DISPENSING KIT COOPERATING WITH A DISPENSING DEVICE FOR A SYSTEM FOR THE PRODUCTION OF A MULTIPLE BATCHES OF RADIOPHARMACEUTICAL

Description

The present invention relates to a dispensing kit for a dispensing device for dispensing a radiopharmaceutical into at least one container, to a dispensing device cooperating with one or more dispensing kits, and to a radiopharmaceutical production system comprising the dispensing device and a plurality of dispensing kits for sequentially producing a plurality of batches of radiopharmaceutical. In particular, the present invention finds advantageous, but not exclusive, application in a production line of liquid radiopharmaceuticals, for example a so-called radiopharmacy, to which the following description will make explicit reference without thereby losing its generality. Context A batch of a radiopharmaceutical is a set of containers, typically vials, bottles, or syringes, filled with the same radiopharmaceutical with a specific production history. This means that, in general, some production batches, even if they are of the same radiopharmaceutical, may differ even if only due to different production periods or circumstances. The typical approach known for producing a batch of a liquid radiopharmaceutical involves the following steps: bringing all sterile, still-packaged materials required for the production of a batch to a work area, typically the work chamber of a pharmaceutical isolator. These materials include the vials to be filled with the respective doses of radiopharmaceutical and at least one disposable dispensing kit. Decontaminating the work area to ensure the radiopharmaceutical's sterile conditions are maintained during dispensing. Removing the materials from the bags and arranging them in the work area. Filling the vials with the radiopharmaceutical and removing them from the work area. Cleaning the work area, removing all materials used to produce the batch, is then possible. At this point, production of a new batch can begin by repeating all the steps described above. Cleaning the work area is necessary to prevent cross-contamination between different batches. The disposable dispensing kit used for a given production batch cannot remain in the work area with the disposable dispensing kit to be used for the next production batch. In fact, the known disposable dispensing kit is an open system, meaning it has surfaces that come into contact with the radiopharmaceutical and are also exposed to the external environment. Therefore, at the end of the production of a radiopharmaceutical batch, the exposed surfaces contain traces of that radiopharmaceutical batch and could release particles or residues into the environment that could potentially contaminate the next batch of radiopharmaceutical. In this regard, the most exposed and contaminating part of the disposable dispensing kit is the needle used to dispense the radiopharmaceutical into the vials. The approach described above involves a waiting time between the production of one batch and the next, which limits daily production capacity. This approach is increasingly incompatible with the growing market demand for radiopharmaceuticals, which requires the production of multiple batches per day. Summary The aim of the present invention is to create a disposable dispensing kit to be used inside a pharmaceutical isolator during the production of a batch of radiopharmaceutical, which is free from the drawbacks described above and, at the same time, is easy to use and easy and economical to produce. In accordance with the present invention, there is provided a dispensing kit for a dispensing device for dispensing a radiopharmaceutical into at least one container, a dispensing device for dispensing a radiopharmaceutical into at least one container, and a radiopharmaceutical manufacturing system for producing a plurality of batches of radiopharmaceutical, as defined in the appended independent claims. Further advantageous features of the present invention are set forth in the dependent claims. The claims describe preferred embodiments of the present invention to be considered an integral part of this specification. Brief description of the drawings The present invention will now be described with reference to the attached drawings, which illustrate a non-limiting embodiment thereof, in which: - Figure 1 illustrates a radiopharmaceutical production system made according to the present invention; - Figure 2 illustrates a dispensing kit set up in the radiopharmaceutical production system of Figure 1 and made according to the present invention; - Figure 3 illustrates an internal part of a cassette of the dispensing kit of Figure 2; and - Figure 4 illustrates a control module of a dispensing device of the radiopharmaceutical production system of Figure 1; and Figures 5 to 17 illustrate a portion of the dispensing device of the radiopharmaceutical production system of Figure 1 during successive phases of operation. Description of embodiments In figure 1, the number 1 generically indicates, as a whole and with some parts not illustrated for the sake of simplicity, a radiopharmaceutical production system, of the type that can be integrated into a larger radiopharmaceutical production line (not illustrated), to produce a plurality of batches of radiopharmaceutical. The radiopharmaceutical production system 1 comprises an isolator, for example a pharmaceutical isolator, of which essentially the interior of a related working chamber 2 is illustrated. The isolator is of the type shielded against ionizing radiation. The radiopharmaceutical production system 1 comprises a support 3, for example of the stair-type, which can be positioned in the working chamber 2 to arrange in an orderly fashion a plurality of empty containers 4, a dispensing device 5 arranged in the working chamber 2, and a plurality of dispensing kits 6, each of which is associated with a respective batch of radiopharmaceutical and is set up in the working chamber 2 so as to cooperate with the dispensing device 5 to produce the batch of radiopharmaceutical as a set of doses of radiopharmaceutical contained in respective containers 4. In the example illustrated in the figures, each container 4 consists of a bottle of the type comprising a rubber stopper and a metal cap. According to alternative embodiments not illustrated, each container 4 consists of a vial, a bottle, or a syringe. Each dispensing kit 6 comprises a cassette(s) 7, a reservoir 8 for a bulk liquid radiopharmaceutical, and a needle assembly 9 comprising a needle (not visible in Figure 1) for introducing a dose of radiopharmaceutical into a container 4 when the latter is appropriately positioned in the dispensing device 5. The dispensing device 5 comprises a frame 10 resting on a floor 11 of the working chamber 2, a plurality of control modules 12 integral with the frame 10 and comprising respective peristaltic pumps 13. The number of dispensing kits 6 set up is equal to the number of control modules 12. The cassette 7 of the respective dispensing kit 6 is releasably mounted on each control module 12. The dispensing device 5 comprises a support body 14 configured to receive and support the needle unit 9 and a movement device 15 for moving the container 4 between an insertion position, in which it is possible to insert or remove one of the containers 4 into or from the dispensing device 5, and a filling position, in which the needle of the needle unit 9 allows the container 4 to be filled, as will be explained in more detail below. Figure 1 illustrates a container 4 in the insertion position. The radiopharmaceutical production system 1 comprises a support 16 arranged in the working chamber 2, in particular mounted on the floor 11, to receive and support the tanks 8. In particular, the support 16 comprises a plurality of seats 17, each of which is adapted to receive a respective tank 8. The support 16 is adapted to rotate around an axis (not shown) perpendicular to the floor 11 and the seats 17 are arranged around this axis. The radiopharmaceutical production system 1 comprises a further support 18 arranged in the working chamber 2, in particular mounted on the floor 11, to receive and support the needle assemblies 9. In particular, the support 18 comprises a plurality of seats 19, each of which is adapted to receive a respective needle assembly 9. The support 18 is adapted to rotate around a further axis (not illustrated) perpendicular to the floor 11 and the seats 19 are arranged around this further axis. The radiopharmaceutical production system 1 includes a further support 20 for holding a plurality of bags 21 containing a diluent solution. Each bag 21 can be connected to a respective dispensing kit 6 for the purpose of diluting the radiopharmaceutical in the corresponding reservoir 8 and / or washing the dispensing kit 6. The radiopharmaceutical production system 1 comprises an active substance meter 22 having a measuring chamber 23 accessible from the working chamber 2 and adapted to contain the reservoir 8 of a dispensing kit 6. The radiopharmaceutical production system 1 also comprises a load cell 24 connected to the measuring chamber 23 for measuring the weight of the contents of the reservoir 8 when the latter is housed in the measuring chamber 23. The radiopharmaceutical production system 1 comprises an exit door 25 for transferring the container 4 with a dose of radiopharmaceutical out of the working chamber 2. In particular, the exit door 25 is formed in the floor 11. The exit door 25 is provided with a lid 26 capable of translating perpendicularly to the floor 11 to close and open the exit door 25. Figure 1 illustrates the lid 26 raised and a container 4 inserted into the exit door 25. Advantageously, the exit door 25 is provided with an actuator (not shown) for raising and lowering the lid 26. The radiopharmaceutical production system 1 comprises a handling system 27 for transferring the reservoir 8 of a certain dispensing kit 6 between the holder 16 and the measuring chamber 23, for transferring the needle assembly 9 of the dispensing kit 6 between the holder 18 and the dispensing device 5, for transferring an empty container 4 from the holder 3 to the dispensing device 5, and for transferring a container 4 with the radiopharmaceutical dose from the dispensing device 5 to the outlet port 25. The handling system 27 comprises at least one tele-gripper, preferably manually controllable from outside the working chamber 2. In the example illustrated in figure 1, the handling system 27 comprises at least two tele-grippers preferably mounted on a front door of the isolator (not shown), in particular a first tele-gripper 28 for transferring the reservoir 8 of a certain dispensing kit 6 between the support 16 and the measuring chamber 23 and for transferring the needle assembly 9 of the dispensing kit 6 between the support 18 and the dispensing device 5, and a second tele-gripper 29 for transferring an empty container 4 from the support 3 to the dispensing device 5 and for transferring the container 4 with the dose of radiopharmaceutical from the dispensing device 5 to the outlet port 25.The transfer to and from the dispensing device 5 occurs by bringing and, respectively, removing the container 4 to and, respectively, from the insertion position described above. Each dispensing kit 6 includes a plurality of conduits for connecting the reservoir 8 and the needle assembly 9 to each other and to various parts of the radiopharmaceutical manufacturing system 1, as will be explained in detail below. Figure 2 illustrates a dispensing kit 6 with the cassette 7 seen from a front side 30 and Figure 3 illustrates the cassette 7 seen from a rear side 31 which is opened to be mounted on a control module 12 of the dispensing device 5. With reference to Figures 2 and 3, the cassette 7 of the dispensing kit 6 comprises a hydraulic control circuit 32 (Figure 3) and the needle assembly 9 of the dispensing kit 6 comprises a needle 33, which communicates with the hydraulic control circuit 32 and can be inserted into the container 4, a needle holder 34 and a cap 35 that can be coupled with the needle holder 34 coaxially to a longitudinal axis 35a of the cap 35 to separate the needle 33 from the external environment when the needle 33 is not being used for dispensing. For example, when the needle assemblies 9 are stored in the holder 18, as illustrated in Figure 1, they must have their respective caps 35 coupled with the related needle holder elements 34. Figure 2, however, illustrates the cap 35 decoupled from the needle holder 34. The needle holder 34 is provided with a sealing element, for example O-ring 37, to create a hermetic seal with the cap 35. In particular, the needle holder 34 comprises a neck 36 from which the needle 33 extends, the O-ring 37 is fitted onto the neck 36 and the cap 35 is suitable to be fitted onto the neck 36 in correspondence with the O-ring 37. The cap 35 comprises a laterally protruding edge 38 to facilitate the grip of the cap 35 when it is desired to detach it from the needle holder 34. The plurality of ducts of the dispensing kit 6 comprises a duct 39 communicating with the bottom of the cap 35 and acting as a drain during washing of the dispensing kit 6 from radiopharmaceutical residues when the cap 35 is coupled to the needle holder element 34. In use, the washing of the dispensing kit 6 occurs at the end of the production of a batch of radiopharmaceutical, with the needle assembly 9 still on the support body 14 of the dispensing device 5. For this purpose, the duct 39 of the cap 35 of each dispensing kit 7 ends with a connector 40, which can be connected to the respective exhaust duct of a plurality of exhausts 41 (figure 1) of the radiopharmaceutical production system 1 accessible from the working chamber 2. The needle assembly 9 includes a second needle 42 communicating with the external environment via a ventilation hole 43, which is formed on the needle holder element 34 and is equipped with a filter. The second needle 42, which is shorter than the other needle 33, allows air to escape from the container 4 when it is filled with the radiopharmaceutical dose through needle 33. Still referring to figure 2, the dispensing kit 7 comprises a conduit 44 to connect the needle 33 with the hydraulic control circuit 32 and the needle group 9 comprising a sterilizing filter 45 arranged between the conduit 44 and the needle 33. The plurality of conduits of the dispensing kit 6 comprises a conduit 46 for filling the reservoir 8 with the radiopharmaceutical and two other conduits 47 and 48 for communicating the reservoir 8 with the hydraulic control circuit 32 in both delivery and return directions. Conduits 46, 47 and 48 extend inside the reservoir 8 through a lid 49 of the reservoir 8. The lid 49 has a ventilation hole 50 equipped with a filter. Conduit 46 ends with a connector 51 that can be connected to a respective delivery connector of a plurality of delivery connectors 52 (Figure 1) of the radiopharmaceutical production system 1 accessible from the working chamber 2 for the supply of the undiluted radiopharmaceutical. The plurality of conduits of the dispensing kit 6 comprises a conduit 53 for communicating the hydraulic control circuit 32 with a bag 21 of diluent solution for the purpose of diluting the radiopharmaceutical in the reservoir 8 and / or washing the dispensing kit 6. The plurality of conduits of the dispensing kit 6 includes a conduit 54 for communicating the hydraulic control circuit 32 with a source of technical gas (not shown) for the purpose of mixing the diluted radiopharmaceutical in the reservoir 8 or of removing radiopharmaceutical residues from the conduits during a wash of the dispensing kit 6. The plurality of ducts of the dispensing kit 6 comprises a duct 55 closed on the hydraulic control circuit 32 and coupleable to a peristaltic pump dispensing device 5, and in particular to the peristaltic pump 13 of the control module 12 on which the cassette 7 of the dispensing kit 6 is mounted. With reference to figure 3, the hydraulic control circuit 32 comprises a plurality of three-way valves 56, which communicate with each other and have respective control interfaces 57 facing the rear side 31 of the box 7. In particular, each control interface 57 is constituted by a T-shaped control element suitable for moving the internal shutter (not shown) of the respective three-way valve 56. With reference to Figures 1 to 3 and Figure 4, the latter illustrating the uppermost control module 12 of the dispensing device 5 free from the respective cassette 7, the front side 30 of each cassette 7 comprises a slot 58 engageable by a lever wrench 59 mounted on a front wall 60 of the control module 12 so as to rotate between a release position, in which the lever wrench 59 is aligned with the slot 58 to allow assembly and disassembly of the cassette 7 from the control module 12, such as the uppermost control module 12 illustrated in Figure 1, and a locking position, in which the lever wrench 59 is transverse to the slot 58 to lock the cassette 7 onto the control module 12, such as the three lowermost control modules 12 of Figure 1. With reference to figures 3 and 4, each control module 12 comprises a plurality of rotary actuators 61 comprising respective control elements 62, each of which can be coupled with a respective control interface 57 of the box 7. In particular, each control element 62 is constituted by a pin suitably shaped to couple with the T-shape of the respective control interface 57. With reference to figures 5 to 17, which illustrate the lower part of the dispensing device 5 comprising the support body 14 and the handling device during successive operating phases of the dispensing device 5 which concern the handling and manipulation of the container 4 before and after a dispensing phase of the radiopharmaceutical dose, the support body 14 has a seat 63 to receive the cap 35. In particular, the seat 63 extends along a substantially vertical axis 63a and is suitable for receiving the cap 35 coaxially, i.e. in the direction of the axis 63a. In this way, the entire needle assembly 9 can be positioned on the support body 14 by engaging the cap 35 in the seat 63.The dispensing device 5 also comprises a retaining element 64 mounted movably on the support body 14 to retain the cap 35 in the seat 63 and a clamp 65 capable of closing around the needle holder element 34 when the cap 35 is in the seat 63 (figure 7). In particular, the retaining element 64 is movable between a release position, in which it frees the cap 35 (figures 5 and 6), and a retaining position, in which it is positioned above the edge 38 of the cap 35 to retain the latter in the seat 63 (figures 7 to 17). In the example illustrated, the retaining element 64 has a first end hinged on the support body 14 to rotate around an axis parallel to the axis 63a of the seat 63 between the release position and the retaining position and a second end 66 in the shape of a hook suitable for positioning itself around the needle holder element 34, and in particular around the neck 36, and overlapping the entire edge 38 (figures 7 and 8). The dispensing device 5 comprises two actuators (not shown) to cause the rotation of the retaining element 64 and, respectively, the closing / opening of the gripper 65. When the clamp 65 is open and the retaining element 64 is in the release position (figure 5), the needle assembly 9 can be positioned on the support body 14. The dispensing device 5 comprises a movement device 67 for mutually translating the support body 34 and the gripper 65 parallel to the axis 63a when the gripper 65 is closed on the needle holder element 34 and the retaining element 64 holds the cap 35 in the seat 63 so as to remove the cap 35 from the needle holder element 34. In particular, the gripper 65 is mounted on the frame 10 and the movement device 67 is adapted to translate the support body 14 with respect to the frame 10, and therefore with respect to the gripper 65, downwards in the direction of the axis 63a (figure 8). The dispensing device 5 comprises a further actuator 68 for moving the gripper 65, when closed, between a cap removal position, in which the jaws of the gripper 65 are located above the seat 63 (figure 8), and a dispensing position, in which the jaws of the gripper are located further away from the seat 63 (figure 9). In particular, the gripper 65 is mounted on the frame 10 to rotate, under the action of the actuator 68, around an axis 65a parallel to the axis 63a. The handling device 15 comprises a support body 69 and a conveyor 70 mounted on the support body 69 to define a path for the container 4 that extends between the insertion position, where the container 4 can be inserted into or removed from the dispensing device 5 (Figure 9), and the filling position, where the needle 33 enters the container 4 when the gripper 65 is in the dispensing position (Figures 14 and 15). The conveyor 70 comprises a sliding surface 71 for the container 4, a curved lateral side 72 to define a U-shaped conveying path, and a rotating arm 73, which is hinged on the support body 69 and has a U-shaped free end 74 to embrace and accompany the container along the side 72, and therefore along the conveying path. The conveyor 70 comprises an actuator 75 to cause the rotation of the rotating arm 73. At the filling position, the side 72 comprises a U-shaped end portion 76 to embrace the neck of the container 4 (figure 14). The dispensing device 5 includes a ring removal / application device 77 and a cap removal / application device 78 disposed along the conveyor 70 at a first removal / application position (Figure 10) and, respectively, a second removal / application position (Figure 12) of the conveyor path. The dispensing device 5 further comprises a crimping device 79 arranged along the conveyor 70 at a crimping position of the conveyor path (Figure 16), between the first removal / application position and the insertion position. The conveyor 70 is designed to move and stop the container 4 in the aforementioned first and second removal / application positions and in the crimping position. The handling device 15 comprises an actuator 80 for lifting the support body 69, and therefore the conveyor 70, when the container 4 is stopped in the first removal / application position or in the second removal / application position or in the filling position or in the crimping position to allow respectively: - to the ring nut removal / application device 77 to remove / apply the ring nut 4a from / to the container 4 (figure 11); or - the cap removal / application device 78 to remove / apply the cap 4b from / to the container 4 (figure 13); or - for needle 33 to enter container 4 when clamp 65 is in the dispensing position (figure 15); or - the crimping device 79 closes the ring 4a on the container 4 containing the dose of radiopharmaceutical. The devices 77, 78, and 79 described above operate in a substantially known manner. In particular, when the ring nut remover / applicator 77 removes the ring nut 4a, it retains it for subsequent reapplication to the same container 4, and similarly, when the cap remover / applicator 78 removes the cap 4b, it retains it for subsequent reapplication to the same container 4. Finally, the radiopharmaceutical production system 1 includes a control unit (not shown) with a human-machine interface. The control unit is designed to control the actuators described above, and in particular the actuators of the dispensing device 5, based on commands that an operator gives via the human-machine interface for the purpose of producing a plurality of batches of radiopharmaceutical, according to the following procedure. The operator manually sets up the four dispensing kits 6 with the empty tanks 8 in the working chamber 2 and places a plurality of empty containers 4 equipped with their respective rings 4a and their respective caps 4b on the support 3, as illustrated in figure 1. At the end of the aforementioned set-up, the working chamber 2 is closed and the laminar flow is activated to maintain class A working conditions. The operator, using the tele-gripper 28, takes a tank 8 of a certain dispensing kit 6 from the holder 16 and inserts it into the measuring chamber 23. He then activates the radiopharmaceutical supply to introduce a certain amount of radiopharmaceutical into the tank 8, through the conduit 46. The activity and weight of the radiopharmaceutical in the tank 8 are measured and controlled via the active substance meter 22 and the load cell 24. In the event that it is necessary to dilute the radiopharmaceutical according to a certain medical prescription, the operator commands the control unit so that the control module 12, and therefore the related peristaltic pump 13, associated with the dispensing kit 6 in use, controls the cassette 7 to transfer a quantity of diluent solution from the related bag 21 to the tank 8, transfer which occurs through the duct 53 and the ducts 47 and 48. To mix the diluted radiopharmaceutical, the operator commands the control unit so that the control module 12 introduces the technical gas into the tank 8, such introduction occurring through the duct 51 and the ducts 47 and 48. The quantity of radiopharmaceutical or diluted radiopharmaceutical in tank 8 is the amount needed to produce one batch of radiopharmaceutical. At this point, it is possible to begin dispensing the radiopharmaceutical into one container 4 at a time, for as many containers as necessary to produce the batch of radiopharmaceutical. The operator commands the control unit so that the dispensing device 5 moves the retaining element 64 to the release position and opens the clamp 65, and via the tele-clamp 28 takes the needle group 9 of the dispensing kit 6 in use from the holder 18 and brings it to the support body 14 inserting the cap 35 into the seat 63 (figure 5). Then the operator commands the control unit so that the dispensing device 5 performs the following steps in sequence: close the clamp 65 (figure 6), move the retaining element 64 to the retained position (figure 7), lower the support body 14 to remove the cap 35 from the needle holder element 34 (figure 8) and move the closed clamp 65 to the dispensing position (figure 9). The operator, using the tele-gripper 29, picks up an empty container 4 from the support 3 and places it in the insertion position, between the free end 74 and the side 72 of the conveyor 70 (figure 9), and then commands the control unit so that the dispensing device 5 automatically carries out a single dispensing cycle, i.e. on the container 4, described below. The handling device 15 moves and stops the empty container 4 sequentially in the first removal / application position (Figures 10 and 11), where the ring remover / applicator 77 removes the ring 4a, in the second removal / application position (Figures 12 and 13), where the cap remover / applicator 78 removes the cap 4b, and finally in the filling position (Figures 14 and 15). At this point, the control module 12, and therefore the related peristaltic pump 13, associated with the dispensing kit 6 in use, controls the cassette 7 to transfer a dose of radiopharmaceutical from the tank 8 to the container 4, this transfer taking place through the conduit 44 and the conduit 47. The actual transfer of the dose of radiopharmaceutical is verified in a known manner via the peristaltic pump 13 and / or the active substance meter 22. Once container 4 has been filled with the radiopharmaceutical dose, handling device 15 reverses some of the steps described above to replace cap 4b on container 4, using cap remover / applicator 78 (Figures 13 and 12), and reattach ring 4a to container 4, using ring remover / applicator 77 (Figures 11 and 10). However, before moving container 4 with the radiopharmaceutical dose to the insertion position, handling device 15 stops container 4 in the crimping position where crimping device 79 closes ring 4a on container 4 (Figures 16 and 17). The handling device 15 closes the single dispensing cycle by returning the closed container 4 with the dose of radiopharmaceutical to the insertion position (figure 9). The operator commands the control unit to open the lid 26 of the exit door 25 (figure 1) and via the tele-gripper 29 picks up the full container 4 from the dispensing device 5 and transfers it to the exit door 25. The operator repeats the single dispensing cycle, each time taking an empty container 4 from the support 3 using the tele-gripper 29, leaving the gripper 65 with the needle 33 in the dispensing position, until the entire batch of radiopharmaceutical has been produced. Once the production of the radiopharmaceutical batch is completed, the operator commands the control unit so that the dispensing device 5 returns the closed gripper 65 to the cap removal position (figure 8), lifts the support body 14 to replace the cap 35 on the needle holder element 34 (figure 7) and, by appropriately controlling the control module 12 associated with the dispensing kit 6 in use, carries out a washing cycle of the dispensing kit 6 itself using the diluent solution of the relevant bag 21. The washing cycle allows the removal of radiopharmaceutical residues from the dispensing kit 6 and their discharge, through the duct 39 of the cap 35 and the relevant discharge duct 41 (figure 1), into a special container outside the pharmaceutical isolator. Once the washing cycle is complete, the operator commands the control unit so that the dispensing device 5 moves the retaining element 64 to the release position (figure 6) and opens the gripper 65 (figure 5). Then, using the tele-gripper 28, the operator takes the needle group 9 of the dispensing kit 6 that has just been washed from the support body 14 and places it back in its respective seat in the support 18 and takes the reservoir 8 from the measuring chamber 23 and places it back in its respective seat in the support 16. At this point, without having to open work chamber 2 to remove the recently used and washed dispensing kit 6, the operator can repeat the procedure described above by selecting another dispensing kit 6 to produce a subsequent batch of radiopharmaceutical. Therefore, the recently used dispensing kit 6 is left in work chamber 2 as initially set up and will be collected and disposed of only along with the other dispensing kits 6 at the end of the production of all batches of radiopharmaceutical. Although the invention described above refers specifically to a very specific embodiment, it is not to be considered limited to such embodiment, as its scope includes all those variations, modifications or simplifications covered by the attached claims, such as, for example: - the manipulation system 27 comprises a single tele-gripper; - instead of tele-grippers, a fully automatic handling system; and - the dispensing device 5 comprises a single control module 12 and the radiopharmaceutical production system 1 comprises an additional support for holding the cassettes 7 of the dispensing kits 6, so that each time the dispensing kit 6 in use is changed, the operator must mount the cassette 7 on the control module 12 with the help of the tele-pliers 28 and 29. The main advantage of the dispensing kit 6, the dispensing device 5 and the radiopharmaceutical production system 1 described above is that they allow the production of a plurality of batches of radiopharmaceutical while avoiding cross-contamination between different batches without the need to clean the working chamber 2 from residual contaminants, i.e. radiopharmaceutical residues, between successive batches, thanks to the cap 35 protecting the needle 33 used for dispensing and the mechanisms of the dispensing device 5 for removing and replacing the cap 35 when the needle 33 is not used for dispensing, which allow for a reduction in exposure to the environment of the surfaces in contact with the radiopharmaceutical. Furthermore, the duct 39 of the hood 35 and the exhaust ducts 41 which open into the working chamber 2 and which can be connected to the ducts 39 of the dispensing kits 6 set up in the working chamber 2, allow the elimination of residues of contaminating substances inside the dispensing kits 6, and therefore further reduce the risk of cross-contamination in the working chamber 2 and allow the collection of residues of contaminating substances in special external disposal containers. As a result, since it is not necessary to open and clean working chamber 2 after each batch of radiopharmaceutical, daily production capacity will be increased.

Claims

1. Dispensing kit for a dispensing device for dispensing a radiopharmaceutical into at least one container, in particular vials, bottles, flasks or syringes, the dispensing kit (6) comprising: a cassette (7), which encloses a hydraulic control circuit (32) and is mountable on the dispensing device (5); a reservoir (8) for the bulk radiopharmaceutical communicating with the hydraulic control circuit (32); a needle assembly (9), which comprises a needle (33) communicating with the hydraulic control circuit (32) and which can be inserted into the container (4) to introduce a dose of radiopharmaceutical, a needle holder element (34) and a cap (35) which can be coupled with the needle holder element (34), preferably by interposing a sealing element (36), to separate the needle (33) from the external environment when the needle (33) is not used for dispensing;and a plurality of ducts comprising a first duct (39) communicating with the bottom of the cap (35) and acting as a drain to wash the dispensing kit (6) from radiopharmaceutical residues when the cap (35) is coupled to the needle holder element (34).; 2. Dispensing kit according to claim 1, wherein the plurality of conduits comprises a second conduit (46) for filling the reservoir (8) with the radiopharmaceutical and a third conduit (47) and a fourth conduit (48) for communicating the reservoir (8) with the hydraulic control circuit (32).

3. Dispensing kit according to claim 1 or 2, wherein the plurality of conduits comprises a fifth conduit (53) for communicating the hydraulic control circuit (32) with a bag (21) of diluent solution for the purpose of diluting the radiopharmaceutical in the reservoir (8) and / or washing the dispensing kit (6).

4. A dispensing kit according to any one of claims 1 to 3, wherein the plurality of conduits comprises a sixth conduit (54) for communicating the hydraulic control circuit (32) with a source of technical gas for the purpose of mixing radiopharmaceutical in the reservoir (8) or removing radiopharmaceutical residues from the conduits during a wash of the dispensing kit (6).

5. Dispensing kit according to any of claims 1 to 4, wherein the plurality of conduits comprises a seventh conduit (44) for communicating the needle (33) with the hydraulic control circuit (32); the needle assembly (9) comprising a sterilizing filter (45) arranged between the seventh conduit (44) and the needle (33).

6. Dispensing kit according to any of claims 1 to 5, wherein the plurality of conduits comprises an eighth conduit (55) closed on the hydraulic control circuit (32) and coupleable with a peristaltic pump (33) of the dispensing device (5).

7. Dispensing kit according to any of claims 1 to 6, wherein the hydraulic control circuit (32) comprises a plurality of three-way valves (56), which communicate with each other and have respective control interfaces (57) facing an open side (31) of the cassette (7); the cassette (7) being mountable on the dispensing device (5) from said open side (31).

8. Dispensing device for dispensing a radiopharmaceutical into at least one container, in particular a vial, bottle, flask or syringe, cooperating with at least one dispensing kit (6) according to any of claims 1 to 7, the dispensing device (5) comprising: a frame (10); at least one control module (12), which is integral with the frame (10) and on which the cassette (7) can be releasably mounted; a support body (14) having a seat (63) for receiving said cap (35); a retaining element (64) movably mounted on the support body (14) for retaining the cap (35) in the seat (63); a clamp (65) capable of closing around said needle holder element (34) when the cap (35) is in the seat (63);a first movement device (67) for mutually translating the support body (14) and the clamp (65) when the clamp (65) is closed on the needle holder element (34) and the holding element (64) holds the cap (35), so as to remove the cap (35) from the needle holder element (34); an actuator (68) for moving the clamp (65) between a cap removal position and a dispensing position; and a second movement device (15) for moving the container (4) between an insertion position, in which it is possible to insert or remove the container (4) into or from the dispensing device (5), and a filling position, in which the needle (33) enters the container (4) when the clamp (65) is in the dispensing position.; 9. Dispensing device according to claim 8, wherein the dispensing kit (6) is according to claim 6 and said control module (12) comprises a peristaltic pump (13).

10. Dispensing device according to claim 8 or 9, wherein the dispensing kit (6) is according to claim 7 and said control module (12) comprises a plurality of actuators (61) comprising respective control elements (62) coupling with respective of said control interfaces (57) of the cassette (7).

11. Dispensing device according to any of claims 8 to 10, wherein the seat (63) extends along a first axis (63a) and is adapted to receive the cap (35) in a coaxial manner, and the gripper (65) is mounted on the frame (10) to rotate, under the action of the actuator (68), around a second axis (65a) parallel to the first axis (63a).

12. Dispensing device according to claim 11, wherein the first movement device (67) is configured to translate the support body (14) relative to the frame (10) in the direction of the first axis (63a).

13. Radiopharmaceutical production system for producing a plurality of radiopharmaceutical batches, each of which consists of a set of radiopharmaceutical doses contained in respective containers (4), in particular vials, bottles, flasks or syringes, the radiopharmaceutical production system (1) comprising: an isolator, which is shielded against ionising radiation and has a working chamber (2); a dispensing device (5) arranged in the working chamber (2); a plurality of dispensing kits (6), each of which is according to any of claims 1 to 7, is associated with a respective radiopharmaceutical batch and is set up in the working chamber (2) so as to cooperate with the dispensing device (5) to introduce radiopharmaceutical doses into respective containers (4); a first support (16) arranged in the working chamber (2) for receiving the reservoirs (8) of the dispensing kits (6);a second support (18) arranged in the working chamber (2) to receive the needle groups (9) of the dispensing kits (6); a plurality of discharge ducts (41), each of which is accessible from the working chamber (2) and can be connected to the first duct (39) of a respective dispensing kit (6); a third support (3) positionable in the working chamber (2) to arrange empty containers (4) in an orderly fashion; and a handling system (27), preferably comprising at least one tele-gripper (28, 29), for transferring the needle group (9) of a certain dispensing kit (6) between the second support (18) and the dispensing device (5) and for transferring an empty container (4) from the third support (3) to the dispensing device (5).; 14. Radiopharmaceutical production system according to claim 13, wherein said dispensing device (5) is according to any of claims 8 to 12 and preferably comprises a plurality of control modules (12), on each of which the cassette (7) of a respective dispensing kit (6) can be releasably mounted.

15. Radiopharmaceutical production system according to claim 13 or 14, and comprising an active substance meter (22) having a measuring chamber (23) accessible from the working chamber (2) and adapted to contain the loading tank (8) of the said certain dispensing kit (6); the handling system (27) being adapted to transfer the tank (8) of the said certain dispensing kit (6) between the first support (16) and the measuring chamber (23).

16. A radiopharmaceutical production system according to any of claims 13 to 15, wherein the working chamber (2) comprises an outlet port (25) for transferring a container (4) containing a dose of radiopharmaceutical out of the working chamber (2), and said handling system (27) is adapted to transfer the container (4) containing a dose of radiopharmaceutical from the dispensing device (5) to the outlet port (25).

17. A radiopharmaceutical production system according to any of claims 13 to 16, wherein the handling system (27) comprises at least a first tele-gripper (28) for transferring the needle assembly (9) of the said certain dispensing kit (6) between the second support (18) and the dispensing device (5), and a second tele-gripper (65) for transferring the empty container (4) from the third support (3) to the dispensing device (5) and the container (4) containing a dose of radiopharmaceutical from the dispensing device (5) to the outlet port (25).

18. A radiopharmaceutical production system according to any of claims 13 to 17, wherein each dispensing kit (6) is according to claim 3 and the radiopharmaceutical production system (1) comprises a fourth support (20) for holding a plurality of bags (21) of diluent solution, each of which is connectable to the fifth conduit (53) of a respective dispensing kit (6).