03/09/2015 GMPNews:TheTruthaboutthe3D/6DRule

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27/05/2015
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Theinstallationofpipeworkleadstorecurrentdiscussionsabouthowdeadlegscanbepreventedandaboutthemaximum
lengthoutgoingpipes/pipeteesmayhaveforthesensor.Thereislessthroughflowindeadlegs.Hence,itishardertoclean
themandduringthermalsanitisationittakeslongeruntilthese"branches"havealsoreachedtherequiredtemperature.Incalls RecommendedEvent

fortenderandteststhe3D/6Druleisoftenusedforthespecification,butnotalwaysinthecompletelycorrectway.Inorderto
furtherexplainthis,pleasereadfollowingthehistoryofthisrule.

Theruleforthepreventionofdeadlegs(inaWFIsystem)ismentionedforthefirsttimeinthedraftoftheFDAGuidesfor
LargeVolumeParenterals(LVP),21CFR212.49in1972.ThisrequirementwastakenupintheFDAGuidetoInspectionsof
highpuritywatersystemsin1993onlynowitwascalled6Drule.ThisdocumentisstillusedbyFDAinspectorsasguidance
forGMPinspections.In2001thedeadlegrulereappearedinanISPEguide.TheISPEBaselineGuideWaterandSteamnow
talksaboutthe3Drule.FurtherstatementscanbefoundinWHOTRS929(1,5D),WHOTRS970(3D)andinASMEBPE
2009(2D).ThisisastandardoftheAmericanSocietyofMechanicalEngineersforBioProcessingEquipment.Thismeans:

Thereisa1.5D,a2D,a3Daswellasa6Drule.
Therulehasbeendescribedforhotstoragewatersystemsbutitisalsousedforallcleaninginplacesystems(CIP).
Aruleofthumbbecametheindustrystandard.

Buthowdoesitworkinpractice?Isonerulemorebindingorbetterthantheothers?
Onehastoknowthatthe3Dandthe6Drulecannotbecompareddirectlybecausetheyhaveadifferentreferencepoint.In
thecaseofthe3DrulethelengthLofthedeadlegismeasuredfromthepipewallofthemainpipeandputinrelationtothe
diameterofthepartingpipe.Theinitial6DrulemeasuresthelengthLbeginninginthecentreofthemainpipe.
PreConferenceCourse
"FundamentalsofVisualInspection
andAQLTesting"
15September2015,Berlin,Germany

GMPNewsbyTopics

AnalyticalQC
APIsandExcipients
BloodandBiologics
ComputerValidation
CounterfeitMedicines
GoodDistributionPractices
Asarulethe"3Dorshorter"hasprovenitselfforwatersystemsandissaidtobestateoftheart.Butthefollowingisalso GMPInspections/Audits
valid:Thehighertheriskorthevalueoftheproducttheshorter.Today1.5Disstateoftheartinthecaseofbiotechnology PharmaTechnology
applications.Butthismayalsomeanthatapieceofpipeinanoldercleansteamsystemmayremain6Dwithoutposinga
QualityAssurance
GMPrisk.
Sterile/Aseptic/Microbiology
10
Validation
MedicalDevices

ConferenceRecommendations Pharmaceutical/Clinical
Development
No. Date Title Location
RegulatoryAffairs
PreConferenceCourse
9344 15September2015 "FundamentalsofVisual Berlin,Germany
InspectionandAQLTesting"
ReconstructionandUpgrading
9251 2930September2015 Heidelberg,Germany
ofGMPFacilities
ProductTransfer
9340 2022October2015 OrganisationofGMP Berlin,Germany
compliantSiteChanges

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