ISO Class 6 Cleanroom (Class 1,000) Regulations

Cleanroom standards and regulations dictate the level of air quality approved for use within an ISO Class 6 Cleanroom environment. The lower the ISO number, the more stringent the standards for acceptable contamination levels. ISO Class 6 Cleanrooms are commonly used in pharmaceutical, biotechnology, electronics, aerospace, and medical device manufacturing industries.

ISO Class 6 Cleanroom Standards

ISO Class 6 modular cleanrooms fall under the ISO 14644-1 equivalent standards that define the number of airborne particles larger than 0.1 microns allowed per cubic meter of air. ISO Class 6 Cleanrooms must maintain 180 to 240 air changes per hour with a ceiling coverage of 25-40% while maintaining the following particle parameters:

• 35,200 particles per cubic meter or less ≥0.5 µm sized particles

• 8,320 particles per cubic meter or less ≥1 µm sized particles

• 293 particles per cubic meter or less ≥5 µm sized particles

Maximum Number of Particles in Air (particles per cubic meter)
ISO Class	FED-STD 209E   Equivalent	Particle Size
		>0.1µm	>0.2µm	>0.3µm	>0.5µm	>1µm	>5µm
ISO 1		10	2
ISO 2		100	24	10	4
ISO 3 | Class 1		1,000	237	102	35	8
ISO 4 | Class 10		10,000	2,370	1,020	352	83
ISO 5 | Class 100		100,000	23,700	10,200	3,520	832	29
ISO 6 | Class 1,000			237,000	102,000	35,200	8,320	293
ISO 7 | Class 10,000					352,000	83,200	2,930
ISO 8 | Class 100,000					3,520,000	832,000	29,300

 

ISO 6 Cleanroom Filtration Requirements

ISO 6 cleanrooms utilize recirculating air to achieve acceptable micron ratings. Within these systems, the air is exhausted through low-return air grills back to the plenum where the HEPA or ULPA fan filter units reclean the air and draw it back into the cleanroom.

ISO 6 Cleanroom Airflow & Air Change Rates Per Hour (ACPH) Standards

ISO 6 cleanroom standards mandate turbulent airflow and 180-240 air changes per hour of HEPA-filtered air. The air in the cleanroom must be recirculated and filtered continuously, ensuring that particles generated inside or introduced from the outside are removed. Additional ISO class 6 air change requirements include:

• Non-unidirectional airflow or mixed airflow patterns are typically used. Airflow is most commonly a vertical flow from the ceiling to the floor, returning for conditioning and filtration through low wall returns. 
• Typical air changes: 180-240 air changes per hour.
• Filtration Ceiling coverage is 25-40%, with a randomized array with filtration located over the highest control areas.
• HEPA filters capture 99.97% of particles that are 0.3 microns in diameter.
• ULPA filters offer an even higher efficiency, capturing 99.999% of particles 0.12 microns and larger.

ISO 6 Cleanroom Layout & Design

ISO 6 cleanroom and design principles dictate that each cleanroom design should optimize air quality and minimize contamination risks. Fundamental ISO 6 cleanroom design standards include:

Airflow Patterns

Using laminar airflow (unidirectional airflow) ensures that air moves in a controlled manner, minimizing turbulence and particle buildup.

Positive Pressure

Positive pressure helps to keep contaminants from entering the controlled environment. When doors are opened, the clean air flows outward rather than allowing contaminated air to flow in.

Isolated Zones

Cleanrooms are typically divided into different areas, such as gowning areas, buffer zones, and critical manufacturing spaces, with progressively stricter cleanliness standards.

Typical ISO 6 Cleanroom Applications

ISO 6 cleanrooms are typically used in the manufacturing of products in the following industries:

• Pharmaceutical
• Medical Device
• Biotechnology
• Electronics
• Aerospace

Contact NCI for ISO 6 Cleanrooms Today

Contact us for more information regarding ISO 6 (Class 1,000) hardwall and softwall cleanrooms, apparel, components, supplies, furniture, and equipment. NCI is your trusted source for premium ISO 6 cleanroom products.