Cleanroom Requirements in

the ISO 14644

one of my professional Followers; Who ask for

Where I found cleanroom layout mandatory Requirement.

And what is testing/measuring Requirement in cleanroom.

Like Temperature. Pressure, Humidity, Dust Particles.

The Answer

• Basic clean room design requirements and

considerations
• Some General Requirements
• Common Parameters that are measured and
monitored
• Examples of testing/measuring requirements for
different types of cleanrooms :
- ISO Class 5 Cleanroom
- ISO Class 8 Cleanroom:
• ISO 14644 Series of Standards

Cleanroom layout mandatory requirements depend on the

type and classification of the cleanroom, as well as the
process and product that are being handled inside.

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However, some general requirements are:

- Internal surfaces: Every surface in the cleanroom should be

smooth and impenetrable by microorganisms. They should
also be strong enough not to crack or shatter besides being
easy to clean. The materials for the surfaces shouldn’t create
flakes or dust¹.

- Airflow: A cleanroom’s airflow system should be effective at

circulating particles out of the room.

The optimal layout depends on the size of the room, the

number of people working inside, the equipment inside, etc.

Some cleanrooms use unidirectional airflow, which means

that the air flows in one direction only, usually from ceiling to
floor⁵.

- Employee access: The number of people allowed into a

cleanroom should be strictly controlled and only specially-
trained personnel given access. They should also wear
appropriate protective clothing and follow proper hygiene
and gowning procedures¹.

- Pressure cascade: A cleanroom should have a positive

pressure relative to the surrounding areas, which means that
the air flows from the cleanroom to the outside and not vice
versa.

This prevents contamination from entering the cleanroom.

The pressure difference should be maintained by a HVAC
system that regulates the air supply and exhaust³.

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As for the testing/measuring requirements in a cleanroom,
they also vary depending on the type and classification of the
cleanroom, as well as the standards and regulations that
apply to the specific industry or product. However, some
common parameters that are measured and monitored are:

- Temperature: The temperature in a cleanroom should be

controlled and maintained within a certain range that is
suitable for the process and product. The temperature should
also be uniform throughout the room and not fluctuate
significantly³.

- Humidity: The humidity in a cleanroom should also be

controlled and maintained within a certain range that is
suitable for the process and product. The humidity should
also be uniform throughout the room and not fluctuate
significantly³.

- Pressure: The pressure in a cleanroom should be measured

and monitored to ensure that it is positive relative to the
surrounding areas and that it follows a pressure cascade
regime. The pressure should also be stable and not fluctuate
significantly³.

- Dust particles: The dust particles in a cleanroom should be

measured and monitored to ensure that they do not exceed
the limits specified by the cleanliness class of the cleanroom.
The dust particles should also be distributed evenly
throughout the room and not accumulate in certain areas³

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You can find the cleanroom layout mandatory requirements
in the ISO 14644-4:2022 standard, which specifies the design,
construction, and start-up requirements for creating a
cleanroom².

The standard provides detailed checklists that include

important performance parameters to be considered, such as
internal surfaces, airflow, employee access, and pressure
cascade. The standard also identifies energy management
design approaches to support an energy efficient cleanroom
design and provides construction guidance for start-up and
verification.

The testing/measuring requirements in a cleanroom depend

on the type and classification of the cleanroom, as well as the
standards and regulations that apply to the specific industry
or product. However, some common parameters that are
measured and monitored are temperature, humidity,
pressure, and dust particles³.

The ISO 14644-3:2019 standard specifies the test methods for

determining the performance of cleanrooms and associated
controlled environments. The standard covers various aspects
of testing and measuring, such as test procedures, test
equipment, test conditions, test frequency, test data analysis,
and test reports.

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Some examples of testing/measuring requirements for
different types of cleanrooms are:

- ISO Class 5 Cleanroom: This type of cleanroom is equivalent

to the Class 100 cleanroom in the US Federal Standard 209E.
It requires an unidirectional airflow system that provides a
minimum average airflow velocity of 0.45 m/s (90 fpm) and a
minimum airflow volume of 0.37 m3/s (800 cfm) per square
meter of filter area⁴. The temperature should be controlled
within a range of 20°C ± 2°C (68°F ± 4°F) and the relative
humidity within a range of 50% ± 10%⁵. The pressure should
be positive relative to the surrounding areas and follow a
pressure cascade regime. The dust particles should not
exceed a concentration of 3.52 x 10^3/m^3 for particles
equal to or larger than 0.5 µm and 29/m^3 for particles equal
to or larger than 5 µm⁵.

- ISO Class 8 Cleanroom: This type of cleanroom is equivalent

to the Class 100000 cleanroom in the US Federal Standard
209E. It requires a non-unidirectional airflow system that
provides a minimum average airflow velocity of 0.05 m/s (10
fpm) and a minimum airflow volume of 0.04 m3/s (80 cfm)
per square meter of filter area⁵. The temperature should be
controlled within a range of 22°C ± 2°C (72°F ± 4°F) and the
relative humidity within a range of 55% ± 10%⁵. The pressure
should be positive relative to the surrounding areas and
follow a pressure cascade regime. The dust particles should
not exceed a concentration of 3.52 x 10^6/m^3 for particles
equal to or larger than 0.5 µm and 2.37 x 10^4/m^3 for
particles equal to or larger than 5 µm⁵.

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ISO 14644 is a series of standards that specify the
requirements for cleanrooms and associated controlled
environments. Cleanrooms are spaces that are designed to
control and filter out contaminants like dust, airborne
microbes, and aerosol particles, providing the cleanest
possible area for certain industries or products.

ISO 14644 standards were first formed from the US Federal

Standard 209E Airborne Particulate Cleanliness Classes in
Cleanrooms and Clean Zones.

The need for a single standard for cleanroom classification

and testing was long felt.

ISO 14644 consists of the following parts:

- Part 1: Classification of air cleanliness by particle

concentration

- Part 2: Monitoring to provide evidence of cleanroom

performance related to air cleanliness by particle
concentration

- Part 3: Test methods

- Part 4: Design, construction and start-up

- Part 5: Operations

- Part 6: Vocabulary

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- Part 7: Separative devices (clean air hoods, gloveboxes,
isolators and mini-environments)

- Part 8: Classification of air cleanliness by chemical

concentration (ACC)

- Part 9: Classification of surface cleanliness by particle

concentration

- Part 10: Classification of surface cleanliness by chemical

concentration

- Part 11: Assessment of suitability for use of equipment by

airborne particle concentration

- Part 12: Specifications for monitoring air cleanliness by

nanoscale particle concentration

- Part 13: Cleaning of surfaces to achieve defined levels of

cleanliness in terms of particle and chemical classifications

- Part 14: Assessment of suitability for use of equipment and

materials by airborne chemical concentration

Each part of ISO 14644 specifies different aspects of

cleanroom design, construction, operation, testing,
monitoring, and maintenance. The standards are intended for
use by users, specifiers, designers, purchasers, suppliers,
builders, and performance verifiers of cleanroom
installations.

I hope this answers your questions. If you need more

information or clarification, please let me know.

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Source:

(1) ISO 14644-4:2022 – Cleanroom, Design &

Construction. https://blog.ansi.org/iso-14644-4-
2022-cleanroom-design-construction/
(2) Basic clean room design requirements and
considerations – PharmOut.
https://www.pharmout.net/basic-cleanroom-
requirements/.
(3) ISO Class 5 Cleanroom: Class 100 Cleanroom
Requirements.
https://www.pristinecleanbags.com/cleanroom-
ultimate-guide/iso-5-cleanrooms/.
(4) Clean Room Classifications (ISO 8, ISO 7, ISO 6, ISO 5)
| Mecart. https://www.mecart-
cleanrooms.com/learning-center/cleanroom-
classifications-iso-8-iso-7-iso-6-iso-5/.
(5) Everything You Need To Know: Cleanroom
Classifications, Requirements ….
https://www.neslo.com/blog/cleanroom-
classifications.