KeepingProductCleanInandOutoftheCleanroom
--(Part1)TheInterface
ByBarbaraKanegsberg,EdKanegsberg,KevinaO’Donoghue
Areyouawarethatincorrectmaterialstransfercouldposeoneofthebiggestpotentialsourcesofcontaminationwithinacleanroom?Howmanyofyoucansaythatwhileperformingthetransferofmaterialsintothecleanroomenvironmentyouarefullyawareofyouractions,practices,andmethods?
KEEPTHEPRODUCTCLEAN
Paperwork,rawmaterialsformanufacturingtheproduct,tools,andequipmentmustbesuccessfullytransferredtothecleanroom.Thegoalofamaterialstransferprogramistokeepcontaminationfromtheoutsideworldfromenteringthecleanroom.Benefitsofinvestingeffortinamaterialstransferprogramincludehigherqualityproduct,lowercosts,andanenhancedcompetitiveposition.
Somematerialsaredoublebagged,somesinglebagged,andmaybestoredforlongperiodsoftimeincardboardboxesinwarehouseenvironments.Othermaterialssuchastoolsmaynotbebaggedatallandarelikelytohavecomefromanuncontrolledenvironment.
Contaminationcontrolprotocolsformaterialtransferarevital.Materialsbroughtintothecleanroomthathavenotbeencleanedeffectivelyduringthetransferprocessareanimmensesourceofparticulateandthinfilmcontamination.Inadequatelycleanedmaterialscanbeahugesourceofsporeformingbacteria,extremelyresistantbugsthatareverydifficulttoeradicatefromacleanroomenvironment.Manufacturersofallcriticalproductshouldbeconcernedabouttheimpactofbiologicalcontamination,notjustthoseproducingmedicaldevicesandpharmaceuticals.Manypeoplearenotawarethatbiologicalcontaminationwilldramaticallyaffectparticulatecountswhicharerequiredineverycleanroomindustry.Atthesametime,sterilityisnotenough;“deaddirt”canwreckhavocwithcriticaldevices.Watersolublelubricantsandnear-neutralpHprocessescanprovidewater,warmth,andnutrients,afavourableenvironmentforbiologicalcontamination.
ROOMDESIGN
Materialstransfermaybethroughahatchleadingdirectlyfromanunmonitoredmanufacturingareatoacleanroomoratransferhatchbetweentwocleanrooms.Isthisanoptimalarrangementforyourprocess?Withahatch,employeesaretemptedtostandoneitherside,engaginginlivelyconversation,evenenjoyingtheirmorningcoffee.Suchbehaviourincreasesthelikelihoodofcontamination.Fornewconstruction,consideramaterialtransferroom.
Materialtransferroomsshouldfunctionlikegowningroomswitha‘clean’sideanda‘dirty’side.Veryoftenalineoftapeseparatestheseareas.Inpractice,a“lineinthesand,”doesnotkeeppersonnelfromcrossingovertothe‘clean’sideinadequatelygownedorinstreetclothes.Toooftenweseeissueswithhighlevelsofcontaminationonthe‘clean’sideofthematerialtransferroomwheretherootcauseisthe‘dirty’side.
Ratherthanastripoftape,consideran“étagère,”aphysicalbarriersuchasrackingorcabinetsthatallowsexpeditedtransferofmaterialswhilediscouragingpersonnelmovementtothecleanside.Ifrackingorcabinetsareonwheels,itissimpletomovethemtoallowaccessoflargeequipmentorbulkymaterials.Ofcourse,becausesuchbarriersarenotphysicallydistinctrooms,thedirtysideofthetransferroomshouldalsobefairlyclean.
CONVENIENCE
Cleaningmaterialswithinthetransferareamustbeconvenient.Awipedownstationshouldalwaysbevisibleinthematerialtransferroomwithalow-residuecleaningagentsuchasisopropylalcohol(IPA)andlow-lintwipesreadilyaccessible.Ifthereisahatchratherthanaroom,considerwipedownstationsimmediatelybeforeandimmediatelyaftertransfer.Ifnowipedownstationispresent,thereisthetemptationforpersonneltopassmaterialinwithoutcleaningit.
TRANSFERVERSUSGOWNING
Thechanging/gowningareasshouldnotbeusedforwipingdownandtransferringmaterialstoavoidpotentialcontaminationofpersonnelandcleanroomclothing.Goodpracticewithinacleanroomshouldgenerallyallowcleanmaterialstocomeinonewayandusedmaterialstoexitbyanotherarea.
STAYTUNED
InPart2,wewilldiscusstechniquesforcleaningduringtransfer,managingbulkymaterials,andautomation.
Dr.KevinaO’Donoghue,isaMicrobiologistatSpecializedSterileEnvironments,Galway,[email protected].
BarbaraKanegsbergandEdKanegsberg,“theCleaningLadyandtheRocketScientist,”areindependentconsultantsincriticalandprecisioncleaning,surfacepreparation,andcontaminationcontrol.TheyaretheeditorsofTheHandbookforCriticalCleaning,CRCPress.ContactthematBFKSolutionsLLC.,310-459-3614;[email protected];www.bfksolutions.com.