Device and method for applying adhesive labels to containers for drugs or radiopharmaceuticals

Abstract

An applicator device for applying adhesive labels to cylindrical drug or radiopharmaceutical containers in a highly sterile environment, the applicator device (1) having a feeder device (4) to feed a label tape (5) and a roller system (6) to support and rotate a container (7) about a first axis (7a), longitudinally pull the label tape (5) out of the feeder device (4) to advance it at least as far as the container (7) as the latter rotates, and impart to the label tape (5) a fold such that a label comes off the backing tape (8) and sticks on the container (7); the feeder device (4) having a first body (24) with a cage-like structure defining a spiral housing, which is coaxial to a second axis (24a) to allow the housing of the label tape (5) wound as a coil whose coils do not touch each other, and terminates with an outlet (18) for longitudinal extraction of the label tape (5).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority from Italian patent application no. 102024000018823 filed on August 9, 2024, the entire disclosure of which is incorporated herein by reference.Technical field

[0002] This invention relates to a label applicator device for applying adhesive labels to cylindrical drug or radiopharmaceutical containers in a highly sterile environment and a corresponding method for applying adhesive labels to cylindrical drug or radiopharmaceutical containers.

[0003] In particular, this invention finds advantageous, but not exclusive, use in applying labels to disposable containers as part of a process for dispensing a radiopharmaceutical in said disposable containers, to which the following description will explicitly refer without any loss of generality thereby.Background

[0004] Current Good Manufacturing Practice (GMP) guidelines stipulate that the material used in a highly sterile environment, conventionally classified as Grade A, for example during an injectable pharmaceutical product handling operation, which is exposed to the surrounding environment, must first be decontaminated. This is preferably done using vaporised hydrogen peroxide decontamination systems that provide greater control and repeatability of the process.

[0005] As part of a process for dispensing radiopharmaceuticals in disposable containers, such as bottles, it is common practice today to apply drug identification labels to the respective containers before they are placed in a Grade A working chamber. This choice is essentially linked to the fact that the application of labels downstream of the dispensing step presents a technical difficulty and is, therefore, costly.

[0006] In particular, the most common approach today for preparing labelled containers prior to the radiopharmaceutical dispensing step comprises the following steps: placing a set of pre-sterilised bottles in a double bag under a laminar flow hood; placing a set of unsterilised labels under the hood and, using sanitary gloves and a germicidal spray, manually sanitising the set of labels; opening the double bag and taking out the bottles under the hood; applying the labels to the bottles individually under the hood; putting the labelled bottles inside a sterile bag and closing it under the hood; transferring the sterile bag with the labelled bottles into an antechamber of a dispensing system and closing the antechamber door; using glove flanges integrated into the antechamber, sanitising the outside of the bag that became contaminated during transfer from the chamber to the antechamber; and using glove flanges, opening the bag and taking out the labelled bottles and transferring the labelled bottles from the antechamber to the working chamber of the dispensing system.

[0007] The labelling step described above that precedes the radiopharmaceutical dispensing step has negative implications both in practice and in terms of GMP guidelines. From a practical point of view, this labelling step has numerous steps that slow down and complicate the entire process, and also introduces risks related to incorrect handling by the operator. In addition, the use of sanitary gloves to handle labels is a particularly complex operation and not without failures.

[0008] A possible simplification of the labelling step described above would involve carrying out all the steps inside the antechamber. However, this is actually made impossible by the need to use the glove flanges of the antechamber, since the gloves attached to these flanges are so thick that the operator wearing them cannot apply the labels - an operation that is already difficult even when using sanitary gloves that are thinner.

[0009] From a regulatory point of view, especially considering the most recent guidelines in force, the manual application of germicidal products is strongly discouraged because it is difficult to control and cannot be repeated, as it depends on the experience and skill of the operator.Summary

[0010] The purpose of this invention is to provide a method for applying the labels to containers for a radiopharmaceutical prior to the radiopharmaceutical dispensing step, which is free from the drawbacks described above and, at the same time, is easy and inexpensive to implement.

[0011] In accordance with this invention, a label applicator device for applying adhesive labels to cylindrical drug or radiopharmaceutical containers in a highly sterile environment and a method for applying adhesive labels to cylindrical drug or radiopharmaceutical containers in a highly sterile environment are provided, as defined in the appended independent claims. Additional advantageous features of this invention are stated in the dependent claims.

[0012] The claims describe preferred embodiments of this invention to be considered an integral part of this description.Brief description of the drawings

[0013] This invention will now be described with reference to the accompanying drawings, which illustrate a non-limiting example of an embodiment, wherein: Figures 1 and 2 illustrate, from the same axonometric view, the label applicator device of this invention in two respective operating configurations; Figure 3 illustrates the label applicator device in the operational configuration of Figure 2 in a longitudinal cross-section view; and Figure 4 shows an exploded view of a part of the label applicator device in Figures 1 and 2. Description of embodiments

[0014] In Figures 1 and 2, reference number 1 generically denotes, as a whole, a label applicator device for applying adhesive labels, one at a time, to respective cylindrical drug or radiopharmaceutical containers.

[0015] The label applicator device 1 comprises a support frame 2 provided with a plurality of legs 3 for resting on the floor of a highly sterile environment, for example the antechamber or working chamber of a drug or radiopharmaceutical dispensing system configured in a pharmaceutical isolator.

[0016] The label applicator device 1 comprises a feeder device 4 mounted on the support frame 2 to feed a label tape 5, a roller system 6 mounted on the support frame 2 and configured to rotate a drug or radiopharmaceutical container 7 around an axis 7a coincident with the cylindrical symmetry axis of the container 7, longitudinally pull out the label tape 5 from the feeder device 4 to advance it at least as far as the container 7 while the latter rotates to apply a label to the container 7. In the example illustrated by the figures, the container 7 is a bottle.

[0017] Specifically, the label tape 5 comprises a flexible backing tape 8 and a plurality of adhesive labels (not illustrated) arranged along the backing tape 8. The roller system 6 adopts a well-known principle to detach a label for application to the container 7, that is, it imparts a fold to the label tape 5 such that a label detaches itself from the backing tape 8 and sticks onto the container 7. According to this known principle, the roller system 6 works on one container 7 at a time and is manually operated.

[0018] Referring to Figures 1 to 3, the roller system 6 comprises at least one pair of parallel rollers 9 and 10 for supporting and rotating the container 7 about the axis 7a and for advancing the label tape 5 according to a direction 5a oriented by the roller 10 to the other roller 9, and a folding element 11 (Figure 3) arranged between the two rollers 9 and 10 and near another roller 10 for imparting said fold to the label tape 5 while the label tape 5 transits between the roller 10 and the folding element 11.

[0019] In particular, the folding element 11 consists of a plate placed tangentially to the roller 10, with the interposition of a space for the passage of the label tape 5, as illustrated in Figure 3. In the example illustrated in the figures, the labels are arranged on the face of the label tape 5 that partially wraps around the roller 10 from underneath, such that the folding element 11 imparts the fold on the other face of the label tape 5 causing a label to peel off and the roller 10 transfers and attaches this label to the outer surface of the container 7 as the latter rotates.

[0020] The roller system 6 comprises a crank 12 angularly integral with the roller 9 to make the roller 9 rotate. The roller 9 comprises friction elements 13 on the surface, consisting, for example, of multiple rubber rings, to rotate the container 7, which rests on the rollers 9 and 10. Thus, the roller 9 is a drive roller and the other roller 10 is dragged by the rotation of the container 7.

[0021] The roller system 6 comprises an additional roller 14 that, in use, presses the container 7 against the rollers 9 and 10 to promote adherence of the container 7 to the roller 9. The roller 14 preferably comprises at least one surface friction element 15, consisting of, for example, a rubber ring. In addition, the roller system 6 comprises a handle 16, which rotatably supports the roller 14 and is movable between a first position, in which it moves the roller 14 away from the other rollers 9 and 10 to allow the container 7 to be placed on the rollers 9 and 10 or the container 7 to be removed from the rollers 9 and 10 (Figure 1), and a second position, in which the roller 14 presses the container 7 onto the rollers 9 and 10 (Figure 2).

[0022] The roller system 6 comprises a return element 17, preferably cylindrical in shape, arranged parallel and adjacent to the roller 9. In use, before labelling begins, the label tape 5 is, in the following order, partially wound under the roller 10, turned around the folding element 11, partially wound under the roller 9 and returned above the return element 17. In this way, the label tape 5 is held tightly around the roller 9 and the rotation of the latter drags and advances the label tape 15 through the roller system 6.

[0023] The feeder device 4 comprises an outlet 18 for longitudinal extraction of the label tape 5 and the roller system 6 comprises an additional return element 19 for returning the label tape 5 from the outlet 18 to the roller 10. The roller system 6 comprises an elastic plate 19a to press the label tape 5 against the return element 19 to tension the label tape 5 in the path to the rollers 9 and 10.

[0024] The roller system 6 also comprises a position adjuster 20 arranged upstream, relative to the direction 5a, of the roller 10 to adjust the transverse position of the label tape 5 and thus adjust the vertical position of the label on the container 7 (Figures 1 and 3). The position adjuster 20 comprises a rod 21, which is mounted transversely in the support frame 2 and on which the label tape 5 slides, and a movable slider 22, which is drilled to slide along the rod 21 to contact a side edge of the label tape 5 and is provided with a knob 23 to tighten a screw (not shown) that locks the position of the slider 22.

[0025] The feeder device 4 comprises a first body 24 having cage-like structure defining a spiral housing, which is coaxial to an axis 24a, preferably parallel to the axis 7a, and ends with the outlet 18 to allow the housing of the label tape 5 wound as a coil whose coils, indicated with 25 in Figure 3, do not touch each other. "Cage-like structure" refers to a structure characterised by thin elements.

[0026] With special reference to Figures 3 and 4, the body 24 comprises a spiral element 26 (Figure 3) coaxial to the axis 24a and a plurality of transverse elements 27 projecting transversely from the spiral element 26 and arranged in a regular manner along the spiral element 26 to define the spiral housing. In particular, each transverse element 27 comprises a respective section essentially parallel to the axis 24a and, therefore, straight. In the example illustrated in the figures, the transverse elements 27 are completely straight.

[0027] The body 24 comprises a plurality of radial elements 28 extending radially with respect to the axis 24a at a certain distance D from the spiral element 26. Each radial element 28 is integral with the ends of a respective subset of the transverse elements 27 that correspond to different coils of the spiral element 26. The distance D is a little greater than the width of the label tape 5. This distance D coincides with the length of each of the transverse elements 27.

[0028] Thus, the cage-like structure of the body 24 is defined at least by the thin elements consisting of the spiral element 26 and the transverse elements 27. Other thin elements that define this cage-like structure are the radial elements 28.

[0029] The feeder device 4 comprises another body 29, which is attached to a portion 30 of the support frame 2, and the body 24 is releasably coupled to the body 29 such that the body 29 is arranged against the spiral element 26 to allow an operator to insert the label tape 5 laterally into the spiral housing of the body 24 and to prevent the label tape 5 from coming out laterally from this spiral housing while the label tape 5 itself is longitudinally extracted from the outlet 18 while the labels are applied to the containers 7.

[0030] The body 29 consists of a plate having a shape that extends to overlap the entire outermost coil of the spiral element 26. The plate defining the body 29 preferably comprises multiple openings 31 to allow passage of a decontamination agent for decontamination of the label tape 5 placed inside the feeder device 4, as will be explained in more detail below.

[0031] The portion 30 of the support frame 2 extends essentially vertically. The body 29 is, on the one hand, fixed to one end of the portion 30 by means of a spacer element 32 and, on the opposite side, provided with a pin 33 designed to engage a central hole 34 of the body 24 to partially couple another body 29 with the body 24.

[0032] The body 29 comprises, along an outer edge 35 thereof, multiple notches 36 and the body 24 comprises multiple, corresponding tabs 37, which are transverse to the axis 24a and arranged along the outermost coil of the spiral element 26 and are designed to cross the notches 36 and, following an angular rotation of the body 24 with respect to the body 29, to grasp the outer edge 35 to completely couple the body 29 and another body 24.

[0033] The label applicator device 1 described above enables the following method for applying adhesive labels to drug or radiopharmaceutical containers 7 in a highly sterile environment equipped with glove-flanges, for example an antechamber (not shown) of a drug or radiopharmaceutical dispensing system, to be carried out. Typically, the antechamber comprises a door for access from the outside and glove flanges are mounted on this door. Typically, the antechamber communicates with a working chamber where the dispensing of the drug or radiopharmaceutical in the already labelled containers takes place.

[0034] First of all, the method involves making the label tape 5 outside said environment, for example by printing the various labels already attached to the backing tape 8 using a known printer in a laboratory of a production line of a drug or radiopharmaceutical that comprises the above-mentioned dispensing system.

[0035] The label tape 5 is inserted into the feeder device 4 of the label applicator device 1. Specifically, the body 24 is decoupled from the other body 29 (as illustrated in Figure 4) and the label tape 5 is inserted laterally into the spiral housing of the body 24, winding the label tape 5 like a coil along this spiral housing and leaving a first section of the label tape 5, comprising the first label to be applied, outside the outlet 18.

[0036] The label applicator device 1 is prepared for labelling. In particular, the body 24 is coupled to the other body 29 to close the feeder device 4 and the first section of the label tape 5 is manually extracted from the feeder device 4 to pass it around the return element 19, around the rollers 10 and 9, passing over the folding element 11 and then around the return element 17, as illustrated in Figure 3. Obviously, the label tape 5 must have an initial section without labels so that the backing tape 8 is located between the return element 17 and the roller 9 (drive roller) and the first label is located below the roller 10, that is, before the folding element 11.

[0037] The above-mentioned preparation of the label applicator device 1 may be done outside or inside said environment, that is, before or after placing the label applicator device 1 in said environment.

[0038] In addition to the label applicator device 1, sealed sterile bags enclosing containers 7 and their caps are placed in this environment.

[0039] At this point, said environment is closed (with reference to the example cited above, the antechamber door is closed) and a decontamination cycle is started inside it, for example using vaporised hydrogen peroxide, to decontaminate the entire label tape 5 and the sterile bags containing the containers 7 in one go. The decontamination agent enters and circulates easily in the feeder device 4 thanks to the special open structures of the bodies 24 and 29, in particular thanks to the cage-like structure of the body 24 and the openings 31 of the body 29.

[0040] It should be observed that the decontamination agent reaches almost every point on the label tape 5 since the various coils of the label tape 5 do not touch each other and the label tape 5 touches only a few points on the body 24, due to its special cage-like structure, that is, made of thin elements 26, 27 and 28, which defines a spiral housing for the label tape 5. For example, Figure 3 clearly illustrates that the contact points are those where the label tape 5 rests on the transverse elements 27 due to gravity.

[0041] At the end of the decontamination cycle, an operator, using the glove flanges, removes the containers 7 from the bags, and uses the label applicator device 1 to apply the labels to the containers 7, one at a time, in particular by placing one container 7 at a time in the roller system 6 and operating the roller system 6 manually to rotate the container 7 so that a respective label detaches from the backing tape 8 and sticks onto the container 7.

[0042] More specifically, the operator raises the handle 16 to place a container 7 on the rollers 9 and 10 (Figure 1), then lowers the handle 16 so as to press the container 7 onto the rollers 9 and 10 (Figure 2) and at the same time turns the crank 12 to rotate the roller 9 by an angle such that a label is detached from the backing tape 8 and sticks to the outer surface of the container 7 as the latter rotates. The operator repeats these operations for each container 7.

[0043] As can be seen, the label applicator device 1 allows the operator to apply decontaminated labels to sterile containers 7 without the need to handle the labels directly.

[0044] The labelled containers 7 are then transferred, either manually or in an automated manner, in any case without contact with the external environment, to another highly sterile environment where the step for dispensing the drug or radiopharmaceutical into the containers 7 takes place.

[0045] At the end of the dispensing process, the operator can re-open said environment (with reference to the example cited above, the antechamber door is opened) to retrieve the waste materials, that is, the opened bags, the backing tape 8 of the label tape 5, and take out the label applicator device 1 or just the body 24 to reload the feeder device 4 and carry out a new labelling step.

[0046] Although the invention described above makes particular reference to a very precise embodiment, it is not to be construed as limited to this embodiment, since all the variations, modifications or simplifications covered by the attached claims fall within its scope, such as for example: the label applicator device 1 comprises, instead of the roller system 6 manually operated by means of a crank 12, a motorised roller system comprising an electric gearmotor or a step motor operated by a switch pressed by the operator; and the body 24 comprises, instead of radial elements 28, another spiral element that mirrors the spiral element 26, and transverse elements 27 connect the two spiral elements.

[0047] The main advantage of the label applicator device 1 described above is that it allows labels to be applied to drug or radiopharmaceutical containers under aseptic conditions, as the label applicator device 1 is easily operated even with the glove flanges integrated in a highly sterile environment, for example the antechamber of a dispensing system. This is essentially enabled by the fact that the feeder device 4 of the label applicator device 1 allows the housing of a label tape 5 wound as a coil whose coils do not touch each other and with a very small number of contact points between the label tape 4 and the body 24 supporting the label tape 5.

Examples

Embodiment Construction

[0014]In Figures 1 and 2, reference number 1 generically denotes, as a whole, a label applicator device for applying adhesive labels, one at a time, to respective cylindrical drug or radiopharmaceutical containers.

[0015]The label applicator device 1 comprises a support frame 2 provided with a plurality of legs 3 for resting on the floor of a highly sterile environment, for example the antechamber or working chamber of a drug or radiopharmaceutical dispensing system configured in a pharmaceutical isolator.

[0016]The label applicator device 1 comprises a feeder device 4 mounted on the support frame 2 to feed a label tape 5, a roller system 6 mounted on the support frame 2 and configured to rotate a drug or radiopharmaceutical container 7 around an axis 7a coincident with the cylindrical symmetry axis of the container 7, longitudinally pull out the label tape 5 from the feeder device 4 to advance it at least as far as the container 7 while the latter rotates to apply a label to the cont...

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority from Italian patent application no. 102024000018823 filed on August 9, 2024, the entire disclosure of which is incorporated herein by reference.Technical field

[0002] This invention relates to a label applicator device for applying adhesive labels to cylindrical drug or radiopharmaceutical containers in a highly sterile environment and a corresponding method for applying adhesive labels to cylindrical drug or radiopharmaceutical containers.

[0003] In particular, this invention finds advantageous, but not exclusive, use in applying labels to disposable containers as part of a process for dispensing a radiopharmaceutical in said disposable containers, to which the following description will explicitly refer without any loss of generality thereby.Background

[0004] Current Good Manufacturing Practice (GMP) guidelines stipulate that the material used in a highly sterile environment, conventionally classified as Grade A, for example during an injectable pharmaceutical product handling operation, which is exposed to the surrounding environment, must first be decontaminated. This is preferably done using vaporised hydrogen peroxide decontamination systems that provide greater control and repeatability of the process.

[0005] As part of a process for dispensing radiopharmaceuticals in disposable containers, such as bottles, it is common practice today to apply drug identification labels to the respective containers before they are placed in a Grade A working chamber. This choice is essentially linked to the fact that the application of labels downstream of the dispensing step presents a technical difficulty and is, therefore, costly.

[0006] In particular, the most common approach today for preparing labelled containers prior to the radiopharmaceutical dispensing step comprises the following steps: placing a set of pre-sterilised bottles in a double bag under a laminar flow hood; placing a set of unsterilised labels under the hood and, using sanitary gloves and a germicidal spray, manually sanitising the set of labels; opening the double bag and taking out the bottles under the hood; applying the labels to the bottles individually under the hood; putting the labelled bottles inside a sterile bag and closing it under the hood; transferring the sterile bag with the labelled bottles into an antechamber of a dispensing system and closing the antechamber door; using glove flanges integrated into the antechamber, sanitising the outside of the bag that became contaminated during transfer from the chamber to the antechamber; and using glove flanges, opening the bag and taking out the labelled bottles and transferring the labelled bottles from the antechamber to the working chamber of the dispensing system.

[0007] The labelling step described above that precedes the radiopharmaceutical dispensing step has negative implications both in practice and in terms of GMP guidelines. From a practical point of view, this labelling step has numerous steps that slow down and complicate the entire process, and also introduces risks related to incorrect handling by the operator. In addition, the use of sanitary gloves to handle labels is a particularly complex operation and not without failures.

[0008] A possible simplification of the labelling step described above would involve carrying out all the steps inside the antechamber. However, this is actually made impossible by the need to use the glove flanges of the antechamber, since the gloves attached to these flanges are so thick that the operator wearing them cannot apply the labels - an operation that is already difficult even when using sanitary gloves that are thinner.

[0009] From a regulatory point of view, especially considering the most recent guidelines in force, the manual application of germicidal products is strongly discouraged because it is difficult to control and cannot be repeated, as it depends on the experience and skill of the operator.Summary

[0010] The purpose of this invention is to provide a method for applying the labels to containers for a radiopharmaceutical prior to the radiopharmaceutical dispensing step, which is free from the drawbacks described above and, at the same time, is easy and inexpensive to implement.

[0011] In accordance with this invention, a label applicator device for applying adhesive labels to cylindrical drug or radiopharmaceutical containers in a highly sterile environment and a method for applying adhesive labels to cylindrical drug or radiopharmaceutical containers in a highly sterile environment are provided, as defined in the appended independent claims. Additional advantageous features of this invention are stated in the dependent claims.

[0012] The claims describe preferred embodiments of this invention to be considered an integral part of this description.Brief description of the drawings

[0013] This invention will now be described with reference to the accompanying drawings, which illustrate a non-limiting example of an embodiment, wherein: Figures 1 and 2 illustrate, from the same axonometric view, the label applicator device of this invention in two respective operating configurations; Figure 3 illustrates the label applicator device in the operational configuration of Figure 2 in a longitudinal cross-section view; and Figure 4 shows an exploded view of a part of the label applicator device in Figures 1 and 2. Description of embodiments

[0014] In Figures 1 and 2, reference number 1 generically denotes, as a whole, a label applicator device for applying adhesive labels, one at a time, to respective cylindrical drug or radiopharmaceutical containers.

[0015] The label applicator device 1 comprises a support frame 2 provided with a plurality of legs 3 for resting on the floor of a highly sterile environment, for example the antechamber or working chamber of a drug or radiopharmaceutical dispensing system configured in a pharmaceutical isolator.

[0016] The label applicator device 1 comprises a feeder device 4 mounted on the support frame 2 to feed a label tape 5, a roller system 6 mounted on the support frame 2 and configured to rotate a drug or radiopharmaceutical container 7 around an axis 7a coincident with the cylindrical symmetry axis of the container 7, longitudinally pull out the label tape 5 from the feeder device 4 to advance it at least as far as the container 7 while the latter rotates to apply a label to the container 7. In the example illustrated by the figures, the container 7 is a bottle.

[0017] Specifically, the label tape 5 comprises a flexible backing tape 8 and a plurality of adhesive labels (not illustrated) arranged along the backing tape 8. The roller system 6 adopts a well-known principle to detach a label for application to the container 7, that is, it imparts a fold to the label tape 5 such that a label detaches itself from the backing tape 8 and sticks onto the container 7. According to this known principle, the roller system 6 works on one container 7 at a time and is manually operated.

[0018] Referring to Figures 1 to 3, the roller system 6 comprises at least one pair of parallel rollers 9 and 10 for supporting and rotating the container 7 about the axis 7a and for advancing the label tape 5 according to a direction 5a oriented by the roller 10 to the other roller 9, and a folding element 11 (Figure 3) arranged between the two rollers 9 and 10 and near another roller 10 for imparting said fold to the label tape 5 while the label tape 5 transits between the roller 10 and the folding element 11.

[0019] In particular, the folding element 11 consists of a plate placed tangentially to the roller 10, with the interposition of a space for the passage of the label tape 5, as illustrated in Figure 3. In the example illustrated in the figures, the labels are arranged on the face of the label tape 5 that partially wraps around the roller 10 from underneath, such that the folding element 11 imparts the fold on the other face of the label tape 5 causing a label to peel off and the roller 10 transfers and attaches this label to the outer surface of the container 7 as the latter rotates.

[0020] The roller system 6 comprises a crank 12 angularly integral with the roller 9 to make the roller 9 rotate. The roller 9 comprises friction elements 13 on the surface, consisting, for example, of multiple rubber rings, to rotate the container 7, which rests on the rollers 9 and 10. Thus, the roller 9 is a drive roller and the other roller 10 is dragged by the rotation of the container 7.

[0021] The roller system 6 comprises an additional roller 14 that, in use, presses the container 7 against the rollers 9 and 10 to promote adherence of the container 7 to the roller 9. The roller 14 preferably comprises at least one surface friction element 15, consisting of, for example, a rubber ring. In addition, the roller system 6 comprises a handle 16, which rotatably supports the roller 14 and is movable between a first position, in which it moves the roller 14 away from the other rollers 9 and 10 to allow the container 7 to be placed on the rollers 9 and 10 or the container 7 to be removed from the rollers 9 and 10 (Figure 1), and a second position, in which the roller 14 presses the container 7 onto the rollers 9 and 10 (Figure 2).

[0022] The roller system 6 comprises a return element 17, preferably cylindrical in shape, arranged parallel and adjacent to the roller 9. In use, before labelling begins, the label tape 5 is, in the following order, partially wound under the roller 10, turned around the folding element 11, partially wound under the roller 9 and returned above the return element 17. In this way, the label tape 5 is held tightly around the roller 9 and the rotation of the latter drags and advances the label tape 15 through the roller system 6.

[0023] The feeder device 4 comprises an outlet 18 for longitudinal extraction of the label tape 5 and the roller system 6 comprises an additional return element 19 for returning the label tape 5 from the outlet 18 to the roller 10. The roller system 6 comprises an elastic plate 19a to press the label tape 5 against the return element 19 to tension the label tape 5 in the path to the rollers 9 and 10.

[0024] The roller system 6 also comprises a position adjuster 20 arranged upstream, relative to the direction 5a, of the roller 10 to adjust the transverse position of the label tape 5 and thus adjust the vertical position of the label on the container 7 (Figures 1 and 3). The position adjuster 20 comprises a rod 21, which is mounted transversely in the support frame 2 and on which the label tape 5 slides, and a movable slider 22, which is drilled to slide along the rod 21 to contact a side edge of the label tape 5 and is provided with a knob 23 to tighten a screw (not shown) that locks the position of the slider 22.

[0025] The feeder device 4 comprises a first body 24 having cage-like structure defining a spiral housing, which is coaxial to an axis 24a, preferably parallel to the axis 7a, and ends with the outlet 18 to allow the housing of the label tape 5 wound as a coil whose coils, indicated with 25 in Figure 3, do not touch each other. "Cage-like structure" refers to a structure characterised by thin elements.

[0026] With special reference to Figures 3 and 4, the body 24 comprises a spiral element 26 (Figure 3) coaxial to the axis 24a and a plurality of transverse elements 27 projecting transversely from the spiral element 26 and arranged in a regular manner along the spiral element 26 to define the spiral housing. In particular, each transverse element 27 comprises a respective section essentially parallel to the axis 24a and, therefore, straight. In the example illustrated in the figures, the transverse elements 27 are completely straight.

[0027] The body 24 comprises a plurality of radial elements 28 extending radially with respect to the axis 24a at a certain distance D from the spiral element 26. Each radial element 28 is integral with the ends of a respective subset of the transverse elements 27 that correspond to different coils of the spiral element 26. The distance D is a little greater than the width of the label tape 5. This distance D coincides with the length of each of the transverse elements 27.

[0028] Thus, the cage-like structure of the body 24 is defined at least by the thin elements consisting of the spiral element 26 and the transverse elements 27. Other thin elements that define this cage-like structure are the radial elements 28.

[0029] The feeder device 4 comprises another body 29, which is attached to a portion 30 of the support frame 2, and the body 24 is releasably coupled to the body 29 such that the body 29 is arranged against the spiral element 26 to allow an operator to insert the label tape 5 laterally into the spiral housing of the body 24 and to prevent the label tape 5 from coming out laterally from this spiral housing while the label tape 5 itself is longitudinally extracted from the outlet 18 while the labels are applied to the containers 7.

[0030] The body 29 consists of a plate having a shape that extends to overlap the entire outermost coil of the spiral element 26. The plate defining the body 29 preferably comprises multiple openings 31 to allow passage of a decontamination agent for decontamination of the label tape 5 placed inside the feeder device 4, as will be explained in more detail below.

[0031] The portion 30 of the support frame 2 extends essentially vertically. The body 29 is, on the one hand, fixed to one end of the portion 30 by means of a spacer element 32 and, on the opposite side, provided with a pin 33 designed to engage a central hole 34 of the body 24 to partially couple another body 29 with the body 24.

[0032] The body 29 comprises, along an outer edge 35 thereof, multiple notches 36 and the body 24 comprises multiple, corresponding tabs 37, which are transverse to the axis 24a and arranged along the outermost coil of the spiral element 26 and are designed to cross the notches 36 and, following an angular rotation of the body 24 with respect to the body 29, to grasp the outer edge 35 to completely couple the body 29 and another body 24.

[0033] The label applicator device 1 described above enables the following method for applying adhesive labels to drug or radiopharmaceutical containers 7 in a highly sterile environment equipped with glove-flanges, for example an antechamber (not shown) of a drug or radiopharmaceutical dispensing system, to be carried out. Typically, the antechamber comprises a door for access from the outside and glove flanges are mounted on this door. Typically, the antechamber communicates with a working chamber where the dispensing of the drug or radiopharmaceutical in the already labelled containers takes place.

[0034] First of all, the method involves making the label tape 5 outside said environment, for example by printing the various labels already attached to the backing tape 8 using a known printer in a laboratory of a production line of a drug or radiopharmaceutical that comprises the above-mentioned dispensing system.

[0035] The label tape 5 is inserted into the feeder device 4 of the label applicator device 1. Specifically, the body 24 is decoupled from the other body 29 (as illustrated in Figure 4) and the label tape 5 is inserted laterally into the spiral housing of the body 24, winding the label tape 5 like a coil along this spiral housing and leaving a first section of the label tape 5, comprising the first label to be applied, outside the outlet 18.

[0036] The label applicator device 1 is prepared for labelling. In particular, the body 24 is coupled to the other body 29 to close the feeder device 4 and the first section of the label tape 5 is manually extracted from the feeder device 4 to pass it around the return element 19, around the rollers 10 and 9, passing over the folding element 11 and then around the return element 17, as illustrated in Figure 3. Obviously, the label tape 5 must have an initial section without labels so that the backing tape 8 is located between the return element 17 and the roller 9 (drive roller) and the first label is located below the roller 10, that is, before the folding element 11.

[0037] The above-mentioned preparation of the label applicator device 1 may be done outside or inside said environment, that is, before or after placing the label applicator device 1 in said environment.

[0038] In addition to the label applicator device 1, sealed sterile bags enclosing containers 7 and their caps are placed in this environment.

[0039] At this point, said environment is closed (with reference to the example cited above, the antechamber door is closed) and a decontamination cycle is started inside it, for example using vaporised hydrogen peroxide, to decontaminate the entire label tape 5 and the sterile bags containing the containers 7 in one go. The decontamination agent enters and circulates easily in the feeder device 4 thanks to the special open structures of the bodies 24 and 29, in particular thanks to the cage-like structure of the body 24 and the openings 31 of the body 29.

[0040] It should be observed that the decontamination agent reaches almost every point on the label tape 5 since the various coils of the label tape 5 do not touch each other and the label tape 5 touches only a few points on the body 24, due to its special cage-like structure, that is, made of thin elements 26, 27 and 28, which defines a spiral housing for the label tape 5. For example, Figure 3 clearly illustrates that the contact points are those where the label tape 5 rests on the transverse elements 27 due to gravity.

[0041] At the end of the decontamination cycle, an operator, using the glove flanges, removes the containers 7 from the bags, and uses the label applicator device 1 to apply the labels to the containers 7, one at a time, in particular by placing one container 7 at a time in the roller system 6 and operating the roller system 6 manually to rotate the container 7 so that a respective label detaches from the backing tape 8 and sticks onto the container 7.

[0042] More specifically, the operator raises the handle 16 to place a container 7 on the rollers 9 and 10 (Figure 1), then lowers the handle 16 so as to press the container 7 onto the rollers 9 and 10 (Figure 2) and at the same time turns the crank 12 to rotate the roller 9 by an angle such that a label is detached from the backing tape 8 and sticks to the outer surface of the container 7 as the latter rotates. The operator repeats these operations for each container 7.

[0043] As can be seen, the label applicator device 1 allows the operator to apply decontaminated labels to sterile containers 7 without the need to handle the labels directly.

[0044] The labelled containers 7 are then transferred, either manually or in an automated manner, in any case without contact with the external environment, to another highly sterile environment where the step for dispensing the drug or radiopharmaceutical into the containers 7 takes place.

[0045] At the end of the dispensing process, the operator can re-open said environment (with reference to the example cited above, the antechamber door is opened) to retrieve the waste materials, that is, the opened bags, the backing tape 8 of the label tape 5, and take out the label applicator device 1 or just the body 24 to reload the feeder device 4 and carry out a new labelling step.

[0046] Although the invention described above makes particular reference to a very precise embodiment, it is not to be construed as limited to this embodiment, since all the variations, modifications or simplifications covered by the attached claims fall within its scope, such as for example: the label applicator device 1 comprises, instead of the roller system 6 manually operated by means of a crank 12, a motorised roller system comprising an electric gearmotor or a step motor operated by a switch pressed by the operator; and the body 24 comprises, instead of radial elements 28, another spiral element that mirrors the spiral element 26, and transverse elements 27 connect the two spiral elements.

[0047] The main advantage of the label applicator device 1 described above is that it allows labels to be applied to drug or radiopharmaceutical containers under aseptic conditions, as the label applicator device 1 is easily operated even with the glove flanges integrated in a highly sterile environment, for example the antechamber of a dispensing system. This is essentially enabled by the fact that the feeder device 4 of the label applicator device 1 allows the housing of a label tape 5 wound as a coil whose coils do not touch each other and with a very small number of contact points between the label tape 4 and the body 24 supporting the label tape 5.

Examples

Embodiment Construction

[0014]In Figures 1 and 2, reference number 1 generically denotes, as a whole, a label applicator device for applying adhesive labels, one at a time, to respective cylindrical drug or radiopharmaceutical containers.

[0015]The label applicator device 1 comprises a support frame 2 provided with a plurality of legs 3 for resting on the floor of a highly sterile environment, for example the antechamber or working chamber of a drug or radiopharmaceutical dispensing system configured in a pharmaceutical isolator.

[0016]The label applicator device 1 comprises a feeder device 4 mounted on the support frame 2 to feed a label tape 5, a roller system 6 mounted on the support frame 2 and configured to rotate a drug or radiopharmaceutical container 7 around an axis 7a coincident with the cylindrical symmetry axis of the container 7, longitudinally pull out the label tape 5 from the feeder device 4 to advance it at least as far as the container 7 while the latter rotates to apply a label to the cont...

Claims

1. A label applicator device for applying adhesive labels to cylindrical drug or radiopharmaceutical containers in a highly sterile environment, the label applicator device (1) comprising: a feeder device (4) to feed a label tape (5) consisting of a backing tape (8) and a plurality of adhesive labels arranged along the backing tape (8); and a roller system (6) configured to support and rotate a container (7) about a first axis (7a) coincident with the axis of cylindrical symmetry of the container (7), longitudinally pull the label tape (5) out of the feeder device (4) to advance it at least as far as the container (7) as the latter rotates, and impart to the label tape (5) a fold such that a label comes off the backing tape (8) and sticks on the container (7); the feeder device (4) comprising a first body (24) having a cage-like structure defining a spiral housing, which is coaxial to a second axis (24a), preferably parallel to the first axis (7a), to allow the housing of the label tape (5) wound as a coil whose coils do not touch each other, and terminates with an outlet (18) for longitudinal extraction of the label tape (5).

2. The label applicator device according to claim 1, wherein the first body (24) comprises a spiral element (26) coaxial to the second axis (24a) and a plurality of transverse elements (27) projecting from the spiral element (26) and arranged in a regular manner along the spiral element (26) to define the spiral housing.

3. The label applicator device according to claim 2, wherein each transverse element (27) comprises a respective length substantially parallel to the second axis (24a).

4. The label applicator device according to claim 2 or 3, wherein the first body (24) comprises a plurality of radial elements (28) extending radially with respect to the second axis (24a) at a certain distance (D) from the spiral element (26), each radial element (28) being integral with the ends of a respective subset of the transverse elements (27) that correspond to different coils of the spiral element (26) .

5. The label applicator device according to claim 3, wherein said certain distance (D) is greater than the width of the label tape (5).

6. The label applicator device according to any one of claims 2 to 5, and comprising a support frame (2) on which the roller system (6) is mounted; the feeder device (4) comprising a second body (29), which is attached to the support frame (2), and the first body (24) being releasably coupled to the second body (29) such that the second body (29) is arranged against the spiral element (26) to allow lateral insertion of the label tape (5) into the spiral housing of the first body (24) and prevent it from coming out laterally during application of the labels to the containers (7).

7. The label applicator device according to any one of claims 1 to 6, wherein the roller system (6) comprises at least one pair of rollers (9, 10) for supporting and rotating the container (7) about the first axis (7a) and advancing the label tape (5), and a folding element (11) arranged in proximity to a roller (10) of the pair of rollers (9, 10) for imparting said fold to the label tape (5).

8. A method for applying adhesive labels to cylindrical drug or radiopharmaceutical containers in a highly sterile environment provided with glove flanges, by means of the label applicator device according to any one of claims 1 to 7, the method comprising: - making, outside said environment, a label tape (5) comprising a backing tape (8) and a plurality of adhesive labels arranged along the backing tape (8); - inserting the label tape (5) into the feeder device (4) of the label applicator device (1) and preparing the latter for labelling; - arranging in said environment the label applicator device (1) and a plurality of containers (7) enclosed in respective sealed envelopes; - starting a decontamination cycle in said environment to decontaminate the label tape (5) and sealed envelopes; - at the end of the decontamination cycle, within said environment, through the glove flanges, taking out a container (7) from its respective envelope, putting the container (7) into the roller system (6) of the label applicator device (1), and operating the roller system (6) to rotate the container (7) and advance the label tape (5) to such an extent that a label comes off the backing tape (8) and sticks on the container (7).

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