DE212022000185U1 - Device for packaging containers for pharmaceutical use facilities - Google Patents

Abstract

Device (4) for packaging containers (8) of facilities for pharmaceutical use, comprising:
- a closure robot arm (12) which can be moved from a gripping position in which it picks up a protective layer (16, 16', 16") from a stack of protective layers (16, 16', 16") to a release position , in which he places the protective layer (16, 16 ', 16") on a container (8) of devices for pharmaceutical use so as to cover a peripheral edge (20) which delimits an access chamber (24) of the container (8). ;
- a welding device (36) which is set up to support and weld the protective layer (16, 16', 16"), the welding device (36) comprising a plurality of centering pins (40) which are set up to hold the protective layer (16, 16', 16") and to prevent the protective layer (16, 16', 16") from shifting parallel to a lying surface (P) of the protective layer (16, 16', 16") itself.

Description

FIELD OF USE

The present invention relates to a device for packaging containers of devices for pharmaceutical use, such as syringes.

STATE OF THE ART

As is well known, the purpose of packaging devices is to hermetically assemble and seal containers of devices for pharmaceutical use, such as syringes, also known as tubs, so as to maintain the sterility of their contents in a range classified as ISO ₅ under laminar Ensure flow.

The containers are hermetically sealed by means of layers made of Tyvek, which are conveniently applied to the containers by welding in a known manner. It is emphasized that Tyvek is the trade name for a nonwoven material of high-density polyethylene fibers formed by fibrillating a sheet through rapid evaporation of a solvent and then welding during extrusion.

The layers made from Tyvek are stacked on special trays and must then be removed from the device, correctly placed on the trays and then welded. Typically, for each container, an inner protective layer (Tyvek-made layer) placed inside each initially opened container and an outer protective layer (Tyvek-made lid) welded over the container and glued to its bottom surface are provided is used.

Sealing the container by welding the outer protective layer, after correctly positioning the outer protective layer on the open container, takes place by a hot squeegee pressed onto the top by the system with controlled force and time.

Positioning the outer protective layer on the open container, prior to welding, is critical to the sterility of the final product because if the outer protective layer is not positioned accurately, a discontinuity of the weld bead can occur, jeopardizing the sterility of the seal.

To this end, there are fairly precise requirements that the outer protective layer must protrude from the container by at least 1 mm on each side.

To ensure the correct quality of the final product, the weld (visible to the naked eye or a dedicated camera) must be centered within the tolerances described above with respect to both the container and the outer protective layer.

The solutions of the known technology are unable to guarantee the accuracy and repeatability of the positioning and at the same time an appropriate positioning speed. In particular, the approaches of the known art allow vertical displacements of the outer protective layers before the welding step, with a possible risk of welding defects and subsequent rejection of the sealed container.

Additionally, laminar airflow is used during all packaging steps to ensure sterility and prevent contaminant particles from entering the container to be sealed.

The packaging devices of the known art are not able to guarantee the provision of laminar flow during the packaging steps, nor are they able to control or significantly reduce the possible production of particles during the handling of the protective layers, since they involve relative sliding of the protective layers when they are removed from the layer packs from which they are separated.

In addition, after the container has been sealed by welding the outer protective layer, the container must be bagged and sealed in a suitable bag, a so-called steribag, which is single or double, to ensure the sterility of the contents in an area classified as ISO5 is to ensure under laminar flow.

The packaging device must pick up the container previously sealed with the outer protective layer and insert it into a previously picked up and opened bag to accommodate the container itself.

After the container has been automatically inserted into the bag, sealing of the bag (Steribag) is carried out by a welding squeegee, which is pressed onto the bag by the system with controlled force and time.

Positioning the bag before opening and inserting the container is critical to the effectiveness of the device because if the bag is positioned incorrectly it will move unevenly can open, making the insertion of the container non-continuous and impossible and causing the device to stop.

The opening height of the bag and consequently the pulling distance of the bag, i.e. the distance over which the bag, once opened, is advanced to be stretched and pulled before being welded, is crucial for the correct welding of the final product, as , if the final product is treated at the wrong height/distance, the welding is not continuous and creates wrinkles, compromising the sterility of the seal.

The approaches of the known technology are unable to precisely and repeatedly control the opening and pulling steps of the bag, resulting in non-negligible waste.

Furthermore, in the known approaches, the integrity check of the bag weld is the responsibility of the operator at the end of the line; this way the operator can only visually inspect the outer bag when a double bag is used. This subsequent verification is therefore not accurate and does not take place in a timely manner to be able to correct any malfunctions of the device.

Finally, in the known approaches, the bag is welded in an effort to minimize the air inside the bag during various operations.

In fact, the air trapped inside the bag is critical to both the double bag packaging process and the secondary packaging in a box, since the boxes, “inflated” with air, protrude laterally from the pallet that contains them, with the Risk of container breakage occurring during subsequent pallet handling steps.

Therefore, the approaches of the known technology are not particularly effective in controlling/reducing the amount of air in the bag.

PRESENTATION OF THE INVENTION

There is therefore a need to overcome the inconveniences and limitations mentioned with respect to the prior art.

This need is met by a device for packaging containers of pharmaceutical use facilities according to claim 1.

DESCRIPTION OF DRAWINGS

• 1-2 perspektivische Teilansichten einer Vorrichtung gemäß einer Ausführungsform der vorliegenden Erfindung zeigen;
• 3 eine Seitenansicht einer Schweißvorrichtung der Vorrichtung von 1-2 zeigt;
• 4 eine perspektivische Teilansicht einer Vorrichtung gemäß einer Ausführungsform der vorliegenden Erfindung zeigt;
• 5 eine Draufsicht des in 4 gezeigten Details V zeigt;
• 6a-6b perspektivische Teilansichten von Details der Vorrichtung von 4 zeigen;
• 7 eine perspektivische Ansicht eines Behälters gemäß der vorliegenden Erfindung zeigt, wobei einzelne Teile voneinander getrennt sind;
• 8 eine perspektivische Ansicht eines Beutels zeigt, der einen Behälter gemäß der vorliegenden Erfindung beinhaltet, wobei einzelne Teile voneinander getrennt sind.

Further features and advantages of the present invention will appear from the following description of its preferred and non-limiting examples of embodiments, in which:

• 1-2 show partial perspective views of a device according to an embodiment of the present invention;
• 3 a side view of a welding device of the device of 1-2 shows;
• 4 shows a partial perspective view of a device according to an embodiment of the present invention;
• 5 a top view of the in 4 details shown V shows;
• 6a-6b perspective partial views of details of the device from 4 show;
• 7 shows a perspective view of a container according to the present invention, with individual parts separated from one another;
• 8th shows a perspective view of a bag containing a container according to the present invention, with individual parts separated from one another.

Elements or portions of elements belonging to all of the embodiments described below are indicated by the same reference numerals.

DETAILED DESCRIPTION

With reference to the above figures, reference numeral 4 is used to indicate a device for packaging containers 8 of pharmaceutical use facilities.

The device 4 for packaging containers 8 includes a closure robot arm 12 which can be moved from a gripping position in which it picks up a protective layer 16 from a stack of protective layers 16 to a release position in which it places the protective layer 16 on a Container 8 of devices for pharmaceutical use is deposited so as to cover a peripheral edge 20 which delimits an access chamber 24 of the container 8.

The closure robot arm 12 is advantageously connected to at least one position control camera 56, which is set up to record the coordinates of the center of gravity G of the protective layer 16 in relation to a lying surface P on which the protective layer 16 lies and/or a rotation angle of the protective layer 16 in relation towards an axis Z perpendicular to the lying surface P capture so as to ensure the correct positioning and release of the protective layer 16 on the peripheral edge 20.

According to one embodiment, the device 4 includes a position control camera 28 operably connected to motor means 32 of the shutter robot arm 12 to provide feedback control of the actual position of the protective layer 16 with respect to the peripheral edge 20.

According to one embodiment, the device 4 for packaging containers 8 comprises a welding device 36 which is set up to support and weld the protective layer 16, the welding device 36 comprising a plurality of centering pins 40 which are set up to center the protective layer 16 and one To prevent displacement of the protective layer 16 parallel to the lying surface P of the protective layer 16 itself.

Preferably, the centering pins 40 are configured such that they prevent a vertical movement of the protective layer 16 along a vertical direction Z perpendicular to the lying surface P of the protective layer 16.

The centering pins 40, for example, have a mushroom-shaped configuration with a vertical body 44 and a head 48 which protrudes from the body so as to create an undercut with respect to the vertical direction Z perpendicular to the lying surface P of the protective layer 16.

According to one embodiment, the closure robot arm 12 is provided with at least one suction cup adapted to engage each protective layer 16 from the corresponding stack of protective layers 16. In particular, the closure robot arm 12 is set up to lift each protective layer 16 with at least one suction cup along a lifting direction perpendicular to a lying surface P of each protective layer 16.

According to one embodiment, the device 4 includes at least one laminar flow hood (not shown) configured to generate an air flow from above to the stack of protective layers 16.

The air flow, preferably laminar, provides a barrier to the entry of impurities into the containers 8.

The device 4 comprises at least one internal storage station 60 which is arranged to store the protective layers 16 and at least one internal dimension control station 64 which is arranged to control the dimensions of the protective layers 16.

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

For example, the sensors include a control sensor for a closing protective layer 16" (lid), which typically always has a single type of thickness. This control sensor is typically an ultrasonic sensor. There is also a control sensor for the protective layer 16', which can have a single or double thickness. In particular, two different types of control sensors can be provided for the protective layer, depending on the type of protective layer used. For thinner layers, an ultrasonic sensor is used, while for thicker layers, a fiber optic sensor is used. In both cases, the check aims at detecting that a single layer has been picked up.

The device 4 for packaging containers 8 of facilities for pharmaceutical use comprises a bagging robot arm 112 which can be moved from a gripping position in which it picks up a container 8 which has previously been sealed with at least one protective layer 16abt to a release position, in which he inserts the container 8 into a bag 68 after the bag 68 itself has been opened at the side of a suitable opening 72. Typically, the bag 68 has a rectangular or square shape and the opening 72 extends along its entire length on one of the sides of the bag 68.

Advantageously, the bagging robot arm 112 is connected to at least one position control camera 78, which is set up to detect the coordinates of a center point M of the opening 72 with respect to a lying surface P on which the bag 68 lies (before it is opened), and / or a To detect the angle of rotation of the bag 68 with respect to an axis perpendicular to the lying surface in order to ensure the correct positioning and release of the container 8 inside the bag 68.

Preferably, the packaging device 4 comprises an expanding device 76 which is designed to widen the opening 72 of the bag 68 through which the container 8 is to be inserted.

The position control camera 78 monitors and controls the vertical dimension of the spreader 76 along a vertical axis Z right to a resting plane of the bag 68 after the opening 72 has been expanded.

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

Preferably, the nozzles 84 are connected to the movable blades 80.

According to one embodiment, the device 4 comprises a welding device 88, which is set up to weld the opening 72 of the bag 68 after inserting the container 8.

According to one embodiment, the device 4 comprises an integrity control camera 92 which is set up to monitor the integrity of the weld seam.

Preferably, the integrity control camera 92 is configured to perform a double check on the weld: in other words, double check means checking the integrity of the weld for each bag in which the container is inserted.

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

For example, a linear camera is connected to a linear flash light.

According to a possible embodiment, the device 4 is provided with a suction device 94 with external suction cups, which is adapted to suck air through a Tyvek window provided on the bag 68.

According to a possible embodiment, the camera 78 is also set up to check the dimensions of the bag 68 before it is opened, so as to guide the spreader 76 according to the actual dimensions of the bag 68 to be opened.

The operation of the device for packaging containers of pharmaceutical use facilities according to the present invention will now be described.

In particular, the closure robot arm 12 moves to the gripping position in which it picks up a protective layer 16 from a stack of protective layers 16 and then moves to the release position in which it deposits the protective layer 16 on a container 8 of pharmaceutical use devices , so as to cover the peripheral edge 20 delimiting the access chamber 24 of the container 8.

The closure robot arm 12 is advantageously connected to at least one position control camera 56, which is set up to record the coordinates of the center of gravity G of the protective layer 16 in relation to the lying surface P on which the protective layer 16 lies, and/or a rotation angle of the protective layer 16 in relation on a Z axis perpendicular to the lying surface P in order to ensure the correct positioning and release of the protective layer 16 on the peripheral edge 20. This ensures that the protective layer 16 perfectly covers the access chamber 24, taking care to seal the entire peripheral edge 20 of the container 8. For this purpose, it is in fact essential not only to correctly position the center of gravity G of protective layer 16 with respect to the access chamber 24, but also to prevent the layer itself, although its center of gravity coincides with the center of the access chamber 24, from being in relation to the vertical axis rotates perpendicular to the protective layer 16 and the access chamber 24 does not close correctly.

Thanks to the feedback control carried out by the position control camera 28, the closure robot arm 12 is able to correctly position the protective layer 16 to close the access chamber 24 of the container 8.

While gripping the protective layer 16, the laminar flow hood creates a flow of air from above to the stack of protective layers 16 to provide a barrier to the entry of impurities into the containers 8.

After the protective layer 16 has been correctly positioned, it is welded to the peripheral edge using the welding device 36.

In particular, as shown, the welding device 36 comprises a plurality of centering pins 40, which are designed to center the protective layer 16 and to prevent the protective layer 16 from shifting parallel to the lying surface P of the protective layer 16 itself.

The centering pins 40 prevent the vertical movement of the protective layer 16 along a vertical direction Z perpendicular to the lying surface P of the protective layer 16 due to the presence of the head 48 which protrudes from the body such that an undercut with respect to the vertical direction Z perpendicular to the Lying surface P of the protective layer 16 is generated.

As can be seen, the device 4 for packaging containers 8 of facilities for pharmaceutical use includes a bagging robot arm 112 which moves from a gripping position in which it picks up a container 8 previously sealed by at least one protective layer 16 Release position is movable in which he inserts the container 8 into a bag 68 after the bag 68 itself has been opened at the side of a suitable opening 72.

The bagging robot arm 112 is advantageously connected to at least one position control camera 78, which shows the coordinates of a center point M of the opening 72 with respect to a lying surface P on which the bag 68 lies and/or a rotation angle of the bag 68 with respect to an axis reads perpendicular to the lying surface in order to ensure the correct positioning and release of the container 8 inside the bag 68.

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

Preferably, the packaging device 4 comprises an expanding device 76 which is designed to widen the opening 72 of the bag 68 through which the container 8 is to be inserted.

The position control camera 78 monitors and controls the vertical dimension of the spreader 76 along a vertical axis Z perpendicular to a support plane of the bag 68 after it has expanded the opening 72.

This expansion is achieved, for example, by a pair of movable blades 80 adapted to perform at least partial opening of the bag 68 and by nozzles 84 adapted to deliver compressed air to facilitate opening of the bag 68.

Preferably, the nozzles 84 are connected to the movable blades 80. In this way, a single operation can effectively expand the opening with the combined mechanical action of the movable blades 80 and fluid dynamic action of the nozzles 84.

Finally, as shown, the opening 72 of the bag 68 can be welded to the welding device 88 after the container 8 has been inserted into the bag 68.

It is also possible to suck air from inside the already closed bag 68 with the suction device 94, which is provided with external suction cups that suck air through a special window made of Tyvek provided on the bag 68 itself.

As can be seen from the foregoing, the approaches described above overcome the disadvantages of the known technology.

In particular, thanks to the special system for receiving the protective layers from above, it is possible both not to disturb the laminar flow that protects the containers and to prevent sliding between layers and thus the possible rise of contaminating particles. In addition, this type of recording from above with the help of suction cups reduces the risk of picking up two protective layers together, which occurs in the solutions of the known technology.

In addition, the packaging device allows individual layers of Tyvek to be picked up and positioned at different heights according to the indications of at least one camera, guaranteeing greater precision and repeatability in positioning the layers in relation to the container to be sealed.

Indeed, as illustrated, the position in which the protective layers made of Tyvek are placed on the container depends on the actual positioning of the layers themselves when picked up; the container is mechanically centered and therefore fixed. The higher precision compared to the approaches of the known technology is due to the fact that the camera detects the relative position of the protective layer and the container in the plane and guides the gripping robot to adjust the coordinates to the actual positioning of the protective layer and them then precisely placed on the container, which is fixed to prevent misalignment of the edges.

In addition, the container is inserted into the welding device while the outer protective layer rests on top and is held in place laterally and vertically by “mushroom-shaped pins” on the 4 sides to prevent it from moving before welding.

In fact, the mushroom-shaped pins prevent the outer protective layer, made of Tyvek, from being lifted during transportation or during welding; thus, the protective sheet, which is made of Tyvek, cannot move prior to welding because it is vertically constrained, and during displacement, air cannot get under the sheet which would lift it and possibly cause it to move laterally from the cylindrical pins to solve.

In addition, the step of opening and pulling the bag before welding is carried out at variable heights for each bag, following the indications and measurement of a dedicated camera that communicates with the handling robot and with the machine automation: in this way allows the variable height that the bags are opened and pulled at the optimal position, resulting in improved process stability, which means better machine efficiency and less waste.

In addition, an automatic integrity check is carried out for each bag weld by a dedicated linear camera, both for a single bag and a double bag: the camera records all the folds in the weld and rejects the corresponding final product.

The technical advantage lies in the automatic inspection of both bags by the camera in the case of a double bag and not just the outer one through visual inspection; In this way, unlike the approaches of the known technology, the device itself can detect a mismatch of the inner seal.

In addition, after the bag has been sealed, the air inside the bag is evacuated thanks to the external suction cups that act on the air-permeable window (made of Tyvek) of the bag itself. This suction step takes place either on the top or the side, depending on the format chosen and the resulting position of the Tyvek window in the bag.

This allows the overall shape of the bags to be controlled after the containers are bagged and the risk of breakage of over-inflated bags that occurs with prior art approaches can be avoided.

The scope of the invention is defined by the following claims.

Claims (11)

Device (4) for packaging containers (8) of facilities for pharmaceutical use, comprising: - a closure robot arm (12) which can be moved from a gripping position in which it picks up a protective layer (16, 16', 16") from a stack of protective layers (16, 16', 16") to a release position , in which he places the protective layer (16, 16 ', 16") on a container (8) of devices for pharmaceutical use so as to cover a peripheral edge (20) which delimits an access chamber (24) of the container (8). ; - a welding device (36) which is set up to support and weld the protective layer (16, 16', 16"), the welding device (36) comprising a plurality of centering pins (40) which are set up to hold the protective layer (16, 16', 16") and to prevent the protective layer (16, 16', 16") from shifting parallel to a lying surface (P) of the protective layer (16, 16', 16") itself. Device (4) for packaging containers (8) from facilities for pharmaceutical use Claim 1 , wherein the centering pins (40) are set up in such a way that they prevent vertical movement of the protective layer (16, 16', 16") along a direction perpendicular to the lying surface (P) of the protective layer (16, 16', 16"). Device (4) for packaging containers (8) from facilities for pharmaceutical use Claim 1 or 2 , wherein the centering pins (40) have a mushroom-shaped configuration with a vertical body (44) and a head (48) protruding from the vertical body (44) so as to have an undercut perpendicular to the vertical direction (Z). to the lying surface (P) of the protective layer (16, 16 ', 16"). Device (4) for packaging containers (8) of facilities for pharmaceutical use according to one of Claims 1 until 3 , wherein the closure robot arm (12) is connected to at least one position control camera (56), which is set up to detect the coordinates of the center of gravity (G) of the protective layer (16, 16 ', 16") in relation to a lying surface (P), on which the protective layer (16, 16', 16") lies, and/or to detect an angle of rotation of the protective layer (16, 16', 16") with respect to an axis (Z) perpendicular to the lying surface (P). thus ensuring the correct positioning and release of the protective layer on the peripheral edge (20). Device (4) for the packaging of containers (8) of devices for pharmaceutical use according to one of the Claims 1 until 4 comprising a position control camera (28) operatively connected to drive means (32) of the closure robot arm (12) so as to provide feedback control of the actual position of the protective layer (16, 16', 16") with respect to the peripheral edge (20). Device (4) for packaging containers (8) of facilities for pharmaceutical use according to one of Claims 1 until 5 , wherein the closure robot arm (12) is provided with at least one suction cup adapted to engage each protective layer (16, 16', 16") from the corresponding stack of protective layers (16, 16', 16") and whereby the shutter Robot arm (12) is set up to lift each protective layer (16, 16', 16") with at least one suction cup in a lifting direction perpendicular to a lying surface (P) of each protective layer (16, 16', 16"). Device (4) for packaging containers (8) of facilities for pharmaceutical use according to one of Claims 1 until 6 , wherein the device (4) comprises at least one laminar flow hood which is designed to generate an air flow from above to the stack of protective layers (16, 16 ', 16"). Device (4) for packaging containers (8) of facilities for pharmaceutical use according to one of Claims 1 until 7 , the at least one internal storage station (60) which is set up to store the protective layers (16, 16 ', 16"), and at least one internal dimension control station (64) which is set up to store the dimensions of the protective layers (16, 16', 16") to control includes. Device (4) for packaging containers (8) of facilities for pharmaceutical use according to one of Claims 1 until 8th , wherein the device (4) comprises control sensors for a first protective layer (16 ') and for a second protective layer (16"), which overlaps the first protective layer (16'). Device (4) for packaging containers (8) from facilities for pharmaceutical use Claim 9 , wherein the control sensors include an ultrasonic sensor for dimensional verification and/or detection of a first type of protective layer (16, 16', 16") or a second protective layer (16") that has a first thickness. Device (4) for packaging containers (8) from facilities for pharmaceutical use Claim 10 , wherein the control sensors include a fiber optic sensor for dimensional verification and/or detection of a second type of protective layer (16, 16', 16") having a second thickness that is greater than the first thickness of the first type of protective layer.

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