An ISO 7 cleanroom is a controlled environment designed to minimize airborne particles, ensuring a specific level of cleanliness crucial for various industries. Defined by the ISO 14644-1 standard, it allows for a maximum of 352,000 particles 0.5 micrometers or larger per cubic meter of air. This makes it a moderately clean environment, suitable for many applications.
Understanding ISO 7 Cleanroom Classification
The ISO 7 classification is part of a broader system (ISO 14644-1) that categorizes cleanrooms based on particle concentration. Lower ISO numbers indicate a higher level of cleanliness. An ISO 7 cleanroom, also sometimes referred to as a Class 10,000 cleanroom (using the older FED-STD-209E standard), sits in the middle range of cleanliness.
- Particle Count: The key characteristic is the maximum allowable particle count per cubic meter of air. This is strictly controlled to maintain the environment's cleanliness.
- Air Changes per Hour (ACH): High ACH, typically around 60 changes per hour, is a common requirement to help remove particles and maintain the ISO 7 standard. HEPA filtration systems are vital in achieving this.
- Applications: ISO 7 cleanrooms find use in various industries, including:
- Pharmaceutical manufacturing: For processes sensitive to contamination.
- Medical device production: Ensuring sterility and preventing contamination.
- Electronics assembly: Minimizing the risk of dust or particle damage to sensitive components.
- Research laboratories: Providing a controlled environment for experiments.
Key Features of an ISO 7 Cleanroom
- HEPA Filtration: High-Efficiency Particulate Air (HEPA) filters are essential, removing a large percentage of airborne particles.
- Controlled Airflow: Precisely controlled airflow patterns prevent the buildup of particles and maintain a uniform environment.
- Hard-walled or Soft-walled construction: Both types are possible, depending on the specific needs and budget. Hard-walled cleanrooms offer better environmental control. Modular wall facilities are also commonly used.
- Monitoring and Maintenance: Regular monitoring and maintenance are essential to ensure the cleanroom continuously meets the ISO 7 standard.
In summary, an ISO 7 cleanroom offers a controlled environment with a specified limit on airborne particles, making it suitable for applications requiring moderate cleanliness. The specific requirements and design can vary depending on the application and industry.
