Preparation packaging assembly
By designing sealed formulation packaging components, the problems of high energy consumption and high cost in the production of radiopharmaceuticals have been solved, achieving aseptic control and improving production efficiency, and adapting to the needs of small-batch production.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- SICHUAN DONGFULONG PHARM PACKAGING MATERIAL CO LTD
- Filing Date
- 2025-05-12
- Publication Date
- 2026-05-19
AI Technical Summary
In the production of radiopharmaceuticals, the existing cleaning-drying-sterilization process equipment has a low utilization rate, resulting in high energy consumption and excessive production costs, which cannot meet the needs of small-batch production.
A formulation packaging assembly has been designed, including a tray, vials, caps, and sealing paper. By limiting the thickness relationship between the receiving cavity, vials, and caps, the vials and caps are sealed to ensure sterility and pre-seal in a Class A clean environment, reducing subsequent processing steps.
It reduces equipment energy consumption and production costs, ensures drug sterility, simplifies the production process, facilitates operation in confined spaces, and meets the needs of small-batch production of radiopharmaceuticals.
Smart Images
Figure CN224257227U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of aseptic packaging technology, and in particular to a pharmaceutical packaging component. Background Technology
[0002] Radiopharmaceuticals are a newly emerging type of injectable drug. These drugs are typically manufactured using aseptic processes. To ensure product sterility, the industry commonly employs C+Isolator filling technology to achieve dynamic aseptic environment control. This method has the following problems:
[0003] Existing cleaning-drying-sterilization processes are designed for large-scale production of conventional pharmaceuticals, while radioactive drugs, due to their short half-life, require an order-driven, small-batch production model. The fixed operating cycles of large-scale cleaning and sterilization equipment do not match the needs of small-batch production, resulting in high energy consumption when the equipment is idle. Furthermore, in the current process, pharmaceutical companies need to configure independent bottle washing machines, cap washing machines, drying ovens, and sterilization cabinets, leading to high production costs. Utility Model Content
[0004] This utility model provides a formulation packaging component, which aims to improve the problems of high cost and high energy consumption of equipment in the production of radioactive drugs by pharmaceutical companies.
[0005] Specifically, this utility model provides a pharmaceutical packaging assembly, including a tray, a vial, a cap, and a sealing paper. The tray has an upward-opening receiving cavity; the vial is placed vertically within the receiving cavity; the cap is placed above the vial neck axis and in contact with the vial (200); the cap includes a cap portion and an extension portion, the extension portion being connected to the cap portion for sealing the vial neck; the cap portion is used to stop the vial from the outside; the sealing paper is adhered to the upper surface of the tray to seal the vial and the cap within the tray; the height H1 of the receiving cavity satisfies the following formula:
[0006] 0mm≤H1-H2-H3≤5mm;
[0007] Wherein, H2 is the height of the vial; H3 is the thickness of the cap.
[0008] Optionally, the tray includes a bottom wall and side walls surrounding the bottom wall to enclose and form the receiving cavity; the bottom wall is provided with a plurality of upwardly extending limiting posts, and the internal space formed by three or four adjacent limiting posts is used to place the vial.
[0009] Optionally, a folded edge is provided at one end of the sidewall away from the bottom wall, the folded edge extending in a direction parallel to the bottom wall, and the sealing paper is hot-pressed onto the folded edge.
[0010] Optionally, the length of the tray is 100mm-200mm, the width is 50mm-150mm, and the height is ≤70mm; the number of internal spaces is 6-20.
[0011] Optionally, the sidewall includes a first segment, a second segment, and a third segment connected in sequence. The first segment is connected to the bottom wall to form a first space; the second segment extends horizontally; and the third segment is connected to the outer edge of the second segment to form a second space that communicates with the first space.
[0012] Optionally, the formulation packaging assembly further includes a cap material laid on the bottle cap; the cap material is located within the second space and between the bottle cap and the sealing paper.
[0013] Optionally, the formulation packaging assembly further includes a first breathing bag, and the tray is sealed inside the first breathing bag.
[0014] Optionally, the formulation packaging assembly further includes a second breathing bag, and the tray and the first breathing bag are sealed inside the second breathing bag.
[0015] Optionally, the bottle cap includes a rubber stopper and an aluminum cap, the rubber stopper being located inside the aluminum cap, and the end of the rubber stopper used to seal the bottle opening having a bevel, the bevel abutting against the bottle opening of the vial.
[0016] Optionally, the bottle cap is an aluminum-plastic cap, which includes a plastic cap plate and an aluminum outer shell connected to the plastic cap plate. The portion of the plastic cap plate and the aluminum outer shell parallel to the plastic cap plate is the cap portion, and the flange of the aluminum outer shell is the extension portion.
[0017] The beneficial effects of this utility model are as follows:
[0018] The pharmaceutical packaging component provided by this invention ensures effective control of insoluble particles and bacterial endotoxins by sealing the vials and caps in a tray after cleaning and disinfection. When using this packaging component, pharmaceutical companies only need to perform necessary hydrogen peroxide surface sterilization before the vials enter the isolator; no additional processing such as cleaning, drying, inner packaging, or sterilization of the packaging materials (including vials and caps) is required. Therefore, there is no need to purchase cleaning and drying equipment, saving on factory facilities, production energy consumption, and manpower.
[0019] Furthermore, by limiting the height H1 of the receiving cavity, the height H2 of the vial, and the thickness H3 of the cap to satisfy the formula: 0mm ≤ H1 - H2 - H3 ≤ 5mm, the sealed formulation packaging assembly has no gap or only a small gap between the cap and the sealing paper, preventing the cap from falling off during use and transportation. In addition, during drug filling, operators or robots can simply remove the stopper from the same location, eliminating the need for long-distance transfer of the stopper, facilitating operation in confined spaces and benefiting production within isolators. Attached Figure Description
[0020] Figure 1 This is a schematic exploded view of a formulation packaging component provided in one embodiment of the present invention;
[0021] Figure 2 This is a schematic structural diagram of a tray in a formulation packaging assembly provided in one embodiment of the present invention;
[0022] Figure 3 This is a schematic top view of a tray in a pharmaceutical packaging assembly provided in one embodiment of the present invention;
[0023] Figure 4 This is a schematic exploded view of a formulation packaging component provided in an embodiment of the present invention;
[0024] Figure 5 This is a schematic structural diagram of the rubber stopper in a formulation packaging assembly provided in one embodiment of the present invention.
[0025] Explanation of reference numerals in the attached figures:
[0026] 100. Tray; 101. Receiving cavity; 102. Internal space; 110. Limiting post; 120. Folded edge; 131. First section; 132. Second section; 133. Third section; 200. Vial; 300. Cap; 301. Cap part; 302. Extension part; 310. Rubber stopper; 311. Bevel; 320. Aluminum cap; 400. Sealing paper; 500. Cap material; 600. First breathing bag; 700. Second breathing bag. Detailed Implementation
[0027] To make the technical problems solved, technical solutions, and beneficial effects of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present utility model and are not intended to limit the present utility model.
[0028] In the description of this utility model, it should be understood that the terms "longitudinal," "radial," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model 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, and therefore should not be construed as a limitation of this utility model. In the description of this utility model, unless otherwise stated, "a plurality of" means two or more.
[0029] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.
[0030] Figure 1 This is a schematic exploded view of a formulation packaging component provided in one embodiment of this utility model. Figure 1 As shown, and with reference Figures 2 to 5 This utility model provides a pharmaceutical packaging assembly, including a tray 100, a vial 200, a cap 300, and a sealing paper 400. The tray 100 has an upward-opening receiving cavity 101. The vial 200 is placed vertically within the receiving cavity 101. The cap 300 is placed above the axis of the vial neck and in contact with the vial (200). The cap 300 includes a cap portion 301 and an extension portion 302. The cap portion 301 is used to stop outside the vial 200. The extension portion 302 is connected to the cap portion 301 and is used to seal the vial neck. The sealing paper 400 is adhered to the upper surface of the tray 100 to seal the vial 200 and the cap 300 within the tray 100. The height H1 of the receiving cavity 101 satisfies the following formula:
[0031] 0mm≤H1-H2-H3≤5mm;
[0032] Where H2 is the height of vial 200; H3 is the thickness of cap 301.
[0033] The formulation packaging component provided in this embodiment of the invention involves pre-cleaning and drying the vials 200 and caps 300 during preparation. Both vials 200 and caps 300 are then sealed within a tray 100 in a Class A cleanroom environment with air supply, ensuring effective control of insoluble particles and bacterial endotoxins throughout the entire packaging component. When using this packaging component, pharmaceutical companies only need to perform necessary hydrogen peroxide surface sterilization before it enters the isolator. No additional processing such as cleaning, drying, inner packaging, or sterilization of the packaging materials (including vials 200 and caps 300) is required. Therefore, there is no need to purchase cleaning and drying equipment, saving on factory facilities, production energy consumption, and manpower.
[0034] Furthermore, by limiting the height H1 of the receiving cavity 101, the height H2 of the vial 200, and the thickness H3 of the cap 301 to satisfy the formula: 0mm ≤ H1 - H2 - H3 ≤ 5mm, the sealed formulation packaging assembly has no gap or only a small gap between the cap 300 and the sealing paper 400, preventing the cap 300 from falling off during use and transportation. In addition, during drug filling, operators or robots can simply remove the cap from the same location, eliminating the need for long-distance transfer of the cap, facilitating operation in confined spaces, and benefiting production within isolators.
[0035] In some embodiments of this utility model, the tray 100 has a length of 100mm-200mm, a width of 50mm-150mm, and a height of ≤70mm, which is relatively small in size to adapt to the relatively small production area of radiopharmaceuticals. The tray 100 includes a bottom wall and side walls arranged around the bottom wall to form a receiving cavity 101; a plurality of upwardly extending limiting posts 110 are provided on the bottom wall, and the internal space 102 formed by three or four adjacent limiting posts 110 is used to place vials 200; since some radiopharmaceuticals, especially RDC drugs used for cancer treatment, are usually produced in small batches, the number of internal spaces 102 can be limited to 6-20 to meet the needs of small batches of radiopharmaceuticals.
[0036] like Figure 2 , Figure 3 As shown, in some embodiments of this utility model, a folded edge 120 is provided at the end of the side wall away from the bottom wall. The folded edge 120 extends in a direction parallel to the bottom wall, and the sealing paper 400 is heat-pressed onto the folded edge 120. The folded edge 120 increases the contact area between the tray 100 and the sealing paper 400 during heat-pressing, improves the heat-pressing effect, and thus improves the sealing effect.
[0037] In some embodiments of this utility model, the sidewall includes a first segment 131, a second segment 132, and a third segment 133 connected in sequence. The first segment 131 is connected to the bottom wall to form a first space; the second segment 132 extends horizontally, and the third segment 133 is connected to the outer edge of the second segment 132 to form a second space communicating with the first space. Specifically, the receiving cavity 101 consists of the first space and the second space.
[0038] Furthermore, the formulation packaging component also includes a cap 500, which is laid on top of the bottle cap 300. The cap 500 is located within the second space and between the bottle cap 300 and the sealing paper 400. Due to the arrangement of the first and second spaces, the first segment 131, the second segment 132, and the third segment 133 form a stepped structure. The cap 500, located within the second space, prevents particles that fall off when the sealing paper 400 is torn from entering the first space, thus preventing particles from falling into the vial 200. Furthermore, both the sealing paper 400 and the cap 500 are made of Tyvek paper.
[0039] like Figure 4 As shown, in some embodiments of this utility model, the formulation packaging component further includes a first breathing bag 600, and the tray 100 is sealed inside the first breathing bag 600. The first breathing bag 600, during transportation and storage after the tray 100 is sealed, can prevent contaminants such as insoluble particles and bacterial endotoxins from entering the interior of the first breathing bag 600, thereby ensuring the sterility and stability of the pharmaceutical packaging material and meeting stringent pharmaceutical packaging specifications.
[0040] To further improve the sterility and stability of the pharmaceutical packaging material, the formulation packaging assembly also includes a second breathing bag 700, a tray 100, and a first breathing bag 600 encapsulated within the second breathing bag 700.
[0041] like Figure 5 As shown, in some embodiments of this utility model, the bottle cap 300 includes a rubber stopper 310 and an aluminum cap 320. The rubber stopper 310 includes a first cover plate and a first extension, with the first extension formed on one side of the first cover plate. The aluminum cap 320 includes a second cover plate and a second extension, with the second extension surrounding the second cover plate to form a cylindrical structure. The rubber stopper 310 is located inside the cylindrical structure, and the side of the first cover plate opposite to the first extension abuts against the second cover plate. The first cover plate is a cap portion 301, and the first extension and / or the second extension is an extension portion 302.
[0042] Furthermore, the diameter of the first extension is larger than the diameter of the inner wall at the mouth of the vial 200; a bevel 311 is provided at the end of the first extension away from the first cap. In the formulation packaging assembly, the bevel 311 abuts against the mouth of the vial 200, and the first cap is spaced apart from the vial 200, so that the rubber stopper 310 is in a suspended state, avoiding the rubber stopper 310 being difficult to remove due to interference fit after being inserted into the mouth, thus affecting the filling efficiency of the medicine. In pharmaceutical applications, after the medicine is filled into the vial 200, the first extension of the rubber stopper 310 can be inserted into the mouth, so that the first cap contacts the vial 200, and then the aluminum cap 320 is crimped and locked by a capping machine to complete the sealing of the vial 200.
[0043] In some alternative embodiments of this invention, the bottle cap 300 is an aluminum-plastic cap, which includes a plastic cap plate and an aluminum outer shell connected to the plastic cap plate. The portion of the plastic cap plate and the aluminum outer shell parallel to the plastic cap plate is the cap portion 301, and the flange of the aluminum outer shell is the extension portion 302. In the formulation packaging assembly, the aluminum-plastic cap is placed on the vial 200, and the aluminum outer shell is not crimped. In application, the aluminum-plastic cap is removed, the vial 200 is filled with medicine, the aluminum-plastic cap is then placed on the vial 200, and the aluminum outer shell is crimped and locked by a crimping machine to complete the sealing of the vial 200.
[0044] The above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although this utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this utility model, and should all be included within the protection scope of this utility model.
Claims
1. A formulation packaging component, characterized in that, The device includes a tray (100), a vial (200), a cap (300), and a sealing paper (400). The tray (100) has an upward-opening receiving cavity (101). The vial (200) is placed vertically within the receiving cavity (101). The cap (300) is placed above the neck axis of the vial (200) and in contact with the vial (200). The cap (300) includes a cap portion (301) and an extension portion. An extension (302) is connected to a cap (301) for sealing the bottle opening; the cap (301) is used to stop outside the vial (200); a sealing paper (400) is adhered to the upper surface of the tray (100) to seal the vial (200) and the cap (300) within the tray (100); the height H1 of the receiving cavity (101) satisfies the following formula: 0mm≤H1-H2-H3≤5mm; Wherein, H2 is the height of the vial (200); H3 is the thickness of the cap (301).
2. The formulation packaging assembly according to claim 1, characterized in that, The tray (100) includes a bottom wall and side walls surrounding the bottom wall to enclose and form the receiving cavity (101); a plurality of upwardly extending limiting posts (110) are provided on the bottom wall, and the internal space (102) formed by three or four adjacent limiting posts (110) is used to place the vial (200).
3. The formulation packaging component according to claim 2, characterized in that, The side wall is provided with a folded edge (120) at one end away from the bottom wall. The folded edge (120) extends in a direction parallel to the bottom wall, and the sealing paper (400) is hot-pressed onto the folded edge (120).
4. The formulation packaging component according to claim 2, characterized in that, The length of the tray (100) is 100mm-200mm, the width is 50mm-150mm, and the height is ≤70mm; the number of internal spaces (102) is 6-20.
5. The formulation packaging component according to claim 2, characterized in that, The sidewall includes a first segment (131), a second segment (132), and a third segment (133) connected in sequence. The first segment (131) is connected to the bottom wall to form a first space. The second segment (132) extends horizontally, and the third segment (133) is connected to the outer edge of the second segment (132) to form a second space that communicates with the first space.
6. The formulation packaging assembly according to claim 5, characterized in that, The formulation packaging assembly also includes a cap material (500) laid on the bottle cap (300); the cap material (500) is located in the second space and between the bottle cap (300) and the sealing paper (400).
7. The formulation packaging assembly according to claim 1, characterized in that, The formulation packaging assembly also includes a first breathing bag (600), and the tray (100) is sealed inside the first breathing bag (600).
8. The formulation packaging assembly according to claim 7, characterized in that, The formulation packaging assembly also includes a second breathing bag (700), in which the tray (100) and the first breathing bag (600) are encapsulated.
9. The formulation packaging assembly according to claim 1, characterized in that, The bottle cap (300) includes a rubber stopper (310) and an aluminum cap (320). The rubber stopper (310) is located inside the aluminum cap (320). One end of the rubber stopper (310) used to seal the bottle opening is provided with a bevel (311), and the bevel (311) abuts against the bottle opening of the vial (200).
10. The formulation packaging assembly according to claim 1, characterized in that, The bottle cap (300) is an aluminum-plastic cap, which includes a plastic cover plate and an aluminum outer shell connected to the plastic cover plate. The plastic cover plate is the cap portion (301), and the flange of the aluminum outer shell is the extension portion (302).