Cleanroom Classification: A Comprehensive Guide to Design and Maintenance

Introduction

Cleanrooms are spaces where environmental conditions are carefully controlled. These spaces are commonly used in specific industries such as pharmaceuticals, electronics, medical, aerospace, and biotechnology. In these rooms, the amount of airborne particles, temperature, humidity, and even air pressure are precisely regulated to prevent contamination and its negative effects on processes and products. In order for these rooms to function optimally, they require a precise classification. Cleanroom classification, as one of the basic principles in the design and construction of these spaces, plays a key role in determining the cleanliness and air quality inside the rooms. This process is of great importance for determining air quality and controlling contaminants in the space. For example, in the pharmaceutical and medical product manufacturing industries, even very fine airborne particles can have serious effects on the quality of the final product. Therefore, cleanroom classification is a tool specifically designed to ensure the level of cleanliness required in each industry.

Types of Cleanroom Classification

Cleanroom classification is one of the most important steps in the design and construction of these spaces, which is usually carried out based on global standards. One of the most important and authoritative standards for this classification is ISO 14644-1. This standard specifically examines the number of airborne particles in different sizes and places them in different categories. Below, we will examine some of the most important classes and their applications.

Class 1

This class has the highest level of cleanliness and is only used for processes that are very sensitive. In Class 1 cleanrooms, the number of airborne particles must be less than 0.1 micrometers and the contamination level must be about one particle per cubic meter of air. As such, this class is essential for highly sensitive industries such as semiconductor equipment production, pharmaceuticals, and the production of sterile drugs. According to statistics, in Class 1 cleanrooms, even a single airborne particle can have a detrimental effect on the quality of products.

Class 10

Class 10 is another widely used class of cleanrooms. This class is suitable for industries that require high cleanliness, but not as meticulous as Class 1 rooms. In this class, the number of airborne particles is less than 10 particles per cubic foot. For example, this class is used in the manufacturing industry of electronic components and computer chips, which are sensitive to airborne particles. Research has shown that in Class 10 cleanrooms, even the smallest changes in the level of contamination can disrupt the performance of electronic systems.

Class 100

Class 100 cleanrooms are suitable for pharmaceutical and biotechnology industries that require contamination control, but at a lower level than Classes 1 and 10. In these rooms, the number of airborne particles should not exceed 100 particles per cubic foot. In this class, the number of particles larger than 0.5 microns is controlled and is usually used in processes that are less sensitive to contamination, such as pharmaceutical packaging or industrial parts manufacturing.

Class 1000 and 10,000

These two classes are used more for more general industries and applications that are less sensitive to contamination. Class 1000 and 10,000 cleanrooms are suitable for consumer product manufacturing processes, food packaging, and other industrial processes that require large-scale contamination control. Specifically, in these rooms, the number of airborne particles should be less than 1,000 particles and 10,000 particles per cubic foot.

Factors Affecting the Choice of Classification

Choosing the right class for your cleanroom depends on several factors. These factors must be carefully considered to determine the best class based on the specific needs of the industry. Here are some of the most important ones.

Industry Type

Industries that require higher precision, such as pharmaceuticals and medical device manufacturing, typically require cleanrooms with higher classes (Class 1 and 10). These industries must meet very strict health and safety standards. For example, in the production of sterile drugs or vaccines, even the smallest airborne particle can contaminate the product and pose a health risk.

Application Type

Each manufacturing process has its own specific requirements that influence the choice of cleanroom classification. For example, in the electronic chip manufacturing industry, any contamination can disrupt the performance of the systems. In this case, the use of Class 1 or 10 cleanrooms is essential. While in other industries, such as the production of household appliances, the use of Class 100 or 1000 cleanrooms may be sufficient.

Costs

The costs of designing and maintaining cleanrooms depend heavily on the class chosen. Cleanrooms with higher classes require more sophisticated equipment and advanced ventilation systems, which results in higher costs. While cleanrooms with lower classes are usually less expensive.

Cleanroom Design Process According to Classification

Needs Consultation and Assessment

Before starting the cleanroom design, the specific needs of the customer must first be carefully assessed. This assessment includes examining the type of industry, production process, and hygiene requirements. At this stage, design engineers must collect detailed information on the production processes and the sensitivity of products to contamination. This information helps them to suggest the best design based on actual needs.

Cleanroom Space Design

At this stage, the cleanroom space must be designed to provide optimal environmental conditions for production processes. This design includes items such as ventilation systems, air filters, the number of doors and windows, and the arrangement of equipment. For cleanrooms with higher classes, special ventilation systems must be used that continuously purify the air. The design must be such that no unauthorized air movement occurs and the air flows evenly in the space.

Selecting the right equipment and materials

One of the key steps in cleanroom design is selecting the right equipment for air filtration. HEPA and ULPA filters should be selected according to the classification requirements. These filters are capable of filtering airborne particles down to micrometer sizes. Also, the materials used to make the walls and floors should have anti-pollution and antibacterial properties to prevent dust accumulation.

Ventilation systems and HEPA filters

The ventilation system is one of the main components of clean rooms. These systems must be able to purify the air inside the room and provide uniform air flow in all sections. In higher class clean rooms, HEPA and ULPA filters are usually used, which can remove very fine particles from the air. In particular, HEPA filters are capable of filtering up to 99.97% of airborne particles with sizes of 0.3 micrometers or larger.

Conclusion

Cleanroom classification is one of the essential factors in the design and implementation of these spaces, and by choosing the right class, the highest level of quality and safety can be achieved. This process is especially critical in sensitive industries such as pharmaceuticals, electronics, and biotechnology. By adhering to international standards and using advanced equipment, clean rooms can be designed with optimal performance and optimal costs.