Understanding ISO 5 and ISO 8 Cleanrooms: Standards, Requirements, and Key Differences
In industries such as pharmaceuticals, biotechnology, electronics, and healthcare, maintaining a controlled environment is essential to ensure product quality and safety. Cleanrooms are specially designed spaces that control airborne particles, temperature, humidity, and pressure. Among the various classifications, ISO 5 and ISO 8 cleanrooms are two of the most commonly used standards, each serving specific purposes based on cleanliness requirements.
What Is an ISO Cleanroom?
An ISO cleanroom is classified according to the International Organization for Standardization (ISO) 14644-1 standard, which defines the maximum allowable particle concentration per cubic meter of air. The classification ranges from ISO Class 1 (the cleanest) to ISO Class 9 (the least clean). The lower the class number, the fewer particles are permitted, meaning a more controlled environment.
ISO 5 Cleanroom
An ISO 5 cleanroom is one of the highest cleanliness levels used in industries that require extremely low particle contamination. This environment allows a maximum of 3,520 particles (≥0.5 µm) per cubic meter of air.
Typical applications include:
Semiconductor manufacturing
Pharmaceutical aseptic filling areas
Nanotechnology and optical product assembly
Advanced medical device production
To maintain such high standards, ISO 5 cleanrooms use High-Efficiency Particulate Air (HEPA) or Ultra-Low Penetration Air (ULPA) filters, laminar airflow systems, and strict gowning protocols. Air changes can range from 240 to 360 per hour, ensuring constant filtration and purity.
ISO 8 Cleanroom
An ISO 8 cleanroom allows a higher particle count, with up to 3,520,000 particles (≥0.5 µm) per cubic meter of air. While not as stringent as ISO 5, ISO 8 environments still require precise control and are suitable for processes that do not involve direct product exposure to contaminants.
Common uses include:
Packaging and preparation areas
Pharmaceutical support zones
Electronics assembly and testing
Laboratory and research spaces
The airflow rate in ISO 8 cleanrooms is much lower, typically 10 to 25 air changes per hour, and HEPA filtration is used to maintain cleanliness.
Key Differences Between ISO 5 and ISO 8 Cleanrooms
Feature ISO 5 Cleanroom ISO 8 Cleanroom
Particle Limit (≥0.5 µm) 3,520 per m³ 3,520,000 per m³
Air Changes per iso class 5 cleanroom Hour 240–360 10–25
Filtration Type HEPA/ULPA HEPA
Airflow Pattern Laminar (unidirectional) Turbulent
Typical Applications Critical production zones General support areas
ISO 8 Clean Room Requirements
To comply with ISO 8 clean room requirements, facilities must maintain specific environmental controls, including:
Proper air filtration using HEPA filters.
Pressure differentials to prevent contamination from adjacent areas.
Temperature and humidity regulation for product stability.
Routine monitoring and testing to verify air cleanliness levels.
Personnel gowning and hygiene protocols to minimize particle introduction.
Conclusion
Both ISO 5 and ISO 8 cleanrooms play essential roles in contamination control across various industries. The key difference lies in their level of cleanliness and application purpose. ISO 5 environments are required for the most sensitive manufacturing processes, while ISO 8 cleanrooms serve as controlled areas that support less critical operations.