Pharmaceutical production in the pharmaceutical industry is one of its main tasks. The importance of medicines and the differences in the nature of pharmaceutical materials constitute special requirements for pharmaceutical production. At present, pharmaceutical production has begun to adopt GMP as a system that must be implemented and a law that is enforced. The implementation of GMP involves design, manufacturing, installation, use, management, verification and other aspects. How to adapt the spray dryer as one of the pharmaceutical equipment, take this opportunity to exchange our views and practices, please correct me if you have any problems, so as to jointly improve development.
one. Spray dryer features:
A spray dryer is a device that directly atomizes a liquid material by spraying it, and contacts the hot air in a drying chamber to evaporate water rapidly, thereby directly obtaining the powder product. This device has the following characteristics in terms of performance:
1. The powder product can be directly obtained from the liquid raw material. Generally, the particle diameter D50 of the high-speed centrifugal spray drying is in the range of 60 to 125 μm (ie, 250 to 120 mesh), and the particle diameter D50 of the pressure spray drying is 125 to 250 μm (ie, 120 to 60 mesh) range.
2, drying time is very short, generally only 5 ~ 40Sec.
3. The temperature of the droplets during the drying process is not high, and the heat impact on the product is small. It is not easy to suffer from defects such as protein changes, vitamins, loss of active ingredients, etc. The quality of heat sensitive materials, organisms and drugs is basically close to vacuum. Dry standard.
4. The product basically maintains a spherical shape similar to the droplets, and has good dispersibility, fluidity and solubility.
5. Change the water content of the liquid raw material or the conditions of spray drying, etc., and adjust the residual moisture, particle size, bulk density, etc. within the product within a certain range, the production process is simplified, and the control and management are very convenient.
Due to these characteristics of spray drying, the application of spray drying in the pharmaceutical industry is expanding.
two. Characteristics of pharmaceutical materials:
Whether it is a chemical synthetic drug, a biological product, or a botanical drug, a natural drug is a heat-sensitive material. The hot air temperature is relatively low, and the composition is complicated, especially the material properties of various varieties of botanical drugs are large, polypeptide, polysaccharide, high protein, The characteristics of strong hygroscopicity, high viscosity, low softening point, and ensuring the active ingredient and the active ingredient are not destroyed have put forward higher requirements on the medicinal dryer.
three. Basic requirements for GMP equipment:
1. The layout of the equipment should be compatible with the process flow. The production capacity should be compatible with the batch, and the design and manufacture should meet the requirements of the production process.
2. The equipment should be easy to operate and maintain, easy to clean and disinfect. Not only to prevent foreign bodies and bacteria from flowing, but also to have online cleaning and online sterilization.
3, the material of the contact parts of the equipment and materials should be non-toxic, corrosion-resistant, not chemically reacted with the material, and must not have easy to fall off coatings, fibers and particulate matter.
4, the inner wall of the equipment must be smooth and flat, no recessed structure, all corners should be arc transition.
5, the equipment drive is stable, noise, dust, sewage discharge should comply with relevant national regulations.
6, the equipment itself is well sealed, all lubricants, coolant should avoid contact with materials, packaging containers.
4. Type and basic functions of the medicinal spray dryer:
According to the characteristics of the spray dryer; the characteristics of the drug materials; and the requirements of the GMP for the equipment, for most materials:
A. Model: It adopts open cycle, vertical drop and flow type. It is recommended to use high-speed centrifugal rotary spray dryer, especially Chinese medicine. If the dry powder particle size is required to be 100 mesh (150 μm) or more, a pressure nozzle spray dryer can be selected.
B. Basic functions that the equipment should have:
1. In order to ensure that the dry product is not polluted, the material of the contact part with the material and hot air is made of stainless steel, and the stainless steel grade should be adapted to the pH value of the pharmaceutical material.
2, in order to meet the hygiene requirements, the air into the tower must be sterilized and filtered, the degree of purification of the de-injecting agent is considered at level 100, and the rest can be considered at the level of 100,000...300,000. The drying tower should be operated under a slight positive pressure. The finished product is outputted at the lower part of the cone of the drying tower, and the finished product is collected and distributed in the clean room.
3. In order to ensure that the emission concentration of the exhaust gas meets the environmental protection requirements, the secondary dust removal should be considered. The * level is carried out by the high-efficiency cyclone separator, and the second stage can be used for the dry powder bag filter or the wet dust collector for the tail powder recovery. For dryers with strong hygroscopicity and multi-species production, wet dust collectors are suitable.
4, the equipment itself is well sealed, no pollution source and material contact, the inner wall is smooth and flat, the structure is as simple as possible, easy to disassemble, easy to clean, stable operation.
5. Contents related to the selection of medicinal spray dryers and customer conditions:
1. Equipment production capacity: The hourly water evaporation is the capacity index of the dryer, and directly affects the investment size and equipment utilization. When converting the annual dry powder index, the operating time of the dryer should be fully increased, and continuous production should be arranged for a long time to reduce the output requirement per unit hour. It is appropriate to reserve the capacity for expected development.
2. Drying process parameters: a) Inlet air temperature: as far as possible under the conditions that the material can withstand, the exhaust air temperature should be reduced as much as possible to meet the requirements of the finished product moisture content, and the temperature difference between the inlet and outlet air is large, which is beneficial to increase the production capacity and Heat utilization.
b) The solid content of the feed liquid, increase the feed concentration and reduce the initial moisture content, not only can increase the production capacity of dry powder under the same water evaporation condition of the equipment, but also increase the bulk density of the product and increase the specific gravity of the dry powder.
3, hot air system: hot air energy, general pharmaceuticals have steam conditions and the inlet air temperature of the drug is not high, steam + electricity zui economically suitable, other such as electricity, fuel or gas indirect heating hot air stove can also, depending on The customer has the possibility to decide. The high temperature limit of the hot air system should be considered to leave room for one. It is possible to adjust the inlet air temperature for the variety, and the other can also use the high temperature hot air to disinfect the equipment, which is similar to the effect of dry heat sterilization. Taking into account the heat-resistant temperature value of the high-efficiency filter and the reasonable economic premise, it is recommended to design the hot air system according to 2000C.
4. Electrical control requirements: As a production machine, in order to ensure that production operations and product quality are not affected by human factors, the necessary automation should be considered.
a) The inlet air temperature is controlled automatically, and the exhaust air temperature is controlled automatically. In particular, the stability of the exhaust air temperature has a direct impact on the stability of the remaining moisture content of the product. As for the control accuracy, under the set temperature conditions, the inlet air temperature is ±5 °C, and the exhaust air temperature is about 1.5-2.5 °C, which is economically suitable.
b) Rotating atomizer speed adjustment: For multi-variety materials due to viscosity, solid content changes and particle size for control adjustment products, atomizer frequency conversion stepless speed regulation function should be considered.
c) Operation control of the inlet and exhaust fans: In order to improve the operation intensity and direct convenience, it is considered to use the remote control butterfly to control the air volume in the electronic control room. If the inverter speed is used to adjust the fan speed directly, the fan power can be saved 30%. The advantages.
d) Other control requirements require conventional manual control or higher requirements.
5. In order to improve the scope of operation and strengthen the drying effect, the necessary attachments should be considered:
a) Primary cold air system: If the design and manufacture of the hot air distributor of the dryer is not properly adjusted, the vortex tumbling and hanging material (commonly known as the pan top) of the top material may occur. The primary air cooling system uses purified air to enter the air from the ventilation duct. It can prevent the powder in the tower from rising and cool the atomizer, improve and solve the pan-top problem, and the adjustment control is extremely convenient.
b) Tower wall jacket cooling system: For materials with high thermal denaturation and low softening point, after long-term operation, if the tower wall temperature is higher than the material softening point, the adsorbed dry powder is again melted and hanged, using the tower wall jacket. The cooling system can perform natural ventilation or forced ventilation cooling on the top of the tower wall, so that the temperature of the tower wall is always below the softening point temperature of the material, and the effect is obvious.
c) Tower wall air sweeping device: The material is normal due to agglomeration and adhesion static electricity, but it needs to be cleaned up in time, otherwise it will affect the color and denaturation of the product, and will be rapping with the tower wall (such as electric hammer, air). Hammer) can also shake the adsorption powder on the tower wall, but the rapping area is limited, and it can not be completely cleaned. The tower wall air sweeping device is used to clean the air from the blowpipe of the straight cone around the tower. The hole is blown out and the accumulated material on the entire area of ​​the straight cone of the tower is purged, and the effect is also obvious.
d) Pneumatic conveying system: dry powder after drying, due to high temperature, such as immediate bagging, there is often agglomeration and condensation, plus direct collection from the cyclone separator, limited by the layout and structure of the dryer, collecting powder The clean room must be very close to the dryer, which often causes inconvenience in the layout of the production process in the workshop. The pneumatic conveying system is used to send the powder from the main cyclone to the clean room hopper for product packaging, and to purify the air with dehumidification. Product cooling while the product is being transported over long distances.
e) CIP cleaning system: The importance of cleaning is self-evident. The CIP cleaning system can fully and effectively solve the automatic cleaning of all parts in contact with the powder, ensuring that the batch materials of different batches are not cross-mixed and staged and cleaned. Reliability, improved cleaning and improved operating conditions. CIP cleaning system has multiple cleaning media (cold water, hot water, solvent, deionized water, compressed air, low pressure steam) recycling, hot air chamber; drying tower body; main cyclone separator and inlet and outlet ducts; small cyclone for pneumatic conveying The separator and the four working areas of the inlet and outlet pipes are automatically operated manually or according to the setting procedure. The work is reliable and good.
These attachments are clearly targeted and we have configured them for some dryers on our customers. The test results of the equipment that has been put into production have achieved the expected results. Of course, these attachments need to increase thermal energy, the complexity of the equipment manufacturing structure is complicated, and the cost is also increased.
6. The development of new drugs and the improvement of production process requirements will inevitably lead to the innovative development of equipment. As a professional design and manufacturing unit of equipment, we are willing to maintain close cooperation with the people on the medical industry front, learn from practice and continue to The industry provides advanced quality and cheap equipment and good service, which not only contributes to the development of its own professional field, but also to the development of the pharmaceutical industry.
one. Spray dryer features:
A spray dryer is a device that directly atomizes a liquid material by spraying it, and contacts the hot air in a drying chamber to evaporate water rapidly, thereby directly obtaining the powder product. This device has the following characteristics in terms of performance:
1. The powder product can be directly obtained from the liquid raw material. Generally, the particle diameter D50 of the high-speed centrifugal spray drying is in the range of 60 to 125 μm (ie, 250 to 120 mesh), and the particle diameter D50 of the pressure spray drying is 125 to 250 μm (ie, 120 to 60 mesh) range.
2, drying time is very short, generally only 5 ~ 40Sec.
3. The temperature of the droplets during the drying process is not high, and the heat impact on the product is small. It is not easy to suffer from defects such as protein changes, vitamins, loss of active ingredients, etc. The quality of heat sensitive materials, organisms and drugs is basically close to vacuum. Dry standard.
4. The product basically maintains a spherical shape similar to the droplets, and has good dispersibility, fluidity and solubility.
5. Change the water content of the liquid raw material or the conditions of spray drying, etc., and adjust the residual moisture, particle size, bulk density, etc. within the product within a certain range, the production process is simplified, and the control and management are very convenient.
Due to these characteristics of spray drying, the application of spray drying in the pharmaceutical industry is expanding.
two. Characteristics of pharmaceutical materials:
Whether it is a chemical synthetic drug, a biological product, or a botanical drug, a natural drug is a heat-sensitive material. The hot air temperature is relatively low, and the composition is complicated, especially the material properties of various varieties of botanical drugs are large, polypeptide, polysaccharide, high protein, The characteristics of strong hygroscopicity, high viscosity, low softening point, and ensuring the active ingredient and the active ingredient are not destroyed have put forward higher requirements on the medicinal dryer.
three. Basic requirements for GMP equipment:
1. The layout of the equipment should be compatible with the process flow. The production capacity should be compatible with the batch, and the design and manufacture should meet the requirements of the production process.
2. The equipment should be easy to operate and maintain, easy to clean and disinfect. Not only to prevent foreign bodies and bacteria from flowing, but also to have online cleaning and online sterilization.
3, the material of the contact parts of the equipment and materials should be non-toxic, corrosion-resistant, not chemically reacted with the material, and must not have easy to fall off coatings, fibers and particulate matter.
4, the inner wall of the equipment must be smooth and flat, no recessed structure, all corners should be arc transition.
5, the equipment drive is stable, noise, dust, sewage discharge should comply with relevant national regulations.
6, the equipment itself is well sealed, all lubricants, coolant should avoid contact with materials, packaging containers.
4. Type and basic functions of the medicinal spray dryer:
According to the characteristics of the spray dryer; the characteristics of the drug materials; and the requirements of the GMP for the equipment, for most materials:
A. Model: It adopts open cycle, vertical drop and flow type. It is recommended to use high-speed centrifugal rotary spray dryer, especially Chinese medicine. If the dry powder particle size is required to be 100 mesh (150 μm) or more, a pressure nozzle spray dryer can be selected.
B. Basic functions that the equipment should have:
1. In order to ensure that the dry product is not polluted, the material of the contact part with the material and hot air is made of stainless steel, and the stainless steel grade should be adapted to the pH value of the pharmaceutical material.
2, in order to meet the hygiene requirements, the air into the tower must be sterilized and filtered, the degree of purification of the de-injecting agent is considered at level 100, and the rest can be considered at the level of 100,000...300,000. The drying tower should be operated under a slight positive pressure. The finished product is outputted at the lower part of the cone of the drying tower, and the finished product is collected and distributed in the clean room.
3. In order to ensure that the emission concentration of the exhaust gas meets the environmental protection requirements, the secondary dust removal should be considered. The * level is carried out by the high-efficiency cyclone separator, and the second stage can be used for the dry powder bag filter or the wet dust collector for the tail powder recovery. For dryers with strong hygroscopicity and multi-species production, wet dust collectors are suitable.
4, the equipment itself is well sealed, no pollution source and material contact, the inner wall is smooth and flat, the structure is as simple as possible, easy to disassemble, easy to clean, stable operation.
5. Contents related to the selection of medicinal spray dryers and customer conditions:
1. Equipment production capacity: The hourly water evaporation is the capacity index of the dryer, and directly affects the investment size and equipment utilization. When converting the annual dry powder index, the operating time of the dryer should be fully increased, and continuous production should be arranged for a long time to reduce the output requirement per unit hour. It is appropriate to reserve the capacity for expected development.
2. Drying process parameters: a) Inlet air temperature: as far as possible under the conditions that the material can withstand, the exhaust air temperature should be reduced as much as possible to meet the requirements of the finished product moisture content, and the temperature difference between the inlet and outlet air is large, which is beneficial to increase the production capacity and Heat utilization.
b) The solid content of the feed liquid, increase the feed concentration and reduce the initial moisture content, not only can increase the production capacity of dry powder under the same water evaporation condition of the equipment, but also increase the bulk density of the product and increase the specific gravity of the dry powder.
3, hot air system: hot air energy, general pharmaceuticals have steam conditions and the inlet air temperature of the drug is not high, steam + electricity zui economically suitable, other such as electricity, fuel or gas indirect heating hot air stove can also, depending on The customer has the possibility to decide. The high temperature limit of the hot air system should be considered to leave room for one. It is possible to adjust the inlet air temperature for the variety, and the other can also use the high temperature hot air to disinfect the equipment, which is similar to the effect of dry heat sterilization. Taking into account the heat-resistant temperature value of the high-efficiency filter and the reasonable economic premise, it is recommended to design the hot air system according to 2000C.
4. Electrical control requirements: As a production machine, in order to ensure that production operations and product quality are not affected by human factors, the necessary automation should be considered.
a) The inlet air temperature is controlled automatically, and the exhaust air temperature is controlled automatically. In particular, the stability of the exhaust air temperature has a direct impact on the stability of the remaining moisture content of the product. As for the control accuracy, under the set temperature conditions, the inlet air temperature is ±5 °C, and the exhaust air temperature is about 1.5-2.5 °C, which is economically suitable.
b) Rotating atomizer speed adjustment: For multi-variety materials due to viscosity, solid content changes and particle size for control adjustment products, atomizer frequency conversion stepless speed regulation function should be considered.
c) Operation control of the inlet and exhaust fans: In order to improve the operation intensity and direct convenience, it is considered to use the remote control butterfly to control the air volume in the electronic control room. If the inverter speed is used to adjust the fan speed directly, the fan power can be saved 30%. The advantages.
d) Other control requirements require conventional manual control or higher requirements.
5. In order to improve the scope of operation and strengthen the drying effect, the necessary attachments should be considered:
a) Primary cold air system: If the design and manufacture of the hot air distributor of the dryer is not properly adjusted, the vortex tumbling and hanging material (commonly known as the pan top) of the top material may occur. The primary air cooling system uses purified air to enter the air from the ventilation duct. It can prevent the powder in the tower from rising and cool the atomizer, improve and solve the pan-top problem, and the adjustment control is extremely convenient.
b) Tower wall jacket cooling system: For materials with high thermal denaturation and low softening point, after long-term operation, if the tower wall temperature is higher than the material softening point, the adsorbed dry powder is again melted and hanged, using the tower wall jacket. The cooling system can perform natural ventilation or forced ventilation cooling on the top of the tower wall, so that the temperature of the tower wall is always below the softening point temperature of the material, and the effect is obvious.
c) Tower wall air sweeping device: The material is normal due to agglomeration and adhesion static electricity, but it needs to be cleaned up in time, otherwise it will affect the color and denaturation of the product, and will be rapping with the tower wall (such as electric hammer, air). Hammer) can also shake the adsorption powder on the tower wall, but the rapping area is limited, and it can not be completely cleaned. The tower wall air sweeping device is used to clean the air from the blowpipe of the straight cone around the tower. The hole is blown out and the accumulated material on the entire area of ​​the straight cone of the tower is purged, and the effect is also obvious.
d) Pneumatic conveying system: dry powder after drying, due to high temperature, such as immediate bagging, there is often agglomeration and condensation, plus direct collection from the cyclone separator, limited by the layout and structure of the dryer, collecting powder The clean room must be very close to the dryer, which often causes inconvenience in the layout of the production process in the workshop. The pneumatic conveying system is used to send the powder from the main cyclone to the clean room hopper for product packaging, and to purify the air with dehumidification. Product cooling while the product is being transported over long distances.
e) CIP cleaning system: The importance of cleaning is self-evident. The CIP cleaning system can fully and effectively solve the automatic cleaning of all parts in contact with the powder, ensuring that the batch materials of different batches are not cross-mixed and staged and cleaned. Reliability, improved cleaning and improved operating conditions. CIP cleaning system has multiple cleaning media (cold water, hot water, solvent, deionized water, compressed air, low pressure steam) recycling, hot air chamber; drying tower body; main cyclone separator and inlet and outlet ducts; small cyclone for pneumatic conveying The separator and the four working areas of the inlet and outlet pipes are automatically operated manually or according to the setting procedure. The work is reliable and good.
These attachments are clearly targeted and we have configured them for some dryers on our customers. The test results of the equipment that has been put into production have achieved the expected results. Of course, these attachments need to increase thermal energy, the complexity of the equipment manufacturing structure is complicated, and the cost is also increased.
6. The development of new drugs and the improvement of production process requirements will inevitably lead to the innovative development of equipment. As a professional design and manufacturing unit of equipment, we are willing to maintain close cooperation with the people on the medical industry front, learn from practice and continue to The industry provides advanced quality and cheap equipment and good service, which not only contributes to the development of its own professional field, but also to the development of the pharmaceutical industry.
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