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01 <br /> ,U� fina T a. <br /> t�,,EO <br /> , <br /> Gas Sterilization Report <br /> Description Lot# ,�' Quantity(cartons) Sterilization Date Reference 4 <br /> 16C NANO I6-09 190 2019.i L IO JRDE02019!110 <br /> Process Parameters <br /> Item $ <br /> Unit of Measure Setting Tolerance Range <br /> Precondition temperature C 50 45—55 45-55 <br /> Precondition humidity "SRH 40 40-70 40^65 <br /> qp <br /> Precondition hold MINS 480 360^-720 480 <br /> Interval time MINS 1 <40 20 <br /> Initial evacuation KPa -60 -60±5.0 -61.3 <br /> Humidity injection time MINS i 0-4 3 <br /> Humidity injection pressure KPa ! -60±5.0 61.! <br /> Humidity dwell MINS 30 30±2 30 <br /> EO injection pressure KPa ! -30±5.0 -29.8 <br /> EO Weight(99.9%) Kg Is 15±0.5 15.0 <br /> Humidity %RH 1 40~70 43.1^-65.7 <br /> Exposure temperature C 50 45^-55 4Q-53.6 <br /> Exposure time t <br /> � ;, MINS 480 450-~-500 480 <br /> EO concentration mg,/L 600 580--620 600 <br /> Cleanings NUMBER 3 3 3 <br /> Evacuation KPa -60 -60±5 -62.5 <br /> Hold MINS 15 15-20 15 <br /> Aeration time MINS 30 30--45 30 <br /> Aeration temperature / 8-23 <br /> Aeration time Days 7 7-8 7 <br /> We hereby certify that the above rationed goods were produced according to quality management system <br /> of IS013485:2016. <br /> And ETO Sterilization is comply the applicable international standard of IS011135: 2014. <br /> i.' <br /> r <br /> tae®s:xsto <br /> 3080 YONGE S T SUITE 3020,TORONTO CANADA M4N3Ni <br /> WW � ADAVIFS.COM 1.888.510.1388 <br />