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Understanding Cleanroom Classifications in Modular Design

Cleanrooms are essential for many industries, including pharmaceuticals, biotechnology, electronics, and aerospace. These spaces are designed to maintain specific environmental conditions, such as temperature, humidity, and particulate contamination, to ensure the safety and quality of products. One of the critical aspects of cleanroom design is understanding cleanroom classifications, which determine the level of cleanliness required in a given space. This blog will explore cleanroom classifications in modular design, how they impact the construction process, and why they are crucial for industries that rely on controlled environments.


Person steralizing a modular cleanroom.

What is Cleanroom Classification?

Cleanroom classification is a standardized system that determines the level of cleanliness in a cleanroom based on the number of particles allowed in the air. The classification system, such as the ISO (International Organization for Standardization) standard or the Federal Standard 209E (which has now been replaced by ISO 14644-1), uses a scale to measure the number of particles of a specific size per cubic meter of air. The higher the cleanliness level, the fewer the particles, ensuring that the environment remains free from contaminants.


For example, an ISO Class 1 cleanroom is the most stringent classification, allowing only a few particles per cubic meter of air. This type of cleanroom is used in industries like semiconductor manufacturing, where even the smallest particle can cause defects. On the other hand, an ISO Class 9 cleanroom allows more particles and is typically used for less sensitive applications, such as certain types of laboratories.


Understanding cleanroom classifications helps companies determine the right design and systems needed to meet regulatory requirements and maintain product integrity.


Understanding Cleanroom Classification Standards

The most widely recognized cleanroom classification standards are ISO 14644-1 and the now-deprecated Federal Standard 209E. Let’s break down these standards:

  • ISO 14644-1: This is the international standard that defines cleanroom classifications. It categorizes cleanrooms from ISO Class 1 to ISO Class 9 based on the number of particles per cubic meter of air. For example:

    • ISO Class 1: 10 particles or fewer per cubic meter for particles 0.1 microns and larger.

    • ISO Class 5: 3,520 particles or fewer per cubic meter for particles 0.5 microns and larger.

  • Federal Standard 209E: Although no longer in use, this older standard categorized cleanrooms based on the number of particles per cubic foot of air, with similar classifications to ISO 14644-1.


Cleanroom classification systems like these ensure that cleanrooms meet the specific environmental requirements of the industries they serve. This includes air cleanliness, temperature, humidity, and airflow rate.


The Role of Cleanroom HVAC and Filtration Systems

HVAC (Heating, Ventilation, and Air Conditioning) systems play a vital role in maintaining cleanroom environments. Cleanrooms require precise control over temperature, humidity, and airflow to ensure a controlled environment. HVAC systems in cleanrooms are designed to filter and circulate air to maintain optimal conditions and prevent contamination.


The air filtration system is one of the key components in cleanroom design. High-efficiency particulate air (HEPA) filters or ultra-low penetration air (ULPA) filters are commonly used to remove particles from the air. These filters are rated based on their efficiency in trapping particles of different sizes. In higher-class cleanrooms, the HVAC system and filtration system must work together to maintain a constant airflow rate, minimizing the possibility of contamination.


In addition to HVAC, maintaining proper airflow patterns, such as unidirectional (laminar) flow, is crucial for keeping contaminants away from sensitive areas. Modular cleanroom designs allow for easy integration of these systems to create an environment that meets specific classification standards.


Different samples of bacteria and viruses in a cooler.

Key Considerations in Cleanroom Design

Cleanroom design is a complex process that involves a variety of factors, from layout to materials used in construction. Whether you are building a new cleanroom or upgrading an existing space, several critical elements need to be considered:

  • Space Layout: The design of the cleanroom must minimize the risk of contamination. This includes separating high-traffic areas from clean zones, controlling air pressure differentials, and ensuring proper flow patterns.

  • Material Selection: All materials used in the construction of the cleanroom must be chosen with care to avoid contamination. Non-shedding materials that are easy to clean, such as stainless steel and special plastics, are commonly used.

  • Air Filtration Systems: Cleanrooms require highly efficient filtration systems to maintain air quality. The selection of HEPA or ULPA filters depends on the classification level required for the cleanroom.

  • Cleanroom Certification: Once a cleanroom is built, it must be certified to ensure it meets the necessary standards. Cleanroom certification involves testing the air quality, verifying the HVAC system's performance, and confirming the space adheres to the required classification.


For industries requiring highly controlled environments, hiring a cleanroom contractor or cleanroom builder with experience in modular design can help streamline the construction and certification process. A cleanroom contractor will ensure that the facility is designed and constructed in accordance with the required standards, while also considering future scalability and flexibility.


Modular Cleanroom Design

Modular cleanrooms are becoming increasingly popular due to their flexibility and efficiency. Unlike traditional cleanroom construction, which can be costly and time-consuming, modular cleanrooms can be assembled quickly and often involve pre-fabricated components. These components are designed to meet cleanroom classification standards and can be easily customized to meet specific needs.


Modular cleanrooms are built using standardized components that can be easily adapted as requirements change. For instance, if the cleanroom needs to be upgraded to a higher classification level, additional filtration systems and HVAC units can be added to the existing structure. This modular approach is especially beneficial for industries like pharmaceuticals, where production needs may shift, requiring modifications to the cleanroom environment.


Cleanroom Construction and Management

The process of building and managing a cleanroom involves several stages, from design to certification and maintenance. Working with an experienced cleanroom contractor or cleanroom builder is essential for ensuring that all aspects of the project are handled efficiently and in compliance with regulations.


Construction management plays a key role in the successful implementation of a cleanroom. This involves planning, budgeting, scheduling, and overseeing the entire construction process. Whether building a cleanroom from scratch or renovating an existing space, effective construction management ensures that the project stays on track and meets the necessary standards.


Furthermore, once the cleanroom is operational, ongoing maintenance is essential to ensure that air filtration systems, HVAC, and other critical components continue to perform optimally. Regular monitoring and certification updates help maintain the cleanroom’s compliance with industry standards.


The Importance of Cleanroom Design and Classification

For businesses that rely on controlled environments, understanding cleanroom classifications is essential for designing a space that meets specific industry standards. Cleanroom certification ensures that the environment is safe, clean, and suitable for the intended applications. Modular cleanroom design offers flexibility and scalability, allowing businesses to adapt to changing needs.


Man in cleanroom checking his samples in freezer storage.

DesignTek Consulting’s Expertise in Cleanroom Design and Construction

At DesignTek Consulting, we specialize in cleanroom design and construction management, helping clients build cleanrooms that meet stringent requirements and provide optimal performance. Our team of experts works closely with clients to understand their unique needs, from the initial design phase to certification and ongoing maintenance. If you're looking to build or upgrade a cleanroom, our experienced cleanroom contractors can guide you through the entire process, ensuring that your facility complies with industry standards. Check out our services.


Contact us today to learn more about how we can help you with your cleanroom design and construction needs.

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