This application claims the benefit of priority to European Application Serial No. 20 191 379.5, filed on Aug. 17, 2020, which is hereby incorporated by reference in its entirety.
This disclosure relates to the manufacturing of containers.
Containers or receptacles are used to store goods. In some cases, containers may impact the quality or safety of the goods stored inside them. Manufacturing processes that involve cleanroom conditions and several rounds of testing have been proposed to manufacture containers that meet strict safety and quality requirements.
One aspect features a holder configured to hold a container during a manufacturing process. The container includes a body that extends along an axis and a flange that extends radially to the axis, and the holder includes one or more fastening elements that are configured to engage one or more of a top surface, a bottom surface, or a peripheral surface of the flange.
In some implementations, the holder includes a support surface configured to support the bottom surface of the flange, and a pair of opposing fastening elements is configured to engage the peripheral surface of the flange and secure the flange to the support surface. In other implementations, the support surface is configured to support the bottom surface of the flange, and the fastening element is configured to apply suction between the support surface of the holder and the bottom surface of the flange. In other implementations, the holder includes a pair of opposing fastening elements, each of which is configured to clamp the top and bottom surfaces of the flange, respectively.
In some implementations, the holder includes a support surface configured to support the bottom surface of the flange and a pair of opposing fastening elements. Each fastening element includes a holding clip configured to engage the top surface of the flange and clamp the bottom surface of the flange against the support surface. In some examples, each holding clip is pivotable about a pivot axis and comprises a biasing element that applies a biasing force that pivots the holding clip about the pivot axis and towards the support surface. In some examples, the holding clip includes an opening element configured to receive an opening force in an opposite direction to the biasing force and pivot the holding clip about the pivot axis and away from the support surface.
In some examples, the holder includes a passageway that extends between a top opening in a top surface of the holder and a bottom opening in a bottom surface of the holder. The passageway extends along a longitudinal axis and is configured to communicate with an interior space of the container, and the longitudinal axis and container axis are coaxial.
Another aspect is a transport device that includes a holder configured to hold a container during a manufacturing process and a base plate that is configured for connection to a conveyor system. The container comprises a body that extends along an axis and a flange that extends radially to the axis. The holder comprises one or more fastening elements that are configured to engage one or more of a top surface, a bottom surface, or a peripheral surface of the flange. The base plate and the holder define a pair of interlocking surfaces that releasably connect the holder and the base plate. The interlocking surface of the base plate defines a recess, and the bottom opening of the holder is received in the recess of the base plate.
In some implementations, the transport device includes an anti-rotation device that prevents the interlocking surfaces from rotating relative to one another around the longitudinal axis. In some constructions, the pair of interlocking surfaces are conical surfaces that form an angle relative to the longitudinal axis of the passageway. The base plate may include one or more pins that extend radially relative to the longitudinal axis, and the interlocking surface of the holder may include one or more radially extending slots that each receive a respective pin, wherein one or more pairs of pins and slots form the anti-rotation device. The interlocking surface of the holder may include a circumferentially extending groove that communicates with each slot of the anti-rotation device.
In some implementation, the holder includes a connection surface configured to engage an external actuator for moving the holder relative to the base plate. A wall of the passageway may form the connection surface. In some constructions, the wall of the passageway that forms the connection surface is conically shaped and forms an angle relative to the longitudinal axis.
In another aspect, a manufacturing system includes a conveyor system; a plurality of transport devices that are each coupled to the conveyor system; and at least one actuator configured to engage the connection surface of each holder and move the holder relative to the base plate.
In some implementations, the actuator includes a motor connected to a drive shaft, and the drive shaft engages the connection surface to lift and rotate the holder relative to the longitudinal axis. In some implementations, the system includes a camera that captures images of the container as the holder is rotated by the actuator. In some implementations the actuator includes a motor connected to a drive shaft, and the drive shaft engages the connection surface to lift and move the holder transversely to the longitudinal axis.
In some implementations, the manufacturing system includes a coating station with a coating nozzle configured travel along the longitudinal axis of the passageway and into the interior of a container to coat an inside wall of the container. In some implementations, the manufacturing system includes an inspection station with a light source positioned below the bottom opening of the holder and configured to emit light through the passageway and into the interior of a container and a receiver positioned on the opposite side of the transport device from the light source and configured to detect the light emitted by the light source.
Another aspect is a method of manufacturing a container including a body that extends along an axis from a first end to a second end, wherein the second end comprises a flange that extends radially to the axis. The method includes the steps of gripping the container by its first end; placing the flange of the container onto a holder that comprises one or more fastening elements; engaging the one or more fastening elements with one or more of a top surface, a bottom surface, or a peripheral surface of the flange; sequentially moving the holder to a plurality of workstations; maintaining the engagement between the one or more fastening elements and the flange as the holder is at each of the plurality of workstations and as the holder is moved between workstations.
In some implementations, the plurality of workstations includes one or more inspection stations, at which the container is rotated about the container axis and inspected using a camera or a sensor. In some implementations, the plurality of workstations includes one or more coating stations, at which one or more surfaces of the container are coated. In some implementations, the plurality of workstations includes one or more assembly stations, at which additional parts are assembled to the container.
In some examples, the container is a syringe barrel that has a hollow needle. The workstations include a first inspection station, at which the barrel is rotated about the barrel axis and an outer surface of the barrel is inspected using a camera or a sensor; a first coating station, at which the surface of the needle is coated; a second coating station, at which an inside surface of the barrel is coated; a second inspection station, at which the barrel is rotated about the barrel axis and the coating of the inside of the barrel is inspected using a camera or a sensor, and/or at which laser light is emitted through the inside of the barrel and through the needle to detect for blockages; a first assembly station, at which a needle cap is loosely placed on the needle; a shaking station, at which the holder, the barrel, and the cap are shaken to align the cap and the needle; a third inspection station, at which the barrel is rotated about the barrel axis and the alignment of the cap and the needle is inspected using a camera or a sensor; a second assembly station, at which the needle cap is pressed onto a tip of the syringe barrel; a fourth inspection station, at which the barrel is rotated about the barrel axis and the needle cap and the needle are inspected using a camera or a sensor.
In implementations in which the container is a syringe barrel, gripping the syringe barrel by its first end may include gripping a barrel tip or a needle connected to the barrel tip.
Like reference numbers represent corresponding parts throughout the disclosure.
The devices and methods provided herein are described in the exemplary context of manufacturing syringe barrels for pre-filled syringes. However, it should be understood that the devices and methods provided herein may be applied to other types of medical containers, e.g., vials or bottles, as well as to manufacture containers for non-medical applications.
Referring to
Syringe barrels can be made of various materials, such as metal, glass, or polymers (plastics). Some syringes are pre-filled with a single dose of medication. Pre-filled syringes are used to both package and deliver the medication and face certain requirements. For example, the material of the syringe barrel must be free from impurities, so-called extractables and leachables, that affect the stability or efficacy of the medication stored in the barrel. The material of the barrel should also prevent oxygen permeation and form a tight seal with the gasket during storage. High-performance plastics, such as cyclic olefin polymers (COP), may be used for the barrel of a pre-filled syringe.
Generally speaking, syringe barrels are molded, coated, and assembled with a needle cap. There may be quality controls between each of the steps to check the barrels for defects.
In the present disclosure, the barrel 1 is held by the flange 4, as shown by the arrows in
An example of a holder 10 that holds a barrel 1 according to the concept of
The holding clips 14 may be opened to fully expose the recess in the support surface 12. A gripper (not shown) that holds the barrel 1 by the needle 5 may drop the barrel 1 onto the holder 10 from above, so that the flange 4 lands in the recess. Once the flange 4 makes contact with the support surface 12, the holding clips 14 may close and engage the top surface 4a of the flange 4. The barrel 1 is thus secured in the holder 10, and a conveyor system may move the holder 10 and the barrel 1 to different workstations in a manufacturing system.
As shown in the cross-section of
The combination of the biasing element 20, the opening element 22, and the external actuator 300 enables the holder 10 to hold the flange 4 without the use of additional energy. The illustrated biasing element 20 is a spring, but other types of biasing elements are conceivable. The illustrated opening element 22 is a rounded projection on the holding clip 14, but other elements that enable an actuator 300 to mechanically engage the holding clip 14 may also be used. The illustrated design may be opened and closed without control electronics that form part of the holder 10 itself. However, the biasing element 20 and the opening element 22 may be replaced by corresponding elements that open and close the holding clip 14 via induction.
The concept of
The holder 10 of
In addition to holding the flange 4, the holder 10 of
The passageway 28 also enables the inside of the barrel 1 to be coated with lubricant, e.g., silicone, as described in reference to
During the manufacturing process, the barrel 1 and the holder 10 may be moved to the coating station 302 so that the bottom surface 26 of the holder 10 is positioned above a top surface 304a of the coating table 304, and the bottom opening 24b of the holder 10 is substantially aligned with an aperture 304b in the coating table. Initially, the coating unit 306 is retracted through the aperture 304b to prevent a collision between the nozzle 308 and the holder 10. Once the holder 10 and the barrel 1 are in place, the motor 312 moves the nozzle 308 upwards, through the passageway 28, and into the barrel 1 (
In addition to the holder 10, the present disclosure also describes a transport device 100 that enables the barrel 1 to be moved relative to the barrel axis A. Returning to
Referring again to
An actuator (not shown) that is external to the transport device 100 may move the holder 10 and the barrel 1 along the barrel axis A to separate or disengage the interlocking surfaces 104, 30. For this purpose, the holder 10 includes a connection surface or element 32 that engages the external actuator. In
In some manufacturing steps, it is also necessary to rotate the barrel 1 about the barrel axis A. In some implementations, the external actuator may lift and then rotate the holder 10 relative to the base plate 102. The transport device 100 may include an anti-rotation device that prevents the holder 10 from rotating relative to the base plate 102 when the anti-rotation device is engaged.
As shown in
Rotation of the holder 10 and the barrel 1 by the rotation device 314 may be used, for example, to inspect the barrel 1 or the needle 5 using cameras or other optical sensors. Such inspection processes may be used to check the quality of the molding process, the silicone coating process, or the placement of the needle 5 in the needle cap 6 (
As part of the manufacturing process, a needle cap 6 may be placed on the needle 5. The tip of the needle 5 may catch on the inner surface of the needle cap 6. Pushing down on the needle cap 6 in this state may damage the tip of the needle 5 and render the assembled syringe unusable. Shaking the needle 5 and the loosely placed needle cap 6 may dislodge the needle tip and ensure proper alignment of the needle 5 and the cap 6 before final assembly.
In step 204, the barrel 1 and the needle 5 may be rotated by a rotation device 314 and inspected for defects. The inspection may incorporate the use of cameras, lights, and other sensors. In step 206, the needle 5 may be coated with silicone or a similar material. In this step, the barrel 1 does not rotate. In step 208, the transport device 100 moves to a coating station 302 where the inside of the barrel 1 is coated with silicone. In step 210, the transport device 100 moves to a further workstation that includes a rotation device 314, cameras, lights, and sensors that inspect the quality of the silicone coating. In step 212, the transport device 100 moves to a further workstation that includes a laser that shines through the passageway, the barrel 1, and the hollow needle 5 and a sensor above the needle 5 that inspects the needle 5 for blockages. In step 214, a further workstation loosely places a cap 6 on the needle 5. In steps 212 and 214, the holder 10 may remain stationary relative to the base plate 102. In step 216, a shaking device 320 may shake the holder 10 to align the needle 5 and cap 6. In step 218, a rotation device 314, cameras, lights, and sensors may be used to inspect the alignment of the needle 5 and cap 6. In step 220, an external device may press the cap 6 downwards to attach the cap 6 to the barrel tip 2. Following a final inspection in step 222, the syringe barrel 1 may be packaged in step 224 for further processing.
In
Furthermore, although the holder 10, the transport device 100, and the manufacturing process 200 are described for a syringe barrel 1, the same can be used for a vial or other type of container that also includes a radial flange.
While this specification contains many specific details of implementations, these should not be construed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features that may be specific to particular implementations. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in combination with one another. Moreover, although features may be described herein as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination of features.
Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system modules and components in the implementations described herein should not be understood as requiring such separation in all implementations.
Particular implementations of the subject matter have been described. Other implementations are within the scope of the following claims.
Number | Date | Country | Kind |
---|---|---|---|
20191379 | Aug 2020 | EP | regional |
Number | Name | Date | Kind |
---|---|---|---|
4786063 | Engelhardt et al. | Nov 1988 | A |
5425460 | Barbarian | Jun 1995 | A |
6958097 | Luttringhaus-Henkel | Oct 2005 | B2 |
Number | Date | Country |
---|---|---|
2564185 | Jan 2019 | EP |
2654664 | May 1991 | FR |
Entry |
---|
EPO Miscellaneous Notification in European Appln No. 20191379.5, dated Jul. 27, 2021, 11 pages. |
Extended European Search Report in European Appln No. 20191379.5, dated Apr. 30, 2021, 10 pages. |
Number | Date | Country | |
---|---|---|---|
20220048060 A1 | Feb 2022 | US |