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 an ISO 6 Hardwall Cleanroom?

An ISO 6 Hardwall Cleanroom is a controlled environment designed to meet the cleanliness standards of ISO 14644-1, specifically classified as ISO 6. This classification allows a maximum particle count of 35,200 particles per cubic meter for particles greater than 0.5 microns. The cleanroom features rigid hardwall construction, typically made of materials like steel or composite panels, which provide durability and easy maintenance. It is commonly used in industries where a moderate level of contamination control is necessary.

2. What are the benefits of a Hardwall Cleanroom?

Hardwall cleanrooms, such as the ISO 6 version, offer several advantages:

• Durability: The rigid panels ensure long-term structural integrity, providing a stable environment for sensitive processes.

• Particle Control: Effective at maintaining low contamination levels by using advanced air filtration systems and sealed environments.

• Easy Maintenance: Hardwall construction is easy to clean and maintain compared to softwall options, ensuring a consistently high level of cleanliness.

Overall, Hardwall Cleanrooms are ideal for processes that require a stable, controlled environment with minimal contamination risk.

3. How does an ISO 6 Hardwall Cleanroom differ from other cleanrooms?

ISO 6 Hardwall Cleanrooms offer moderate contamination control compared to other ISO classifications like ISO 5 or ISO 7. These cleanrooms are specifically designed to allow a maximum particle count of 35,200 particles per cubic meter, which is higher than stricter classifications such as ISO 5. The main differences include:

• Air Quality: ISO 6 cleanrooms allow a higher particle count than ISO 5.

• Construction: Hardwall cleanrooms have rigid panels, offering better durability and ease of cleaning than softwall cleanrooms.

• Applications: ISO 6 cleanrooms are suitable for industries that don't require the extreme cleanliness of ISO 5 but still need a controlled environment, such as in some pharmaceutical, electronics, or research fields.

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

ISO 6 Hardwall Cleanrooms are typically constructed with durable materials that minimize particle shedding and contamination. These materials include:

Steel: Provides strength, durability, and ease of cleaning.

Aluminum: Lightweight and resistant to corrosion, often used for frame structures.

Composite Panels: Offer thermal insulation and improved contamination control properties.

These materials are selected for their ability to maintain a sterile environment and facilitate regular cleaning.

5. What is the particle count requirement for an ISO 6 Cleanroom?

For an ISO 6 Cleanroom, the particle count must not exceed 35,200 particles per cubic meter for particles larger than 0.5 microns. This limit ensures that the environment is suitable for moderate contamination-sensitive operations, like certain pharmaceutical or electronic manufacturing processes. The cleanliness standard is less strict compared to ISO 5 but still provides adequate control for many industrial applications.

6. How do you maintain an ISO 6 Hardwall Cleanroom?

Maintaining an ISO 6 Hardwall Cleanroom involves several key practices to ensure a clean environment:

Regular Cleaning: Routine cleaning of surfaces, floors, and air ducts to prevent the accumulation of contaminants.

Filter Replacement: Periodic replacement of HEPA filters and other filtration systems to maintain air quality.

Monitoring: Regular particle count testing and airflow validation to ensure the cleanroom meets ISO standards.

Proper maintenance ensures that the cleanroom remains within the required cleanliness level for safe and efficient operations.

7. What industries use ISO 6 Hardwall Cleanrooms?

ISO 6 Hardwall Cleanrooms are used across several industries that require moderate contamination control, including:

• Pharmaceuticals: For drug production and research where a sterile environment is necessary but not as stringent as ISO 5.

• Electronics: In semiconductor manufacturing or assembly processes that demand a clean environment to prevent defects.

• Biotechnology: For lab research where controlled environmental conditions are crucial.

These industries benefit from the balance of cleanliness and operational efficiency that an ISO 6 cleanroom provides.

8. What is the air filtration system used in an ISO 6 Hardwall Cleanroom?

An ISO 6 Hardwall Cleanroom typically employs HEPA (High-Efficiency Particulate Air) filters, which can remove 99.97% of particles that are 0.3 microns or larger. The filtration system is designed to maintain air quality by continuously removing airborne particles, preventing contamination of the controlled environment. The HEPA filters are a key component in meeting ISO 6 cleanliness standards.

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

For an ISO 6 Cleanroom, a minimum of 150 air changes per hour (ACH) is required to maintain appropriate cleanliness levels. The high rate of air exchanges ensures the constant removal of airborne contaminants and the introduction of fresh, filtered air, which is critical for maintaining the cleanroom's specified particle count.

10. What is the airflow design in an ISO 6 Hardwall Cleanroom?

ISO 6 Hardwall Cleanrooms typically use laminar airflow systems, where air flows in a unidirectional manner. This design minimizes the risk of particle contamination by ensuring that airborne particles are carried in a specific direction, usually toward air vents or filters. The cleanroom's air pressure and flow are carefully designed to prevent the entry of external contaminants.

11. How is temperature controlled in an ISO 6 Cleanroom?

Temperature control in an ISO 6 Cleanroom is achieved through a combination of HVAC systems that regulate the air temperature to ensure a stable environment. The typical temperature range is maintained between 18-24°C (64-75°F), depending on the specific requirements of the industry. Temperature regulation is crucial to prevent any thermal-related contamination or instability in sensitive processes.

12. What is the role of HEPA filters in an ISO 6 Hardwall Cleanroom?

HEPA filters play a vital role in maintaining the cleanliness of an ISO 6 Hardwall Cleanroom by removing airborne particles from the air. These filters capture 99.97% of particles larger than 0.3 microns, ensuring that the cleanroom environment stays free from harmful contaminants. HEPA filters are integral to achieving and maintaining the particle count requirements for ISO 6 certification.

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

Yes, ISO 6 Hardwall Cleanrooms are commonly used in pharmaceutical manufacturing. While they do not provide the ultra-cleanliness of ISO 5, ISO 6 cleanrooms offer adequate contamination control for less sensitive pharmaceutical processes, such as formulation, packaging, and certain stages of drug development. They ensure a controlled environment that meets industry standards for cleanliness without the need for more expensive ISO 5 cleanrooms.

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

The dimensions of an ISO 6 Hardwall Cleanroom can vary based on specific needs and space requirements. Common configurations include:

• Small cleanrooms: Around 2 x 3 meters (ideal for small-scale production or testing).

• Larger cleanrooms: Can be custom-designed for more expansive operations, with dimensions tailored to the process requirements.

Cleanroom dimensions depend on the application, available space, and equipment needs.

15. What certifications are needed for an ISO 6 Hardwall Cleanroom?

To ensure compliance, an ISO 6 Hardwall Cleanroom must undergo certification under the ISO 14644-1 standard. This involves rigorous testing to verify particle count, airflow, temperature, humidity, and other environmental factors. Additionally, manufacturers may require specific certifications for their cleanroom, such as cGMP (current Good Manufacturing Practice) for pharmaceutical applications, ensuring compliance with industry-specific regulations.

16. How do you achieve ISO certification for a Hardwall Cleanroom?

Achieving ISO certification for a Hardwall Cleanroom involves several key steps:

• Design and Construction: Ensure the cleanroom is built according to ISO 14644-1 standards, with attention to materials, airflow, and environmental controls.

• Testing: Conduct particle count tests, airflow assessments, and other necessary environmental measurements to verify compliance.

• Documentation: Submit all necessary documentation to an accredited certifying body for review and approval.