Interpretation of several requirements of pharmaceutical lyophilizer for packaging containers
The products processed by vacuum freeze-drying of pharmaceutical freeze-drying machines are easy to preserve for a long time. After adding water, they can return to the state before freeze-drying and maintain the original biochemical characteristics. The freeze-drying technology is very suitable for heat-sensitive substances such as antibiotics, vaccines, blood products, enzymes, hormones, and other biological tissues. It is widely used in the fields of medicine, pharmacy, biological research, chemical industry, food, and so on.
Although biopharmaceutical is a small branch of the pharmaceutical industry, its importance is increasing day by day. Biological agents are bioactive substances, which are particularly sensitive to temperature, very unstable, and easy to react with each other. Due to the above characteristics, the storage life of biological agents is very short, and they usually need to be frozen, otherwise, they will deteriorate quickly. So what kind of packaging should be used for biological agents produced by pharmaceutical freeze-drying machines by freeze-drying method?
1. Heat transfer performance
The success of freeze-drying depends largely on the good heat conduction performance of the container. For this reason, the containers used in the freeze-drying process must meet the following requirements: they must be made of materials that can provide good heat conductivity, and the weaker the thermal insulation of the container, the better; In order to save energy, the container should have high heat conversion efficiency and can well transfer the heat generated by the shelf of the lyophilizer to the container.
Containers made of materials with low heat transfer coefficient have very low heat conduction efficiency; The shape, size, or quality of the container will also affect the heat transfer efficiency of the container; If too many materials are used in the manufacture of containers, these materials will become a thermal barrier to prevent energy from being transmitted into the container. Low thermal conductivity often leads to the failure of freeze-drying of products.
The sublimation surface will automatically face downward towards the bottom of the serum container, and the lyophilizer will move inward towards the center of the frozen body. If the container has obvious thermal insulation, the whole sublimation process cannot be controlled; If the sublimation process is not controlled, some chemicals will be vacuum dried rather than freeze-dried. The medicament processed in this way does not have its due performance. The maintenance of its activity, shelf life, and rapid reorganization will be greatly reduced.
2. Sealing performance
In the later stage of freeze-drying processing, the agent has been freeze-dried by the freeze-drying machine, and the equipment will create an ultra-dry environment. Before taking the container containing medicine out of the ultra-dry environment, the container must be sealed. This is because after drying, the internal residual moisture of the agent is reduced to less than 3%. Once exposed to the external environment with a humidity level much higher than itself, the freeze-drying opportunity will absorb moisture from the external environment as much as possible. Once the medicament absorbs water, the quality will deteriorate immediately; The function of the freeze-drying agent will be weakened. The reabsorption of water by the agent will lead to the loss of due performance of the agent, which will not achieve the expected treatment effect, and even lead to the manufacturer having to recall the product.
Using containers that cannot be sealed in the lyophilizer is a common mistake made by biological pharmaceutical manufacturers. For example, many diagnostic reagents are loaded in test tubes for freeze-drying processing in the freeze-drying machine. These test tubes are sealed with screw caps. Now there is no feasible method to seal these test tubes in the freeze-drying machine, so manufacturers have to gather a large group of employees to seal the containers manually. This process is generally carried out in a workshop that does not meet the freeze-drying processing requirements of the freeze-drying machine. In this way, the agent just freeze-dried by the freeze-drying machine will be exposed to the environment with a high humidity level, the agent will absorb a large amount of water in the environment, and its performance will become unstable.
