EP2190747B1 - Method and device for the sterile or aseptic handling of containers - Google Patents
Method and device for the sterile or aseptic handling of containers Download PDFInfo
- Publication number
- EP2190747B1 EP2190747B1 EP08774844A EP08774844A EP2190747B1 EP 2190747 B1 EP2190747 B1 EP 2190747B1 EP 08774844 A EP08774844 A EP 08774844A EP 08774844 A EP08774844 A EP 08774844A EP 2190747 B1 EP2190747 B1 EP 2190747B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- container
- stopper
- closed
- containers
- negative pressure
- 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.)
- Not-in-force
Links
- 238000000034 method Methods 0.000 title claims abstract description 24
- 238000012360 testing method Methods 0.000 claims description 12
- 230000003287 optical effect Effects 0.000 claims description 7
- 238000004659 sterilization and disinfection Methods 0.000 description 11
- 230000001954 sterilising effect Effects 0.000 description 10
- 230000005855 radiation Effects 0.000 description 6
- 239000007788 liquid Substances 0.000 description 5
- 238000011161 development Methods 0.000 description 4
- 230000018109 developmental process Effects 0.000 description 4
- 230000036512 infertility Effects 0.000 description 4
- 230000001012 protector Effects 0.000 description 4
- 238000005429 filling process Methods 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 238000001228 spectrum Methods 0.000 description 3
- 238000001514 detection method Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 238000012369 In process control Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 238000002788 crimping Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000011143 downstream manufacturing Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000010894 electron beam technology Methods 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000020169 heat generation Effects 0.000 description 1
- 238000010965 in-process control Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000004886 process control Methods 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/027—Packaging in aseptic chambers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
- B65B31/02—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
- B65B31/025—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas specially adapted for rigid or semi-rigid containers
- B65B31/027—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas specially adapted for rigid or semi-rigid containers closed by a stopper
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B7/00—Closing containers or receptacles after filling
- B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
- B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
- B65B7/2821—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers applying plugs or threadless stoppers
Definitions
- the invention is based on a method and a device for the sterile or aseptic handling of containers according to the preamble of the independent claims.
- a method for the sterile dosage of vials is already known. After assembling the vial and cap, they are rinsed. Then a protector is put on. In an autoclave, the assembly is sterilized. After cooling and removal of protector and cap, the liquid is filled into the vial. Subsequently, the vial is closed again. Filling is recorded with a video camera for documentation purposes. After encapsulation, the vial is provided with an identification of the dosing time by means of a laser beam.
- Inventive method and apparatus for sterile handling of containers are characterized in that it is checked whether a container is sealed intact with a stopper by determining whether in the interior of the container an expected negative pressure, preferably vacuum, is still present.
- the combination of the with the stopper be sterilized sealed container and also be supplied in this combination for filling. This prevents that a separate feeding of the plug must be made to close with the necessary sterilization processes.
- the integrity check ensures that the supplied containers with stoppers comply with the sterility requirements, since they are properly sealed containers, the interior of which in each case still meets the sterility requirements. This concept also makes it possible to use the stopper to be removed during the filling operation, preferably with the same handling device, after closing to close it.
- the already-to-be-provided manipulator for example a gripping device, for stopper removal is preferably also used for closing the filled container. As a result, the cost of the system can be reduced again.
- the checking of the expected negative pressure takes place on the basis of a force measurement of that force which is necessary for the removal of the plug from the container.
- a corresponding force measuring device can be provided at the plug removal device, for example a manipulator, or is present anyway.
- the force is a measure of whether the interior of the container is still subjected to the expected negative pressure, which suggests the integrity of the arrangement container plug. If the vacuum is still present, the force which is required to remove the plug is significantly greater than would be the case in the case of a damaged container-plug connection with concomitant internal pressure compensation. Thus, the force is a good indicator of the integrity of the stoppered container assembly. Since the manipulator for removing the plug anyway has to come into mechanical contact with this, also a force measurement is easy to implement.
- the checking of the expected negative pressure takes place optically.
- the container is preferably irradiated with a laser beam.
- the optical spectrum of the incoming radiation on the other side can draw conclusions about the medium or to be drawn to the pressure conditions inside the container.
- At negative pressure is to be expected with a changed spectrum, as this would be the case at ambient pressure, thus in the situation of a no longer properly sitting plug.
- Such optical inspection devices can be installed without much additional effort and are known in principle.
- a plurality of sealed containers are placed in at least one tray.
- the containers located in the tray, closed with plugs and applied in the interior negative pressure, are subsequently sterilized.
- the sterilization can be done, for example, the manufacturer of the containers and plugs.
- a plug 12 is placed by a plug closure 16 on a container 10 and closed by applying a negative pressure. This creates a negative pressure in the interior of the container 10.
- the containers 10 sealed in this way under reduced pressure, preferably a vacuum, are then filled by trays 19 into trays 18, so that a plurality of containers 10 closed with stoppers 12 are now positioned in a tray 18.
- This tray 18 with the containers 10 disposed therein enters a sterilizer 20, in which the containers 10 are sterilized. Subsequently, the trays 18 are provided with an outer packaging as transport protection.
- the thus sterilized containers 10 are then placed in a clean room 22 in which several stations are arranged.
- a test unit 24 This unit 24 checks whether there is the expected negative pressure in the interior of the still closed container 10, as an indicator of an intact, with the stopper 12 still properly closed container 10.
- a stopper removal device 26 removes a corresponding manipulator or a gripping device 44 the plug 12.
- filled containers 10 may be subjected to an internal process control 30, which determines whether the container 10 has been filled with the correct amount of liquid.
- a closing station 32 which may also be part of the filling machine 28, the filled container 10 is closed again with the stopper 12.
- Verification of whether the container is sealed intact with a stopper is carried out.
- a laser 36 irradiates the preferably transparent container 10.
- the radiation passing through the container 10 is detected on the other side by an optical receiver 38.
- the properties of the detected radiation provide information about whether the interior of the container 10 still prevails an expected negative pressure. This can be seen whether the container 10 is still intact with the stopper 12 is closed.
- a gripping device 44 is now provided with a gripper 42, which serves to remove the plug 12 from the container 10.
- the gripping device 44 is also provided with a force measuring device 46, which determines a measure of the force required to remove the plug 12. On the basis of the detected force is detected, whether in the interior of the container 10 nor the expected negative pressure prevails or whether the container 10 is not properly closed. Upon application of a negative pressure or vacuum inside the container 10, a significantly higher force for removing the plug 12 is required, thus providing information about the integrity of Ve gleiches of the container 10 with the stopper 12.
- the container 10 is on its underside with a Flange 40 is provided, which cooperates with a holding device, not shown, for applying a counter force for removing the plug 12.
- FIG. 5 the top view of a beam gripper 48 is shown with a plurality of openings for receiving a plurality of plugs 12th
- the devices shown in the figures operate as follows.
- the containers 10 are preferably filled in the pharmaceutical sector with drugs under aseptic conditions and closed again with the stopper 12.
- the containers 10 may be, for example, vials or bottles made of glass or plastic or the like.
- the liquid pharmaceuticals filled in the containers 10 are removed in the hospital or at the doctor, for example, by puncturing the stopper 12 with an injection needle.
- the plug 12 is equipped accordingly.
- the container 10 and the stopper 12 are closed. This can be done for example by the manufacturer of the containers 10 and / or the plug 12.
- a negative pressure preferably a vacuum
- the plug closure device 16 can be, for example, a manipulator, that is to say a robot with a gripper. Under certain circumstances, it could also be provided to arrange a protector via the stopper 12, which protects the stopper 12 for the further handling operations. However, this protector is not mandatory.
- the respective sealed containers 10 are fed by the gripping device 19 to a tray 18.
- the tray 18 has receptacles and openings which are matched to the outer diameter of the container 10, so that a plurality of these containers 10 are received in the tray 18 and thus can be simultaneously supplied to the further processing operations.
- pre-formatting is helpful for further handling, it is not absolutely necessary.
- the thus loaded with containers 10 tray 18 is now fed to a sterilizer 20.
- the negative pressure or the vacuum remains in the interior of the containers 10 continue to exist, unless the closures have remained intact, that is, the plug 12 closes the container 10 in the correct manner, so that the negative pressure can not escape.
- the sterilizer 20 relies on conventional sterilization methods, which are based for example on radiation sterilization (for example by means of gamma rays), heat generation, for example by means of plasma, or electron beams or the like.
- the sterilizer 20 could either be inline, that is as part of the filling process and thus in the spatial vicinity of the filling machine 28, take place.
- the sterilizer 20 could be arranged spatially separated from the filling machine 28, for example, in special companies that perform the sterilization of container 10 with attached plug 12 with fitting in the interior of the container 10 negative pressure. By the sterilization process and the interior of the container 10 is sterilized. At a sterilizer 20 spatially remote from the filling machine 28, the tray 18 could be correspondingly packaged to be transported to the filling machine 28 under sterile conditions.
- the sealed containers 10 enter the clean room 22.
- any packaging that may be present is removed from the containers 10 or the trays 18. Also arranged in the tray 18 containers 10 could be separated again. Alternatively, the containers 10 can still be arranged on the tray 18 are supplied to the clean room 22.
- test unit 24 determines whether the plug 12 still properly closes the container 10. This is determined on the basis of indicators of the pressure conditions in the interior of the container 10. Closes the plug 12, the container 10 still properly, so prevails in the interior nor a negative pressure or a vacuum. In case of failure, however, the interior will be exposed to ambient pressure. Different embodiments of the test unit 24 will be later in connection with the FIGS. 3 and 4 explained in more detail. Containers 10, in which there is no expected negative pressure in the interior, are removed and not filled because they do not meet the sterility requirements.
- the opened container 10 is now in the filling machine 28 with the desired liquid in the desired amount dosed.
- the desired filling quantity is checked and, if necessary, corrective measures are initiated during deviations.
- the weight or the level of the filled container 10 is determined, for example by means of X-radiation or optically.
- the corresponding stopper 12 is again placed on the filled container 10.
- the same gripping device 44 could hold the removed plug 12 during the filling process and then put it back on in the course of the closing. A separate stopper feed would be eliminated.
- the gripping device 44 could be a so-called pick and place device.
- a further freeze-drying may be necessary before closing with the stopper 12 in order to remove condensate from the container 10.
- the sealed container 10 is further transported to a capping station, not shown, which still touches a cap on the container 10 closed with the stopper 12 and connects to the container 10, for example by means of crimping.
- a corresponding marking of the container 10 with regard to production information or the like, for example by means of a laser, can still follow.
- the test unit 24 can fall back on any physical principles that are suitable to carry out a vacuum detection or vacuum detection in the interior of the container 10.
- optical methods are suitable when a laser 36 irradiates the interior of the container 10.
- the incident radiation is detected by a receiver 38.
- On the basis of the frequency spectrum can be detected, for example, whether in the interior of the container 10 is applied a vacuum or not. So the optical Absorbtions in vacuum is different than at ambient pressure. It would also be possible to arrange the receiver 38 on the same side as the laser 36 and to redirect the radiation passing through the interior through a reflector to the receiver 38.
- FIG. 4 A further advantageous embodiment of the test unit 24 is in FIG. 4 shown.
- the plug 12 To fill the container 10, the plug 12 must be removed anyway. This is done by the gripping device 44.
- This gripping device 44 can now be additionally equipped by a force measuring device 46 or this is anyway present in a robot arm. Based on the force required to remove the plug 12 from the container 10, conclusions can be drawn on the prevailing in the interior of the container 10 pressure conditions. Thus, a significantly increased force is required to remove the plug 12 at vacuum or vacuum from the container 10 than at ambient pressure.
- the detected force is compared with a threshold. If the force is below the limit, then this is an indication of a no longer intact container 10, as based on the detected force, everything points to a broken vacuum.
- the container 10 is provided at the bottom with a surrounding this annular mounting flange 40.
- the upper side of the fastening flange 40 is surrounded by a stationary holding device 50, so that the container 10 can not be moved upward during the removal of the plug 12.
- the gripping device 44 can also be designed as a bar gripper 48. Then it becomes possible for a plurality of plugs 12 to be simultaneously removed from the respective container 10. Gripping devices 44 or beam grippers 48 can be used on the plug removal devices 26. Furthermore, they can be positioned so that the removed plugs 12 are placed back on the containers 10 after the filling of the containers 10 at the closing station 32. Thanks to this multiple functionality of the gripping devices, the overall structure of the system can be further simplified.
- Methods and apparatus for sterile handling of containers are particularly suitable for filling liquid or free-flowing bulk materials, which are subject to special sterility requirements. This is the case in particular in the pharmaceutical industry or in foodstuffs. However, the use of methods and apparatus for sterile handling of containers is not limited to these fields of application.
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
- Sealing Of Jars (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Examining Or Testing Airtightness (AREA)
Abstract
Description
Die Erfindung geht aus von einem Verfahren und einer Vorrichtung zur sterilen oder aseptischen Handhabung von Behältnissen nach der Gattung der unabhängigen Ansprüche. Aus der
Es ist Aufgabe der vorliegenden Erfindung, die Handhabungsschritte insbesondere im Vorfeld des Abfüllvorgangs zu reduzieren. Diese Aufgabe wird gelöst durch die Merkmale der unabhängigen Ansprüche.It is an object of the present invention to reduce the handling steps, in particular in the run-up to the filling process. This object is solved by the features of the independent claims.
Erfindungsgemäßes Verfahren und erfindungsgemäße Vorrichtung zur sterilen Handhabung von Behältnissen zeichnen sich dadurch aus, dass überprüft wird, ob ein Behältnis unversehrt mit einem Stopfen verschlossen ist, indem ermittelt wird, ob im Innenraum des Behältnisses ein erwarteter Unterdruck, vorzugsweise Vakuum, noch vorhanden ist. Somit kann die Kombination des mit dem Stopfen verschlossenen Behältnisses sterilisiert werden und auch bereits in dieser Kombination zum Befüllen angeliefert werden. Dadurch wird verhindert, dass ein separates Zuführen der Stopfen zum Verschließen mit den notwendigen Sterilisationsprozessen erfolgen muss. Weiterhin wird durch die Integritätsüberprüfung sichergestellt, dass die zugelieferten Behältnisse mit Stopfen den Sterilitätsanforderungen entsprechen, da es sich um ordnungsgemäß verschlossene Behältnisse handelt, deren Innenraum in jedem Fall noch den Sterilitätsanforderungen entspricht. Dieses Konzept erlaubt es auch, den im Rahmen des Füllvorgangs zu entfernenden Stopfen vorzugsweise mit derselben Handlingseinrichtung nach dem erfolgten Füllen zum Verschließen zu verwenden. Auf eine Einrichtung zur separaten Stopfenzuführung kann verzichtet werden. Der ohnehin vorzusehende Manipulator, beispielsweise eine Greifeinrichtung, zur Stopfenentfernung wird vorzugsweise auch zum Verschließen des befüllten Behältnisses verwendet. Dadurch können die Kosten der Anlage nochmals reduziert werden.Inventive method and apparatus for sterile handling of containers are characterized in that it is checked whether a container is sealed intact with a stopper by determining whether in the interior of the container an expected negative pressure, preferably vacuum, is still present. Thus, the combination of the with the stopper be sterilized sealed container and also be supplied in this combination for filling. This prevents that a separate feeding of the plug must be made to close with the necessary sterilization processes. Furthermore, the integrity check ensures that the supplied containers with stoppers comply with the sterility requirements, since they are properly sealed containers, the interior of which in each case still meets the sterility requirements. This concept also makes it possible to use the stopper to be removed during the filling operation, preferably with the same handling device, after closing to close it. On a device for separate Stopfenzuführung can be dispensed with. The already-to-be-provided manipulator, for example a gripping device, for stopper removal is preferably also used for closing the filled container. As a result, the cost of the system can be reduced again.
In einer zweckmäßigen Weiterbildung ist vorgesehen, dass die Überprüfung des erwarteten Unterdrucks anhand einer Kraftmessung derjenigen Kraft erfolgt, die für die Entfernung des Stopfens aus dem Behältnis notwendig ist. Eine entsprechende Kraftmesseinrichtung kann an der Stopfenentfernungseinrichtung, beispielsweise ein Manipulator, vorgesehen werden beziehungsweise ist ohnehin vorhanden. Die Kraft ist ein Maß dafür, ob das Innere des Behältnisses noch mit dem erwarteten Unterdruck beaufschlagt ist, was auf die Unversehrtheit der Anordnung Behältnis-Stopfen schließen lässt. Bei noch vorhandenem Unterdruck ist die Kraft signifikant größer, die zum Entfernen des Stopfens aufzubringen ist, als dies bei beschädigter Behältnis-Stopfen-Verbindung mit einhergehendem Druckausgleich im Inneren der Fall wäre. Somit ist die Kraft ein guter Indikator für die Integrität der Anordnung von Behältnis mit Stopfen. Da der Manipulator zum Entfernen des Stopfens ohnehin mit diesem in mechanischen Kontakt treten muss, ist auch eine Kraftmessung leicht zu realisieren.In an expedient development, it is provided that the checking of the expected negative pressure takes place on the basis of a force measurement of that force which is necessary for the removal of the plug from the container. A corresponding force measuring device can be provided at the plug removal device, for example a manipulator, or is present anyway. The force is a measure of whether the interior of the container is still subjected to the expected negative pressure, which suggests the integrity of the arrangement container plug. If the vacuum is still present, the force which is required to remove the plug is significantly greater than would be the case in the case of a damaged container-plug connection with concomitant internal pressure compensation. Thus, the force is a good indicator of the integrity of the stoppered container assembly. Since the manipulator for removing the plug anyway has to come into mechanical contact with this, also a force measurement is easy to implement.
In einer zweckmäßigen Weiterbildung ist vorgesehen, dass die Überprüfung des erwarteten Unterdrucks optisch erfolgt. Hierzu wird vorzugsweise das Behältnis mit einem Laserstrahl durchstrahlt. Anhand des optischen Spektrums der auf der anderen Seite ankommenden Strahlung können Rückschlüsse auf das Medium beziehungsweise auf die Druckverhältnisse im Inneren des Behältnisses gezogen werden. Bei Unterdruck ist mit einem veränderten Spektrum zu rechnen, als dies bei Umgebungsdruck, also in der Situation eines nicht mehr ordnungsgemäß aufsitzenden Stopfens, der Fall wäre. Solche optischen Überprüfungseinrichtungen lassen sich ohne großen Zusatzaufwand installieren und sind prinzipiell bekannt.In an expedient development, it is provided that the checking of the expected negative pressure takes place optically. For this purpose, the container is preferably irradiated with a laser beam. On the basis of the optical spectrum of the incoming radiation on the other side can draw conclusions about the medium or to be drawn to the pressure conditions inside the container. At negative pressure is to be expected with a changed spectrum, as this would be the case at ambient pressure, thus in the situation of a no longer properly sitting plug. Such optical inspection devices can be installed without much additional effort and are known in principle.
In einer zweckmäßigen Weiterbildung ist vorgesehen, dass mehrere verschlossene Behältnisse in zumindest einem Tray platziert werden. Die in dem Tray befindlichen Behältnisse, mit Stopfen verschlossen und im Innenraum anliegendem Unterdruck, werden nachfolgend sterilisiert. Das Sterilisieren kann beispielsweise beim Hersteller der Behältnisse und Stopfen erfolgen. Es wäre jedoch auch denkbar, dies unmittelbar vor dem Abfüllen vorzunehmen. Die Handhabung mittels Trays vereinfacht Transport und Zuführung der Behältnisse zu nachgelagerten Prozessschritten.In an expedient development it is provided that a plurality of sealed containers are placed in at least one tray. The containers located in the tray, closed with plugs and applied in the interior negative pressure, are subsequently sterilized. The sterilization can be done, for example, the manufacturer of the containers and plugs. However, it would also be conceivable to do so immediately before bottling. Handling by means of trays simplifies transport and feeding of the containers to downstream process steps.
In einer zweckmäßigen Weiterbildung ist vorgesehen, dass das Überprüfen, ob ein Behältnis unversehrt mit einem Stopfen verschlossen ist, unter Reinraumbedingungen erfolgt. Damit kann gewährleistet werden, dass beim Entfernen des Stopfens zur Überprüfung bzw. zum anschließenden Befüllen des Behältnisses eine erneute Sterilisation des Behältnisses nicht mehr erfolgen muss. Dadurch reduzieren sich die erforderlichen Schritte zur Sterilisation der Behältnisse.In an expedient refinement, it is provided that checking whether a container is closed intact with a stopper takes place under clean-room conditions. This can be ensured that when removing the plug for checking or for subsequent filling of the container a re-sterilization of the container no longer needs to be done. This reduces the necessary steps to sterilize the containers.
Weitere zweckmäßige Weiterbildungen ergeben sich aus weiteren abhängigen Ansprüchen und aus der Beschreibung.Further expedient developments emerge from further dependent claims and from the description.
Ein Ausführungsbeispiel des Verfahrens und der Vorrichtung zur sterilen Handhabung von Behältnissen ist in den Figuren dargstellt und wird nachfolgend näher beschrieben.An embodiment of the method and apparatus for sterile handling of containers is dargstellt in the figures and will be described in more detail below.
Es zeigen:
- Die
schematisch die drei Prozessschritte vom Verschließen der Behältnisse bis hin zum Sterilisieren,Figur 1 - die
Figur 2 die Prozessschritte vom Überprüfen, ob das Behältnis unversehrt mit einem Stopfen verschlossen ist, bis hin zum Verschließen der befüllten Behältnisse, - die
Figur 3 das Überprüfen des Unterdrucks mittels optischer Verfahren, - die
Figur 4 das Überprüfen des Unterdrucks mittels mechanischer Kraftmessung, sowie - die
Figur 5 einen Balkengreifer zum Entnehmen bzw. Aufsetzen mehrerer Stopfen.
- The
FIG. 1 schematically the three process steps from closing the Containers right through to sterilization, - the
FIG. 2 the process steps from checking that the container is closed intact with a stopper, to closing the filled containers, - the
FIG. 3 checking the negative pressure using optical methods, - the
FIG. 4 Checking the negative pressure by means of mechanical force measurement, as well - the
FIG. 5 a beam gripper for removing or placing a plurality of plugs.
In einer Vakuumkammer 14 wird ein Stopfen 12 durch eine Stopfenverschließeinrichtung 16 auf ein Behältnis 10 aufgesetzt und unter Anlegung eines Unterdrucks verschlossen. Somit entsteht auch im Inneren des Behältnisses 10 ein Unterdruck. Die so unter Unterdruck, vorzugsweise ein Vakuum, verschlossenen Behältnisse 10 werden anschließend von einer Greifeinrichtung 19 in Trays 18 befüllt, so dass nun mehrere, mit Stopfen 12 verschlossene Behältnisse 10 in einem Tray 18 positioniert werden. Dieses Tray 18 mit den darin angeordneten Behältnissen 10 gelangt in einen Sterilisator 20, in dem die Behältnisse 10 sterilisiert werden. Anschließend werdne die Trays 18 mit einer Umverpackung als Transportschutz versehen.In a
Die so sterilisierten Behältnisse 10 werden anschließend in einen Reinraum 22 gebracht, in dem mehrere Stationen angeordnet sind. Eine davon ist eine Prüfeinheit 24. Diese Einheit 24 überprüft, ob im Innenraum des noch verschlossenen Behältnisses 10 der erwartete Unterdruck herrscht, als Indikator für ein unversehrtes, mit dem Stopfen 12 noch ordnungsgemäß verschlossenes Behältnis 10. Als Teil einer Stopfenentfernungseinrichtung 26 entfernt ein entsprechender Manipulator bzw. eine Greifeinrichtung 44 den Stopfen 12. Anschließend wird das geöffnete Behältnis 10 - sofern es als ordnungsgemäß verschlossen erkannt wurde - in einer Füllmaschine 28 befüllt. Gegebenenfalls können befüllte Behältnisse 10 einer Innen-Prozess-Kontrolle 30 unterzogen werden, die ermittelt, ob das Behältnis 10 mit der korrekten Flüssigkeitsmenge befüllt wurde. In einer Verschließstation 32, die auch Bestandteil der Füllmaschine 28 sein kann, wird das befüllte Behältnis 10 mit dem Stopfen 12 wieder verschlossen.The thus sterilized
Gemäß
In einer alternativen Ausgestaltung der Prüfeinheit 24 ist nun eine Greifeinrichtung 44 mit einem Greifer 42 vorgesehen, der der Entnahme des Stopfens 12 aus dem Behältnis 10 dient. Die Greifeinrichtung 44 ist zudem mit einer Kraftmesseinrichtung 46 versehen, die ein Maß für die zum Entnehmen des Stopfens 12 erforderliche Kraft ermittelt. Anhand der erfassten Kraft wird erkannt, ob im Innenraum des Behältnisses 10 noch der erwartete Unterdruck herrscht oder ob das Behältnis 10 nicht mehr ordnungsgemäß verschlossen ist. Bei Anliegen eines Unterdrucks bzw. Vakuums im Inneren des Behältnisses 10 ist eine signifikante höhere Kraft zum Entnehmen des Stopfens 12 erforderlich, was somit Aufschluss gibt über die Unversehrtheit des Veschlusses des Behältnisses 10 mit dem Stopfen 12. Das Behältnis 10 ist an seiner Unterseite mit einem Flansch 40 versehen, welcher mit einer nicht dargestellten Haltevorrichtung zum Aufbringen einer Gegenkraft zur Entnahme des Stopfens 12 zusammenwirkt.In an alternative embodiment of the
Gemäß
Die in den Figuren gezeigten Einrichtungen arbeiten wie folgt. Die Behältnisse 10 werden vorzugsweise im pharmazeutischen Bereich mit Arzneimittel unter aseptischen Bedingungen befüllt und mit den Stopfen 12 wieder verschlossen. Bei den Behältnissen 10 kann es sich beispielsweise um Vials oder Flaschen aus Glas oder Plastik oder ähnliches handeln. Die in den Behältnissen 10 abgefüllten flüssigen Pharmazeutika werden im Krankenhaus oder beim Arzt beispielsweise dadurch entnommen, dass der Stopfen 12 mit einer Injektionsnadel durchstochen wird. Der Stopfen 12 ist hierfür entsprechend ausgestattet.The devices shown in the figures operate as follows. The
Zur Reduzierung der Sterilisationsschritte im Vorfeld der Abfüllung der Behältnisse 10 wird nun vorgeschlagen, dass in einem ersten Schritt Behältnis 10 und Stopfen 12 verschlossen werden. Dies kann beispielsweise beim Hersteller der Behältnisse 10 und/oder der Stopfen 12 erfolgen. Um im nachfolgenden Sterilisationsschritt sicher zu erkennen, dass das Behältnis 10 durch den Stopfen 12 noch ordnungsgemäß verschlossen ist beziehungsweise der Verschluss vor Weiterverarbeitung unversehrt ist, wird im Innenraum des Behältnisses 10 ein Unterdruck, vorzugsweise ein Vakuum, erzuegt. Dies geschieht in der Vakuumkammer 14, in der das Behältnis 10 mittels Stopfenverschließeinrichtung 16 mit dem Stopfen 12 verschlossen wird. Bei der Stopfenverschließeinrichtung 16 kann es sich beispielsweise um einen Manipulator, also einen Roboter mit Greifer, handeln. Unter Umständen könnte auch vorgesehen sein, über den Stopfen 12 einen Protektor anzuordnen, welcher den Stopfen 12 für die weiteren Handlingsvorgänge schützt. Jedoch ist dieser Protektor nicht zwingend erforderlich.In order to reduce the sterilization steps prior to the filling of the
In einem weiteren Schritt werden die jeweils verschlossenen Behältnisse 10 durch die Greifeinrichtung 19 einem Tray 18 zugeführt. Das Tray 18 weist Aufnahmen und Öffnungen auf, die auf den Außendurchmesser des Behältnisses 10 abgestimmt sind, so dass mehrere dieser Behältnisse 10 im Tray 18 aufgenommen werden und somit gleichzeitig den weiteren Bearbeitungsvorgängen zugeführt werden können. Diese sogenannte Vorformatierung ist zwar für das weitere Handling hilfreich, jedoch nicht zwingend erforderlich.In a further step, the respective sealed
Das so mit Behältnissen 10 beschickte Tray 18 wird nun einem Sterilisator 20 zugeführt. Der Unterdruck bzw. das Vakuum bleibt im Innenraum der Behältnisse 10 weiterhin bestehen, sofern die Verschlüsse unversehrt geblieben sind, das heißt der Stopfen 12 verschließt das Behältnis 10 in korrekter Weise, so dass der Unterdruck nicht entweichen kann. Der Sterilisator 20 greift auf übliche Sterilisationsverfahren zurück, die beispielsweise auf Strahlensterilisation (beispielsweise mittels Gammastrahlen), Wärmeerzeugung, beispielsweise mittels Plasma, oder Elektktronenstrahlen oder ähnliches basieren. Der Sterilisator 20 könnte entweder inline, das heißt im Rahmen des Abfüllvorgangs und somit in räumlicher Nähe der Füllmaschine 28, erfolgen. Ebenso gut könnte jedoch der Sterilisator 20 räumlich getrennt von der Füllmaschine 28 angeordnet sein, beispielsweise bei speziellen Firmen, die die Sterilisation von Behältnis 10 mit aufgesetztem Stopfen 12 mit im Innenraum des Behältnisses 10 anliegendem Unterdruck durchführen. Durch das Sterilisationsverfahren wird auch der Innenraum des Behältnisses 10 sterilisiert. Bei einem von der Füllmaschine 28 räumlich entfernten Sterilisator 20 könnte das Tray 18 entsprechend verpackt werden, um zur Füllmaschine 28 unter sterilen Bedingungen transportiert zu werden.The thus loaded with
Nach erfolgter Sterilisation gelangen die verschlossenen Behältnisse 10 in den Reinraum 22. Zuvor wird eine eventuell vorhandene Verpackung um die Behältnisse 10 beziehungsweise der Trays 18 entfernt. Auch könnten in dem Tray 18 angeordnete Behältnisse 10 wieder vereinzelt werden. Alternativ können die Behältnisse 10 noch auf dem Tray 18 angeordnet dem Reinraum 22 zugeführt werden.After sterilization, the sealed
In dem Reinraum 22 befindet sich die Prüfeinheit 24. Sie könnte jedoch auch in einem separatem Reinraum, der von demjenigen der Füllmaschine 28 getrennt ist, angeordnet sein. Die Prüfeinheit 24 ermittelt, ob der Stopfen 12 das Behältnis 10 noch ordnungsgemäß verschließt. Dies wird anhand von Indikatoren der Druckverhältnisse im Innenraum des Behältnisses 10 ermittelt. Verschließt der Stopfen 12 das Behältnis 10 noch ordnungsgemäß, so herrscht im Innenraum noch ein Unterdruck bzw. ein Vakuum vor. Im Fehlerfall jedoch wird auch der Innenraum Umgebungsdruck ausgesetzt sein. Unterschiedliche Ausführungen der Prüfeinheit 24 werden später in Verbindung mit den
Bei integren Behältnissen 10 - im Innenraum herrschte noch der erwartete Unterdruck - werden die jeweiligen Stopfen 12 entfernt. Dies kann beispielsweise mittels der ebenfalls im Reinraum 22 angeordneten Greifeinrichtung 44 erfolgen. Das geöffnete Behältnis 10 wird nun in der Füllmaschine 28 mit der gewünschten Flüssigkeit in der gewünschten Menge dosiert. Im Rahmen einer In-Prozesskontrolle 30 wird die gewünschte Füllmenge kontrolliert und gegebenenfalls bei Abeweichungen Korrekturmaßnahmen eingeleitet. Hierzu wird beispielsweise das Gewicht oder der Füllstand des befüllten Behältnisses 10 ermittelt, beipielsweise mittels Röntgenstrahlung oder auf optischem Wege.In integral containers 10 - in the interior there was still the expected negative pressure - the
Anschließend wird in der Verschließstation 32 der entsprechende Stopfen 12 wieder auf das befüllte Behältnis 10 aufgesetzt. Hierzu könnte vorzugsweise dieselbe Greifeinrichtung 44 den entnommenen Stopfen 12 während des Füllvorgangs halten und anschließend im Rahmen des Verschließens wieder aufsetzen. Eine separate Stopfenzuführung würde damit entfallen. Als Greifeinrichtung 44 könnte eine sogenannte Pick and Place - Einrichtung vorgesehen sein. Gegebenenfalls könnte vor dem Verschließen mit dem Stopfen 12 noch ein Gefriertrocknen notwendig sein, um Kondensat aus dem Behältnis 10 zu entfernen.Subsequently, in the
Anschließend wird das verschlossene Behältnis 10 zu einer nicht dargestellten Kappenaufsetzstation weitertransportiert, welche auf das mit dem Stopfen 12 verschlossene Behältnis 10 noch eine Kappe aufsetzt und mit dem Behältnis 10 beispielsweise mittels Bördelung verbindet. Auch eine entsprechende Markierung des Behältnisses 10 hinsichtlich Produktionsinformationen oder ähnliches beispielsweise mittels Laser kann sich noch anschließen.Subsequently, the sealed
Die Prüfeinheit 24 kann auf beliebige physikalische Prinzipien zurückgreifen, die geeignet sind, eine Unterdruckerkennung bzw. Vakuumerkennung im Innenraum des Behältnisses 10 durchzuführen. Hierzu eignen sich beispielsweise optische Verfahren, wenn ein Laser 36 den Innenraum des Behältnisses 10 durchstrahlt. Die auftreffende Strahlung wird von einem Empfänger 38 erfasst. Anhand des Frequenzspektrums lässt sich beispielsweise erfassen, ob im Innenraum des Behältnisses 10 ein Vakuum anliegt oder nicht. So ist das optische Absorbtionsverhalten in Vakuum ein anderes als bei Umgebungsdruck. Möglich wäre auch, den Empfänger 38 auf derselben Seite als den Laser 36 anzuordnen und die den Innenraum passierende Strahlung durch einen Reflektor zum Empfänger 38 hin umzuleiten.The
Eine weitere vorteilhafte Ausgestaltung der Prüfeinheit 24 ist in
Um die Entnahme des Stopfens 12 zu erleichtern, ist das Behältnis 10 am unteren Rand mit einem diesen ringförmig umgebenden Befestigungsflansch 40 versehen. Die Oberseite des Befestigungsflansches 40 wird von einer ortsfesten Halteeinrichtung 50 umgeben, so dass das Behältnis 10 bei der Entnahme des Stopfens 12 nicht nach oben hin mitbewegt werden kann. Die Greifeinrichtung 44 kann auch als Balkengreifer 48 ausgeführt sein. Dann wird es möglich, dass mehrere Stopfen 12 gleichzeitig von dem jeweiligen Behältnissen 10 entfernt werden. Greifeinrichtungen 44 bzw. Balkengreifer 48 können an den Stopfenentfernungseinrichtungen 26 zum Einsatz kommen. Weiterhin können sie so positioniert sein, dass die entnommenen Stopfen 12 nach dem erfolgten Füllen der Behältnisse 10 bei der Verschließstation 32 wieder auf die Behältnisse 10 aufgesetzt werden. Dank dieser Mehrfachfunktionalität der Greifeinrichtungen kann sich der Gesamtaufbau der Anlage weiter vereinfachen.In order to facilitate the removal of the
Verfahren und Vorrichtung zur sterilen Handhabung von Behältnissen eignen sich insbesondere für Füllmaschinen flüssiger oder rieselfähiger Schüttgüter, die besonderen Sterilitätsanforderungen unterliegen. Dies ist insbesondere in der pharmazeutischen Industrie oder bei Lebensmitteln der Fall. Der Einsatz von Verfahren und Vorrichtung zur sterilen Handhabung von Behältnissen ist jedoch auf diese Anwendungsgebiete nicht eingeschränkt.Methods and apparatus for sterile handling of containers are particularly suitable for filling liquid or free-flowing bulk materials, which are subject to special sterility requirements. This is the case in particular in the pharmaceutical industry or in foodstuffs. However, the use of methods and apparatus for sterile handling of containers is not limited to these fields of application.
Claims (11)
- Method for the sterile or aseptic handling of containers (10), comprising at least the following step:checking, prior to at least one container (10) being filled, so that the container (10) is closed in an intact state by a stopper (12), in that it is determined whether an expected negative pressure, preferably vacuum, is present in the interior of the container (10).
- Method according to Claim 1, characterized in that the step of checking the expected negative pressure takes place by way of measuring the force which is necessary for removing the stopper (12) from the container (10).
- Method according to Claim 1, characterized in that the step of checking the expected negative pressure takes place optically.
- Method according to one of the preceding claims, characterized in that, once it has been checked whether the container (10) is closed in an intact state by a stopper (12), the stopper (12) is removed, the container (10) is filled, and the container (10) is closed by the stopper (12) which has been removed or at some other stopper.
- Method according to one of the preceding claims, characterized in that, prior to the step of checking whether the container (10) is closed in an intact state by a stopper (12), the container (10) is closed by the stopper (12) to generate a negative pressure, preferably a vacuum, in the interior of the container (10).
- Method according to one of the preceding claims, characterized in that, once the container (10) has been closed by the stopper (12) and a negative pressure or vacuum has been generated in the interior of the container (10), the closed container (10) is sterilized.
- Method according to one of the preceding claims, characterized in that, the step of checking whether the container (10) is closed in an intact state by a stopper (12) takes place under clean-room conditions.
- Apparatus for the sterile or aseptic handling of containers, comprising a testing unit (24) for checking a container (10) as to whether it is closed in an intact state by a stopper (12), wherein the testing unit (24) determines whether an expected negative pressure, preferably a vacuum, is present in the interior of the container (10), the testing unit (24) being installed prior to the containers (10) being filled.
- Apparatus according to the preceding claim, characterized in that the testing unit (24) comprises an optical signal transmitter (36) with a receiver (38), which checks whether an expected negative pressure, preferably a vacuum, is present in the interior of the container (10).
- Apparatus according to Claim 8, characterized in that the testing unit (24) comprises a force-measuring device (46) which determines the force which is necessary for removing the stopper (12) from the container (10), for the purpose of determining whether an expected negative pressure, preferably a vacuum, is present in the interior of the container (10).
- Apparatus according to one of the preceding apparatus claims, characterized by the provision of a gripping device (44) which removes the stopper (12) prior to the container (10) being filled and places the stopper on the container (10) again once the container (10) has been filled.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102007042218A DE102007042218A1 (en) | 2007-09-05 | 2007-09-05 | Method and device for sterile or aseptic handling of containers |
PCT/EP2008/058796 WO2009030545A1 (en) | 2007-09-05 | 2008-07-07 | Method and device for the sterile or aseptic handling of containers |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2190747A1 EP2190747A1 (en) | 2010-06-02 |
EP2190747B1 true EP2190747B1 (en) | 2011-09-28 |
Family
ID=39743148
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP08774844A Not-in-force EP2190747B1 (en) | 2007-09-05 | 2008-07-07 | Method and device for the sterile or aseptic handling of containers |
Country Status (6)
Country | Link |
---|---|
US (1) | US20100180551A1 (en) |
EP (1) | EP2190747B1 (en) |
AT (1) | ATE526242T1 (en) |
DE (1) | DE102007042218A1 (en) |
DK (1) | DK2190747T3 (en) |
WO (1) | WO2009030545A1 (en) |
Families Citing this family (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102009027452A1 (en) * | 2009-07-03 | 2011-01-05 | Robert Bosch Gmbh | Device for filling and closing pharmaceutical containers |
FR2955563B1 (en) * | 2010-01-26 | 2013-09-06 | Spc France | MACHINE FOR FILLING A PLURALITY OF CONTAINERS, SYSTEM INCLUDING SUCH A MACHINE AND PROCESS FOR PRODUCING THE SAME |
EP3208202B1 (en) * | 2010-08-06 | 2019-11-20 | Hospira Australia Pty Ltd | System for producing vials containing a substance comprising an oxygen-sensitive formulation |
US10524980B2 (en) * | 2016-09-13 | 2020-01-07 | Vanrx Pharmasystems, Inc. | Apparatus and method for aseptically filling pharmaceutical containers with a pharmaceutical fluid using rotary stage |
US20130091805A1 (en) * | 2011-10-14 | 2013-04-18 | Applied Silicone Corporation | System and method for curing, sterilization and aseptic packaging of medical devices |
KR20150009982A (en) | 2012-05-03 | 2015-01-27 | 쇼오트 아게 | Method and device for treating containers and substances stored therein for medical, pharmaceutical or cosmetic applications |
WO2013166379A1 (en) * | 2012-05-03 | 2013-11-07 | Vanrx Pharmaceuticals, Inc. | Cover removal system for use in controlled environment enclosures |
DE102012103899B4 (en) * | 2012-05-03 | 2016-09-22 | Schott Ag | Method and device for treating containers for storing substances for medical or pharmaceutical applications |
KR101655726B1 (en) | 2012-05-03 | 2016-09-07 | 쇼오트 아게 | Method and device for treating containers and substances stored therein for medical, pharmaceutical or cosmetic applications |
JP6336327B2 (en) * | 2013-05-08 | 2018-06-06 | エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft | Cap supply device for containers containing biological samples |
JP6709023B2 (en) * | 2015-06-30 | 2020-06-10 | 株式会社安川電機 | Chemical liquid filling system, chemical liquid filling method, robot system, and tray |
EP3225559A1 (en) * | 2016-04-01 | 2017-10-04 | Selo Deutschland GmbH | Method for automated filling of a bag, and filling device |
US11530064B2 (en) * | 2016-09-13 | 2022-12-20 | Vanrx Pharmasystems Inc. | Apparatus and method for monitoring and controlling the removal of a cover from a sealed tube in an aseptic environment |
US11981473B2 (en) | 2020-09-27 | 2024-05-14 | V Anrx Pharmasystems Inc. | Cover removal system for use in controlled environment enclosures |
CN113895721B (en) * | 2021-10-26 | 2023-02-03 | 梅州市瑞山天泉有限公司 | Sterile packaging device and method thereof |
US12037150B2 (en) | 2022-01-31 | 2024-07-16 | Vanrx Pharmasystems Inc. | Apparatus and method for monitoring and controlling the aseptic filling and sealing of pharmaceutical containers with a pharmaceutical fluid using rotary stage |
Family Cites Families (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2700497A (en) * | 1950-02-02 | 1955-01-25 | Merck & Co Inc | Bottle stoppering machine |
US3247640A (en) * | 1960-06-06 | 1966-04-26 | Colgate Palmolive Co | Filling aerosol containers |
DE2033031A1 (en) * | 1970-07-03 | 1972-01-13 | Fa Hermann Heye, 4962 Obernkirchen | Element of a machine, e.g. crown cork closure element of a Kronenkorkver closing machine |
US3805594A (en) * | 1971-10-19 | 1974-04-23 | Mitsubishi Heavy Ind Ltd | Pressure testing apparatus for bottles |
US3802252A (en) * | 1972-06-09 | 1974-04-09 | Benthos Inc | Pressure and vacuum monitoring apparatus |
US3995479A (en) * | 1974-11-01 | 1976-12-07 | Schlumberger Technology Corporation | Apparatus for protecting downhole instruments from torsional and lateral movements |
US4364485A (en) * | 1981-05-15 | 1982-12-21 | Schering Corporation | Injectable fluid container and method |
US4511044A (en) * | 1982-02-24 | 1985-04-16 | The West Company | Seal force monitor apparatus, system, and method for in-process determination of integrity of sealed containers |
US4850696A (en) * | 1987-03-27 | 1989-07-25 | Toyo Glass Company Limited | Vacuum degree inspecting device for sealed up vessel |
US4788850A (en) * | 1987-04-06 | 1988-12-06 | Five X Corporation | Bottle testing apparatus |
DE4004965A1 (en) * | 1990-02-19 | 1991-08-22 | Sensys Gmbh & Co Kg | Testing of containers, esp. of foodstuffs, for closure sealing - applying and removing strong magnetic field, evacuating closure vibrations to determine underpressure in container |
US5033254A (en) * | 1990-04-19 | 1991-07-23 | American National Can Company | Head-space calibrated liquified gas dispensing system |
US5232839A (en) * | 1990-06-14 | 1993-08-03 | Difco Laboratories Incorporated | Detecting microbiological growth |
US5548992A (en) * | 1995-06-06 | 1996-08-27 | The United States Of America As Represented By The United States Department Of Energy | Leak test adapter for containers |
JP4216467B2 (en) * | 1998-03-13 | 2009-01-28 | ベクトン・ディキンソン・アンド・カンパニー | Medical device assembly and packaging method |
US5939620A (en) * | 1998-04-24 | 1999-08-17 | Crown Cork & Seal Technologies Coporation | Leak detecting device for detecting a leak in a container |
IL140486A0 (en) * | 1998-06-29 | 2002-02-10 | Astrapak Ltd | Plug and gland aseptic package system |
US5996401A (en) * | 1998-08-27 | 1999-12-07 | The United States Of America As Represented By The Secretary Of The Navy | Leak test adapter system |
JP2004175395A (en) * | 2002-11-27 | 2004-06-24 | Daiwa Can Co Ltd | Method and device for inspecting internal pressure of sealed container |
ES2232269B1 (en) | 2003-01-21 | 2006-03-01 | Grifols, S.A. | PROCEDURE FOR THE STERILE DOSAGE OF ROADS. |
AU2004213429A1 (en) * | 2003-02-19 | 2004-09-02 | The Coca-Cola Company | System and method for aseptic filling of packages with liquid products |
-
2007
- 2007-09-05 DE DE102007042218A patent/DE102007042218A1/en not_active Withdrawn
-
2008
- 2008-07-07 DK DK08774844.8T patent/DK2190747T3/en active
- 2008-07-07 EP EP08774844A patent/EP2190747B1/en not_active Not-in-force
- 2008-07-07 WO PCT/EP2008/058796 patent/WO2009030545A1/en active Application Filing
- 2008-07-07 AT AT08774844T patent/ATE526242T1/en active
- 2008-07-07 US US12/676,071 patent/US20100180551A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
DE102007042218A1 (en) | 2009-03-12 |
WO2009030545A1 (en) | 2009-03-12 |
EP2190747A1 (en) | 2010-06-02 |
ATE526242T1 (en) | 2011-10-15 |
DK2190747T3 (en) | 2012-01-16 |
US20100180551A1 (en) | 2010-07-22 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
EP2190747B1 (en) | Method and device for the sterile or aseptic handling of containers | |
DE69721321T2 (en) | METHOD FOR HANDLING, FILLING AND SEALING PACKAGING CONTAINERS | |
EP0993418B1 (en) | Method and facility for sealing bottles with sterile sealing caps | |
BE1017059A3 (en) | METHOD AND DEVICE FOR CONTROLLING ADJUSTMENT. | |
DE3878671T2 (en) | METHOD FOR PACKAGING AND STERILIZING A PHARMACEUTICAL PRODUCT AND THE CORRESPONDING PACKAGING. | |
EP2490650A2 (en) | Sensor device for a packaging machine designed as a capsule filling and sealing machine or for a capsule control device | |
DE102008030267B3 (en) | Method for filling dual-chamber systems in pre-sterilizable carrier systems and pre-sterilisable carrier system | |
EP3342719A1 (en) | Device and method for filling nested containers | |
WO2012080190A1 (en) | Method for filling a cavity, in particular a blister of a blister packaging, with a liquid, and semifinished product for use in such a method | |
EP3127859B1 (en) | Method for aseptic filling of a container, a sterile filling device for same, an aseptic machine | |
DE102005014116B4 (en) | Method and device for controlled filling | |
EP3760236B1 (en) | Validation of cleaning in a container filling device | |
EP3699101A1 (en) | Method and device for producing filled containers | |
DE102010028715B4 (en) | Device and method for checking objects for pharmaceutical applications | |
DE102012013320A1 (en) | Apparatus and method for closing a filled container | |
WO2021018428A1 (en) | Apparatus and method for weighing pharmaceutical containers nested in a carrier | |
EP3808696B1 (en) | Validation of cleaning in a container filling device | |
EP3463695B1 (en) | Device and method for inspecting containers | |
WO2011026585A1 (en) | Method and testing device for the non-contact leak testing of packaging means | |
EP2185466B1 (en) | Method for filling bottles and use of a filler cap | |
DE102019104390A1 (en) | Device and method for producing filled containers | |
Verjans | Innovation in aseptic processing: case study through the development of a new technology | |
EP3241771B1 (en) | Filling device with housing and air flow device | |
DE102022107540A1 (en) | Process for filling a medicinal product | |
DE19812057A1 (en) | Ultra-clean vessel for medicinal substances, made and filled more economically |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
17P | Request for examination filed |
Effective date: 20100406 |
|
AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR |
|
AX | Request for extension of the european patent |
Extension state: AL BA MK RS |
|
DAX | Request for extension of the european patent (deleted) | ||
GRAP | Despatch of communication of intention to grant a patent |
Free format text: ORIGINAL CODE: EPIDOSNIGR1 |
|
GRAS | Grant fee paid |
Free format text: ORIGINAL CODE: EPIDOSNIGR3 |
|
GRAA | (expected) grant |
Free format text: ORIGINAL CODE: 0009210 |
|
AK | Designated contracting states |
Kind code of ref document: B1 Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR |
|
REG | Reference to a national code |
Ref country code: GB Ref legal event code: FG4D Free format text: NOT ENGLISH |
|
REG | Reference to a national code |
Ref country code: CH Ref legal event code: EP |
|
REG | Reference to a national code |
Ref country code: IE Ref legal event code: FG4D |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R096 Ref document number: 502008005047 Country of ref document: DE Effective date: 20111215 |
|
REG | Reference to a national code |
Ref country code: SE Ref legal event code: TRGR |
|
REG | Reference to a national code |
Ref country code: DK Ref legal event code: T3 |
|
REG | Reference to a national code |
Ref country code: NL Ref legal event code: VDEP Effective date: 20110928 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: LT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 Ref country code: NO Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20111228 Ref country code: HR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 Ref country code: FI Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 |
|
LTIE | Lt: invalidation of european patent or patent extension |
Effective date: 20110928 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: CY Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 Ref country code: LV Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 Ref country code: GR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20111229 Ref country code: SI Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: SK Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 Ref country code: IS Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120128 Ref country code: CZ Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: PT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120130 Ref country code: NL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 Ref country code: EE Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 Ref country code: RO Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 |
|
PLBE | No opposition filed within time limit |
Free format text: ORIGINAL CODE: 0009261 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: PL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 |
|
26N | No opposition filed |
Effective date: 20120629 |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R097 Ref document number: 502008005047 Country of ref document: DE Effective date: 20120629 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: SE Payment date: 20120726 Year of fee payment: 5 |
|
BERE | Be: lapsed |
Owner name: ROBERT BOSCH G.M.B.H. Effective date: 20120731 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MC Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20120731 |
|
REG | Reference to a national code |
Ref country code: CH Ref legal event code: PL |
|
REG | Reference to a national code |
Ref country code: SE Ref legal event code: EUG |
|
REG | Reference to a national code |
Ref country code: DK Ref legal event code: EBP |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: CH Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20120731 Ref country code: ES Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20120108 Ref country code: LI Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20120731 Ref country code: SE Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20120708 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: BE Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20120731 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: BG Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20111228 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: DK Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20120731 Ref country code: MT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: TR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20110928 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: LU Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20120707 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: HU Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20080707 |
|
REG | Reference to a national code |
Ref country code: AT Ref legal event code: MM01 Ref document number: 526242 Country of ref document: AT Kind code of ref document: T Effective date: 20130707 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: IE Payment date: 20140721 Year of fee payment: 7 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: AT Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20130707 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: GB Payment date: 20140721 Year of fee payment: 7 Ref country code: FR Payment date: 20140724 Year of fee payment: 7 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: IT Payment date: 20150728 Year of fee payment: 8 |
|
GBPC | Gb: european patent ceased through non-payment of renewal fee |
Effective date: 20150707 |
|
REG | Reference to a national code |
Ref country code: IE Ref legal event code: MM4A |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: GB Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20150707 |
|
REG | Reference to a national code |
Ref country code: FR Ref legal event code: ST Effective date: 20160331 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: FR Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20150731 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: IE Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20150707 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: IT Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20160707 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: DE Payment date: 20190924 Year of fee payment: 12 |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R082 Ref document number: 502008005047 Country of ref document: DE Representative=s name: DREISS PATENTANWAELTE PARTG MBB, DE Ref country code: DE Ref legal event code: R081 Ref document number: 502008005047 Country of ref document: DE Owner name: SYNTEGON TECHNOLOGY GMBH, DE Free format text: FORMER OWNER: ROBERT BOSCH GMBH, 70469 STUTTGART, DE Ref country code: DE Ref legal event code: R081 Ref document number: 502008005047 Country of ref document: DE Owner name: SYNTEGON TECHNOLOGY GMBH, DE Free format text: FORMER OWNER: ROBERT BOSCH PACKAGING TECHNOLOGY GMBH, 71332 WAIBLINGEN, DE |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R119 Ref document number: 502008005047 Country of ref document: DE |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: DE Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20210202 |