CLEANROOMS

EXPLAINED

Lighthouse Worldwide Solutions

 What Is A Cleanroom?
A cleanroom is a specifically designed room that controls contamination. Cleanrooms are used in
practically every industry where small particles can adversely affect the manufacturing process and
product. The main components of a cleanroom are what keeps the cleanroom clean. To control
contamination in a cleanroom clean air is required, access is limited and outside contamination
is restricted. The main contaminators inside a cleanroom are people. A HVAC system is used to
provide air at a define temperature and humidity and HEPA filters are used to provide sterile air
into the cleanroom. The internal design and materials of construction inside a cleanroom must be
smooth, antistatic, easily sterilized and cleaned and do not cause particle traps where dirt can build
up. The number of air changes per hour coupled with the cleanroom design of interior structures and
materials define the Cleanroom classification. The key component is the High Efficiency Particulate
Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size. All of the air
delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness
performance is necessary, Ultra Low Particulate Air (ULPA) filters are used.

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What is Cleanroom Classification?
A cleanroom is classified or also defined as certified based on the level of air cleanliness. The cleaner
the air or particle concentration based on a known sample volume then the higher the cleanroom
classification. Particle Counters are used to certify cleanrooms based on cleanroom standards. There
are several standards in operation. Cleanrooms are classified by how clean the air is. In the USA the
Federal Standard 209 (A to D) the number of particles equal to and greater than 0.5mm is measured
in one cubic foot of air, and this count is used to classify the cleanroom. This standard has been
surpassed by ISO 14644-1 which came out in 1999 however FS 209 which has been around since
1963 and was published by the Institute of Environmental Sciences and Technology (IEST).

This metric nomenclature is also accepted in the most recent 209E version of the Standard. Federal
The cleanroom classification standards FS 209E and ISO 14644-1 require specific particle count
measurements and calculations to classify the cleanliness level of a cleanroom or clean area.

CLEANROOM ISO CLASSES

Controlling the Cleanroom Environment

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing
unidirectional or turbulent air flow principles. Unidirectional air flow systems direct filtered air
downward in a constant stream. Unidirectional air flow systems are typically employed across 100%
of the ceiling to maintain constant, unidirectional flow. Laminar flow criteria is generally stated in
portable work stations (LF hoods), and is mandated in ISO-1 through ISO-4 classified cleanrooms.

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Cleanrooms need a lot of air. The cleaner the cleanroom needs to be, the more air it will need to
use. Air handling systems are designed to circulate air through the room, removing contamination
as air is generated and keeping the temperature and humidity stable. The amount of air we put into
the room is important as well.
The more air that goes in,
the faster the room cleans
itself. This can be important
for rooms that occasionally
experience high amounts of
contamination, or something
like a sampling room or
dispensary where the room
needs to be cleaned quickly
between operations.

Facility Control

To maintain a cleanroom the whole facility needs to be properly controlled.

■ Access to different areas needs to be

tightly controlled.
■ Room pressure cascades need to be
maintained to enable the process core
to be sterile.
■ SOPs should be developed and
followed for cleaning the cleanroom.
■ Continuous monitoring of the
filters and air flows and frequent
recertification of thecleanroom is
required.
■ In the aseptic core it is critical that the
environmental conditions are recorded
and monitored during processing for
viable and non-viable contamination.

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Air Handling Units (AHU’s)

When we think of cars the heart of the car is the engine. With cleanrooms the heart of the cleanroom
is the Air Handling Unit. The AHU uses a centrifugal fan to circulate air to various parts of a
cleanroom facility. In fact a cleanroom facility would have many AHU’s each serving different rooms
and parts of the building. Each AHU would have its fan sized to the room(s) requirements. The
selection of the fan will depend on the air volume and the static pressure required. For example one
or two AHU’s would be specified for Grade A/B rooms and another. For Grade C/D rooms as there
are less air changes required in the lower grade rooms and environments. The use of variable air
volume (VAV) systems is becoming more accepted as this technology enables fan speed variation for
different environments.

The Cooling Coil is used to cool and dehumidify the air. Both DX (direct expansion) cooling and CW
(chilled water) cooling coils are available for use depending on the system design. The coil diameter,
no. of rows of copper tubes are calculated on the basis of surface area required for effective heat
transfer.

Filters are used to remove particles and contaminants of various sizes from the air. The type of air
filter being used will very much depend on the application of the system. In the AHU there are a
few filtration stages. The final filter for cleanroom applications would be HEPA and in semiconductor
applications HEPA and ULPA filters are used. HEPA Filter is very efficient and is able to achieve
efficiencies up to 99.97%, removing minute particles and airborne bacteria from the air.

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Apart from AHU’s used in cleanroom FFU’s applications, Filter Fan filter units are flexible and
economic solutions to remove particles from the recirculated air of turbulent or unidirectional
ventilated cleanrooms. Fan filter units are stand-alone units with integrated HEPA-filter, fan and
control system. They supply purified air to cleanrooms by removing harmful airborne particles from
recirculating air. FFUs create a positive room pressure that reduces the contamination risk. Newly
built cleanrooms now use a combination of AHU’s and FFU’s.

How is a cleanroom Certified?

Cleanrooms are certified to a specific class, based on ISO 14644-1, or similar standards. Cleanroom
testing and certification involves checking that the cleanroom is functioning to the specific
parameters and ISO classification. The room must perform, according to the standards, to meet
or exceed the ISO parameters to maintain compliance. Typically the room is initially certified when
construction is completed to ensure it was built to the client’s specifications. The room is also
then routinely retested (annually or semiannually) to ensure the quality has not changed during
operations. The standards which cleanrooms are tested to are ISO14644-1, ISO 144644-2 and ISO
14644-3.

Cleanroom Testing (Annually or Semi Annual based upon specification)

Airflow volume / Velocity Assures that both unidirectional (velocity preferred) and non-
Readings unidirectional flow (airflow volume preferred) areas are properly
balanced and unidirectional zones are maintaining proper air patterns.

HEPA Filter Integrity Test HEPA filters and system for leakage through the filtration system.
Testing This test is not required by ISO standards, but many auditing
agencies such as the FDA will require it.

Non-Viable Particle Reports the amount of airborne particulate of a specified size in the
Counting clean zone. This test determines cleanliness class.

Room Pressurization Verifies that room differential pressures are operating according to
Testing the design.

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Optional Cleanroom Testing

Optional tests are based upon the organization’s need for monitoring, industry requirements and
internal QA/SOPs.
Air Balancing Adjusts airflow in the air handling systems to achieve design airflow,
room exchange rates and pressure cascade.

Airflow Visualization Verifies the airflow direction using a source of visible fog.
Testing/
Smoke Testing
Viable Environmental Air and surface sampling for microbe enumerations.
Monitoring (EM)
Room Air Exchange States if the area is meeting its design airflow.
Rates
Temperature/Relative Examines whether the air HVAC controls are functioning uniformly
Humidity Testing and properly.
Lighting, Vibration, and Assures workers comfort.
Sound Testing
Humidity Testing Evaluates moisture in the air that could affect product.

Particle Deposition Measures the effects of particles deposited upon surfaces and
Testing measure the quantity (number or mass).
Recovery Test Performed to determine if the room is capable of returning to the
specified cleanliness level.

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What equipment is used to certify a
Cleanroom?
Air Handling Units (AHU’s)
Anemometers are used to capture the flow of air entering the
cleanroom through the AHU grilles. An airflow capture hood or
balometer is used to measure the volume of air coming out of
grilles and diffusers in HVAC systems. Most modern balometers
also have anemometers built into them.

HEPA Filter Integrity Testing

The HEPA filter integrity test is typically performed on cleanroom

supply air HEPA filters using a photometer to scan the filter surface
for pinhole leaks that could allow the transmission of
contaminant particles that would be unacceptable in a critical
application.

HEPA filters are capable of removing 100% of airborne particulate

above 5µm. Below that, they are less efficient and typically will remove 95% to 99.9995% in the
0.15µm to 0.25µm particle size range. The grade of the filter chosen for the application determines
the overall filtration capability.

Access is required to the relevant air handling unit related to

the HEPA filter to be tested. The air system should be operating
as normal for the duration of the HEPA test, so the introduced
test aerosol will be pulled through the HEPA filter. Access is
also required to the air output side of the HEPA filter, so that a
technician is able to scan the HEPA filter surface at 25mm from
the installation for traces of the test aerosol. A HEPA integrity test
certificate is provided upon completion of the test. ISO 14644-
2: Specifications for testing and monitoring to prove continued
compliance with ISO 14644-1 outlines the HEPA filter test methods
and identifies two methods one using a photometer and another
using a particle counter to test the filter integrity.

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Photometer filter testing

A photometer is used to scan over the filter face which is downstream of the introduced test aerosol.
The tests require that an aerosol challenge be introduced upstream of the filter. This is to ensure that
there is actually a challenge present against which we can make a downstream measurement. The
common oils for this purpose are:

■ Poly-alpha olefin (PAO) – Emery 3004 or Durasyn 162

■ Shell ondina (EL) food quality mineral oil
■ Dioctyl sebacate (DOS)
■ Di-2-ethyl hexyl sebacate (DEHS)
■ Dioctyl (2-ethyl hexyl) phthalate (DOP)
■ Paraffin oil.

The filter gasket, frame and media are scanned for leaks. The
maximum permissible leak is set at 0.01%, although lower
limits may be used.

Particle Counter filter testing

A particle counter with the right accessories is a versatile instrument as not only can it perform
cleanroom filter integrity testing a particle counter is also used for certification based
on ISO 14644-1 and ISO 8573 for gas sampling. A particle counter covers 4 important tests in a
cleanroom environment.
■ Cleanroom certification based on ISO 14644-1
■ Continuous monitoring based on GMP standards for regulation
■ Gas sampling of gases introduced into the cleanroom
■ Filter Integrity testing based on ISO 14644-2 and ISO 14644-3
For filter testing the particle counter method uses a lower concentration of test aerosol using latex
particles. Because the particle counter is more sensitive than the photometer less concentrations of
test aerosol are used. Which is less likely to shorten the filters life span.

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Non-Viable Particle Counting

For cleanroom certification and ongoing continuous monitoring particle counters are widely used
to provide Pass/Fail results based on cleanroom standards. Particle counters come with cleanroom
standard calculations built into the firmware and once you enter the basic parameters and take
your samples the particle counter will verify if the room meets the criteria for cleanliness based on
whatever standard is been tested. If the test fails, the operator is alerted.

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