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 to select the right HEPA filters for cleanrooms?

Selecting the right HEPA filters for cleanrooms involves considering the filter efficiency, the type of cleanroom, and the size of the particles to be filtered. For ISO 5 cleanrooms, a HEPA filter with a minimum efficiency of 99.97% for 0.3-micron particles is required. It is also important to match the filter size and airflow capacity to the cleanroom’s HVAC system to ensure optimal performance.

2. What are the best practices for cleanroom cleaning?

Best practices for cleanroom cleaning include:

• Regular surface cleaning: Use lint-free wipes and approved disinfectants.

• Proper gowning and hygiene: Personnel must adhere to strict gowning protocols.

• Frequent air filtration checks: Ensure HEPA filters and HVAC systems are regularly maintained.

This ensures the cleanroom environment remains contaminant-free and operates efficiently.

3. How to set up a hardwall cleanroom for pharmaceuticals?

Setting up a hardwall cleanroom for pharmaceuticals requires selecting materials resistant to contamination and easy to clean, such as stainless steel and epoxy-coated flooring. The design should include HEPA filtration, precise temperature, and humidity controls, and proper airflow to maintain cleanliness. It is also essential to implement strict protocols for personnel gowning and hygiene.

4. What are the requirements for cleanroom doors?

Cleanroom doors must meet several key requirements:

• Air-tight seals: To prevent particle leakage.

• Non-porous materials: To reduce the risk of contamination.

• Easy to clean surfaces: To facilitate maintenance and reduce particle buildup.

These features help maintain the integrity of the controlled environment.

5. What are the testing standards for cleanrooms?

Testing standards for cleanrooms include verifying particle counts, airflow rates, and environmental parameters such as temperature and humidity. Regular audits ensure compliance with ISO standards. Key tests include airborne particle testing, air pressure differential measurements, and cleanliness validation through surface contamination assessments.

6. How to control temperature in an ISO 5 hardwall cleanroom?

Temperature control in an ISO 5 hardwall cleanroom is achieved using an HVAC system equipped with precise temperature sensors and controllers. The system should be able to maintain a consistent temperature range that is suitable for sensitive processes and products. Regular monitoring and adjustments ensure the cleanroom stays within the required temperature limits.

7. What are the benefits of hardwall cleanrooms?

Hardwall cleanrooms offer several benefits:

• Superior structural integrity: Provides a more permanent solution.

• Enhanced contamination control: Durable walls minimize particle generation.

• Long-term reliability: Designed for demanding, high-performance environments.

These features make hardwall cleanrooms ideal for critical industries such as pharmaceuticals and electronics manufacturing.

8. What are the challenges in maintaining ISO 5 cleanrooms?

Maintaining ISO 5 cleanrooms involves challenges such as:

• Regular replacement of filters: Ensuring continuous airflow and efficiency.

• Maintaining tight seals: Preventing contamination from external sources.

• Continuous monitoring: Ensuring all environmental parameters are consistently within range.

Routine inspections and proactive maintenance can mitigate these challenges.

9. How to choose the right flooring for a hardwall cleanroom?

Choosing the right flooring for a hardwall cleanroom involves selecting materials that are durable, non-shedding, and easy to clean. Options like seamless epoxy or vinyl flooring are ideal for cleanroom environments as they help maintain a contamination-free space. The flooring should also be resistant to wear from heavy traffic and equipment.

10. What are the cleaning agents used in hardwall cleanrooms?

Cleaning agents used in hardwall cleanrooms include:

• Approved disinfectants: These are designed to kill bacteria and viruses without leaving residues.

• Surface cleaners: For general cleaning of walls and surfaces.

• Anti-static agents: To prevent static buildup on surfaces.

These cleaning agents ensure that the cleanroom remains hygienic and free from contaminants.

11. How to select a cleanroom contractor?

Selecting a cleanroom contractor involves evaluating their experience with the specific type of cleanroom needed, understanding their design and construction capabilities, and ensuring they have the necessary certifications. It is also important to check their reputation for meeting deadlines, maintaining quality standards, and providing ongoing support after construction.

12. What materials are used in hardwall cleanrooms?

Materials commonly used in hardwall cleanrooms include:

• Steel panels: For the structural walls.

• Epoxy-coated flooring: Non-porous and easy to clean.

• Stainless steel fixtures: Resistant to corrosion and contamination.

These materials are chosen for their durability, low particle shedding, and ease of maintenance.

13. How to achieve ISO certification for a cleanroom?

Achieving ISO certification for a cleanroom involves adhering to specific cleanliness standards, such as particle counts, air filtration, and environmental controls. Regular testing and monitoring must be conducted to demonstrate compliance with ISO standards. An external audit by a certification body will also be required to verify the cleanroom’s performance.

14. What is the difference between hardwall and softwall cleanrooms?

Hardwall cleanrooms have rigid, durable walls made of materials like steel or composite panels, offering enhanced structural integrity and contamination control. Softwall cleanrooms, in contrast, use flexible plastic or vinyl walls, making them easier to install and reconfigure but typically less durable and permanent than hardwall options.

15. How to control humidity in an ISO 5 hardwall cleanroom?

Humidity in an ISO 5 hardwall cleanroom can be controlled using the HVAC system, which should include both humidification and dehumidification capabilities. Regular monitoring of humidity levels ensures they remain within the required range, preventing condensation or static issues that could affect sensitive processes.

16. What are the air filtration requirements for ISO 5 hardwall cleanrooms?

ISO 5 hardwall cleanrooms require the use of HEPA filters with an efficiency of 99.97% at 0.3 microns or higher. The HVAC system should maintain consistent airflow with a high number of air changes per hour to ensure that the environment meets the strict cleanliness standards required for ISO 5 certification.

17. How to design a cleanroom for food processing?

Designing a cleanroom for food processing involves using materials that are resistant to contamination, easy to clean, and durable. The design should incorporate smooth, non-porous surfaces and effective air filtration systems to maintain a contamination-free environment. Temperature and humidity control is also important to ensure food safety and quality.

18. How to validate an ISO 5 hardwall cleanroom?

To validate an ISO 5 hardwall cleanroom, regular testing is necessary, including airborne particle measurements, airflow tests, and environmental parameter checks. It’s essential to ensure the cleanroom consistently meets ISO 5 requirements for cleanliness and performance. Documentation of the results and any corrective actions taken is also crucial for maintaining certification.

19. How to design a cleanroom for healthcare applications?

Designing a cleanroom for healthcare applications requires ensuring strict contamination control through the use of appropriate materials, HEPA filtration, and precise airflow management. The cleanroom should also support a clean, sterile environment with strict protocols for gowning and decontamination. HVAC systems must maintain consistent temperature and humidity levels to support sensitive healthcare processes.

20. How to maintain an ISO 5 hardwall cleanroom?

Maintaining an ISO 5 hardwall cleanroom involves regularly monitoring airborne particle levels, maintaining HVAC systems, and ensuring proper cleaning and maintenance protocols. Filters should be replaced at recommended intervals, and the integrity of seals and doors must be checked regularly to prevent contamination.