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EO1cMJ1flM#Ak*1kAEO Sterilization process specification review <br /> {it{r C 7FMAt4J <br /> Sterilization condition I YN/LF-01 Sterilization Run No. 202307030201 <br /> ajitfff A �I:P*fff <br /> EO sterilization process steps Set point Limits Observation Acceptability <br /> HumidificationjnJlW <br /> Steam injection pressure rise P1 <br /> bW9.l:JJ4k .UPl (A kPa) / 0 4 19.7 > -18.5 $ {uass <br /> Steen injection pressure rise 132 <br /> >nliia�/1 P2(AkP.) 0-4 -19.6> -18.4 o Mpass <br /> Relative humidity during humidification HI <br /> 1JIIT$i:trbstfrlil (%Rif) 5(1 0 -80 35.7-50.9 a{$pass <br /> Relative humidity during humidification HL <br /> JJW9kt4Y,iVJkII2 (%RN) 50 0 Ho s6.1-52.2 �{i'Ipass <br /> Humidification timehllt6dllf(U) (min) / 0-- 30 0_g n{ypas„ <br /> Humidity dwell&N <br /> Relative humidity during this period III <br /> {:i5d it{�(I(1iSi':isful (%RH) 0 80 38.6 59.1 ^f#F Voss <br /> Relative humidity during this period I12 <br /> f)ili kIIYWJ(&IStIl2 (%RII) / 0 80 39.0-63.H n {Vass <br /> Humidity dwell (min) 10 9- II 10.0 �{JF pass <br /> N2 injection A K't*1+aA <br /> Increased pressurr due to N2 injection PI <br /> FJ1 Mill (ki'a) <br /> Increased pressure due to N2 injection PI <br /> A`(7 Aff,)J1.)TfftPl (kPa) <br /> EO injection EORA <br /> min:33.6 <br /> Temperature of LO injection Eoi1J.iGlJf (C) / 12 50 max:39.1 AM pass <br /> EO injection pressure rise PI <br /> LOft")JIMfill'I(OkPa) 10 40 33.5 -4iVass <br /> FO injection pressure rise P2 <br /> Eoii1XM)J!9E{tti�1P2(AkPa) 10-40 33.5 U{i�pass <br /> EO concentration (Pressure changed) <br /> EO Oft (1Lb Vit) (m L) 300 800 592.0 -1#pass <br /> 11) injoction time WOtAlftfnl (min) / 10 - 90 54.6 AMpass <br /> EO injection weight L'Oi:j:� �tt'&{4".ki (/\kg) 14 13- IS SjA90)39.9 !;}ilpnna <br /> EO concentration after EO injection d.elling (sensor) <br /> 999 0.0 {Apaaa <br /> N2 injection B 'K6tttXB <br /> Increased pressure due to NZ injection PI <br /> (kPa) <br /> Increased pressure due to N2 injection P2 <br /> 9 01ATIJJ F ffMP2 (kPa) <br /> EO exposure POfVM <br /> EO concentration at the exposure start from SEC sensor <br /> Tc7F#Irt31eo3tF1?e(mg/L) 0 - 999 0.0 - o.o ${�4pass <br /> Temperature during this period EO TlfVnJAPiiQ1QTl (C) 49 4.5 - 55 49.1 51.0 ${}{pass <br /> Tmporaturc during this period LO TZ1t/Hdf)-N.t,LtT2 (Y:) 49 45 - 55 49.8 - 51.6 �414Voss <br /> Pressure during this period EO PIf1aAJtht1k)JPl (kPa) -10 30 7.5, 11..1 {}{Ifpuss <br /> Pressure during this period EO P2{)=fHA-FL!11JJP2(kPa) -10 30 1.7 14.6 o♦'{FVass <br /> Exposure time FAJ'FJHlblfal (min) 480 479 481 480.0 d�fipass <br /> �3 tf1/1J<9�1 <br />