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��Z.1�7F�i��w'�rc Ethylene Oxide Sterilaation Process Record <br />7E�U:S$ SterSwer: k�4lIN; Sterilization Balch: 2019091707 Fiml n..,, <br />20190917 �t bC Order: <br />JU[Icle Name�d'v2&: <br />l.ol No.�i�IL$ <br />Specl0uLionA4iS1$4¢ <br />CTtL'ND;lS C! <br />puantly]!.LLt <br />�90�tI <br />TATTOO NEEDLES <br />19-09 <br />AYE �": <br />t2TOtxu <br />TC���F : <br />$ u�i.$ <br />w FSiA tilt <br />�����: <br />�diA�� <br />9Q4$ <br />❑alS <br />❑�Fo}� <br />Ofi$� <br />3terilizaGon Process <br />'Tc�iIFt <br />Stan time <br />3F 9.`t9iO1 <br />Entl time <br />L:YttY t+l <br />Tlme <br />elapsed(minJ <br />SEOf <br />F7eaSng�f.14 <br />20t9i9J17 18:17 <br />2Dt9f3%17 19:22 <br />�t <br />Keetxm warm A^.ac <br />207919i1719:'cB <br />20191911723:48 <br />Propels Parameters�83:Jg <br />Sattin Value <br />9 <br />i4"''a$ <br />Mtual Value <br />�;�•iw <br />Requlrcmant$$t <br />PasaJFail <br />A{6/TS73 <br />7 <br />mIn@1•fA <br />maz$�¢C <br />ViCcum value (KPa)BIJTiI$ <br />-50.0 <br />-50.2 <br />•520 <br />-08.0 <br />pass <br />207&'9it6 D�1q <br />leak test4me(minJliio�(iisf(q <br />t0 <br />10 <br />a <br />6 <br />Fail <br />Prossure change at end of leak lest (KPa)fiii)EA$ <br />•-. <br />0 ? <br />0.0 <br />3.0 <br />Pass <br />20t9'9itB e:<7 <br />Prc!!urc change at odd of steam JnjeNon (KPaI>m>4.b�h°F'!Y$ <br />20 <br />2 t a. �49.9,E:-47.8 <br />1.0 <br />3.0 <br />Pass <br />15 <br />Pressure change atendo/EO Injection (KPa)iIEOlEA1J'lE:BiQ <br />99A <br />29A 7g'-gg.O.tU:•1B.8 <br />0.0 <br />700.0 <br />Pass <br />EO weight injaUad(Kg)¢JEOJi: <br />— <br />O.0 <br />1D o <br />Pass <br />TempenlurolTt)dudng EO eYpowrc(CIkG11AF21E1a�,Yf <br />49.0 <br />Y:n: <br />45.7 <br />Wx: <br />525 <br />45.0 <br />55.0 <br />Pass <br />Humidity(RN)during EO ezposure('L RN )�c7iilJYAtlEftigJ2 <br />— <br />Yin; <br />51.0 <br />¢ax- <br />63.8 <br />30.0 <br />55.0 <br />Pass <br />Pnlasure lPl)during EO e:posure(KpaJ �ta"IftQ#A)3jJ <br />— <br />Min: <br />-25.1 <br />ILu: <br />-18.8 <br />— <br />._ <br />p� <br />EO dwell (min)JFiEatj7 <br />450 <br />481 <br />G79 <br />487 <br />Pass <br />Numbers 01 elf washasriit7i'tZiiCi( <br />3 <br />3 <br />2 <br />4 <br />Pass <br />20190917 �t bC Order: <br />'�? 1�i1. <br />blix7�': <br />�90�tI <br />AYE �": <br />RinnaO <br />TC���F : <br />$ u�i.$ <br />w FSiA tilt <br />�����: <br />�diA�� <br />9Q4$ <br />❑alS <br />❑�Fo}� <br />Ofi$� <br />3terilizaGon Process <br />'Tc�iIFt <br />Stan time <br />3F 9.`t9iO1 <br />Entl time <br />L:YttY t+l <br />Tlme <br />elapsed(minJ <br />SEOf <br />F7eaSng�f.14 <br />20t9i9J17 18:17 <br />2Dt9f3%17 19:22 <br />�t <br />Keetxm warm A^.ac <br />207919i1719:'cB <br />20191911723:48 <br />250 <br />Pre-y2a:um§J Ir'rt <br />20t9.�•.72348 <br />201919%7723'55 <br />7 <br />Ie0k tesliA::Ci9g1 <br />2C1919i".723:55 <br />207919'780:05 <br />iD <br />swam injeUpn00t� <br />2015'9115 D.OS <br />207&'9it6 D�1q <br />9 <br />EO injeMicnlW€s <br />207919%'18 0:14 <br />2079+3/780:46 <br />02 <br />EO dx+ellk3j <br />20191+180:46 <br />20t9�`A'tB 8:47 <br />451 <br />EO Removal EOiECs <br />20t9'9itB e:<7 <br />2079.1fte a5t <br />< <br />airwashirg'�`Ci1f?. <br />207 &'9118 B -St <br />20t9.11169.CT <br />15 <br />n:pressure lhl <br />2019!91759:07 <br />2019J9�t89:38 3t <br />