[Pular para o conteúdo](https://www.sigmaaldrich.com#main-content) [](https://www.sigmaaldrich.com/BR/pt) Produtos Carrinho0 BRPT Produtos [Login / Registrar-se](https://www.sigmaaldrich.com/oidc-sign-in) [Nº do Pedido](https://www.sigmaaldrich.com/BR/pt/order-lookup) [Pedido rápido](https://www.sigmaaldrich.com/BR/pt/quick-order) Carrinho0 [Página inicial](https://www.sigmaaldrich.com/BR/pt)[Aplicativos](https://www.sigmaaldrich.com/BR/pt/applications)[Testes microbiológicos](https://www.sigmaaldrich.com/BR/pt/applications/microbiological-testing)Pyrogen Testing # Pyrogen Testing  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). The sterility of a product does not imply that it is free of pyrogens. Therefore, drugs that are purported to be sterile must also be tested for pyrogens to prevent febrile reactions in patients.  Pyrogen contamination can occur during production or the administration of pharmaceuticals, biotherapeutics, and medical devices, but the presence of pyrogens can also be an inherent characteristic of the product, such as adjuvants in vaccines or synthetic lipopeptides. [Request Information](https://www.sigmaaldrich.com/BR/pt/campaigns/pyrogen-testing) * * * ## Related Products Slide 1 of 7 1 of 2 [ \ Millipore \ PYR0MATKIT \ Kit PyroMAT®](https://www.sigmaaldrich.com/BR/pt/product/mm/pyr0matkit) Visualização rápida [ \ Millipore \ PYR0MATCELLS \ Células PyroMAT®](https://www.sigmaaldrich.com/BR/pt/product/mm/pyr0matcells) Visualização rápida [ \ Millipore \ MATHKSA \ Sistema de controle NEP HKSA ® Sistema PyroMAT MAT](https://www.sigmaaldrich.com/BR/pt/product/mm/mathksa) Visualização rápida [ \ Millipore \ MATFLAGELLIN \ NEP Control Flagellin- PyroMAT® System MAT](https://www.sigmaaldrich.com/BR/pt/product/mm/matflagellin) Visualização rápida [ \ Millipore \ 1.44161 \ Reference Standard Endotoxin](https://www.sigmaaldrich.com/BR/pt/product/mm/144161) Visualização rápida [ \ Millipore \ 1.44155 \ PyroDetect Cryoblood](https://www.sigmaaldrich.com/BR/pt/product/mm/144155) Visualização rápida [ \ Millipore \ 1.44154 \ PyroDetect Kit](https://www.sigmaaldrich.com/BR/pt/product/mm/144154) Visualização rápida * * * ## Featured Categories [](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/pyrogen-testing) [Pyrogen Testing](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/pyrogen-testing) Ensure safety: Pyrogen testing is vital for pharmaceuticals, devices. Monocyte Activation Test (MAT) detects endotoxin, non-endotoxin pyrogens. [Shop Products](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/pyrogen-testing) [](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) [Sterility Testing Consumables, Media & Instruments](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) Laboratory instruments and consumables for sterility testing in microbiological quality control: Sterility test media, pumps, hardware and accessories. [Shop Products](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) [](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/microbial-filtration) [Microbial Filtration](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/microbial-filtration) Speed up your time-to-result with rapid microbial testing using our complete membrane filtration systems; used in bioburden testing, food and beverage analysis, and cannabis microbiology testing. [Shop Products](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/microbial-filtration) Overview Related Articles & Protocols Support  ## [](https://www.sigmaaldrich.com)BIOSAFETY TESTING SERVICES [Cell line characterization services](https://www.sigmaaldrich.com/BR/pt/US/en/services/testing/cell-viral-bank-testing/cell-line-characterization) to confirm cell line species origin and history, as well as characterize and test cell line identity, genetic stability, and purity (including Pyrogen testing). ## [](https://www.sigmaaldrich.com)What is a Pyrogen? A pyrogen is a substance that causes a rise in temperature (fever reaction) in a human or animal through the activation of the innate immune system. They constitute a heterogeneous group of contaminants comprising microbial and non-microbial substances. Pyrogens can be classified into two groups: endotoxins and non-endotoxin pyrogens (NEPs). Endotoxins are substances found in Gram-negative bacteria. Non-endotoxin pyrogens are other microbial substances, including those derived from Gram-positive bacteria or viruses and pyrogens originating from yeasts and fungi. Non-microbial pyrogenic substances can also originate from rubber particles, microscopic plastic particles, or metal compounds in elastomers. Several test methods are available for the detection of pyrogens. They can be classified based on the type of contaminant they detect, and the need for animal materials to perform the test as described in the below table: | | | | |---------------------|--------------------------------------|--------------------------------| | | Detection of Broad Range of Pyrogens | Detection of Endotoxins Only | | Animal-based method | Rabbit pyrogen test (RPT) | Bacterial endotoxin test (BET) | | *In vitro* method | Monocyte activation test (MAT) | Recombinant factor C (rFC) | ## [](https://www.sigmaaldrich.com)Rabbit Pyrogen Testing The rabbit pyrogen test (RPT) involves measuring the rise in temperature of rabbits following the intravenous injection of the tested product. The RPT gives qualitative results and the sensitivity is quite low. The robustness of the test is also limited, due to development of pyrogen tolerance in rabbits after repeated injections, or stress from the rabbits when performing the assay. ## [](https://www.sigmaaldrich.com)Monocyte Activation Test The [Monocyte Activation Test (MAT)](https://www.sigmaaldrich.com/BR/pt/products/industrial-microbiology/pyrogen-testing) is an alternative to animal-based methods for the detection of both endotoxin and non-endotoxin pyrogens. The monocyte activation test mimics the human immune reaction by incubating monocytes with the tested sample. If pyrogens are present, monocytes are activated and produce inflammatory molecules, cytokines, responsible for the febrile reaction. The cytokines are then detected using an immunological assay (ELISA) involving specific antibodies and an enzymatic color reaction.  __Please Note:__ The European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years.  [Read the article](https://www.edqm.eu/en/news/european-pharmacopoeia-put-end-rabbit-pyrogen-test) and [discuss further with our Experts](https://www.sigmaaldrich.com/BR/pt/campaigns/pyrogen-testing) to start the move.  ## [](https://www.sigmaaldrich.com)Bacterial Endotoxin Testing (LAL test) The most common method for endotoxin testing is the Limulus amoebocyte lysate test (LAL test); an assay based on the lysate of amoebocytes from the horseshoe crab blood. The lysate from horseshoe crab blood cells naturally reacts with bacterial endotoxins in a coagulation reaction. This method has a high sensitivity for the quantification of endotoxins, but it does not detect non-endotoxin pyrogens. ## [](https://www.sigmaaldrich.com)Recombinant Factor C (rFC) Testing The recombinant Factor C is a genetically engineered protein normally found in the Limulus amebocyte lysate cascade. In this test, Factor C reacts with endotoxin and couples with a marker to produce a quantifiable, fluorescent end product. The recombinant Factor C test uses the same principle as the LAL test, but without the need for animal-derived material.  [Shop All Products](https://www.sigmaaldrich.com/search/pyrogen-testing?focus=products&page=1&perpage=30&sort=relevance&term=Pyrogen%20Testing&type=product) [](https://www.sigmaaldrich.com/documents-search) [Looking for More Specific Information?](https://www.sigmaaldrich.com/documents-search) Visit our document search for data sheets, certificates and technical documentation. [Find Documents](https://www.sigmaaldrich.com/documents-search) * * * - [Cell Culture FAQs: Bacterial Endotoxin Contamination](https://www.sigmaaldrich.com/BR/en/technical-documents/technical-article/microbiological-testing/pyrogen-testing/what-is-endotoxin) FAQs on bacterial endotoxin contamination, details on endotoxin testing using the LAL assay, and tips to avoid contamination in cell cultures. - [See All (1)](https://www.sigmaaldrich.com/BR/pt/search/facet-search?focus=sitecontent&term=facet-search) ### Find More Articles and Protocols Enter Keywords Search * * * ## Related Webinars [](https://www.sigmaaldrich.com/BR/pt/collections/webinars/w924713416) [Monocyte Activation Test: A Powerful Tool to Assess Pyrogenic Risk in Pharmaceutical Process](https://www.sigmaaldrich.com/BR/pt/collections/webinars/w924713416) In this webinar, we discuss how monocyte activation tests performed with the PyroMAT® System detect endotoxin and non-endotoxin pyrogens. [](https://www.sigmaaldrich.com/BR/pt/collections/webinars/w877364779) [*In Vitro* Pyrogen Detection in Pharma](https://www.sigmaaldrich.com/BR/pt/collections/webinars/w877364779) Learn how our PyroMAT® System provides a robust solution for in vitro Pyrogen Test in pharma with a ready-to use kit. [](https://www.sigmaaldrich.com/BR/pt/collections/webinars/w343863313) [Risk Considerations for the Presence of Pyrogens and the Need for the MAT Test in Pharmaceutical Processing](https://www.sigmaaldrich.com/BR/pt/collections/webinars/w343863313) In this lecture, you will learn how to test for pyrogen (including non-endotoxin pyrogens) in your pharmaceutical samples, what are the existing methods in order to have a controlled process. ## How Can We Help In case of any questions, please submit a [customer support request](https://www.sigmaaldrich.com/BR/pt/support/customer-support) or talk to our customer service team: Email [custserv@sial.com](mailto:custserv@sial.com) or call +1 (800) 244-1173 ## Additional Support - [Chromatogram Search](https://www.sigmaaldrich.com/chromatogram-search) Use the Chromatogram Search to identify unknown compounds in your sample. - [Calculadoras e aplicativos](https://www.sigmaaldrich.com/BR/pt/support/calculators-and-apps) Conjunto de ferramentas na Web - ferramentas e recursos científicos de pesquisa para química analítica, ciências biológicas, síntese química e ciências de materiais. - [Customer Support Request](https://www.sigmaaldrich.com/BR/pt/support/customer-support) Selecione uma opção abaixo e preencha o formulário para contatar os nossos especialistas em assistência. - [FAQ](https://maestro.my.site.com/knowledgeportal/s/) Explore our Frequently Asked Questions for answers to commonly asked questions about our products and services. __Featured Articles__ [Cell Culture FAQs: Bacterial Endotoxin Contamination](https://www.sigmaaldrich.com/BR/en/technical-documents/technical-article/microbiological-testing/pyrogen-testing/what-is-endotoxin) FAQs on bacterial endotoxin contamination, details on endotoxin testing using the LAL assay, and tips to avoid contamination in cell cultures. [In Vitro Pyrogen Detection in Pharma](https://www.sigmaaldrich.com/BR/en/collections/webinars/in-vitro-pyrogen-detection-in-pharma) *In Vitro* Pyrogen Detection in Pharma [Monocyte Activation Test: A Powerful Tool to Assess Pyrogenic Risk in Pharmaceutical Process](https://www.sigmaaldrich.com/BR/en/collections/webinars/monocyte-activation-test) In this webinar, we discuss how monocyte activation tests performed with the PyroMAT™ System detect endotoxin and non-endotoxin pyrogens. [Risk Considerations for the Presence of Pyrogens and the Need for the MAT Test in Pharmaceutical Processing](https://www.sigmaaldrich.com/BR/en/collections/webinars/pyrogens-and-mat-tests) In this webinar, Tim Sandle will explain why the presence of pyrogens could be harmful for pharmaceutical processes, and how to control and limit their presence. Topo __Faça login para continuar__ Para continuar lendo, faça login ou crie uma conta. 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