[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 [首頁](https://www.sigmaaldrich.com/TW/zh)[應用](https://www.sigmaaldrich.com/TW/zh/applications)[微生物測試](https://www.sigmaaldrich.com/TW/zh/applications/microbiological-testing)微生物負荷檢測 # 微生物負荷檢測 ![一名女科學家正在觀察培養皿中的微生物培養物。](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") 生物負荷是指在滅菌前,表面(或完整物品)、裝置內部或液體樣本中存在活的微生物。生物負荷可能源自製造過程中使用的原料,或透過製造環境中的人員,或於終端產品包裝過程中引入。由於潛在污染源眾多,產品的生物負荷可能因批次而異,因此會實施例行檢測作為品質控制的一部分。   * * * ## 相關產品 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/TW/zh/product/mm/mmhawg124) 快速查看 [![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/TW/zh/product/mm/mxqua4k01) 快速查看 [![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/TW/zh/product/mm/mmsmcts48) 快速查看 [![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/TW/zh/product/mm/mmsmcsd48) 快速查看 [![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/TW/zh/product/mm/mmsmcra48) 快速查看 [![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/TW/zh/product/mm/ezstream1) 快速查看 [![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/TW/zh/product/mm/ezfitefun6) 快速查看 [![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/TW/zh/product/mm/ezfitefun3) 快速查看 [![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/TW/zh/product/mm/jbrmhwg05505) 快速查看 [![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/TW/zh/product/mm/mha000p2t) 快速查看 [![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/TW/zh/product/mm/105458) 快速查看 [![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/TW/zh/product/mm/146431) 快速查看 [![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/TW/zh/product/mm/146763) 快速查看 [![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/TW/zh/product/mm/146049) 快速查看 * * * ## 精選類別 [![微生物過濾](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/categories/industrial-microbiology/microbial-filtration/ez-product-family.jpg "適用於膜過濾的 EZ 產品系列")](https://www.sigmaaldrich.com/TW/zh/products/industrial-microbiology/microbial-filtration) [微生物過濾](https://www.sigmaaldrich.com/TW/zh/products/industrial-microbiology/microbial-filtration) 透過我們完整的膜過濾系統進行快速微生物檢測,加速獲得檢測結果的時間;該系統適用於生物負荷檢測、食品與飲料分析,以及大麻微生物學檢測。 [瀏覽商品](https://www.sigmaaldrich.com/TW/zh/products/industrial-microbiology/microbial-filtration) [![微生物培養基](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/categories/industrial-microbiology/granucult-prime-macconkey-agar-culture-media-granules.jpg "微生物學用 GranuCult® Prime MacConkey 瓊脂")](https://www.sigmaaldrich.com/TW/zh/products/industrial-microbiology/microbial-culture-media) [微生物培養基](https://www.sigmaaldrich.com/TW/zh/products/industrial-microbiology/microbial-culture-media) 探索高品質的微生物培養基。您可選擇脫水型或即用型產品,均符合業界標準及法規要求。 [瀏覽商品](https://www.sigmaaldrich.com/TW/zh/products/industrial-microbiology/microbial-culture-media) [![Milli-Q® 桌上型實驗室純水處理系統](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 純水與超純水淨化系統 64")](https://www.sigmaaldrich.com/TW/zh/products/water-purification/milli-q-benchtop-water-purification-systems) [Milli-Q® 桌上型實驗室純水處理系統](https://www.sigmaaldrich.com/TW/zh/products/water-purification/milli-q-benchtop-water-purification-systems) Milli-Q® 系統採用創新水處理技術,專為滿足實驗室研究需求、永續發展目標及其他主要要求而設計。 [瀏覽商品](https://www.sigmaaldrich.com/TW/zh/products/water-purification/milli-q-benchtop-water-purification-systems) * * * 概覽 相關文章與操作規範 支援 ## 生物負荷檢測的基礎知識 生物負荷檢測(或稱微生物檢測)是一種品質控制流程,旨在檢測並定量分析產品在不同生產階段(即從初始製造到最終分銷)所遭受的微生物污染。有效的品質控制與精確的檢測結果對於將消費者風險降至最低至關重要,且受監管的生產環境亦有此要求。因此,生物負荷分析通常被納入例行檢測中,以確保每批製造產品的安全性、品質及法規遵循性。 生物負荷檢測的適用對象包括醫療器材、藥品、食品與飲料、水、包裝材料、原料、人體組織、動物組織以及化妝品。當遵循下文所述的標準方法時,務必確保檢測方法不會將細菌引入檢測樣本,亦不會殺死檢測樣本中的細菌。 - [生物負荷檢測的膜過濾法](https://www.sigmaaldrich.com#membrane) - [生物負荷檢測的直接接種法](https://www.sigmaaldrich.com#direct) - [生物負荷檢測之最可能數(MPN)法](https://www.sigmaaldrich.com#most) [索取資訊](https://www.sigmaaldrich.com/TW/zh/campaigns/microbial-filtration) ## 生物負荷檢測的[](https://www.sigmaaldrich.com)膜過濾法 對於含有抗菌物質的產品而言,[膜過濾](https://www.sigmaaldrich.com/TW/zh/products/industrial-microbiology/microbial-filtration)法是首選的方法。在此方法中,樣本會通過孔徑為 0.45 µm 的膜過濾器。該膜作為屏障,可截留大於膜孔徑的微生物。過濾過程中,可使用真空以加速流程。 隨後將濾膜轉移至培養基中,並置於培養箱內:若檢測細菌,則於 30–35 °C 培養至少 5 天;若檢測真菌,則於 20–25 °C 培養至少 5 天。接著對培養物進行計數,以確定樣品中的微生物污染程度。應採取適當措施,避免可能導致假陽性結果的交叉污染。 ## 生物負荷檢測的[](https://www.sigmaaldrich.com)直接塗布法 生物負荷檢測的直接塗布法包括傾注法與塗佈法。由於傾注法具有更高的理論精確度,因此較為推薦。在傾注法中,將滅菌[培養基](https://www.sigmaaldrich.com/TW/zh/products/industrial-microbiology/microbial-culture-media)加入含有待測樣品的培養皿中,並使其凝固。相反地,在塗佈法中,則將樣品加入含有已滅菌且凝固之培養基的培養皿中。 無論採用何種方法,在將樣本加入培養系統後,均需對培養皿進行培養,並對生長的菌落進行計數。 ## 生物負荷檢測中的[](https://www.sigmaaldrich.com)最可能數(MPN)法 最可能數(MPN)法是一種用於測定樣本中細菌近似濃度的定量方法。原始溶液或樣本會按數量級(通常為 10 倍或 2 倍)分級稀釋至培養液中,並評估其中是否存在微生物。MPN 法的缺點在於,必須在適當的稀釋度下進行大量重複實驗,才能縮小信賴區間。 此外,此方法僅適用於細菌檢測,對於真菌的計數則無法提供可靠的結果。 [![文件搜尋](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/ecommerce/document-search.png "文件搜尋")](https://www.sigmaaldrich.com/documents-search) [想了解更多具體資訊嗎?](https://www.sigmaaldrich.com/documents-search) 請造訪我們的文件搜尋頁面,查閱產品資料表、認證書及技術文件。 [搜尋文件](https://www.sigmaaldrich.com/documents-search) ## 相關文章 - [基於螢光的快速微生物檢測](https://www.sigmaaldrich.com/TW/zh/technical-documents/technical-article/microbiological-testing/bioburden-testing/milliflex-quantum-rapid-detection) Milliflex® Quantum 系統可利用螢光染色技術快速檢測微生物污染。 - [Comparison of Single-Use Funnels vs. Reusable Funnels for the Membrane Filtration Method in QC Microbiology](https://www.sigmaaldrich.com/TW/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/TW/en/technical-documents/technical-article/microbiological-testing/bioburden-testing/s-pak-membrane-filter) S-Pak® membrane filters for microbial bioburden testing - [Milliflex Oasis® 過濾系統](https://www.sigmaaldrich.com/TW/zh/technical-documents/technical-article/microbiological-testing/bioburden-testing/milliflex-oasis-filtration) Milliflex Oasis® 過濾系統是監控製程中樣品、水、可過濾原料和成品的生物負荷和微生物限度測試的完整解決方案。該系統可提高 QC 實驗室的生產力,同時降低出現錯誤結果的風險。 - [Microbial Detection Using Chromogenic and Fluorogenic Culture Media](https://www.sigmaaldrich.com/TW/en/technical-documents/technical-article/clinical-testing-and-diagnostics-manufacturing/bacteriology/overview-chromogenic-media) Selective media enable faster results and visual confirmation for the detection, identification, and enumeration of microorganisms - [查看全部 (14)](https://www.sigmaaldrich.com/TW/zh/search/facet-search?focus=sitecontent&term=facet-search) ## 相關協定 - [Routine Water and Beverage Microbiological Analysis Using the 55-Plus™ Monitor](https://www.sigmaaldrich.com/TW/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/TW/en/technical-documents/protocol/microbiological-testing/bioburden-testing/micropresure-filtration) MicropreSure® on-line filtration system for in-process microbiology testing - 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