The importance of FFU in the return air of the 100-level clean workshop of the pharmaceutical factory

The importance of FFU in the return air of the 100-level clean workshop of the pharmaceutical factory

There are often local 100-level districts in the clean room of the pharmaceutical factory or require a room or several rooms to be 100 or require a certain area of ​​a certain room to be a hundred-level area. These areas are generally not large from tens of square meters. A few square meters or even a few square meters are usually part of a process line in a clean area but they all play a very important role in the clean room. They are often the core part of the workshop process, such as potting, packaging, plugging, potting of biological products, lyophilization, stoppering, etc. The normal operation of the 100-level zone directly affects product quality. The following describes the practices of several hundred-level zones in combination with the characteristics of the clean workshops of pharmaceutical plants.

According to the "Pharmaceutical Quality Management Regulations" (GM) (revised in 1998), the current pharmaceutical plants are generally divided into 300,000, 100,000, 100, and 100 cleanliness areas according to different types of production areas. The highest level of cleanliness. The 100-level area is generally located in the inner area of ​​the workshop. There are 10,000-level or 100,000-level areas. The 100-level area is part of the workshop assembly line. The entire assembly line also includes the 10,000-level area or the 100,000-level area. The general level of the Bai-level area is lower (≤2.8m). The environmental enclosure has higher requirements on noise (the “Clean Factory Design Specification” requires ≤65dB(A). The air duct around the ceiling of the 100-level area is used for the 100-level area to process the air supply. The space is tight.

Temperature and humidity control and supplementary fresh air mode in the 100-level zone:

The 100-level area of ​​the clean area of ​​the pharmaceutical factory is usually the same as that of the 10,000-class clean area. It is the same as the temperature and humidity requirements of the 10,000-level clean area. The same class of clean water, wet treatment and fresh air can be combined with the 10,000-class clean area. Considering the same plan, as shown in Figure 1, a set of combined air conditioners is used to process the air supply of the air-conditioning system in the 10,000-story and the squad-zone. The 100-level zone should consider the FFU (FanFilterUnit) fan heat to increase the number of air exchanges. Balance the temperature and humidity of the 100-level and 10,000-level rooms. The heat and humidity of the process equipment in each room are also considered. This treatment has the following advantages: 1 The air handling system is simple. Avoid a small air handling system or a fresh air treatment system in the 100th district. 2 Avoid setting up the dry coil in the 100-level vertical air duct and avoiding a series of problems caused by the dry coil. For example, the dry coil cold source problem is because the dry coil requires less chilled water, which is less than 2m 3h. The air-conditioning system uses chilled water (712 °C water) because the water temperature is too low, which can cause condensation. The vertical air duct environment in the 100-level area is equipped with dry coils, which causes problems such as insufficient fan head pressure in the FFU system. Engineering practice has proved that this air treatment method is effective. The temperature, humidity, positive pressure value and cleanliness of the 100-level zone can be better guaranteed. The whole assembly line The Wan-level area and the Bai-level area are operated simultaneously for one air-conditioning system. Unified control Unified adjustment of temperature and humidity is simple and reliable.

Hundred-level zone circulating wind treatment:

The 100-level zone of the pharmaceutical plant usually has a vertical laminar flow section with a wind speed of 0.25 to 0.3 m s. If the waste is too small, it is not easy to ensure cleanliness. The circulating air volume should take into account the air supply volume in the 100-level zone. The circulating air treatment methods in the 100-level area of ​​the pharmaceutical factory generally have the following first methods: in the upper part of the 100-level area, there are static pressure tanks in the 100-level area. The ceiling is covered with FFU fan purification unit. Figure 1 The circulating wind enters from the lower part of the side wall of the 100-level area. The vertical air duct enters the static pressure tank through the vertical air duct and is sent into the room through the FFU. The FFU itself has a high-efficiency filter and a fan. In this way, the circulating air pressure filtration is completely simple to be processed by the FFU. The circulating air treatment can be completed in the ceiling of the 100-level zone. The layout of the air conditioning system is compact and convenient. The construction is relatively simple. The upper static pressure tank of the 100-level area is negative pressure relative to the 100-level zone. The leakage between the FFU and the hanger of the 100-level zone is the impact of the indoor flow static pressure tank on the cleanliness of the 100-level zone. In recent years, with the improvement of FFU manufacturing technology, the cost and noise of FFU stand-alone have been decreasing, and the efficiency of fans has been continuously improved. There are more and more FFU treatment methods in the 100-level pharmaceutical factory. At present, the noise of single-machine FFU products is between 52 and 57 dB(A). If the number of FFUs is more than tens or even more, the noise of the 100-level zone is difficult to meet the requirements of the specification. The second way. The top of the 100-level area is equipped with a high-efficiency filter for the top of the static pressure box (the full rate should be ≥65%). Figure 2 uses the circulating fan to enter the static pressure box from the vertical air duct of the 100-level area and then send it to the static pressure box. The device is sent indoors. This method has the following advantages: The cost of the 100-level zone is lower than that of the FFU system. 2 It can better control the noise of the circulating wind system. The 100-level clean area of ​​the pharmaceutical factory is small. The circulating air volume is more than 50,000m 3h (guaranteed 50m 2 hundred-level area). In actual engineering, multiple circulating fans can be used to control the circulating fan to be fully pressurized within 420a. In this way, the low-power fan is used to reduce the noise of the fan itself, and the noise of the hundred-level zone can be effectively controlled by installing a muffler on the fan inlet and the air duct. I designed a biological engineering workshop in Shenzhen, a freeze-drying powder needle line, the area of ​​the potting and sealing area of ​​the 100-level district is 4.5m × 6.6m. The above method is used to treat the circulating air in the 100-level area. Three centrifugal fans are used as the circulating air chassis. In the room (freeze machine room is not clean area muffler is also set in the freeze-drying machine room) air volume 9600m3h · Taiwan full pressure 405a noise 66dB (A) by installing sound-absorbing materials in the wind chassis in the fan inlet and outlet ducts installed muffler control Noise control measures such as wind speed inside the duct. The static noise 62dB (A) in the 100-level zone meets the specification requirements. It has been running well for more than 2 years. The disadvantage of this method is that it requires a large space to set up the circulating air chassis and handle the noise. Usually, the air ducts around the 100-level area are relatively dense and need careful layout. In this way, the upper static pressure tank of the 100-level zone is positive pressure relative to the indoor zone of the 100-level zone. The leakage between the high-efficiency filter and the hanger of the ceiling is the static pressure tank flowing into the room, which directly affects the cleanliness of the 100-level zone. The construction quality requirements are high. The third way The 10,000-level clean room contains a local hundred-level zone. This situation is also more common in the clean areas of pharmaceutical plants. In this case, the area of ​​the local hundred-level area is generally within 10m 2 . You can use the 10,000-level purification air-conditioning system to control the indoor temperature and humidity to supplement the fresh air. Increase the circulating air volume in the local hundred-level zone. The circulating air treatment mode can adopt the above-mentioned method, that is, the static pressure box in the ceiling of the local 100-level zone is filled with FFU and the circulating wind is processed by FFU as shown in Fig. 3. The circulating air treatment method can also adopt the above-mentioned second method, that is, in the ceiling of the local 100-level area as a static pressure tank, the high-efficiency filter is filled with the circulating fan as shown in Fig. 4. In order to improve the vertical laminar flow effect of the local 100-level zone, the top 100-level ceiling can be appropriately reduced according to the height of the process equipment and the operation requirements, or the 100-level laminar flow hood can be directly assembled under the ceiling of the clean area and antistatic can be installed at the boundary of the 100-level zone. The skirt is shown in Figure 5.

Hundred-level zone circulating wind return mode:

The circulating air return mode of the 100-level area can be adopted as the return air of the grille floor as shown in Figure 6 or the return air of the lower part of the side wall. See Figure 1 to Figure 5. Grille floor return air method The indoor airflow has a good vertical laminar flow effect. However, it is necessary to set the return air static pressure box (about 500mm to 800mm high) under the grille return air floor to generally lower the floor of the 100th level. However, in the actual implementation, it is often difficult to reduce the floor area of ​​the 100-level area, and it is difficult to coordinate with the surrounding clean area. The area of ​​the 100-level area of ​​the pharmaceutical factory is small. The reasonable arrangement of the return air outlet under the side wall can generally meet the vertical laminar flow requirement of the 100-level area. The construction is convenient and the construction cost is low. The relevant information indicates that the return air is taken from the lower part of the two side walls of the room. When the room width is less than 3 m, the vertical laminar airflow of the room can reach 0.3 m above the floor. In actual implementation, it is possible to arrange a return air outlet under the four side walls of the 100-level zone. If the room width is large, you can add a return air shaft in the center of the room. Arrange the side air return ports on the four sides of the shaft. Reduce the space between the room and the side wall to ensure the vertical airflow of the room airflow. Other requirements The wind speed of the return air outlet of the room side of the 100-level area should be controlled at 1.5~2.0ms according to the specifications. There are often process lines in the 100-level area of ​​the pharmaceutical factory. The process lines are connected to other clean room rooms. The process line has holes in the wall. The hole should be minimized during construction. When calculating the positive pressure air volume in the 100-level zone, the positive pressure air volume leaking through the hole should be considered to reduce the amount of return air passing through the 100-level room.

SW-CJ-1FD single-sided single-sided (medical) vertical air purification workbench

This is a purification workbench widely used in medical and health, pharmaceutical, chemical experiments, etc., and provides a sterile, dust-free and clean environment.

Characteristics

1, vertical flow

2, using adjustable air volume fan system, light touch switch and stepless adjustment voltage. Ensure that the wind speed in the work area is always ideal.

Technical Parameters

model

SW-CJ-1FD

Cleanliness

Level 100 @≥0.5μm (US Federal 209E)

Number of colonies

<0.5 pcs/dish. (diameter 90mm culture plate)

noise

≤62dB(A)

average wind speed

0.25-0.45m/s

Vibration half-peak

<=0.5um (x, y, z direction)

Illuminance

≥300LX

power supply

AC, single phase 220V/50HZ

Maximum power consumption

400W

weight

120KG

Working size

870*600*520mm

Dimensions

1050*680*1600mm

High efficiency filter specifications and quantities

865*555*38*1

Fluorescent / UV lamp specifications and quantities

16W*1/15W*1

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