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

• Preparation

• Installation of frames

• Installation of filters and FFU fans

• Connecting power supply and debugging

The main function of a clean room is to provide a controlled micro-environment for the production of sensitive items in order to reduce the level of airborne contaminants such as dust particles and microorganisms, thus avoiding adverse effects on product quality. Therefore, its testing is one of the key steps in ensuring product quality.

Items tested in the clean room

• Dust Particle Count

• Sedimentation and Planktonic Bacteria

• Temperature and Humidity

• Air Velocity and Volume

• Noise

• Differential Pressure

Testing Instruments

Commonly used instruments for clean room testing include dust particle counters, bacterial samplers, differential pressure meters, anemometers, illuminance meters, temperature and humidity meters, and so on. These instruments need to be calibrated regularly to ensure the accuracy of the test data.

Testing Process

The testing process usually consists of four stages: preparation, testing, data analysis and result evaluation. Before testing, it is necessary to ensure that the environment inside the clean room is stable, and after testing, the data is analyzed scientifically to determine whether the clean room meets the technical requirements.

1. How to ensure proper cleanroom decontamination?

Ensuring proper cleanroom decontamination involves several steps. Firstly, establish a stringent cleaning protocol that includes regular cleaning schedules and the use of appropriate disinfectants. Secondly, train personnel on proper cleaning techniques and the importance of contamination control. Lastly, conduct regular inspections and audits to ensure compliance with the decontamination procedures.

2. What are the air change rates for ISO 5 cleanrooms?

The air change rates for ISO 5 cleanrooms typically range from 240 to 480 air changes per hour. This high rate ensures that airborne particles are continuously removed, maintaining the necessary cleanliness levels. The exact rate can vary depending on specific cleanroom design and application requirements.

3. What are the best materials for hardwall cleanroom construction?

The best materials for hardwall cleanroom construction are those that provide durability, ease of cleaning, and resistance to contamination. These include:

• Stainless steel for frames and surfaces

• Epoxy-coated steel or aluminum panels

• Polycarbonate or tempered glass windows

Using these materials helps maintain a sterile environment and ensures longevity.

4. How to ensure compliance with cleanroom regulations?

Ensuring compliance with cleanroom regulations requires a comprehensive approach. Establish and document standard operating procedures (SOPs) that align with relevant standards such as ISO 14644. Regularly train and certify employees on these procedures, and conduct routine audits to identify and rectify any non-compliance issues. Periodic reviews and updates to the SOPs should be conducted to reflect any regulatory changes.

5. How to ensure proper sealing in a hardwall cleanroom?

Proper sealing in a hardwall cleanroom is crucial to maintain its integrity. Use high-quality, cleanroom-grade sealants around all joints, seams, and penetrations. Ensure that doors and windows are properly fitted with gaskets to prevent air leaks. Regularly inspect and maintain seals to prevent degradation over time.

6. How to integrate equipment into a hardwall cleanroom?

To integrate equipment into a hardwall cleanroom, follow a systematic approach. Begin by mapping out the cleanroom layout to ensure optimal placement of equipment without disrupting airflow. Next, install equipment using cleanroom-compatible materials and methods. Finally, validate the equipment to ensure it meets cleanroom standards and does not compromise cleanliness.

7. What is the lifespan of a hardwall cleanroom?

The lifespan of a hardwall cleanroom can vary depending on factors such as usage, maintenance, and the materials used in construction. Typically, a well-maintained hardwall cleanroom can last between 10 to 15 years. Regular inspections and timely repairs can help extend its lifespan.

8. What are the noise levels in hardwall cleanrooms?

Noise levels in hardwall cleanrooms are generally kept below 60 decibels (dB) to ensure a comfortable working environment. The specific noise level can vary based on the equipment used and the cleanroom's design. Adequate noise control measures, such as sound-absorbing panels and isolation of noisy equipment, can help maintain acceptable noise levels.

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

Testing air quality in an ISO 5 hardwall cleanroom involves several steps. Use particle counters to measure airborne particulate levels, ensuring they meet ISO 5 standards. Additionally, conduct microbial sampling to detect any biological contaminants. Regular monitoring and documentation of air quality data are essential to maintaining compliance.

10. What are the vibration control measures for cleanrooms?

Vibration control measures for cleanrooms include:

• Isolating sensitive equipment on vibration-dampening platforms

• Using anti-vibration pads under machinery

• Designing the cleanroom structure to minimize external vibration transmission

Implementing these measures ensures that vibrations do not affect cleanroom operations or compromise cleanliness.

11. What are the challenges in designing hardwall cleanrooms?

Designing hardwall cleanrooms presents several challenges. These include ensuring proper airflow to maintain cleanliness levels, selecting materials that are both durable and easy to clean, and integrating complex systems such as HVAC and filtration. Additionally, meeting stringent regulatory standards and accommodating future scalability can be challenging.

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

Choosing the right flooring for a hardwall cleanroom involves considering factors such as durability, ease of cleaning, and resistance to chemicals and contaminants. Epoxy-coated floors, vinyl floors, and seamless polyurethane floors are popular choices. It's essential to select a flooring material that meets the cleanroom's specific requirements and usage conditions.

13. What are the installation steps for hardwall cleanrooms?

The installation steps for hardwall cleanrooms typically include:

1. Site preparation and layout planning
2. Installation of structural components and panels
3. Integration of HVAC and filtration systems
4. Electrical and plumbing installations
5. Sealing and validation of the cleanroom

Following these steps ensures a properly constructed and functional cleanroom.

14. What are the gowning procedures for ISO 5 cleanrooms?

Gowning procedures for ISO 5 cleanrooms are critical to minimizing contamination. Personnel must follow a strict sequence:

• Remove all jewelry and personal items.

• Don cleanroom-approved garments, starting with shoe covers, followed by coveralls, gloves, and head coverings.

• Perform a final inspection in a mirror to ensure proper gowning.

Adhering to these procedures helps maintain the cleanroom's integrity.

15. What are the cleanroom validation protocols?

Cleanroom validation protocols include several key steps. Initially, perform a risk assessment to identify potential contamination sources. Subsequently, conduct tests such as particle count analysis, airflow visualization, and microbial sampling. Document all findings and corrective actions, ensuring compliance with regulatory standards.

16. What are the requirements for cleanroom ventilation?

Cleanroom ventilation requirements focus on maintaining air cleanliness and controlling environmental conditions. This includes achieving a specific number of air changes per hour, using HEPA filters to remove particulates, and ensuring positive air pressure to prevent contamination ingress. Proper design and regular maintenance of the ventilation system are essential.

17. What are the standards for cleanroom construction materials?

Standards for cleanroom construction materials emphasize durability, cleanliness, and resistance to contaminants. Materials should be non-shedding, easy to clean, and capable of withstanding regular exposure to disinfectants. Commonly used materials include stainless steel, epoxy-coated surfaces, and cleanroom-grade plastics.

18. What are the fire safety requirements for hardwall cleanrooms?

Fire safety requirements for hardwall cleanrooms include using fire-resistant materials in construction, installing fire detection and suppression systems, and ensuring clear and accessible emergency exits. Regular fire safety drills and maintenance of fire safety equipment are also crucial to ensuring a safe working environment.

19. What are the airflow patterns in hardwall cleanrooms?

Airflow patterns in hardwall cleanrooms are designed to ensure optimal cleanliness. Typically, laminar flow is used, where air moves uniformly in parallel streams, either horizontally or vertically. This controlled airflow minimizes turbulence and helps remove contaminants effectively, maintaining the required cleanliness levels.

20. What are the requirements for cleanroom ceilings?

Cleanroom ceilings must meet several requirements. They should be constructed from non-shedding, easy-to-clean materials like coated metal or cleanroom-rated tiles. Ceilings must also integrate with the HVAC system to accommodate HEPA filters and lighting fixtures, ensuring a seamless and contaminant-free environment.