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:Xffibl.0i$ Sterilizer: <br />{`4 Zrkiihx Ethylene Oxide Sterilization Process Record <br />k�31t$ Sterilization Batch: 2016721501 (3j� Date: <br />Article Name"{I18?Y 4 <br />Lot Ni <br />Specificadoin[li*/nf4S <br />CTWNO;flftt <br />OuamayittjH <br />Canndges <br />18.11 <br />86 <br />�Vft <br />❑a1& <br />❑�o#S <br />❑#8fi= <br />Sterilization Process <br />�Tc1i <br />Start time <br />3HBaJfkg <br />End time <br />SSJWRI <br />Time <br />elapsed(min) <br />Via? <br />HeaBngW+S <br />201 817 21 5 15:47 <br />2016/12/1521:01 <br />314 <br />KeepingwarmiZZ <br />201&121521:01 <br />2018112152201 <br />60 <br />Pre-vacuum+.0k6A:2!! <br />201&127522:01 <br />2018112152209 <br />8 <br />leak testilt$i�3.ry <br />2018112152209 <br />2018112152214 <br />5 <br />steam in)ectanfIRWr <br />207&12152214 <br />2018!121522' <br />10 <br />EO mjecbmw4ri <br />201&121522'24 <br />20181121523:1 <br />54 <br />EO tlY.ellkM <br />201&121523:18 <br />2018112/67:78 <br />480 <br />EO RPmo+al Ei, <br />201&1216718 <br />201&12167:23 <br />5 <br />a� .vashing 21r(A& <br />Process Pareme[BroriaS!3 iE <br />Seting Value <br />.�, <br />20 <br />Actual Value <br />3tfQaft$ <br />Raquimment�92 <br />Passffail <br />minii/l•ffi <br />maxBC*ffi <br />Vaccum value (KPa)191t•£fg <br />-50.0 <br />-50.3 <br />32.0 <br />48.0 <br />Pass <br />Leaktest time(min)MIi�fuiefN7 <br />5 <br />5. <br />4 <br />6 <br />Pass <br />Pressure change at end of leak test(KPal*XXjJlff <br />- <br />0.3 <br />0.0 <br />3.0 <br />Pass <br />Pressure change at end of steam injection(KPa)L0$S flijJ�ftfff <br />2.0 <br />2.7 <br />9il'-4g.9/u:-07.2 <br />1.0 <br />3.0 <br />Pass <br />Pressure change at end of EO injection(KPa)AOEO9-lK)j.Mffi <br />99.0 <br />318 <br />OR 47.2F:.154 <br />OA <br />100.0 <br />Pau <br />EO weight injected(ftbPiEOR <br />- <br />O.0 <br />t0.o <br />Pau <br />Temperature (TI) during EO exposure(C),. 5MO 113Ms'I4 <br />50.0 <br />4in: <br />48.9 <br />Yox: <br />51.1 <br />4&0 <br />55.0 <br />Pass <br />Humidity (RH) during EO exposure(% RH)X�00Rkhkl'OJ3f <br />- <br />Min: <br />40.5 <br />04a: <br />49.1 <br />30.0 <br />85.0 <br />Pau <br />Pressurl during EO exposure(Kpa) XMIRMElaff/t <br />-- <br />Mil: <br />-19.0 <br />vax: <br />-15A <br />- <br />- <br />Pau <br />EO dwell(min)�i9at f47 <br />480 <br />480 <br />479 <br />481 <br />Pass <br />Numbers of air washes.?.4Lii tcbY9t <br />3 <br />3 <br />2 <br />Pass <br />20187215 kf l�Ortler-. <br />bll�:7`: <br />rtfE <br />�Vft <br />❑a1& <br />❑�o#S <br />❑#8fi= <br />Sterilization Process <br />�Tc1i <br />Start time <br />3HBaJfkg <br />End time <br />SSJWRI <br />Time <br />elapsed(min) <br />Via? <br />HeaBngW+S <br />201 817 21 5 15:47 <br />2016/12/1521:01 <br />314 <br />KeepingwarmiZZ <br />201&121521:01 <br />2018112152201 <br />60 <br />Pre-vacuum+.0k6A:2!! <br />201&127522:01 <br />2018112152209 <br />8 <br />leak testilt$i�3.ry <br />2018112152209 <br />2018112152214 <br />5 <br />steam in)ectanfIRWr <br />207&12152214 <br />2018!121522' <br />10 <br />EO mjecbmw4ri <br />201&121522'24 <br />20181121523:1 <br />54 <br />EO tlY.ellkM <br />201&121523:18 <br />2018112/67:78 <br />480 <br />EO RPmo+al Ei, <br />201&1216718 <br />201&12167:23 <br />5 <br />a� .vashing 21r(A& <br />201&1216723 <br />201812167:43 <br />20 <br />repressure Vt2 <br />2018112167-43 <br />201WI2116 8 181 <br />35 <br />