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4f 4A Z. .1Z 1' i tfi!4�A Ethylene Oxide Sterilization Process Record <br /> A 011AFM 11 Sterilizer: kIWAtt Sterilization Batch: 2019032701 H Date: 20190327 Ift6,Order: 1 <br /> Article NamellOW?M Lot No.r1_i"lit III SpecificationtttNW11i" CTNtNO;lAft Quanlity0f <br /> OA VINCI Cartridges 03-19 70C 11 TN 11113 <br /> _�— .._.... _ <br /> of t A: <br /> _... !x <br /> naCl�if. <br /> Requirement =k Time <br /> Setting Value Actual Value PasslFait Sterilization Process Start time End time elapsed(mir <br /> Process ParametersSii7!i'36Akit;(h 14 4iti minlg±l Utt maxk 4A �;1>1+� '.4 XiWAN ifMIl#A �'4111lfiul <br /> Vaccum value(KPa)f*I%r,!A -50.0 -50.3 520 480 Pass HeaungN0 201913/27 16'43 201913127 21:51 308 <br /> Leak test time(min)M MM(xl 5 170 4 6 Fail Keeping warm .1 201913127 18 06 201913127 22:51 285 <br /> Pressure change at end of leak test(KPs)if 11111k)N(f •-- 0.6 00 30 Pass Pre-vacuum Nl4+1 ii"-` 201913127 20 06 201913 27 22.58 172 <br /> Pressure change at end of steam infection(KPa)1let ki fh)1 4 (PC 20 18 011-50 0t.; -48 2 10 30 Pass leak test-AMO ' 201913/27 20 14 201913127 23 03 169 <br /> Pressure change at end of EO Injection(KPa))i0EOki fl))9F4tM 99.0 322 Ilii 48.36+ •16 1 00 1000 Pass steam inleetionMIX 201913/27 20 19 201913127 2314 175 <br /> EO weight Injected(Kg)WOR ••- 00 100 Pass EO allectionAlVi 701913/27 23.14 201913127 23'59 45 <br /> Temperature(TI)during EO exposuref r)AN AV..44+1119 495 M i,: 482 521 aFi 0 55.0 Pass EO dwefl-Kill 201913(27 23'59 2019028 7'59 480 <br /> Humidity(RH)during EO exposure(`4 RH)XM$ftK#i f 'VIQ %hii:n: 47 4 L1,J� 6 14 300 65.0 Pass EO Removal E004 201913128 7 59 201913!28 6'03 4 <br /> Pressure(Pt)during EO exposure(Kpa)kilbltft 1411k Off; •21 0 16,1 Pass aur washing"`'41„A201913178 8 03 201913/28 8 33 30 <br /> EO dwell(min)k 9II0001 _ 480 480 479 481 Pass repressure 0'S" 201913128 8:33 201913/28 9 1 t 38 <br /> Numbers of aN washes 7^O+M-I 6 <br />