Clean Room Cleanliness Levels

During the manufacturing process of medical devices it is important that contaminants are absent from the process which is why cleanrooms are used.

Clean room cleanliness levels.

Common applications are medical devices pharmaceutical and semiconductor manufacturing. Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. If this isn t what you find when you check in then we promise to make it right. Cleanroom operations often consist of several different components working simultaneously to ensure that processes or products are protected.

Cleanrooms typically have a cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure. A sterile cleanroom for the pharmaceutical industry will need to achieve iso 5. 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. Good isn t good enough we re committed to high levels of cleanliness.

Iso class 3 500 750 air changes per hour with a ceiling coverage of 60 100. Cleanrooms are designed to maintain extremely low levels of particulates such as dust airborne organisms or vaporized particles. 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 8 is the starting cleanroom level.

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. Friction e g rubbing scrubbing the soiled area with a brush is an old and dependable method. 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. Iso class 2 500 750 air changes per hour with a ceiling coverage of 80 100.

That means clean well maintained clutter free rooms that meet our standards. A cleanroom or clean room is a room that has hepa filtration to remove particles from the air.