Apparatus and method for force controlled closure of a pharmaceutical container

By using a force-controlled sealing process, and by aligning and controlling the sealing force with pressure units and mating elements, the problem of inconsistent sealing of drug containers caused by path control in the prior art is solved, and a reliable sealing effect of drug containers is achieved.

CN116867709BActive Publication Date: 2025-11-11SYNTEGON TECHNOLOGY GMBH
View PDF 2 Cites 0 Cited by

Patent Information

Application Number
CN202280016172.0
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2021-02-23
Filing Date
2022-02-22
Publication Date
2025-11-11
Estimated Expiration
2042-02-22

AI Technical Summary

Technical Problem

Existing drug container sealing devices may suffer from manufacturing tolerance issues due to path-controlled design, which could lead to glass breakage, damage to the sealing components, or incorrect container closure, thus failing to guarantee a reliable seal.

Method used

The sealing process employs a force-controlled method, aligning the closure element and container opening via first and second retaining devices, and utilizing a pressure unit and mating elements to move along the closure element's moving axis. The sealing force is controlled to ensure that the sealing process stops once the maximum contact pressure is reached, independent of the path travel distance.

Benefits of technology

It achieves reliable and reproducible drug container sealing, compensates for manufacturing tolerances, avoids damage caused by over-sealing, and ensures that each container is uniformly and reliably sealed.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN116867709B_ABST
    Figure CN116867709B_ABST
Patent Text Reader

Abstract

The present invention relates to a device (10) for sealing a drug container (12) by means of a closure (14).
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] This invention relates to an apparatus for sealing a drug container by means of a closure element. Furthermore, this invention relates to a method for sealing a drug container by means of a closure element. Background Technology

[0002] The aforementioned types of apparatus and methods are known from the prior art, for example from US10 781 003 B2. Such apparatus allows multiple closure elements to be pressed simultaneously onto multiple drug containers.

[0003] Known devices operate in a path-controlled manner. This means that the closure element is always pressed, pushed, or moved the same distance onto or into the drug container. Multiple closures or closure elements are arranged together on a plate and moved a certain distance in the direction of the drug container to be closed. In this path-controlled closure of multiple drug containers with closures by means of a common plate, a disadvantage is that glass breakage, closure damage, or improper container closure may occur due to manufacturing tolerances in the height of the drug container or closure. These failures may also be caused by manufacturing tolerances in the device or in the container's nest / carrier. This means that a reliable seal of the container cannot be adequately guaranteed. Summary of the Invention

[0004] The objective of this invention is to provide an improved apparatus or method for ensuring a reliable and reproducible closed process.

[0005] This invention addresses the task by means of a device for sealing a drug container using a closure element. The sealing process is not path-controlled, but rather force-controlled through a simple design.

[0006] The device has a first holding device. The first holding device is located in a first plane. The first holding device is designed to hold at least one medicine container. In particular, it can accommodate multiple containers. The containers can be received in the holding device individually or in a nest (when handling containers in a nest case). Therefore, the holding device can also be designed to receive nests or other types of carriers with containers. For this purpose, a corresponding receiving portion can be provided in the first holding device, which can hold the nest.

[0007] The second retaining device is located in a second plane parallel to and spaced apart from the first plane. The second retaining device is designed to receive at least one closure for sealing the opening of a drug container. In particular, multiple closures can be received. The closures can be received individually or within the nest (when handling the closures of a nest cover) in the retaining device. Therefore, the retaining device can also be designed to receive a nest or a carrier with closures formed in other ways. For this purpose, a corresponding receiving portion can be provided in the second retaining device to hold the nest.

[0008] The two retaining devices are aligned with each other or can be aligned with each other so that the closure and the opening of the container are aligned.

[0009] The device includes at least one pressure unit carrying a pressure element (particularly a piston with a pin-shaped design), a mating element, and a drive mechanism.

[0010] With the aid of a drive mechanism, the mating element and the pressure unit can move relative to each other along a closure axis orthogonal to the plane.

[0011] As the pressure unit (carrying a pressure element connected to it) and the mating element move toward each other, the closure and the container come into contact with each other between the pressure element and the mating element. Due to further movement / processing toward each other, the closure and the container are subjected to force / pressure between the pressure element and the mating element, such that the closure is pressed onto or into the container in the direction of the closure's axis of movement to close the container's opening.

[0012] According to the invention, the pressure element is mounted such that it can be translated into the pressure unit in the direction of the closure's axis of movement. The movable mounting structure is designed to resist movement of the pressure element relative to the pressure unit. The movable mounting structure is designed such that the maximum contact force acting on the container and the closure, particularly the adjustable maximum contact force, is specified by it. In other words, the maximum contact pressure required for the container and the closure to be pressed against / into each other can be preset.

[0013] The device according to this application enables a force-controlled and path-independent closure process of a drug container.

[0014] The movable mounting structure of the pressure element relative to the pressure unit determines the maximum contact pressure or maximum contact force acting between the container and the closure. The closure is pressed against or into the container. When the closure contacts the container, a contact pressure or contact force is generated for the closure process. The closure process for the container continues until a specified maximum contact pressure is reached (e.g., the closure can be pushed deeper and deeper into the container). If the maximum contact pressure (or maximum contact force) specified by the movable mounting structure is exceeded, the pressure element translates in a direction opposite to the direction in which the closure and the container move towards each other along the closure's axis of movement toward the pressure unit. Therefore, the contact pressure applied to the closure and the container by the pressure element does not increase further, and the closure process is completed. During this "yielding" (movement toward or into the pressure unit), the pressure element may maintain the maximum contact pressure, i.e., force, acting on the closure and the container, or the pressure element may reduce or completely release said force. However, the force used to press the closure and the container into / on each other does not increase via the contact pressure.

[0015] Therefore, the container sealing process depends on a specified maximum contact pressure or maximum contact force, which is specified by the movable mounting structure and is independent of the path. When the maximum contact pressure (which is typically specified such that it corresponds to the pressure required to reliably seal the container) is reached, the pressing / pressing process terminates, and the pressure or force used to press the container and closure against each other no longer increases. This termination criterion is independent of the distance the pressure element or pressure unit has moved. After the maximum contact pressure has been reached, the pressure element effectively yields in the direction of the pressure unit. Therefore, manufacturing tolerances of the container can be compensated for using the device according to the invention. Furthermore, even if, for example, the closure is improperly positioned on the container and cannot be properly pressed in or pressed on, the contact force will not increase further.

[0016] The device can be designed to have only one pressure element and one mating element, such that only one drug container is sealed at a time. If multiple drug containers need to be sealed, this can be done sequentially or simultaneously. Due to manufacturing tolerances, the end distance between the pressure element and mating element of the first container closure pair may differ from the end distance between the pressure element and mating element of the second container closure pair.

[0017] Drug containers can be vials (injection bottles), syringes, or cartridges.

[0018] Suitable closures are provided for various drug containers. These closures may be press-fit caps (caps with integrated rubber stoppers), rubber stoppers with aluminum press-fit caps, vial stoppers, syringe stoppers, or cartridge stoppers.

[0019] Alignment of the closure and the opening of the drug container refers to the following arrangement: the closure can be fitted or inserted into or onto the container, thereby closing the opening. For alignment, the central longitudinal axis of the closure can be aligned with the central longitudinal axis of the drug container.

[0020] The pressure unit may be fixed in the device, and the mating element may be movable relative to the pressure unit. Alternatively, the mating element may be fixed in the device, and the pressure unit may be movable. Both the pressure unit and the mating element may also be movable in the device.

[0021] The pressure unit and mating element can be moved toward each other along the axis of movement of the closure by means of a drive device. The drive device can move the pressure unit, the mating element, or both the pressure unit and the mating element, or it can be designed and arranged for this purpose. Additional drive devices can also be provided such that both the pressure unit and the mating element include a drive device.

[0022] The pressure element can be specifically designed as a pin-shaped piston, but it can also be designed as a cylindrical pin, cuboid, cylindrical disk, or plate (circular or angular). Various shapes are conceivable, such as shapes suitable for corresponding openings in a nest; for example, the pressure element can have a clover shape.

[0023] The mating elements can be designed as pin-shaped pistons, cylindrical pins, cuboids, cylindrical disks, or plates. Various shapes are conceivable; for example, they can also be shapes suitable for corresponding openings in the nest, such as clover shapes.

[0024] Multiple pressure elements and common mating elements, particularly plate-shaped mating elements, can be provided, which serve as mating support structures.

[0025] In an advantageous embodiment, one (or more) drive devices may be mechanical, pneumatic, hydraulic or electric.

[0026] The mating elements can be arranged below and above the container and closure along the direction of gravity. If the mating elements are arranged above the container and closure (with the pressure unit carrying the pressure element arranged accordingly below), the mating elements can act on the closure, thereby pressing the closure against the container. If the mating elements are arranged below the container and closure (with the pressure unit carrying the pressure element arranged above), the mating elements can act on the container, thereby pressing the closure against the container.

[0027] The contact force used to seal drug containers is typically in the range of 20N to 100N per container and closure.

[0028] Pressure elements can be connected to the pressure unit via mechanical, pneumatic, hydraulic, or electric pressure limiting devices. Combinations of various types of pressure limiting devices are also possible. A pressure limiting device restricts the compressive force that can be applied or the limit value that can be specified by it.

[0029] In particular, pressure limiting devices may include a combination of mechanical and pneumatic components, such as springs, especially compression springs or disc springs, that can be combined with cylinders.

[0030] The first holding device and / or the second holding device may be designed to be movable relative to the pressure unit and / or the mating element in the direction of the closure movement axis.

[0031] In one example, the first retaining device is fixed, and the second retaining device is movable. During the closure process, the second retaining device moves toward the first retaining device in the direction of the closure movement axis, for example, by a drivable mating element or a drivable pressure unit. The container arranged on the first retaining device and the closure member arranged on the second retaining device contact each other for pressing the closure member onto or into the container. Other combinations are conceivable; for example, the first retaining device may also be movable relative to the second retaining device in the direction of the closure member movement axis. When the drivable pressure unit moves, the first retaining device also moves in the direction of the second retaining device to bring the container and the closure member into contact.

[0032] Embodiments of the present invention, particularly those with a drivable pressure unit, can be configured such that the pressure element passes through a channel in the first holding device to contact the container from a side opposite the opening of the container (from the side of the bottom of the container).

[0033] The device can be designed, for example, to enclose containers with different extension dimensions in the direction of the enclosing axis of movement. Pressure elements with different extension dimensions or basic positions in the direction of the enclosing axis of movement can be provided.

[0034] In an embodiment of the invention with a drivable mating element, the drivable mating element can contact a movable second retaining device (with a closure) on a side opposite to the closure. In this respect, the second retaining device can be moved relative to the first retaining device in the direction of the closure's movement axis by the drivable mating element, so that the closure contacts the container. In an alternative embodiment, the drivable mating element can be disposed on a side of the first retaining device (in which the container is received).

[0035] The device may include a controller for controlling the drive unit and / or additional drive units. The controller is designed to control the drive unit and / or additional drive units such that closing the container opening with the closure is force-controlled. Specifically, the controller is designed to abort the pressing / pressing process after the maximum contact force has been reached. However, the abort may not occur immediately upon reaching the maximum contact force, but rather after the pressure unit and mating element have moved further toward each other following the achievement of the maximum contact force. For example, a certain distance may be specified, and then the distance may be further reduced after reaching that distance. Alternatively, a certain distance must be traveled at the achieved maximum contact force before abort. This prevents erroneous termination due to brief force spikes.

[0036] Specifically, the device may include one or more force measuring devices. These force measuring devices can detect the forces acting on all container / closure pairs between the pressure unit and the mating element. If multiple force measuring devices are present, specifically, one force measuring device may be provided for each pressure element, the force measuring device being designed to detect the forces on the corresponding container / closure pair.

[0037] The force measuring device can be connected to the controller by means of a signal.

[0038] The first retaining device may have multiple receptacles for the container. Furthermore, the second retaining device may have corresponding multiple receptacles for the closure. The pressure unit may include corresponding multiple pressure elements. The pressure elements may be connected to the pressure unit via corresponding multiple pressure limiting devices. The pressure elements may also be connected to the pressure unit via a common pressure limiting device.

[0039] For example, they can all be held in place relative to the pressure unit via a common pneumatic pressure chamber. If the pneumatic pressure in the pressure chamber is exceeded when the closure is pressed, the pressure element yields. The contact pressure is thus limited to the specified pneumatic pressure in the pressure chamber. Similarly, the pressure can be specified hydraulically, electrically, or electromechanically. Each pressure element can also have its own pressure limiting device, which allows its individual contact pressure to be preset.

[0040] The receiving portion of the first retaining device can be designed such that the container can be held securely within the first retaining device with some play or by clamping. The first retaining device can also be designed without a separate receiving portion, allowing the containers to be held loosely against each other.

[0041] In one embodiment, the second retaining device may be designed to securely hold the closure in a clamping manner, or may be received in the second retaining device with clearance and capable of translational displacement along the movement axis of the closure.

[0042] The aforementioned task is also solved by the method according to this application. For the advantages and further improvements of the method, refer to the explanation relating to the apparatus.

[0043] A method for sealing a drug container, wherein the device described above may be used in particular, includes at least the following steps: providing, aligning and pressing or pressing in.

[0044] In the first step (providing), at least one drug container and at least one closure for sealing the opening of the container are provided. As described above, this provision can be made, for example, by means of a first holding device for receiving at least one drug container and / or by means of a second holding device for receiving at least one closure for sealing the opening of the drug container.

[0045] Subsequently (alignment), the drug container and closure are aligned relative to each other such that the opening of the closure and the container are aligned with each other. In other words, the container and closure will be aligned so that the closure is fitted onto or into the container. In particular, the drug container and closure can be aligned such that the central longitudinal axis of the closure coincides with the central longitudinal axis of the drug container. This can be achieved, for example, by constructing retaining devices that are aligned with each other or by a drive mechanism that actuates one or both retaining devices.

[0046] Subsequently (pressed on or pressed in), the closure is pressed onto or into the container along the closure's movement axis to seal the opening.

[0047] During the closure process, the container and closure are pressed against each other in a controlled manner. During the closure process, the contact pressure between the container and closure is applied only to a predefined value that reaches the maximum contact pressure. This reliably prevents damage caused by excessive force.

[0048] Multiple containers can be closed simultaneously with their respective closures. In one embodiment, as described above, the containers can be received, with clearance or by clamping, in multiple receptacles of a first retaining device, and the closures can be received accordingly in multiple receptacles of a second retaining device.

[0049] The container and closure can be pressed together by the pressure between the corresponding pressure element and the mating element.

[0050] For all containers and closures, the contact pressure or contact force can be the same. The maximum contact pressure can be specified in particular by connecting the pressure element to a pressure limiting device of the pressure unit.

[0051] A first end distance may be created between a first pressure element and its associated mating element, with a first container closure pair disposed between the first pressure element and its associated mating element. A second end distance may be created between a second pressure element and its associated second mating element, with a second container closure pair disposed between the second pressure element and its associated second mating element. The first end distance and the second end distance may be different.

[0052] The end distance defines the distance between the pressure element and its associated mating element when the container closure process is complete (after the maximum contact pressure has been reached). The end distance between the pressure element and its associated mating element depends on the extension dimension of the container (or closure) in the direction of the closure's movement axis, particularly its height. This can vary for containers of the same type due to manufacturing tolerances. Because of the different extension dimensions of the containers in two container / closure pairs, the respective containers and closures can contact each other at different distances between the pressure element and its associated mating element. Therefore, for two container-closure pairs with containers having different extension dimensions in the direction of the closure's movement axis, the contact pressure required for closure is set at different end distances.

[0053] The closure can be pressed on or pressed in by a driveable mating element. The mating element can be arranged on a first side of the container, for example, on the side where the container opening is located.

[0054] The drivable mating element can apply a closing force toward the second side of the container opposite to the first side in the direction of the closing element's movement axis.

[0055] In another embodiment of the method, the pressing or pressing of the closure can be performed by a driveable pressure unit carrying a pressure element. The driveable pressure unit carrying the pressure element can be arranged on a first side of the container, for example, on the side opposite the opening of the container. A non-movable mating element can be arranged on the side of the container opposite the first side. The non-movable mating element can apply a closing force as a reaction force against the direction of movement of the driveable pressure unit carrying the pressure element.

[0056] The maximum contact pressure or force between the container and the closure can be limited by a pressure limiting device that connects a pressure unit to a pressure element. The maximum contact pressure or force between the container and the closure is adjustable via the pressure limiting device, particularly for different containers and different container masses.

[0057] In an advantageous embodiment of the method, simultaneous or individual adjustment of the maximum contact pressure can be performed using a pressure limiting device. The pressure limiting device can be designed to allow simultaneous adjustment of the maximum contact pressure, for example, by connecting multiple pressure elements to the pressure unit using only one pressure limiting device, to achieve a simple design implementation. Alternatively, the maximum contact pressure can be adjusted individually, for example, by connecting each pressure element to the pressure unit via a corresponding pressure limiting device. This facilitates a more precise closure process.

[0058] For further embodiments of the method, the aspects described in conjunction with the apparatus or those to be explained below may work. Attached Figure Description

[0059] The invention is explained below with reference to the accompanying drawings, in which identical or functionally identical elements are given the same reference numerals, but are given only once where applicable. The drawings show:

[0060] Figure 1 This is a schematic partial cross-sectional side view of a device for closing a drug container by means of a driveable mating element.

[0061] Figure 2 It is a schematic partial cross-sectional side view of a device for sealing a drug container by means of an actuated pressure unit. Detailed Implementation

[0062] Figure 1 An apparatus for sealing a drug container is shown, which is indicated as a whole by reference numeral 10.

[0063] The device 10 has a first holding device 16 and a second holding device 20.

[0064] The first holding device 16 has a plurality of receiving portions 44. The receiving portions 44 are for receiving drug containers 12. (The holding device 16 may also have a single receiving portion for receiving a nest of containers.) Each drug container 12 includes an opening 24. Each of the receiving portions 44 has a channel 40. The channel 40 is arranged opposite to the opening 24 of each drug container 12.

[0065] The second retaining device 20 includes a plurality of receiving portions 46. The receiving portions 46 are for receiving the closure element 14 for closing the opening 24 of the container 12. (The retaining device 20 may also have a single receiving portion for receiving a nest of closure elements.)

[0066] Figure 1 The device 10 includes a mating element 28 having a drive mechanism 30. Figure 1 In the device 10, the mating element 28 is in the form of a plate.

[0067] exist Figure 1 In this configuration, the mating element 28 has two cylindrical first stops 21. The first stops 21 protrude vertically from the end face 23 of the mating element 28. The end face 23 of the mating element 28 is designed to contact the second retaining device 20. The first stops 21 are laterally adjacent to the retaining device 20, respectively.

[0068] The device 10 has a controller 38 for controlling the drive unit 30. The controller 38 is connected to the drive unit 30 by means of signals.

[0069] The device 10 has a pressure unit 34 with a pressure element 26. Figure 1 In this configuration, pressure element 26 is designed as a pin-shaped piston. Pressure element 26 is connected to pressure unit 34 via pressure limiting device 52. Pressure limiting device 52 adjustably specifies the contact force that can be applied by pressure element 26.

[0070] A cylindrical second stop 35 is arranged on both sides of the pressure unit 34. The longitudinal axis of the second stop is parallel to the central longitudinal axis of the pressure element. The stops extend in the same direction as the pressure element 26. The distance between the second stops is the same as that between the first stops on the mating element 28.

[0071] The first retaining device 16 is arranged to extend in the first plane 18. The second retaining device 20 is arranged to extend in the second plane 22. The second plane 22 is arranged parallel to and spaced apart from the first plane 18. The first and second retaining devices 16 and 20 are aligned with each other such that the closure 14 and the opening 24 of the container 12 are aligned with each other.

[0072] In this example, the mating element 28 is located on the side 48 of the container 12 facing the opening 24, parallel to the plane 22 (the mating element 28 is arranged above the container 12 and the closure 14 along the direction of gravity).

[0073] A pressure unit 34 carrying a pressure element 26 is arranged on the side 50 of the container 12 opposite to the opening 24 of the container 12, parallel to the plane 18 (the pressure unit 34 is arranged below the container 12 along the direction of gravity).

[0074] The first and second holding devices 16 and 20 are formed separately from the mating element 28 and the pressure unit 34 and are respectively arranged between the mating element 28 and the pressure unit 34. The first holding device 16 is spaced apart from the pressure unit 34.

[0075] The pressure element 26 protrudes from the pressure unit 34 in the direction of the first holding device 16. The pressure element 26 is arranged in the pressure unit 34 such that it passes through the channel 40 and contacts the container 12 on the side opposite the opening 24 of the container 12 (in other words, the container 12 rests on the pressure element 26). In this configuration, the pressure element 26 is mounted to be translatably movable relative to the pressure unit 34 in a direction orthogonal to the closure axis 32 of the planes 18, 22. The movable mounting structure is designed to allow for presetting, and in particular adjusting, the maximum contact pressure applied between the container 12 and the closure 14 during the closure process.

[0076] Furthermore, the first and second retaining devices 16 and 20 are movably mounted relative to the pressure unit 34 in the direction of the closing member's moving axis 32. The first retaining device 16 is mounted via a second stop. Furthermore, the second retaining device 20 is movably arranged in the direction of the closing member's moving axis 32 and relative to the first retaining device 16.

[0077] The mating element 28 can be moved relative to the pressure unit 34 in the direction of the closing member movement axis 32 by the drive device 30. The movement of the mating element 28 toward the pressure unit 34 corresponds to the closing movement direction.

[0078] When the mating element 28 moves in the closing movement direction, the closure 14 contacts the container 12 and presses against the container 12.

[0079] Contact pressure acts between container 12 and closure 14 to press closure 14 onto container 12. As closure 14 is pressed onto container 12, the contact pressure increases. When the contact pressure between each container 12 and its corresponding closure 14 reaches the maximum contact pressure predetermined by the installation of pressure element 26, pressure element 26 moves along closure movement axis 32. Essentially, the pressure element yields, thereby limiting the maximum contact force acting on the container.

[0080] Due to manufacturing tolerances, container 12 may have different extension dimensions in the direction of the closure movement axis 32. Therefore, closure 14 and container 12 will not reach maximum contact pressure at the same travel distance of pressure element 26 or at the same time.

[0081] All containers 12 are positioned on pressure elements 26. Via pressure limiting device 52, the maximum contact pressure is set to the same value for each pressure element 26. In other words, the installation of the pressure elements 26 yields when the same pressure or force is reached.

[0082] When the contact pressure between the closure 14 and the container 12 reaches the maximum contact pressure, as the pressure unit 34 and the mating element 28 continue to move toward each other, the corresponding pressure element 26 yields and moves into the pressure unit 34, thereby maintaining the maximum contact pressure.

[0083] If the maximum contact pressure is achieved at different travel distances of the two pairs of container closures, the end distance between the pressure element 26 and the mating element 28 of the first container closure pair 12, 14 may be different from the end distance between the pressure element 26 and the mating element 28 of the second container closure pair 12, 14.

[0084] The first stop arranged on the mating element 28 and the second corresponding stop arranged near the pressure unit 34 are designed to contact each other and limit the maximum travel distance of the mating element 28 relative to the pressure unit 34 during closed movement.

[0085] Figure 2 It shows Figure 1 An alternative embodiment of the device 10 shown.

[0086] and Figure 1 Compared to the device 10 shown, the mating element 28 is fixed. The pressure unit 34 can be moved relative to the mating element 28 along the closure movement axis 32 by means of the drive device 30.

[0087] The movement of pressure unit 34 toward mating element 28 corresponds to Figure 2 The closed movement direction in device 10.

[0088] As the pressure unit 34 moves along the closure axis 32 onto the mating element 28, the pressure element 26 passes through the channel 40 in the direction of the closure axis 32 and presses the container 12 out of the holding device 16. During this process, the container 12 contacts the closure 14, and the container 12 is pressed into the closure 14 (or the closure 14 is pressed onto the container 12). Pressing continues until a predetermined maximum contact pressure or force is exceeded, which can be set via the pressure limiting device 52 for the installation of the pressure element 26, and the pressure element 26 does not actually move further, but rather moves into the pressure unit 34 as the pressure unit 34 moves further toward the mating element 28.

[0089] according to Figure 1 The device 10 can compensate for manufacturing tolerances in the extension dimension of the container 12 on the closure movement axis 32, thereby assigning each container 12 to be closed to a pressure element 26.

Claims

1. An apparatus (10) for sealing a drug container (12) by means of a closure (14), comprising a first retaining device (16) located in a first plane (18) for receiving at least one drug container (12), and a second retaining device (20) located in a second plane (22) parallel to and spaced apart from the first plane (18) for receiving at least one closure (14) for sealing an opening (24) of the drug container (12), wherein, Two retaining devices (16, 20) are aligned or can be aligned with each other such that the closure (14) is aligned with the opening (24) of the drug container (12). The device (10) includes a mating element (28) and at least one pressure unit (34) carrying a pressure element (26). The device (10) includes a drive device (30) by means of which the mating element (28) and the pressure unit (34) are movable along an axis (3) of the closure orthogonal to the first plane (18) and the second plane (22). 2) While moving relative to each other, during the movement of the pressure unit (34) carrying the pressure element (26) and the mating element (28) toward each other, the closure (14) and the drug container (12) come into contact between the pressure element (26) and the mating element (28), and are pressurized between the pressure element (26) and the mating element (28), such that the closure (14) is pressed onto or into the drug container (12) by contact force in the direction of the closure movement axis (32) to close the opening (24) of the drug container (12). The feature is that the pressure element (26) is mounted to be translatably movable relative to the pressure unit (34) in the direction of the closure movement axis (32), and the movable mounting structure is designed such that the movable mounting structure resists the movement of the pressure element relative to the pressure unit and the maximum contact pressure applied to the drug container (12) and the closure (14) during closure operation is predetermined by the movable mounting structure, and the contact force is the same for all drug containers (12) and closures (14), and the first pressure element (26) and the first pressure The first end distance between the mating elements (28) associated with the element (26) and the second end distance between the second pressure element (26) and the second mating element (28) associated with the second pressure element (26) are different. The first container-closure pair (12, 14) is arranged between the first pressure element (26) and the mating element (28) associated with the first pressure element (26), and the second container-closure pair (12, 14) is arranged between the second pressure element (26) and the second mating element (28) associated with the second pressure element (26).

2. The device (10) according to claim 1, characterized in that, The pressure element (26) is connected to the pressure unit (34) via a mechanical, pneumatic, hydraulic or electric pressure limiting device (52), which limits the contact force that can be applied by the pressure element (26).

3. The apparatus (10) according to any one of the preceding claims, characterized in that, The first holding device (16) and / or the second holding device (20) are designed to be movable relative to the pressure unit (34).

4. The apparatus (10) according to claim 1 or 2, characterized in that, The mating element (28) in the device (10) can be translated relative to the pressure unit (34) along the moving axis (32) of the closure by means of the drive device (30), or the mating element (28) can be arranged immovably in the device (10).

5. The apparatus (10) according to claim 1 or 2, characterized in that, The pressure unit (34) in the device (10) can be translated relative to the mating element (28) along the moving axis (32) of the closure by means of a drive device (30) or another drive device (36), or the pressure unit (34) is arranged immovably in the device (10).

6. The apparatus (10) according to claim 1 or 2, characterized in that, A controller (38) is provided for controlling the drive unit (30) and / or an additional drive unit (36), the controller (38) being designed to control the drive unit (30) and / or the additional drive unit (36) such that the closure of the opening (24) of the drug container (12) by the closure member (14) is carried out in a force-controlled manner.

7. The apparatus (10) according to claim 1 or 2, characterized in that, A pressure unit (34) carrying a pressure element (26) is arranged on the side of the first retaining device (16). The pressure element (26) passes through a channel (40) formed on the first retaining device (16) during a closing operation for contacting the drug container (12) so as to contact the drug container (12) at the end opposite to the opening (24). A mating element (28) is arranged on the side of the second retaining device (20). Alternatively, a pressure unit (34) carrying a pressure element (26) is arranged on the side of the second retaining device (20). The pressure element (26) passes through a channel (42) formed on the second retaining device (20) during a closing operation for contacting the closure (14) so ​​as to contact the closure (14) on the side opposite to the opening (24). A mating element (28) is arranged on the side of the first retaining device (16).

8. The apparatus (10) according to claim 1 or 2, characterized in that, The first holding device (16) includes a plurality of receptacles (44) for the drug container (12), the second holding device (20) includes a plurality of corresponding receptacles (46) for the closure (14), and the pressure unit (34) carries a plurality of corresponding pressure elements (26), which are connected to the pressure unit (34) via a plurality of corresponding pressure limiting devices (52) or via a common pressure limiting device (52).

9. The apparatus (10) according to claim 1 or 2, characterized in that, The pressure limiting device (52) is designed to preset the same maximum contact force acting on the drug container (12) and the closure (14), or the pressure limiting device (52) is designed to preset the maximum contact force acting on the drug container (12) and the closure (14) in an individually adjustable manner.

10. The apparatus (1) according to claim 1 or 2, characterized in that, The pressure element (26) is a piston with a pin design.

11. The apparatus (1) according to claim 1 or 2, characterized in that, The movable mounting structure is designed such that the maximum contact pressure applied to the drug container (12) and the closure (14) during closure operation is predetermined by the movable mounting structure in an adjustable manner.

12. The apparatus (1) according to claim 3, characterized in that, The first retaining device (16) and / or the second retaining device (20) are designed to be movable along the moving axis (32) of the closure.

13. The apparatus (1) according to claim 6, characterized in that, The controller (38) is designed to interrupt the press-in / press-up operation after the maximum contact force has been reached.

14. The apparatus (1) according to claim 13, characterized in that, The controller (38) is designed not to interrupt immediately when the maximum contact force is reached, but to interrupt after the pressure unit and the mating element have moved further toward each other after the maximum pressing force is reached.

15. The apparatus (1) according to claim 9, characterized in that, The pressure limiting device (52) is designed to preset the same maximum contact force acting on the drug container (12) and the closure (14) in an adjustable manner.

16. A method for sealing a drug container (12) by means of a closure (14) using the device (10) according to any one of the preceding claims, the method comprising the steps of: - Provide at least one drug container (12) and at least one closure (14) for closing the opening (24) of the drug container (12), - Align the drug container (12) and the closure (14) relative to each other such that the closure (14) and the opening (24) of the drug container (12) are aligned with each other, - Press the closure (14) onto or into the drug container (12) along the closure movement axis (32) to close the opening (24), characterized in that the drug container (12) and the closure (14) are pressed into or onto each other in a force-controlled manner such that the contact force applied to the drug container (12) and the closure (14) is applied only to a predetermined value that reaches the maximum contact force.

17. The method according to claim 16, characterized in that, Multiple drug containers (12) are simultaneously sealed with corresponding closures (14).

18. The method according to claim 16 or 17, characterized in that, The pressing or pressing of the closure (14) is performed by means of a driveable mating element (28) arranged on a first side (48) of the drug container (12), wherein the driveable mating element (28) applies a contact force toward a second side (50) of the drug container opposite to the first side (48) in the direction of the closure movement axis (32); and the maximum contact force acting on the drug container (12) and the closure (14) is limited by a pressure limiting device (52) that connects a pressure unit (34) to a pressure element (26).

19. The method according to claim 16 or 17, characterized in that, The pressing or pressing of the closure (14) is performed by means of a driveable pressure unit (34) carrying a pressure element (26), the pressure unit (34) being arranged on a first side (48) of the drug container (12), wherein a mating element (28) arranged on a second side (50) of the drug container opposite to the first side (48) forms a mating support structure for the pressure unit (34), such that the drug container and the closure are arranged between the pressure unit (34) and the mating element (28), and the maximum contact force acting on the drug container (12) and the closure (14) is limited by a pressure limiting device (52) that connects the pressure unit (34) to the pressure element (26).

20. The method according to claim 16 or 17, characterized in that, The method includes the step of applying maximum contact force to the drug container (12) and the closure (14).

21. The method according to claim 16 or 17, characterized in that, The method includes the step of adjusting the maximum contact force to the same value or at least two different values ​​for multiple pairs of drug containers (12) and closures (14).

22. The method according to claim 18, characterized in that, The mating element (28) is arranged on the side (48) where the opening (24) of the drug container (12) is located.

23. The method according to claim 18, characterized in that, The pressure unit (34) is immovable.

24. The method according to claim 19, characterized in that, The pressure unit (34) is arranged on the side (48) opposite the opening (24) of the drug container (12).

25. The method according to claim 19, characterized in that, The mating element (28) is immovable.

Citation Information

Patent Citations

  • Method, system, and apparatus for pharmaceutical container filing and lyophilizing

    US10781003B2

  • Production method for pre-filled syringe, and pre-filled syringe production device

    CN104602738A