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J�f XZ,9W IM AMIA Ethylene Oxide Sterilization Process Record <br /> X10WW Sterilizer: X PIA-9 Sterilization Batch: 2018041001 F3 J91 Date: 20180410 JA&Order: 1 <br /> Article Name*At* Lot No.1l:i"Mt1 SpecificationlltW1411 CTN/NO;Sllik Cluantitylli(tlit <br /> DA VINCI Cartridges 04.18 50CTN bU> `i; gig <br /> 0fV- : lair <br /> Vra��u. � ��yy����{ Ik .fes <br /> oft Jt1'>.- o Trr �... ..�.rA'Tri 0*T <br /> Requirement'1'* *«> Time <br /> Process Parametersz`f#"c(yik �^rJ Value Actin Value PasslFail Sterilization Process ^^8tatt t End time <br /> � e1W4f1 minlRd�4fi maxAil�4Y � 1 T�'4b kiii#4' MJffR4rl elapsed(m <br /> Vaccum value(KPa)HG!"9A -500 -50.2 -52.0 48.0 Pass Heafing))OA 201814/10 21:24 201814110 23:11 107 <br /> Leak test time(min)91tUXbt0jtfa1 10 5 4 6 Pass KeepingwarmW94 2018/411023:11 2018/41110:11 60 <br /> Pressure change at and of leak test(KPa)lM MlkJJ(A --- 0.3 00 3.0 Pass Pre-vacuumMlifi ft'i! 2018/4111011 2018141110:19 8 <br /> Pressure change at end of steam injection(KPa)bl1*)RI91JJ4b* 2.0 17.3 1.0 3.0 Fail leak testdl944A 201814/110:19 2018/41110:24 5 <br /> Pressure change at end of EO Injection(KPa)bUEOJ9JR)J1f4k9Y 99.0 36.6 1 K:-32.3ki:4.3 0.0 100.0 Pass steam injectionbui4i 2018!4/11 0:24 201814/110:44 20 <br /> EO weight injected(Kg)hgEO$ --- 0.0 10.0 Pass EO injection WRi 2018/4/110:44 2018/4/11 1:03 19 <br /> Temperature(T11)during EOexposure(C)X1WIrlA4E4k A 49.0 Nin: 49.1 11nx: 52.2 45.0 550 Pass EOdwellACA 2018/41111:03 2018/4/119:04 481 <br /> Humidity(RH)during EO exposure(%RH)7i:IMOElk 4 M)k -- Min: 40.6 Max: 56.6 30.0 85.0 Pass EO Removal E0J4Jt- 201814/119:04 2018/4/11 9:10 6 <br /> Pressure(P1)during EOexposure(Kpa)X181*11AM41r9b --- Min: -1.8 Ilex: 4.3 --- --- Pass I air washing It"'04A 2018/41119:10 2018/41119:28 18 <br /> EO dwell(min)*1104M 480 481 479 481 Pass repressure fit y! 2018/4/11 9:28 2018/4/11 10:00 32 <br /> Numbers of air washes+,T%??l!%?k* 3 3 2 J 4 Pass <br />