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ISO Cleanroom Standard

Clean rooms
are classi ed by how clean the air is. In Federal Standard 209 (A to D) of the USA, the number of particles equal to and
greater than 0.5mm is measured in one cubic foot of air, and this count is used to classify the cleanroom. This metric
nomenclature is also accepted in the most recent 209E version of the Standard. Federal Standard 209E is used
domestically. The newer standard is TC 209 from the International Standards Organization. Both standards classify a
cleanroom by the number of particles found in the laboratory's air. The cleanroom classi cation standards FS 209E
and ISO 14644-1 require speci c particle count measurements and calculations to classify the cleanliness level of a
cleanroom or clean area. In the UK, British Standard 5295 is used to classify cleanrooms. This standard is about to be
superseded by BS EN ISO 14644-1.

Leading Clean Room Manufacturers

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Cleanrooms are classi ed according to the number and size of particles permitted per volume of air. Large numbers like “class 100” or “class 1000” refer to FED_STD-209E, and denote the number of particles
of size 0.5 mm or larger permitted per cubic foot of air. The standard also allows interpolation, so it is possible to describe e.g. “class 2000.”

Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 µm or larger permitted per cubic meter of air. So, for example, an ISO class 5 cleanroom has
at most 105 = 100,000 particles per m3.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, there is no such thing as zero particle concentration. Ordinary room air is
approximately class 1,000,000 or ISO 9.

Before global cleanroom classi cations and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration’s standards (known as FS209E) were applied
virtually worldwide. However, as the need for international standards grew, the ISO established a technical committee and several working groups to delineate its own set of standards.

FS209E contains six classes, while the ISO 14644-1 classi cation system adds two cleaner standards and one dirtier standard (see chart below). The "cleanest" cleanroom in FS209E is referred to as Class 1; the
"dirtiest" cleanroom is a class 100,000. ISO cleanroom classi cations are rated according to how much particulate of speci c sizes exist per cubic meter (see second chart). The "cleanest" cleanroom is a class 1
and the "dirtiest" a class 9. ISO class 3 is approximately equal to FS209E class 1, while ISO class 8 approximately equals FS209E class 100,000.

By law, Federal Standard 209E can be superseded by new international standards. It is expected that 209E will be used in some industries over the next ve years, but that eventually it will be replaced
internationally by ISO 14644-1.

International Organization for Standardization Logo

ISO is an independent, non-governmental international organization with a membership of 162 national standards
bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based,
market relevant International Standards that support innovation and provide solutions to global challenges.

Airborne Particulate Cleanliness Class Comparison

ISO 14644-1 FEDERAL STANDARD 209E

ISO Class English Metric

ISO 1

ISO 2

ISO 3 1 M1.5

ISO 4 10 M2.5

ISO 5 100 M3.5

ISO 6 1,000 M4.5

ISO 7 10,000 M5.5

ISO 8 100,000 M6.5

ISO 9

Airborne Particulate Cleanliness Class (by cubic meter):

CLASS Number of Particles per Cubic Meter by Micrometer Size

0.1 microns 0.2 microns 0.3 microns 0.5 microns 1 micron 5 microns

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

In cleanrooms, particulate concentration changes over time – from the construction and installation of equipment to its operational status. ISO delineates three cleanroom classi cation standards: as-built, at-
rest and operational. As instruments and equipment are introduced and particulates rise, an "as-built" cleanroom becomes an "at-rest" cleanroom. When people are added to the matrix, particulate levels rise
still further in the "operational" cleanroom.

ISO 14644-2 describes the type and frequency of testing required to conform to certain standards. The following tables indicate mandatory and optional tests.

Required Testing (ISO 14644-2)

Schedule of Tests to Demonstrate Continuing Compliance

Test Parameter Class Maximum Time Interval Test Procedure

<= ISO 5 6 Months

Particle Count Test 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 14644-1 Annex B6

Containment Leakage All Classes 24 Months ISO 1464401 Annex B4

Recovery All Classes 24 Months ISO 14644-1 Annex B13

Airflow Visualization All Classes 24 Months ISO 14644-1 Annex B7

Today, in addition to ISO 14644-1 and ISO 14644-2, eight other cleanroom standards documents are being prepared. Many are in the nal voting stage and can be legally used in the trade (see chart).

ISO Document Title

ISO 14644-1 Classification of Air Cleanliness

ISO 14644-2 Cleanroom Testing for Compliance

ISO 14644-3 Methods for Evaluating and Measuring Cleanrooms and Associated Controlled Environments

ISO 14644-4 Cleanroom Design and Construction

ISO 14644-5 Cleanroom Operations

ISO 14644-6 Terms, Definitions and Units

ISO 14644-7 Enhanced Clean Devices

ISO 14664-8 Molecular Contamination

ISO 14698-1 Biocontamination: Control General Principles

ISO 14698-2 Biocontamination: Evaluation and Interpretation of Data

ISO 14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces

The USA Source for ISO documents is:

Institute of Environmental Sciences & Technology (IEST)

5005 Newport Drive, Suite 506
Rolling Meadows, IL 60008-3841
http://www.iest.org
Phone: (847) 255-1561
Fax: (847) 255-1699

The source for FS209E documents at the General Services Administration is:

Standards Order Desk

Naval Publications and Forms Center
700 Robbins Avenue
Section D BLD4
Philadelphia, PA 19111
Phone: (215) 697-2667
Fax: (215) 697-2978

ISO and Federal Air Change Rates for Cleanrooms

A critical factor in cleanroom design is controlling air-change per hour (ACH), also known as the air-change rate, or ACR. This refers to the number of times each hour that ltered outside air replaces the
existing volume in a building or chamber. In a normal home, an air-conditioner changes room air 0.5 to 2 times per hour. In a cleanroom, depending on classi cation and usage, air change occurs anywhere
from 10 to more than 600 times an hour.

ACR is a prime variable in determining ISO and Federal cleanliness standards. To meet optimal standards, ACR must be painstakingly measured and controlled. And there is some controversy. In an appendix
to its ISO 14644-1 cleanliness standard, the International Standards Organization addressed applications for microelectronic facilities only. (ISO classes 6 to 8; Federal Standards 1,000, 10,000 and 100,000.) The
appendix contained no ACR standards for pharmaceutical, healthcare or biotech applications, which may require higher ACR regulations.

According to current research, case studies and experiments, using an ACR range (rather than one set standard) is a better guideline forcleanliness classi cation. This is true because the optimal ACR varies
from cleanroom to cleanroom, depending on factors such as internal equipment, sta ng and operational purpose. Everything depends on the level of outside contaminants trying to enter the facility versus
the level of contaminants being generated on the inside.

The breadth of these ranges re ects how dramatically people and processes a ect cleanliness. Low-end gures within each contamination class generally indicate air velocity and air change requirements for
an as-built or at-rest facility – where no people are present and no contaminating processes under way. When there are people and processes producing contaminants, more air changes are required to
maintain optimal cleanliness standards. For instance, some manufacturers insist on as many as 720 air changes per hour to meet Class 10 standards.

Determining the appropriate number of air changes for a particular application requires careful evaluation of factors such as the number of personnel, e ectiveness of garbing protocol, frequency of access,
and cleanliness of process equipment.

Rajan Jaisinghani, in his paper "Energy E cient Low Operating Cost Cleanroom Air ow Design," presented at ESTECH 2003, recommended the following ranges based on FS209E classi cations:

FS Cleanroom Class ISO Equivalent Class Air Change Rate

1 ISO 3 360-540

10 ISO 4 300-540

100 ISO 5 240-480

1,000 ISO 6 150-240

10,000 ISO 7 60-90

100,000 ISO 8 5-48

Jaisinghani’s recommendations concur with other recent studies of ACR, which criticize some existing air rate standards (developed in the 1990s) as being unscienti c because they are based on fans and lters
inferior to today’s models. So when these older standards are applied, the resulting ACR is often too high. In fact, some studies have found that reducing the ACR (and its attendant air turbulence) can result in
a cleaner atmosphere.

This was demonstrated in a study conducted by Paci c Gas and Electric (San Francisco) and the Lawrence Berkeley National Laboratory (Berkeley). The study measured air change rates in several ISO Class-5
cleanrooms and came to the conclusion that there is "no consistent design strategy for air change rate, even for cleanrooms of the same cleanliness classi cation."

ACR rates have critical design implications, especially when considering desired cleanliness, fan size and lower energy costs. The PG&E/Berkeley study caused many designers to reduce fan sizes. In short, a
lower ACR often resulted in cleaner air.

The study revealed three abiding principles:

Lower air change rates result in smaller fans, which reduce both initial investment and construction cost.
Fan power is proportional to the cube of air change rates or airflow. A 30-percent reduction in air change rate results in a power reduction of approximately 66 percent.
By minimizing turbulence, lower airflow may improve cleanliness.

The study focused on Class-5 cleanrooms, concluding that an ACR range of from 250 to 700 air changes per hour is standard, but that "actual operating ACRs ranged from 90 to 625." It added that all of these
optimized cleanrooms were certi ed and performing at ISO Class-5 conditions with these lower ACRs. Finally, the study concluded that rarely does a Class-5 facility require an ACR of more than 300.

The study also found that the "[b]est practice for ACRs is to design new facilities at the lower end of the recommended ACR range," with variable speed drives (VSDs) built in so that air ow adjustments can be
made under actual operating conditions.

In his report "An examination of ACRs: An opportunity to reduce energy and construction costs," Peter Rumsey, PE, CEM, essentially concurred with the PG&E-commissioned study by Berkeley. Rumsey issued
a caveat, then brushed it aside by citing research subsequent to Berkeley’s: "Air cleanliness is a critical component of any cleanroom, far outweighing energy saving priorities. Designers and operators need
evidence from others who have tried similar strategies in order to address the perceived risks of lowering air change rates."

Rumsey then went on to cite studies done by International Sematech (Austin, Texas); the Massachusetts Institute of Technology (Cambridge, Mass.); Intel (Santa Clara, Calif.); and Sandia National Laboratories
(Albuquerque, N.M.), which echoed the Berkeley study.
In summary, current research and thinking on air change rates indicate that some existing standards are too high and can be lowered while still meeting all ACR criteria.

Federal and ISO Ceiling Fan Coverage Specifications

Achieving the optimal air change rate requires proper ceiling fan coverage. The cleanest modular cleanroom incorporates lter/fan units (FFUs) in every 2′ x 4′ (610 mm x 1219 mm) ceiling bay. This near-100%
coverage provides a laminar ow of ltered air to quickly remove contaminants from the room, thus meeting FS209E standards for Class 10 and ISO Class 1 standards.

Such coverage, especially in a large cleanroom, can lead to higher energy consumption, thus increasing costs for both initial construction and ongoing operation. In most cases, a smaller percentage of ceiling
coverage produces adequate cleanliness.

This table illustrates the percentage of ceiling coverage recommended for each cleanliness class, again as a range:

Class Ceiling Coverage (Percentage)

ISO 8 (Class 100,00) 5 – 15%

ISO 7 (Class 10,000) 15 – 20%

ISO 6 (Class 1,000) 25 – 40%

ISO 5 (Class 100) 35 – 70%

ISO 4 (Class 10) 50 – 90%

ISO 3 (Class 1) 60 – 100%

ISO 1 – 2 80 – 100%

Federal and ISO Airflow Velocity Standards

In addition to ACR and ceiling coverage, the third factor integral to maintaining cleanliness is fan-generated air speed. Again, higher air ow velocity results in a "cleaner" cleanroom. The term "ventilation
e ciency" refers to the speed of ltered air passing through the cleanroom in addition to the number of air changes per hour (ACH or ACR).

An earlier chart showed a range of recommended air change rates (ACRs) for di erent classes of cleanrooms. Ranges are given because as-built and at-rest facilities require a smaller ACR than an operational
cleanroom, where both people and equipment are actively engaged. Non-operational cleanrooms are found in the lower range; operational cleanrooms higher.

Combining all three factors – ACR, ceiling coverage and air ow velocity-results in the following table:

Class ISO 146144-1 (Federal Standard 209E) Average Airflow Velocity m/s (ft/min) Air Changes Per Hour Ceiling Coverage

ISO 8 (Class 100,000) 0.005 – 0.041 (1 – 8) 5 – 48 5 – 15%

ISO 7 (Class 10,000) 0.051 – 0.076 (10 – 15) 60 – 90 15 – 20%

ISO 6 (Class 1,000) 0.127 – 0.203 (25 – 40) 150 – 240 25 – 40%

ISO 5 (Class 100) 0.203 – 0.406(40 – 80) 240 – 480 35 – 70%

ISO 4 (Class 10) 0.254 – 0.457 (50 – 90) 300 – 540 50 – 90%

ISO 3 (Class 1) 0.305 – 0.457 (60 – 90) 360 – 540 60 – 100%

ISO 1 – 2 0.305 – 508 (60 – 100) 360 – 600 80 – 100%

Before deciding on the appropriate velocity and air changes for your application, Terra Universal recommends careful evaluation of factors such as number of personnel, e ectiveness of garbing protocol,
access frequency and cleanliness of process equipment. Once the required air change gure is established, the number of required FFUs can be determined using this formula:

No. of FFUs = (Air Changes/Hour ÷ 60) x (Cubic ft. in room ÷ 650*)

*CFM output of a loaded FFU

Meeting Class 100 standards using the low-end air change recommendation (240/hour) inside a 12′ x 12′ x 7′ (3302 mm x 3302 mm x 2134 mm) cleanroom, with 1008 cu. ft. of volume, requires 6 FFUs. To meet
the same standard using the high-end air change recommendation (480/hour) requires 12 FFUs.

Positive Pressure
Cleanrooms are designed to maintain positive pressure, preventing "unclean" (contaminated) air from owing inside and less-clean air from owing into clean areas. The idea is to ensure that ltered air
always ows from cleanest to less-clean spaces. In a multi-chambered cleanroom, for instance, the cleanest room is kept at the highest pressure. Pressure levels are set so that the cleanest air ows into
spaces with less-clean air. Thus, multiple pressure levels may need to be maintained.

A di erential air pressure of 0.03 to 0.05 inches water gauge is recommended between spaces. In order to ensure that pressure di erentials remain constant when doors are opened, or other events occur,
control systems must be in place.

Laminar and Turbulent Air Flow

ISO 5 (Class 100) and cleaner facilities rely on unidirectional, or laminar, air ow. Laminar air ow means that ltered air is uniformly supplied in one direction (at a xed velocity) in parallel streams, usually
vertically. Air is generally recirculated from the base of the walls back up to the ltering system.

ISO 6 (Class 1,000) and above cleanrooms generally utilize a non-unidirectional, or turbulent, air ow. This means the air is not regulated for direction and speed. The advantage of laminar over turbulent
air ow is that it provides a uniform environment and prevents air pockets where contaminants might congregate.

Clean Rooms Power Pages

Cleanrooms Portable Cleanrooms Softwall Cleanrooms

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A cleanroom is a specially designed enclosed space where little space, provides mobility, is cost e ective, and o ers A softwall cleanroom is a con ned controlled space with a
airborne particulates have been limited or removed by a exceptional clean and ltered air ow to create an metal frame, clear panel walls, an entrance, high e ciency
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Cleanroom products are specially designed and engineered A modular clean room is a prefabricated, controlled
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