Cleanrooms are specially designed environments crucial for industries requiring a high level of cleanliness and sterility, such as pharmaceutical, biotech, and semiconductor manufacturing. These controlled environments are essential for producing products that require a contaminant-free environment, and designing and constructing these cleanrooms require careful planning and attention to detail.
This comprehensive guide will delve into the key elements required for cleanroom design. It will explore the critical factors considered when designing a cleanroom. It includes the classification of cleanrooms, layout, air filtration and ventilation, lighting, surfaces and materials, and personnel and gowning procedures.
By understanding these key elements, you will know the requirements to design a sterile environment that meets your specific needs and requirements.
1. Classification
It refers to the level of cleanliness required for the specific application and the number of airborne particles allowed per cubic meter of air. The classification system used in cleanroom design is based on the number and size of particles present in the air.
The ISO standard classification system is widely used and is based on the number of particles of size 0.1 μm or larger per cubic meter of air. The higher the classification number, the more stringent the requirements for air cleanliness.
Cleanrooms are designed to limit the number and size of particles per cubic meter of air, with the Federal Standard 209E being the most widely used system in the US. The classification of cleanrooms ranges from Class 1 to 9, with Class 1 being the most sterile and Class 9 being the least. The definition of cleanrooms is based on the concentration of particles, specifically those that are 0.5 microns or larger and measured in µg/m3.
According to News Medical, Class 9 can have 352 million particles µg/m3, but Class 1 cleanrooms should not have 0.5-micron particles or larger per cubic meter of air. It is to remember that several other standards and systems are followed worldwide.
It is crucial to determine the classification requirements for the cleanroom at the early stages of design to ensure that the correct air filtration, ventilation, and surface materials are used. Failure to meet the classification requirements can lead to contamination and product failure, resulting in significant financial losses.
2. Airflow
Airflow is a critical element in cleanroom design, as it plays a significant role in controlling contamination. The design of a cleanroom’s airflow system should consider the number of people working in the room, the equipment generating heat, and the classification of the cleanroom.
Cleanroom airflow should be designed to create a unidirectional, laminar flow of filtered air. This airflow should move from the cleanest area of the room to the least clean area. This design ensures that any particles generated in the room are quickly removed from the clean area and directed toward the floor.
3. Filtration
Filters are critical components in cleanroom design, as they are crucial in maintaining a sterile environment. The air entering the cleanroom should be filtered to remove any airborne particles that could contaminate the cleanroom. It is achieved using high-efficiency particulate air (HEPA) filters, which remove particles as small as 0.3 microns.
Cleanroom designers should consider the placement and design of the filtration system to ensure that the air entering the cleanroom is properly filtered. The filter should be as close to the cleanroom as possible to filter the air before entering the room. The number of filters required and their size will depend on the cleanroom classification, and the airflow rate required.
4. Materials and Surfaces
The choice of materials and surfaces is crucial, as they can significantly impact the cleanliness and sterility of the environment. In recent years, new materials and surface coatings have allowed for greater control of contamination in cleanrooms.
The surfaces of a cleanroom should be smooth, non-porous, and easy to clean. Using stainless steel or epoxy-coated flooring and walls is common in cleanrooms, as they are durable and easy to maintain.
Epoxy flooring is renowned for its strength, sustainability, and decorative properties for any surface. It creates a smooth and robust surface that significantly enhances the floor’s load-carrying capacity.
In addition, Daily Civil states that epoxy floor help maintains clean and safe conditions for workers, equipment, and inventory. Therefore, it is crucial to choose low-emitting materials and surfaces to ensure the safety and sterility of the environment.
New materials, such as nanomaterials and graphene, are being developed to improve the performance of cleanroom surfaces. These materials have unique properties that allow for greater contamination control, such as self-cleaning and anti-static properties.
5. Lighting and Acoustics
These are often overlooked elements in cleanroom design, but they can significantly impact the environment’s cleanliness and the productivity and safety of workers.
Lighting is crucial in cleanrooms to allow workers to see clearly and perform their tasks accurately. The type of lighting used should be non-reflective and non-shedding to prevent contamination. LED lighting is popular, providing bright and uniform illumination while producing less heat and reducing energy consumption.
Noise levels can impact worker productivity and even cause stress. It is also one of the leading causes of hearing impairment in workers. According to Psychreg, a person with reduced hearing ability feels more exhausted than a normal one at the end of the day, ultimately impacting their productivity. Also, noise can compromise the cleanliness of the environment.
Proper acoustic design, including sound-absorbing materials and noise reduction technology, can reduce noise levels in the cleanroom and create a more comfortable and productive work environment.
6. Monitoring and Control
They ensure that the environment is maintained at the required level of cleanliness and sterility. In addition, recent advancements in monitoring technology have made it easier to detect and control contamination in real time.
Cleanrooms should have a comprehensive monitoring system that tracks temperature, humidity, particle counts, and airflow rates. The monitoring system should be able to detect any variations from the acceptable range and provide immediate feedback for remediation.
Cleanroom designers should also consider incorporating automated control systems to regulate environmental parameters. These systems can adjust temperature, humidity, and airflow rates automatically, reducing the risk of human error and ensuring that the environment remains sterile.
Ensure to Meet the Required Standards When Designing Cleanrooms
Cleanroom design is critical in industries where a sterile environment is necessary to ensure product quality, safety, and regulatory compliance. A well-designed cleanroom can prevent contamination, improve product yield, and reduce waste and costs.
The essential element of cleanroom design outlined in this article plays a crucial role in creating a sterile environment that meets the required standards for cleanliness and safety.
By carefully designing and maintaining a cleanroom, companies can ensure that their products meet the required standards and regulatory compliance and protect the health of their workers and customers.