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Views: 198 Author: Site Editor Publish Time: 2025-09-01 Origin: Site
Clean Rooms must be divided into clean areas, semi-clean areas, and auxiliary areas. Functional areas should be independent and physically separated.
Processes must adhere to unidirectional flow to prevent cross-contamination between personnel and materials.
Core clean areas should be located in the building center or upwind to minimize external interference.
Unidirectional cleanrooms: Utilize vertical or horizontal laminar flow with an airflow velocity of 0.3-0.5 m/s. They are suitable for applications requiring high cleanliness levels, such as semiconductors and biopharmaceuticals.
Non-unidirectional clean rooms: Maintain cleanliness through high-efficiency filtration and dilution, with an air change rate of 15-60 times/hour. They are suitable for applications requiring low to medium cleanliness levels, such as food and cosmetics.
Mixed-flow cleanrooms: Utilize unidirectional flow in the core area and non-unidirectional flow in the peripheral areas, balancing cost and efficiency.
Pressure Differential Control: The pressure differential between the clean and non-clean areas should be ≥5 Pa, and the pressure differential between the clean and outdoor areas should be ≥10 Pa. The pressure gradient of adjacent clean areas should be reasonable, and the pressure in high cleanliness areas should be higher than that in low cleanliness areas.
Core process areas (such as photolithography and etching) must meet ISO 14644-1 Class 1 or Class 10, with a particle concentration ≤ 3520 particles/m³ (0.5μm).
Auxiliary areas may meet ISO 7 or 8 cleanliness levels.
Temperature: 22±1°C, relative humidity: 40%-60%, with a constant temperature and humidity air conditioning system.
Conductive epoxy flooring or anti-static PVC flooring with a resistance of ≤ 1×10⁶Ω is used.
Personnel must wear anti-static clothing and shoe covers, and equipment grounding resistance must be ≤ 1Ω.
The core process area is located in the center of the building, with equipment rooms and test rooms located around it.
Materials enter through airlocks, while personnel enter through air showers.
The exhaust system is independent, with exhaust air filtered through HEPA filters.
The sterile filling area must meet Class A (ISO Class 5), with some areas meeting Class 100 standards.
Cell culture and bacterial manipulation areas must meet Class B (ISO Class 6).
Auxiliary areas (such as sterilization rooms and material storage) must meet Class C (ISO Class 7) or Class D (ISO Class 8).
Experiments involving highly pathogenic microorganisms must be conducted in a BSL-2 or BSL-3 laboratory equipped with a negative pressure environment, double-door interlocks, and emergency showers.
The sterilization room must be constructed of fire-resistant and high-temperature-resistant materials and equipped with a steam sterilizer or hydrogen peroxide mist disinfection equipment.
The bacterial and cell rooms should be located separately and physically separated from the clean filling area.
Materials enter through a pass-through window, while personnel enter through the gowning room and buffer room.
The exhaust system should be equipped with high-efficiency filtration and activated carbon adsorption.
Ready-to-eat food inner packaging rooms must meet Class 100000 (ISO Class 8) standards, with a particle concentration ≤ 3.52 million/m³ (0.5μm).
Raw material processing and non-ready-to-eat food packaging rooms must meet Class 300000 (ISO Class 9).
Temperature: 18-26°C, relative humidity ≤ 75% to prevent condensation from breeding microorganisms.
Clean work areas (such as inner packaging rooms) are located upwind, while semi-clean areas (such as raw material processing) are located downwind. Materials enter through the buffer room, while personnel enter through the changing room and hand washing and disinfection area.
The exhaust system is equipped with primary and secondary filters, and the filters are replaced regularly.
Emulsification and filling rooms must meet Class 100000 standards.
Raw material storage and packaging rooms must meet Class 300000 standards.
Wall surfaces should be finished with mildew-resistant paint or color-coated steel plates. Floors should be finished with epoxy self-leveling paint, and joints should be sealed.
Enclosed clean room lamps should be used to prevent dust accumulation.
The emulsification and filling rooms are located separately, each equipped with a Class 100 Clean Room workbench.
Materials enter through a Transfer Window, while personnel enter through a dressing room and air shower.
The exhaust system should be equipped with an activated carbon adsorption device to remove volatile organic compounds.
Cleanroom noise level ≤ 65dB(A), using low-noise fans and silencers.
Average illumination ≥ 500lx, uniformity ≥ 0.7, using shadowless lamps or LED cleanroom lamps.
≥ 40m³ fresh air per person per hour, with exhaust compensation and positive pressure maintained.
High-efficiency filters should be replaced every 6-12 months, and primary and medium-efficiency filters should be cleaned monthly.
Floors and walls should be cleaned and disinfected weekly, and equipment surfaces should be wiped daily.
Airborne bacteria and suspended particulates should be tested regularly, and records maintained.
Each clean area floor should have at least two emergency exits, with the evacuation doors opening in the same direction as the escape route.
Bypass doors should be installed in the Air Shower Room, which is mandatory for rooms with more than five people.
The clean area should utilize a gas fire extinguishing system (such as HFC-227ea) to prevent water damage to equipment.
Emergency lighting and evacuation signs should be provided, with a continuous power supply of 30 minutes or longer.
Biosafety laboratories should be equipped with emergency evacuation routes and eyewash stations.
Chemical storage areas should be equipped with leak-proof trays and absorbent materials.
