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EP-4740222-A1 - SINGLE-USE SHIELDED CONTAINER FOR A VIAL CONTAINING A DOSE OF RADIOPHARMACEUTICAL

EP4740222A1EP 4740222 A1EP4740222 A1EP 4740222A1EP-4740222-A1

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.

Inventors

  • BRUNETTI, ALESSANDRO
  • TESTA, MARCO
  • GALASSI, Filippo

Assignees

  • Comecer S.p.A.

Dates

Publication Date
20260513
Application Date
20240703

Claims (6)

  1. 1. 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. 2. The single-use shielded container according to claim 1, wherein the two identification codes are uniquely associated with each other.
  3. 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. 4. The single-use shielded container according to claim 3, wherein said 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 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. 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. 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 1 to 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) •

Description

"SINGLE -USE SHIELDED CONTAINER FOR A VIAL CONTAINING A DOSE OF RADIOPHARMACEUTICAL" CROSS-REFERENCE TO RELATED APPLICATIONS 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 . TECHNICAL FIELD 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 . 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 . BACKGROUND 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 . 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 . 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 . SUMMARY 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 . 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 . The claims describe preferred embodiments of the present invention to be considered an integral part of the present description . BRIEF DESCRIPTION OF THE DRAWINGS The present invention will now be described with reference to the attached drawings , which show a non-limiting embodiment thereof , wherein : 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 Figure 2 illustrates the single-use shielded container of Figure 1 in a sectional view along a longitudinal plane . DESCRIPTION OF EMBODIMENTS 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 . 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 . 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 . 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 . The second rigid casing 8 comprises a second cylindric