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i <br /> NEW AGE TATTOO SUPPLY CO.,LTD. <br /> jC( ; File Numbering NATS/SWT-24-12 _7��d <br /> 3�FI Lr,,rX_M!1TH)J Certification of EO Gas Sterilization <br /> # N Report No.: 2024122301 <br /> �kf' Customer Saltwater tattoo Inc <br /> nr'nfni{i7,product codes SAA,, Product Name )lUrr Specification l�` lot No. .Quantity <br /> Needle Cartridges/Platinum <br /> / Needle/Dispossable Tube <br /> k <br /> Sterilization mode Chamber No. Sterilization date Ster.Lot No. <br /> EO 4k1 EO Gas 1# 2024:l.'-23 2412230A <br /> k �c f� Sterilization parameters iXi Validated P=T Tolerance QT Actual <br /> BUM"TA Preconditioning Temperature CC) _48 ±q 44.2-51.2- <br /> 5-}A,j 55 -x.25 51.6-64.5 <br /> �j,,,, ,[;z PreconditioningRH (%RH) <br /> 1,)'iAfl fi] Preconditioning Time (min) 360 4-20 362 <br /> fgF.2 Initial Evacuation Vacuum (kPa) <br /> -24 ±2 -25.7 <br /> Cilt,tfaj Keep Pressure (min) <br /> 20 ±10 16 <br /> Weight of EO Injection (kg/25m3) — 20 <br /> +0.5 20.0 <br /> Rate of EO Injection (kPa/min) 0.5 <br /> +0.2 0.46 <br /> r- <br /> kl�l-LT�l�jx EO-Concentration (mg/L) 600 4-200 526 <br /> EO Y /\AJ�)±)7TJ EO injection Pressure Changed(kpa) <br /> >31 // 5:-25.3 E:7.0 <br /> g1}�Hff�Exposure Time (min) <br /> 720 ±20 724 <br /> 52 ±3 49.0-54.5 <br /> kffi&I Sterilization Temperature ("C) <br /> ,,.. �_ 55 ±25 52.4-64.2 <br /> kkffij f,(-Chamber RH of Sterilization (%RH) <br /> r-_ ,. :�: -15 ±2 15.2 <br /> �$;tikes T�Ix Post-Evacuation Vacuum (kPa) <br /> r �_. <br /> -1,rl� The Number of Ventilators(Times) 4 <br /> filY#)r t�lX Aeration Temperature (°C) <br /> 42 4-5 37.2-44.8 <br /> a;i'Flttrfill Aeration Time (day) <br /> 7 // 7 <br /> fid?f- NominalPopulation (cfu/unit) 1.9x10 <br /> Strain Bacillus otrophaeus ATCC9372 <br /> I BI#lt Lot No. <br /> -'J180216 D Tt D-value (min) 3.1 <br /> � fF; ti•)jib Culture <br /> I! ff9PGIIt�X Culture Temperature 36` time(days) 7C _ <br /> f_ F H)t1)Culture Date 2018-07-162018-07-23 <br /> rd 4th 5th th 7th <br /> fn `8'J-fiij Culturetime (day) 1St 2"d 3 4 5 ' 6 — <br /> A! idi Observed Item <br /> Positve control <br /> + + + + + + <br /> $�j p J 117r f�i 3a A BI test of sterility ® a�conformity O f� ' non-conformity <br /> Mit conclusion: �t 6.H ;i ra V r>�tTr <br /> ?rT)ffi Tia }.-f 10 T. J1 ijl, �a fr � <br /> The sterilization cycles were performed as per the validated parameters with no deviations.The Sterile Assurance <br /> Level(SAL)of 10-6 is assured. <br /> We hereby certify that the above mentioned goods have been sterilized by "Ethylene Oxide" Z3 <br /> YIWU LIHENG STERILIZATION SERVICES CO.,LTD. <br /> ADD: NO.5 DIANXIA ,SUXl TOWN ,YIWU CITY, ZHEJIANG (-] SrT, 1 <br /> �{A �Report Date: 1 V_ �{ <br /> imt�Company stamp:�� <br /> VI�U UNENG STERILIlAiIGN SERVICES CG., I <br /> Page I of 2 <br />