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• ISO Class 2 at 0.5 µm• ISO Class 3 at 1.0 µm• ISO Class 5 at 5.0 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

locationsThis 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. 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 is used to determine the minimum number of sampling locations.

For example, a 2,000 square meter cleanroomwould 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!


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am cleanroom build and performance revisions to iso 14644-1

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