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

Indoor transfer air between
rooms
Internal
People
Work surface shedding
Process equipment
Raw and semi-finished material
Liquids, pressurized gases used
in process
Chemicals used for cleaning
Room construction materials
Airborne Particle Physical Controls
Filtration
Utilizing HEPA / ULPA
filters to remove particles
from supply air.
Makeup air entering through the
air conditioning systems
Infiltration through doors,
windows, and wall penetrations
for pipes, ducts, etc.
Largest source of internal
particles: skin scales, hair,
textile fibers
Rubbing one item against
another
Spray, painting, welding,
grinding
During transport
During preparation, processing
and packaging
Out-gassing to room
Dust generated from wall, floor,
ceiling, door, fibrous insulation
Dilution
Diluting internally
contaminated air with
clean, filtered air
seal space penetrations.
Multiple level filtrations
Seal wall penetrations, multiple
level pressurizations &
depressurizations to obtain proper
airflow directions
Garments, proper gowning
procedures, air shower before entry
Use cleanroom suitable or rated
furniture
Local filtration and exhaust
cleaning and sterilization before
entry, use airlock & pass-through
Local exhaust
Use cleanroom suitable or rated
cleaners
Constructed with special building
materials
Isolation
Containing or isolating
particle generations with barriers
HEPA: 99.97% Higher air change rate, Process exhaust

(Eff @0.3 µm) better dilution. Mini environment

ULPA: 99.997%

(Eff @0.12 µm)