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

ISO 6 Cleanrooms support research and development activities by providing a controlled environment that minimizes contamination risks. This clean environment is crucial for experiments and processes in fields such as pharmaceuticals, biotechnology, and electronics, where even the smallest particles can impact results. The cleanroom's precise air filtration, temperature, humidity, and airflow controls create ideal conditions for testing and innovation.

2. How does the airflow velocity impact cleanroom performance?

Airflow velocity in a cleanroom significantly impacts its performance by determining how effectively contaminants are removed from the environment. Proper airflow ensures that airborne particles are efficiently filtered out, maintaining the desired cleanliness level. A high airflow velocity can help reduce the accumulation of particles, while an inadequate flow might result in contamination and failure to meet the required standards.

3. How does humidity control work in an ISO 6 Cleanroom?

Humidity control in an ISO 6 Cleanroom is achieved through an HVAC system that adjusts and maintains the relative humidity at a constant level, typically between 40-60%. The system uses dehumidifiers or humidifiers as necessary to ensure that humidity levels do not fluctuate, which is crucial for maintaining product integrity, preventing static build-up, and ensuring optimal conditions for processes such as semiconductor manufacturing or drug production.

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

Waste management in an ISO 6 Hardwall Cleanroom involves using sealed containers to prevent contaminants from escaping into the environment. All waste materials are handled with care and disposed of according to strict guidelines. Waste removal is conducted frequently to ensure the cleanroom remains uncontaminated and continues to meet cleanliness standards for sensitive operations.

5. How does a cleanroom’s design affect its performance?

The design of a cleanroom plays a critical role in its performance by influencing air circulation, contamination control, and space utilization. For example, the choice of materials, airflow direction, and filter placement can all impact the cleanroom's ability to maintain a controlled environment. A well-designed cleanroom ensures optimal air quality, minimizes the risk of contamination, and meets industry-specific requirements for cleanliness.

6. How do you measure particle size in an ISO 6 Cleanroom?

Particle size in an ISO 6 Cleanroom is typically measured using laser particle counters, which detect and measure the size of particles in the air. These counters provide real-time data on particle concentrations, helping to ensure the cleanroom meets ISO 6 standards for cleanliness. The measurement of particle size allows for accurate assessment of air quality and cleanroom performance.

7. What are the key components of an ISO 6 Hardwall Cleanroom?

Key components of an ISO 6 Hardwall Cleanroom include:

Rigid walls: Provide structural stability and prevent contamination from outside.

HEPA filters: Remove airborne particles to maintain cleanliness.

HVAC system: Regulates airflow, temperature, and humidity for optimal cleanroom conditions.

These components work together to maintain the environment required for sensitive processes.

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

For ISO 6 certification, cleanroom testing includes particle count testing to measure the airborne particle concentration, airflow velocity testing to ensure proper airflow and air changes per hour, and pressure differential testing to verify that the cleanroom maintains a positive pressure relative to surrounding areas. These tests ensure that the cleanroom meets the cleanliness standards defined by ISO 14644-1.

9. How often should the air pressure be tested in an ISO 6 Cleanroom?

Air pressure in an ISO 6 Cleanroom should be tested regularly to ensure the positive pressure is maintained. It is typically tested at least once a month or after any major changes to the HVAC system or cleanroom layout. Routine testing ensures that the cleanroom remains at the correct pressure differential, preventing contaminants from entering the controlled environment.

10. How do you maintain a positive pressure environment in an ISO 6 Cleanroom?

To maintain a positive pressure environment in an ISO 6 Cleanroom, an HVAC system is used to continuously supply filtered air into the cleanroom. This system ensures that the air pressure inside the cleanroom is higher than the surrounding areas, preventing contaminants from entering when doors or windows are opened. Regular monitoring and adjustments help maintain this positive pressure.

11. What is the ideal flooring material for an ISO 6 Hardwall Cleanroom?

The ideal flooring material for an ISO 6 Hardwall Cleanroom should be smooth, non-porous, and easy to clean. Common materials include epoxy resin flooring and vinyl flooring. These materials are durable, resistant to chemical spills, and help minimize particle contamination, ensuring the cleanroom maintains the required cleanliness standards.

12. What is the difference between ISO 6 and ISO 5 Hardwall Cleanrooms?

The main difference between ISO 6 and ISO 5 Hardwall Cleanrooms lies in their cleanliness levels. An ISO 6 Cleanroom allows up to 35,200 particles per cubic meter (≥0.5 microns), whereas an ISO 5 Cleanroom allows only 3,520 particles per cubic meter. ISO 5 provides stricter contamination control and is typically used in more sensitive environments, such as semiconductor fabrication or high-precision pharmaceutical manufacturing.

13. What are the environmental controls in an ISO 6 Hardwall Cleanroom?

Environmental controls in an ISO 6 Hardwall Cleanroom include airflow management, temperature control, humidity regulation, and particle filtration. The HVAC system is responsible for controlling temperature and humidity within specified ranges, while HEPA filters ensure that airborne particles are removed. These controls help maintain a stable and clean environment for sensitive manufacturing or research activities.

14. What are the advantages of using hardwall construction over softwall?

Hardwall construction offers several advantages over softwall:

• Stability: Rigid walls provide greater structural integrity.

• Better contamination control: Hardwalls prevent external contaminants from entering the cleanroom more effectively.

• Ease of cleaning: Hardwall cleanrooms are easier to maintain and keep free from particles compared to softwall designs.

These benefits make hardwall cleanrooms a preferred choice for industries with strict cleanliness requirements.

15. What materials should be avoided in an ISO 6 Cleanroom?

In an ISO 6 Cleanroom, materials that shed particles or generate contamination should be avoided. These include:

• Carpet: Can trap dust and particles, making it difficult to maintain cleanliness.

• Textiles: Fabrics can release fibers and lint into the air.

• Wood: It can produce dust and particles that are difficult to control.

Using non-shedding, non-porous materials is essential to maintaining a clean environment.

16. What are the most common contaminants in an ISO 6 Cleanroom?

The most common contaminants in an ISO 6 Cleanroom include:

• Dust: Small particles that can settle on surfaces or enter the air.

• Fibers: Lint or textile fibers that can be released by clothing or materials.

• Microorganisms: Bacteria, fungi, and viruses that can affect sensitive processes.

Effective filtration, regular cleaning, and strict protocols help prevent these contaminants from affecting the cleanroom environment.