US20230373669A1

US20230373669A1 - Device for filling pharmaceutical containers

Info

Publication number: US20230373669A1
Application number: US18/339,541
Authority: US
Inventors: Florian Boerret; Simon ACKERMANN; Fabian Kleinheinz
Original assignee: Bausch and Stroebel SE and Co KG
Current assignee: Bausch and Stroebel SE and Co KG
Priority date: 2020-12-23
Filing date: 2023-06-22
Publication date: 2023-11-23
Also published as: DE102020134866A1; EP4267469A2; WO2022136525A2; WO2022136525A3; CN116723984A

Abstract

An apparatus for filling pharmaceutical containers includes a filling device with a linear transport device that preferably includes circulating holding elements for the containers. The holding elements are movable along a transport direction from a coupling side to a decoupling side of the transport device. A processing station includes a filling station arranged at the transport device for filling the containers with a pharmaceutical substance. A coupling element transfers the containers to the transport device, and a decoupling element receives the containers from the transport device. A first feed unit provides containers of a first type to be filled, and a second feed unit feeds containers of a second type to be filled. An interface element is arrangeable on the feed side with respect to the transport device. Containers of the first type or the second type can be selectively fed directly or indirectly to the transport device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of international application number PCT/EP2021/087243, filed on Dec. 22, 2021, and claims the benefit of German application number 10 2020 134 866.5, filed on Dec. 23, 2020. The contents of international application number PCT/EP2021/087243 and German application number 10 2020 134 866.5 are incorporated herein by reference in their entireties and for all purposes.

FIELD

The present disclosure relates to an apparatus for filling pharmaceutical containers of different types, wherein the containers in particular comprise syringes, vials and/or carpules. Vials can also be referred to as “bottles” or “phials.” Containers can also be referred to as “vessels.” The pharmaceutical substance is in particular a medically active substance (agent). For filling, the apparatus comprises a filling device which can also be referred to as a “filling machine” and which comprises a filling station.

BACKGROUND

An object underlying the present disclosure is to provide an apparatus of the type mentioned at the onset with a structurally simple design.

SUMMARY

In an aspect of the present disclosure, an apparatus for filling pharmaceutical containers of different types is provided. The containers comprise syringes, vials and/or carpules. The apparatus comprises a filling device with a transport device which is in particular linear and preferably comprises circulating holding elements for the containers which can be moved 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 at the transport device, for filling the containers with a pharmaceutical substance. The apparatus further comprises a coupling element for transferring the containers to the transport device and a decoupling element for receiving the containers from the transport device. The apparatus further comprises a first feed unit for providing containers of a first type to be filled, and a second feed unit for feeding containers of a second type to be filled. The apparatus further comprises an interface element which is or can be arranged at at least one interface position, and preferably exactly one interface position, on the feed side with respect to the transport device, and via which the containers of the first type of the first feed unit or the containers of the second type of the second feed unit can selectively be fed directly or indirectly to the transport device.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary and the following description may be better understood in conjunction with the drawing figures, of which:

FIG. 1 : shows a schematic representation of an apparatus in accordance with the present disclosure for filling pharmaceutical containers, comprising a filling device;

FIG. 2 : schematically shows a plurality of pharmaceutical containers (top) accommodated in a common carrier and a plurality of pharmaceutical containers (bottom) held on a transport device of the apparatus;

FIG. 3 : shows an enlarged non-schematic and simplified representation of the filling device in accordance with detail A;

FIG. 4 : shows an enlarged partial representation in accordance with detail C in FIG. 3 ;

FIG. 5 : shows an enlarged representation of a removal unit of the apparatus from FIG. 1 in accordance with detail B in a non-schematic, simplified representation;

FIG. 6 : shows a further embodiment of the apparatus in accordance with the present disclosure in a partial representation;

FIG. 7 : shows a further embodiment of the apparatus in accordance with the present disclosure in a partial representation; and

FIG. 8 : shows a further embodiment of the apparatus in accordance with the present disclosure in a partial representation.

DETAILED DESCRIPTION

Although the present disclosure is illustrated and described herein with reference to specific embodiments, the present disclosure is not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents without departing from the present disclosure.
The present disclosure relates to an apparatus for filling pharmaceutical containers of different types, wherein the containers in particular comprise syringes, vials and/or carpules, the apparatus comprising:

- a filling device with a transport device which is in particular linear and preferably comprises circulating holding elements for the containers which are movable 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 at 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 receiving the containers from the transport device,
- a first feed unit for providing containers of a first type to be filled, and a second feed unit for feeding containers of a second type to be filled,
- an interface element which is arranged or is arrangeable at at least one interface position, and preferably exactly one interface position, on the feed side with respect to the transport device, and via which the containers of the first type of the first feed unit or the containers of the second type of the second feed unit are selectively feedable directly or indirectly to the transport device.

In the apparatus in accordance with the present disclosure, the containers of the transport device can preferably be transferred separated via a coupling element and in particular can be coupled into the circulating holding elements. The transport device is preferably linear. After being filled at the filling station, the containers can be decoupled from the transport device via the decoupling element. The feed units can be used to feed containers of the first type and containers of the second type, whereby the apparatus has a high versatility. Both containers of the first type and containers of the second type can be filled by the filling device. In the present case, the “type” of the containers is determined in particular by the manner of the containers being provided by the respective feed unit. This is discussed below. The interface element is arranged at at least one and preferably exactly one interface position. Via the interface element, the containers of the first type or the containers of the second type can selectively be fed directly or indirectly to the transport device, depending on the use of the apparatus and in particular the filling device. This preferably makes it possible to preferably equip the apparatus with a structurally simple design and/or compact construction. In this case, it is in particular advantageous if the filling device is constructed and/or positioned independently of the feed units. This advantageously makes it possible to form apparatuses in accordance with the present disclosure that differ from one another on the feed side in terms of the feed units, with the filling device in a substantially standardized design, for example in a modular design. This also makes it possible to easily scale the apparatuses. Advantageously, manufacturing costs can be reduced due to the possibility of using standardized components, and training effort and maintenance effort can be decreased.
Position and orientation information, such as “on,” “above,” “below,” “horizontal” or the like refer in the present case to use of the apparatus in accordance with specifications. In particular, at least one frame of the apparatus is positioned on a set-down surface, for example a hall or a laboratory. The set-down surface can be regarded as oriented horizontally.
The apparatus preferably comprises a control device for controlling the operation of the apparatus and also the filling device. It is understood that the apparatus for the respectively active components can have drive devices. These drive devices are not explained below. Such drive devices are known to the person skilled in the art.
Preferably, exactly one, preferably linear, transport device of the filling device is provided for the transport of the containers from the coupling element to the decoupling element.
It is understood that a modification of the apparatus may possibly be necessary to selectively feed containers from the first feed unit or the second feed unit. As a result of the use of the interface element, the modification effort, and thus a downtime of the apparatus, can be kept low. Preferably, no modification is required.
It can be provided that different interface elements are to be positioned at the same interface position, depending on the feeding of the containers from the first feed unit or the second feed unit.
It can be provided that the first feed unit or the second feed unit comprises the interface element, or that the filling device comprises the interface element.
The interface element and preferably the further transport elements of the apparatus for containers, for example transport wheels, cell chains, the transport device, etc., are advantageously designed such that they can cover different formats. In this context, “format” is understood in particular to mean containers of different types which differ from one another with regard to their container type (vials, syringes or carpules) and/or with regard to their container properties (such as in particular size).
The apparatus preferably comprises a plurality of format sets with respective format parts which differ from one another in a container-specific, container-component specific and/or processing-specific nature, wherein in particular the interface element and/or the coupling element and/or the decoupling element is a format part. The same applies to the further interface element mentioned below. Furthermore, it is preferably provided that the rest of the transport elements for containers can be format parts. The holding elements of the transport device can preferably be format parts. In a corresponding manner, holding element carriers of the transport device that each comprise a plurality of holding elements can be format parts.
It can be provided that the interface element is formed separately from the coupling element, wherein the containers can be transferred from the interface element indirectly via at least one further transport element or directly to the coupling element.
Alternatively, it can be provided that the coupling element is or forms the interface element.
It is understood that when format parts are used, for example, the interface element can be exchanged depending on the format to be used. However, there is preferably exactly one defined interface position.
The apparatus preferably comprises a frame of the filling device that is or can be positioned on a set-down 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 substructure or a “table,” can be positioned on a set-down surface, for example the floor of a laboratory or of a hall.
The coupling element can be arranged on the frame.
In the present case, “arranged on the frame” can be understood to mean, in particular, “held on the frame,” and vice versa.
It can be provided that the interface element is arranged on the frame.
In a preferred embodiment, it has proven to be advantageous if the filling device has an introduction element which is arranged on the frame. The containers can be transferred from the introduction element to the coupling element. The containers can be transferred from the interface element to the introduction element.
It can be advantageous if only the coupling element, or the coupling element and a further transport element for the containers, is arranged on the frame of the filling device on the feed side, for example the aforementioned introduction element, wherein preferably exactly one further transport element is in particular arranged on the frame of the filling device.
The first feed unit and the second feed unit can comprise separate frames. Alternatively, the first and second feed units can comprise a common frame.
On the feed side, the apparatus preferably comprises a second frame which is adjacent to the frame and on which the interface element and components of one of the feed units, the first feed unit or the second feed unit, are arranged, wherein the containers can be transferred via the interface element directly or indirectly across a boundary between the frames to a transport element of the filling device. For example, the interface element transfers the containers directly to a transport element of the filling device, for example the introduction element or the coupling element. Alternatively, at least one interposed transport element can be arranged on the second frame, which in turn transfers the containers across the boundary to the filling device.
The frames can be aligned with one another, wherein in particular longitudinal directions of the frames coincide.
The frame and the second frame can, for example, be positioned non-aligned with one another and oriented relative to one another at an angle. The angle can preferably be 90° or substantially 90°. This is in particular the angle between longitudinal directions of the frames.
On the feed side, the apparatus can preferably comprise a third frame which is adjacent to the second frame and on which components of the respectively other feed unit, the second feed unit or the first feed unit, are arranged, wherein the containers can be transferred from this other feed unit directly or indirectly to the interface element across a boundary between the frames. In this way, containers of the other feed unit can be fed via the interface element to the filling device.
In a preferred embodiment, the third frame can be oriented non-aligned with the second frame and at an angle relative thereto. The angle can preferably be 90° or substantially 90°. This can be the angle between the longitudinal directions of the frames.
It can be provided that the third frame extends along a boundary between the frame of the filling device and the second frame.
It can be provided that the third frame is aligned with the frame of the filling device, wherein the second frame is 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 feed unit is advantageously designed for providing the containers of the first type as bulk goods and comprises a transport element or storage element from which the containers positioned thereon can be picked up. In the present case, bulk goods can be understood as a “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 transferred separately directly or indirectly to the interface element.
The first feed unit preferably comprises at least one of the following:

- a washing device for the containers;
- a sterilization device for the containers;
- a drying device for the containers.

Preferably, the aforementioned devices are arranged on the feed unit in this order. The transport or storage element of the feed unit preferably adjoins the output side of the drying device.
The containers of the second type are, for example, vials, syringes or carpules.
The second feed unit preferably comprises a device for feeding containers accommodated in a common carrier and a handling device for removing the containers from the common carrier. For example, the containers are accommodated in the carrier usually referred to as a “nest.” The carrier can be arranged in a receiving unit, for example referred to as “tub.” The receiving unit can be opened in order to remove the carrier. The containers can be removed from the carrier via the handling device and, for example, be transferred to a transport element of the second feed unit for separation and, from there, can be fed directly or indirectly to the interface element.
It is advantageous if holding elements of the transport device have container receptacles with a predetermined or predeterminable distance from one another, and if in the first feed unit and/or in the second feed unit or downstream the interface element in the feed direction, the distance of the containers from one another can be adjusted to the distance of the container receptacles. The distance of the container receptacles from one another can be referred to as a so-called “machine pitch” of the filling device. It is advantageous if the separate containers can be coupled into the transport device with a distance from one another (“pitch”) that corresponds to the machine pitch. The distance is preferably already adapted in the first and/or second feed unit, or alternatively downstream of the interface element.
In the first feed unit, the containers of the first type are, for example, already picked up separately from the transport or storage element with the correct distance (“pitch”).
In the second feed unit, it can be provided that the distance of the containers in the common carrier (“nest pitch”) is adapted, if necessary, before the transfer to the interface element. This can preferably be achieved by means of the handling device. How this takes place is described, for example, in the non-prepublished patent application DE 10 2020 134 783.9 by the same applicant. The entire disclosure of this patent application is incorporated in its entirety into the present patent application.
Alternatively, for example, a pitch adaptation wheel can be used.
The at least one processing station is preferably designed such that containers can be processed on it without a change in the distance, which containers have the aforementioned distance of the container receptacles from one another (“machine pitch”). A plurality of processing stations preferably has this property. In this way, a filling device that can be used in a particularly versatile manner can be formed.
The at least one processing station preferably comprises a first weighing station for weighing the containers before 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 advantageously 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 degree of filling of the containers can be determined from the difference between the gross weight and the tare weight. When the containers are underfilled, refilling is preferably provided. This can preferably take place in or on the second weighing station.
The containers can preferably be filled while they move along the transport direction.
The at least one processing station preferably comprises a closing station for closing the containers with closing elements. The closing elements can comprise mushroom plugs or plungers, for example depending on the type of the containers. The closing station is preferably downstream of the second weighing station, if present, in the transport direction.
The at least one processing station advantageously comprises a monitoring station for checking the presence of a closing element on the respective container, wherein the monitoring station is preferably arranged downstream of the closing station in the transport direction.
An advantageous embodiment of the apparatus in accordance with the present disclosure is characterized by 100% monitoring during the processing of the containers. In particular, it can be provided that the filling quantity with the pharmaceutical substance is checked for each container by means of the gross weight and the tare weight, if necessary refilled, and the presence of a closing element on the container is checked.
The apparatus advantageously comprises at least one isolator device, which covers 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 applying the atmosphere to the containers. For example, the respective frame is preferably covered along an entire outer contour with an isolator device for providing the atmosphere. The atmosphere comprises, for example, a protective gas such as H₂O₂.
The filling device advantageously comprises a separate or independent isolator device. The filling of the containers can in this way be carried out under an atmosphere for protection and/or for decontamination purposes with protective gas. In particular, the filling device is thereby also suitable in particular for filling the containers with toxic or highly sensitive pharmaceutical substances.
Instead of an isolator device, hood-shaped machine protection with glass or plastic panes can, for example, be provided for covering the at least one frame.
It is advantageous if the apparatus comprises a first removal unit for receiving filled containers and a second removal unit for receiving filled containers, and 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 exactly one further interface position, and via which the containers can be selectively fed indirectly or directly to the first removal unit or the second removal unit. The advantages from the presence of the interface element which were explained at the beginning can thereby likewise be achieved on the decoupling side of the apparatus. As a result, the apparatus has high versatility. The containers can selectively be fed to the first removal unit or to the second removal unit via the further interface element.
It is advantageous if 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 containers were fed.
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 containers were fed.
It is understood that a modification of the apparatus may possibly be necessary to selectively transfer containers to the first removal unit or to the second removal unit. As a result of the use of the interface element, the modification effort, and thus a downtime of the apparatus, can be kept low. Preferably, no modification is required.
It can be provided that different interface elements are to be positioned at the same interface position, depending on the transfer of the containers to the first removal unit or to the second removal unit.
It can be provided that the first removal unit or the second removal unit comprises the interface element, or that the filling device comprises the interface element.
As already mentioned, the further interface element can be a format part of a respective format set. Advantageously, the further interface element is designed such that it can cover different formats like the first interface element.
It can be provided that the further interface element is formed separately from the decoupling element, wherein the containers can be transferred directly from the decoupling element or indirectly via at least one further transport element to the further interface element.
Alternatively, it can be provided that the decoupling element is or forms the further interface element.
It is understood that when format parts are used, for example, the further interface element can be exchangeable depending on the format to be used. However, there is preferably exactly one defined further interface position.
The decoupling element can, for example, be arranged on the frame of the filling device.
It can be provided that the further interface element is arranged on the frame of the filling device.
In a preferred embodiment, it has proven to be advantageous if the filling device has a discharge element which is arranged on the frame of the filling device. The decoupling element can transfer the containers to the discharge element. From the discharge element, the containers can, for example, be transferred directly or indirectly to the further interface element.
It can be advantageous if only the decoupling element or the decoupling element and a further transport element for the containers are arranged on the frame of the filling device on the removal side, for example the above-mentioned discharge element, wherein in particular exactly one further transport element is preferably arranged on the frame of the filling device.
A second frame and a third frame were mentioned above. Below, reference is made to a fourth frame and a fifth frame. It is understood that the designation “second, third, fourth, fifth” serves merely to better understand the explanations in order to be able to better distinguish the frames from one another. For example, the second and third frames can be omitted. In this case, four or five frames need not necessarily be present.
The first removal unit and the second removal unit can comprise separate frames. Alternatively, the first removal unit and the second removal unit can comprise a common frame.
On the removal side, the apparatus preferably comprises a fourth frame which is adjacent to the frame of the filling device and 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, wherein the containers can be transferred from a transport element of the filling device directly or indirectly to the further interface element across a boundary between the frames. For example, a transport element of the filling device, for example the decoupling element or the discharge element, transfers the containers directly to the further interface element. Alternatively, at least one interposed transport element can be arranged on the fourth frame, which in turn receives the containers across the boundary from the filling device.
The frames can be aligned with one another, wherein in particular longitudinal directions of the frames coincide.
The frame of the filling device and the fourth frame can, for example, be positioned non-aligned with one another and oriented relative to one another at an angle. The angle can preferably be 90° or substantially 90°. This is in particular the angle between longitudinal directions of the frames.
On the removal side, the apparatus can preferably comprise a fifth frame which is adjacent to the fourth frame and on which components of the respective other removal unit, the second removal unit or the first removal unit, are arranged, wherein the containers can be transferred to this further removal unit directly or indirectly from the further interface element across a boundary between the frames.
In a preferred embodiment, the fifth frame can be oriented non-aligned with the fourth frame and at an angle relative thereto. The angle can preferably be 90° or substantially 90°. This can be the angle between the longitudinal directions of the frames.
It can be provided that the fifth frame extends along a boundary between the frame of the filling device and the fourth frame.
It can be provided that the fifth frame is aligned with the frame of the filling device, wherein the fourth frame is arranged between the fifth frame and the frame of the filling device.
The first removal unit can preferably comprise a further transport device at which at least one further processing station is arranged for further processing of the containers.
The at least one further processing station comprises, for example, a monitoring station for checking a correct seat of a closing element on the respective container. In the case of a negative determination, the container can be discharged, for example.
Alternatively or additionally, the at least one further processing station preferably comprises a closing station for attaching a closing element to the already closed containers. In this case, the closing station is used in particular in connection with already closed vials in order to place crimp caps on the containers.
A crimping station for crimping the crimp caps is preferably provided as another processing station.
The apparatus preferably comprises a first removal unit for receiving filled containers and a second removal unit for receiving the containers, wherein the first removal unit comprises a further transport device at which at least one further processing station for processing containers is arranged, wherein containers can be transported via the further transport device to the second removal unit. In such an embodiment, for example, the aforementioned further interface element is not used. The containers can, for example, be fed from the filling device via at least one transport element to the further transport device and, if necessary, be processed there. Reference is made to the above explanations regarding the at least one further processing station. Alternatively, for example without further processing, the containers can be transported through the further transport device. Downstream of the further transport device, the containers processed thereon can be fed, for example, to a receiving unit, in particular for storing. The containers that are only transported through can be fed to a common carrier, for example.
The second removal unit preferably comprises a handling device via which the containers can be transferred into a common carrier, and a device for conducting the carriers away. For example, the containers can be inserted again into the carriers from which they have been removed by means of the second feed unit. Preferably, a conveying device is provided via which the carrier can be transported from the second feed unit to the second removal unit.
In the first removal unit and/or in the second removal unit or upstream of the further interface element in the removal direction, the distance of the containers from one another is preferably adjustable from the distance of the container receptacles to the distance from one another in a common carrier. This makes it possible, in particular, to adjust the distance of the containers in the filling device (“machine pitch”) to a different distance, for example that of the containers in the carrier. This can in particular be the “nest” in which the carriers are again inserted with the “nest pitch.” In the second removal unit, the handling device can, for example, be designed to adjust the machine pitch to the nest pitch. Alternatively, for example, a pitch adaptation wheel can be used.
Further details of the preferred embodiment of the filling device, in particular its transport device, are described in the non-prepublished patent application entitled “Apparatus for processing pharmaceutical containers and filling device” by the same applicant with the same filing date. The entire disclosure of this patent application is incorporated in its entirety into the present patent application.
Preferred embodiments of the apparatus in accordance with the present disclosure for filling pharmaceutical containers are described below with reference to the drawing. Identical or functionally equivalent features and components are always used with the same reference numerals.
A first preferred embodiment of the apparatus is discussed first with reference to FIGS. 1 to 5 . The explanations with respect to this embodiment apply in a corresponding manner to the subsequently explained embodiments. The advantages that can be achieved using the embodiment explained first can also be achieved with the embodiments explained subsequently. For this reason, the embodiments explained subsequently are described with respect to the respective main differences from the embodiment of FIGS. 1 to 5 . In all other respects, the explanations made with respect to them apply.
In the present example, pharmaceutical containers comprise in particular vials (also referred to as bottles or phials), syringes and/or carpules. The containers are processed with the apparatus, in particular filled using the filling device.
FIG. 1 shows a schematic representation, a so-called layout representation, of an advantageous embodiment of an apparatus in accordance with the present disclosure for processing containers 12, which overall is denoted by reference numeral 10. The containers 12 are shown only schematically in the drawing in FIGS. 2 and 4 .
The apparatus 10 comprises a filling device which is denoted by reference numeral 14 and is shown in FIG. 3 in a detail view. The filling device 14 may also be referred to as a filling machine.
Furthermore, the apparatus 10 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. Downstream of the filling device 14 in a decoupling direction or removal direction of the containers 12, the apparatus 10 comprises a first removal unit 20 and a second removal unit 22.
The apparatus 10 comprises a control device 23 for controlling the operation of the apparatus 10 and also the filling device 14. It is understood that the apparatus 10 has drive devices for the respectively active components. These drive devices are not shown in the drawing and are not explained. Such drive devices are known to the person skilled in the art.
The feed units 16, 18 are provided for providing and feeding containers 12 of different types. In order to remove the containers 12, the removal units 20 and 22 are provided for further processing as desired.
In the present case, the “type” of the containers 12 is determined in particular by the shape of the containers being provided by the feed units 16, 18.
The first feed unit 16 is designed to provide containers 12 as bulk goods (“bulk”). In this case, the containers 12 are, for example, vials or carpules.
The feed unit 16 comprises a transport element 24 which can also be regarded as a storage element. In the present example, the transport element 24 is a turntable 26 on which the containers 12 are arranged, for example, standing upright.
From the turntable 26, the containers 12 can be picked up separately and fed directly or indirectly to an interface element 28 of the apparatus 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.
Unless explained in more detail below, the transport elements of the apparatus 10 are transport wheels.
The interface element 28 is arranged at one and in particular exactly one interface position 32. In this case, the interface element 28 is positioned on a frame 34 of the feed unit 16.
Accordingly, the containers 12 are transferred indirectly from the turntable 26 to the interface element 28.
The frame 34, which can also be referred to as a substructure or “table,” can be positioned on a set-down surface 36 of a room, such as a laboratory or a hall. A clean room atmosphere or clean room environment can be provided.
The feed unit 16 furthermore comprises an element denoted by reference numeral 38 in FIG. 1 . In the present case, the element 38 is a placeholder for further components of the feed unit 16. For example, the feed unit 16 comprises, preferably in this order, a washing device, a sterilization device and/or a drying device for the containers 12.
The second feed unit 18 is designed to remove containers 12 (so-called RTUs/ready-to-use objects) from a common carrier 40. A device 42 is provided to feed the carriers 40 (arrow 44). By means of the device 42, the carriers 40 can be removed, for example, from a receiving unit (also referred to as “tub”) not shown in the drawing.
The containers 12 can be removed from the carriers 40, also referred to as a “nest,” by means of a handling device 46 of the feed unit 18. Subsequently, the containers 12 can be fed to the interface element 28 via at least one further transport element 48, 50. The transport element 48 in the present case is a cell chain 52 with which the containers 12 are separated.
The feed unit 18 also comprises a frame 54 which is separate from the frame 34, is adjacent to the latter, and is positioned on the set-down surface 36.
Depending on whether the containers 12 are to be fed to the filling device 14 as bulk goods of the first feed unit 16 or via the carrier 40 of the second feed unit 18, the containers 12 to be filled are selectively introduced by the feed unit 16 or by the feed unit 18 via the interface element 28. The containers 12 are separately transferred to the filling device 14 in both cases.
In the present example, the filling device 14 has a frame 56 for positioning on the set-down surface 36, which is adjacent to the frame 34. A transport device 58 is provided for transporting the containers 12. The transport device 58 is linear, wherein the containers 12 can be moved along a transport direction 60.
For receiving the containers 12, the transport device 58 comprises holding elements 62. A respective holding element 62 has a container receptacle 64.
For example, it is provided that the transport device 58 has a plurality of holding element carriers 66 with a respective plurality of holding elements 62. In the present example, each holding element carrier 66 has six holding elements 62, wherein the present disclosure is not limited to this number.
In the present example, the filling device 14 is cycle-type, wherein a number of containers 12 that corresponds to the number of holding elements 62 (“locations”) can be processed at each processing station 68.
It can be provided that the filling device 14 is designed for non-cycled processing of the containers 12.
The circulating holding elements 62 move on a transport segment 70 of the transport device 58 in the transport direction 60. The holding elements 62 void of containers are moved counter to the transport direction 60 on a return segment 72.
The filling device 14 is designed such that a distance 74 of adjacent containers 12 from one another in the filling device 14 is the same, regardless of the type of the containers 12, the type and size of the containers 12 to be processed (within the scope of use of the apparatus). This distance (“machine pitch”) is defined in the transport device 58 by the distance of the container receptacles 64 from one another. The processing stations 68 also have this constant machine pitch.
Containers 12, which are introduced by the first feed unit 16, are picked up by the turntable 26 such that the distance is already adjusted to the machine pitch.
When feeding containers 12 from the second feed unit 18, it is preferably possible to already adjust the distance of the containers 12 to the distance 74 by means of the handling device 46. If a distance 76 of the containers 12 in the carrier 40 (“nest pitch”) deviates from the distance 74, the distance can be adapted by means of the handling device 46 described in a separate patent application of the applicant. Otherwise, for example, a pitch adaptation wheel can be used.
It is advantageous if the distance of the containers 12 has already been adjusted to the machine pitch at the interface element 28.
The use of a constant machine pitch offers the advantage of a structurally simple and compact design of the apparatus 10, in particular of the filling device 14.
Nevertheless, the apparatus 10, in which the transport elements for the containers 12 preferably cover a format range, can have a plurality of format sets 78. FIG. 1 shows, by way of example, two format sets 78.
A respective format set 78 has container-specific, container-component-specific or processing-specific format parts which, if necessary, can be replaced in the apparatus 10 in order to be able to process the desired containers 12. With regard to holding elements and holding element carriers of the transport device 58, however, the format parts of the format sets 78 do not differ in that the container receptacles 64 in the different format sets 78 are each formed to ensure the constant machine pitch.
It is understood that the transport elements of the apparatus 10 can likewise 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. From the interface element 28, the containers 12 are indirectly transferred to the transport device 58 via two transport elements: first to an introduction element 82 and subsequently to a coupling element 84. The containers 12 are introduced into the filling device 14 via the introduction element 82. The containers 12 are coupled into the transport device 58 via the coupling element 84.
The introduction element 82 and the coupling element 84 are arranged at, and in particular on, the frame 56. This has proven advantageous for a scalable modular design of the apparatus 10.
In the present case, the frame 34 is aligned with the frame 56, wherein their respective longitudinal directions coincide.
The frame 54 is oriented at an angle, preferably 90°, relative to the frame 34. In this case, 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 makes it possible to construct the apparatus 10 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.
As is clear in particular from FIG. 3 , a plurality of processing stations 68 are arranged at the transport device 58. In relation to the transport direction 60, the processing stations 68 comprise a first weighing station 86, a filling station 88, a second weighing station 90, a closing station 92 and a monitoring 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), at the filling station 88. The filling station 88 comprises filling elements (not shown in the drawing) for engaging in the containers 12 which are held on a handling device 96. Pump units and/or metering units 98 are provided for feeding the substance.
The closing station 92 serves to close the containers 12 with closing elements (not shown in the drawing), for example mushroom plugs or plungers.
The monitoring station 94 is used to check whether a closing element is arranged on a respective container 12. Otherwise, the container 12 can be discharged from the apparatus 10.
At least one isolator device 102 is provided in the apparatus 10 and comprises a cover element 104 for covering at least one frame. The frame is, for example, covered on the upper side by means of the cover element 104, which moreover comprises side walls. It is understood that maintenance openings may be present.
It is advantageous that the filling device 14 has an independent frame 56 and, in combination therewith, an independent isolator device 102. This makes it possible to carry out the processing of the containers 12, in particular the filling, in an atmosphere for protection and/or for decontamination purposes with a protective gas. The protective gas is, for example, H₂O₂. For this reason, the filling device 14 is in particular also suitable for filling the containers 12 with toxic or highly sensitive pharmaceutical substances.
On the decoupling side, the filling device 14 comprises a decoupling element 106 for receiving the containers 12 from the transport device 58. Furthermore, the filling device 14 comprises a discharge element 108 which receives the containers 12 from the decoupling element 106.
The decoupling element 106 and the discharge element 108 are arranged at and in particular on the frame 56.
A further interface element 110 is provided on the apparatus 10 on the removal side. The interface element 110 is arranged at an interface position and in particular exactly one interface position 112. In the present case, the interface element 110 is arranged at and in particular on, a frame 114 of the first removal unit 20 which is adjacent to the frame 56.
In the present example, the frame 114 is arranged aligned with the frame 56, wherein the longitudinal directions thereof coincide.
In the present case, the discharge element 108 transfers the containers 12 across a boundary 116 between the frames 56 and 114 to the interface element 110.
The containers 12 processed by the filling device 14 can be selectively transferred via the interface element 110 to the removal unit 20 or the removal unit 22 for further processing. Depending on the desired type of further processing, containers 12 of the first or second type can be transferred to the removal unit 20 or to the removal unit 22.
As is clear from FIGS. 1 and 5 , the first removal unit 20 comprises a further transport device 118 of the apparatus 10. The transport device 118 is preferably designed to correspond to the transport device 58 and preferably has the same machine pitch.
From the interface element 110, the containers 12 can be fed to the transport device 118. In the present case, this is done indirectly via a plurality of transport elements 120, wherein the number thereof is exemplary and non-limiting.
Further processing stations 68 are arranged at the transport device 118. In relation to the transport direction 60, first a monitoring station 122, thereafter a closing station 124 and thereafter a crimping station 126 are arranged at the transport device 118.
A correct seat of the closing elements on the containers 12 can be checked by means of the monitoring station 122. In the event of a negative determination, the corresponding container 12 can be discharged, for example.
The closing station 124 is used in order to, in particular, finally close, with crimp caps, containers 12, specifically vials, that are already closed with closing elements. For this purpose, crimp caps are placed on the already present closing elements by 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 by way of example, and can be fed, for example, to a receiving unit 130. This can be referred to as “storing.”
The removal unit 22 has an independent frame 132. The frame 132 is adjacent to the frame 114 and is oriented at an angle thereto, 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 apparatus 10 in order to ensure easy accessibility of the components of the removal units 20, 22.
It is advantageous that the filling device 14 is accessible on both sides, on the one hand between the feed unit 18 and the removal unit 22, and also from the opposite side. As a result, the filling device 14 is also characterized by high ease of maintenance.
From the interface element 110, the containers 12 can selectively be fed indirectly to the removal unit 22 as mentioned. For this purpose, for example, a transport element 134 is provided for transferring the containers 12 across the boundary between the frames 114 and 132.
In functional terms, the removal unit 22 is designed to at least partially correspond to the second feed unit 18 and, on the input side, comprises, for example, transport elements 136, 138, wherein the latter may 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 by the feed unit via a conveying device 144 (arrow 146).
When the containers 12 are placed in the carrier 40, the distance 74 is reset by means of the handling device 142 to the nest pitch with the distance 76.
A device 148 for conducting the filled carriers 40 away is provided (arrow 150).
FIGS. 6 to 8 show partial views of the apparatus in accordance with the present disclosure in preferred embodiments in a layout representation corresponding to FIG. 1 . In this case, only the filling device 14 and the feed units 16 and 18 are shown in FIG. 6 . FIGS. 7 and 8 show only the filling device 14 and the removal units 20, 22.
It is understood that, for example, the variants shown in FIGS. 7 and 8 can be implemented at the output side of the apparatus in the apparatuses in accordance with FIGS. 1 and/or 6 . In a corresponding manner, the variant in accordance with FIG. 6 can be implemented on the input side of the apparatus in the apparatuses in accordance with FIGS. 1, 7 and/or 8 .
The apparatus 152 in accordance with FIG. 6 provides that the frame 54 is aligned with the frame 56, wherein the longitudinal directions thereof coincide. The frame 34 is arranged between the frames 54 and 56 and is each adjacent thereto. The frame 34 is oriented 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 selectively of the feed unit 16 or the feed unit 18 are selectively fed to the introduction element 82 indirectly via transport elements 154. The containers 12 of the feed unit 18 are fed to the interface element 28 via transport elements 156.
It is understood that only two transport elements 154, 156 are shown by way of example in each case. Their number is non-limiting.
In the apparatus 158 in accordance with FIG. 7 , the frame 132 is aligned with the frame 56, and the respective longitudinal directions coincide. The frame 114 is arranged between the frames 56, 132, in each case oriented at an angle of preferably 90° thereto, and is adjacent to the frames 56 and 132.
The interface element 110 is arranged on the frame 114. The discharged containers 12 are fed from the discharge 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.
In this case too, it is understood that the number of transport elements 160, 162, 164 is non-limiting.
In the apparatus 166 in accordance with FIG. 8 , the frames 132 and 114 are aligned with one another. They are each oriented at an angle to the frame 56, wherein the angle is preferably 90°.
In deviation from previous apparatuses 10, 152 and 158, no interface element via which the containers 12 are selectively fed to the first removal unit 20 or the second removal unit 22 is provided in the apparatus 160.
Instead, the containers 12 discharged via the discharge element 108 are coupled into the transport device 118 via transport elements 168. This also applies to the containers 12 to be conveyed into the carrier 40. Accordingly, these containers 12 are transported through the transport device 58 to the second removal unit 22 so that they pass through a part of the removal unit 20.
By way of example, three (non-limiting) transport elements 168 are shown in FIG. 8 from the discharge element 108 until the coupling into the transport device 118. One of them is arranged on a separate frame 170 and could instead be arranged on the frame 56 or the frame 114.
On the decoupling side of the transport device 118, the containers 12 are transferred to the handling device 142 via a plurality of transport elements 172. In this case, the last transport element 172 is again the cell chain 140.
One of the transport elements 172 in this case forms an interface element 174. The interface element 174 at an interface position 176, in the present case on the frame 132, serves to decouple the containers 12 as bulk goods which are transferred into the receiving unit 130, in the present case via a further transport element 178.
It is understood that in the present case, the number of transport elements 172 and 178 is not limiting for the present disclosure.
The design and mode of operation of the closing stations 92 and/or 124 are preferably as described in the non-prepublished patent application DE 10 2020 134 792.8 by the same applicant. The entire disclosure of this patent application is incorporated in its entirety into the present patent application.

Claims

1. An apparatus for filling pharmaceutical containers of different types, wherein the containers in particular comprise syringes, vials and/or carpules, the apparatus comprising:

a filling device with a transport device which is in particular linear and preferably comprises circulating holding elements for the containers which are movable 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 at 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 receiving the containers from the transport device,

a first feed unit for providing containers of a first type to be filled, and a second feed unit for feeding containers of a second type to be filled,

an interface element which is arranged or is arrangeable at at least one interface position, and preferably exactly one interface position, on the feed side with respect to the transport device, and via which the containers of the first type of the first feed unit or the containers of the second type of the second feed unit are selectively feedable directly or indirectly to the transport device.

2.-24. (canceled)