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Ethylene Oxide Sterilization Process Record <br /> !kM#LtW-tzJ Sterilizer. *MAN,Sterilization Batch: 2019032701 HM Date. 20190327 YF?X Order: <br /> Article Name*Y, Lot NoA i" Mt V'7 SpecificationW141-T.t" CTN/NO;Vb QuantityCOR I-illC 4 ik <br /> DA VINCI Cartridges 03-19 70CTN441 Ai <br /> mail <br /> U V1�t <br /> ILI <br /> Requirement'&* Time <br /> Setting Value PasstFail Sterilization Process Start time End time <br /> Process ParametersAVOIlk Actual Value of 4 6 X Ok ki#Y it Mill(61 M*[IT ral elapsed(mif <br /> J; -M minGIMA maxMXMtEAt <br /> Vaccum value(KPa)1KA0YvI4 -50,0 -50,3 -520 .480 Pass HeatingA04 2019/3127 1643 2019/3127 21,51 306 <br /> Leak test timeiminjillIUMM14M 5 170 4 6 Fail Keeping warm 201913127 1806 201 91,V27 2251 285 <br /> Pressure change at end of leak test(KP&)MMK)JO — 0-6 00 30 Pass Pre-vacuum 04f!14, 201913127 20'06 201913/27 22.58 <br /> A, 90A 201913127 20 14 2019/3127 23:03 <br /> Pressure change at end Of steam injection(KPa)JMWJaYKMfftM 20 is iii'-50.01';-48 2 10 30 Pass leak test <br /> Pressure change at end of ED injection(KP&)Jl11EOA0Kb1M,#1 990 322 q,'J,.48 Ui-16 1 00 1000 Pass steam iniection)AM? 20IRW27 2019 201913127 23.14 14 175 <br /> ED weight Injected(Kii)JAEOR on 100 Pass ED trIjectionAl-Pi 201913127 2314 201913127 23:59 45 <br /> Temperature(TI)during ED exposur9(1C)*#1PkMMi%&A 49.5 lttw 48.2 Mwt521 450 55,0 Pass E0 oweill K M 201913127 23 59 2019IW28 759 480 <br /> Humidity(RH)during ED exposure(%RH)AIIIIIIAMM 44MIA Nin: 474 llt,x 614 300 85-0 Pass ED Removal E04M, 201913128 7 59 2019.W8 8 03 4 <br /> Pressure(PI)during ED exposure(Kpa).-XMPft 14&4411, �%tiir -210 %Ix: -161 — Pass air washing"1" 2019131288:03 201913/28833 30 <br /> ED dwell(min)*004 PI 480 480 479 481 Pass Irepressure 0-11 201913/288.33 201913/289.11 38 <br /> Numbers of air washes'.' 3 3 2 4 Pass <br />