Plant and method for filling and sealing objects in a sterile environment

Abstract

The invention relates to a plant, which can be operated in a plurality of operating modes, for filling objects in a sterile environment, said plant comprising a filling station, a station arranged downstream of the filling station, a freeze dryer, a first transport device (2) for transporting objects from the filling station towards the second station, a second transport device (3) for transporting objects to the freeze dryer, and a transfer device (4) arranged at a junction point between the first transport device (2) and the second transport device (3), wherein, in a first operating mode, objects can be transported from the filling station to the freeze dryer, in a second operating mode, objects can be transported from the freeze dryer towards the second station, and in a third operating mode, objects can be transported from the filling station towards the second station, wherein the first transport device comprises a linear transport path (20), wherein the junction point is provided on the linear transport path (20), wherein the transfer device (4) can be configured selectively in a rest state and in at least one working state, wherein, in the rest state, objects can be transported by means of the first transport device (2) such that the objects pass the junction point and, while passing the junction point, remain within the first transport device (2). The invention also relates to a method for filling and sealing objects.

Description

[0001] Equipment and method for filling and sealing objects in a sterile environment

[0002] SCOPE OF APPLICATION AND STATE OF THE ART

[0003] The invention relates to a system and a method for filling and sealing objects in a sterile environment.

[0004] A sterile environment is, for example, a cleanroom created within an isolator or a closed or open restricted access barrier system (RABS). In the context of this application, an isolator is defined as a decontaminated unit that allows its interior to be isolated from the external environment. Isolators and RABS are used particularly in the manufacture, processing, and handling of pharmaceutical products, biopharmaceutical products, biological products, high-potency products, and / or other highly sensitive products.

[0005] Particularly for the manufacture and / or processing of pharmaceutical and / or biopharmaceutical products, stringent sterility requirements are placed on the products. Requirements for cleanrooms in the pharmaceutical industry are specified, among other things, in Annex 1 of the EU GMP Guide concerning the manufacture of sterile medicinal products (EU Annex 1).

[0006] For the processing of pharmaceutical and / or biopharmaceutical products, it is known to fill the products into empty, sterilized containers, such as vials, syringes, cartridges or ampoules, and then to seal the containers.

[0007] It is known to pre-sterilize containers and introduce them into the sterile environment in outer packaging. In the sterile environment, a final outer packaging is preferably opened and the containers are removed. Alternatively, it is known to feed the containers in bulk, with washing and / or sterilization of the containers taking place in a feed area.

[0008] For filling and sealing, the containers are subsequently transported to various processing stations. These processing stations include, for example, a tare weighing station, a filling station, a gross weighing station, and a sealing station. For transport to the processing stations, it is known to move the containers in a row at a defined distance using a transport device comprising linear transport sections, such as a rake, a screw conveyor, a belt conveyor, an oval conveyor, and / or rotating transport wheels.

[0009] For high flexibility, it is known to process different containers and / or products in one system, whereby, depending on the application, the objects are either fed into a freeze dryer before sealing or the objects are sealed without additional freeze-drying.

[0010] TASK AND SOLUTION

[0011] One objective of the invention is to create a system and a method that allow flexible processing of different objects in a sterile environment.

[0012] This problem is solved by the items having the features of claims 1 and 6. Further advantageous embodiments result from the dependent claims.

[0013] According to a first aspect, a system for filling and sealing objects in a sterile environment is provided, comprising a filling station, a station downstream of the filling station, a freeze dryer, a first transport device for transporting the objects from the filling station towards the second station, a second transport device for transporting the objects to the freeze dryer, and a transfer device arranged at a junction between the first transport device and the second transport device, wherein the system is optionally operable in several operating modes, wherein in a first operating mode the objects can be transported from the filling station to the freeze dryer, in a second operating mode the objects can be transported from the freeze dryer towards the second station, and in a third operating mode the objects can be transported from the filling station towards the second station.and wherein the first transport device has a linear transport track, wherein the node is provided on the linear transport track, wherein the transfer device is optionally configurable in a rest state and in at least one working state, wherein in the rest state the objects can be transported by means of the first transport device, such that the objects pass the node and remain in the first transport device when passing the node.

[0014] According to a second aspect, a method for filling and sealing objects in a sterile environment is provided by means of a system comprising a filling station, a station downstream of the filling station, a freeze dryer, a first transport device for transporting the objects from the filling station towards the second station, a second transport device for transporting the objects to the freeze dryer, and a transfer device arranged at a junction between the first transport device and the second transport device, wherein the system is optionally operated in one of several operating modes, wherein in a first operating mode the objects are transported from the filling station to the freeze dryer, and in a second operating mode the objects are transported from the freeze dryer towards the second station.and in a third operating mode, the objects are transported from the filling station towards the second station, wherein the first transport device has a linear transport track, the node being provided on the linear transport track, the transfer device being optionally configured in a rest state or in at least one working state, wherein in the rest state the objects are transported by means of the first transport device, such that the objects pass the node and the objects remain in the first transport device when passing the node and are transported from the filling station towards the second station.

[0015] The terms "first", "second", etc. are used in connection with the registration only for differentiation purposes and do not indicate any order or ranking.

[0016] The terms "a", "an", "a", etc. serve only as indefinite articles and not as counters. In particular, configurations include more than one second transport device, more than one freeze dryer, more than one transfer device, and / or a first transport device with more than one linear transport path.

[0017] In one embodiment, the objects are sealable pharmaceutical containers, in particular vials, syringes, cartridges, or ampoules. The second station can be configured according to the objects to be filled. For example, the second station is designed as a closing station for attaching a protective cap, such as a crimp cap. In other embodiments, the second station is designed as an inspection station.

[0018] In some configurations of the system, a station for inserting a sealing element, in particular a plug, is provided upstream of the transfer device. In the third operating mode, the plugs are fully inserted into the objects. For objects, especially vials, which are transported to the freeze dryer, some configurations involve sealing the objects in several steps, with a station for inserting a sealing element, in particular a plug, provided upstream of the transfer device. At this station, only the sealing element, in particular a plug, is inserted, and the objects are hermetically sealed by means of the plug in the freeze dryer. In some configurations, a second sealing element, for example an additional protective cap, is attached at the second station downstream of the transfer device.

[0019] The objects can be transported using the linear transport track of the first transport unit. A linear transport track is defined as a transport track by which, in continuous transport, all objects, or in clocked transport, at least all objects of a given cycle, are arranged in a straight line. Depending on the design, the first transport unit may comprise several transport units, with all transport units being designed as linear transport tracks and arranged in a straight line, or the transport tracks being partially offset.

[0020] Transport systems with a linear transport path are advantageous for transporting different objects, especially different sealable pharmaceutical containers such as vials, cartridges, syringes, or ampoules. The first transport system thus allows different objects to be filled within the system and, after filling, transported by the first transport system towards the second station, for example, a sealing station.

[0021] The second transport device can be operated in configurations with two transport directions. In the first operating mode of the system, the second transport device is operated to transport the objects away from the first transport device towards the freeze dryer, and in the second operating mode of the system, the second transport device is operated to transport the objects from the freeze dryer towards the first transport device. In other configurations, two second transport devices are provided, one for transporting the objects to the freeze dryer and the other from the freeze dryer to the first transport device.

[0022] In some configurations, the node is located between the linear ends of the transport track. The term "linear ends" refers to the ends of the linear transport track. In one configuration, two transfer devices are provided to transfer the objects from the first transport device to the second transport device and vice versa.

[0023] In a further development of the system, the transfer device can be configured optionally in a rest state, a first working state or a second working state, wherein in the first working state the transfer device is configured to divert the objects from the first transport device, in particular from the linear transport track and transfer them to the second transport device, and wherein in the second working state the transfer device is configured to transfer the objects from the second transport device to the first transport device and to introduce them into the first transport device, in particular into the linear transport track.

[0024] By selectively configuring the transfer device in either the first or second operating state, a transfer from the first transport device to the second transport device and from the second transport device to the first transport device is possible at a single junction using only one transfer device instead of two separate transfer devices. This allows for a compact system design. In some configurations, the device has multiple junctions, each with at least one transfer device. In other configurations, exactly one junction is provided.

[0025] In some configurations, both transport systems are set up to transport the objects in a timed sequence. In other configurations, both transport systems are set up to transport the objects continuously.

[0026] In other configurations, the first transport device is configured to transport the objects at intervals, and the second transport device is configured to transport the objects continuously. In other configurations, the first transport device is configured to transport the objects continuously, and the second transport device is configured to transport the objects at intervals.

[0027] For a transfer from a timed to a continuous transport or from a continuous transport to a timed transport, the transfer device in embodiments has a segment wheel, wherein the segment wheel is configured to transfer the objects transported along the first transport device from a timed transport to a continuous transport or from a continuous transport to a timed transport.

[0028] In the context of this application, a segment wheel is defined as a wheel comprising several segments, adjustable relative to each other in the circumferential direction, each segment having a number of pockets. The segments are movable in the first circumferential sections for transferring objects to or receiving objects from a clocked transport device, in particular a clocked linear conveyor of a transport device, and in the second circumferential sections continuously movable in the circumferential direction for transferring objects to or receiving objects from a continuous transport device, in particular a transport wheel of a transport device rotating at a continuous circumferential speed.

[0029] In some embodiments, the transfer device comprises exactly one segment wheel, which is used for both the first and second operating modes of the system. In other embodiments, the segment wheel and / or format parts of the segment wheel are interchangeable for operating the system in the first and second operating modes. In one embodiment, the segment wheel is removed and / or moved to a rest position when the transfer device is at rest.

[0030] In some configurations, the first and second transport devices comprise linear transport sections. In these configurations, the first and second transport sections run at an angle to each other, particularly at an angle of approximately 90°.

[0031] The system and process allow for the handling of different objects for filling by selectively operating the system in the first, second, or third operating mode. In some configurations, objects are diverted from the linear transport path of the first transport unit in the first operating mode and fed into the linear transport path of the first transport unit in the second operating mode at a single transfer point. This enables a particularly compact system design. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Further advantages and aspects of the invention will become apparent from the claims and from the following description of an exemplary embodiment, which is explained with reference to the schematic figures. These figures show:

[0033] Fig. 1 schematically shows a device for the manufacture and / or processing of objects in a sterile environment comprising a first transport device, a second transport device and a transfer device in a first operating mode and

[0034] Fig. 2 schematically shows the device according to Fig. 1 in a second operating mode and

[0035] Fig. 3 schematically shows the device according to Fig. 1 in a second operating mode.

[0036] DETAILED DESCRIPTION OF THE EXECUTION EXAMPLES

[0037] Figs. 1, 2 and 3 schematically show a system 1 for filling schematically represented objects 5 in a sterile environment.

[0038] The system comprises several stations 61, ...67, a freeze dryer 7, a first transport device 2, a second transport device 3 and a transfer device 4 arranged between the first transport device 2 and the second transport device 3.

[0039] The system 1 can be operated either in a first operating mode shown in Fig. 1, in a second operating mode shown in Fig. 2, or in a third operating mode shown in Fig. 3.

[0040] In the illustrated embodiment, the first transport device 2 comprises three linear transport sections 20, 21, 22. However, this design is merely exemplary, and other designs with, for example, only one linear transport section 20 are conceivable. In the illustrated embodiment, the linear transport sections 20, 21, 22 are operated with a fixed transport direction, independent of the operating mode of the system 1 (in this embodiment, from left to right in the plane of the drawing, as schematically indicated by an arrow). In the illustrated embodiment, the second transport device 3 comprises a linear transport section 30, a rotating transport wheel 31, an intermediate wheel 32, and a discharge wheel 33. However, this design is also merely exemplary, and other designs are conceivable.

[0041] At stations 61, ..., 67, various process steps are carried out to fill the objects 5. In the schematic diagram, five stations 61, ..., 65 are arranged along a linear transport section 21 of the first transport device 2 upstream of the transfer device 4. Two stations 66, 67 are arranged along a linear transport section 22 of the first transport device 2 downstream of the transfer device 4. However, the number and arrangement of stations 61, ..., 67 are merely exemplary.

[0042] The freeze dryer 7 is arranged on the linear transport section 30 of the second transport device 3.

[0043] The transfer device 4 is located on the linear transport route 20.

[0044] The transfer device 4 can be configured either in a first operating state shown in Fig. 1 for a first operating mode of the system 1, in a second operating state shown in Fig. 2 for a second operating mode of the system 1 or in a standby mode shown in Fig. 3 for a third operating mode of the system 1.

[0045] As schematically shown in Fig. 1 by means of arrows, in the first operating mode of the system 1, objects 5 are removed from the first transport device 2 and transferred to the second transport device 3 by means of the transfer device 4 configured in the first working state.

[0046] The objects 5 can thus be fed into the freeze dryer 7.

[0047] In the second operating mode shown in Fig. 2, the objects 5 are transferred from the second transport unit 3 to the first transport unit 2 by means of the transfer device 4 and fed into the first transport unit 2. After processing in the freeze dryer, the objects 5 can thus be returned to the first transport unit 2 and fed to the system via further stations 66, 67. In the third operating mode shown in Fig. 3, the transfer device 4 is in a standby state, so that the objects 5 remain in the first transport unit 2 and are fed to the system 1 via further stations 66, 67.

[0048] The system can be operated in three different modes, allowing for flexible use in filling different objects with different products.

[0049] In the illustrated embodiment, exactly one transfer device 4 is provided on the linear transport section 20, which can be configured as desired. This allows for a compact design of the system 1.

[0050] The illustrated transfer device 4 comprises a wheel designed as a segment wheel 40. The segment wheel 40 is operable and / or configurable to discharge objects 5 from the first transport device 2 in the first operating mode of the system 1 shown in Fig. 1, and to discharge objects 5 into the first transport device 2 in the second operating mode of the system 1 shown in Fig. 2.

[0051] The arrangement and distribution of objects 5 in system 1 is merely exemplary. Depending on the condition, operating mode and / or use of system 1, objects 5 may be present in a different distribution within system 1.

[0052] In the illustrated embodiment, exactly one second transport device 3 is provided. Depending on the operating mode, the second transport device 3 is operated with a first or a second transport direction, so that objects 5 transported by means of the second transport device 3 are transported away from the transfer device 4 or towards the transfer device 4, depending on the operating mode.

[0053] In the illustrated embodiment, the first transport device 2 and the second transport device 3 each comprise a linear transport section 20, 30, wherein the objects 5 can be transported one after the other in a row along the first transport section 20 and along the second transport section 30. In the illustrated embodiment, the second transport section 30 runs at an angle of approximately 90° to the first transport section 20.

[0054] The second transport device shown further comprises the transport wheel 31, the intermediate wheel 32, and the discharge wheel 33. Defective parts can be removed from the device 1 by means of the discharge wheel 33. The intermediate wheel 32 allows objects 5 to be transferred from the transport wheel 31 to the linear transport track 30 and from the linear transport track 30 to the transport wheel 31 in different directions.

[0055] The first transport device 2 is configured to transport the objects 5 in a timed manner. The second transport device 3 is configured to transport the objects 5 continuously. For timed transport, the first transport device 2 includes a so-called transport rack, whereby each stroke of the transport rack moves a certain number of objects 5 in the transport direction. The transport wheel 31 of the second transport device 3 can be operated for continuous transport such that it rotates at a constant speed.

[0056] The segment wheel 40 comprises several segments, each with a number of pockets in which the objects 5 can be received. The segments are independently adjustable in the circumferential direction of the segment wheel 40. In the first operating mode, one segment of the segment wheel can be synchronized with the first transport device 2 for the transfer of the objects 5. Following the transfer of the objects 5, the segment of the segment wheel 40 can be synchronized with the transport wheel 31, which rotates at a constant speed, so that the objects 5 can be transferred to the transport wheel 31. In the second operating mode, one segment of the segment wheel 40 can be synchronized with the second transport device 3, in particular the transport wheel 31, for the transfer of the objects 5.Following the transfer of objects 5, the segment of the segment wheel 40 can be synchronized to the clocked transport route 20, so that a transfer of objects 5 to the transport route 20 is possible.

[0057] The objects 5 are, in various embodiments, sealable pharmaceutical containers, in particular vials, syringes, cartridges or ampoules. The device 1, in various embodiments, serves to fill and seal the objects 5 designed as containers.

[0058] The stations 61, ..., 65 located upstream of the transfer unit 4 include, for example, a tare weighing station, a filling station, a gross weighing station, a first closing station, and a first control station. The stations 66, 67 located downstream of the transfer unit 4 include, for example, a second closing station and a second control station. In some embodiments, a sealing device is merely placed at the first closing station in the first operating mode of the system 1, but the objects are not hermetically sealed with the sealing device. Sealing takes place in the freeze dryer in some embodiments. In the second operating mode of the system 1, the objects coming from the freeze dryer 7 are fed back into the first transport unit 2 and then supplied to stations 66, 67.In some designs, a protective cap is attached to the second locking station.

[0059] In the third operating mode of system 1, the objects are sealed at the first locking station using the sealing elements. In some configurations, the second locking station in the third operating mode serves to crimp the sealing elements installed by the first locking station. In other configurations, the objects are hermetically sealed at the first locking station, with a second sealing element, for example, an additional protective cap, being attached at the second locking station.

[0060] The design of the device is merely exemplary and numerous variations are conceivable, with objects taking 5 different paths in Annex 1.

Claims

Patent claims 1. A system for filling objects in a sterile environment comprising a filling station, a station downstream of the filling station, and a freeze dryer, a first transport device (2) for transporting the objects from the filling station towards the second station, a second transport device (3) for transporting the objects to the freeze dryer, and a transfer device (4) arranged at a junction between the first transport device (2) and the second transport device (3), wherein the system is operable in several operating modes, wherein in a first operating mode the objects can be transported from the filling station to the freeze dryer, in a second operating mode the objects can be transported from the freeze dryer towards the second station, and in a third operating mode the objects can be transported from the filling station towards the second station, characterized in thatthat the first transport device has a linear transport section (20), wherein the node is provided on the linear transport section (20), wherein the transfer device (4) is optionally configurable in a rest state and in at least one working state, wherein in the rest state the objects can be transported by means of the first transport device (2) so that the objects pass the node and remain in the first transport device (2) when passing the node.

2. System according to claim 1, characterized in that the node is arranged between the linear ends of the linear transport section (20).

3. System according to claim 1 or 2, characterized in that the transfer device (4) is optionally configurable in the rest state, in a first working state or in a second working state, wherein in the first working state the transfer device (4) is configured to divert the objects from the first transport device (2) and transfer them to the second transport device (3), and wherein in the second working state the transfer device (4) is configured to transfer the objects from the second transport device (3) to the first transport device (2) and to divert them into the first transport device (2).

4. System according to claim 1, 2 or 3, characterized in that one of the first transport device (2) or the second transport device (3) is configured to transport the objects (5) in a timed manner, and the other is configured to transport the objects (5) continuously.

5. System according to claim 4, characterized in that the transfer device (4) has a segment wheel (40) which is configured to transfer the objects (5) transported along the first transport device (2) from a clocked transport to a continuous transport or from a continuous transport to a clocked transport.

6. System according to one of claims 1 to 5, characterized in that the first transport device (2) and the second transport device (3) each comprise a linear transport section (20, 30), wherein in particular the second transport section (30) runs at an angle, further in particular at an angle of approximately 90° to the first transport section (20).

7. Method for filling objects (5) in a sterile environment by means of a system comprising a filling station, a station (66, 67) downstream of the filling station and a freeze dryer (7), a first transport device (2) for transporting the objects from the filling station towards the second station, a second transport device (3) for transporting the objects to the freeze dryer and a transfer device (4) arranged at a junction between the first transport device (2) and the second transport device (3), wherein the system is selectively operated in one of several operating modes, wherein in a first operating mode the objects are transported from the filling station to the freeze dryer, in a second operating mode the objects are transported from the freeze dryer towards the second station, and in a third operating mode the objects are transported from the filling station towards the second station,characterized in that the first transport device has a linear transport section (20), wherein the node is provided on the linear transport section (20), wherein the transfer device (4) is optionally configured in a rest state or in at least one working state, wherein in the rest state the objects are transported by means of the first transport device, such that the objects pass the node and when passing the node the objects remain in the first transport device (2).

8. Method according to claim 7, characterized in that the transfer device (4) is optionally configured in the rest state, in a first working state or in a second working state, wherein in the first working state the objects are ejected from the first transport device (2) and transferred to the second transport device (3) by means of the transfer device (4), and wherein in the second working state the objects are transferred from the second transport device (3) to the first transport device (2) and introduced into the first transport device (2) by means of the transfer device (4).

9. A method according to claim 7 or 8, characterized in that the objects (5) are transported in a timed manner by means of one of the first transport device (2) or the second transport device (3), and the objects (5) are transported continuously by means of the other.

0. A method according to claim 9, characterized in that the transfer device (4) has a segment wheel (40), wherein objects (5) transported by means of the segment wheel (40) are transferred from a timed transport to a continuous transport or from a continuous transport to a timed transport.

1. A method according to any one of claims 7 to 10, characterized in that the first transport device (2) and the second transport device (3) comprise a linear transport section (20, 30), wherein, in particular, the objects (5) are transported along the second transport section (30) at an angle, in particular at an angle of approximatelyThey are transported at 90° to the first transport route (20).

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