- General design principles
Functional zoning
The clean room should be divided into clean area, quasi clean area and auxiliary area, and the functional areas should be independent and physically isolated.
The process flow should follow the principle of unidirectional flow to avoid cross contamination between personnel and materials.
The core clean area should be located in the center of the building or upwind to reduce external interference.
Airflow organization
Unidirectional flow clean room: using vertical laminar flow or horizontal laminar flow, with an airflow velocity of 0.3~0.5m/s, suitable for high cleanliness demand scenarios such as semiconductors and biomedicine.
Non-unidirectional flow clean room: maintains cleanliness through efficient filtration and dilution, with a ventilation rate of 15~60 times/hour, suitable for low to medium cleanliness scenarios such as food and cosmetics.
Mixed flow clean room: The core area adopts unidirectional flow, while the surrounding areas adopt non unidirectional flow, balancing cost and efficiency.
Differential pressure control
The pressure difference between the clean area and the non clean area is ≥5Pa, and the pressure difference between the clean area and the outdoor area is ≥10Pa.
The pressure gradient between adjacent clean areas should be reasonable, and the pressure in high cleanliness areas should be higher than that in low cleanliness areas.
- Industry classification design requirements
(1). Clean rooms in semiconductor industry
Cleanliness class
The core process area (such as photolithography and etching) needs to meet ISO 14644-1 level 1 or 10, with a particle concentration of ≤ 3520 particles/m3 (0.5um), and the cleanliness of the auxiliary area can be relaxed to ISO 7 or 8.
Temperature and humidity control
Temperature 22±1℃, relative humidity 40%~60%, using a constant temperature and humidity air conditioning system.
Anti static design
The ground adopts conductive epoxy flooring or anti-static PVC flooring, with a resistance value of ≤ 1*10^6Ω.
Personnel must wear anti-static clothing and shoe covers, and the grounding resistance of the equipment should be ≤12Ω
Layout example
The core process area is located in the center of the building, surrounded by equipment rooms and testing rooms. Materials enter through airlocks, and personnel enter through air shower.
The exhaust system is independently set up, and the exhaust gas is filtered by hepa filter before being discharged.
(2). Clean room in biopharmaceutical industry
Cleanliness class
The sterile preparation filling area needs to reach class A (ISO 5) and class 100 locally; Cell culture and bacterial operation areas need to reach class B (ISO 6), while auxiliary areas (such as sterilization room and material storage) need to reach level C (ISO 7) or level D (ISO 8).
Biosafety requirements
Experiments involving highly pathogenic microorganisms must be conducted in BSL-2 or BSL-3 laboratories, equipped with negative pressure environment, double door interlock, and emergency sprinkler system.
The sterilization room should use fire-resistant and high-temperature resistant material, and be equipped with steam sterilizers or hydrogen peroxide atomization disinfection equipment.
Layout example
The bacterial room and cell room are independently set up and physically isolated from clean filling area. Material enter through pass box, while personnel enter through change room and buffer room; The exhaust system is equipped with hepa filter and activated carbon adsorption device.
(3). Clean rooms in food industry
Cleanliness class
The food packaging room needs to reach a level of class 100000 (ISO 8), with a particle concentration of ≤ 3.52 million/m3 (0.5um).
The raw material processing and non ready to eat food packaging room must reach a level of class 300000 (ISO 9).
Temperature and humidity control
Temperature range of 18-26℃, relative humidity ≤75%, to prevent the growth of microorganisms in condensed water.
Layout example
The cleaning area (such as inner packaging room) is located upwind, while the quasi cleaning area (such as raw material processing) is located downwind;
Materials enter through buffer room, while personnel enter through the change room and hand washing and disinfection area. The exhaust system is equipped with primary and medium filter, and the filter screen is replaced regularly.
(4). Clean room in cosmetics industry
Cleanliness class
The emulsification and filling room needs to reach class 100000 (ISO 8), and the raw material storage and packaging room needs to reach class 300000 (ISO 9).
Material selection
The walls are coated with anti mold paint or sandwich panel, the floors are self leveling with epoxy, and the joints are sealed. The lighting fixtures are sealed with clean lamps to prevent dust accumulation.
Layout example
The emulsification room and filling room are independently set up, equipped with local class 100 clean bench; Materials enter through the pass box, while personnel enter through the change room and air shower; The exhaust system is equipped with an activated carbon adsorption device to remove organic volatile compounds.
- General technical parameters
Noise control: Clean room noise ≤65dB(A), using low-noise fan and muffler.
Lighting design: Average illuminance>500lx, uniformity>0.7, using shadowless lamp or LED clean lamp.
Fresh air volume: If the fresh air volume per person per hour is greater than 40m3, compensation for exhaust and maintenance of positive pressure are required.
Hepa filters are replaced every 6-12 months, primary and medium filters are cleaned monthly, floors and walls are cleaned and disinfected weekly, equipment surfaces are wiped daily, air settling bacteria and suspended particles are regularly detected, and records are kept.
- Safety and emergency design
Safe evacuation: Each clean area on each floor should have at least 2 safety exits, and the opening direction of evacuation doors should be consistent with the direction of escape. A bypass door must be installed in the shower room when there are more than 5 people present.
Firefighting facilities: The clean area adopts a gas fire extinguishing system (such as heptafluoropropane) to avoid water damage to equipment. Equipped with emergency lighting and evacuation signs, with a continuous power supply time of more than 30 minutes.
Emergency response: The biosafety laboratory is equipped with emergency evacuation routes and eye wash stations. The chemical storage area is equipped with leak proof trays and absorbent materials.
Post time: Sep-29-2025