Summary of ISO 14644 (ISO Cleanliness Classes) : Pharmaceutical Guidelines

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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.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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