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Safety Standards for Cleanrooms - September 2017
The use of cleanrooms is commonly required for manufacturers
of sensitive electronic equipment, pharmaceuticals, sterile medical devices and
in any other critical manufacturing environment where the contaminants present
in outside air could destroy the product’s functionality.
Though cleanrooms are critical parts of the manufacturing
environments in which they are used, they are surprisingly unregulated by the
U.S. government. In fact, the only federal standard that regulated cleanrooms
was canceled in 2001, though manufacturers still widely use the standard as a guideline.
It is important to keep in mind that the Food and Drug Administration (FDA)
does have Quality Systems Regulations in place that require manufacturers to
use structures that ensure their products meet provisions, and that the
business follows good manufacturing practices; however, this does not specifically
address cleanroom conditions.
The International Organization for Standardization (ISO), of
which the United States is a member, covers the classification of air purity in
cleanrooms, and specifies the requirements for testing and monitoring cleanrooms
to prove compliance. But from an employer’s perspective, it is not ISO 14644-1
and ISO 14644-2 standards that should determine how to treat your cleanroom
facility; rather, it makes the most business sense for you to treat your
cleanroom with the utmost care to ensure that the facility stays up to
What Does Clean Mean?
Individual subsets of industries set their own standards for
just how “clean” companies’ cleanrooms must be. For example, integrated circuit
manufacturers must operate in a cleanroom of no more than ISO 4, which does not
allow any particles greater than 5 micro-meters in size, or one-thousandth of a
millimeter. Depending on the type of manufacturing that is performed at your
workplace, your ISO rating can vary. Check your industry cleanroom standards to
determine the proper ISO rating.
Standards aside, a cleanroom is only useful if it is maintained
properly. Many employers are unaware of the fact that a particle 200 times
smaller than the width of a human hair can cause a major contamination disaster
in a cleanroom. Contamination will not only cost your company because of
expensive downtime while the problem is fixed, but it will also result in
increased product costs. For example, many electronic products produced in a
contaminated cleanroom will not function properly and will result in product
recall, while medical devices manufactured in a contaminated cleanroom will not
meet FDA regulations.
Building a cleanroom properly is the first step to saving money
in the long run, since it is much easier to eliminate the possibility of contamination
as the facility is being built. Removing contamination after the fact is not only
extremely difficult, but also enormously costly in both time and money. It is
important to warn your employees that contamination can come from many unexpected
sources, including the following:
- Other elements of the building or facility that
hold the cleanroom, including walls, floors, ceilings, paint, coatings and air
- Equipment and supplies, such as loose particles
from friction, vibrations, brooms, mops, items brought into the cleanroom and
- Microorganisms, like viruses, bacteria and
- People are often the largest source of contamination.
This can come from skin flakes and oil, hair, saliva, cosmetics or perfume, and
clothing debris like lint and fibers. However, it can also come simply from
peoples’ presence; a motionless person, standing or seated, generates 100,000
0.3 micron-sized particles each minute, and a person walking at a swift pace
will generate 10,000,000 particles per minute.
Ensuring that the facility meets the accurate air quality standards
starts with requiring employees to wear the proper equipment while inside the
To lower your cleanroom’s risk of contamination, take the
- Warn employees about the danger to the company in
bringing personal items—such as wallets and phones—out while in the cleanroom.
- Encourage employees to make as subtle and slow
of movements as possible while in the cleanroom.
- Check periodically for leakages in the shell