Standard documents and classifications

Cleanroom standard is a synthesis of technical requirements and specifications issued by the Ministry of Health, a quality certificate provided to create a clean room that ensures the following parameters: cleanliness, humidity. , temperature, pressure and desirable microbial control.

There are three main standards for clean rooms from 1963 to present:

Federal Standard 209 clean room standard (1963): This standard was first specified in 1963 (named 209), and then continuously improved, completing versions 209 A (1966). , 290 B (1973)…, until 209 E (1992).
Federal Standard 209 E cleanroom standards (1992): This standard defines the concentration of dust in the air according to the standard unit (air volume unit is m ^ 3). The clean room classification is determined according to the log scale of dust content with a diameter greater than 0.5 \ mum.
Clean room standard ISO 14644-1: The International Standards Organization (ISO) has set international standards for clean rooms. ISO 14644-1 was released in 1999 titled "Classification of air cleanliness"
Table of standards Iso 14644-1:

Application of clean room grades:

1) Class 1 (Cleanroom Class 1)

- Room type of factories manufacturing integrated circuits with technology of very small size

2) Class 10 (Cleanroom Class 10)

- Room type of semiconductor factories used for the manufacture of integrated circuits with a width of less than 2 ILm.

3) Class 100 (Cleanroom Class 100)

- Room type requires no bacteria, dust to use in the production of sterile injectable drugs.

- Type of tissue culture surgery room.

- Type of postoperative room after bone tissue transplant surgery.

4) Class 1000 (Cleanroom Class 1000)

- Type of production room for high quality optical equipment.

- Type of room for manufacturing micro-bearings.

5) Class 10,000 (Cleanroom Class 10,000)

- Type of room for assembly of hydraulic and pneumatic equipment, servo control valves, timing devices and high-quality actuators.

- Room type for use in the production of sterile injectable drugs.

6) Class 100,000 (Cleanroom Class 100,000)

- Room type for optical work.

- Type of room for assembly of electronic, hydraulic and pneumatic components.

- Types of rooms used for the production of pharmaceuticals and foodstuffs.

Photos of 1 clean room.


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