2017515 TestingCompressedAirLinesForMicrobiologicalContamination

Testing Compressed Air Lines For

Microbiological Contamination
Mon, 05/01/2006 - 12:00am by Rudy Pina

Anairimpactionmicrobialassessmentofyourairsupply
mayindicateyouhaveunwantedinhabitantsinyour
compressedairsystem.

INTRODUCTION
Manufacturersofmedicaldeviceswholabeltheirproductas
sterilemayusecompressedairinvariousapplications.
Applicationsincludeinjectionmolding,operationof
conveyorbelts,and/orasepticcleaningprocesses.The
manufacturermayusethesesystemsonacontinuousbasis
oronanasneededbasis.

Themanufacturermaynotrealizethatthecompressedair
systemcouldbeharboringmicroorganisms.Whentheair
supplysystemisoperating,itmayunleashcontaminants
whichcouldadverselyaffecttheproduct,including
operationalcharacteristics,bycompromisingsterileclaims,
orproductaesthetics.

Theconditionorthequalityofthesuppliedair,froma
microbiologicalstandpoint,maynotbeobviousunless
microbiologicaltestingisperformed.Asimpleairimpaction
microbialassayofcompressedairlines,however,willalert
themanufacturertothevarioustypesofviable
microorganismsthatmightbepresent.

Manufacturersofmedicaldevices,pharmaceutical
operations,orthoseclassifiedassterilefill,areconstantly
assessingtheenvironmentalimpactontheproductduring
themanufacturingprocess.Thisassessmentusually
includesthefacility,theequipment,andthepersonnel
involvedintheassemblyprocess.Samplingmayinclude,
butisnotlimitedto,surfacesampling,particulatecounts,

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wateranalysis,andproducttesting.However,compressed
aircaneasilybeoverlookedifnotinitiallyinsertedintothe
environmentalmonitoringprotocoloridentifiedbyan
experiencedenvironmentalscientist.

Theengineeringdepartmentmaydesignthefacility
wherebytheaircompressorissegregatedfromthearea
wheretheproductisassembledforlogicalhygienicreasons.
However,thissegregationmayleadtoafalsesenseof
securitybecauseitispossiblethattheenvironmentalair
sourcethatfeedsintothecompressormaycontain
biologicalflorasimilartothatofthemanufacturing
environment.Itcouldbepossiblyevenhigherin
microbiologicallevelsifthelocationoftheaircompressoris
lesscontrolledthanthatofthemanufacturingenvironment.
Ifthecompressedairsupplyisnotproperlyengineeredwith
filters,dryers,andappropriategauges,thesemicrobiological
inhabitantscouldeventuallyreachtheproduct.

CompressorastheCulprit
Thecompressoritselfcanfunctionastheculpritbycreating
acontaminatedenvironmentfortheproduct.Forexample
thecompressorsprefilterscanbecomeoverloadedwith
dustandlint,causingthefiltertoceasefunctioning
properly,therebyresultinginmigrationandpotentialstrike
through.Also,theremaybeacontaminantinthe
environmentwhichissmallerthantheporesizeofthepre
filter.Again,thismayleadtotheinefficiencyofthepre
filter.

Microorganisms

Amicroorganismthatiscapableofformingaviablecolony
formingunit(CFU)andwhichexistswithinthecompressed
airlinesystemiscalledthemicrobiologicalparticle(MP)as
perISO85734:2001(E).Themicrobialloadonaproductis
referredtoasBioburden,asperANSI/AAMI/ISO11737.
TheBioburdencancomefromvarioussources,suchas
humancontact,airconditioningsystems,themanufacturing
processitself,rawmaterials,andanyothervectorthatthe
productisexposedto.However,theleastlikelyconsidered
vectorforcontaminationisthecompressedairsystem.
Maybethisisbecausethecompressedairnetworkis
consideredtobeaclosedsystem,underhighpressure
(usually160poundsofpressureandgreater)andis
expectedtosupplycontinuoushighqualityfilteredair.

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Microorganismscanrangefromfungalspores,tobacterial
spores,andvariousvegetativemicroorganisms,depending
ontheenvironmentalconditions.Theseorganismscanrange
insizefromlessthanonemicrontoseveralmicronsinsize.
Therefore,whendesigninganairsupplysystem,every
effortshouldbetakentoensureentrapmentofthese
contaminantsbeforetheygettotheproduct.

Figure1.Schematicofairimpactionpartialflow
sampling

TestCompressedAirLinesRoutinely
Compressedairlinesshouldbetestedonaroutinebasisin
ordertodeterminethemicrobiologicalcleanlinessoftheair
supply.Compressedairlinesundergothesamechangesas
otherdynamicsystems,suchascontraction,condensation,
sedimentation,andinthecaseofcompressors,oxidation
whentheairlinesarestagnantoveranextendedperiodof
time.

Testingshouldbeconductedonaperiodicbasis,andthe
frequencyofthetestingshouldtakeintoconsideration
importantfactorssuchas:

Increased/Reducedproductionschedules

Seasonalchanges

Equipmentchanges/modifications

Replacementofhardwareand/orfilters/dryers

Inactivityofsystem

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Methodology
Asimpletestthatutilizesairimpactionontogrowthmedia
issuggested.Ageneralsamplingmethodwouldbetoreduce
thepressureofthecompressedairline(whichusuallyis
160poundspersquareinchorgreater),usingabuiltinor
externalregulatorattachaflowmeter,andadjusttheflow
toasuitablerate,forexample,1cubicfootperminuteand
attachtheairimpactionsamplerwhichhasbeenprepared
withaPetriplate.Youshouldselectparametersbestsuited
foryourapplicationorthosenotedinISO85734.See
Figure1.

TestEquipment
TheSlitSampler(alsoknownastheslittoagarsampler)is
adevicewhichutilizesarotatingstagewhichholdsthePetri
plate.Theairimpactsthesurfaceoftheagarwithwhatever
organismsarepresent,theorganismsbecomeimpinged
ontotheagar,theplateisincubated,andtheorganismsare
allowedtogrow.ISO85737offersfurtherdetailsand
shouldbereviewedbeforetestingisconducted.Two
companiesthatmanufactureSlitSamplersareNew
BrunswickScientificandtheBarramundiCorporation.See
Figures2and3.

Figure2.SlitSampler
(NewBrunswickScientificsModelSTA230Slitto
AgarAirSampler.)

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Figure3.SlitSampler
(BarramundiModelP320)

Thegeneralconceptisthatcompressedair,underreduced
pressure,calledPartialFlowisforcedoverthesurfaceofa
Petriplate.ThePetriplateis100millimetersindiameteror
greater,basedonthesamplingdeviceused.Bacteriaare
impingedontothesurfaceoftheagar.Subsequent
incubationofthePetriplatewillallowthebacteriatogrow.
Careshouldbetakentoensurethatequipmentusedhas
beenproperlydisinfectedinordertominimizethe
introductionofbacterianotassociatedwiththecompressed
airsupply.Anegativecontrolshouldbeusedasa
qualitativemeasure,andtheendpointtobetestedshould
bepurgedandasepticallycleanedtominimizefalseresults.

Importantfactorstoconsiderwhendevelopingasampling
planinclude:

1.Compressedairlinesbeingtestedversussamplingtime
Acompressedairsystemmayrequirevarioussampling
times,forexample:

Iftheairsystemisstatic,alongersamplingtimemaybe
appropriate
Iftheairsystemisinuse,ashortersamplingtimemaybe
appropriateCautionshouldbetakentominimizethepossibility
ofconfluentgrowth.

2.Selectionofmedia

Abroadspectrum,nonselectivemediawillallowthegrowthof
allmicroorganismsandcanoverwhelmtheprocessandresult
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inconfluentgrowth.
Aselectivemediacanpotentiallylimitoverallgrowthandresult
incountsthatarequantitative.Howevertheseresultsmaynot
reflectthetotalflorainyourcompressedairsystem.

Theagarusedcanbeabroadspectrumagarsuchas
SoybeanCaseinDigestAgar(SCDA),commonlyreferredto
asTrypticSoyAgar(TSA)whichwillallowthegrowthof
mostnonfastidiousorganisms.Aselectiveagarmaybe
usedifyouaretryingtoisolateacertaintypeof
microorganisms,suchasSabouraudDextroseAgar,whichis
usedforthecultivationoffungi.

Followingincubation,theagarplate(s)arereadonacolony
counterandrecorded.Adetaileddescriptionofsampling
techniquesandincubationperiodscanbefoundinISO
85737.Itisrecommendedthattheviableorganismsbe
identifiedinordertoassesstheimpactontheenvironment
andproduct.

Itmaybebeneficialtoconductparticlecountsofthe
compressedairlinesbeforeconductingmicrobiological
countstomoreaccuratelydeterminethemicrobiological
samplingtime.Thiscanbeperformedunderthegeneral
rulethatthehighertheparticlecountthehigherthe
microbiologicalcount.Correlationbetweenthesetwo
variablesshouldbedeterminedsothatparticulatetesting
canbeusedtopredictfuturemicrobiologicalresults.

AlternativeMethods
Industryoffersvariousotherinstrumentswhichalsoserve
asmicrobialdetectionsystems.Theseinstrumentsmayor
maynotcomplywiththeISO8573standardsandare
offeredhereforinformationalpurposesonly.SeeTable1.

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2017515 TestingCompressedAirLinesForMicrobiologicalContamination

Figure4.NewBrunswickScientificairsamplersshow
ifacontaminationhas
occurred,andwhenthecontaminationeventtook
place,byusingaparticledistributionguide.

Manufacturer MethodofCapture

Millipore Impaction

NewBrunswick Impaction

Biotest CentrifugalImpaction

ThermoElectron MultiStageImpaction

Table1.Microbialsamplers

Conclusion
Theprocessofconductingaroutineenvironmental
monitoringprogramofyourcompressedairlineswillassist
youinidentifyingthemicroorganisms,ifany,thatmaybe
presentinyoursystem.Onceyouknowthetypesand
quantitiesofthesepotentialenvironmentalcontaminantsthe
sooneryoucanstarttoidentifytheirimpactonyour
finishedproduct,andyoucanbegintodevelopsystemsto
protectyourproduct.

References

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2017515 TestingCompressedAirLinesForMicrobiologicalContamination

1.InternationalStandardISO85731:2001,TechnicalCorrigendum
1,CompressedairPart1:contaminantsandpurityclasses,
20020401.
2.InternationalStandardISO85734:2001,CompressedairPart
4:Testmethodsforsolidparticlecontent,FirstEdition200106
15.
3.InternationalStandardISO85737:2003,CompressedairPart
7:Testmethodforviablemicrobiologicalcontaminantcontent,
FirstEdition20030501.
4.ANSI/AAMI/ISO11137:1994&ANSI/AAMI/ISO
11137:1994/A1:2002,Sterilizationofhealthcareproducts
RequirementsforvalidationandroutinecontrolRadiation
sterilization,3ed.
5.ANSI/AAMI/ISO117373:2004,SterilizationofMedical
DevicesMicrobiologicalMethodsPart3:Guidanceon
evaluationandinterpretationofbioburdendata.

RudyPinaisPresidentofDynatecScientific
Laboratories,11940GoldenGateRoad,ElPaso,TX79936.He
maybereachedat9158491322orRpina51@sbc
global.net.Mr.Pinahasworkedinthemedicaldevice
industryforthepastthirtyyears.Hehasservedonthe
TexasDepartmentofHealthAdvisoryBoardforthe
developmentoftheMoldRules.Hehasalsoservedasan
industrymemberontheDallasDistrictFoodandDrug
AdministrationIndustryMedicalDeviceCoalition.Heisa
currentmemberwiththeAssociationfortheAdvancement
ofMedicalInstrumentation(AAMI).

DynatecScientificLaboratories,isamedicaldevicetesting
laboratory.Conductsbiocompatibilitytesting,sterility
assurance,environmental,andcleanroom
studies.OperationsincludetheUnitedStatesandMexico.

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