What is the pyrogen test?
What is the pyrogen test?
Pyrogen test is performed to check the presence or absence of pyrogens in all aqueous parenterals. Rabbits are used to perform the test because their body temperature increases when pyrogen is introduced by the parenteral route. For this test, three healthy rabbits are selected each weighing at least 1.5 kg.
What is pyrogen test in pharmacy?
Pyrogen testing determines the presence or absence of pyrogens in parenteral pharmaceutical products and is regulated by several standards from organizations such as the Food and Drug Administration (FDA), United States Pharmacopeia (USP), or European Pharmacopeia (EP).
What is pyrogen in pharmaceutical industry?
A pyrogen is a substance that causes fever after intravenous administration or inhalation. Gram negative endotoxins are the most important pyrogens to pharmaceutical laboratories.
What is LAL test of pyrogen?
Limulus amebocyte lysate test is an aqueous extract of blood cells (amoebocytes) which obtain from the horseshoe crab ( Limulus polyphemus ). LAL test is recommended in all international pharmacopeias as the method for finding bacterial endotoxins. Gram-negative bacteria produce endotoxins (pyrogen).
Why do we do pyrogen test?
Testing for pyrogens is a critical step in ensuring parenteral pharmaceutical product and medical device safety. It is part of the mandatory release tests to avoid life-threatening fever reactions induced by pyrogenic substances.
What is the purpose of pyrogen?
protein and polysaccharide substances called pyrogens, released either from bacteria or viruses or from destroyed cells of the body, are capable of raising the thermostat and causing a rise in body temperature. Fever is a highly significant indicator of disease.
How are pyrogens formed?
protein and polysaccharide substances called pyrogens, released either from bacteria or viruses or from destroyed cells of the body, are capable of raising the thermostat and causing a rise in body temperature.
How is LAL test performed for?
Test procedure: A BET involves analyzing the liquid sample or sample extract using Limulus Amebocyte Lysate (LAL). LAL is a reagent made from the blood of the horseshoe crab. In the presence of bacterial endotoxins, the lysate reacts to form a clot or cause a color change depending on the technique.
What is LAL testing used for?
A bacterial endotoxin test (BET), such as LAL (limulus amebocyte lysate), is an in vitro assay used to detect bacterial endotoxins. The bacterial endotoxin test uses the lysate from blood cells from horseshoe crabs to detect bacterial endotoxins.
Why is LAL important?
The LAL (limulus amebocyte lysate) testing, also known as bacterial endotoxin testing, is an in vitro assay used to detect the presence and concentration of bacterial endotoxins in drugs and biological products, and is an important part of pharmaceutical microbiology.
The Pyrogen test is designed to limit the risk of febrile reaction following parentral administration of drugs. It includes both In vitro and In vivo tests. In Vitro Test / LAL Test In Vivo Test / Rabbit Test. LAL Test: Limulus Amoebocyte Lysate Test. (In Vitro Test)
Are the USP and AAMI documents sufficient for pyrogen and endotoxins?
FDA has found that the published USP and AAMI documents describing methods and calculation of pyrogen and endotoxins testing limits [7] provide industry with appropriate information. We also note the continued development of USP Chapters and and FDA guidance documents.
What are pyrogenic surface contaminants?
Pyrogens are another common surface contaminant that is generally not addressed in the hospital sterilization processes. The outer coatings of spores and bacteria contain endotoxins (e.g. lipopolysaccharides (LPS), peptidoglycans (PGN) sor lipoteichoic acids), which are potent modulators of the human immune system.
What is the maximum temperature at which pyrogens are destroyed?
It has been reported that 650 C for 1 minute or 180 C for 4 hours, likewise, will destroy pyrogens. Studies by Tsuji et al, published in 1978, have shown that at lower temperatures (of 170 C), thermal destruction follows second-order rate, and a 3 log reduction of endotoxin levels at lower temperatures might not be practical.