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NEW AGE TATTOO SUPPLY CO.,LTD. <br /> jC4 5 File Numbering NATS/SWT-24-09 <br /> 4XZ'JAXMilRYJ Certification of EO Gas Sterilization <br /> }( A�rffl; Report No.: 2024092601 <br /> l'' Customer Saltwater tattoo Inc <br /> i` PWS product codes P'P'n Product Name Specification tl Lot No. quantity <br /> Needle Cartridges/Platinum <br /> / Needle/Dispossable Tube 6"fN5 <br /> Sterilization mode Chamber No. Sterilization date Ster.Lot No. <br /> EO'�M*kf EO-Gas 1# ---fff 21(,-)f )-211-1 — <br /> T<MV&Sterilization parameters Validated `IGiJfjQ =Tolerance T Actual <br /> $1IAMIx Preconditioning Temperature (°C) 48 — ±4 44.2-51.2 <br /> RARI Preconditioning RH (%RH) 55 ±25 51.6-64.5 <br /> FltMFrtrRlPreconditioning Time (min) 360 ±20 362 <br /> M-M!Initial Evacuation Vacuum (kPa) -24 ±2 -25,7 <br /> WTHIIA, Keep Pressure (min) 20 ±10 16 <br /> TcfiJfJAI� Weight of EO Injection (kg/25m3) 20 ±0.5 20.0 <br /> TC <br /> 1JjJ0Ait =Rate of EO Injection (kPa/min) 0.5 ±0.2 0.46 <br /> ki'Jr ( Yfx EO-Concentration (mg/L) 600 ±200 526 <br /> EO?-tA JAf)]JA EO injection Pressure Changed(kpa) >31 // S:-25.3 E:7.0 <br /> T�fflIlfiH] Exposure Time (min) 720 ±20 724 <br /> TcM&Plt Sterilization Temperature (`C) 52 ±3 49.0-54.5 <br /> T<MNPA Chamber RH of Sterilization (%RH) 55 ±25 52.4-64.2 <br /> WAAAS I-Post-Evacuation Vacuum (kPa) -15 ±2 -15.2 <br /> A,'U'Alft The Number of Ventilators(Times) 4 // 4 <br /> MY-f)Tffift Aeration Temperature (°C) 42 ±5 37.2-44.8 <br /> AO—TRIM Aeration Time (day) 7 // 7 <br /> 1,t-j #A Strain Bacillus atrophaeus ATCC9372 f�-J-r-11 NominalPopulation (cfu/unit) 1.9x106 <br /> BI A s Lot No. 180216 D 4t!D-value (min) 3.1 <br /> fry fm lx Culture Temperature 36°C f;';r-Pt A Culture time(days) 7 <br /> M,4 D PJ Culture Date 2018-07-162018-07-23 <br /> f'-MIOV111 Culture time (day) hr 2"d 3,d 4u 5th 6tn 7th <br /> 7J �iZc Observed Item - - - - - - — <br /> Mft-A M Positve control + + + + + + <br /> $�J#aT#�IJ�Gli3A Bltest ofsterility �/ A conformity ❑7 anon-conformity <br /> Mid conclusion: <br /> Aajig;TFA7rXT<M, V111)�k1A17 tl—'I�ri, J Ik*-T 10-1 <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" L� <br /> YIWU LIHENG STERILIZATION SERVICES CO.,LTD. <br /> ADD: NO.5 DIANXIA ,SUXI TOWN ,YIWU CITY, ZHEJIANG <br /> JR A H M Report Date: <br /> Compan `st m yy <br /> YIN LIHENC SIERILIL` i101i SERVICES CO.,LTD. <br /> ------ ---- - - - -- - Page 1 of 2 <br /> ---------- <br />