Note: Descriptions are shown in the official language in which they were submitted.
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Method and device for producing a primary
individual packing of a wafer
The invention relates to a process and a device for the
manufacture of a primary unit pack of a wafer, particularly
of a wafer that has been separated from an active substance
film of one or more active substances for use as a dosage
unit and administration form for medicaments.
Apart from the known dosage forms for medicaments, such as
tablets, capsules, drops or similar administration forms,
there is the administration form of the "wafer". This is a
small thin plate of an active substance film comprising a
predetermined amount of active substance and with a thick-
ness and dimensions adapted according to the amount of ac-
tive substance to be delivered. A wafer is flexible, soft,
of small weight and can be torn. Since there is a direct
correlation between the contact surface of the wafer and
the dosage amount of the active substance, its dimensions
must be identical to the greatest possible extent with the
dimensions calculated, and must lie within the range of
tolerance. Because the dosage is dependent on the surface
area, the soft active substance material must not be
stretched prior to cutting since otherwise the amount of
active substance would be changed. For this reason, the
manufacture of the wafer and the packaging of a single wa-
fer or the packaging of several wafers in a primary pack
unit is costly.
From DE 198 00 682 A1 there is known a process for the
manufacture of a primary pack unit for film-like or wafer-
like administration forms (wafers) for oral application,
21368451.1
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plied to square or rectangular wafers, the course of this
process - which is in principle also applicable to unit
packs of wafers - is different from that of the manufacture
of wafers of another shape. For square or rectangular wa-
fers, the first step is to convey an upper packaging mate-
rial web and a lower packaging material web, without cold
or hot forming, on top of one other via respective deflect-
ing shafts, while the film-like or wafer-like administra-
tion form is simultaneously conveyed between the two webs
of packaging material by means of rollers or gripper feed
systems. In this process, it is also possible to feed an
active substance film in the form of a web material - sin-
gle-webbed or multi-webbed, parallel and spaced at a dis-
tance from one another - with the desired Width of the dos-
age units. Subsequently, dosage units are singled out from
the web-shaped active substance film by means of a cross-
cutting apparatus which is positioned immediately in front
of the deflecting shafts. In a further process step, the
two webs of packaging material are sealed together with the
help of a heated sealing tool in such a way that the single
dosage units are sealed into compartments and are com-
pletely enclosed by sealed seams or sealed areas. In fur-
ther process steps, perforations are punched between the
compartments and primary pack units are partitioned off.
Fox wafers which are to have a shape other than square or
rectangular, the process for the manufacture of the primary
package unit according to DE 198 00 682 AI is configured as
follows: In a first process step, a laminate of the web-
like active substance film and a carrier sheet is provided,
out of which the dosage units are punched with a punching
device in a further process step without poaching through
the carrier sheet. The partially punched laminate is subse-
quently rerouted over an edge or a deflecting shaft with
the help of roller feed or gripper feed systems so that the
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dosage units thereby become detached from the carrier
sheet. If necessary, an additional stripping device can be
used for this purpose. Thereafter, an upper web of packag-
ing material and a lower web of packaging material without
cold or hot forming are conveyed on top of one another by
means of respective deflecting shafts, whereby the dosage
units becoming detached from the carrier sheet are simulta-
neously conveyed between the two webs of packaging mate-
rial. Subsequently, the two webs of packaging material are
sealed together with the help of a heated sealing tool in
such a way that the single dosage units are sealed into
compartments and are completely enclosed by sealed seams or
sealed areas. In further process steps, perforations are
punched between the compartments and primary packaging
units are partitioned off. It goes without saying that this
process can also be applied to the manufacture of square or
rectangular wafers and the packaging thereof in primary
unit packs.
Also known from the aforementioned DE 198 00 682 A1 are de-
vices for carrying out the respective processes. One of
these devices has a supply device for a laminate made up of
an active substance film and a carrier sheet, a cutting or
punching device for the active substance film for punching
a wafer on the carrier sheet, a separating tool for detach-
ing the active substance film from the carrier sheet, a
pulling device for the carrier sheet, and thereby also for
the active substance film With the wafer, a packaging mate-
rial feeding and packaging material pulling device for two
webs of packaging material which receive the respective wa-
fer, a heated sealing tool for the packaging material, and
a cutting tool for separating the sealed pouch.
The wafer material is elastic and may, as a consequence of
the mechanical stress occurring when it is transported be-
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tween the upper packaging material web and the lower pack-
aging material web, change its shape and its dimensions,
there being a risk of the amount of active substance in the
single Wafer changing as well since the area of the wafer
is decisive for dosing the active substance. With the above
described processes it is not possible to ensure the re-
quired constancy of the active substance amount since the
wafer material is in each case subjected to mechanical
stress prior to being inserted between the packaging mate-
rial webs.
It is the object of the invention to configure a process
and a device for the manufacture of a primary unit pack of
a wafer according to the introductory part of claim 1 and
the introductory part of claim 6 such that the wafer mate-
rial is not subjected to mechanical stress.
This object is achieved in a process according to the in-
troductory part of claim 1 and in a device according to the
introductory part of claim 6 by the respective characteriz-
ing features of said claims. Advantageous embodiments are
indicated in the respective sub-claims.
The process according to the invention consists in that a
laminate made up of a carrier sheet and an active substance
film is provided and pulled off, the carrier sheet becoming
detached from the active substance film in the process and
being separately wound up. Due to the forward motion of the
carrier sheet, the active substance film is also moved for-
ward. With its front end, the active substance film is con-
veyed, without mechanical stress, between two resting pack-
aging material Webs, is fixed by said packaging material
webs and in order to produce the wafer is crosscut at a
predetermined rearward distance from the packaging material
webs. Subsequently the wafer, which is fixed between the
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packaging material webs, is pulled forward, together and
synchronously with said webs, whereby the pulling force
acts on the packaging material webs, and is fed to a seal-
ing station. In this sealing station, the packaging mate-
rial webs are sealed, outside of the area where the wafer
is placed, to form a pouch or bag which is subsequently
separated from the packaging material webs.
The laminate is produced in a known manner by using a coat-
ing process, and is subsequently cut into strips which are
coiled up; the width of a coil corresponds to the width of
the desired wafer or to a multiple of said width of the wa-
fer. If a plurality of wafers is cut from the coil, the in-
dividual wafers are spread out so as to be arranged over
the width necessary for inserting them in the packaging
material webs. The coil is provided as a supply coil. The
special advantage of this process is that the wafer is con-
veyed and guided without mechanical stress. The process is
carried through in such a way that the respective length by
which the carrier sheet, and thereby also the active sub-
stance film, is pulled forward corresponds to the desired
length of a wafer, so that the wafers can be reproduced in
an extremely precise manner and axe always the same. As a
consequence, each wafer also has the same active substance
dose. Thereafter, the single wafer is fixed over its entire
extent between the packaging material webs while said webs
are being pulled forward, and it is not subjected to me-
chanical stress in the process. Vrhen the packaging material
webs are sealed to form a bag, there is no risk of damaging
the wafer fixed between said webs. The process is easily
accomplished.
In a preferred embodiment, the active substance film, which
has been detached from the carrier sheet, is conveyed in
vertical orientation between the packaging material webs,
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which in this process step are in a resting condition and
arranged at a distance from each other. The packaging mate-
rial webs are subsequently put against the wafer and are
pulled forward on both sides of the active substance film,
at the same speed of pulling and in the same direction of
pulling so that the active substance film between the pack-
aging material webs is pulled forward along with them with-
out being subjected to mechanical stress. At the infeed of
the active substance film the packaging material webs axe
guided through a clamping device which presses the packag-
ing material webs against the wafer and fixes them; this
takes place at the end of the work cycle, during which the
active substance film has been placed with its front end
between the packaging material webs. A relative motion be-
tween the wafer and the webs of packaging material is thus
impossible. In this position, the active substance film is
crosscut at a predetermined distance from the clamping sta-
tion in order to separate a wafer, and in the next opera-
tional step is drawn between the packaging material webs
and pulled forward along with them, completely and without
being subjected to stress.
The device far carrying out the process comprises, in a
known manner, a supply device for the laminate, which lami-
nate is formed of a carrier sheet and an active substance
film; a separating tool for detaching the active substance
film from the carrier sheet; a pulling device for said car-
rier sheet and thereby for the active substance film as
well; a cutting tool fox said active substance film; a de-
vice for feeding the packaging material and pulling it for-
ward, for two packaging material webs, which may be taken
from a packaging material roll and be separated by means of
a separating method and deflected; a heated sealing tool
for the packaging material; and a cutting tool for separat-
ing the finished side-sealed bag. In accordance with the
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invention, the device for feeding and pulling the packaging
material is provided with a receiving and clamping device
for the front end of the active substance film, which de-
vice is arranged in vertical direction below the separating
tool for detaching the active substance film and below the
cutting tool for said active substance film, in such a way
that during a feed cycle the active substance film, which
has been detached from the carrier sheet, moves downwards
in vertical direction into the receiving and clamping de-
vice. During this process the active substance film is not
subjected to mechanical stress.
The receiving and clamping device is preferably formed of
clamping rolls between which the packaging material webs
are guided under tension and which are movable in horizon-
tal direction and thereby transversely to the direction in
which the active substance film is pulled forward, in oppo-
site direction to each other, between a receiving position
for receiving the active substance film and a clamping po-
sition for clamping the active substance film. To form an
infeed funnel for the active substance film, two pairs of
clamping rolls may be arranged one above the other.
In the following, the invention will be explained by means
of an example of an embodiment. The accompanying drawings
are schematic representations of:
Fig. 1: a device for the manufacture of a primary unit pack
of a wafer, and
Figs. 2 to 5: an associated receiving and clamping device
of the wafer, in successive process steps.
The device shown in Fig. 1 is provided at its entry side
with a supply roll 1 with a laminate 4, made up of a car-
rier sheet 2 and an active substance film 3, which is to be
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pulled forward; a deflecting roll 5 and a stripping device
6 for detaching the active substance film 3 from the car-
rier sheet 2; and a coil 8 for winding up the carrier sheet
2. Below the separating roll 7, there are arranged guide
paths or guide bars 9 for exact alignment of the active
substance film 3, which has been detached from the carrier
sheet 2, a crosscutting device 10 with a knife (not shown),
and a device 11 for feeding and pulling the packaging mate-
rial, for two packaging material webs 12, which device 11
on the side of the cutting device has a receiving and
clamping device formed of two pairs of clamping rollers 13
and 14 which are arranged one above the other. The packag-
ing material webs 12 are arranged on supply rolls 15 and
are guided via the clamping rollers 13 and 14 to the pull-
ing rolls 16, by means of which they axe fixed by clamping
and pulled forward, as a consequence of which they are also
lying, under tension, on the clamping rollers 13 and 14.
Between these rollers (13, 14) and the pulling rolls 16
there are arranged heated cross-sealing and longitudinal-
sealing tools 17 and 18, and in the direction of pulling,
following the pulling rolls 16, a flat knife 19 as a cut-
ting device.
To manufacture a primary unit pack of a wafer, a laminate
4, which has the predetermined width of the wafer, is drawn
off, by the predetermined length of the wafer, from the
supply coil 1 by actuating the coil 8. In this process, the
active substance film 3 is removed from the carrier sheet 2
by means of the separating roll 7, and is oriented down-
wards i.n vertical direction by the guide paths or guide
bars 9, said guide paths or bars not possessing any clamp-
ing function for clamping the active substance film 3. In
this process, the front end of the active substance film 3
moves between the clamping rollers 13 and 14, which are in
their receiving position at a distance from each other and
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along which on the side of the active substance film the
packaging material webs 12 are guided and, in the receiving
position, rest against said rollers under tension. In the
preceding cycle the packaging material webs 12 have been
provided with a transverse sealed seam 20 which now forms
the front or bottom seam of the side-sealed bag, that is,
of the primary unit pack of the wafer, which is being pro-
duced. This process step is depicted in Fig. 2. In the next
process step (Fig. 3) the packaging material webs 12 are
pressed by means of the clamping rollers 13, 14 against the
front region of the active substance film 3 which has been
pulled forward and this active substance film iS fixed be-
tween the packaging material webs 12 by the said rollers
(13, 14) being moved towards each other. A wafer 21 of the
predetermined length is now separated from the active sub-
stance film 3 by the crosscutting device 10. Thereafter,
the packaging material webs 12 are pulled forward, along
with the wafer clamped between them, by synchronous actua-
tion of the pulling rolls 16, to the position of the rear-
ward transverse sealed seam (Fig. 4), the wafer 21 being
moved free of friction and at the same speed as the packag-
ing material webs 12. In this position the packaging mate-
rial webs 12 are heat-sealed with each other on the two
longitudinal sides by the two longitudinal-sealing tools 18
and on the rearward transverse side by the transverse-
sealing tool 17. The width of the resulting transverse
sealed seam is selected such that it can be divided cross-
wise and forms both the sealed seam of the primary unit
pack which has just been manufactured, but which has yet to
be separated, and the front or bottom seam of the following
unit pack. After sealing, the clamping rollers 13, 14 are
moved back to their receiving positions and are thereby
opened. This process step is shown in Fig. 5. The next cy-
cle again starts with inserting the active substance film
between the clamping rollers 13 and 14, which are in the
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receiving position, as described above. After each cycle, a
primary unit pack 22 of a wafer 21 - which unit pack has
been manufactured in the above-described manner - is sepa-
rated by the flat knife 19 from the following unit pack.
LIST OF REFERENCE NUMERALS
1 supply coil
2 carrier sheet
3 active substance film
4 laminate
5 deflecting roll
6 stripping device
7 separating roll
8 coil
9 guide paths or guide bars
10 crosscutting device
11 device for feeding and pulling the packaging material
12 packaging material web
13 clamping roller
14 clamping roller
supply roll
16 pulling roll
17 transverse-sealing tool
18 longitudinal-sealing tool
19 flat knife
transverse sealed seam
21 wafer
22 unit pack
