6 x 8M ISO 7 Modular Cleanroom
Reference Price:US$12000-25000



Cleanroom
6 x 8M ISO 7 Modular Cleanroom
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Summary
6 x 8M ISO 7 Modular Cleanroom
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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.
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 | |
Equipment | Air 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. | |
Temperature | 21-27*C (or as per required) |
Humidity | 30-60°C (or as per required) |
Application | Pharmaceutical factory, hospital, medical device factory, electronics factory, food factory,cosmetics factory, etc. |
Qualification Documents | CE GMP ISO |
Full Service | FAT and SAT Service, Professional Consultation, Training, 24 hours technical support |
Cleanrooms Airflow
When designing the airflow system for an ISO 7 modular cleanroom, several factors must be considered:
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.
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 modular cleanroom expansion?
Modular cleanroom expansion offers flexibility to adapt to changing needs. This approach allows for quick installation and minimal disruption. It can also be cost-effective compared to traditional construction methods.
How to retrofit an existing cleanroom to ISO 7 standards?
To retrofit a cleanroom to ISO 7 standards, start by assessing current conditions and identifying areas needing improvement.
Next, upgrade filtration systems, improve air handling, and ensure proper materials are used to meet cleanliness levels.
Finally, conduct thorough testing and documentation to confirm compliance with ISO 7 requirements.
What materials are used in modular cleanroom construction?
Common materials for modular cleanroom construction include:
- Cleanroom wall panels for contamination control
- Vinyl or epoxy flooring for easy maintenance
- Aluminum or stainless steel frames for structural integrity
These materials ensure durability and hygiene in cleanroom environments.
How to select a cleanroom contractor?
Selecting a cleanroom contractor involves evaluating their experience and qualifications. Look for contractors with expertise in cleanroom design and compliance with industry standards.
Request references and review past projects to ensure they meet your specific needs.
How to calculate the ROI of a modular cleanroom?
To calculate the ROI of a modular cleanroom, first determine the total costs of installation and operation.
Next, analyze the expected benefits, such as increased productivity and reduced contamination risks.
Finally, compare the financial gains against the initial investment to evaluate the return.
How to optimize space in a modular cleanroom?
Space optimization in a modular cleanroom can be achieved through strategic layout design. Use vertical space for storage and ensure equipment is placed for easy access.
Regularly assess workflows to identify areas for improvement and enhance overall efficiency.
What certifications are available for cleanroom manufacturers?
Cleanroom manufacturers can obtain various certifications, including:
- ISO 14644 for cleanroom standards
- ISO 9001 for quality management
- FDA compliance for pharmaceutical applications
These certifications ensure adherence to industry regulations and best practices.
What type of flooring is suitable for cleanrooms?
Suitable flooring for cleanrooms includes:
- Vinyl flooring for easy cleaning and durability
- Epoxy flooring for chemical resistance
- Conductive flooring to reduce static electricity
These options help maintain cleanliness and safety standards.
How do you test cleanroom air quality?
Testing cleanroom air quality involves using particle counters to measure airborne contaminants.
Conduct air sampling for microbial contamination and monitor temperature and humidity levels.
Regular testing ensures compliance with cleanliness standards and operational efficiency.
What are the specifications for ISO 7 cleanrooms?
ISO 7 cleanrooms must maintain a maximum allowable particle count of 352,000 particles per cubic meter.
The air cleanliness level requires a controlled temperature and humidity environment.
Additionally, airflow must be regulated to ensure proper ventilation and contamination control.
How to control contamination in modular cleanrooms?
Contamination control in modular cleanrooms requires strict protocols and regular monitoring.
Implement proper gowning procedures and use suitable cleaning agents to maintain hygiene.
Regularly inspect and maintain equipment, especially air filtration systems, to prevent contamination.
What is the role of cleanroom operators?
Cleanroom operators are responsible for maintaining cleanliness and compliance within the environment.
They follow protocols for gowning, cleaning, and equipment operation to prevent contamination.
Additionally, operators monitor conditions and report any irregularities to ensure consistent performance.
What is the impact of vibration on cleanroom operations?
Vibration can negatively impact cleanroom operations by affecting sensitive equipment and processes.
Excessive vibration may lead to contamination risks and compromised product quality.
Proper isolation techniques and equipment placement help mitigate these vibrations and maintain operational integrity.
What is the lifespan of a modular cleanroom?
The lifespan of a modular cleanroom typically ranges from 10 to 20 years, depending on materials and usage.
Regular maintenance and upgrades can extend its operational life significantly.
Proper care ensures that the cleanroom remains compliant with industry standards throughout its lifespan.
What are the advantages of prefabricated cleanrooms?
Prefabricated cleanrooms offer several advantages, including:
- Faster installation times compared to traditional builds
- Customization options to fit specific needs
- Reduced costs due to streamlined construction processes
These benefits make prefabricated cleanrooms an attractive choice for many industries.
How to assess cleanroom compliance with regulations?
To assess cleanroom compliance, conduct regular audits and inspections of systems and protocols.
Review documentation for adherence to relevant standards, such as ISO or FDA guidelines.
Implement corrective actions for any identified non-compliance issues to maintain regulatory standards.
How to choose the right modular cleanroom system?
Choosing the right modular cleanroom system involves evaluating your specific operational requirements.Consider factors such as size, airflow needs, and contamination control measures.
Additionally, assess the manufacturer's reputation and available customization options to fit your needs effectively.
What are the benefits of a modular cleanroom?
Modular cleanrooms provide flexibility in design, allowing for easy expansion or reconfiguration.
They are typically quicker to install and can be more cost-effective than traditional cleanroom builds.
Moreover, they can be tailored to meet specific industry requirements and regulatory standards.
What is the purpose of a cleanroom?
The primary purpose of a cleanroom is to maintain a controlled environment with minimal contamination.
Cleanrooms are essential in industries like pharmaceuticals, electronics, and biotechnology.
They ensure the integrity of sensitive processes and products by controlling air quality and particulate levels.
What are the key components of a modular cleanroom system?
Key components of a modular cleanroom system include:
- Wall panels designed for easy cleaning and contamination control
- Air filtration systems to maintain air quality
- HVAC systems for temperature and humidity regulation
These components work together to create a compliant cleanroom environment.
What are the airflow requirements for ISO 7 cleanrooms?
ISO 7 cleanrooms require a minimum airflow rate to maintain cleanliness standards.
Typically, this involves a minimum of 20 air changes per hour and a controlled temperature and humidity environment.
Proper airflow design helps dilute airborne contaminants and ensures even distribution within the space.
What are the key features of modular cleanrooms?
Key features of modular cleanrooms include:
- Flexible design for easy reconfiguration
- Quick installation and minimal disruption
- High-quality materials that ensure cleanliness and durability
These features make modular cleanrooms ideal for dynamic operational environments.
How to conduct a risk assessment for cleanrooms?
Conducting a risk assessment for cleanrooms involves identifying potential contamination sources and assessing their impact.
Evaluate existing controls and develop strategies to mitigate identified risks effectively.
Regularly review and update the assessment to adapt to changes in operations or regulations.
How to manage cleanroom inventory?
Effective cleanroom inventory management involves implementing strict tracking systems for materials and supplies.
Regularly review inventory levels to ensure availability without excess stock, which can lead to contamination.
Utilize clear labeling and organization to maintain efficiency and compliance within the cleanroom environment.
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