Validation protocol for radiation.docx
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Validationprotocolforradiation
COMPANYNAME:
-………………………………
PRODUCTNAME:
-……………………………….
TableofContents
1.PROTOCOLAPPROVALSHEET:
-
TheValidationProtocolshallbePrepared,ReviewedandApprovedbytheconcernedpersonnel.Itshallbesignedanddatedasshownbelow.
Preparedby:
NAME
DESIGNATION
SIGNATURE
DATE
Assistantmanager-QA(validation)
Checkedby:
NAME
DESIGNATION
SIGNATURE
DATE
GM-Production
GM-Q.C
Approvedby:
NAME
DESIGNATION
SIGNATURE
DATE
GM-Qualityassurance
2.REVISIONHISTORY:
-
REVISION
REVISIONDATE
REASONFORREVISION/CHANGEREQUEST
REVISEDBY
01
11/06/2010
Originalrelease
3.OBJECTIVE:
Todeterminethatradiationsterilisationprocessconsistentlyperformsasintendedbyrunningthesystemonitsintendedschedulesandrecordingallrelevantinformationanddataandtestresultsmustdemonstratethattheprocessmeetspre-determinedspecificationsundernormalconditions,andwhereappropriateworstcaseconditions.
4.SCOPE:
-
Thescopeofvalidationprotocolistoprovidesterilizationvalidationstrategiesofradiationofmedicaldevice.Thisdocumentwillshowtwoapproachesforreducingoreliminatingbioburdenonmedicaldevices.Thiswillalsoshowtestmethod,samplingmethodandacceptancecriteriausedinvalidatingradiationsterilisationofmedicaldevices.
5.RESPONSIBILITY:
-
PERSON
RESPONSIBILITY
Validationteam
ØPreparationofprotocol
ØOrganizationofvalidationactivity
ØCollectingthesamplesandsendingtoQC
ØReviewandinterpretationoffinalresults
ØPreparationofreport
Qualitycontrol
ØReviewofprotocolandreport
ØAnalyzingthetestsamples
ØReportingandinterpretationofresults
Production
ØReviewofprotocolandreport
ØConductingthevalidationactivityaspertheprotocol
Qualityassurancemanager
ØReviewandapprovethevalidationprotocol
6.STANDARDSFORREGULATORYREQUIREMENT:
-
∙ISO11137:
2006Sterilizationofhealthcareproducts—RadiationPart1:
Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
∙ISO11137:
2006Sterilizationofhealthcareproducts—RadiationPart2:
Establishingthesterilization
∙ISO11137:
2006Sterilizationofhealthcareproducts—RadiationPart3:
Guidanceondosimetricaspectsdose
∙ISO11737-1,Sterilizationofmedicaldevices—Microbiologicalmethods—Part1:
Determinationofapopulationofmicroorganismsonproducts
∙ISO11737-2,Sterilizationofmedicaldevices—Microbiologicalmethods—Part2:
Testsofsterilityperformedinthevalidationofasterilizationprocess
∙ISO10993-1:
2002BiologicalevaluationofmedicaldevicesPart1:
Evaluationandtesting
7.LISTOFSOPs:
-
∙SOPfore-beamsterilizationprocess
∙SOPforgammasterilizationprocess
∙SOPforenvironmentalmonitoring
∙SOPforsamplingprocedure
∙SOPfortestingmethod
∙SOPformaterialhandlingincludingbiologicalindicator
8.PREREQUISITE:
-
Thefollowingrequisitemustbefulfilledbeforetheradiationsterilizationprocessvalidation.
ØEquipmentQualification:
-
Equipmentassociatedwithradiationsterilizationprocessmustbequalifiedpriortoprocessqualification.
ØCalibration:
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Allprocesssensing,controlling,indicating,andrecordingdevicesonthesterilizerorindependentsystemsassociatedwithsterilizermustbecalibratedandrecoded.Calibrationprogrammustbedocumentedanddetailedprocedureofcalibrationfrequencyforalltheinstrumentsshouldbeidentified.
ØProductandpackagingmaterialevaluation:
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AsperAAMITIR17productandpackagingmaterialmustbeevaluatedfortensilestrength,impactstrength,andshearstrengthandpackagingintegrity.
ØProductgrouping:
-
Forefficientandcost-effectivevalidationperformance,similardevicescanbegroupedintofamilies.Productfamiliesforradiationprocessesshouldbeselectedbasedonbioburden.
Familyofproductsmustbeofsimilardesignandmaterialsofconstruction,andsimilarbioburdenlevels,butcanbeofdifferentsizes.
ØSelectionoffamilyrepresentative:
-
Eachfamilyofproductswillcontainanumberofdevices.Fromthesedevices,therepresentativechallengeproductisselected.Theselecteddevicewillbethemostdifficultdevicetosterilizeinthefamilygroupandwillbeusedinverificationdoseexperiments.Familyrepresentativeshouldbeselectedbasedonfollowingcriteria:
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∙numberofmicroorganisms
∙typesofmicroorganisms
∙sizeofproduct
∙numberofcomponents
∙complexityofproduct
∙degreeofautomationduringmanufacture(manuallyassembled
∙productswillgenerallyhavehigherbioburdenlevels)manufacturingenvironment
9.PROCESSANDVALIDATIONAPPROACH:
-
ØE-beamSterilisationProcess:
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Theproductisqualifiedfore-beamsterilisationforproductandpackagingintegrity,strengthandproductcharacteristics.Theproductisloadedonconveyorbeltaccordingtopre-establishedloadingpattern,consideringthenumberoftote,toteloadingandpackagingloadwrappingforshipment.Electronsaregeneratedbyelectronaccelerators.Acceleratorismachinewhichcontainfivecomponentssuchas,
ØElectrongun
ØHighvoltagefield
ØVacuumtube
ØElectromagnet
ØScamhorn
Acceleratoruseselectricalenergytogeneratefreeelectrons,acceleratethemtohighspeedandthendirectthemthroughaccelerator,atmaterialpassingonaconveyor.
ØGammaSterilisationProcess:
-
ThesterilisationprocessbyGammaRadiationinvolvesexposingtheproducttoradioactivesourcewhichemitsirradiation.GammaRadiationkillsmicroorganismsbyattackingtheDNAmolecule.BothdirectandindirectmechanismsareinstrumentalinthedisruptionoftheDNAbond,whichresultsinthepreventionofcellulardivisionand,consequently,thepropagationoflife.
Gammarayshavelowdoseratebuthighpenetrationpowerupto50cm.
TherearetwotypesofsterilisationprocessbyGammaRadiation,
1.CONTINUOUSPROCESS:
-workswithanautomatedconveyancesystemmovingproductthroughthemaze.
2.BATCHPROCESS:
-worksbyloadingasetnumberofcarriersandpositioninginirradiationchamber.
Ø
E-beamsterilisationprocessandparameters:
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Sterilisationprocessstepsprocessparameterstobeconsider
Product
ØBioburdenlevel
ØProductcompatibility
ØProductcharacteristics(density,geometry)
ØProductfamily/grouping
Electronspassthroughproductload
Electrongeneratedbyelectronaccelerators
Productloadingonconveyorbelt
ØGammasterilisationprocessandparameters:
-
Ø
Productloadinginradiationchamber
Product
SterilisationprocessstepsProcessparameterstobeconsider
GAMMARADIATION
ØValidationofradiationsterilization:
-
Radiationsterilisationvalidationcanbedonebyfollowingsteps.
1)Processqualification
2)Productandpackagingqualification
3)Administrativeproceduretoreviewandapprovedocumentation
4)Maintenanceofvalidation
1)Processqualification:
-
vDeterminationofproductloadingpattern:
–
Loadingpatternmustbespecifiedincludingnumberoftotes,toteloading,packaging,loadwrappingforshipment,minimumsterilisationdosefortheparticularloadingpatternandlocationofdosimeters.
vBio-burdendetermination:
–
Bioburdenisthepopulationofviablemicroorganismsonarawmaterial,acomponentofafinisheddevice.Theassessmentofthebioburdenincludesthenumberofmicroorganismswiththeiridentities.Dosesettingandproductgroupingisbasedonbioburdenlevel.
Obtainsamplesrandomlyfromthreedifferentbatchesofroutineproductionprocesses.
Bioburdenevaluationmustbeperformed
Performbioburdendeterminationbyextractingeachdeviceindividuallyandfilteringtheextractthroughasterilebacterialretentivefilter.
Performbioburdenrecoveryvalidation(Anadditionalnonsterilesamplesarerequiredforthis.)
Determinetheaveragebioburdenperdeviceforeachlot,aswellastheoverallbatchaveragebioburden
Calculatetheoverallaveragebioburden.Ifaspike(asinglevalueatleast2Xtheoverallaverage)occurs,thespikevaluemaybeusedratherthantheaverageforthedoseselection.
vDeterminetheVerificationDose:
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Doseverificationcanbedonebymethod1,method2orVDmaxmethod.Refertotheappendix1fordescriptionofthismethod.
Ifanysinglebatchaverageis2timesgreaterthantheoverallbioburdenaverage,useittodeterminetheverificationdose.Ifnot,usetheoverallaverage.
Randomlyselectpackageddevicesfromasinglebatchofproducts.Thesecanbeselectedfromanyofthebatchesusedforbioburdenorfromafourthbatchrecentlymanufacturedinasimilarmanner.
Sterilitytestingmustbeperformedonthesterilisedsamples.Bacteriostasisandfungistasistestingmustbeperformedonthisproduct.
vEvaluationofsterilitytestresults:
-
Theverificationdoseisacceptableiftwo
(2)orlesssamplesshowgrowth.Ifmorethantwo
(2)samplesshowgrowth,theverificationtestisrejected.Aninvestigationshallbeperformedtoevaluateifthefailurecouldbeduetoincorrecthandlingofproduct,incorrectperformanceofthetest,orincorrectdosing.Ifsodetermined,theverificationdoseexperimentcanberepeated.
vSterilisationdoseselection:
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Iftheverificationdoseisfoundacceptable,thenasterilizationdoseisdetermined.
vProductdosemapping:
–
Dosemappingofproductinanestablishedloadingpatternshouldbeconductedtodeterminetheminimumandmaximumdosezonesanddoseuniformity.
Prepareeachproductsamplesandplaceinfinalpackaging.
Sendthesamplesforproductfunctionality,packageandshippingevaluation.Theeffectofshippingandhandlingonthepackageshallbeevaluatedusingap