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)6 AWnbWjk#JapF Wuxi Zhushi Sterilization Factory
<br />)Mt -A- File Number SZLF/ST01_05-02 1 Version/revision number B/1
<br />fZ AT( I J Certification of EO Gas Sterilization
<br />;PrP Customer
<br />MW Approved by:
<br />Approved 411% R M
<br />2M. col
<br />Suzhou Lengfeng Medical Instruments Co.,Ltd
<br />leu PVP Productcodes
<br />R'P p I Producttname
<br />42-5 Lot No
<br />/
<br />i]
<br />KWADRON NEEDLES
<br />0101,011AO120,0219, 0225.030ZUT0303.0304,0306,0311UT,0312,03128,03110T,0320,0320,
<br />033018,0402,04078,0410,0510,0515, 05150, 0523, 0525, 0530, 06D6, 0606&0610,06106,0613,
<br />0618, 0618& 0619, 0701, 0205, 0709, 07098, 07M 0717B, 0720, 07208, 0801, 0B01B4 0002, 0B1L
<br />0815,0020, 00220, 0822PT, 0826, 090617; 0909, 0915t 0915AT5, 0915MZ4 09151614 0920UT, 0925,
<br />1005, IODSH, 1010,
<br />093�110BIIT,51109,119B,11136,1115,S11B'112OUT,1121, 112111P2TZ,, 11NUT 1123,1127, 1205,
<br />1202, 1210, 1212, 1215U& 1219,1223,1225% U26, 1230,1231t 0108, 0110. 0111, 0115, 0117 -SL
<br />0128, 0130, 0201, 0203s 022, 0226, 0229, 0305, 0306, 031$ 0322, 0325, 0406, 0416, D42, 0428,
<br />0506, 0SUB, 052, 0515, 0516, 0520,0521,0522,0529.0530,0603,0600, 0612, 0617, 0626,0622UA.
<br />070L 0202.0703, 0706,0707, 0710, 0718, 0219, 02204 072Z, 0723, 0726, 0230, 0807, 0310, 0817,
<br />081& 0901,0902, 0904, 0905, 0906, 0914, 0915, 0916, 0917, 0921, 0923, 092641006,1007,1000.
<br />1009,1010,1011,1012,1013,1017,1021,1022,102& 1024,1030,1104.1109,1111,1112,1113,
<br />111M, 112% 1121, 1123, IMP 1130, 1201,1204MiS 1205, 1207o 1298, 1210T6L 1211, 1215.
<br />MOM 1211M 1221, 1222, 12A 1225, 1220,1231,F0726
<br />TTom�+ lY
<br />Sterilization mode
<br />fiTgQ.
<br />bd
<br />Chamber NO.
<br />`}Y,y,
<br />EO y J` EO -Gas
<br />2#
<br />TM00 Sterilization parameters
<br />R51! Validated
<br />tifAg Tolerance
<br />SRF Actual
<br />fIRAZA Preconditioning Temperature (°C)
<br />50
<br />±4
<br />50.5-53:5
<br />T511MA Preconditioning RH (%RH)
<br />55
<br />±10
<br />49-55
<br />YMttt(Al Preconditioning Time (min)
<br />360
<br />±20
<br />350
<br />7AW? Initial Evacuation Vacuum (]tpa)
<br />-25
<br />±2
<br />-25.0
<br />19ARtful Keep Pressure (min)
<br />20
<br />±10
<br />15
<br />XMP0AAR Weight of EO Injection(kg/25M3)
<br />15
<br />-1-1.25
<br />15
<br />7F i3F1171j%t Rate of EO Injection (Icpa/min)
<br />0.5
<br />±0.2
<br />0.50
<br />Tci'i'f*Ajx EO -Concentration (mg/L)
<br />600
<br />±50
<br />600
<br />E09IAA BJJ91 EO Injection Pressure Changed(kpa)
<br />>25
<br />//
<br />5:25.013:8.0
<br />41FM Qt(al Exposure Time (min)
<br />720
<br />±20
<br />720
<br />kffiffi& Sterilization Temperature (0C)
<br />52
<br />±3
<br />50.5-53.5
<br />TCN &A Chamber RH of Sterilization (Yo RH)
<br />55
<br />±10
<br />49,5-55.5
<br />A'MM Post Evacuation Vacuum (kpa)
<br />-20
<br />±2
<br />-20.5
<br />#1;'L&ft The Number of Ventilator (times)
<br />6
<br />//
<br />6
<br />MrTRAE Aeration Temperature (0C)
<br />42
<br />±5
<br />38.540.5
<br />f07#ratfa7 Aeration Time (day)
<br />7
<br />//
<br />7
<br />WLOI#4' Strain
<br />BocillusPtrophoeusATCC9372
<br />3r)fg!"NominalPopulation(cfu/unit)
<br />1.7x106
<br />BI Lot N0.
<br />200825
<br />D fft D -Value (min)
<br />3.0
<br />tri -ml Culture Temperat
<br />3600
<br />)niful
<br />Culture time(days)
<br />7
<br />inrP HM Culture Date
<br />2019-2020
<br />i rPHI iljCulture time(day
<br />1st
<br />2nd
<br />3rd
<br />4d1
<br />Sul 6th
<br />7`11A,"WHiR
<br />Observed Item
<br />IMMIR Positive control
<br />+
<br />+
<br />+
<br />+
<br />+ +
<br />+
<br />�lJ3eT)fil3c li l $u` Bl test of sterility
<br />❑o($ conformity
<br />Wk' Conclusion:
<br />.r.l�unA1 7'GI 17)(' F1069*f-f�)f2ic'i -, /'�° 7 (4T0
<br />The sterilization cycles were performed as per the validated param gfi t{ n viations.
<br />The Sterile Assurance Level (SAL) of 106 is assured.'
<br />1Y ,
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