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.

That means clean well maintained clutter free rooms that meet our standards. Iso class 2 500 750 air changes per hour with a ceiling coverage of 80 100. With manual cleaning the two essential components are friction and fluidics. Good isn t good enough we re committed to high levels of cleanliness.

If your cleanroom requires additional components portafab has several different solutions that you can use to enhance your build clean room components. Iso class 3 500 750 air changes per hour with a ceiling coverage of 60 100. Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Friction e g rubbing scrubbing the soiled area with a brush is an old and dependable method.

The recommended air changes per hour for an iso class 1 clean room is 500 750 and the ceiling coverage should be 80 100. Cleanroom operations often consist of several different components working simultaneously to ensure that processes or products are protected. If this isn t what you find when you check in then we promise to make it right. Cleanrooms typically have a cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure.

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. 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. 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. Common applications are medical devices pharmaceutical and semiconductor manufacturing.

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. A sterile cleanroom for the pharmaceutical industry will need to achieve iso 5.