Blow-Fill-SealTechnique
TheBlow Fill SealTechniquehasbeendevelopedsothatformationofthecontainer,fillingandsealingtakesplacein
asinglemachineunderacontrolledenvironmentthatenablesthepackagingofapharmaceuticalliquidinanasepticmanner.
ThefollowingpictureshowthemajorphasesintheintegratedpackagingofparenteralsolutionsusingtheAFP®system.
Asepticpackagingprocess
Asthecontainerismade,filledandsealedwithinasinglemachineandtheprocessisprotectedusingasterileairshowerand
additionally,allprocessmedia(solution,airetc.)aresterilefiltered,thechanceofcontaminationisveryremote.Addingtothefactthat
duringthewholecycle,opencontainersremainexposedtothecleanroomairforlessthan1.5seconds,theBlow-Fill-Sealtechnologybecomestheprocessofchoicewherecontaminationofparticlematterandmicrobialcontaminationisaprimary
concern.ProductDescription
Inordertomeetthedifferentcustomers'requirements,SPMhasdevelopedanextensivemachineprogramforbottleandampoulemanufacturingincludingmachineswithonemouldandtwomoulds.
ThemachinecanfilltheplasticcontainerparenteralssuchasLargeVolumeParenterals(LVP),SmallVolumeParenterals(SVP)andEye,Ear,NoseCareProducts.TechnologyAdvantage
Machineseparationbetweenfillingandmechanicalside(dark/whitesidetechnology)
GradeAatpointoffill,andasepticdesign(CIP/SIP)Upto20'000units/hourcapacity
Volumesrangingfrom0.1mLtomorethan1000mL
Precisiontime-pressure-dosing
FDACFR21Part11compliant
In-housecontainerdevelopment,prototyping,andcontractmanufacturingAFP®Blow-Fill-Sealmachineshasstrictdesignstandardandoperator-friendly,equipmentwithlowestwear,highestprocessrepeatabilityandreliability,thusmeetingallcurrentpharmaceuticalregulationsoftheHealthAuthorities.