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Ethylene Oxide Sterilization Process Record <br /> *M#L!A 9 Sterilizer. ANUIL Sterilization Batch, 2018092201 H NJ Date: 20180922 Jift?k Order; I <br /> Article Name*M Lot No.-T-J"'Itt-LI, Specification IM1401 i CTN/N0;ffi4k OuarititylkS lkilrimtl, <br /> DA VINCI cartridges 09-18 100CTN WPM <br /> ZEAL <br /> AW AU, <br /> 41W5 T--It- <br /> Setting Value Actual Value Requirementg* Pass/Fail Sterilization Process Start time End time Time <br /> Process Parameters l# elapsed(mi <br /> Ci!11 mlnG+fft maxlAXII A" <br /> Vaccum value(KPs)f%Jkq!)t -50,0 -504 -52.0 -48,0 Pass HeatingAIA 2018022 19-06 2018/912220.45 99 <br /> Leak test time(min)MUNIAPt(111 5 1 6 4 6 1 Pass Keeping warmU A: 2018022 20.45 201819/22 21.45 60 <br /> Pressure change at end of leak test(KPa)WMFK)j* — 02 0-0 3-0 Pass Pre-vacuum OM;rk ' 20I819/22 21.45 2018022 21-52 7 <br /> Pressure change at end of steam Injection(KPa)AQJVKiX)Aftlft 20 26 44:-50.0&-i:-474 10 3.0 Pass leak test.*U&M 2018022 21:52 2018/9/22 21:57 5 <br /> Pressure change at and of EO injection(KPa)bREOr.IK)jl*%* 99,0 306 -47AU.-18.8 00 100.0 Pass steam irqed#onWiV 2018/9/22 21:57 2018IW22 22:08 11 <br /> EO weight Injected(K911MEOS -- 0.0 10.0 Pass EO wyection NIA 20I6/9/22 22:08 2018!9/22 22:47 39 <br /> Temperature(TI)during EO exposure(C)ANIMMX1119 50.0 Min: 492 Max] 51,8 45,0 55.0 Pass Wdwell kM 2018/9122 22A7 2018/9M 6:47 480 <br /> Humidity(RH)during EO exposure(%RH)X0KJ4VWVfi[ ... Vin: 34.5 Mix, 504 300 85.0 Pass EO Removal E04ft 201819/236:47 2018/9/23 6:51 4 <br /> Pressure(131)during EO exposure(Kpa)ANIRO1i'0101 --- Min: -22-5 Max: -168 — Pass air washing 2018/8/23 6:51 201819/23 7:110 Is <br /> EO dwell(min)X00104 480 480 479 481 Pass repressure 201819M 71-- <br /> 1 10 F 201 12 <br /> Numbers of air wa*hes!2!At*9k?k#& 3 1 3 1 2 1 4 Pass I <br />