In Parenteral Pharmaceutical Products, Pyrogen Testing Is Conducted To Determine Whether They Are Pyrogenic or Not

 

Pyrogen Testing

Pyrogen Testing is important in advanced healthcare because it identifies the presence of pyrogen in an organism that causes fever. Lipopolysaccharides and lepoteichoic acid contain pyrogen. Contaminated pyrogenic products can harm the human body by causing fever. Pyrogen testing is used to detect the presence of pyrogens in pharmaceutical dosage forms and medical devices. Pyrogen-contaminated injections can cause temperature dysregulation (fever), body aches, inflammation, shock, multiorgan failure, and other life-threatening complications after administration.

A pyrogen is a substance that causes a temperature rise (fever reaction) in humans or animals by activating the innate immune system. They are a diverse group of contaminants that include both microbial and non-microbial substances. Pyrogens are divided into two types: endotoxins and non-endotoxin pyrogens (NEPs). Endotoxins are Gram-negative bacteria-derived substances. Non-endotoxin pyrogens are microbial substances derived from Gram-positive bacteria or viruses, as well as pyrogens derived from yeasts and fungi. Non-microbial pyrogenic substances can also be produced by rubber particles, microscopic plastic particles, or metal compounds found in elastomers.

According to Coherent Market Insights, The global Pyrogen Testing Market is estimated to be valued at US$ 979.7 million in 2020 and is expected to exhibit a CAGR of 12.4% over the forecast period (2020-2027).

Pyrogen testing determines the presence or absence of pyrogens in parenteral pharmaceutical products and is governed by a number of standards established by organisations such as the Food and Drug Administration (FDA), the United States Pharmacopeia (USP), and the European Pharmacopeia (EP) (EP). A product's sterility does not imply that it is free of pyrogens. To prevent febrile reactions in patients, drugs that are claimed to be sterile must also be tested for pyrogens. Pyrogen contamination can occur during the manufacturing or administration of pharmaceuticals, biotherapeutics, and medical devices, but pyrogens can also be an inherent feature of the product, such as adjuvants in vaccines or synthetic lipopeptides.

Pyrogens are a chemically diverse group of compounds (derived from bacteria, viruses, fungi, or the host itself) that cause a rise in temperature (febrile response) in humans or animals. Pyrogens are classified into two types: exogenous pyrogens and endogenous pyrogens.