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Although international pharmacopeias recommend using standard membrane filtration for sterility testing, certain products are not filterable or deformable. These products are normally tested using direct inoculation – using a range of sterility testing media including soybean casein digest medium (TSB), and Fluid Thioglycollate medium (FTM standard and clear). In this method, the test sample is directly inoculated into the required media, ensuring that the amount of sample is below 10% of the total media volume. - [Advantages of Direct Inoculation](https://www.sigmaaldrich.com#direct-inoculation) - [Culture Media for Direct Inoculation](https://www.sigmaaldrich.com#culture-media) - [Soybean-Casein Digest Medium (Trypticase Soy Broth, TSB)](https://www.sigmaaldrich.com#digest-medium) - [Fluid Thioglycollate Medium (FTM)](https://www.sigmaaldrich.com#fluid-medium) - [Clear Thioglycollate Medium](https://www.sigmaaldrich.com#clear-medium) - [Complete sterility testing solutions for complete confidence](https://www.sigmaaldrich.com#complete-testing) * * * ## ADVANTAGES OF DIRECT INOCULATION[](https://www.sigmaaldrich.com) In the direct inoculation (immersion) method, the test articles are inoculated directly into tubes or bottles containing an appropriate medium and incubated for 14 days. To comply with the different direct inoculation methods for sterility testing requirements, we offer a wide range of customized sterility testing media in various volumes sizes and bottles (from 9 mL tubes up to 750 mL) to fit your applications. The direct inoculation method: - Provides a mode for sterility testing of materials that cannot be easily filtered. - Consumes less product volume during the conduct of the bacteriostasis and fungistasis (B&F) testing. ## CULTURE MEDIA FOR DIRECT INOCULATION[](https://www.sigmaaldrich.com) In the direct inoculation method, the sample is directly inoculated into two types of media. One medium allows the growth of anaerobes, while the other medium supports the growth of aerobes. Fluid thioglycollate medium (FTM) is the commonly used medium for anaerobes, while tryptic soy broth (also called soybean casein digest medium) is more suitable for aerobes. The aerobic and anaerobic microorganisms are detected separately in the respective media at the end of the incubation period. ### Soybean-Casein Digest Medium (Trypticase Soy Broth, TSB)[](https://www.sigmaaldrich.com) Soybean-Casein Digest medium is suitable for culturing fungi and aerobic bacteria. This medium is used for sterility testing by direct inoculation. It is also used as a pre-enrichment broth for nonsterile products. Desculpe, ocorreu um erro inesperado Response not successful: Received status code 500 * * * ### Fluid Thioglycollate Medium (FTM)[](https://www.sigmaaldrich.com) Fluid Thioglycollate medium is suitable for the detection of anaerobic and aerobic bacteria. This medium is used for sterility testing by direct inoculation as described in the USP, EP, and JP. Desculpe, ocorreu um erro inesperado Response not successful: Received status code 500 * * * ### Clear Thioglycollate Medium[](https://www.sigmaaldrich.com) Clear Thioglycollate medium has the same growth promotion properties as the standard FTM and is compliant with the USP, EP, and JP. This alternative formulation brings extra visual clarity versus the FTM, which has slight turbidity or haze due to the presence of agar. Desculpe, ocorreu um erro inesperado Response not successful: Received status code 500       [Request More Information](https://www.sigmaaldrich.com/BR/en/campaigns/sterility-testing-consumables) * * * ## Complete Sterility Testing Solutions for Complete Confidence[](https://www.sigmaaldrich.com) Discover our full sterility testing portfolio based on over 45 years of experience and expertise. Our large variety of devices and pumps, along with sterile culture media and rinsing fluids can help you to stay compliant, whether you use membrane filtration or direct inoculation methods. Reduce the sterility testing workload and focus on your critical lab activities thanks to our extended Steritest® services portfolio. The experienced application and validation engineers will assist in method development and validation implementation within the QC microbiology laboratory. They will also provide basic and advanced technical training on sterility testing, in person or remotely. [](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/191/851/steritest-system-brochure-br1495en-ms.pdf) [Brochure: Sterility Testing Complete Portfolio](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/191/851/steritest-system-brochure-br1495en-ms.pdf)   [](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/133/839/complete-solutions-steritest-system-poster-ps2737en-ms.pdf) [Poster: Complete Solutions for Complete Confidence with the Steritest® System](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/133/839/complete-solutions-steritest-system-poster-ps2737en-ms.pdf)   [](https://www.sigmaaldrich.com/BR/en/services/product-services/validation-services/pharma-microbiology-method-development-validation) [Pharma Microbiology Method Development & Validation](https://www.sigmaaldrich.com/BR/en/services/product-services/validation-services/pharma-microbiology-method-development-validation)   [Request Information](https://www.sigmaaldrich.com/BR/en/campaigns/sterility-testing-consumables) __Related Articles__ - [Sterility Testing Culture Media & Rinsing Fluids](https://www.sigmaaldrich.com/BR/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-membrane-culture-media-rinsing-fluids) - [Steritest® NEO Membrane Filtration Sterility Test](https://www.sigmaaldrich.com/BR/en/technical-documents/technical-article/microbiological-testing/sterility-testing/steritest-neo-sterility-test) - [Steritest® Symbio Sterility Testing Pump Guide](https://www.sigmaaldrich.com/BR/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-hardware-accessories) - [Early Microbial Detection with Milliflex® Rapid System 2.0](https://www.sigmaaldrich.com/BR/en/technical-documents/technical-article/microbiological-testing/sterility-testing/early-microbial-detection-enumeration-milliflex) - [Screen Cell-Based Immunotherapeutics for Microbial Contaminants Using the Milliflex® Rapid System](https://www.sigmaaldrich.com/BR/en/technical-documents/technical-article/microbiological-testing/sterility-testing/screen-cell-based-immunotherapeutics-for-microbial-contaminants) - [Sterility Testing of Products in Isopropyl Myristate](https://www.sigmaaldrich.com/BR/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-increased-chemical-compatibility) - [Sterility Testing of Products with Antimicrobial Properties](https://www.sigmaaldrich.com/BR/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-with-antimicrobial) __Related Product Categories__ - [Sterility Testing Consumables, Media & Instruments](https://www.sigmaaldrich.com/BR/en/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) - [Pyrogen Testing](https://www.sigmaaldrich.com/BR/en/products/industrial-microbiology/pyrogen-testing) Topo __Faça login para continuar__ Para continuar lendo, faça login ou crie uma conta. 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[Filtros de vírus](https://www.sigmaaldrich.com/BR/pt/products/pharma-and-biopharma-manufacturing/viral-clearance/virus-filters) - [Inativação de vírus](https://www.sigmaaldrich.com/BR/pt/products/pharma-and-biopharma-manufacturing/viral-clearance/virus-inactivation) - [Biologia de proteínas](https://www.sigmaaldrich.com/BR/pt/products/protein-biology) - [Anticorpos](https://www.sigmaaldrich.com/BR/pt/products/protein-biology/antibodies) - [Anticorpos de validação aprimorados](https://www.sigmaaldrich.com/BR/pt/products/protein-biology/antibodies/enhanced-validation-ab) - [Anticorpos para citometria de fluxo](https://www.sigmaaldrich.com/BR/pt/products/protein-biology/antibodies/flow-cytometry-antibodies) - [Anticorpos Prestige^®](https://www.sigmaaldrich.com/BR/pt/products/protein-biology/antibodies/prestige-antibodies) - [Anticorpos primários](https://www.sigmaaldrich.com/BR/pt/products/protein-biology/antibodies/primary-antibodies) - [Anticorpos secundários](https://www.sigmaaldrich.com/BR/pt/products/protein-biology/antibodies/secondary-antibodies) - 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[Terpenos](https://www.sigmaaldrich.com/BR/pt/applications/environmental-testing-and-industrial-hygiene/cannabis-testing/terpenes-cannabis) - [Teste de água potável](https://www.sigmaaldrich.com/BR/pt/applications/environmental-testing-and-industrial-hygiene/drinking-water-testing) - [Testes de solo, resíduos sólidos e águas subterrâneas](https://www.sigmaaldrich.com/BR/pt/applications/environmental-testing-and-industrial-hygiene/soil-solid-waste-groundwater-testing) - [Teste de água residual e de água de processo](https://www.sigmaaldrich.com/BR/pt/applications/environmental-testing-and-industrial-hygiene/waste-water-and-process-water-testing) - [Testes e fabricação de alimentos e bebidas](https://www.sigmaaldrich.com/BR/pt/applications/food-and-beverage-testing-and-manufacturing) - [Análise química](https://www.sigmaaldrich.com/BR/pt/applications/food-and-beverage-testing-and-manufacturing/chemical-analysis-for-food-and-beverage) - [Formulação de aromas e fragrâncias](https://www.sigmaaldrich.com/BR/pt/applications/food-and-beverage-testing-and-manufacturing/flavor-and-fragrance-formulation) - [Análise microbiológica](https://www.sigmaaldrich.com/BR/pt/applications/food-and-beverage-testing-and-manufacturing/microbiological-analysis-for-food-and-beverage) - [Conformidade regulatória](https://www.sigmaaldrich.com/BR/pt/applications/food-and-beverage-testing-and-manufacturing/regulatory-compliance-for-food-and-beverage) - [Genômica](https://www.sigmaaldrich.com/BR/pt/applications/genomics) - [Edição avançada de genes](https://www.sigmaaldrich.com/BR/pt/applications/genomics/advanced-gene-editing) - [Clonagem e expressão](https://www.sigmaaldrich.com/BR/pt/applications/genomics/cloning-and-expression) - [Purificação de DNA e RNA](https://www.sigmaaldrich.com/BR/pt/applications/genomics/dna-and-rna-purification) - [Epigenética](https://www.sigmaaldrich.com/BR/pt/applications/genomics/epigenetics) - [Triagem de genômica funcional](https://www.sigmaaldrich.com/BR/pt/applications/genomics/functional-genomics-screening) - [Expressão e silenciamento de genes](https://www.sigmaaldrich.com/BR/pt/applications/genomics/gene-expression-and-silencing) - 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[Fase III e fabricação](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/biotech-resource-hub/phase-iii-and-manufacturing) - [Regulamentação](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/biotech-resource-hub/regulatory) - [Programas de inicialização](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/biotech-resource-hub/startup-programs) - [Fracionamento de plasma sanguíneo](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/plasma-manufacturing) - [Fabricação de terapia celular](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/cell-therapy-manufacturing) - [Fabricação de produtos farmacêuticos clássicos](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/classical-pharma-manufacturing) - [Estratégias de preenchimento final](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/classical-pharma-manufacturing/final-fill-strategies) - [Estratégias de formulação de líquidos](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/classical-pharma-manufacturing/liquid-formulation-strategies) - [Estratégias de formulação de sólidos](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/classical-pharma-manufacturing/solid-formulation-strategies) - [Estratégias de filtragem estéril](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/classical-pharma-manufacturing/sterile-filtration-strategies) - [Fabricação de terapia gênica](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing) - [Processamento upstream de vetores virais](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-upstream-processing) - [Processamento downstream de vetores virais](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-downstream-processing) - [Formulação do vetor viral e preenchimento final](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-formulation-and-final-fill) - [Caracterização de vetores virais e testes de biossegurança](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-characterization-and-biosafety-testing) - [Desenvolvimento e fabricação de contratos de vetores virais](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/gene-therapy-manufacturing/viral-vector-contract-development-and-manufacturing) - [Análise farmacêutica e controle de qualidade](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/pharmaceutical-analysis-quality-control) - [Caracterização de produtos biológicos e biossimilares](https://www.sigmaaldrich.com/BR/pt/applications/pharmaceutical-and-biopharmaceutical-manufacturing/pharmaceutical-analysis-quality-control/biologics-biosimilars-characterization) - 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[Expressão de proteínas](https://www.sigmaaldrich.com/BR/pt/applications/protein-biology/protein-expression) - [Marcação e modificação de proteínas](https://www.sigmaaldrich.com/BR/pt/applications/protein-biology/protein-labeling-and-modification) - [Pulldown de proteína](https://www.sigmaaldrich.com/BR/pt/applications/protein-biology/protein-pulldown) - [Purificação de proteínas](https://www.sigmaaldrich.com/BR/pt/applications/protein-biology/protein-purification) - [Quantificação de proteínas](https://www.sigmaaldrich.com/BR/pt/applications/protein-biology/protein-quantitation) - [Análise estrutural de proteínas](https://www.sigmaaldrich.com/BR/pt/applications/protein-biology/protein-structural-analysis) - [Western Blotting](https://www.sigmaaldrich.com/BR/pt/applications/protein-biology/western-blotting) - [Espectrometria de massa de proteínas](https://www.sigmaaldrich.com/BR/pt/applications/protein-biology/protein-mass-spectrometry) - [Áreas de pesquisa e doenças](https://www.sigmaaldrich.com/BR/pt/applications/research-disease-areas) - 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