Laserfiche WebLink
91Ll X M6 <br />lltl,W)9 SrF.F91d'LA'1lON <br />T�l� (->•/� %C 7VC <br />"I'A 7 A -r- M p <br />Certification of EO Sterilizationp)IJj <br />X0:95$' Doc. No. <br />HYST/QR2-25-06 <br />��t.�u� Version No.: <br />0/B <br />Effective date: <br />1 2021-04-05 <br />Report no.:2022090638 <br />4P Customer <br />Yiwu Limem tattoo equipment co., Ltd <br />7'4p;t8, Productname <br />' Specification <br />W- Batch <br />al Quantity <br />fjCMR;ti' tattoo cartridge needle <br />800 box <br />E0822 <br />8 T <br />XM% x_� Sterilization mode <br />ALrt EO gas <br />Sterilizer no. <br />HYST/ST-05 <br />XN Q Sterilization date <br />2022-08-28 <br />TC 5 Sterilization batch <br />2022082805A <br />Sterilization parameters <br />Unit <br />R* Requirements <br />9 FiTJ Actual <br />i6tZ Validated <br />Min. <br />Max. <br />Min. <br />Max. <br />Loading tem. prior to preconditioning <br />°C <br />>_10.0 <br />10.0 <br />/ <br />31.2 <br />NAOM #{ Preconditioning temperature <br />°C <br />48.0 <br />44.0 <br />52.0 <br />45.6 <br />50.4 <br />FM3M C Preconditioning RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />46.3 <br />55.1 <br />N1 EgRftal Preconditioning time <br />Minute <br />360 <br />340 <br />380 <br />360 <br />�k R$I3 Transfertime <br />Minute <br />5560 <br />/ <br />60 <br />/ <br />1AM! Initial evacuation depth <br />kPa <br />-24.0 <br />-26.0 <br />-22.0 <br />-25.9 <br />41115-131A Evacuation rate <br />kPa/min <br />154.0 <br />/ <br />4.0 <br />2.6 <br />Will, (7 Pressure holding time <br />Minute <br />20 <br />10 <br />30 <br />20 <br />'(*ffif jJ3c-It Leak test pressure rise OP <br />kPa <br />151.0 <br />/ <br />1.0 <br />0.6 <br />Y "CaARf(q (X'iiKjA) Moisture injection time (if used) <br />Minute <br />10 <br />10 <br />EO eAA* EO injection rate <br />kPa/min <br />0.5 <br />0.3 <br />0.7 <br />0.5 <br />X-MMER EO Injection weight <br />kg <br />20.0 <br />19.5 <br />20.5 <br />20.1 <br />EO ev\tAff-Ji VM Pressure rising after EO injection AP <br />kPa <br />>_31.0 <br />31.0 <br />/ <br />S:-25.3 <br />E:10.7 <br />OP:36.0 <br />EO 9fJ EO concentration commence of exposure (theorical) <br />mg/I <br />600 <br />400 <br />800 <br />586 <br />T(MMI Exposure temperature <br />°C <br />52.0 <br />49.0 <br />55.0 <br />51.2 <br />54.3 <br />T(MfJA Exposure RH <br />%RH <br />55.0 <br />30.0 <br />80.0 <br />51.2 <br />59.3 <br />Xmiltrol Exposure time <br />Minute <br />720 <br />700 <br />740 <br />720 <br />Post-evacuation depth <br />kPa <br />-15.0 <br />-17.0 <br />-13.0 <br />-15.1 <br />-14.9 <br />3t1L1 JJ Inflation pressure <br />kPa <br />-5.0 <br />-7.0 <br />-3.0 <br />-5.1 <br />-4.9 <br />A'Qk* Number of repetition <br />Times <br />>_4.0 <br />4 <br />/ <br />4 <br />A'�'(RflpJ Duration of flushing <br />Minute <br />150 <br />120 <br />180 <br />174 <br />BI 5EMiAe MA BI test of sterility <br />©a Conformity; ❑ T A 4 non -conformity. <br />WiConclusion: <br />X,M LIV-20 A BI 5cMWR o ISO 11135:201410MV,5*, 1'cpp SAL(10-6)44Y'Rj t-> TMV2tV-FWT- <br />Above all, sterilization process and BI sterility testing are meeting with EN ISO 11135:2014 and validated requirements, and Sterile Assurance <br />Level (SAL) of 106 is achieved and products can be released from sterilization process. <br />f,)'igM Prepator: t <br />IM Approval(QA):A��A <br />Zhejiang Huanyi Sterilization Technology Co., Ltd. (stamp) <br />f:Ria : rlt IAI ITV RFfnRD 1/2 <br />