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liiifiali Report No,: 2020092417 <br />V-1 Customer <br />#ItiIApproval by: ,,,a1' <br />X si ilffif ltiilf tli I 1 {j 4 itJ (YIWU CITY SOLONG IMP & EXP CO., LTD) <br />Product codes <br />r'r`Ali 4;*Product Name <br />JIMSpecificatlon <br />#ti;;Lot No. <br />W1Okymio, <br />/ <br />f4f1 <br />Tattoo Needle Cartridge <br />RL, RS ,RM ,M I <br />05/2020 <br />72C 1 rr t� <br />Sterilization mode <br />X099 <br />Chamber No. <br />7FIin��1 <br />Sterilization date <br />Tctld#tt�; <br />$ter. Lot No. <br />EO `t(CG7cf EO•Gas <br />211 <br />2020.09.15 <br />2020091502A <br />TcWOR Sterilization parameters <br />U)t Validated <br />tilfoJ0 4 Tolerance <br />DRi; Actual <br />3W1:t° IM Preconditioning Temperature ( IC) <br />48 <br />t4 <br />45.49,7 <br />YjAj2jX Preconditioning RH (%RH) <br />55 <br />t25 <br />42.8.59.9 <br />ffi !4ltin, Preconditioning Time (min) <br />360 <br />t20 <br />360 <br />YAM! Evacuation Vacuum (kPa) <br />19-fiilli n7 Keep Pressure ( min) <br />xffifijimAjft Weight of EO Injection (kg) <br />-37 <br />t2 <br />-36.9 <br />20 <br />110 <br />20 <br />20 <br />10.5 <br />2041 <br />RJM1AIAi** Rate of ED Injection (kPa/min) <br />7FlWi4TWR1Y EO&Concentration (rap./L) <br />EO MiAlIM01 ))((( EO Injection Pressure Changed(kpa) <br />01111111011 Exposure Time (min) <br />0.5 <br />10.2 <br />0.50 <br />600 <br />1200 <br />534 <br />>31 <br />// <br />S:-36.2 E'r3.4 <br />720 <br />120 <br />720 <br />7FIWa91 Sterilization Temperature CC) <br />52 <br />t3 <br />50.9-54.8 <br />XMiV& Chamber RH of Sterilization (%RH) <br />M't)l4 M. Post Evacuation Vacuum (kPa) <br />55 <br />t1S <br />47.7-64.5 <br />-25 <br />t2 <br />-25.0 <br />*a%&OR The Number of Ventilators(Times) <br />6 <br />// <br />6 <br />0101+0 Strain <br />Badflus atrophaeus <br />ATCC9372 <br />%f'ff44,12NominalPopulation (cfu/unit) <br />1.8x106 <br />81 It'if Lot No, <br />200810 <br />0 (ti D•value (min) <br />3.1 <br />)MRIX Culture Temperature <br />35V <br />ift"11 dI Culture time(days) <br />7 <br />f(F0I3Mculture Date <br />2020-0 mW2020.09-23 <br />*014(u7Culture time (day) <br />1" <br />2"1 <br />3'1 <br />411 <br />St, <br />6th <br />7111' <br />JX*i9A Observed Item <br />— <br />— <br />— <br />— <br />— <br />— <br />— <br />6fiAX01 Posltvecontroi <br />f <br />+ <br />+ <br />+ <br />+ <br />+ <br />+ <br />iiiA#i?7G'�l)�i:lifliii�e2` tri flF Bi test of sterility <br />^c, #ii conformity no II <br />Mi$ conclusion: <br />lt.L•,�ddjl�iir�IC1&�f#fL3lE7Ct�N, 'S•1�TAg4s�t��. 3,:i��k'iz 10� �4�J(� <br />The sterilization cycles were performed as per the validated parameters with no(n Ste rance <br />Level(SAL)of 104 Is assured. <br />:a! <br />#R?i El JirJ Report <br />�>1F Company <br />R.Yve 1.Y> <br />RSF- <br />