Liquid preparation tank for sterile preparation production

Abstract

The utility model discloses a liquid preparation tank for producing a sterile preparation, and belongs to the technical field of pharmaceutical equipment. The device comprises a tank body structure consisting of an inner cylinder, an inner upper seal head and an inner lower seal head, a jacket cylinder is arranged on the outer wall of the inner cylinder, and a lower jacket cylinder is arranged on the outer wall of the inner lower seal head; an outer barrel is arranged on the outer wall of the jacket barrel and the outer wall of the lower jacket barrel, a water inlet penetrating through the outer barrel and the jacket barrel is formed in the upper portion of the outer barrel, a speed reducer is arranged on the lower portion of the inner lower end socket, a stirring paddle is arranged in the inner lower end socket, and a paddle rod of the stirring paddle is connected with the speed reducer in a shaft seal mode. The speed reducer drives the stirring paddle to stir substances in the tank. Water with different temperatures is input through the water inlet to achieve temperature rise or temperature reduction, in the heating and heat preservation process, the temperature change is stable, the tank sticking phenomenon is avoided, and in the temperature reduction process, the situation that the local temperature is too low, substance precipitation is caused, and consequently the process stability and the product quality are affected is avoided.

Description

Technical Field

[0001] The utility model belongs to the technical field of pharmaceutical equipment, and particularly relates to a liquid preparation tank for aseptic preparation production. Background Art

[0002] During the drug preparation process, the jacket of the liquid preparation tank is used to heat or cool the substances in the tank. Generally, industrial steam is used as the heating medium and chilled water is used as the cooling medium. If some substances in the tank are very sensitive to temperature, when industrial steam enters the jacket, heat transfer will occur quickly between the industrial steam and the substances in the tank that are in contact with the jacket. For the part that is not in contact, the temperature of the tank wall will be the same as that of the industrial steam, and the temperature will exceed 100°C, and can even reach 140°C. When the substances in the tank evaporate, they will quickly come into contact with the overheated tank wall, and after the solvent evaporates, substances will precipitate, resulting in material loss and impurity generation, affecting the normal production of products. When cooling, if 4°C chilled water is introduced according to the general design, the substances in the tank will cool down rapidly, and the local temperature will be too low. Under the condition of sudden cooling, substances may precipitate, affecting process stability and product quality. Content of the Utility Model

[0003] Aiming at the problems existing in the above-mentioned prior art, the utility model provides a liquid preparation tank for aseptic preparation production to solve the technical problems of unstable temperature change of the liquid inside the tank body of the existing liquid preparation tank and sticking of the tank and precipitation of substances caused by unstable temperature change.

[0004] In order to achieve the above purpose, the technical solution adopted by the utility model is: to provide a liquid preparation tank for aseptic preparation production, the liquid preparation tank includes an inner cylinder body, an inner upper head is arranged at the top of the inner cylinder body, and an inner lower head is arranged at the bottom of the inner cylinder body. The inner upper head, the inner cylinder body and the inner lower head form a tank body structure; an outer jacket cylinder is arranged on the outer wall of the inner cylinder body, and a lower outer jacket cylinder is arranged on the outer wall of the inner lower head. An outer cylinder body is arranged on the outer walls of the jacket cylinder and the lower outer jacket cylinder. A heat insulation layer is arranged between the jacket cylinder and the lower outer jacket cylinder and the outer cylinder body. A first water-containing cavity is arranged between the jacket cylinder and the inner cylinder body, and a second water-containing cavity is arranged between the lower outer jacket cylinder and the inner lower head. The first water-containing cavity is communicated with the second water-containing cavity; an inlet is arranged at the upper part of the outer cylinder body, which penetrates through the outer cylinder body and the jacket cylinder. An outlet is arranged at the bottom of the outer cylinder body, which penetrates through the outer cylinder body and the lower outer jacket cylinder. A sampling port is arranged at the lower part of the outer cylinder body, which penetrates through the outer cylinder body, the jacket cylinder and the inner cylinder body; a feed port is arranged on the inner upper head; a discharge port with a valve, a speed reducer and a stirring paddle are arranged at the bottom of the inner lower head; the paddle of the stirring paddle is located inside the inner lower head, and the paddle rod of the stirring paddle is connected with the speed reducer by means of a shaft seal.

[0005] The beneficial effects of the present utility model adopting the above technical solutions are as follows: Waters at different temperatures are input into the water-containing cavity through the water inlet to achieve the heating or cooling of the substances in the tank. During the heating and heat preservation processes, the temperature changes stably, avoiding the phenomenon of sticking to the tank. During cooling, local over-low temperature is avoided, preventing the precipitation of substances and thus affecting the process stability and product quality. The stirring paddle arranged at the upper part of the inner lower head is driven by a speed reducer, which can effectively promote the uniform mixing of materials, improve the liquid preparation efficiency and product quality. The heat preservation layer is provided to reduce the heat loss during the heating process, improve the energy utilization efficiency, reduce costs, and the heat preservation layer can also protect the materials in the tank from the influence of the external temperature. The water-containing cavities communicate with each other. During heating, it can ensure that heat can be evenly and quickly transferred to all parts of the inner cylinder, improve the heat efficiency, reduce the heating time, and ensure the uniformity of the temperature of the materials in the tank. The sampling port arranged at the lower part of the outer cylinder can realize sampling without interrupting heating and stirring, facilitating real-time monitoring and adjustment of process parameters. The discharge port is equipped with a valve, which has the characteristics of simple operation and good sealing performance, and can ensure the smoothness of the discharging process. The paddle rod of the stirring paddle is connected with the speed reducer by means of a shaft seal, which can improve the sealing performance, reduce friction and wear, and improve the stirring efficiency.

[0006] Further, the inner cylinder and the inner upper head are connected by a flange and bolts, and the inner upper head and the inner lower head are elliptical.

[0007] The beneficial effects of the present utility model adopting the above technical solutions are as follows: The tight connection of the inner cylinder and the inner upper head by a flange and bolts can ensure the sealing performance between the inner cylinder and the inner upper head, and facilitate installation and maintenance on the premise. The shape of the elliptical head can improve the fluidity and mixing effect of the materials. During the stirring process, the materials can flow more smoothly in the tank, reducing dead corners and stagnant areas, thereby improving the stirring uniformity.

[0008] Further, a buffer plate is arranged on the outer wall of the inner cylinder, and the buffer plate is horizontally aligned with the water inlet.

[0009] The beneficial effects of the present utility model adopting the above technical solutions are as follows: A buffer plate horizontally aligned with the water inlet is arranged on the outer wall of the inner cylinder, which helps to reduce the impact of water flow on the inner cylinder and improve the stability and reliability of the equipment operation.

[0010] Further, the jacket cylinder body, the lower jacket cylinder body and the outer cylinder are bow-shaped, and the heat preservation layer material is aluminum silicate.

[0011] The beneficial effects of the present utility model adopting the above technical solutions are as follows: The arched structure can enhance the overall strength and rigidity of the tank body, helping to improve the pressure-bearing capacity and anti-deformation ability of the tank body. In addition, the arched design can also reduce the heat dissipation at the joints of various components of the tank body. As a thermal insulation layer material, aluminum silicate has excellent thermal insulation performance, which can effectively reduce the heat transfer to the outside world, improve the heating efficiency and reduce energy consumption; the aluminum silicate thermal insulation layer has good heat insulation effect and also has good thermal stability, ensuring the stability and uniformity of the internal temperature of the liquid mixing tank.

[0012] Furthermore, the feed inlet is arranged at the upper side of the inner upper head; the discharge outlet is arranged at the exact bottom of the inner lower head, and the control valve on the discharge outlet is a pneumatic piston valve.

[0013] Furthermore, the inner upper head is provided with a manhole, a breather port, a pressure sensor port, a rupture disc port, a pressure gauge port, an integrated sight glass lamp port, and a cleaning port.

[0014] The beneficial effects of the present utility model adopting the above technical solutions are as follows: The manhole provides a passage for inspecting, repairing, and cleaning the inside of the tank; the breather port is used to install a breather, and the breather can effectively block harmful substances such as harmful gases and dust that are harmful to the human body; the rupture disc port prevents the tank body from bursting due to overpressure, thus protecting the safety of equipment and personnel; the pressure sensor port, the pressure gauge port, and the integrated sight glass lamp port are all beneficial for real-time monitoring and controlling the state of the materials in the tank, improving stability and product quality; the setting of the cleaning port is beneficial for thoroughly removing the residues in the tank and reducing the risk of cross-contamination. The inner upper head is provided with multiple interfaces, making the liquid mixing tank more functional and capable of meeting various process requirements.

[0015] Furthermore, the number of cleaning ports is 2.

[0016] The beneficial effects of the present utility model adopting the above technical solutions are as follows: The two cleaning ports can be used simultaneously or alternately, enabling the cleaning liquid to enter the tank more quickly and flexibly and cover all corners, thereby shortening the cleaning time, improving the cleaning efficiency. In addition, it can also reduce the existence of dead corners and residues and improve the cleaning effect.

[0017] Furthermore, a reserved port is provided on the inner upper head.

[0018] The beneficial effects of the present utility model adopting the above technical solutions are as follows: The setting of the reserved port makes the liquid mixing tank more flexible in subsequent upgrades, transformations, or adding new functions.

[0019] Furthermore, 3 legs and a temperature sensor port are arranged below the inner lower head, and the 3 legs are circumferentially distributed below the inner lower head.

[0020] The beneficial effects of the present utility model adopting the above technical solutions are as follows: There are 3 legs arranged below the inner lower head, and the circumferential distribution can ensure the stability of the liquid preparation tank during placement and use; the setting of the temperature sensor port enables the operator to monitor the temperature inside the tank in real time and avoid abnormal temperature.

[0021] The beneficial effects of the present utility model are:

[0022] In the present utility model, the liquid preparation tank can be connected to a temperature control circulation system to realize temperature-controlled water bath heating of the liquid preparation tank. Water at different temperatures is transported from the water inlet to the water cavity to realize the heating or cooling of the substances inside the tank. The device of the present utility model includes a thermal insulation layer, and the thermal insulation layer can protect the materials inside the tank from the influence of the external temperature, making the temperature change inside the tank stable and avoiding the phenomenon of sticking to the tank. Description of the Drawings

[0023] Figure 1 It is a structural schematic diagram of a liquid preparation tank for sterile preparation production;

[0024] Figure 2 It is a top perspective view of a liquid preparation tank for sterile preparation production;

[0025] Among them, 1. Outer cylinder; 2. Inner cylinder; 3. Jacketed cylinder; 4. Inner upper head; 5. Inner lower head; 6. Flange; 7. Bolt; 8. Lower jacketed cylinder; 9. Water inlet; 10. Water outlet; 11. Sampling port; 12. Buffer plate; 13. Discharge port; 14. Pneumatic plunger valve; 15. Temperature sensor port; 16. Reducer; 17. Agitator; 18. Manhole; 19. Feed port; 20. Respirator port; 21. Pressure sensor port; 22. Bursting disc port; 23. Pressure gauge port; 24. Integrated sight glass lamp port; 25. Cleaning port; 26. Reserved port; 27. Leg. Detailed Embodiment

[0026] The following makes a detailed description of the specific embodiments of the present utility model in conjunction with the drawings.

[0027] In the embodiments of the present utility model, as Figures 1-2As shown in the figure, a liquid preparation tank for sterile preparation production is provided. The volume of this liquid preparation tank is 230L. The liquid preparation tank in this utility model includes an inner cylinder body 2. An inner upper head 4 is arranged at the top of the inner cylinder body 2, and an inner lower head 5 is arranged at the bottom of the inner cylinder body 2. The materials of the inner upper head 4, the inner cylinder body 2, and the inner lower head 5 are all stainless steel. The inner upper head 4, the inner cylinder body 2, and the inner lower head 5 form a tank structure by welding, and the weld coefficient is 0.85. In another preferred embodiment of this utility model, in order to ensure the sealing performance between the inner cylinder body 2 and the inner upper head 4 and facilitate installation and maintenance, the inner cylinder body 2 and the inner upper head 4 are connected by a flange 6 and bolts 7. At the same time, in order to improve the fluidity and mixing effect of the materials in the tank, during the stirring process, the materials can flow more smoothly in the tank, reducing dead corners and stagnant areas, thereby improving the stirring uniformity. The inner upper head 4 and the inner lower head 5 are set as elliptical. In this embodiment, an outer jacket cylinder 3 is arranged on the outer wall of the inner cylinder body 2. The material of the outer jacket cylinder 3 is stainless steel. A plurality of stainless steel connecting columns are arranged between it and the inner cylinder body 2. The two ends of the stainless steel connecting columns are respectively connected to the inner wall of the outer jacket cylinder 3 and the outer wall of the inner cylinder body 2 by welding or other means. A first water-containing cavity is formed between the outer jacket cylinder 3 and the inner cylinder body 2. An outer lower jacket cylinder 8 is arranged on the outer wall of the inner lower head 5. The material of the outer lower jacket cylinder 8 is stainless steel. A plurality of stainless steel connecting columns are arranged between it and the inner lower head 5. The two ends of the stainless steel connecting columns are respectively connected to the inner wall of the outer lower jacket cylinder 8 and the outer wall of the inner lower head 5 by welding or other means. A second water-containing cavity is formed between the outer lower jacket cylinder 8 and the inner lower head 5. The first water-containing cavity is communicated with the second water-containing cavity. The water-containing cavity is used to be filled with hot water / cold water to heat / cool the substances in the tank. An outer cylinder body 1 is arranged on the outer walls of the outer jacket cylinder 3 and the outer lower jacket cylinder 8. The material of the outer cylinder body 1 is stainless steel. A plurality of stainless steel connecting columns are arranged between it and the outer jacket cylinder 3 and the outer lower jacket cylinder 8. The two ends of the stainless steel connecting columns are respectively connected to the inner wall of the outer cylinder body 1 and the outer walls of the outer jacket cylinder 3 and the outer lower jacket cylinder 8 by welding or other means. A heat-insulating layer is filled in the cavity between the outer cylinder body 1 and the outer jacket cylinder 3 and the outer lower jacket cylinder 8. By setting the heat-insulating layer, the heat loss during the heating process can be reduced, the energy utilization efficiency can be improved, the cost can be reduced, and the heat-insulating layer can also protect the materials in the tank from the influence of the external temperature.In another preferred embodiment of the present utility model, the clamping sleeve body 3, the lower clamping sleeve body 8, and the outer cylinder body 1 are in an arc shape, and the thermal insulation layer material is aluminosilicate. The arc-shaped structure can enhance the overall strength and rigidity of the tank body, helping to improve the pressure-bearing capacity and anti-deformation ability of the tank body. In addition, the arc-shaped design can also reduce the heat dissipation at the joints of various components of the tank body. Aluminosilicate has excellent thermal insulation performance, which can effectively reduce the heat transfer to the outside world, improve the heating efficiency and reduce energy consumption; the aluminosilicate thermal insulation layer has good heat preservation effect and also has good thermal stability, ensuring the stability and uniformity of the internal temperature of the liquid mixing tank; in this embodiment, a water inlet 9 passing through the outer cylinder body 1 and the clamping sleeve body 3 is provided at the upper part of the outer cylinder body 1 for inputting water into the water-containing cavity, and a water outlet 10 passing through the outer cylinder body 1 and the lower clamping sleeve body 8 is provided at the lower part of the outer cylinder body 1. A sampling port 11 passing through the outer cylinder body 1, the clamping sleeve body 3, and the inner cylinder body 2 is provided at the lower part of the outer cylinder body 1. The sampling port provided at the lower part can realize sampling without interrupting heating and stirring, which is convenient for real-time monitoring and adjustment of process parameters; a buffer plate 12 is provided on the outer wall of the inner cylinder body 2, and the buffer plate 12 is horizontally aligned with the water inlet 8. The buffer plate 12 helps to reduce the influence of water flow impact on the inner cylinder body 2, improving the stability and reliability of the equipment operation; a feed port 19 is provided on the inner upper head 4; a discharge port 13 with a valve, a speed reducer 16, and a stirring paddle 17 are provided at the bottom of the inner lower head 5. The control valve of the discharge port 13 is a pneumatic plunger valve 14. Controlled by the pneumatic plunger valve 14, it has the characteristics of simple operation and good sealing performance, and can ensure the smoothness of the discharging process; the blades of the stirring paddle 17 are located inside the inner lower head 5, and the paddle rod of the stirring paddle 17 is connected to the speed reducer 16 by means of shaft sealing. Connecting by means of shaft sealing can improve the sealing performance, reduce friction and wear, and improve the stirring efficiency. The speed reducer 16 drives the stirring paddle 17 to rotate, which can effectively promote the uniform mixing of materials, improve the liquid mixing efficiency and product quality; in another preferred embodiment of the present utility model, the feed port 19 is provided at the upper side of the inner upper head 4; the discharge port 13 is provided at the exact bottom of the inner lower head 5.

[0028] Such as Figure 2As shown, in another preferred embodiment of the present utility model, in order to make the functions of the liquid preparation tank more complete and meet various process requirements, a plurality of interfaces are provided on the inner upper head 4, including a manhole 18, a breather port 20, a pressure sensor port 21, a rupture disk port 22, a pressure gauge port 23, an integral sight glass lamp port 24, and a cleaning port 25. The manhole 18 provides a passage for inspecting, maintaining, and cleaning the inside of the tank; the breather port 20 is used to install a breather, which can effectively block harmful substances such as harmful gases and dust that are harmful to the human body; the rupture disk port 22 prevents the tank body from bursting due to overpressure, thereby protecting the safety of equipment and personnel; the pressure sensor port 21, the pressure gauge port 23, and the integral sight glass lamp port 24 are all conducive to real-time monitoring and supervision of the material state inside the tank, improving stability and product quality; the setting of the cleaning port 25 is conducive to thoroughly removing the residues inside the tank and reducing the risk of cross-contamination; in another preferred embodiment of the present utility model, in order to improve the cleaning efficiency and cleaning effect, the number of cleaning ports 25 is set to 2; in another preferred embodiment of the present utility model, in order to make the liquid preparation tank more flexible during subsequent upgrades, transformations, or addition of new functions, a reserved port 26 is provided on the inner upper head 4; in another preferred embodiment of the present utility model, in order to support the tank body to stand on the ground and ensure its stability during placement and use, 3 legs 27 are provided below the inner lower head 5. The material of the legs is stainless steel, and the 3 legs are circumferentially distributed below the inner lower head 5. At the same time, in order for the operator to real-time monitor the temperature inside the tank and avoid abnormal temperature, a temperature sensor port 15 is provided below the inner lower head 5.

[0029] Excipients in sterile preparations such as emedastine fumarate eye drops, azelastine hydrochloride eye drops, and polyvinyl alcohol eye drops include hydroxypropyl beta-cyclodextrin or hydroxypropyl methylcellulose. Hydroxypropyl beta-cyclodextrin and hydroxypropyl methylcellulose are sensitive to temperature changes. As the temperature changes, the viscosity of hydroxypropyl beta-cyclodextrin and hydroxypropyl methylcellulose will increase. In addition, hydroxypropyl methylcellulose will also degrade.

[0030] The performance of the liquid preparation tank will be described below by taking the preparation of hydroxypropyl beta-cyclodextrin aqueous solution using the liquid preparation tank in this application as an example.

[0031] Hydroxypropyl-β-cyclodextrin and sterile water are added into the liquid preparation tank through the feed port 19. Then, water at a temperature of 74 °C is input into the water-containing cavity from the water inlet 9. Then, the substances in the tank are stirred by the blades of the stirring paddle 17 for 2.5 h. During the stirring process, the temperature of the water in the water-containing cavity is controlled to be 69.8 °C to 74.3 °C through an external temperature-controlled circulation system. During the entire heat preservation and stirring process, no wall sticking phenomenon occurs to the hydroxypropyl-β-cyclodextrin. After the stirring is completed, a hydroxypropyl-β-cyclodextrin aqueous solution with uniform concentration is obtained. Then, the hydroxypropyl-β-cyclodextrin aqueous solution is output through the discharge port 13 and enters the next production process. When using the liquid preparation tank in this application to prepare the hydroxypropyl-β-cyclodextrin aqueous solution, the properties of the hydroxypropyl-β-cyclodextrin remain stable, the phenomena of sticking to the tank or solute precipitation can be avoided, the concentration of the prepared solution is uniform and the impurities are few, no material loss will occur during the preparation process, ensuring the smooth progress of the production process, thereby ensuring that the content of the active ingredient of the drug meets the standard requirements and guaranteeing the safety and effectiveness of the drug.

[0032] Although the specific implementation manners of the present invention have been described in detail with reference to the accompanying drawings, it should not be construed as a limitation on the protection scope of this patent. Within the scope described in the claims, various modifications and deformations that can be made by those skilled in the art without creative efforts still fall within the protection scope of this patent.

Claims

1. A liquid preparation tank for sterile preparation production, characterized in that: It includes an inner cylinder body (2), an inner upper head (4) is arranged at the top of the inner cylinder body (2), an inner lower head (5) is arranged at the bottom of the inner cylinder body (2), and the inner upper head (4), the inner cylinder body (2) and the inner lower head (5) form a tank structure; a jacket cylinder body (3) is arranged on the outer wall of the inner cylinder body (2), a lower jacket cylinder body (8) is arranged on the outer wall of the inner lower head (5), an outer cylinder body (1) is arranged on the outer walls of the jacket cylinder body (3) and the lower jacket cylinder body (8), a heat insulation layer is provided between the jacket cylinder body (3) and the lower jacket cylinder body (8) and the outer cylinder body (1), a first water-containing cavity is provided between the jacket cylinder body (3) and the inner cylinder body (2), a second water-containing cavity is provided between the lower jacket cylinder body (8) and the inner lower head (5), and the first water-containing cavity communicates with the second water-containing cavity; a water inlet (9) penetrating through the outer cylinder body (1) and the jacket cylinder body (3) is arranged at the upper part of the outer cylinder body (1), a water outlet (10) penetrating through the outer cylinder body (1) and the lower jacket cylinder body (8) is arranged at the bottom of the outer cylinder body (1), and a sampling port (11) penetrating through the outer cylinder body (1), the jacket cylinder body (3) and the inner cylinder body (2) is arranged at the lower part of the outer cylinder body (1); a feed inlet (19) is arranged on the inner upper head (4); a discharge port (13) with a valve, a speed reducer (16) and a stirring paddle (17) are arranged at the bottom of the inner lower head (5), the paddle blades of the stirring paddle (17) are located inside the inner lower head (5), and the paddle rod of the stirring paddle (17) is connected with the speed reducer (16) by means of a shaft seal.

2. The liquid preparation tank for sterile preparation production according to claim 1, wherein: The inner cylinder body (2) and the inner upper head (4) are connected by a flange (6) and bolts (7), and the inner upper head (4) and the inner lower head (5) are elliptical.

3. The liquid preparation tank for aseptic preparation production according to claim 2, characterized in that: A buffer plate (12) is arranged on the outer wall of the inner cylinder body (2), and the buffer plate (12) is horizontally aligned with the water inlet (9).

4. The liquid preparation tank for sterile preparation production according to claim 3, characterized in that: The jacket cylinder body (3), the lower jacket cylinder body (8) and the outer cylinder body (1) are bow-shaped.

5. The liquid preparation tank for sterile preparation production according to claim 4, wherein: The feed inlet (19) is arranged at the upper side of the inner upper head (4); the discharge port (13) is arranged at the exact bottom of the inner lower head (5), and the control valve on the discharge port (13) is a pneumatic plunger valve (14).

6. The liquid preparation tank for aseptic preparation production according to claim 5, wherein: A manhole (18), a breather port (20), a pressure sensor port (21), a rupture disk port (22), a pressure gauge port (23), an integrated sight glass lamp port (24) and a cleaning port (25) are arranged on the inner upper head (4).

7. The liquid preparation tank for aseptic preparation production according to claim 6, characterized in that: The number of the cleaning ports (25) is 2.

8. The liquid preparation tank for aseptic preparation production according to claim 7, characterized in that: A reserved port (26) is arranged on the inner upper head (4).

9. The liquid preparation tank for sterile preparation production according to claim 8, characterized in that: Three support legs (27) and a temperature sensor port (15) are arranged below the inner lower head (5), and the three support legs are circumferentially distributed below the inner lower head (5).

Images