CLEAN ROOM
STANDARDS
AND
DESIGN GUIDELINES
Definition
A clean room is an enclosed space in which airborne particulates, contaminants, and
pollutants are kept within strict limits.
Specifications
Clean room specifications for particulate matter (such as dust) are defined according to
the maximum allowable particle diameter, and also according to the maximum allowable
number of particles per unit volume.
For non-particulate contaminants, the maximum allowable density in terms of microbes
per cubic meter, or molecule s per cubic meter, is specified.
Rules applicable
1. Contaminants must not be introduced into the controlled environment from outside.
2. The apparatus within the controlled environment must not generate or otherwise
give rise to contaminants (for example as a result of friction, chemical reactions, or
biological processes).
3. Contaminants must not be allowed to accumulate in the controlled environment.
4. Existing contaminants must be eliminated to the greatest extent possible, and as
rapidly as possible.
Contamination
Contamination is a process or act that causes materials or surfaces to be soiled with
contaminating substances.
Broad categories of surface contaminants
Film type and particulates
Sources of contaminants
1. Facilities
Walls, floors and ceilings
Paint and coatings
Construction material (sheet rock, saw dust etc.)
Air conditioning debris
Room air and vapors
Spills and leaks
2. People
Skin flakes and oil
Cosmetics and perfume
Spittle
Clothing debris (lint, fibers etc.)
Hair
3. Tool Generated
Friction and wear particles
Lubricants and emissions
Vibrations
Brooms, mops and dusters
4. Fluids
Particulates floating in air
Bacteria, organics and moisture
Floor finishes or coatings
Cleaning chemicals
Plasticizers (outgasses)
Deionized water
5. Product generated
Silicon chips
Quartz flakes
Cleanroom debris
Aluminum particles
Key Elements of Contamination Control
HEPA (High Efficiency Particulate Air Filter)
These filters are extremely important for maintaining contamination control. They
filter particles as small as 0.3 microns with a 99.97% minimum particle-collective
efficiency.
CLEANROOM ARCHITECTURE
Cleanrooms are designed to achieve and maintain airflow in which essentially the
entire body of air within a confined area moves with uniform velocity along parallel
flow lines. This air flow is called laminar flow. The more restriction of air flow, the
more turbulence. Turbulence can cause particle movement.
FILTRATION
In addition to the HEPA filters commonly used in cleanrooms, there are a number of
other filtration mechanisms used to remove particles from gases and liquids. These
filters are essential for providing effective contamination control.
CLEANING
Cleaning is an essential element of contamination control. Decisions need to made
about the details of cleanroom maintenance and cleaning. Applications and
procedures need to be written and agreed upon by cleanroom management and
contractors (if used). There are many problems associated with cleaning.
CLEANROOM GARMENTS
The requirements for cleanroom garments will vary from location to location. It is
important to know the local garment requirements of the cleanroom management.
Gloves, face masks and head covers are standard in nearly every cleanroom
environment. Smocks are being used more and more. Jump suits are required in very
clean environments.
HUMANS IN CLEANROOMS
There are both physical and psychological concerns when humans are present in
cleanrooms. Physical behavior like fast motion and horseplay can increase
contamination. Psychological concerns like room temperature, humidity,
claustrophobia, odors and workplace attitude are important. Below are several
ways people produce contamination:
1. Body Regenerative Processes-- Skin flakes, oils, perspiration and hair.
2. Behavior-- Rate of movement, sneezing and coughing.
3. Attitude-- Work habits and communication between workers.
People are a major source of contamination in the cleanroom.
COMMODITIES
Care is taken when selecting and using commodity items in cleanrooms. Wipers,
cleanroom paper and pencils and other supplies that service the cleanroom should be
carefully screened and selected. Review of the local cleanroom requirements for
approving and taking these items into the cleanroom are essential. In fact, many
cleanroom managers will have approval lists of these types of items.
COSMETICS
Many cosmetics contain sodium, magnesium, silicon, calcium, potassium or iron.
These chemicals can create damaging particles. Cleanroom managers may ban or
restrict cosmetics in the cleanroom. This is usually dependent upon the threat to the
product being made in the cleanroom. A recent mirror on a space telescope was
fogged up from the cologne that was present in the cleanroom.
MEASUREMENT AND INSTRUMENTATION
Some important measurements related to contamination control are particle count, air
flow & velocity, humidity, temperature and surface cleanliness. Cleanroom managers
usually have specific standards and/or instruments to measure these factors.
ELECTROSTATIC DISCHARGE (ESD)
When two surfaces rub together an electrical charge can be created. Moving air
creates a charge. People touching surfaces or walking across the floor can create a
triboelectric charge. Special care is taken to use ESD protective materials to prevent
damage from ESD. Cleaning managers should work with their personnel to
understand where these conditions may be present and how to prevent them.
CLEAN ROOM STANDARDS
Cleanrooms are classified by the cleanliness of their air.
Count of number of particles equal to and greater than 0.5 mm is measured in one
cubic foot of air is used to classify the room.
MEASURED PARTICLE SIZE
CLASS (MICROMETERS)
0.1 0.2 0.3 0.5 5.0
1 35 7.5 3 1 NA
10 350 75 30 10 NA
100 NA 750 300 100 NA
1,000 NA NA NA 1,000 7
10,000 NA NA NA 10,000 70
100,00
NA NA NA 100,000 700
0 Federal Standard
209D Class Limits
Class Name Class Limits
Fed
0.1mm 0.2mm 0.3mm 0.5mm 5mm eral
Volume Volume Volume
Volume Units Volume Units
Units Units Units
SI English (m3) (ft3) (m3) (ft3) (m3) (ft3) (m3) (ft3) (m3) (ft3)
M1 350 9.91 75.7 2.14 30.9 0.875 10.0 0.283 -- --
M
1 1 240 35.0 265 7.50 106 3.00 35.3 1.00 -- --
1.5
M2 3 500 99.1 757 21.4 309 8.75 100 2.83 -- --
M
10 12 400 350 2 650 75.0 1 060 30.0 353 10.0 -- --
2.5
M3 35 000 991 7 570 214 3 090 87.5 1 000 28.3 -- --
M 26 10
100 -- -- 750 300 3 530 100 -- --
3.5 500 600
75 2 30
M4 -- -- 875 10 000 283 -- --
700 140 900
M
1 000 -- -- -- -- -- -- 35 300 1 000 247 7.00
4.5
M5 -- -- -- -- -- -- 100 000 2 830 618 17.5
M
10 000 -- -- -- -- -- -- 353 000 10 000 2 470 70.0
5.5
1 000
M6 -- -- -- -- -- -- 28 300 6 180 175
000
M 100 3 350 100 24
-- -- -- -- -- -- 700
6.5 000 000 000 700
10 000 283 61
M7 -- -- -- -- -- -- 1 750
000 000 800
Standard 209E Airborne Particulate Cleanliness Classes
CONTROL PARAMETERS OF CLEAN ROOM
Common Requirements:
Temperature
Humidity
Special & Unique Requirements:
Air Flow Pattern
Pressurization
Particle count
Microbial Contamination
Electrostatic Discharge (ESD)
Gaseous Contamination
Process specific
Particle Sources & Control
Sources of contamination Description Control methods
External
Outdoor air Infiltration through doors, and Tighter exterior wall construction,
cracks at windows, and walls exterior zone pressurization,
vestibules at main entrances, and
seal space penetrations.
Makeup air entering through the Multiple level filtrations
air conditioning systems
Infiltration through doors, Seal wall penetrations, multiple
Indoor transfer air between windows, and wall penetrations level pressurizations &
rooms for pipes, ducts, etc. depressurizations to obtain proper
airflow directions
Internal
Largest source of internal Garments, proper gowning
People particles: skin scales, hair, procedures, air shower before entry
textile fibers
Rubbing one item against Use cleanroom suitable or rated
Work surface shedding
another furniture
Spray, painting, welding,
Process equipment Local filtration and exhaust
grinding
cleaning and sterilization before
Raw and semi-finished material During transport
entry, use airlock & pass-through
Liquids, pressurized gases used During preparation, processing Local exhaust
in process and packaging
Out-gassing to room Use cleanroom suitable or rated
Chemicals used for cleaning
cleaners
Dust generated from wall, floor, Constructed with special building
Room construction materials
ceiling, door, fibrous insulation materials
Airborne Particle Physical Controls
Filtration Dilution Isolation
Utilizing HEPA / ULPA Diluting internally Containing or isolating
filters to remove particles contaminated air with particle generations with barriers
from supply air. clean, filtered air
HEPA: 99.97% Higher air change rate, Process exhaust
(Eff @0.3 µm) better dilution. Mini environment
ULPA: 99.997%
(Eff @0.12 µm)
