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Analysis of the application of freeze - drying technology
First, freeze-dried technology profile
Vacuum freeze-drying technology referred to as freeze-drying, is a collection of vacuum, refrigeration, drying and other technologies as one of the high-tech drying technology. Not only that, freeze-drying technology also involves heat and mass transfer, fluid mechanics, automatic control, food nutrition, bioengineering, materials science and other multidisciplinary field of expertise. Freeze-drying technology is the preferred method of drying and preservation of medical biological products because of the dehydration and drying of products under vacuum and low temperature. In the early twentieth century, freeze-drying technique was widely used by scholars from all over the world after its effect on the preservation of biological products by Shaker was good.
In the 1940s, after the army preserved penicillin and plasma, it was used in commercial production for the dry preservation of lyophilized species, media, hormones, vitamins, human plasma and pharmaceutical products. The mid-20th century, due to the continuous advent of various types of freeze-drying equipment, freeze-drying technology to continuously improve. Rapid development of electronic technology provides multidimensional technical information and means to promote the vacuum freeze-drying equipment, automatic control system gradually improved, the drying process with the help of computer to achieve full automatic control, and produced a number of equipment and provide a variety of drying process for Independent control of group control. China's freeze-dried technology is mainly developed in the 1980s to meet the market demand, equipment performance and product quality gradually reached the international level, its range of applications from a simple medical biological products gradually expanded to food, materials, Aviation and other aspects.
Freeze-dried technology can be used to dry thermosensitive materials and substances that require biological activity. The process is generally frozen in the low temperature environment was first dried liquid to make it contained moisture condensation, and then in a vacuum environment for the solid sublimation of the material to make it dry. Freeze-drying technology can not only prevent physical and chemical degeneration of materials in the drying process to a maximum extent, but also reduce damage to biological tissues and cell bodies and death of viable cells and viruses. The use of lyophilization method can concentrate liquid drugs without changing color and loose state, dissolve immediately after adding water, not only has good stability, but also reduces the chance of being contaminated, so it is easy to transport and can be stored for a longer period of time. Drugs The quality has also been improved.
Such as human plasma freeze-dried, the shelf life of the previous few months can be extended to 5 to 10 years; measles vaccine live attenuated lyophilized, its shelf life can be extended from the previous 3 months to 1 year. The disadvantage of lyophilization is investment, maintenance and high product costs. Now many pharmaceutical companies in our country use the freeze-dried technology to process biological medicines, such as antibiotics, vaccines, enzyme preparations and plasma.
Second, the performance of freeze-drying machine
Lyophilizer performance worth serious analysis. In addition to the application of freeze-drying machine with the most advanced freeze-drying technology, but also should have the safety, reliability, applicability and economy of the performance indicators.
First, some specifications and capacities of the performance indicators of the freeze dryer, including the area of ​​the separator, the distance between the separators, the amount of water trapped in the condenser, etc., should be matched with the throughput of the freeze dryer.
Second, the freeze dryer separator to be flat, the temperature should be uniform, the point temperature difference should be limited to ± 1 ℃, in such conditions to protect the production of the same batch of products produced by the quality of uniform;
Third, the water vapor condenser should be able to be within 2 ~ 5h the temperature dropped to the desired level, usually below 45 ℃;
Fourth, the empty box vacuum measurement, it should be within 30min to reach 2.66 Pa. Because the freeze dryer dryer box, plies and condensers are required to withstand the corresponding internal and external pressure, once it occurs in a vacuum environment Leakage will result in drug contamination. Therefore, the internal and external pressure parts of the freeze dryer must be subjected to a rigorous vacuum test to conform to the specific specifications;
Fifth, the general use of large round-corner freeze-dried cabinet structure, freeze-drying cabinet material should be high corrosion resistance of high quality stainless steel, and the design should be reasonable, easy to clean, and all direct or indirect contact with the drug cabinet, Layers, hoses, condensers, valves and other components should be corrosion-resistant low-carbon stainless steel. Box, plate and condenser and other components for easy cleaning, the internal structure design should be as simple as possible, there can not be difficult to clean the dead angle structure. Clean, you must use 50 ~ 65 ℃ ultrafiltration water, and can not be reused. Freeze dryer parts should be easy to disassemble to facilitate maintenance and care. The surfaces of the freeze-drying cabinet and the slab are mirror-polished to reduce the amount of vacuum deflation and ease of cleaning.