Designing and Building a Cleanroom: Understanding the Fundamentals of Cleanroom Construction

Cleanrooms are specialized environments designed and built to minimize the presence of contaminants in the air, such as dust, bacteria, and other particles. These facilities are used in several industries, including pharmaceuticals, semiconductors, and biotechnology, where the controlled environment is a critical factor in the production process.

Designing and building a cleanroom requires a thorough understanding of the fundamentals of cleanroom construction. It includes the materials and equipment, the layout and flow of the space, and the requirements for maintaining a clean environment.

This article will provide an overview of the key considerations for designing and building a cleanroom, focusing on the principles and best practices for achieving a high level of cleanliness.


Cleanrooms are classified according to the number and size of particles permitted per cubic meter of air. The most commonly used classification system is the one developed by the Federal Standard 209E, which defines cleanrooms based on the number of particles 0.5 microns or larger per cubic meter of air. 

These classifications range from Class 1 to Class 9, with Class 1 being the cleanest and Class 9 being the least clean.

While Class 9 cleanrooms have up to 352 million particles per cubic meter of air, according to News Medical Life Sciences, Class 1 cleanrooms must have no particles of 0.5 microns or larger µg/m3.

It’s important to note that the classification system is not fixed, and several other systems and standards are used worldwide, such as ISO 14644-1. The standard used in a particular industry or for a specific application will depend on the requirements of the product or process being performed.

In addition to the particle count, other factors considered in cleanroom classification include temperature, humidity, and airflow. Proper control of these factors is essential to maintaining the desired level of cleanliness in the cleanroom smihub.

Principles of Cleanroom Construction

By following these principles of cleanroom construction, designers and builders can ensure that the cleanroom effectively controls contaminants and maintains a high level of cleanliness. Additionally, these principles are widely used in different standards and guidelines, so following them will help to comply with the specific standards.

The principles of cleanroom construction revolve around controlling contaminants in the air and reducing particles and other contaminants on surfaces. Several major principles are essential to the design and construction of a cleanroom:

  • Airflow: One of the most crucial principles of cleanroom construction is controlling airflow.
  • Particle control: Cleanrooms are designed to minimize the presence of particles in the air, and this is achieved through the use of HEPA filters and other air purification systems.
  • Surface control: Contaminants can also be found on surfaces, so using materials that are easy to clean and free of particles is necessary.
  • Personnel control: People and their clothing can contaminate the cleanroom. It’s necessary to control the movement of people and have strict clothing rules and personal hygiene.

The principles of cleanroom construction are essential to creating an environment that is free from contaminants and capable of maintaining a consistent level of cleanliness. One company that has a reputation for utilizing these principles in their cleanroom designs is American Cleanroom Systems.

They specialize in cleanroom construction, designing, building, and maintaining cleanrooms that meet various industries’ specific requirements, including pharmaceuticals, semiconductors, and biotechnology.

Pressure and Airflow

Cleanrooms are designed to maintain a lower air pressure inside the room than in the surrounding area. It is known as negative air pressure and helps to prevent contaminants from entering the room from the outside.

Proper airflow within the cleanroom is also necessary, as it helps minimize the movement of particles and maintains a clean environment. One of the most common airflow systems used in cleanrooms is laminar airflow. A smooth, unidirectional flow of air characterizes it. 

Laminar airflow systems are typically used in areas where a high degree of control over the air is required, such as in the production of semiconductors or pharmaceuticals.

Another crucial aspect of airflow in cleanrooms is the usage of HEPA filters, which remove particles larger than 0.3 microns from the air. According to MedlinePlus, a HEPA filter can filter maximum harmful particles, like dust, mold spores, pet dander, dust mites, and other irritating allergens. 

These filters are installed in the air-handling systems of cleanrooms, and they help to maintain a high level of air purity.


Cleanliness is a prime factor in cleanroom construction, as it is essential for maintaining a controlled environment free from contaminants. The level of cleanliness required in a cleanroom will depend on the specific industry or application. However, in general, cleanrooms are designed to minimize the presence of particles, bacteria, and other microorganisms.

One of the primary methods for maintaining cleanliness in a cleanroom is through specialized cleaning and disinfection protocols. These protocols involve specialized cleaning agents and equipment and procedures like wet and dry cleaning to remove dust and other particles from surfaces.

Another important aspect of cleanroom cleanliness is personal protective equipment (PPE), such as gowns, gloves, and face masks. These garments help minimize the introduction of contaminants into the cleanroom by the personnel working inside.

Materials and Equipment

The selection of materials and equipment is an essential aspect of cleanroom construction, as it plays a critical role in maintaining a clean environment. It’s crucial to choose the materials in cleanroom construction for their ability to resist the accumulation of dust and other particles and for their ease of cleaning and decontamination.

One of the most commonly used materials in cleanroom construction is stainless steel, known for its durability and resistance to corrosion. Steel is widely used in industrial production and for other purposes. According to Statista, about 1.95 billion metric tons of crude steel were produced worldwide in 2021.

Other materials commonly used in cleanrooms include fiber reinforced plastic, PVC, polypropylene, and PVC-coated fabrics. These materials are chosen for their non-outgassing and non-particulating properties, which help minimize the presence of particles in the air.

Project Management and Approvals

The project management process typically begins with a project plan. It includes a detailed scope of work, a schedule, and a budget. The project plan is then used to guide the construction process and ensure that all stakeholders know the project’s objectives and timelines.

One of the aspects of project management for cleanroom construction is the need for compliance with relevant regulations and standards. It includes compliance with local building codes and safety regulations and with industry-specific standards such as ISO 14644.

You must get the approvals for the cleanroom design and construction from the relevant authorities before using the cleanroom. It includes review and approval by building code officials, fire marshals, and other regulatory bodies. 

In addition, it’s necessary to have a professional engineering firm or consultant to ensure that the design and construction of the cleanroom comply with the relevant regulations and standards.

A Thorough Understanding of the Fundamentals Help Get a Desired Output

Designing and building a cleanroom requires a comprehensive understanding of the basic of cleanroom construction. From selecting the appropriate materials and equipment to understanding the principles of cleanliness, cleanroom construction is a complex process that requires careful planning and execution.

By following the guidelines and standards networthexposed of the specific industry, cleanrooms can be designed and built to provide a controlled environment suitable for sensitive manufacturing processes. The result is a safe, reliable, and high-quality space for the production of high-value products.

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