Bioburden | 合法醫療器材資訊網

TheUnitedStatesPharmacopeia(USP)outlinesseveralteststhatcanbedonetoquantitativelydeterminethebioburdenofnon-steriledrugproducts.

From Wikipedia, the free encyclopedia

Number of bacteria living on a surface that has not been sterilized

Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized.[1]

The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on pharmaceutical products and medical products for quality control purposes. Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden or microbial limit testing on these products proves that these requirements have been met. Bioburden testing for medical devices made or used in the USA is governed by Title 21 of the Code of Federal Regulations and worldwide by ISO 11737.

The aim o...

61 MICROBIOLOGICAL EXAMINATION OF NONSTERILE ... | 合法醫療器材資訊網

The Most. ProbableNumber (MPN) Method is generally the least accurate method for microbial counts; however, for certain product groups with very low bioburden, ... Read More

生菌試驗（Bioburden）簡介 | 合法醫療器材資訊網

... 並依據各式醫療器材之Bioburden，來決定滅菌參數。本實驗室依據無菌試驗(Sterility Test)之ISO及USP規範，來驗證環氧乙烷滅菌確效製程，以確保其安全性及有效性。 Read More

In | 合法醫療器材資訊網

2018年6月4日 — The methodology for the bioburden test is commonly modified from USP <61>, USP <71> Sterility Tests, and water-testing guidelines, such as USP < ... Read More

樣品生菌數檢驗(二) | 合法醫療器材資訊網

2019年10月2日 — 所以參照USP<61>或中華藥典7007.1微生物計數法確定總負荷菌標準，因此 ... groups with very low bioburden, it may be the most appropriate method. Read More

Microbial Enumeration Test | 合法醫療器材資訊網

我們是大分子藥廠(protein Drug)，未來藥劑使用方式為注射，USP中Microbial ... DS如果宣稱是非無菌原料，則可以考量訂定負荷菌(bioburden)規格或TAMC/TYMC規格。 Read More

(PDF) A new standard for bioburden testing | 合法醫療器材資訊網

A new standard for bioburden testing: USP chapter in development ... 2.6.12/USP <61> and “Microbiological Examination of Nonsterile Products: Tests for ... Read More

Bioburden | 合法醫療器材資訊網

The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products. Read More

Pharmaceutical Microbiology Manual (PMM) | 合法醫療器材資訊網

2020年8月25日 — Chapter 8: Bioburden Estimation for Medical Devices. ... (USP) for pharmaceutical microbiology testing, including antimicrobial. Read More

Microbiological Examination of Nonsterile Products | 合法醫療器材資訊網

... also known as microbial bioburden testing or microbial limits testing. USP <62> is the method used to determine the presence or absence of objectionable ... Read More

USP <1115> Bioburden Control of Non | 合法醫療器材資訊網

2019 USP. ▻ No well defined regulatory standards or guidance exists for the microbiological / bioburden control of non-sterile pharmaceutical manufacturing ... Read More

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