Lyophilized injectable powders are characterized by their solid state, light weight, resistance to breakage, and high stability; these attributes facilitate storage and transport, thereby reducing associated costs.
The stability of lyophilized preparations is critically influenced by temperature and humidity; therefore, it is recommended to store them in a low-temperature (e.g., 2–8°C) and low-humidity environment to control variations in moisture content. When stored at room temperature, the temperature generally should not exceed 25°C.
The hermeticity and moisture permeability of packaging materials are paramount to maintaining product stability. Consequently, it is essential to select rubber stoppers that exhibit excellent sealing properties, low moisture permeability, and a low moisture transmission rate, while also ensuring that the stopper insertion and crimping operations are executed securely.
Biological products, such as vaccines, must adhere to strict cold chain management protocols during storage and transport.