Sealing device and method for sealing sterile goods containers

Abstract

Main claim: Sealing device (1) for the automated sealing of sterile goods containers (3), comprising a dispenser (7) which receives a stack of seals (2) in a guide rail (24) and has a removal opening (23) for a seal (2) of the stack, wherein the dispenser (7) is coupled via an interface (5) to a traversing unit (25) having at least two axes of movement, wherein an associated control unit (26) is programmed to move the dispenser (7) relative to a sterile goods container (3) by means of the traversing unit (25) in order to • to insert a seal (2) taken from the dispenser (2) into an anchoring point (4) of the sterile container (3) (step S1), • to remove the seal (2) from the dispenser (7) (step S2), • if necessary, place the seal (2) up to a stop in the anchoring point (4), if not already done previously (step S3), • to fold over or bend over a closure (6) of the seal (2) (step S4), and • to completely close the closure (6) of the seal (1), in particular by locking it (step S5).

Description

[0001] Sterile containers from the medical sector must be sealed before sterilization. Currently, this is done manually. Automated processing is desirable.

[0002] The object of the invention is to provide a sealing device and a method for the automated sealing of sterile goods containers that enable efficient, precise, and reliable sealing. In particular, undesirable malfunctions should be avoided, and ease of use should be ensured. The device and the method should enable both rapid execution and precise positioning of the seals on the sterile goods container, with the aim of integration into a fully automated overall process for handling the sterile goods containers.

[0003] With regard to the device, the aforementioned problem is solved according to the invention by a sealing device for the automated sealing of sterile goods containers, comprising a dispenser which receives or is provided for receiving a stack of seals in a guide rail and has a removal opening for a seal from the stack, wherein the dispenser is coupled via an interface to a traversing unit having at least two axes of movement, wherein an associated control unit is programmed to move the dispenser relative to a sterile goods container by means of the traversing unit in order to: • to insert a seal taken from the dispenser into an anchoring point of the sterile container (step S1), • to remove the seal from the dispenser (step S2), • If necessary, place the seal up to a stop in the anchoring point, if this has not already been done (step S3), • to fold over or bend over a closure of the seal (step S4), and • to completely close the seal, in particular by locking it (step S5).

[0004] Step S3 may be omitted if the seal was already inserted far enough in step S1. Steps S4 and S5 can also be performed together in a single step.

[0005] The automated sealing device enables a fast and efficient sealing process by eliminating manual steps and increasing production speed. Using a controlled traversing unit with at least two axes of motion, precise and accurate positioning of the dispenser relative to the sterile container is ensured. This minimizes errors and guarantees consistent sealing. The system can, at least in principle, handle various types of sterile containers and seals, as it offers adjustable parameters and settings. This makes it versatile and able to meet the requirements of diverse applications. Problems or new requirements in the sealing process can be easily addressed by reprogramming or adapting existing programs.

[0006] Advantageous configurations are the subject of the dependent claims and the following description.

[0007] Advantageously, the dispensing opening is secured by a spring mechanism, particularly in the form of a ball detent, to prevent the seals from falling out unintentionally. The seal is only released from the dispenser when a preset dispensing force is reached or exceeded during step S2.

[0008] A particularly simple setup is achieved when the guide rail is vertically oriented and the dispensing opening provides access to the bottom seal of the stack. The vertically oriented guide rail allows easy access to the bottom seal. This ensures a smooth and efficient dispensing process, as the next seal is always easily accessible without the need for cumbersome re-sorting of the stack. The stack slides down from the top simply by gravity, without the need for any other means.

[0009] Preferably, a rod is connected to or molded onto the dispenser, featuring a number of pressure points for performing steps S3 to S5. The rod with its pressure points allows steps S3 to S5 to be carried out precisely and reliably. The pressure points ensure correct placement and fixation of the seal in the anchoring point, as well as a secure closure, thus increasing the quality and security of the sealing process. This design eliminates the need for additional, separate actuators – only the traversing unit is required.

[0010] It is advantageous if the handling unit has sensors to precisely control and monitor the positioning of the dispenser relative to the sterile container. This allows deviations or inaccuracies in the placement of the seals to be detected and corrected, thus improving the quality and reliability of the sealing process.

[0011] Furthermore, it is preferred that the seal is made of a dimensionally stable material and comprises an elongated base element from which an insertion element and a locking element project laterally, and wherein the base element has a film hinge between the locking element and the insertion element. This is a robust construction that ensures that the seal is stably and securely attached to the container and fulfills its function even under adverse conditions.

[0012] With regard to the method, the aforementioned problem is solved according to the invention by a method for the machine sealing of sterile goods containers, in particular using a sealing device of the type mentioned above, comprising the following steps: • Provide a stack of seals in a dispenser, • Moving the dispenser to insert a seal from the dispenser into an anchoring point of a sterile container (step S1), • Moving the dispenser to strip the seal from the dispenser (step S2), • If necessary, move the dispenser to place the seal until it stops in the anchoring point, if this has not already been done (step S3), • Moving the dispenser to flip or bend over a closure of the seal (step S4), and • Moving the dispenser to fully close the seal, in particular by locking it (step S5), with all movements of the dispenser being relative to a sterile container.

[0013] Instead of moving the dispenser when the sterile container is stationary, a moving unit can also be provided that moves the sterile container when the dispenser is stationary.

[0014] Preferably, the dispenser is moved horizontally during steps S1 and S3, vertically during steps S2 and S5, and along a circular path during step S4, in particular with the film hinge of the seal to be sealed as the center point.

[0015] The tasks, features and advantages mentioned with regard to the device are analogous to the method and vice versa.

[0016] In summary, the invention proposes an automation of sterile container handling, specifically during the sealing process prior to sterilization. Compared to previous manual handling, this process results in increased efficiency and reduced personnel costs in this area.

[0017] Exemplary embodiments of the invention are explained in more detail below with reference to the accompanying drawings. These show: Fig. 1. A schematic representation of successive steps in affixing a seal to a sterile goods container, Fig. 2 a top view of a sterile goods container and a sealing device arranged next to it, Fig. 3 a detailed view in section (AA) of Fig. 2, and Fig. 4 the sealing device Fig. 2 and Fig. 3 in perspective view.

[0018] Identical or equivalent elements are provided with the same reference symbols in all figures.

[0019] In Fig. Figure 1 shows, purely schematically, the application of a seal 2 to a medical container, in particular a sterile container 3, based on three successive process steps or procedural stages.

[0020] Generally, a seal is a tamper-evident closure for a container or housing. By affixing a seal to the closure of a container or device, it can later be determined whether the container or device has been (unauthorized) opened. This is done by checking whether the seal is still intact or has been destroyed or damaged in the meantime.

[0021] In this specific application, the seal 2 is attached to the locking mechanism 14 of a sterile container 3 before the sterile container 3 is sterilized. The locking mechanism 14 is typically integrated into the lid 15 of the sterile container 3 and is therefore part of the lid geometry. Here in the example of Fig. 1 is therefore shown purely schematically as part of the corresponding cover and locking contour, whereby the details of the design are not important.

[0022] The seal 2, in its delivered state, comprises an elongated, preferably rod-like, base element 16 made of a dimensionally stable material. An elongated insertion element 17 projects laterally, approximately in a central region, from the base element 16, essentially perpendicular to the side. At the upper end of the base element 16, an elongated locking element 18 also projects laterally, essentially perpendicular to the side, pointing in the same direction as the insertion element 17. In this example, the locking element 18 is slightly shorter than the insertion element 17. The seal 2, which is essentially F-shaped overall, can be manufactured integrally or in one piece from a single material, in particular polypropylene or a similar plastic, which can preferably be further processed by injection molding.Between the locking element 18 and the insertion corner element 17, a film hinge 19 is incorporated into the base element 16 as a preferred bending point, at which the base element 16 can be bent or folded over as shown when a corresponding force is applied. Preferably, this is a predominantly plastic deformation.

[0023] The part of the seal 2 consisting of the locking element 18 and the section of the base element 16 above the film hinge 19 is hereinafter also referred to as the closure 6 of the seal 2. The part of the seal 2 consisting of the insertion element 17 and the section of the base element 16 below the film hinge 19 is referred to as the fastening section.

[0024] The insertion element 17 is designed to be inserted into a lateral insertion opening 20 in the locking mechanism 14 of the sterile container 3 and serves to secure or anchor the seal 2. For this purpose, the seal 2 is attached in a first conceptual step as described in the upper part of Fig. The insertion element 17 is aligned and moved towards the sterile container 3 until it engages in the insertion opening 20 and the base element 16 rests against the side surface of the locking mechanism 14 or the container lid (stop position). Then, the closure 6 of the seal 2, which extends above the locking mechanism 14 of the sterile container 3, is bent over the edge of the lid by approximately 90° at the film hinge 19, as shown. This is in the middle part of Fig. 1 indicated. When bent, the locking element 18 first engages an upper through-hole 21 in the locking mechanism 14 and then a precisely fitting locking recess 22 in the insertion element 17, so that a locking mechanism of the closure 6 is formed that can only be released by destruction (pull-through or push-through seal). The final state of the seal is shown in the lower part of Fig. 1 shown.

[0025] The aforementioned sealing steps can, in principle, be performed manually. However, according to the invention, it is proposed that the seals 2 described above for sealing a sterile container 3 be applied automatically using a sealing device 1, starting from a point on the sterile container 3, or rather, its designated anchoring point 4. The closed sterile container 3 to be sealed can be moved into the working area of ​​the sealing device 1 using systems known per se, such as a robot arm, a conveyor system, or a traversing unit.

[0026] Via an interface 5 (interface, such as a connecting element, an intermediate piece or a mounting adapter), which is connected to a system or a traversing unit with at least two automatically movable degrees of freedom, preferably more degrees of freedom (e.g. articulated arm robot - not shown), a corresponding movement of the sealing device 1 can be carried out in order to • to insert the seal 2 into the anchoring point 4 of the sterile container 3 (step S1), • to strip or remove the seal 2 from the sealing device 1 (step S2), • Place the seal 2 fully in the anchoring point 4 (step S3), • to fold over the closure 6 of the seal 2 (step S4), • and to fully close or snap into place the closure 6 of the seal (1) (step S5).

[0027] This is achieved, among other things, using several geometries or pressure surfaces, which are part of the sealing device 1 and are described in more detail below.

[0028] The movement unit 25 for the dispenser, which has at least two axes of movement (so that the dispenser 7 can be moved in at least two directions of movement), is only in Fig. 4 schematically indicated, as is the associated control unit 26.

[0029] Alternatively, the sealing device 1 can be static (stationary), and the sterile container 3 can perform the corresponding movements and navigation using drive and traversing systems known per se (not shown). The relative movements between the sterile container 3 and the sealing device 1 are identical as described above. However, it is preferably proposed to move the sealing unit 1, since less mass needs to be moved and the overall system is therefore more dynamic.

[0030] It is proposed that the seals 2 be contained in any number (limited by the storage capacity) in a magazine or dispenser 7 of the sealing device 1, which is geometrically adapted to the shape of the seals 2, for example, by means of grooves 13 on both sides or another guide rail 24, so that the seals can be stacked on top of each other. The seal 2 to be applied is removed from a dispensing opening 23 at the bottom of the dispenser 7, with the stack sliding down from above due to the effect of gravity.

[0031] The lower seal 2 (i.e., the first seal 2 to be applied) is held in place by a spring mechanism, specifically a ball detent 9 or a similar device like a spring-loaded pin, thus preventing it from unintentionally falling out of the dispensing opening 23. Only when the seal 2 to be removed is pressed downwards with additional force can it overcome the ball of the ball detent 9 and be removed downwards. In other words, the ball detent 9 must have sufficient spring force to support the weight of all the seals 2 in the dispenser 7 without the lower seal 2 falling out, while simultaneously ensuring reliable removal by an additional force generated by the reaction force at the anchoring point 4.

[0032] The transfer of the seal 2 occurs in steps S1 and S2 through a corresponding automated movement of the sealing device 1. Here, the seal 2 is inserted into the anchoring point 4 of the sterile container 3 by pushing the insertion element 17 at least partially into the corresponding insertion opening 20 in a horizontal movement (step S1). Subsequently, the sealing device 1 is moved upwards relative to this in a vertical movement, so that the seal 2 is released from the dispenser 7, past the compressed ball detent 9, and remains in the anchoring point 4 (step S2).

[0033] Since the seal 2 is not yet firmly seated at the stop in the anchoring point 4 (otherwise a collision could occur between the sterile container 3 and the sealing device 1), but is still relatively loosely positioned in the anchoring point 4, it is pressed into the anchoring point 4 in a further horizontal movement with the help of an adapted horizontal pressure surface 8 of the sealing device 1 - until the insertion element 17 is inserted as completely as possible into the insertion opening 20 (step S3).

[0034] As an alternative to the previous description, a dispenser 7 of the seals 2 can be static and independent of the closure mechanism. For this purpose, it is suggested to remove the seals using a suction cup and to proceed according to the following steps – these are the same for both variants.

[0035] In step S4, the closure of the seal 2 is folded over using an adapted, preferably rounded (transitioning from vertical to horizontal) pressure surface 10 of the sealing device 1. It is advantageous if the entire sealing device 1 automatically follows a trajectory that comes as close as possible to a radius whose center point is in the film hinge 19 of the seal 2.

[0036] In step S5, the seal 2 is completely closed with an adapted vertical pressure surface 11 of the sealing device 1 by moving the entire sealing device 1 vertically downwards. After the sealing process, the sealing device 1 returns to its starting position.

[0037] In the example, the pressure points 8, 10, 11 are arranged on a vertical rod 27, which extends downwards in extension of the dispenser 7.

[0038] In order to avoid excessively strong constraint forces during the various steps to be carried out and any collisions that may occur, the sealing device 1 is connected to the interface 5 via a compliant or elastic structure 12, which can absorb these forces to a small but sufficient extent through deformation.

[0039] It is proposed that additional control systems, such as sensors or optical systems like cameras, be used to verify the position of the anchor point. For example, in conjunction with a robot guidance camera, the navigation of the sealing device 1 in relation to the sterile container 3 can be achieved.

[0040] Furthermore, the contact forces for the seal 2 can be determined, monitored, and regulated using a force-torque sensor, which is installed, for example, between interface 5 and the active unit. The dispenser 7 may also contain additional state-of-the-art sensors that monitor the fill level.

[0041] The seals 2 themselves can be replenished in the dispenser 7 using a singulation and feeding system conforming to the state of the art, such as a spiral, vibratory, oscillating, or linear conveyor. The seals 2 can also be lined up in large numbers and held in a magazine using a strip of material (e.g., paper strip) or a system corresponding to the state of the art, similar to a nail gun. The seals 2 can also be bonded together, and the seal 2 inserted into the anchoring point 4 in step S1 can be separated from the other seals 2 in the stack after step S1 by retracting the sealing device 1.

[0042] As shown in feasibility analyses, it is helpful to place the sterile container 3 on a suitable support plate or table for the application of the seals 1 on both sides and to rotate it 180° after sealing the first side, as otherwise the robot's gripper would block the way for the second seal. Reference symbol list 1 Sealing device 2 seals 3 sterile containers 4 anchor point 5 Interface 6 Closure 7 donors 8 Horizontal pressure surface 9 ball pressure piece 10 Rounded pressure surface 11 Vertical pressure surface 12 Elastic structure 13 grooves (both sides) 14 Locking 15 lids 16 Basic element 17 Insert element 18 locking elements 19 Film joint 20 insertion openings 21 Through-hole 22 Rest recess 23. Sampling opening 24 guide rail 25 traversing unit 26 Control unit 27 Staff

Claims

[1] Sealing device (1) for the automated sealing of sterile goods containers (3), comprising a dispenser (7) which receives a stack of seals (2) in a guide rail (24) and has a removal opening (23) for a seal (2) of the stack, wherein the dispenser (7) is coupled via an interface (5) to a traversing unit (25) having at least two axes of movement, wherein an associated control unit (26) is programmed to move the dispenser (7) by means of the traversing unit (25) relative to a sterile goods container (3) in order to • to insert a seal (2) taken from the dispenser (2) into an anchoring point (4) of the sterile container (3) (step S1), • to remove the seal (2) from the dispenser (7) (step S2), • if necessary, place the seal (2) up to a stop in the anchoring point (4), if not already done previously (step S3), • to fold over or bend over a closure (6) of the seal (2) (step S4), and • to completely close the closure (6) of the seal (1), in particular by locking it (step S5). [2] Sealing device (1) according to claim 1, wherein the removal opening (23) is secured by a spring mechanism, in particular in the form of a ball pressure piece (9), to prevent the seals (2) from falling out unintentionally. [3] Sealing device (1) according to one of the preceding claims, wherein the guide rail (24) is vertically aligned and the removal opening (23) allows access to the lowest seal (2) of the stack. [4] Sealing device (1) according to one of the preceding claims, wherein a rod (27) is connected to or formed on the dispenser (7) which has a number of pressure points (8, 10, 11) for carrying out steps S3 to S5. [5] Sealing device (1) according to one of the preceding claims wherein the moving unit (25) has sensors to precisely control the positioning of the dispenser (7) relative to the sterile container (3). [6] Sealing device (1) according to one of the preceding claims wherein the seal (2) consists of a dimensionally stable material and comprises an elongated base element (16) from which an insertion element (17) and a locking element (18) project laterally, and wherein the base element has a film hinge (19) between the locking element (18) and the insertion element (17). [7] Method for the automated sealing of sterile goods containers (3), in particular using a sealing device (1) according to one of the preceding claims, comprising the following steps: • Providing a stack of seals (2) in a dispenser (7), • Moving the dispenser (7) to insert a seal (2) from the dispenser (7) into an anchoring point (4) of a sterile container (3) (step S1), • Moving the dispenser (7) to remove the seal (2) from the dispenser (7) (step S2), • If necessary, move the dispenser (7) to place the seal (2) until it stops in the anchoring point (4), if this has not already been done (step S3), • Moving the dispenser (7) to flip over or bend over a closure (6) of the seal (2) (step S4), and • Moving the dispenser (7) to fully close the closure (6) of the seal (1), in particular by locking it (step S5), with all movements of the dispenser (7) being relative to a sterile container (3). [8] Method according to claim 7, wherein the dispenser (7) is moved horizontally during steps S1 and S3. [9] Method according to claim 7 or 8, wherein the dispenser (7) is moved vertically during steps S2 and S5. [10] Method according to claim 7, 8 or 9, wherein the dispenser (7) is moved along a circular path during step S4. [11] Computer program product, namely control program for a sealing device (1) according to one of claims 1 to 6, comprising instructions which, when the program is executed by a control unit (26), cause the control unit to perform the steps of the method according to one of claims 7 to 10 using the sealing device (1).

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