验证方案包装包括报告英文样本.docx

验证方案包装包括报告英文样本.docx

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验证方案包装包括报告英文样本

XXXGroupCorp.

MedicalPolymerproductsCo.，LTD

Packinginspectproject

Name：

theartsandcraftsinspectionofpacking

DocumentsserialNo：

VP-002

draftsman

examineandapprove

ratifier

Sign

Date

Collectsigndept.

Collectionsign

Date

Catalogue

1.Purpose

2.Contextofinspection

3.Resultsanalysisandappraise

4.Finalapproval

5.Organizationofinspection

6.Dutyanddividethework

1.Inspectpurpose:

ThedisposablePlasticBloodbagsmadebyusarepackedinnerpackagewithPVCandover-packagewithhightemperatureco-explasticbagswhicharemadefromPP-PETmaterial.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction（MDD93/42/EEC）,AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts：

thegeneralrequirementsandinspectmethods，withregardtoourinnerpacking，wecarryouttheinspectionsinordertoapproveofmeasuringuptherequirementsofmedicaldeviceinstruction（MDD93/42/EEC）.

2.Inspectcontents

Thefirstpart：

theinspectionofsinglepacking.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction（MDD93/42/EEC），AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts：

thegeneralrequirementsandinspectmethods，withregardtoourinnerpacking，wecarryouttheinspectionsasfollowing:

1）PreliminarycontaminatedInspectionofsinglepacking:

2）Non-ventilateinspectionofsinglepacking:

3）Preventbacteriuminspectionofsinglepacking:

4）Assistanceto-leakageinspectionofsinglepacking:

5）Biologicalcompatibilityinspectionofsinglepacking:

6）Toxicityinspectionofsinglepacking

7）Labelsysteminspectionofsinglepacking

1）PreliminarycontaminatedInspectionofsinglepacking：

omnivorouslyholdingsamples10PCS（triplebags250mlwithlot0218,0219,0220）aftersterilization，themethodsofinspectionrefertoEN1174-1/2/3:

1996theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thefirstpart：

essencerequirementslist，theappraiseofsterilizationofmedicaldevice-animalculecontaminatedappraise---thesecondpart：

instructionofapplication，theappraiseofsterilizationofmedicaldevice-animalculequantityinproducts---thethirdpart：

theconfirmmethodinstructionofinspectiontechnical.

2）Non-ventilateinspectionofsinglepacking：

takeout5piecesaftersterilizationconvenientlywithlot021811，021812，and021813andsendtoinspectcenter.

AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts：

thegeneralrequirementsandinspectmethods.

3）Preventbacteriuminspectionofsinglepacking：

takeout5piecesconvenientlyaftersterilizationwithlot021811，021812，and021813andsendtoinspectcenter.

AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts：

thegeneralrequirementsandinspectmethods.

4）Anti-leakageinspectionofsinglepacking：

takeout5piecesconvenientlywithlot021811，021812，and021813andsendtoinspectcenter.

WhenfilledtonominalcapacitywithwaterasspecifiedinISO3696andsealed，theplasticcontainershallnotdevelopleaksunderconditionsofcentrifugationat5000gat37℃for10min.Theplasticcontaineristhensqueezedbetweentwoplatestoaninternalpressureequivalentto50kPaaboveatmosphericpressureat（23+5）℃for10min.Noleakageisallowedonvisualinspection.

Note；whentheplasticcontainerisfilledwithanticoagulantsolution，leakagemaybedetectedbypressingtheplasticcontaineragainstsheetsofbluelitmuspaperandobservingthedevelopmentofpinkspotsonthepaper.ThedetailinformationreferstoISO3826:

1993plasticcollapsiblecontainersforhumanbloodandbloodcomponents.

5）Biologicalcompatibilityinspectionofsinglepacking：

takeout5piecesconvenientlyaftersterilizationwithlot021811，021812，and021813andsendtoinspectcenter.

ThemethodsofexperimentsrefertoISO10993-1:

1997biologicalappraiseofmedicaldevicethefirstpart：

appraiseandtest.

6）Toxicityinspectionofsinglepacking：

takeout5piecesconvenientlyaftersterilizationwithlot021811，021812，and021813andsendtoinspectcenter.ThemethodofexperimentsreferstoISO3826:

1993plasticcollapsiblecontainersforhumanbloodandbloodcomponents.

7）Labelsysteminspectionofsinglepacking

Takeout5piecesconvenientlylabelstuckwithlot021811，021812，021813，inspectonebyoneaccordingtoEN980packageandsymbolofmedicalpolymerproductsincluding:

（1）Generaldemands

a）Thesymbolindicatedonpackageshouldbeinstructtoshipments，storage，tearingopenandusage

b）Thesymbolindicatedonpackageshouldbeclear，perspicuity，fastness，Itisforbiddentobrushofforslurintheprocessofsterilization，shipmentsandstorage.

c）Thesymbolofparliamentarypackingshouldbetypedontheoutersurfacebutnotexceptforconsideringthatremovingcaninfluenceonthequalityinthepackage.

（2）Thegeneralinformationonthesinglepacking

a）Productsname.styleorspecification

b）Themanufacturename，addressandbrands

c）Productionlotordate:

d）“non-sterilize”lettersand/thenon-sterilizesymbolofdrawing“destroyedafterusing”letters：

e）Ifthesinglepackingisbroken，donotusetheproducts.“Packagebrokennottouse”mustbeindicated.

f）Singleuseinstruction/symboldesign:

g）Expirydate:

Thesecondpart----over-packageinspection

1.Inspectpurpose:

.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction（MDD93/42/EEC），AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts：

thegeneralrequirementsandinspectmethods，withregardtoourpackingmaterial，wecarryouttheinspectionsasfollowing:

1）Non-ventilateinspectionofsinglepacking:

2）Preventbacteriuminspectionofsinglepacking:

3）Agglutinateofsealinspectionofsinglepacking:

2.Contentsofinspection:

1）Non-ventilateinspectionofover-package：

Takeofftheouterpacking，andtakeout5piecesconvenientlywithlotnumber0111，0120，0127andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts：

thegeneralrequirementsandinspectmethods，thepersonwhoconcerningwillcarryoutNon-ventilateinspectionofsinglepacking..

2）Preventbacteriuminspectionofover-package：

Takeofftheouterpacking，andtakeout5piecesconvenientlywithlotnumber0111，0120，0127andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts：

thegeneralrequirementsandinspectmethods，thepersonwhoconcerningwillcarryoutpreventbacteriuminspectionofsinglepacking.

4）Agglutinateofsealinspectionofover-package：

accordingtotherequirements，puttheproductsintosinglepacking，settingtheparameteronthesealmachine，eachgroupscanseal5pieceswithlotnumber0111，0120，0127andsendtoinspectcenter.AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts：

thegeneralrequirementsandinspectmethods，thepersonwhoconcerningwillcarryoutagglutinateofsealinspectionofsinglepacking:

GroupsParameter

Sealtemperature

Conveyspeed

1

200℃

High

2

210℃

High

3

220℃

High

.

3.Thefinalapproval:

Theabove-mentionedexperimentswerecheckedandapprovedbyinspectiongroupswithappraiseandanalysis，theeligibilitydocumentswillhandovertodepartmentsforputtingintoapplication.

3.Inspectionorganization

4.1Inspectionprincipal：

ChengYunliang

Workshopmember：

ZhangYanhongDongLujingDouXiaojie

Manufacturedepartments’member：

TianXuefeiZhaoZhendongLiXiouyingZhangCuiyan

4.2Dutyanddividethework

Workshop：

chargetherecordsofprocessofproduction；strictlycontroltheprocessofproduction

Manufacturedepartments：

harmonizeanddocorrespondentdocumentsintheprocessofinspection.

5.Worksschedule:

Invision，theworkwillbefinishedinMar，.

XXXGroupCorp.

MedicalPolymerproductsCo.，LTD

Packinginspectreports

Name：

theartsandcraftsinspectionofpacking

DocumentsserialNo：

VP-002

draftsman

examineandapprove

ratifier

Sign

Date

Collectsigndept.

Collectionsign

Date

Catalogue

1.Summarize

2.Packinginspectionproject

3.Contentsofinspectioninsinglepackage

4.Contentsofinspectioninover-package

5.Conclusionofinspection

6.Attachmentdocuments

1.Summarize

ThedisposablePlasticBloodbagsmadebyusarepackedinnerpackagewithhightemperatureco-explasticbagswhicharemadefromPP-PETmaterial.Mid-packingusuallyareadoptedaluminumplastic.BasedontherequirementsfromEuropeanCommunity—MedicalDeviceinstruction（MDD93/42/EEC）andBP/CX-21-07，AccordingtotherequirementsfromEN868-1-MedicalDevicesterilizedpackingmaterialandsystem---thefirstparts：

thegeneralrequirementsandinspectmethods，withregardtoourinnerpacking，wecarryouttheinspectionsinordertoapproveofmeasuringuptherequirementsofmedicaldeviceinstruction（MDD93/42/EEC）.

2.Inspectproject

TheinspectprojectiscompiledbyTechnologyDeptwithcollectsignedbyseveralofdepartments，andauthorizedbyadminister.

3.Inspectcarryingintoexecution

Accordingtopackinginspectproject，wecomposedinspectiongroupstoinspectitemsasfollowing:

3.1PreliminarycontaminatedInspectionofsinglepacking:

Descriptionandtype：

250mltriplebags，lotnumber0218，0219，and0220:

Inspectreference：

GB15980-1995thedispo