Clean Room Standards

What makes a clean room a cleanroom.

Clean room standards. Cleanroom classification particle count. A cleanroom is an enclosed room equipped to control the levels of airborne particulate matter. Cleanrooms are designed to maintain extremely low levels of particulates such as dust airborne organisms or vaporized particles. When people are added to the matrix particulate levels rise still further in the operational cleanroom.

In the uk british standard 5295 is used to classify cleanrooms. As stated before cleanrooms are classified by how clean the air is according to the quantity and size of particles per volume of air. The basis of cleanroom standards is the micrometer or micron for short µm which is the size of the particles to be filtered. Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required.

Positive pressure keeps new particles from entering the clean area. As instruments and equipment are introduced and particulates rise an as built cleanroom becomes an at rest cleanroom. A cleanroom or clean room is a room that has hepa filtration to remove particles from the air. The cleanroom classification standards fs 209e and iso 14644 1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area.

A cleanroom or clean room is a facility ordinarily utilized as a part of specialized industrial production or scientific research including the manufacture of pharmaceutical items integrated circuits crt lcd oled and microled displays. Common applications are medical devices pharmaceutical and semiconductor manufacturing. Cleanroom requirements and standards provide a direct and easy to understand way of detailing the differences between the eight classes of cleanrooms. Cleanroom markets applications overview biotech cleanrooms nanotech cleanrooms cleantech cleanrooms university cleanrooms government cleanrooms.

Iso 14644 1 cleanroom standards. Iso delineates three cleanroom classification standards. This control is achieved by air pressure and filters. Federal standard 209e cleanroom standards for iso an older standard.

Generally speaking a clean room is an enclosed room that has equipment which controls the amount of particulate matter in the air by using air pressure and filters. Cleanrooms are rated based on the number of particles they can handle. Through its members it brings together experts to share knowledge and develop voluntary consensus based market relevant international standards that support innovation and provide solutions to global challenges. Iso is an independent non governmental international organization with a membership of 162 national standards bodies.

To meet requirements of a clean room as defined by federal standard 209e and newer iso standards all clean rooms must not exceed a particulate count as specified in the air.