3 x 3M ISO 5 Modular Cleanroom
Reference Price:US$5000.00-7500.00



Cleanroom
3 x 3M ISO 5 Modular Cleanroom
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Summary
3 x 3M ISO 5 Modular Cleanroom
Validation
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
Can a modular cleanroom be relocated?
Yes, a modular cleanroom can be easily relocated. Its design allows for quick disassembly and reassembly at a new site.
Before relocating, assess the new environment's requirements. This ensures that cleanliness standards are maintained after the move.
How to upgrade an existing cleanroom to ISO 5?
To upgrade to ISO 5, start with a thorough assessment of the current cleanroom. Evaluate the air filtration and flow requirements.
Next, upgrade HEPA filters and improve interior materials to reduce contamination risks. After modifications, conduct validation testing to confirm compliance.
Finally, document all changes and update standard operating procedures for future reference.
What is the cost of building a modular cleanroom?
The cost of building a modular cleanroom varies significantly. On average, expect to pay between $100 and $300 per square foot.
Key factors influencing cost include:
- Cleanroom classification
- Material and equipment choices
- Installation and labor expenses
Consulting multiple suppliers can provide more accurate estimates.
What are the common cleanroom layout designs?
Common cleanroom layout designs include:
- Linear layout: Suitable for small cleanrooms.
- Circular layout: Ideal for large cleanrooms.
- U-shaped layout: Best for complex processes.
Choose a layout based on operational efficiency and space utilization.
How to write a cleanroom SOP (Standard Operating Procedure)?
To write a cleanroom SOP, first define its purpose and scope. This ensures that all personnel understand its significance.
Next, outline each operational step clearly. Use straightforward language to facilitate comprehension.
Finally, review and approve the SOP, ensuring compliance with industry standards. Regular updates are essential for ongoing relevance.
What are the design considerations for a modular cleanroom?
Designing a modular cleanroom requires careful consideration of several factors:
- Functional requirements: Define the necessary cleanliness level.
- Space layout: Optimize workflow and accessibility.
- Environmental control: Manage temperature, humidity, and airflow effectively.
Material selection and equipment positioning are also crucial to minimize contamination risks.
What are the certification bodies for cleanrooms?
Certification bodies for cleanrooms include:
- ISO (International Organization for Standardization)
- ANSI (American National Standards Institute)
- FS209E (Federal Standard)
These organizations establish and verify cleanroom standards and procedures.
How often should an ISO 5 cleanroom be tested?
An ISO 5 cleanroom should be tested regularly, typically every six months. This ensures ongoing compliance with cleanliness standards.
Additionally, retesting is required after significant changes or equipment replacements. This helps identify potential issues promptly.
What is the temperature and humidity requirement for ISO 5?
ISO 5 cleanrooms should maintain a temperature range of 20°C to 24°C. Relative humidity should be maintained between 30% and 60%.
These conditions help control airborne particles and microorganisms, ensuring a sterile environment.
How to control airflow direction in a cleanroom?
To control airflow direction, design an effective HVAC system. Strategically place supply and return vents to direct airflow appropriately.
Adjustable vents and airspeed sensors can facilitate dynamic airflow management. This maintains air quality and cleanliness levels.
How to manage cleanroom supplies?
Effective cleanroom supply management involves a systematic inventory system. Regularly check and record inventory levels to ensure sufficient supplies.
Implement clear labeling and categorization for quick access to necessary items. Establish usage protocols and procurement processes for compliance.
How to validate a modular cleanroom?
Validating a modular cleanroom involves several key steps. Begin with design qualification to ensure compliance with standards.
Next, conduct installation qualification to verify correct installation of all systems. Finally, perform operational qualification to confirm performance under real conditions.
Document all validation results for future audits and references.
How to integrate automation in a modular cleanroom?
Integrating automation requires careful planning. Start by selecting suitable automated equipment, such as monitoring systems and robotics.
Ensure compatibility with the cleanroom's environmental control systems. This maximizes efficiency and maintains cleanliness standards.
Training personnel on new technologies is essential for successful implementation.
How to monitor air quality in an ISO 5 cleanroom?
Monitoring air quality involves using real-time sensors to track particulate levels. Regularly calibrate these sensors to ensure accuracy.
Implement data logging systems to record air quality metrics over time. This facilitates compliance checks and helps identify trends.
What are the safety protocols for cleanroom operations?
Safety protocols in cleanrooms include:
- Proper gowning procedures to minimize contamination.
- Regular training on equipment use and emergency procedures.
- Strict access control to limit entry and exit.
Routine inspections and audits help maintain compliance with safety standards.
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