Clean room environmental control

Clean room environmental control

In order to improve product quality, safety and hygiene, pharmaceuticals, food manufacturing and medical instrument manufacturing, biochemical and bacterial culture require a special sterile production space - clean room. In the production of pharmaceuticals, microparticles and microorganisms are the main targets for the environmental control of clean room production. â–  The cleanliness of the clean room controls the control of the number of dust particles. The air purification system plays a very important role in controlling the number of dust particles in the clean room. When the air cleanliness required for injection production is 100, the vertical and horizontal one-way flow patterns are adopted, and the air flow speed is greater than 0.25 m/s and 0.35 m/s respectively; when the air cleanliness requirement is 10000 or 100000, For non-unidirectional flow, the number of air changes is greater than 25 times/hour and 15 times/hour respectively (the number of air changes of 300,000 is not less than 12 times/hour), so as to take away the dust and dust generated in the production process in time, and maintain the clean room environment. Cleanliness.
Strict control of the pressure difference between the clean room and the adjacent room is also an important part of ensuring the cleanliness of the production room. The clean room of different cleanliness and the pressure difference between clean and non-clean areas should be greater than 5 Pascal, the pressure difference between clean area and outdoor should be greater than 10 Pascal, and the opening and closing of air supply, return air and exhaust air system should be connected. Lock and operate in sequence to avoid backflow of air and reduce contamination of the clean room environment by low levels of dust. Before each production and after a certain production cycle, the number of dust particles should be tested under static conditions in the clean room after cleaning to evaluate and master the content of dust particles in the clean room.
The clean room is divided into two types: biological clean room and non-biological clean room. The biological clean room air purification system must be operated continuously; the non-bio clean room air purification system should be turned on 4 hours before use. The dust particles are detected by a dust particle counter and buffered for 0.5 to 1 hour after being cleaned by the environment. To avoid human pollution, the clean room is limited to two people in the clean room. Dynamic monitoring of critical control points should be carried out during the production of injections. Control of microbial content. Controlling the microbial content in the clean room environment is still based on good air purification system facilities, and the filtration efficiency can reach 99.9%-99.99% to filter out bacteria and dust in the air. In the production, the clean room temperature is strictly controlled at 18 ~ 26 ° C, the relative humidity is controlled at 45% ~ 65%, in order to destroy the growth conditions that are beneficial to the bacteria, plus the disinfection and disinfection of the disinfectant, the environmental control effect is satisfactory. For disinfection of daily disinfectant, after the end of daily production, wipe the machine table, table top, doors and windows, walls, etc. with 75% ethanol or 2 ‰ 新洁尔灭溶液, and disinfect the floor with 3% to 5%. After every 3 days of production, use 75% ethanol or 2 ‰ 洁 尔 溶液 对 对 对 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有 所有The microbial content in the clean room is controlled by the bacterial propagules produced during the production process. These measures can only control the amount of bacteria and the types of bacteria in the clean indoor air. If there are more molds, it is necessary to spray the room with 5% stone carbonate first, then fumigation with formaldehyde to achieve the aseptic effect, and only then can it be killed. Bacteria, bacteria spores. At the end of each production cycle, the clean room with aseptic requirements is disinfected first before production in the next cycle. After detecting the number of dust particles in the clean room, the formaldehyde gas fumigation is carried out in the clean room, from the result of long-term testing. Look, this environmental sterilization method works well.
Formaldehyde gas sterilization technology. Formaldehyde fumigation not only has a good sterilization effect on molds that are not easy to kill, but also has a good effect on killing bacterial spores in the environment. Formaldehyde fumigation operation needs attention: first ensure that the room temperature reaches above 35 ° C, the relative humidity is above 60%; secondly, the amount of formaldehyde is required to reach the room volume of 10 g / cubic meter; in addition, the room disinfection time is not less than 12 hours; It is reminded that the same proportion of ammonia water is used for neutralization before formaldehyde replacement, which will minimize the harm to the human body and the pollution of the environment. In order to prevent bacteria from becoming resistant to formaldehyde, it is better to use ozone to alternate effects.
â– Reducing the influence of operators on the aseptic environment. The person is the biggest source of pollution in the aseptic environment. Therefore, the number of people working in the clean area and the number of people in the operating room, the magnitude of the operation and the style, texture, and wear of the overalls are The bacterial content has a significant effect. Maintaining a sterile environment requires the following two aspects: strict control of the style, texture, wear, cleaning, and sterilization cycle of the clean overalls; strict control of the number of operators, restraining the behavior of personnel, and ensuring the purification level of the clean area.


APB-777.JPG

APB-777 type clean transfer window


The device is a necessary auxiliary equipment for the clean room. It is mainly used for the transfer of small items between the clean area and the clean area and the non-clean area to reduce the number of times the clean room is opened and reduce the clean room. The degree of pollution.


Features:

1. The stainless steel plate is used in the work area, which is smooth and smooth, and the inner corner arc transitions.

2. The two sides of the transfer window are equipped with a fan to start the interconnection function, so that any one of the two doors can be automatically supplied with air.

3. The lighting and ultraviolet germicidal lamp are used synchronously with the start of the fan.

4. Please indicate when ordering when the user has special requirements.

Technical Parameters

model

APB-557

APB-777

Cleanliness level

Level 100 @≥0.5μm (US Federal 209E)

average wind speed

0.25-0.45m/s

noise

≤62dB(A)

power supply

AC, single phase 220V/50HZ

High efficiency filter size

480*460*38mm*1

680*460*38mm*1

Working size

420*480*400mm

500*480*500mm

Dimensions

650*540*850mm

650*530*850mm

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