Clean room temperature and humidity range and clean room temperature and humidity requirements

The application of clean workshops in modern factories or enterprises is more and more extensive, so that products can be manufactured and stored safely in a good environmental space; then, what are the standards, what needs to be done, and what aspects should be paid attention to? This is a relatively broad question, covering a wide range. The difference between the temperature and humidity requirements of the clean pharmaceutical cleanroom (clean room) and the ordinary production area of ​​the central air-conditioning plant is that it not only needs to meet the comfort of the producer (employee), but also needs to take into account the requirements of the production process and product characteristics. Next, sz-pharma will talk about the temperature and humidity range of the clean workshop and the temperature and humidity requirements of the clean workshop. 1. Temperature and humidity range of clean workshop With the continuous improvement of production technology of factories and enterprises, more and more processing technologies have strict requirements on the control of environmental temperature and humidity. For example, the clean room above 100,000 level should keep the room dry and tidy. If necessary, it should be sterilized according to the requirements. When the clean room has no special requirements for temperature and humidity, it is advisable to wear clean work clothes without feeling comfortable. The temperature is generally controlled at 20 in winter. ~22℃; summer

24~26℃; fluctuation ±2℃. Second, the temperature and humidity requirements of the clean room The humidity of the clean room in winter is controlled at 30-50% RH, and the humidity of the clean room in summer is controlled at 50-70% RH. The higher the level of clean room, the stricter the requirements for temperature and humidity. In the natural environment, the temperature and humidity of the indoor environment of the clean workshop are affected by different climates throughout the year, and it is not easy to control when it is high or low. Especially in the rainy season, the temperature rises, the precipitation increases significantly, and the outdoor precipitation does not stop, resulting in high indoor humidity. Therefore, when designing and constructing a clean workshop, it is necessary to configure the corresponding power or number of dehumidifiers according to its actual situation to control the appropriateness of the room, so as to achieve the humidity standard of the corresponding level of clean workshop. 3. The following examples are the temperature and humidity requirements for clean workshops used in our common fields: 1. Food workshops in the food industry have relatively high requirements for production cleanliness, usually 100,000 and 10,000. Some industries require 1000-level / 100-level or above , but at the same time, the lower the humidity in the workshop, the easier it is to breed bacteria. Bacteria and other biological contamination (mold, virus, fungus, mites) can multiply actively in an environment with a relative humidity of more than 60%. Some flora can grow when the relative humidity exceeds 30%. The effects of bacteria and respiratory infections are minimized when the relative humidity is in the range of 40% to 60%. If the humidity is too high, the product will deteriorate. At the same time, the temperature should not be too high. If the temperature is too high, the producer will be exposed to the product after sweating, which will contaminate the product and reduce the quality/yield of the product. 2. Electronics industry The most important link in the production area in the field of electronics manufacturing is anti-static, which will adversely affect electronic products and reduce the output of products, cause short circuits to products and even cause employees to faint. Therefore, the relative humidity of the clean workshop of the electronics industry should not be lower than 30%. In order to reduce the generation of static electricity, the relative humidity of the anti-static area of ​​the clean workshop should not be less than 50%. Dust is easy to fly in the air that is too dry, and there is no clean workshop in the electronics industry. In the case of special requirements, the temperature is controlled at 23

About ±2℃, the relative humidity is controlled between 55±5%RH, in this production environment, people feel comfortable and static electricity disappears. 3. Biopharmaceuticals Temperature is one of the important factors affecting the stability of formulations in the external environment. Generally speaking, as the temperature increases, the degradation rate of the drug increases, and the change of temperature has a great influence on the stability of the preparation, especially biological products, which are very sensitive to heat. Therefore, the drug production workshop should not only strictly control the indoor temperature range, but also ensure that the temperature fluctuation is as small as possible.  Relative humidity is also an important factor affecting the stability of formulations. For solid formulations, moisture in the air can

A film is formed on its surface, which becomes the condition for the decomposition reaction, and the speed of the degradation reaction is proportional to the relative humidity of the environment. In addition, the importance of relative humidity to drug production is also reflected in the fact that the production environment is prone to mold contamination when the relative humidity reaches 60% or more, and mold can grow when the relative humidity exceeds 60%. High and low, the drugs basically have to grow mold. Temperature and humidity requirements of drug production workshop Clean area (sterile environment): temperature should be 20-24 ℃, relative humidity: 45-60%RH; control area (sterile environment): temperature should be 18-26 ℃, relative humidity: 50-65%RH. Combining the above fields, we can summarize the effects of temperature and humidity on the clean workshop: the appearance of electrostatic charge, bacterial growth, personnel comfort, water absorption and other aspects. As the general principle of clean pharmaceutical cleanroom temperature, the machining accuracy is getting finer and finer, and the requirements for the temperature fluctuation range are getting smaller and smaller. Therefore, the temperature and humidity control of the clean pharmaceutical cleanroom is determined by its production process, but its accuracy also depends on the size of its room, such as measuring room, grating engraving room, precision instrument manufacturing and assembly workshop, etc. The first two are small rooms, and the air conditioning accuracy (here mainly refers to temperature and humidity) requires high requirements; the latter two are larger production workshops, and the temperature and humidity accuracy requirements are low. Therefore, the size of the room will also determine the accuracy of the constant temperature and humidity workshop.

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