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Understanding ISO Class 10 Cleanrooms
What is a Class 10 Clean Room?
An ISO10 cleanroom is a controlled environment defined by the ISO 14644-1 standard for particulate cleanliness. This classification refers to the maximum allowable particle count of airborne particles of a specified size within a cubic meter of air. An ISO10 cleanroom allows no more than 10,000 particles per cubic meter of air for particles 0.5 microns or larger.
These cleanrooms are commonly used in industries where a high level of cleanliness is required but not to the extent of more stringent classifications (such as ISO1 or ISO 5). Typical industries that use ISO10 cleanrooms include pharmaceutical manufacturing, microElectronics, Semiconductor production, and aerospace.
Cleanroom Classification
Airborne Particle Limits
The ISO10 cleanroom is designed to maintain a specific particle count in the air, limiting contamination to 10,000 particles per cubic meter for particles ≥0.5 microns. This is essential for sensitive manufacturing processes where even the smallest particles can lead to defects.
Particle Size Limits
In an ISO10 cleanroom, the maximum allowable number of particles is 10,000 per cubic meter, with each particle measuring 0.5 microns or larger. These particles are considered the most significant source of contamination in sensitive environments.
Cleanroom Design Requirements
Filtration Systems
To achieve ISO10 status, HEPA filters are installed to capture airborne contaminants. Additionally, proper pressurization helps maintain the flow of clean air into the room, preventing the intrusion of external contaminants.
The room's construction and materials must also be compatible with high levels of cleanliness, using non-shedding materials that do not contribute to particulate contamination.
Environmental Controls
Temperature, humidity, and pressure are closely controlled in Class 10 cleanrooms to prevent any external factors from contributing to contamination.
Air Changes Per Hour
Air Changes Per Hour (ACH) is a key parameter in cleanroom design, indicating how many times the air volume is replaced within one hour. For Class 10 cleanrooms, maintaining a minimum of 30 air changes per hour is typically required to ensure sufficient particle removal and to maintain cleanliness.
The higher the ACH, the more effective the cleanroom is in maintaining a sterile environment. A high rate of air exchange is achieved using HEPA or ULPA filtration systems that continuously filter particles from the air.
| Cleanroom Class | Particles/m³ (≥0.5µm) | Typical ACH |
|---|---|---|
| ISO 1 | 10 | 300-600 |
| ISO 5 | 3,520 | 200-300 |
| ISO 10 | 10,000 | 30-60 |
Industry Applications
Semiconductor Manufacturing
ISO10 cleanrooms are essential in semiconductor manufacturing, where even minute contamination can result in significant product defects, compromising the quality and functionality of electronic components.
- HEPA and ULPA filters trap particles down to 0.3 microns
- Regular monitoring of airborne particles is essential
- Positive air pressure prevents particle infiltration
Pharmaceutical Production
In pharmaceutical manufacturing, cleanrooms prevent contamination of drugs and medical products, ensuring patient safety and regulatory compliance.
- Stringent gowning procedures for personnel
- Continuous air quality monitoring
- Compliance with GMP Standards
iso 14644-1 vs. Other Standards
Cleanroom classification is vital for ensuring product quality and safety by defining acceptable airborne particle levels and contamination control. ISO 14644-1 is the global standard for cleanroom classification, compared with FED 209E and other related standards.
Key Features of ISO 14644-1:
- Uses particle size and concentration as primary criteria
- Defines cleanrooms from ISO1 (cleanest) to ISO9 (least clean)
- Focuses on counting airborne particles of size 0.5 microns or larger
- Applicable across pharmaceuticals, semiconductor manufacturing, and biotechnology
Conclusion
An ISO10 cleanroom provides a controlled environment with strict limits on particulate contamination. It is less stringent than higher classes (such as ISO1), but it still offers a high level of cleanliness necessary for sensitive processes in industries like pharmaceuticals, electronics, and aerospace. Cleanroom design and operations ensure that particle levels are kept within the specified limits to protect products, processes, and equipment from contamination.
