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I metodi di analisi della sterilità devono essere il più accurati possibile, data la loro importanza per i dispositivi medici, i prodotti farmaceutici e le formulazioni, i materiali tissutali e altri prodotti che dichiarano di essere sterili o privi di microrganismi vitali.  * * * ## Prodotti correlati Slide 1 of 16 1 of 4 [ \ Millipore \ TZHALA210 \ Dispositivo Steritest® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzhala210) Visualizzazione rapida [ \ Millipore \ STBMTSB12 \ Brodo al digerito di soia e caseina](https://www.sigmaaldrich.com/IT/it/product/mm/stbmtsb12) Visualizzazione rapida [ \ Millipore \ SYMBLFH01 \ Pompa Steritest® Symbio LFH](https://www.sigmaaldrich.com/IT/it/product/mm/symblfh01) Visualizzazione rapida [ \ Millipore \ SYMBABR01 \ Rompifiale di vetro Steritest®](https://www.sigmaaldrich.com/IT/it/product/mm/symbabr01) Visualizzazione rapida [ \ Millipore \ STBMFTM12 \ Tioglicolato fluido in bottiglia con tappo a vite e setto perforabile.](https://www.sigmaaldrich.com/IT/it/product/mm/stbmftm12) Visualizzazione rapida [ \ Millipore \ STBMRFK34 \ Fluido K](https://www.sigmaaldrich.com/IT/it/product/mm/stbmrfk34) Visualizzazione rapida [ \ Millipore \ TZHALV205 \ Dispositivo Steritest® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzhalv205) Visualizzazione rapida [ \ Millipore \ TZHASY210 \ Unità Steritest® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzhasy210) Visualizzazione rapida [ \ Millipore \ TZHASV210 \ Dispositivo Steritest® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzhasv210) Visualizzazione rapida [ \ Millipore \ TZHAPC210 \ Dispositivo Steritest® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzhapc210) Visualizzazione rapida [ \ TZHACA210 \ Steritest® NEO Device](https://www.sigmaaldrich.com/IT/it/product/mm/tzhaca210) Visualizzazione rapida [ \ Millipore \ TZHVAB210 \ Dispositivo Steritest® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzhvab210) Visualizzazione rapida [ \ Millipore \ TZHVMD210 \ Dispositivo Steritest® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzhvmd210) Visualizzazione rapida [ \ Millipore \ TZHVDV210 \ Dispositivo Steritest® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzhvdv210) Visualizzazione rapida [ \ Millipore \ TZHVSL210 \ Dispositivo Steritest® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzhvsl210) Visualizzazione rapida [ \ Millipore \ TZVC00010 \ Dispositivo Steridilutor® NEO](https://www.sigmaaldrich.com/IT/it/product/mm/tzvc00010) Visualizzazione rapida * * * ## Categorie in primo piano [](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) [Materiali di consumo, terreni di coltura e strumenti per i test di sterilità](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) Strumenti da laboratorio e materiali di consumo per i test di sterilità nel controllo di qualità microbiologico: terreni di coltura per test di sterilità, pompe, componenti e accessori. 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[Acquista i prodotti](https://www.sigmaaldrich.com/IT/it/products/industrial-microbiology/microbial-filtration) * * * Panoramica Articoli e protocolli correlati Assistenza Le procedure di verifica della sterilità vengono applicate ai prodotti in molti settori industriali, tra cui quello alimentare e delle bevande, ma i settori principali sono quello farmaceutico e quello medico, dove la verifica della sterilità dei prodotti rimane un compito fondamentale e di routine per i microbiologi. - [Metodi di verifica della sterilità nel settore farmaceutico](https://www.sigmaaldrich.com#pharmaceutical) - [Metodi di verifica della sterilità per dispositivi medici](https://www.sigmaaldrich.com#medical-devices) - [Flusso di lavoro dei test di sterilità](https://www.sigmaaldrich.com#workflow) ## [](https://www.sigmaaldrich.com)Metodi di verifica della sterilità farmaceutica I metodi farmacopeici per il test di sterilità dei prodotti farmaceutici richiedono che i campioni vengano coltivati in due terreni di coltura separati. Nei test di sterilità vengono utilizzati due diversi tipi di terreni di coltura per favorire la crescita di anaerobi residui, oltre che di aerobi e funghi. Il terreno fluido tioglicolato (FTM) viene solitamente utilizzato per la coltura di batteri anaerobici e di alcuni batteri aerobici, mentre il terreno di digestato di caseina e soia (SCDM) viene solitamente utilizzato per la coltura di funghi e batteri aerobici. I campioni vengono incubati per 14 giorni rispettivamente a 32,5 °C e 22,5 °C, prima dell'esame. Qualsiasi torbidità nei terreni di coltura può indicare una crescita e deve essere indagata. Esistono due metodi raccomandati per i test di sterilità dei prodotti farmaceutici: la filtrazione su membrana e l'inoculazione diretta. ### Test di sterilità mediante filtrazione a membrana Il test di sterilità mediante filtrazione su membrana è il metodo normativo di scelta per i prodotti farmaceutici filtrabili, come citato nell'USP <71>, nella Farmacopea UE < 2.6.1> e nella Farmacopea JP <4.06>. I campioni vengono fatti passare attraverso un filtro a membrana da 0,45 µm in un contenitore di filtrazione e viene aggiunto un terreno di coltura per l'incubazione. Questo metodo di test di sterilità può fornire una maggiore sensibilità rispetto ad altri metodi, poiché l'intero campione, o un campione composito, viene fatto passare attraverso un unico filtro. La filtrazione offre inoltre l'opportunità di eliminare i componenti del campione che potrebbero causare torbidità o inibire la crescita, come antibiotici o conservanti. ### Test di sterilità mediante inoculazione diretta Nell'inoculazione diretta, un piccolo volume di campione viene prelevato in modo asettico dall'unità campione e inoculato direttamente in un volume adeguato di terreno di coltura prima dell'incubazione. Sebbene semplice, questo metodo di analisi può presentare alcune limitazioni significative. È possibile inoculare nel terreno di coltura solo piccoli volumi di prodotto, limitando la sensibilità del test. Se il campione appare torbido o opaco dopo l'inoculazione, può essere difficile distinguere la torbidità dalla crescita microbica al termine del periodo di incubazione. Inoltre, se il prodotto ha proprietà antimicrobiche, il campione deve essere neutralizzato in modo da non inibire la crescita microbica. ## [](https://www.sigmaaldrich.com)Metodi di test di sterilità per dispositivi medici Per i test di sterilità dei dispositivi medici si raccomanda il test di sterilità a trasferimento diretto. Il dispositivo da testare è a contatto diretto con il mezzo di prova per tutto il periodo di incubazione, durante il quale qualsiasi microrganismo presente all'interno o sulla superficie del dispositivo crescerà e prolifererà. Inoltre, il test di sterilità con lavaggio del prodotto è preferibile per i prodotti con tubi cavi, come i sistemi di trasfusione e infusione, in cui il percorso del fluido è etichettato come sterile. Il lume del prodotto viene lavato con un fluido di risciacquo, l'eluato viene filtrato su membrana e posto in un mezzo adatto all'incubazione. ## [](https://www.sigmaaldrich.com)Flusso di lavoro del test di sterilità 1\. Preparazione del test: inserire il tubo del dispositivo di filtrazione a membrana nella pompa 2\. Pre-bagnatura del filtro: pre-bagnare il dispositivo di filtrazione a membrana per ottimizzare la filtrazione e ridurre al minimo l'adesione del prodotto al filtro. 3\. Filtrazione del campione: filtrare una quantità uguale di prodotto in entrambi i contenitori. I microrganismi vengono trattenuti da un filtro con pori di 0,45 µm. 4\. Risciacquo: tutti i composti inibitori vengono risciacquati utilizzando una o più soluzioni di risciacquo adeguate. 5\. Riempimento dei terreni di coltura: i dispositivi di filtrazione a membrana vengono riempiti con terreni di coltura sterili TSB e FTM. 6\. Tempo di incubazione: 14 giorni. 7\. Risultati finali del test: controllo visivo della torbidità/assenza di torbidità. [](https://www.sigmaaldrich.com/documents-search) [Cerchi informazioni più specifiche?](https://www.sigmaaldrich.com/documents-search) Visita la nostra sezione di ricerca documenti per schede tecniche, certificati e documentazione tecnica. [Trova documenti](https://www.sigmaaldrich.com/documents-search) ## Articoli correlati - [Steritest® Symbio Sterility Testing Pump Guide](https://www.sigmaaldrich.com/IT/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-hardware-accessories) The user-friendly Steritest® Symbio pumps and accessories are designed for easy and reliable sterility testing. The system improves your workflow and maximizes safety, confidence, and convenience. - [Steritest® NEO Membrane Filtration Sterility Test](https://www.sigmaaldrich.com/IT/en/technical-documents/technical-article/microbiological-testing/sterility-testing/steritest-neo-sterility-test) Sterility testing is one of the most crucial steps in pharmaceutical product release. Regulatory-compliant membrane filtration sterility testing devices ensure the safety of pharmaceutical products. - [Sterility Testing Culture Media & Rinsing Fluids](https://www.sigmaaldrich.com/IT/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-membrane-culture-media-rinsing-fluids) Our sterility testing media and fluids are formulated and tested to meet EU, US, and JP pharmacopeia regulations, and are supplied with full certification containing pH, sterility, and growth promotion information. - [Sterility Testing by Direct Inoculation](https://www.sigmaaldrich.com/IT/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-direct-inoculation) Direct inoculation of culture media is the method of choice for sterility testing of non-filterable samples. Select from our range of sterility testing media including soybean casein digest medium (TSB), and Fluid Thioglycollate medium (FTM standard and clear). - [Sterility Testing of Products in Isopropyl Myristate](https://www.sigmaaldrich.com/IT/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-increased-chemical-compatibility) Irradiated Isopropyl Myristate (IPM) enhances filterability for sterility testing of viscous products using the Steritest® NEO device. - [Vedi tutto (9)](https://www.sigmaaldrich.com/IT/it/search/facet-search?focus=sitecontent&term=facet-search) ## Protocolli correlati - [Testing Cells for Bacterial and Fungal Contamination](https://www.sigmaaldrich.com/IT/en/technical-documents/protocol/cell-culture-and-cell-culture-analysis/mammalian-cell-culture/testing-for-bacteria) Cell culture protocol for testing cell lines for bacterial and fungal contamination. Free ECACC handbook download. ### Scopri altri articoli e protocolli Inserisci le parole chiave Cerca ## Come possiamo aiutarti In caso di domande, invia una [richiesta di](https://www.sigmaaldrich.com/IT/it/support/customer-support) [assistenza clienti](https://www.sigmaaldrich.com/IT/it/support/customer-support) oppure contatta il nostro team di assistenza clienti: Invia un'e-mail [a](mailto:[email protected]) [[email protected]](mailto:[email protected]) oppure chiama il numero +1 (800) 244-1173 ## Assistenza aggiuntiva - [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. * * * [ \ Preparati all'imprevisto. \ Durante il periodo di incubazione, potrebbe essere necessario accedere al contenitore per effettuare una subcoltura, una reincubazione, identificare microrganismi in terreni torbidi o iniettare un liquido. Scopri le nostre 2 soluzioni sicure per il prelievo di campioni a scopo di test di sterilità: la guida per ago Steritest® e la valvola senza ago Steritest®. \ Richiedi un campione gratuito](https://www.sigmaaldrich.com/IT/it/campaigns/lead-generation/steritest-sampling-solutions-free-sample) * * * __Articoli in primo piano__ [Steritest® Symbio Sterility Testing Pump Guide](https://www.sigmaaldrich.com/IT/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-hardware-accessories) The user-friendly Steritest® Symbio pumps and accessories are designed for easy and reliable sterility testing. The system improves your workflow and maximizes safety, confidence, and convenience. [Steritest® NEO Membrane Filtration Sterility Test](https://www.sigmaaldrich.com/IT/en/technical-documents/technical-article/microbiological-testing/sterility-testing/steritest-neo-sterility-test) Sterility testing is one of the most crucial steps in pharmaceutical product release. Regulatory-compliant membrane filtration sterility testing devices ensure the safety of pharmaceutical products. [Sterility Testing Culture Media & Rinsing Fluids](https://www.sigmaaldrich.com/IT/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-membrane-culture-media-rinsing-fluids) Our sterility testing media and fluids are formulated and tested to meet EU, US, and JP pharmacopeia regulations, and are supplied with full certification containing pH, sterility, and growth promotion information. [Sterility Testing by Direct Inoculation](https://www.sigmaaldrich.com/IT/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-direct-inoculation) Direct inoculation of culture media is the method of choice for sterility testing of non-filterable samples. Select from our range of sterility testing media including soybean casein digest medium (TSB), and Fluid Thioglycollate medium (FTM standard and clear). Top __Autenticati per continuare__ Per continuare a leggere, autenticati o crea un account. Autenticati__Non hai un Account?__Registrazione Per comodità dei nostri clienti, questa pagina è stata tradotta da un sistema di traduzione automatica. Abbiamo fatto il possibile per fornire una traduzione automatica accurata, ma non possiamo garantire che essa sia perfetta. Se il contenuto della traduzione automatica non vi soddisfa, consultate la versione inglese. 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