Validation protocol for radiation.docx

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:

-

∙numberofmicroorganisms

∙typesofmicroorganisms

∙sizeofproduct

∙numberofcomponents

∙complexityofproduct

∙degreeofautomationduringmanufacture（manuallyassembled

∙productswillgenerallyhavehigherbioburdenlevels）manufacturingenvironment

9.PROCESSANDVALIDATIONAPPROACH:

-

ØE-beamSterilisationProcess:

-

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:

-

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:

-

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:

-

Iftheverificationdoseisfoundacceptable,thenasterilizationdoseisdetermined.

vProductdosemapping:

–

Dosemappingofproductinanestablishedloadingpatternshouldbeconductedtodeterminetheminimumandmaximumdosezonesanddoseuniformity.

Prepareeachproductsamplesandplaceinfinalpackaging.

Sendthesamplesforproductfunctionality,packageandshippingevaluation.Theeffectofshippingandhandlingonthepackageshallbeevaluatedusingap