The pharmaceutical freeze-dryer must implement the GMP standard to achieve a high degree of sterility and cleanness. It is highly reliable, safe and easy to maintain. For this reason, pharmaceutical freeze-dryers often use a steam sterilization system (SIP) to ensure complete sterilization without dead ends. Therefore, in the future, the research of pharmaceutical freeze-dryers will continue in the direction of sterility and high reliability, such as automatic feeding methods and vacuum control methods.
At the same time supplemented with cleaning system in place (CIP), on-site cleaning of the drying chamber, condenser, main valve and pipeline pre-set drainage gradient to ensure no liquid retention. At the same time have to deal with power outages, water stoppages, erroneous operation protection measures, in the event of failure, the drug can be implemented to protect; achieve lyophilizer operation of the computer control, with power outages stop three countermeasure systems, multi-channel interlocking automatic alarm.
Nowadays, with the rapid development of biotechnology, polypeptide protein drugs are emerging, and the clinically applicable peptides, proteases, hormones, vaccines, cell growth factors and monoclonal antibodies have become the focus of development. In order to prevent the denaturation of drugs, freeze-drying methods are widely used to prepare solid drugs.
After decades of development, although the pharmaceutical freeze-drying technology has made great progress, there are still many problems that need to be resolved. In freeze-drying process, there will be a variety of freezing and drying stress, so that the drugs have varying degrees of denaturation, and the freeze-drying method itself also has the disadvantages of low drying rate, long drying time, high energy consumption in drying process, and large investment in drying equipment.
Therefore, in order to improve the stability and economic efficiency of drugs, it is necessary to further study the damage and protection mechanism of drugs in the process of freeze-drying. At the same time, the use of advanced refrigeration and vacuum equipment and control methods to develop low-cost, good performance freeze-drying Machine, continue to improve the theory of heat and mass transfer at low temperature and low pressure to optimize the freeze-drying process.
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