What to Know

When Considering
a Cleanroom
by Simplex Technical Staff
What to Know When Considering a Cleanroom
by Simplex Technical Staff
Does your business plan include the development of an area in your plant for clean
manufacturing? Are you concerned that you make the right purchase? Do you want to
make sure you consider the right factors when you evaluate different models?
There are numerous considerations when evaluating a cleanroom. The goal of this
white paper is to touch on the basics. You may very well need to employ the services of a
cleanroom consultant to help you. Here are a few things to keep in mind as you start to
consider cleanrooms and controlled environments.

1. What’s the application? Better quality or better yield is the primary reason for
investing in a cleanroom space. It goes straight to your bottom line.
Numerous manufacturing procedures now require a controlled environment in which
you limit the amount of dust and dirt in the area of the manufacturing. Medical
instrument manufacturing and packaging, electronics and computer manufacturing, food
preparation and some military applications are but a few of the instances that have strict
requirements for maintaining a clean environment. You need to know the requirement for
your specific product or process. If the product you are manufacturing is regulated by a
government agency, or you are contracting with a private firm that requires a certain
level of clean manufacturing, they should have the cleanroom standards already
documented. Check with them first.
There are different levels of cleanrooms. ISO—the International Standards
Organization, ranks cleanrooms ISO Class 1 (the cleanest) through ISO Class 9. The lower
the ISO rating, the cleaner the environment. Measurement of contamination is done in
“parts-per-cubic-meter.” An ISO Class 6 cleanroom, for example, is rated at 35,200 parts
per cubic meter. That means the room can have no more than 35,200 particles greater
than .5 micron in size per cubic meter. These are particles that are not visible to the
human eye. (As a comparison, a particle of cigarette smoke is between .5 and 2 micron
in size. The end of a piece of human hair is about 60 to 100 microns in size).
Particle counts are performed at the work surface height. The pre-filters remove the
dirt and dust you can see (call them baseballs and boulders). HEPA filters capture the
particles you can’t see with a human eye. A light manufacturing area (defined as an
environment that is not generating smoke or oil mist, such as storm window assembly
and packaging) with pre-filtration on a HVAC system might be equivalent to an ISO Class
8 room, with 3,520,000 parts per cubic meter that measure greater than .5 micron. This
is comparable to room air.
Again, know what the manufacturing requirements are.

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2. Know the basic principles behind how a cleanroom works. The majority
of cleanrooms, easily more than 90%, are positive-pressure rooms—designed to keep
contaminants from entering the room. Air is introduced into the cleanroom, typically at
the ceiling level, after passing through a fan-powered HEPA filter that removes particles
as small as .5 microns. This creates a pressurized room in which the air pressure in the
room is greater than outside the room—hence, positive pressure. The air, and the
contaminants in the air, are then pushed down towards the floors, and ultimately pushed
out vents in the lower portions of the walls of the room.
This means that air and contaminants from
the processes in the room are constantly
flowing out of the room. In addition, the air
exiting the room, either through vents or when
doors are opened, is at a pressure sufficient
enough to prevent contaminants from entering
via those openings.
Negative-pressure rooms are designed to
keep contaminants from leaving the room. A
negative pressure room is used in instances of
infectious diseases and pathogens, bio-
The concept behind a cleanroom is to push air into contaminants and some hazardous processes
the room from the top, down into the room, and
then out vents at floor level, carrying with it any using chemicals, flammables and potentially
contaminants from the manufacturing process.
Note that these technicians are fully gowned. explosive liquids and powders. Your concern is
not what gets into the room, but what gets out.
In a negative pressure room, air is pulled out of the enclosure through reversed HEPA
filters, creating a negative pressure inside the room (which prevents contaminants from
leaving the room), while air is constantly being drawn in through venting and other
openings. The force of the air entering the room prevents contaminants from escaping.
Because they are so prevalent, for purposes of this white paper we will be discussing
positive-pressure rooms.

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3. ISO standards are the industry norm for rating cleanrooms. ISO
standards were adopted by the industry in 2001. If you do any serious research into ISO
standards, you are likely to come across the Federal Standard 209E for cleanrooms,
which was the industry norm until ISO standards were developed. The federal standards
were officially cancelled by the US Department of Commerce in November 2001, but they
are still widely referenced.
“ISO classifications expanded the horizon for classifying clean space,” according to
Richard Matthews of Filtration Technology, Inc., in Greensboro, NC, who chaired the ISO
board that developed these standards. Here are the Federal standards and their ISO
equivalents. Note that ISO created three new levels that the Federal standard did not
address.
ISO Class 9 = No comparable Federal standard
ISO Class 8 = Federal standard Class 100,000
ISO Class 7= Federal standard Class 10,000
ISO Class 6 = Federal standard Class 1,000
ISO Class 5 = Federal standard Class 100
ISO Class 4 = Federal standard Class 10
ISO Class 3 = Federal Standard Class 1
ISO Class 2 = No comparable Federal standard
ISO Class 1 = No comparable Federal standard
Whenever possible, refer to the ISO standards because they are internationally
accepted. If you are dealing with partners in other countries, this will make issues much
simpler.

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4. It’s all about air changes per hour, sometimes. With some exceptions, a
cleanroom is a cleanroom is a cleanroom. Achieving a cleaner class of cleanroom is all
about airflow. It’s a matter of bringing clean air in through HEPA filters in the ceiling and
moving contaminated air out through vents in the walls or floors. The greater the number
of HEPA filters and vents, the greater the rate of air change. You can see from this chart
what the requirements are:
Class Average Airflow Velocity Air changes/hour Recommended
ISO Class 8 not applicable 10-20 20 to 40
ISO Class 7 not applicable 30-70 50 to 80
ISO Class 6 not applicable 70-160 100 to 180
ISO Class 5 .2-.5 m/sec (40-90 ft./min) not applicable 300-400
ISO Class 4 .3-.5 m/sec (60-90 ft./min) not applicable
ISO Class 9 through ISO Class 6 rooms are determined based on air changes per hour.
ISO Class 5 through ISO Class 1 rooms are based on the flow of air through the room in
meters per second. How are you getting the air into the space and how are you pushng it
out? It’s easy to clean the air. The more difficult question is: Are you moving the air out of
the area properly? Where does air enter the clean space and how conveniently is it moved
out, carrying with it the contaminants from the manufacturing process? Placement of
work tables, chairs and equipment becomes more crucial. An item incorrectly placed
creates “dead space” where particles are trapped.
These environments are prevalent in micro-electronics and will play a big part in
nanotechnology as we get more involved in that industry. At these levels it is very
important that you consult with a knowledgeable expert.

5. Every cleanroom has three different states or conditions. Cleanrooms

are measured for particulate count at three different levels: As Built, At Rest and
Operational. As Built refers to the cleanroom as it is when it is built, empty of any
equipment, materials or workers. Cleanrooms are typically certified by the manufacturer
as to their level of cleanliness at the As Built level. At Rest refers to the cleanroom once
equipment, machinery, furniture and product have been moved in, before the workers. All
these elements bring with them sources of contamination, so you can expect a change in
particulate count. Finally, there is the Operational level. This refers to the cleanroom
when all the equipment and materials are moved in and there are workers in there

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 performing tasks. Again, you are
likely to see a change in
particulate count. Machinery
that performs an excellent
function outside of a cleanroom
can be a source of pollution
inside a cleanroom. Metal
shavings, gases and oil mist
from pneumatic machinery and
This enclosure is in As Built state, before equipment and materials vapors from outgassing plastics
are moved in. Notice that it is within an existing room and takes
advantage of the air conditioning infrastructure that is already are all sources of contamination.
installed. Cleanrooms are certified by the manufacturer in an As Any process that involves
Built state.
friction or movement is going to
cause particulation. In order to prevent a drastic increase in contamination at the
operational level it is important to adhere to proper protocol and procedures—things like
gowning, house cleaning and workflow. If your process must involve machinery, then it
may be necessary to further isolate that machine within the cleanroom in order to
prevent it from contaminating the rest of the operation. A common solution is to build a
cleanroom within the cleanroom using either partitions, or more commonly curtains, to
isolate the machine. It may also be necessary to vent that area separately from the rest
of the room.
This change in particulate count from As Built, At Rest and Operational levels is another
reason that you need to involve a cleanroom expert early on in the process.

6. Modularity. Things
change. You can count on that.
A cleanroom with a modular
design allows the original
layout to be expanded without
having to rebuild from scratch.
Your need for clean
Modular cleanrooms as large as 5,000 square feet, and even larger, are manufacturing space will
often required for assembly lines, packaging operations and other
environments. increase or expansion will
dictate that you move to larger
facilities. Modularity in a cleanroom is important. With a modular design you can, with
ease, expand the size of your cleanroom as your needs increase, without having to toss
out part or all of your original cleanroom investment. And in the event you move to a new
facility, you can disassemble your modular cleanroom and take it with you.

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 There are also cleanroom
designs that incorporate
casters so that the enclosure
can be easily moved around
your factory floor. An example
where this might be applicable
is an injection mold facility
where the manufacturing area
is ISO Class 9, but production
This modular enclosure can be moved throughout a factory to contain has an order for an I.V.
specific processes that require a higher degree of protection against component that requires an ISO
contamination. Cleanrooms and enclosures should be in place and
the HEPA filters operating for 24 hours to insure proper levels. Class 7 environment (an I.V.
system has to be manufactured
in at least an ISO Class 7 cleanroom). You can create this environment on the factory
floor by enclosing the injection-mold machine in a portable cleanroom outfitted with
casters and a HEPA unit installed in the ceiling grid. Simply roll the enclosure to the
appropriate machine and attach softwall curtains to contain it.
Another advantage to a modular cleanroom is in its tax benefits. A modular cleanroom
can be written off in seven years. An existing room within your facility that is transformed
into a cleanroom—referred to as “stick-built”—has to be written off over a much longer
period of time.

7. Envision future plans. Don’t make the mistake of trying to get along with a
minimum of cleanroom space. You will be surprised at the speed your cleanroom needs
increase. Better to plan for too much space than not enough.

8. Don’t underestimate air conditioning needs. You might start with three
workers in your cleanroom, and then find you need to increase to five or six. All that extra
body heat, as well as any heat-producing machinery in your clean area, and that
cleanroom quickly starts getting hot and uncomfortable. Also take into consideration that
basic cleanroom clothing includes a hair covering, booties and a smock. Anything cleaner
than Class 7 requires additional safeguards—masks, beard covers, goggles, etc. It is
better to err on the side of too much when planning for air conditioning.
This is where you get into the difference between single-pass and recirculating rooms.
A single-pass room is a simple design in which air is pumped into the room from the top
and blown out vents at the bottom. If you have to air condition your cleanroom, then you
don’t want to just blow that expensive air-conditioned air through the cleanroom and out
into a warehouse or other environment where it does little good. A recirculating design

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uses a double-ceiling system (the space between the ceilings is called a plenum) or a
double wall (the space in the walls is called an air chase), or a combination of these two.
Cooled, clean air is introduced through the HEPA filters and then flows out of the room,
carrying with it any contaminants, into either the air chase or the ceiling plenum, where it
is reintroduced into the room
after once again passing through
the HEPA filters.
When you plan and budget for
your cleanroom, consider that
installation of a recirculating
system for that enclosure is
going to be at least 50% of the
installation costs. If it is possible
Rather than ceiling plenums and air chases in the walls, this room
uses an elaborate system of ducting to recirculate air leaving the to place the cleanroom in an
room, and bringing it back in through the ceiling to pass through the area where air conditioning is
HEPA filters before re-entering the room. The gowning area on the
right end of the room provides technicians a place to gown before already in place that will be a
entering the main cleanroom, reducing the risk of contamination. huge money-saver.

9. Not considering all that is needed. It pays to bring in an expert early in the
planning process. They can help you troubleshoot airflow problems, the types of testing
procedures you must employ, and how to develop cleanroom protocols. A knowledgeable
professional will point out things you will not even consider.

10. Think about process

flow. Give some thought to the
workflow in your cleanroom. You
want materials to come in one end
and exit the other, and in the
meantime, completing all the
necessary assembly and
packaging that is needed. The goal
is not only to improve productivity
and yield but to maintain or
improve the speed of the
A well-organized cleanroom includes attention to process flow.
manufacturing process. Again, this
Make sure furniture and equipment do not hinder air flow. is an area where you should
Materials should come in one end and go out the other.
employ a consultant.

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11. The need for interior isolation. Every cleanroom ISO Class 7 or cleaner should
have an anteroom for gowning, set off from the larger cleanroom with softwall curtains at
least. This keeps street dirt from getting into the clean area. Interior isolation is also
important in food processing and pharmaceuticals to prevent cross-contamination. A
recent Simplex project called for dividers for a vitamin processing operation. If vitamin
B12 meanders into the Vitamin C work area, that’s cross-contamination—a huge
problem. Cross contamination can mean manufacturing shutdowns and product recalls
and lost profits.

12. Clearance issues. People are often eager to use as much of their space as
possible. It is a good idea to give yourself some extra room overhead between the
outside ceiling of your cleanroom and the ceiling of your building—Simplex recommends
three feet—to allow you to change out the pre-filters, HEPA’s and ULPA's without a big
hassle. The other issue to consider is that without enough clearance, a minimum of six
inches, you run the risk of starving your filters for air.

13. More need for clearance. Regarding installation of the room itself, three feet is
important all the way around the side walls. It will make the installation easier, as you will
have more room to work with. The common space solution is to place the cleanroom
against the walls and this is often done. This is great for maximizing the footprint but will
make the install more difficult.

14. Look for a cleanroom with extensive plans and instructions. The
performance of your cleanroom hinges a great deal on the quality of the assembly. Look
for a company that supplies the approval drawings with layout and elevations, and also
shows the HEPA and lighting layout. Look for a manufacturer that supplies installation
drawings with every panel marked with a letter or number that corresponds to the panel
or part on the drawing. For large cleanrooms and critical applications you might need to
consider a specialty contractor knowledgeable in cleanroom construction.

15. Know the difference between a cleanroom and a clean zone and be
clear in what you need. Cleanrooms are areas in which the particulate count is
measured and controlled. There is a requirement for a specific level of clean. A clean
zone is an area within an existing cleanroom that is even cleaner, much like the injection
mold operation cited in #4.

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There are also areas that a manufacturer may want to isolate, but not have to maintain at
a certain ISO level. A recent project Simplex completed involved a manufacturing and
warehousing facility where inventory was stored adjacent to the manufacturing area.
Dust from the manufacturing process was drifting into the storage area. Although the
product was not required to be clean when it was shipped, the manufacturer wanted it to
be free from excessive dust—for aesthetic reasons. The goal in this case was isolation,
not making the environment clean in the sense of a cleanroom. Simplex installed 300
running feet of industrial opaque vinyl curtain and two industrial strip doors that created
a clean zone where product could be stored. Inventory could be shipped without the need
for a second cleaning.

16. Establish cleanroom operating procedures and have them

documented. Make sure your employees read them, are familiar with them, and
follow them—always. The single biggest source of contamination in a clean area is—you
guessed it—the worker in that area. If your cleanroom requirements call for gowning and
booties, then no employee should ever enter that space without them. To do otherwise
contaminates your workplace and sacrifices the integrity of your manufacturing process.

NOTE: Maintaining clean environments can be a complicated and critical task. The
information provided here is meant to give the reader a basic understanding of the issues
involving the selection of a cleanroom. Simplex recommends that you always consult and
work with a cleanroom professional when implementing any sort of isolation procedures
in your workplace, laboratory or hospital, thus ensuring that you maintain the highest
standards.

Simplex Isolation Systems wishes to thank Richard Matthews of Filtration Technology, Inc.,
in Greensboro, NC, for his input on this white paper.

Founded in 1979, Simplex Isolation Systems designs and manufactures custom

cleanrooms that are modular and expandable, as well as a number of products for
use in process isolation and contamination control. Simplex products are distributed
in the U.S and Canada through a nationwide dealer network. To learn more about the
complete line of isolation systems and safety products and solutions from Simplex, call
1-800-854-7951, or visit the Simplex website at www.SimplexIsolationSystems.com.

14500 Miller Ave. • Fontana, CA 92336

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