Am Cleanroom Build and Performance Revisions to ISO 14644-1

Revisions to ISO 14644-1:2015
Cleanrooms and associated controlled environments

In December of 2015, the International Organization for
Standardization (ISO) committee ISO/TC 209, Cleanrooms and
Associated Controlled Environments issued the second edition of
ISO 14644 parts 1 and 2.
Revisions to ISO 14644-1 AMCleanroomBuild.com

Updated Name
The first update to ISO 14644-1 was changing the name to
“Classification of air cleanliness by particle concentration” from the
1999 edition’s “Classification of air cleanliness”.

Changes to Table 1
Concentration limits were removed from the following ISO
Classes and particle sizes:
• ISO Class 1 at 0.2 µm

Changes to Table 1 (Continued)
The removal of a particle limit for ISO Class 5 at 5.0 µm was one
of the issues that caused the delay in the approval of ISO 14644-
1:2015. This was due to the requirements in EU-GMP Annex 11.
It was decided that the use of an M descriptor was the proper
way to handle the issue.

Changes to Section 5.1
Original
“At-rest or operational classification may be performed periodically based
upon risk assessment of the application, typically on an annual basis”.
Updated to include
“Where the installation is equipped with instrumentation for continuous or
frequent monitoring of air cleanliness by particle concentration and other
parameters of performance as applicable, the time intervals between
classification may be extended provided that the results of the monitoring
remain within the specified limits”

Changes to Annex A:
Establishment of sampling
locations
This section has the most significant change to the specification. The 1999 Annex A was removed and
replaced with a modified version of 1999 Annex B.
In paragraph A.2.2, the requirement for the particle counter to be calibrated to ISO 21501-4 is stated.
In the notes for that section it reads, “Some particle counters cannot be calibrated to all of the required
tests in ISO 21501-4. If this is the case, record the decision to use the counter in the test report”.
Only the newest particle counters can meet the ISO 21501-4. Check with your particle counter
manufacturer to see if yours does.

Changes to Annex A (Continued)
The determination of
sample locations for
classification in ISO
14644-1:1999 was
calculated by using the
formula 𝑁𝐿 = 𝐴. In the
2015 version the location
is derived from Table A.1

The cleanroom is still divided into equal grids but now the location
should be representative of the characteristics of the grid.
• Representative means that features such as cleanroom or clean
zone layout, equipment disposition and airflow systems should be
considered when selecting sampling locations.
• Example- A location under a HEPA filter may not be representative if
a cleanroom is a non-unidirectional airflow.

• Additional sampling locations may be selected for critical
locations and to help divide the cleanroom into equal parts but
must be noted in the report.

If a cleanroom is larger than 1,000 Square Meters (10,764
Square Feet) a new formula 𝑁𝐿 = 27 𝑋
𝐴
1000
is used to
determine the minimum number of sampling locations.
For example, a 2,000 square meter cleanroom
would now require 54 sampling locations.

The 2015 version has increased the minimum number of sample
locations to insure 95% confidence that at least 90% of the
cleanroom does not exceed the class limit.
With the increase in sample locations, the requirement for the
95% confidence calculation has been removed from the report.

When one sample location is required, the minimum number of
samples is now one instead of the 3 samples required in the
1999 version.
The pass/fail is based on the concentration levels only.

Annex B: Examples of
Classification Calculations
This annex contains 6 examples of classification calculations with
formulas and math.

Changes to Annex C:
Counting and Sizing of
Airborne Macroparticles
The 1999 version of Annex C was removed and replaced with a
modified version of 1999 Annex E.
The Concentrations of ultrafine particles (particles smaller than
0.1 μm) will be addressed in a separate standard to specify air
cleanliness by nano-scale particles.

Annex D:
Sequential Sampling
Procedure
This annex is the same as 1999 Annex F.

Changes to Annex E:
Specification of intermediate
decimal cleanliness classes and
particle size thresholds
A new table has been added for intermediate decimal classes if
required.

Revisions to ISO 14644-1 AMCleanroomBuild.comRevisions to ISO 14644-1 AMCleanroomBuild.com

Annex F: Test Instruments
This Annex describes the measuring apparatus that should be
used.
It’s informative only and should not prevent use of improved
apparatuses as they become available.

To make your facility compliant with the new ISO 14644-1 standards,
hire a company who understands the changes and has the experience
to implement them.
Contact AMCBP Today!

World Headquarters: 2213 RR 620 N. Suite 105, Austin, Texas 78734
Phone: (888) 729-1548 Website: www.amcleanroombuild.com

Am Cleanroom Build and Performance Revisions to ISO 14644-1

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