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The Chameleon Method No PR# <br /> 37 W.Yokuts Ave. Suite 5,Stockton CA,95207 <br /> December 18, 2025 <br /> Photo 1: Kwadron needles with lot number 25001 and associated sterilization lot number. <br /> C r -- <br /> Wuxi Zhushi Sterilization Facto <br /> Filc Number AA/001 01-04 Version/revision number N2 <br /> Certification of EO GAS Sterilization <br /> Customer Kwadron Sp.z o.o.s .k. <br /> Product codes Product name Lot No <br /> / Kwadron Cartridge 25001 <br /> System/Kwadron <br /> O lima <br /> Sterilization mode Chamber NO. Cartridge e <br /> EO-Gas L# 0,18;0,20;0,25;0,30;0,35;0,40mm <br /> RL RS MG;FL;SEM•TRL;ERL•CF o <br /> Stelization parameters Validated Tolerance Actual <br /> Preconditioningtemperature °C 50 f4 51 p <br /> PreconditioningRH RH% 55 t10 54-55 <br /> PreconditioningTime min 360 ±20 379 <br /> Initial Evacuation Vacuum a) -25 f2 -26 t, <br /> Kee Pressure min 20 f10 25 <br /> Weight of EO Injection k _5m3) 15 t1.25 15 <br /> Rate ofEO Injection a/min 0.5 f0.2 0.5 <br /> EO-Concentration m 600 ±50 619 <br /> EO Injection Pressure Changed k a) >25 N o :�—' <br /> S:-_S.OE:8.0 . ��••Ear <br /> Exposure Time min 720 t20 711 °..m® �•. � <br /> Sterilization Temperature °C 52 t3 51-52 <br /> Chamber RH of Sterilization(%W 55 ±10 55-55 <br /> pow.en ntvbu.Y.ei[.pNa� <br /> i <br /> Post Evacuation Vacuum a) -20 t2 -20 <br /> STERILE EO 14 <br /> The Number ol'ventilator times 6 H 6 <br /> Aeration Temperature °C) 42 f5 40-42 ' <br /> Aeration Time(day) 7 // 7 <br /> Strain Bocillus Ptrophoeus Nominal Population(efu/unit) 1.7x106 <br /> '* ATCC9372 <br /> Lot N0. 5411 D-Value(min) P `—,�` ``L ``�t``.L` <br /> l <br /> Alexander Cruz, REHS 1 <br />