[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 产品应用服务资源支持 [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)微生物负荷检测 # 微生物负荷检测 ![一位女科学家正在观察培养皿中的微生物培养物。](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/applications/microbiological-testing/microbial-bioburden-and-water-testing.jpg "Microbial bioburden and water testing") 生物负荷是指在灭菌前,表面(或整个物品)、设备内部或液体样本中存在的活微生物。生物负荷可能源自制造过程中使用的原材料,也可能通过制造环境中的工作人员或在最终产品包装过程中引入。由于潜在污染源众多,产品的生物负荷在不同批次之间可能存在波动,因此作为质量控制的一部分,需实施例行检测。   * * * ## 相关产品 Slide 1 of 14 1 of 4 [![Milliflex Oasis®过滤装置 pore size 0.45 μm, mixed cellulose esters (MCE) membrane, white filter, volume 100 mL](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/740/999/57d1a874-3e8b-4456-ba0b-9bea13c3b597/640/57d1a874-3e8b-4456-ba0b-9bea13c3b597.jpg) \ Millipore \ MMHAWG124 \ Milliflex Oasis®过滤装置](https://www.sigmaaldrich.com/SG/zh/product/mm/mmhawg124) 快速浏览 [![Milliflex® Quantum Standard Kit with validation protocol A4 format, For the rapid detection of microbial contamination](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/972/533/f9a807e1-1ae9-48f2-aff5-af69cf99d912/640/f9a807e1-1ae9-48f2-aff5-af69cf99d912.jpg) \ Millipore \ MXQUA4K01 \ Milliflex® Quantum Standard Kit](https://www.sigmaaldrich.com/SG/zh/product/mm/mxqua4k01) 快速浏览 [![MILLIFLEX OASIS®胰蛋白酶培养基板 suitable for (Tryptic soy media plates for aerobic and anaerobic microflora)](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/340/014/d03ccec6-f3e3-45f0-b57e-e2355bf6b10d/640/d03ccec6-f3e3-45f0-b57e-e2355bf6b10d.jpg) \ Millipore \ MMSMCTS48 \ MILLIFLEX OASIS®胰蛋白酶培养基板](https://www.sigmaaldrich.com/SG/zh/product/mm/mmsmcts48) 快速浏览 [![MILLIFLEX OASIS®沙氏葡萄糖培养基板 ready-to-use](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/413/705/c83bfc3d-aa07-436a-bcf6-e240dbf40c3b/640/c83bfc3d-aa07-436a-bcf6-e240dbf40c3b.jpg) \ Millipore \ MMSMCSD48 \ MILLIFLEX OASIS®沙氏葡萄糖培养基板](https://www.sigmaaldrich.com/SG/zh/product/mm/mmsmcsd48) 快速浏览 [![MILLIFLEX OASIS® R2A低营养培养基板 suitable for (R2A low nutrient media plates for waterborne microorganisms)](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/172/915/f3689899-b415-4685-aab9-66b7723cafef/640/f3689899-b415-4685-aab9-66b7723cafef.jpg) \ Millipore \ MMSMCRA48 \ MILLIFLEX OASIS® R2A低营养培养基板](https://www.sigmaaldrich.com/SG/zh/product/mm/mmsmcra48) 快速浏览 [![EZ-Stream®真空泵 suitable for bioburden testing, for use with EZ-Fit® Filtration Manifold](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/317/602/37cc1a9f-7c02-4f7d-8737-d390b740587b/640/37cc1a9f-7c02-4f7d-8737-d390b740587b.jpg) \ Millipore \ EZSTREAM1 \ EZ-Stream®真空泵](https://www.sigmaaldrich.com/SG/zh/product/mm/ezstream1) 快速浏览 [![EZ-Fit® Manifold 6-place, For EZ-Fit® Filtration Units](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/165/205/0d45b425-2e69-4da5-b4a0-798eb9c756f1/640/0d45b425-2e69-4da5-b4a0-798eb9c756f1.jpg) \ Millipore \ EZFITEFUN6 \ EZ-Fit® Manifold](https://www.sigmaaldrich.com/SG/zh/product/mm/ezfitefun6) 快速浏览 [![EZ-Fit® Manifold 3-place, For EZ-Fit® Filtration units](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/111/632/b0ba7611-c6c4-486f-81ec-ddf9b5596461/640/b0ba7611-c6c4-486f-81ec-ddf9b5596461.jpg) \ Millipore \ EZFITEFUN3 \ EZ-Fit® Manifold](https://www.sigmaaldrich.com/SG/zh/product/mm/ezfitefun3) 快速浏览 [![55-Plus™ monitor ready-to-use, disposable filtration unit, pore size 0.45 μm, white filter (gridded), mixed cellulose esters (MCE) membrane, suitable for (microbiological analysis), suitable for water monitoring](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/344/304/25f962b0-cb57-49a5-b4f7-2a389a2b50c4/640/25f962b0-cb57-49a5-b4f7-2a389a2b50c4.jpg) \ Millipore \ JBRMHWG05505 \ 55-Plus™ monitor](https://www.sigmaaldrich.com/SG/zh/product/mm/jbrmhwg05505) 快速浏览 [![胰蛋白胨葡萄糖提取物肉汤培养基 ampoule capacity 2 mL, ampoule filling volume 2 mL, ready-to-use, pack of 50 tests, for heterotrophic bacteria](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/313/178/88cc8756-5e09-462b-99fb-cf877e6d5018/640/88cc8756-5e09-462b-99fb-cf877e6d5018.jpg) \ Millipore \ MHA000P2T \ 胰蛋白胨葡萄糖提取物肉汤培养基](https://www.sigmaaldrich.com/SG/zh/product/mm/mha000p2t) 快速浏览 [![胰蛋白胨大豆琼脂培养基 - 脱水培养基 GranuCult® prime, EP, USP, JP, ISO 11133, FDA (BAM), granular, suitable for microbiology](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/295/209/27e42456-0eb4-4281-8870-c5b50448ab81/640/27e42456-0eb4-4281-8870-c5b50448ab81.jpg) \ Millipore \ 1.05458 \ 胰蛋白胨大豆琼脂培养基 - 脱水培养基](https://www.sigmaaldrich.com/SG/zh/product/mm/105458) 快速浏览 [![胰蛋白胨大豆琼脂-即用沉降板 ReadyPlate™, plate diam. 90 mm, according to ISO, FDA-BAM, EP, USP, sterile, pack of 20 and 100 plates](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/355/786/ff04018b-3adf-4fa0-b833-b9c4d1e28600/640/ff04018b-3adf-4fa0-b833-b9c4d1e28600.jpg) \ Millipore \ 1.46431 \ 胰蛋白胨大豆琼脂-即用沉降板](https://www.sigmaaldrich.com/SG/zh/product/mm/146431) 快速浏览 [![Plate Count Agar ReadyPlate™, diam. 55 mm, ready-to-use, sterile, box of 20 plates, for aerobic bacteria](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/657/351/1617f536-2a54-4fde-83e7-43005954d03f/640/1617f536-2a54-4fde-83e7-43005954d03f.jpg) \ Millipore \ 1.46763 \ Plate Count Agar](https://www.sigmaaldrich.com/SG/zh/product/mm/146763) 快速浏览 [![R2A Agar Chromogenic Heimplate, plate diam. 90 mm, ready-to-use, settle Plate for long Incubation, aseptically filled, box of 20 plates, for heterotrophic bacteria](https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/images/313/483/cf9ab428-d7bc-4919-8edb-bb1226f56e33/640/cf9ab428-d7bc-4919-8edb-bb1226f56e33.jpg) \ Millipore \ 1.46049 \ R2A Agar Chromogenic](https://www.sigmaaldrich.com/SG/zh/product/mm/146049) 快速浏览 * * * ## 精选分类 [![微生物过滤](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/categories/industrial-microbiology/microbial-filtration/ez-product-family.jpg "用于膜过滤的EZ产品系列")](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) 借助我们完整的膜过滤系统进行快速微生物检测,缩短获得结果所需的时间;该系统广泛应用于生物负荷检测、食品和饮料分析以及大麻微生物学检测。 [选购商品](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/microbial-filtration) [![微生物培养基](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/categories/industrial-microbiology/granucult-prime-macconkey-agar-culture-media-granules.jpg "用于微生物学的 GranuCult® Prime 麦康凯琼脂")](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/microbial-culture-media) [微生物培养基](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/microbial-culture-media) 探索高品质的微生物培养基。您可以选择脱水型或即用型产品,这些产品均符合行业标准和监管要求。 [选购商品](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/microbial-culture-media) [![Milli-Q® 台式实验室水净化系统](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/categories/water-purification/ziq7003t0c-utrapure-pure-water-purification-system64.jpg "Milli-Q® IQ 7003/05/10/15 纯水和超纯水净化系统 64")](https://www.sigmaaldrich.com/SG/zh/products/water-purification/milli-q-benchtop-water-purification-systems) [Milli-Q® 台式实验室水净化系统](https://www.sigmaaldrich.com/SG/zh/products/water-purification/milli-q-benchtop-water-purification-systems) Milli-Q® 系统采用创新的水净化技术,专为满足实验室研究需求、可持续发展目标及其他主要要求而设计。 [选购商品](https://www.sigmaaldrich.com/SG/zh/products/water-purification/milli-q-benchtop-water-purification-systems) * * * 概述 相关文章与操作规程 支持 ## 生物负荷检测基础 生物负荷检测或微生物检测是一种质量控制流程,用于检测和定量分析产品在不同生产阶段(即从初始制造到最终分销)的微生物污染情况。有效的质量控制和准确的检测结果对于最大限度地降低消费者风险至关重要,也是受监管生产环境所必需的。因此,生物负荷分析通常被纳入常规检测中,以确保每批生产产品的安全性、质量及符合监管要求。 生物负荷检测适用于医疗器械、药品、食品和饮料、水、包装材料、原材料、人体组织、动物组织以及化妆品。在遵循下文所述的标准方法时,必须确保检测方法不会将细菌引入待测样品,也不会杀死待测样品中的细菌。 - [生物负荷检测的膜过滤法](https://www.sigmaaldrich.com#membrane) - [生物负荷检测的直接接种法](https://www.sigmaaldrich.com#direct) - [微生物负荷检测中的最可能数(MPN)法](https://www.sigmaaldrich.com#most) [索取信息](https://www.sigmaaldrich.com/SG/zh/campaigns/microbial-filtration) ## 生物负荷检测的[](https://www.sigmaaldrich.com)膜过滤法 对于含有抗菌物质的产品,[膜过滤](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/microbial-filtration)是首选方法。该方法中,样品通过孔径为0.45 µm的膜过滤器。膜作为屏障,可截留大于膜孔径的微生物。过滤过程中可使用真空以加快速度。 随后将滤膜转移至培养基中,并置于培养箱内:细菌检测时在30–35 °C下培养至少5天,真菌检测时在20–25 °C下培养至少5天。对培养物进行计数,以确定样品中的微生物污染水平。应采取适当措施,避免可能导致假阳性结果的交叉污染。 ## 生物负荷检测的[](https://www.sigmaaldrich.com)直接涂布法 生物负荷检测的直接涂布法包括倾注法和涂布法。由于倾注法具有更高的理论准确度,因此更受青睐。在倾注法中,将灭菌[培养基](https://www.sigmaaldrich.com/SG/zh/products/industrial-microbiology/microbial-culture-media)加入装有待测样品的培养皿中,待其凝固。相反,在涂布法中,将样品加入装有无菌、已凝固培养基的培养皿中。 无论采用哪种方法,在将样本加入培养系统后,均需对培养皿进行培养,并计数所得菌落。 ## 生物负荷检测中的[](https://www.sigmaaldrich.com)最可能数(MPN)法 最可能数(MPN)法是一种用于确定样品中细菌近似浓度的定量方法。将原始溶液或样品按数量级(通常为10倍或2倍)分装到培养基中,并检测其中是否存在微生物。MPN法的缺点在于,为了缩小置信区间,需要在适当的稀释度下进行大量重复试验。 此外,该方法仅适用于细菌检测,对于真菌计数无法提供可靠的结果。 [![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) 请访问我们的文档搜索页面,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 - [基于荧光的微生物快速检测](https://www.sigmaaldrich.com/SG/zh/technical-documents/technical-article/microbiological-testing/bioburden-testing/milliflex-quantum-rapid-detection) Milliflex® Quantum 系统可利用荧光染色技术快速检测微生物污染。 - [Comparison of Single-Use Funnels vs. Reusable Funnels for the Membrane Filtration Method in QC Microbiology](https://www.sigmaaldrich.com/SG/en/technical-documents/technical-article/microbiological-testing/bioburden-testing/single-use-funnels-vs-reusable-funnels-membrane-filtration-method-qc-microbiology) Comparison of convenience, operating time, accuracy, costs and safety aspects of single-use funnels vs. reusable funnels for the membrane filtration method in QC microbiology. - [S-Pak® Membrane Filters](https://www.sigmaaldrich.com/SG/en/technical-documents/technical-article/microbiological-testing/bioburden-testing/s-pak-membrane-filter) S-Pak® membrane filters for microbial bioburden testing - [显色培养基概述](https://www.sigmaaldrich.com/SG/zh/technical-documents/technical-article/clinical-testing-and-diagnostics-manufacturing/bacteriology/overview-chromogenic-media) 选择性培养基可以为微生物的检测、识别和计数提供更快的结果和肉眼确认 - [EN ISO 11133和制备用水和微生物培养基性能测试](https://www.sigmaaldrich.com/SG/zh/technical-documents/technical-article/food-and-beverage-testing-and-manufacturing/microbiological-analysis-for-food-and-beverage/en-iso-11133-water-for-the-preparation-and-performance-testing) 了解在采用EN ISO 11133集中纯化水和Milli-Q® IX纯水系统产出的纯水制备微生物培养基及进行性能测试时,如何比较两种水源。测试包括针对李斯特菌和沙门氏菌病原体的专用培养基。 - [查看全部 (15)](https://www.sigmaaldrich.com/SG/zh/search/facet-search?focus=sitecontent&term=facet-search) ## 相关协议 - [Routine Water and Beverage Microbiological Analysis Using the 55-Plus™ Monitor](https://www.sigmaaldrich.com/SG/en/technical-documents/protocol/microbiological-testing/bioburden-testing/55-plus-monitor) Routine water and beverage microbiological analysis using the 55-Plus™ Monitor - [MicropreSure® On-line Filtration System for In-process Microbiology Testing](https://www.sigmaaldrich.com/SG/en/technical-documents/protocol/microbiological-testing/bioburden-testing/micropresure-filtration) MicropreSure® on-line filtration system for in-process microbiology testing - 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