silicOne And thermOplAsticEXTRUSION:

BRINGING SILICONE TO LIFETM

silicOneMOLDING:

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silicOne mOlding AtSSF,collaborationwithourcustomersisnottheexception,itisthenorm.Our

experienceddesignengineersareatthereadytoassistinthedevelopmentofyoursilicone

designrequirements.Customershavecometouswithjustaglimmerofanideaorarough

designsketchedonapadofpaper—notevenbesurethatit’safeasibledesign—and

we’vehelpedthemturnitintoaviableproduct.Ourengineersworkwithyoutodetermine

ifyourdesigncanworkandhowtomakeitcometolife.Weoffersupportformaterial

selection,designspecsandprojectmanagement.We’llrecommendthetypeofmolding

thatbestsuitsyourneeds.Andtheteamwillhelpdesignthebestproductionprocessfor

consistencyandquality.Ourknowledgeable,experiencedengineersinspiretrust.

Engineeringservicesworkswithyoutotakeyoufromdesigntoprototypethroughthe

developmentandpilotphasestoavalidatedproduct.Youcanbringusprojectsanywhere

alongthepathandwecantakethemtocompletion!Inadditiontoourvastexperience,

wehavetheequipmenttosmoothlytransitionyoufromthedevelopmentphaseintothe

manufacturingphase.AtSSF,we’rehereforthelonghaulandthat’swhywecontinueto

investinnewtechnology.Whenyoutourourfacilities—andwehopeyouwill—you will

seestate-of-the-artequipmentandsophisticatedQAmeasuringtechniques.

deVelOpment OptiOns fOr mOlded pArts. Weareknownforourquickturnaroundfromiterativeprototypedesignstoaprototype

product–ofteninlessthan2weeks.Weareabletoprovidesuchfastprototypedelivery

inpartduetoourin-housestate-of-thearttoolroom.AtSSF,wehaveover100yearsof

combineddesignandtool-makingexperience.Infact,wehandleallourowntooling

needs!SSF’sunsurpassedtechnicalexpertisecombinedwithstate-of-the-artCAD/CAM

softwareandequipmentfacilitatesourunparalleledtool-makingcapabilities.

Additionally,ourdedicatedR&Dproductionteamisdeterminedtoprovideaquick

turnaroundofsamplesduringthedesignphase.

SSF’sin-housetooling/engineering/automationteamcandesignaswellasmanufacture

themoldsandequipmenttoenhancemediumtohighvolumesiliconecomponents.

FullyautomatedmoldingatSSFallowsforreducedprocessvariation,helpingtoensure

improvedconsistencyandhighqualitycomparedtoamanualmoldingoperation.

WhenyoupartnerwithSSF,youarenotworkingwithmerelyamoldingcompany,you

areworkingwithexpertswhointimatelyunderstandtheregulatoryrequirements

necessaryforvalidatedproductionformedicalapplications.Withthesupportofour

in-housescientistsandengineers,conductingprocessvalidationsforlongand

shorttermimplantsisapartofourdailyroutine.Additionally,ourqualitysystemis

designedtoensureouron-goingprocessesarecontrolledproperlytomaintainthe

integrityofthosevalidations.

SILICONEM

OLD

ING

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mOlding cApAbilitiesSiliconematerialsaretypicallymoldedbythefollowingmethods:

• LiquidInjectionMolding

• TransferMolding

• CompressionMolding

liquid injectiOn mOlding/liquid silicOne rubberLiquidInjectionMoldingisoften

chosenforhighvolumeapplications,

verytighttolerances,elaborate

geometries,thinwallsorvery

small parts.

trAnsfer/cOmpressiOn mOldingTransferandCompressionMoldingareanoptionwhenpartgeometryandtoolingdictate.

prOcess VAlidAtiOnAtSSF,processvalidationisintrinsicallydriventounderstandeachprocessandobjectively

proveitsrobustness.Yearsofexperiencehavetaughtushowtomeaningfullyvalidateour

processes.Wedon’tperformvalidationsjusttomeetanextrinsicauditrequirement.

SSFdevelopsanextensiveandtime-testedvalidationprogramforeverynewprocess.

OurprocessvalidationsforEVERYpartarecarefullyconductedtoensureweconsistently

producepartswithinspecificationsinacost-effective,timelymannertomeetyourbudget

and timeline requirements. Typical activities we include during process development:

• Moldfunctionanalysis

• Moldingparameterdesignedexperiment(s)

• Evaluationrunandinitialcapabilityanalysisreport

• Testmethodvalidations

AllofourmoldingcanbeperformedinanISO7or8cleanroomcoupledwiththeuseof

scientificallydesignedexperiments,measurementstudiesandstatisticalanalysisto

deliverthequalityyourequireforyourmedicaldeviceneeds.

MOLD

INGCAPABILITIE

S

AtSSF,wealsounderstandhowimportantconfidentialityistoyou.Ourproductionschedule

allowsustodedicateFridaysfortoursandcustomerdemonstrationstoensurethat

potentialorcurrentcustomerscannotvisitourmanufacturingfloorwhileyourprojectis

running.Youcantrustthatwemaintainthehighestlevelofrespectforyourconfidentiality.

Ourgoalistoexceedyourexpectations—andwe’rehappytosaythatmanyofour

customershavetoldusthat“SSFsetsthestandardfortherestofoursuppliers.”

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BRINGING SILICONE TO LIFETM

P: 805-239-4284 • F: 805-239-0523 • www.ssfab.com

Our ApprOAch fOr prOcess VAlidAtiOn includes:

1. Equipment Qualification (EQ)

2. Installation Qualification (IQ)

Typical activities performed for Molding IQs:

• Equipmentqualificationsandcalibrations

• Moldinstallationverification

3. Operational Qualification (OQ)

Typical activities performed for Molding OQs:

• Parameterwindowverificationexperimentsovermultiplerawmateriallots

• Materialtesting(RubberProcessAnalyzer,RPA)

• FailureModeandEffectsAnalysis(pFMEA)

4. Performance Qualification (PQ)

Typical activities performed for Molding PQs:

• PQrunsovermultiplerawmateriallots

• Capability/toleranceintervalcalculation/acceptance

• Analysisofvariance

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