3/7/23, 4:38 PM Cleanroom Validation | ISO Class Cleanroom Testing and Certification | ISO Cleanroom

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Cleanroom Validation Services

We offer a full range of ISO and EU GMP

Cleanroom Testing & Validation Services.
ISO Cleanroom are specialists in the testing and validation of cleanrooms to
the ISO 14644 series of classification. The report you will receive following
your test meets the requirements of ISO 14644 and if requested EU GMP
ensuring client facilities are audit ready and compliant with the
requirements of regulatory bodies.

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3/7/23, 4:38 PM Cleanroom Validation | ISO Class Cleanroom Testing and Certification | ISO Cleanroom

The ISO validation test can be performed in 3 distinct

states;
1. As-built. The bare bones of a cleanroom, an empty room not yet
populated with any equipment and not in use.
2. At-rest. The cleanroom has now been populated with any equipment
required but is not in use, ie no moving parts and no personnel in the
room during the test.
3. Operational. The cleanroom is now fully operational and operating in
accordance with the defined process.

Validation requirements

Cleanroom Qualification is the overall process of assessing the level of

compliance of a classified cleanroom or clean air equipment with its
intended use. To meet the requirements for ISO 14644-1:2015 a cleanroom
must demonstrate:

Airflow measurement – Volume and velocity.

Airborne particle count.

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In addition to the above ISO requirements, if your process requires EU GMP

qualification, Annex 1 asks for additional tests for the qualification of
cleanrooms and clean air equipment (where relevant to the
design/operation of the installation):

Installed filter leakage and integrity testing.

Air pressure difference measurement.
Airflow direction and visualisation.
Microbial airborne and surface contamination.
Temperature measurement.
Relative humidity measurement.
Recovery testing.
Containment leak testing.

ISO Cleanroom are able to offer all of the above apart from the microbial
airborne and surface contamination tests.

The above tests are not exclusive to EU GMP cleanroom users of course.
There are many circumstances where an ISO 14644 validated cleanroom
would require additional testing.

We believe that the gold standard is to test your cleanroom

through all three operational states

Toni Horsfield. ISO Cleanroom

Cleanroom validation hints and tips

Your installer will test your cleanroom in an ‘As built’ state to prove the
installation but you may want to consider a third-party validation.

Most cleanrooms are tested ‘at rest’ which is important data but the state
that most customers are interested in of course is ‘in operation’.

Validation is not to be confused with the monitoring of the cleanroom

which must take place at a regularity to suit your process. We are able to
provide assistance in formulating your monitoring plan if required.

EU GMP calls for monitoring in 2 states; at rest and in operation as well as

the time taken for the cleanroom to return to the at rest levels once the
activity has finished.

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Suggested frequency of cleanroom validity

Maximum time
Required test Classification Test procedure
interval

<= ISO Class 5 6 months ISO 14644-1:2015

Particle count
>ISO class 6 12 months ISO 14644-1:2015

Air pressure All ISO classes 12 months ISO 14644-3:2015

Airflow All ISO classes 12 months ISO 14644-2:2015

Filter integrity All ISO classes 24 months ISO 14644-3:2005

Containment leak All ISO classes 24 months ISO 14644-3:2005

Recovery All ISO classes 24 months ISO 14644-3:2005

Airflow
All ISO classes 24 months ISO 14644-3:2005
visualisation

Particle counting test

ISO Cleanroom use a Light Scattering Air Particle Counter (LSAPC) with a
flow rate of 50 LPM to measure your airborne particulate. Our particle
counters measure from 03μm to 10μm and are calibrated yearly. The
calibration certificate is included within your validation report.

Air Pressure test

It is necessary to show that the air flows in the correct direction between
rooms in a suit of cleanrooms i.e. from clean to less-clean rooms. A
pressure differential of 5 Pa,10Pa or 15Pa is required (depending on the
design and number of rooms) with the cleanest area at the highest

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pressure. Your cleanroom may have pressure gauges installed but it is

advised to check these instruments. ISO Cleanroom use a calibrated
electric micromanometer to measure pressure differentials.

Air Flow testing

Air volume supply rates (m3/s) or air velocity rates (m/s) depending upon the
design of your cleanroom will be measured using an array of instruments.
Duct velocities will be measured by a static pitot tube. The average air
velocity of filters is measured using calibrated vane anemometers or airflow
measuring hoods (balometer).

Filter integrity test

Your HEPA and ULPA filters have been tested by the manufacturer, however
it is necessary to ensure at installation that the filter has not been
damaged in transit, during installation and that the installation has been
successful with a good seal to the filter housing.

Damage can occur during the life of the filter if large particulate; perhaps
released through maintenance operations hit the filter.

ISO Cleanroom have both a calibrated photometer and LSAPC and can
conduct the test via either method depending on your processes sensitivity
to outgassing.

Containment leek

This test is designed to detect intrusion of unfiltered air into the cleanroom
from outside the cleanroom. Typical weak spots are wall joints, doors,
ceilings and windows. These seals can of course degrade over time
especially in spaces with large temperate variations.

ISO Cleanroom have both a calibrated photometer in combination with with

the Laskin nozzle aerosol generator and LSAPC’s that can conduct this test.
The choice of tests depends on your processes sensitivity to outgassing.

Recovery test

The recovery test is used to verify that the installation can return to a
specified cleanliness level within a finite time, after being exposed briefly to
a source of airborne particulate challenge. ISO Cleanroom would use either
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the Laskin generator to create a cold oil aerosol challenge or the

hcuot ni teG
microspheres, depending on your processes sensitivity to outgassing.

Airflow visualisation tests

The airflow visualisation test demonstrates the airflow direction and/or

pattern which is compared to the design of the cleanroom or clean air
equipment. This is shown using the Laskin generator to create a cold oil
aerosol which can be photographed and filmed to evidence the flow. Or in
cleanrooms sensitive to outgassing a taper or streamer can be used.
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See our reviews on

Gareth Evans Siobhan Carey

10 months ago 11 months ago
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3/7/23, 4:38 PM Cleanroom Validation | ISO Class Cleanroom Testing and Certification | ISO Cleanroom

We contracted ISO Cleanroom to I recently contracted Iso

design, build and validate a large Cleanroom to design and build
cleanroom in our new facility. Toni two modular ISO Class 6
really knows her business, and cleanrooms so that our small
was very helpful through the orthobiologics company could
design process, enabling us to implement in-house manufacture.
make the most of the available They delivered on all of their
space. commitments on cost, schedule
and quality with no fuss. They
When it came to installation,
showed up they day they said the
Anthony and his team did an
would and finished up the day
exceptional job, keeping the install
they said they would. They were
to schedule. We are very happy
extremely organised and
with the professional service we
meticulous, and helped us to
have had from ISO Cleanroom and Load more
address some unforeseen issues
would not hesitate in
that cropped up during the
recommending others to use them
installation.
for any cleanroom requirements.

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