What is the testing of pyrogens?
Pyrogen testing defines the process used by drug manufacturers to determine whether bacterial toxins are present in vaccines and drugs that could cause fever when used on people. It determines whether microbes or their metabolites are present in intravenous solutions during the production process. The most common and oldest form of testing of pyrogens is to injure drugs into rabbits to see if the fever is evolving. A newer test uses blood from crabs to test toxins.
Method of testing the pyrogen rabbit occurred in the 40s of the 20th century after some patients fell ill with intravenous drugs. At that time, hypodermic devices proved to be useful for drug administration directly to the bloodstream for patients who were unable to tolerate oral drugs. Although the hypodermic devices were sterile, the drugs were not always safe.
Sometimes patients have developed high fever, chills and body pain and some people have suffered a shock. Doctors did not know why this occurred, often inOljenečka injection, salt fever or distilled fever of water. Scientists later found that some medicines and vaccines were contaminated in production laboratories with pyrogen endotoxins, strong bacteria that will withstand sterilization.
The human body fights to expose bacterial toxins in the environment through the skin. When contaminated medicines are injected into the bloodstream, toxins bypass normal defense mechanisms. White blood cells begin to release another form of pyrogens that cause a high fever, which could lead to shock and death.
Pyrogens testing in medicine laboratories includes a heating device used to ensure sterilization. The drug is injected into the ears of rabbits to see if the fever is evolving. Rectal temperatures of test animals are analyzed after 30 minutes and again three to three hours later. If animals remain without fever, the solution is without toxins.
Pyrogens tranage in animals usually involves injection of several rabbits at a time within a 10 -minute time frame. The dose for each rabbit depends on body weight, age and sex. The same group of rabbits can be tested repeatedly every few days until they develop tolerance to drugs.
The technique of newer testing of pyrogens is called the Limulus amoebocyte test (LAL). The crabs of the crabs contain a high level of toxins that naturally occur in marine life. Scientists have discovered a way to use blood to test bacterial toxin in drugs and raw materials used to produce the drug. LAL testing procedure can be more sensitive than the rabbit testing methods. Healthcare, which is implanted into humans, undergo LAL testing, along with radioactive drugs and anesthesia.