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The Chameleon Method <br /> 37 W.Yokuts Ave. Suite 5,Stockton CA, 95207 No PR# <br /> December 18,2025 <br /> Photo 2: Kwadron needles with lot number 25037 and associated sterilization certificate. <br /> Wuxi 7.hushi Sterilization Factory <br /> File Number AA/001 of-01 I Vcrsion/revision number I A/l <br /> Certification orEO LEAS Sterilization <br /> Customer Kwadron Sp.z o.o.s .k. <br /> Product codes Product name <br /> Lot No <br /> / Kwadron Cartridge 25037 m <br /> System/Kwadron <br /> t t. <br /> O lima <br /> Sterilization mode Chamber NO. Cartridge type <br /> EO-Gas I# 0,18;0 20;0,25;0,30;0,35;0,40mm .: <br /> RL•RS•MG:FL:SE -TRL:ERL-CF o M� <br /> Stclization parameters Validated Tolerance `s-m.-- <br /> Preconditiortin temperature(IC) 50 t4 <br /> Preconditioning RH % 55 f10 °° '° <br /> .ti... <br /> Preconditioning Time min 360 0±50 <br /> Initial Evacuation Vacuum k a) -25 <br /> Kee Pressure min 20 <br /> Wci t ofEO Injection 5m3 15 <br /> Rate of EO Injection a/min 0.5 <br /> EO-Concentration m 600 EO Injection Pressure <br /> Chan ed a >25 Exposure Time min 720 ±20 <br /> Sterllizadon Temperature °C 52 t3 51-52 <br /> Chamber RH of Sterilization % 55 t10 55-55 <br /> Post Evacuation Vacuum a -20 f2 -21 <br /> The Number of ventilator(times) 6 1 // 6 <br /> Aeration Temperature(°C) 42 t5 40-42 <br /> Aeration Time da 7 // 7 <br /> Strain BocWus Ptrophoeus Nominal Population(cfu/tlnit) 1.7x106 <br /> ATCC9372 <br /> Lot NO. 5531 D-Value min 3 <br /> Culture temp. 36°C Culture tune da s 7 <br /> Culture date 2024-2029 <br /> Culture time 1 2 3 4 5 6 7 <br /> Observed item - - - - <br /> Positive control + + + + + +, ,_ <br /> - ConformitV !L Lys L�y `t�� ;at U It: I P <br /> Alexander Cruz, REHS <br /> 2 <br />