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Wuxi Zhushi Sterilization Factory <br />File Number EW/001_01-02 Version/revision number A/1 <br /> <br />Certification of EO GAS Sterilization <br /> <br />Customer Kwadron Sp. z o.o. sp. k. <br />Product codes Product name Lot No <br />/ Kwadron Cartridge <br />System / Kwadron <br />Optima <br />0224 <br /> <br /> <br />Sterilization mode Chamber NO. Cartridge type <br />EO-Gas 1# 0,18; 0,20; 0,25; 0,30; 0,35; 0,40mm <br />RL; RS; MG; FL; SEM; TRL; ERL; CF <br />Stelization parameters Validated Tolerance Actual <br />Preconditioning temperature (°C) 50 ±4 50 <br />Preconditioning RH (RH %) 55 ±10 50-56 <br />Preconditioning Time (min) 360 ±20 376 <br />Initial Evacuation Vacuum (kpa) -25 ±2 -25 <br />Keep Pressure (min) 20 ±10 21 <br />Weight of EO Injection (kg/25m3) 15 ±1.25 15 <br />Rate of EO Injection (kpa/min) 0.5 ±0.2 0.5 <br />EO-Concentration (mg/L) 600 ±50 601 <br />EO Injection Pressure Changed (kpa) >25 // S:-25.0E: 8.0 <br />Exposure Time (min) 720 ±20 732 <br />Sterilization Temperature (°C) 52 ±3 52-53.5 <br />Chamber RH of Sterilization (%RH) 55 ±10 53-56 <br />Post Evacuation Vacuum (kpa) -20 ±2 -20 <br />The Number of ventilator (times) 6 // 6 <br />Aeration Temperature (°C) 42 ±5 40-42 <br />Aeration Time (day) 7 // 7 <br />Strain Bocillus Ptrophoeus <br />ATCC9372 <br />Nominal Population (cfu/unit) 1.7x10⁶ <br />Lot NO. 1155 D-Value (min) 3 <br />Culture temp. 36°C Culture time (days) 7 <br />Culture date 2023-2027 <br />Culture time 1 2 3 4 5 6 7 <br />Observed item - - - - - - <br />Positive control + + + + + + + <br />BI test of sterility Conformity <br />Conclusion: <br />The sterilization cycles was performed as per the validated parameters with no deviations. <br />The sterile Assurance Level (SAL) of 10⁶ is assured <br /> <br />Approved by: …………………………. Company stamp: <br />