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Designing a cleanroom involves careful consideration of various factors to ensure that it meets the specific cleanliness standards required for its intended application, whether in pharmaceuticals, biotechnology, semiconductor manufacturing, aerospace, or other sensitive environments.
Cleanroom design is a complex process that requires careful planning and consideration of various factors:
Design Basis
Layout of functional areas
Air purification system
Walls, ceilings and floors
Lighting and electrical
Your Reliable Manufacturer of Cleanroom design
Design basis
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Clean room grade table
| Comparison Table GMP/USP/ISO/FED209E | ||||||||||||
| project | China GMP/Europe GMP | ISO | FED STD 209E | |||||||||
| Suspended particles P/m3 | level | Static | dynamic | level | Static | level | dynamic | |||||
| ≥0.5um | ≥5μm | ≥0.5μm | ≥5μm | ≥0.5um | ≥5μm | ≥0.5um | ≥5μm | |||||
| A | 3520 | 20 | 3520 | 20 | M3.5 | 3530 | 100 | 5 | 2220 | 20 | 100 | |
| B | 3520 | 29 | 352000 | 2900 | - | - | 6 | 3520 | 29 | 1000 | ||
| C | 352000 | 2900 | 3520000 | 29000 | M5.5 | 353000 | 10000 | 7 | 352000 | 2930 | 10000 | |
| 8. | 3520000 | 29300 | 100000 | |||||||||
| D | 3520000 | 29000 | No regulations | No regulations | M6.5 | 3530000 | 100000 | 9 | 3520000 | 29300 | 100000 | |
Comparison table of ISO grade standards and ventilation times | |
| ISO Class | ACH(AIRCHANGE PER HOUR) |
| ISO 3 | 360-540 |
| ISO 4 | 300-540 |
| ISO 5 | 240-480 |
| ISO 6 | 50-60 |
| ISO 7 | 30-40 |
| ISO 8 | 15-25 |
Functional Area Layout
Raw material area
Cleaning area
Processing area
Packing area
Finished product storage area
Personnel flow
Unidirectional flow
Changing area
Air shower
Hand washing room
Air curtain machine
Insect and rodent prevention facilities
Waste treatment area
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Pharmaceutical | Foods | Electronic |
Clean Room Airflow Design
The airflow pattern in a cleanroom is engineered to direct air in a manner that removes airborne contaminants and prevents them from settling on surfaces. Cleanrooms typically use one of the following airflow patterns:
Unidirectional (Laminar) Flow
In unidirectional flow, air moves in a single direction (usually vertically or horizontally) at a constant velocity, ensuring that contaminants are continuously swept away from cleanroom surfaces. This type of airflow is commonly used in the highest-class cleanrooms (e.g., Class 1 to Class 5,hardwall cleanroom), where precise contamination control is necessary.
Non-Unidirectional (Turbulent) Flow
In turbulent flow, air moves in random directions, typically in a more dispersed and less controlled manner. This airflow pattern is less common but can be used in lower-class cleanrooms (e.g., Class 6 to Class 9) where strict particle control is less critical. The air is typically recirculated within the room and mixed to dilute contaminant levels.
Air Changes per Hour (ACH)
Air changes per hour (ACH) is a measure of how many times the total volume of air in a cleanroom is replaced in one hour. Cleanroom design specifications require specific ACH values depending on the room’s classification:
High-class cleanrooms (e.g., Class 1) require greater ACH rates (often 300-600 ACH).
Lower-class cleanrooms (e.g., Class 7) typically have lower ACH rates (e.g., 20-40 ACH).
The higher the ACH, the greater the volume of air is exchanged, which improves contamination control but may increase energy consumption.
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Air circulation system | Air flow external circulation system | HVAC 3-stage filtration system |
Clean Room Wall Panel
Size and appearance
Ensure that the size and shape of clean room engineering products meet the design requirements and have no obvious defects.
Physical properties
Such as compression, tension, impact resistance and other tests to ensure the strength and durability of the material.
Surface treatment
Confirm that the surface is smooth, the coating is uniform, and there are no bubbles, peeling, etc.
Test report
Fire and corrosion resistance test
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| Cleanroom Panel | MGO Rock Wool Panel | Handmade rock wool panel |
Clean Room Doors And Windows
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Steel standard: Select high-quality steel that meets national and international standards to ensure its corrosion resistance and strength. Surface treatment: The surface of the door body should be treated with anti-rust treatment (such as spraying, anodizing, etc.) to ensure durability and easy cleaning. Insulation material: The door core material should have good heat insulation and sound insulation properties, and insulating materials such as polyurethane or rock wool are usually used. Production process: Production is carried out strictly in accordance with standardized processes, including cutting, forming, welding and painting | Steel standard: Select high-quality steel that meets national and international standards to ensure its corrosion resistance and strength. Surface treatment: The surface of the door body should be treated with anti-rust treatment (such as spraying, anodizing, etc.) to ensure durability and easy cleaning. Insulation material: The door core material should have good heat insulation and sound insulation properties, usually using insulating materials such as polyurethane or rock wool. Production process: Strictly follow the standardized process for production, including cutting, forming, welding and painting, to ensure stable quality in each link. |
Clean Room Floor
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Electrical system design
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- Video
- Workshop
- Data sheet
- Certificate
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Cleanroom design Video Introduction
FAQ
What is the clean room design?
Clean room design refers to the process of creating controlled environments that minimize contamination from airborne particles, chemical vapors, and other pollutants. Clean rooms are essential in various industries, particularly in pharmaceuticals, biotechnology, semiconductor manufacturing, aerospace, and food production, where even minute levels of contaminants can affect product quality and safety.
What are the design requirements for a clean room?
Designing a clean room involves adhering to specific requirements to ensure that the environment is controlled, sterile, and free from contaminants. Below are the key design requirements for a clean room:ISO Standards: Clean rooms are classified according to ISO 14644-1, which specifies the maximum allowable levels of airborne particulate contamination. Design must meet the requirements for the intended ISO class (e.g., ISO Class 5, ISO Class 7).
What are the principles of cleanroom design?
The principles of cleanroom design are essential for creating environments that minimize contamination and maintain controlled conditions. Here are the core principles that guide the design and operation of cleanrooms
What are the four basic components of a cleanroom?
Air Filtration System
Environmental Control Systems
Room Construction and Surfaces
Personnel and Material Flow
What is the clean room design?
Cleanroom design refers to the planning and construction of a controlled environment with specific air quality, temperature, humidity, and cleanliness levels. It focuses on controlling airborne contaminants and maintaining low particle levels to meet industry-specific requirements.
What are the criteria for clean room design?
Key criteria include air filtration (HEPA/ULPA filters), airflow patterns, air changes per hour, temperature and humidity control, cleanroom classification, proper materials for surfaces, contamination control, and adherence to industry standards like ISO 14644.
What are the four basic components of a cleanroom?
The four basic components are the air handling system (including filters), controlled airflow, cleanroom surfaces (smooth, non-shedding), and personnel management (gowning and behavior protocols) to minimize contamination.
How to create a clean room?
To create a cleanroom, begin by selecting the appropriate class based on required cleanliness levels. Install an effective air filtration system (HEPA/ULPA), maintain proper airflow, ensure smooth, easy-to-clean surfaces, and follow strict construction and operational protocols.
What are the GMP guidelines for clean rooms?
GMP (Good Manufacturing Practice) guidelines for cleanrooms include maintaining air cleanliness, controlling environmental factors (temperature, humidity), proper equipment calibration, personnel gowning and hygiene, thorough cleaning protocols, and ensuring product safety and consistency.
What are the basic clean room requirements?
Basic cleanroom requirements include effective air filtration (HEPA/ULPA), specified particle concentration limits, controlled airflow, smooth, easy-to-clean surfaces, proper gowning procedures, and regular cleaning and maintenance protocols to prevent contamination.
What are the surfaces of a cleanroom?
Cleanroom surfaces must be smooth, non-porous, and easy to clean to prevent dust and particle accumulation. Common materials include stainless steel, epoxy-coated steel, and specialized laminates that resist shedding and allow efficient cleaning.
What is a clean room for semiconductor manufacturing?
A cleanroom for semiconductor manufacturing is a highly controlled environment designed to minimize airborne particles and contaminants, as even tiny particles can damage sensitive microelectronic components during production.
What is a clean room for microprocessors?
A cleanroom for microprocessors is designed to protect the manufacturing process of microchips from contamination. It ensures strict control of air quality, temperature, humidity, and particle levels to prevent defects in the microprocessor’s intricate circuits.
What is semiconductor cleaning?
Semiconductor cleaning is the process of removing contaminants (such as particles, organic materials, and metal ions) from silicon wafers and other semiconductor materials. It involves specialized chemicals and techniques to ensure high purity for device fabrication.
What is the standard for cleanroom design?
The standard for cleanroom design is ISO 14644-1, which defines air cleanliness classifications based on the number of airborne particles per cubic meter. It also provides guidelines for construction, operation, and maintenance of cleanrooms.
What is a clean room in pharmaceutical industry?
In the pharmaceutical industry, a cleanroom is a controlled environment where contamination is minimized during the manufacturing of drugs, sterile products, and medical devices. It ensures compliance with GMP and regulatory standards for safety and quality.
What are the FDA classifications for clean rooms?
The FDA classifies cleanrooms based on the risk to product sterility. For example, sterile drug products require Class 100 (ISO Class 5) or better cleanrooms, while non-sterile products might be manufactured in higher classes like Class 10,000 or Class 100,000 (ISO Class 7 and ISO Class 8).
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