Construction of Zhuhai Pharmaceutical Cleanroom

The construction of a pharmaceutical clean room in Zhuhai, also commonly known as a purification room, is a closed space where the concentration of suspended particles in the air is strictly controlled. Its construction and use aim to minimize the introduction, generation, and retention of indoor particles. Meanwhile, other key parameters in the cleanroom, such as temperature, humidity, and pressure, must also be finely regulated according to specific requirements. The cleanliness level of a clean room is usually classified based on the number of specific particle sizes per unit volume of air. These levels are: Level 10, Level 100, Level 1000, Level 10000, Level 100000, Level 300000, and Level 1 million. The smaller the value, the higher the purification level.

Construction of Zhuhai Pharmaceutical Cleanroom, also commonly known as a purification room, is a closed space where the concentration of suspended particles in the air is strictly controlled. Its construction and use aim to minimize the introduction, generation, and retention of indoor particles. Meanwhile, other key parameters in the cleanroom, such as temperature, humidity, and pressure, must also be finely regulated according to specific requirements. The cleanliness level of a clean room is usually classified based on the number of specific particle sizes per unit volume of air. These levels are: Level 10, Level 100, Level 1000, Level 10000, Level 100000, Level 300000, and Level 1 million. The smaller the value, the higher the purification level.

1、 Grade 100 cleanroom standard:

1cleanliness
The maximum number of particles with a particle size greater than or equal to 0.1 microns shall not exceed 100.

2Pressure difference and temperature and humidity
The temperature should be maintained within the range of 22 ℃± 2; Humidity control at 55% ± 5; To ensure cleanliness, it is usually necessary to cover the entire area with flooring and adopt an elevated floor design. At the same time, a MAU+ffu+DC system should be equipped and maintained in a positive pressure state, with a pressure gradient of approximately 10pa between adjacent rooms.

3illuminance
Due to the need for precise operations and the enclosed environment in dust-free cleanrooms, there are strict requirements for lighting. Mainly including the following points:
Local lighting: designed to enhance the brightness of light in a specific location, but usually not used alone.
Mixed lighting: refers to the illumination on the working surface provided by both general lighting and local lighting, with the general lighting accounting for 10% -15% of the total illumination.

2、 Thousand level cleanroom standard:

1Cleanliness requirements
The standard for Class 1000 cleanrooms requires that the number of fine dust particles with a particle size of less than 0.5 microns per cubic meter be controlled below 3500, which meets the international dust-free standard level. However, for chip level production and processing, this standard is not sufficient, and the amount of dust needs to be further strictly controlled within 1000 per cubic meter, known as the 1K level, to meet the demand for higher standards.

2Pressure difference and temperature and humidity management
Maintaining an appropriate pressure differential is crucial to ensure the cleanliness of a Class 1000 cleanroom. Usually, the pressure in clean spaces should be higher than that in non clean spaces, and the higher the cleanliness level of the space, the higher the pressure should be to prevent external pollution from entering. In addition, the fresh air volume needs to be sufficient to compensate for the gap air leakage caused by pressure difference, ensuring the stability of pressure difference. The physical significance of this is to control the leakage (or infiltration) air volume through resistance, ensuring that various gaps in the clean room are not contaminated.

3、 10000 level cleanroom standard:

1Cleanliness requirements
ten thousand levelConstruction of Zhuhai Pharmaceutical CleanroomThe cleanliness standard is cleanlines class 10000, which means that the number of dust particles greater than or equal to 0.5 microns per cubic meter should be controlled within 35000 particles, but less than or equal to 350 particles; At the same time, the number of dust particles above 5 microns per cubic meter is controlled within 300 particles, but not exceeding 3000 particles. This standard can meet the needs of most production and processing.

2Temperature and Humidity Control
The temperature and humidity management of Class 10000 cleanrooms mainly relies on dry coil systems. Through the sensing signal of the air conditioning unit, the system can accurately control the opening of the three-way valve, thereby adjusting the water inlet of the air conditioning unit coil to ensure stable and comfortable environment.

4、 100000 level cleanroom standard:

1cleanliness

The cleanliness standard for a 100000 level clean room is to control particles within 100000 per cubic meter. This type of clean room is widely used in the electronics and pharmaceutical manufacturing industries. If the food industry can have a 100000 level clean room, it indicates that its production conditions are quite good. In addition, a 100000 level clean room requires 15-19 air changes per hour to ensure that the air purification time does not exceed 40 minutes after air changes.

2pressure difference

In a clean room, cleanrooms of the same cleanliness level should maintain a consistent pressure difference. For adjacent clean rooms of different cleanliness levels, the pressure difference should be maintained above 5Pa. At the same time, the pressure difference between the clean room and the non clean room should be greater than 10Pa to ensure air circulation and cleanliness in each area.

3Temperature and humidity

The temperature and humidity of a 100000 level clean room need to be adjusted according to whether wearing clean work clothes produces comfort. In winter, the temperature is generally controlled at 2022 ℃, while in summer it is controlled at 2426 ℃, and the temperature fluctuation range does not exceed ± 2 ℃. As for humidity, it should be controlled at 30-50% in winter and 50-70% in summer to meet the needs of different seasons. In addition, the illumination value of the main production rooms in the clean room (area) should be greater than 300Lx, while the illumination values of auxiliary workshops, personnel purification and material purification rooms, gas rooms, corridors, etc. should be controlled between 200~300Lx to ensure sufficient light to meet production needs.

5、 300000 level cleanroom standard:

1cleanliness

The cleanliness standard for a 300000 level cleanroom is: the number of dust particles greater than or equal to 0.5 microns per cubic meter of air shall not exceed 10500000, while the number of dust particles greater than or equal to 5 microns shall not exceed 60000. In addition, the maximum number of planktonic bacteria per cubic meter is 1000.

2Differential pressure and temperature control

In a 300000 level clean room, the static pressure difference between different clean rooms (zones) should be greater than or equal to 5PA to ensure air circulation and maintain cleanliness. At the same time, the static pressure difference between the clean room (area) and the outside should reach or exceed 10PA to ensure the air quality in each area. In terms of temperature control, the clean room needs to be adjusted according to the actual situation to meet production needs.

6、 Million level cleanroom standard:

1Cleanliness testing

Cleanliness testing is a necessary step in a million level cleanroom. This includes two situations: empty state testing and static testing. Empty state testing refers to the testing conducted when the clean room has been completed and the purified air conditioning system is operating normally, but there are no process equipment or production personnel inside the room. Static testing is conducted when the purified air conditioning system is running and the process equipment is installed but there are no production personnel indoors.

2Ventilation rate

Proper ventilation and air exchange rate are crucial to ensure air quality in million level clean workshops. This helps dilute and eliminate indoor polluted air. According to different cleanliness requirements, when the height of the cleanroom is high, the ventilation frequency should be appropriately increased. In addition, the ventilation system design of million level cleanrooms usually requires multiple filtration stages such as initial filtration, medium filtration, and high-efficiency filtration to ensure the cleanliness of the air. The airflow can only achieve cleanliness after undergoing a series of filtration and purification processes.