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Cleanroom vs. Controlled Environment

January 10, 2023
controlled environment, life science lab” “cleanroom modular walls, lab cabinets
Figure 1. Life Sciences controlled environment

A “controlled environment” typically refers to a separate space where temperature, humidity, air flow, lighting, or access are controlled to meet a specific need such as manufacturing, testing, research, or material storage. They do not require a specific particle count per volume or filtration. To certify a controlled environment, the temperature and humidity are measured and logged to ensure the environment is meeting required specification.

black modular cleanroom, floor to ceiling cleanroom windows
Figure 2. ISO-8 aerospace modular cleanroom

A “cleanroom” refers to a space which meets ISO14644-1 or FED Std 209E cleanroom classification standard. The ISO cleanroom standard includes particles per cubic meter and air changes per hour. The FED cleanroom standard includes particle per cubic foot and air changes per hour. The standards are roughly equivalent but use different units. To certify a cleanroom, the room is particle tested to ensure the designed cleanroom classification is being achieved, air pressure is measured continuously via magnehelic gauges, and filtration is working properly to achieve the required air changes per hour. In pharmaceutical and medical device cleanrooms, it common to use settling plates to measure “viable” contamination.

Cleanrooms can be thought of as “controlled environments” with added requirement of filtration / particle control. 

ISO 14644-1 Cleanroom Standards | Cleanroom Classifications
Class Maximum  Particles/m³ FED STD 209E equivalent
>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 Cleanroom Classifications
Design Requirements for Cleanroom Classifications
Criteria Class 10 ISO4 Class 100 ISO5 Class 1000 ISO6 Class 100,000 ISO8
Air changes per HR/Min 500-600 / 8 to 10 300 to 480 / 5 to 8 180 / 3 60 /1 20 /0.33
Filter coverage % 90 – 100 60 – 70 20 – 30 7 – 15 4  – 5
CFM per square foot 85 – 90 36 – 65 18 – 32 9 – 16 4 – 8
Filter Efficiency 99.9997% ULPAs 99.997% HEPAs 99.997% HEPAs 99.997% HEPAs 99.97% HEPAs
Table 2. Cleanroom Design requirements

Common Applications for Controlled Environments:

  • Life science laboratories
  • Engineering laboratories
  • Laser labs
  • High energy physics facilities
  • Hospitals
  • Cannabis grow rooms
  • Clean manufacturing
  • Food processing rooms
  • Pharmacies
  • Quality labs
white modular engineering lab, controlled environment, windows
Figure 3. Non classified Engineering lab controlled environment
black laser curtains, controlled environment
Figure 4. Non classified Laser lab controlled environment

Common Applications for Cleanrooms:

  • ISO-5/class 100 or ISO-6/class 1000 cleanroom classification
    • Semiconductor manufacturing cleanroom
    • Pharmaceutical manufacturing cleanroom
    • Research and development cleanroom
    • Laser and optics cleanroom
ISO-7 pharmaceutical cleanroom, cleanroom exhaust hood, cleanroom door
Figure 5. Classified Pharmaceutical cleanroom
  • ISO-7/class 10,000 cleanroom classification:
    • PCB electronics manufacturing cleanroom
    • USP797 compounding pharmacy cleanroom (sterile and hazardous)
    • Medical device manufacturing cleanroom
    • Precision industrial manufacturing cleanroom
    • Aerospace composite repair cleanroom
  • ISO-8/class 100,000 cleanroom classification:
    • Cleanroom gown rooms
    • Cleanroom Material Pass rooms
    • Cleanroom hallways
    • Mask manufacturing cleanroom
    • 3-d printing cleanroom
    • Lamination cleanroom
    • Precision industrial manufacturing
    • Nutraceutical cleanroom
    • Pharmaceutical cream manufacturing
    • E-liquid cleanroom
    • Food processing/bottling cleanroom
Property American Cleanroom Systems 2023

The author Anthony Chien has worked at American Cleanroom Systems for past 10 years. He has more than 40 years of cleanroom experience. Anthony has a BS and MS in Electrical Engineering specializing in semiconductor manufacturing from the University of Illinois. American Cleanroom Systems is a design build modular cleanroom manufacturer based in Rancho Santa Margarita CA. It is expert in ISO-5 thru ISO-8 (class 100 to class 100k) modular cleanrooms for pharmaceutical cleanrooms, medical device cleanrooms, and industrial cleanrooms.

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