What is procedure of pyrogen testing?

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 LAL test and how LAL test is performed?

The LAL test is a method of the Bacterial Endotoxin Test (BET) for detecting the presence, and to go some way to determining the level, of Gram-negative bacterial endotoxins in a given sample or substance. From: Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals, 2013.

How does LAL endotoxin testing work?

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.

What is the LAL test and what does it do for medicine?

Performed as a lot release test, the LAL assesses medical devices coming in contact with cerebrospinal fluid or the cardiovascular system. This determines the presence of bacterial endotoxins by testing the blood cells of horseshoe crabs to identify pyrogenic responses.

Why rabbit is used in pyrogen test?

If a pyrogen is present in the test substance, it will cause an elevation of the animal’s body temperature from normal. Rabbits have similar temperature response to endotoxins as humans. For this reason, they are ideal for use in pyrogen detection.

What is pyrogen chemically?

Pyrogens are substances that can produce a fever. The most common pyrogens are endotoxins, which are lipopolysaccharides (LPS) produced by Gram-negative bacteria such as E. coli. The limulus amoebocyte lysate (LAL) test is used to detect endotoxins.

What is MVD in LAL test?

DETERMINATION OF MAXIMUM VALID DILUTION The Maximum Valid Dilution (MVD) is the maximum allowable dilution of a sample at which the endotoxin limit can be determined.

Why LAL test is done?

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.

How does a rabbit test work?

Human chorionic gonadotropin (hCG), a hormone that concentrates in the urine of pregnant women, causes the ovaries of some animals to become deformed. So by cutting open an injected animal and looking at her ovaries, scientists could tell if the woman supplying the urine was pregnant.

Which is preliminary test for rabbit test for pyrogen?

Preliminary test: Record the temperature of animals after IV injection at an interval of 30min and continued for 3 hrs after injection. Animals show temperature variance of 0.6°C should not be used for main test.

How do pyrogens work?

The pyrogens inhibit heat-sensing neurons and excite cold-sensing ones, and the altering of these temperature sensors deceives the hypothalamus into thinking the body is cooler than it actually is. In response, the hypothalamus raises the body’s temperature above the normal range, thereby causing a fever.

Who discovered pyrogen?

The rabbit pyrogen test was first described by Florence Seibert in 1925 [6].