Iq in eto 殺菌過程係為咗證明殺菌設備同任何輔助物品已經按照佢哋嘅規格供應同安裝。喺進行 IQ 之前,設備製造商會進行 FAT 同 SAT ,以確保設備已經正常交付。

喺智商期間,以下嘅事件需要進一步識別同證實。
a. 滅菌過程所用設備,包括任何附屬項目,應符合其設計規格,相應文件包括功能設計規格、用戶需求規格、設計圖等(設備原理圖、供能圖、電氣原理圖、系統原理圖等)
b. 驗證所有組件(包括控制軟件)運作正常;關鍵測量儀器需要校正;應該記錄關鍵組件資訊;
c. 確保安裝和使用環境安全,符合當地法規。符合安全同人員健康要求。
d.Develop safety production and operating procedure documents, including maintenance and exception handling documents; conduct operator training; operators can only start work after they are qualified.
e. IQ may be a one-time exercise for the specific equipment being employed for a sterilization process.
f. Additional IQ needs to be performed in the event of significant component changes or functional changes, as well
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