Introduction
Cleanroom design is a complex and vital process in various industries such as pharmaceuticals, biotechnology, electronics and even the food industry. These rooms are designed to minimize the amount of pollutants and airborne particles, so that the manufactured products reach the consumers without any contamination. Proper cleanroom design not only ensures the quality of the products, but can also be effective in reducing production costs and times. In this article, we will examine the principles of cleanroom design, environmental requirements, international standards such as ISO and GMP, and new trends in this field.
Key Requirements in Cleanroom Design
Air Quality and Purification Systems
One of the most important points in cleanroom design is air quality control. These rooms must be in optimal condition in terms of suspended particles, dust, microbes and other contaminants. In this regard, the use of HEPA (High-Efficiency Particulate Air) or ULPA (Ultra-Low Particulate Air) filters is very crucial. These filters are able to absorb more than 99.99% of suspended particles in the air. Also, the number of air changes per hour or “air changes per hour” (ACH) must be adjusted so that the air flow is correct and suspended particles are minimized. According to ISO 14644-1 standards, this value can vary for cleanrooms depending on the class (for example, ISO Class 7). In many pharmaceutical and biotechnology industries, the use of air filters and air conditioning systems is so important that even a small amount of contamination can affect the quality of products and lead to financial and health losses.
Temperature and humidity control
The temperature and humidity of the environment in the clean room must be carefully controlled. For example, in the pharmaceutical industry, excessive temperature and humidity can cause changes in the chemical properties of raw materials. This can negatively affect the quality of the final product. The temperature should usually be maintained in the range of 18-22 degrees Celsius and the humidity in the range of 40-60 percent. However, depending on the type of industry and the specific requirements of each production process, these values can vary slightly.
Lighting and visibility
In the design of the clean room, lighting should be such that not only the quality of work in the environment is increased, but also the creation of pollution from light sources is prevented. The use of LED lamps, which produce the least amount of heat and pollutants, is recommended. Proper lighting will increase the efficiency and accuracy of employees in performing their tasks and also help to wash surfaces easily and without contamination.
Cleanroom Standards and Classification
ISO Standards
One of the most famous international standards for cleanrooms is ISO 14644-1. This standard defines criteria for the amount of contaminants in the air and the number of suspended particles in it. Cleanrooms are divided into several categories based on the ISO classification. For example:
ISO Class 1: Suitable for sensitive environments such as semiconductor production cleanrooms.
ISO Class 5: For pharmaceutical industries that require a completely particle-free environment.
ISO Class 9: Suitable for industries with lower pollution control requirements.
Each class requires specific filters, proper airflow, and even a different type of construction.
GMP (Good Manufacturing Practices)
In the pharmaceutical industry, compliance with GMP (Good Manufacturing Practices) standards is mandatory for the design of cleanrooms. These standards are especially important in the production of drugs that are directly related to the health of consumers. In this regard, clean rooms must be designed in such a way that all production processes are carried out without any external or internal contamination.
Design considerations by industry type
Depending on the specific needs of each industry, clean room design can vary greatly. For example, in the pharmaceutical industry, the focus is on preventing any biological contamination, while in the electronics industry, controlling fine particles and their absence from affecting production processes is more important. Therefore, each industry requires a specific design that is adjusted based on the characteristics of that industry.
Clean room design principles
Space layout and workflow optimization
One of the basic principles of clean room design is the correct and optimal layout of the room space. To prevent contamination from entering the clean environment, the flow of materials, people and equipment must be carefully planned and designed. In this regard, clean rooms are usually divided into three parts:
Contaminated area: Where contamination enters the clean room.
Storage area: Where materials and equipment are placed before entering the clean room.
Clean area: A space where all contaminant-free production processes are carried out.
Modular design vs. fixed design
In clean room design, the choice between modular and fixed systems is very important. Modular designs can easily meet future changes and needs due to their high flexibility. While fixed designs are more suitable for environments with fixed needs and more precise design. Choosing one of the two depends on the type of industry, the size of the clean room and the project budget.
Contamination control
Contamination control is one of the vital points in clean room design. To reduce contamination, positive pressure and proper airflow should be used. Ventilation systems and filters should be designed in such a way that contamination from the outside does not enter the interior.
Essential Cleanroom Equipment
Air Filters and Ventilation
The use of HEPA and ULPA filters along with powerful ventilation systems is of particular importance to reduce airborne particles. These equipment are essential for any type of cleanroom and play a key role in improving air quality.
Disinfection Equipment
The use of UV Light or ultraviolet lamps to disinfect air and surfaces is one of the most important steps in the cleanroom maintenance process. These systems can help maintain the quality and health of the environment by eliminating bacteria and viruses.
Environmental Control Systems
Environmental automation systems, which include sensors and equipment to monitor temperature, humidity, and air quality, are now an integral part of cleanroom design. These systems continuously monitor the state of the environment and automatically adjust environmental conditions if necessary.
Conclusion
Cleanroom design is a specialized process that requires high precision and adherence to strict standards. These rooms play a vital role in various industries and even the smallest error in design can have a major negative impact on the quality of the final product. Following the correct principles in design, using advanced equipment, and choosing appropriate international standards can help produce quality products and reduce costs. With new trends in technology and environmental management, the future of clean room design is moving towards the use of smart, sustainable, and automated technologies. Therefore, paying attention to these trends in clean room design can be effective in improving efficiency and reducing costs.
