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 is temperature controlled in an ISO 6 Cleanroom?

Temperature in an ISO 6 Cleanroom is controlled through the HVAC system, which includes both cooling and heating components. The system ensures a consistent temperature range, typically between 18°C to 24°C, to maintain both cleanroom integrity and the comfort of personnel. Humidity control is often integrated with temperature management to prevent static buildup and maintain stable conditions for sensitive processes.

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

Several types of equipment are used to test an ISO 6 Hardwall Cleanroom, including:

• Particle counters to measure airborne particles

• Velometers to test airflow velocity

• Pressure gauges to measure pressure differential

• Thermometers and hygrometers to monitor temperature and humidity

These tools ensure the cleanroom meets required cleanliness and environmental standards for ISO 6 certification.

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

The typical dimensions of an ISO 6 Hardwall Cleanroom vary depending on the application, but common sizes include 5 x 5 meters, 8 x 10 meters, or larger spaces such as 8 x 15 meters. The size is determined by the specific needs of the processes or operations being conducted within the cleanroom.

4. How do you handle air contaminants in an ISO 6 Cleanroom?

Air contaminants in an ISO 6 Cleanroom are controlled by:

• HEPA filters to capture airborne particles

• Unidirectional airflow systems to direct air towards exhaust points

• Positive pressure to prevent contamination from entering

These systems work together to ensure the air inside the cleanroom remains free of harmful particles, maintaining the necessary cleanliness level.

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

Yes, ISO 6 Hardwall Cleanrooms are suitable for biotechnology applications. They provide a controlled environment that is essential for research and production activities in the biotechnology industry. These cleanrooms help minimize contamination during sensitive processes such as cell culture, genetic research, and biopharmaceutical production.

6. How often should HEPA filters be replaced in an ISO 6 Cleanroom?

HEPA filters in an ISO 6 Cleanroom should generally be replaced every 1 to 2 years, depending on usage and the environment. Regular monitoring of filter performance is important, as clogged or inefficient filters can reduce airflow and contaminate the cleanroom environment.

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

Yes, ISO 6 Hardwall Cleanrooms are commonly used in pharmaceutical manufacturing. They provide the controlled environment necessary for the production of pharmaceuticals, where contamination control is critical to ensure product safety and efficacy. These cleanrooms support processes such as drug formulation, sterilization, and packaging.

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

ISO 6 certification requires several key tests, including:

• Particle count testing to measure airborne contaminants

• Airflow velocity testing to ensure proper airflow

• Pressure differential testing to verify positive air pressure

• Temperature and humidity measurements to ensure environmental stability

These tests are essential to verify the cleanroom meets the required standards.

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

Common maintenance challenges in an ISO 6 Cleanroom include:

• HEPA filter replacement and ensuring proper airflow

• Airflow management to prevent contamination and ensure balance

• Pressure control to maintain positive pressure

• Temperature and humidity regulation for process stability

Regular maintenance and monitoring are critical to maintaining ISO 6 standards.

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

Air filtration efficiency in an ISO 6 Cleanroom is measured by testing the filter's particle retention capability, typically using a particle counter. The efficiency is based on how well the filter can capture particles of a specific size, such as 0.3 microns or larger. This ensures that the cleanroom environment maintains the desired cleanliness level.

11. How do you verify the integrity of the cleanroom sealing?

The integrity of a cleanroom's sealing is verified through regular leak tests, often conducted using a smoke test or pressure decay test. These tests check for any breaches in the sealing, ensuring that the cleanroom maintains its required air pressure and prevents outside contaminants from entering.

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

An ISO 6 Hardwall Cleanroom improves production efficiency by minimizing contamination, which in turn reduces defects, rework, and downtime. By maintaining consistent environmental conditions such as airflow, temperature, and humidity, it helps ensure high-quality production with fewer disruptions. This leads to higher product yields and increased operational productivity.

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

Waste in an ISO 6 Hardwall Cleanroom is managed by using sealed containers and ensuring that all cleaning materials are non-shedding. Waste is removed frequently to prevent contamination buildup, and disposal follows strict protocols to maintain the cleanroom’s integrity and cleanliness.

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

Temperature fluctuations in an ISO 6 Cleanroom are controlled using an HVAC system that maintains a consistent temperature. The system adjusts the cooling or heating as needed to ensure the temperature stays within the required range, typically between 18°C to 24°C. This helps prevent any environmental factors from affecting sensitive processes or equipment.

15. How do you ensure proper gowning in an ISO 6 Hardwall Cleanroom?

Proper gowning in an ISO 6 Hardwall Cleanroom is ensured through strict protocols and training. Personnel are required to wear protective clothing such as gowns, gloves, masks, and shoe covers to minimize contamination. Gowning procedures are strictly enforced before entering the cleanroom, and personnel are regularly trained on proper techniques.

16. How does a Hardwall Cleanroom differ from a Softwall Cleanroom?

A Hardwall Cleanroom differs from a Softwall Cleanroom in its construction. Hardwall Cleanrooms have rigid walls made of materials like metal, glass, or plastic panels, offering better durability and a more permanent structure. Softwall Cleanrooms, on the other hand, use flexible fabric walls and are often more portable and easier to reconfigure. Both types can meet ISO cleanliness standards, but the choice depends on the application and required flexibility.