Clean rooms are used in industries where particles or contaminants can affect the manufacturing process. It’s a room that can vary in size and complexity, that provides a controlled environment free of pollutants like airborne microbes, dust, chemical vapors, and aerosol particles. 

A clean number controls the number of particles per cubic meter. Physicist Willis Whitfield invented the clean room in 1962. His design featured a highly filtered airflow to flush out air contaminants and was being used in manufacturing facilities around the world within just a few years. These rooms use HEPA filtration to remove particles from the air to get a specific level of sterility. In addition to HEPA filtration and fans, clean rooms also have specific flooring, wall systems, hardware, and ceilings that keep particles down and meet different clean room classes' criteria.  

What Is Clean Room Assembly?

Simply put, clean room assembly is the manufacturing that occurs within a clean room. Clean rooms are often required for pharmaceutical and medical device manufacturing. It’s also used for E-beam column assembly, optics assembly, and metrology tool integration and build. Contamination during assembly could adversely affect the final product. For example, when manufacturing medical devices, they must be in a sterile environment to ensure they don’t become contaminated. The ISO 13485 regulates contamination control in medical device manufacturing, requiring the use of a clean room

There are different classifications of clean rooms. This classification is based on the number of particles per cubic foot. For example, a certified class 10,000 environment will have 10,000 particles per cubic foot, and a class 100 environment will have 100 particles per cubic foot. A light-scattering particle counter determines the concentration of particles in the air. Your typical office has between 500,000 to 1 million particles per cubic feet and your average urban outdoor space has 35 million per cubic meter. A clean room significantly reduces the number of particles in the air.  

The HEPA filter units must stay on at all times. Once you turn them off, particles per cubic foot will quickly increase, and it can take several hours to clean the room again. In addition to having a HEPA filtration system in place, contamination prevention processes must be in place for your clean room to remain clean. This involves wiping down surfaces regularly, making sure doors remain closed, prohibiting eating or drinking, wearing clean room suits over street clothes, and wiping down any equipment or material brought into the clean room. Items with uncontrolled microbes like paper, fabric, and pencils are often not used in a clean room and would be replaced with an alternative.  


If you are looking for a clean room, Applied Engineering has over 1500 square feet of clean room manufacturing floor space that can be expanded to accommodate any manufacturing build plan. We offer clean room assembly between class 10,000 to class 100 environments. Reach out for more information on Applied Engineering’s clean room assembly services.

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