Microbiological Examination of Nonsterile Products | 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

... 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

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

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

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

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

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

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

... 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

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