A Class 8 clean room, also known as an ISO 8 cleanroom or a Class 100,000 cleanroom, is a controlled environment designed to minimize particulate contamination, specifically allowing a maximum particle count of 100,000 particles (≥0.5µm) per cubic foot of interior air.
These rooms are essential in industries where even minute particles can negatively impact production or research outcomes.
Key Characteristics of a Class 8 Clean Room:
- Particle Count Limit: As the name suggests, the primary defining characteristic is the maximum allowable particle concentration. ISO 8 / Class 100,000 allows for 100,000 particles of size 0.5µm or larger per cubic foot.
- Airflow and Filtration: Typically utilizes HEPA (High-Efficiency Particulate Air) filtration systems to remove particles from the air. Airflow patterns are designed to further minimize particle accumulation.
- Construction: Can be either modular hardwall (using rigid panels) or soft-walled (using flexible curtains) depending on the application and budget.
- Personnel Protocols: Strict gowning procedures and entry/exit protocols are enforced to prevent contamination from personnel.
- Regular Monitoring: Particle counts are routinely monitored to ensure the cleanroom maintains its classification.
Applications:
Class 8 clean rooms are used in a variety of industries, including:
- Pharmaceutical Manufacturing: For certain non-sterile processes.
- Electronics Assembly: Where dust can interfere with sensitive components.
- Food and Beverage Processing: To minimize contamination and extend shelf life.
- Cosmetics Manufacturing: To ensure product purity.
- Packaging: For medical devices and other sensitive products.
Comparison to Other Cleanroom Classes:
Cleanrooms are classified based on ISO standards ranging from ISO 1 (cleanest) to ISO 9 (least clean). Class 8 represents a moderate level of cleanliness. A lower ISO number means fewer particles are permitted. For example, an ISO 7 cleanroom (Class 10,000) allows only 10,000 particles (≥0.5µm) per cubic foot, making it a significantly cleaner environment than an ISO 8 cleanroom.
Maintaining a Class 8 Cleanroom:
Proper maintenance is critical for ensuring a Class 8 cleanroom operates effectively:
- Regular Filter Changes: HEPA filters need to be replaced periodically to maintain their efficiency.
- Cleaning Procedures: Routine cleaning using appropriate disinfectants is essential.
- Personnel Training: Proper gowning and entry/exit procedures must be strictly followed.
- Particle Monitoring: Regular air particle testing is crucial to identify potential problems.
In summary, a Class 8 cleanroom provides a controlled environment with a defined particle count limit, crucial for applications where minimizing contamination is essential for product quality and reliability.
