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 you install and maintain HEPA filters in an ISO 6 Cleanroom?

HEPA filters in an ISO 6 Cleanroom are installed within the cleanroom's HVAC system, typically in the ceiling or wall units. Proper sealing is essential to prevent air bypass and ensure filtration efficiency. Regular maintenance involves checking the filters for damage, cleaning or replacing them as needed, and conducting performance tests to ensure they continue to meet the required standards for particle removal.

2. How do you ensure the cleanliness of surfaces in an ISO 6 Hardwall Cleanroom?

Surface cleanliness in an ISO 6 Hardwall Cleanroom is ensured by following strict cleaning protocols. Surfaces are regularly wiped down with approved disinfectants and cleaned using non-shedding materials. Routine checks are conducted to verify that no contamination is present, and a cleaning schedule is followed to maintain the required cleanliness levels.

3. What are the regulations for ISO 6 Hardwall Cleanrooms?

ISO 6 Hardwall Cleanrooms must adhere to ISO 14644-1 for cleanliness standards, which outlines the acceptable particle concentration levels in the air. In addition to ISO standards, the cleanroom must comply with industry-specific regulations, such as those for pharmaceutical and electronic manufacturing, ensuring that the environment is suitable for its intended purpose.

4. How are ISO 6 Hardwall Cleanrooms validated?

ISO 6 Hardwall Cleanrooms are validated by performing particle count tests, airflow tests, and pressure differential measurements. These tests are conducted to ensure that the cleanroom meets the required standards for particle concentration, air changes per hour, and airflow patterns. Validation also includes testing the performance of HEPA filters and other environmental control systems to confirm compliance with ISO 14644-1.

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

An ISO 6 Hardwall Cleanroom improves production efficiency by providing a stable and controlled environment that minimizes contamination risks. This ensures that processes like pharmaceutical manufacturing, electronics assembly, and research activities are not disrupted by particulate contamination. By maintaining consistent conditions for temperature, humidity, and airflow, the cleanroom helps enhance product quality and reduce downtime.

6. What are the different classifications of cleanrooms?

Cleanrooms are classified based on the number of airborne particles present in a given volume of air. The classifications range from ISO 1 (the cleanest) to ISO 9 (the least clean). Each class has specific particle limits, with ISO 6 Cleanrooms allowing up to 35,200 particles per cubic meter of air at 0.5 microns, suitable for moderate contamination control needs.

7. What are the cost factors for designing an ISO 6 Hardwall Cleanroom?

The cost of designing an ISO 6 Hardwall Cleanroom depends on factors such as size, location, materials used, and the complexity of the HVAC system. Additional costs may include HEPA filters, airflow management, and validation processes. The overall design and the level of customization required for specific processes or industries will also influence the total cost.

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

Common maintenance challenges in an ISO 6 Cleanroom include:

• Air filtration: Ensuring HEPA filters are replaced on schedule.

• Environmental control systems: Maintaining stable temperature, humidity, and pressure levels.

• Surface cleanliness: Preventing contamination from settling on surfaces, which requires regular cleaning.

These challenges must be managed to ensure the cleanroom continues to meet cleanliness standards and operate efficiently.

9. How are personnel trained for working in an ISO 6 Cleanroom?

Personnel working in an ISO 6 Cleanroom are trained on cleanroom protocols, including proper gowning procedures, maintaining cleanliness, and minimizing contamination risks. Training also covers how to handle equipment and materials without contaminating the environment and how to use personal protective equipment (PPE) properly. Regular refreshers ensure that staff remain compliant with cleanliness standards.

10. How is contamination controlled during cleanroom construction?

Contamination during cleanroom construction is controlled by using clean materials, isolating construction zones, and frequent cleaning of the site. The construction team also follows strict protocols to minimize the introduction of dust, dirt, and other contaminants into the cleanroom environment. Once construction is complete, the cleanroom undergoes thorough cleaning and testing to ensure it meets cleanliness standards.

11. What is the difference between a cleanroom and a controlled environment?

A cleanroom is a highly controlled space where airborne particles and other contaminants are minimized to specific levels, based on a classification system like ISO 14644-1. A controlled environment, on the other hand, can refer to any space where conditions such as temperature, humidity, or airflow are carefully regulated, but it does not necessarily meet the strict particle control standards required for a cleanroom.

12. 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 systems, and environmental controls. Other factors such as validation, monitoring equipment, and compliance with regulations can further add to the total cost. The size and complexity of the cleanroom also influence the overall price.

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

Achieving ISO certification for a Hardwall Cleanroom involves meeting the cleanliness standards set out in ISO 14644-1. This includes passing tests for particle concentration, airflow patterns, and pressure differentials. The cleanroom must also undergo validation by an accredited third-party and maintain proper documentation and operational protocols to ensure compliance with the standard.

14. How do you control temperature fluctuations in an ISO 6 Cleanroom?

Temperature fluctuations in an ISO 6 Cleanroom are controlled by using a precise HVAC system that adjusts the temperature as needed. Sensors monitor the temperature, and the system automatically adjusts the air conditioning or heating to maintain a consistent range, typically between 18-22°C (64-72°F). This helps to maintain optimal conditions for sensitive processes and products.

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

HEPA filters play a crucial role in an ISO 6 Hardwall Cleanroom by removing 99.97% of particles as small as 0.3 microns. This ensures the cleanroom maintains the required air quality by filtering out airborne contaminants. The filters are integral to meeting the cleanliness standards set by ISO 14644-1 and maintaining a controlled environment for sensitive applications.