The drug freeze dryer must implement GMP standards to achieve high degree of sterility and dust-free, achieving high reliability, safety and easy maintenance. For this purpose, the drug freeze dryer often uses a steam sterilization system (SIP) to ensure complete sterilization and no dead angle. Therefore, the research of pharmaceutical freeze dryers will continue to be carried out in the direction of sterilizing and high reliability, such as automatic feeding mode and vacuum control mode.
At the same time, supplemented by the in-place cleaning system (CIP), the drying chamber, condenser, main valve and pipeline are cleaned in advance to preset the drainage gradient to ensure no liquid retention. At the same time, it has protection measures against power outage, water stoppage and misoperation. Once a fault occurs, it can protect the medicine; realize computer control of the operation and operation of the freeze dryer, and have three countermeasure systems for power failure and water stop, and can automatically alarm by multiple interlocks.
Nowadays, with the rapid development of biotechnology, peptide protein drugs are emerging, and can be applied to clinical polypeptides, proteases, hormones, vaccines, cell growth factors and monoclonal antibodies. In order to prevent drug denaturation, a solid-state drug is currently widely prepared by freeze-drying.
After decades of development, although the pharmaceutical freeze-drying technology has made great progress, there are still many problems that need to be solved. During the freeze-drying process, a variety of freezing and drying stresses are generated to cause different degrees of denaturation of the drug, and the freeze-drying method itself has the disadvantages of low drying rate, long drying time, high energy consumption in the drying process, and large investment in drying equipment.
Therefore, in order to improve the stability and economy of the drug, it is necessary to further study the damage and protection mechanism of the drug during the freeze-drying process, and at the same time develop advanced freeze-drying with low performance and good performance by using advanced refrigeration and vacuum equipment and control means. Machine, continue to improve the theory of heat and mass transfer under low temperature and low pressure, optimize the freeze-drying process.
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