The 4 Elements of Cleanroom Design, Certification and Maintenance Part 1

January 6, 2014

Element 1: HEPA/ULPA Filters

One way AMCBP is “Constructing an Intelligent Tomorrow” is through the work of our Cleanroom
Performance Solutions group.  In this 4-part series, AM Cleanroom Build and Performance’s very own Emil Bordelon,
a NEBB Certified Professional, outlines the four main elements of a cleanroom that are considered during the design,
certification and maintenance phases

The 4 elements are:

1. HEPA/ ULPA filters

2. Airflow
3. Cleanroom Classification
4. Room Pressure

This week Mr. Bordelon will explain the importance of the proper selection of HEPA and ULPA filters.
TYPES OF HEPA / ULPA FILTERS

The first decision that is made during the design phase is the cleanliness class critical for the process or product being
manufactured or handled in the cleanroom. To that end there are two types of filters that are used in the different cleanliness
classification.

 
HEPA (High Efficiency Particulate Air) filters have minimum efficiency of 99.97% at 0.3 µm the Most Penetrating Particle
Size (MPPS). This type of filter is usually used in ISO Class 5 (100) to ISO Class 8 (100,000). The types of industries that
use this type of filter are FDA regulated facilities (drug manufacturers, medical device manufacturers and food and
beverage manufacturers), hospital operating rooms and pharmacies and semiconductor (chip manufacturers, circuit board
manufacturers, hard drive manufacturers and flash memory manufacturers) and companies that provide materials to the
semiconductor companies.

ULPA (Ultra Low Penetration Air) filters have a minimum efficiency of 99.9997 at 0.12 µm MPPS. This type of filter is
usually used in ISO Class 4(10) to ISO Class 1. THE ULPA filters are more costly than the HEPA filters which preclude
using them in all cleanroom cleanliness classes.  This type of filter is used where the smaller size particles are critical to
their process or product – mainly in the semiconductor industry.

Most HEPA / ULPA filters media are made of borosilicate microfibers with binding and water proofing agents. These
materials tend to off gas. With the new stringent process this off gassing creates difficulties and often contaminates these
processes leading to product loss.  The industry is moving to low outgassing filters. One type of filter is made of ePFTE
(expanded Polytetrafluoroethylene – also called Teflon or Gore-Tex filters), and is becoming increasingly popular. It is
corrosion resistant so can be used in highly corrosive areas like a wet benches or chemical manufacturers. It is also water
resistant which makes it more suitable with the wet process. Additionally, with lower pressure drop it saves money on
utilities and has very low off gassing properties.
IMPORTANCE OF LEAK TESTING

In the certification phase it is highly recommended that newly installed HEPA / ULPA filters should be leak tested. Every
HEPA / ULPA filter is scan tested at the factory but most damages to the HEPA / ULPA filters comes from transportation
and installation. Filter leak testing after installing HEPA / ULPA filters is the only way to find these damages.   For
operating cleanrooms ISO 14644-2 Annex A recommends they be tested every 2 years. FDA requires all FDA regulated
facilities must be tested every year or at the interval specified in their Current Good Manufacturing Practices (cGMP).

There are two different methods for leak testing HEPA/ ULPA filters. For FDA regulated facilities a photometer is used
with an oil base aerosol to challenge the HEPA/ ULPA filter. This is an FDA requirement. For other facilities where the oil
aerosol would damage their product or process (especially the semiconductor industry) a particle counter is used with
Polystyrene Latex Spheres (PSL). One benefit of using PSL is you can challenge the HEPA/ ULPA filter at the MPPS for
the HEPA/ ULPA filter or use a specific particle size that is critical to the process.

HEPA/ ULPA filter leaks are reported in percentages of upstream concentration. A .01% leak is a significant leak and needs
to be repaired or the filter replaced. Sometimes the percentage of the leak (the size of the leak) is confused with efficiency
of the filter. Filter leak testing is not efficiency testing. Efficiency testing is only performed at the filter manufacturer under
strict conditions that cannot be reproduced in the field.

A HEPA / ULPA filter with a significant leak 0.1% and an upstream concentration of 1,000,000 particles at 0.1 µm per
cubic foot of air would leak 100 particles at 0.1 µm per cubic feet of air. If you took a 1 Sq. Ft. area directly below the leak
and the airflow from the filter was 100 feet per minute the area would be expose to 100 cubic feet of air per minute which
would mean 10,000 particles at 0.1 µm per minute or 600,000 particles per hour.  As you see even the smallest leak could
have a large impact on the process or product.
THE IMPORTANCE OF CLEANROOM FILTER MAINTENANCE

In the maintenance phase the pressure drop of the HEPA/ ULPA filters is critical.  As the pressure drop increases the
airflow of the HEPA/ ULPA filter starts to be comprised. As the airflow starts dropping off it will reach a point where it is
affecting the cleanroom cleanliness class affecting the process or product. It is recommend that the HEPA/ ULPA filter
should be change out at double the initial pressure drop or 1 inch of water gauge. One key to prolonging this change out is
the pre-filtration of the air going to the HEPA/ ULPA filters.  A schedule for the regular change out of the pre-filters should
be made. One way to determine if the pre-filters need to change is to measure the pressure drop across the pre-filters.
Manufacturers of pre-filters have a max pressure drop for when the pre-filters have to be change. Regular monitoring of the
HEPA / ULPA filters pressure drop should be considered. This testing can be included in the cleanroom certification.

Airflow Design

There are 3 different types of airflow in a cleanroom:

Unidirectional Airflow:

Unidirectional airflow is defined in ISO 14644-4 as “Controlled airflow through the entire cross-section of a clean zone with a steady
velocity and approximately parallel streamlines”. It is also specified as ≤ 14º from perpendicular when performing airflow parallelism. In
IEST RP-CC006.2 it is recommended that a unidirectional airflow cleanroom have at less 80% filter coverage.   ISO Class 1 through 5
are recommended to be unidirectional airflow designs (see ISO 14644-4 table B.2 below). Below is an example of a unidirectional airflow
cleanroom:
Non-Unidirectional Airflow:

Non-unidirectional airflow is defined in ISO 14644-4 as “Air distribution where the supply air entering the clean zone mixes with the
internal air by means of induction”.  ISO Class 6 through 9 are recommended to be non- unidirectional airflow designs (see ISO 14644-4
table B.2 below). Below is an example of a non-unidirectional airflow cleanroom:
Mixed Airflow:

Mixed airflow is defined in ISO 14644-4 as “A combination of both Unidirectional and Non-Unidirectional airflows”. Below is an example of
a mixed airflow cleanroom:
 
Airflow Testing:

There are two methods for measuring airflow depending on the type of airflow used.

Unidirectional Airflow:

The airflow velocity method is used in unidirectional airflow cleanroom. A test instrument is used to measure the speed of the air as it exits the
HEPA / ULPA filter.  There should be a uniformed airflow speed of ± 15 %. In some cases a tighter specification is called for. The speed is
measure in feet per minute or meters per second. In ISO 14644-4 Table B.2 it gives a range of the room airflow velocity for each ISO Class 1
through 3. This is the room airflow velocity not the HEPA / ULPA filter. They can be different depending on filter coverage and ceiling height.

Non-Unidirectional and Mixed Airflow:

The airflow volume method is used in non-unidirectional and mixed airflow cleanrooms. A capture hood is used to measure the volume of air
exiting the HEPA / ULPA filter. The test results are reported in cubic feet per minute or liters per second. The total airflow for the room is
divided by the room volume to calculate the room air change rate per hour.  In ISO 14644-4 Table B.2 it gives a range of air changes per hour
for each ISO Class 6 through 9.

Airflow Visualization:

There are two methods for airflow visualization measurement.

Parallelism:
Airflow parallelism is used in unidirectional airflow cleanrooms to visualize airflow. Using a plum bob and a non-shedding thread that has high
surface area to weight ratio (flow viz) to measure the angle of deflection of the airstream from perpendicular. Below is example of a parallelism
test stand.

Airflow Directional Test:

Airflow directional test is used in non-unidirectional airflow cleanrooms. This test involves using visible vapor to visualize the direction of the
airflow and the effects of process equipment to the airflow. The pharmaceutical industry uses this method for both unidirectional and non-
unidirectional airflow cleanrooms for this reason. Below is an example of an airflow directional test stand.
Cleanroom Design:

Utilizing ISO 14644-4 Table B.2 air change rates and room velocities the basic airflow design for a cleanroom can be made. Below are two
examples of cleanrooms one unidirectional and the other non-unidirectional.

Non-Unidirectional Design:

This example is an ISO class 6 cleanroom 20’ by 20’ with 10’ ceilings. The room volume is 4,000 cubic feet. The recommended air change rate
range by ISO 14644-4 for class 6 is 70 to 160 per hour. Selecting the mid range of 115 air changes per hour the total volume per hour need is
460,000 cubic feet per hour (4,000 x 115). Divide the total volume per hour by 60 will give us 7,667 cubic feet per minute. Using the specified
720 cubic feet per minute per filter we divide 7,667 by 720 we get 10.6 round it up to 11 filters. This would equate out to 1.98 changes per
minute or 118 changes per hour. This room would have a filter coverage of 22%.

Unidirectional Design:

This example is an ISO class 4 cleanroom 20’ by 20’ with 10’ ceilings. The room volume is 4,000 cubic feet. The recommended room velocity
by ISO 14644-4 for class 4 is 0.3 is 0.5 meters per second (59 to 98 feet per minute). Selecting the mid range of 75 feet per minute the total
volume need is 30,000 cubic feet per minute (4,000 x 75). Using the specified 720 cubic feet per minute per filter we divide 30,000 by 720 we
get 41.6 round it up to 42 filters. This would equate out to 75.6 feet per minute. This room would have a filter coverage of 84%.

Utilizing ISO 14644-4 Table B.2 a very basic airflow design can be made but other factors will need to consider before a final cleanroom design
is made. Some of these factors are; exhaust air, make up air, manufacturing process, type of filters to be used, etc. but by understanding the
principle of airflow design these choice should be easier.
Putting this to use:

For over twenty years, our Cleanroom Performance Solutions team has provided cleanroom testing, certification, reporting, construction and
consultation services across multiple markets, such as Semiconductor, Life Sciences,Technology and Research.

With over 30 years of experience, and the NEBB Certification, the AM Cleanroom Build and Performance Engineers and Technicians can
identify and analyze cleanroom performance problems; and suggest the most effective solutions or self-perform the corrections. Our Engineers
and Technicians are experienced in the most sensitive environments such as ISO 14644, Class 1 through Class 9, and have helped develop the
industry’s standard protocols and testing specifications, as well as some of the key instrumentation, testing media, and standard documentation in
use today.

Cleanroom Specifications:

In November, 2001, the GSA cancelled the cleanroom certification standard, Federal Standard 209E (FS) and replaced it with ISO 14644-1. In
the last 13 years, Federal Standard 209E has not been an active specification but its terminology is still around. If a customer is asked, “What is
the classification of your cleanroom?” 8 out of 10 times they will use a FS 209 E classification even if the cleanroom is being certified to ISO
14644-1.

Why after all this time is this still happening? One reason is the ISO 14644-1 cleanroom classification does not do much to identity the class. For
example, an ISO Class 6 shows 35,200 particles at 0.5 µm per cubic meter of air, whereas the Federal Standard class 1,000 (which is the
equivalent of ISO class 6) means 1,000 particles at 0.5 µm per cubic foot of air. The second reason is almost all particle counters have a one
cubic foot of air per minute sample rate. The results are reported in cubic feet per minute which means you have to think of class limits in cubic
feet which leads you back to the Federal Standard 209E classification. One cubic foot per minute sample must be multiplied by 35.315 to reach
one cubic meter. ISO 14644-1 requires all the results to be reported in cubic meters.

There are major differences between the two specifications. The first is ISO 14644-1 is based on 0.1 µm whereas Federal Standard 209E was
based on 0.5 µm thus the reason that the two specifications do not match up (see the chart below). Two cleaner classes, ISO Class 1 & 2, and one
less clean class, ISO Class 9 (room air), were added.  The ISO Class 1, 2 or 9 are rarely used.

Another major change is that ISO 14644-1 is not a standalone specification. It is one of 10 parts in the ISO 14644 series (see the list below).
There are plans to add more parts – ISO 14644-11 and 12 are in draft form right now.

 Part 1: Classification of air cleanliness

 Part 2: Specification for monitoring to prove continued compliance with ISO 14644-1
 Part 3: Test methods
 Part 4: Design, construction and start-up
 Part 5: Operations
  Part 6: Vocabulary
 Part 7: Separative devices( clean air hoods, gloveboxes, isolators, and mini-environments
 Part 8: Classification of air cleanliness by chemical concentration
 Part 9: Classification of surface cleanliness by particle concentration
 Part 10: Classification of surface cleanliness by chemical concentration

Design:

As stated in Part 1 of this series, the dividing line between pharmaceutical and semiconductor cleanrooms is ISO Class 5. The majority of
pharmaceutical cleanrooms are between ISO Class 5 and Class 8. The majority of semiconductor cleanrooms are between ISO Class 3 and Class
5. To determine the proper ISO Class the following requirements must be considered: 1) type of product and process 2) particle sizes and
quantity that is detrimental to your product 3) choose an ISO Class that fits that parameters of 1 and 2.

The next step in the cleanroom design phase is compliance to ISO 14644-1 which means meeting the requirement in ISO 14644-2. There are
different ways to stay compliant and the first step is to develop a monitoring program. ISO 14644-2 defines what cleanroom monitoring is and
what intervals are allowed.

Monitoring: Observations made by measurements in accordance with a defined method and plan to provide evidence of the performance of an
installation.

Below are listed the intervals:

 Continuous: updating that occurs constantly

  Frequent: updating that occurs at specified intervals not exceeding 60 minutes during operation
 6 Months: updating that occurs at an average interval not exceeding 183 days throughout periods of operational use, subject to no
interval exceeding 190 days
 12 Months: updating that occurs at an average interval not exceeding 366 days throughout periods of operational use, subject to no
interval exceeding 400 days
 24 Months: updating that occurs at an average interval not exceeding 731 days throughout periods of operational use, subject to no
interval exceeding 800 days

In section 4 of ISO 14664-2 as stated below in 4.2.4 and 4.2.5, if the facility is equipped with monitoring instruments the testing in Table 1 and 2
can be extended. The most efficient way to install these monitoring instruments is during construction. It can be retrofitted after construction but
will be more costly and may involve down time for the facility.

4.2.4 Where the installation is equipped with instrumentation for continuous or frequent monitoring of the

airborne particle concentration, and air pressure difference, where applicable, the maximum time interval as stated

in Table 1 may be extended, provided that the results of continuous or frequent monitoring remain within the

specified limit(s).

4.2.5 In those installations that require additional tests, and where the installation is equipped with

instrumentation for continuous or frequent monitoring of the test parameter applicable, the maximum time
interval(s) as stated in Table 2 may be extended, provided that the results of continuous or frequent monitoring

remain within the specified limit(s).

The second way to stay compliant is to have the facility certified semi-annual or yearly depending on the cleanliness classification. This may be
a more cost efficient solution depending on the size of the facility and cost of the monitoring instrumentation. Testing in Table 1 and 2 must be
performed at the stated time interval for the cleanliness classification.

Table 1- Schedule of testing to demonstrate compliance with particle concentration limits

Classification Maximum time interval Test method

≤ ISO Class 5 6 months Annex B in ISO 14644-1:1999

> ISO Class 5 12 months Annex B in ISO 14644-1:1999

NOTE: Particle count tests will normally be performed in the operational state, but may also beperformed in the at-rest
state in accordance with the designated ISO classification.

Table 2 –Schedule of additional test for all classes

 Test Parameter Maximum time interval Test Procedure

Airflow  volume a or airflow velocity 12 months ISO 14644-3:-, Clause B.4

Air pressure difference b 12 months ISO 14644-3:-, Clause B.5

NOTE: These tests may normally be performed in either the operational or at-rest state in accordance with the
designatedISO classification

a 
Airflow volume may be determined by ether velocity or volume measurement techniques.b This test will not apply to
clean zones which are not totally enclosed

Testing:

In Federal Standard 209E, the number of locations required to certify a cleanroom is based on cleanroom class and type of airflow design-
unidirectional or non-unidirectional. In ISO 14644-1, the number of locations is solely based off the size of the cleanroom in square meters. The
formula is the square root of the square meters of the cleanroom.  A 100 square meter (1076 Sq. Ft.) cleanroom would have a minimum of 10
locations. The minimum number of locations is one with 3 samples or 3 locations. The locations should be evenly distributed throughout the
cleanroom.
For the sample volume, you should sample a sufficient volume of air that a minimum of 20 particles would be detected if the particle
concentration for the largest considered particle size were at the class limit for the designated class. For an ISO Class 1 cleanroom (10 particles
@ 0.1 µm per cubic meter) the sample volume would be 2 cubic meters or 71 minutes with a 1 cubic foot per minute counter. The minimum
sampling time is one minute.

The particle counter industry has come out with some new particle counters with new features. One is the ability to normalize the count to 1
cubic meter. The counter will sample one cubic foot of air but would report the results in cubic meters which eliminates the need to multiply the
results. The other is a 50 liter per minute counter which would allow a 20 minute sample time for a cubic meter.

Putting this to use:

For over twenty years, our Cleanroom Performance Solutions team has provided cleanroom testing, certification, reporting, construction and
consultation services across multiple markets, such as Semiconductor, Life Sciences,Technology and Research.

With over 30 years of experience, and the NEBB Certification, the AM Cleanroom Build and Performance Engineers and Technicians can
identify and analyze cleanroom performance problems; and suggest the most effective solutions or self-perform the corrections. Our Engineers
and Technicians are experienced in the most sensitive environments such as ISO 14644, Class 1 through Class 9, and have helped develop the
industry’s standard protocols and testing specifications, as well as some of the key instrumentation, testing media, and standard documentation in
use today.
Room Pressure:

The main function of room pressure is to mitigate infiltration of particles from a less clean cleanroom to a cleaner cleanroom i.e. ISO Class 5 to
ISO Class 4. The cleanest area in the fab should have the highest pressure cascading out to the less clean areas. In drawing 1, the cleanest room
would be the Dry Lab ISO Class 5 then the Wet Lab ISO Class 6 and finally the Gown Room ISO Class 7 then outside of the cleanroom facility.

Drawing 1
In Fed. Std. 209B published in 1973 the minimum pressure requirement was 0.05 inches of water gauge (12 Pascal (Pa)). This requirement was
removed from the later Fed. Std. 209 standards. The 0.05” w. g. (12 Pa) requirement  was found to be on the high side due to the cascading
requirement (see drawing 1) with a 3 room cascade the pressure from the cleanest room to the exterior would be 0.15” w. g. or higher (37 Pa) .
This higher pressure causes some issues i.e. doors not closing correctly or hard to open, higher air leakage and high demands on the HVAC
system. The requirement now  was modified to 0.03” to 0.05” w. g. (7 to 12 Pa). With the lower pressure and the same 3 room cascade the
pressure from the cleanest room to the exterior would be .09’ w. g. (22 Pa) (see drawing 2). This is a reductionof the differential pressure by
0.06” w. g. (14 Pa).  ISO 14644-4 has a recommendation of 5 to 20 Pascal (0.02” to 0.08” w. g.).

Drawing 2
DESIGN

Constructing a cleanroom facility is like constructing a building inside of a building. A cleanroom needs to have a separate HVAC system,
lighting system, flooring and wall system and a differential pressure to the interior of the building.  An exterior wall of a building should not be
used as a cleanroom wall. Also there should never be a door from the cleanroom to the outside of the building. This is due to wind pressure – a
10 mile per hour wind has a wind pressure of .05 “w. g. (12.9 Pa).  A 30 mile per hour wind has a wind pressure of .47 “w. g. (116.2 Pa).  A 50
mile per hour wind has a wind pressure of 1.3” w. g. (322 Pa). Of course, the wind pressure can vary due to conditions such as temperature, air
density, and altitude.

Pressurizing a cleanroom is like keeping a balloon inflated that has a leak in it. There should be a constant airflow with constricted air return to
build the pressure. For example, the Wet Lab ISO Class 6 is 600 sq. ft. with a 10 foot ceiling equals a room volume of 6,000 cubic feet. The
recommended air change rates for ISO Class 6 is 70 to 160 changes per hour mid-range would be 115 changes per hour. To meet this air change
rate the airflow requirement is 11,700 cubic feet per minute (CFM). An air return flow rate of 450 feet per minute (FPM) through an 80% open
grill with a 30% grill deflection will create a 0.062” w. g. (15.4 Pa) pressure. Dividing 11,700 CFM by 450 FPM will equal a return area of 26
Sq. Ft. To calculate the running feet of air return divide the return area required (26 sq. ft.) by the height of the air return(1.5’) times the gill
opening (80%) equals 22 running feet ( 21.6 feet rounded up). It is recommended not to exceed 600 FPM air return flow rate as this will create
higher noise levels and vibration in the return space.

A cleanroom should be built tight with very little air leakage but there are always leakages that cannot be stopped i.e. gaps around doors, loose
fitting ceiling tiles, penetrations though walls. Also, every time a door opens in a positive room there is airflow from that room causing a loss of
air. Also, there is the air loss through the exhaust system if one is installed. To combat these air losses, makeup air is supplied to the cleanroom.
It also supplies fresh air to the cleanroom. The makeup air is filtered and usually supplied to the return side of the recirculation air handler which
feeds the filters in the cleanroom.
CONTROLS

With today’s advance control systems and pressure transducers, the monitoring and controlling of the cleanroom room pressures have been
simplified. Gone are the days of an employee walking around checking magnehelic gauges and documenting the room pressures. Today room
pressures are monitored on a computer screen with the data stored for later use with low and high pressure alarms. With makeup air handlers
(MAHU) being equipped with variable frequency drives (VFD) pressure control is also mostly automatic. The one major problem is with a lot of
traffic going in and out of the cleanroom, the MAHU may start to hunt (ramp up and down rapid). One fix is to program a delay into the VFD
and another is to have a wider range of set points.

TESTING

For this test, an Air Data Meter (Electronic Micro Manometer) is used to measure pressure across a door or pass throughs. The meter has two
ports – one positive and one negative. A testing tube is placed under the door or across the pass throughs to the other room.  Connect the testing
tube to the negative port of the meter. Take a reading – if the number is positive, the air is flowing away from you. If the number is negative, the
air is flowing to you. Take the average of the four readings and document the result. The four readings should be similar – if there is a major
difference, check for door openings or the MAHU hunting.

PUTTING THIS TO USE

For over twenty years, our Cleanroom Performance Solutions team has provided cleanroom testing, certification, reporting, cleanroom
construction and consultation services across multiple markets, such as Semiconductor, Life Sciences, Technology and Research.
With over 30 years of experience, and the NEBB Certification, the AM Cleanroom Build and Performance Engineers and Technicians can
identify and analyze cleanroom performance problems; and suggest the most effective solutions or self-perform the corrections. Our Engineers
and Technicians are experienced in the most sensitive environments such as ISO 14644, Class 1 through Class 9, and have helped develop the
industry’s standard protocols and testing specifications, as well as some of the key instrumentation, testing media, and standard documentation in
use today.
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.

By law, Federal Standard 209E can be superseded by new international standards. It is

expectedthat 209E will be used in some industries over the next five years, but that eventually it
will be replaced internationally by ISO 14644-1.

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. 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

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 14644-1 Annex 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

Today, in addition to ISO 14644-1 and ISO 14644-2, eight other cleanroom standards documents
are being prepared. Many are in the final 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 14644-8 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 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.

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.

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 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.

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 Hour Ceiling Coverage
(Federal Standard 209E) Velocity
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 – 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 – 0.508 (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, 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 ensure that pressure differentials 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, 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.