What is pyrogen PPT?
PYROGENS DEFINITION: Pyrogens are fever producing substances, which are metabolic products of microorganisms. Chemically, they are lipid substances associated with a carrier molecule, which is usually a polysaccharide. The carrier may also be a peptide. These carriers increase the solubility of the lipid.
What are the types of pyrogens?
There are two types of natural pyrogens: (1) endogenous pyrogens that the host’s pyrogen cytokines and (2) exogenous pyrogens that are microbial substance (e.g. lipopolysaccharides in the cell wall of certain bacteria).
What are the characteristics of pyrogens?
Bacterial endotoxins (pyrogens) are polysaccharides from bacterial membranes. They are water soluble, heat stable, and filterable. If they are present in a preparation and administered to a patient they can cause fever and also leukopenia in immunosuppressed patients.
What are the sources of pyrogen?
There can be several sources of pyrogens in parenteral and medical device products. Usual sources are: the water used as the solvent or in the processing; packaging components; the chemicals, raw materials or equipment used in the preparation of the product.
Why do we do 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 pyrogens chemical nature?
Pyrogens are bacterial cell wall fragments. They are not bacteria. Typically, they are complex carbohydrates. Being chemically stable, pyrogens are not necessarily destroyed by conditions that kill bacteria.
How are pyrogens produced?
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.
What are pyrogens PDF?
Background: Pyrogens are fever causing microbial and non-microbial constituents of variable chemical composition. Their presence in dialysis fluids, parenteral drugs, biopharmaceuticals, cosmetics and on solid medical devices is considered a major health concern worldwide.
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. Fever is a highly significant indicator of disease.
What are pyrogens explain pyrogen testing in detail?
How do you test for pyrogen?
Monocyte Activation Test (MAT) The Rabbit Pyrogen Test and the Limulus Amebocyte Lysate (LAL) test are broadly used for pyrogen detection. Both methods use animals and show some limitations. The rabbit pyrogen test shows a lack of robustness as an animal reaction can differ greatly from a human reaction.
How do you detect pyrogens?
Currently, the only available replacement for the RPT and for the assessment of non-endotoxin pyrogens is the Monocyte Activation Test (MAT). This in vitro test method can detect all pyrogens that activate the Toll-Like Receptor (TLRs) pathway, including endotoxins and non-endotoxin pyrogens (NEPs).
Which is the best Test to test for pyrogens?
2. Pyrogen Testing Rabbit test (sham test) LAL Test (Bacterial Endotoxin Test)Depyrogenation Techniques Physically removal of Pyrogens Inactivation of PyrogensComparison of Pyrogen Test of IP, BP, USP. 3. A. Rabbit test (sham test)B. LAL Test (Bacterial Endotoxin Test)
Which is an example of an exogenous pyrogen?
• Exogenous pyrogen is a fever-producing agents of external origin, e.g., bacterial endotoxins and other microbial products, antigen-antibody complexes, viruses and synthetic polynucleotides, incompatible blood and blood products, and androgen breakdown products such as etiocholanolone. 4.
What are the sources of pyrogen in parenteral products?
Source of pyrogen The sources of pyrogens in parenteral products include; • water used at the end stages of the purification. • crystallization of the drug or excipients : water used during processing. • packaging components; chemicals, raw materials or equipment used in the preparation of the product.
How does the LAL test for pyrogens work?
Test for pyrogens Rabbit test LAL Test In Vitro Pyrogen Test (IPT) Leucocyte count By measuring Electrical resistance Pyrogen testing defines a process used by drug manufacturers to determine if bacterial toxins are present in vaccines and drugs that might cause fever when used on humans. 12.