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Ethylene Oxide Sterilization Process Record <br /> X M#A-4-Sterilizer- *0#03-Sterilization Batch; 2019032701 HM Date- 20190327 JU),Order: <br /> Article Name,401di-tX Lot No.It.�fftvi SpecificationIN44/41 ca CTNINOAD Quantityllk fik T-i'4�k <br /> DA VINCI Cartridges 03-19 70CTN <br /> 0f9=-t,t <br /> Will t In- <br /> J*0 J11: AI <br /> IV"ITT 11%1,Irv; <br /> DI:; Li 4 W_ <br /> RequIrement'M* Time <br /> Setting Value Actual Value Pass/Fail Sterilization Process Start time End time elapsed(mir <br /> Process ParametersiflY.011 )f MINI to] M*11f fill AN <br /> Vaccurn value(KPa))JI AIM -50.0 -W3 -520 -48,0 Pass Heatingiii0k 2019/312716:43 2019/3127 21-61 308 <br /> Setting <br /> Leak test time(min)WM1NiA#lNJ 5 170 4 6 Fail Keeping warm A,j14 201913127 18:06 201913127 22:51 285 <br /> Pressure change at end of leak tog(KPa)MtMF,)Jfft 0.6 0,0 3.0 Pass Pre-vacuum)AM, "G 201913/27 20,06 201913127 22"58 172 <br /> Pressure change at end of steam injection(KPa)bnJVA3l`I1JJV4t#1 2,0 1,8 iriy-50.0ki,-48.2 to 3,0 Pass leak testANOM 201913t27 20 14 201913127 2103 169 <br /> Pressure change at end of EO injection(KPa)bQE0A3K)J14A 99.0 322 1FFI:-48.Wi:-16 1 00 100,0 Pass steam injectiontimW 201913127 20-19 2019/3127 23:14 175 <br /> EO weight injected(I(g)ME0111 --- 0.0 10.0 Pass EO injection)AW)i 2019t3127 23,14 2019/3127 23:59 45 <br /> Temperature(TI)during EO exposur*'C)*MWM#i.l$1AJ.q, 49,5 Mto: 48,2 lla%: 521 1 450 55.0 Pass Mdwell;kM 2019/3/27 23:59 201913/28 7-59 480 <br /> Humidity(RH)duting E0exposure(%RH)MI11*14#4MA Min: 474 Max: 61,4 30O 85.0 Pass EO Removal E043lta. 201913/28 7:59 2019/3128 8 03 4 <br /> Pressure(PI)during EO exposure(Kpa)AIW11ftfRM!*X)J Min: -210 Vax! -16.1 Pass airwashing"1' 201913/288:03 2079131288:33 30 <br /> EO dwell(min)XM04M 480 480 479 481 Pass repressure fik';' 1 2019/3/28 8:33 201913/289.11 1 38 <br /> Numbers of air washes!'-"V+WX 0 3 3 2 4 Pass <br />