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Pharmaceutical Vacuum Freeze Dryer

Apr 26, 2019

Application of Pharmaceutical Vacuum Freeze Dryer in Freeze-drying of Bioprotein Drugs


     Application of Pharmaceutical Vacuum Freeze Dryer in Freeze-drying of Bioprotein Drugs

With the rapid development of biotechnology, polypeptides and proteins have been emerging, which can be applied to clinical polypeptides, proteases, hormones, vaccines, cell growth factors and monoclonal antibodies have become the focus of development. In order to prevent denaturation of drugs, freeze-drying method is widely used to prepare solid drugs.

     After decades of development, drug freeze-drying technology has made great progress, but there are still many problems that need to be solved urgently. In the process of freeze-drying, a variety of freezing and drying stresses will occur, which will result in varying degrees of denaturation of drugs. In addition, the freeze-drying process itself also has some shortcomings, such as 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 economy 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, advanced refrigeration and vacuum equipment and control means are used to develop freeze-dryer with low price and good performance, and continue to improve the heat and mass transfer theory at low temperature and low pressure, and optimize the freeze-drying process.

Pharmaceutical Vacuum Freeze Dryer

    There are many classifications of pharmaceutical freeze dryer, which can be divided into three types according to shelf area: large, medium and small. Usually, the freeze-drying area is smaller than 1.5m2, medium-sized between 1.5m2 and 50 m2, and large-scale over 50 m2. According to its purpose and use, it can be divided into experimental freeze dryer, pilot freeze-dryer and industrial production freeze-dryer.

small scale Pharmaceutical Vacuum Freeze Dryer

Pharmaceutical Vacuum Freeze Dryer 1

     Pharmaceutical freeze dryer must implement GMP standard to achieve high sterilization, dust-free, high reliability, safety and easy maintenance. For this reason, pharmaceutical freeze dryer often uses steam sterilization system (SIP) to ensure complete sterilization and no dead angle. At the same time, auxiliary in-situ cleaning system (CIP) is used to clean the drying chamber, condenser, main valve and pipeline in situ, and to ensure no liquid retention. At the same time, it has protective measures to deal with power cut, water cut and misoperation. Once there is a breakdown, it can protect medicines. It realizes computer control of freeze dryer operation. It has three countermeasures system of power cut and water cut, and it can automatically alarm by multi-channel interlocking.

     Because pharmaceutical freeze dryer must implement GMP standard, the future research of pharmaceutical freeze dryer will still be in the direction of asepsis and high reliability, such as automatic feeding mode, vacuum control mode and so on.


Pharmaceutical Freeze Dryer Sildom