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The Bench Top Lyophilizers is a kind of pharmaceutical machinery, and the quality of the medicine directly affects the safety of human life. Therefore, the pharmaceutical machinery should strictly meet the requirements of the pharmaceutical production specifications. For the desktop freeze dryer, the freeze-drying box is in contact with the drug, so there should be strict requirements for the freeze-drying box.
In order to avoid contamination, the door of the Bench Top Lyophilizers should be designed to be separated from the rest of the machine by a partition wall so that the door can be opened to the sterile room; and the vents of the lyophilizer and the cold trap are also led to Mushroom room. A sterilizing filter should be installed at the venting port to reduce the contamination of the Bench Top Lyophilizers by the external environment. Some freeze-drying boxes also have small doors that can be used to access the products in small doors. The doors are only opened during maintenance to reduce pollution.
The materials used in the lyophilization box and the inner wall of the door and the structural parts in the lyophilization box shall be inert to the drug, that is, it shall be a corrosion-resistant material; the metal material shall be 304 or 316 stainless steel, and the non-metal material shall be glass or silicone rubber. Or medical rubber, polytetrafluoroethylene. The materials of valves, instruments, pipes, etc. connected to the freeze-drying box are also required to meet the above requirements.
The surface of the freeze-drying box and the inner wall of the box door and the structure of the freeze-drying box should be smooth, no dead angle, clean and no water. The brine for indirect refrigeration and heating should also be inert to the drug; in case it leaks, it will have an effect on the drug.
The lyophilization box should be equipped with cleaning and sterilizing functions. For Bench Top Lyophilizers s with hydraulic tamping function and steam sterilization, in order to prevent the contamination of the hydraulic oil vapor and the problem of piston rod sterilization, the piston rod Isolation bellows should be installed. In order to reduce the cold spot during sterilization, it is not a blind pipe of steam flow (such as vacuum probe, pressure transmitter and safety valve and other "dead leg" interface), the ratio of length to inner diameter cannot be greater than 6.
Strictly required Bench Top Lyophilizers vacuum measuring head should use a condenser vacuum probe with a constant temperature heating jacket of 150 °C to avoid incomplete sterilization in the vacuum probe. The pumping system for benchtop freeze dryers should use a dry pump system that does not have oil contamination.
The welding of the process pipeline connected with the freeze-drying box should use the trajectory welding. The inside of the pipeline should be inspected by endoscopy. The pipeline should be clean flanged. The valve should be equipped with a diaphragm valve. The installation of the pipeline should have the necessary inclination. Pay attention to the proper angle of inclination to ensure that the drain is drained.
With the development of the freeze-drying industry and the maturity of freeze-drying technology, more and more manufacturers are aware of this emerging science and technology, and the demand for Bench Top Lyophilizers is increasing and the requirements are higher.
Bench Top Lyophilizers have the following advantages over conventional methods: freeze-drying:
* Many heat sensitive substances do not degenerate or inactivate.
* When drying at low temperatures, some of the volatile components in the material are lost.
* During the lyophilization process, the growth of microorganisms and the action of enzymes cannot be carried out, so that the original traits can be maintained.
* Since it is dried in a frozen state, the volume is almost constant, and the original structure is maintained, and concentration does not occur.
* Since the moisture in the material exists in the form of ice crystals after pre-freezing, the inorganic salt-soluble substances originally dissolved in water are evenly distributed in the material. When sublimating, the dissolved substances dissolved in water are precipitated, which avoids the phenomenon that the inorganic salt carried by the internal moisture migration to the surface in the general drying method is precipitated on the surface to cause surface hardening.
* The material after drying is porous and spongy. After adding water, it dissolves quickly and completely, and almost immediately restores its original character.
* Since drying is carried out under vacuum, there is very little oxygen, so some easily oxidizable substances are protected.
* Drying can remove 95% to 99% of water, so that the dried product can be preserved for a long time without deterioration.
*Because the material is in a frozen state, the temperature is very low, so the temperature of the heat source for heating is not high, and the heater with normal temperature or low temperature can meet the requirements. If the freezer compartment of the table lyophilizer is separated from the drying chamber, the drying chamber does not need to be insulated, and there is not much heat loss, so the utilization of heat energy is economical.
Bench Top Lyophilizers technology is mainly used in:
(1) freeze-drying of biological products with poor thermal stability, biochemical products, blood products, genetic engineering products, etc.;
(2) To maintain the structure and activity of biological tissues, the treatment of biological tissues such as cortex, bone, cornea and heart valve for surgery; (3) Coffee to maintain food color, aroma, taste and nutrients, and to quickly rehydrate Freeze-drying of seasonings, meat, seafood, fruits and vegetables;
(4) Application in microcapsule preparation, drug controlled release materials, etc. Processing of health products such as ginseng, royal jelly, and turtles and Chinese herbal preparations to maintain the invariability of fresh substances;
(5) Ultrafine powder functional materials such as: optical fibers, superconducting materials, microwave dielectric materials, magnetic powders, and treatment of catalysts capable of accelerating reaction engineering.
The surface of the freeze-drying box and the inner wall of the box door and the structure of the freeze-drying box should be smooth, no dead angle, clean and no water. The brine for indirect refrigeration and heating should also be inert to the drug; in case it leaks, it will have an effect on the drug.
The lyophilization box should be equipped with cleaning and sterilizing functions. For Bench Top Lyophilizers s with hydraulic tamping function and steam sterilization, in order to prevent the contamination of the hydraulic oil vapor and the problem of piston rod sterilization, the piston rod Isolation bellows should be installed. In order to reduce the cold spot during sterilization, it is not a blind pipe of steam flow (such as vacuum probe, pressure transmitter and safety valve and other "dead leg" interface), the ratio of length to inner diameter cannot be greater than 6.
Strictly required Bench Top Lyophilizers vacuum measuring head should use a condenser vacuum probe with a constant temperature heating jacket of 150 °C to avoid incomplete sterilization in the vacuum probe. The pumping system for benchtop freeze dryers should use a dry pump system that does not have oil contamination.
The welding of the process pipeline connected with the freeze-drying box should use the trajectory welding. The inside of the pipeline should be inspected by endoscopy. The pipeline should be clean flanged. The valve should be equipped with a diaphragm valve. The installation of the pipeline should have the necessary inclination. Pay attention to the proper angle of inclination to ensure that the drain is drained.
With the development of the freeze-drying industry and the maturity of freeze-drying technology, more and more manufacturers are aware of this emerging science and technology, and the demand for Bench Top Lyophilizers is increasing and the requirements are higher.
Bench Top Lyophilizers have the following advantages over conventional methods: freeze-drying:
* Many heat sensitive substances do not degenerate or inactivate.
* When drying at low temperatures, some of the volatile components in the material are lost.
* During the lyophilization process, the growth of microorganisms and the action of enzymes cannot be carried out, so that the original traits can be maintained.
* Since it is dried in a frozen state, the volume is almost constant, and the original structure is maintained, and concentration does not occur.
* Since the moisture in the material exists in the form of ice crystals after pre-freezing, the inorganic salt-soluble substances originally dissolved in water are evenly distributed in the material. When sublimating, the dissolved substances dissolved in water are precipitated, which avoids the phenomenon that the inorganic salt carried by the internal moisture migration to the surface in the general drying method is precipitated on the surface to cause surface hardening.
* The material after drying is porous and spongy. After adding water, it dissolves quickly and completely, and almost immediately restores its original character.
* Since drying is carried out under vacuum, there is very little oxygen, so some easily oxidizable substances are protected.
* Drying can remove 95% to 99% of water, so that the dried product can be preserved for a long time without deterioration.
*Because the material is in a frozen state, the temperature is very low, so the temperature of the heat source for heating is not high, and the heater with normal temperature or low temperature can meet the requirements. If the freezer compartment of the table lyophilizer is separated from the drying chamber, the drying chamber does not need to be insulated, and there is not much heat loss, so the utilization of heat energy is economical.
Bench Top Lyophilizers technology is mainly used in:
(1) freeze-drying of biological products with poor thermal stability, biochemical products, blood products, genetic engineering products, etc.;
(2) To maintain the structure and activity of biological tissues, the treatment of biological tissues such as cortex, bone, cornea and heart valve for surgery; (3) Coffee to maintain food color, aroma, taste and nutrients, and to quickly rehydrate Freeze-drying of seasonings, meat, seafood, fruits and vegetables;
(4) Application in microcapsule preparation, drug controlled release materials, etc. Processing of health products such as ginseng, royal jelly, and turtles and Chinese herbal preparations to maintain the invariability of fresh substances;
(5) Ultrafine powder functional materials such as: optical fibers, superconducting materials, microwave dielectric materials, magnetic powders, and treatment of catalysts capable of accelerating reaction engineering.
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