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Cleanrooms and Contamination Control: Ensuring Product Quality and Safety

Cleanrooms are controlled environments where the level of air contaminants is strictly regulated to minimize the risk of contamination. They are used in a variety of industries, including pharmaceuticals, semiconductors, biotechnology, and medical device manufacturing, to protect sensitive products and processes from dust, bacteria, and other particles that can cause defects or contamination. 

A cleanroom is designed to maintain a low level of particulate contamination by controlling the airflow, temperature, humidity, and the use of air filters. These controlled environments are necessary for manufacturing and researching sensitive products such as semiconductors, pharmaceuticals, medical devices, and biotechnology products. 

This level of control is achieved through the use of high-efficiency particulate air (HEPA) filters, which remove 99.97% of particles 0.3 microns or larger, and ultra-low particulate air (ULPA) filters, which remove 99.999% of particles 0.12 microns or larger. 

By maintaining a controlled environment and monitoring the levels of particulate contamination, a cleanroom ensures that the products manufactured or researched within it are of the highest quality and free from contamination.

Cleanroom Classification

Classification of cleanrooms is done according to the number and size of particles per cubic meter of air. The most common classification system is ISO 14644, which defines nine classes of cleanliness, with Class 1 being the cleanest and Class 9 the least clean. The classes are based on the maximum allowable concentration of particles in the air, with Class 1 having the lowest and Class 9 having the highest.

Class 1: This is the cleanest class of cleanroom, with less than 10 particles of size 0.1 microns or larger per cubic meter of air. These rooms are used for applications such as aerospace, semiconductor manufacturing, and biotechnology. These rooms are used for critical operations that require high levels of cleanliness, such as the production of microprocessors, disk drives, and other sensitive electronic components.

Class 2-8: These classes have increasing levels of allowable particles per cubic meter of air and are used for applications such as electronics assembly, medical device manufacturing, and pharmaceutical production. These classes are used for operations that require a lower level of cleanliness than Class 1 but still need to maintain a certain level of cleanliness.

Class 9: The least clean class of cleanroom, with no limit on the number of particles per cubic meter of air. These rooms are used for storage or non-critical operations. They are not suitable for operations that require high levels of cleanliness, but they can be used for activities such as equipment storage and maintenance.

In June 2022, the modular cleanroom expert ABN unveiled INTEGRA, the first off-the-shelf cleanroom solution capable of reaching ISO Class 4 cleanliness requirements.

Design and Construction

The design and construction of a cleanroom are crucial to controlling contamination. The room should be built with smooth, non-porous surfaces that are easy to clean, and the HVAC system should be designed to maintain a constant temperature and humidity. 

The use of HEPA filters is also important for removing particles from the air. The room should be designed to minimize the number of corners, crevices, and other areas where particles can accumulate. The construction materials used should be non-shedding, easy to clean, and should not generate particles.

Maintenance and Management

Proper maintenance and management are essential for maintaining a cleanroom’s classification. This includes regular cleaning and disinfection, monitoring for contaminants, and using appropriate garments and equipment to minimize the risk of contamination. 

It is also important to have a plan in place for dealing with potential contamination incidents. This includes regular monitoring of the air quality, temperature, and humidity and performing regular cleaning and disinfection of the room and equipment. A well-trained and educated staff is also essential for the maintenance and management of a cleanroom.

Cleanroom Garments and Equipment

Cleanroom garments and equipment are designed to minimize the risk of contamination by controlling the release of particles from the wearer. This includes using cleanroom-specific garments such as jumpsuits and face masks, as well as equipment such as gloves and boots. 

Cleanroom garments are designed to be low-linting, non-shedding, and easy to clean. Based on EMR’s research, the worldwide cleanroom technology and clothing market will reach USD 15.09 billion in 2021, owing to increased usage in different end-use sectors. The market is estimated to increase at a CAGR of 9.7% during the projected timeline of 2023-2028, aided by improved technologies.


Cleanrooms play a crucial role in protecting sensitive products and processes from contamination. By designing, building, and maintaining a cleanroom to meet the appropriate class of cleanliness, as well as using the correct garments and equipment, companies can ensure the quality and safety of their products. 

The ongoing monitoring and management of a cleanroom are essential to maintaining a controlled environment and minimizing the risk of contamination.

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