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 design a cleanroom for aerospace applications?

Designing a cleanroom for aerospace applications involves ensuring stringent contamination control and maintaining precise environmental conditions. Key considerations include selecting materials that do not outgas or shed particles, incorporating HEPA filtration, and maintaining consistent temperature and humidity levels. The layout should facilitate easy workflow while minimizing contamination risks.

2. How to design a cleanroom for food processing?

Designing a cleanroom for food processing requires using materials that are easy to clean and resistant to bacterial growth. The design should incorporate smooth, non-porous surfaces, proper ventilation, and HEPA filtration to maintain air quality. Ensure there are separate zones for different stages of processing to prevent cross-contamination.

3. What materials are used in hardwall cleanrooms?

Materials used in hardwall cleanrooms include:

• Non-shedding wall panels

• Stainless steel for furniture and fixtures

• Epoxy or vinyl flooring

These materials are chosen for their durability, ease of cleaning, and low particle generation to maintain a contamination-free environment.

4. How to select the right HEPA filters for cleanrooms?

Selecting the right HEPA filters for cleanrooms involves considering filter efficiency, airflow capacity, and compatibility with existing HVAC systems. It’s crucial to choose filters that meet or exceed ISO 5 standards, which typically require a minimum efficiency of 99.97% for particles as small as 0.3 microns. Consulting with suppliers and reviewing product specifications can help ensure the right choice.

5. How to achieve ISO certification for a cleanroom?

Achieving ISO certification for a cleanroom involves several steps. First, ensure that the cleanroom design and operation meet the applicable ISO standards. Conduct thorough documentation of all processes and procedures. Regularly audit the cleanroom to identify and rectify any non-compliance issues. Finally, undergo an external audit by a certified body to obtain the official certification.

6. What equipment is needed for an ISO 5 hardwall cleanroom?

An ISO 5 hardwall cleanroom requires:

• HEPA filters and HVAC systems

• Air showers and pass-throughs

• Cleanroom-compatible furniture and equipment

This equipment helps maintain the necessary cleanliness levels and operational efficiency.

7. What are the key features of hardwall cleanrooms?

Key features of hardwall cleanrooms include durable and non-shedding wall panels, advanced HEPA filtration, and precise environmental controls. These cleanrooms offer superior contamination control, structural integrity, and ease of maintenance, making them ideal for critical applications like pharmaceuticals and electronics manufacturing.

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

The air filtration requirements for ISO 5 hardwall cleanrooms include using HEPA filters capable of capturing 99.97% of particles as small as 0.3 microns. The cleanroom must maintain a consistent airflow with a high number of air changes per hour to ensure minimal particle contamination.

9. How to improve air flow in a hardwall cleanroom?

Improving airflow in a hardwall cleanroom involves optimizing the HVAC system design, ensuring proper placement of supply and return air vents, and using laminar flow hoods where necessary. Regular maintenance of HEPA filters and monitoring airflow patterns can help maintain optimal conditions.

10. How to achieve ISO 5 standards in hardwall cleanrooms?

Achieving ISO 5 standards in hardwall cleanrooms requires implementing stringent contamination control measures, including the use of high-efficiency HEPA filters, maintaining a high number of air changes per hour, and enforcing strict gowning and cleaning protocols. Regular testing and monitoring of particle counts are essential to ensure compliance.

11. How to ensure compliance with ISO 5 standards?

Ensuring compliance with ISO 5 standards involves regular monitoring of particle counts, maintaining proper filtration and airflow, and adhering to strict cleaning and gowning protocols. Conduct routine audits and inspections to identify and address any deviations from the standards.

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

Setting up a hardwall cleanroom for pharmaceuticals involves selecting materials that are compatible with pharmaceutical manufacturing, installing HEPA filtration systems, and ensuring precise control of temperature and humidity. The layout should support efficient workflow and include separate zones for different stages of production to prevent cross-contamination.

13. What are the power requirements for hardwall cleanrooms?

The power requirements for hardwall cleanrooms depend on the size of the cleanroom and the equipment used. Key power-consuming components include HVAC systems, HEPA filters, lighting, and process equipment. Ensure a reliable power supply and consider backup generators to maintain continuous operation.

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

Controlling temperature in an ISO 5 hardwall cleanroom involves using precise HVAC systems equipped with temperature sensors and controllers. Regularly monitor and adjust the temperature settings to maintain the desired range, ensuring stable conditions for sensitive processes and equipment.

15. What are the challenges in designing hardwall cleanrooms?

Challenges in designing hardwall cleanrooms include ensuring effective contamination control, maintaining consistent environmental conditions, and selecting appropriate materials. Balancing the need for functionality with regulatory compliance and cost considerations can also be complex.

16. How to train staff for working in a hardwall cleanroom?

Training staff for working in a hardwall cleanroom involves providing comprehensive training on:

• Gowning procedures

• Cleanroom protocols

• Contamination control

Regular refresher courses and hands-on training sessions help ensure staff adhere to best practices and maintain the cleanroom's integrity.

17. What are the environmental control requirements for hardwall cleanrooms?

Environmental control requirements for hardwall cleanrooms include maintaining specific temperature, humidity, and air quality standards. Use precise HVAC systems, HEPA filtration, and continuous monitoring to ensure conditions meet ISO 5 standards.

18. How to test air quality in an ISO 5 hardwall cleanroom?

Testing air quality in an ISO 5 hardwall cleanroom involves using particle counters to measure airborne particle concentration. Regularly perform these tests to ensure compliance with ISO 5 standards, and document results to track performance and identify any issues promptly.