A raw material medicine freeze-drying plate layer structure and a processing method thereof

Abstract

A raw material medicine freeze-drying plate layer structure, including a main plate layer and a bent plate layer, further including a connecting block, the bent plate layer includes a horizontal part and an inclined part connected with the horizontal part and arranged obliquely upward, the upper and lower panels of the horizontal part are parallel, the upper and lower panels of the inclined part are parallel, the length of the main plate layer is a, the length of the horizontal part is b, then a > b, one side of the connecting block is welded with the main plate layer and the opposite side is welded with the horizontal part. Its processing method includes the following steps, S1, respectively processing the main plate layer and the bent plate layer; S2, welding the main plate layer and the bent plate layer; S3, hoisting and welding the main plate layer and the bent plate layer after welding, and then leveling the horizontal part of the bent plate layer; S4, assembling and welding the fourth sealing block at the edge of the bent plate layer, and leveling after welding is completed, wherein the fourth sealing block is arranged opposite to the connecting block; S5, hoisting and welding the main plate layer and the bent plate layer after welding again, and then leveling the horizontal part of the bent plate layer.

Description

Technical Field

[0001] This invention relates to a freeze dryer and its manufacturing method, and more particularly to a freeze-drying plate structure and processing method for a raw material drug. Background Technology

[0002] Unlike lyophilized pharmaceuticals stored in vials or trays, active pharmaceutical ingredients (APIs) are typically lyophilized directly on lyophilization plates. To prevent leakage and facilitate post-lyophilization discharge, the API lyophilization plates are designed with one side bent upwards and the remaining sides fitted with side panels. Furthermore, to ensure uniform and thorough lyophilization and discharge, high requirements are placed on the temperature uniformity and flatness of the lyophilization plate surface. In addition, to prevent leakage of the heat exchange medium (usually silicone oil) within the lyophilization plates and subsequent drug contamination, the airtightness of the plates is also crucial.

[0003] Chinese patent document CN204461030U discloses a flip-type shelf with one side of the upper panel bent upwards, forming a cavity between the bent part and the lower panel. This allows the front inlet (feed port) to carry refrigerant, ensuring that the raw materials falling into the front inlet can also be freeze-dried relatively quickly. However, in this technical solution, the lower panel is horizontal overall, resulting in an irregular cross-section of the cavity formed between the bent part of the upper panel and the lower panel. This is not conducive to ensuring the uniformity of the overall temperature of the upper panel, and after bending a large part of the upper panel, it is impossible to flatten it, thus failing to guarantee the flatness of the upper panel. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide a simple structure for freeze-drying raw materials that is conducive to improving temperature uniformity and flatness and reducing processing difficulty.

[0005] The present invention further provides a processing method for the above-mentioned freeze-dried plate structure of the active pharmaceutical ingredient.

[0006] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0007] A freeze-dried plate structure for a raw material drug includes a main plate layer and a bent plate layer, and also includes a connecting block. The bent plate layer includes a horizontal part and an inclined part connected to the horizontal part and arranged obliquely upward. The upper and lower panels of the horizontal part are parallel, and the upper and lower panels of the inclined part are parallel. The length of the main plate layer is a, and the length of the horizontal part is b, then a > b. One side of the connecting block is welded to the main plate layer, and the opposite side is welded to the horizontal part.

[0008] As a further improvement to the above technical solution: a first protrusion is provided on one side of the connecting block and extends into the main body plate layer, and a second protrusion is provided on the other side of the connecting block and extends into the horizontal part.

[0009] As a further improvement to the above technical solution: the main plate layer is provided with a first heat exchange medium hole on its side, the bent plate layer is provided with a second heat exchange medium hole on its side, and the connecting block is provided with a connecting hole for connecting the first heat exchange medium hole and the second heat exchange medium hole.

[0010] As a further improvement to the above technical solution: multiple first guide tubes are provided between the upper and lower panels of the main body plate, and multiple second guide tubes are provided between the upper and lower panels of the bent plate, with the second guide tubes arranged perpendicular to the first guide tubes.

[0011] As a further improvement to the above technical solution: both the first guide tube and the second guide tube are square tubes.

[0012] As a further improvement to the above technical solution:

[0013] The angle between the horizontal part and the inclined part is α, where 155°≤α≤175°.

[0014] A method for processing the above-mentioned lyophilized plate-layer structure of the active pharmaceutical ingredient includes the following steps:

[0015] S1. Process the main body panel and the bent panel separately:

[0016] The processing of the main plate layer is as follows: assemble and weld the upper panel, lower panel and first guide tube of the main plate layer. After welding, level the plate. Then assemble and weld the first sealing block, second sealing block and connecting block at the edge of the main plate layer. After welding, level the plate. Then process the first sealing block, second sealing block and connecting block to the target size. The first sealing block and the connecting block are arranged opposite each other, and the second sealing block is located at both ends of the connecting block.

[0017] The processing steps for the bent plate layer are as follows: assemble the upper and lower panels of the bent plate layer, level them, and then weld them to the second guide pipe;

[0018] S2. Welding the main body plate and the bent plate: Insert the second protrusion of the connecting block between the upper and lower panels of the bent plate, then assemble and weld the third sealing block at the edge of the bent plate, wherein the third sealing block is located at both ends of the connecting block.

[0019] S3. After welding, the main plate layer and the bent plate layer are leveled, and then the horizontal part of the bent plate layer is leveled.

[0020] S4. Assemble and weld the fourth sealing block at the edge of the bent plate layer. After welding, level the plate. The fourth sealing block is arranged opposite to the connecting block.

[0021] S5. After welding, the main plate and the bent plate are leveled again, and then the horizontal part of the bent plate is leveled.

[0022] As a further improvement to the above technical solution: in step S1, rolling is used for leveling during the main plate processing.

[0023] As a further improvement to the above technical solution: in step S1, the bending plate layer is leveled using a mold during the leveling process.

[0024] As a further improvement to the above technical solution: in steps S1, S2 and S4, vacuum brazing is used during welding.

[0025] Compared with the prior art, the advantages of the present invention are as follows: The freeze-dried plate structure of the raw material disclosed in the present invention includes a main plate layer, a bent plate layer, and a connecting block for connecting the main plate layer and the bent plate layer. The upper and lower panels of the horizontal part of the bent plate layer are parallel, and the upper and lower panels of the inclined part are also parallel, which helps to ensure the uniformity of the overall temperature of the upper panel of the freeze-dried plate layer. Furthermore, the main plate layer and the bent plate layer can be processed separately and then welded together by the connecting block, and can be leveled separately, which helps to ensure the flatness of the upper and lower panels of the main plate layer and the bent plate layer, while reducing the processing difficulty.

[0026] The processing method for the freeze-dried plate structure of the active pharmaceutical ingredient disclosed in this invention involves first processing the main plate layer and the bent plate layer separately, and then performing leveling treatment on each of them. This helps to ensure the flatness of the upper and lower panels of the main plate layer and the bent plate layer, while reducing the processing difficulty. The entire processing involves multiple leveling and lifting treatments, which helps to reduce the impact of welding deformation on the flatness of the upper and lower panels of the freeze-dried plate layer. When welding the main plate layer and the bent plate layer, the third sealing block is welded first, and the fourth sealing block is not welded, which helps to release welding stress.

[0027] Other features and advantages of the present invention will be described in detail in the following detailed description section. Attached Figure Description

[0028] Figure 1 This is a three-dimensional structural diagram of the freeze-dried active pharmaceutical ingredient plate structure of the present invention with the top panel hidden.

[0029] Figure 2 This is a top view of the freeze-dried plate structure of the active pharmaceutical ingredient of the present invention after the top panel is hidden.

[0030] Figure 3 This is a cross-sectional view of the freeze-dried plate structure of the active pharmaceutical ingredient of the present invention after the top panel is hidden.

[0031] Figure 4 yes Figure 3 A magnified view of a portion of the image.

[0032] Figure 5 This is a side view schematic diagram of the main plate layer obtained by the processing method of the present invention.

[0033] Figure 6 This is a top view of the structure after welding the sealing block and connecting block to the edge of the main plate layer in the processing method of the present invention.

[0034] Figure 7 This is a front view schematic diagram of the enlarged state of the bent plate layer obtained by the processing method of the present invention.

[0035] Figure 8 This is a top view of the structure after the main plate layer and the bent plate layer of the processing method of the present invention are welded.

[0036] Figure 9 This is a top view of the structure after the third sealing block is welded to the bent plate layer using the processing method of this invention.

[0037] Figure 10 This is a schematic diagram of the main structure after the bending plate layer is welded to the third sealing block and leveled according to the processing method of the present invention.

[0038] Figure 11 This is a top view of the structure after the fourth sealing block is welded to the bent plate layer using the processing method of this invention.

[0039] Figure 12 This is a side view of the structure after the fourth sealing block is welded to the bent plate layer and leveled according to the processing method of the present invention.

[0040] The labels in the diagram represent:

[0041] 1. Main plate layer; 11. First heat exchange medium hole; 12. First guide pipe; 13. Enclosure plate; 2. Bending plate layer; 21. Horizontal part; 22. Inclined part; 23. Second heat exchange medium hole; 24. Second guide pipe; 3. Top panel; 4. Bottom panel; 5. Connecting block; 51. First protrusion; 52. Second protrusion; 53. Connecting hole; 6. First sealing block; 7. Second sealing block; 8. Third sealing block; 9. Fourth sealing block. Detailed Implementation

[0042] In the description of this invention, it should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0043] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0044] In this invention, unless otherwise explicitly specified and limited, the terms "assembly," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0045] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0046] Example 1

[0047] Figures 1 to 4 This invention illustrates an embodiment of the freeze-dried pharmaceutical raw material plate structure. The freeze-dried pharmaceutical raw material plate structure of this embodiment includes a main plate layer 1 and a bent plate layer 2, and also includes a connecting block 5. The bent plate layer 2 includes a horizontal portion 21 and an inclined portion 22 connected to the horizontal portion 21 and arranged obliquely upwards. The upper panel 3 and lower panel 4 of the horizontal portion 21 are parallel, and the upper panel 3 and lower panel 4 of the inclined portion 22 are also parallel. The length of the main plate layer 1 is 'a', and the length of the horizontal portion 21 is 'b', where 'a' > 'b'. One side of the connecting block 5 is welded to the main plate layer 1, and the opposite side is welded to the horizontal portion 21. The length 'b' of the horizontal portion 21 is sufficient to minimize welding deformation and meet the minimum bending dimension, while the length of the inclined portion 22 needs to be determined based on the sublimation slope of the freeze-drying process. The included angle α between the horizontal portion 21 and the inclined portion 22 satisfies 155° ≤ α ≤ 175°. In a preferred embodiment, α = 160°.

[0048] The freeze-dried plate structure of the active pharmaceutical ingredient in this embodiment includes a main plate 1, a bent plate 2, and a connecting block 5 for connecting the main plate 1 and the bent plate 2. The upper panel 3 and the lower panel 4 of the horizontal part 21 of the bent plate 2 are parallel, and the upper panel 3 and the lower panel 4 of the inclined part 22 are also parallel, which helps to ensure the uniformity of the overall temperature of the upper panel 3 of the freeze-dried plate. Furthermore, the main plate 1 and the bent plate 2 can be processed separately and then welded together by the connecting block 5. They can be leveled separately, which helps to ensure the flatness of the upper panel 3 and the lower panel 4 of the main plate 1 and the bent plate 2, while reducing the processing difficulty.

[0049] See details Figure 4 Furthermore, in this embodiment, the connecting block 5 has a first protrusion 51 on one side that extends into the main body plate 1 (i.e., between the upper panel 3 and the lower panel 4 of the main body plate 1), and a second protrusion 52 on the other side that extends into the horizontal portion 21 (i.e., between the upper panel 3 and the lower panel 4 of the horizontal portion 21). By providing the first protrusion 51 and the second protrusion 52, the positioning and cooperation between the connecting block 5 and the main body plate 1 and the horizontal portion 21 are facilitated, reducing height errors and improving the connection strength between the connecting block 5 and the main body plate 1 and the horizontal portion 21.

[0050] See details Figure 1 and Figure 2 In this embodiment, the main plate 1 has a first heat exchange medium hole 11 on its side, and the bent plate 2 has a second heat exchange medium hole 23 on its side. The connecting block 5 has a connecting hole 53 for connecting the first heat exchange medium hole 11 and the second heat exchange medium hole 23. The connecting hole 53 enables communication between the main plate 1 and the bent plate 2. The heat exchange medium can enter the main plate 1 from the first heat exchange medium hole 11, enter the bent plate 2 through the connecting hole 53, and finally flow out through the second heat exchange medium hole 23. This helps to maintain the overall temperature uniformity of the freeze-drying plate and reduces the number of openings on the side of the plate, resulting in a simple and reasonable structure. Of course, in other embodiments, the heat exchange medium can also enter the bent plate 2 from the second heat exchange medium hole 23, enter the main plate 1 through the connecting hole 53, and finally flow out through the first heat exchange medium hole 11.

[0051] Furthermore, in this embodiment, multiple first guide pipes 12 are provided between the upper panel 3 and the lower panel 4 of the main plate layer 1, and multiple second guide pipes 24 are provided between the upper panel 3 and the lower panel 4 of the bent plate layer 2. The second guide pipes 24 are arranged perpendicularly to the first guide pipes 12. The internal arrangement of the first guide pipes 12 and the second guide pipes 24 is beneficial to improving the structural strength and mechanical properties of the main plate layer 1 and the bent plate layer 2. At the same time, it can optimize the flow of the heat exchange medium inside the main plate layer 1 and the bent plate layer 2, so that the temperature of the upper panel 3 of the freeze-drying plate layer remains uniform, and the heat exchange effect between the heat exchange medium and the raw drug is improved.

[0052] See details Figure 4 and Figure 5 In a preferred embodiment, both the first guide tube 12 and the second guide tube 24 are square tubes. The large flow area of ​​the square tube helps to keep the temperature of the part of the upper panel 3 in contact with the square tube basically the same as the temperature of the other parts, and also helps to ensure the flatness of the upper panel 3 and the lower panel 4.

[0053] Example 2

[0054] Figures 5 to 12This invention illustrates an embodiment of a processing method for a lyophilized plate-like structure of a pharmaceutical raw material. The processing method for this embodiment includes the following steps:

[0055] S1. Process the main body layer 1 and the bent layer 2 separately:

[0056] The processing of the main body plate 1 is as follows: the upper panel 3, the lower panel 4 and the first guide tube 12 of the main body plate 1 are assembled and welded. After welding, the plate is leveled. Then the first sealing block 6, the second sealing block 7 and the connecting block 5 at the edge of the main body plate 1 are assembled and welded. After welding, the plate is leveled to achieve sealing around the main body plate 1. Then the first sealing block 6, the second sealing block 7 and the connecting block 5 are processed to the target size. The first sealing block 6 and the connecting block 5 are arranged opposite each other, and the second sealing block 7 is located at both ends of the connecting block 5.

[0057] The processing procedure for the bent plate layer 2 is as follows: assemble the upper panel 3 and the lower panel 4 of the bent plate layer 2, level them, and then weld them to the second guide pipe 24.

[0058] The processing method of the freeze-dried plate structure of the raw material in this embodiment first processes the main plate 1 and the bent plate 2 separately, and then performs leveling treatment on each. This helps to ensure the flatness of the upper panel 3 and the lower panel 4 of the main plate 1 and the bent plate 2, while reducing the processing difficulty. When processing the main plate 1, welding is performed first and then leveling is performed. This helps to reduce the impact of welding deformation on the flatness of the upper panel 3 and the lower panel 4. After welding, the first sealing block 6, the second sealing block 7 and the connecting block 5 are processed to the target size. This helps to reduce the impact of welding deformation on the size of each sealing block and connecting block 5. Since the upper panel 3 and the lower panel 4 of the bent plate 2 are irregularly shaped plates, they are leveled first and then welded to the second guide tube 24 during processing. This helps to reduce the leveling difficulty. The steps are reasonable and effective.

[0059] S2. Welding the main body plate 1 and the bent plate 2: Insert the second protrusion 52 of the connecting block 5 between the upper panel 3 and the lower panel 4 of the bent plate 2 to facilitate the positioning and matching of the connecting block 5 and the horizontal part 21, reduce height error, and then assemble and weld the third sealing block 8 on the edge of the bent plate 2, wherein the third sealing block 8 is located at both ends of the connecting block 5.

[0060] When welding the main plate 1 and the bent plate 2, weld the third sealing block 8 first, and do not weld the fourth sealing block 9, which is beneficial to the release of welding stress.

[0061] S3. After welding, the main plate layer 1 and the bent plate layer 2 are leveled, and then the horizontal part 21 of the bent plate layer 2 is leveled.

[0062] The main body plate 1 and the bent plate 2 after welding are leveled and the horizontal part 21 is leveled. This helps to reduce the impact of welding deformation on the flatness of the upper panel 3 and the lower panel 4 of the horizontal part 21, and makes the upper panel 3 and the lower panel 4 of the horizontal part 21 remain parallel.

[0063] S4. Assemble and weld the fourth sealing block 9 at the edge of the bent plate layer 2. After welding, level the plate. The fourth sealing block 9 is arranged opposite to the connecting block 5.

[0064] After welding the fourth sealing block 9, leveling is performed, which helps to reduce the impact of welding deformation on the bent plate layer 2.

[0065] S5. After welding, the main plate layer 1 and the bent plate layer 2 are leveled again, and then the horizontal part 21 of the bent plate layer 2 is leveled.

[0066] After the fourth sealing block 9 is welded again, the main body plate layer 1 and the bent plate layer 2 are leveled and the horizontal part 21 is leveled. This helps to reduce the impact of welding deformation on the flatness of the upper panel 3 and the lower panel 4 of the freeze-dried plate layer, and makes the upper panel 3 and the lower panel 4 remain parallel.

[0067] In a preferred embodiment, in step S1, the main body plate 1 is leveled by rolling during the processing. Since the main body plate 1 is large, rolling ensures its flatness while improving processing efficiency.

[0068] In a preferred embodiment, in step S1, the bending plate layer 2 is leveled using a mold during the processing. Since the bending plate layer 2 is small in size, using a mold for leveling helps the irregularly shaped bending plate layer 2 achieve higher flatness, while having a smaller impact on overall processing efficiency.

[0069] In a preferred embodiment, vacuum brazing is used during steps S1, S2, and S4. Vacuum brazing helps ensure the sealing of the weld joint, prevents leakage of the heat exchange medium, and improves welding reliability.

[0070] While the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the invention. Any person skilled in the art can make many possible variations and modifications to the technical solutions of the present invention, or modify them into equivalent embodiments, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention, without departing from the scope of the present invention, should fall within the protection scope of the present invention.

Claims

1. A freeze-dried plate structure for a pharmaceutical raw material, comprising a main plate layer (1) and a bent plate layer (2), characterized in that: It also includes a connecting block (5). Multiple first guide pipes (12) are provided between the upper panel (3) and the lower panel (4) of the main plate layer (1). Multiple second guide pipes (24) are provided between the upper panel (3) and the lower panel (4) of the bent plate layer (2). The bent plate layer (2) includes a horizontal part (21) and an inclined part (22) connected to the horizontal part (21) and arranged obliquely upward. The upper panel (3) and the lower panel (4) of the horizontal part (21) are parallel. The upper panel (3) and the lower panel (4) of the inclined part (22) are parallel. The main plate (1) is parallel to the horizontal part (21), the length of the main plate (1) is a, the length of the horizontal part (21) is b, then a > b. The connecting block (5) is welded to the main plate (1) on one side and to the horizontal part (21) on the other side. The main plate (1) is provided with a first heat exchange medium hole (11) on the side, the bent plate (2) is provided with a second heat exchange medium hole (23) on the side, and the connecting block (5) is provided with a connecting hole (53) for connecting the first heat exchange medium hole (11) and the second heat exchange medium hole (23).

2. The lyophilized plate structure of the active pharmaceutical ingredient according to claim 1, characterized in that: The connecting block (5) has a first protrusion (51) on one side and extends into the main body plate (1), and a second protrusion (52) on the other side and extends into the horizontal part (21).

3. The lyophilized plate structure of the active pharmaceutical ingredient according to any one of claims 1 to 2, characterized in that: The second guide tube (24) is arranged perpendicular to the first guide tube (12).

4. The lyophilized plate structure of the active pharmaceutical ingredient according to claim 3, characterized in that: Both the first guide tube (12) and the second guide tube (24) are square tubes.

5. The lyophilized plate structure of the active pharmaceutical ingredient according to any one of claims 1 to 2, characterized in that: The included angle between the horizontal part (21) and the inclined part (22) is α, where 155°≤α≤175°.

6. A method for processing a lyophilized plate-like structure of a pharmaceutical raw material according to any one of claims 1 to 5, characterized in that: Includes the following steps, S1. Process the main body plate (1) and the bent plate (2) respectively: The processing of the main plate (1) is as follows: the upper panel (3), lower panel (4) and first guide pipe (12) of the main plate (1) are assembled and welded. After welding, the plate is leveled. Then the first sealing block (6), second sealing block (7) and connecting block (5) at the edge of the main plate (1) are assembled and welded. After welding, the plate is leveled. Then the first sealing block (6), second sealing block (7) and connecting block (5) are processed to the target size. The first sealing block (6) and connecting block (5) are arranged opposite to each other, and the second sealing block (7) is located at both ends of the connecting block (5). The processing procedure of the bent plate layer (2) is as follows: assemble the upper panel (3) and lower panel (4) of the bent plate layer (2), level them, and then weld them to the second guide pipe (24); S2, Welding the main body plate (1) and the bent plate (2): Insert the second protrusion (52) of the connecting block (5) between the upper panel (3) and the lower panel (4) of the bent plate (2), and then assemble and weld the third sealing block (8) at the edge of the bent plate (2), wherein the third sealing block (8) is located at both ends of the connecting block (5). S3. After welding, the main plate layer (1) and the bent plate layer (2) are leveled, and then the horizontal part (21) of the bent plate layer (2) is leveled. S4. Assemble the fourth sealing block (9) at the edge of the bent plate layer (2) and weld it. After welding, level it. The fourth sealing block (9) is arranged opposite to the connecting block (5). S5. After welding, the main plate layer (1) and the bent plate layer (2) are leveled again, and then the horizontal part (21) of the bent plate layer (2) is leveled.

7. The processing method of the lyophilized plate structure of the active pharmaceutical ingredient according to claim 6, characterized in that: In step S1, the main body plate (1) is leveled by rolling during the processing.

8. The processing method of the freeze-dried plate structure of the active pharmaceutical ingredient according to claim 6, characterized in that: In step S1, the bending plate layer (2) is leveled using a mold during the processing.

9. The processing method of the freeze-dried plate structure of the active pharmaceutical ingredient according to claim 6, characterized in that: In steps S1, S2 and S4, vacuum brazing is used during welding.

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