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4& <br /> XMIUAT'% <br /> Ethylene Oxide Sterilization Process Record <br /> AUUM-lif Sterilizer: XNAVII Sterilization Batch: 2018032001 HM Date. 20180320 3A?k Order: <br /> Article Name*&94 Lot No.11"At Specification)MM vI CTNINCIA10 Ouarifity9tik i_ft44a <br /> IDA VINCI Cartridges 03-18 2DCTN Mfg <br /> Ali 11._M:1 y ., *iT <br /> 11tovW <br /> ikJL <br /> Process ParametersAINWIR Setting Value Actual Value Requirement-V* Pass/Fail Sterilization Process, I^,Start time-, End time Time <br /> R Z.M tlliM lapl(m <br /> minilitift maxil),ift M <br /> Vaccurn value(Kft)MWA -50,0 -50,3 -SZO -48.0 Pass HeatinglAIA 20181312019:10 201813120 22;37 207 <br /> Leak test time(min)JIMM41141111 5 5 4 6 Pass Keeping warm UC 2018/3/2022:37 201813/2023:37 60 <br /> Pressure change at end of leak test(KPa)MIJWJR)jfft --- 0.3 0,0 3,0 Pass Pre-vacuum+UMA-"i' 2018/3120 23:37 2018/3t20 23,45 8 <br /> Pressure change at end of steam injection(KPa)IMW.)CiJUj*ftIft 2,0 6'8 11t:-49.71;;-429 1.0 3.0 Fail leak testfflMO, A 2018/312023:45 201813/2023:50 5 <br /> Pressure change at end of ED Injection(KPa))MEOJF,IUJ 14M 99,0 70.7 1 W-42.51F,1:27_8 0.0 100.0 Pass steam injection)JUV 20I6/3/20 2150 2018020 23:54 4 <br /> EO weight Injected(I(q))IIIE0111 — 0.0 110.0 Pass EO iryectionllM 201813120 231-54 2018/31210:26 32 <br /> Temperature(TI)during EO 9xposur*C)*M*8W*fiS 60.0 Min: 48.9 Max: 51,5 45.0 55.0 Pass EO dwell 2018131210:26 2018/3/218:25 479 <br /> Humidity(RH)during ED exposure(% Min: 45.4 Max: 63.8 30.0 85.0 Pass EO Removal E004t. 2018/3121 8:25 2018r3121 8!34 9 <br /> Pressure(PI)during EO exposure(Kpa)A 1111WIRM#10i — ifill: 15.9 Max: 27.8 — — Pass air washing`V'(0 A; 2018/3/21 8:34 2018131218:51 17 <br /> EO dwell(mln)XjItN 00 480 479 479 461 Pass repressure W12 2018/3/21 8:61 201813/21 9:23 32 <br /> L Numbers of air washes',"MM&A 3 3 2 4 Pass <br />