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W r� �AZiAX04R p f&*rA� All <br /> zw;n A N1MITAN vi \ersion No. i <br /> WIMI f Z. kil=lfx**FPR r 01 Certification of EO Sterilization <br /> Zhellang Huanyl Ste illation Technology Co.. ltd. tAt8Jill 2020/01/02 <br /> Effective Delc <br /> #� agns Report No.: 2020031310 <br /> ?4P Customer ( YIWU CITY SOLONG IMP & EXP CO.r LTD ) <br /> 71AIMP Product codes r" lla ZEA Product Name 90 Specification #Ii -5 Lot No. %t:9 Quantity <br /> / iRL , 3RL, SRL CP0402086 6000PCS <br /> Eyebrow Makeup Needles <br /> Tc �7i z� TC�I �$ TC� Q � 7FI�J #1�s' <br /> Sterilization mode Chamber No. Sterilization date Ster. Lot No. <br /> EO dtii* XM EO-Gas 2# 2020-03-04 2020030402A <br /> kf Of Sterilization parameters *5% Validated k404 Tolerance WV7 Actual <br /> jfj%7rmFxPreconditioning Temperature ( 'C ) 48 ±4 45.1-51.1 <br /> WAWA Preconditioning RH ( %RH ) 55 ±25 42.2-62.3 <br /> Mi ARIN Preconditioning Time ( min ) 360 ±20 360 <br /> ]A�! Initial Evacuation Vacuum ( kPa ) -37 ±2 -37.1 <br /> OffiR# fH7 Keep Pressure ( min ) 20 ±10 20 <br /> XMMIN AMweight ofEOInjection ( kg ) 20 ±0.5 19.9 <br /> XffiA9/1i'lAA * Rate of EO Injection ( kPa/min ) 0.5 ±0.2 0.49 <br /> X _M4t#A fj EO-Concentration ( mg/L) 600 ±200 538 <br /> EO tftA. e rW39[ EO injection Pressure Changed(kpa) > 31 // S:36.5 E:-3.5 <br /> j'� )flIritrul Exposure Time ( min ) 720 ±20 720 <br /> XMMP� Sterilization Temperature ( 'C ) 52 ±3 51.2-53.7 <br /> Teti.911 Chamber RH of Sterilisation (%RH ) 55 ±25 46.2-65.9 <br /> jt 'i } "s"IRPost -Evacuation Vacuum ( kPa ) -25 ±2 -25.1 <br /> #fit iMk The Number of Ventilators(Times) 6 // 6 <br /> r`4IVRP�A Strain Bacillus atrophaeus ATCC9372 VI$*j)iF NominalPopulation ( cfu /unit ) 1.8x106 <br /> BI #tt-F; Lot No. 200118 D fk D-value ( min ) 3.0 <br /> if rp t Culture Temperature 35°C fgrpafffl] Culturetime(days) 7 <br /> torr Q PA Culture Date 2020-03-05^2020-0342 <br /> k9-nnff7 Culture time ( day ) 1$t 2nd 3rd 4th Still 6th 7' <br /> UnWiZA' Observed Item — — — — — — — <br /> fIH iVUH Positvecontrol + + + + + + + <br /> t'I lgtTg %r#j)Ecfiisjt'�a ag BI test of sterility e p$ conformity 04N A 4 non-conformity <br /> aiQ conclusion : w <br /> !k -L 3h X17' F�f+ �l��MZr9TCMr <br /> The sterilization cycles were performed as per the validated parameters wi jn�o tat' ns. Ile Assurance <br /> Level(SAL)of 106 is assured. <br /> WMApproval by: Date: 3 , <br /> Comp Y <br />