Injection is an important and commonly used clinical drug dosage form, which is mainly categorized into injection solution, sterile powder for injection and concentrated solution for injection. Lyophilized powder injection is the active ingredient of the drug (usually biological products, antibiotics, etc.) is frozen and dried into powder under aseptic environment for storage and transportation, and then dissolved with water for injection or other dissolving solution for use when needed.
● Freezing phase: First, the drug solution is thoroughly mixed and loaded into a freezing container via syringe or other means. Then, the drug solution in the container is rapidly frozen using freezing equipment to form a homogeneous ice crystal structure. The process of freezing is critical as it determines the structure and morphology of the ice crystals during subsequent dehydration.
● Vacuum dehydration stage: The frozen container of drug solution is transferred to a lyophilizer, where the ambient pressure is reduced by a vacuum system to evaporate the water out as a solid (ice) instead of going through a liquid state. This process is called sublimation, which is the direct transition from solid to gas, bypassing the intermediate step of the liquid state and avoiding the problems of decomposition or reaction that may occur when the drug is in the liquid state.
● Wrapping Up: At the end of the dehydration process, the lyophilized drug is usually sealed to prevent moisture from re-entering. The resulting lyophilized powder is then ready for use as a Lyophilized Injection.
● Long-term stability: Because lyophilization effectively reduces the drug's contact with moisture, such formulations have longer-term stability than liquid formulations. This is especially important in drugs that need to be stored for a long period of time, such as vaccines and biological products.
● Easy to transport and store: Lyophilized powder injections are less susceptible to temperature, light and other factors, allowing them to be transported and stored under a wider range of conditions, reducing the risk of drug loss and deterioration during transportation. This is particularly important for drugs that need to be transported over long distances.
● Solubility and Stability: Lyophilized Injections need to be injected into the patient through dissolution at the time of use. Such formulations usually have a high degree of stability after dissolution, which ensures the efficacy and safety of the drug after injection.
● Multi-purpose drug formulations: Suitable for complex drug formulations that require a number of different ingredients to be mixed together. Lyophilized technology allows for the separate preservation of individual components, avoiding possible interaction problems that may occur in the liquid state.
● Lyophilizer: It is the core equipment for the preparation of lyophilized powder injection, which realizes the process of freezing and dehydration by controlling the temperature and pressure. Lyophilizers usually include a freezing zone, a vacuum zone, and a heating zone, and are capable of completing the entire freeze-drying process.
● Vial Linkage Production Line: This line mainly use for vial bottle freeze-dried powder's liquid filling. lt's made up ofultrasonic bottle washing machine, tunnel drying sterilizer, automatic filling half-stoppering machine, automatic sealing machine, labeling machine. lt can according to customer technology andproduction requirements, equipment upgradingand upgrading.
We can provide all the equipments in the production process of lyophilized powder injection, SINOPED has been serving in the major famous pharmaceutical factories for many years, with rich experience and professional technology, which is trustworthy.
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