|
�TAARA IR UM Certification of E0 Gas Sterilization
<br />rP Customer
<br />ifrl� Approved by: fJ M
<br />ll+'riJ�hif77 GA/
<br />Wuxi Zhushi
<br />Sterilization Factory
<br />3CT a s
<br />File Number
<br />SZLF/ST01-05-02
<br />M*/frg3o'f-5
<br />Version/revision number
<br />B/1
<br />�TAARA IR UM Certification of E0 Gas Sterilization
<br />rP Customer
<br />ifrl� Approved by: fJ M
<br />Suzhou Lengfeng Medical Instruments Co.,Ltd
<br />7'4"MA4- Productcodes
<br />1'`au Productname
<br />424� Lot No
<br />/
<br />KWADRON NEEDLES
<br />0101, 0114,0120,0219,02251 0302UT,030310304,0306,034",, 0312 0312B, 9317UT, 03201 032%
<br />0330n, 0407,0407% 0410, 05104 0515,05159,0523,0525,0530,0606,06068.0610.0610%0613,
<br />0618, 061BB, 0619, 0701,070%070%07098, 0712, 9717%0720, 07209, 0001, OU91B,9B02, O81L
<br />0815,082010822%0822",,0826,090601:0909,0915,0915AT3. 0915012, 0935TM, 092001; 0925,
<br />0930AT5. 0930M 1005,1005% 1010, 1010a IDIOM. 1010M, 1015M 1017B, 1028, 1108,
<br />130BU1;33f,'4109B, 1113B,1115,IUD, 1120UTe 1121, 1122,1122M, 1122UT, 1123, 1127, 1205,
<br />1207,1210, 1212, 1215UA 1219,1223412258,1226,1230,1231, 0108, 0110, 0111, 0115, 0137-lt
<br />0128,0130,0201,0203,0223,0226,0229,0305.0306,0312,0322,0325,0406,0416,0423,0428,
<br />0506,0508,0512,0515,0516,0520,0521,0522.0529.0530.0603, 0608, 0612.0617.0626.062N
<br />07010702,0703,0706,0707,0730.0718,9719,0720,0722,0723.0726.0730,0007,0810,0817,
<br />Me, U901,0902,0904,090%0906,0914,0915,0916, 0917, 0921, 092%%6, 1006, 10071 100%
<br />109, 1010P 1011, 1012. 1013, 1017, 1n211022,1023,1024,1030,1104,1309,11111112,1113.
<br />1116M, 1120.1121,1123,1224.1130. 120L 1204hM. 1205, 1207, 1208, 12101M, 121L 1215,
<br />1218TM, 1219TH 122141222,1224,1225,122%1231, IBM
<br />TyK p
<br />Sterilization mode
<br />Chamber NO.
<br />EO �O*XM EO -Gas
<br />2#
<br />TDMA T Sterilization parameters
<br />1� Validated
<br />ii;i'P• A Tolerance
<br />-tIlT• Actual
<br />TrAMA Preconditioning Temperature CDC)
<br />5o
<br />±4
<br />50,5-53:5
<br />TJNMMA Preconditioning RH (% RH)
<br />55
<br />±10
<br />4955
<br />M -MM], Preconditioning Time (min)
<br />360
<br />±20
<br />350
<br />MA?t Initial Evacuation Vacuum (kpa)
<br />-25
<br />±2
<br />-25,0
<br />QW117 Keep Pressure (min)
<br />20
<br />±10
<br />i5
<br />XNAI PAIR Weight of EO Injection(kg/25m3)
<br />is
<br />±1.25
<br />15
<br />T(1iP)1JflXA* Rate of EO InjectionUcpa/min)
<br />0.5
<br />±0.2
<br />0.50
<br />9M'U i I EO -Concentration (mg/L)
<br />600
<br />±50
<br />600
<br />EO h--AJJ1Fa 1E0J711 EO Injection Pressure Changed 0cpa)
<br />>25
<br />//
<br />S: -25.0E: 8.0
<br />•('f:lii alfa] Exposure Time (min)
<br />720
<br />±20
<br />720
<br />XMM)R Sterilization Temperature (°C)
<br />52
<br />±3
<br />50.5-53.5
<br />Xfa1k Chamber RH of Sterilization (%RH)
<br />55
<br />±10
<br />49.5-55.5
<br />(A!2j Post Evacuation Vacuum (kpa)
<br />-20
<br />±2
<br />-20.5
<br />ALVXe The Number of Ventilator (times)
<br />6
<br />//
<br />6
<br />XT-WA&F Aeration Temperature (°C)
<br />42
<br />±5
<br />38,540,5
<br />f#lill$Ipl Aeration Time (day)
<br />7
<br />//
<br />7
<br />01%#�Ka Strain
<br />Bocillus Ptrophoeus ATCC9372
<br />3VP-3g*t Nominal Population(cf i/unit)
<br />1.7X 106
<br />BI Lot NO,
<br />200825
<br />D I D -Value (min)
<br />3.0
<br />f4-VA9E Culture Temperat
<br />360CIna'0Ml
<br />Culture time (days)
<br />7
<br />ia- F1 Culture Date
<br />2019-2020
<br />Ju P11tiM Culture time(day
<br />1st
<br />2nd
<br />3rd
<br />4th
<br />5th
<br />6th
<br />7th
<br />$ 3,ME t Observed Item
<br />IRift±IT IR Positive control
<br />+
<br />+
<br />+
<br />+
<br />+
<br />+
<br />+
<br />i91Tihtl7clli� Bl test of sterility
<br />❑q conformity
<br />Mil Conclusion:
<br />The sterilization cycles were performed as per the validated param, o�stJn viations.
<br />The Sterile Assurance Level (SAL) of 106 is assured.`
<br />va-'`7. Co
<br />,,����>y Pagelof2
<br />
|