To maintain ISO 5 classification, the following criteria must be met:

Particle Concentration Limits (per cubic meter of air)

0.5 microns: ≤ 3,520 particles

5 microns: ≤ 0.1 particles (the particle count drops significantly for larger particles)

Class 100 (in U.S. classification): ISO 5 cleanrooms are often referred to as Class 100 cleanrooms in the U.S. classification system.

Airflow Design

• Laminar or Unidirectional Airflow: To maintain the cleanliness, air must flow in a uniform direction, typically from ceiling to floor, with minimal turbulence to prevent particles from settling.

• HEPA or ULPA Filters: Air is filtered through High-Efficiency Particulate Air (HEPA) or Ultra-Low Penetration Air (ULPA)filters that capture particles down to 0.3 microns or smaller. ULPA filters provide even higher efficiency, capturing particles down to 0.12 microns.

1. What is the airflow design for a Hardwall Cleanroom?

The airflow design for a Hardwall Cleanroom typically features a unidirectional flow system, where air is supplied from the ceiling and flows towards the floor in a controlled manner. This design helps to continuously remove airborne particles and maintain clean conditions. HEPA filters are used to filter out contaminants, and the airflow is balanced to maintain proper air pressure and circulation, ensuring the cleanroom meets the required cleanliness standards.

2. How does the airflow velocity impact cleanroom performance?

Airflow velocity directly influences a cleanroom’s ability to control particle contamination. Proper airflow ensures that airborne particles are efficiently removed, preventing contamination of sensitive materials and processes. Too low a velocity can result in stagnant air and contamination buildup, while excessively high velocity might disturb settled particles, affecting cleanliness and stability. Maintaining optimal airflow velocity is crucial for meeting ISO 6 standards.

3. What are the health and safety requirements for ISO 6 Cleanrooms?

Health and safety requirements for ISO 6 Cleanrooms include ensuring that all personnel wear appropriate protective clothing such as gowns, gloves, and masks to prevent contamination. The cleanroom must also maintain positive air pressure, preventing outside contaminants from entering. Furthermore, adequate ventilation must be provided to ensure that the air quality is safe for workers, and all equipment should comply with safety standards to minimize any risks associated with the cleanroom environment.

4. What types of cleanroom testing are required for ISO 6 certification?

To achieve ISO 6 certification, several tests are required, including particle count testing to assess airborne contamination levels, airflow velocity testing to ensure proper air distribution, and pressure differential testing to verify that the cleanroom maintains a positive pressure. These tests are essential to confirm that the cleanroom meets the ISO 14644-1 standards for air cleanliness and contamination control.

5. How many air changes per hour are needed for an ISO 6 Cleanroom?

An ISO 6 Cleanroom typically requires 20 to 60 air changes per hour (ACH) to ensure that the air remains clean and free of contaminants. The exact number depends on the specific requirements of the cleanroom’s design and use. Adequate air changes are critical for maintaining the cleanliness standards required for sensitive processes and ensuring that the air is constantly filtered to remove particles.

6. How does an ISO 6 Hardwall Cleanroom improve production efficiency?

An ISO 6 Hardwall Cleanroom improves production efficiency by providing a stable, controlled environment with minimal contamination. By maintaining consistent airflow, temperature, and humidity, it helps prevent defects caused by airborne particles. This results in fewer product reworks and defects, leading to improved yield, lower downtime, and overall enhanced operational efficiency in industries such as pharmaceuticals and electronics.

7. How is air pressure controlled in an ISO 6 Hardwall Cleanroom?

Air pressure in an ISO 6 Hardwall Cleanroom is controlled through the HVAC system by maintaining a continuous supply of filtered air, ensuring the cleanroom remains at a positive pressure relative to surrounding areas. This positive pressure prevents contaminants from entering the cleanroom when doors or windows are opened. Regular monitoring and adjustments are made to maintain the pressure differential, ensuring consistent cleanroom conditions.

8. What are the costs associated with installing an ISO 6 Cleanroom?

The costs associated with installing an ISO 6 Cleanroom include construction costs, HVAC system installation, air filtration units, and environmental control systems. Additional costs might include testing and validation to ensure compliance with ISO standards. The total cost can vary based on the size of the cleanroom, complexity of the design, and industry-specific requirements, but it generally represents a significant investment in infrastructure.

9. How do you manage waste in an ISO 6 Hardwall Cleanroom?

Waste management in an ISO 6 Hardwall Cleanroom is handled with great care to avoid contaminating the environment. Waste is placed in sealed, non-permeable containers and is frequently removed to prevent buildup. All materials used for cleaning and waste disposal must be non-shedding to ensure no additional contaminants are introduced. A strict waste disposal protocol ensures that any waste generated does not compromise the cleanroom’s integrity.

10. What is an ISO 6 Hardwall Cleanroom?

An ISO 6 Hardwall Cleanroom is a controlled environment designed to meet the cleanliness standards set by ISO 14644-1 for Class 6. This type of cleanroom has rigid walls, HEPA filtration systems, and precise airflow management to ensure that airborne particles are kept below 35,200 particles per cubic meter at 0.5 microns. It is used in industries such as pharmaceuticals, biotechnology, and electronics, where a clean environment is crucial for the production and research processes.

11. How do ISO 6 Cleanrooms support research and development activities?

ISO 6 Cleanrooms support research and development activities by providing a controlled and sterile environment, reducing the risk of contamination in sensitive experiments and processes. By maintaining stringent particle control, temperature, humidity, and airflow standards, these cleanrooms ensure that research and development efforts are not compromised by external contaminants, fostering accurate results and innovation in fields such as pharmaceuticals and electronics.

12. How do ISO 6 Hardwall Cleanrooms maintain humidity control?

Humidity control in ISO 6 Hardwall Cleanrooms is achieved through the HVAC system, which uses humidifiers and dehumidifiers to maintain a consistent relative humidity level, typically between 40-60%. Proper humidity regulation is crucial for preventing static build-up, maintaining product integrity, and ensuring that sensitive materials or equipment are not damaged by fluctuations in moisture levels.

13. Can ISO 6 Hardwall Cleanrooms be used in biotechnology?

Yes, ISO 6 Hardwall Cleanrooms are suitable for use in biotechnology, as they provide a controlled environment that meets the necessary cleanliness and contamination control standards required for research and production. These cleanrooms support activities such as cell culture and genetic research, where contamination can impact the quality of results and the effectiveness of the processes.

14. What are the typical dimensions of an ISO 6 Hardwall Cleanroom?

The typical dimensions of an ISO 6 Hardwall Cleanroom can vary depending on the specific application and space requirements. However, common sizes range from 5 x 5 meters to 10 x 10 meters or larger. The design is highly customizable to fit the needs of the particular processes or research activities that will take place inside the cleanroom.

15. How do you clean an ISO 6 Hardwall Cleanroom?

Cleaning an ISO 6 Hardwall Cleanroom involves using non-shedding materials to wipe down surfaces and remove contaminants. The cleaning procedure is scheduled regularly and includes disinfecting walls, floors, ceilings, and equipment. Only approved cleaning agents and methods are used to prevent introducing new contaminants, and the cleanroom is regularly monitored for cleanliness to ensure it meets the required standards.

16. What are the common maintenance challenges in an ISO 6 Cleanroom?

Common maintenance challenges in an ISO 6 Cleanroom include maintaining HEPA filters, ensuring the HVAC system operates efficiently, and managing airflow to meet cleanliness standards. Other challenges include controlling humidity and temperature fluctuations, as well as maintaining the cleanliness of surfaces and equipment. Regular monitoring and preventative maintenance are essential to avoid disruptions and ensure the cleanroom remains in optimal condition.