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atie,l U' I•i.) $f�fi.:;gann r <br /> , ,�• ., I ' •' ! 4; Flfe:tneaare 2011-04 0.5 � <br /> `; Report no.:2023051221 <br /> �;)I, Customer I '� :;! ;-_ , ( YIWU CITY SOLONG RIP $ FYP CO., LTD ) <br /> s r iftti Batch--- !r(fr� O.uanGty <br /> i uo � : ar0duct ndnte iil-} 'rop; ,h: dtnnl _--__ <br /> R[ 2024.01 61 <br /> - <br /> J�;7i Ster,Lrat,on mode t i' c'. ' E0 gas I klkjllifA41 Sterilizer no. I HYST/ST•02 <br /> Jki i F. i stet hrat,on date 2023-05.11 i k {` At Vi Sierilrzation batch 2023051102A <br /> sc k Requirements �ZwrUi Actual <br /> ktYir�i Steril nation parameters Unit Max. Min. Max. <br /> . �� Validated Min. , <br /> +_In ), t,+z) tp Ij a Loading tem. prior to preconditioning `C 210.0 10.0 / 19.8 <br /> fTt= Precondit,er,ingtemperature `C 48.0 44.0 52.0 45.7 ( 50.1 <br /> --onclit on.ng RH %RH 55.0 30.0 80.0 48.2 I 55.9 <br /> Precondit.on,ng time Minute 360 340 380 <br /> 360 <br /> �s:lt8 o. -,ans-et ti ne Minute S60 / 60 / <br /> Initial evacuation depth kPa -37.0 .39.0 -35.0 -36.9 <br /> ;:L Evacuation rate <br /> kPa/min <_4.0 / 4.0 1.7 <br /> JKLi•BJii? Pressure holding time <br /> Minute 20 10 30 20 <br /> _fir yfJ Leak test pressure rise vP <br /> kPa S!.0 / 1.0 0.5 <br /> i'. •1'' , Moisture injection time (if used) Minute 10 10 <br /> EO PP?.i EO Injection rate kPa/min 0.5 0.3 0.7 0.7 <br /> rCJfii�t SLfit. EOlnjecton :veight kg 20.0 19.5 20,5 19.9 <br /> l S:-36.4 E.1.8 <br /> 1 ; tJA . ressure rising after EO injection _P kPa t31.0 I 31.0 / <br /> EO Xr 3 � z a P:38.2 <br /> £O :?- '1 =0 ccncentrat on commenr,e of exposure Ithuor oaf) 400 800 622 <br /> mg/I 600 <br /> C 52.0 49.0 55.0 51.4 54.4 <br /> y,,h omit[ =xpos re ternoeratvP <br /> .HRH 55.0 30.0 80.0 51.3 i 60.3 <br /> Minute 720 700 740 720_ <br /> ;,1, V, (uj :xposJ+e time --- <br /> `tlL1 kPa -25.0 -27.0 -23.0 -251 -?4.9 <br /> Pest-evacuation depth <br /> kPa -S.0 -1.0 -3.0 -5.1 15 0 <br /> /1 ,rf a'rn pressure <br /> limes ?6.0 6 / 6 <br /> %urr(o-, cf repet:Lon - <br /> - fvLnute S05 1 90 120 118 <br /> }0z-(8; ; r)uraticn of flu:ning <br /> rprrlu:ion: <br /> j• .j4 <br /> Fkrfurrue d a•, (:r•r If;(' hihdnted p,ttanti'r r: sv,t'n tin nova+Dons <br /> DaW <br /> , vrv(;atOr - <br /> yt Y� „ � �• S , Z_ <br /> �w1 n <br /> :: Approval((JA): <br /> Lu.ryro,;l; Huany, Sterilization Technology Co., Ltd. r swmp .i <br />