MINNCAREDRYFOG2DISPENSECYCLEREPORT

GENERALINFORMATION
CompanyName: MarcyrlPharma
Location: ElObour
Country: Egypt
ContactName(s): MinaHelmyHelmy
MinaMaherMikhail
0
RoomIdentification: SterileFillingArea
Date: April21,2017

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DATA ADDITIONALREMARKS
TotalRoomVolume(m) 360
InitialRelativeHumidity(%) 22%

RoomTemperature(C) 28

NumberofNozzles 2
AirPressureinVessel(bar) 0.7
AitPressureinDFHead(bar) 4

PreparedSolution:
Minncare(ml) 722
PurifiedWater(ml) 7738
TotalVolume(ml) 8460

Diffusion:
TotalDiffusionTimeT1(Minutes) 95
Interruption(s)?(Yes/No) No
IfYes:Reason(s)
IfYes:TotalTimeofInterruption(s)(Minutes)
TotalDiffusionProcedureTimeT2(Minutes) 95
ActualResidualSolutioninVessel(ml) 20
ExpectedResidualinVessel(ml) 20

ContactTime:
TotalContactTime(Minutes) 60
Reason(s)If>90Minutes

Venting:
TotalVentingTime(Minutes) 120

CALCULATIONS
DiffusedSolution(ml) 8440
DiffusedMinncare(ml) 720
DiffusedMinncareperm(ml) 2.0
ExpectedMinncareperm(ml) 2.0
DiffusedWater(ml) 7720
DiffusedWaterperm(ml) 21
TotalProcedureTime(Minutes) 275
TotalDiffusionFlowRate(ml/Minute) 89
TotalDiffusionFlowRate(LPH) 5.33
ActualDiffusionFlowRateperNozzle(LPH) 2.67
ExpectedDiffusionFlowRateperNozzle(LPH) 2.51
FlowRateVariancefromExpected(%) 6.13%