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0 • <br /> 040020010005/rev 01.1 /09.01.01 Page:1 of 1 <br /> ETO Sterilisation Certiricate <br /> s X, Effl-0 <br /> Af f.4 General Information <br /> XM#tt' Sterilization No. 11407111 <br /> W;9V1;AT*-k' O&M*) TATSOULSPEARMAN,INC. <br /> Customer name/order NO.(delivery note) <br /> lftt H M Date of reception 2014-07-09 <br /> M-ifllf Temperature of Environment 22'C <br /> �a` Name of proudct 40 4 T odes u 1t" Product LOT Cases <br /> TATTOO NEEDLE 140701 80CS <br /> )IV- Physical Process Data <br /> f'-!Ffi_Plr P1 Preconditioning time 9h <br /> X tW 8 X11 Date of sterilization 2014-07-11 <br /> 7FM#It41, Chamber No. 1 <br /> TCM#tt 1 Sterilization No. 11407111 <br /> nt, W Aeration time 12 h <br /> ifMj?; 3�91 X-M, <br /> The detail date of the precondftioning,stehlization,aeration process please refers to GOALS, <br /> z�# 1 Result of physical process control <br /> The physical acceptance criteria of the preconditioning,the cycle and the aeration were in <br /> compliance with the validated specifications of cycle no.zQM <br /> OtOXWORMIcrobloloulcal Process Data <br /> The microbiological process control with biological indicators has been performed according to the <br /> BI sterility test SOP 032005 . <br /> 14T,w*-#fAw19^BI. Biological Indicator strip <br /> No of biological indicators 19 per chamber load. �+l*F*Manufacture:Future <br /> A j9 LOT.: 140705 <br /> 1TWIM Expiration Date:20160704 <br /> t s-rrr-Ll M Date of incubation 2014-07-11 <br /> M-ri4ift Incubation conditions 7 days at 35t21C. <br /> 09-: YARMA Result of microbiological process control <br /> TG37-iS <br /> > No arowth from Bacillus subtilis has been detected. <br /> ; 31 Remarks: <br /> GOALS QA <br /> 1CgT R 91 Date of release: S� Sig re/ ' <br /> - F <br /> J��1 i1=tet• �t <br /> ,r' <br />