Single-use shielded container for a vial containing a dose of radiopharmaceutical

Abstract

A single-use shielded container for a vial containing a dose of radiopharmaceutical, the single-use shielded container (1) having a lower part (2), which is cup-shaped to accommodate the vial (3) and includes a first shielding body (5) in the shape of a cup; an upper part (4), which acts as a lid to close the lower part (2) and comprises a second shielding body (7); a first RFID tag (25) arranged in the lower part (2); and a second RFID tag (26) arranged in the upper part (4). The two RFID tags (25, 26) incorporate two respective identification codes.

Description

[0001] "SINGLE -USE SHIELDED CONTAINER FOR A VIAL CONTAINING A DOSE

[0002] OF RADIOPHARMACEUTICAL"

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS

[0004] This Patent Appl ication claims priority from Italian Patent Application No . 102023000014019 filed on July 5 , 2023 , the entire disclosure of which is incorporated herein by reference .

[0005] TECHNICAL FIELD

[0006] The present invention relates to a single-use or disposable shielded container for a bottle or vial containing a dose of radiopharmaceutical and a corresponding method for packaging a dose of radiopharmaceutical .

[0007] In particular, the present invention finds advantageous but not exclusive application in the packaging of doses of radiopharmaceutical in liquid form, to which the following description will make explicit reference without thereby losing generality .

[0008] BACKGROUND

[0009] To date , doses of a radiopharmaceutical in liquid form produced by pharmaceutical companies or radiopharmacies are distributed inside respective containers , e . g . hermetically sealed bottles , each of which is in turn placed inside a respective shielded container, e . g . of the type comprising one or more shielding bodies made , for example , of lead, to contain the ionising radiation emitted by the radiopharmaceutical . In particular, the shielded container comprises a cup-shaped lower part to accommodate the vial , and an upper part acting as a lid to close the lower part .

[0010] In this case , the shielded container is considered " single-use" or disposable because its reuse is to be avoided during the packaging of the radiopharmaceutical dose . In fact , inexpensive shielded containers are often used in which the shielding bodies , integrated into rigid plastic casings , e . g . ABS , which may deteriorate after a number of cycles of use . For example , the closing system between the top and bottom could become damaged and no longer guarantee the integrity of the shielded container during transport . Reuse of only the lower part or only the upper part , i . e . the lid, is also to be avoided .

[0011] In the state of the art , erroneous reuse can only be discovered by a voluntary check by an operator, and this does not guarantee that reuse can be discovered as often as it actually happens .

[0012] SUMMARY

[0013] The purpose of the present invention is to provide a single-use shielded container for a vial containing a radiopharmaceutical in liquid or solid form or in powder form, which allows it to be reliably detected i f it is to be reused and, at the same time , easy and inexpensive to manufacture .

[0014] In accordance with the present invention, a single-use shielded container for a vial containing a dose of radiopharmaceutical and a method for packaging a dose of radiopharmaceutical as defined in the appended claims are provided .

[0015] The claims describe preferred embodiments of the present invention to be considered an integral part of the present description .

[0016] BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The present invention will now be described with reference to the attached drawings , which show a non-limiting embodiment thereof , wherein :

[0018] Figure 1 illustrates the single-use shielded container of the present invention in an exploded axonometric view along a longitudinal axis of the container; and

[0019] Figure 2 illustrates the single-use shielded container of Figure 1 in a sectional view along a longitudinal plane . DESCRIPTION OF EMBODIMENTS

[0020] In Figures 1 and 2 , 1 generically denotes a single-use shielded container, which comprises a cup-shaped lower part 2 to house a bottle or vial 3 of the known type for a dose of liquid radiopharmaceutical , and an upper part 4 acting as a lid to close the lower part 2 . Speci fically, the upper part 4 is screwed onto the lower part 2 by rotating coaxially with respect to a longitudinal axis la of the single-use shielded container 1 .

[0021] The lower part 2 comprises a first cup-shaped shielding body 5 and a first rigid casing 6 coaxially covering the first shielding body 5 . The upper part 4 comprises a second shielding body 7 and a second rigid casing 8 that coaxially covers the second shielding body 7 . For example , the two shielding bodies 5 and 7 are made of lead and the two rigid casings 6 and 8 are made of plastic .

[0022] The first rigid casing 6 comprises a first cylindrically symmetrical portion 9 , which is shaped to accommodate the first shielding body 5 and has a first open end 10 for receiving the first shielding body 5 during assembly of the single-use shielded container 1 , and a first circular cap 11 for closing the f irst open end 10 . In particular, the first cap 11 is fixed on the first open end 10 , e . g . by ultrasonic resistance welding .

[0023] With particular reference to Figure 2 , the first cylindrically symmetrical portion 9 comprises a central cupshaped portion 12 , which on one side , i . e . a concave side 13 , is adapted to accommodate the vial 3 , and on the other side , i . e . a convex side 14 , is fitted by the first shielding body 5 .

[0024] The second rigid casing 8 comprises a second cylindrically symmetrical portion 15 , which is shaped to accommodate the second shielding body 7 and has a second open end 16 for receiving the second shielding body 7 during assembly of the single-use shielded container 1 , and a second circular cap 17 for closing the second open end 16 . In particular, the second cap 17 is fixed on the second open end 16 , e . g . by ultrasonic resistance welding .

[0025] The first shielding body 5 has , at the opening of its cup-like shape , an end portion 18 having a truncated cone shape which is coupled, within the first rigid casing 6 , with a corresponding end portion 19 having a truncated cone shape of the first cylindrically symmetrical portion 9 . The second cylindrically symmetrical portion 15 has an end portion 20 that has a shape complementary to that of the end portion 19 , and the second shielding body 7 has an end portion 21 that engages the end portion 20 internally with shape coupling . In this way, when the upper portion 4 closes the lower portion 2 , the end portions 19 and 20 are coupled together and the end portion 21 covers the end portion 18 so as to maintain a minimum ef fective shielding thickness in all directions .

[0026] With particular reference to Figure 2 , the second rigid casing 6 , and in particular the second cylindrically symmetrical portion 15 , comprises a central portion 22 transverse to the longitudinal axi s la, the central portion 12 having, at the opening of its own cup shape an edge 23 facing the central portion 22 when the upper portion 4 closes the lower portion 2 , and the single-use shielded container 1 comprises an O-ring 24 arranged on the central portion 22 and adapted to come into contact with the edge 23 so as to hermetically close the vial 3 within the central portion 12 .

[0027] With reference to both Figures 1 and 2 , the single-use shielded container 1 comprises a f irst RFID tag 25 arranged in the lower part 2 and a second RFID tag 26 arranged in the upper part 4 . The two RFID tags 25 and 26 comprise two respective identi fication codes . In particular, the identi fication codes are stored in a known way in the respective digital memories of the RFID tags 25 and 26 .

[0028] The two identi fication 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 identi fication and the single-use shielded container 1 is itsel f uniquely identi fiable .

[0029] Advantageously, the first RFID tag 25 is arranged between the first shielding body 5 and the first rigid casing 6 and the second RFID tag 26 is arranged between the second shielding body 7 and the second rigid casing 8 . In this way, the two RFID tags 25 and 26 are concealed within the lower part 2 and upper part 4 , respectively .

[0030] In particular, the first RFID tag 25 is arranged between the first cap 11 and an outer face 27 of a bottom of the first shielding body 5 and the second RFID tag 26 i s arranged between the second cap 17 and an outer face 28 of a bottom of the second shielding body 7 . In this regard, the RFID tags 25 and 26 are applied to the outer faces 27 and 28 during the assembly of the single-use shielded container 1 , i . e . when shielding bodies 5 and 7 are inserted into the respective rigid casings 6 and 8 .

[0031] According to a further aspect of the invention, a dose of radiopharmaceutical is packaged in accordance with the packaging method described below .

[0032] The dose of radiopharmaceutical is inserted into the vial 3 and the latter is inserted into the single-use shielded container 1 , which includes the two RFID tags 25 and 26 , which in turn comprise two respective identi fication codes . Typically, the vial 3 is inserted into the single-use shielded container 1 in a special insertion station (not shown) of a packaging line (not shown) .

[0033] The insertion station comprises a portal on which an RFID reader is mounted and the packaging line comprises a control unit , which is configured to control the entire packaging line , and in particular the RFID reader, and to communicate with a database , which either forms part of the packaging line or is remotely located and communicates with the control unit via the Internet . Prior to any use or delivery of the single-use shielded container 1 , e . g . immediately before , during, or immediately after its assembly, the two identi fication codes of the two RFID tags 25 and 26 are stored in the database together with two respective usage statuses . In the above-mentioned storage phase , the two usage statuses are set so that they initially indicate that the lower part 2 and upper part 4 are not in use .

[0034] In conj unction with the insertion of the vial 3 into the single-use shielded container 1 , i . e . before the vial 3 is inserted into the single-use shielded container 1 , the RFID tags 25 and 26 are read by an RFID reader to acquire the respective identi fication codes . The control unit queries the database to acquire the usage statuses associated with the two acquired identi fication codes .

[0035] I f the usage statuses acquired indicate that lower part 2 and upper part 4 are not used, then the control unit communicates with the database to change the usage statuses so that they indicate that lower part 2 and upper part 4 are now used . This prevents reuse of the single-use shielded container 1 or at least one of its parts 2 and 4 . In fact , i f the usage statuses acquired indicate that at least the lower 2 or the upper part 4 is used, then the control unit stops the insertion of the vial 3 into the single-use shielded container 1 . Although the above-described invention specifically refers to a very specific embodiment, it is not to be intended as limited to that embodiment, being included in its scope all those variations, modifications or simplifications as covered by the appended claims, such as, for example:

[0036] - the RFID tag 25 is placed between a side wall of the first shielding body 5 and a side surface of the first cylindrically symmetrical portion 9; - the RFID tags 25 and 26 are applied to the outside of the respective rigid casings 6 and 8.

[0037] The main advantage of the single-use shielded container 1 is that it allows easy identification of itself or of each of the two lower and upper parts 2 and 4 and thus avoids reuse thereof.

Claims

CLAIMS1. A single-use shielded container for a vial containing a dose of radiopharmaceutical, the single-use shielded container (1) comprising: a lower part (2) , which is cupshaped to accommodate the vial (3) and includes a first shielding body (5) in the shape of a cup; an upper part (4) , which acts as a lid to close the lower part (2) and comprises a second shielding body (7) ; a first RFID tag (25) arranged in the lower part (2) ; and a second RFID tag (26) arranged in the upper part (4) ; first and second RFID tags (25, 26) comprising two respective identification codes.

2. The single-use shielded container according to claim 1, wherein the two identification codes are uniquely associated with each other.

3. The single-use shielded container according to claim 1 or 2, wherein the lower part (2) comprises a first rigid casing (6) which covers the first shielding body (5) , and the upper part (4) comprises a second rigid casing (8) which covers the second shielding body (7) ; the first RFID tag (25) being arranged between the first shielding body (5) and the first rigid casing (6) and the second RFID tag (26) being arranged between the second shielding body (7) and the second rigid casing (8) .

4. The single-use shielded container according to claim 3, wherein said first rigid casing (6) comprises a firstcylindrically symmetrical portion (9) , which is shaped to accommodate the first shielding body (5) and has a first open end (10) for receiving the first shielding body (5) during assembly of the single-use shielded container (1) , and a first cap (11) for closing the first open end (10) ; the first RFID tag (25) being arranged between the first cap (11) and an outer face (27) of a bottom of the first shielding body (5) .

5. The single-use shielded container according to claim 3 or 4, wherein said second rigid casing (8) comprises a second cylindrically symmetrical portion (15) , which is shaped to accommodate the second shielding body (7) and has a second open end (16) for receiving the second shielding body (7) during assembly of the single-use shielded container (1) , and a second cap (17) for closing the second open end (16) ; the second RFID tag (26) being arranged between the second cap (17) and an outer face (28) of a bottom of the second shielding body (7) .

6. A method for packaging a dose of radiopharmaceutical, comprising :- placing the radiopharmaceutical dose in a vial (3) ; placing the vial (3) in a single-use shielded container ( 1 ) ; the method being characterised in that said single-use shielded container (1) is according to any one of claims 1to 5 and in that it comprises:- storing in a database the two identification codes together with two respective usage statuses and setting the two usage statuses so that they initially indicate that the lower part (2) and the upper part (4) are not used;- in conjunction with inserting the bottle (3) into the single-use shielded container (1) , reading the first RFID tag (25) and the second RFID tag (26) using an RFID reader to acquire their respective identification codes;- querying the database to acquire the usage statuses associated with the two acquired identification codes;- if the usage statuses acquired indicate that lower part (2) and upper part (4) are not used, changing the usage statuses in the database to indicate that lower part (2) and upper part (4) are used;- if the usage statuses acquired indicate that at least the lower (2) or the upper part (4) is used, stopping inserting the vial (3) into the single-use shielded container (1) •

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