EP4267469A2 - Dispositif de remplissage de contenants pharmaceutiques - Google Patents
Dispositif de remplissage de contenants pharmaceutiquesInfo
- Publication number
- EP4267469A2 EP4267469A2 EP21843976.8A EP21843976A EP4267469A2 EP 4267469 A2 EP4267469 A2 EP 4267469A2 EP 21843976 A EP21843976 A EP 21843976A EP 4267469 A2 EP4267469 A2 EP 4267469A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- containers
- transport
- frame
- filling
- unit
- 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.)
- Pending
Links
- 238000012545 processing Methods 0.000 claims abstract description 40
- 230000008878 coupling Effects 0.000 claims abstract description 24
- 238000010168 coupling process Methods 0.000 claims abstract description 24
- 238000005859 coupling reaction Methods 0.000 claims abstract description 24
- 239000003814 drug Substances 0.000 claims abstract description 6
- 238000005303 weighing Methods 0.000 claims description 16
- 238000000605 extraction Methods 0.000 claims description 13
- 238000003860 storage Methods 0.000 claims description 6
- 238000002788 crimping Methods 0.000 claims description 5
- 238000009434 installation Methods 0.000 claims description 5
- 238000005202 decontamination Methods 0.000 claims description 4
- 230000003588 decontaminative effect Effects 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- 238000011144 upstream manufacturing Methods 0.000 claims description 4
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 238000004659 sterilization and disinfection Methods 0.000 claims description 3
- 238000005406 washing Methods 0.000 claims description 3
- 239000012212 insulator Substances 0.000 claims 1
- 238000012546 transfer Methods 0.000 description 14
- 238000013461 design Methods 0.000 description 7
- 230000002349 favourable effect Effects 0.000 description 7
- 239000000969 carrier Substances 0.000 description 5
- 238000006243 chemical reaction Methods 0.000 description 4
- 238000012423 maintenance Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 3
- 235000001674 Agaricus brunnescens Nutrition 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 230000001276 controlling effect Effects 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 239000011261 inert gas Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 238000005086 pumping Methods 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- 230000006978 adaptation Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 235000020004 porter Nutrition 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 102000012498 secondary active transmembrane transporter activity proteins Human genes 0.000 description 1
- 108040003878 secondary active transmembrane transporter activity proteins Proteins 0.000 description 1
- 238000012549 training Methods 0.000 description 1
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
- B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
- B65B5/10—Filling containers or receptacles progressively or in stages by introducing successive articles, or layers of articles
- B65B5/12—Introducing successive articles, e.g. confectionery products, of different shape or size in predetermined positions
-
- 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
- B65B21/00—Packaging or unpacking of bottles
- B65B21/02—Packaging or unpacking of bottles in or from preformed containers, e.g. crates
- B65B21/14—Introducing or removing groups of bottles, for filling or emptying containers in one operation
-
- 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
- B65B23/00—Packaging fragile or shock-sensitive articles other than bottles; Unpacking eggs
- B65B23/22—Packaging glass ampoules, lamp bulbs, radio valves or tubes, or the like
-
- 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
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
-
- 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
- B65B35/00—Supplying, feeding, arranging or orientating articles to be packaged
- B65B35/10—Feeding, e.g. conveying, single articles
-
- 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
- B65B43/00—Forming, feeding, opening or setting-up containers or receptacles in association with packaging
- B65B43/42—Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position; Supporting containers or receptacles during the filling operation
- B65B43/46—Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position; Supporting containers or receptacles during the filling operation using grippers
-
- 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
- B65B43/00—Forming, feeding, opening or setting-up containers or receptacles in association with packaging
- B65B43/42—Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position; Supporting containers or receptacles during the filling operation
- B65B43/54—Means for supporting containers or receptacles during the filling operation
Definitions
- the present invention relates to a device for filling pharmaceutical containers of different types, the containers in particular comprising syringes, vials and/or carpules. Vials can also be referred to as “vials” or “vials”. Containers can also be referred to as "vessels”.
- the pharmaceutical substance is in particular a medically active substance (agent).
- the device includes a filling device, which can also be referred to as a “filling machine” and which includes a filling station.
- the object of the present invention is to provide a device of the type mentioned at the outset with a structurally simple design.
- a device for filling pharmaceutical containers of different types comprising: a filling device with a transport device, in particular linear, which preferably comprises circulating holding elements for the containers, which along a transport direction from a coupling side to a decoupling side of the transport device, and with at least one processing station for the containers, which comprises a filling station arranged on the transport device for filling the containers with a pharmaceutical substance, a coupling element for transferring the containers to the transport device and a decoupling element for taking over the containers from the transport device, a first supply unit for providing containers of the first type to be filled and a second supply unit for supplying containers of the second type to be filled, an interface element which is or can be arranged on the supply side with respect to the transport device at at least one interface position and preferably exactly one interface position, via which the transport device is connected indirectly or directly either the containers of the first type can be fed to
- the containers can be transferred to the transport device via a coupling element, preferably individually, and in particular can be coupled into the circulating holding elements.
- the transport device is preferably designed to be linear.
- the containers can be decoupled from the transport device via the decoupling element.
- Containers of the first type and containers of the second type can be supplied via the supply units, as a result of which the device has a high level of versatility. Both containers of the first type and containers of the second type can be filled with the filling device.
- the "genus" of the containers is determined in particular by the form in which they are provided by the respective supply unit. This will be discussed further below.
- the interface element is arranged at at least one and preferably exactly one interface position.
- the containers of the first type or the containers of the second type can be fed directly or indirectly to the transport device via the interface element.
- This preferably offers the possibility of equipping the device with a structurally simple design and/or a compact design. It is particularly favorable here if the filling device is constructed and/or positioned independently of the feed units.
- This advantageously allows the filling device to be used in an essentially standardized design, for example in a modular rer construction to form devices according to the invention, which differ on the supply side by the supply units from each other.
- This also offers the possibility of easy scaling of the devices.
- production costs can be lowered due to the possibility of using standardized components, and training costs and maintenance costs can be reduced.
- position and orientation information such as “on”, “above”, “below”, “horizontal” or the like refers to the intended use of the device.
- at least one frame of the device is positioned on an installation area, for example a hall or a laboratory.
- the installation surface can be regarded as horizontally aligned.
- the device preferably comprises a control device for controlling and/or regulating the operation of the device and also the filling device. It goes without saying that the device can have drive devices for the respectively active components. These are not explained below. Such drive devices are known to those skilled in the art.
- Precisely one, preferably linear, transport device of the filling device is preferably provided for transporting the containers through from the coupling element to the decoupling element.
- the interface element and preferably the other transport elements of the device for containers - for example transport wheels, cell chains, the transport device, etc. - are advantageously designed in such a way that they can cover different formats.
- format is understood to mean, in particular, containers of different types that differ from one another with regard to their container type (vials, syringes or cartridges) and/or with regard to their container properties (such as, in particular, size).
- the device preferably comprises several format sets with respective format parts that differ from one another in a container-specific, container-component-specific and/or processing-specific nature, with the interface element and/or the coupling element and/or the decoupling element in particular being a format part.
- other transport elements for containers can be format parts.
- the holding elements of the transport device can preferably be format parts.
- holding element carriers of the transport device each of which includes a plurality of holding elements, can be format parts.
- the interface element can be formed separately from the coupling element, in which case the containers can be transferred from the interface element indirectly via at least one further transport element or directly to the coupling element.
- the coupling element is or forms the interface element.
- the interface element can be exchangeable depending on the format to be used. However, there is preferably exactly one defined interface position.
- the device preferably comprises a frame of the filling device which is positioned or can be positioned on an installation surface.
- the components of the filling device can be arranged and held on the frame.
- the frame which can also be referred to as a base or "table", can be positioned on a surface, for example the floor of a laboratory or a hall.
- the coupling element can be arranged on the frame.
- the filling device has an infeed element that is arranged on the frame.
- the containers can be transferred from the infeed element to the infeed element.
- the containers can be transferred from the interface element to the transfer element.
- first feed unit and the second feed unit may comprise separate racks.
- the first and second feed units may comprise a common frame.
- the device preferably comprises, on the feed side, a second frame adjoining the frame, on which the interface element and components of one of the feed units—the first feed unit or the second feed unit—are arranged, with the containers directly or indirectly crossing a boundary between the frames via the interface element can be transferred to a transport element of the filling device.
- the interface element transfers the containers directly to a transport element of the filling device, for example the infeed element or the coupling element.
- at least one intermediate transport element can be arranged on the second frame, which in turn transfers the containers across the border to the filling device.
- the frames can be aligned with one another, with the longitudinal directions of the frames in particular coinciding.
- the cradle and the second cradle may be positioned misaligned and oriented at an angle relative to each other.
- the angle may preferably be 90° or substantially 90°. This is in particular the angle between the longitudinal directions of the frames.
- the device can preferably comprise, on the feed side, a third frame adjoining the second frame, on which components of the other feed unit - the second feed unit or the first feed unit - are arranged, with the containers from this other feed unit directly or across a boundary between the frames are indirectly transferable to the interface element.
- the third frame in a preferred embodiment, may be misaligned with the second frame and at an angle relative thereto. The angle may preferably be 90° or substantially 90°. This can be the angle between the longitudinal directions of the frames.
- the third frame runs along a boundary between the frame of the filling device and the second frame.
- the third frame is aligned with the frame of the filling device, with the second frame being arranged between the third frame and the frame of the filling device.
- the containers of the first type can preferably be vials or carpules.
- the first supply unit is expediently designed as bulk goods for providing the containers of the first type and includes a transport element or storage element from which the containers positioned on it can be picked up.
- Bulk goods can be understood here as "bulk" of containers.
- the containers are arranged, for example, on a turntable forming the transport element or storage elements. The containers can be picked up from the turntable and individually transferred directly or indirectly to the interface element.
- the first supply unit preferably comprises at least one of the following: a washing device for the containers; a sterilization device for the containers; a drying facility for the containers.
- a washing device for the containers preferably comprises a washing device for the containers; a sterilization device for the containers; a drying facility for the containers.
- the above means are arranged on the supply unit in this order.
- the transport or storage element of the feed unit preferably follows on the outlet side of the drying device.
- the containers of the second type are, for example, vials, syringes or cartridges.
- the second supply unit preferably comprises a device for supplying containers accommodated in a common carrier and a handling device for removing the containers from the common carrier.
- the containers are housed in what is commonly referred to as a "nest" carrier.
- the carrier can be arranged in a receiving unit, for example referred to as a "tub".
- the receiving unit can be opened to remove the carrier.
- the containers can be removed from the carrier via the handling device and, for example, transferred to a transport element of the second feed unit for separating and, starting from this, fed directly or indirectly to the interface element.
- holding elements of the transport device have container receptacles at a predetermined or predeterminable distance from one another and if the distance between the containers in the first feed unit and/or in the second feed unit or downstream of the interface element in the feed direction can be adjusted to the distance between the container receptacles .
- the distance between the container receptacles can be referred to as the so-called "machine stitch" of the filling device.
- the individual containers can be coupled into the transport device at a distance from one another ("pass") which corresponds to the machine pass.
- An adaptation of the distance is preferably already carried out in the first and/or second feed unit or alternatively downstream of the interface element.
- the containers of the first type are, for example, already picked up individually at the correct distance (“stitch”) from the transport or storage element.
- a stitch delay wheel can be used, for example.
- the at least one processing station is preferably designed in such a way that containers can be processed on it without changing the distance, which have the above-mentioned distance between the container receptacles ("machine stitch").
- a plurality of processing stations preferably have this property. In this way, a particularly versatile filling device can be formed.
- the at least one processing station preferably includes a first weighing station for weighing the containers prior to filling. This allows the tare weight of the unfilled containers to be determined.
- the first weighing station is preferably upstream of the filling station in the transport direction.
- the at least one processing station favorably comprises a second weighing station for weighing the containers after filling, which is preferably downstream of the filling station in the transport direction.
- the gross weight of the filled containers can be determined by means of the second weighing station.
- the filling level of the containers can be determined from the difference between the gross weight and the tare weight. If the containers are underfilled, refilling is preferably provided. This can preferably be done at or on the second weighing station.
- the containers can preferably be filled while moving along the transport direction.
- the at least one processing station preferably includes a closing station for closing the containers with closing elements.
- the closing elements can comprise, for example, mushroom plugs or piston plugs, depending on the type of containers.
- the closing station is preferably downstream of the second weighing station, if present, in the direction of transport.
- the at least one processing station favorably comprises a control station for checking the presence of a closing element on the respective container, the control station preferably being arranged downstream of the closing station in the transport direction.
- An advantageous embodiment of the device according to the invention is characterized by a 100% check during processing of the containers.
- the filling quantity with the pharmaceutical substance is checked for each container by means of the gross weight and the tare weight, refilled if necessary and the presence of a closing element on the container is checked.
- the device advantageously comprises at least one isolator device covering at least one frame with a cover element, preferably for providing an atmosphere for protection and/or for decontamination purposes between the cover element and the frame and, for example, for charging the containers with the atmosphere.
- the respective frame is preferably along an entire outer contour an isolator device for providing the atmosphere.
- the atmosphere includes an inert gas such as H2O2.
- the filling device favorably comprises a separate or independent isolator device.
- the containers can be filled in an atmosphere for protection and/or for decontamination purposes with protective gas.
- the filling device is particularly suitable for filling the containers with toxic or highly sensitive pharmaceutical substances.
- a hood-shaped machine guard with glass or plastic panes can be provided to cover the at least one frame.
- the device comprises a first removal unit for taking over filled containers and a second removal unit for taking over filled containers, as well as a further interface element which is or can be arranged with respect to the transport device at at least one further interface position, and preferably precisely one further interface position, via which the containers can be fed indirectly or directly either to the first extraction unit or to the second extraction unit.
- a further interface element which is or can be arranged with respect to the transport device at at least one further interface position, and preferably precisely one further interface position, via which the containers can be fed indirectly or directly either to the first extraction unit or to the second extraction unit.
- both the containers of the first type and the containers of the second type can be transferred to the first removal unit, depending on which ones were supplied. It is advantageous if both the containers of the first type and the containers of the second type can be transferred to the second removal unit, depending on which ones were supplied.
- first removal unit or the second removal unit includes the interface element or that the filling device includes the interface element.
- the further interface element can be a format part of a respective format set.
- the further interface element is advantageously designed in such a way that, like the first interface element, it can cover different formats.
- the decoupling element is or forms the further interface element.
- the further interface element can be exchangeable depending on the format to be used. However, there is preferably exactly one further defined interface position.
- the decoupling element can be arranged, for example, on the frame of the filling device.
- the filling device has an ejection element that is arranged on the frame of the filling device.
- the decoupling element can transfer the container to the discharge element.
- the containers can, for example, be transferred directly or indirectly from the discharge element to the further interface element.
- a second frame and a third frame have been mentioned above. Reference is made below to a fourth frame and a fifth frame. It goes without saying that the designation "second, third, fourth, fifth" is only used to better understand the explanations, in order to be able to better distinguish the frames from one another.
- the second and the third frame can be omitted. In this case, four or five frames do not necessarily have to be present.
- the first extraction unit and the second extraction unit can comprise separate frames. Alternatively, the first extraction unit and the second extraction unit can comprise a common frame.
- the device preferably comprises a fourth frame adjoining the frame of the filling device, on which the further interface element and components of one of the removal units - the first removal unit or the second removal unit - are arranged, with the containers being transported by a transport element of the filling device directly or indirectly via a Boundary between the frames can be transferred to the further interface element.
- a transport element of the filling device for example the decoupling element or the ejection element, transfers the containers directly to the further interface element.
- at least one intermediate transport element can be arranged on the second frame, which in turn receives the containers across the border from the filling device.
- the frames can be aligned with one another, with the longitudinal directions of the frames in particular coinciding.
- the frame of the filling device and the fourth frame can, for example, be positioned out of alignment with one another and oriented at an angle relative to one another.
- the angle may preferably be 90° or substantially 90°. This is in particular the angle between the longitudinal directions of the frames.
- the device can preferably comprise a fifth frame adjoining the fourth frame, on which components of the respective other removal unit - the second removal unit or the first removal unit - are arranged, with the containers of this further removal unit moving from the further interface element across a boundary between the frames can be transferred directly or indirectly.
- the fifth frame in a preferred embodiment, may be oriented non-aligned and at an angle relative to the fourth frame. The angle may preferably be 90° or substantially 90°. This can be the angle between the longitudinal directions of the frames.
- the fifth frame runs along a boundary between the frame of the filling device and the fourth frame.
- the fifth frame is aligned with the frame of the filling device, with the fourth frame being arranged between the fifth frame and the frame of the filling device.
- the first removal unit can preferably include a further transport device on which at least one further processing station for further processing of the containers is arranged.
- the at least one further processing station includes, for example, a control station for checking that a closing element is correctly seated on the respective container. In the event of a negative determination, the container can be ejected, for example.
- the at least one further processing station preferably includes a closing station for attaching a closing element to the already closed containers.
- the closing station is used in particular in connection with vials that have already been sealed, in order to place crimp caps on the containers.
- a crimping station for crimping crimp caps is preferably provided as a further processing station.
- the device preferably comprises a first removal unit for taking over filled containers and a second removal unit for taking over the container, wherein the first removal unit comprises a further transport device on which at least one further processing station for processing containers is arranged, wherein containers can be transported through the further transport device to the second removal unit.
- the further interface element mentioned above is not used, for example.
- the containers can be fed to the further transport device, for example via at least one transport element, and processed there if necessary. Reference is made to the above explanations for at least one further processing station.
- the containers can be transported through the further transport device, for example without further processing. Downstream of the further transport device, the containers processed on this device can be fed, for example, to a receiving unit, in particular for magazining.
- the containers that have only been transported through can, for example, be fed to a common carrier.
- the second removal unit preferably comprises a handling device, via which the containers can be transferred to a common carrier, and a device for removing the carrier.
- the containers can be reinserted into the carrier from which they were removed by the second feed unit.
- a conveyor device is preferably provided, via which the carrier can be transported from the second supply unit to the second removal unit.
- the distance between the containers can preferably be adjusted in the first removal unit and/or in the second removal unit or in the further interface element in the removal direction upstream of the distance between the container receptacles and the distance from one another in a common carrier.
- this gives the possibility of setting the distance between the containers in the filling device ("machine stitch") to a different distance, for example that of the containers in the carrier.
- This can in particular be the "nest” in which the carrier again be used with the "nest stitch”.
- the handling device can be designed to adjust the machine stitch to the nest stitch.
- a stitch delay wheel can be used, for example.
- FIG. 1 a schematic representation of a device according to the invention for filling pharmaceutical containers, comprising a filling device;
- FIG. 2 schematically a plurality of pharmaceutical containers accommodated in a common carrier (above) and a plurality of pharmaceutical containers held on a transport device of the device (below);
- FIG. 3 an enlarged representation of the filling device according to detail A, non-schematic and simplified;
- FIG. 4 an enlarged partial representation according to detail C in FIG. 3;
- FIG. 5 an enlarged representation of a removal unit of the device from FIG. 1 according to detail B in a non-schematic, simplified representation
- FIG. 6 a further embodiment of the device according to the invention in a partial illustration
- FIG. 7 a further embodiment of the device according to the invention in a partial illustration.
- FIG. 8 a further embodiment of the device according to the invention in a partial illustration.
- a first preferred embodiment of the device will first be discussed with reference to FIGS.
- the explanations relating to this embodiment apply in a corresponding manner to the subsequently explained embodiments.
- the advantages that can be achieved using the embodiment discussed first can also be achieved with the embodiments discussed subsequently.
- the embodiments explained below are described in relation to the respective essential differences compared to the embodiment of FIGS. Otherwise, the explanations given in relation to these apply.
- pharmaceutical containers include, in particular, vials (also referred to as bottles or phials), syringes and/or cartridges.
- the containers are processed with the device, in particular filled with the filling device.
- FIG. 1 shows a schematic representation, a so-called “layout” representation, of an advantageous embodiment of a device according to the invention for processing containers 12, denoted overall by the reference numeral 10.
- the containers 12 are only shown schematically in the drawing in FIGS shown.
- the device 10 includes a filling device, which is identified by the reference numeral 14 and is shown in FIG. 3 in a detailed view.
- the filling device 14 can also be referred to as a filling machine.
- Device 10 further comprises a first feed unit 16 and a second feed unit 18 upstream of the filling device 14 in a feed direction of the containers 12.
- the device 10 comprises a first removal unit 20 and a second removal unit 22 .
- the device 10 comprises a control device 23 for controlling and/or regulating the operation of the device 10 and also of the filling device 14. It goes without saying that the device 10 has drive devices for the respectively active components. These are not shown in the drawing and will not be explained. Such drive devices are known to those skilled in the art.
- the supply units 16, 18 are provided for providing and supplying containers 12 of different types. To remove the containers 12, the removal units 20 and 22 are provided as desired for further processing.
- the “genus” of the containers 12 is determined in particular by the form in which they are provided by the supply units 16 , 18 .
- the first supply unit 16 is designed to provide containers 12 as bulk goods.
- the containers 12 are, for example, vials or carpules.
- the supply unit 16 includes a transport element 24, which can also be regarded as a storage element.
- the transport element 24 is a turntable 26 on which the containers 12 are arranged, for example, in an upright position.
- the containers 12 can be picked up individually from the turntable 26 and fed directly or indirectly to an interface element 28 of the device 10 .
- the interface element 28 is a transport element; In the present case, the transfer from the turntable 26 to the interface element 28 takes place via a further transport element 30.
- the transport elements of the device 10 are transport wheels.
- the interface element 28 is arranged at one, and in particular exactly one, interface position 32 .
- the interface element 28 is positioned on a frame 34 of the feed unit 16 .
- the containers 12 are transferred indirectly from the turntable 26 to the interface element 28 .
- the frame 34 also referred to as a substructure or "table" is positioned on a floor space 36 of a room such as a laboratory or a hall.
- a clean room atmosphere or environment may be provided.
- the feed unit 16 also includes an element identified by the reference numeral 38 in FIG.
- the element 38 is in the present case as a placeholder for other components of the supply unit 16.
- the feed unit 16 includes, preferably in this order, a washing device, a sterilization device and/or a drying device for the containers 12.
- the second supply unit 18 is designed to remove containers 12 (so-called RTU/ready-to-use objects) from a common carrier 40 .
- a device 42 is provided to feed the carriers 40 (arrow 44).
- the carriers 40 can be removed, for example, from a receiving unit (also referred to as a "tub"), which is not shown in the drawing.
- the containers 12 can be removed from the carrier 40, also referred to as a “nest”, by means of a handling device 46 of the feed unit 18.
- the containers 12 can then be fed to the interface element 28 via at least one further transport element 48 , 50 .
- the transport element 48 is a cell chain 52 with which the containers 12 are separated.
- the feed unit 18 also includes a stand 54 separate from and adjacent to the stand 34 and positioned on the deck 36 .
- the containers 12 to be filled are introduced either from the supply unit 16 or from the supply unit 18 via the interface element 28 . In both cases, the containers 12 are transferred individually to the filling device 14 .
- the filling device 14 has a frame 56 for positioning on the installation surface 36, which frame is adjacent to the frame 34.
- a transport device 58 is provided for transporting the containers 12 .
- the transport device 58 has a linear design, with the containers 12 being able to be moved along a transport direction 60 .
- the transport device 58 comprises holding elements 62 for receiving the containers 12.
- a respective holding element 62 has a container receptacle 64.
- the transport device 58 has a plurality of holding element carriers 66 with a respective plurality of holding elements 62 .
- each holding element carrier 66 has six holding elements 62, the invention not being restricted to this number.
- the filling device 14 is clocked, with a number of containers 12 being able to be processed at processing stations 68 in each case, which number corresponds to the number of holding elements 62 ("positions").
- the revolving holding elements 62 move on a transport segment 70 of the transport device 58 in the transport direction 60.
- the container-less holding elements 62 are moved counter to the transport direction 60 on a return segment 72.
- the filling device 14 is designed so that a distance 74 between adjacent containers 12 in the filling device 14 is the same, regardless of the type of container 12, type and size of the container 12 to be processed (within the scope of the device).
- This distance (“machine stitch") is defined in the transport device 58 by the distance between the container receptacles 64 from one another.
- the processing stations 68 also have this constant machine stitch.
- Containers 12, which are fed in by the first feed unit 16 are picked up by the turntable 26 in such a way that the distance is already set to the machine stitch.
- the device 10 in which the transport elements for the containers 12 preferably cover a format range, can have a plurality of format sets 78.
- Figure 1 shows two format sets 78 as an example.
- a respective format set 78 has container-specific, container-component-specific or processing-specific format parts, which can be exchanged on the device 10 if necessary in order to be able to process the desired container 12 .
- the format parts of the format sets 78 do not differ insofar as the container receptacles 64 in the different format sets 78 are each designed to ensure the constant machine stitch. It goes without saying that the transport elements of the device 10 can also be format parts.
- the containers 12 are transferred to the filling device 14 from the interface element 28 across a boundary 80 between the frames 34 and 56 .
- the containers 12 are transferred indirectly from the interface element 28 to the transport device 58 via two transport elements: first to a transfer element 82 and then to a coupling element 84.
- the containers 12 are transferred to the filling device 14 via the transfer element 82.
- the containers 12 are coupled into the transport device 58 via the coupling element 84 .
- the transfer element 82 and the coupling element 84 are arranged on and in particular on the frame 56 . This proves to be advantageous for a scalable, modular structure of the device 10.
- the frame 34 is aligned with the frame 56, with their respective longitudinal directions coinciding.
- the frame 54 is oriented at an angle relative to the frame 34, preferably 90°.
- the frame 54 is aligned with the boundary 80 between the frames 34 and 54.
- Such an arrangement of the filling device 14 and the feed units 16 and 18 allows the device 10 to be constructed in a space-saving manner and at the same time with the largest possible edge line, so that the respective components are easily accessible for maintenance purposes.
- processing stations 68 are arranged on the transport device 58 .
- processing stations 68 include a first weighing station 86, a filling station 88, a second weighing station 90, a closing station 92 and a control station 94.
- a tare weight of the unfilled containers 12 can be determined by means of the first weighing station 86 .
- the containers are filled with the pharmaceutical substance, in particular a medically active substance (agent).
- the filling station 88 includes filling elements, not shown in the drawing, for engaging in the containers 12, which are held on a handling device 96. Pumping and/or dosing units 98 are provided for supplying the substance.
- the closing station 92 is used to close the container 12 with closing elements, not shown in the drawing, such as mushroom stoppers or piston stoppers.
- the control station 94 serves to check whether a closing element is arranged on a respective container 12 . Otherwise the container 12 can be ejected from the device 10 .
- At least one isolator device 102 is provided in the device 10, which comprises a cover element 104 for covering at least one frame.
- the frame is covered on the top side, for example, by means of the cover element 104, which also includes side walls. It goes without saying that maintenance openings can be present.
- the filling device 14 has an independent frame 56 and, in combination with this, an independent isolator device 102 .
- This makes it possible to process the containers 12, in particular the filling, in an atmosphere for protection and/or for decontamination purposes with an inert gas.
- the shielding gas is H2O2, for example.
- the filling device 14 is particularly suitable for filling the container 12 with toxic or highly sensitive pharmaceutical substances.
- the filling device 14 includes a decoupling element 106 for receiving the containers 12 from the transport device 58 .
- the decoupling element 106 and the discharge element 108 are arranged on and in particular on the frame 56 .
- Another interface element 110 is provided on the device 10 on the removal side.
- the interface element 110 is arranged at an interface position and in particular at precisely one interface position 112 .
- the interface element 110 is arranged on and in particular on a frame 114 of the first extraction unit 20 which adjoins the frame 56 .
- the frame 114 is arranged in alignment with the frame 56, with their longitudinal directions coinciding.
- the ejection element 108 transfers the containers 12 to the interface element 110 via a boundary 116 between the frames 56 and 114.
- the containers 12 processed by the filling device 14 can optionally be transferred to the removal unit 20 or the removal unit 22 via the interface element 110 for further processing.
- containers 12 of the first or second type can be transferred to the removal unit 20 or to the removal unit 22 .
- the first removal unit 20 comprises a further transport device 118 of the device 10.
- the transport device 118 is preferably designed to correspond to the transport device 58 and preferably has the same machine stitch.
- the containers 12 can be fed to the transport device 118. In the present case, this takes place indirectly via a plurality of transport elements 120, the number of which is exemplary and non-limiting.
- Further processing stations 68 are arranged on the transport device 118 .
- a control station 122, then a closing station 124 and then a flanging station 126 are arranged on the transport device 118 first.
- Correct seating of the closing elements on the containers 12 can be checked by means of the control station 122 . If the determination is negative, the corresponding container 12 can be ejected, for example.
- the closing station 124 is used in order to finally close containers 12 that have already been closed with closing elements, specifically vials, with flanged caps.
- closing elements specifically vials
- flanged caps are placed on the already existing closing elements via the closing station 124 .
- the crimp caps can be crimped at the crimping station 126.
- the containers 12 further processed at the removal unit 20 can be decoupled, for example via transport elements 128 shown as an example, and fed to a receiving unit 130, for example. This may be referred to as "magazining".
- the removal unit 22 has an independent frame 132 .
- the 132 is adjacent to and oriented at an angle to frame 114, preferably 90°.
- the frame 132 is aligned with the boundary 116 between the frames 56 and 114. In this way, a compact design with the largest possible edge line can also be achieved on the decoupling side of the device 10 in order to ensure good accessibility of the components of the removal units 20, 22.
- the filling device 14 is accessible from both sides, on the one hand between the feed unit 18 and the removal unit 22 and on the other hand.
- the filling device 14 is characterized by a high level of maintenance friendliness.
- the containers 12 can, as mentioned, optionally be supplied to the removal unit 22 indirectly.
- a transport element 134 is provided, for example, for transferring the containers 12 across the boundary between the frames 114 and 132.
- the removal unit 22 is designed at least partially to correspond to the second supply unit 18 and comprises, for example, transport elements 136, 138 on the input side, the latter being able to be a cell chain 140.
- the containers 12 can be conveyed into the carrier 40 by means of a further handling device 142 .
- the carrier 40 if previously emptied, is preferably fed from the feed unit via a conveyor 144 (arrow 146).
- the distance 74 is adjusted again to the nest stitch with the distance 76 by means of the handling device 142.
- FIGS. 6 to 8 show partial views of the device according to the invention in preferred embodiments. Only the filling device 14 and the feed units 16 and 18 are shown in FIG. In Figure 7 and 8, only the filling device 14 and the removal units 20, 22 are shown.
- the variants shown in FIGS. 7 and 8 can be implemented on the output side of the device in the devices according to FIG. 1 and/or 6.
- the variant according to FIG. 6 can be implemented in a corresponding manner on the input side of the device in the devices according to FIGS. 1, 7 and/or 8.
- the frame 54 is aligned with the frame 56, with their longitudinal directions coinciding.
- Rack 34 is positioned between and abuts racks 54 and 56, respectively.
- the frame 34 is aligned at an angle of preferably 90° to the respective frame 54, 56.
- the interface element 28 is arranged on the frame 34 . From the interface element 28 , the containers 12 are selectively fed to the feed unit 16 or the feed unit 18 to the infeed element 82 indirectly via transport elements 154 . The supply of containers 12 of the supply unit 18 to the interface element 28 takes place via transport elements 156.
- transport elements 154, 156 are shown only by way of example. Their number is non-limiting.
- the frame 132 is aligned with the frame 56 with the respective longitudinal directions coinciding.
- the frame 114 is arranged between the frames 56, 132, aligned at an angle of preferably 90° to them and borders on the frames 56 and 132.
- the interface element 110 is arranged on the frame 114 .
- the ejected containers 12 are fed from the ejection element 108 via a transport element 160.
- the containers 12 are transferred to the removal unit 20 via transport elements 162, and the containers 12 are transferred to the removal unit 22 via transport elements 164.
- the number of transport elements 160, 162, 164 is non-limiting.
- the frames 132 and 114 are aligned with one another. They are each aligned at an angle to the frame 56, the angle preferably being 90°.
- no interface element is provided in the device 160 via which the containers 12 are selectively fed to the first removal unit 20 or the second removal unit 22.
- the containers 12 discharged via the discharge element 108 are coupled into the transport device 118 via transport elements 168 .
- three transport elements 168 are shown, non-limitingly, in FIG. One of these is placed on a separate stand 170 and could be placed on stand 56 or stand 114 instead.
- the last transport element 172 is in this case again
- one of the transport elements 172 forms an interface element 174.
- the interface element 174 at an interface position 176 is used to decouple the containers 12 as bulk goods, which are transferred to the receiving unit 130, in this case via a further transport element 178.
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
- Basic Packing Technique (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
L'invention concerne un dispositif de remplissage de contenants pharmaceutiques (12) de différents types, ces contenants (12) comprenant en particulier des seringues, flacons et/ou carpules. Le dispositif (10 ; 152 ; 158 ; 166) comprend un dispositif de remplissage (14) qui comporte un dispositif de transport (58), en particulier un dispositif de transport linéaire, qui comprend de préférence des éléments de retenue (62) périphériques pour les contenants (12), qui peuvent être déplacés le long d'une direction de transport (60), d'un côté d'accouplement à un côté de désaccouplement du dispositif de transport (58), et au moins une station de traitement (68) pour les contenants (12), cette station de traitement comprenant une station de remplissage (88) qui est disposée sur le dispositif de transport (58) pour le remplissage des contenants (12) avec une substance pharmaceutique, un élément d'accouplement (84) pour remettre les contenants (12) au dispositif de transport (58) et un élément de désaccouplement (106) pour recevoir les contenants (12) en provenance du dispositif de transport (58), une première unité d'alimentation (16) pour fournir des contenants (12) à remplir d'un premier type et une deuxième unité d'alimentation (18) pour fournir des contenants (12) à remplir d'un deuxième type, un élément d'interface (28) qui est disposé ou peut être disposé au niveau d'au moins une position d'interface (32), de préférence précisément au niveau d'une position d'interface (32) sur le côté d'alimentation par rapport au dispositif de transport (58) et par l'intermédiaire duquel, sélectivement, les contenants (12) du premier type peuvent être introduits directement ou indirectement dans le dispositif de transport (58) depuis la première unité d'alimentation (16) ou les contenants (12) du deuxième type peuvent être introduits directement ou indirectement dans ce dispositif de transport depuis la deuxième unité d'alimentation (18).
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102020134866.5A DE102020134866A1 (de) | 2020-12-23 | 2020-12-23 | Vorrichtung zum Befüllen pharmazeutischer Behälter |
PCT/EP2021/087243 WO2022136525A2 (fr) | 2020-12-23 | 2021-12-22 | Dispositif de remplissage de contenants pharmaceutiques |
Publications (1)
Publication Number | Publication Date |
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EP4267469A2 true EP4267469A2 (fr) | 2023-11-01 |
Family
ID=80112430
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP21843976.8A Pending EP4267469A2 (fr) | 2020-12-23 | 2021-12-22 | Dispositif de remplissage de contenants pharmaceutiques |
Country Status (5)
Country | Link |
---|---|
US (1) | US20230373669A1 (fr) |
EP (1) | EP4267469A2 (fr) |
CN (1) | CN116723984A (fr) |
DE (1) | DE102020134866A1 (fr) |
WO (1) | WO2022136525A2 (fr) |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7783383B2 (en) * | 2004-12-22 | 2010-08-24 | Intelligent Hospital Systems Ltd. | Automated pharmacy admixture system (APAS) |
DE102008001287A1 (de) | 2008-04-21 | 2009-10-22 | Robert Bosch Gmbh | Füll- und Verschließmaschine für Behälter |
ITTO20120931A1 (it) | 2012-10-23 | 2013-01-22 | Fameccanica Data Spa | Metodo e apparato per la realizzazione di un flusso continuo e ordinato di contenitori |
WO2016198391A1 (fr) * | 2015-06-11 | 2016-12-15 | I.M.A. Industria Macchine Automatiche S.P.A In Sigla Ima S.P.A. | Procédé et machine pour remplir et sceller des bouteilles, des cartouches, des seringues, et analogues |
DE102017120762A1 (de) * | 2017-09-08 | 2019-03-14 | Krones Ag | Flexible Anlage zum Behandeln von Behältnissen |
DE102020134783A1 (de) | 2020-12-23 | 2022-06-23 | Bausch + Ströbel Maschinenfabrik Ilshofen GmbH + Co. KG | Handhabungsvorrichtung für pharmazeutische Behälter und Verarbeitungssystem für pharmazeutische Behälter mit einer Handhabungsvorrichtung |
DE102020134792A1 (de) | 2020-12-23 | 2022-06-23 | Bausch + Ströbel Maschinenfabrik Ilshofen GmbH + Co. KG | Schließvorrichtung zum Verschließen pharmazeutischer Behälter und System zum Verarbeiten pharmazeutischer Behälter |
-
2020
- 2020-12-23 DE DE102020134866.5A patent/DE102020134866A1/de active Pending
-
2021
- 2021-12-22 WO PCT/EP2021/087243 patent/WO2022136525A2/fr active Application Filing
- 2021-12-22 CN CN202180086047.2A patent/CN116723984A/zh active Pending
- 2021-12-22 EP EP21843976.8A patent/EP4267469A2/fr active Pending
-
2023
- 2023-06-22 US US18/339,541 patent/US20230373669A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
WO2022136525A3 (fr) | 2022-08-18 |
DE102020134866A1 (de) | 2022-06-23 |
WO2022136525A2 (fr) | 2022-06-30 |
CN116723984A (zh) | 2023-09-08 |
US20230373669A1 (en) | 2023-11-23 |
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