Author:DennisMcCullough

P&GCLEANDESIGNSTANDARDS

(forProcess/PackingEquipment,WaterSystems,Facilities&Utilities)

&

CLEANING&SANITIZATIONGUIDELINES

Concurrences

Name

Title

Signature(s)

Function

GiovannideAmicis

VP

viae-mail2011/5/9

Engineering

NoraZorich

VP

viae-mail2011/5/13

R&D

BernieO”Keefe

VP

viae-mail2011/5/13

Manufacturing

FinalApproval

Name

Title

Signature(s)

Function

GaleBeckett

VP

viae-mail2011/5/13

QA

RevisionHistory:

Date

Change

Person

Comments

2011/8/04

FinalApprovedGlobalCleanDesignStandards

D.McCullough

ReviisiontoPACEDocument

2011/5/25

FinalApprovedGlobalCleanDesignStandards

D.McCullough

FinalRevisionforDeployment

2011/5/2

FinalRevisionforApproval

D.McCullough

FinalRevisionforApproval

2011/3/22

Edited2ndVersion(PostInput)

D.McCullough

2ndRevisionforInput

2011/2/15

Edited1stVersion(PostInput)

D.McCullough

1stRevisionforInput

2010/11/23

DraftPostedtocGMPSite

D.McCullough

1stDraftforInput

TABLEOFCONTENTS

TOC\o"1-3"\h\z

HYPERLINK

TableofContents

2

SECTION1:CLEANDESIGNINTRODUCTION

3

SECTION2:MICRO/CLEANDESIGNBACKGROUND

10

SECTION3:MICRORISKASSESSMENT(MRA)

11

SECTION

4:CLEANINGANDSANITIZATION

11

HYPERLINK

SECTION5

HYPERLINK

SECTION

HYPERLINK

SECTION

HYPERLINK

AcronymsList

142

HYPERLINK\l"Acknowledgment"

AcknowledgementsPage

144

P&GCLEANDESIGNSTANDARDS

SECTION1:CLEANDESIGNINTRODUCTION

Purpose:ThepurposeofthisdocumentistoprovidetheminimumexpectedstandardforthecleandesignofequipmentandfacilitieswithinP&Gandatexternalcontractmanufacturingpartners.Thisdocumentcanalsobeusedtoassessthedegreeofmicrobiologicalriskposedbyexistingequipmentandfacilitiesandprovideguidanceastotheappropriatechangesrequiredtoreduceoreliminatetheserisks.ThisdocumentbuildsoninformationcontainedinthecurrentcGMP(CurrentGoodManufacturingPractices)manualand/orspecificbusinessunit(BU)Clean/SanitaryDesignStandards.Ifminordiscrepanciesbetweenthestandardsarefound,thehigher,moreprotectivestandardapplies.Forpurposesofthisdocumentfromaterminologystandpoint,cleandesignexecutionwillresultindeliveryofsanitarysystems.Theterms“cleandesign”and“sanitarydesign”areusedinterchangeablythroughoutthesestandards.

ThisCleanDesignStandardsdocumentwillbehousedonthecGMP(TCC)website.AtthistimeownershipwillremainwithMikeHaney(GlobalFabric&HomeCareEngineering),NeilLewis(GlobalF&HCMicrobiologist),ArazShawki(Health&WellBeingEngineering),andDennisMcCullough(FluorEngineering/P&GSnacksJackson,TN).Ifquestions,additionalinputorchangesarerequired,pleasecontactoneoftheaboveindividuals.Aswell,theembeddeddocumentbelowcontainsthelistofcross-BUandcross-disciplineresourcesthathaveprovidedinputtothisdocumentandtheycanalsobesourcesofinformationasneeded.

InadditiontothisP&Gcleandesignstandardsdocument,theremaybeexternalregulatoryagencyortechnicalorganizationstandardsthatmustbeconsideredforsomeP&Gproductsandprocesses,especiallyforregulatedproducts.Thesemayinclude

FDA(USFood&DrugAdministration)

,

GMA(GroceryManufacturersAssociation)

,

ASMEBPE(AmericanSocietyofMechanicalEngineersBioProcessingEquipment)

,

EMCA(EuropeanMedicinesControlAgency)

,

EHEDG(EuropenaHygienicEngineering&DesignGroup)

andequivalentregional/country/localcontrolagencies(e.g.,CountryBoardsofHealth)localenvironmentalandsafetyagencies;e.g.,NFPA(NationalFireProtectionAssociation),CE(ConformitéEuropéene),ATEX(EUdirectiveforequipmentplacedinexplosiveenvironments(

ATEX

))andP&GProcessSafetyStandards:(

HSEKnowledgeSystem

).

ItisexpectedthatallP&Gemployeesthroughtheuseofthisstandard,andotheridentifiedreferences,understandthelinkagebetweentheneedforcleandesign,microbiologicalcontrolandourconsumers.“Ourobjectivemustbetodelivertotheconsumertheexpectedproductexperiencefreeofdefectsandcontamination.AnythingshortofthisobjectiveisfailingtodeliveronourconsumerpromiseandcouldnegativelyimpactbrandandcompanyequityTherefore,itisimperativethatwedesignqualityintoourproductsandprocessesfromthebeginning”.Theapplicationofcleandesigntoourmanufacturingsystemsisakeycomponentofdesigningqualityintoourproductsfromtheoutsetandthepreventionofmicrobiologicalcontamination

InasimilarmannertoourcompanyPVP’s(Purpose,Values&Principles)andsafetyprogram(SafetyTriangle),thebasisoftheMicro/CleanDesignProgramcanbeconsideredinrelationtotheideasinthefollowingtwoconcepts:

MicroImpactTriangle

DQIe2e(DesigningQualityIn:EndtoEnd)

AdditionalinformationregardingmicrobiologicalcontaminationmanagementwithinP&GProductSupplycanbefoundatthe

P&GProductSupplyMicrobiologywebsite

and

P&GWQA(WorldwideQualityAssurance)website

.

ThisstandardisintendedtobeusedbyallP&Gengineersastherequiredstandardofdesignandconstructionofallprocess,facilitiesandequipmentusedinthemanufactureofmicrobiologicalsusceptibleproduct.Thisstandarddoesnottaketheplaceofthenormalprojectreviewandapprovalstepshoweveritisdesignedtogiveclearguidanceandinstructionastotherequiredstandardsminimizingreworkanddelays.Ifthesestandardscannotbemet,thenthealternativeproposalmustbereviewedandapprovedpriortoimplementationbyrelevantAssociateDirectorsofEngineering,QualityAssuranceandMicrobiology.

Thestandardswillbeintheformofgeneralandspecifictechnicalrequirementsanddetailedrisktables,witheachrisktablesummarizingthekeymicro/cleandesignrequirementsassociatedwitheachoftheabovecoreequipmentcomponents.Theattributerisks;‘Minimal’,‘Moderate’and‘High’riskaredefinedwithinthefollowingtable:

MicrobialRiskLevelAttributeDescriptions

Minimalriskmeansadesigntominimizemicrobialrisk.Minimalrisksystemsdonotprecludecontaminationbutrathersuggestthelikelihoodislow.Thisrepresentstheminimumbasescoperequirementfornewequipmentandfacility/utilityinstallations,anddestinationpointforexistinginstallations,representingthelowestmicroriskdesignbasis

ModerateriskmeansadesignthatrequiresadditionalriskmanagementusingWashout/cleaning,Sanitization,andValidationprocedurescombinedwithMicroDailyManagementtools.Thesuccessfulmanagementoftherisksishighlydependentuponvalidationofproceduresandthecompleteexecutionoftheproceduresattherequiredfrequencies.Thisdesignstandardmaybeusedinsituationwherethe

preferreddesignstandardcannotbeused(e.g.,insomecasesexistinginstalledlegacysystems)andonlywiththeagreementofEngineering,QAandMicrobiology.ItrepresentsareducedmicroriskdesignbasiswhencombinedwithappropriateMDMprogrammitigationprocedures/actionsasdefinedbyMicrobiology.

Projectsexecutingtothesedesignstandardswillneedtodefinethestepsandtimelinenecessarytoachieveminimalriskstandards.Thisoftenrequiresadditionalexpenseafterinstallationanddedicationofresourcestoclosethedesigngaps.ProjectteamsshouldidentifyandofferfordecisionValueAddsolutionstoclosethesegaps.IfwearedesigningtoModeraterisk,thentheproposalmustbereviewedandapprovedpriortoimplementationbyrelevantAssociateDirectorsofEngineering,QualityAssuranceandMicrobiology.

Highriskrepresentsdesignexecutionsthatarenotacceptable.HighriskdesignshaveahighprobabilitythatmicrocontaminationwillbedetectedbytheMicroDailyManagementsystemsorthatthewashout/cleaning/sanitizationprocedurescannotbevalidated.Thiswouldrequireextraordinaryriskmanagementsystemsandprocedurestocontrolwhicharenormallybeyondthecapabilityofourmanufacturingsites.Existingsystemsbuilttothesedesignstandardswillrequiremodificationtoachievetherequiredstandard.

Theintentionisthatwewouldbuildtotheminimalriskrequirementsatalltimesformicrosusceptibleproducts.Ifweareunabletodothisthenthemoderateriskstandardmustbeusedbutisshouldberecognizedthatthiswillbeaccompaniedbysomeadditionalproceduralormitigationstrategies–additionalsamplingormorefrequentcleaningandsanitization.ThehighrisksectionofthetableismeanttodefinewhatwemustNOTdesignorconstruct(notacceptable)formicrobiologicallysusceptibleproducts

CleanequipmentdesignassumesappropriateClean-in-Place(CIP)canbecompletedwithoutcompletedisassemblyofindividualequipmentcomponentsorsystems.Itisrecognizedthatanythingcanbecleanedeffectivelyiffullydismantled,howeverthisisnotnormalpracticeandisnotconsistentwithroutineandefficientoperations.

Whenimplementingcleandesign,costisaconsiderationbutitisnot‘theonly’consideration.Itisimportantthatweconsidertheholisticvalueofcleandesignsystems(bothinitialinvestmentandon-goingoperatingcosts)versustheindividualunitexpenditure.(Forexample:thecostsofcontaminations,productrecalls,increasedcleaningandsanitizations(C&S)andlaborcosts)

Thebasicprinciplesofcleandesignarethefollowing:

UseofInertMaterials(MaterialsofConstruction)

Inerttorawmaterials,product,processconditionsandcleaning/sanitizingagents

Nonreactive,additiveorabsorptive

Selectionbaseduponproductandrawmaterialrequirements(viacorrosion/compatibilitytesting)

SuitableMetallurgy(e.g.,Stainlesssteel–316L)(viacorrosion/compatibilitytesting)

Singlepolymerplastics-e.g.PE(Polyethylene),PP(Polypropylene),PTFE(Polytetrafluoroethylene;e.g.,Dupont’sTeflon?)viacorrosion/compatibilitytesting)

Seals&gaskets–EPDM(ethylenepropylenedieneMonomer(M-class)rubber),PTFE(Polytetrafluoroethylene;e.g.,Dupont’sTeflon?),Viton,Silicone(viacorrosion/compatibilitytesting)

Suitablematerialsofconstructionforaggressiveproducts/materials(e.g.,Titanium,Teflon/PTFE)

Structuralintegrityconsiderationstomeettechnical/requirements,buildingandconstructionregulations

SmoothSurfaces(ReferenceSection7.2)

Facilitatescleaning

Aidsintheremovalofbiofilm(s)duringcleaning

Maintainedthroughjoints,welds,pumps,valves,mixers,tanks,heatexchangersandancillaryequipment

Specifiedinoriginaldesign

Minimumspecificationformicro/cleandesign:0.8Raμm(micronorμm;e.g.,32Raμinch)

PreventProduct/MaterialAccumulation

Productaccumulationisundesirablebecauseit:

Inhibitscleaninginplaceoptions

CreatesidealMicrobiologicalhabitatsandcreatesenvironmentforadaption

SignificantlyincreasesthecomplexityoftheCleaning&Sanitizationprocess

Accumulationpreventionisakeypartofthebasicdesign

Residues,interruptedflowofmaterial

Stratificationofmaterials

Deadlegsincirculatingsystems(ReferenceSection7.7)

Drainable

Allowingvalves,pipes,tanks,andequipmenttofullyempty

Slopingpipe-work

Specificdrainpoints

PrudentuseofNonreturnvalves

Locationofvalves–deadlegs

ImpactofTransfer&Deliveryhoses

CleaninPlace/SanitizeinPlace

Mustcleaneffectivelybeforesanitization

Cleaningsystemadequatelydesigned:

Cleaningagenteffectiveforproductremoval

Sufficientpressure/flow

Design-locationofcleaningapparatus(e.g.sprayballs/jets)

Systemdesignedtoallowaccesstoallcontactparts:

Noproductaccumulationwithinsystem

Nodeadlegs

EasytoDismantle

Importantinareasthatrequirefrequentaccess:

Performinginspectionsaftercleaning

SystemsthatcannotbeCleanedinplace

Spoolsections

Simplicity

SystemsmustbebuiltinsuchawaythateverypartofthesystemcanbeC&Sseparatelytominimizedowntime

Eachunitoperationreducescleaningefficiency.

TheoverlyingrequirementsofthisdocumentwillbeinsupportofcGMPSharePointsiteindefiningdesignapplicationstandardsforequipment(ProcessandPacking),facilitiesandutilities.Forreference,thisCleanDesignStandardsdocumentwillbestoredwithinthe

cGMPSite

.

Whereapplicable,additionalreferencematerialsand/orlinkshavebeenaddedand/orinsertedintothetexttoprovidethereaderadditionalreferencematerial.

cGMPSite

cGMP:3-9CoreEquipment(Process&PackingComponents)

TheroleofP&GEngineersistodesignoutmicroriskfromequipment,facilities,andprocessesonwhichP&Gproductsaremanufactured.ItshouldberecognizedthatP&Gcannoteliminatemicrobiologicalriskasthecompanydoesnotproduceproductsinasterileenvironmentsotheriskofbacterialgrowthisalwayspresent.Theapplicationofcleandesignrequirementstokeyequipmentandfacilitiesdesigncansignificantlyreducetheriskofcontaminationduringmanufacturing.Inadditiontomeetingcleandesignstandards,projectsmustmeetlocalrequirementsandregulations(i.e.,codes)includingdesigncompatibilitywithsafedesignpractices;(e.g.,isolationofhazardousenergysources).

TosuccessfullydelivercleandesignofsanitarysystemsformicrosusceptibleproductstheP&GEngineermustbepreparedtoanswerthefollowingquestions:

Introduction/Basis

Whatisthebusinessneed?

WhatroledoestheEngineerplay?

CleanDesignRequirements

Whatarethekeyrequirements?

Whyisitimportant?

WhatelementsdoIneedtoconsider?

WhataretheCleanDesignspecificationsforequipment?

WhataretheCleaningandSanitization(C&S)requirements(orcurrentC&Spracticesforexistingequipment)?

Somerealcaseexamples(“Do’s/Don’tExamples”)

MicrobiologyandCleanDesigninP&GProjectExecutions

Whatisthemicroriskoftheproductcurrently?

Istherealikelihooditwillincreaseinthefuture?

HowmustImanageMicroriskinthedifferentphasesofmyproject?

Whoarethekeycontactpersons?

WherecanIfindtheinformation?

Forprojectexecutionofcleandesign,theprocesswilltypicallyfollowthebelowflowchartattheappropriateSIMPL(SuccessfulInitiativeManagement&ProductLaunchMode),MOPD/MOPaD/MOMD(MethodologyofProduct/ProcessDesignModel/MethodologyofPack(ag)ingDevelopment/MethodologyofMaterialsDesign),andEWP(EngineeringWorkProcess)steps.

Allprojectsinvolvingmicrosusceptibleproductsarerequiredtohaveadetailedmicroriskassessment/designapprovalatthefollowingcriticalgates(atminimum):

Priortobeingsubmittedforfunding

Priortocompletionofdesign

Afterconstruction(beforestart-up)irrespectiveofthescaleoftheproposedchange.

Theflowprocessasksfordeterminationofwhethertheproduct/intermediates/rawmaterialsaremicrosusceptible.Iftheanswertothisquestionis“YES”andwearechanginganyofthefollowing,thenthecleandesignstandardsmustbefollowed.

Rawmaterialsand/orsuppliers

Productformulationorproductcharacteristics(includinganytransformationchange(s))

ProcessConditions(temperature,pressure,batch/residencetime,pH,etc.)

Equipmentand/ormaterialsofconstruction

Facilities/Utilities

Controlsandinstrumentation

Iftheansweris“NO”andtheproduct/intermediates/rawmaterialsarenotmicrosusceptible,thenmicro/cleandesignisnotrequiredbutitisstronglyrecommendedgivenanychangetotheformulationandprocessinthefuturecouldrendertheproductsusceptiblerequiringasignificantlevelofadditionalinvestmentandrework.Adecisionwhichleadsto“CleanDesignNotRequiredbutRecommended”mustbereviewedwiththeappropriateMicrobiologist.ItisimportanttokeepinmindtechnicalreviewswithP&Gmicrobiologyexpertsandtofollowanoverallapproachsimilartothe

HS&EORA(Health,Safety&EnvironmentOverallRiskAssessment)

processtofullyunderstandprojectchangeimplications.Inaddition,properchangemanagementshouldbefollowedforanyprojectchanges.

ThefollowingrepresentsaRoadmapforprojectcleandesignexecution.TheroadmapprovidesaguidefortheP&GEngineerandProjectManagertoimplementcleandesignwithinthestandardSIMPL,MOPD/MOPaD/MOMD,andEWPworkprocesses.Thisincludescall-outofspecificpointsforreviewandapproval/sign-offofcleandesigndeliverableswithintheappropriatestepsofthedefinedworkprocessesnotedabove.

EWP/SIMPL/MOPD/MOPaD/MOMDRoadmapforCleanDesignExecution:

ExampleRoadmap(view)

Additionally,theroadmapidentifiesuser“Tools”thatcanbeleveragedthroughoutthisprocess.Theseincludebutarenotlimitedtothefollowing:

Tools:

CleanDesignAssessmentChecklist:TheobjectiveofthischecklistisenabletheprojectteamtoreviewprojectscopeviaastandardlistofquestionstoidentifygapsandissuesrelativetoCleanDesignStandardsThesequestionsassisttheprojectteamwithkeyconsiderationsthatenablesystemandequipmentdesigntomeetsanitarydesignrequirements.ThischecklistissimilartotheChecklistBasedDesignReviews(CBDR)includedinEWPbutcontainsmorespecificsregardingmicroriskandcleandesignpractices.Today,thesetwochecklistsareindependentofoneanotheralthoughtheymaybecombinedinthefuture.

OPLOne-PointLesson):Anexampleapproachof“HowtoManageanInitiativefromaMicroPointofView”fromHHC/EMEA(HouseholdCare/Europe-MiddleEast-AfricaRegion)isincludedbelowasareference:

PACE:TheattachedexamplePACEchart(andPACEExplained)issuggestedforuseduringprojectexecutionandintheSIMPL/EWPgateapprovalprocess.SlightadaptationsandclarificationsmayberequiredforspecificBU’sbutthisshouldserveasastartingpointtodefinetherequireddecisionapprovalprocessformicro/cleandesignexecution.

*GlobalEngineeringMicroSPOC:BUEngineering/ProjectExpertMicro/CleanDesignResources

**P&GMCO:P&GCorporateMicrobiologyCapabilityOrganization

CleanDesignPACEDocument(view)

EachoftheabovetoolsarestructuredtoprovidetheP&GEngineerkeyreviewanddecisionpointswithinexistingprojectexecutionworkprocesses.ThecriteriaforsuccesswillbedependentuponearlyFrontEndEngineering(FEE),identificationofMicroCleanDesignCompliance(MCDC)issues/gapsandadherencetothePACEmodelfordeliveryandconfirmationthroughoutthedesignworkprocess.AswithallP&Gprojects,validationwillberequiredtoconfirmMicroCompliancehasbeenmet.

AkeynoteforanyprojectexecutionfortheP&Gengineeristounderstandtheimplicationsofnotfollowingcleandesign.Byselectingnottofollowmicro/cleandesignrequirementswithinprojectexecutions,microdailymanagement(MDM))practicesmustbefollowedincludingthoroughC&S.CleandesignexecutioncanavoidtheoperationalimpactswhichmaybecausedbyfrequentC&Sorsystem/equipmentdismantlingforcleaning.Inaddition,futurechangesmayresultinmicrosusceptibleproductsandmaterialsbeingintroducedintothesesystemspotentiallyresultingincostlyandtimeintensivecapitaland/oroperationalupgrades.WhereCleanDesignStandardscannotbemet,thenthealternativeproposalmustbereviewedandapprovedpriortoimplementationbyrelevantAssociateDirectorsofEngineering,QualityAssuranceandMicrobiology.

Anotherkeyexpectationistoensureintegrationofmicro/cleandesignandHS&Esafetydesignpractices.

Safetyisacorecomponentofourdesignwork.Changestoexistingequipment,facilities,utilities,etc.andnewinstallationsandconstructionmustbereviewedbyappropriateHealth,SafetyandEnvironmentalresources.Earlycollaboration,withHS&E,inthedesignprocessiscrucialtoestablishingtechnicalsafetyprinciplesandpreventingreworkandoverspendonprojects.Technicalsafetystandardsaredesignedbyfunctionalcompetency(e.g.,welding,processsafetypractices,thermal,pressurevessels)andhavesomepre-designrequirements,whichshouldbereviewedpriortoinitiatingworkwithvendors.Inaddition,therearein-processandpre-installationstepstocompleteaswell.Otherconsiderations,alsoincludedinachangereview,includeindustrialhygiene,fireprotection,environmentalcomplianceandprotection,andlegalrequirementswhichshouldbeincludedinprojectplanning.Thus,upstreaminnovationreviewsbyyourChangeManagementReviewBoardarecrucial.Referencecorporatechangereviewsite:

ORAWizard

.

SECTION2:MICRO/CLEANDESIGNBACKGROUND

2.1MICROBIOLOGICALCLASSIFICATION

ThemajorityofliquidproductsandsomedryproductsproducedbyP&Ghavesomedegreeofsusceptibilitytomicrobiologicalcontamination.Thespecificmicrobiologicalrisksposedbyindividualproductswillbeassessedusingavarietyoftechniquesincludingbutnotlimitedtophysiochemicalparameters,susceptibilitytesting,watercontent,previoushistory,etc.

Thedeterminationofthemicrobiologicalriskofallnewproducts,intermediates,andrawmaterialwillbeownedandexecutedbytheMCO(MicrobiologyCapabilityOrganization)inconjunctionwiththebusinessunit(BU)microbiologydepartments.Thesemicrobiologicalriskassessmentswillbeusedduringtheprojectdesignreviewstoensurethatallnecessarymodificationsordesignrequirementshavebeenincorporatedintheequipment,facility/processdesigns,andprojectappropriationstoallowtherelevantmanufacturingsite(s)todevelopandimplementthenecessarymicrobiologicalmanagementsystems.

Theoperatingparametersofmicro-susceptibleproductswillbedefinedwithinglobalmanufacturingstandardsorBUSOP’s.Thismustbereferencedpriortoexecutionofanyprojectinvolvingmicro-susceptibleproducts.(ReferenceP&GProductSupplyMicrobiologylinkinIntroductionsection.)Cleandesignisrequiredforallprojectsinvolvingmicrobiologicallysusceptiblematerials,intermediatesandproducts.

2.1.1RawMaterials(RM)&Intermediates

Themicrobiologicalsusceptibilityandbio-burdenofallRawMaterialsandIntermediateswillbedeterminedbytheMCOassoonasthematerialbecomesacandidateorpotentialcandidatetobeusedinaproduct.Arawmaterialwillonlybeconsiderednotsusceptibleorhostileifitcancompletelysatisfyoneormorephysicochemicalparameterssuchaslowwateractivity,highconcentrationofsolvents,presenceofperoxideorbleach,etc.Theseparameterswillconsistentlypreventorinhibitmicrobiologicalgrowthinthematerial.Theadditionofpreservativesdoesnotmakearawmaterialorintermediatehostileornotsusceptibleasmicro-organismscanadapttopreservatives.TheprocessforevaluationisformallydefinedandmanagedbytheMCO.Note:Combustibilitytestingmayalsoberequiredfordry,rawmaterials.Thisistheminimuminformationrequiredforarawmaterial(RM)atstartofdevelopment,asextensivecost/designmayberequiredtopreventcombustionofparticularlyflammable/combustibleingredients.

Ifarawmaterialisdeterminedtobesusceptiblethenanappropriatemicrobiologicaltest,forexample,atotalviableorganism(TVO)testwillbeincludedintheRawMaterialspecification..

2.1.2FinishedProducts

Finishedproductsareeitherdefinedassusceptibleornon-susceptible,someBUshavedifferentdesignationsformicrobiologicalsusceptibilitysuchasMRC(MicroRiskclassification)howevertheseprimarilyreferencetothereleasesystemoftheproduct.Therearenodifferencesinthecleandesignrequirementsfo