[跳轉至內容](https://www.sigmaaldrich.com#main-content) [![Merck](https://www.sigmaaldrich.com/static/logos/purple/merck.svg)](https://www.sigmaaldrich.com/TW/zh) 產品 購物車0 TWZH 產品 產品應用服務資源支援 [登入 / 註冊](https://www.sigmaaldrich.com/oidc-sign-in) [訂單查詢](https://www.sigmaaldrich.com/TW/zh/order-lookup) [快速下訂](https://www.sigmaaldrich.com/TW/zh/quick-order) 購物車0 [Home](https://www.sigmaaldrich.com/TW/en)[Sterility Testing](https://www.sigmaaldrich.com/TW/en/applications/microbiological-testing/sterility-testing)Sterility Testing by Direct Inoculation # Sterility Testing by Direct Inoculation ## Sterility Testing by Direct Inoculation for Non-Filterable Samples ![Direct inoculation is a sterility testing procedure to assess the safety of pharmaceutical products.](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/technical-documents/articles/microbiological-testing/sterility-testing/direct-inoculation-products.jpg "Direct inoculation sterility testing media") Reliable sterility testing and the development or validation of product-specific methods are critical steps in the drug development process. 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) [Request Information](https://www.sigmaaldrich.com/TW/en/campaigns/sterility-testing-consumables) * * * ## 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. 抱歉，發生意外錯誤。 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. 抱歉，發生意外錯誤。 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. 抱歉，發生意外錯誤。 Response not successful: Received status code 500       [Request More Information](https://www.sigmaaldrich.com/TW/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. [![Brochure: Sterility Testing Complete Portfolio](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/technical-documents/articles/microbiological-testing/sterility-testing/neo-membrane-filteration/steritest-neo-brochure.jpg "Brochure: Sterility Testing Complete Portfolio")](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/339/066/steritest-brochure-br1495en-ms.pdf) [Brochure: Sterility Testing Complete Portfolio](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/339/066/steritest-brochure-br1495en-ms.pdf)   [![Brochure: Beverage Safety Testing](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/technical-documents/articles/microbiological-testing/sterility-testing/neo-membrane-filteration/steritest-neo-brochure-2.jpg "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) [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)   [![Pharma Microbiology Method Development & Validation](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/support/product-services/BioM_Calibration_and_Verification.jpg "At Your Service")](https://www.sigmaaldrich.com/TW/en/services/product-services/validation-services/pharma-microbiology-method-development-validation) [Pharma Microbiology Method Development & Validation](https://www.sigmaaldrich.com/TW/en/services/product-services/validation-services/pharma-microbiology-method-development-validation)   __Related Articles__ - 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[Sterility Testing of Products in Isopropyl Myristate](https://www.sigmaaldrich.com/TW/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/TW/en/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-with-antimicrobial) - [無菌測試培養基及沖洗液](https://www.sigmaaldrich.com/TW/en/uat-testing/zh/technical-documents/technical-article/microbiological-testing/sterility-testing/sterility-testing-membrane-culture-media-rinsing-fluids) __Related Product Categories__ - [Sterility Testing Consumables, Media & Instruments](https://www.sigmaaldrich.com/TW/en/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) - [Pyrogen testing](https://www.sigmaaldrich.com/TW/en/products/industrial-microbiology/pyrogen-testing) 頂部 __登入以繼續__ 若要繼續閱讀，請登入或建立帳戶。 登入__還沒有帳戶？__註冊 支援[客戶支援](https://www.sigmaaldrich.com/TW/zh/support/customer-support)[聯絡我們](https://www.sigmaaldrich.com/TW/zh/collections/offices)[常見問題](https://maestro.my.site.com/knowledgeportal/s/)[安全資料表 (SDS)](https://www.sigmaaldrich.com/TW/zh/documents-search?tab=sds)[證書 (COA/COO)](https://www.sigmaaldrich.com/TW/zh/documents-search?tab=coa)[品質與法規](https://www.sigmaaldrich.com/TW/zh/life-science/quality-and-regulatory-management)[計算機與應用程式](https://www.sigmaaldrich.com/TW/zh/support/calculators-and-apps)[網路研討會](https://www.sigmaaldrich.com/TW/zh/collections/webinars) 訂單[訂單查詢](https://www.sigmaaldrich.com/TW/zh/order-lookup)[快速訂購](https://www.sigmaaldrich.com/TW/zh/quick-order)[客製化產品](https://www.sigmaaldrich.com/TW/zh/services/custom-products)[電子商務解決方案](https://www.sigmaaldrich.com/TW/zh/life-science/ecommerce/ecommerce-solutions) 公司簡介[關於我們](https://www.sigmaaldrich.com/TW/zh/life-science/about-us)[責任](https://www.sigmaaldrich.com/TW/zh/life-science/ssbi)[活動](https://www.sigmaaldrich.com/TW/zh/collections/events)[新聞稿](https://www.sigmaaldrich.com/TW/zh/collections/press)[節目](https://www.sigmaaldrich.com/TW/zh/life-science/partnership-programs)[工作機會](https://careers.merckgroup.com/global/en)[辦公室](https://www.sigmaaldrich.com/TW/zh/collections/offices) 社交媒體 [![LinkedIn icon](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/icons/linkedin.svg)](https://www.linkedin.com/company/merck-life-science) [![X icon](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/icons/x-icon.svg)](https://x.com/Merck_lifesci) [![Facebook Icon](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/icons/facebook.svg)](https://www.facebook.com/Merck.lifescience) [![Instagram Icon](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/icons/instagram.svg)](https://www.instagram.com/mercklifescience/) [![YouTube Icon](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/icons/youtube.svg)](https://www.youtube.com/@MerckLifeScience/featured) Merck __Research.開發。生產。__ 我們是全球生命科學產業的領導供應商，提供研究、生物技術開發與生產，以及藥物治療開發與生產的解決方案與服務。 [![Vibrant M string](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/icons/vibrant-m-string-1-rrvcrp.svg)](https://www.sigmaaldrich.com/TW/zh) [Sigma-Aldrich® 溶液](https://www.sigmaaldrich.com/TW/zh/life-science/sigma-aldrich)[BioReliance® 解決方案](https://www.sigmaaldrich.com/TW/zh/life-science/bioreliance)[Millipore® 溶液](https://www.sigmaaldrich.com/TW/zh/life-science/millipore)[SAFC® 解決方案](https://www.sigmaaldrich.com/TW/zh/life-science/safc)[Milli-Q® 解決方案](https://www.sigmaaldrich.com/TW/zh/life-science/milliq)[Supelco® 解決方案](https://www.sigmaaldrich.com/TW/zh/life-science/supelco) © 2026 Merck KGaA, Darmstadt, Germany 和/或其附屬公司。版權所有，包括用於 AI 訓練的文字和資料挖掘以及類似技術。 未經許可，嚴禁複製本網站的任何資料。 [網站使用條款](https://www.sigmaaldrich.com/TW/zh/life-science/legal/site-use-terms)|[隱私權政策](https://www.sigmaaldrich.com/TW/zh/life-science/legal/privacy-statement)|[一般銷售條款](https://www.sigmaaldrich.com/TW/zh/life-science/legal/terms-and-conditions)|[版權同意書](https://www.sigmaaldrich.com/TW/zh/life-science/legal/copyright-consent)|[網站地圖](https://www.sigmaaldrich.com/TW/zh/site-map) An unknown error has occured.