Clean Room Cleanliness Levels

Common applications are medical devices pharmaceutical and semiconductor manufacturing.

Clean room cleanliness levels.

Clean room classification iso class this refers to the level of cleanroom particulate cleanliness based on a number of airborne particles of a certain size per cubic metre. The recommended air changes per hour for an iso class 1 clean room is 500 750 and the ceiling coverage should be 80 100. Iso class 3 500 750 air changes per hour with a ceiling coverage of 60 100. Cleanroom operations often consist of several different components working simultaneously to ensure that processes or products are protected.

Iso 8 is the starting cleanroom level. Cleanrooms are designed to maintain extremely low levels of particulates such as dust airborne organisms or vaporized particles. The ambient air outside in a typical city environment contains 35 000 000 particles per cubic meter 0 5 micron and larger in diameter corresponding to an iso 9 cleanroom which is at the lowest level of cleanroom standards. In addition to reducing the safety and effectiveness of the medical devices contamination in a cleanroom could lead to a shutdown resulting in the loss of significant amounts of.

Iso class 2 500 750 air changes per hour with a ceiling coverage of 80 100. Good isn t good enough we re committed to high levels of cleanliness. During the manufacturing process of medical devices it is important that contaminants are absent from the process which is why cleanrooms are used. If your cleanroom requires additional components portafab has several different solutions that you can use to enhance your build clean room components.

If this isn t what you find when you check in then we promise to make it right. With manual cleaning the two essential components are friction and fluidics. Cleaning is done manually in use areas without mechanical units e g ultrasonic cleaners or washer disinfectors or for fragile or difficult to clean instruments. A sterile cleanroom for the pharmaceutical industry will need to achieve iso 5.

Cleanrooms typically have a cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure. That means clean well maintained clutter free rooms that meet our standards.