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A..r ��I <br /> f G kt'kii';it i Ethylene Oxide Sterilization Process Record <br /> kla MA''-Sterilizer: Xtfift Sterilization Batch: 2018050601 HMI Date: 20180506 tffrX Order: 1 <br /> Article Namre*,W,�94 LotNoA 'I'tt°; Specification ill!f?i!Vt} CTN/NO;V t ouantitylJcGl <br /> - Envy Cartridges 17.06 5CTNS 111 rf <br /> uirementti R <br /> Process Parametersi'I#"i' I4 Setting Value Actual Value ReqPasslFall Sterilization Process Start time tEnd time Time <br /> iia;i f ��Frfdi --- — _ ___�_ ^, /f� {)F ktltiilP+ `1f [t�I i„kint ? elapsed min <br /> mifl&'I' maxAl KIff <br /> Vaccum value(KPa)it A lilt 50 0 -502 -52 0 -48 0 Pass Heatfng!„I#k_ 20181516 20 06 201815/622 15 129 <br /> Leak� test time(min))�,fAMiitltt n 5 5 4 6 Pass Keeping warm(ti 20#8/516 22 15 201815/6 23:15 60 essute change at end of leak test(KPa)MIWti,./JUS --- 0.3 00 30 Pass Pre-vacuum f!J k;e, 2018/5/6 23 15 2018/5/6 23 22 7 <br /> 3ressure change at end of steam Injection(KPa)IAI*h'I-Jii,ll4�(M 2.0 7_.2 i� 4891, -47 7 T 0 30 Pass leak test i0 iC{x A 201815/6 23:22 20181616 2327 5 <br /> Pressure change at end of EO injection(KPa)JAJE01u R 1l�ftf€t 99 0 t45 5 N4-47.9$,_, -2-4 00 100 0 _—Pass steam snlecxani l-W 2018/516 23 27 2018/51?0107 40 <br /> EO weight injeeted(Kg)ME0111 00 100 Pass Eta injection NIP, � 2018/517 0 07 20181517 0 57 -� 50 —� <br /> Temperature(TI)during EO exposure(r)k PAWR 4MIQ 50.0 N i r,; 489 ti:,x. 622 45.0 550 Pass EO dwell;~_tti 20181517 0 57 2018/5/7 8.57 480-- <br /> Humidity(RH)during EO exposure(%RH)k MWPAIIi i+1>`IA - ti1:,,. 466 'M-. 63.9 300 850 Pass Et)Removai EOMlt 2018/517 8 57 2018/5/7 9.03 6 <br /> Pressure(P1)during EO exposure(Kpa)'h tAr'f1#itll.ft f 7a 111 t, 12.0 H:,x -24 _ Pass air washing 20181517 9'03 201815/7 9 20 17 <br /> EO dwell(min))Cflf`fal 480 4810 -479 - - 481— -Pass repressure ht" 2018/517 9 20 20181517 9 53 --33 `— <br /> Numbers of air washes'^',,Y6i;?kJ& 3 3 2 4 -+ Pass <br />