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DIR X,19 F <br /> fik!A Ethylene Oxide Sterilization Process Record <br /> WMAISterilizer: XJW#tlq Sterilization Batch: 2018082101 F1 M Date. 20180821 RE�X order: <br /> III-9t <br /> Aricl"N&MO'OM t Specification*41V n CT NNO;X111*kQuaditYlk# <br /> t ic 4ik <br /> DAVINCIcattfidges 08-18 50CTN )MA <br /> xis A-W Vr <br /> AIR" <br /> M, <br /> Time <br /> Setting Value Actual Value Requirementg* Pass/Fail Sterilization Process start time End time alapsed(mi <br /> Process ParametemiVY0111 *AAft it-40 m in At Kmi IA)C ok *41+** WOMW )f it"011 MOM it <br /> Vaccurn value(KP8)81W211t -%o -503 -520 480 Pass HeatingJAIA. 2018/8/211 18:01 20168!21 1922 81 <br /> Leak test time(min)MOVIIA1104 5 5 4 6 pass Keeping warm MC 201818/21 1922 2018021 20.22 60 <br /> Pressure change at end of leak test JKP&)Sbfi;)J* 02 00 30 Pass Pre-vacuum0i0f;6 2018/8121 20-22 20IM121 20,29 7 <br /> Pressure <br /> a leak <br /> as"" <br /> 9,at of <br /> ac <br /> Pressure change at end of steam injection(KPa)WX9Wb-*kM ZO 62 JrJ-50-0,4-1,43 8 10 3,0 Fail leak testif N 4A 20181812120:29 201818/2120,34 5 <br /> Pressure <br /> of 0 Injection <br /> 99,0 358 9-43.8ki:-&O 00 1000 Pass steam injoction)AIN 20181812120:34 2016021 2018 4 <br /> ressure change at end of EO injection(KPa)JME0h3Tk)J*4t* <br /> EO weight injected(Kg)JIME-010.0 10.0 Pass E0 injection WAJ 20201818f21 20 38 20111021 21 20 42 <br /> 11: <br /> Temperature(TI)during EO exposuM IC) Pft Mi*&1 50.0 Witc 492 Max: 2 450 55,0 Pass EO dwelBk M 201802121.20 2018181225:20 480 <br /> 522 <br /> Humidity(RH)during Eo exposure(%RH)*111111*9MI AS --- Min: US 1 Max: 559 300 85.0 Pass EO Removal EWA' 201818122 5:20 201818/22 5:25 5 <br /> 4 _a 0 - — Pass air waOing Y'LA A: 201818122 5:25 201W&22 5:43 18 <br /> Pressure(PI)during EO exposure(Kpo)W1111PAIMS[kh -- MW -15.7 Max: -8-0 <br /> EO dwell(min)XIIIIIIIII41 480 480 479 481 Pass represstoe 33 <br /> Numbers of air w*shes!2!I6t*NkIXJk 3 3 2 4 Pass <br />