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CLEANROOM AIRFLOW VELOCITIES

Air is of fundamental importance to cleanrooms, either as a contamination source (microorganisms carried
in the air-stream) or as a control measure to minimize contamination (through the supply of clean air and
controlling the direction of air movement). Therefore, controlling a cleanroom requires careful attention to
the factors of air filtration, air velocity and air flow. While cleanrooms are typically designed to achieve
turbulent airflow, with clean air devices, and EU / WHO GMP Grade A / ISO 14644 class 5 areas, the air is
designed to be unidirectional whereby the air direction and air velocity are designed to remove any
contamination deposited into the air-stream away from the critical area. These devices contain HEPA
filters, which control the air-speed and direction.

Unidirectional flow and be defined as an airflow moving in a single direction, in a robust and uniform
manner, and at sufficient speed to sweep particles away from the critical processing or testing area with
regularity. Hence the object of the unidirectional airflow is to push outward any contamination which might
be deposited into the air-stream and to avoid the potential for contamination dropping out of the air, either
though gravity or by striking a object, and falling onto a critical surface.

Part of the control of air rests with air direction and this is a factor of airflow velocity. Poor airflow uniformity
leads to turbulent airflow and vortex formation. In terms of the velocity of the air, this is described in some
regulatory documents: 0,.45 meters per second within arrange of 20%. Whether achieving good airflow
(and thereby avoiding poor airflow) needs to conform to the range specified in regulatory guidance
documents has been a long-standing issue, particularly given the non-scientific origins of the regulatory

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guidance values. This article considers regulatory guidance on airflow velocities and the way that these
are verified, and whether satisfactory airflow can be achieved outside of these guidance values. The
discussion extends to consideration of the verification of these parameters at working height, especially in
light of if this the most appropriate location by which to measure air velocities.

Unidirectional Airflow and a Short History of Air Velocities

Unidirectional airflow is obtained through High Efficiency Particulate Air (HEPA) filters. HEPA filters
function through a combination of three important aspects. With this, there are one or more outer filters
that work like sieves to stop the larger particles of dirt, dust, and hair. Inside those filters, there is a
concertina - a mat of very dense fibres - which traps smaller particles. The inner part of the HEPA filter
catch particles as they pass through in the moving air stream. There are different grades of HEPA filters
based on their ‘efficiency ratings (1).

The concept of laminar airflow (what is now described today as ‘unidirectional airflow’) was introduced with
the first industrial cleanrooms and clean spaces of the 1960s. It was noted that when air is introduced into
the cleanroom at a high velocity which causes the air to travel along a unidirectional path over a required
distance. In doing so, contamination is swept away from the critical area unlike the more random
distribution and transition of contaminants in turbulent flow cleanrooms (2).

The development of laminar flow technology was completed in 1961 by a team led by Willis Whitfield at
the Sandia Corporation (later the Sandia National Laboratories) based at Albuquerque, New Mexico, USA,
in partnership with the U.S. Atomic Energy Commission (3). This concept of laminar airflow led to the
development of specialised airflow cabinets whereby greater levels of cleanliness could be achieved
through air passing at a sufficient velocity. It was this work that showed that an airflow velocity of 90 feet
per minute was adequate to achieve the necessary levels of particle cleanliness (avoiding settling particles
of a diameter of 5.0 µm and greater) whilst maintaining unidirectional flow. This velocity also fitted with the
capabilities of the fans in use at the time in relation to noise reduction. While this was effective, a fuller
range – such as 25 to 250 feet per minute – was not explored (4). While the range of 90 feet per minute
suited the Sandia Corporation conditions, this velocity part of the first U.S. cleanroom standard - Federal
Standard 209 in 1963 (a forerunner to the ISO 14644 cleanroom standard). 90 feet per minute ±20 feet
per minute (which, when metricised becomes 0.45 metres per second) also became adopted by regulatory
authorities, when the FDA adopted the FS 209 document. The velocity also became part of EU GMP. At no
stage was this velocity reconsidered to determine what the most applicable range was based on science,
or even whether it was necessary to state a range at all.

The inclusion of 90 feet per minute in the first iteration of FS 209 came with the explanatory text that the
velocity was “not mandatory”. With the first revision – FS 290A in 1966 – the text “individual circumstances
may dictate other values” was added. The 1973 version changes the range from 90 feet per minute ±20
feet per minute to 90 feet per minute ±20% (72 -108 feet per minute) but continued with explanatory text
indicating that other values could be considered. In 1987 the first U.S. FDA guidance for aseptic

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processing adopted the 90 feet per minute ±20% air velocity requirement, although in the same year the
FS 209C standard dropped mention of any specific velocity completely, placing the emphasis upon air
visualization (5).

Current Airflow Velocities Guidance

Regulatory standards for cleanroom unidirectional airflow velocities differ in terms of where measurements
are to be taken from and in terms of how much weight should be placed upon specific velocities. In terms
of position, the U.S. FDA guidance, the requirement is to measure airflow velocities below the filter face at
a distance of 6 inches (6). Similarly, to meet ISO 14644 measurements of the airflow velocity should be at
approximately 150 mm to 300 mm from the filter face (7). However, under EU (and WHO) GMP, the
requirement is to measure airflows at working height, with working height to be defined by the user. The
velocity is assessed using an anemometer, a device for measuring wind speed. There are two common
designs – vane and hot wire. The typical testing frequency is six-monthly or following any maintenance
work or filter changes (8).

Neither EU GMP or FDA provide any recommendations about the number of readings to take. According
ISO 14644-3:2005 the number of measuring points should be sufficient to determine the supply airflow
rate in cleanrooms and clean zones. This should be the square root of 10 times of area in square meters.
However, not less than 4 readings should be taken. At least one point per filter should be measured.

In each case, the airflow velocity range is recommended to be in the range 0.45 metres per second, ±20%
(that is 0.36 to 0.45 ms-1). EU GMP Annex 1, for example states that “Laminar air flow systems should
provide a homogeneous air speed in a range of 0.36 to 0.54 m/s (guidance value) at the working position
in open clean room applications” (9). However, more flexibility is provided with the FDA 2004 guidance
which states: “at a velocity sufficient to sweep particles away from the filling / closing operation and
maintain unidirectional airflow during operation.”

The 2004 guidance further states, via a footnote to the main text: “A velocity from 90 feet per minute is
generally established, with a range of ±20% around the set point. Higher velocities may be appropriate in
operations generating high levels of particulates.”

The air velocity range quoted in the regulatory documents is stated to be a “guidance value”, inferring that
higher or slower air velocities could be used provided there is sufficient justification. In theory, the risk from
lower air velocities is from insufficient laminarity and an inability of the air velocity to effectively sweep
away any particles in the air-stream. The risk arising from faster airflow velocities is from turbulence, and a
tendency for the air to potentially eddy. However, do the standards really seek to imply that, say, going to
0.45 ±30% would present a contamination risk? If they do, then this is not based on sound science.

While the air velocities remain guidance, experience suggests that some regulators are more open to
considering velocities outside of these ranges than others. Furthermore, it is often the case that lower
airflows can provide the same level of particle control and unidirectional pattern; and sometimes faster
airflows are required, either as a result of equipment balancing or due to remove particles from certain
operations (such as where powder is handled). In such cases satisfactory air patterns can be

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demonstrated through airflow visualisation. This is why, in this author’s opinion, the airflow velocities
should be removed from future updates, and placed with individual user assessments based on air pattern
visualisation and particle counting. Consideration of this is discussed next.

Why Consider Alternative Airflow Velocities?

As indicated above, an airflow velocity of 0.45 meters/second (90 feet per minute), with a range of plus or
minus 20 percent around the setpoint, has been established, albeit open to different degrees of
interpretation, since the 1960s and it has formed regulatory guidance since the mid-1980s. There has
been regulatory drift towards seeing these airflow velocities are mandatory. This is a mistake, since lower
velocities, requiring lower energy use, may achieve the same effect; and higher velocities may be
appropriate in operations generating high levels of particulates.

What should be stipulated instead is where air velocity becomes related to performance expectations
where the air in critical areas is supplied, via point of use as HEPA- filters, in a unidirectional manner and
at a velocity sufficient to sweep particles away from the critical area during operations, irrespective of the
velocity setting. This means setting air velocity parameters for each processing line or item of equipment
and ensuring these are justified and appropriate to maintain air quality under dynamic conditions within a
defined space.

Literature also supports this position. Work by Whyte, which looked at airflow velocities covering the range
of 0.1 m/s to 0.6 m/s showed that airflow velocities below 0.3 m/s were insufficient to provide stable
unidirectional airflow and for achieving the required low levels of particle and bacterial concentrations.
Increasing the airflow velocity up to 0.6 m/s gave low airborne counter, although this was on the basis of a
‘law of diminished returns’ in that the amount of additional energy expended did not alter the particle levels
significantly. The assessment suggested that an airflow velocity of 0.3 m/s was optimal (10).

Where alternate airflow velocities are proposed, these can be assessed through the recording of particle
counts and by airflow visualisation studies. The revised text to EU GMP Annex 1 (not in force at the time of
writing but profiled in a recent edition of the Journal of GxP Compliance) (11) puts greater emphasis upon
airflow movement than with air velocity:

“Grade A: The local zone for high risk operations, e.g. filling zone, stopper bowls, open ampoules and
vials, making aseptic connections. Normally, such conditions are provided by a localised air flow
protection, such as laminar air flow work stations or isolators.”

The reference to ‘laminar airflow’ is confusing and outdated. Moreover, the inference that isolators require
the same air velocities as to other Grade A devices is out of step with most studies (such as Peters et al
(12) and Midcalf et al (13)). The draft goes on to read:

“Unidirectional air flow systems should provide a homogeneous air speed in a range of 0.36 - 0.54 m/s
(guidance value), the point at which the air speed measurement is taken should be clearly justified in the
protocol. During initial qualification and requalification air speeds may be measured either close to the
terminal air filter face or at the working height, Where ever the measurement is taken it is important to note

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that the key objective is to ensure that air visualization studies should correlate with the airspeed
measurement to demonstrate air movement that supports protection of the product and open components
with unidirectional air at the working height, where high risk operations and product and components are
exposed. The maintenance of unidirectional airflow should be demonstrated and validated across the
whole of the grade A area. Entry into the grade A area by operators should be minimized by facility,
process and procedural design.”

Despite this the draft guidance does not go as far to remove the ‘guidance’ airflow velocity values of 0.45
meters per second ±20%. However, it is suggested in this paper that airflow visualisation studies can
provide the means to consider alternate airflow velocities. This approach recognises actual performance,
in the operational state with equipment running and person el carrying out the necessary activities, ahead
of velocity.

Airflow Visualisation Studies

The purpose of flow visualization is to confirm the smoothness, flow patterns and other spatial and
temporal characteristics of airflow in an installation. For this, the airflow is examined through airflow
visualisation mapping whereby smoke is generated, and the behaviour of the smoke is studied and then
captured by a video camera. Air-flow studies can demonstrate a significant amount of information. This
can relate to contamination control in assessing whether air-flows are drawing potentially contaminated air
towards a critical zone of whether certain objects in the air-stream cause contamination by forcing the air
to change direction (14).

To measure the aerodynamic performance of the unidirectional airflow unit, smoke should be introduced at
the filter face so that the distribution of the smoke downwards and away from the critical zone can be
seen. Smoke should also be introduced at the working height, immediately above the area where product
or product components are exposed. The assessment should note the impact of the machine upon the
airflow. Does the smoke, for example, entrails inwards when the air impacts upon the filling machine
guarding? What is the effect of disturbances caused by the motion of machine operations? The biggest
risk will be when potential airborne particles accumulate in vortex regions. When a unidirectional air flow
strikes and object, an obstacle will create a 'wake region'. Such regions should be studied for vortices and
potential particle accumulation (15).

Any regions of stagnation should be detected. When unidirectional air flow meets an object, wakes and
vortex streets can be formed. This causes turbulence. This can lead to pockets of stagnation in front of
machinery and work surfaces that are perpendicular to the main direction of the air flow. Such pockets
can be unpredictable in speed and direction and require mapping. Another potential risk from large
surfaces is that wake regions can entrain ambient air into clean zones. A consideration of the impact of
Grade B areas upon Grade A zones should be considered in such circumstances. Ideally, the pattern
should show that the air is characterized by a smooth flow, free of any disturbances (such as small and
temporary vortices or eddies) and unimpeded.

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From the above, the importance of airflow patterns is demonstrated and it is arguably more important to
ensure that an appropriate airflow pattern is in place than with seeking to achieve an airflow within a
particular range. However, even where a case can be made to vary the airflow velocity it remains
important to measure airflow velocities at commissioning, periods of requalification and at the start and
end of each test session to ensure consistency and to verify that airflows remain within validated
parameters. Where airflows are found outside of range it is important that an airflow velocity study be
conducted in the ‘as found’ state to assess whether the air pattern have changed to the extent that they
pose a contamination concern. This leaves one question to consider: where, in terms of position, should
airflow velocities be assessed?

Airflow Velocity Measurements: Working Height or Filter Face

European regulatory guidance indicates that airflow velocities should be measured at working height. This
leads to two considerations. First, what is working height? And second, is working height the correct
location to select, especially as a determinant of airflow patterns as described above.

Assuming first that working height needs to be measured, this is something to be determined by the user.
For aseptic filling, for example, an appropriate definition of working height would be a point just above the
vial neck opening, to ensure that any particles that might enter the air-stream are directed away from the
open neck position. The complexity that emerges from this is that there will be various ‘working heights’
should vials of different sizes be used on a given line.

However, is working height the right location to measure airflow velocities? With airflow velocity studies,
the measurement of the velocity at the working position can be highly variable due to the equipment size
and configuration within the unidirectional airflow device and it can be argued that proper airflow pattern at
the working position is more important than achieving the specified airflow velocity at the working position.
In a sense, the velocity measurement at the working position is more for information purposes in terms of
helping to understand the observed airflow pattern. This means that the FDA guidance in relation to
ensuring consistent measurements below the filter face is more accurate predictor of airflow patterns than
the European position of measuring airflow velocity at working height.

A final point to make is that if there are areas of concern arising from airflow visualization studies then
these are be partly verified through environmental monitoring (16). This is notwithstanding some of the
inherent weaknesses associated with environmental monitoring. However, trend data can be particularly
useful for assessing clean air device performance particularly if a problem is detected at a later stage such
as an airflow velocity reading out of range or damage to HEPA filter media. Satisfactory environmental
monitoring data, provided the monitoring locations are representative of contamination concerns, can be a
useful risk mitigation factor.

Summary

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In summary, the consensus of the regulations, especially as enshrined in European GMP, is for airflow
velocities of 0.45 ms-1 (90 feet per minute) +/‐20%. However, these values are arbitrary and their origin
lying in the early days of cleanrooms. Hence other velocities maybe more suitable for achieving
contamination control. The way this can be achieved is through focusing on airflow visualization. If a
company intends to do this, it will be important to ensure the rationale and justification are sound. The
rationale will need to include:

The “operational” airflow visualization under the actual ranges.For the height at which the velocity is
measured (either the working position or, more appropriately, below the filter face) is recorded and
justified.
In addition, it is good practice that where airflow velocities need to be adjusted, that airflow visualization
patterns are always repeated before any processing recommences. Here airflows are a critical factor
affecting the distribution of particles within a clean space (17). Moreover, it is similar best practice for
environmental monitoring locations to be selected in relation to airflow visualization patterns.

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