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4-,L QXffilzflMt+A Ethylene Oxide Sterilization Process Record <br /> X*#L p 4 Sterilizer: TcSAM Sterilization Batch: 2019072501 M Date: 20190725 YUk Order: 1 <br /> Article Name'I At# Lot No.IiAtP. Specification**IV 11 CTN1NO;J06 Quantity4ltiik �1"4�if1 <br /> DA VINCI cartridges 07-19 70CTNS MAIM NX <br /> MM. if is <br /> vj <br /> 0111 <br /> Requirementg* Time <br /> Setting Value Actual Value Pass/Fail Sterilization Process Start time End time <br /> Process Panametersit ?If!tlt '`•*. empsed(n <br /> Wfi t 3 U-Ift minJl+l�i(t maxlRXI( 4;Mitfif;iPi ktlliz� Y ,JFjW'R. #il( Rm 9111 <br /> Vaccum value(KPa)XAZk -50.0 -50.2 -52:0 48.0 Pass Heatingbti 20190/2518:26 2019(712519.22 56 <br /> Leak test tinWmin)ftX:NAPIN 10 10 4 6 Fail Keeping warm UA 2019/7/2519:22 2019012520-22 60 <br /> Pressure change at end of leak test(KPa)*Xlk)l#i --- 0.3 0.0 3.0 Pass Pre-vacuum f/M n"i' 201917/25 20:22 2019/7/25 20:29 <br /> Pressure change at end of steam injection(KPa)bl1 :;ikf7-1*4t* 2.0 2.1 P:49.7ti"i:-47:6 1.0 3.0 Pass teak testili"O'A 20190/25 20:29 201917/25 20-39 10 <br /> Pressure change at end of EO injection(KPa)1ME0JGJX *4t4[t 99.0 28.2 1 A:A7 9tir-197 0.0 100.0 Pass steam intectionhUX 2019/7/25 20:39 2019!7125 20:59 20 <br /> EO weight injected(Kg)D8E011 -- 0.0 10,0 Pass EO injectionMIA 2019/7125 20:59 2019!7125 21:29 30 <br /> Temperature(Tt)during EDexposure(IC)7E9fNOWINAR 49.0 Nin: 48.2 N�,z: 52.8 45.0 55,0 Pass EOdwellkrii 2019/712521:29 2019/7/285:29 480 <br /> Humidity(RH)during EO exposure(%RH)AIWIRIRM1WWN Nin: 42,9 Viii: 64.4 30.0 85.0 Pass EO Removal EO Trt,. 2019/7/28 5:29 2018/7/26 5:33 4 <br /> Pressure(Pt)during EO exposure(Kpa)*19MPrStlf ORi b --- Nin: -26.8 Wnx i -19.7 — --- Pass air washing,i'041 2019/7!28 5 33 20190!26 6,10 37 <br /> EO dwell(min)"XK41►#111) 480 480 479 481 Pass repressure fC'. 2019/7M610 20190/26 6:51 41 <br /> Numbers of air washes!ZIUM&fit 3 3 2 A 0ass <br />