A cleanroom is a controlled environment for manufacturing or processing products or materials. It reduces the entrance and accumulation of particulate matter and other pollutants, including bacteria, dust, and chemical fumes. Its cleanliness level is assessed in terms of particles per cubic meter of air and categorized according to the measurement.
The International Organization for Standardization (ISO) has established a classification system for cleanrooms based on the number of particles per cubic meter of air. The codes vary from ISO Class 1 to ISO Class 9, with 1 being the cleanest.
Here is a closer look at some of the industries that can require specific cleanroom applications:
Maintaining an exceptionally high level of cleanliness is essential to ensuring the purity and safety of drugs and other biotech products. Cleanrooms are created with the purpose of creating a regulated environment that reduces the amount of contaminants and particles in the air. This helps to ensure that all operations are carried out in a controlled manner. While cleanrooms can aid in adhering to FDA and other pertinent regulations, they cannot guarantee a completely sterilized environment.
Most cleanrooms in these industries are classified between ISO Class 5 and ISO Class 8, indicating a moderate to low level of cleanliness. They typically emphasize pressurization control, cross-contamination elimination, and outdoor and interior air filtering.
The presence of contaminants during the manufacturing process can cause serious issues in the performance and reliability of electronic devices. This can result in electrical failures, short circuits, and other faults, leading to decreased performance and costly repairs. Therefore, electronics cleanrooms are designed to ensure the manufacturing process is carried out in a sterile and regulated environment.
The ISO classification required for this industry’s applications depends on the type of component being manufactured. For example, microprocessors and memory chips need an ISO Class 5 or ISO Class 6 cleanroom. On the other hand, consumer electronics and other less critical applications utilize ISO Class 7 or ISO Class 8.
The aerospace industry’s extreme conditions necessitate the rigorous prevention of contaminants that can compromise the performance and durability of components. These pollutants can disrupt electrical systems, cause structural failure, and contribute to corrosion and deterioration of the parts over time.
Aerospace cleanrooms are typically classified between ISO Class 5 and ISO Class 7, depending on the part’s complexity. Furthermore, they usually focus on temperature and humidity control, monitoring systems, and high-efficiency particulate air (HEPA) filtration.
Cleanrooms are essential to the food processing industry, as they prevent contamination. They also ensure product quality, lower the risk of foodborne illness, and boost consumer satisfaction.
Food processing cleanrooms are generally classified between ISO Class 7 and ISO Class 8, indicating a low cleanliness level. ISO Class 7s are for processing highly perishable foods, such as dairy products or seafood. Meanwhile, producing packaged or non-perishable foods utilizes ISO Class 8 controlled rooms.
Cleanrooms are vital in the medical industry for maintaining the quality of medical products and ensuring the safety of patients. They also provide researchers and scientists with a controlled space for developing new medical devices, equipment, and technologies. Medical devices — such as catheters, surgical instruments, and implants — are often manufactured in ISO Class 7 and ISO Class 8 cleanrooms.
Here are other key areas where cleanrooms are frequently utilized:
At HARBEC, we are dedicated to delivering high-quality products that meet the requirements of multiple industries! We have a decentralized ISO Class 8 cleanroom with flexible production capabilities, such as advanced manufacturing techniques and quality control.
Our decentralized cleanrooms are developed to constantly provide efficiency, adaptability, and cost-effectiveness. They also feature cutting-edge HEPA units, an enclosed conveyor on the injection molding machine, and a convenient pass-through.
Contact us at (888) 521-4416 to partner with us! You can also request a quote, and we will gladly assist you with your needs.‹ Back To All News
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