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Version No <br /> RF'T fZ TciV!1AA`;IRS. a] Certification of EO Sterilization <br /> Zhejiang Huanyi Sterilization Technology Co.,ltd. !(- j3j <br /> Gneetive Date 2020/01!02 <br /> Report No.: 2020031310 <br /> 4�P Customer (YIWU CITY SOLONG IMP & EXP CO., LTD) <br /> r"`n M Mi Product codes a?,* Product Name rhfi4 Specification #ftp Lot No. �r Quantity <br /> / , t); 1RL, 3RL, 5RL CP0402086 600OPCS <br /> Eyebrow Makeup Needles <br /> ki iT� L kffi1 9 X k1 #tk <br /> Sterilization mode Chamber No. Sterilization date Ster. Lot No. <br /> EO 04,9 C] EO-Gas I 2# 2020-03-04 2020030402A <br /> k-ffi*Vt Sterilization parameters i Validated kVFJA4-L- Tolerance 9�-f%7 Actual <br /> N #1 AU'a Preconditioning Temperature (°C) 48 ±4 45.1-51.1 <br /> M1�!AiSRE Preconditioning RH (%RH) 55 ±25 42.2-62.3 <br /> NAnl1� Preconditioning Time (min) 360 ±20 360 <br /> �i sem'. Initial Evacuation Vacuum (kPa) -37 ±2 -37.1 <br /> 1�1t111Id] Keep Pressure (min) 20 <br /> ±10 20 <br /> T,N rIjhUA--_s Weight of EO Injection (kg) 20 ±0.5 19.9 <br /> kl3ii,�7111\ Rate of EO Injection (kPa/min) 0.5 ±0.2 0.49 <br /> Tct ~%f i fX EO-Concentration (mg/U 600 ±200 538 <br /> EO ijHABiJrT)71A EO Chang <br /> injection Pressure ed(kpa) >31 // S:-36.5 E:-3.5 <br /> 1 b <br /> f�f fl lad Exposure Time (min) 720 ±20 720 <br /> X-Miga Sterilization Temperature CC) 52 ±3 51.2-53.7 <br /> TtLI;FJ Chamber RH of Sterilization (%RH) 55 ±25 46.2-65.9 <br /> Post-Evacuation Vacuum (kPa) -25 ±2 -25.1 <br /> R`,;Xt The Number of Ventilators(Times) I 6 // 6 <br /> Mt_fJi,}A-, Strain Bacillus atrophaeus ATCC9372 Jt,-�EA NominalPopulation (cfu /unit) 1.8x105 <br /> BI ifs 7 Lot No. 200118 D fA D-value (min) 3.0 <br /> PAI-AM Culture Temperature 35°C to ftll'ITj Culture time(days) 7 <br /> t� E1 N Culture Date 2020-03-052020-03-12 <br /> 1arEifi1 Culture time (day) 1st 2nd 3rd 4th 5th 6th 7th <br /> �Xi A Observed Item — <br /> FND N Positve control + + + + + + + <br /> 1J#oT f'1Ji `zA ' BI test of sterility �/ a conformity ❑T A non-conformity <br /> Rit conclusion: " _ <br /> #Tfrt;Rl�ALrRX �, 6J.hM,� ta4, 3L 9i 7x IL 106 <br /> The sterilization cycles were performed as per the validated parameters wig n_o viat' ns. He Assurance <br /> Level(SAL)of 10-6 is assured. 1-4 <br /> y' <br /> �t4 Approval by: J' �` # Date: •(� <br /> rill- Comp Y 0 <br />