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-- _.7 <br /> 1 <br /> I <br /> i, <br /> Z.M.K e1i iI,fli!i. A Ethylene Oxide Sterilization Process Record q <br /> Jc�tll0i� SteriGzet_ klihJtCt� Sterilization Batch: 2025032501 <br /> Fl WI Date, 20250325 YA& Order: <br /> Article Name1",Z:FAx- Lot No.'1:�ntt SpecdieaUonlll7f :` <br /> CTNINO:tnV Ouanulylk� t-�Aik <br /> 32503 0801RL <br /> ttHlt� $Ifhit': ��a:Cl-�- <br /> -_--- <br /> -- 32503 1001HL <br /> t'3TTrzge Needle - - <br /> -- -- 1201RL 3504 <br /> 'anndge Needle 32503 - — 502L <br /> 32503 1401RL <br /> <;artn�geNeBdle 150k <br /> 32503 080317E <br /> Ca:,ndge Needle <br /> _ - bllirls'st1;1! <br /> ❑Ate ❑r.o ❑tsT <br /> - Reg Time <br /> wrerne"IM E End lime <br /> Pass/Fall Sterilization Process Start time efapee0(minl <br /> Setting Value Actual Value 4laIT_*_* x1iiY8 i{19Hf41 � !tM <br /> Process Parameters-' f:7 r<l tiA � mintid•(tl ma ciIrl9t <br /> 35a 360 <br /> •:t4 0 Pass MeaUn9'.L�h 202SM2519.09 2025raM 19.10 t <br /> 35.0 19:10 2025l125 20.10 60 <br /> Vacwm value(KPa)f9)tt4t(E 0 t t Pass Keeping warmR3i <br /> t0 10 <br /> Leak test tlmeimin)IIIMMi 0t In' Pass Pre-vaeuum$11liM! 2t125 10 2�Sr7f2S 20 t5 S <br /> 0.4 e e 3-0 <br /> Pressure change in end of leak lest (KPa)711flr=_- d0:.35 Ot;.! -33 0 t 0 <br /> 3 0 Pass leak testiR�'iY.t+rt 202ST25 2015 202513+'25 20:25 10 <br /> Pressure change at end of steam injection (KPa)b0#6 ffijJ�/till -' 20 <br /> 3L y 318 111 •33 5 -0' <br /> 00 toe 0 Pass steam trnlectgn'.tli$ 2025r3/2520:25 202VY2 20.53 26 <br /> Pressure change at end of EO injection (KPa) 1IIEO1. f )JIyV1 00 <br /> t00 Pass EOInteGionhli5 202573r2520'63 2p2S/3/252230 97 <br /> ED weight inlected(fthnEORt 450 550 Pass ED&-etlki7 <br /> 2025r3rW5 22 30 2025rY28 6 29 479 <br /> _-490 4m: 460 $W 516 <br /> urel Z►k titrF tit3itlt EO Removal EOKI! 2025r3r26 6:29 2025rSr26 6 36 <br /> Temperature (T1)durhtg EO expos 85.0 Fail <br /> Yin: 93 0 Nn r 906 0 2025r3r26 6.36 2026r' 7 19 ; <br /> Humidity IRFi) during EO exposurtq% RH I k ON10 m.4N 19 _ Pass air washing i•t111tk _— <br /> e '3 �Mrf31P1�ik/7 Cn- -60 Ilnr_ _"025r3f25719 2025t3?675_' ?3 <br /> Pressure(P/)dunng EO axposurs (KP ) -_-'1 Pass tepressue ih - <br /> 48G <br /> 479 4711 Alit <br /> EO dwell (min)WOMI A" 5 7 Pass <br /> b 1 <br /> Numbers of air weshee!M)'1't£" <br />