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i <br /> tina davies <br /> )VO Gas Sterilization Report <br /> Description Lot# Quantity(cartons) Sterilization Date Reference# <br /> 14 curved 14C-301 F 37 2019.06.13 JRDEO20190613 <br /> Process Parameters <br /> Item <br /> Unit of Measure Setting Tolerance Range <br /> Precondition lemperature 'C 50 45^-55 45--55 <br /> Precondition humidity %RIl 40 40^-70 40^65 <br /> Precondition hold MINS 480 360^720 480 <br /> Interval time MINS / <40 �0 <br /> Initial evacuation KPa -60 -60:5.0 -61.8 <br /> Humidity injection time MINS / 0--4 3 <br /> Humidity injection pressure KPa / -60:5.0 -61.2 <br /> Humidity dwell MINS 30 30:2 30 <br /> EO injection pressure KPa / -30±5.0 -30.1 <br /> EO Weight(99.9%) Kg 15 15±0.5 15.0 <br /> Humidity %RH / 40-70 42.7.66.5 <br /> Exposure temperature 'C 50 4555 46.9^-52.4 <br /> Exposure time MINS 480 480^-500 480 <br /> EO concentration mg/L 600 580^620 600 <br /> Cleanings NUMBER 3 3 3 <br /> Evacuation KPa -60 -6015 -60.8 <br /> Hold MINS 15 15^20 15 <br /> Aeration time MINS 30 30-45 30 <br /> Aeration temperature C / / 21^-33 <br /> Aeration time Days 7 7-8 7 <br /> We hereby certify that the above mentioned goods were produced according to quality management system <br /> of IS013485:2016. <br /> And ETO Sterilization is comply with the applicable international standard of 15011135: 2014. <br /> ISO <br /> 13488:2010 <br /> 3080 YONGE STREET SUITE 3020,TORON-r0 CANADA M4N3N1 <br /> WWW.TINADAVIF,S COM 1.888.510.1388 <br />