4 x 6M ISO 5 Modular Cleanroom
Reference Price:US$13000-15000




Cleanroom
4 x 6M ISO 5 Modular Cleanroom
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Summary
4 x 6M ISO 5 Modular Cleanroom
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Installation & Validation
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Cleanrooms Detail
An ISO 5 modular cleanroom is a controlled environment that meets stringent cleanliness standards as defined by the International Organization for Standardization (ISO). It is designed to maintain a maximum allowable particle concentration of no more than 3,520 particles per cubic meter for particles ≥0.5 micrometers in size.
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 |
an ISO 5 modular cleanroom is essential for processes that require strict control of airborne particulate contamination to ensure product integrity and compliance with industry standards.
Cleanrooms Airflow
The airflow principle in an ISO 5 modular cleanroom is critical for maintaining the required cleanliness levels and ensuring that the environment remains free from contamination. Here are the key aspects of the airflow principle in an ISO 5 cleanroom:
Cleanrooms Installation
Cleanrooms Testing
Cleanroom testing is a series of tests performed on the interior environment of a cleanroom to verify that it meets specific cleanliness requirements. These tests usually involve the measurement of a number of parameters such as air cleanliness, temperature and humidity, air velocity and air volume, noise, illumination, etc. inside the clean room. The purpose of the testing is to ensure that the clean room is able to provide a stable and contamination-free environment during the production process.
FAQ
What is the role of laminar flow in ISO 5 cleanrooms?
Laminar flow provides a continuous stream of filtered air. This helps to minimize particle contamination in critical areas.
It creates a uniform airflow pattern, protecting sensitive processes. Proper laminar flow is essential for maintaining ISO 5 standards.
What are the guidelines for cleanroom design?
Guidelines for cleanroom design include:
- Defining cleanliness requirements.
- Optimizing workflow and space usage.
- Selecting appropriate materials and finishes.
These ensure effective contamination control and operational efficiency.
How to integrate automation in a modular cleanroom?
Integrating automation in a modular cleanroom enhances efficiency. Automated systems can manage environmental controls and monitoring.
Utilize robotics for material handling and processing tasks. This reduces human intervention and minimizes contamination risks.
How to monitor air quality in an ISO 5 cleanroom?
Monitoring air quality involves using particle counters and sensors. Regular sampling and data logging are crucial for compliance.
Establish baseline measurements and compare them to standards. Continuous monitoring helps maintain ISO 5 cleanliness levels.
How does pressure differential work in cleanrooms?
Pressure differential maintains air cleanliness by controlling airflow. Higher pressure in cleanrooms prevents contaminants from entering.
Regularly monitoring pressure differentials ensures proper functioning. This is crucial for maintaining a sterile environment.
How to conduct a risk assessment for a cleanroom?
Conducting a cleanroom risk assessment involves identifying potential hazards. Analyze the likelihood and impact of each risk on operations.
Develop and implement mitigation strategies to address these risks. Regularly review and update assessments as conditions change.
What are the common contaminants in a cleanroom?
Common contaminants in cleanrooms include:
- Dust particles
- Microbial contamination
- Chemical residues
- Skin flakes
Understanding these contaminants is vital for effective control measures.
What are the key components of a modular cleanroom?
Key components of a modular cleanroom include:
- Wall panels for containment.
- Air handling units for ventilation.
- HEPA or ULPA filters for air cleanliness.
- Specialized lighting systems.
These components ensure a controlled environment for sensitive processes.
How to certify a modular cleanroom?
To certify a modular cleanroom, follow industry standards and guidelines. Conduct thorough testing of air quality and particle counts.
Document all procedures and results for compliance verification. Engage with certification bodies for official assessment.
How to select the right modular cleanroom supplier?
Selecting the right modular cleanroom supplier involves several steps:
- Assess their experience and reputation in the industry.
- Review their compliance with cleanroom standards.
- Check client references and case studies.
Compare pricing and support options to find a suitable match.
How to choose the right flooring for an ISO 5 cleanroom?
Choose flooring materials that are smooth and non-porous. Consider options like vinyl or epoxy for easy cleaning.
Ensure the flooring can withstand regular cleaning and disinfecting. This is crucial for maintaining a contamination-free environment.
What is the role of cleanroom technology in pharmaceuticals?
Cleanroom technology is essential in pharmaceuticals for product integrity. It helps maintain strict environmental controls during manufacturing.
This reduces the risk of contamination and ensures compliance with regulations. Effective cleanroom design supports pharmaceutical quality assurance.
What is the role of gowning rooms in a cleanroom?
Gowning rooms serve as a transition area between clean and non-clean zones. They help minimize contamination by ensuring proper attire.
Personnel must don cleanroom garments and undergo decontamination before entry. This process is crucial for maintaining a sterile environment.
What is the difference between class 100 and ISO 5 cleanrooms?
Class 100 cleanrooms refer to environments with a maximum of 100 particles per cubic foot. ISO 5 cleanrooms have similar standards but use metric measurements.
Both classifications ensure high cleanliness levels, but ISO 5 is more globally recognized. Understanding these differences aids in compliance and design.
What are the benefits of a modular cleanroom?
Benefits of a modular cleanroom include:
- Flexibility in design and layout.
- Quick installation and scalability.
- Cost-effectiveness compared to traditional builds.
These advantages make modular cleanrooms ideal for evolving industry needs.
How to calculate airflow for a modular cleanroom?
To calculate airflow for a modular cleanroom, determine the required air changes per hour. Multiply the cleanroom volume by the desired air change rate.
Use the formula: Airflow (CFM) = Volume (Cubic Feet) × Air Changes per Hour / 60. This ensures adequate ventilation and particle control.
What is the airflow rate for an ISO 5 cleanroom?
The airflow rate for an ISO 5 cleanroom typically ranges from 100 to 400 CFM. This depends on the room size and specific design requirements.
Maintaining appropriate airflow is essential for controlling contaminants. Regular monitoring ensures compliance with cleanliness standards.
How to upgrade an existing cleanroom to ISO 5?
To upgrade a cleanroom to ISO### How to upgrade an existing cleanroom to ISO 5?
To upgrade an existing cleanroom to ISO 5, begin with an assessment of current conditions. Identify areas needing improvement, such as air filtration and airflow.
Install HEPA or ULPA filters and enhance ventilation systems. Ensure compliance with ISO 5 standards through rigorous testing and documentation.
What is a modular cleanroom?
A modular cleanroom is a prefabricated, flexible space designed for controlled environments. These cleanrooms can be easily assembled and customized to specific needs.
They allow for rapid deployment and scalability, ideal for industries requiring strict cleanliness. Modular designs facilitate efficient space usage and compliance with standards.
How often should an ISO 5 cleanroom be tested?
ISO 5 cleanrooms should be tested at least quarterly to ensure compliance. Regular testing includes air particle counts and microbiological assessments.
Additional tests may be required after significant changes or events. Consistent monitoring is vital for maintaining cleanroom integrity and performance.
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