ALL ABOUT

CLEANROOMS

1. INTRODUCTION TO CLEANROOMS -HISTORY, CONCEPTS AND STANDARDS

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What is a cleanroom?

Cleanroom is a specially created controlled environment, to aid certain engineering processes. Widely
used in manufacturing and research of semiconductors, electronics, aerospace components,
pharmaceutical and biotech processes, cleanrooms have low level of airborne pollutants, microbes, vapors
etc. to aid certain engineering processes.

As per ISO 14644-1:2015,

“A cleanroom is a room in which the concentration of airborne particles is CONTROLLED,

and which is CONSTRUCTED and used in a manner to minimise the INTRODUCTION,
GENERATION, and RETENTION of particles inside the room and in which other relevant
parameters, e.g. temperature, humidity, and pressure, are controlled as necessary.

Cleanrooms are

Ø maintained at higher pressure compared to adjacent areas to minimise INTRODUCTION of airborne particles.
Ø built with materials that do not generate particles and the the personnel wear cleanroom clothing that controls
dispersion, thereby minimising the GENERATION of particles.
Ø supplied with large quantities of highly filtered air that removes airborne particles instantly, either by dilution
effect or piston effect. This is how RETENTION of particles is tackled.

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Why are cleanrooms required?
Cleanrooms are required

Ø Airborne particles or contaminants affect the quality of products.

Ø Cleanroom personnel, machinery, building structure, adjacent areas produce particles or contaminants.
Ø Cleanrooms continuously filter these particles out to maintain cleanliness in the production zone.

Sources of contaminants
Ø Facilities • Other particles of sneezing and • Bacteria, organics, and
• Walls, floors, and ceilings breathing moisture
• Paint and coatings Ø Tools • Floor finishes or coatings
• Construction materials • Non cleanroom materials • Cleaning chemicals
• Debris • wear and tear particles • Plasticizers (off-gasses)
• air and vapours • Machinery vibration • Deionized water
• Spills and leaks • Lubricants and emissions Ø Products
Ø Personnel • Brooms, mops, and dusters • Silicon chips
• Skin flakes, oil, and particles • Raw-material bags and • Quartz flakes
• Cosmetics and perfumes containers • Clean room debris
• Clothing debris Ø Fluids • Metal particles
• Hair & Water vapor • Particulates floating in air

Human Activity

Humans contribute to more than two-third of contamination generation in the cleanrooms

Activity Particles / min (0.3 µm & larger) Activity Particles / min (0.3 µm & larger)
Motionless 100,000 Walking (8 km/h) 10,000,000
Walking (3 km/h) 5,000,0000 Running 100,000,0000

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Usage Industries
Cleanrooms are used in many industries such as
• Pharmaceuticals • Semiconductors • R&D Facilities
• Biotechnology • Automotive • Electronic components
• Laboratories • Aerospace • Optical products
• Hospitals • Medical devices • Sterile products
• Electronics • Food & beverages • Integrated circuits

Food 7.9%

Hospitals
9.7%
Others 27.5%

Fig 1- Estimated Cleanroom

Pharmaceutical
Area Usage by Industries
19.0%
Pharmaceutical, biotech, hospitals,
Medical
semiconductors, electronic manufacturing
Devices 5.6%
facilities are the largest users of cleanrooms.

Cleanroom industry is very fast growing as

Electronics many of the companies are moving towards
11.9% Semiconduct cleaner and stringent manufacturing process to
or 12.8% provide with better quality products.

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History of Cleanrooms
Hospitals ware the first users of cleanrooms. The usage dates back to 19th century. Lord
Lister at Royal Infirmary, Glasgow, in 1860, used Carbolic Acid to kill bacteria, clean the
surgical instruments, wound and surgeons hands to contain infections.

Physicians at Aberdeen Royal Infirmary in Scotland An hospital operating room in 1890. You may notice Operating room in 1907 with the clinicians wearing
using Lister’s spray in 1889. doctors wearing gowns to minimise contamination. masks, gowns, gloves.

It is only after the World War-II that the other industries cleanroom technology. Other industries such as optics,
gyroscopes, pharma, aerospace and defence components embraced cleanrooms to aid qualitative manufacturing.

Downward ”Piston-Effect” Cleanroom at Washington Hospital, Manchester, developed by Sir John Charnley, Western Electric producing gyroscopes, 1955, in a
pioneer of hip replacement surgery led to the evolution of unidirectional (laminar) flow cleanrooms. cleanroom with vinyl flooring & HEPA Filters

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History of Cleanrooms

Invention of unidirectional or laminar flow cleanrooms

Ø Invention of Laminar flow or unidirectional flow cleanrooms was a revolution in

the entire manufacturing industry. The credit goes to Texas born Physicist Willis
J Whitefield and his team. He is also regarded as the father of modern
cleanrooms.

Ø The team working at Sandia Laboratories, Albuquerque, New Mexico, USA,

constructed a Laminar Flow cleanroom of small size of 1.8 m W x 3 m L x 2.1
m H, in the year 1961.

Ø The supply air was supplied through a bank of High Efficiency Particulate Air
(HEPA) filters

Ø The return air was sucked out through a grating floor, through which the
Mr. Whitefield in the cleanroom he invented. contaminants generated swept away

Ø The concept of unidirectional flow cleanroom ventilation was very quickly

adopted by a large variety of industries, as high quality cleanrooms were
urgently required.

Ø HEPA filters (also called Absolute Filters then) removed 99.95% of 0.3 micron
particles

Ø The room was positively pressurised to eliminate the chances of contaminants

from the adjacent rooms.

Cross-section of the original unidirectional airflow room.

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Types of Cleanrooms
The cleanrooms are classified based on the method employed for ventilating the room. There are
three types of cleanrooms, Unidirectional, Non-Unidirectional & Mixed Airflow Cleanrooms

1. Unidirectional Cleanrooms
• Unidirectional are also called as Laminar Airflow Cleanrooms.
• These cleanrooms use more air volume and provide superior cleanliness
• HEPA or ULPA filters are installed in the ceiling or wall that allow the air to
pass through the cross-section of the room, either vertically or horizontally.
• In a vertical down flow, the entire room is bathed in a uniform shower of
downward-flowing ultra clean air. The contamination generated in the space
is swept down and out through the floor. (Piston Effect)
• The air flows linearly at a velocity of 0.4-0.5 M/Sec (~90 Ft/min)
• Return air is extracted either through the grated / raised floor or through
return air risers located close to the floor.
Vertical unidirectional (laminar) airflow clean room.

• ISO Class 5 or cleaner areas have unidirectional flow, with air changes per
hour (ACPH) of at least 240.
• In a horizontal flow, air enters from one wall and returns on the opposite.
• The ceiling shall be complete with HEPA/ULPA Filters (70-100%)
• Horizontal UD cleanrooms have some limitations such as any obstruction
in the room blocks the complete flow, the air becomes contaminated after
leaving the first work station leaving dirty air to workstations behind,
movement of personnel also degrades the flow.
• Unidirectional flow cleanrooms find application in semiconductors,
aerospace components, precision electronics etc. Horizontal unidirectional (laminar) airflow clean room.

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Types of Cleanrooms
2. Non-unidirectional Cleanrooms
• Non-Unidirectional are also called as Turbulently Ventilated Cleanrooms.
• These cleanrooms use less air volume compared to laminar flow.
• The clean air shall be pumped into the room through ceiling mounted or
plenum mounted HEPA filters, that dilute the contaminated air, thereby by
improving the cleanliness by reducing the particle count.
• The return air shall be extracted through return air risers at the bottom or
ceiling mounted grills/ diffusers.
• ISO Class 6 or less cleaner areas have non-unidirectional flow, with air
changes per hour (ACPH) in the range of 20-120.
• These cleanrooms find application in pharmaceuticals, biotechnology, R&D
Labs, food & beverages etc.

Non-unidirectional airflow clean room.

3. Mixed Flow Cleanrooms

• Mixed flow cleanrooms have a combination of Unidirectional & Non-
unidirectional flow patterns, based on the special requirements.
• Most of the cleanroom shall be non-unidirectional with localised laminar
airflow stations.
• For e.g. in a pharma dispensing booth, entire room shall be a non-
unidirectional cleanroom (ISO Class 7 or 8), but the dispensing booth shall
be ISO Class 5. in these cases, it is not viable to make the entire room
ISO-5 classified.
• These cleanrooms find application in pharmaceuticals, biotechnology, R&D
Labs etc.
Mixed airflow clean room.

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Cleanroom Classification Standards
Brief history of cleanroom classification

Ø Technical Order (T.O.) 00-25-203 by U.S. Airforce, in 1961 is the first of cleanroom standards.
Ø It covered cleanroom design concepts, permissible particle count and operating procedures such as
entry, exit, clothing, men and material movement etc.
Ø However, Federal Standard 209 is considered to be the most widely accepted and used cleanroom
standard across the world for decades. This was a benchmark for decades.
Ø The particle concentration was supposed to be measured at equal to and grater than 0.5 μm, as this
was the range of sizes that was easily measurable by particle counters.
Ø At the end of 20th century, ISO-14644 standard superseded all other cleanroom standards existed till
then.
Ø ISO 146444 and Fed 209 also served as a reference to industry-specific standards such as GMPs in
pharma.
Ø Many countries have come up with their own cleanroom standards.
Ø Cleanrooms are mainly classified according to number and size of particles permitted per unit volume of
air (Particles / cubic meter or particles/ cubic feet).
Ø 0.1 μm, 0.2 μm, 0.3 μm, 0.5 μm, 1.0 μm and 5.0 μm are the commonly used particles sizes for defining
the airborne particle concentration limits.

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Cleanroom Classification Standards
Timeline Of Cleanroom Standards

1960 1970 1980 1990 2000-10

U.S. Air Force TO 00-25-203 Fed 209 B Fed 209 C Fed 209 E

US-MIL-STD-1246 Germany VDI 2083:3 Fed 209 D ISO 14644-1 ISO 14644-2

Fed 209 Australia AS 1386 RUSSIA GOST R 50766 To

Fed 209A Britain BS 5295 ISO 14644-14

Japan JIS B 9920

France AFNOR X44101

Comparison of international cleanroom standards

ISO FED 209 D FED 209 E BS 5295 AS 1386 AFNOR VDI 2083 JIS B EU GMP
14644 (1988) (1992) (1989) (1989) X44101(1989) (1990) 9920 (1990) (2010)

Class-1 - - - - - - 1 -
Class-2 - - - - - 0 2 -
Class-3 1 M 1.5 C 0.035 - 1 3 -
Class-4 10 M 2.5 D 0.35 - 2 4 -
Class-5 100 M 3.5 E/F 3.5 4000 3 5 A/B
Class-6 1 000 M 4.5 G/H 35 - 4 6 -
Class-7 10 000 M 5.5 J 350 400 000 5 7 C
Class-8 100 000 M 6.5 K 3500 4 000 000 6 - D
Class-9 - - - - - - - -

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Cleanroom Classification Standards
History of Federal 209 Standard

1963 1966 1976 1987 1988 1992

Fed 209 Fed 209 A Fed 209 B Fed 209 C Fed 209 D Fed 209 E

*Federal Standard 209 was cancelled in 2001

Airborne Particulate Cleanliness Classes As Per FED 209E

Class Name Class Limits (particles per ft3) with sizes equal to and larger than the particle sizes
SI English 0.1 μm 0.2 μm 0.3 μm 0.5 μm 5.0 μm
M1 9.91 2.14 0.875 0.283 -
M 1.5 1 35 7.5 3 1 -
M2 99.1 21.4 8.75 2.83 -
M 2.5 10 350 75 30 10 -
M3 991 214 87.5 28.3 -
M 3.5 100 - 750 300 100 -
M4 - 2,140 875 283 -
M 4.5 1 000 - - - 1,000 7
M5 - - - 2,830 17.5
M 5.5 10 000 - - - 10,000 70
M6 - - - 28,300 175
M 6.5 100 000 - - - 1,00,000 700
M7 - - - 2,83,000 1,750

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Cleanroom Classification Standards
International Standard ISO 14644

§ ISO 14644 and parts are the most widely used cleanroom standards across the world. Federal standard is
also still used alongside ISO 14644 in some parts of the world and still acceptable to use Fed 209E.
§ ISO 14644 (Cleanrooms and associated controlled environments) and its parts from 1 through 16 cover all
aspects of cleanrooms right from air cleanliness classifications, testing, construction and designing of
cleanrooms, cleanroom operations, separative devices, energy efficiency, nanoscale and chemical particle
concentration etc.
Parts of ISO 14644 Standard
Part Description Part Description

ISO 14644-1 Classification of air cleanliness ISO 14644-11 -

ISO 14644-2 Specifications for testing and monitoring Specifications for monitoring air cleanliness by
ISO 14644-12
nanoscale particle concentration
ISO 14644-3 Test Methods
ISO 14644-4 Design, construction and start-up Cleaning of surfaces to achieve defined levels
ISO 14644-13 of cleanliness in terms of particle and chemical
ISO 14644-5 Operations classifications
ISO 14644-6 Vocabulary Assessment of suitability for use of equipment
ISO 14644-14
Separative devices (clean air hoods, by airborne particle concentration
ISO 14644-7
gloveboxes, isolators and minienvironments) Assessment of suitability for use of equipment
Classification of airborne molecular ISO 14644-15 and materials by airborne chemical
ISO 14644-8 concentration
contamination
Classification of surface cleanliness by particle Energy efficiency in cleanrooms and
ISO 14644-9 ISO 14644-16
concentration separative devices

Classification of surface cleanliness by Particle deposition rate applications (under

ISO 14644-10 ISO 14644-17
chemical concentration development as on 1st Apr, 2019)

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References

§ International Standard ISO 14644-1:2015(E), Cleanrooms and associated controlled environments Part 1:
Classification of air cleanliness by particle concentration, ©ISO 2015.
§ Cleanroom Technology: Fundamentals of Design, Testing and Operation by W. Whyte © 2001, published by
John Wiley & Sons Ltd.
§ ASHRAE Design Guide for Cleanrooms: Fundamentals, Systems, and Performance, © 2017

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