Raw material medicine freeze-drying plate layer structure
By designing the freeze-dried plate layer structure of the main board layer and the bent board layer, combined with multiple leveling and welding steps, the problem of insufficient temperature uniformity and flatness is solved, the uniformity of the lyophilization effect and the thoroughness of the discharge are achieved, and the processing difficulty and sealing risks are reduced.
Patent Information
- Application Number
- CN202422114814.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-08-29
- Publication Date
- 2025-07-29
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
In the prior art, the temperature uniformity and flatness of the freeze-dried plate layer of the raw material drug substance are insufficient, and the processing is difficult and the sealing is insufficient, resulting in uneven freeze-drying effect and incomplete discharge.
A lyophilized plate layer structure including the main plate layer and the bent plate layer is designed. The main plate layer and the bent plate layer are connected by connecting blocks. The horizontal and inclined portions of the bent plate layer are parallel to the main plate layer. Multiple leveling and welding steps are adopted to ensure the flatness and temperature uniformity of the plate layer, and the temperature uniformity is optimized through the flow guide and the heat exchange medium hole.
The temperature uniformity and flatness of the freeze-dried plate layer are improved, the processing difficulty is reduced, the consistency of the freeze-drying effect and thorough discharge are ensured, and the risk of leakage of heat exchange media is reduced.
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Figure CN223165831U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to a freeze dryer, in particular to a freeze-drying plate layer structure for bulk drugs. Background Art
[0002] Different from drugs freeze-dried in vials or on freeze-drying trays, bulk drugs are generally directly freeze-dried on the freeze-drying plate layer. In order to prevent the liquid medicine from flowing out and facilitate discharging after freeze-drying, one side of the freeze-drying plate layer for bulk drugs is designed to be bent upward, and baffles are installed on the other sides. At the same time, in order to ensure uniform freeze-drying effect and complete discharging of bulk drugs, high requirements are imposed on the temperature uniformity and flatness of the surface of the freeze-drying plate layer. In addition, in order to prevent the heat exchange medium (usually silicone oil) in the freeze-drying plate layer from leaking and causing drug contamination, very high requirements are also imposed on the sealing performance of the plate layer.
[0003] Chinese patent document CN204461030U discloses a turnover plate type shelf, in which one side of the upper panel is bent upward and a cavity is formed between the bent part and the lower panel, so that the front opening (feeding port) can also carry the refrigerant, ensuring that the bulk drugs falling at the front opening can also be freeze-dried relatively quickly. However, in this technical solution, the lower panel is horizontal as a whole, so that the cross-section of the cavity formed between the bent part of the upper panel and the lower panel is irregular, which is not conducive to ensuring the temperature uniformity of the whole upper panel, and the upper panel cannot be leveled after locally bending the large-size upper panel, and the flatness of the upper panel cannot be ensured. Content of the Utility Model
[0004] The technical problem to be solved by the utility model is to overcome the deficiencies of the prior art and provide a freeze-drying plate layer structure for bulk drugs with a simple structure, which is beneficial to improving temperature uniformity and flatness and reducing the processing difficulty.
[0005] The utility model further provides a processing method for the above freeze-drying plate layer structure of bulk drugs.
[0006] To solve the above technical problems, the utility model adopts the following technical solutions:
[0007] A freeze-drying plate layer structure for bulk drugs includes a main body plate layer and a bent plate layer, and further 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 panel and the lower panel of the horizontal part are parallel, and the upper panel and the lower panel of the inclined part are parallel. The length of the main body plate layer is a, and the length of the horizontal part is b, where a > b. One side of the connecting block is welded to the main body plate layer, and the opposite side is welded to the horizontal part.
[0008] As a further improvement of the above technical solution: a first convex part is provided on one side of the connecting block and extends into the main body plate layer, and a second convex part is provided on the other side of the connecting block and extends into the horizontal part.
[0009] As a further improvement of the above technical solution: a first heat exchange medium hole is provided on the side of the main board layer, a second heat exchange medium hole is provided on the side of the bent board layer, and a communication hole for communicating the first heat exchange medium hole and the second heat exchange medium hole is provided on the connecting block.
[0010] As a further improvement of the above technical solution: a plurality of first diversion tubes are provided between the upper panel and the lower panel of the main board layer, a plurality of second diversion tubes are provided between the upper panel and the lower panel of the bent board layer, and the second diversion tubes are arranged perpendicular to the first diversion tubes.
[0011] As a further improvement of the above technical solution: both the first diversion tube and the second diversion tube are square tubes.
[0012] As a further improvement of the above technical solution:
[0013] The included angle between the horizontal portion and the inclined portion is α, and 155° ≤ α ≤ 175°.
[0014] A processing method for the lyophilization board layer structure of the above raw material medicine includes the following steps
[0015] S1. Process the main board layer and the bent board layer separately:
[0016] The processing process of the main board layer is as follows: assemble the upper panel, the lower panel and the first diversion tubes of the main board layer and weld them. After welding, level them. Then assemble the first sealing block, the second sealing block and the connecting block at the edge of the main board layer and weld them. After welding, level them. Then process the first sealing block, the second sealing block and the connecting block to the target dimensions, wherein the first sealing block and the connecting block are arranged opposite to each other, and the second sealing block is located at both ends of the connecting block;
[0017] The processing process of the bent board layer is as follows: assemble the upper panel and the lower panel of the bent board layer, level them and then weld them with the second diversion tubes;
[0018] S2. Weld the main board layer and the bent board layer: snap the second convex portion of the connecting block between the upper panel and the lower panel of the bent board layer, and then assemble the third sealing block at the edge of the bent board layer and weld it, wherein the third sealing block is located at both ends of the connecting block;
[0019] S3. Lift and level the welded main board layer and bent board layer, and then level the horizontal portion of the bent board layer;
[0020] S4. Assemble the fourth sealing block at the edge of the bent board layer and weld it. After welding, level it, wherein the fourth sealing block and the connecting block are arranged opposite to each other;
[0021] S5. Lift and level the welded main board layer and bent board layer again, and then level the horizontal portion of the bent board layer.
[0022] As a further improvement of the above technical solution: in step S1, rolling leveling is adopted during the processing of the main board layer.
[0023] As a further improvement of the above technical solution: in step S1, die leveling is adopted during the processing of the bent board layer.
[0024] As a further improvement of the above technical solution: in steps S1, S2 and S4, vacuum brazing is adopted during welding.
[0025] Compared with the prior art, the advantages of the present utility model are as follows: the lyophilization board layer structure of the bulk drug disclosed by the present utility model includes a main board layer, a bent board layer and a connecting block for connecting the main board layer and the bent board layer. The upper panel and the lower panel of the horizontal part of the bent board layer are parallel, and the upper panel and the lower panel of the inclined part are parallel, which is beneficial to ensuring the uniformity of the overall temperature of the upper panel of the lyophilization board layer; and the main board layer and the bent board layer can be processed separately and then welded through the connecting block, and leveling treatment can be carried out separately, which is beneficial to ensuring the flatness of the upper panel and the lower panel of the main board layer and the bent board layer, and at the same time reducing the processing difficulty.
[0026] The processing method of the lyophilization board layer structure of the bulk drug disclosed by the present utility model first processes the main board layer and the bent board layer separately and performs leveling treatment separately, which is beneficial to ensuring the flatness of the upper panel and the lower panel of the main board layer and the bent board layer, and at the same time reducing the processing difficulty; during the whole processing process, leveling and hanging leveling are carried out multiple times, which is beneficial to reducing the influence of welding deformation on the flatness of the upper panel and the lower panel of the lyophilization board layer; when welding the main board layer and the bent board layer, the third sealing block is welded first, and the fourth sealing block is not welded, which is beneficial to the release of welding stress.
[0027] Other features and advantages of the present utility model will be described in detail in the subsequent specific implementation part. Brief Description of the Drawings
[0028] Figure 1 is a schematic three-dimensional structure diagram of the lyophilization board layer structure of the bulk drug of the present utility model after hiding the upper panel.
[0029] Figure 2 is a schematic top view structure diagram of the lyophilization board layer structure of the bulk drug of the present utility model after hiding the upper panel.
[0030] Figure 3 is a schematic cross-sectional structure diagram of the lyophilization board layer structure of the bulk drug of the present utility model after hiding the upper panel.
[0031] Figure 4 is Figure 3 a partial enlarged view of
[0032] Figure 5It is a schematic side view structure of the main board layer obtained by the processing method of the present utility model.
[0033] Figure 6 It is a schematic top view structure of the main board layer of the present utility model after welding the sealing block and the connecting block at the edge.
[0034] Figure 7 It is a schematic front view structure of the bent board layer in an enlarged state obtained by the processing method of the present utility model.
[0035] Figure 8 It is a schematic top view structure of the main board layer and the bent board layer of the present utility model after welding.
[0036] Figure 9 It is a schematic top view structure of the bent board layer of the present utility model after welding the third sealing block.
[0037] Figure 10 It is a schematic front view structure of the bent board layer of the present utility model after leveling after welding the third sealing block.
[0038] Figure 11 It is a schematic top view structure of the bent board layer of the present utility model after welding the fourth sealing block.
[0039] Figure 12 It is a schematic side view structure of the bent board layer of the present utility model after leveling after welding the fourth sealing block.
[0040] Each label in the figure represents:
[0041] 1. Main board layer; 11. First heat exchange medium hole; 12. First guide pipe; 13. Enclosing board; 2. Bent board layer; 21. Horizontal part; 22. Inclined part; 23. Second heat exchange medium hole; 24. Second guide pipe; 3. Upper panel; 4. Lower panel; 5. Connecting block; 51. First convex part; 52. Second convex part; 53. Communication hole; 6. First sealing block; 7. Second sealing block; 8. Third sealing block; 9. Fourth sealing block. Detailed implementation manners
[0042] In the description of the present utility model, it should be understood that the orientation or positional relationship indicated by the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present utility model.
[0043] In addition, the terms "first" and "second" are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the present utility model, "a plurality of" means two or more, unless otherwise specifically defined.
[0044] In the present utility model, unless otherwise clearly specified and defined, terms such as "assembled", "connected", "joined", "fixed", etc. shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.
[0045] The present utility model will be further described in detail below in conjunction with the accompanying drawings of the specification and specific embodiments.
[0046] Embodiment 1
[0047] Figures 1 to 4 An embodiment of the lyophilization plate layer structure of the bulk drug of the present utility model is shown. The lyophilization plate layer structure of the bulk drug in 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 upward. The upper panel 3 and the lower panel 4 of the horizontal portion 21 are parallel, and the upper panel 3 and the lower panel 4 of the inclined portion 22 are parallel. The length of the main plate layer 1 is a, and the length of the horizontal portion 21 is b, then 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. Among them, the length b of the horizontal portion 21 only needs to meet the minimum bending size to reduce welding deformation, while the length of the inclined portion 22 needs to be determined according to the sublimation slope of the lyophilization process; the included angle between the horizontal portion 21 and the inclined portion 22 is α, satisfying 155° ≤ α ≤ 175°. As a preferred embodiment, α = 160°.
[0048] The lyophilization plate layer structure of the bulk drug in this embodiment includes a main plate layer 1, a bent plate layer 2, and a connecting block 5 for connecting the main plate layer 1 and the bent plate layer 2. The upper panel 3 and the lower panel 4 of the horizontal portion 21 of the bent plate layer 2 are parallel, and the upper panel 3 and the lower panel 4 of the inclined portion 22 are parallel, which is beneficial to ensuring the uniformity of the overall temperature of the upper panel 3 of the lyophilization plate layer; and the main plate layer 1 and the bent plate layer 2 can be processed separately and then welded into one body through the connecting block 5, and can be leveled separately, which is beneficial to ensuring the flatness of the upper panel 3 and the lower panel 4 of the main plate layer 1 and the bent plate layer 2, and at the same time reducing the processing difficulty.
[0049] See specifically Figure 4 , further, in this embodiment, a first convex portion 51 is provided on one side of the connecting block 5 and extends into the main body plate layer 1 (i.e., between the upper panel 3 and the lower panel 4 of the main body plate layer 1), and a second convex portion 52 is provided on the other side of the connecting block 5 and extends into the horizontal portion २१ (i.e., between the upper panel 3 and the lower panel 4 of the horizontal portion २१). By providing the first convex portion 51 and the second convex portion 52, it is convenient for the positioning and fitting of the connecting block 5 with the main body plate layer 1 and the horizontal portion २१, reducing the height error, and at the same time improving the connection strength between the connecting block 5 and the main body plate layer 1 and the horizontal portion २१.
[0050] See specifically Figure 1 and Figure 2 , in this embodiment, a first heat exchange medium hole 11 is provided on the side of the main body plate layer 1, a second heat exchange medium hole २३ is provided on the side of the bent plate layer २, and a communication hole 53 for communicating the first heat exchange medium hole 11 with the second heat exchange medium hole २३ is provided on the connecting block 5. Through the communication hole 53, the main body plate layer 1 and the bent plate layer २ are connected. The heat exchange medium can enter the main body plate layer 1 from the first heat exchange medium hole 11, enter the bent plate layer २ through the communication hole 53, and finally flow out through the second heat exchange medium hole २३, which is beneficial to keeping the overall temperature of the freeze-drying plate layer uniform and reducing the openings on the side of the plate layer. The structure is simple and reasonable. Of course, in other embodiments, the heat exchange medium can also enter the bent plate layer २ from the second heat exchange medium hole २३, enter the main body plate layer 1 through the communication hole 53, and finally flow out through the first heat exchange medium hole 11.
[0051] Further, in this embodiment, a plurality of first diversion tubes 12 are provided between the upper panel 3 and the lower panel 4 of the main body plate layer 1, and a plurality of second diversion tubes २४ are provided between the upper panel 3 and the lower panel 4 of the bent plate layer २. The second diversion tubes २४ are arranged perpendicular to the first diversion tubes 12. The internal setting of the first diversion tubes 12 and the second diversion tubes २४ is beneficial to improving the structural strength and mechanical properties of the main body plate layer 1 and the bent plate layer २, and at the same time can optimize the flow of the heat exchange medium inside the main body plate layer 1 and the bent plate layer २, so that the temperatures at various parts of the upper panel 3 of the freeze-drying plate layer are kept uniform, and the heat exchange effect between the heat exchange medium and the raw drug is improved.
[0052] See specifically Figure 4 and Figure 5 , as a preferred embodiment, both the first diversion tube 12 and the second diversion tube २४ are square tubes. The square tube has a large flow area, which is beneficial to keeping the temperature of the part of the upper panel 3 in contact with the square tube basically the same as that of other parts, and at the same time is beneficial to ensuring the flatness of the upper panel 3 and the lower panel 4.
[0053] Embodiment 2
[0054] Figures 5 to 12An embodiment of the processing method of the freeze-drying platen structure of the active pharmaceutical ingredient of the present utility model is shown. The processing method of the freeze-drying platen structure of the active pharmaceutical ingredient in this embodiment includes the following steps.
[0055] S1. Process the main platen 1 and the bent platen 2 respectively:
[0056] The processing process of the main platen 1 is as follows: Assemble the upper panel 3, the lower panel 4 and the first diversion tube 12 of the main platen 1 and weld them. After welding, level them. Then assemble the first sealing block 6, the second sealing block 7 and the connecting block 5 at the edge of the main platen 1 and weld them. After welding, level them to achieve the sealing around the main platen 1. Then process the first sealing block 6, the second sealing block 7 and the connecting block 5 to the target size, where the first sealing block 6 and the connecting block 5 are arranged oppositely, and the second sealing block 7 is located at both ends of the connecting block 5.
[0057] The processing process of the bent platen 2 is as follows: Assemble the upper panel 3 and the lower panel 4 of the bent platen 2, level them and then weld them to the second diversion tube 24.
[0058] In the processing method of the freeze-drying platen structure of the active pharmaceutical ingredient in this embodiment, the main platen 1 and the bent platen 2 are processed separately and leveled respectively, which is beneficial to ensuring the flatness of the upper panel 3 and the lower panel 4 of the main platen 1 and the bent platen 2, and at the same time reducing the processing difficulty. When processing the main platen 1, welding is carried out first and then leveling, which is beneficial to reducing the influence of welding deformation on the flatness of the upper panel 3 and the lower panel 4. And after welding is completed, the first sealing block 6, the second sealing block 7 and the connecting block 5 are processed to the target size, which is beneficial to reducing the influence of welding deformation on the sizes of the sealing blocks and the connecting block 5. Since the upper panel 3 and the lower panel 4 of the bent platen 2 are special-shaped plates, leveling is carried out first and then welded to the second diversion tube 24, which is beneficial to reducing the leveling difficulty. The steps are reasonable and effective.
[0059] S2. Weld the main platen 1 and the bent platen 2: Snap the second convex part 52 of the connecting block 5 between the upper panel 3 and the lower panel 4 of the bent platen 2 to facilitate the positioning and matching of the connecting block 5 and the horizontal part 21 and reduce the height error. Then assemble the third sealing block 8 at the edge of the bent platen 2 and weld it, where the third sealing block 8 is located at both ends of the connecting block 5.
[0060] When welding the main platen 1 and the bent platen 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. Lift and level the welded main platen 1 and bent platen 2, and then level the horizontal part 21 of the bent platen 2.
[0062] Lift and level the main board layer 1 and the bent board layer 2 after flat welding, which is beneficial to reducing the influence of welding deformation on the flatness of the upper panel 3 and the lower panel 4 of the horizontal part 21, and making the upper panel 3 and the lower panel 4 of the horizontal part 21 parallel.
[0063] S4. Assemble the fourth sealing block 9 at the edge of the bent board layer 2 and weld it. After welding, level it. The fourth sealing block 9 is arranged opposite to the connecting block 5.
[0064] Leveling after welding the fourth sealing block 9 is beneficial to reducing the influence of welding deformation on the bent board layer 2.
[0065] S5. Lift and level the main board layer 1 and the bent board layer 2 after welding again, and then level the horizontal part 21 of the bent board layer 2.
[0066] Lift and level the main board layer 1 and the bent board layer 2 after welding the fourth sealing block 9 again and level the horizontal part 21, which is beneficial to reducing the influence of welding deformation on the flatness of the upper panel 3 and the lower panel 4 of the freeze-drying board layer, and making the upper panel 3 and the lower panel 4 parallel.
[0067] As a preferred embodiment, in step S1, rolling is used for leveling during the processing of the main board layer 1. The main board layer 1 is large in size. Using rolling treatment is beneficial to improving the processing efficiency while ensuring the flatness of the main board layer 1.
[0068] As a preferred embodiment, in step S1, die leveling is used for leveling during the processing of the bent board layer 2. The bent board layer 2 is small in size. Using die leveling is beneficial to the bent board layer 2 with special shape having a high flatness, and has little influence on the overall processing efficiency at the same time.
[0069] As a preferred embodiment, in steps S1, S2 and S4, vacuum brazing is used for welding. Using vacuum brazing is beneficial to ensuring the sealing performance of the weld position, avoiding the leakage of heat exchange medium, and having good welding reliability.
[0070] Although the present invention has been disclosed above with preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make many possible changes and modifications to the technical solution of the present invention, or modify it into an equivalent embodiment with equivalent changes, without departing from the scope of the technical solution of the present invention. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention shall fall within the scope of protection of the technical solution of the present invention.
Claims
1. A freeze-dried lamellar structure of an active pharmaceutical ingredient, comprising a main lamella (1) and a bent lamella (2), characterized in that: It further 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 upward. The upper panel (3) and the lower panel (4) of the horizontal portion (21) are parallel, and the upper panel (3) and the lower panel (4) of the inclined portion (22) are parallel. The length of the main body 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 body plate layer (1), and the opposite side is welded to the horizontal portion (21).
2. The lyophilization platen structure of the bulk drug substance according to claim 1, wherein: One side of the connecting block (5) is provided with a first convex portion (51) extending into the main body plate layer (1), and the other side of the connecting block (5) is provided with a second convex portion (52) extending into the horizontal portion (21).
3. The lyophilization platen structure of the bulk drug according to claim 2, wherein: A first heat exchange medium hole (11) is provided on the side of the main body plate layer (1), a second heat exchange medium hole (23) is provided on the side of the bent plate layer (2), and a communication hole (53) for communicating the first heat exchange medium hole (11) with the second heat exchange medium hole (23) is provided on the connecting block (5).
4. The lyophilized plate layer structure of the bulk drug according to any one of claims 1 to 3, characterized in that: A plurality of first flow guide pipes (12) are provided between the upper panel (3) and the lower panel (4) of the main body plate layer (1), and a plurality of second flow guide pipes (24) are provided between the upper panel (3) and the lower panel (4) of the bent plate layer (2). The second flow guide pipes (24) are arranged perpendicular to the first flow guide pipes (12).
5. The lyophilized platen structure of the bulk drug according to claim 4, wherein: Both the first flow guide pipe (12) and the second flow guide pipe (24) are square pipes.
6. The lyophilized platen structure of the active pharmaceutical ingredient according to any one of claims 1 to 3, characterized in that: The included angle between the horizontal portion (21) and the inclined portion (22) is α, and 155° ≤ α ≤ 175°.
Citation Information
Patent Citations
Turning plate structure type shelf
CN204461030U
Cited By
Raw material medicine freeze-drying plate layer structure and processing method
CN118960321A
A raw material medicine freeze-drying plate layer structure and a processing method thereof
CN118960321B