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The issue of drug safety affects all sectors of society. Under the current background, the production of drugs has received more and more attention from people. As far as drug safety is concerned, the stability and activity of drugs are more important factors, and they all have strict regulations. The author has learned that there is a key technology in the stability of drugs - freeze drying. Freeze-drying technology has a high status in the pharmaceutical industry. However, because it covers many complicated aspects such as refrigeration, it still needs to be continuously improved.
Freeze-drying technology is a technology that uses the principle of sublimation to dry. It is to freeze the dried aqueous material into a solid state in advance at a low temperature, and then to sublimate the frozen water molecules directly into water vapor under a suitable vacuum environment. The process of preserving substances by removing water. The product obtained by freeze-drying is called freeze-dried product, and the process is called lyophilization.
In the pharmaceutical machinery industry, freeze dryers, as the carrier of this technology, are mechanical equipment consisting of refrigeration systems, vacuum systems, heating systems, and electrical instrumentation control systems. In general, the main components of the freeze dryer are divided into drying ovens, condensers, refrigeration units, vacuum pumps, heating and cooling devices.
The author has learned that freeze dryers are widely used in bioengineering, pharmaceutical industry, food industry, materials science and deep processing of agricultural and sideline products. Taking medicine freeze-drying as an example, the freeze-drying of pharmaceutical products includes both traditional Chinese medicine and western medicine. In traditional Chinese medicine, freeze-drying is mainly limited to lyophilization of small amounts of Chinese medicinal materials such as ginseng, pilose antler, yam, and Cordyceps sinensis. Most Chinese patent medicines have not yet been lyophilized. In western medicine, especially injections, the freeze-drying process is used more often, which not only improves the quality of the drug, but also extends the shelf life, bringing convenience to both doctors and patients.
Specifically, compared with ordinary drying, freeze-drying can not perform the growth of microorganisms and the action of enzymes, but it can prevent the denaturation of the original biological and chemical characteristics of dried substances to some extent, and has good stability and easy long-term preservation. specialty. Normal drying uses a heating method, which is usually performed at a temperature of 0° C. or higher, and the dried product undergoes great changes in physical and chemical shapes. In addition, ordinary drying also consumes a lot of energy, and it also has an adverse effect on the environment. Therefore, as a carrier of the freeze-drying technology, the freeze-dryer has become one of the most popular targets for many bio-enterprises and medical institutions, and high-quality companies have also become the targets for drug machine purchasers.
It is reported that the freeze dryer produced by Ningbo Shuangjia Instrument Co., Ltd. (hereinafter referred to as “Shuangjiaâ€) has gained market and customer reputation for its excellent quality and sophisticated system. Automatic control system Programmable freeze dryer, all lyophilization processes, from lyophilization to defrost, are controlled programmatically. The partition heating system can control the temperature through the circulating heat generated by the heating partitions, so the temperature uniformity is more accurate and the freeze-drying speed can also be increased at the same time. The sample pre-frozen system can pre-freeze the sample before lyophilization.
Pure nitrogen backfill system uses a backfill system to fill the vacuum chamber with sterile air or nitrogen to protect the sample from contamination. Safety lid system In order to preserve the sample permanently after lyophilization, a capping system is used under vacuum to achieve safe and accurate sealing. The anti-vacuum pump oil back-injection system prevents the vacuum pump oil from flowing back into the system and contaminating the sample. The secondary delay start-up system of the compressor can protect the compressor and prolong the service life of the compressor.
However, high-quality equipment still requires late maintenance and maintenance. Some manufacturers recommend that customers pay attention to the removal of moisture in the cold trap chamber before work. Dry the cold trap if necessary and open the drain valve before each freeze drying operation. In addition, do not switch frequently during use, such as the operation of the refrigerator caused by the shutdown, can not start immediately, at least 20 minutes before starting again, so as not to damage the refrigerator. After freeze-drying, the ice on the cold trap coil will turn into water, which can be cleaned with a towel. When the lyophilization is finished, the “inflator valve†should be opened slowly to inflate the cold trap so as not to damage the vacuum gauge.
The manufacturer also recommends that customers regularly have regular inspections to see if the liquefier on the bottom of the machine has dust and dirt and if necessary clean it. When inspecting the heat exchanger, it is necessary to roll over the chassis so that it lies on a cushion, and high-pressure air can be used to blow the heat exchanger as appropriate. In addition, over-dirty liquefiers can increase power consumption and even damage the machine, and should be avoided in no-load situations. Freeze dryer switch should also avoid continuous switching, so as to avoid overload trip.
Freeze-drying technology is a technology that uses the principle of sublimation to dry. It is to freeze the dried aqueous material into a solid state in advance at a low temperature, and then to sublimate the frozen water molecules directly into water vapor under a suitable vacuum environment. The process of preserving substances by removing water. The product obtained by freeze-drying is called freeze-dried product, and the process is called lyophilization.
In the pharmaceutical machinery industry, freeze dryers, as the carrier of this technology, are mechanical equipment consisting of refrigeration systems, vacuum systems, heating systems, and electrical instrumentation control systems. In general, the main components of the freeze dryer are divided into drying ovens, condensers, refrigeration units, vacuum pumps, heating and cooling devices.
The author has learned that freeze dryers are widely used in bioengineering, pharmaceutical industry, food industry, materials science and deep processing of agricultural and sideline products. Taking medicine freeze-drying as an example, the freeze-drying of pharmaceutical products includes both traditional Chinese medicine and western medicine. In traditional Chinese medicine, freeze-drying is mainly limited to lyophilization of small amounts of Chinese medicinal materials such as ginseng, pilose antler, yam, and Cordyceps sinensis. Most Chinese patent medicines have not yet been lyophilized. In western medicine, especially injections, the freeze-drying process is used more often, which not only improves the quality of the drug, but also extends the shelf life, bringing convenience to both doctors and patients.
Specifically, compared with ordinary drying, freeze-drying can not perform the growth of microorganisms and the action of enzymes, but it can prevent the denaturation of the original biological and chemical characteristics of dried substances to some extent, and has good stability and easy long-term preservation. specialty. Normal drying uses a heating method, which is usually performed at a temperature of 0° C. or higher, and the dried product undergoes great changes in physical and chemical shapes. In addition, ordinary drying also consumes a lot of energy, and it also has an adverse effect on the environment. Therefore, as a carrier of the freeze-drying technology, the freeze-dryer has become one of the most popular targets for many bio-enterprises and medical institutions, and high-quality companies have also become the targets for drug machine purchasers.
It is reported that the freeze dryer produced by Ningbo Shuangjia Instrument Co., Ltd. (hereinafter referred to as “Shuangjiaâ€) has gained market and customer reputation for its excellent quality and sophisticated system. Automatic control system Programmable freeze dryer, all lyophilization processes, from lyophilization to defrost, are controlled programmatically. The partition heating system can control the temperature through the circulating heat generated by the heating partitions, so the temperature uniformity is more accurate and the freeze-drying speed can also be increased at the same time. The sample pre-frozen system can pre-freeze the sample before lyophilization.
Pure nitrogen backfill system uses a backfill system to fill the vacuum chamber with sterile air or nitrogen to protect the sample from contamination. Safety lid system In order to preserve the sample permanently after lyophilization, a capping system is used under vacuum to achieve safe and accurate sealing. The anti-vacuum pump oil back-injection system prevents the vacuum pump oil from flowing back into the system and contaminating the sample. The secondary delay start-up system of the compressor can protect the compressor and prolong the service life of the compressor.
However, high-quality equipment still requires late maintenance and maintenance. Some manufacturers recommend that customers pay attention to the removal of moisture in the cold trap chamber before work. Dry the cold trap if necessary and open the drain valve before each freeze drying operation. In addition, do not switch frequently during use, such as the operation of the refrigerator caused by the shutdown, can not start immediately, at least 20 minutes before starting again, so as not to damage the refrigerator. After freeze-drying, the ice on the cold trap coil will turn into water, which can be cleaned with a towel. When the lyophilization is finished, the “inflator valve†should be opened slowly to inflate the cold trap so as not to damage the vacuum gauge.
The manufacturer also recommends that customers regularly have regular inspections to see if the liquefier on the bottom of the machine has dust and dirt and if necessary clean it. When inspecting the heat exchanger, it is necessary to roll over the chassis so that it lies on a cushion, and high-pressure air can be used to blow the heat exchanger as appropriate. In addition, over-dirty liquefiers can increase power consumption and even damage the machine, and should be avoided in no-load situations. Freeze dryer switch should also avoid continuous switching, so as to avoid overload trip.
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