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tio'na davies <br /> EO Gas Sterilization Report <br /> Description Lot# Quantity (cartons) Sterilization Date Reference # <br /> PAL Needle Cartridges 082024 107CTNS 2024.8.19 PO# 725 <br /> Process Parameters <br /> Item <br /> Unit of Measure Setting Tolerance Range <br /> Precondition temperature °C 48 45-55 47-52 <br /> Preconditionh-unidity %RHDFDF 52 40-70 47-61 <br /> Precondition hold MINS 480 360-720 508 <br /> hiterval time MINS / <40 39 <br /> Initial evacuation KPa -60 -60t5.0 -60.1 <br /> Humidity injection time MINS / 0-4 4 <br /> Humidity injection pressure KPa / -60f5.0 -61.7 <br /> Humidity dwell MINS 30 30±2 32 <br /> EO injection pressure KPa / -3015.0 -33.1 <br /> EO Weight (99.9%) Kg 15 15f0.5 15.2 <br /> Humidity %RH / 40-70 49.1-60.1 <br /> Exposure temperature °C 50 45-55 47.7-52.1 <br /> Exposure time MINS 480 480-500 490 <br /> EO concentration mg/L 600 580-620 601 <br /> Cleanings NUMBER 3 3 3 <br /> Evacuation KPa -60 -60±5 -60.2 <br /> Hold MINS 15 15-20 17 <br /> Aeration time NUNS 30 30-45 39 <br /> Aeration temperature °C / / 5-15 <br /> Aeration time Days 7 7-8 8 <br /> We hereby certify that the above mentioned goods have been sterilized by EO Gas according to the regulation of ISO 13485:2016 <br /> AMN <br /> ISO <br /> IttY <br /> 13485:2010 <br /> 3080 YONGE STREET SUITE 3020, TORONTO CANADA M4N3N1 <br /> WWW.TINADAVIES.COM 1.888.510. 1388 <br />