EP2291320A1

EP2291320A1 - Device and method for checking the leak tightness of caps on medical hollow bodies

Info

Publication number: EP2291320A1
Application number: EP09765621A
Authority: EP
Inventors: Thomas Fischer; Manfred Simader; Günter Kavallar
Original assignee: Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
Current assignee: Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
Priority date: 2008-06-19
Filing date: 2009-06-18
Publication date: 2011-03-09
Anticipated expiration: 2029-06-18
Also published as: BRPI0914203A2; EP2291320B1; MX2010013514A; CA2728135C; US8567261B2; RU2011101683A; BRPI0914203B8; PT2291320E; US20110126638A1; BRPI0914203B1; WO2009153041A1; ES2528930T3; JP2011524530A; WO2009153041A8; JP5631872B2; CA2728135A1; RU2516962C2; DE102008030271A1

Abstract

The invention relates to a device (1) for checking the leak tightness of caps (13) on medical hollow bodies (9), having a drive (3), a retaining element (7) for the hollow body (9), a retaining device (11) for the cap (13), wherein the retaining device (11) is pivot-supported relative to the retaining element (7), and a relative rotation sensor for the retaining device (11) opposite to the retaining element (7), wherein a torque can be applied to the cap (13) by means of the drive (3), the retaining element (7) and the retaining device (11), and wherein a hollow body (9) and a cap (13) are detected by the retaining device (11) and the retaining element (7) from the same side – as viewed along the longitudinal axis (19) of a hollow body (9).

Description

Device and method for testing the tightness of caps on medical hollow bodies

description

The invention relates to a device for testing the tightness of caps on medical hollow bodies according to the preamble of claim 1 and to a method for testing the tightness of caps on medical hollow bodies according to the preamble of claim 11.

Devices of the type mentioned are not yet known. In order to test a medical hollow body, for example a syringe or carpule, for its tightness, a manual method has hitherto been used. For this purpose, random samples of the closed hollow bodies are taken at the end of the production process. These are checked manually by the test person trying to twist the cap relative to the hollow body. If the cap sits tight enough on the hollow body and thereby a sealing washer between the hollow body and the cap is sufficiently compressed so that a desired tightness is ensured, it is the test subject only with considerable effort or not possible to twist the cap. If the cap is not firmly enough connected to the hollow body, so that the gasket is not sufficiently compressed and thus a desired tightness is not guaranteed, the cap is much easier to turn manually.

The disadvantage of this procedure is that each test person has a different subjective feeling for the force to be applied, so that the statements for the tightness gained from the assessments of the test persons are highly subjective, not well reproducible. barely and hard to document. Another disadvantage is that only samples of the closed hollow body can be tested, while it would be desirable to perform a 100% inspection. A further disadvantage is that it is not possible to intervene directly in the closing process after a lack of tightness of one or more hollow bodies has been determined, so that a larger number of already completely closed hollow bodies is located in the production line, which then all have to be checked , If the lack of tightness is due to a fault in the capper, a larger amount of rejects will be created before the problem can be solved.

The object of the invention is therefore to provide a device for testing the tightness of caps on medical hollow bodies, which allows an objective, well reproducible, documentable, non-destructive and identical for each test specimen. Furthermore, the device should be capable of being able to carry out a 100% inspection of the hollow bodies produced, ie not only to check random samples, but the entire production volume.

The object is achieved by a device having the features of claim 1. It comprises a drive, a holding element for the medical hollow body and a holding device for the closure cap. In this case, the holding device is rotatably mounted relative to the holding element. The device further comprises a sensor for the relative rotation of the holding device relative to the holding element. It is characterized in that by means of the drive, by means of the holding element and the holding device a rotary moment in the closure cap is introduced, and that a hollow body and a closure cap of the holding device and the holding element of - along the longitudinal axis of the hollow body seen - the same side are detected. In order to be able to introduce a torque into the cap without, for example, the hollow body rotates when the drive interacts with the holding device, it is necessary to grip the cap and the hollow body with different holders, the holders must be rotatably mounted against each other. For the initiation of a torque in the closure cap, it is irrelevant whether the drive interacts with the holding element or with the holding device. Since the closure cap - in leaky caps at least until the moment of tearing - is firmly connected to the hollow body, a torque is introduced into this even when the drive interacts with the holding element. Usually, a body in which, for example, a lid to be turned on or turned off, seen from its longitudinal axis - detected on different sides. For example, one holder may grasp the body in the region of its bottom while another holder grips the lid. In contrast, it is provided in the present device that a hollow body and a closure cap of the holding device and the holding element of - along the longitudinal axis of the hollow body seen - the same side are detected. The holding member for the hollow body is thus arranged relative to the holding device for the closure cap so that it detects the hollow body in a region which more or less directly - as seen along the longitudinal axis of the hollow body - connects to the closure cap. In this way, the opposite along the longitudinal axis of the hollow body remains Page free, which makes it possible to equip existing production facilities with the device. In a known manner, in this case, the hollow bodies are grasped at their opposite side from the closure cap in order to be transportable through the production plant. This can be done, for example, by arranging the hollow bodies in magazines. But it can also be that the hollow bodies are detected by grippers, which transport them through the production plant. In any case, in the case of existing production plants, the end of a hollow body opposite the closure cap is typically not accessible, since it is intended to transport the hollow body through the plant. Retrofitting the system with the device according to the invention can thus take place in a particularly economical manner when the device engages only at the end of the hollow body, on which the closure cap is arranged. The holding device for the closure cap and the holding element for the hollow body are rotatably mounted relative to each other, so that a torque in the closure cap can be introduced without, for example, the hollow body rotates when the drive cooperates with the holding device. A sensor is provided which can detect a relative rotation of the holding device relative to the holding element.

Also preferred is a device which is characterized in that the holding device and the holding element are arranged on the same side, viewed along a longitudinal axis of the hollow body. It would also be possible, for example, to bring the holding device for the closure cap from the side to the hollow body on which the closure cap is arranged. At the same time, it could be opposite of the longitudinal axis of the hollow body. the side of a holding element for the hollow body to be brought, which extends almost along the extension of the hollow body almost directly to the cap and engages around the hollow body in this area. Preferably, however, if both the holding device and the holding element are arranged on the same side, it is preferable for both the holding device and the holding element to approach the hollow body from the side on which the closure cap is arranged.

Furthermore, a device is preferred in which the holding device and the holding element are arranged integrally with one another on or in a basic body of the device. In this way, the device does not consist of different separate parts, but has a single body comprising the described elements. This also means that the device can be constructed very compact.

A device is preferred in which the sensor for the relative rotation of the holding device relative to the holding element is a torque sensor. In this case, it can be provided that a torque is introduced into the closure cap via the drive, which initially has a relatively small value, which is then preferably increased linearly up to a nominal value. The setpoint preferably corresponds to a torque in which a closure cap which is sufficiently firmly connected to a hollow body, so that a sealing element arranged between the hollow body and the closure cap is compressed in such a way that a desired tightness is achieved, especially not yet twisting. If the test specimen is tight, then the torque sensor will be the preferably linear increase of the torque. register, preferably also serve the control until the target value is reached, and then turn off the drive so that no further torque is introduced into the cap. In this case, the test specimen has passed the leak test and can be removed from the device. On the other hand, if the cap is not firmly seated on the hollow body, it will possibly start to rotate at a lower torque, at the latest at the nominal value, when the drive interacts with the holding device. At the moment of tearing off, the torque introduced into the closure cap breaks, since a discontinuous transition from static friction to sliding friction takes place between the closure cap and the sealing element or between the sealing element and the hollow body. This drop in torque can be detected by the torque sensor, which thus detects the onset of a positive rotation of the holding device relative to the holding element. The nonlinear torque curve measured on the sensor is indicative of a leaking specimen. A torque can be introduced into the closure cap by the drive interacting with either the holding device or with the holding element. If a leaking cap breaks loose in this second case, it is held in place by the holding device while the hollow body rotates relative to it because the drive interacts with the holding element. For the introduction of a torque in the cap, it is irrelevant in any case whether the drive interacts with the holding element or with the holding device. Since the closure cap - in leaky caps at least until the moment of tearing - is firmly connected to the hollow body, a torque is introduced into this even when the drive interacts with the holding element. A device is also preferred, which is characterized in that the sensor for the relative rotation of the holding device relative to the holding element is an angle sensor which detects the angle of rotation of the holding device relative to the holding element. In this case, for example, a setpoint torque can be introduced directly into the closure cap, wherein the angle sensor determines whether the closure cap can be rotated relative to the hollow body. If this is the case, the test specimen has failed the tightness test. In contrast, the sealing cap of a sealed test object can not be twisted when the setpoint torque is initiated. The introduction of the desired torque in the cap can be done in a particularly simple way, for example, characterized in that the drive is acted upon by a defined nominal current or a defined nominal voltage. For this purpose, it is necessary to know the relationship between the relevant electrical variables and the torque generated by the drive very accurately. It can then be generated a defined torque, without the need for a separate torque sensor should be provided.

In connection with the embodiment described above, however, it is also preferred that a torque sensor is provided in addition to the angle sensor. This can determine, for example, whether the torque generated by setting an electrical variable for the drive actually corresponds to the desired setpoint torque. For this purpose, it can simply serve to record the torque, or use a control system to ensure that the setpoint torque is always applied. But it is also possible to operate the device so that a preferably linearly increasing torque introduced into the cap is, and that an incipient relative rotation between the holding member and holding device is not registered by a collapse of the measured value at the torque sensor, but by the additionally provided angle sensor. The torque sensor is then used only for detecting the momentarily applied torque and can thus monitor, for example, the linearity of the torque curve, preferably serve a control, or allow a logging of the introduced into the cap torques.

In connection with the two embodiments described above, a device is preferred in which a device for limiting the speed is provided. This is advantageous in particular when a setpoint torque is introduced into the closure cap by setting an electrical nominal size of the drive. Namely, when the cap breaks loose and begins to rotate, with the preset electrical rating not being timely reduced from its nominal value to a smaller value, the constant torque is still introduced into the cap so that it will be accelerated in rotation when the between the cap and the sealing element or between the sealing element and the hollow body prevailing sliding friction is not large enough to prevent this. Such acceleration can ultimately lead to excessive speed and possibly even damage to the machine. A device for limiting the speed provides a remedy by the drive is driven so when reaching a certain maximum speed that a further increase in speed is not possible. This maximum Speed can preferably be adjusted so that the device is not damaged.

Further preferred embodiments will become apparent from the dependent claims.

The object of the invention is also to provide a method for testing the tightness of caps on medical hollow bodies, which allows an objective, non-destructive and identical for each specimen examination, which is possible in 100% of the manufactured in a plant sealed hollow bodies.

This object is achieved by a method having the features of claim 11. It is preferably used a device having the features of claims 1 to 10. The method comprises the following steps: A hollow body is grasped and held by means of the retaining element. In addition, the closure cap is grasped and held by means of the holding device. By means of the drive, a torque is introduced into the cap. By means of a sensor, a relative rotation of the holding device relative to the holding element is detected. It is thus possible to judge whether, when a torque is introduced into the closure cap, it can be rotated relative to the hollow body. Therefore, in the manner already described tightly closed leaking hollow bodies distinguishable.

A method is also preferred which is characterized in that the torque introduced into the closure cap is detected by a torque sensor. On the one hand, this can be used to log the torque introduced. be used to control the linearity of a torque ramp. On the other hand, with the torque sensor via the torque introduced into the closure cap, an incipient relative rotation of the holding device relative to the holding element can be determined, because the torque acting on the closure cap breaks in the moment of incipient relative rotation when a discontinuous transition between static friction and sliding friction takes place ,

A method is also preferred in which the angle of rotation of the holding device relative to the holding element can be detected by an angle sensor. The possible relative rotation of the holding device relative to the holding element upon initiation of a setpoint torque can thus be detected, for example, by the angle sensor.

Furthermore, a method is preferred in which both the torque introduced into the closure cap by a torque sensor and the rotation angle of the holding device relative to the holding element are detected by an angle sensor. In the event that a desired torque is introduced by setting an electrical nominal size of the drive in the cap, the torque sensor of the logging or control of the actually acting on the cap torque. In the case of a leaky test piece, the angle sensor determines a relative rotation of the closure cap relative to the hollow body. However, the torque sensor can also be used to initiate a torque ramp, so a preferably linear torque curve, in the cap. A relative rotation of the closure cap relative to the hollow body can then optionally detected either by the angle sensor alone or both by the angle sensor and by the torque sensor via a break in torque. If the onset of relative rotation by both sensors is detected in parallel, there is a redundancy which makes the method particularly safe and easy to reproduce.

Furthermore, a method is preferred, which is characterized in that a desired value for a torque is adjustable. The limit torque at which the closure cap just does not begin to rotate relative to the hollow body depends on various parameters. For example, the coating of the cap plays a role here because it influences its friction properties. Furthermore, the sealing element arranged between the closure cap and the hollow body is important. Also, the material used for the hollow body, for example, the type of glass, plays a significant role, since also here very different friction properties can result. This may even result in differences in each delivered batch, so that for each batch with which the filling or closing line is sent, a separate setpoint must be determined and set. The setpoint - ie the limit torque - also depends on how the cap is attached to the hollow body. It can be connected, for example by crimping or crimping with the hollow body.

A method is also preferred in which a hollow body is identifiable as a bad part if, when a torque is introduced into the closure cap, the amount of which is less than or equal to the nominal value, a collapse of the torque in the rotary torque sensor is detectable. This method is responsive to the fact that over time a preferably linearly increasing torque is introduced into the closure cap. This is increased up to a preset setpoint if the cap does not break loose first and begin to rotate. If the cap is tight, the torque can be increased to the setpoint without rotation. On the other hand, if it is a leaking specimen, the torque will break at a value less than or equal to the target value, because the cap breaks loose and a transition from static to sliding friction occurs. Thus, if such a break-in is detected in the torque sensor, the test object can be identified as a bad part, so that it can be singled out at the end of the production line.

Finally, a method is preferred in which a hollow body can be identified as a bad part if a change in the angle of rotation of the holding device relative to the holding element can be detected by the angle sensor when a defined torque is introduced into the closure cap. Here it is mentioned that, for example, by applying the drive with an electrical nominal size, a defined torque is introduced into the cap. If a tightly closed hollow body is in engagement with the testing device, no change in the angle of rotation of the holding device relative to the holding element will be detectable, since the closure cap will not tear when the defined torque is introduced. On the other hand, if the test object is leaking, the closure cap will break loose, so that a change in the angle of rotation can be detected. In this case, the hollow body is identifiable as a bad part, so that it is ausnehmbar as a scrap at the end of the production line. The invention will be explained in more detail below with reference to FIG.

The sole FIGURE shows a device 1 for testing the tightness of sealing caps on medical hollow bodies. It has a drive 3 which is able to effect a rotation about a longitudinal axis 5. The device 1 also has a holding element 7, which is suitable for holding a hollow body 9 against rotation. The hollow body 9 can be a syringe, a carpule, a vial or a multi or double chamber system. It is essential that the hollow body is a medical hollow body.

The device 1 further comprises a holding device 11, which can hold a cap 13 against rotation. The closure cap 13 may be formed, for example, as a crimp cap or as a crimp cap. It is essential that it is firmly connected to the hollow body 9, so that a sealing element arranged between the closure cap 13 and the hollow body 9 is compressed such that it seals the hollow body 9 tightly.

The holding device 11 is rotatably mounted relative to the holding element 7, and it can be by means of the drive 3 via the holding device 11, a torque directly into the cap 13 are introduced. Alternatively, by means of the drive 3 via the retaining element 7, a torque can be introduced directly into the hollow body 9. Even then, a torque is introduced into the closure cap 13, since it is firmly connected to the hollow body 9, at least until the moment of detachment. It is also a sensor for the relative rotation of the holding device 11 opposite provided the holding element 7, which may be formed as a torque sensor 15 or as an angle sensor 17.

The hollow body 9 has a longitudinal axis 19 which coincides with the longitudinal axis 5 of the device 1. The holding device 11 and the holding element 7 are designed such that they grasp the hollow body 9 and the closure cap 13 from the same side as seen along the longitudinal axis 19. In particular, the holding device 11 and the holding element 7 are arranged on the same side of the hollow body 9, viewed along the longitudinal axis 19. In a particularly preferred manner, it is provided that an axial distance along the longitudinal axis 19 between the holding device 11 and the holding member 7 is so small that the holding member 7 detects the hollow body in a region along the longitudinal axis 19 more or less directly to the Closure cap 13 connects. As a result, the end of the hollow body 9, which lies opposite the closure cap 13 along the longitudinal axis 19, remains free. It can for example be used to transport the hollow body 9 along the production line. For this purpose, the hollow body 9 optionally sorted in magazines or detected by grippers.

It is also preferred if the axial distance along the longitudinal axis 19 between the holding device 11 and the holding element 7 is adjustable. For this purpose, for example, a pneumatic stroke control with pneumatic connections 21, 21 'may be provided. This makes it possible to match the axial distance between the holding device 11 and the holding element 7 to the specific geometry of the test object to be examined. For example, due to a variable head height in different batches of test lend the height of the cap variable. The device 1 can be adapted to such changes by changing the axial distance between the holding device 11 and the holding element 7. In this way, it is ensured that the holding element 7 engages around the hollow body 9 always at the same relative position to the closure cap 13. This results in a particularly good reproducibility of the measurement.

It can also be provided that the entire device 1 or sub-elements of the device 1 in the axial direction along the longitudinal axes 5 and 19 are displaced. This, too, can preferably take place via a pneumatic control, for which pneumatic connections 21, 21 'can likewise be provided. This makes it possible to compensate for length tolerances of the hollow body 9. The hollow body 9 is typically held in the production line at its end opposite the closure cap. The device 1 can now approach from the side - along the longitudinal axis 19 - to the hollow body 9, on which the closure cap 13 is arranged. It continues to drive on the hollow body 9, until the cap 13 is in the region of the holding device 11. The axial distance between the holding device 11 and the holding element 7 is then varied so that the holding element 7 can grip the hollow body 9 in a region which adjoins the closure cap 13 more or less directly along the longitudinal axis 19. In this way, different lengths hollow body 9 can be tested without a conversion of the device 1 or the production plant is needed. In addition, length tolerances of the hollow body 9 can be compensated in the same way. From the figure it is clear that the holding device 11 and the holding element 7 are here arranged integrally with each other in a base body 23 of the device 1. This allows a very compact construction of the device 1.

At least the holding device 11 can be sterilized since it comes close to the opening of the hollow body 9 spatially particular. In no case should there be any carryover of germs, viruses or bacteria. However, it is preferred that the retaining element 7, in particular the entire device 1, be sterilized. Thus, the use of the device 1 is also possible in a generally aseptic production plant.

In the following, the operation of the device 1 and the method will be explained in more detail. The tightness of a sealed hollow body 9 is checked by the device 1 not directly, but indirectly by the application of torque. The torque can be introduced via the drive 3 mediated by the holding device 11 in the cap 13. The holding device 11 is rotatably mounted relative to the holding element 7, so that the hollow body 9 does not rotate when a torque is introduced into the closure cap 13. Conversely, the torque can also be imparted via the drive 3 mediated by the holding element 7 in the hollow body 9. Here, too, a torque is introduced into the closure cap 13, because it is firmly connected to the hollow body 9, at least until the moment of tearing. In this case, the rotatable mounting of the retaining element 7 relative to the holding device 11 ensures that the closure cap 13 does not rotate when a torque is introduced into the hollow body 9. First, a hollow body 9 is detected by means of the holding element 7, and a closure cap 13 is detected and held by means of the holding device 11. It can then be introduced into the cap 13, a torque. A sensor is provided which optionally detects a relative rotation of the holding device 11 relative to the holding element 7. This sensor can be designed, for example, as a torque sensor 15.

It can then be provided that initially a small torque is introduced into the closure cap 13, which is for example linearly increased up to a desired value. If the closure cap 13 breaks loose during this torque ramp and begins to rotate, the torque detectable at the torque sensor 15 breaks due to the discontinuous transition from static friction to sliding friction, so that a nonlinear torque curve, in particular a collapse of the otherwise increasing torque, occurs Torque is detectable. The nominal value up to which the torque ramp is driven is chosen such that a closure cap 13, which sealingly closes a hollow body 9, just can not break loose and begin to rotate. Thus, if an intruding torque is detectable in the torque sensor 17, if its magnitude is less than or equal to a preset desired value, the test specimen is a hollow body 9 whose closure cap 13 does not close it in a sealing manner. The test object is then marked as a bad part and can preferably be discarded at the end of the production line.

The sensor for detecting a relative rotation of the holding device 11 relative to the holding element 7 can also be used as an angle sensor 17 be educated. In this case, it is possible to initiate a defined torque in the closure cap 13, for example by acting on the drive 3 with a defined electrical nominal value, and to determine via the angle sensor 17 whether the closure cap 13 is torn open and begins to rotate. Again, the defined torque is chosen so that a tight-fitting cap 13 just can not break loose. If a change in the angle of rotation can be registered in the angle sensor 17, the test object is a bad part which can be identified and preferably sorted out at the end of the production line.

It is also possible to integrate both a torque sensor 15 and an angle sensor 17 into the device 1. It is then possible, for example, to drive a (preferably regulated) torque ramp, whereby the tearing off of a closure cap 13 can not be detected by the breaking in of the torque at the torque sensor 15, but by a change in the angle of rotation in the angle sensor 17. However, the tearing of the cap 13 can also be detected both by a collapse of the torque in the torque sensor 15 and by a change in the angle of rotation in the angle sensor 17. In this way, one has two parameters for assessing the tight fit of the closure cap 13 on the hollow body 9, so that this embodiment is particularly error-prone and provides particularly good reproducible test results.

However, the torque sensor 15 may also serve to a defined torque, which is generated by acting on the drive 3 with a constant electrical nominal size, with a Preset setpoint to compare or log. Here, a regulation can be provided, which causes a variation of the nominal value of the electrical variable with a deviation of the torque, so that the present torque can be equal to the desired value. A tearing of the cap 13 under the action of the preset target torque can also be detected here both by a collapse of the torque in the torque sensor 15 as well as a change in the angle of rotation in the angle sensor 17.

The setpoint for the torque at which a tight-fitting cap 13 just does not break loose and begins to rotate is preferably adjustable. It can then be adapted to the specific conditions present in a given batch of candidates. The torque at which a close-fitting closure cap 13 just does not tear depends, for example, on the coating of the closure cap 13, on the sealing element arranged between the closure cap 13 and the hollow body 9, and on the material of the hollow body 9. Therefore, the limit torque setpoint must be redetermined and set for each lot of DUTs.

Preferably, a device for limiting the rotational speed of the holding device 11 is provided for the device 1. Namely, if a closure cap 13 breaks loose and at the same time a constant torque is introduced into it, the rotation of the holding device 11 is accelerated, as a result of which speeds of rotation can possibly be reached which can lead to damage to the device 1. The means for limiting the speed is preferably set so that they drive the drive 3 in such a way can, that at most a maximum speed of the holding device 11 is reached, in which the device 1 is not damaged.

The device 1 can be integrated into a production line, preferably it can be arranged immediately behind a closure station within the production line. In this way, it is possible, without exception, to check all sealed in the closure station hollow body to its tightness, and so to be able to immediately determine a possible error in the production plant. The production can then be interrupted immediately and the error corrected. In contrast to traditional testing methods, which are sampled at the end of the production line, there are no accumulated product losses.

Of course, it is also possible to arrange the device 1 at the end or outside a production line and thus also to check samples.

Furthermore, it is possible to integrate the device 1 in laboratory equipment in order to determine, for example, desired values, ie torques at which a tight fitting cap 13 just will not break loose. Integration of the device in laboratory equipment also makes it possible to calibrate repaired, refurbished or newly manufactured devices 1, and to check their proper functioning.

After all, it has been found that the device 1 makes it possible for the first time to qualitatively test the tightness of a closure cap on a medical hollow body in an objective method which is a non-destructive and 100% identical for each test object. Inspection possible directly in the production plant. The test results can be documented and evaluated.

Claims

claims

1. A device for testing the tightness of caps (13) on medical hollow bodies (19), with

a drive (3), a holding element (7) for the hollow body (9),

- A holding device (11) for the closure cap (13), wherein the holding device (11) relative to the holding element (7) is rotatably mounted, and

- A sensor for the relative rotation of the holding device (11) relative to the holding element (7), characterized in that by means of the drive (3), by means of the holding element (7) and the holding device (11) a torque in the closure cap (13) can be introduced is that, and that a hollow body (9) and a closure cap (13) of the Haltevor- direction (11) and the holding element (7) of - along

Longitudinal axis (19) of a hollow body (9) seen - the same side are detected.

2. Apparatus according to claim 1, characterized in that the holding device (11) and the holding element (7) on - along a longitudinal axis (19) of the hollow body (9) seen - the same

Side are arranged.

3. Device according to one of claims 1 or 2, characterized in that the holding device (11) and the holding element (7) are arranged integrally with each other in a base body (23) of the device (1).

4. Device according to one of claims 1 to 3, characterized in that the sensor for the relative rotation of the holding device (11) relative to the holding element (7) is a torque sensor (15).

5. Apparatus according to claim 1 to 3, characterized in that the sensor for the relative rotation of the holding device (11) relative to the holding element (7), an angle sensor (17) is provided, the angle of rotation of the holding device (11) relative to the holding element ( 7).

6. Apparatus according to claim 5, characterized in that a torque sensor (15) is provided.

7. Device according to one of claims 5 or 6, characterized in that a device for limiting the speed is provided.

8. Device according to one of the preceding claims, characterized in that the closure cap (13) is a crimp cap or a crimp cap.

9. Device according to one of the preceding claims, characterized in that the hollow body (9) is a syringe, a ne carpule, a vial, or a multi or double chamber system.

10. Device according to one of the preceding claims, characterized in that at least the holding device (11), preferably the holding device (11) and the Halteele- ment (7), in particular the entire device (1) is sterilizable.

11. Method for testing the tightness of sealing caps (13) on medical hollow bodies (9), in particular using a device (1) according to one of claims 1 to 10, characterized by the following steps:

- Detecting and holding the hollow body (9) by means of the holding element (7),

- Detecting and holding the closure cap (13) by means of the holding device (11),

- Introducing a torque in the cap (13) by means of the drive (3) and

- Detecting a relative rotation of the holding device (11) relative to the holding element (7) by means of a sensor.

12. The method according to claim 11, characterized in that in the closure cap (13) introduced torque by a torque sensor (15) is detected.

13. The method according to claim 11, characterized in that the angle of rotation of the holding device (13) relative to the holding element (7) by an angle sensor (17) is detected.

14. The method according to claims 12 and 13, characterized in that in the closure cap (13) introduced torque by a torque sensor (15) and the rotation angle of the holding device (11) relative to the holding element (7) by an angle sensor (17) be recorded.

15. The method according to any one of claims 12 or 14, characterized in that a desired value for a torque is adjustable.

16. The method according to claims 12 and 15, characterized in that a hollow body (9) is marked as bad part, if upon initiation of a torque in the cap (13) whose amount is less than or equal to the desired value, a collapse of the Torque in the torque sensor (15) is detectable.

17. The method according to any one of claims 13, 14 or 15, characterized in that a hollow body (9) is marked as bad part, if at initiation of a defined torque in the closure cap (13) a change in the angle of rotation of the holding device (11) relative to the holding element (7) by the angle sensor (17) is detectable.