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Ethylene Oxide Sterilization Process Record <br /> ,K91VAq Sterilizer: :kMjltl S►oriliza(IonBatch, 2021120701 <br /> UM Oate: 20211207 411�:Order 1 <br /> Article Namew79- 0; Lot No.'I:,njftl, SPecdIcationi. CTN1N0;1111a OuarvityRit <br /> t,A a r aye neeoro 21-12 N1213M1G1 <br /> 10DMmes til <br /> t4i: Psfixtt -- - <br /> - 7t _t1r_ — <br /> �6 n ti8 A. <br /> Setting Value Actual Value Requirement!V.f T me <br /> Pracess Paramctersiinip t PaswFail Sterilization Process Start time End time <br /> 19 d :R.(a minfk4,lli maxRi:jC �414i^, 4 kpgi2Fi 7(Y,„ir?;q �Atg1 S etapsed(mm) <br /> P Pi <br /> Vaccumvalue(KPa)RAITI 350 -354 c <br /> y_0 -34.0 Pa_s- Healingtilkl 202102J121:04 21021112l72127 <br /> Leak Zest lime(minJfit9t13 Otfllj 1 10 9 11 <br /> P.rs KeePrrgwarms3, 2021112772127 2o2im2172227 60 <br /> Pressure change at end of leak lest(KPa)MI JJ&jl M -- 0.3 00 30 Pass Pre-Vacuum piai At'1' 2021112f12Z:Z7 202111217 22 32 5 <br /> Pressure change at end of steam injection(KPa)M$09;};jtR,(R 20 22 M:•34,99:-W 1 0 30 Pass to51It Af0;jtj 202171T/722 32 2021I1217 2142 10 <br /> Pressure change at end ofEO Injection(KPa)38EOhi10itit4t 328 328 dJ-33BIi'•08 0.0 100.0 Pass steam injeciic ii 2021112/722:42 2021112J72312 30 <br /> EO weight InjectedlKg)tpEOil — 0 0 100 Pass £O irt)ection:ll Pi 202111W 23 12 202111217,23?8 16 <br /> Temperature(711 during EOexposure(1r).-,XfJ rR#!%8Dt 490 Yin. 460 01,u: 516 4:.0_ 55.o Pass EOdwelkTa 2021112,72328 2021/1218776 4g0 <br /> Humidity(RH)during EO exposurel%RH)kIp K#-!IAffl J -- Min; 469 V.,, E3 5 KID 65.0 Pass EO Removal EOlj fS 2021112/87 28 21Mif1218 7 34 6 <br /> Presmire(Pt)during EO exposure Mile)-TcX PZO, will -67 lhe: Oct - <br /> - - Pass air washing�'L�' 202111218 7 34 2021112tS 8 1% 43 <br /> EO dwell(min)A 111114 N 460 400 s79 481 Pass repressure 2021112/8617 202111216849 32 <br /> Number;of air 6 Pass <br />