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WALL Milt!k!A Ethylene Oxide Sterilization Process Record <br /> X ik#L%i q Sterilizer: X 01i At 9 Sterilization Batch: 2018121301 it 41 Date- 20181213 JR&Order.. I <br /> Article NamoftMt# Lot 1`40.1i"Ift%','- SpecificationM1411.N CTNlt40;Xlft Quanbtylk.11 <br /> DA VINCI Cartridges 12.18 70CTN M9 Af A <br /> *0 W <br /> ARM M-, ' : <br /> ickMl <br /> Setting Value Actual Value Requirement'V* Pass/Fail Sterilization Process Start time End time Time <br /> elapsed(mi <br /> Process ParameterskINVIlk <br /> minjgI,M maxf;kM rii) M*111110 1ER4 <br /> Vaccum value(KPa)fik A 111.1t -Wo -503 -520 -48,0 Pass Heating)jwla 201EV12113 20 30 2018112113 23'11 161 <br /> Leak test Urne(min)XIMMM 5 5 4 6 Pass I Keeping worm Wi'V, 2018!12113 23 11 2018112113 2313 2 <br /> A�­P,,.uniichange at end of test(KPs)J11Wl0A 02 0,0 3,0 Pass Pre-vacuum tll!�Nik",' 2018/12113 23,13 2018112JI3 23:20 7 <br /> ressure_In,at end of leak test(VIP-wo li;141 — <br /> Pressure change at end of steam Injection(KPa)hDJWQIRMtftM 2,0 26 iiil 50 Of.. -47 4 1 a 30 Pass leak testAl M A 2018112113 2120 2018112/13 23:2 5 <br /> Pressure change at end of EO Injection(KPs)h0E0A7WJ*#Atft 990 30.6 iii!-47 4-6, -16 8 00 100,0 Pass steam ojectioniftIA; 2018!12113 23,25 20I8/12/13 2336 11 <br /> EO weight Injectecift)JAE0111 00 10,0 Pass EO injection),uh 201811211323:36 201&12114010 34 <br /> Temperature(Ti)during EO exposure(r)ANKMIX&A Soo Min 490 11;4x: 50,6 45.0 550 Pass EO dwell,-K M 2018/12/14 0.10 2018/12 14 8.09 479 <br /> Humidity(RH)during EO exposure(%RH)-*1%WMW1WJW,& --- %Uw 38,6 473 WO 85,0 Pass EO Removal EOWt 2018112/14 8:09 2018!12114 8:14 5 <br /> Pressure(131)during EO exposure(Kpa)A 1111WIM400i -- Min: -216 Uax: -16.8 — — Pass air washing 2018112114 8.14 2018112J14 0:34, 20 <br /> EO dwell(min)*111111,tM 480 479 479 481 Pass repressure tPx-r, 1 2018112J14 8 34 1 2018/12/14 9:08 34 <br /> Numbers of air washe%;!2'U+&Mk 3 3 2 4 Pass <br />