開始週期階段（選擇參數/殺菌配方）序號潛在風險內容現有工藝條件下嘅風險評估風險評估

9.1 ETO 殺菌期間，操作員唔可以離開操作區域，並且必須持續觀察 ETO 殺菌過程。如果出現任何異常現象，必須立即停機，並切斷電源檢查。

就本文件而言，以下條款同定義適用於氧化乙烯殺菌3.1通氣部分

外觀檢查：檢查主機、控制架、電氣控制櫃表面有無損壞。
電源檢查：確保電源符合要求，檢查水泵同真空泵嘅旋轉方向。
Turn on the power and observe whether the instrument display values are normal; otherwise, cut off the power, inspect and repair before restarting.
Pipeline Inspection: Check for leaks in the water supply, vacuum, and medication delivery pipelines, and ensure all valves are in standby mode; adjust if necessary.

2.1.1 The overall shape should be precise, with smooth, clean surfaces and uniform color. There should be no burrs, sharp edges, cracks, visible scratches, or unevenness.
2.1.2 All external text, graphics, and symbols must be printed clearly, with precise and durable markings.
2.1.3 Fasteners must be securely installed. All control switches and adjustment knobs (or buttons) should operate smoothly and reliably without obstructions.

Within a certain range of gas concentration, the higher the concentration, the better theEO Gas Sterilization effect; beyond 1000 mg/L, the improvement in sterilization effect is not significant.