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5E%** Vi'G *fflpt17 Wuxi Zhushi Sterilization Factory
<br /> 3Z#*ii File Number SZLF/STOL05-02 I Ak*/fOQk-t - Version/revision number B/1
<br /> }r% Za9XMi09 Certification of EO Gas Sterilization
<br /> AXP Customer Suzhou Lengfeng Medical Instruments Co. , Ltd
<br /> !' AM-9' Productcodes 7` A ,? f Productname 42477 Lot No
<br /> / KWADRON NEEDLES 0101,0114. 0120,0219, 0225, 0302UT, 0303,030410306,0311UT, 0312, 0312B, 0317UT,0320,0328,
<br /> 033018, 0407, 04070, MID, 0510, 0515, 05158, 0523, 0525, 0530, 0605, 0606% 0610, 06106, 0613,
<br /> 0618, 06188, Mom 0701 0705, 0709, 07090, 071210717% 0720, 0720B, 0001, 00018, 080$ 081L
<br /> 0815, 0820, 08226, 082281: 0026, 0906U 4 0909, 0915, 0915AT5, 0915M$ 09157M, 092001; 0925,
<br /> T y a Y 0930M, 0930TM, 1005, 10058, 1010. 101084 1010M, 1010TT1, 1015KT5, 10178, 1028, 11084
<br /> %` L�FJ 14 X 3108UT, 1109, 1109B, 11138, 1115, 1118, 1120UT, 1121, 1122, 1122TW, 1122UT, 1123, 11270 1205,
<br /> 12071 1210, 1212. 1215U& 1219, 1223, 1225B, 1226, 1230, 1231, 0100, 0110, 0111, 0115, 0117-M.
<br /> Sterilization mode Chamber NO. CUB, 0130, 0201, 0203, 0223, 0226, 0229, 03054 0306, 0312, 0322, 0325, 0406, 0416, 0423, 0428,
<br /> 0506, 0508, 05124 0515,0516, 0520, 0521p 05221 0529,0530, 0603,960& 0612, 0617, 0626,0627 UA
<br /> 070L 0702, 0702, 0706, 0707, 0710, 071% 0719, 0720, 0722, 0723, 0726, 07304 0007, 0810, 08171
<br /> BO 1t(J*XMJ EO-Gas 2# 0818, 0901, 0902, 0904, 0905, 0906, 0914, 0915, 09164 0917, 0921, 0923, 0926, 1006, 1007, 1008,
<br /> 1009, 1010, One 1012, 1013, 1017, 1021110221 1023p 1024, 1030, 1104, 1109, 1111, 1112, 11 13,
<br /> 1116TM, 1120, 1121, 1123, 1124, 1130, 1201, 1204M 1205, 1207, 1200, 1210TH. 1211, 12151
<br /> 1218TH, 12192Mt 172L 1222, 1224, 1225o UZUr 123 1p F0720
<br /> kM3Jk Sterilization parameters *75T Validated i'11*91M Tolerance �Prf'T. Actual
<br /> AMMA Preconditioning Temperature COC) 50 ±4 50,5-53:5
<br /> NAME PreconditioningRH (% RH) 55 ±10 49-55
<br /> RAW][W][ Preconditioning Time (min) 360 ±20 350
<br /> MAMA Initial Evacuation Vacuum (kpa) -25 ±2 -25.0
<br /> WER51 11 Keep Pressure (min) 20 ±10 15
<br /> 7cMMMAR Weight of EO Injection (kg/25ms) 15 ±1.25 15
<br /> ( MPJ)J[lXi1** Rate of EO Injection (Itpa/min) 0.5 ±0.2 0.50
<br /> XM"(4*$M EO-Concentration (mg/L) 600 ±50 600
<br /> EO EO Injection Pressure Changed (kpa) >25 // S:-25.OE: 6.0
<br /> M IN Exposure Time (min) 720 ±20 720
<br /> TCMM Sterilization Temperature (°C) 52 ±3 50,5-53.5
<br /> TcMI Chamber RH of Sterilization (% RH) 55 ±10 49.5-55:5
<br /> A'tiM!j - Post Evacuation Vacuum (kpa) -20 +_2 -20.5
<br /> #J157=i &R The Number of Ventilator (times) 6 // 6
<br /> X# R)5[ Aeration Temperature (°C) 42 ±5 38.540.5
<br /> **0109 Aeration Time (day) 7 // 7
<br /> Mrt- 'Nl1*A Strain Bod lus Ptrophoeus ATCC9372 M$9* Nominal Population(cfu/unit) 1,7x 106
<br /> BI M-s- Lot NO. 200825 D M D-Value (min) 3.0
<br /> MrFMJi Culture Temperat 360C *rFO 7 Culture time (days) 7
<br /> ili0 QM Culture Date 2019-2020
<br /> iuOWIh7Culture time (day', 1st 2nd 3rd 4 1 5th but 7th
<br /> UrlAid:R Observed Item - - - - - - -
<br /> 15Mxllld Positive control + + + + + + +
<br /> -t0Ml,r#fiJ rGMiAftMX BI test of sterility ❑'M conformity
<br /> fZK^ Conclusion :
<br /> The sterilization cycles were performed as per the validated param a�(s OtCng viations.
<br /> The Sterile Assurance Level (SAL) of 106 is assured. /�
<br /> 4%* Approved by: a --'F� 4k a R M R '✓mate:
<br /> A* Comp Amp:
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