EP2291320B1 - Vorrichtung und verfahren zur prüfung der dichtigkeit von verschlusskappen auf medizinischen hohlkörpern - Google Patents

Vorrichtung und verfahren zur prüfung der dichtigkeit von verschlusskappen auf medizinischen hohlkörpern Download PDF

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Publication number
EP2291320B1
EP2291320B1 EP09765621.9A EP09765621A EP2291320B1 EP 2291320 B1 EP2291320 B1 EP 2291320B1 EP 09765621 A EP09765621 A EP 09765621A EP 2291320 B1 EP2291320 B1 EP 2291320B1
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EP
European Patent Office
Prior art keywords
torque
hollow body
cap
retaining
closure cap
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Application number
EP09765621.9A
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German (de)
English (en)
French (fr)
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EP2291320A1 (de
Inventor
Thomas Fischer
Manfred Simader
Günter Kavallar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
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Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
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Publication of EP2291320A1 publication Critical patent/EP2291320A1/de
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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B67—OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
    • B67B—APPLYING CLOSURE MEMBERS TO BOTTLES JARS, OR SIMILAR CONTAINERS; OPENING CLOSED CONTAINERS
    • B67B3/00—Closing bottles, jars or similar containers by applying caps
    • B67B3/26—Applications of control, warning, or safety devices in capping machinery
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B67—OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
    • B67B—APPLYING CLOSURE MEMBERS TO BOTTLES JARS, OR SIMILAR CONTAINERS; OPENING CLOSED CONTAINERS
    • B67B3/00—Closing bottles, jars or similar containers by applying caps
    • B67B3/26—Applications of control, warning, or safety devices in capping machinery
    • B67B3/261—Devices for controlling the tightening of threaded caps, e.g. testing the release torque

Definitions

  • the invention relates to a device for testing the tightness of caps on medical hollow bodies according to the preamble of claim 1, and as shown in US 45 39852 and a method for testing the tightness of caps on medical hollow bodies according to claim 10.
  • 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 able to perform a 100% inspection of the hollow body produced, so not only to examine samples, but the entire production volume.
  • 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.
  • 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 retaining element and the holding device, a torque in the closure cap can be 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.
  • one holder may grasp the body in the region of its bottom while another holder grips the lid.
  • 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.
  • 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.
  • 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.
  • the end of a hollow body opposite the closure cap is typically not accessible, since it is intended for transporting 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.
  • 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 could be of the along the longitudinal axis of the hollow body opposite Side are brought a holding element for the hollow body, 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, when both the holding device and the holding element are arranged on the same side, preferably such that both the holding device and the holding element approach from the side of the hollow body, on which the closure cap is arranged.
  • a device is preferred in which the holding device and the holding element are arranged integrally with one another on or in a base body of the device.
  • 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.
  • 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 value 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, just can not twist , If the test specimen is tight, the torque sensor thus becomes the preferably linear increase in 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.
  • a torque can be introduced into the cap by the drive interacts 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.
  • 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.
  • 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.
  • 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 target 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.
  • a device in which a device for limiting the speed is provided.
  • This is particularly advantageous when a desired torque is introduced by setting an electrical nominal size of the drive in the cap. 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 may ultimately result in 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.
  • 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.
  • a device which has the features of claims 1 to 9.
  • the method comprises the following steps: A hollow body is grasped and held by means of the retaining element.
  • the closure cap is detected and held by means of the holding device.
  • a torque is introduced into the cap.
  • a sensor 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. This can on the one hand the logging of the introduced torque or 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.
  • 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.
  • the torque sensor of the logging or control of the actually acting on the cap torque.
  • the angle sensor determines a relative rotation of the closure cap relative to the hollow body.
  • 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 the relative rotation is detected in parallel by both sensors, there is a redundancy which makes the method particularly safe and easy to reproduce.
  • 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, here the coating of the cap plays a role, since it influences their 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 fed, 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 can be identified 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 desired value, the torque in the torque sensor collapses 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 the test piece is leaking, 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 designated as a bad part, so that it can be singled out at the end of the production line.
  • a method is preferred in which a hollow body can be marked as a bad part if, when a defined torque is introduced into the closure cap, a change in the angle of rotation of the holding device relative to the holding element can be detected by the angle sensor.
  • a defined torque is introduced into the closure cap. If a sealed 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.
  • the hollow body is identifiable as a bad part, so that it is ausseidbar as a scrap at the end of the production line.
  • 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 introduced directly into the closure cap 13 by means of the drive 3 via the holding device 11 a torque.
  • a torque can be introduced directly into the hollow body 9.
  • a torque is introduced into the cap 13, since it is - at least until the moment of tearing - firmly connected to the hollow body 9.
  • 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.
  • 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.
  • 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.
  • 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.
  • the hollow body 9 optionally sorted in magazines or detected by grippers.
  • the axial distance along the longitudinal axis 19 between the holding device 11 and the holding element 7 is adjustable.
  • a pneumatic stroke control with pneumatic connections 21, 21 ' may be provided.
  • the height of the cap can be 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.
  • 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.
  • the hollow body 9 is typically held in the production line at its end opposite the 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.
  • different lengths hollow body 9 can be tested without a conversion of the device 1 or the production plant is needed.
  • length tolerances of the hollow body 9 can be compensated in the same way.
  • 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.
  • 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.
  • the torque can also be imparted via the drive 3 mediated by the holding element 7 in the hollow body 9.
  • 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.
  • 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.
  • 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.
  • a small torque is introduced into the 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 non-linear torque curve, in particular a collapse of the otherwise increasing torque, can be detected ,
  • 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.
  • 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.
  • 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, then the test object is a bad part which may be marked and preferably sorted out at the end of the production line.
  • both a torque sensor 15 and an angle sensor 17 into the device 1. It can then be driven, for example, a - preferably regulated - torque ramp, the tearing of a cap 13 is not detected by the breaking of the torque to 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.
  • 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.
  • a regulation can be provided which causes a variation of the torque from the desired value, a variation of the electrical nominal size, 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 tight-fitting cap 13 just does not break 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.
  • 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.
  • the device 1 it is also possible to arrange the device 1 at the end or outside a production line and thus also to check samples.
  • 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.
  • the device 1 for the first time allows a qualitative test of the tightness of a cap on a medical hollow body in an objective process that a non-destructive and identical for each specimen 100% test directly in the production facility.
  • the test results can be documented and evaluated.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Sealing Of Jars (AREA)
  • Examining Or Testing Airtightness (AREA)
  • External Artificial Organs (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Lining Or Joining Of Plastics Or The Like (AREA)
EP09765621.9A 2008-06-19 2009-06-18 Vorrichtung und verfahren zur prüfung der dichtigkeit von verschlusskappen auf medizinischen hohlkörpern Active EP2291320B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102008030271A DE102008030271A1 (de) 2008-06-19 2008-06-19 Vorrichtung und Verfahren zur Prüfung der Dichtigkeit von Verschlusskappen auf medizinischen Hohlkörpern
PCT/EP2009/004387 WO2009153041A1 (de) 2008-06-19 2009-06-18 Vorrichtung und verfahren zur prüfung der dichtigkeit von verschlusskappen auf medizinischen hohlkörpern

Publications (2)

Publication Number Publication Date
EP2291320A1 EP2291320A1 (de) 2011-03-09
EP2291320B1 true EP2291320B1 (de) 2014-11-05

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EP09765621.9A Active EP2291320B1 (de) 2008-06-19 2009-06-18 Vorrichtung und verfahren zur prüfung der dichtigkeit von verschlusskappen auf medizinischen hohlkörpern

Country Status (11)

Country Link
US (1) US8567261B2 (ru)
EP (1) EP2291320B1 (ru)
JP (1) JP5631872B2 (ru)
BR (1) BRPI0914203B8 (ru)
CA (1) CA2728135C (ru)
DE (1) DE102008030271A1 (ru)
ES (1) ES2528930T3 (ru)
MX (1) MX2010013514A (ru)
PT (1) PT2291320E (ru)
RU (1) RU2516962C2 (ru)
WO (1) WO2009153041A1 (ru)

Families Citing this family (1)

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Publication number Priority date Publication date Assignee Title
CN103552712B (zh) * 2013-10-28 2015-06-03 中达电通股份有限公司 药瓶瓶盖安装就位的检测方法及装置

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CA2728135A1 (en) 2009-12-23
ES2528930T3 (es) 2015-02-13
BRPI0914203B1 (pt) 2020-04-28
WO2009153041A1 (de) 2009-12-23
PT2291320E (pt) 2015-02-10
BRPI0914203B8 (pt) 2021-02-02
JP5631872B2 (ja) 2014-11-26
RU2011101683A (ru) 2012-07-27
BRPI0914203A2 (pt) 2015-11-03
CA2728135C (en) 2016-02-23
WO2009153041A8 (de) 2010-03-04
US8567261B2 (en) 2013-10-29
DE102008030271A1 (de) 2009-12-31
US20110126638A1 (en) 2011-06-02
MX2010013514A (es) 2011-04-11
EP2291320A1 (de) 2011-03-09
RU2516962C2 (ru) 2014-05-20
JP2011524530A (ja) 2011-09-01

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