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Clean Rooms

What is a Clean Room?

A Clean Room is a room, which has High Efficiency Particulate Air (HEPA) filtration that removes particles from the air in the room. Clean room is used in every industry for manufacturing processes where a high level of cleanliness is essential. Cleanrooms are used commonly in industries like medical devices and pharmaceutical manufacturing, biotech and much more.

Cleanrooms Overview

Clean Rooms are used where small particles can adversely impact the manufacturing process and the quality and hygiene of the manufactured product. Clean rooms help in reducing the contamination caused by particles and control the environmental parameters such as temperature, humidity and pressure. The most important component of clean rooms is the HEPA filter, which assists in reducing particles that are 0.3 micron and larger in size.

Air in the enclosed room is passed through the clean room and the HEPA filters. In some cases where rigorous cleanliness is essential, the Ultra Low Particulate Air (ULPA) filters are used in the cleanrooms process.

It is of utmost importance for the personnel to undergo a training process to control the contamination in the clean room. They should always enter the clean room with a must wear special clothing, which is designed to not expose contamination that are naturally released or generated by skin and body.

Types of Clean Rooms

There are 3 types of clean rooms available in India:

  • Modular Partition

The walls of Modular Partition clean rooms are a composite construction, which is made using two skins of high pressure Stainless and Precoated Galvanized Iron framework with a sealed and insulated interior. You can get additional wall heights using a stacking technique. The walls panel of a modular clean room are properly sealed with a flush finish by the SS framework. The two skin layers of high pressure stainless & precoated galvanized iron are packed with insulation materials inside.

  • Modular Ceiling

There are 2 types of modular ceiling clean rooms – Load-bearing/Walkable Ceiling and Non Walkable Ceiling.

Load-bearing/ Walkable ceiling:

The walkable ceiling clean room comes with a benefit of incorporating flush lights, air conditioning vents and fittings and some other fittings that are required to be mounted on the ceiling. The walkable ceiling is a self supporting ceiling, which does not need any support from superstructure. Not only this, this type of modular ceiling clean room panel can take a load of 150 kgs and can incorporate all the factory made cut outs as well. You can know more about the product by contacting our customer support as well.

Non Walkable Ceiling:

The Non Walkable Ceiling Clean Room comes with an advantage of incorporating flush lights, air conditioning vents and fittings and other ceiling fittings. Just like the Walkable ceiling, the non walkable ceiling is also a self supporting ceiling, which does not need any support from superstructure and comes with all the provisions of all factory made cut outs. But, unlike the walkable ceiling, this clean room ceiling cannot take a weight load.

  • Flooring

To ensure a clean room facility, flooring is one thing to look at with utmost importance. To ensure clean room facility maintain its hygiene, you can install Epoxy flooring with or without conductive properties, vinyl flooring with or without conductivity and raised flooring.

ISO Clean Room Classifications

Clean room classifications are on the basis of how clean the air is in the enclosed area. As per the Federal Standard 209 (A to D) of the USA, the number of particles equal to and greater than 0.5 µm is measured in one cubic foot of air, and this is used as a benchmark for ISO cleanroom classification. This is also acceptable in the Federal Standard 209E version, which is used domestically. The latest version of the standard is TC 209 from the International Standards Organization and both of these standards classify clean rooms on the basis of the number of particles found in the area’s air.

Clean Room Classification is based on the number and size of particles permitted per volume of air in an enclosed area. Large numbers like “class 100” or “class 1000” refer to FED_STD-209E, which refers to the number of particles of size 0.5 µm or larger permitted per cubic foot of air.

As per Federal Standards 209E and ISO 14644-1, there is a log-log relationship between particle size and its concentration, which concludes that there is nothing as a 0 particle concentration. The ordinary room air falls under approx. Class 10,00,000 or ISO 9 clean room classification.

 

Class Maximum
Particles/m3
FED STD 209E
>=0.1 µm >=0.2 µm >=0.3 µm >=0.5 µm >=1 µm >=5 µm equivalent
ISO 1 10 2          
ISO 2 100 24 10 4      
ISO 3 1,000 237 102 35 8   Class 1
ISO 4 10,000 2,370 1,020 352 83   Class 10
ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100
ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 Class 1,000
ISO 7       352,000 83,200 2,930 Class 10,000
ISO 8       3,520,000 832,000 29,300 Class 100,000
ISO 9       35,200,000 8,320,000 293,000 Room Air

Frequently Asked Questions (FAQs)

What are Clean Rooms used for?

Clean Room is a controlled environment, which is free of pollutants or dust particles like airborne microbes, aerosol particles. These pollutants and particles are filtered out to provide a clean room and environment. Cleanrooms are majorly used for manufacturing products such as Most cleanrooms are used for manufacturing products such as medical devices, pharmaceutical products, medical equipment, biotech, electronics and much more.

What is a ISO 8 Clean Room?

ISO 8 is the least cleanroom classification after ISO 9. A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. The same Federal Standard is a class 1,00,000 or 1,00,000 particles per cubic foot.

How clean are Clean Rooms?

Very Clean: The clean room classification standards Federal Standard 209E and ISO 14644-1 measures the clean room on the basis of particle count, size and concentration. Both these cleanroom classification measures and calculates to classify the cleanliness level of a clean room.

What is not allowed in a Clean Room?

It is not allowed for any personnel to bring any personal items like watches, pens, lighters, any beauty products and other personal belongings in clean rooms. Not only this, any personnel entering into clean rooms is required to wear a special clothing and he/she must undergo a special training to control the contamination in a clean room or not cause any contamination in a clean room environment.