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2f'4Ws 0vc. Nv. rfrsr/grl2-2s-oG <br /> M il:rmkj Vu:sion No.r 0/B <br /> nonn,i >ncinremsx Certification of EO Sterilization <br /> !f.RtUWiEffective date: 2021.04.05 <br /> #612G s Report No. : 2021070230 <br /> 9P Customer 2�Z7: r5 X � 1ff�sl�j$ tfi [7 � iS(} 74 �l YIWU CITY SOLONG IMP&EXP CO,LTD <br /> i"' nu $ t Product Name reM Specification fit 9- Lot No. 1� Quantity <br /> Tattoo Needle Cartridge RL , RSJ RM 2021/06 20CTNS <br /> Tc�7a` � TcT�i � 7Fi�iQ1(�1 ki�i#tt � -- <br /> Sterilization mode Chamber No. Sterilization date Stec Lot No. <br /> EO rLf# Ply EO-Gas tri 2021-06 23 2021062302A <br /> TCI$ #t Sterilization parameters ift)t Validated ki-TMA- Tolerance 3IMT% Actual <br /> MIAMI Preconditioning Temperature ( 'C ) 48 ±4 44.0-51.7 <br /> 9::ARA Preconditioning RH ( %RH ) 55 ±25 40.2-57.6 <br /> MITA n Preconditioning Time ( min ) 360 ±20 360 <br /> ffk'Ai Initial Evacuation Vacuum ( kPa ) -37 ±2 -37. 1 <br /> f4OUE11 fn) Keep Pressure ( min ) 20 ±10 20 <br /> )MIMAI Weight of EO Injection ( kg ) 20 ±0.5 20.0 <br /> XffiPtVJflAA* Rate ofE0Injection ( kPa/min ) 0.5 ±0.2 0.6 <br /> )TM if*Mft EO-Concentration ( mg/L ) 600 ±200 541 <br /> EOiT- A �'Ji Fffijjfft EO injection Pressure Changed(kpa) > 31 /J S:-36.5 E:-3.3 <br /> f'� flOffaExposure Time ( min ) 720 ±20 720 <br /> T. INEAE Sterilization Temperature CC ) 52 ±3 51. 1-54.2 <br /> 'F, f`{ MIChamber RHofSterilization ( %RH ) 55 ±25 43.2-61.9 <br /> 1fIis 1, M Post -Evacuation Vacuum ( kPa ) -25 ±2 -24.9 <br /> A `t`t ; tThe Number ofVentilators(Times) 6 // 6 <br /> Bacillus atrophaeus <br /> �$ i�l#IStrain SFfi�"19NominalPopulation ( cfu /unit ) 2.2x106 <br /> ATCC9372 <br /> BI lit q- Lot No. 20210302 D f l D-value ( min ) 3.0 <br /> }SsM1 Culture Temperature 351C }A ORIfal Culture time(days) 7 <br /> 4011,11`6100 Culture time ( Days ) 2021-06-24-- 2021-07-01 <br /> Culture time ( day ) 1 2 3 4 5 6 7 <br /> NMEA Observed Item — — — — — — — <br /> PHffRlftfi Positve control + + + + + + + <br /> t lJ3ua qT i 9 a Bl test of sterility e M conformity ❑ T AA non-conformity <br /> fNi8 conclusion : <br /> 12� Snj2E #iN' f ( Zii'BTeI'# . ,rTe7(A#f : 3cj2hfi10-6TilbYeul . ` knftit�C #7 = <br /> The sterilization cycles were performed as per the validated parameters with no deviations. The Sterile Assurance <br /> Level(SAL)of 106 is assured. <br /> #ft7fEApproval by: R e Z/ , Z <br /> ink Mp % <br /> MIME 1 / 2 <br /> QUALITY RECORD <br />