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
Class	>0.1 um	>0.2 um	>0.3 um	>0.5 um	>1 um	>5 um	FED STD 209E equivalent
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 10,000 ISO7	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.