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有關滅菌鍋平衡時間
#1
維尼 發表於 2021 / 11 / 19
您好, en 285 規範 ≤800L的chamber≤15秒；＞800L的不超过30秒; 請問平衡時間是指執行何種滅菌cycle 下, 進行比對的呢?
- 管理員回覆
- 您好，
主要適用於多孔的滅菌行程(porous cycle)。如果是液體滅菌行程(fluid cycles)則不用計算平衡時間。
請參考 Annex 1 draft, 2020的要求：
8.57 Validation of porous cycles should include a calculation of equilibration time, exposure time, correlation of pressure and temperature and maximum temperature range during exposure. Validation of fluid cycles should include temperature, time and/or F0. These critical processing parameters should be subject to defined limits (including appropriate tolerances) and be confirmed as part of the sterilization validation and routine cycle acceptance criteria.
From TPDA
2022/1/25
