hand washing—a critical aspect of personal hygiene in...

Microbiology Topics.Scott Sutton, Coordinator[

“Microbiology Topics” discusses various topics in microbiology of practical use in validation and compli-ance. We intend this column to be a useful resource for daily work applications.

Reader comments, questions, and suggestions are needed to help us fulfill our objective for this column. Case studies from readers are most welcome. Please send your comments and suggestions to column coordinator Scott Sutton at scott.sutton@microbiol.org or journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTSThefollowingkeypointsareaddressedinthisarticle:

•Good personal hygiene is a requirement of allpharmaceuticalactivities,fromoperatingonthelinethroughvalidations.However,studiesshowpoorcomplianceasaruletobasichandwashingtechnique.

•Poorhandwashingtechniquemayresultinincreasedabsenteeism,particularlyintimeofapotentialH1N1pandemic.

•Limitedavailabilitytoadequatefacilitiesmayleadtopoorcomplianceorpoorefficacyofwashingifperformed.Thesefacilitiesincludeappropriatelyconstructedandsourcedwatersupply,soapsupply,andperhapsmostimportantly,adequateprovisionsforthoroughdryingofhands.

•While“antibacterial”labelclaimsdonoharm,theyshouldnotbereliedupontoprotectagainstpoorpractice.

•Jewelrycaninterferewithadequatecleansingand

shouldberemovedbeforewashing.Jewelryshouldbediscouragedinareaswherehandcleanlinessisimportant.

•Trainingforcomplianceinhandwashingisdifficult.Therehavebeennumerousreportsofthedifficultyintrainingandthesubsequentmonitoringofhealthcareworkersforcompliancewithhandwashingrequire-ments.Suggestionsfortrainingandapotentiallyusefulmonitoringtoolareprovided.

•Manystudiesuseextendedperiodsoftimeduringthewash(1.5-2minutesinsome).Thisisnotapracticalregimen.AhandwashingregimentissuggestedforpharmaceuticalmanufacturingworkersbasedontheCentersforDiseaseControl(CDC)handwash-ingprotocol.

•Validationpersonnelshouldcarefullyevaluateper-sonnelpracticeswhenmicrobialtestingisrequiredinvalidationprotocols.Itislikelythatsimplepro-cesses,suchashandwashing,aregenerallyassumedtobeundercontrolwhentheymaybeanundetectedsourceofproductcontamination.

INTRODUCTION Whendevisingvalidationprotocols,whethertheyareprocesssimulationmediafills,environmentalmonitoringqualifications,sanitizerqualificationprograms,orper-sonnelqualificationprograms,wetendtotakethebasicrequirementsforgranted.Handwashingisanactivitythatisundoubtedlytakenforgranted.Whilethefirsttwoactivitiesmentionedabovearemoreaconcernfortheasepticmanufacturer,theremainingenvironmentandpersonnelqualificationstudiesareacurrentgoodmanu-

Hand Washing—A Critical Aspect of Personal Hygiene in PharmaScott Sutton

ABOUT THE AUTHORScott Sutton, Ph.D., is a consultant with Vectech Pharmaceutical Consultants and operates The Microbiology Network (www.microbiol.org), which provides services to microbiology-related user’s groups. Dr. Sutton can be reached at scott.sutton@microbiol.org.

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facturingpractice(CGMP)concernforallmanufacturers.Thesepracticesmustbebasedonsolidfundamentals.Knowledgeandtraininginthesefundamentalsbeginswithadequatepreparationofthepersonnel.Beyondthis,itisaclearrequirementintheCGMP(1)asfollows:

“21CFR211.28PersonnelResponsibilities:“(a)Personnelengagedinthemanufacture,processing,

packing,orholdingofadrugproductshallwearcleanclothingappropriateforthedutiestheyperform.Protec-tiveapparel,suchashead,face,hand,andarmcoverings,shallbewornasnecessarytoprotectdrugproductsfromcontamination.

“(b)Personnelshallpracticegoodsanitationandhealthhabits.

“(c)Onlypersonnelauthorizedbysupervisoryperson-nelshallenterthoseareasofthebuildingsandfacilitiesdesignatedaslimited-accessareas.

“(d)Anypersonshownatanytime(eitherbymedi-calexaminationorsupervisoryobservation)tohaveanapparentillnessoropenlesionsthatmayadverselyaffectthesafetyorqualityofdrugproductsshallbeexcludedfromdirectcontactwithcomponents,drugproductcon-tainers,closures,in-processmaterials,anddrugproductsuntiltheconditioniscorrectedordeterminedbycom-petentmedicalpersonnelnottojeopardizethesafetyorqualityofdrugproducts.Allpersonnelshallbeinstructedtoreporttosupervisorypersonnelanyhealthconditionsthatmayhaveanadverseeffectondrugproducts.“

Inadditiontotheconcernoverthequalityofourvali-dationstudies,thereisapersonnelconsiderationaswell.Properhand-washingtechniqueisthemosteffectivemeanstoslowthespreadofdisease.Properhandwashingisparticularlyimportantinthistimeofincreasedconcernoverglobalpandemic.TherehavebeenascoreofrecentarticlesonthebestwaystominimizethespreadoftheH1N1virustransmission(2,3).Recentworkhasshownthathandwashingmaybeanextremelyeffectiveandeconomicalwaytoslowthespreadofthevirus(4).

Anobviousconsiderationintryingtoestablishtheefficacyofhand-washingregimensisthemethodtodeter-minethatefficacy.Anin-depthreviewofmethodologyisoutsidethescopeofthisarticle,buttheinterestedreaderisreferredtoASTM-E1174-00,Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel,orConsumer Hand Wash Formulations,orthetwoEuropeanstandardsprEN12054(describingsuspensiontests)andprEN12791(describingthein vivotest).Wewillnotdiscussthetestingmethodologiesanyfurther,butthereaderiscautionedthatallresultsreportedbythedif-ferentstudieswill,ofcourse,bedependentonhowtheregimenwastested.

FACILITIESWereturnto theCGMP(1) for the followingbasicrequirements:

“211.52WashingandToiletFacilities.Adequatewashingfacilitiesshallbeprovided,includinghotandcoldwater,soapordetergent,airdriersorsingle-ser-vicetowels,andcleantoiletfacilitieseasilyaccessibletoworkingareas.”

WaterSomeaspectsoftheavailabilityofsoapandwater(intermsofsinks)areself-evident.Firstofall,thereshouldbesoapandwateravailabletothoseenteringandleavingthelabormanufacturingarea.Thewatershouldbeofsufficientquality(atleastpotable).Themechanismtooperatethewaterflowshouldnotencouragetherecon-taminationofthehandsimmediatelyafterwashing.Thisiscommonlyaccomplishedthroughtheuseofelbowleversorfootswitchestoturnthewateronandoff.TheimportanceofthisconsiderationwasemphasizedinthestudyofGriffithet al.(5),whoshowedapositivecor-relationbetweensurfacefilthandrecontaminationofhands—thefaucetswerethemostconsistentlycontami-natedfeatureoftheimmediateenvironment.

Currentbestpracticerecommendssinksbeconve-nientlylocatednearentranceandexitpoints,withsuitablecontrolmechanisms,andtheavailabilityofsoap.

SoapThetypeofsoap,andinparticularthedesignofthesoapdispenser,isanotherimportantaspectoftheeffi-cacyofhandwashing.Wehavethreemajorchoices:Barsoap,refillableliquidsoap,andsealedliquidsoap(forthemomentwewillsetasidethewholequestionofantibacterialsoapsandaddressitlater).Barsoapisnotsuitableasitisaprovenreservoirforbacteria(6).Thisleavesuswithliquidsoap.

Liquidsoapdispenserscomeintwogeneraldesigns.Inthefirst,liquidsoapcanbeaddedtoareservoirwhenrequired.Bestpracticeistocompletelycleanoutthisres-ervoirbeforefillingitagaintopreventbacterialbuildup—Bacteriacanliveinsoap(7,8).Itisnotrecommendedtomerely“top-off”thesoaptorefillthereservoir.So,inchoosingbetweenremovingtheresidualsoapandthoroughlywashingoutthereservoirbeforerefilling,andtheotherchoiceofliftingthelidandtoppingitoff,whichisthemorelikelypractice?Thisdoesnotevenconsiderthenozzlethatgetstouchedbytheuser’shandassoapisdispensed(topreventthatlastdropfromfallingontothecounter).Inaddition,thisfaucetisverylikelytohavedriedsoapcakedtoitsexterior.

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Theothervarietyofpublicarealiquidsoapdispenserhasasealedbagwithanintegralnozzle.Regardlessoftheformulationcontainedwithinthebag,thissystemenablesacleanstartupwitheachrefillofthesoapcontainer.Iwouldurgetheuseofthesealedbagsysteminthelabandmanufacturingarea.Thereisnosenseinriskingthecontaminationofyourhandsbythesoapifthisriskcanbeminimized.

Antibacterial AdditivesTheconceptofantibacterialadditivestosoapsoundsgood.Takesoap,arguablythemostimportantmedi-caladvanceinthelastfewhundredyears,andmakeitbetterbyaddingabiocidetoit.Theproblemwiththisscenarioisthatnooneisactuallyrequiredtoshowthatthebiocideworksinthesoap,onlythatitispresentintheformulation.Thisisnottosaythatreputablemanu-facturersdonoconductappropriatetesting,onlythatthedemonstrationofantimicrobialefficacyisnotrequiredtoputalabelonyourproductthatitisan“Antibacterial”soap.Inaddition,thereisthepossibilityofselectingforbiocideresistanceinsoapsthatmightbeonlymarginallymoreefficaciousthanstandardsoap,ifmoreefficaciousatall(9,10).However,thiscanleadtobettersoapsifformulatedwell.Forexample,Fulset al.(11)foundthatwithaparticularsoapcontainingtriclosan,theuseofagreatervolumeofsoapandlongerwashtimeresultedinamarkedsuperiorityoftheantibacterialsoapoverthetraditional.

Thebiocidesmostcommonlyusedassoapadditivesincludetriclosan,chlorhexidine,EDTA,andalcohols.Triclosanhascomeunderintensescrutinyforpotentialselectionofantibiotic-resistantmutantmicroorganims,particularlyinEurope.ThispromptedtheEuropeanCommission(EC)toformallyexaminethesafetyoftriclosan,andtheScientificSteeringCommitteeoftheEuropeanCommissionadoptedanofficialopinionin2002thattriclosan,usedinbiocidalconcentrations,issafeandeffective(12).Chlorhexidinestillhasaplaceinthesurgicalscrubarena,butisnotamajorcomponentinconsumerproducts.

Tosumthisup,biocidesaddedtosoapmakeananti-bacterialsoap.However,thisisnotaguaranteethattheresultantantibacterialsoapsare,infact,antibacterial.Therehaveevenbeenreportsoftheantibacterialsoapsufferingcontamination(13,14).

HAND JEWELRYHandjewelry(e.g.,rings,bracelets,watches,etc.)shouldberemovedwhenwashinghands.Theseitemsofjewelrymakeitverydifficulttocleanyourhandseffectively.

Alpet al.(15)examinedthehandwashingpracticesoflaboratoryworkers,figuringthatregularexposuretopathogenicorganismswouldmakethemawareofthedangers.Compliancewas100%fortheactitselfaftertraining,but36.7%worearing,46.9%awatch,and6.1%bracelet—allofwhichharboredpathogenicorganismsafterhandwashing.Thiswascorrectedbyrepeatedinterventions.Fagerneset al.(16),inastudyofhealth-careworkers,examinedtheimpactofwearingasingleplainring(ratherliketheweddingringmanyofusarenolongerabletoremove).Thegoodnewsisthatthetotalbioburdenafterwashingwasnotdifferentbetweenringwearingandnoringsubjects,althoughthestudyshowedaclearincreaseinEnterbacteriacaecontaminationwhencomparedtothesubjectswithoutrings.

DRYINGSeveralteamshavelookedatpapertowelsvs.hotairdryerinregardstocleaningandtransmissionofcontamination.MatthewsandNewsom(17)comparedhotairdriersandpapertowelsforthepotentialtospreadairbornemicroorganismsduringthedryingprocess.TheirdesignfocusedonairsamplingusingCasellaslit-to-agarsamplerforairbornebacteriaduringdrying(inthesomewhatcontrolledenvironmentofabiologicalsafetycabinet).Theyfoundminordifferencesinairborneviablecountsinacomparisonbetweenonemodelofdryerandpapertowels,significantlylessairborneviablecountsfortwoothermodelsincomparisontopapertowels.Blackmoreexpandedthiscomparison,conductingastudy(18)ontheeffectofdryingbyairblower,bypapertowel,andfinallybyclothtowelonacontinuousroller.Thefingertipsofthelefthandweresampledbytouchingtonutrientagarandthenthehandswerewashed.Afterwashing,thehandsweredriedbyoneofthethreemethodsandsampledagain.Theexpelledairfromtheairdrierswassampledbyblowingitonto“nutrientagar”from6inchesforacontrolledperiodoftime(differingbycycletimeofthemodelofairdrier).Thepaperandclothtowelsweresampledbytouchplates.Blackmorereportsthattheairblowerstested(inpubliclocations)harboredbacteriaandcouldserveasasourceforrecontaminationofhandsafterwashing.Thesituationwithcontinuousclothdryingwasnotencouragingeither.Theclothrollertowelswereverygoodwhennewbutoverthecourseofthreemonths(thelengthoftimestudied)theybecamecontaminated.Inaddition,shefound(in1989)thatthesecontinuousclothtowelsarelaunderedandre-used.Thelaunderedmaterialwascontaminatedaswell(rangeof10-60CFU/touchplate)asinstalledintherollerdispenser.Oneexplanationfortheapparentcontradictionintheresultsisofferedby

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MeersandLong(19)whodidalimitedstudytoevalu-atethepurchaseofhot-airdryersfortheirhospitalandsampledtheairbefore,during,andafterdrying,findinganincreaseincountsonlyafterdrying.Theyconcludedthatitwasdifficultforsmallparticlestoescapefromskinwhilemoist(coveredwithwater).Whatwasimportantwasthattheskinbethoroughlydried.

Harrisonet al.(20)tookacloserlookattransmissionofbacteriabetweenhandsandpapertowels.Theylookedatbothdirectionsoftransmission,reasoningthattheconcernoveracontaminatedtoweltransmittingtothehandisclear,butthereisalsoapossibilityforacontami-natedhandtotransferbacteriatothedispenserwhilefreeingjammedtowels.Usingawall-mountedpapertoweldispenserandarangeofpapertowels,volunteers(witheithercleanorcontaminatedhands)wereaskedtoclearjammedtowelsfromthedispenser(thedispensereithercleanorcontaminated).Theyfoundthatwhilethecontaminatedhandsonlymarginallycontaminatedthedispenser(0.01%-0.64%)thedispenserwasfairlyeffectiveatcontaminatinghands(12.4-13.1%).

Inlookingatthepotentialfordirtyhandstocontami-natesurfacesweshouldalsoconsiderdryness.Patricket al.(21)instudyingthisissueconcludedthat,“…bacte-rialnumberstranslocatingontouchcontactdecreasedprogressivelyasdryingwithanairorclothtowelsystemremovedresidualmoisturefromthehands...Carefulhanddryingisacriticalfactordeterminingtheleveloftouch-contact-associatedbacterialtransferafterhandwashinganditsrecognitioncouldmakeasignificantcontributiontowardsimprovinghandcarepracticesinclinicalandpublichealthsectors.”

ReinforcingthisconsiderationistherecentstudyofYamamotoet al.(22)wholookedatdryingbypapertowel,byhotair,andbyhotairsupplementedwithUVlight.Inaddition,thehotairdryingwasperformedeitherbyholdingthehandsstationaryorbyrubbingthehandstogether.Afterlookingatallvariablestheyconcludedthatthehotairdryeriseffectiveifthehandswereheldmotionless(i.e.,notrubbed)untildry.TheUVlightalsoseemedtohelpindecreasingresidualviablecellsforthehotairdryer.Papertowelswereshowntobemoreeffec-tivewhenmeasuredbyfingertipsampling,butequivalentbyothermeasures.

TRAINING AND MONITORINGAllbudgetaryresourcesspentonapersonnelhygieneprogramwillbeineffectiveiftrainingandmanagementattentionisincompleteorindifferent.Complianceisuniversallythemajorprobleminhand-washingprograms(23).Thefirstproblemtoaddressistodetermineasuit-

ableprocedureforhandwashing.Severalareavailable;although,nonearespecificallydirectedtothepharma-ceuticalworker.Apotentiallyusefulmethodispresentedinthenextsection.

Trainingbecomesthenextissue.Trainingbyroteisalwaysanoption,butthisisnotaparticularlyeffectiveoneas“everyoneknows”howtowashtheirhandsandanychangesmadesolelytomeetstandardoperatingprocedure(SOP)requirementswillbetransitoryatbest.Thereareseveraltoolsavailableforassistanceintraining,particularlyintheevaluationofcleaningefficacy.Acom-monmethodistouseafluorescentgelasamarker.Afterwashing,thehandsareheldunderUVlighttodetermineefficacyofcleaning.OnesuchactivityisavailableontheInternetathttp://www.bam.gov/teachers/activities/epi_4_hand_wash.pdf(downloaded9/27/09).Thisactivityguideisusefulinsupplyingateachingresourceforhandwashingthatincludesalessonoutlineandthreeseparatesourcesofthefluorescentgeltouseasamarker.

Thefinalissueismonitoringcompliance.Thisispar-ticularlydifficultasself-assessmentisnotoriouslyinac-curate,atleastamonghealthcareworkerswhoconsistentlyself-reportmoreconscientioushygienebehaviorthanwhatisobservedindependently(24-27).Ontheotherhand,Stevensonet al.(28)reportatoolforself-report-ingthatisdirectedatthegeneralpopulationthatmighthaveuseasamonitoringmethod,perhapscoupledwithobservation.Observationofbehaviorshouldbeincludedinanyevaluationhoweverelsecomplianceismeasuredinyourfacility.

A SUGGESTED HAND WASHING PROTOCOLThefollowingstepwiseprocedureisrecommendedforhandwashinginthepharmaceuticalenvironment.ThefollowingprotocolisbasedonaCentersforDiseaseCon-trol(CDC)handwashingprotocol:

•Removejewelryfromhandsandwrists•Considerthesink,includingthefaucetcontrols,

contaminated.Avoidtouchingthesinkandfaucetcontrolswithyourhands.

•Turnwateronusingelbowcontrols(orfootcontrol).Ifthesearenotavailable,useapapertowelandthenwetyourhandsandwrists.

•Applysoapfromadispenser(donotusebarsoapwhichwillcertainlybemicrobiallycontaminated).Assumethecontrolleverforthesoapiscontaminated.Worksoapintoalather.

•Vigorouslyrubtogetherallsurfacesofthelatheredhandsforatleast20seconds.Frictionhelpsremovedirtandmicroorganisms.Washaroundcuticles,

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inthefingerwebbing,thebackofthehandsandunderfingernailsinadditiontorubbingthepalmstogether.

•Rinsehandsthoroughlyunderastreamofwater.Runningwatercarriesawaydirtanddebris.Pointfingersdownsowaterandcontaminationwon’tdriptowardelbows.

•Dryhandscompletely(leavewaterrunning):•Useacleandrypapertowel.Beawarethatif

thetoweljamsandyouneedtoworktoreleaseityoushouldre-washyourhandsifyoutouchthedispenser.

•Useahot-airblower(preferablyonethathasanintegralUVlight).Starttheunitwithyourelbow(notyourwethands).Donotrubyourhandstogetherwhiledryingthemcompletelyunderthehotairflow.

•Useelboworfoottoturnfaucetoff.Ifappropriatefaucetcontrolsarenotavailable,useacleanpapertoweltoturnoffthefaucet.

•Donottopoffthesoapdispenser.Thisleadstocon-taminatedreservoirsinadditiontothecontamina-tioninthenozzle.Ifpossible,useasoapdispenserthatisrefilledinasealedcontainerthatincludesthesoapinaplasticbagandafreshnozzle.

•Donotassumeantibacterialsoapsareefficacious.Treatallsoapsaspotentiallycontaminatedandexercise sanitarypractices in regularly cleaningdispensers.

IMPLICATIONS FOR VALIDATION AND COMPLIANCEProperlytrainingpersonnelregardingroutinecleanlinessisanobviousneedforallmanufacturingandtesting.Thisneedisheightenedinhigh-riskmanufacturingsuchasinasepticprocessing.Thisneedisalsoheightenedinsituationswhereinmicrobialtestingispartofvalidationtestingbutisnotusuallyconductedinroutinemanufac-turing.Forexample,preparationofgranulatingliquidsforsolidproductsdoesnotusuallyincludemicrobialtesting.Preparationofaqueouscoatingliquidsdoesnotusuallyincludemicrobialtesting.Cleanequipmentstor-agedoesnotusuallyincludemicrobialtesting.Alloftheseexampleswouldlikelyincludemicrobialtestingforprocessvalidationorcleaningvalidation.Thetwoafore-mentionedformulationexampleslikelydonotcontainpreservativesintheirrespectiveformulations.Dependingontheformulation,microbialgrowthcouldbeeasilysupportedinthesesituations.Cleanequipmentholdtimevalidationshouldincludemicrobialtesting.Drugdispensingpracticesmaynotroutinelyincludemicro-

bialtestingeventhoughliquidmaterialsthatsupportmicrobialgrowthmayberoutinelydispensedforuseinmanufacturingcommercialproduct.Validationperson-nelshouldcarefullyevaluatepersonnelpracticeswhenmicrobialtestingisrequiredinvalidationprotocols.Itislikelythatsimpleprocesses,suchashandwashing,aregenerallyassumedtobeundercontrolwhentheymaybeanundetectedsourceofproductcontamination.

SUMMARYHandwashingisanactivitythatisfrequentlytakenforgranted.Everypharmaceuticalprocessthatincludessomeaspectofhumaninterventionissubjecttocon-tamination,andtheintegrityofwell-designedandcon-trolledpharmaceuticalprocessesmaybecompromisedbycarelesshandwashing.Employeeawarenessofthispotential,coupledwitheffectivetraining,willminimizeinadvertentcontaminationduetocarelesshand-wash-ingtechniques.

Thereareseveralkeypointstoensureeffectivehand-washing.Itisimportanttousepropertechniqueinstor-ingthesoapinacleanmanner(topreventexcessivecontamination),removealljewelry,touseenoughsoaptodothejob,washthoroughly(timeandapplication),andtocompletelydryyourhandswhilepreventingrecontamination.

Asfordryingmethod,theredoesnotseemtobestrong,unambiguousdatashowingsuperiorityforeitherpapertoweldryingorhotairdrying(althoughUVirradiationwhenusedwithhotairseemspreferable).

Techniqueandprocedureareparamountinminimiz-ingtransmission.Oncetrained,ongoingcompliancewiththehand-washingprocedureshouldbemonitoredaspartofanongoingcontaminationcontrolprogramforthefacility,andanaidtominimizeemployeeabsenceduetoillness.

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