环氧乙烷灭菌柜控制系统改造项目
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| 环氧乙烷灭菌记录-参数表 EO Sterilization Record-Parameter | ||||||||||||||||
| 灭菌批号 Sterilization Lot No.： | 日期 Date ： | 2019/1/5 | 操作员 Operator： | wangjin | ||||||||||||
| Sterilization Phase | Start | End | Setting | Actual | Acceptable range允收范围 | Pass/Fail | ||||||||||
| 灭菌过程 | 开始值 | 结束值 | 设定值 | 实际值 | Min 最小值 | Max 值 | 合格/不合格 | |||||||||
| 加 热 Heating | 加热时间 Heating time | 11:13 | 13:37 | 2 H:24 M | 6 H | PASS | ||||||||||
| 加热温度 Heating temperature | 25.0 | 52.1 | 50.0 | ---- | ||||||||||||
| 保 温 Keep Warm | 保温时间 Time dwelled | 13:37 | 14:37 | 1 H | 1 H | 40 min | 2 H | PASS | ||||||||
| 保温温度 Temperature dwelled | Min | 50.1 | Max | 52.1 | 50.0 | 均值 | 51.0 | 48 | 53 | PASS | ||||||
| 预真空 Prevacuum | 预真空时间 Vacuum time | 14:37 | 14:46 | 9 min | PASS | |||||||||||
| 预真空压力 Vacuum pressure | 7.9 | -50.5 | -50.0 | -50.5 | -65 | 55 | PASS | |||||||||
| 预真空速率 Vacuum rate | kPa/min | 6.5 | 10.0 | PASS | ||||||||||||
| 測漏 Leakage Test | 保压时间 Leakage Test time | 14:46 | 15:01 | 15 min | 15 min | 9 min | 16 min | PASS | ||||||||
| 保压泄漏率 Leakage rate | -50.5 | -50.0 | kPa/min | 0.03 | 0.3 | PASS | ||||||||||
| 加 湿 Humidifying | 加湿时间 Humidifying time | 15:01 | 15:18 | 17 min | PASS | |||||||||||
| 湿度变化 Humidifying change | RH | 44.2 | RH | 46.6 | RH | 50.0 | 30 | 90 | PASS | |||||||
| 加湿次数 Humidifying times | 4 | 1 | 50 | PASS | ||||||||||||
| 加 药 EO injection | 加药时间 EO injection time | 15:18 | 15:41 | 5 min | 30 min | |||||||||||
| 加药量 EO injected weight | kg | ---- | kg | ---- | kg | ---- | kg | ---- | 2 | 7.5 | ||||||
| EO温度Temperature of EO gas | Min | 47.8 | Max | 49.7 | 57 | 均值 | 48.5 | 15 | 60 | |||||||
| 加药速率 EO injection rate | kg/min | |||||||||||||||
| 灭 菌 EO Exposure | 灭菌时间 EO exposure time | 15:41 | 23:41 | 8 H | 8 H | 3 H:55 M | 10 H | PASS | ||||||||
| 灭菌温度 EO exposure temperature | Min | 49.2 | Max | 51.9 | 50.0 | AVG | 50.9 | 45 | 55 | PASS | ||||||
| 灭菌湿度 EO exposure humidity | Min | 52.0 | Max | 64.7 | 50 | AVG | 60.4 | 30 | 90 | PASS | ||||||
| 灭菌压力 EO exposure pressure | Min | -17.8 | Max | -11.7 | AVG | 6.1 | PASS | |||||||||
| 清 洗 Flushing | 清洗时间 Flushing time | 23:41 | 1:28 | 1 H:48 M | ||||||||||||
| 抽真空压力 Vacuum pressure | -40.0 | Min | -40.5 | -55 | 0 | PASS | ||||||||||
| 放空压力 Reief pressure | -3.0 | Max | -2.3 | -10 | 0 | PASS | ||||||||||
| 清洗次数 Flushing times number | 10 | 10 | 1 | 11 | PASS | |||||||||||
| 置换时间 Areation time | 10 min | 10 min | 1 min | 3 H | PASS | |||||||||||