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內毒素樣品檢測時效

#1
QC 發表於 2019 / 09 / 24
您好, 想請教有關內毒素樣品取樣後,有相關規定需於多久內檢測呢? 像是水會參考USP 1231建議,當樣品冰2~8度,則需於12小時內檢測, 但像是其他樣品的話不知是否有規範? 麻煩專家解惑,謝謝
管理員回覆
您好,

依據USP 42<1117>「Viable microorganisms in most microbiology samples, particularly water, environmental monitoring and bioburden samples, are sensitive to handling and storage conditions. Critical parameters in these conditions include product (or sample) composition, container composition, time of storage, and temperature of storage. Therefore, it is important to minimize the amount of time between the sampling event and the initiation of testing and to control, as much as possible, the conditions of storage….」及WHO TRS No.961 Annex 2之8.3 「Samples awaiting testing should be stored under suitable conditions to minimize changes to any microbial population present. Storage conditions should be validated, defined and recorded.」
段落中提到取樣至檢測時間越短越好,儲存條件也應盡可能管控。


From TPDA
2019/12/10

 

 

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