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15093177890@163.com
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15093177890
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B06-1 Qidi Zhenghang Intelligent Manufacturing Industrial Park, Intersection of Xinxiang Road and Luoning Road, Shangjie District, Zhengzhou City, Henan Province
Zhengzhou Kewangda Biological Instrument Co., Ltd
Analysis of the key points of freeze-drying technology for freeze-drying equipment
Date: 2025-05-08Read: 12
1. Preparation of material system.
In order to ensure the freeze-drying effect, maintain the activity of the drug and the survival of the cells, a certain amount of protective agents and additives must be added to the freeze-drying machine before freeze-drying. Materials, protective agents, and additives together form a multi-component system, which we call the 'material system'. Protective agents and additives interact with materials, so different types and concentrations of protective agents and additives should be used for different materials. In recent years, almost every major advancement in the field of biopharmaceuticals has been related to the use of cocktail like raw material systems. Discussion on protection and additives.
2. Research on the physical properties of material systems.
The physical properties of material systems, such as condensation temperature, phase change heat, glass transition temperature, and heat capacity before and after glass transition, can have a significant impact on the freeze-drying process. During the drying process, if the sublimation rate of the material is high, more gaps are required to prevent collapse. These are also related to the physical properties of the material system. In recent years, it has been found that when material systems undergo different "temperature histories" (thermal histories), such as "annealing" at different temperatures for different times, it will bring significant changes to physical properties. Differential scanning calorimetry is an effective and widely recognized technique for measuring the physical properties of material systems.
3. Selection and Implementation Technology of Cooling and Solidification Process
For the cooling and solidification process of the material system, two issues need to be addressed: one is the determination of the cooling temperature; Another option is to choose a suitable cooling program. The final temperature of the cold vulcanization process should be the full curing temperature, which should be lower than the eutectic point temperature or glass transition temperature of the material system. The material system after cooling and solidification is actually a mixed system with both crystalline and glassy states. When determining the final cooling temperature, it is necessary to first measure the eutectic point temperature and glass transition temperature of the material system.
