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La sterilità di un prodotto non implica che sia privo di pirogeni. Pertanto, anche i farmaci dichiarati sterili devono essere testati per la presenza di pirogeni, al fine di prevenire reazioni febbrili nei pazienti.  La contaminazione da pirogeni può verificarsi durante la produzione o la somministrazione di prodotti farmaceutici, bioterapeutici e dispositivi medici, ma la presenza di pirogeni può anche essere una caratteristica intrinseca del prodotto, come ad esempio gli adiuvanti nei vaccini o i lipopeptidi sintetici. [Richiesta di informazioni](https://www.sigmaaldrich.com/IT/it/campaigns/pyrogen-testing) * * * ## Prodotti correlati Slide 1 of 7 1 of 2 [ \ Millipore \ PYR0MATKIT \ Kit PyroMAT®](https://www.sigmaaldrich.com/IT/it/product/mm/pyr0matkit) Visualizzazione rapida [ \ Millipore \ PYR0MATCELLS \ Cellule PyroMAT®](https://www.sigmaaldrich.com/IT/it/product/mm/pyr0matcells) Visualizzazione rapida [ \ Millipore \ MATHKSA \ HKSA - Controllo di pirogeni non endotossici (NEP) per test MAT con sistema PyroMAT®](https://www.sigmaaldrich.com/IT/it/product/mm/mathksa) Visualizzazione rapida [ \ Millipore \ MATFLAGELLIN \ Flagellina, controllo per NEP per test di attivazione dei monociti del sistema PyroMAT®](https://www.sigmaaldrich.com/IT/it/product/mm/matflagellin) Visualizzazione rapida [ \ Millipore \ 1.44161 \ Reference Standard Endotoxin](https://www.sigmaaldrich.com/IT/it/product/mm/144161) Visualizzazione rapida [ \ Millipore \ 1.44155 \ PyroDetect Cryoblood](https://www.sigmaaldrich.com/IT/it/product/mm/144155) Visualizzazione rapida [ \ Millipore \ 1.44154 \ PyroDetect Kit](https://www.sigmaaldrich.com/IT/it/product/mm/144154) Visualizzazione rapida * * * ## Categorie in evidenza [](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/pyrogen-testing) [Test dei pirogeni](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/pyrogen-testing) Assicurare la sicurezza: Test sui pirogeni dei prodotti farmaceutici con il Monocyte Activation Test (MAT) per rilevare endotossine e pirogeni non endotossinici. [Acquista i prodotti](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/pyrogen-testing) [](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) [Materiali di consumo, supporti e strumenti per test di sterilità](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) Strumenti di laboratorio e materiali di consumo per i test di sterilità nel controllo di qualità microbiologico: Supporti per test di sterilità, pompe, hardware e accessori. [Acquista i prodotti](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) [](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/microbial-filtration) [Filtrazione microbica](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/microbial-filtration) Accelerate il vostro time-to-result con test microbici rapidi utilizzando i nostri sistemi completi di filtrazione a membrana; utilizzati nei test di bioburden, nelle analisi di alimenti e bevande e nei test di microbiologia della cannabis. [Acquista i prodotti](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/microbial-filtration) Panoramica Articoli e protocolli correlati Supporto  ## [](https://www.sigmaaldrich.com)Che cos'è un pirogeno? Un pirogeno è una sostanza che provoca un aumento della temperatura (reazione febbrile) in un essere umano o in un animale attraverso l'attivazione del sistema immunitario innato. Costituiscono un gruppo eterogeneo di contaminanti che comprende sostanze microbiche e non microbiche. I pirogeni possono essere classificati in due gruppi: endotossine e pirogeni non endotossinici (NEP). Le endotossine sono sostanze presenti nei batteri Gram-negativi. I pirogeni non endotossinici sono altre sostanze microbiche, comprese quelle derivate da batteri Gram-positivi o virus e i pirogeni provenienti da lieviti e funghi. Le sostanze pirogene non microbiche possono anche provenire da particelle di gomma, particelle microscopiche di plastica o composti metallici negli elastomeri. Sono disponibili diversi metodi di analisi per la rilevazione dei pirogeni. Possono essere classificati in base al tipo di contaminante che rilevano e alla necessità di materiali animali per eseguire il test, come descritto nella tabella seguente: | | | | | | |----------------------------|--------------------------------------------|------------------------------------|---|-----------------------------------------| | | Rilevazione di una vasta gamma di pirogeni | Rilevamento delle sole endotossine | | | | Metodo basato sull'animale | Test dei pirogeni del coniglio (RPT) | | | Test delle endotossine batteriche (BET) | | *Metodo in vitro* | Test di attivazione dei monociti (MAT) | Fattore C ricombinante (rFC) | | | ## [](https://www.sigmaaldrich.com)Test di pirogeno del coniglio Il test di pirogeno del coniglio (RPT) consiste nel misurare l'aumento di temperatura dei conigli dopo l'iniezione endovenosa del prodotto testato. Il RPT fornisce risultati qualitativi e la sensibilità è piuttosto bassa. Anche la robustezza del test è limitata, a causa dello sviluppo della tolleranza ai pirogeni nei conigli dopo iniezioni ripetute, o dello stress dei conigli durante l'esecuzione del test. Nota: il Rabbit Pyrogen Testing (RPT) è ora vietato in Europa e il Monocyte Activation Test (MAT) è il metodo di scelta per rilevare i pirogeni endotossinici e non endotossinici. ## [](https://www.sigmaaldrich.com)Monocyte Activation Test Il [Test di attivazione dei monociti (MAT)](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/pyrogen-testing) è un'alternativa ai metodi basati sugli animali per la rilevazione di pirogeni endotossici e non endotossici. Il test di attivazione dei monociti imita la reazione immunitaria umana incubando i monociti con il campione analizzato. In presenza di pirogeni, i monociti si attivano e producono molecole infiammatorie, le citochine, responsabili della reazione febbrile. Le citochine vengono quindi rilevate con un test immunologico (ELISA) che prevede l'uso di anticorpi specifici e una reazione enzimatica a colori.  Nota: a partire dal luglio 2025, la Commissione della Farmacopea Europea (Ph. Eur.) raccomanda l'uso del test di attivazione dei monociti (MAT) come metodo preferenziale per il test dei pirogeni. Il Rabbit Pyrogen Test (RPT) è ora vietato in Europa. [Leggi l'articolo](https://www.edqm.eu/en/-/ph.-eur.-bids-adieu-to-rabbit-pyrogen-test-in-its-monographs) e [discutere ulteriormente con i nostri esperti](https://www.sigmaaldrich.com/IT/it/campaigns/pyrogen-testing) per passare al MAT che rileva pirogeni endotossinici e non endotossinici e per seguire la tendenza normativa. ## [](https://www.sigmaaldrich.com)Test di endotossina batterica (test LAL) Il metodo più comune per il test delle endotossine è il test del lisato di amebociti di Limulus (LAL test); un test basato sul lisato di amebociti del sangue di granchio di cavallo. Il lisato delle cellule ematiche del granchio di cavallo reagisce naturalmente con le endotossine batteriche in una reazione di coagulazione. Questo metodo ha un'elevata sensibilità per la quantificazione delle endotossine, ma non rileva i pirogeni non endotossinici. ## [](https://www.sigmaaldrich.com)Fattore C ricombinante (rFC) Il Fattore C ricombinante è una proteina geneticamente modificata che si trova normalmente nel lisato amebocitario di Limulus. In questo test, il Fattore C reagisce con l'endotossina e si accoppia con un marcatore per produrre un prodotto finale quantificabile e fluorescente. Il test del Fattore C ricombinante utilizza lo stesso principio del test LAL, ma senza la necessità di materiale di derivazione animale.  [Acquista tutti i prodotti](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) [Cercate informazioni più specifiche?](https://www.sigmaaldrich.com/documents-search) Visita la nostra ricerca di documenti per schede tecniche, certificati e documentazione tecnica. [Trova i documenti](https://www.sigmaaldrich.com/documents-search) * * * - [Cell Culture FAQs: Bacterial Endotoxin Contamination](https://www.sigmaaldrich.com/IT/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. - [Vedi tutti (1)](https://www.sigmaaldrich.com/IT/it/search/facet-search?focus=sitecontent&term=facet-search) ### Trova altri articoli e protocolli Inserire le parole chiave Ricerca * * * ## Relative Webinar [](https://www.sigmaaldrich.com/IT/it/collections/webinars/w924713416) [Test di attivazione dei monociti: Un potente strumento per valutare il rischio pirogeno nel processo farmaceutico](https://www.sigmaaldrich.com/IT/it/collections/webinars/w924713416) In questo webinar, discutiamo di come i test di attivazione dei monociti eseguiti con il sistema PyroMAT® rilevano i pirogeni endotossinici e non endotossinici. [](https://www.sigmaaldrich.com/IT/it/collections/webinars/w877364779) [*In Vitro* Pyrogen Detection in Pharma](https://www.sigmaaldrich.com/IT/it/collections/webinars/w877364779) Scopri come il nostro sistema PyroMAT® fornisce una soluzione robusta per il test in vitro dei pirogeni nel settore farmaceutico con un kit pronto all'uso. [](https://www.sigmaaldrich.com/IT/it/collections/webinars/w343863313) [Considerazioni sul rischio per la presenza di pirogeni e la necessità del test MAT nella lavorazione dei prodotti farmaceutici](https://www.sigmaaldrich.com/IT/it/collections/webinars/w343863313) In questa lezione imparerete come testare i pirogeni (compresi quelli non endotossinici) nei vostri campioni farmaceutici, quali sono i metodi esistenti per avere un processo controllato. ## Come possiamo aiutarvi In caso di domande, inviate una [richiesta di assistenza clienti](https://www.sigmaaldrich.com/IT/it/support/customer-support) o rivolgetevi al nostro servizio clienti: Email [custserv@sial.com](mailto:custserv@sial.com) o chiama +1 (800) 244-1173 ## Supporto aggiuntivo - [Chromatogram Search](https://www.sigmaaldrich.com/chromatogram-search) Use the Chromatogram Search to identify unknown compounds in your sample. - [Strumenti di calcolo e app](https://www.sigmaaldrich.com/IT/it/support/calculators-and-apps) Strumenti e risorse scientifiche online per la chimica analitica, le life science, la sintesi chimica e la scienza dei materiali. - [Customer Support Request](https://www.sigmaaldrich.com/IT/it/support/customer-support) Assistenza clienti inclusa assistenza per ordini, prodotti, account e problemi tecnici del sito web. - [FAQ](https://maestro.my.site.com/knowledgeportal/s/) Explore our Frequently Asked Questions for answers to commonly asked questions about our products and services. __Articoli in evidenza__ [Cell Culture FAQs: Bacterial Endotoxin Contamination](https://www.sigmaaldrich.com/IT/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/IT/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/IT/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/IT/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. Top __Autenticati per continuare__ Per continuare a leggere, autenticati o crea un account. 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