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What is a Cleanroom?

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
>0.1 um >0.2 um >0.3 um >0.5 um >1 um >5 um
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
>0.1 um >0.2 um >0.3 um >0.5 um >5 um
 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.
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