1、EO-Sterilization Record Per Load环氧乙烷灭菌批记录Furnace No箱号：a Date日期：2010-08-27 Order班次：a Sterilization No灭菌批号：100827-1-482 Rec/记录：Article Name物品名称Production No生产批号Specifice规格/型号Quantity数量（箱）Remark备注Required Operation During Sterilization Cycle 灭菌过程操作要求Required操作要求 Actual实际值Temperature()温度 50-56 50.1-57.6
2、Pressure(kPa)压力 -35-35 -19.2-26.7Humidity(%RH)湿度 30-80 46.2-69.1Exposure time(min)灭菌时间 480 480Num of Change Air 换气次数 3 3Speed of Air Removal(kPa/min)抽真空速率 5.0 5.0Weight of EO used Before(kg)加药前重量Weight of EO used After(kg)加药后重量Weight of EO used (kg)加药重量Pressure Changed(Mpa)加药前后压力值 -19-26.7Required O
3、peration 操作要求 Start Time开始实际 End Time结束时间 Actual Time实际时间 Sterilization Information 灭菌情况 Release 验收Conditioning 预热 21:15:23 22:02:41 47 minWarm_Up保温 22:02:41 23:02:41 60 minPassed 合格Rejected 拒收Hold 待定Micro验收员 QA Manager主管Air Removal抽真空 23:02:41 23:13:47 11 minPressure Time保压时间 23:13:47 23:27:14 13 m
4、inEO Injection充入环氧乙烷 23:27:14 23:59:01 31 minExposure Time灭菌时间 23:59:01 07:59:03 480 minInjector加药者 Operator操作员 Super主管EO Removal换气时间 07:59:03 08:14:06 15 minFinishing清理完毕 08:14:06Furnace No箱号：a Date日期：2010-08-27 Order班次：a Sterilization No灭菌批号：100827-1-482 Rec/记录：环氧乙烷灭菌批记录(EO-Sterilization Batch Rep
5、ort)Chamber No灭菌器编号： 01 Sterilization No.灭菌批号： 131223-1-001 Date 日期：2013-12-23 Order 班次：Article Name物品名称Production No生产批号Specification规格/型号Quantity数量Remark备注Parameters During Sterilization Cycle灭菌过程参数Required设定值Actual实际值安全自毁注射器 20131206-3 2.5ml 10万 灭菌温度Chamber Temperature while Sterilization() 47-53
6、 S:48.5 E：52.6灭菌压力Chamber Pressure while Sterilization(kPa) -600 S:-57.1 E:-15.5灭菌湿度Chamber Humidity while Sterilization(%RH) 30-80 33.5-52.8, 灭菌时间Exposure time(min) 480 480预真空度Pre-Vacuum Value(kPa) 加湿压力幅度Pressure Amplitude while Humidifying(kPa)加湿前后压力Pressure Changed while Humidifying(kPa) 加药压力幅度Pr
7、essure Amplitude while EO Injection(kPa) 加药前后压力Pressure Changed while EO Injection(kPa) / S:-57.1 E：-15.3加药重量Weight of EO used(kg) 20Kg 20KgSterilization Phase灭菌过程Start Time开始时间End Time结束时间Actual Time实际时间Sterilization Information灭菌情况Release验收预 热 Conditioning 8:30 15:30 440 Passed 合 格Rejected 拒 收Hold 待 定抽真空 Air Removal 15:30 15:40 10保压时间 Pressure Time 15:40 15:45 5充入EO EO Injection 16:00 17:10 70Injector 加药者 Operator操作员EO Manger灭菌主管灭菌时间 Exposure Time 17:10 1:10 480换气时间 EO Removal 1:10 1:20 10 Micro Lab Manger质检员QA Manager主管清理完毕 Finishing 1:20 1:38 18
