Q&A討論區
本交流園地目的是開放工業界同仁技術分享交流
歡迎大家踴躍回應分享經驗
請注意下列事項:
互動回應資料僅供參考並非標準答案
提問時請註明產業類別或性質,以便問題交流
禁止任何廣告

 

 

純水holding time 驗證

#1
Ching 發表於 2019 / 09 / 03
您好 1 想請問純水取樣到化驗須於兩小時內操作完畢,此規定是因為放置超過兩小時會造成微生物判斷上甚麼樣的結果嗎?(放置太久微生物會增長 or 放置太久微生物會減少) 2 如果要做純水holding time 驗證,想請問要使用甚麼樣的菌株較適合
管理員回覆

1.    請參考USP <1231> Water for Pharmaceutical Purpose的說明,摘錄如下:Consideration should also be given to the timeliness of microbial enumeration testing after sample collection. The number of detectable planktonic bacteria in a sample collected in a scrupulously clean sample container will usually drop as time passes. The planktonic bacteria within the sample will tend to either die or to irretrievably adsorb to the container walls, reducing the number of viable planktonic bacteria that can be withdrawn from the sample for testing. The opposite effect can also occur if the sample container is not scrupulously clean and contains a low concentration of some microbial nutrient that could promote microbial growth within the sample container. Because the number of recoverable bacteria in a sample can change positively or negatively over time after sample collection, it is best to test the samples as soon as possible after being collected. If it is not possible to test the sample within about 2 h of collection, the sample should be held at refrigerated temperatures (2°–8°) for a maximum of about 12 h to maintain the microbial attributes until analysis. In situations where even this is not possible (such as when using off-site contract laboratories), testing of these refrigerated samples should be performed within 48 h after sample collection. In the delayed testing scenario, the recovered microbial levels may not be the same as would have been recovered had the testing been performed shortly after sample collection. Therefore, studies should be performed to determine the existence and acceptability of potential microbial enumeration aberrations caused by protracted testing delays.
根據USP建議較短的時間,通常不用特別驗證。如果要驗證最長的保持時間(例如冷藏,48小時),建議從水系統的原水,各個單元處理後的水,以及純水循環迴路在水系統確效的檢驗結果,以及過去監測趨勢中較常被檢出的細菌,選出代表性的細菌來試驗。因為水生菌大多數為格蘭氏陰性菌,Pseudomonas屬可能是一個選擇。

From TPDA
2019/10/2

 

 

暱稱
回覆內容
姓名
公司名稱
部門
聯絡電話+分機
Email
驗證碼