Disposable shielding container for vials containing a dose of radiopharmaceutical
By introducing RFID tags into radiopharmaceutical containers, the problem of difficult detection during repeated use of shielding containers is solved, enabling reliable identification and management and ensuring the stability and safety of shielding effectiveness.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- COMMIC CO LTD
- Filing Date
- 2024-07-03
- Publication Date
- 2026-06-05
AI Technical Summary
In the existing technology, the shielding containers of radiopharmaceuticals are difficult to reliably detect when reused, and this may lead to a decrease in shielding effectiveness, posing a safety hazard.
A disposable shielding container was designed, containing RFID tags at the bottom and top, which are identified and managed through an RFID system to ensure the container's uniqueness and non-reusability.
It enables reliable identification and management of shielding containers, avoids reuse, and ensures the stability and safety of shielding effectiveness.
Smart Images
Figure CN122162199A_ABST
Abstract
Description
Cross-reference to related applications
[0001] This patent application claims priority to Italian Patent Application No. 102023000014019, filed on July 5, 2023, the entire contents of which are incorporated herein by reference. Technical Field
[0002] The present invention relates to a disposable or reusable shielded container for containing a bottle or vial of a dose of radiopharmaceutical, and a corresponding method for packaging a dose of radiopharmaceutical.
[0003] In particular, the invention has an advantageous, but not exclusive, application in the packaging of doses of radiopharmaceuticals in liquid form, which will be explicitly mentioned in the following description without losing its generality.
[0004] background To date, doses of liquid radiopharmaceuticals produced by pharmaceutical companies or radiopharmacists have been dispensed into individual containers, such as sealed vials, each of which is placed within its own shielding container. These shielding containers typically consist of one or more shields made of, for example, lead, to contain and shield the ionizing radiation emitted by the radiopharmaceutical. Specifically, the shielding container includes a cup-shaped lower section to house the vial and an upper section that acts as a lid to seal the lower section.
[0005] In this context, the shielding container is considered "single-use" or disposable after use because its reuse should be avoided during radiopharmaceutical dosage packaging. In fact, inexpensive shielding containers are often used, with the shielding integrated into a rigid plastic shell (such as ABS), which can deteriorate after multiple cycles of use. For example, the sealing system between the top and bottom may fail, thus no longer guaranteeing the integrity of the shielding container during transport. Reusing only the bottom or only the top (i.e., the lid) should also be avoided.
[0006] Under current technological conditions, erroneous reuse can only be detected through voluntary checks by operators, which does not guarantee that reuse will be detected as frequently as it actually occurs.
[0007] Overview The purpose of this invention is to provide a disposable shielding container for vials containing radiopharmaceuticals in liquid, solid, or powder form, which can be reliably tested if reused, while being easy to manufacture and inexpensive.
[0008] According to the present invention, a disposable shielded container for a vial containing a dose of radiopharmaceutical is provided as defined in the appended claims, and a method for packaging a dose of radiopharmaceutical.
[0009] The claims describe preferred embodiments of the invention and should be considered an integral part of this specification. Brief description of the attached diagram The present invention will now be described with reference to the accompanying drawings, which illustrate non-limiting embodiments of the invention, wherein: - Figure 1 An exploded axial view of the disposable shielding container of the present invention is shown along its longitudinal axis. Figure 2 for Figure 1 Disposable shielding container.
[0011] - Figure 2 It shows Figure 1 A cross-sectional view of the disposable shielding container along the longitudinal direction.
[0012] Description of implementation methods exist Figure 1 and Figure 2 In this context, 1 generally represents a disposable shielding container, which includes a cup-shaped lower part 2 for containing a bottle or vial 3 of a known type for a single dose of liquid radiopharmaceutical, and an upper part 4 that acts as a cap to close the lower part 2. Specifically, the upper part 4 is rotated onto the lower part 2 by rotating coaxially about the longitudinal axis 1a of the disposable shielding container 1.
[0013] The lower part 2 includes a first cup-shaped shield 5 and a first rigid outer shell 6 coaxially covering the first shield 5. The upper part 4 includes a second shield 7 and a second rigid outer shell 8 coaxially covering the second shield 7. For example, the two shields 5 and 7 are made of lead, and the two rigid outer shells 6 and 8 are made of plastic.
[0014] The first rigid housing 6 includes a first cylindrical symmetrical portion 9, shaped to accommodate the first shielding body 5, and having a first open end 10 for receiving the first shielding body 5 during the assembly of the disposable shielding container 1; and a first circular cover 11 for closing the first open end 10. Specifically, the first cover 11 is fixed to the first open end 10, for example by ultrasonic resistance welding.
[0015] Special Reference Figure 2 The first cylindrical symmetrical portion 9 includes a central cup-shaped portion 12, one side (i.e., concave surface 13) of which is adapted to accommodate a small bottle 3, and the other side (i.e., convex surface 14) is fitted with a first shield 5.
[0016] The second rigid housing 8 includes a second cylindrical symmetrical portion 15, shaped to accommodate the second shield 7, and has a second open end 16 for receiving the second shield 7 during assembly of the disposable shield container 1, and a second circular cover 17 for closing the second open end 16. Specifically, the second cover 17 is fixed to the second open end 16, for example by ultrasonic resistance welding.
[0017] The first shield 5 has a frustoconical end 18 at its cup-shaped opening, which is coupled within the first rigid housing 6 to a corresponding frustoconical end 19 of the first cylindrical symmetrical portion 9. The second cylindrical symmetrical portion 15 has an end 20 with a shape complementary to that of end 19, and the second shield 7 has an end 21 that is internally engaged with end 20 by shape coupling. Thus, when the upper portion 4 closes the lower portion 2, ends 19 and 20 are coupled together, and end 21 covers end 18, thereby maintaining a minimum effective shielding thickness in all directions.
[0018] Special Reference Figure 2 The second rigid outer shell 6, particularly the second cylindrical symmetrical portion 15, includes a central portion 22 perpendicular to the longitudinal axis 1a. The central portion 12 has an edge 23 at its own cup-shaped opening, which faces the central portion 22 when the upper portion 4 closes the lower portion 2. The disposable shielding container 1 includes an O-ring 24 disposed on the central portion 22 and adapted to contact the edge 23, thereby sealing the vial 3 within the central portion 12.
[0019] refer to Figure 1 and Figure 2 The disposable shielding container 1 includes a first RFID tag 25 disposed in the lower part 2 and a second RFID tag 26 disposed in the upper part 4. These two RFID tags 25 and 26 contain two respective identification codes. Specifically, these identification codes are stored in their respective digital memories in a known manner.
[0020] The two identification codes of the two RFID tags 25 and 26 are uniquely associated with each other. In this way, the lower part 2 and the upper part 4 are "linked" to each other in terms of identification, and the disposable shielding container 1 itself is uniquely identifiable.
[0021] Advantageously, the first RFID tag 25 is disposed between the first shield 5 and the first rigid housing 6, and the second RFID tag 26 is disposed between the second shield 7 and the second rigid housing 8. In this way, the two RFID tags 25 and 26 are respectively hidden inside the lower part 2 and the upper part 4.
[0022] Specifically, a first RFID tag 25 is disposed between the bottom outer surface 27 of the first cover 11 and the first shield 5, and a second RFID tag 26 is disposed between the bottom outer surface 28 of the second cover 17 and the second shield 7. Therefore, during the assembly of the disposable shielding container 1, i.e. when the shields 5 and 7 are inserted into their respective rigid housings 6 and 8, RFID tags 25 and 26 are applied to the outer surfaces 27 and 28.
[0023] According to another aspect of the invention, a dose of radiopharmaceutical is packaged according to the following packaging method.
[0024] The radiopharmaceutical agent is inserted into vial 3, and vial 3 is then injected into disposable shielded container 1, which contains two RFID tags 25 and 26, each containing a unique identification code. Typically, vial 3 is inserted into disposable shielded container 1 at a dedicated insertion station (not shown) on the packaging line (not shown).
[0025] The insertion station includes an entrance on which an RFID reader is installed; the packaging line includes a control unit configured to control the entire packaging line, specifically the RFID reader, and to communicate with a database. This database is either part of the packaging line or located remotely and communicates with the control unit via the internet.
[0026] Before the disposable shielded container 1 is used or delivered, such as immediately before, during, or immediately after its assembly, the two identification codes of the two RFID tags 25 and 26, along with their respective usage states, are stored in the database. During this storage phase, two usage states are set so that they initially indicate that the lower part 2 and the upper part 4 are not in use.
[0027] Simultaneously with inserting vial 3 into disposable shielded container 1, but before insertion, the RFID reader reads RFID tags 25 and 26 to obtain their respective identification codes. The control unit queries the database to retrieve the usage status associated with these two acquired identification codes.
[0028] If the acquired usage status indicates that lower part 2 and upper part 4 are not used, the control unit communicates with the database to change the usage status so that it indicates that lower part 2 and upper part 4 are in use. This prevents the reuse of the disposable shielding container 1 or any of its parts 2 and 4. In fact, if the acquired usage status indicates that at least lower part 2 or upper part 4 is in use, the control unit will stop inserting vial 3 into the disposable shielding container 1.
[0029] While the above invention refers specifically to a very particular embodiment, it is not intended to limit it to that embodiment. Its scope includes all variations, modifications, or simplifications covered by the appended claims, such as, for example: - The RFID tag 25 is placed between the side wall of the first shield 5 and the side of the first cylindrical symmetrical part 9; - RFID tags 25 and 26 are applied to the outside of their respective rigid housings 6 and 8.
[0030] The main advantage of the disposable shielding container 1 is that it can easily identify itself or the two parts 2 and 4 above and below, thus avoiding its reuse.
Claims
1. A disposable shielding container for a vial containing a dose of radiopharmaceutical, said disposable shielding container (1) comprising: The lower part (2) is cup-shaped to accommodate the vial (3) and includes a cup-shaped first shield (5); the upper part (4) acts as a lid to close the lower part (2) and includes a second shield (7); a first RFID tag (25) disposed in the lower part (2); and a second RFID tag (26) disposed in the upper part (4); the first RFID tag (25) and the second RFID tag (26) include two respective identification codes.
2. The disposable shielding container according to claim 1, wherein the two identification codes are uniquely associated with each other.
3. The disposable shielding container according to claim 1 or 2, wherein the lower part (2) includes a first rigid shell (6) covering the first shield (5), and the upper part (4) includes a second rigid shell (8) covering the second shield (7); the first RFID tag (25) is disposed between the first shield (5) and the first rigid shell (6), and the second RFID tag (26) is disposed between the second shield (7) and the second rigid shell (8).
4. The disposable shielding container according to claim 3, wherein the first rigid shell (6) includes a first cylindrical symmetrical portion (9) having a shape adapted to accommodate the first shielding body (5) and having a first open end (10) for receiving the first shielding body (5) during the assembly of the disposable shielding container (1), and a first cover (11) for closing the first open end (10); the first RFID tag (25) is disposed between the first cover (11) and the outer surface (27) of the bottom of the first shielding body (5).
5. The disposable shielding container according to claim 3 or 4, wherein the second rigid shell (8) includes a second cylindrical symmetrical portion (15) adapted to accommodate the second shield (7) and has a second open end (16) for receiving the second shield (7) during assembly of the disposable shielding container (1), and a second cover (17) for closing the second open end (16); the second RFID tag (26) is disposed between the second cover (17) and the outer surface (28) of the bottom of the second shield (7).
6. A method for packaging a dose of radiopharmaceutical, comprising: - Place the dose of the radiopharmaceutical into a vial (3); - Place the vial (3) into a disposable shielded container (1); The method is characterized in that the disposable shielding container (1) is according to any one of claims 1 to 5, and comprises: - Store the two identification codes and their respective usage states in the database, and set the two usage states so that they initially indicate that the lower part (2) and the upper part (4) are not in use; - Insert the bottle (3) into the disposable shielded container (1) and simultaneously use an RFID reader to read the first RFID tag (25) and the second RFID tag (26) to obtain their respective identification codes; - Query the database to obtain the usage status related to the two acquired identification codes; -If the obtained usage status indicates that the lower part (2) and the upper part (4) are not used, then change the usage status in the database to indicate that the lower part (2) and the upper part (4) have been used; If the acquired usage status indicates that at least the lower part (2) or the upper part (4) has been used, then stop inserting the vial (3) into the disposable shielding container (1).