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xy -C �1 °0 , - (I Ij Duc Rn. Hyst/an2 25 oG <br /> "I XMIA - -- �; tGPX19l9] Iuz4. s, ver,lonNo., oio <br /> ImAWYt StIMMIau Certification of EOste rilization !j:,y1UlUl Effective date: 2021A4A5 <br /> 4K %tW 'q Report no.:2021072123 <br /> 4P Customer ( YIWU CIN SOLONG IMP & EXP CO., LTD ) <br /> Y' A -*90 Product name Specification Wa Batch is � Quantity <br /> Eyebrow Makeup Cartridge RL RS CP0402086 1 20 <br /> XMVA Sterilization mode EO gas W Ill JUL Sterilizer no. HYST/ST-02 <br /> X-N HAJ Sterilization date 2021-07-20 TCM#It Sterilization batch 2021072002A <br /> Sterilization parameters ' Requirements SMT* Actual <br /> Unit Validated Min. Max, Min. I Max, <br /> PuijEhT�1S h �Paj Loadingtem, priorto preconditioning 'C 10.0 10.0 / 36.4 <br /> Rk3MY Preconditioning temperature °C 48.0 44.0 52.0 46.6 51.9 <br /> NA3MMIA Preconditioning RH YRH 55.0 3010 80.0 44.8 55.5 <br /> TMIKIII(aj Preconditioning time Minute 360 340 380 360 <br /> #11f Cal Transfertime Minute 560 / 60 / <br /> NA!2 Initial evacuation depth kPa -37.0 -39.0 -35.0 -37.1 <br /> 1 Evacuation rate kPa/min 54.0 / 4.0 2.3 <br /> WERffl Pressure holdingtime Minute 20 10 30 20 <br /> JniisjK)J3),71t Leak test pressure rise jn�P kPa 51.0 / 1.0 0.8 <br /> '-y J�8f17 ( VAM ) Moisture Injection time (if used) Minute 10 10 <br /> EO .9X3t* EO injection rate kPa/min 0,5 0.3 0.7 0.6 <br /> TZMPJFhk EOlnjectionweight kg 20.0 19.5 2015 1915 <br /> EO $jvjpXjJ5MIPressure rising after EO injection OP kPa 25:-38.3 E:-3.231.0 31.0 / <br /> D P:33.1 <br /> EO MJY EO concentration commence of exposure (theorical) me/] 600 400 800 639 <br /> XMIMSE Exposure temperature °C 52.0 49.0 55,0 52.6 54.7 <br /> XMMA E Exposure RH %RH 55.0 30.0 80.0 52.6 66.4 <br /> x-01111 an time Minute 720 700 740 720 <br /> A''LMM Post-evacuation depth kPa -25.0 -27.0 -23.0 -25. 1 -25.0 <br /> A'°CE)i Inflation pressure kPa -5.0 -7.0 -3.0 -5.1 -5.0 <br /> A& 7rI( & Number of repetition Times a6,0 6 / 6 <br /> A&ERV91 Duration of flushing Minute 105 90 120 108 <br /> Bl Xilil Bl test of sterility Z o fr Conformity; ❑ Ts** non-conformity. <br /> MiQ Conclusion : <br /> The sterilization cycles were performed as per the validated parameters with no deviations. <br /> 4011 Prepator: �� N M Date: <br /> 41:06 Approval(QA): R M Date: <br /> Zhejiang Huanyi Sterilization Technology Co., Ltd. ( stamp ) <br /> jd1 fl W,A QUALITY RECORD I / I <br />