Cleanroom Classifications:Introduction for Microelectronics Cleanroom A clean room means a room in which the quantity of particles floating in the air and, when necessary, the temperature, humidity, and pressure, can be controlled, the main objective of the dust in a given room is determined according to the requirements of the products to be handled in the room. (A) Cleanliness and the number of ventilation cycles. The cleanliness of the room depends upon the number of ventilation cycles performed per unit time. the structure should be contrived so that the air flow is distrube ...
A clean room means a room in which the quantity of particles floating in the air and, when necessary, the temperature, humidity, and pressure, can be controlled, the main objective of the dust in a given room is determined according to the requirements of the products to be handled in the room.
(A) Cleanliness and the number of ventilation cycles. The cleanliness of the room depends upon the number of ventilation cycles performed per unit time. the structure should be contrived so that the air flow is distrubed as little as possible and due care should be taken to prevent the accumulation of dust on surfaces anywhere in the clean room. In order to maintain the cleanliness of the room, the inflow of contaminating particles from outsid must be prevented. To obtain the required room pressure, outside air of apprepriate quality and quantity is necessary.
(B) Material and anxiliary equipment for clean room Material is employed for the ceiling, walls and floor. when necessary, such auxiliary equipment as air showers in the entrances and pass-boxes in the walls must be installed.
(C) Control of personnel , materials Personnel and materials brought, are the main sources of dust in clean rooms, so adequate controls must be adopted. For example, all personnel should be made to pass through air showers and change into dust-free clothes before entering clean rooms.
|Cleanliness Grade||Level of Cleanliness||Microbe concentration Number/Vessel||Applicable Range|
|Surgical Area||Surrounding Area||Surgical Area||Surrounding Area|
|Special Clean Operating Room||100||0||0.2||0.4||The Aseptic Operations of Joint Replacement, organ Transplantation, Brain Surgery, Cardiac Surgery and Ophthalmology|
|Standard Clean Operating Room||1000||2,000||0.75||1.5||The Aseptic Operations of Brain Surgery, Plastic Surgery, Urinary Surgery, Hepatobiliary and Bone Surgery, Pancreatic Surgery, Ovum Transplantation and General Surgery|
|Ordinary Clean Operating Room||10000||20,000||2||4||The Operations of General Surgery and Gynecology and Obstetrics|
|Quasi Clean Operating Room||300000||5||Anorectal Surgery and Surgery for the Infected Part|
Clean rooms are classified according to the cleanliness level of the air inside the controlled environment. The clean room class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic meters of air. The primary authority in the US and Canada is the ISO classification system ISO 14644-1.
This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room.
The most common ISO clean room classes are ISO 7 and ISO 8. The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Class 10,000 and Class 100 000.
The old Federal Standard 209E ( FS 209E ) includes these clean room classes : Class 100,000; Class 10,000; Class 1,000; Class 100; Class 10; Class 1. This standard was replaced in 1999 by ISO-14644-1. It was withdrawn in 2001, but it is still widely used.
Clean rooms must also follow industry-specific and international standards. For example, EU GMP (A-B-C-D), applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies.