[跳转至内容](https://www.sigmaaldrich.com#main-content) [![Merck](https://www.sigmaaldrich.com/static/logos/purple/merck.svg)](https://www.sigmaaldrich.com/SG/zh) 产品购物车0 SGZH 产品 [登录 / 注册](https://www.sigmaaldrich.com/oidc-sign-in) [订单查询](https://www.sigmaaldrich.com/SG/zh/order-lookup) [快速订购](https://www.sigmaaldrich.com/SG/zh/quick-order) 购物车0 [主页](https://www.sigmaaldrich.com/SG/zh)[应用](https://www.sigmaaldrich.com/SG/zh/applications)[微生物检测](https://www.sigmaaldrich.com/SG/zh/applications/microbiological-testing)无菌性试验 # 无菌性试验无菌试验是GMP微生物学检测的一项要求，旨在确认无菌产品在放行和患者使用前不含活微生物。由于无菌试验对医疗器械、药品及制剂、组织材料以及其他声称无菌或不含活微生物的产品至关重要，因此其检测方法必须尽可能准确。 * * * ## 相关产品 Slide 1 of 16 1 of 4 [![Steritest® NEO 设备 For liquids in ampoules or collapsible bags., Blue base canister with a single-needle adapter., pkg of 10 blisters per box, Single packed](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/339/785/70ef386f-e967-4690-b80b-427bda70efa1/640/70ef386f-e967-4690-b80b-427bda70efa1.jpg) \ 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[![Steritest® NEO 设备 For liquids in small vials., Blue base canister with a vented double needle for small vials with septa., pkg of 10 blisters per box, Single packed](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/355/023/446a2e87-fdfd-490f-a1c1-bbb4b79dfd64/640/446a2e87-fdfd-490f-a1c1-bbb4b79dfd64.jpg) \ Millipore \ TZHASV210 \ Steritest® NEO 设备](https://www.sigmaaldrich.com/SG/zh/product/mm/tzhasv210) 快速浏览 [![Steritest® NEO 设备 For liquids in plastic containers., Blue base canister with a non-coring single needle minimizes blockage when piercing plastic containers.](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/281/054/9621ed94-ce36-4a6e-9896-80c12af11f2c/640/9621ed94-ce36-4a6e-9896-80c12af11f2c.jpg) \ Millipore \ TZHAPC210 \ Steritest® NEO 设备](https://www.sigmaaldrich.com/SG/zh/product/mm/tzhapc210) 快速浏览 [![Steritest® NEO Device For liquids in cartridges and small soft plastic containers., Blue base canister with single short (20 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"无菌检测耗材、培养基及仪器")](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) [无菌检测耗材、培养基及仪器](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) 用于微生物质量控制中无菌检测的实验室仪器及耗材：无菌检测培养基、泵、硬件及配件。 [浏览商品](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/sterility-testing-consumables-media-and-filtration) [![热原检测](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/categories/industrial-microbiology/pyrogen-testing-monocyte-activation-test.jpg "热原检测 MAT")](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/pyrogen-testing) [热原检测](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/pyrogen-testing) 确保安全：热原检测对药品和医疗器械至关重要。单核细胞活化试验（MAT）可检测内毒素和非内毒素热原。 [浏览商品](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/pyrogen-testing) [![微生物过滤](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/categories/industrial-microbiology/microbial-filtration/milliflex-oasis-filtration-system-for-bioburden-testing.jpg "Milliflex Oasis® 生物负荷检测过滤系统")](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/microbial-filtration) [微生物过滤](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/microbial-filtration) 借助我们完善的膜过滤系统进行快速微生物检测，缩短获得结果的时间；该系统广泛应用于生物负荷检测、食品饮料分析以及大麻微生物学检测。 [浏览商品](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/microbial-filtration) * * * 概述相关文章与协议支持无菌检测程序广泛应用于多个行业的产品，包括食品和饮料制造商，但主要应用于制药和医疗领域，在这些领域，产品的无菌检测仍是微生物学家的一项至关重要且常规的工作。 - [药品无菌检测方法](https://www.sigmaaldrich.com#pharmaceutical) - [医疗器械无菌检测方法](https://www.sigmaaldrich.com#medical-devices) - [无菌检测工作流程](https://www.sigmaaldrich.com#workflow) ## [](https://www.sigmaaldrich.com)药品无菌检测方法药典规定的药品无菌检测方法要求将样本分别在两种不同的培养基中进行培养。无菌试验中使用两种不同类型的培养基，以促进残留厌氧菌、需氧菌及真菌的生长。通常使用液态硫代乙酸盐培养基（FTM）培养厌氧菌和部分需氧菌，而大豆酪蛋白水解物培养基（SCDM）通常用于培养真菌和需氧菌。样本在检查前需分别于32.5 °C和22.5 °C下培养14天。培养基中出现的任何混浊现象可能表明有微生物生长，必须进行调查。药品无菌检测推荐采用两种方法：膜过滤法和直接接种法。 ### 膜过滤无菌试验如《美国药典》<71>、《欧盟药典》<2.6.1>及《日本药典》<4.06>所述，膜过滤无菌试验是可过滤药物的首选法规方法。样品通过过滤罐中的0.45 µm膜滤器，并加入培养基进行培养。与其他方法相比，该无菌检测方法的灵敏度更高，因为整个样品或混合样品均通过单一滤器。过滤过程还能冲洗掉样品中可能导致浑浊或抑制微生物生长的成分，例如抗生素或防腐剂。 ### 直接接种无菌检测在直接接种法中，需无菌操作从样品容器中取出一小体积样品，直接接种到适量培养基中，随后进行培养。虽然该方法操作简单，但存在一些显著局限性。由于只能将少量产品接种到培养基中，因此限制了检测的灵敏度。如果接种后样品出现浑浊，在培养期结束时，可能难以区分是微生物生长导致的浑浊还是其他原因造成的浑浊。此外，如果产品具有抗菌特性，则必须对样品进行中和处理，以免抑制微生物生长。 ## [](https://www.sigmaaldrich.com)医疗器械无菌检测方法建议采用直接转移无菌试验法对医疗器械进行无菌检测。在整个培养期间，待测器械与培养基直接接触，期间器械内部或表面的任何微生物都会生长和繁殖。此外，对于输血和输液组件等具有中空管路且流体通道标注为无菌的产品，建议采用产品冲洗无菌检测法。该方法需用冲洗液冲洗产品管腔，将洗出液经膜过滤后置于适宜的培养基中进行培养。 ## [](https://www.sigmaaldrich.com)无菌检测工作流程 1\. 试验准备——将膜过滤装置的管路接入泵 2\. 滤膜预润湿——对膜过滤装置进行预润湿，以优化过滤效果并最大限度减少产品在滤膜上的附着。 3\. 样品过滤——将等量的产品过滤至两个罐中。微生物被孔径为0.45 µm的滤膜截留。 4\. 冲洗——使用合适的冲洗液冲洗掉所有抑制性物质。 5\. 培养基灌注——向膜过滤装置中注入 TSB 和 FTM 无菌培养基。 6\. 培养时间——14天。 7\. 最终检测结果——目视检查浊度/无浊度。 [![文档搜索](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/ecommerce/document-search.png "文档搜索")](https://www.sigmaaldrich.com/documents-search) [需要更详细的信息吗？](https://www.sigmaaldrich.com/documents-search) 请访问我们的文档检索功能，查阅数据表、证书和技术文档。 [查找文档](https://www.sigmaaldrich.com/documents-search) ## 相关文章 - [Steritest® Symbio Sterility Testing Pump Guide](https://www.sigmaaldrich.com/SG/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/SG/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/SG/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/SG/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/SG/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. - [查看全部 (8)](https://www.sigmaaldrich.com/SG/zh/search/facet-search?focus=sitecontent&term=facet-search) ## 相关协议 - [Testing Cells for Bacterial and Fungal Contamination](https://www.sigmaaldrich.com/SG/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. ### 查看更多文章和操作规程输入关键词搜索 ## 我们能为您提供什么帮助如有任何疑问，请提交[客户支持请求](https://www.sigmaaldrich.com/SG/zh/support/customer-support); 或联系我们的客服团队：发送邮件至 [[email protected]](mailto:[email protected]) 或致电 +1 (800) 244-1173 ## 其他支持 - [Chromatogram Search](https://www.sigmaaldrich.com/chromatogram-search) Use the Chromatogram Search to identify unknown compounds in your sample. - [计算器与应用](https://www.sigmaaldrich.com/SG/zh/support/calculators-and-apps) 网络工具箱 - 用于分析化学、生命科学、化学合成和材料科学的科学研究工具和资源。 - [Customer Support Request](https://www.sigmaaldrich.com/SG/zh/support/customer-support) Customer support including help with orders, products, accounts, and website technical issues. - [FAQ](https://maestro.my.site.com/knowledgeportal/s/) Explore our Frequently Asked Questions for answers to commonly asked questions about our products and services. * * * [![](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/banners/promotional/sterility-testing/sterility-testing-mobile.jpg) \ 未雨绸缪。 \ 在培养期间，可能需要打开培养箱进行传代培养、重新培养、鉴定混浊培养基中的微生物，或注入液体。了解我们两种安全的无菌性检测采样方案：Steritest® 带针头导管和 Steritest® 无针头阀。 \ 索取免费样品](https://www.sigmaaldrich.com/SG/zh/campaigns/lead-generation/steritest-sampling-solutions-free-sample) * * * __精选文章__ [Steritest® Symbio Sterility Testing Pump Guide](https://www.sigmaaldrich.com/SG/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/SG/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/SG/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/SG/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). 顶部 __登录以继续。__ 如要继续阅读，请登录或创建帐户。登录__暂无帐户？__注册为方便客户阅读，本页通过机器进行翻译。我们已尽力确保机器翻译的准确性，但机器翻译并非尽善尽美。如果您对机器翻译内容不满意，请参阅英文版本。 An unknown error has occured. - English - EN - 中文 - ZH [了解更多](https://www.sigmaaldrich.com)