FS209E and ISO Cleanroom Standards

Terra Universal is the leading expert in the design and fabrication of critical-environment
applications. We offer a complete range of equipment, furnishing and supplies for
cleanrooms and laboratories. Following are the rigorous standards to which Terra Universal
adheres. Download this page as a PDF document.

Before global cleanroom classifications 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 classification 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
classifications are rated according to how much particulate of specific 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.

In November 2001, Federal Standard 209E was superseded by the new ISO 14644-1
international standards. References to FS209E are still used; the comparison chart below
illustrates the relationship between the two standards.

Terra cleanroom walls are made of durable, easy-to-clean, ISO-grade materials, as specified
in FDA guidance documents. Combined with your cGMP processes, they will help you
comply with operational requirements.

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 Classes (by cubic meter):
CLASS Number of Particles per Cubic Meter by Micrometer Size
0.1 micron 0.2 micron 0.3 micron 0.5 micron 1 micron 5 microns
ISO1 10 2
ISO2 100 24 10 4
ISO3 1,000 237 102 35 8
ISO4 10,000 2,370 1,020 352 83
ISO5 100,000 23,700 10,200 3,520 832 29
ISO6 1,000,000 237,000 102,000 35,200 8,320 293
ISO7 352,000 83,200 2,930
ISO8 3,520,000 832,000 29,300
ISO9 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
classification standards: as-built, at-rest and operational. Read more about cleanroom and
gowning room design considerations/recommendations. 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.

A Guide to Gowning Procedures

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 Test Procedure
Interval
Particle Count Test <= ISO 5 6 Months ISO 14644-1 Annex A
> ISO 5 12 Months
Air Pressure All Classes 12 Months ISO 14644-1 Annex
Difference 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 Test Procedure
Interval
Installed Filter All Classes 24 Months ISO 14644-1 Annex
Leakage B6
Containment Leakage All Classes 24 Months ISO 14644-1 Annex
B4
Recovery All Classes 24 Months ISO 14644-1 Annex
B13
Airflow Visualization All Classes 24 Months ISO 14644-1 Annex
B7

In addition to ISO 14644-1 and ISO 14644-2, eight other cleanroom standards documents
exist, as well as three specific to biocomtamination applications.

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 14644-8 Molecular Contamination
ISO 14644-9 Surface Cleanliness by Particle Concentration
ISO 14644-10 Surface Cleanliness by Chemical Concentration
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 More About
Rolling Meadows, IL 60008-3841 Cleanroom Design
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 filtered 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
classification 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 for cleanliness classification. This is true because the
optimal ACR varies from cleanroom to cleanroom, depending on factors such as internal
equipment, staffing 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 reflects how dramatically people and processes affect cleanliness.
Low-end figures 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, effectiveness of garbing
protocol, frequency of access, and cleanliness of process equipment. Learn more about
fan/filter units and see the models offered by Terra, such as room-side replaceable, ducted
and energy-efficient.

Rajan Jaisinghani, in his paper "Energy Efficient Low Operating Cost Cleanroom Airflow
Design," presented at ESTECH 2003, recommended the following ranges based on FS209E
classifications:

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 unscientific because they
are based on fans and filters 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 Pacific 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
classification."

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 certified 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
flow adjustments can be made under actual operating conditions. Control can be performed
manually or automatically. See the Smart modular cleanroom control systems offered by
Terra.

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. Read Terra's
blog post "What Makes a Room Suitable for Aseptic Proceses?"
Federal and ISO Ceiling Fan
Cleanroom Cost
Coverage Specifications Considerations
Achieving the optimal air change rate requires proper ceiling
fan coverage. The cleanest modular cleanroom
incorporates filter/fan units (FFUs) in every 2’ x 4’ (610 mm x 1219 mm) ceiling bay. This
near-100% coverage provides a laminar flow of filtered 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. Read more about FFU
placement and performance efficiency; see the FFU-coverage formula below to help
calculate the quantity of necessary ceiling modules.

This table illustrates the percentage of ceiling coverage recommended for each cleanliness
class, again as a range:
Class Ceiling Coverage (Percentage)
ISO 8 (Class 100,000) 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 airflow velocity results in a "cleaner" cleanroom. The
term "ventilation efficiency" refers to the speed of filtered 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 different
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 airflow velocity—results in the
following table:

Class ISO 146144-1 Average Airflow Air Changes Per Ceiling Coverage
(Federal Standard Velocity Hour
209E) m/s (ft/min)
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 – 150 – 240 25 – 40%
40)
ISO 5 (Class 100) 0.203 – 0.406 (40 – 240 – 480 35 – 70%
80)
ISO 4 (Class 10) 0.254 – 0.457 (50 – 300 – 540 50 – 90%
90)
ISO 3 (Class 1) 0.305 – 0.457 (60 – 360 – 540 60 – 100%
90)
ISO 1 – 2 0.305 – 0.508 (60 – 360 – 600 80 – 100%
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,
effectiveness of garbing protocol, access frequency and cleanliness of process equipment.

Once the required air change figure 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 flowing inside and less-clean air from flowing into clean areas. The idea is to ensure
that filtered air always flows 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 flows into spaces with less-clean air. Thus, multiple pressure levels
may need to be maintained.

A differential air pressure of 0.03 to 0.05 inches water gauge is recommended between
spaces. In order to minimize disruptions to these cascading pressures when doors are opened,
air locks are often specified between rooms of differing ISO cleanliness levels. Automated
fan controls simplify pressure balancing by allowing fan speed adjustments at a centralized
console panel. Why is pressure differential important and how is it measured? Read Terra's
"Under Pressure in Critical Environments" blog for answers.

Laminar and Turbulent Air Flow

ISO 5 (Class 100) and cleaner facilities rely on unidirectional, or laminar, airflow. Laminar
airflow means that filtered air is uniformly supplied in one direction (at a fixed velocity) in
parallel streams, usually vertically. Air is generally recirculated from the base of the walls
back up to the filtering system.
ISO 6 (Class 1,000) and above cleanrooms generally utilize a non-unidirectional, or
turbulent, airflow. This means the air is not regulated for direction and speed. The advantage
of laminar over turbulent airflow is that it provides a uniform environment and prevents air
pockets where contaminants might congregate. See more about the importance of airflow
uniformity.

http://www.cleanairtechnology.com/cleanroom-classifications-class.php

What is a Cleanroom?
Cleanroom Overview | Cleanroom Air Flow Principles | Cleanroom Classifications | ISO
14644-1 Cleanroom Standards
BS 5295 Cleanroom Standards

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Typically used in manufacturing or scientific research, a cleanroom is a controlled

environment that has a low level of pollutants such as dust, airborne microbes, aerosol
particles, and chemical vapors. To be exact, a cleanroom has a controlled level of
contamination that is specified by the number of particles per cubic meter at a specified
particle size. The ambient air outside in a typical city environment contains 35,000,000
particles per cubic meter, 0.5 micron and larger in diameter, corresponding to an ISO 9
cleanroom which is at the lowest level of cleanroom standards.

Cleanroom Overview
Cleanrooms are used in practically every industry where small particles can adversely affect
the manufacturing process. They vary in size and complexity, and are used extensively in
industries such as semiconductor manufacturing, pharmaceuticals, biotech, medical device
and life sciences, as well as critical process manufacturing common in aerospace, optics,
military and Department of Energy.

A cleanroom is any given contained space where provisions are made to reduce particulate
contamination and control other environmental parameters such as temperature, humidity and
pressure. The key component is the High Efficiency Particulate Air (HEPA) filter that is used
to trap particles that are 0.3 micron and larger in size. All of the air delivered to a cleanroom
passes through HEPA filters, and in some cases where stringent cleanliness performance is
necessary, Ultra Low Particulate Air (ULPA) filters are used.

Personnel selected to work in cleanrooms undergo extensive training in contamination

control theory. They enter and exit the cleanroom through airlocks, air showers and/or
gowning rooms, and they must wear special clothing designed to trap contaminants that are
naturally generated by skin and the body.

^ Back to top

Depending on the room classification or function, personnel gowning may be as limited as

lab coats and hairnets, or as extensive as fully enveloped in multiple layered bunny suits with
self contained breathing apparatus.

Cleanroom clothing is used to prevent substances from being released off the wearer’s body
and contaminating the environment. The cleanroom clothing itself must not release particles
or fibers to prevent contamination of the environment by personnel. This type of personnel
contamination can degrade product performance in the semiconductor and pharmaceutical
industries and it can cause cross-infection between medical staff and patients in the
healthcare industry for example.

Cleanroom garments include boots, shoes, aprons, beard covers, bouffant caps, coveralls,
face masks, frocks/lab coats, gowns, glove and finger cots, hairnets, hoods, sleeves and shoe
covers. The type of cleanroom garments used should reflect the cleanroom and product
specifications. Low-level cleanrooms may only require special shoes having completely
smooth soles that do not track in dust or dirt. However, shoe bottoms must not create slipping
hazards since safety always takes precedence. A cleanroom suit is usually required for
entering a cleanroom. Class 10,000 cleanrooms may use simple smocks, head covers, and
booties. For Class 10 cleanrooms, careful gown wearing procedures with a zipped cover all,
boots, gloves and complete respirator enclosure are required.

^ Back to top

Cleanroom Air Flow Principles

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters
employing laminar or turbulent air flow principles. Laminar, or unidirectional, air flow
systems direct filtered air downward in a constant stream. Laminar air flow systems are
typically employed across 100% of the ceiling to maintain constant, unidirectional flow.
Laminar flow criteria is generally stated in portable work stations (LF hoods), and is
mandated in ISO-1 through ISO-4 classified cleanrooms.

Proper cleanroom design encompasses the entire air distribution system, including provisions
for adequate, downstream air returns. In vertical flow rooms, this means the use of low wall
air returns around the perimeter of the zone. In horizontal flow applications, it requires the
use of air returns at the downstream boundary of the process. The use of ceiling mounted air
returns is contradictory to proper cleanroom system design.
Cleanroom Classifications
Cleanrooms are classified 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 classification standards FS 209E and ISO 14644-1 require specific 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.

Cleanrooms are classified 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 metre 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.

^ Back to top

ISO 14644-1 Cleanroom Standards

maximum particles/m3 FED STD 209E
Class
>=0.1 µm >=0.2 µm >=0.3 µm >=0.5 µm >=1 µm >=5 µm equivalent

ISO 1 10 2

ISO 2 100 24 10 4

ISO 3 1,000 237 102 35 8 Class 1

ISO 4 10,000 2,370 1,020 352 83 Class 10

ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100

ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 Class 1,000

ISO 7 352,000 83,200 2,930 Class 10,000

ISO 8 3,520,000 832,000 29,300 Class 100,000

ISO 9 35,200,000 8,320,000 293,000 Room Air

BS 5295 Cleanroom Standards
maximum particles/m3

Class >=0.5 µm >=1 µm >=5 µm >=10 µm >=25 µm

Class 1 3,000 0 0 0

Class 2 300,000 2,000 30

Class 3 1,000,000 20,000 4,000 300

Class 4 20,000 40,000 4,000