EP2190747B1 - Verfahren und vorrichtung zur sterilen oder aseptischen handhabung von behältnissen - Google Patents

Verfahren und vorrichtung zur sterilen oder aseptischen handhabung von behältnissen Download PDF

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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
Application number
EP08774844A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP2190747A1 (de
Inventor
Berthold Duethorn
John Peter Lysfjord
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.)
Robert Bosch GmbH
Original Assignee
Robert Bosch GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Robert Bosch GmbH filed Critical Robert Bosch GmbH
Publication of EP2190747A1 publication Critical patent/EP2190747A1/de
Application granted granted Critical
Publication of EP2190747B1 publication Critical patent/EP2190747B1/de
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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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.

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  • 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)
EP08774844A 2007-09-05 2008-07-07 Verfahren und vorrichtung zur sterilen oder aseptischen handhabung von behältnissen Not-in-force EP2190747B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102007042218A DE102007042218A1 (de) 2007-09-05 2007-09-05 Verfahren und Vorrichtung zur sterilen oder aseptischen Handhabung von Behältnissen
PCT/EP2008/058796 WO2009030545A1 (de) 2007-09-05 2008-07-07 Verfahren und vorrichtung zur sterilen oder aseptischen handhabung von behältnissen

Publications (2)

Publication Number Publication Date
EP2190747A1 EP2190747A1 (de) 2010-06-02
EP2190747B1 true EP2190747B1 (de) 2011-09-28

Family

ID=39743148

Family Applications (1)

Application Number Title Priority Date Filing Date
EP08774844A Not-in-force EP2190747B1 (de) 2007-09-05 2008-07-07 Verfahren und vorrichtung zur sterilen oder aseptischen handhabung von behältnissen

Country Status (6)

Country Link
US (1) US20100180551A1 (da)
EP (1) EP2190747B1 (da)
AT (1) ATE526242T1 (da)
DE (1) DE102007042218A1 (da)
DK (1) DK2190747T3 (da)
WO (1) WO2009030545A1 (da)

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DE102009027452A1 (de) 2009-07-03 2011-01-05 Robert Bosch Gmbh Vorrichtung zum Füllen und Verschließen von pharmazeutischen Bahältnissen
FR2955563B1 (fr) * 2010-01-26 2013-09-06 Spc France Machine pour remplir une pluralite de recipients, systeme incluant une telle machine et procede de fabrication afferent
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
CN105501503B (zh) 2012-05-03 2018-01-12 肖特公开股份有限公司 用于处理或加工容器的方法和设备
DE102012103899B4 (de) * 2012-05-03 2016-09-22 Schott Ag Verfahren und Vorrichtung zur Behandlung von Behältern zur Aufbewahrung von Substanzen für medizinische oder pharmazeutische Anwendungen
ES2643052T3 (es) * 2012-05-03 2017-11-21 Vanrx Pharmasystems Inc. Sistema de retirada de cubierta para uso en recintos de entorno controlado
KR101655726B1 (ko) 2012-05-03 2016-09-07 쇼오트 아게 의료, 제약 또는 화장품 어플리케이션들을 위한 물질들을 저장하기 위한 컨테이너들을 처리하기 위한 방법 및 장치
JP6336327B2 (ja) * 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 生物学的サンプルを収容する容器のためのキャップ供給装置
JP6709023B2 (ja) * 2015-06-30 2020-06-10 株式会社安川電機 薬液充填システム、薬液充填方法、ロボットシステム、及びトレイ
EP3225559A1 (de) * 2016-04-01 2017-10-04 Selo Deutschland GmbH Verfahren zur automatisierten befüllung eines beutels sowie befüllungs-vorrichtung
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 (zh) * 2021-10-26 2023-02-03 梅州市瑞山天泉有限公司 一种无菌包装装置及其方法

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Also Published As

Publication number Publication date
WO2009030545A1 (de) 2009-03-12
ATE526242T1 (de) 2011-10-15
US20100180551A1 (en) 2010-07-22
EP2190747A1 (de) 2010-06-02
DE102007042218A1 (de) 2009-03-12
DK2190747T3 (da) 2012-01-16

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