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4 x 5M ISO 7 Modular Cleanroom

Reference Price:US$8600

Short Description:

The 4 x 5 meter ISO 7 modular cleanroom is designed to provide a controlled environment that effectively reduces airborne particles, making it suitable for applications in pharmaceuticals, biotechnology, and electronics where moderate cleanliness standards are important.

  • Anti-Static:
  • frames: Iron Cube
  • partition:
  • class:
  • size:
  • FFU: AC Fans
  • noise:
  • mobile pulley: Yes
  • Product Certification: ASHRAE 110 ASTM E84 CAN/CSA C22.2 CE NFPA 45
  • customs code:
  • production state: Production

Cleanroom

4 x 5M ISO 7 Modular Cleanroom

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Summary

Cleanroom

4 x 5M ISO 7 Modular Cleanroom

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Validation

Installation & Validation

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Cleanrooms Detail

In today’s manufacturing and research environments, the demand for cleanrooms is on the rise, especially in industries like pharmaceuticals, semiconductors, and biotechnology. The ISO 7 modular cleanroom is a versatile solution designed to effectively ensure product quality and safety.

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ISO 7 Cleanroom Standards

An ISO 7 cleanroom must meet specific air cleanliness standards, including:

  • No more than 352,000 particles per cubic meter of air (0.5 micrometers and larger).

  • No more than 3,520 particles per cubic meter of air (5 micrometers and larger).

These standards ensure that operations within the cleanroom remain uncontaminated, safeguarding both products and personnel.


Cleanroom Project Scope(from structure, HVAC,electric to autoc ontrol)1. Cleanroom Structure: Wall Panel, Ceiling Panel, Windows, Doors, Fttings, Flooring
2. HVAC: AHU, Chiller, dehumidifier, Ducting, Piping, etc.
3. Electric: Lighting, Switch, Cables, Wires, Power Distribution Cabinet, etc
4. Auto- control: PLC Controller, Sensors for Humidity and Temperature, Control Panel
5. Process Piping System: Gas, Water Pipeline
EquipmentAir shower, Cargo shower, Mist shower, Dynamic pass box, Static pass box, Sampling booth,Weighing booth, Dispensing booth,
Medicine stability test chamber, isolator, VHP sterilizer,Biological safety chamber, FFU, LAF, etc.
Temperature21-27*C (or as per required)
Humidity30-60°C (or as per required)
ApplicationPharmaceutical factory, hospital, medical device factory, electronics factory, food factory,cosmetics factory, etc.
Qualification DocumentsCE GMP ISO
Full ServiceFAT and SAT Service, Professional Consultation, Training, 24 hours technical support


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Cleanrooms Airflow

When designing the airflow system for an ISO 7 modular cleanroom, several factors must be considered:

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Air Changes Per Hour (ACH):

  • ISO Class 7 cleanrooms typically require 30-50 air changes per hour to maintain cleanliness.

  • The exact number depends on the cleanroom’s size, usage, and contamination sources.

Cleanrooms Installation

Cleanrooms Testing

Importance of testing

Clean room testing is extremely important to ensure product quality and the stability of the production environment. It can help to confirm whether the clean room meets the intended cleanliness requirements, and whether the various environmental indicators comply with the specified standards.

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Testing Items

  • Suspended particles: Detects the number of suspended particles in the air in the clean room to ensure that the air cleanliness is up to standard.

  • Temperature and humidity: Monitor the temperature and humidity in the clean room to ensure environmental stability during the production process.

  • Noise: Evaluates the noise level in the clean room to minimize the impact on staff.

  • Static electricity: Detect static electricity buildup in the clean room to prevent damage to sensitive components from electrostatic discharge.

  • Microbial contamination: Detecting microbial levels in the clean room, especially critical for the healthcare industry.

FAQ

What are the benefits of a modular cleanroom?

Modular cleanrooms offer flexibility, rapid deployment, and ease of reconfiguration. They can be customized to meet specific industry requirements efficiently.


What are the challenges of modular cleanroom design?

Challenges in modular cleanroom design include:

  1. Ensuring compliance with strict regulatory standards.
  2. Balancing adaptability with structural integrity.
  3. Integrating various systems such as HVAC and filtration seamlessly.
    Addressing these issues is crucial for effective design.

What is the difference between cleanroom and controlled environment?

A cleanroom is specifically designed to minimize contamination, maintaining strict cleanliness standards. In contrast, a controlled environment may regulate temperature and humidity but is less stringent about particulates.


What are the benefits of using modular cleanrooms over conventional ones?

Benefits of modular cleanrooms include:

  1. Faster installation and setup times.
  2. Cost-effectiveness through prefabricated designs.
  3. Greater flexibility for future modifications.
    These advantages make modular options increasingly popular across various industries.

How does humidity control work in cleanrooms?

Humidity control in cleanrooms is achieved through specialized HVAC systems that regulate moisture levels. Dehumidifiers or humidifiers may be used to maintain optimal conditions, ensuring product integrity.


What are the advantages of prefabricated cleanrooms?

Prefabricated cleanrooms provide several advantages:

  1. Faster construction and reduced labor costs.
  2. Improved quality control through factory assembly.
  3. Greater design flexibility for customization.
    These factors contribute to their growing popularity in various sectors.

What is the impact of vibration on cleanroom operations?

Vibration can adversely affect sensitive equipment and processes within cleanrooms. It may lead to contamination, equipment malfunction, or compromised product quality. Minimizing vibration is essential for maintaining operational integrity.


What is the purpose of a cleanroom?

The primary purpose of a cleanroom is to provide a controlled environment that minimizes contamination. This is crucial for industries like pharmaceuticals, electronics, and aerospace, where product integrity is paramount.


How to implement a cleanroom training program?

To implement a cleanroom training program:

  1. Develop comprehensive training materials covering protocols and procedures.
  2. Schedule regular training sessions for all personnel.
  3. Assess understanding through tests and practical demonstrations.
    This ensures staff are well-prepared for cleanroom operations.

What is the importance of airflow visualization in cleanrooms?

Airflow visualization is vital for identifying potential contamination sources. It helps to:

  1. Optimize airflow patterns for effective ventilation.
  2. Ensure compliance with cleanliness standards.
  3. Enhance overall operational efficiency.
    This process is essential for maintaining cleanroom integrity.

How to ensure air quality in modular cleanrooms?

Ensuring air quality in modular cleanrooms involves:

  1. Regular monitoring of particulate levels.
  2. Utilizing high-efficiency air filters (HEPA/ULPA).
  3. Implementing effective HVAC systems for consistent airflow.
    These measures help maintain a controlled, contaminant-free environment.

How to choose the right modular cleanroom system?

Choosing the right modular cleanroom system requires:

  1. Assessing specific industry requirements and regulations.
  2. Evaluating design flexibility and future scalability.
  3. Considering budget constraints and installation timelines.
    These factors guide the selection process for optimal performance.

What are the benefits of modular cleanroom expansion?

Benefits of modular cleanroom expansion include:

  1. Enhanced capacity to accommodate growing operations.
  2. Flexibility to adapt to changing technology demands.
  3. Minimal disruption during the expansion process.
    These advantages support sustained operational efficiency and compliance.

How to train staff for cleanroom operations?

Training staff for cleanroom operations involves:

  1. Conducting orientation sessions on cleanroom protocols.
  2. Providing hands-on training for gowning and procedures.
  3. Regularly updating training to reflect new technologies and practices.
    This ensures staff are competent and compliant in their roles.

How to ensure proper cleanroom airflow patterns?

To ensure proper airflow patterns:

  1. Design the cleanroom layout to promote unidirectional airflow.
  2. Regularly monitor airflow with specialized equipment.
  3. Adjust air supply and return locations as needed.
    These practices help maintain a contaminant-free environment.

What is the lifespan of a modular cleanroom?

The lifespan of a modular cleanroom typically ranges from 10 to 20 years. Regular maintenance and upgrades can significantly extend its operational life, ensuring continued compliance and performance.


How to calculate the ROI of a modular cleanroom?

To calculate the ROI of a modular cleanroom:

  1. Determine the total investment costs, including design, installation, and maintenance.
    2.2. Estimate the annual savings from increased efficiency and reduced contamination risks.
  2. Calculate the payback period by dividing total costs by annual savings.
    This process provides insights into the financial benefits of the investment.

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Product International Certification

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