Method for securing a stopper on a container, securing station for securing a container closed with a stopper

Abstract

According to the invention, in a method for securing a stopper on a container with a closure lid using a securing station, it is proposed that measurements of quantities, in particular movement quantities, around an axis are carried out during the securing process to assess the securing process and that the recorded measured values ​​are evaluated to detect insufficiently secured containers.

Description

[0001] The invention relates to a method for securing a stopper on a container with a closure lid, wherein the container is preferably a pharmaceutical or medical container, wherein during securing a relative movement about an axis is carried out at least between the closure lid and a securing tool.

[0002] The invention further relates to a securing station for securing a container closed with a stopper with a closure lid, wherein the container is preferably a pharmaceutical or medical container, wherein the container and the closure lid are arranged to be movable relative to one another along an axis, wherein the securing station has at least one securing tool for securing.

[0003] It is known from practice to secure pharmaceutical or medical containers using stoppers and closure lids.

[0004] The invention is based on the object of securing medical or pharmaceutical containers with a stopper and a closure lid in such a way that contaminants outside the container do not come into contact with the contents of the container due to the high tightness of the closure lid.

[0005] To achieve this object, the invention proposes the features of claim 1. In particular, in a method for securing a stopper on a container with a closure lid, the invention proposes that during the securing process, a detection, in particular a measurement and / or determination, of a variable determined at least by a relative movement about the axis between the container and the closure lid is carried out.

[0006] The invention makes it possible to monitor the quality of motion transmission between components that must be synchronized and / or in a predetermined relationship to each other for proper securing. This allows conclusions to be drawn as to whether securing was carried out according to specifications or whether unforeseen and / or undesirable deviations have occurred. The aforementioned parameter can thus be easily used to check quality during the securing process. Subsequent tests, such as visual ones, can thus be supplemented and / or even replaced, or at least simplified.

[0007] The recording can, for example, be a measurement and / or a determination. In the case of a measurement, a measured value can be obtained that can be easily processed further. In the case of a determination, deviations from a specified value can be used to make a quality statement.

[0008] Securing can, for example, be the fluidic closure and / or sealing of the contents of the container.

[0009] The measured value can be equal to the relative movement (slippage) between the closure cap and the container, especially if the closure cap and the container are mounted without slippage in their respective receptacles. However, other contributions to the value can also occur, in particular slippage between the closure cap and its receptacle and / or slippage between the container and its receptacle.

[0010] The measured value can, for example, also be an absolute speed on the closure lid side, which is compared with a target speed on the drive side. In this case, a relative movement between the container and the closure lid, as well as the target speed as a further input variable, are included in the measured value and determine this. The value can also be determined by a relative movement between an associated receptacle and the container and / or between an associated receptacle and the closure lid. The formula thus results in nm=na+Dbv+Db+Dv, where n m = Speed ​​on the following side n a = Speed ​​on the driving side D bv = Slippage (relative movement) between container and lid D b = Slippage between container and associated (coupled) receptacle D v= Slippage between the closure cover and the associated (coupled) receptacle.

[0011] The size n m is therefore at least by D bv determined, here even additionally by n a , D b and D v .

[0012] In an alternative, which can also be combined with the described solution, in order to achieve the stated object in a method of the type mentioned at the outset, it can be provided that during the securing a detection, in particular a measurement and / or determination, of a quantity determined at least by a rotationally connecting coupling of the container is carried out.

[0013] The rotationally connected coupling of the container can be achieved by coupling a receptacle that contacts the container, for example, the lower and / or driving receptacle described below, to the container. This allows for coupling to a drive.

[0014] In a further alternative, which can also be combined with one or both of the solutions described, in order to achieve the stated object in a method of the type mentioned at the outset, it can be provided that during the securing a detection, in particular a measurement and / or determination, of a quantity determined at least by a rotationally connecting coupling of the closure cover is carried out.

[0015] The rotationally connected coupling of the closure cover can be achieved by coupling a receptacle that contacts the closure cover, for example, the upper and / or follower receptacle described below, to the closure cover. This allows for coupling to an abutment.

[0016] It has been found that the mounts can become dirty during use, so slippage at one of the couplings can occur more frequently. Monitoring this slippage is often of significant value in assessing a well-executed securing system.

[0017] What is particularly advantageous is that it is possible to correlate the relative movement around the axis between the container and the closure lid and the quality of securing via the measurable and / or determinable quantity.

[0018] This also makes it possible to detect in a timely manner if the container is not closed properly with the lid, thus preventing rejection.

[0019] For example, it can be provided that the determined magnitude of the relative movement is used by a quality management system in particular to analyze and assess the quality of the process.

[0020] In an advantageous embodiment, it can be provided that the size is determined by measuring a preferably rotary relative movement between a receptacle carrying the container, preferably driving it, preferably the lower receptacle, and a receptacle receiving the closure lid, preferably moving along with it, preferably the upper receptacle.

[0021] For example, it can be provided that the plug on the container with the closure lid is sufficiently secured as soon as the rotational movement of the follower holder is simultaneous with the rotational movement of the driving holder or is within a tolerance band.

[0022] A particular advantage is that it is possible to compare the rotational movements of the driving mount and the moving mount in order to assess the quality of the securing.

[0023] In an advantageous embodiment, the variable can be an absolute value on the follower and / or drive side, a time between pulses to a sensor, a traveled angle, and / or a rotational speed, preferably in each case in comparison with a setpoint. Alternatively or additionally, acceleration values ​​can also be recorded.

[0024] In this case, it can be provided, for example, that the driving recording is driven by a motor, wherein the setpoint is, for example, a set speed of the motor, wherein, for example, the size of the absolute value of the moving recording is measured and / or determined and compared with the setpoint.

[0025] A particular advantage is that this allows for very precise reference measurements and allows for quick determination of deviations between the target value and the absolute value. The comparison can also provide useful information on how the process should be adjusted to generate the most identical movement possible on the driving and following sides.

[0026] In an advantageous embodiment, the variable can be determined from a measurement of a relative movement of a lower and / or driving receptacle against a closure lid of the medical container. Thus, for example, a slippage between the closure lid and the container and / or a slippage between the container and the driving receptacle can be detected.

[0027] In an advantageous embodiment, the variable can be determined from a measurement of the relative movement of an upper and / or moving receptacle against a medical container. Thus, slippage between the closure lid and the container can be detected when the moving receptacle rests against the closure lid.

[0028] In an advantageous embodiment, the variable can be determined from a measurement of the relative movement of a closure cap, for example, the one already mentioned, against a container, for example, the one already mentioned. This allows for the detection of any slippage between the closure cap and the container. Such slippage must not occur with a tight crimp or securing device.

[0029] The term crimping refers to a joining process in which two components are connected to one another by plastic deformation, for example by flanging, squeezing, crimping or folding.

[0030] In particular, a lower edge of the closure lid can be flanged.

[0031] In an advantageous embodiment, the size can be determined from a measurement of a crimp disc against a container, for example, the one already mentioned. Thus, any slippage between the crimp disc and the closure lid and / or any slippage between the closure lid and the container can be detected.

[0032] In an advantageous embodiment, the size can be determined from a measurement of a crimping disc, for example, the one already mentioned, against an upper and / or follower receptacle, for example, the one already mentioned. This allows for the proper movement of the crimping disc on the closure cap to be detected.

[0033] For example, the rotation of the closure cap can be detected via markings on the closure cap. For example, the rotation of the container can be detected via markings on the container.

[0034] For example, a rotation of the driving mount can be fixed.

[0035] A rotation of the moving recording can be detected, for example, by a coupled measuring device.

[0036] What is particularly advantageous is that various options for determining and / or measuring the magnitude of the relative movement can be realized.

[0037] In an advantageous embodiment, it can be provided that the container with plug and closure lid are pressed together by an upper and / or rotating receptacle on the one hand and a lower and / or driving receptacle on the other hand, so that a rotational movement is transmitted from the lower, preferably driving receptacle, to the upper, preferably rotating receptacle.

[0038] Thus, a detachable coupling between the lower and upper holder is advantageously realized, whereby in particular the rotational movement of the upper holder can be compared and assessed with the rotational movement of the lower holder.

[0039] In an advantageous embodiment, it can be provided that the driving receptacle engages the container from below and / or the moving receptacle engages from above.

[0040] The advantage here is that, for the best possible transmission of the movement of the driving lower mount, there are as few interfering contours as possible on the upper mount, which could negatively influence the preferably directed airflow within a clean room, where the securing process preferably takes place. This would often be the case if the motor were mounted on the upper mount.

[0041] Alternatively or additionally, the features of the independent claim directed to a method are provided according to the invention to achieve the stated object. In particular, to achieve the stated object in a method for securing a stopper on a container with a closure lid of the type described above, it is proposed that a variable determined by a relative movement of a container, in particular a vial, for example, and a closure lid, for example, the one already mentioned, be determined and compared with at least one rotational drive movement of at least one of the receptacles. Preferably, a comparison is made with the rotational drive movements of both receptacles.

[0042] A particularly advantageous feature is that by comparing the rotational drive movements, deviations from the relative movement can be detected and appropriate countermeasures can be initiated. This also has the advantage of reducing the number of incorrectly secured containers.

[0043] In an advantageous embodiment, it can be provided that the container is driven and / or the closure lid is rotating.

[0044] A particular advantage is that only one drive is required.

[0045] In an advantageous embodiment, it can be provided that a measured value of a movement variable of the relative movement, in particular a speed and / or a torque and / or a pulse interval, of the container, receptacle(s), crimping disc (e.g. flanging disc) and / or closure lid is recorded.

[0046] This makes it advantageous that the measured values, which are compared with a target value, for example, can be recorded at different positions or locations.

[0047] For example, it can also be provided that measured values ​​are recorded at several locations simultaneously, which advantageously enables validation and verification of the recorded measured values.

[0048] In an advantageous embodiment, it can be provided that during detection a target value of the movement quantity is provided by a specification, in particular wherein the target value is provided to a driving side of the container and / or the target value is compared with an actual value of a, for example, the already mentioned, following side.

[0049] A particularly advantageous feature is that if there are deviations between the target and actual values, it can be assumed that the closure cap has not been adequately secured to the container, which in turn allows rejects to be quickly detected and / or prevented. It is also advantageous that appropriate countermeasures can be initiated if the actual value deviates from the target value. One countermeasure could, for example, be subjecting the container, especially the vial, or at least parts of it, to another crimping process.

[0050] In a further advantageous embodiment, it can be provided that a reference value of the movement quantity is measured during detection, in particular on the drive side of the container.

[0051] For example, it can be provided that the movement value of the driving side is measured and serves as a reference value for the following side.

[0052] What is particularly advantageous is that a target specification of the movement size can be initiated via the reference value, whereby this target value can in turn be compared with a measured actual value of the movement size of the following side.

[0053] In an advantageous embodiment, it can be provided that a difference value between the measured value and the target value and / or reference value is determined and in particular assessed.

[0054] The advantage is that by assessing the difference value, possible incorrect settings can be quickly identified and avoided, which in turn allows for the generation of a more effective and cost-effective process.

[0055] In an advantageous embodiment, it can be provided that a message is issued as a result of the assessment, in particular when the difference value has reached a certain value.

[0056] The value can, for example, be a previously defined upper and / or lower limit value that differs from the target value.

[0057] It is therefore particularly advantageous that the procedure can be interrupted in good time when a report is received, reviewed and examined for possible disruptive factors in order to reduce further rejections.

[0058] In an advantageous embodiment, it can be provided that the detection of the relative movement is started before securing and / or wherein the detection is completed after securing, in particular wherein a detection period comprises at least a period of securing.

[0059] This makes it particularly advantageous that the securing process can be monitored throughout the entire process, allowing rapid intervention in the event of any deviations from target values. It is also advantageous that countermeasures can be taken before scrap occurs. This also makes it advantageous that a more cost-effective process can be implemented.

[0060] Thus, for example, it is still advantageous to detect before the locking tool is engaged whether the follower holder is moving simultaneously with the driving holder.

[0061] Furthermore, it can be provided, for example, that the securing preferably only begins when it is detected that the driving and the following recordings are moving simultaneously.

[0062] In an advantageous process sequence, the securing tool only starts the actual crimping (moving the crimping disc into the aluminum cap) when the driving and rotating holders move simultaneously.

[0063] In an advantageous embodiment, it can be provided that an acceleration of the relative movement, preferably of the moving and / or driving receptacle, is detected before securing. Detecting the acceleration before securing is particularly advantageous because it allows for early detection of disruptive factors that could have a negative impact on securing, preferably before the locking tool engages. It is thus further advantageous that rejects can be prevented by interrupting the process in the event of a deviation in acceleration.

[0064] Interference factors that can be detected by measuring acceleration can include, for example, contamination of the holders. This contamination particularly hinders the smooth transmission of motion between the driving holder and the moving holder. Early detection prevents unintentional deformation of an incompletely applied closure cap or damage to the container caused by the securing tool and / or the respective holder. A container whose closure cap could not be successfully applied can thus be automatically returned for further application without any problems.

[0065] In an advantageous embodiment, it can be provided that the detection of the movement quantity is carried out on a side facing away from the container, preferably a side facing the closure lid or a closure lid.

[0066] The advantage here is that the focus of the detection of the movement size is particularly on the movement of the closure lid, which allows a sufficient assessment of the quality of the securing.

[0067] A preferred application of the invention provides that in a method for securing a stopper on a container, in particular as described above, the container with the stopper on the one hand and the closure lid on the other hand are pressed against each other along a pressing direction and that a preferably signed force contribution of the securing, preferably in the pressing direction, is detected during the pressing.

[0068] By pressing them against each other, it is advantageous to transfer movement from a driving mount to a moving mount.

[0069] Another particularly advantageous feature is that this enables continuous force monitoring during securing, whereby fluctuations in the acting forces can be quickly detected, assessed and, if possible, prevented.

[0070] In an advantageous embodiment, it can be provided that a measurement of a feed force of the securing tool, in particular of a crimping disc, for example the one already mentioned, is carried out during a force contribution transverse to the pressing direction.

[0071] What is particularly advantageous is that it can be determined whether the contact force of the securing tool, in particular the crimping disc, is sufficient for the securing process.

[0072] Another advantage is that it is possible to determine, for example, whether and / or when the locking tool is first used.

[0073] In an advantageous embodiment, it can be provided that a measurement of a restoring force of the securing tool, in particular of a crimping disc, for example the one already mentioned, is carried out during a force contribution longitudinal to the pressing direction.

[0074] What is particularly advantageous is that, for example, when the force contribution decreases along the pressing direction, it can be determined whether and / or when the locking tool is no longer engaged.

[0075] In an advantageous embodiment, it can be provided that a measurement of an adjustment path, in particular transverse to the force contribution and / or along the force contribution, of the securing tool, in particular of the crimping disc, takes place during a force contribution.

[0076] In this case, it can be provided, for example, that the securing tool travels a defined adjustment path to carry out the securing, whereby this adjustment path determines, for example, the path over which the securing tool must be moved, in particular for a first intervention.

[0077] It is particularly advantageous that, in addition to and / or alternatively to measuring the feed and return force, the adjustment path of the locking tool can be used to determine whether and / or when the locking tool is engaged.

[0078] Another advantage is that the feed force can be varied via the adjustment range. This allows, for example, a comparison to be made between the measured feed force and the corresponding measured adjustment range of the locking tool.

[0079] In an advantageous embodiment, it can be provided that a preferably axial pressing force, in particular a force acting on the container, is maintained during a detection period of the force contribution, which comprises at least a period of securing.

[0080] For example, it can be provided that the axial pressing force, which acts in particular on the container, is measured before the securing tool, in particular the crimping disc, is engaged.

[0081] It is therefore particularly advantageous that forces that act during securing but are not caused by the axial pressing force and have an additional influence on the axial pressing force can be determined and evaluated.

[0082] In an advantageous embodiment, it can be provided that in order to maintain a pressing force or the pressing force, the lower and / or follower receptacle carries out an axial displacement, in particular during the securing period.

[0083] In this case, it can be provided, for example, that the lower and / or the upper holder is driven pneumatically, for example via pneumatic cylinders, which are designed, for example, with a regulation, in particular with pneumatic valves for generating a constant pneumatic pressure.

[0084] This makes it particularly advantageous to generate a sufficient axial compression force over the entire securing period, which in turn reduces the number of containers secured due to insufficient compression force. Another advantage is that a defined axial compression force ensures that the plugs are sufficiently pressed into the container and that the containers are correctly closed. Excessive compression can thus be avoided. This can increase process reliability.

[0085] In an advantageous embodiment, it can be provided that the force contribution comprises a contact pressure of the securing tool, in particular of the crimping disc or a crimping disc, in particular wherein a determination and assessment of the contact pressure is carried out.

[0086] For example, a defined contact force can be determined to ensure sufficient securing. Furthermore, an upper and lower contact force limit can be defined at which securing can be performed with minimal rejects.

[0087] The limit values ​​can be determined, for example, by means of field tests and / or by empirical values.

[0088] It is particularly advantageous that it can be detected in good time, for example, if the contact pressure is insufficient for the securing process.

[0089] Another advantage is that by assessing the contact pressure, influences that cause errors can be identified and / or prevented.

[0090] In an advantageous embodiment, it can be provided that a message is issued as a result of the assessment, in particular if the contact force exceeds a certain threshold value.

[0091] Exceeding a certain threshold value can, for example, be the exceeding of a specified upper limit of the contact force.

[0092] This makes it particularly advantageous to quickly detect and alert the user when the contact force, for example, the contact force between the driving and the follower holder, is too high, thus impairing the preferably rotary movement of the holders. This also makes it advantageous that appropriate countermeasures can be initiated before the securing process is carried out.

[0093] In an advantageous embodiment, it can be provided that a message is issued as a result of the assessment, in particular if the contact pressure falls below a certain threshold value.

[0094] Falling below a certain threshold value can, for example, be falling below a specified lower limit of the contact pressure.

[0095] A particular advantage is that it can be detected early on if the contact pressure is too low for securing, so that the contact pressure can be corrected accordingly, for example by moving the lower holder.

[0096] In an advantageous embodiment, it can be provided that the recording period of the movement quantity and the recording period of the force contribution overlap at least partially in time, in particular during the securing period.

[0097] For example, it can be provided that a measured value of a movement variable of the relative movement is recorded in the same period of time as, for example, a measured value of a contact pressure force.

[0098] This makes it advantageous to compare two physically different variables, which can be used to assess the overall security.

[0099] In a further advantageous embodiment, it can be provided that at least two methods can be carried out in parallel, preferably independently of one another.

[0100] A particularly advantageous feature is that securing can be performed on multiple containers simultaneously and / or at different times. This also advantageously allows, for example, the securing process at this securing station to be interrupted, allowing at least one other securing process being performed in parallel to continue without complications.

[0101] Another advantage is that throughput times can be reduced, which in turn increases profitability.

[0102] To achieve the stated object, the invention provides, alternatively or additionally, the features of the independent claim directed to a security station. In particular, the invention proposes that the security station have at least one sensor designed to detect a variable determined at least by a relative movement around the axis between the container and the closure lid.

[0103] Alternatively or additionally, to achieve the stated object, the features of the first or second independent claim directed to a security station are provided according to the invention. In particular, in addition to or as a replacement for the previous solution, it is proposed that the security station have at least one sensor designed to detect a variable determined at least by a rotationally connecting coupling of the container, in particular by a coupling of a receptacle contacting the container to the container. This enables monitoring of the coupling to the receptacle, for example, by comparing a rotational speed of the container with a rotational speed of the associated receptacle.

[0104] Alternatively or in addition to the previous solution, it is thus proposed that the securing station have at least one sensor designed to detect a variable determined at least by a rotationally connecting coupling of the closure cover, in particular by a coupling of a receptacle contacting the closure cover to the closure cover. This enables monitoring of the coupling to the receptacle, for example, by comparing a rotational speed of the closure cover with a rotational speed of the associated receptacle.

[0105] In this case, it can be provided, for example, that the at least one sensor measures a certain size of the relative movement around the axis of a lower and / or driving receptacle to an upper and / or following receptacle.

[0106] What is particularly advantageous is that the at least one sensor makes it possible to monitor various relevant variables, which enable a qualitative assessment of the securing.

[0107] In addition, it can be provided, for example, that at least one sensor, in particular a distance measuring sensor, is designed to measure a distance of a movement that can occur due to a compression of the container with the stopper on the one hand and the closure lid on the other hand.

[0108] In a further advantageous embodiment, it can be provided that the container can be positioned on a lower rotatable, preferably driving, holder and the closure lid can be positioned on an upper rotatable, preferably moving, holder.

[0109] A particularly advantageous feature is that only one receptacle needs to be driven. Furthermore, it can be provided, for example, that the container can be decoupled or removed from the lower receptacle.

[0110] In a further advantageous embodiment, it can be provided that the security station is designed to carry out a previously claimed method.

[0111] What is particularly advantageous is that the advantages of the already claimed method can be realized.

[0112] In a further advantageous embodiment, it can be provided that the security station is part of a process machine, wherein the process machine has a boundary which forms a clean room, in particular an isolator or a RABS, wherein the security station is in the clean room.

[0113] RABS (restricted access barrier systems) refers to cleanrooms used, for example, in the pharmaceutical industry for aseptic production. A distinction can be made between O-RABS (open restricted access barrier systems) and C-RABS (closed restricted access barrier systems).

[0114] This enables a broad application of the invention in pharmaceutical plants, for example for the automatic filling of containers with a substance.

[0115] A particular advantage is that the securing station, the container with plug and the closure lid can thus be protected from contamination.

[0116] In a further advantageous embodiment, it can be provided that the at least one sensor, in particular a motion sensor, is designed to detect a movement variable of the relative movement, in particular pulses to sensors, a covered angle, a rotational speed and / or a torque.

[0117] Thus, the sensor can advantageously capture various measured values, which can be used either individually or in combination to assess the quality of the securing. Furthermore, it can be provided, for example, that several sensors are located at different positions, which in turn advantageously enables validation and / or verification of the measured values ​​relative to one another and can reduce measurement inaccuracies or errors.

[0118] For example, it can also be provided that the at least one motion sensor is a Hall sensor and / or is aligned transversely to a longitudinal extent of the securing station, in particular transversely to a shaft on which the upper receptacle is preferably mounted by an axial bearing.

[0119] Alternatively or additionally, optical sensors, bending sensors (e.g. strain gauges), and piezoelectric sensors can be used.

[0120] In a further advantageous embodiment, it can be provided that the securing station has a drive unit, in particular for the recording, and / or wherein the drive unit preferably comprises a linear drive, preferably a pneumatic cylinder.

[0121] This makes it possible, for example, to press the mounts against each other in such a way that the movement between the driving and the follower mount is as slip-free as possible. It is also particularly advantageous to maintain an axial pressing force over a locking period, for example, using a pneumatic cylinder with appropriate control, particularly pneumatic valves.

[0122] Furthermore, it can be provided, for example, that the linear drive is designed in particular to be self-locking, for example as an electric cylinder.

[0123] In a further advantageous embodiment, it can be provided that at least two security stations are present, which can preferably be controlled and / or regulated independently of one another.

[0124] A particularly advantageous feature is that complications that may arise, for example, at one securing station do not lead to an interruption of the process at at least one other securing station. This also advantageously allows the securing process to run in parallel at several containers, thereby reducing processing times.

[0125] Another advantage is that complications can be detected and eliminated early.

[0126] In a further advantageous embodiment, it can be provided that the security station has at least two motion sensors, wherein one of the at least two motion sensors is designed to detect the movement quantity of the lower receptacle and the second motion sensor is designed to detect the movement quantity of the upper receptacle.

[0127] A particular advantage is that it is possible to compare both movement variables, for example the speeds, whereby a slip between the driving and the following recording can provide information about the need for readjustment of one of the two movement variables, for example.

[0128] For example, readjustment can also involve replacing the supports. Furthermore, the motion sensor of the lower support can be integrated, preferably into a motor that drives the lower support.

[0129] Alternatively or additionally, the features of the independent claim directed to a securing station are provided according to the invention to achieve the stated object. In particular, to achieve the stated object, it is proposed in a securing station of the type described above that the securing station have at least one force measuring sensor designed to detect a force contribution, in particular a contact force generated by the securing tool during securing along a pressing action.

[0130] The securing tool, in particular the crimping disc or a crimping disk, can preferably be arranged in an interchangeable manner on the securing station.

[0131] A particularly advantageous feature is that it can be determined, for example, whether the clamping force of the securing tool is too low, too high, or optimally adjusted for securing. Another advantage is that an optimally adjusted clamping force of the securing tool can significantly reduce the number of incorrectly secured containers, thus significantly reducing costs.

[0132] The invention will now be described in more detail using an exemplary embodiment, but is not limited to the exemplary embodiment. Further exemplary embodiments arise from combining the features of one or more claims with one another and / or with one or more features of the exemplary embodiment.

[0133] It shows in a highly simplified representation Fig. 1 a two-dimensional representation of a securing station with an upper and lower receptacle, container, plug, closure cover and securing tool with crimping disc, whereby a boundary of a process machine forms a clean room, Fig. 2 A two-dimensional representation of another securing station according to the invention with bearing and strain gauges, Fig. 3 A two-dimensional representation of another security station according to the invention with two motion sensors, Fig. 4 A two-dimensional representation of a securing station according to the invention with axial pressing of the upper and lower receptacles and engagement of the securing tool, Fig. 5 is a schematic representation of a method for securing a plug with a closure cap, showing the force contributions and the movement quantities for the method steps, Fig. 6 a representation of the temporal progression of the force contributions and motion quantities of the process steps in two-dimensional coordinate systems, Fig. 7 a two-dimensional representation of the method of securing several parallel security stations in a process machine, Fig. 8 a two-dimensional representation of the process according to Fig. 7 with procedures interrupted at two backup stations due to complications.

[0134] Fig. 1 shows a securing station 1, designated as a whole by 1, for carrying out a method for securing a container 3 closed with a plug 2. The plug 2 of the container 3 is inserted into an opening of the container 3, with a closure lid 4 being positioned above the plug 2 on the container 3.

[0135] The securing station 1 has a securing tool 6 with a crimping disc 7.

[0136] The container 3 and the closure lid 4 are arranged so as to be movable relative to one another along an axis 5.

[0137] The container 3 is positioned on a lower, rotatably driven holder 8, 11. The lower holder 11 has a drive unit (not shown). The drive unit can comprise, for example, a linear drive, preferably a pneumatic cylinder, for axial displacement (compression / release) and a rotary drive for setting the holder in a rotational movement 24 at a fixed, predetermined speed.

[0138] Above the closure lid 4, an upper, rotatable receptacle 9, 10 is formed. In this exemplary embodiment, a sensor 14 is arranged transversely to a longitudinal extension of a shaft of the upper receptacle 10 for detecting a variable 20 determined at least by a relative movement about the axis 5 between the container 3 and the closure lid 4 (cf. Fig. 2). The sensor 14 shown in this embodiment is a transmitter 21 that detects pulse intervals of the upper holder 10 to determine a movement quantity 18.

[0139] In a further embodiment, the sensor 14 detects an acceleration of the relative movement.

[0140] In further embodiments, the sensor 14 can be designed to detect a traveled angle, a rotational speed and / or a torque of the container 3, the receptacle(s) 10, 11, the crimping disk 7 and / or the closure lid 4.

[0141] The upper follower holder 9, 10 forms the follower side 12, while the lower driving holder 8, 11 marks the driving side 13.

[0142] In another embodiment, this may be reversed.

[0143] In a further embodiment, a difference in rotational speeds between the receptacle 11 and the container 3 and / or a difference in rotational speeds between the receptacle 10 and the closure lid 4 can also be detected as a variable. This results in a variable that characterizes a coupling or slippage at the lower receptacle 11 and / or the upper receptacle 10.

[0144] In the embodiment shown, the receptacles 10, 11 can be pressed together along a pressing direction 16.

[0145] The security station 1 is part of a process machine that has a barrier 22 forming a clean room 15, in particular a RABS (Restricted Access Barrier System, closed C-RABS or open O-RABS) or isolator. Thus, the security station 1 can be protected, in particular, from contamination.

[0146] In this embodiment, a force measuring sensor 25 is designed as a load cell on the upper holder 10, which detects an axial pressing force between the lower holder 11 and the upper holder 10.

[0147] In a further exemplary embodiment (not shown), it is provided that the sensor 14 is arranged such that the movement variable 18, in this case the measured pulses per unit time of the relative movement of the lower and / or driving receptacle 8, 11 against the closure lid 4 of the container 3, is determined. Furthermore, in exemplary embodiments (not shown), it is also provided that the sensors 14 are arranged to determine the movement variable 18 of the relative movement of the closure lid 4 and / or the crimping disc 7 against the container 3 and / or the crimping disc 7 against the upper receptacle 10.

[0148] Fig. 2 shows in addition to Fig. 1 shows a further embodiment of a security station 1 according to the invention.

[0149] The following side 12 is provided with a bearing 27. In the illustrated embodiment, the force sensor 25 is designed as a strain gauge on the following side 12.

[0150] The securing tool 6 is horizontally movable, whereby a contact pressure in the pressing direction 16 can be generated, which is maintained by the feed force of the securing tool 6 during securing. A further force measuring sensor 25 integrated in the securing tool 6 is designed to detect the contact pressure and / or feed force of the securing tool 6, in particular of the crimping disc 7. Another sensor 14 integrated in the securing tool 6 additionally measures the adjustment path of the securing tool 6. The driving receptacle 8 is connected to a drive unit 28.

[0151] Fig. Figure 3 shows a further securing station 1 according to the invention with a second motion sensor 21, which is additionally designed to detect the motion variable 18 of the lower support 11. Thus, the rotational motion variable 18 of the lower driving support 8, 11, which forms a reference value of the motion variable 18, is detected by a further sensor 14.

[0152] Fig. Figure 4 shows the upper receptacle 10 and the lower receptacle 11 in a crimped state. The crimping disc 7 of the securing tool 6, the driving receptacle 8, and the follower receptacle 9 perform a rotational movement 24. To maintain the crimping force, the lower and / or upper receptacle performs an axial displacement in the crimping direction 16.

[0153] Fig. 5 shows the various process steps of the securing station 1 from left to right, which are carried out to secure the plug 2 on the container 3 with the closure lid 4.

[0154] Additionally, forces 23 and movement quantities 18 detected by sensors 14 are shown below the respective process steps in a two-dimensional coordinate system over a detection period 19, which includes the securing period. The detection of the relative movement begins before securing and is completed after securing.

[0155] In a first method step, the securing tool 6, in particular the crimping disc 7, is not engaged.

[0156] In the illustrated embodiment, the time between two pulses 26 transmitted to the sensor 21 is recorded as a measure of the movement quantity 18 of the rotational movement 24 of the upper holder 10 and is displayed in the coordinate system. It can be seen in the coordinate system that the upper holder 10 and lower holder 11 initially do not perform a rotational movement 24, since there is no contact between the lower holder 11 and the upper holder 10 at the beginning of the securing process.

[0157] The force 23 is measured simultaneously with the detection of the movement quantity 18 via the force measuring sensor 25, so that the detection period 19 of the movement quantity 18 and the detection period 19 of the force 23 at least partially overlap in time, in particular during the securing period.

[0158] With a constant rotational movement of the driving side 13, equally spaced pulses 26 are generated on the following side 12.

[0159] It can be seen that the force 23 is non-existent at the beginning of the process, since the upper and lower receptacles 10, 11 are not pressed against each other and the locking tool 6 of the crimping disc 7 is not engaged.

[0160] In a further process step, the container 3 with the stopper 2 and the closure lid 4 is pressed together by the upper and lower receptacles 10, 11, with the upper receptacle 10 gripping the container 3 from above. Thus, the force 23 increases.

[0161] It can thus be said that the container 3 with the stopper 2 on the one hand and the closure lid 4 on the other hand are pressed against each other.

[0162] The lower receptacle 11, which engages the container 3 from below and on which the container 3 is arranged, is now driven by the drive unit 28, whereby preferably a rotational movement 24 about the axis 5 is created between the container 3 and the closure lid 4.

[0163] Thus, the rotational movement 24 is transmitted from the lower driving mount 8, 11 to the upper follower mount 9, 10. This is also reflected in the coordinate system in which the pulses 26 detected by the encoder 21 are now represented.

[0164] It is also evident that due to the axial compression between the upper and lower mounts 10, 11, an initially increasing compression force 23 is detected, followed, for example, by reaching a stop or switching off a pressure control. The axial compression force is maintained. To maintain the compression force, the lower and / or upper mounts 10, 11 can perform an axial displacement.

[0165] Furthermore, it can be seen that the movement size 18 of the moving holder 9 is constant, since the pulse intervals of the pulses 26 are constant, whereby it can be assumed that the upper and lower holders 10, 11 have identical movement sizes 18.

[0166] In a next process step, a first contact is made between the closure lid 4 of the container 3 and the crimping disc 7 or the securing tool 6.

[0167] By measuring a feed force of the securing tool 6 transversely to the pressing direction 16, a further increase in the force 23 by a force contribution 17 is shown, which arises because the closure cover 4 is folded over by a contact force of the securing tool 6, in particular by a contact force of the crimping disc 7, and is thus detected by the force measuring sensor 25.

[0168] The contact pressure results from the feed force of the securing tool 6, in particular the crimping disc 7. The contact pressure is maintained via the feed force of the securing tool 6 during securing.

[0169] Thus, in addition to the axial pressing force, the force 23 includes a contact force of the securing tool 6, in particular of the crimping disc 7, as a force contribution 17, which can thus be continuously monitored and assessed.

[0170] In a further embodiment not shown, it is also provided that an adjustment path of the securing tool 6, in particular transversely to the force contribution 17 and / or along the force contribution 17 of the securing tool 6, in particular of the crimping disk 7, is additionally measured during the force contribution 17.

[0171] In a next method step, the securing tool 6, in particular the crimping disc 7, is moved by a restoring force so that the securing tool 6, in particular the crimping disc 7, is no longer engaged. The restoring force of the securing tool 6 is measured during the force contribution 17 along the pressing direction 16.

[0172] The restoring force causes a decrease in the contact pressure of the securing tool 6, in particular of the crimping disc 7. This is reflected in a reduction of the force contribution 17. The detected force 23 is thus reduced to the axial pressing force of the upper and lower receptacles 10, 11, which was already detected in a previous process step.

[0173] In a next process step, the pressure between the container 3 with the plug 2 and the closure lid 4 is reduced by the upper and lower receptacles 10, 11 until no more force 23 is detected. Securing is thus completed, and the container 3 can be decoupled from the lower receptacle 11 after it is no longer driven.

[0174] Fig. Figure 6 shows again the forces 23, force contributions 17 and movement quantities 18 recorded in the two-dimensional coordinate systems over the entire recording period 19 of the securing process. In contrast to Fig. Figure 5 additionally shows another two-dimensional coordinate system in which an irregular progression of the relative movement variable 18 is recorded and displayed over the securing recording period 19. This may be due, for example, to a coupling between the upper and lower mounts 10, 11, e.g., due to contamination, being insufficient to transfer the rotational movement 24 of the lower mount 11 to the upper mount 10 without slippage. By measuring the relative movement variable 18, the error can be quickly detected, assessed, and eliminated.

[0175] Fig. Figure 7 shows eight securing stations 1 of the process machine, with the securing process at each securing station 1 running parallel and independently of each other. The lower and upper supports 10, 11 are pressed together at each securing station 1.

[0176] Fig.Figure 8 also shows eight securing stations 1 of the process machine, which operate independently of one another. At six securing stations 1, the lower and upper holders 10, 11 are pressed together, and the securing tool 6 is engaged.

[0177] At the second securing station 1 from the left, the securing process is interrupted, independent of the other securing stations 1, and the upper and lower receptacles 10, 11 are not pressed together. Here, it was detected that the closure lid 4 was not placed on the container 3. The process was thus interrupted in time. This allows the closure lid 4 to be repositioned on the container 3 without producing any rejects.

[0178] At the fifth securing station 1 from the left, the securing process is also interrupted independently of the other securing stations 1. Here, it can be seen that the closure lid 4 is incorrectly, obviously crookedly, placed on the container 3. Here, too, a timely interruption of the process can prevent rejection due to an inadequately sealed container 3. According to the invention, in a method for securing a stopper 2 on a container 3 with a closure lid 4 using a securing station 1, it is proposed that during the securing process, measurements of variables 20, in particular movement variables 18, are carried out around an axis 5 to assess the securing process, and the recorded measured values ​​are evaluated to detect inadequately secured containers 3. List of reference symbols 1 security station 2 plugs 3 containers 4 closure lids 5 axis 6 securing tool 7 Crimping disc 8 driving recording 9 continuous recording 10 upper shot 11 lower shot 12 running pages 13 driving side 14 Sensor 15 Cleanroom 16 Pressing direction 17 Power contribution 18 Movement size 19 Recording period 20 size 21 donors 22 Demarcation 23 Force 24 Rotational movement 25 force measuring sensor 26 Impuls 27 Storage 28 Drive unit 29 Process machine

Claims

[1] Method for securing a stopper (2) on a container (3) with a closure lid (4), wherein the container (3) is preferably a pharmaceutical or medical container (3), wherein during the securing a relative movement about an axis (5) is carried out at least between the closure lid (4) and a securing tool (6), characterized by that during securing, a detection, in particular a measurement and / or determination, of a variable (20) determined at least by a relative movement about the axis (5) between the container (3) and the closure lid (4) is carried out. [2] Method according to the preamble of claim 1 or according to claim 1, characterized bythat during securing, a detection, in particular a measurement and / or determination, of a size determined at least by a rotationally connecting coupling of the container (3), in particular by a coupling of a receptacle (8, 11) contacting the container (3) to the container (3), and / or by a rotationally connecting coupling of the closure lid (4), in particular by a coupling of a receptacle (10) contacting the closure lid (4) to the closure lid (4), is carried out. [3] Method according to claim 1, characterized by that the size (20) is determined by measuring a preferably rotary relative movement between a receptacle (8) and / or lower receptacle (11) contacting, in particular supporting, preferably driving the container (3), and a receptacle (9) receiving the closure lid (4) and preferably running therealong, preferably upper receptacle (10). [4] Method according to one of the preceding claims, characterized by that the variable (20) is / are an absolute value on the follower and / or driving side (9, 8), a time between pulses to a sensor (21), a covered angle and / or a speed, preferably in each case in a comparison with a setpoint value, and / or an acceleration value. [5] Method according to one of the preceding claims, characterized by that the variable (20) is determined from a measurement of a relative movement of a lower and / or driving receptacle (11, 8) against a closure lid (4) of the medical container (3) and / or a relative movement of an upper and / or moving receptacle (10, 9) against a preferably medical container (3) and / or a relative movement of one or the closure lid (4) against one or the container (3) and / or a crimping disc (7) against one or the container (3) and / or one or the crimping disc (7) against one or the upper and / or moving receptacle (10, 9). [6] Method according to one of the preceding claims, characterized by that the container (3) with plug (2) and closure lid (4) are pressed together by an upper and / or follower and lower and / or driving receptacle (10, 11), so that a rotary movement is transmitted from the lower and / or driving receptacle (11, 8) to the upper and / or follower receptacle (10, 9). [7] Method according to the preceding claim characterized by that the driving receptacle (8) engages the container (3) from below and / or the moving receptacle (9) engages from above. [8] Method for securing a stopper (2) on a container (3) with a closure lid (4), in particular according to one of the preceding claims, wherein a relative movement of one or the container (3), in particular vials, and one or the closure lid (4) is determined and compared with at least one rotational drive movement of at least one of the receptacles (8, 9). [9] Method according to one of the preceding claims, wherein the container (3) is driven and / or the closure lid (4) is rotating. [10] Method according to one of the preceding claims, wherein a measured value of a movement variable (18) of the relative movement, in particular a rotational speed and / or a torque and / or pulse spacing, of the container (3), receptacle(s), crimping disc (7) and / or closure lid (4) is detected. [11] Method according to one of the preceding claims, wherein during the detection a target value of the movement quantity (18) is provided by a specification, in particular wherein the target value is provided to a driving side (13) of the container (3) and / or the target value is compared with an actual value of one or the following side (12). [12] Method according to one of the preceding claims, wherein a reference value of the movement quantity (18), in particular the driving side (13) of the container (3), is measured during the detection. [13] Method according to one of the preceding claims, wherein a difference value between the measured value and the target value and / or reference value is determined and in particular assessed. [14] Method according to one of the preceding claims, wherein a message is output as a result of the assessment, in particular when the difference value has reached a certain value. [15] Method according to one of the preceding claims, wherein the detection of the relative movement is started before securing and / or wherein the detection is completed after securing, in particular wherein a detection period (19) comprises at least one period of securing. [16] Method according to one of the preceding claims, wherein an acceleration of the relative movement of the receptacles (8, 9), preferably of the moving and / or driving receptacle (8, 9), is detected before securing. [17] Method according to one of the preceding claims, wherein the detection of the movement quantity (18) is carried out on a side facing away from the container (3), preferably a side facing the or a closure lid (4). [18] Method, in particular according to one of the preceding claims, for securing a stopper (2) on a container (3) with a closure lid (4), wherein the container (3) is preferably a pharmaceutical or medical container (3), wherein during the securing a relative movement about an axis (5) is carried out at least between the closure lid (4) and a securing tool (6), characterized by that the container (3) with the stopper (2) on the one hand and the closure lid (4) on the other hand are pressed against each other along a pressing direction (16) and that a preferably signed force contribution (17) of the securing, preferably in the pressing direction (16), is detected during the pressing. [19] Method according to one of the preceding claims, wherein a measurement of a feed force of the securing tool (6), in particular of a crimping disc (7), is carried out during a force contribution (17) transverse to the pressing direction (16). [20] Method according to one of the preceding claims, wherein a measurement of a restoring force of the securing tool (6), in particular of a crimping disc (7), is carried out during a force contribution (17) along the pressing direction (16). [21] Method according to one of the preceding claims, wherein a measurement of an adjustment path, in particular transverse to the force contribution (17) and / or along the force contribution (17), of the securing tool (6), in particular of the crimping disc (7), is carried out during a force contribution (17). [22] Method according to the preceding claim, wherein a preferably axial pressing force, in particular one acting on the container (3), is maintained during a detection period (19) of the force contribution (17), which comprises at least a period of securing. [23] Method according to one of the preceding claims, wherein in order to maintain a pressing force or the pressing force, the lower and / or follower receptacle (11, 9) performs an axial displacement, in particular during the securing period. [24] Method according to one of the preceding claims, wherein the force contribution (17) comprises a contact pressure of the securing tool (6), in particular of the crimping disc (7), in particular wherein a determination and assessment of the contact pressure is carried out. [25] Method according to one of the preceding claims, wherein a message is issued as a result of the assessment, in particular when the contact pressure exceeds a certain threshold value. [26] Method according to one of the preceding claims, wherein a message is output as a result of the assessment, in particular when the contact force falls below a certain threshold value. Method according to one of the preceding claims, wherein the detection period (19) of the movement variable (18) and the detection period (19) of the force contribution (17) at least partially overlap in time, in particular during the securing period. [27] Method according to one of the preceding claims, wherein at least two methods can be carried out in parallel, preferably independently of one another. [28] Securing station (1) for securing a container (3) closed with a stopper (2) with a closure lid (4), wherein the container (3) is preferably a pharmaceutical or medical container (3), wherein the container (3) and the closure lid (4) are arranged to be movable relative to one another along an axis (5), wherein the securing station (1) has at least one securing tool (6) for securing, characterized by that the securing station (6) has at least one sensor (14) which is designed to detect a variable determined at least by a relative movement about the axis (5) between the container (3) and the closure lid (4). [29] Securing station (1) for securing a container (3) closed with a stopper (2) with a closure lid (4), wherein the container (3) is preferably a pharmaceutical or medical container (3), wherein the container (3) and the closure lid (4) are arranged to be movable relative to one another along an axis (5), wherein the securing station (1) has at least one securing tool (6) for securing, characterized by that the securing station (6) has at least one sensor (14) which is designed to detect a size determined at least by a rotationally connecting coupling of the container (3), in particular by a coupling of a receptacle (8, 11) contacting the container (3) to the container (3), and / or by a rotationally connecting coupling of the closure lid (4), in particular by a coupling of a receptacle (10) contacting the closure lid (4) to the closure lid (4). [30] Security station (1) according to one of the preceding device claims, wherein the container can be positioned on a lower rotatable, preferably driving, receptacle (11, 8) and the closure lid (4) can be positioned on an upper rotatable, preferably moving, receptacle (10, 9). [31] Security station (1) according to one of the preceding device claims, wherein the security station (1) is designed to carry out a previously claimed method. [32] Security station (1) according to one of the preceding claims, wherein the security station (1) is part of a process machine (29), wherein the process machine (29) has a boundary (22) forming a clean room (15), in particular an isolator or a RABS, wherein the security station (1) is in the clean room (15). [33] Security station (1) according to one of the preceding device claims, wherein the at least one sensor (14), in particular a motion sensor, is designed to detect a movement variable (18) of the relative movement, in particular pulses to the sensor (21), a covered angle, a rotational speed and / or a torque. [34] Security station (1) according to one of the preceding device claims, wherein the security station (1) has a drive unit (28) in particular for the reception, and / or wherein the drive unit (28) preferably comprises a linear drive, preferably a pneumatic cylinder. [35] Security station (1) according to one of the preceding device claims, wherein at least two security stations (1) are present, which are preferably controllable and / or adjustable independently of one another. [36] Security station (1) according to one of the preceding device claims, wherein the security station (1) has at least two motion sensors, wherein one of the at least two motion sensors is designed to detect the movement quantity (18) of the lower receptacle (11) and the second motion sensor is designed to detect the movement quantity (18) of the upper receptacle (10). [37] Securing station (1), in particular according to the preceding claim, for securing a container (3) closed with a stopper (2) with a closure lid (4), wherein the container (3) is preferably a pharmaceutical or medical container (3), wherein the container (3) and the closure lid (4) are arranged to be movable relative to one another along an axis (5), wherein the securing station (1) has at least one securing tool (6) for securing, characterized bythat the securing station (1) has at least one force measuring sensor which is designed to detect a force contribution (17), in particular a contact pressure force of the securing along a pressing which can be generated by the securing tool (6).

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