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5 x 10M ISO 7 Modular Cleanroom

Reference Price:US$13800-26000

Short Description:

The 5 x 10 meter ISO 7 modular cleanroom is designed to provide a controlled environment that effectively minimizes airborne contamination, making it ideal for applications in pharmaceuticals, biotechnology, and electronics where moderate cleanliness standards are essential.

  • 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

5 x 10M ISO 7 Modular Cleanroom

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Summary

Cleanroom

5 x 10M 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

How to calculate the ROI of a modular cleanroom?

To calculate ROI, identify the total investment costs of the cleanroom. Then, analyze the financial benefits generated over time, such as increased production efficiency and reduced contamination risks.


What are the key features of modular cleanrooms?

Key features include flexibility in design, high-performance filtration systems, and rapid installation capabilities. They can be easily reconfigured to meet changing needs.


What is the impact of cleanroom design on productivity?

Cleanroom design significantly influences workflow efficiency and contamination control. A well-designed layout minimizes unnecessary movement, allowing personnel to focus on tasks.
Enhancing air circulation and maintaining optimal temperature also promote worker comfort, increasing productivity.


How to retrofit an existing cleanroom to ISO 7 standards?

Begin by upgrading filtration systems to HEPA or ULPA filters to meet ISO 7 requirements.
Next, improve HVAC systems for better air quality and control.
Finally, modify surfaces and materials for easier cleaning and compliance.


What equipment is needed for an ISO 7 cleanroom?

Essential equipment includes:

  • HEPA or ULPA filters
  • Proper HVAC systems
  • Monitoring devices for temperature and humidity
    This ensures compliance with ISO 7 standards.

How to handle hazardous materials in cleanrooms?

Always wear appropriate personal protective equipment (PPE) when handling hazardous materials.
Implement strict storage protocols and ensure proper labeling for safety.
Additionally, establish clear procedures for disposal and emergency response.


How to monitor cleanroom environments?

Regular monitoring involves using sensors to track temperature, humidity, and particle counts.
Implement a data logging system to maintain records for compliance audits.
Routine inspections should also be conducted to ensure all systems function correctly.


What are the common applications of modular cleanrooms?

Modular cleanrooms are commonly used in industries such as:

  • Pharmaceuticals
  • Biotechnology
  • Electronics manufacturing
    They provide controlled environments for sensitive processes and products.

How to perform cleanroom testing?

Cleanroom testing involves regular particle count measurements to assess air cleanliness.
Conduct microbial testing to ensure contamination levels are within acceptable limits.
Document findings and compare them against industry standards for compliance.


What are the future trends in modular cleanroom technology?

Future trends include increased automation in cleanroom operations and enhanced energy efficiency.
Smart technologies for real-time monitoring and control are also emerging.
Sustainability practices in cleanroom design and construction are gaining traction.


How to select appropriate cleanroom seals and gaskets?

Choose seals and gaskets that are compatible with cleaning agents and resistant to chemicals.
Ensure they fit properly to prevent leaks and maintain cleanroom integrity.
Regularly inspect and replace them as needed to maintain effectiveness.


How do you test cleanroom air quality?

Testing air quality involves sampling air for particulate contamination using specialized equipment.
Use active and passive methods to gather accurate data on particle counts and microbial levels.
Analyze results to ensure compliance with cleanroom standards and make necessary adjustments.


How to manage cleanroom inventory?

Implement a tracking system for supplies and equipment within the cleanroom.
Regularly audit inventory to ensure adequate stock levels and expiration dates.
Establish clear procedures for ordering and restocking materials as needed.


What are the best practices for cleanroom operation?

Best practices include strict gowning procedures and maintaining cleanliness at all times.
Regular training for personnel on protocols and emergency procedures is essential.
Routine maintenance and monitoring of equipment ensure optimal cleanroom performance.


What is the difference between cleanroom and controlled environment?

A cleanroom specifically focuses on minimizing airborne particles and contamination.
In contrast, a controlled environment may regulate temperature and humidity but not necessarily cleanliness.
Both environments serve different industrial and research purposes.


How does temperature affect cleanroom operations?

Temperature fluctuations can impact product quality and worker comfort in cleanrooms.
Maintaining a stable temperature is crucial for compliance with industry standards.
Proper HVAC systems ensure consistent environmental conditions for optimal performance.


How to achieve energy efficiency in cleanrooms?

Implement energy-efficient HVAC systems and LED lighting to reduce consumption.
Regular maintenance of equipment ensures optimal performance and energy use.
Consider using advanced monitoring systems to track and optimize energy usage.


How to document cleanroom processes?

Establish standard operating procedures (SOPs) for all cleanroom activities.
Document each process, including monitoring results and maintenance activities, for compliance.
Regularly review and update documentation to reflect current practices and regulations.


How to deal with cleanroom emergencies?

Prepare an emergency response plan for potential contamination or equipment failure.
Train personnel on procedures for addressing emergencies effectively.
Regular drills ensure readiness and familiarity with emergency protocols.

What is the difference between modular### What is the difference between modular and traditional cleanrooms?

Modular cleanrooms are prefabricated and can be easily reconfigured, while traditional cleanrooms are built on-site and are often fixed in design.
Modular options allow for quicker installation and flexibility, making them suitable for changing needs.
Traditional cleanrooms may have more integrated systems but lack the adaptability of modular designs.


How to choose the right modular cleanroom system?

Assess your specific requirements, including size, layout, and regulatory needs.
Evaluate different configurations and materials based on durability and maintenance.
Consult with manufacturers to ensure the system meets industry standards and operational goals.


How to conduct a risk assessment for cleanrooms?

Identify potential hazards, including contamination sources and equipment failures.
Evaluate the likelihood and impact of each risk, prioritizing them based on severity.
Develop mitigation strategies and continuously review and update the assessment as needed.


What are the airflow requirements for ISO 7 cleanrooms?

ISO 7 cleanrooms typically require a minimum of 0.45 m/s (90 ft/min) air velocity through HEPA filters.
Air changes per hour should be maintained at 30 to 60 to ensure proper ventilation.
Achieving uniform airflow distribution is crucial for maintaining cleanliness and compliance.

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