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_ Aa1111i ktChkltJ,iiJ - Wuxi %hushi Sterilization Factory <br />Y1'1 Ei 1'i Ic \umber 1/.I,f 1T01 05 02 lid*/f%i Vi Version/revision number <br />Original Record of III Growth Test after sterilization <br />Customer:. Suzhou Lengfeng Medical Instruments Co Itd <br />Ahfpl;w Product \400: KIi,1URON \IiI;I11.Gti <br />,"j <br />B/1 <br />li;i <br />W7:1J14A Test Sta <br />I'rorlurt <br />Lc,t : <br />11(Ni, 0;''til1 <br />0"I; <br />Om) Oxl 1182' (Nix <br />flu 113 <br />01(17 Illllx <br />nl �►, ul.O, <br />nl:t;, <br />0I�'tiil%. OI:I�.. 012 <br />01418 <br />ill11.4@, <br />of to <br />o <br />10 Ojl j <br />Hoc iIIus <br />Otrophocus ATCC9372 <br />Hangzhou Future Biotech Co.. Ltd <br />u"o4 n""„ u''"'1 <br />rr <br />ti <br />6='171 1 0041 <br />03031 11 <br />r, <br />130ATS, 030k,03112 <br />03101 <br />IJL 0,1121T <br />oil 1 <br />031•,1 <br />T 0.11(; n'4"12 032;1 <br />03^1 <br />03 <br />(K4'(1 (r4 <br />(I,I,1l, 03.t2, <br />01111. <br />()-1081 <br />011 M1(1111 <br />O '!) <br />irt-91 <br />,I <br />1 r►;,:4r� <br />Temperature: :36°C <br />ij)4tlxttuj Culture time: 7days <br />65L <br />j <br />012111 (A)2t(A)2t 416214A, <br />a1' 7l <br />1 <br />(tt' at o" ri <br />1;,. <br />115M) Oa5(1 <br />121 Al0:,181 <br />T 0:520 <br />0,521 <br />06;011T a ON) IKTti (II ll' (k;0:4 (Mi(II <br />1 <br />1 I),t <br />(WIL', W417 061.18 (M;rN.►. <br />1)11091 T. 1ki1(I, <br />0611 <br />(N;Ii (N;I8 OI 231 <br />(N;"I <br />KoI <br />(17(13 117011 07(N)t1 <br />O7IOKTti <br />9 <br />)7 1 #�ka 07 Ho 071 <br />0 (I <br />0+x'1, (I,,:,,, <br />0907, <br />OX25a <br />0901 (Nlll'I A <br />(Mimi <br />(NN)') <br />(Nllki (NN)7 INgNI INt1i1 <br />1 <br />(M1191 5 (YR22 (024 <br />(0.1 241 1 <br />1007a 1015 <br />IOIh <br />I018 <br />101 )IO.4t1 <br />I tat0 <br />11084 <br />111 I 111:, 1118 I <br />I I !L I <br />12 Oa <br />I I2'@2MZ 112131 <br />1 11 t <br />I129KTS, 11:40, <br />1207, <br />12Iv5, <br />121ti, 1="I <br />120211 <br />12295 1228 1"4"9 1231 <br />- <br />MniFl <br />Test Item: <br />431 Growth Test Record <br />l:`XIIJUl <br />test Datu, <br />4H <br />2021 <br />ndard: ISO 11737-2:2009 <br />MR99 Test F(IuiI,n,unt: <br />104MA N ItI Ii=�t'f Electric Constant temp Incubation Container, <br />k9 <br />�'�i;Vfi fest Record and Result: <br />iQ i:f}� Ultrs-Clean-Bench. <br />1, 41Eu�,P,rl�# !,ample Prepared: 4�l4;f1�11i1J�}l�r��, i�Cii�C Hake Incuh:ttiun Medium, Test Liquid <br />according to standards <br />2, }$'911/1 h Test Method: i'[MMAo N IA 't,"ibA Direct Inoculation,Viewand Record Everyday <br />Pit!111rttL I)''1cr•tion r.nrnolusi„n: <br />i'sc111;iJ�kl�ll711i'l� IS()111:4;•2U14 }-rflf.tt'1'�i%ktrScV <br />'i✓�1J�T�/1%1�10)•t�id��=rlc Bl Growth Test Record Time Table <br />Strain: <br />IG1JiPit111 431 Manufacturer: kn#i,W'3:tt7F#t �if�l4`d <br />Hoc iIIus <br />Otrophocus ATCC9372 <br />Hangzhou Future Biotech Co.. Ltd <br />131 <br />Lot NO. :200825 <br />tMd6rfift Nominal Population:1.7x 106cfu/unit <br />irt-91 <br />Incubation <br />Temperature: :36°C <br />ij)4tlxttuj Culture time: 7days <br />t ,VjvfAq <br />Strip \o(1 269) <br />(1 <br />1:14) <br />1 <br />2 <br />:3 <br />4 <br />5 <br />6 <br />7 <br />8 <br />9 <br />10 <br />ll <br />12 <br />13 <br />24 <br />hour <br />- <br />- <br />- <br />4H <br />hour- <br />168huur <br />(II <br />-264) <br />14 <br />15 <br />16 <br />17 <br />18 <br />19 <br />20 <br />21 <br />22 <br />23 <br />24 <br />25 <br />26 <br />24 <br />hour <br />- <br />_ <br />- <br />- <br />- <br />- <br />- <br />« <br />48 <br />hour- <br />168hour <br />- <br />- <br />- <br />- <br />- <br />kPi <br />Result: <br />(1 <br />250) <br />(26~x) il•t iF2l 18 1%R4h1%ffI1ATAku <br />After ItiH <br />hours <br />Incubation, the(I 250nre <br />no bacteria growth.l'osttivel''ti#)hacuvir, growth well. <br />il-1 <br />`ote# <br />4:sPI l: represent negative, <br />(t), ke%Plf[: represent positive <br />ll f@1�, ti�'i}tn�lyi� 111 (1 254:) �:1'k. <br />1t'1.t'11K+•i;fill iiiIt:Kt`4, R11)J �lEr�:kt'�r,S„kl'i <br />All testing Dis no bacteria growth except the positive control growth well. It sho ` at<�poplit�ii of this Lot <br />Is qualified. For this tot, the placement of DI and tolla�e <br />ated on ISO 11135:2 0 , Tjie results intima .d that, <br />t�J ii`f Test by: I 4% ti i t1 N( Review by: 111f� XRIIl! ;'1 1 I Jul poi t pat <br />1 <br />4141 Com qy $tam <br />Page 2 0l 2 <br />