Summary of ISO 14644 (ISO Cleanliness Classes) : Pharmaguideline
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  • Oct 20, 2011

    Summary of ISO 14644 (ISO Cleanliness Classes)

    ISO-14644 consists of Classification of Air Cleanliness, Cleanroom Testing for Compliance, Cleanroom Design & Construction, Cleanroom Operations, Terms, Definitions & Units and Minienvironments & Isolators.

    ISO-14644-1 Classification of Air Cleanliness

    Cleanliness class designations and quantity have changed from FS209E (see table A). Along with the obvious change to metric measure of air volume, ISO 14644-1 adds three additional classes - two cleaner than Class 10 and one dirtier than Class 100,000.

    Table A
    Airborne Particulate Cleanliness Classes
    CLASS
    Number of Particles per Cubic Meter by Micrometer Size
    0.1 um
    0.2 um
    0.3 um
    0.5 um
    1 um
    5 um
    ISO 1
    10
    2
    -
    -
    -
    -
    ISO 2
    100
    24
    10
    4
    -
    -
    ISO 3
    1,000
    237
    102
    35
    8
    -
    ISO 4
    10,000
    2,370
    1,020
    352
    83
    -
    ISO 5
    100,000
    23,700
    10,200
    3,520
    832
    29
    ISO 6
    1,000,000
    237,000
    102,000
    35,200
    8,320
    293
    ISO 7
    NA
    NA
    NA
    352,000
    83,200
    2,930
    ISO 8
    NA
    NA
    NA
    3,520,000
    832,000
    29,300
    ISO 9
    NA
    NA
    NA
    35,200,000
    8,320,000
    293,000
    Table B compares FED STD 209E to the new ISO 14644-1.
    Table B
    Airborne Particulate Cleanliness Class Comparison
    ISO 14644-1
    FED STD 209E
    1
    NA
    NA
    2
    NA
    NA
    3
    1
    M1.5
    4
    10
    M2.5
    5
    100
    M3.5
    6
    1,000
    M4.5
    7
    10,000
    M5.5
    8
    100,000
    M6.5
    9
    NA
    NA
    ISO-14644-2 Cleanroom Testing for Compliance
    ISO 14644-2 determines the type and frequency of testing required to conform with the standard. Table C indicates which tests are mandatory and table E indicates which tests are optional.

    Table C
    Strategic Testing(Required)
    Table 1 Schedule of tests to demonstrate continuing compliance
    Test Parameter
    Class
    Maximum Time Interval
    Test Procedure
    Particle Count Test
    <= ISO 5
    6 Months
    ISO 14644-1 Annex A
    Recovery
    > ISO 5
    12 Months
    ISO 14644-1 Annex A
    Air Pressure Difference
    All Classes
    12 Months
    ISO 14644-1 Annex B5
    Airflow
    All Classes
    12 Months
    ISO 14644-1 Annex B4
    Table D
    Strategic Testing (Required)
    Table 2 Schedule of additional optional tests
    Test Parameter
    Class
    Maximum Time Interval
    Test Procedure
    Installed Filter Leakage
    All Classes
    24 Months
    ISO 14644-3 Annex B6
    Containment Leakage
    All Classes
    24 Months
    ISO 14644-3 Annex B4
    Recovery
    All Classes
    24 Months
    ISO 14644-3 Annex B13
    Airflow Visualization
    All Classes
    24 Months
    ISO 14644-3 Annex B7

    ISO-14644-4 Cleanroom Design & Construction

    This document will be a primer on the design and construction of cleanrooms. It will cover all aspects of the process from design development to startup and commissioning.

    ISO-14644-5 Cleanroom Operations

    This document will be a primer on cleanroom operation. It will cover all aspects of the operation of a cleanroom including entry and exit procedures for equipment and personnel, education and training, cleanroom apparel, and facility issues such as maintenance, housekeeping, monitoring, system failure, etc.

    ISO-14644-6 Terms, Definitions & Units

    This document will provide a consistent reference for all terms, definitions and units discussed across all ISO cleanroom standards.

    ISO-14644-7 Minienvironments & Isolators

    This document will focus on specialized stand-alone clean spaces including their design, construction, and operations.

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