U.S. patent application number 17/440403 was filed with the patent office on 2022-05-26 for method and device for orienting and/or displacing a sterile object packaged in a film bag relative to the film bag.
This patent application is currently assigned to Bausch + Strobel Maschinenfabrik Ilshofen GmbH + Co. KG. The applicant listed for this patent is Bausch + Strobel Maschinenfabrik Ilshofen GmbH + Co. KG. Invention is credited to Hans Werner KREFT, Timo KUPFER, Jurgen MUNZ.
Application Number | 20220161958 17/440403 |
Document ID | / |
Family ID | 1000006180888 |
Filed Date | 2022-05-26 |
United States Patent
Application |
20220161958 |
Kind Code |
A1 |
KUPFER; Timo ; et
al. |
May 26, 2022 |
METHOD AND DEVICE FOR ORIENTING AND/OR DISPLACING A STERILE OBJECT
PACKAGED IN A FILM BAG RELATIVE TO THE FILM BAG
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.
Inventors: |
KUPFER; Timo; (Obersontheim,
DE) ; MUNZ; Jurgen; (Obersontheim, DE) ;
KREFT; Hans Werner; (Schnelldorf-Unterampfrach, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bausch + Strobel Maschinenfabrik Ilshofen GmbH + Co. KG |
Ilshofen |
|
DE |
|
|
Assignee: |
Bausch + Strobel Maschinenfabrik
Ilshofen GmbH + Co. KG
Ilshofen
DE
|
Family ID: |
1000006180888 |
Appl. No.: |
17/440403 |
Filed: |
March 16, 2020 |
PCT Filed: |
March 16, 2020 |
PCT NO: |
PCT/EP2020/057054 |
371 Date: |
September 17, 2021 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B65B 69/0008
20130101 |
International
Class: |
B65B 69/00 20060101
B65B069/00 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 19, 2019 |
DE |
10 2019 203 662.7 |
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.
Description
[0001] 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.
[0002] 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.
[0003] 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).
[0004] Packaging systems with a plurality of nested packages are
frequently used in the production and packaging of
pharmaceuticals.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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:
[0013] 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,
[0014] b) clamping the end region between clamping surfaces of the
gripper bars, the two gripper bars jointly forming a gripper
assembly,
[0015] c) winding a portion of the film bag adjacent to the clamped
end region onto a peripheral portion of the gripper assembly
and
[0016] 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).
[0017] 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.
[0018] 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.
[0019] 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.
[0020] 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.
[0021] 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.
[0022] The horizontal transport direction preferably also runs
perpendicular to an extension direction of the gripper bars.
[0023] 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.
[0024] 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.
[0025] 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.
[0026] 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] 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.
[0033] 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:
[0034] FIG. 1 a perspective view of a device according to a first
embodiment of the invention, and
[0035] FIGS. 2-5 illustrate an embodiment of the method according
to the invention which can be carried out with the device from FIG.
1.
[0036] All figures are simplified, diagrammatic illustrations
intended substantially to explain the basic principles of the
invention.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] 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.
[0042] 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).
[0043] 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.
[0044] 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.
[0045] 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.
[0046] 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.
[0047] 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 12a 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.
[0048] 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 12a securely between two
clamping surfaces 18f.
[0049] Complementary positive locking structures 19, for example,
can be provided on the clamping surfaces 18f to increase clamping
security. Apart from this, the clamping surfaces 18 in the example
shown are preferably substantially flat.
[0050] FIGS. 3 and 4 illustrate a subsequent step c), in which a
portion of the film bag 12 adjacent to the clamped end region 12a
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.
[0051] 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.
[0052] For example, the gripper assembly 24 is rotated about the
axis of rotation twice by approximately 90.degree..
[0053] 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.
[0054] 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.
[0055] 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 36o 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.
[0056] 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 24k and 40k respectively (cf. FIG. 4) which
are configured to be in planar contact with each other during
cutting.
[0057] 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.
[0058] 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 18f 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.
* * * * *