Pyrogen detection tests have been recognized as an absolute necessity since the beginning of the injectable pharmaceutical industry. Pyrogens are substances that, if ingested at high levels, can cause fever, shock, and even death. Endotoxins are natural compounds found in the outer cell membrane of gram-negative bacteria and are released after cell destruction. Endotoxin is a type of febrile substance (pyrogen). Today, endotoxin detection tests are performed on raw materials, processed materials, and for pharmaceutical and medical products in the final stages of production.
Rabbit pyrogen testing is one of the standard methods of pyrogen testing. The test, which takes about four hours, is performed by injecting a sample into a rabbit’s ear vein and monitoring its temperature changes.
Padra Serum Alborz Company performs pyrogenicity testing services in accordance with PIC / S requirements and in the method mentioned in the latest version of European Pharmacopeia.