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.

Installation Steps

• Environment Preparation

• Frame Assembly

• Filter and Fan Installation

• Commissioning

• Air Supply and Exhaust Volume Testing

• Airflow Control Inspection

• Inspection Instruments and Equipment

• Testing Standards and Criteria

• Testing Steps and Processes

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

ISO 6 Cleanrooms provide a controlled environment that is essential for research and development (R&D) in various industries, such as pharmaceuticals, biotechnology, and electronics. By maintaining a specified level of cleanliness and minimizing particle contamination, they enable precise experiments and testing. These cleanrooms ensure that R&D processes are not compromised by airborne contaminants, which is crucial when developing sensitive products or conducting high-precision tests.

2. What are the most common uses of an ISO 6 Cleanroom in manufacturing?

ISO 6 Cleanrooms are commonly used in manufacturing processes that require moderate contamination control. Some typical applications include:

• Pharmaceutical production: For drug formulation, testing, and packaging.

• Electronics manufacturing: For the assembly of semiconductors and other delicate components.

• Biotechnology: In lab environments for research or small-scale production of biotech products.

These cleanrooms ensure a controlled environment for manufacturing processes that demand minimal airborne contamination.

3. How do you reduce particle contamination during ISO 6 Cleanroom construction?

Reducing particle contamination during the construction of an ISO 6 Cleanroom involves several key steps:

• Use of Clean Materials: Selecting materials that generate fewer particles, such as stainless steel and smooth surfaces.

• Controlled Environment: Building the cleanroom in a controlled environment to prevent external contaminants from entering.

• Air Filtration: Ensuring that the air filtration system is operational during construction to remove airborne particles.

By following these practices, the cleanroom can meet its stringent cleanliness requirements once construction is complete.

4. Can ISO 6 Hardwall Cleanrooms be used for pharmaceutical manufacturing?

Yes, ISO 6 Hardwall Cleanrooms are suitable for pharmaceutical manufacturing, particularly for processes that do not require the extreme cleanliness of higher ISO classifications. They are ideal for certain stages of pharmaceutical production, such as:

• Drug packaging: Where contamination control is needed but not as strictly as in other stages.

• Formulation: For creating pharmaceutical products in a clean environment.

While not as clean as ISO 5 cleanrooms, ISO 6 provides sufficient control for many pharmaceutical processes.

5. How is air filtration efficiency measured in an ISO 6 Cleanroom?

Air filtration efficiency in an ISO 6 Cleanroom is typically measured using particle counters. These devices assess the number and size of particles in the air to ensure the cleanroom is meeting the required standards. The HEPA filters used in the cleanroom should remove 99.97% of particles greater than 0.3 microns. Regular testing ensures the efficiency of the filtration system and helps maintain the necessary cleanliness levels.

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

Waste management in an ISO 6 Hardwall Cleanroom is crucial to maintaining the clean environment. Key strategies include:

• Proper containment: Using sealed containers for waste to prevent contamination.

• Scheduled disposal: Regular removal of waste to prevent accumulation of particles.

• Training: Ensuring staff follow procedures to minimize contamination during waste handling.

Effective waste management ensures that the cleanroom environment remains controlled and free of contaminants.

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

To achieve ISO 6 certification, several tests are required to verify the cleanliness and operational efficiency of the cleanroom:

Particle count tests: To measure the number and size of airborne particles.

Airflow velocity tests: To ensure that air is circulating correctly and effectively.

Pressure differential tests: To verify that the cleanroom maintains the appropriate pressure to prevent contamination from external sources.

These tests ensure the cleanroom meets the ISO 14644-1 standards for cleanliness and performance.

8. What materials are used in an ISO 6 Hardwall Cleanroom?

The materials used in an ISO 6 Hardwall Cleanroom are chosen for their durability, ease of cleaning, and ability to minimize particle contamination. Common materials include:

• Steel: Used for frame structures and panels due to its strength.

• Aluminum: Lightweight and corrosion-resistant, often used in frames and doors.

• Composite panels: Provide insulation and improve contamination control.

These materials help maintain a clean, stable environment in the cleanroom.

9. What equipment is used to test an ISO 6 Hardwall Cleanroom?

To test the performance of an ISO 6 Hardwall Cleanroom, various equipment is used, including:

Particle counters: For measuring airborne particles.

Velometers: To test airflow velocity and ensure proper air distribution.

Manometers: To check air pressure differentials and verify the cleanroom’s integrity.

These testing tools ensure the cleanroom meets ISO standards and maintains its cleanliness.

10. How do you design airflow systems in an ISO 6 Cleanroom?

Designing airflow systems in an ISO 6 Cleanroom involves ensuring that the air is filtered, distributed, and exhausted effectively. The airflow system should be designed to:

• Provide unidirectional airflow: This minimizes particle buildup and contamination.

• Maintain positive pressure: Prevents external contaminants from entering the cleanroom.

• Ensure appropriate air changes per hour (ACH): Typically around 150 ACH for an ISO 6 cleanroom to maintain cleanliness.

Proper airflow design is crucial for maintaining the required air quality and cleanliness levels.

11. How is the airflow tested in an ISO 6 Cleanroom?

Airflow in an ISO 6 Cleanroom is tested using equipment like velometers and anemometers to measure air velocity and direction. Testing ensures that the air distribution is uniform, with air flowing from clean areas to less clean areas. The testing also verifies that the cleanroom maintains the required air changes per hour (ACH), which is critical for controlling contamination.

12. How do ISO 6 Hardwall Cleanrooms impact product quality?

ISO 6 Hardwall Cleanrooms significantly impact product quality by ensuring that manufacturing processes are carried out in a controlled environment with minimal contamination. By limiting airborne particles and other contaminants, these cleanrooms help reduce defects in products, particularly in sensitive industries like electronics, pharmaceuticals, and biotechnology. The controlled environment helps maintain the integrity and consistency of the production process, leading to higher-quality products.

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

A positive pressure environment is maintained in an ISO 6 Cleanroom by carefully controlling the airflow. This is achieved by:

• Constantly circulating filtered air: Ensures that the air pressure inside the cleanroom is higher than the surrounding areas.

• Regular monitoring of air pressure differentials: To verify that the positive pressure is maintained.

• Using airlocks and tightly sealed doors: To prevent air from entering when the cleanroom is opened.

These measures ensure that contaminants from outside the cleanroom are prevented from entering.

14. 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 the level of cleanliness and the particle count. ISO 5 cleanrooms allow for a maximum of 3,520 particles per cubic meter, whereas ISO 6 allows up to 35,200 particles per cubic meter. ISO 5 cleanrooms are used in more sensitive processes that require stricter contamination control, such as semiconductor manufacturing, while ISO 6 is suitable for processes that need moderate cleanliness, such as drug packaging or assembly of non-sensitive electronics.

15. How do you control particulate matter in an ISO 6 Cleanroom?

Particulate matter in an ISO 6 Cleanroom is controlled through a combination of air filtration, airflow management, and routine cleaning. Key methods include:

• HEPA filtration: Removes 99.97% of airborne particles.

• Unidirectional airflow: Reduces the accumulation of particles.

• Regular cleaning: Ensures surfaces and equipment remain free from particles.

By implementing these strategies, particulate matter is minimized, helping to maintain the cleanroom's specified particle count.