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Two persons in protective clothing are inspecting cleanroom blueprints.

Home Services TechnologyCleanroom Standards

Technology

Different Types of Cleanroom Standards

As critical environments for high-precision manufacturing, medical research, and pharmaceutical production, cleanrooms must be designed and operated in compliance with stringent international and national standards. Common cleanroom standards include the ISO 14644 series, GMP (Good Manufacturing Practice), FDA regulations, as well as various country- or industry-specific standards. These standards specify clear requirements for air cleanliness classes, particle control, microbial limits, temperature and humidity, pressure differentials, air change rates, and monitoring methodologies, thereby ensuring product quality and personnel safety.

A person wearing protective clothing is inspecting a wafer.

International Universal Standards

ISO 14644-1 Air Cleanliness Classes

Table 1: ISO 14644-1 Cleanroom Standard
Class	> 0.1 μm	> 0.2 μm	> 0.3 μm	> 0.5 μm	> 1 μm	> 5 μm	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
ISO 9	–	–	–	35,200,000	8,320,000	293,000	Room Air

ISO 14644-2: Monitoring and verification of cleanrooms in operation.
ISO 14644-3: Test methods, including airflow, pressure differential, filtration efficiency, and microbial sampling.
ISO 14644-4: Cleanroom design and construction.
ISO 14644-5: Cleanroom operation.
ISO 14644-7: Separative devices (such as clean benches, pass box etc.)
ISO 14698: Primarily used for biological contamination control

U.S. Standards

Federal Standard FED STD 209E (Cancelled but still used as a reference)

Table 2: FED STD 209E Cleanroom Standards
Class	> 0.1 μm	> 0.2 μm	> 0.3 μm	> 0.5 μm	> 5 μm	ISO equivalent
1	35	7	3	1	–	ISO 3
10	350	75	30	10	–	ISO 4
100	–	–	–	100	–	ISO 5
1000	–	–	–	1000	7	ISO 6
10,000	–	–	–	10,000	70	ISO 7
100,000	–	–	–	100,000	700	ISO 8

FDA cGMP (Current Good Manufacturing Practice): A mandatory standard for cleanrooms in the production of pharmaceuticals and medical devices.

European Standards

EU GMP (European Union Good Manufacturing Practice)

Table 3: EU GMP Cleanroom Classification
EU GMP Grades	ISO equivalent	Description
A	ISO 5	The highest grade, typically required for local laminar flow hoods, isolators, or aseptic filling zones.
B	ISO 5	Serves as the background environment for Grade A areas, ensuring a clean background for aseptic operations.
C	ISO 7 / ISO 8	Primarily used for preparation of sterile ingredients, secondary operations, and non-critical processes in sterile product manufacturing.
D	ISO 7 / ISO 8