be done, and the appropriate dilution factor should be selected to eliminate the interference.
Through the effective endotoxin testing of disposable blood transfusion equipment and component blood, the safety of patients is ensured, and the safety of clinical blood is ensured. At the same time, the success of the plasma pyrogen test also provides the possibility to carry out clinical cause testing, which is of great significance.
Creative BioMart provides comprehensive and accurate services to customers in the testing and removal of endotoxin in pharmaceutical equipment
