Material-mediated pyrogenicity testing is applied to determine the presence or absence of pyrogens in parenteral pharmaceutical products. Various standards of organizations such as the US Food and Drug Administration (FDA), the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP) regulate this test method.
For example, the ISO 10993-11 standard published by the International Standards Organization (ISO) describes requirements for the procedures to be followed in assessing the potential of medical device materials to cause adverse systemic reactions (ISO 10993-11 Biological evaluation of medical devices - Part 11: Systemic toxicity tests). Systemic toxicity refers to toxicity that is not limited to adverse effects at the point of contact between the body and the device. Pyrogenicity is the state of rising body temperature. According to ISO, all medical devices must be tested for material-induced pyrogenicity.
The mentioned standard includes methods for evaluating the possible negative effects of medical devices on patient organs and tissues away from the contact area. For example, any chemical released from a device material relates to the effects on behavior, general health, and target organs such as the liver, heart, kidneys, and brain.
For some device types, actual material or product samples are usually obtained by implantation in test animals, but in most cases tests are performed using suitable liquid extracts.
Pyrogenicity is the ability of a chemical or other substance to produce an inflammatory response. The source of the pyrogenic response may be due to endotoxin contamination and should not be confused with the material-mediated pyrogenic response.
Material-mediated pyrogenicity occurs as a result of contamination by a group of pyrogens other than those containing endotoxins, but those that form non-endotoxin pyrogens. More specifically, material-induced pyrogenicity is thought to arise from the surfaces or materials of medical devices, as well as from contaminations during manufacture or packaging. Material-mediated pyrogenicity is understood to result from contaminants from mold release agents, machining aids, cutting fluids or cleaning agents, among others.
Briefly, pyrogen is the substance that causes fever, and pyrogenicity is the ability of a chemical agent or other substance to produce a febrile response.
Our organization also provides material-mediated pyrogenicity testing services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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