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In modern scientific experiments and production processes, the need for a clean environment has become increasingly important. A Clean Room (clean shed) can provide a working environment with low particulate matter and low microbial contamination, especially in the fields of pharmaceuticals, Semiconductors, and biotechnology. This article will give you a detailed introduction on how to make a small clean room, including design, material selection, construction, and maintenance.
Determine the design specifications
The first step in making a small modular clean room is to clarify the design specifications. According to the ISO 14644 standard, the levels of clean rooms are divided into multiple levels, such as ISO 1 to ISO 9. The lower the level, the higher the cleanliness requirement. When designing a clean shed, the appropriate level should be selected according to actual needs.
1.Determine the cleanliness level
ISO 5 cleanliness level: No more than 3,520 particles of 0.5 microns and above are allowed per cubic meter of air.
ISO 7 cleanliness level: No more than 352,000 particles per cubic meter of air.
ISO 8 cleanliness: no more than 3,520,000 particles per cubic meter of air.
Choosing the right cleanliness level will directly affect the subsequent design and material selection. For environments with high cleanliness requirements, more complex air filtration and flow design are required.
2. Space size and layout
Space area: Depending on the use requirements, the area of a small clean shed should usually be between 1 square meter and 10 square meters.
Height requirement: At least 2 meters in height is required to install air filtration systems and lighting equipment.
In terms of layout, the placement of equipment, the activity space of operators, and the entry and exit channels of items should be considered to ensure efficient work in the clean room.
3. Ventilation and airflow design
The airflow design of the clean room is crucial, and laminar or turbulent ventilation is usually used.
Laminar ventilation: Air is delivered in a parallel flow, which is suitable for environments with high cleanliness requirements.
Turbulent ventilation: Air flows in a random manner, which is suitable for lower-level clean rooms.
According to the calculation formula:
Q = A / V
Wherein, ( Q ) is the air flow (m³/h), ( A ) is the effective area of the clean room (m²), and ( V ) is the wind speed (m/s). The appropriate wind speed is generally 0.45-0.5 m/s.
Material selection
Choosing the right material is very important for the construction of a small clean room. The main materials include walls, ceilings, floors, filters and lighting equipment.
1. Wall and ceiling materials
Material selection: It is recommended to use smooth, dust-free materials such as stainless steel, PVC or aluminum-plastic panels.
Surface treatment: Walls and ceilings should be dust-proofed to reduce the adhesion of particulate matter.
The design of the walls and ceilings should ensure seamless connection to avoid dust accumulation and facilitate cleaning and maintenance.
2.floor Materials
Material Selection: Wear-resistant and easy-to-clean floor materials such as epoxy resin coating or polyvinyl chloride (PVC) flooring should be selected.
Anti-slip design: Floor materials should have certain anti-slip properties to ensure the safety of operators.
The design of the floor should consider the drainage system to avoid the accumulation of water and dirt.
3. Filters and lighting equipment
Filter Selection: HEPA filters (high-efficiency Air Filters) are a common choice, which can filter out 99.97% of particles with a diameter of 0.3 microns.
Lighting equipment: Dust-proof and waterproof LED lamps should be selected to ensure the brightness and cleanliness in the modular clean room.
The filter should be replaced regularly to ensure its stable performance and avoid the loss of cleanliness due to filter failure.
Construction process
After clarifying the design specifications and material selection, the next step is the actual construction process. The construction process includes the construction of infrastructure, the installation of equipment, and the commissioning of the system.
1 .Infrastructure Construction
Ground Preparation: Ensure that the ground is flat, remove debris, and waterproof if necessary.
-Wall and Ceiling Construction: Build the walls and ceiling of the clean room according to the design drawings. The height and sound insulation of the wall must meet the design requirements. Prefabricated panels or on-site construction can be used to ensure seamless merging of joints to avoid dust accumulation.
Construction Materials: The materials of the walls and ceilings should be installed according to the previous selection to ensure a smooth surface that is easy to clean and maintain.
Channel and Door Settings: Install doors for entering and exiting the clean room, preferably automatic doors or airtight doors, to ensure the airtightness of the clean room.
2. Equipment and System Installation
HVAC System Installation: Install a heating, ventilation and air conditioning (HVAC) system in the clean room. The system should ensure the filtration and circulation of air and maintain the required temperature and humidity.
Lighting Equipment Installation: Install dust-proof lighting fixtures on the top of the clean room to ensure uniform light and no shadows, so that operators can perform delicate work.
All equipment should be installed accurately according to the design requirements to ensure the functionality and safety of the clean room.
3.System Debugging and Verification
System Debugging: After completing the equipment installation, conduct a comprehensive system debugging to ensure the normal operation of the air flow, temperature control and humidity control systems.
Cleanliness Verification: Cleanliness testing is carried out according to ISO 14644 standard. A particle counter is used to measure the number of particles in the air to ensure that the designed cleanliness level is achieved.
Records and Compliance: The results of all tests and debugging must be recorded to ensure compliance with relevant standards and specifications.
Relevant Standards and Specifications
In the process of making a small clean room, a series of standards and specifications must be followed to ensure the compliance of its design, construction and maintenance.
ISO 14644: Standards for modular clean rooms and related controlled environments, which stipulates the classification and test methods of clean rooms.
GMP (Good Manufacturing Practice): Production environment standards applicable to pharmaceuticals and medical devices to ensure the safety and effectiveness of the production process.
ASHRAE 170: Ventilation and air quality standards for medical facilities, providing specific requirements for air flow.
1. Other related standards
ISO 9001: Quality management system standard, emphasizing continuous improvement and customer satisfaction.
ISO 14001: Environmental management system standard, focusing on the performance of enterprises in environmental protection.
2. References
iso 14644-1:2015: Cleanrooms and controlled environments Part 1: Classification of air cleanliness.
iso 14644-2:2015: Cleanrooms and controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
The above standards and specifications provide scientific basis and guidance for the design and construction of cleanrooms, ensuring cleanliness.
