Equipment for packaging containers of devices for pharmaceutical use

Abstract

A device (4) for packaging containers (8) of devices for pharmaceutical use, comprising: a robot arm (112), the robot arm (112) being able to move from a clamping position, in which the robot arm picks up a container (8) previously sealed by at least one protective sheet, to a release position, in which the robot arm inserts the container (8) into the bag through an appropriate opening provided on the side of the bag; wherein the robot arm (112) is connected to at least one position control camera (78), and at least one position control camera (78) is configured to read the coordinates of the midpoint of the opening relative to the flat plane in which the bag is located and / or the rotation angle of the bag relative to an axis perpendicular to the flat plane to ensure correct positioning and release of the container (8) in the bag.

Description

Technical Field

[0001] The present invention relates to an apparatus for packaging containers of devices for pharmaceutical use, such as syringes. Background Art

[0002] As is well known, the purpose of packaging equipment is to hermetically assemble and seal containers of devices for pharmaceutical use, such as syringes, also known as tubular containers, to ensure the sterility of their contents in an area classified as ISO 5 under laminar flow.

[0003] The container is hermetically sealed by means of a sheet made of Tyvek, which is suitably applied to the container by welding in a known manner. It is noted that Tyvek is a trade name for a nonwoven fabric material of high-density polyethylene fibers, which is formed by fibrillation of the sheet by rapid evaporation of a solvent and subsequent welding during extrusion.

[0004] The sheets made of Tyvek are stacked on a special tray and then have to be taken out of the equipment, correctly placed on the tray and then welded. Typically, for each container, an inner protective sheet (sheet made of Tyvek) is used which is placed inside each initially opened container and an outer protective sheet (cover made of Tyvek) which is to be welded over the container and has adhesive provided on its lower surface.

[0005] When the outer protective sheet is correctly positioned on the open container, the sealing of the outer protective sheet to the container is performed by welding it, by means of a hotbar which is pressed by the system on the top with a controlled force and time.

[0006] The positioning of the outer protective sheet on the open container prior to welding is decisive for the sterility of the finished product, since if the outer protective sheet is not positioned correctly, discontinuities in the weld seam may result, thus endangering the sterility of the seal.

[0007] For this purpose, there are rather precise requirements according to which the outer protective sheet must protrude from the container by at least 1 mm on each side.

[0008] In order to ensure the required quality of the finished product, the welding mark (visible to the naked eye or by a dedicated camera) must be centered within the tolerances described above relative to both the container and the outer protective sheet.

[0009] The solutions of the known art do not guarantee the accuracy and repeatability of said positioning and at the same time do not guarantee a sufficient positioning speed. In particular, the solutions of the known art allow a vertical displacement of the outer protection sheet before the welding step, with the potential risk of welding defects and subsequent waste of the sealed container.

[0010] Furthermore, laminar air flow is applied throughout all packaging steps to ensure sterility and prevent contaminating particles from entering the containers to be sealed.

[0011] Packaging devices of known technology do not ensure laminar flow during the packaging step, nor do they control or significantly reduce the possibility of particle generation during the handling of the protective sheets, because they provide relative sliding of the protective sheets when they are taken out of the packaging of the sheets from which they are separated.

[0012] Furthermore, when the container has been sealed by welding the outer protective sheet, it must be bagged and welded in a suitable bag called a sterilization bag, either single or double, to ensure the sterility of the contents in an area classified as ISO 5 under laminar flow.

[0013] The packaging equipment must pick up the container, which has been previously sealed with an outer protective sheet, and insert it into a bag that has been previously picked up and opened to contain the container itself.

[0014] After the automatic insertion of the container into the bag, the sealing of the bag (sterilization bag) is performed by welding rods which are pressed onto the bag by the system with controlled force and time.

[0015] Positioning the bag before opening it and inserting the container is decisive for the efficiency of the device, since if the bag is incorrectly positioned it may open unevenly, making insertion of the container discontinuous and impossible and causing the device to stop.

[0016] The opening height of the bag and therefore the pulling distance of the bag, i.e. the distance the bag once opened is advanced to be stretched and pulled before welding, is decisive for the correct welding of the finished product, because if the finished product is handled at the wrong height / distance, the weld is discontinuous and wrinkles are created, thus invalidating the sterility of the seal.

[0017] The known art solutions do not allow for precise and repeatable control of the bag opening and pulling steps, so that non-negligible waste occurs.

[0018] Furthermore, in known solutions, the integrity check of the bag weld is left to the operator at the end of the production line; in this way, if double bags are used, the operator can only visually check the outer bag. This post-verification is therefore inaccurate and it does not occur in time to then correct any malfunction of the equipment.

[0019] Finally, in known solutions, the bags are welded by trying to minimize the air inside the bag during the different working steps.

[0020] In fact, the air trapped inside the bags is crucial both for the double bagging process and for the secondary packaging in boxes, since boxes "inflated" with air protrude laterally from the platform that houses them, risking rupturing the containers during subsequent platform handling steps.

[0021] Therefore, the known art solutions are also not particularly effective in controlling / reducing the amount of air in the bag.

[0022] US 2014 / 0180479 A1 discloses an apparatus for packaging articles, comprising a robotic arm that picks up articles and releases them into a bag and a camera that acquires an image of the position in which the articles are packed in the bag. Summary of the invention

[0023] There is therefore a need to address the inconveniences and limitations mentioned with respect to the known techniques.

[0024] This need is met by a device for packaging containers of devices for pharmaceutical use according to claim 1 . BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Other features and advantages of the invention will be more readily understood from the following description of preferred and non-limiting examples of embodiment, in which:

[0026] Figure 1 to Figure 2 shows a partial perspective view of an apparatus according to an embodiment of the present invention;

[0027] Figure 3 Shows Figure 1 to Figure 2 A side view of a welding fixture of the device;

[0028] Figure 4 shows a partial perspective view of an apparatus according to an embodiment of the present invention;

[0029] Figure 5 Shows Figure 4 A plan view of detail V shown in;

[0030] FIG. 6A to FIG. 6B Shows Figure 4 A partial perspective view of a detail of the device;

[0031] Figure 7 shows a perspective view of a container according to the invention, with the different parts separated from one another;

[0032] Figure 8 A perspective view of a bag containing a container according to the invention is shown, with the different parts separated from each other.

[0033] Elements or parts of elements belonging to all embodiments described below will be denoted by the same reference numerals. DETAILED DESCRIPTION

[0034] With reference to the preceding figures, reference numeral 4 is used to indicate an apparatus for packaging a container 8 of a device for pharmaceutical use.

[0035] The device 4 for packaging containers 8 includes a robotic closing arm 12, which is capable of moving from a clamping position, in which the robotic closing arm 12 picks up a protective sheet 16 from a stack of protective sheets 16, to a release position, in which the robotic closing arm 12 places the protective sheet 16 on the container 8 of the device for pharmaceutical use to cover the peripheral edge 20 that defines the entry compartment 24 of the container 8.

[0036] The robotic closing arm 12 is advantageously connected to at least one position control camera 56, which is configured to obtain the coordinates of the center of gravity G of the protective sheet 16 relative to the flat plane P on which the protective sheet 16 is located and / or the rotation angle of the protective sheet 16 relative to the axis Z perpendicular to the flat plane P, so as to ensure the correct positioning and release of the protective sheet 16 at the peripheral edge 20.

[0037] According to an embodiment, the device 4 comprises a position control camera 28 operatively connected to the motor means 32 of the robotic closing arm 12 for feedback control of the actual position of the protection sheet 16 relative to the peripheral edge 20 .

[0038] According to an embodiment, the equipment 4 for packaging containers 8 includes a welding fixture 36 configured to support and weld the protective sheet 16, and the welding fixture 36 includes a plurality of centering pins 40, which are configured to center the protective sheet 16 and to prevent any displacement of the protective sheet 16 parallel to the flat plane P of the protective sheet 16 itself.

[0039] Preferably, the centering pins 40 are configured in such a way as to prevent a vertical movement of the protection sheet 16 along a vertical direction Z perpendicular to the lying plane P of the protection sheet 16 .

[0040] For example, the centering pin 40 has a mushroom-shaped configuration having a vertical body 44 and a head 48 protruding from the body to create an undercut with respect to the vertical direction Z perpendicular to the lying plane P of the protection sheet 16 .

[0041] According to an embodiment, the robot closing arm 12 is provided with at least one suction can configured to engage each protection sheet 16 from a corresponding stack of protection sheets 16. Specifically, the robot closing arm 12 is configured to lift each protection sheet 16 along a lifting direction perpendicular to the lying plane P of each protection sheet 16 by the at least one suction can.

[0042] According to an embodiment, the device 4 comprises at least one lamination hood (not shown) configured for generating an air flow towards said stack of protective sheets 16 from above.

[0043] The air flow, preferably laminar flow, provides a barrier to the ingress of impurities into the container 8 .

[0044] The device 4 comprises at least one internal storage station 60 configured for storing the protection sheet 16 and at least one internal size control station 64 configured for controlling the size of said protection sheet 16 .

[0045] According to a possible embodiment, the device 4 comprises control sensors for the protection sheet 16, 16' which closes the peripheral edge of the container and for the further protection sheet 16, 16" which overlaps the protection sheet 16, 16' and closes the peripheral edge 20 of the container 8.

[0046] For example, the sensors comprise control sensors for closing a protective sheet 16" (cover), which usually always has a single type of thickness. The control sensors are usually ultrasonic sensors. There are also control sensors for a protective sheet 16', which can have a single thickness or a double thickness. In particular, depending on the type of protective sheet used, two different types of control sensors for the protective sheets can be provided. For thinner sheets, ultrasonic sensors are used, while for thicker sheets, optical fiber sensors are used. In both cases, the check is intended to detect that a single sheet has been removed.

[0047] The device 4 for packaging containers 8 of devices for pharmaceutical use comprises a robotic bagging arm 112 capable of moving from a gripping position in which the robotic bagging arm 112 picks up a container 8 previously sealed by at least one protective sheet 16, to a releasing position in which the robotic bagging arm 112 inserts said container 8 into a bag 68 after having opened the bag 68 itself on the side of a suitable opening 72. Typically, said bag 68 has a rectangular or square shape and said opening 72 extends one of the sides of the bag 68 over its entire length.

[0048] Advantageously, the robotic bagging arm 112 is connected to at least one position-controlled camera 78, which is configured to obtain the coordinates of the midpoint M of the opening 72 relative to the flat plane P on which the bag 68 is located (before the bag 68 is opened) and / or the rotation angle of the bag 68 relative to an axis perpendicular to the flat plane, so as to ensure the correct positioning and release of the container 8 in the bag 68.

[0049] Preferably, the packaging device 4 comprises a stretcher device 76 configured for widening said opening 72 of the bag 68 through which the container 8 is to be inserted.

[0050] The position control camera 78 monitors and controls the vertical dimension of the stretcher device 76 along a vertical axis Z which is perpendicular to the resting plane of the bag 68 after the stretcher device has widened the opening 72 .

[0051] For example, the spreader device 76 includes a pair of movable blades 80 configured to perform at least partial opening of the bag 68 , and a nozzle 84 configured to deliver compressed air to facilitate said opening of the bag 68 .

[0052] Preferably, a nozzle 84 is coupled to said movable blade 80 .

[0053] According to an embodiment, the device 4 comprises welding means 88 configured for welding said opening 72 of the bag 68 when the container 8 is inserted into the bag 68 .

[0054] According to an embodiment, the device 4 comprises an integrity control camera 92 configured for controlling the integrity of said weld.

[0055] Preferably, the integrity control camera 92 is configured to perform a plurality of weld integrity checks, each weld integrity check inspecting a respective bag of the plurality of bags into which the container is inserted.

[0056] For example, the integrity control camera 92 is a linear camera.

[0057] For example, a linear camera is coupled to a linear lighting flash.

[0058] According to a possible embodiment, the device 4 is provided with a suction device 94 having an external suction can configured to suck air through a window made of Tyvek provided on the bag 68 .

[0059] According to a possible embodiment, the camera 78 is also configured to control the size of the bag 68 before it is opened, so as to guide the stretcher device 76 according to the actual size of the bag 68 to be opened.

[0060] The operation of the apparatus for packaging containers of devices for pharmaceutical use according to the present invention will now be described.

[0061] Specifically, the robotic closing arm 12 moves to a clamping position, in which it picks up a protective sheet 16 from a stack of protective sheets 16, and then moves to a releasing position, in which it places the protective sheet 16 on a container 8 of a device for pharmaceutical use to cover the peripheral edge 20 that defines an entry compartment 24 of the container 8.

[0062] The robotic closing arm 12 is advantageously connected to at least one position-controlled camera 56 configured to acquire the coordinates of the centre of gravity G of the protective sheet 16 relative to the lying plane P on which said protective sheet 16 is situated and / or the angle of rotation of the protective sheet 16 relative to the Z axis perpendicular to said lying plane P, in order to ensure the correct positioning and release of the protective sheet 16 at said peripheral edge 20. This ensures that the protective sheet 16 perfectly covers the access compartment 24, carefully sealing the entire peripheral edge 20 of the container 8. For this purpose, in fact, not only must the centre of gravity G of the protective sheet 16 be correctly positioned relative to the access compartment 24, but it must also be prevented that the sheet itself rotates relative to a vertical axis perpendicular to the protective sheet 16 and incorrectly closes the access compartment 24, despite the fact that the centre of gravity of the sheet coincides with the centre of the access compartment 24.

[0063] Due to the feedback control performed by the position control camera 28 , the robotic closing arm 12 is able to correctly position the protection sheet 16 to close the access compartment 24 of the container 8 .

[0064] During the clamping of the protective sheets 16 , the laminating hood generates an air flow from above towards the stack of said protective sheets 16 in order to obtain a barrier against the ingress of foreign matter into the container 8 .

[0065] After the protection sheet 16 has been properly positioned, the welding fixture 36 is used to weld the protection sheet 16 to the peripheral edge.

[0066] In particular, as can be seen, said welding jig 36 comprises a plurality of centering pins 40 configured to center the protection sheet 16 and prevent any displacement of the protection sheet 16 parallel to the lying plane P of the protection sheet 16 itself.

[0067] Due to the presence of the head 48, the centering pin 40 prevents the protective sheet 16 from vertically moving along the vertical direction Z perpendicular to the flat plane P of the protective sheet 16. The head protrudes from the body, so that an undercut is generated relative to the vertical direction Z perpendicular to the flat plane P of the protective sheet 16.

[0068] As can be seen, the device 4 for packaging containers 8 of devices for pharmaceutical use comprises a robotic bagging arm 112 which can be moved from a clamping position in which it picks up a container 8 previously sealed by at least one protective sheet 16, to a releasing position in which it inserts the container 8 into the bag 68 after having opened the bag 68 itself on the side of a suitable opening 72.

[0069] Advantageously, the robotic bagging arm 112 is connected to at least one position-controlled camera 78, which reads the coordinates of the midpoint M of the opening 72 relative to the flat plane P in which the bag 68 is located and / or the rotation angle of the bag 68 relative to an axis perpendicular to the flat plane, so as to ensure the correct positioning and release of the container 8 in the bag 68.

[0070] This allows the container 8 , previously closed by the protective sheet 16 , to be perfectly aligned with the opening 72 of the bag 68 , through which the container 8 is inserted into the bag 68 itself.

[0071] Preferably, the packaging device 4 comprises a stretcher device 76 configured to widen said opening 72 of the bag 68 through which the container 8 is inserted.

[0072] After the stretcher device 76 widens the opening 72 , the position control camera 78 monitors and controls the vertical dimension of the stretcher device 76 along a vertical axis Z which is perpendicular to the resting plane of the bag 68 .

[0073] This widening is achieved, for example, by a pair of movable blades 80 configured to perform at least partial opening of the bag 68 , and by a nozzle 84 configured to deliver compressed air to facilitate said opening of the bag 68 .

[0074] Preferably, the nozzle 84 is coupled to said movable vane 80. In this way, a single operation can utilize the combined mechanical action of the movable vane 80 and the fluid dynamic action of the nozzle 84 to effectively widen the opening.

[0075] Finally, as can be seen, after the container 8 has been inserted into the bag 68 , said opening 72 of the bag 68 can be welded by means of a welding device 88 .

[0076] It is also possible to suck the air from inside the already closed bag 68 by means of a suction device 94 provided with an external suction can which sucks the air through special windows made of Tyvek provided on the bag 68 itself.

[0077] As can be appreciated from the above, the above described solution overcomes the disadvantages of the known technology.

[0078] In particular, thanks to a specific system for picking up the protective sheets from above, it is possible both not to disturb the laminar flow of the protective container and to prevent slipping between the sheets and thus possible lifting of contaminating particles. Moreover, this type of picking up from above, by means of a suction can, reduces the risk of picking up two protective sheets together, which occurs in solutions of the known art.

[0079] Furthermore, the packaging device allows picking up individual sheets made of Tyvek and positioning them at different heights according to the indication of at least one camera, thus ensuring greater precision and repeatability of the positioning of the sheet relative to the container to be sealed.

[0080] In fact, as can be seen, the position in which the protective sheet made of Tyvek is placed on the container depends on the actual positioning of the sheet when it is picked up; the container is mechanically centered and therefore fixed. The higher precision compared to the solutions of the known art is due to the fact that the camera detects the relative position of the protective sheet and the container in the plane and guides the gripper robot to adapt the coordinates to the actual positioning of the protective sheet and then place it precisely on the fixed container, preventing misalignment of the edges.

[0081] Furthermore, the container is inserted into a welding jig with the outer protective sheet resting on top and held in place laterally and vertically by "mushroom shaped" pins on the sides of the packaging device 4 to prevent it from moving prior to welding.

[0082] In fact, the mushroom-shaped pins prevent the outer protective sheet made of Tyvek from lifting during transport or welding; therefore, the protective sheet made of Tyvek cannot be moved before welding because it is vertically constrained and, during translation, air cannot get under the sheet, which would lift it and possibly cause it to escape laterally from the cylindrical pins.

[0083] Furthermore, the bag opening and pulling steps before welding are performed at a variable height for each bag, following instructions and measurements from a handling robot and a dedicated camera that communicates with the machine automation: in this way, the variable height allows the bags to be opened and pulled at the optimal position, generating improved process stability, which means better machine efficiency and less waste.

[0084] Furthermore, in the case of single and double bags, each bag weld undergoes an automatic completeness check by means of a dedicated linear camera: the camera intercepts any wrinkles in the weld and the corresponding finished product is discarded.

[0085] The technical advantage is that in the case of a double bag both bags are automatically checked by camera and not only by visual inspection; in this way, unlike solutions of known technology, the device can detect even non-uniform inner seals.

[0086] Furthermore, the air inside the bag is exhausted after it has been welded, thanks to an external suction can working on a breathable window (made of Tyvek) in the bag itself. This suction step takes place at the top or at the side, depending on the chosen format and the resulting position in the bag of the window made of Tyvek.

[0087] This allows controlling the general shape of the bag after bagging the container and prevents the risk of rupture of an over-inflated bag, which occurs in known art solutions.

[0088] The scope of protection of the present invention is defined by the appended claims.

Claims

1. An apparatus (4) for packaging a container of a device for pharmaceutical use, comprising: a robotic bagging arm (112) movable from a gripping position in which it picks up a container (8) previously sealed by at least one protective sheet (16) to a releasing position in which it inserts the container (8) into the bag (68) through a suitable opening (72) provided on a side of the bag (68); wherein the robotic bagging arm (112) is connected to at least one position control camera (78); Characterized in that the position control camera (78) is configured to read the coordinates of the midpoint (M) of the opening (72) relative to the flat plane (P) on which the bag (68) is located and / or the rotation angle of the bag (68) relative to an axis (Z) perpendicular to the flat plane (P) to ensure the correct positioning and release of the container (8) in the bag (68); wherein the apparatus (4) comprises a stretcher device (76) configured to widen the opening (72) of the bag (68) into which the container (8) is to be inserted, and wherein, after the stretcher device (76) widens the opening (72), the position control camera (78) monitors and controls the vertical dimension of the stretcher device (76) along a vertical axis (Z) perpendicular to the flat plane (P) of the bag (68).

2. The device (4) for packaging containers (8) of devices for pharmaceutical use according to claim 1, wherein: The spreader device (76) includes: a pair of movable blades (80) configured to perform at least partial opening of the bag (68) and a nozzle (84) configured to deliver compressed air to facilitate opening of the bag (68).

3. The device (4) for packaging containers (8) of devices for pharmaceutical use according to claim 2, wherein: The nozzle (84) is coupled to the pair of movable blades (80).

4. The device (4) for packaging containers (8) of devices for pharmaceutical use according to claim 1, wherein: The apparatus (4) comprises a welding device (88) configured to weld the opening (72) of the bag (68) after the container (8) is inserted into the bag (68), and wherein the apparatus (4) comprises an integrity control camera (92) configured to control the integrity of the weld.

5. The device (4) for packaging containers (8) of devices for pharmaceutical use according to claim 4, wherein: The integrity control camera (92) is configured to perform a plurality of weld integrity controls, each of the weld integrity controls controlling a respective bag of the plurality of bags into which the container is inserted.

6. The device (4) for packaging containers (8) of devices for pharmaceutical use according to claim 4, wherein: The integrity control camera (92) is a linear camera.

7. The device (4) for packaging containers (8) of devices for pharmaceutical use according to claim 6, wherein: The linear camera is connected with a linear lighting flash.

8. The device (4) for packaging containers (8) of devices for pharmaceutical use according to claim 1, wherein: The device (4) is provided with a suction device (94) provided with an external suction can configured to suck air through a window of suitable air permeable material provided on the bag (68).

9. The device (4) for packaging containers (8) of devices for pharmaceutical use according to claim 1, wherein: The apparatus (4) comprises a size control camera (28) configured to control the size of the bag before opening so as to guide the stretcher device (76) according to the actual size of the bag (68) to be opened.

Images