A “cleanroom” is a controlled environment that’s used for manufacturing processes or scientific research. These facilities have advanced filtration systems and other preventative measures to limit contamination from dust, airborne microbes, or other pollutants. Many corporations utilize cleanrooms during production, especially if their products’ quality can easily be affected by contaminants.
How Are Cleanroom Facilities Regulated?
Complying with federal cleanroom standards requires strict adherence to governmental guidelines and a commitment to enacting rigorous preventative measures. In the U.S., the FDA’s requirements for cleanrooms include strict environmental controls, including a monitoring system for the cleanroom’s operations, which must be housed in a separate, adequately sized space. There must also be equipment that can limit the concentration of various microorganisms while controlling space’s humidity, temperature, and air pressure. To keep a cleanroom “clean,” facility operators often install air showers to limit particle contamination, utilize sticky flooring to help trap foot-borne contaminants, and require individuals working in the facility to wear protective gowns.
Understanding Cleanroom Classifications
All cleanroom classifications are directly associated with the number and size of particles that are permitted per unit of air volume. As documented by Federal Standard 209, a cleanroom’s class is determined by calculating the number of particles smaller than 0.5 micrometers in a single cubic foot of the room’s air. The ISO, an international regulatory body, has cleanroom classifications ranging from 1-9, with ISO class 1 being the “cleanest” rating.
To achieve a “cleaner” classification, facility operators may need to augment the space’s square footage or reduce the amount of equipment or people inside it. However, this will depend on the processes occurring within the cleanroom.
Partner With a Specialty Coatings Supplier That Leverages Cleanroom Facilities
Transcontinental Advanced Coatings has manufacturing facilities in the U.S. and Europe that create a range of high-performance coating products. As a leader in the coatings industry, we’re committed to providing clients across industries with state-of-the-art technology by maintaining cleanroom facilities that meet ISO standards. To learn more about how your company can benefit from our coating solutions, complete our contact form.