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MMi�tft9F <br /> Ethylene Oxide Sterilization Process Record <br /> WMAN41 Sterilizer: kMAt+#Sterilization Batch, 2018112001 0 Date: 20181120 lff?k Order: 1 <br /> Article Naame*Ah K X Lot No.tl iwAt t" Specificationw4M 41 CTN/NO;I{Q CA)3f*ty*tlt <br /> DA VINCI Cartridges 11-t8 5OCTNS hnA4: � <br /> IRIV -: Kim <br /> 7Cilj:;�? :f:i7 <br /> �4 : <br /> R+lit <br /> Setting Value Actual Value Requirement E ak Passlfa:ii Sterilization Process End tkrw Time <br /> Process ParameterskI IV 0 fDt aNpsod( <br /> iS(cl<i I rift minill'JIVI maXIIXf(t ^qi/13�tli kNiiti wM I�illfft�A9 Aa! <br /> Vaccum value(KPa)�X'_?J% -50 0 -50.4 -52.0 A80 Pass Hewang Wt ,k <br /> [018**Mm t19;11 201W1112021.54 163 <br /> Leak teat tinw(min)iilirlWIN 5 5 4 6 Pass Keepingwarm Nis 201811112021;54 20181110022.54 60 <br /> Pressure change at and of leak test(KPa)*VfFbf -- 0.2 00 30 Pass Pre-vacuum talk;fi° 2018/11/20 22:54 2018/11/20 21,02 8 <br /> Pressure change at end of steam injection(KPe)JV*9Ik h*ftfA 2.0 28 dA-50.0t,472 10 30 —Pass klak lestiolitifAR 201 811 1120 23;02 2018111/20 23.07 5 <br /> Pressure change at and of EO injection(KPa)A0E0Iu Hi)J*4tffi 99.0 323 ltd-47.2k1,-14-9 00 1000 Pass steam orctionhiiV 2018/1112023:07 2018111/20 23,15 8 <br /> EO weight inoded(Kg)AOE0a 00 100 Pass I EO vwcaar1h1A 2018111120 2315 2018/11/20 23 50 35 <br /> Tempershua(T1)during EO expoxrce(IC)*SI M iliiA 50.0 11 nN 49.0 Max: 51.7 45.0 550 Pass EO dwell-kr* 2018tt 1/20 23.50 2018/111217:51 481 <br /> Humidity(RH)during EOexposurs(%RH)*MIRf)t8+(tMA Vin: 399 a:�x: 49.7 30.0 $5.0 Pass EO Removal E040 2018t11t21 T51 20/8h1/2I T55 4 <br /> Pnesure(PI)during EOexposure(Kpa)AMIW Vf*IE)J — Yin: -196 W": -14.9 --- --- Pass arwastwVIll 0AA, 20181111217'.55 20181111218.15 20 <br /> EOdw�imin)AOf04 480 461 479 481 Pass mpressure3k'* 201N11121815 2018/11/2/849 34 <br /> Numbers of air washe6jAt*JjL kl3t 3 3 2 4 Pass <br />