Freeze-dried vacuum dried products are stored at a temperature below -15°C. The lower the temperature, the longer the storage time. For example, freeze-dried vaccines can be stored for more than one year at -15°C, but can only be stored for 6 months at 0-8°C.
If stored at 25°C, they will lose their effectiveness in 10 days. The storage temperature of freeze-dried vaccines is closely related to the properties of freeze-dried protective agents. The freeze-dried vaccines in some countries can be stored at 4-6°C because heat-resistant protective agents are used. Most live wet vaccines can only be made and used immediately, and can only be stored for a short period of time at 0-8°C.
Inactivated vaccines, serum, diagnostic fluids, etc. are more suitable for storage at 2-8°C. They cannot be overheated or lower than 0°C. Frozen vaccines should be stored at low temperatures below -70°C. In short, no matter what kind of vaccine, the primary structure, secondary structure and three-dimensional structure of the vaccine antigen should be maintained as much as possible to protect its antigenic determinant in order to maintain the good immunogenicity of the vaccine.
Biological products should avoid bacterial contamination, prevent bacterial mutation, maintain the activity of live bacteria and live viruses, and add additives and protective agents during the freeze-drying process. It is necessary to study the damage and protection mechanism of drugs during the freeze-drying process, select freeze dryers with good performance, and optimize the freeze-drying process.
Freeze-dried product process optimization: freeze-drying process optimization for drugs, diagnostic reagents, proteins, peptides, enzymes, antibodies, antigens, etc., including protective agent screening, freeze-drying curve optimization, freeze-drying stability testing, freeze-drying production process design, etc.
