A cleanroom is a controlled environment that has a low level of environmental pollutants such as dust, bacteria, and other particles. These controlled environments are used in a variety of industries, including pharmaceuticals, semiconductors, biotechnology, aerospace, medical device manufacturing, and research facilities.
The level of cleanliness in a cleanroom is measured by the number of particles present per cubic meter of air. The cleanliness of a room is classified by the International Organization for Standardization (ISO) into various classes, with ISO Class 1 being the cleanest and ISO Class 9 being the least clean.
In this article, we will take a closer look at the different types of cleanrooms and their corresponding ISO classifications, as well as the construction and maintenance of cleanrooms.
ISO Class 1-4 Cleanrooms
ISO Class 1 cleanrooms are the cleanest and most controlled environments in the classification of cleanrooms. These cleanrooms typically have less than 10 particles per cubic meter of air and are used in industries where very little contamination can be tolerated.
Examples of industries that use ISO Class 1 cleanrooms include semiconductor manufacturing, pharmaceutical research and development, and aerospace. In order to achieve such a low level of contamination, strict controls must be put in place for personnel, equipment, and materials entering and exiting the cleanroom. Air filtration systems and HEPA filters are used to maintain air quality, and special garments are worn by personnel working in the cleanroom.
ISO Class 2-4 cleanrooms are slightly less controlled than ISO Class 1 cleanrooms but still maintain a high level of cleanliness. These cleanrooms typically have between 10 and 100 particles per cubic meter of air and are used in industries such as medical device manufacturing, biotechnology research, and research laboratories.
The level of control and monitoring is less strict in these cleanrooms as compared to ISO Class 1 cleanrooms but still requires specific protocols such as gowning and an air filtration system.
ISO Class 5-8 Cleanrooms
ISO Class 5-8 cleanrooms are less controlled than ISO Class 1-4 cleanrooms and have a higher level of environmental pollutants. These cleanrooms typically have between 100 and 10,000 particles per cubic meter of air and are used in industries such as food manufacturing, electronics assembly, and laboratory testing.
The level of control and monitoring is less strict as compared to ISO Class 1-4 cleanrooms and typically requires less stringent protocols, and air filtration may not be as advanced.
Construction and Maintenance of Cleanrooms
The construction of cleanrooms is a complex process that involves the use of specific materials and construction methods to minimize the level of contaminants.
Walls, floors, and ceilings are typically made of materials that do not emit particles, and special seals are used to prevent air leaks. In addition, HVAC systems must be in place to control the flow of air and maintain the appropriate level of cleanliness. According to industry insiders, Samsung Electronics plans to begin building cleanroom facilities at its new processor facility in Taylor, Texas, in the first quarter of 2023.
To maintain the cleanliness of a cleanroom, regular monitoring and testing must be conducted to ensure that the appropriate level of cleanliness is being maintained. This includes regular testing of the air quality, as well as visual inspections of the cleanroom for contaminants. Cleaning and maintenance procedures must also be followed to keep the cleanroom free of contaminants.
Personnel and Gowning Procedures
One of the key elements in maintaining a cleanroom environment is controlling the personnel who enter and exit the cleanroom. To minimize the risk of contamination, personnel must follow strict gowning procedures before entering a cleanroom.
These procedures typically involve wearing special garments, such as full-body suits, face masks, gloves, and shoe covers. These garments are designed to reduce the number of particles that are shed from the body and clothing of personnel. Research by Technavio projects that the cleanroom apparel market will increase by USD 672.21 million between 2021 and 2025 at a CAGR of 4%, with the medical category accounting for the biggest market share.
The type of garment worn depends on the class of cleanroom. For example, in ISO Class 1 cleanrooms, personnel may be required to wear full-body suits, while in ISO Class 5-8 cleanrooms, a lab coat and face mask may be sufficient. Gowning procedures must be followed every time a person enters the cleanroom and must be removed before leaving the cleanroom.
Cleanrooms are essential in many industries, where a low level of environmental pollutants is required to prevent contamination. The level of cleanliness in a cleanroom is measured by the number of particles present per cubic meter of air and is classified by the ISO into various classes.
Understanding the different types of cleanrooms and their corresponding ISO classifications, as well as the construction and maintenance of cleanrooms, is important for ensuring that the appropriate level of cleanliness is maintained in these controlled environments.
With the proper understanding of cleanrooms and the proper protocols in place, industries can continue to produce high-quality products without the risk of contamination.