Clean room standards are a combination of technical requirements and specifications issued by the Ministry of Health, the quality certification kit provides to create a clean room that ensures the following parameters: cleanliness, humidity. , temperature, pressure and control the amount of germs as desired.
The first standard of a clean room is how much the amount of dust suspended in the air is controlled (all kinds of dust are not excluded). You try to make a comparison between a human hair with a diameter of about 100 µm, the dust particles suspended inside a clean room are from 0.5 to 50 µm in diameter, so a hair can be from 2 to 200 times larger than the suspended dust particles. mezzanine.
Comparison of hair diameter and suspended particles
In 1963 in the US, the clean room standard was first given seriously, and now this standard has been used for the whole world. Clean room standard stipulates the amount of dust particles suspended in a unit volume of air, people are divided into dust size ranges, which is the type of room determined by the number of dust particles larger than 0.5 µm in size per body. volume is 1 cubic foot (ft3) of cleanroom air.
1. Federal Standard 209 cleanroom (1963)
This is the first standard for clean rooms, specified in 1963 named 209, later improved, completed versions 209 A (1966), 209 B (1973), up to standard 209 E (1992).
Dust limit in standard 209 (1963)
2. Federal Standard 209 E (1992)
This standard determines the concentration of badger dust in the air in standard units (the unit of air volume is m3). The cleanroom classification is determined on a logarithmic scale of dust content greater than 0.5 μm in diameter. Below is the standard table FS 209 E.
Dust limit in standard 209 E (1992)
3. ISO 14644-1 . Standard
According to the International Standards Organization (ISO) has specified international standard clean room standards. The ISO 14644-1 standard was released in 1999 called “Classification of Air Cleanliness”.
Limits of dust content in ISO 14644-1
Based on these standards, class cleanrooms are classified into the following categories:
1. Class 1 sạch clean room standard
– It is a room belonging to integrated circuit factories with micro-sized technology.
– Class 1 clean room is cleaner than class 10 clean room
2. Class 10 . clean room standard
– A room belonging to semiconductor manufacturing plants used to produce integrated circuits with a width of less than 2 ILm.
Class 10 cleanrooms are cleaner than class 100 clean rooms.
3. Class 100 . clean room standard
– A type of room that requires no bacteria and dust to be used to produce sterile injectable drugs.
– It is a type of tissue transplant surgery room.
– The type of post-operative room after bone tissue transplant surgery.
– Class 100 clean rooms are cleaner than class 1,000 clean rooms
4. Class 1,000 clean room standard
– It is a type of room that produces high-quality optical equipment.
– It is a type of super-small bearing production room.
– Class 1000 clean rooms are cleaner than class 10,000 clean rooms.
5. Class 10,000 clean room standard
– As a type of assembly room for hydraulic and pneumatic equipment, servo control valves, timing devices and high quality actuators.
– Room type used for the production of sterile injectable drugs.
– Class 10,000 clean rooms are cleaner than class 100,000 clean rooms.
6. Class 100,000 clean room standard
– The type of room used for optical work.
– A room used to assemble electronic, hydraulic and pneumatic components.
– A room used for the production of pharmaceuticals and foodstuffs.