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EOxmkIW*�f(&**EO Sterilization process specification review <br /> G4fiP]:G JE��It'$ <br /> Sterilization condition I YNAF-01 Sterilization Run No. I 202307030201 <br /> Boo comDon is/lot# I 100%/A Tempf product <br /> Temp of product 36 <br /> EO CMTEP-9 ifti ffi mm 3MVI n195M <br /> EO sterM—ti—process steps Set point Limits Observation Acceptability <br /> HeatingIVIA <br /> Temperature at the end of heatingTllAI$t.1`"i](R•ffltJ1i11JET1("C) 49 45-55 49.0 e4fFpass <br /> Temperature at the end of heat ingT21]]lIM.Iil7(R409)RT2(�C) 49 45-55 50.0 .&Pass <br /> ConditioningSIM <br /> Temperature during this periodTl*&i!L4MAIAITl (C) 49 45- 56 49.0-52.9 *41)ass <br /> Temperature during this periodT29kJUitWZg(T2(L^) 49 45-65 50.0-54.1 *#Kpass <br /> Conditioning ttme♦ ;MR•IfnJ(mi.n) 30 29- 31 30.0 1 a Mpass <br /> PrevacuumfAlz <br /> Pressure at Lite end or vacuumingPi M All,M3kfJ)PJP1 (kpa) '20 -21 --19 -20 $#pass <br /> I'masure at the end of vacuumi-aI2hh A-?.I I4ElKbP2(kPa) 20 -21 --19 -19.0 **Pass <br /> Rate AP for vacuuminsPIhIIA*?A*PI Wa/min) 0 - 5 1.7 a Nipass <br /> Rate AP for vacuumingP2JIhAtA*P2(kPa/min) 0- 5 1.7 u*Pass <br /> Vacuum tin MA!?.'lilfnl (min) 0-00 15.1 ff*pass <br /> Vacuum Leak Test A!tM 1 MbC <br /> Pressure rise in leak test P1iLIAfiilJ3i'I-MP1(AkPa) 2 0 - 2 u.:) $}$pass <br /> Pressure rise in leak test P2iNlWLDAftMP2(AkPa) 0- 2 0.2 ofllpass <br /> Holding timatVI WO] (min) .1 6 5.0 ft4pass <br /> Rate AP of leakPIMW& *Pl (Wa/min) 0.d 0 - 3 0.I -814pass <br /> Rate AP of leakNiOlibaR*P2 (kPa/min) 0.4 0 - 3 0.1 ,",4pass <br /> N2 replacementJK'tWA <br /> N2 changes timesA'%AA2k k (times) / <br /> Pressure at the end of N2 injection Pi <br /> At®(i]: 4±11jJPl UP.) <br /> Pressure at the end of N2 injection P2 <br /> ll(A"(aA4ItIt1§JJP2(kPa) <br /> N2 Injection timeA'WiiLAPI ](Min) <br /> N2 replacement vacuum pressure PIW'f AA!;!IL)JIOftPI(kPa) <br /> N2 replacement vacuum pressure Ply(—tAf A!2!'Jk)Jf(lP](k]'a) <br /> Vacuum timetblk 11111a] (Yin) / <br />