SterilityTest
Asagloballeaderinsterilitytesting,weofferyouanunparalleledexperiencein generatingprotocolsandperformingmethodsuitabilitytesting(inhibition/suppression) tovalidatetestingprocessesbasedonproduct-specificformulations,lotsizes,andfill volumes.Reliablesterilitytestinganddevelopmentorvalidationofproduct-specific methodsarekeyprocessesindrugdevelopmentTestrecordscanbeestablishedfor in-processandfinalproducttestingofpharmaceuticalsandformulations
AboutSterilityTest
Sterilitytestingisusedtoconfirmthatsterileproductsdonotcontainlive microorganismsbeforereleaseandadministration.Duetotheimportanceofsterility testingmethodsformedicaldevices,pharmaceuticals,formulations,tissuematerials, andotherproductsthatclaimtobesterileorfreeoflivemicroorganisms,itis importantthatsterilitytestingmethodsbeasaccurateaspossible
SterilityTestingMethods
Sterilitytestingisrequiredtoensuretheabsenceofvisiblycontaminating microorganismsinpharmaceuticalpreparations,andthepharmacopeialmethodfor testingthesterilityofpharmaceuticalproductsrequiresthatsamplesbeculturedin twoseparatemedia.Inaseptictesting,thetestersusetwodifferentmediatopromote
thegrowthofresidualanaerobic,aerobicandfungalbacteria.Samplesneedtobe incubatedfor14dayspriortotheassay.Thepresenceofturbidityinthemedia indicatesthatmicrobialgrowthmaybepresentandmustbeinvestigated.Ingeneral, weofferdirectinoculationandmembranefiltrationmethods.
DirectInoculation
Specimensareinoculateddirectlyintobothmediatodetectbothaerobicand anaerobicmicroorganismsAfterinoculation,bothmediaareincubatedfor14days Intermittentobservationsandafinalobservationattheendofthetestperiodare performedtodetectevidenceofmicrobialcontamination
MembraneFiltration
Asterile,closeddeviceallowssimultaneousfiltrationofequalvolumesoftest samplesthroughtwomembranefilters.Samplesareincubatedinbothtypesofmedia for14daystofacilitatethedetectionofaerobicandanaerobicmicroorganisms.
Bacteriostatic/FungalInhibitionTest
Incombinationwithaseptictesting,bacterialinhibitiontestingisperformedtoassess whetherthetestarticleinhibitsthegrowthofmicroorganisms.Theperformanceofthe B/Ftestisnecessarytoverifytheasepticresultsandconfirmtheabsenceof antimicrobialpropertiesinthetestarticlethatwouldinhibitthedetectionof microorganismsduringaseptictesting
VaporizedHydrogenPeroxide(VHP)InvasionTest
Thevaporizedhydrogenperoxide(VHP)entrytestisperformedinaVHP decontaminatedisolator.ThisassayevaluateswhetherVHPhasvisiblyenteredthe testarticlecontainer,whichmayaffectthevalidityoftheresults.
Inadditiontotheaboveservices,weofferasimplifiedvalidationservicethatmakes implementationeasierthanever.Thisallowsyoutogetyourproducttothepatients whoneeditfaster
WhydoSterilityTestsNeedtobePerformedfor14Days?
Thesterilitytestis14days,allowingforanappropriateincubationperiodtodetect slowergrowingmicroorganisms.Whilemanybacterialandfungalorganismscanbe detectedinashortincubationperiod,somemicroorganismsrequirealonger incubationperiodtoproliferate.
Source:https://www.formulationbio.com/sterility-test.html