What Are Cleanroom Classifications?

In industries with high cleanliness requirements such as pharmaceuticals, biomedicine, electronic semiconductors, food processing, and aerospace, Cleanroom is the core environment to ensure product quality and safety. When building and managing Cleanrooms, it is particularly important to determine it‘s cleanliness level, which is what we often call Cleanroom Classifications.

In this article, Amber will take you to learn in detail about the Cleanroom classification standards, the applicable environments of different levels, and how to perform Cleanroom Design according to needs.

What are Cleanroom Classifications?

Cleanroom Classifications classify cleanrooms according to the number of particles per unit volume of air.

ISO 14644-1 is the most widely used standard in the world. It classifies cleanrooms into ISO 1 to ISO 9. Different levels have strict restrictions on the number and size of particles in the air.

For example:

• ISO 1 is the highest level, almost dust-free, suitable for nano-scale semiconductor and aerospace component manufacturing.

• ISO  5 is commonly used in sterile pharmaceuticals and operating rooms.

• ISO 7-8 is suitable for general electronics, food packaging or laboratories.

Which ISO Cleanroom is the Cleanest?

If you are looking for "Which ISO Cleanroom is the cleanest?", the answer is undoubtedly ISO 1.

In an ISO 1 Cleanroom, the number of particles of 0.1 μm and above is controlled to an extremely low level, and almost no particles can be detected per cubic meter of air. This type of environment is common in:

• Nano-process manufacturing

• High-end aerospace device assembly

• Precision sensor production

However, in actual projects, many cleanroom designers will choose ISO 5-7 as the standard for operating rooms, pharmaceutical sterile areas, or electronic cleanrooms based on production needs and cost balance.

How to Design a Cleanroom?

Determine Cleanroom Classifications

The first step in Cleanroom Design is to determine the required Cleanroom Classifications. It is recommended to conduct a comprehensive assessment based on the following factors:

• Product process sensitivity

• Industry regulatory requirements

• Cost and operation and maintenance budget

For example:

• ISO 5 is recommended for the filling area of a pharmaceutical factory

• ISO 7 is recommended for the assembly area of medical devices

• ISO 8 can be used for ordinary laboratories

Reasonable planning of Cleanroom layout

A scientific Cleanroom Design layout should include:

• Scientific division of clean area, quasi-clean area, and buffer area

• One-way flow design for personnel and logistics

• Physical isolation, air pressure gradient setting

Hospital Cleanrooms or Pharma Cleanrooms pay special attention to cross-contamination control. Reasonable layout can effectively ensure air flow and reduce contamination risks.

Optional purification equipment

The performance of the cleanroom depends not only on the building structure, but also on the supporting purification equipment, such as:

• FFU (Fan Filter Unit)

• Air Shower

• Pass Box

• HEPA high-efficiency filter

According to the cleanroom area, cleanliness level and process requirements, the reasonable configuration of equipment quantity and layout points are the key to the success of Cleanroom Design.

Why do cleanrooms need to be classified?

The reason is simple. Different products have different requirements for environmental cleanliness. Too high a level will increase construction and operation costs, while insufficient levels cannot guarantee product quality.

For example:

• Semiconductor lithography workshops need to reach ISO 3

• General operating rooms are controlled at ISO 5-7

• Pharmaceutical buffers usually use ISO 8

By reasonably selecting Cleanroom Classifications, companies can strike a balance between cost and cleanliness requirements, ensuring product quality while reducing operating expenses.

Conclusion

Cleanroom Classifications is not only the basis for cleanroom design and construction, but also an important basis for project acceptance and daily management. A clear understanding of ISO Cleanroom standards, different levels of application scenarios, and scientific Cleanroom Design methods can help companies complete cleanroom project construction efficiently, standardized, and safely.

If you are planning to build a cleanroom project, please contact our professional team. Amber will provide you with a one-stop Cleanroom Design and construction and installation solution.