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Ethylene Oxide Sterilization Process Record <br /> 7 NOUS14 Sterilizer: XM It ISterilization Batch: 2019081701 Elle!Date: 20190817 W&Order: 1 <br /> ArtWeName*M?.* Lot NoAi llf; Specificationno/!Lk; CTNINO:((11k Quantityltkiik 14?jft14jk <br /> DA VINCI Cartridges 08-19 80CTNS bp4(j ; <br /> IF <br /> Requirement%s}t Time <br /> Process Parametersiil OW Setting Value Actin Value Pass/Fail Sterilization process Start Endtime <br /> *2111 itka min�4l#i maxl8� t ^1K1fi1;4QF kMltll fF4f1X1(X! f/�1 a1tti1 map 04 <br /> Vaccumvalue(KPa)TAAVIR -500 -50.3 -52.0 -48.0 Pass HeatingIVA 2019!8/1719:17 2019/&1720:25 68 <br /> Leak test time(min)lHli1 A111 011 10 10 4 6 Fail Keeping warmM tU 20191&17 2025 201918117 21:54 9 <br /> Pressure change at end of leak test(KPa)M UfRb* — 0.3 0.0 3.0 Pass Pre-vacuum PA;Ft i' 201918117 21:54 2019017 22:02 <br /> Pressure change at end of steam injection(1KPa)buil}h'sfkMf4t4(t 2.0 2.2 ili-49 7i� ;-47 5 1.0 3.0 Pass leak testi IMA 2019017 22:02 2019/8117 22;12 10 <br /> Pressure change at end of EO injection(KPa)b0E01�fkj]1f4t* 99.0 23.3 111-47.70.-24.4 0.0 100.0 Pass steam irgeclion)XIN 20191&17 22:12 201918/17 22:23 11 <br /> EO weight injected(K9)bPEOR a_._ 0.0 10.0 Pass EO inlectiontil-M 20191&17 22,23 201918117 22:44 21 <br /> Temperature(Ti)during EO exposura(C).7FI1Pfi�l�fiiWJ1 if 49.0 gin: 48.1 N w 528 45.0 55.0 Pass EO dwell 9F114 2019/&17 22:44 20191&18 6:44 480 <br /> HumidRy(RF)during EO exposure(%RH) PABE(h48 f Min: 40.0 wnx; 58.1 30.0 85.0 Pass EO Removal EO(l R 20191&18 6:44 2019/&18 6:47 3 <br /> Pressure(P7)during EOexposure(Kpa)i�ci�NtBt(f:4KN/] --- Min: -31.1 Max: -24.4 — --- Pass air washing g6CMNA 20190186.47 2019/&187:03 16 <br /> EO dwell(min)9t:180011 480 480 479 481 Pass repressure 1k`2 2019018 7:03 2019018 7:35 32 <br /> Numbers of airwashest*01'11MAk 3 3 2 4 Pass <br />