A Class 8 cleanroom — defined under ISO 14644-1 standards — is one of the most commonly used cleanroom classifications across a variety of industries. From electronics and optics to industrial manufacturing and medical device packaging, Class 8 cleanrooms offer controlled environments that reduce particulate contamination while maintaining cost-efficiency.
What Is a Class 8 Cleanroom?
An ISO Class 8 cleanroom allows up to 3,520,000 particles (≥0.5 µm) per cubic meter of air, making it suitable for environments that require moderate contamination control. It corresponds roughly to Class 100,000 under the now-obsolete FED-STD-209E standard.
While not as stringent as Class 7 or Class 5 environments, Class 8 cleanrooms are often sufficient for:
Assembly of non-critical electronic components
Industrial or automotive parts handling
Pre-cleaning or packaging zones for higher-class cleanrooms
Cosmetics, plastics, or optics-related production
Air Change Rates and Filtration
Maintaining proper airflow and filtration is critical to meeting ISO 8 standards. The key parameters include:
Air Changes per Hour (ACH):
20–30 air changes per hour is the typical requirement
This ensures a consistent flush of contaminants from the room
Air change rate varies based on process sensitivity and personnel density
HEPA Filtration:
HEPA filters must remove at least 99.97% of particles ≥0.3 µm
Filters are often located in ceiling grid layouts to ensure laminar or turbulent air distribution
Airflow Design:
While Class 8 cleanrooms may use turbulent airflow, critical processes can still benefit from directed laminar zones
Return air grilles are often placed low on the wall to facilitate downward flow
Structural and Design Considerations
ISO 8 cleanrooms can be constructed using a variety of materials and modular options depending on space, budget, and intended use:
| Type | Description |
|---|---|
| Hardwall | Rigid wall panels for enhanced durability and containment |
| Softwall | Flexible PVC curtain enclosures for low-cost, easy-to-install setups |
| Modular | Pre-engineered systems offering quick deployment and scalability |
Common materials include powder-coated steel, aluminum, and anti-static PVC. Flooring is often ESD-safe or vinyl depending on the application.
Cleanroom Gowning and Entry Controls
Personnel are a primary source of contamination in any cleanroom environment. ISO 8 environments typically require:
Basic gowning procedures, including lab coats, hair nets, gloves, and shoe covers
Airlocks or gown rooms to separate controlled areas from external zones
Pass-through chambers to transfer materials without disrupting airflow
Monitoring and Validation
ISO 8 cleanrooms must undergo qualification and routine monitoring in accordance with ISO 14644-2 guidelines.
Key validation steps include:
Particle count testing using a calibrated particle counter
HEPA filter integrity testing (DOP/PAO tests)
Airflow measurement and smoke visualization
Temperature and humidity control checks
Validation is typically done at three phases:
As-built (no equipment/personnel)
At rest (equipment installed, idle)
Operational (normal working condition)
Typical Applications of ISO 8 Cleanrooms
ISO Class 8 cleanrooms are widely used in industrial and manufacturing sectors, including:
Plastic and polymer molding
Aerospace composite material handling
Optical assemblies and sensor components
Conclusion
ISO Class 8 cleanrooms offer a practical solution for environments that require contamination control without the cost or complexity of ultra-clean spaces. By meeting key requirements for air change rates, HEPA filtration, gowning protocols, and structural design, manufacturers can ensure process integrity, compliance, and consistent product quality.
