Temperature and humidity requirements and control methods for different drug storage environments

Temperature and humidity requirements and control methods for different drug storage environments In the process of drug storage, the temperature and humidity in the drug environment have a particularly large impact on drugs. In the case of Western medicine, a slightly higher temperature will make vaccine serum, enzyme preparations, Proteins such as biological agents denature proteins to reduce their efficacy; and temperatures can cause certain sugar-coated tablets and capsules to deform and block. The dampness of western medicine is prone to discoloration, agglomeration, deformation, and rupture. The dampness of western medicine will lead to reduced efficacy and microbial growth. In terms of traditional Chinese medicines, Chinese medicines also have a certain range of adaptation to temperature, and too high or too low temperatures can cause changes in the quality of Chinese medicines. When the temperature is higher than 35°C, plants containing many fats tend to flood. If the Chinese medicine is stored improperly, the packaging is not good, and the moisture in the air is absorbed, the water content will increase, and the medicine will easily become moldy and deteriorate. Therefore, the regulation of the emergence of drug testing environments becomes particularly important. Temperature and humidity monitoring in the environment can be measured using a temperature and humidity self-recording instrument or a temperature and humidity recorder.
The state has a certain limit on the range of environmental requirements for drug storage. In the drug storage environment, a temperature and humidity monitor is generally used to monitor the temperature and humidity of the environment. According to Article 18 of the "Regulations for the Implementation of the Quality Management Regulations for Pharmaceutical Business of the State Food and Drug Administration," the pharmaceutical wholesale and retail chain enterprises shall set up warehouses with different conditions of temperature and humidity according to the storage requirements of the drugs they handle. The cold storage temperature is 2~10°C; the cool storage temperature is not higher than 20°C; the normal temperature storage temperature is 0~30°C; the relative humidity of each warehouse should be kept between 45% and 75%. Because the temperature and humidity in the warehouse are easily affected by the temperature and humidity outside the warehouse, the basic principle for regulating the temperature and humidity of the pharmaceutical warehouse is that when the temperature and humidity inside the warehouse are suitable for the storage of the medicine, it is necessary to try to prevent the unfavorable influence of the climate outside the reservoir on the interior of the warehouse. When the temperature and humidity in the warehouse are not suitable for the storage of medicines, effective measures must be taken to adjust the temperature and humidity in the warehouse.
In the “Practice Regulations for the Administration of Pharmaceutical Business Quality Management”, there are requirements for temperature limits in different areas where medicines are stored. Therefore, in the storage environment, the temperature and humidity in the environment is measured by using a self-reporting thermometer and hygrometer. Use appropriate measures to control.

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