Device for closing pharmaceutical containers
The device addresses the issue of unreliable closure of pharmaceutical containers by using a strength sensor to monitor the force applied during closure, ensuring secure sealing and preventing glass fracture.
Patent Information
- Application Number
- EP2021819074
- Authority / Receiving Office
- EP · EP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-11-24
- Filing Date
- 2021-11-19
- Publication Date
- 2025-04-09
- Estimated Expiration
- 2041-11-19
AI Technical Summary
Existing devices for closing pharmaceutical containers with closures can result in glass fracture, damaged closures, or improper closure due to manufacturing tolerances, leading to unreliable container sealing.
A device comprising a first holding device for pharmaceutical containers and a second holding device for closures, equipped with a stamp and counter element that can be driven together to ensure proper alignment and closure, while a strength sensor monitors the force applied to verify a secure seal.
The device ensures reliable closure of pharmaceutical containers by monitoring the force applied during the closure process, preventing glass fracture and ensuring proper sealing, thus enhancing the reliability and safety of the closure process.
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Figure IMGF0001
Abstract
Description
[0001] The present invention relates to a device for closing pharmaceutical containers by means of closures according to the preamble of claim 1. Furthermore, the invention relates to a method for closing pharmaceutical containers by means of closures having the features of the preamble of the independent claim.
[0002] Devices and methods of the type mentioned above are known from the prior art, for example, from US 2018 / 0370665 A1. This allows for the simultaneous pressing of several closures onto several pharmaceutical containers.
[0003] However, the disadvantage of this type of path-controlled closure of multiple pharmaceutical containers with closures using a single plate is that manufacturing tolerances in the height of the pharmaceutical containers can lead to glass breakage, damaged closures, or improperly closed containers. Thus, reliable closure of the containers cannot be sufficiently guaranteed. Therefore, there is a need for optimization.
[0004] The invention is based on the object of providing an improved device and method. It is particularly desirable to monitor the closing process of pharmaceutical containers using simple structural means.
[0005] The invention solves this problem by a device for closing pharmaceutical containers by means of closures according to claim 1.
[0006] The device comprises a first holding device for receiving at least one pharmaceutical container. A second holding device is provided for receiving at least one closure for closing an opening of the pharmaceutical container. The two holding devices can be aligned or are aligned with one another such that the closure and the opening of the pharmaceutical container are aligned with one another.
[0007] A (first) punch and a counter element are provided, wherein the punch and / or the counter element (40) can be driven by means of a drive device and can be moved relative to one another.
[0008] When the punch and the counter element are moved towards each other when the drive device is driven, the punch acts on the closure or on the container in such a way that the closure can come into contact with the container and can be pressed onto the container to close the opening of the container through the interaction of the punch and the counter element.
[0009] The device is characterized by the inclusion of a force sensor. The force sensor can detect the force exerted by the interaction of the plunger and counter element when pressing the closure onto the pharmaceutical container.
[0010] The device according to claim 1 enables monitoring of the closing process of pharmaceutical containers. By monitoring the closing process by detecting the force or a force profile, it can be determined if a closure is lost during its preparation (the closure does not reach the pharmaceutical container to be closed). Furthermore, the detected force or the detected force profile can be used to determine whether the closing process is being carried out correctly. In the simplest case (only one plunger and only one counter element are present), only one pharmaceutical container is closed at a time. If several pharmaceutical containers are to be closed, this can be done sequentially.
[0011] The pharmaceutical container can be a vial (injection bottle), a syringe or a cartridge.
[0012] Suitable closures are available for various pharmaceutical containers. These closures can be press-on caps (caps with integrated rubber stoppers), rubber stoppers with aluminum crimp caps, vial stoppers, syringe stoppers, or cartridge stoppers.
[0013] Alignment of the closure and the opening of the pharmaceutical container means an arrangement such that the closure fits onto the container so that the opening can be closed. Alignment can be achieved by aligning the central longitudinal directions of the closure and the pharmaceutical container.
[0014] Furthermore, the punch and / or the counter element can be displaced by means of the drive device, in particular along the central longitudinal axis of the punch or counter element. The punch, the counter element, or the punch and the counter element can be designed to be movable by means of the drive device.
[0015] For a structurally simple design, the counter element can be stationary, and the punch can be moved relative to the counter element. If the punch is moved toward the counter element, the closure can be pressed onto the container if at least one closure and at least one container are arranged between the punch and counter element.
[0016] The plunger can be positioned either below or above the container and closure, along the direction of gravity. If the plunger is positioned above the container and closure (counter element below), the plunger can, for example, act on the closure and thus press the closure onto the container. If the plunger is positioned below the container and closure (counter element above), the plunger can act on the container and thus, by acting on the container, press the closure onto the container. Other designs, e.g., with a drivable counter element, are also conceivable.
[0017] The (first) stamp can be referred to as a closure stamp, particularly if the closing process of the container by means of the closure is initiated by the (first) stamp.
[0018] The central longitudinal axis of the punch or counter element can be the z-axis, which forms the normal vector of an xy plane.
[0019] The xy plane can in particular be oriented orthogonally to the central longitudinal axis of the counter element.
[0020] Advantageously, the force sensor can be arranged on the plunger or on the counter element. This allows for flexible positioning of the force sensor. Thus, the force applied to the container can be measured directly on the (first) plunger applying the force or on the counter element.
[0021] It can be advantageous if the punch and the counter-element are designed to be movable relative to the first holding device along a plane that is oriented orthogonally to the central longitudinal axis of the counter-element. By making the punch and the counter-element movable relative to the first holding device, the punch and the counter-element can be aligned with one another relative to the first holding device along the plane. This is advantageous when the device is restocked with new pharmaceutical containers and closures, or when multiple pharmaceutical containers or closures are arranged in the holding devices. The travel range of the punch and the counter-element is dimensioned such that all pharmaceutical containers or closures arranged in the holding devices can be reached, particularly when the device has only one punch and only one counter-element.
[0022] In other words, the central longitudinal axis of the counter element is the normal vector of a plane. The plane is an XY plane, dh The holding devices, punch, and counter element are movable relative to each other along the X-axis and the Y-axis. The drive device of the punch can be configured such that the punch can be moved not only along its central longitudinal axis, but also in a plane orthogonal to it.
[0023] Conveniently, the counter element and / or the first holding device can each be movable by means of a further drive device. The counter element and / or the first holding device can each be movable, in particular, along the central longitudinal axis of the counter element or along the central longitudinal axis of the counter element and along a plane oriented orthogonally to the central longitudinal axis.
[0024] The second holding device, if designed separately from the plunger or counter element, can be moved manually or by means of a drivable handling device from a ready position to the first holding device in order to provide one or more closures to the pharmaceutical containers. The use of a handling device can ensure that no contamination of the pharmaceutical containers occurs and can achieve precise alignment of the second holding device to the first holding device. The drivable handling device can be designed, for example, as a robot.
[0025] The device can have a controller for controlling the drive device, for example the drive device of the plunger. The controller is designed to control the drive device in such a way that the closure is pressed onto the pharmaceutical container by means of a force control or a force-displacement control. Force or force and displacement can be detected during pressing and thus monitored. The controller can be electrically or electronically coupled to the force sensor, i.e. an output signal from the force sensor is input to the controller. A displacement sensor can be provided, in particular on the closure plunger, the output signal of which is input to the controller as a further input signal. The controller can also be coupled to further drive devices of the first holding device or of the counter element in order to control these.
[0026] Alternatively, a spring element can be provided, by means of which the force applied during closing can be controlled. Thus, the force applied during the closing process can be controlled via a spring element. In this case, a control system is unnecessary.
[0027] Advantageously, the first holding device and / or the second holding device can each be designed as a holding section that is attached to the stamp or the counter-element. Thus, the holding devices are each formed directly on the stamp or counter-element or integrated into them. As a result, a closure or a container can be inserted directly into or coupled to an associated holding device, with the holding device being attached to the stamp or counter-element. This allows for a particularly simple design of the device, e.g., for individually closing a container with a closure.
[0028] As already indicated above, the holding devices can alternatively be designed separately from the punch or the counter-element. Within the scope of such a separate design, it is conceivable that the punch, when the drive device is driven, can penetrate through a passage formed in the second holding device in order to come into contact with the closure. The counter-element, if designed as a further punch, can penetrate through a further passage formed in the first holding device in order to come into contact with the container at the end of the container facing away from the opening. The punch or the counter-element can thus act directly on the closure or the container. This contributes to a precise closing process.
[0029] Advantageously, the first holding device and the counter element (if the holding devices are designed separately) can be designed to be movable relative to one another along a central longitudinal axis of the counter element. This allows a pharmaceutical container arranged in the first holding device to be raised relative to the holding device. Thus, the pharmaceutical container can be raised for a force measurement shortly before or during a closing process. This contributes to precise force measurement, since the force is introduced into the plunger or the counter element when pressing or closing the closure onto the container, and thus directly into the force sensor and not into the first holding device.
[0030] Advantageously, the first holding device and / or the second holding device can have a plurality of holding sections. Each holding section of the first holding device can accommodate a pharmaceutical container, and each holding section of the second holding device can accommodate a closure. Consequently, the holding devices can each be equipped with a plurality of pharmaceutical containers or closures. This promotes time-efficient closing of the pharmaceutical containers, since refilling is not necessary after each closing. The holding sections in the holding devices can each be arranged adjacent to one another in a row or column. An arrangement in a plurality of rows and columns is also conceivable. The holding devices can each be a nest for receiving a plurality of pharmaceutical containers or closures.
[0031] The counter element can be conveniently designed as a fixed plate, if necessary, or as an additional stamp (counter stamp). Designing the counter element as a fixed plate contributes to a structurally simple design of the device. Designing the counter element as an additional stamp contributes to the targeted actuation of individual containers or closures. The additional stamp can be fixed or optionally movable.
[0032] Specifically, the device can comprise multiple plungers and multiple counter-elements, in particular, multiple additional plungers with force sensors. Thus, multiple pharmaceutical containers can be sealed in parallel or simultaneously and monitored during sealing by a force sensor. Consequently, a shorter throughput time for a defined number of pharmaceutical containers results than in an embodiment of the device with only one sealing plunger and one counter-plunger.
[0033] The problem of the type mentioned above is also solved by a method having the features of the independent claim. Regarding the achievable advantages, reference is made to the relevant statements regarding the device.
[0034] The method for closing pharmaceutical containers, in which in particular a device as described above can be used, comprises at least the following steps: providing, aligning and pressing.
[0035] In the first step, at least one pharmaceutical container and at least one closure for closing an opening of the pharmaceutical container are provided. Such provision can be achieved, for example, by means of a first holding device for receiving at least one pharmaceutical container and / or by means of a second holding device for receiving at least one closure for closing an opening of the pharmaceutical container, as described above.
[0036] Subsequently, the pharmaceutical container and the closure are aligned relative to each other so that the closure and the opening of the pharmaceutical container are aligned. In other words, the container and closure should be aligned such that the closure fits onto the container. The pharmaceutical container and the closure can, in particular, be aligned such that the central longitudinal directions of the closure and the pharmaceutical container coincide. This can be achieved, for example, by driving drive devices of the first holding device and / or the counter element and / or the (first) plunger.
[0037] The closure is then pressed onto the pharmaceutical container to close the opening of the pharmaceutical container.
[0038] The closing process is monitored. For this purpose, the force applied to the pharmaceutical container is recorded when the closure is pressed on, particularly in the form of a force curve or a force-displacement curve.
[0039] Advantageously, the closure can be pressed onto the pharmaceutical container using force-controlled or force-displacement-controlled methods. This facilitates particularly precise pressing of the closure onto the container.
[0040] The closure can be pressed on by a drivable plunger. The plunger can be located on the side of the pharmaceutical container where its opening is located. The force applied to the pharmaceutical container can be detected by a force sensor, which can be arranged on the plunger or on a counter-element located on a second side of the container facing away from the first side, for example, on the side of the pharmaceutical container facing away from the opening. This allows the force applied to the closure by the plunger to be detected by a force sensor.
[0041] It may be advantageous to lift the pharmaceutical container shortly before or during the pressing-on of the closure. The pharmaceutical container can be lifted, in particular, by moving the counter-element and a first holding device that accommodates the pharmaceutical container. The counter-element and a first holding device move relative to each other along the central longitudinal axis of the counter-element.
[0042] The method can expediently provide that if no force or insufficient force is detected when pressing the closure onto the pharmaceutical container, the provision, alignment, and / or pressing of the closure onto the pharmaceutical container is repeated. Alternatively, the pharmaceutical container and / or the closure can be identified as a "defective container" and sorted out. For example, the controller can be coupled to a force sensor and / or a displacement sensor, which are input to the controller as input signals, as described above. The controller can control the drive device of the plunger and optionally also other drive devices of the counter element and the holding device accordingly.
[0043] For example, if a sufficiently large force or a corresponding force profile is detected by the force sensor, the pharmaceutical container is recognized as reliably sealed. If the force or force profile cannot be detected or is insufficiently large, the pharmaceutical containers can be reworked or rejected.
[0044] Likewise, in the case of multi-part closures (e.g. rubber stopper and aluminum crimp cap), when a second component of the closure is applied, it can be detected whether the first component of the closure is still present or is sitting on or on the opening.
[0045] The measures described in connection with the device or those explained below can be used to further develop the method.
[0046] The invention is explained below with reference to the figure, in which identical or functionally equivalent elements are provided with identical reference numerals, if necessary, but only once. They show: Fig.1 shows an embodiment of a device for closing pharmaceutical containers in a schematic, partially sectioned side view.
[0047] Figure 1 shows a device for closing pharmaceutical containers, the device being designated overall by the reference numeral 10.
[0048] The device 10 has a first holding device 12 and a second holding device 14.
[0049] The first holding device 12 has a plurality of holding sections 16. The holding sections 16 serve to receive pharmaceutical containers 18. Each pharmaceutical container 18 has an opening 24. A passage 20 is formed in each holding section 16 opposite the opening 24 of the pharmaceutical containers 18 on the first holding device 12.
[0050] The second holding device 14 serves to receive at least one closure 22 for closing an opening 24 of the pharmaceutical container 18. The closure 22 comprises a cap 26 and a rubber stopper 28. The second holding device 14 has in Figure 1 several holding sections 30 for closures 22. A passage 32 is formed on the second holding device 14 at the holding sections 30, adjacent to the closures 22.
[0051] The device of Figure 1comprises a first plunger 34 with a drive device 36 and a displacement sensor 38 arranged here, for example, on the plunger 34. The plunger 34 is referred to below in the example as the closure plunger 34. In the example, the closure plunger 34 is located on a side 35 of the pharmaceutical container 18 facing the opening 24 (arrangement of the closure plunger 34 along the direction of gravity above the container 18 and closure 22).
[0052] Furthermore, the device comprises a counter element 40 with a drive device 42. In the example, the counter element 40 is designed as an additional punch or counter punch 40. A force sensor 44 is also provided, which in the example is arranged on the counter punch 40. In the example, the counter punch 40 is arranged on the side 41 of the pharmaceutical container 18 facing away from the opening 24 (the counter punch 40 is arranged below the container 18 and closure 22 in the direction of gravity).
[0053] A controller 46 is provided for controlling the drive unit 36. The controller 46 is electrically connected to the force sensor 44 and the displacement sensor 38. The output signals from the displacement sensor 38 and the force sensor 44 are thus input to the controller 46.
[0054] In the example, the first and second holding devices 12, 14 are each formed separately from the closure punch 34 and the counter punch 40, respectively. The first and second holding devices 12, 14 are aligned with one another so that the closure 22 and the opening 24 of the pharmaceutical container 18 are aligned with one another.
[0055] The closure punch 34 and the counter punch 40 are designed to be movable relative to the first holding device 12 along an xy plane. The xy plane is oriented orthogonally to the central longitudinal axis 52 of the counter punch 40. The central longitudinal axis 50 of the closure punch 34 forms a z-axis. The closure punch 34 and the counter punch 40 are movable such that they can reach any position of a pharmaceutical container 18 to be closed. The closure punch 34 and the counter punch 40 are aligned with the central axis 48 of the pharmaceutical container 18 such that the central axes 48 of the pharmaceutical container 18, the central axis 50 of the closure punch, and the central axis 52 of the counter punch 40 are aligned with one another.
[0056] The counter-punch 40 can penetrate through the passage 20 by the drive unit 42 and come into contact with the pharmaceutical container 18. The pharmaceutical container 18 is lifted by the counter-punch 40 along its central longitudinal axis 48 relative to the first holding device 12.
[0057] The closure plunger 34 can penetrate through the passage 32 in the second holding device 14 by driving a drive unit 36 and thereby comes into contact with the closure 22 and presses it onto the pharmaceutical container 18 to close the opening 24 of the pharmaceutical container.
[0058] The device 10 comprises a force-displacement controlled monitoring of the closing process.
[0059] The force sensor 44 of the counter-punch 40 detects a force applied by the closure punch 34 when pressing the closure 22 onto the pharmaceutical container 18. The force is detected on or via the container 18.
[0060] The displacement sensor 38 of the closure plunger 34 detects the travel path of the closure plunger 34 when the closure 22 is pressed onto the pharmaceutical container 18.
[0061] The controller 46 is electrically coupled to the force sensor 44 and the displacement sensor 38, so that the output signals of the sensors are fed into the controller 46. The controller 46 is additionally coupled to the drive devices 36, 42 of the sealing punch and the counter punch and controls them.
Claims
1. Device (10) for closing pharmaceutical containers (18) by means of closures (22), having a first holding device (12) for receiving at least one pharmaceutical container (18), a second holding device (14) for receiving at least one closure (22) for closing an opening (24) of the pharmaceutical container (18), wherein the two holding devices (12, 14) are mutually alignable or are mutually aligned in such a way that the closure (22) and the opening (24) of the container (18) are aligned with one another, wherein a plunger (34) and a counter element (40) are provided, wherein the plunger (34) and / or the counter element (40), by means of a drive device (36, 42), can be driven and moved relative to one another, wherein, when the plunger (34) and the counter element (40) are moved toward one another when the drive device (36, 42) is driven, the plunger (34) acts on the closure (22) or on the container (18) in such a way that the closure (22) can come into contact with the container (18) and, in order to close the opening (24) of the container (18), can be pressed onto the container (18) by the interaction between the plunger (34) and the counter element (40), characterized in that a force sensor (44) is provided, by means of which a force applied by the interaction between the plunger (34) and the counter element (34) when the closure (22) is pressed onto the container (18) can be detected.
2. Device (10) according to claim 1, characterized in that the force sensor (44) is arranged on the plunger (34) or on the counter element (40).
3. Device (10) according to claim 1 or claim 2, characterized in that the plunger (34) and the counter element (40) are designed to be movable relative to the first holding device (12) along a plane, wherein the plane is oriented orthogonally to the central longitudinal axis (52) of the counter element.
4. Device (10) according to any of the preceding claims, characterized in that the counter element (40) and / or the first holding device (12) can each be moved, by means of a further drive device (42), along the central longitudinal axis (52) of the counter element (40), or along the central longitudinal axis (52) of the counter element (40) and along a plane aligned orthogonally to the central longitudinal axis (52).
5. Device (10) according to any of the preceding claims, characterized in that a controller (46) is provided for actuating the drive device (36), wherein the controller (46) is configured to actuate the drive device (36) in such a way that the closure (22) is pressed onto the container (18) by means of a force control or force-displacement control, or in that a resilient element is provided, by means of which the force applied during the closing can be controlled.
6. Device (10) according to any of the preceding claims, characterized in that the first holding device (12) and / or the second holding device (14) are each designed as a holding portion which is fastened to the plunger (34) or to the counter element (40).
7. Device (10) according to any of claims 1 to 5, characterized in that, when the drive device (36) is driven, the plunger (34) can pass through a passage (32), formed in the second holding device (14), in order to come into contact with the closure (22) and / or in that the counter element (40), if said counter element is designed as a further plunger (40), can pass through a further passage (20) formed in the first holding device (12), in order to come into contact with the container (18) on the end of the container (18) that faces away from the opening (24).
8. Device (10) according to any of claims 1 to 5 or 7, characterized in that the first holding device (12) and the counter element (40) designed as a further plunger (40) are designed to be movable relative to one another along a central longitudinal axis (52) of the counter element (40), so that a container (18) arranged in the first holding device (12) can be raised relative to the first holding device (12).
9. Device (10) according to any of the preceding claims, characterized in that the first holding device (12) has a plurality of holding portions (16), in each of which a container (18) can be received, and / or in that the second holding device (14) has a plurality of holding portions (30), in each of which a closure (22) can be received.
10. Device (10) according to any of the preceding claims, characterized in that the counter element (40) is designed as a plate or as a further plunger.
11. Device (10) according to any of the preceding claims, characterized in that the device (10) has a plurality of plungers (34) and a plurality of counter elements (40), in particular a plurality of further plungers (40) with a force sensor (44).
12. Method for closing pharmaceutical containers (18) by means of closures (22) using a device (10) according to any of the preceding claims, wherein the method comprises the following steps: - providing at least one pharmaceutical container (18) and at least one closure (22) for closing an opening (24) of the container (18), - aligning the pharmaceutical container (18) and the closure (22) relative to one another, so that the closure (22) and the opening (24) of the container (18) are aligned with one another, - pressing the closure (22) onto the container (18) in order to close the opening (24) of the pharmaceutical container (18), characterized in that, for the purpose of monitoring the closing process, when the closure (22) is pressed on, the force applied to the pharmaceutical container (18) is detected, in particular in the form of a force curve or a force-displacement curve.
13. Method according to claim 12, characterized in that the closure (22) is pressed onto the container (18) in a force-controlled or force-displacement-controlled manner, and / or in that the closure (22) is pressed on by a drivable plunger (34) which is arranged on a first side (35) of the container (18), for example, on the side (35) on which the opening (24) of the container (18) is arranged, wherein the force applied to the container (18) is detected by a force sensor (44) which is arranged on the plunger (34) or on a counter element (40), which is arranged on a second side (41) of the container (18) that faces away from the first side (35), for example, on the side (41) of the container (18) that faces away from the opening (24).
14. Method according to claim 13, characterized in that, shortly before or when the closure (22) is pressed on, the container (18) is raised along the central longitudinal axis (52) of the counter element (40), in particular by moving the counter element (40) and a first holding device (12), which receives the container (18), relative to one another.
15. Method according to any of claims 12 to 14, characterized in that if, when the closure (22) is pressed onto the container (18), no force or no sufficiently high force is detected, then the provision, alignment and / or pressing of the closure (22) onto the container (18) is repeated, or in that the container (18) and / or the closure are sorted out.
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