All About Cleanrooms | American Cleanroom Systems

A cleanroom is a special enclosure equipped with HEPA filtration to create a super clean work space. They are commonly used for semiconductor manufacturing, pharmaceutical manufacturing, medical device manufacturing, aerospace assembly, and research and development laboratories. The HEPA fan filter units in the plenum clean the air before it enters the cleanroom.

Section view recirculating modular cleanroom, air flows

Figure 1. Air flow diagram recirculating modular cleanroom

The level of cleanliness of a cleanroom is defined by it ISO or FED cleanroom classification. ISO uses particles per cubic meter. FED uses particles per cubic foot.

ISO 14644-1 Estándares de salas limpias | Clasificaciones de salas limpias
Clase	Máximo de Partículas/ft³						ISO Equivalente
Clase	>0.1 um	>0.2 um	>0.3 um	>0.5 um	>1 um	>5 um	ISO Equivalente
ISO 1	10	2
ISO 2	100	24	10	4
ISO 3	1,000	237	102	35	8		Class 1
ISO 4	10,000	2,370	1,020	352	83		Class 10
ISO 5	100,000	23,700	10,200	3,520	832	29	Class 100
ISO 6	1,000,000	237,000	102,000	35,200	8,320	293	Class 1,000
ISO 7				352,000	83,200	2,930	Class 10,000
ISO 8				3,520,000	832,000	29,300	Class 100,000

Table 1. ISO 14644-1 Cleanroom Classifications

US FED STD 209E Estándares de salas limpias | Clasificaciones de salas limpias
Clase	Máximo de Partículas/ft³					ISO Equivalente
Clase	>0.1 um	>0.2 um	>0.3 um	>0.5 um	>5 um	ISO Equivalente
1	35	7	3	1		ISO3
10	350	75	30	10		ISO4
100				100		ISO5
1000				1000	7	ISO6
10,000				10,000	70	ISO7
100,000				100,000	700	ISO8

Table 2. Fed STD 209E Cleanroom Classifications

Who needs a cleanroom?

Pharmaceutical manufacturers require cleanrooms. FDA CGMP regulations require pharmaceutical manufacturers to use cleanrooms to ensure the safety and effectiveness of the drugs being produced. ISO-5 cleanrooms commonly required for aseptic processes. ISO-6 and ISO-7 cleanrooms are commonly used to ensure sterility. Pharmaceutical cleanrooms are typically included in FDA validation (approval) of new drugs.

interior ISO-6 cleanroom, large air return walls, integral coved vinyl cleanroom flooring

Figure 2. ISO-6 pharmaceutical cleanroom

Medical device manufacturers require cleanrooms. FDA GMP regulations require a controlled environment for both sterile and non-sterile medical device and medical device subcomponent manufacturing.

Interior ISO-7 cleanroom, air return walls, cleanroom heat welded vinyl flooring

Figure 3. ISO-7 medical device cleanroom

Precision industrial manufacturing require cleanrooms. Semiconductor manufacturing is a significant industrial cleanroom segment. The amber lighting is for photolithography rooms. Other industrial cleanroom applications included printed circuit board manufacturing, aerospace assembly, and lamination.

Interior ISO-5 cleanroom, amber color lights, raised cleanroom flooring, fume hoods

Figure 4. ISO-5 industrial cleanroom with raised cleanroom floor

Black industrial cleanroom exterior, floor to ceiling cleanroom windows

Figure 5. ISO-8 industrial cleanroom for aerospace

Most popular cleanroom designs are modular, softwall and stick built (gyp-board walls).

Modular cleanrooms are popular due to their wide variety of cleanroom wall choices, durability, fast install, and reasonable cost.

Figure 6. What is modular cleanroom video

Softwall cleanrooms use clear vinyl curtains for walls. They are a popular choice for small lower class cleanrooms.

Softwall cleanroom, clear vinyl curtain walls, aluminum frame

Figure 7. Softwall cleanroom

Stick-built construction cleanrooms are typically only used for the lowest class of cleanrooms.

Cleanroom interior, stick built walls, modular wall, windows

Figure 8. Medical device cleanroom using both modular and stick-built walls.