Annex1andUnidirectionalAirflow

Systems
WorkingHeightVelocity(WHV)
GordonFarquharson
June2012

 Agenda UnidirectionalAirflowSystems

Regulatoryrequirements&expectations.
Measurementmethods.
Locationandlevelofmeasurement.
Casestudyofworkingheightevaluation.
Monitoringvs Certification
Discussionforum

Velocitylimits&ranges.
Theroleofairflowvisualisation.
Airflowuniformity.
Test&monitoringlocations&frequency.

SomecommonproblemswithUDAFsystems
Poorairflowuniformityleadstoturbulentairflowandvortex
formation.
50&75mm(23in)deepminipleatfiltersdontcontrol
airflowaswellasold150mm(6in)deeppleatfiltersdid.
Plenumandfandesignismuchmorecritical.
Undersizedfiltersfailtheinsituaerosolleaktest.
Inappropriateairflowvisualisation.
Lackofagreementaboutthemeasurementplane/level.
Experiencethatvelocityseemstoreduceifyoumeasureat
differentheightsdownfromthefilter.

AirflowControlDevices
Plenum
HEPA

Mounting
frame
Tear-drop
Light

Laminator
Membrane

UDAFGuidance EU
GradeA:Thelocalzoneforhighrisk
operations,e.g.fillingzone,stopperbowls,
openampoulesandvials,makingaseptic
connections.
Normallysuchconditionsareprovidedbya
laminarairflowworkstation.Laminarair
flowsystemsshouldprovideahomogeneous
airspeedinarangeof0.36 0.54m/s
(guidancevalue)attheworkingpositionin
opencleanroomapplications.
Themaintenanceoflaminarity shouldbe
demonstratedandvalidated.
Aunidirectionalairflowandlowervelocities
maybeusedinclosedisolatorsandglove
boxes.
5

This same as
0.45 +/- 20%
Important
working position.
How to interpret
this ???

Means airflow
visualisation

Recognises
performance
ahead of velocity

UDAFGuidance USFDA.

UDAF Velocity

HEPA-filtered4 air should be supplied in critical areas at a velocity sufficient to sweep

particles away from the filling/closing area and maintain unidirectional airflow during
operations. The velocity parameters established for each processing line should be
justified and appropriate to maintain unidirectional airflow and air quality under dynamic
conditions within the critical area (Ref. 3).5
Proper design and control prevents turbulence and stagnant air in the critical area. Once
relevant parameters are established, it is crucial that airflow patterns be evaluated for
turbulence or eddy currents that can act as a channel or reservoir for air contaminants
(e.g., from an adjoining lower classified area). In situ air pattern analysis should be
conducted at the critical area to demonstrate unidirectional airflow and sweeping action
over and away from the product under dynamic conditions. The studies should be well
documented with written conclusions, and include evaluation of the impact of aseptic
manipulations (e.g., interventions) and equipment design. Videotape or other recording
mechanisms have been found to be useful aides in assessing airflow initially as well as
facilitating evaluation of subsequent equipment configuration changes. It is important to
note that even successfully qualified systems can be compromised by poor operational,
maintenance, or personnel practices.
A velocity of 0.45 meters/second (90 feet per minute) has generally been established,
with a range of plus or minus 20 percent around the setpoint. Higher velocities may be
appropriate in operations generating high levels of particulates.

UDAF Velocity

UDAFGuidance FDA.

States performance expectation.

Air in critical areas should be supplied at the point of use as HEPAfiltered uni-directional air-flow at a velocity sufficient to sweep
particles away from the filling/closing area and maintain
unidirectional airflow during operations. The velocity parameters
established for each processing line should be justified and
appropriate to maintain unidirectional airflow and air quality under
dynamic conditions within a defined space.

UDAF Velocity

ManagingthedifferencesUDAFVelocityEUvs FDA.

Thebasicrequirementsarefundamentallythesame.
Regulatorsarecomfortablewith0.45m/s(90fpm)+/20%;
othervelocitiesareOK;ifyouplantousesomething
different,ensuretherationaleandjustificationissound.
Recordedoperationalairflowvisualisationisthenorm.
Beclearabouttheheightatwhichthevelocityistobe
measured.
GEP GoodEngineeringPractice
Shouldincludesconsiderationofsystem&filtervelocity
Useairflowvisualisationtohelpassessthetestandworkinglevel
measurementpoints.

Monitoring&TestingMethods&
Frequency

VelocityMeasurementMethods
Anemometers
Vane
Hotwire

Location
Perpendiculartotheairflowsourceplane
Min50mm(2in)fromfilterface
Otherdefinedtestplane

Frequency
Qualification~typically6monthly(integratedwithfilter
testing)
Monitoring~weeklyforlowtechmethods~continuous
fixedmonitoringsystems

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AirflowVisualisationMethods
Videorecord.
Isothermalaerosol(smoke).Water
vapourorpropyleneglycol.
Shouldincludeoperationsand
interventions.
Choreographthevisualisation.
Mayneedaidstoimproveoptical
contrast.
Pulsedaerosolsourcecanhelpvisualise
velocity.
Multiplenozzleshelpsvisualise
parallelismofflow.
Frequency Atsystemqualificationand
aftersignificantsystemorprocess
change.
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System&Filterfacevelocity
Canbeverydifferent,andthedifferenceis
important

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UnidirectionalAirflowVelocity
UDF video

UDAF - Filter Grid

Filtervel 2550
mmfromfilter
face

Systemvel
100150mm
fromfilterface
WorkHeight
vel 100150
mmfromfilter
face

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Casestudyexperience:
EliLillyinIndianapolishaveundertakensomestudiestoexaminethe
challengeofdeterminingandmeasuringvelocityinUDFatworking
level.
Intheseslides,WHV=workingheightvelocity
Thenextslidesareasummaryofthiswork.
EliLilly(TomSpearman&DonMoore)havemadethisinformation
available.

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Anemometers

Previousstudiesuseda
Shortridge Velgrid Anemometer
withminimumvelocityof50
fpm
Vaneanemometersarealso
relativelyinsensitive.
TheseEliLillystudiesusedaTSI
ThermalAnemometerwith
minimumvelocityof3fpm
(muchmoresensitive)

InstrumentimagefromTSI

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ThermalAnemometer characteristics&requirements

Tensecondtimeconstantisacceptable
Norelevantvariabilityinreadingsduetoflowrate
Anemometermustbefixedheldandnearperfectly
alignedforrotation
Visualalignmentforprobetiltisacceptable
Operatortooperatorvariabilityisnegligible

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ThermalAnemometerProbeOrientation

Rotation
17

Tilt

AccumulatorTableWHVDataCollection
Normal Flow at Working Height
(Eli Lilly Indianapolis Study)
Heading "Area A Normal Flow"

Avg

Average

Stdev

Standard Deviation

COV

Coefficient of
Variability

Represents 6 x 6 grid, with critical location in center.

Coefficient of Variability= Standard Deviation/Average

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Normal Flow Air Column Results

Heading "4" Below Screen Normal Flow"

4 Below Filter Face

Av g

St dev

COV

Heading "16" Below Screen Normal Flow"

16 Below Filter Face

Av g

St dev

COV

Heading "28" Below Screen Normal Flow"

Video

28 Below Filter Face

Av g

St dev

COV

Heading "Area A Normal Flow"

Working Height
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Av g

St dev

COV

GeneralConclusions
Thetypeandsensitivityoftypeofmeasurementinstrument
hasahugeeffectonvelocitymeasurement.
IndividualWHVreadingsareverydependentuponthe
internalgeometricshapeoftheitemsinthecriticalarea
Thermalanemometermeasurementscanbereproducedwhen
followingaconsistentmethod

SmallchangesintheX Y Zplanescausesignificant
variationintheindividualreading
Variabilityinreadingsareshowntobearesultoftheprocessandnot
theanemometer

Individualreadingsdonotprovideforasufficientindicationof
theoverallsystemperformance
Itisimportanttodetermineagoodtestlevelandprove
effectivenessofthecleanairsystembyairflowvisualization.

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DevelopingWHVAcceptanceLimits
Requirements
WHVlocationsmustbeidentifiedbySterilityAssurance.
WHVacceptancelimitsmustbeestablishedforGradeA
UDFhoodsforeachlocation
WHVmusttobeconductedunderthesameconditionsas
airflowpatterntesting.
WHVlimitsmustbeestablishedbymeasuringhood
velocitiesatminimum,maximum,andsetpoint.
OnceWHVacceptancecriteriahavebeenestablishedfora
hood,routineverificationmustoccuronaperiodicbasis.

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S
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CRITICAL
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ThanksforyourattentionQuestions???

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Australia,3150
Tel+61(0)386100169
Thanksforyourattention

Slide 23

S
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CRITICALY
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SCRITICAL
M

Gordon J Farquharson
Chair BSI LBI/030; Chair CEN TC243; Convenor ISO TC209 WG1.
c/o Critical Systems Ltd
www.critical-systems.co.uk
4, Greencroft, Guildford,
Surrey, GU1 2SY, UK.
tel +44 (0)1483 579926
mob +44 (0)7785 265 909
e-mail gj.farquharson@gmail.com & gjf@critical-systems.co.uk

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This presentation has been prepared

and delivered by:-

Gordon J Farquharson
Critical Systems Ltd
Consulting in Safety & Quality Critical Systems
Guildford, Surrey, GU1 2SY, UK
cell +44 (0)7785 265 909
e-mail gj.farquharson@gmail.com

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