US20220161958A1

US20220161958A1 - Method and device for orienting and/or displacing a sterile object packaged in a film bag relative to the film bag

Info

Publication number: US20220161958A1
Application number: US17/440,403
Authority: US
Inventors: Timo Kupfer; Jürgen MÜNZ; Hans Werner Kreft
Original assignee: Bausch and Stroebel Maschinenfabrik Ilshofen GmbH and Co KG
Current assignee: Bausch and Stroebel Maschinenfabrik Ilshofen GmbH and Co KG
Priority date: 2019-03-19
Filing date: 2020-03-16
Publication date: 2022-05-26
Also published as: DE102019203662A1; WO2020187824A1

Abstract

The invention relates to a method for orienting and/or displacing a sterile object packaged in a film bag, comprising: positioning the film bag with the object packaged therein on a support surface so that an end region of the film bag is arranged between two gripper bars of a gripping device; clamping the end region between clamping surfaces of the gripper bars, the two gripper bars jointly forming a gripper assembly; winding a portion of the film bag adjacent to the clamped end region onto a peripheral portion of the gripper assembly; and orienting and/or displacing the object relative to the film bag by a further peripheral portion of the gripper assembly acting on the object in the winding step. The invention also relates to a device configured to carry out this method.

Description

The present invention relates to a method and a device for orienting and/or displacing a sterile object packaged in a film bag relative to the film bag.
The handling of packaged sterile objects plays a major role in medical technology. In particular, when removing a sterile object from its packaging, care must be taken not to contaminate the object during removal, as the packaging is usually used in a non-sterile environment and its outer side is consequently contaminated with germs. In particular, the GMP guidelines must be observed.
To prevent contamination of the object, either the outer side of the packaging can be disinfected prior to removal or the item is removed from the packaging and transferred into a region with suitable cleanliness in such a manner that the object does not come into contact with the outer sides of the packaging. The latter concept is also referred to as the NTT concept (No Touch Transfer).
Packaging systems with a plurality of nested packages are frequently used in the production and packaging of pharmaceuticals.
For example, sterilized receptacles, such as syringes, vials, cartridges or similar, may be packaged in a tray-like container with a peelable film lid, the container itself being sterilized and sealed in a further film bag.
Film bags must first be oriented so that they can be cut open in a defined manner. Orientation can take place manually or automatically. In this case, the bag is tightened across its entire width at the desired cutting edge so that it has as few folds as possible.
Then, the object in the bag is moved away from the intended cutting edge to create sufficient clearance so that the bag can be cut open safely without touching the object. This can also be done manually or can be automated.
In the automated variant, two counter-rotating rollers are used in practice, the bag being drawn in between them which moves the object in the bag away from the intended cutting edge.
Printed document DE 10 2007 027 878 A1 discloses a device and a method for removing a sterile object from a sterile package in which an end region of a film bag is first clamped between two clamping rollers of a clamping device. A further holding device is used to hold another region of the film bag by means of suction cups. The clamping device is then lowered or pivoted to tighten a portion of the film bag between the clamping device and the holding device in which portion a slit is then made in the bag with a cutting device. The object is subsequently removed from the bag through the slit.
Printed document DE 10 2009 002 441 A1 further discloses a device and a method for orienting packages. In this case, a film bag with an object packaged therein is first placed in a vacuum chamber in which a vacuum is then generated so that the film bag unfolds and a partial region of the unfolded bag can be fixed with fastening means.
The object of the present invention is to enable controlled orientation or displacement of the object in the film bag in preparation for opening the bag and removing the object according to the NTT concept.
According to a first aspect of this invention, the object is achieved by a method for orienting and/or displacing a sterile object packaged in a film bag relative to said film bag, the method comprising the following steps:
a) positioning the film bag with the object packaged therein on a support surface so that an end region of the film bag is arranged between two gripper bars of a gripping device,
b) clamping the end region between clamping surfaces of the gripper bars, the two gripper bars jointly forming a gripper assembly,
c) winding a portion of the film bag adjacent to the clamped end region onto a peripheral portion of the gripper assembly and
d) orienting and/or displacing the object relative to the film bag by a further peripheral portion of the gripper assembly acting on the object in step c).
Thus, the gripper assembly uses its contour in conjunction with a rotary movement to align the object in the bag, which enables smooth and controlled orientation or displacement of the object relative to the bag. In particular, the orientation can also take place while transporting the object in the film bag and thus within the cycle time.
According to a preferred development, in a further step e) at least part of the portion of the film bag wound up in step c) can be unwound again from the gripper assembly in order to provide sufficient space for subsequent slitting of the film bag.
Moreover, the method can comprise a step f) in which the film bag is cut open in a region that is wound onto the gripper assembly which enables cutting open to be particularly controlled.
Alternatively or additionally, it can be provided that the method comprises a step g) in which the film bag and thus the object packaged therein is transported parallel to the support surface by moving the gripper assembly which clamps the end region of the film bag, the steps g) and c) preferably overlapping in terms of time for time-saving reasons. The film bag can preferably be transported on the support surface by the gripper assembly in a transport direction running perpendicular to an extension direction of the gripper bars.
According to a further aspect, the object is achieved by a device for orienting and/or displacing a sterile object packaged in a film bag relative to the film bag, comprising a gripping device having two gripper bars which can be moved relative to each other along a clamping direction, towards each other and away from each other between a clamping position and a release position, in order to clamp an end region of the film bag in the clamping position between clamping surfaces of the gripper bars and to release the end region in the release position, the two gripper bars together forming a gripper assembly in the clamping position, and the gripper assembly being rotatable about an axis of rotation running perpendicular to the clamping direction as well as being adjustable in at least one horizontal transport direction.
The horizontal transport direction preferably also runs perpendicular to an extension direction of the gripper bars.
This creates the structural requirements for orienting or displacing an object in a film bag, as described in the independent method claim. In contrast to the system described in DE 10 2007 027 878 A1, for example, there is no need for a holding device separate from the gripping device to do this.
Depending on the position of the axis of rotation, the winding movement of the gripper assembly can comprise superimposing a rotary movement about the axis of rotation with a two-dimensional adjusting movement perpendicular to the axis of rotation. For this purpose, the gripper assembly is preferably further adjustable in two non-parallel directions in an adjustment plane perpendicular to the axis of rotation.
To gently orient or displace the object in the film bag, it can further be provided that the gripper assembly has, in a cross-section perpendicular to the axis of rotation, a peripheral portion with a convexly rounded contour, preferably in the form of a segment of a circle. During the winding movement, the action of this convexly rounded peripheral portion on the object displaces the object in the film bag away from the intended cutting edge.
Both the film bags and the objects (such as tubs) packaged therein can come in different shapes and sizes. However, in practice, there is often only a limited number of standard shapes and standard sizes. It is therefore preferably provided that the shape and size of the gripper assembly is matched to a specific combination of shape and size of a film bag and the shape and size of an object packaged therein. The device can preferably comprise a set in shape and/or size of different pairs of gripper bars interchangeably attachable to the gripping device.
According to a preferred development, the device further comprises a cutting device having a cutting element for cutting open the film bag, and the gripper assembly has a guide slot which is configured to receive a protruding end of the cutting element when cutting open the film bag so that the cutting movement is guided in a safe manner.
Although the film bag is dissected into two parts when cut open, the cut off portion of the bag remains clamped between the gripper bars which ensures safe disposal of the portion.
To hold the film bag securely when cutting it open, it is preferably provided that the cutting device has a contact surface, the guide slot being formed in a peripheral portion of the gripper assembly, in which the gripper assembly has a contact surface that is configured to be in planar contact with the contact surface of the cutting device when cutting open the film bag.
The claimed device preferably also serves to transport the packaged object. The device thus preferably further comprises a support surface, the gripping device being arranged and configured to transport the film bag, which is clamped between the gripper bars, with the object packaged therein on the support surface along the transport direction.
The gripping device can thus also be used as a transport device and the winding can take place during transport and thus be within the cycle time without the need for a separate transport device.
In particular, the film bag can be transported in this manner to a transition between two areas with different clean room classes, the bag being cut, opened and transferred at this transition from the film bag to the adjacent area of higher cleanliness in accordance with the NTT concept.

The present invention is explained in greater detail in the following based on a preferred embodiment which is shown in the associated figures. The drawings show:

FIG. 1 a perspective view of a device according to a first embodiment of the invention, and

FIGS. 2-5 illustrate an embodiment of the method according to the invention which can be carried out with the device from FIG. 1.

All figures are simplified, diagrammatic illustrations intended substantially to explain the basic principles of the invention.
FIG. 1 shows a device 10 for orienting and/or displacing a sterile object packaged in a film bag, the film bag and object in FIG. 1 not being shown for reasons of clarity.
The device 10 comprises a gripping device 16 with two gripper bars 18 each of which extends along a bar direction L, i.e. in the y-direction in the co-ordinate system shown in the figure.
The two gripper bars 18 can be moved relative to each other along a clamping direction K, towards each other and away from each other between a clamping position and a release position (vertical here), FIG. 1 illustrating the release position.
The clamping movement of the gripper bars 18 can be performed, for example, via a drive 20, preferably an electric or pneumatic drive. It may be provided that only one of the bars 18 is movable, while the other is fixedly mounted on a gripper head 22. In the example illustrated, however, both gripper bars, each adjustable separately in clamping direction K, are provided on the gripper head 22.
The gripper head 22 and therefore also the gripper assembly 24, which is formed by the two gripper bars 18 in the clamping position, is preferably provided on a gripper carriage 28 so as to be rotatable about an axis of rotation R that runs perpendicular to the clamping direction K. A drive not shown here is also preferably provided for the rotary movement of the gripper assembly 24.
In the embodiment shown, the gripper carriage 28 is provided so as to be adjustable along a horizontal transport direction T on a guide rail 30, preferably by means of a suitable drive, the guide rail 30 itself in turn being adjustable in a vertical direction V, for example electrically or pneumatically, by suitable drives 38 such that the gripper assembly 24 can be rotated as a whole about the axis of rotation R and can be adjusted in an adjustment plane perpendicular to the axis of rotation R in two non-parallel spatial directions (x, z).
By means of a combined rotary movement about the axis of rotation R and an adjusting movement in the adjustment plane, it is possible to implement the winding movement described in greater detail in conjunction with FIGS. 2-5, in which a portion of the film bag is wound onto a peripheral portion of the gripper assembly 24 and, in the process, the object lying on a support surface not shown in FIG. 1 is oriented or displaced in the film bag.
A preferred embodiment of the method according to the invention, which can be carried out with the device from FIG. 1, is explained in detail below in conjunction with FIGS. 2 to 5.
They are simplified and diagrammatic illustrations which show the gripper bars 18 of the gripper assembly 24 in a sectional view in a sectional plane perpendicular to the axis of rotation and the sterile object 14 packaged in a film bag 12 in a simplified lateral view. It should be noted that the shape of the lower gripper bar in FIGS. 2 to 5 deviates slightly from the shape of the lower gripper bar in FIG. 1, but this has no bearing on the explanation of the invention.
For example, the object 14 may be a so-called tub, i.e. a tub-like plastic container sealed with a peelable film lid, in which, for example, syringes, vials, cartridges or similar receptacles for pharmaceuticals can be accommodated.
In the method according to the invention, the film bag 12 with the object 14 packaged therein is first positioned, in a step a) illustrated in FIG. 2, on a horizontal support surface 36 in such a manner that an end region 12 a of the film bag 12, which may in particular comprise a sealing seam of the bag 12, is positioned between the two gripper bars 18 of the gripping device 16 in the release position.
In a subsequent step b), the gripper bars 18 are then moved towards each other along the clamping direction K (in z-direction) such that they clamp the partial region 12 a securely between two clamping surfaces 18 f.
Complementary positive locking structures 19, for example, can be provided on the clamping surfaces 18 f to increase clamping security. Apart from this, the clamping surfaces 18 in the example shown are preferably substantially flat.
FIGS. 3 and 4 illustrate a subsequent step c), in which a portion of the film bag 12 adjacent to the clamped end region 12 a is wound onto a peripheral portion 24.1 (cf. FIG. 3) of the gripper assembly 24 which is formed by the two gripper bars 18 in the clamping position.
This winding movement, indicated by curved arrows in FIGS. 3 and 4, can be effected in the embodiment shown by superimposing a common rotation of the gripper bars 18 about an axis of rotation R that runs parallel to the y-direction (cf. FIG. 1), which is not shown in the figures, with a two-dimensional adjusting movement of the gripper assembly 24 in an adjustment plane (x-z plane) perpendicular to the axis of rotation R.
For example, the gripper assembly 24 is rotated about the axis of rotation twice by approximately 90°.
During winding (between the positions illustrated in FIGS. 3 and 4), a further peripheral portion 24.2 (cf. FIG. 3) of the gripper assembly 24, here convexly rounded, acts on the object 14 and displaces it relative to the film bag 12 away from the intended cutting edge towards the left, i.e. in the negative x-direction, in order to create sufficient distance between the object 14 and a cutting device 40 with which the film bag 12 can later be cut open.
After displacing or orienting the object 14 in the film bag 12 and before cutting open the bag, part of the portion of the film bag 12 wound onto the gripper assembly 24 can be unwound again (cf. FIGS. 4 and 5), for example to move the gripper assembly 24 into a position suitable for cutting it open.
In the embodiment shown, the cutting device 40 is provided so as to be vertically adjustable (in the z-direction) below the support surface 36 which has an opening 36 o through which the cutting device 40 can be moved upwards, a protruding end of the cutting element 42 being received in a guide slot 46, which is formed in the gripper assembly 24, while the film bag 12 shown in FIG. 5 is being cut open.
To hold the film bag 12 securely during the cutting process, the gripper assembly 24 as well as the cutting device 40 can each have a contact surface 24 k and 40 k respectively (cf. FIG. 4) which are configured to be in planar contact with each other during cutting.
For reasons of time saving, it can be provided in particular that the winding movement and thus the orientation and/or displacement of the object 14 in the film bag 12 takes place overlapping in time with a transport of the film bag 12 in the transport direction (here the x-direction). In particular, the gripping device 16 can thus also serve as a transport device with which the film bag 12 and the object 14 packaged therein can be transported, for example, to a transition or an airlock to an adjacent area of higher cleanliness, the object 14 preferably being transferred into this adjacent area according to the NTT concept after the bag has been cut open.
Even if the film bag is dissected into two parts during the cutting process illustrated in FIG. 5, the cut off portion remains firmly clamped between the clamping surfaces 18 f of the gripper bars 18 and can be fed to a waste container (not shown here) via a transport movement of the gripper assembly 24.

Claims

1. A method for orienting and/or displacing a sterile object packaged in a film bag relative to the film bag, the method comprising:

positioning the film bag with the object packaged therein on a support surface so that an end region of the film bag is arranged between two gripper bars of a gripping device;

clamping the end region between clamping surfaces of the two gripper bars, wherein the two gripper bars jointly form a gripper assembly;

winding a portion of the film bag adjacent to the clamped end region onto a peripheral portion of the gripper assembly; and

orienting and/or displacing the object relative to the film bag by a further peripheral portion of the gripper assembly when winding the portion of the film bag.

2. The method of claim 1, further comprising:

unwinding at least part of the portion of the wound up film bag from the gripper assembly.

3. The method of claim 1, further comprising:

cutting open the film bag in a region which is wound onto the gripper assembly.

4. The method of claim 1, further comprising:

transporting the film bag and the object packaged therein by moving the gripper assembly clamping the end region parallel to the support surface.

5. A device for orienting and/or displacing a sterile object packaged in a film bag relative to the film bag, comprising:

a gripping device having two gripper bars which can be moved relative to each other along a clamping direction towards each other and away from each other between a clamping position and a release position, in order to clamp an end region of the film bag in the clamping position between clamping surfaces of the gripper bars and to release the end region in the release position, wherein the two gripper bars together form a gripper assembly in the clamping position, wherein the gripper assembly is rotatable about an axis of rotation perpendicular to the clamping direction, and wherein the gripper assembly is adjustable at least in a horizontal transport direction.

6. The device of claim 5, wherein the gripper assembly is adjustable in two non-parallel directions in an adjustment plane perpendicular to the axis of rotation.

7. The device of claim 5, wherein the gripper assembly has, in a cross-section perpendicular to the axis of rotation, a peripheral portion with a convexly rounded contour.

8. The device of claim 5, further comprising a cutting device having a cutting element for cutting open the film bag, wherein the gripper assembly has a guide slot that is configured to receive a protruding end of the cutting element when cutting open the film bag.

9. The device of claim 8, wherein the cutting device comprises a contact surface, and wherein the guide slot is formed in a peripheral portion of the gripper assembly, wherein the gripper assembly has a contact surface in the peripheral portion that is configured to be in planar contact with the contact surface of the cutting device when cutting open the film bag.

10. The device of claim 5, further comprising a support surface, wherein the gripping device is arranged and configured to transport the film bag with the object packaged therein on the support surface along the transport direction, the film bag being clamped between the gripper bars.

11. The method of claim 4, wherein the steps of transporting the film bag and the object packaged therein and winding the portion of the film bag adjacent to the clamped end region onto the peripheral portion of the gripper assembly overlap in time.

12. The gripping device of claim 7, wherein the peripheral portion with the convexly rounded contour is in a form of a segment of a circle.