Some complex products require specific manufacturing processes to ensure their safety and reliable performance. What kind of performance? Well, in medical applications, particles in the air as well as the air’s moisture level can lead to bacteria growth that alters adhesion in a medical product applied directly to the skin.
Obviously, “bacteria” and “medical product” never go hand-in-hand. Combatting this possibility (and many others within numerous industries) requires the use of a cleanroom. Impurities of many types — dust/smoke, equipment, microorganisms, inadequate air quality, human error, and others — can cause defects in many products.
How “clean” does a cleanroom need to be? Classifications have been established using the ISO classification system ISO 14644-1 and are rated by the cleanliness level of the air inside the room. The most common ISO classes (ISO 7 and ISO 8) indicate the level of cleanliness of the room based on the quantity and size of particles per volume of air.
In this article, we’ll explore the ins and outs of ISO cleanroom certification, the industries most affected by cleanrooms, and the importance of your converting partner being certified.