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Cleanroom Requirements, Certification and Monitoring per common accepted standards:

Cleanroom Classification and class limits are established in ISO 14644-1
(see table 1) while specifications for testing and monitoring to prove continued compliance is established in ISO 14644-2.

Often there is confusion regarding certification and monitoring. This will explain the differences between monitoring and certification. A cleanroom is a room where control of airborne contaminants as well as other things such as temperature, relative humidity, differential pressure, static electricity and many other factors.

When we certify a cleanroom, to a specific class, we are stating that the room performs to meet or exceed the performance of a specific class, under a specific occupancy status. This is the general means of checking the room for various parameters to guarantee that it is built to a specific set of requirements and re-testing those same parameters to assure nothing has changed.

Monitoring of a cleanroom is done for several reasons.
1.To ensure that the cleanroom parameters have not altered in any way. That something in the construction or supporting equipment is 100% operational and operating to the same performance as the room was when it was certified.

2.To ensure that the process in the room is in control at all times.

3.To ensure the behavior of the cleanroom staff is in control at all times.

Per ISO-14644-2 cleanroom particle classifications in cleanrooms cleaner then ISO class 5 require a maximum time interval of 6 months to demonstrate compliance to ISO 14644-1. Cleanrooms less clean as ISO Class 5 require 12 month interval between demonstration of compliance. (see table 2)

If a continuous or frequent monitoring plan is established for airborne particles and air pressure differential, then the schedule of the particle counting certification testing may be modified. This monitoring plan shall be based upon risk assessment related to the application of the installation.

This risk assessment is based upon the type of facility, the possible causes of contamination, and it’s impact on the product or process performed in the facility. Experience with different tooling, and facilities as well as an understanding of the nature of particle generation can greatly assist in better choices as to what and where particle monitoring should be performed.

Note it is impractical and expensive to establish the minimum monitoring points based upon the solely on the area in square meters. This works in certification, clearly as you must establish coverage and testing guidelines regardless of the process and risk assessment. However in a monitoring program, risk assessment is extremely important to determining what and where to monitor.

The precise count levels required by ISO 14644-1 for each classification, by particle size, are given below.
(Table 1) Airborne Particulate Cleanliness Classes (by cubic meter)
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 7 352,000 83,200 2,930
ISO 8 3,520,000 832,000 29,300
ISO 9 35,200,000 8,320,000 293,000

ISO 14644-2 determines the type and frequency of testing required to conform with the standard. The following tables indicate which tests are mandatory and which tests are optional.
(Table 2) Required Testing (ISO 14644-2)
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
> ISO 5 12 Months
Air Pressure Difference All Classes 12 Months ISO 14644-1 Annex B5
Airflow All Classes 12 Months ISO 14644-1 Annex B4
Optional Testing (ISO 14644-2)
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

The focus of the testing program is to monitor the performance of your facility in order to identify significant changes in efficiency. This will ensure changes can be addressed before they become a major source of contamination effecting productivity.

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