U.S. patent application number 10/298669 was filed with the patent office on 2004-05-20 for systems and methods for forming blister packages with support members for pharmaceutical product packaging.
Invention is credited to Bagley, Stuart, Rosenbaum, Ron, Siegel, Todd.
Application Number | 20040093835 10/298669 |
Document ID | / |
Family ID | 32297505 |
Filed Date | 2004-05-20 |
United States Patent
Application |
20040093835 |
Kind Code |
A1 |
Siegel, Todd ; et
al. |
May 20, 2004 |
Systems and methods for forming blister packages with support
members for pharmaceutical product packaging
Abstract
Systems and methods are provided for forming both backing and
support members of a solid pharmaceutical product package as well
as the blister portions for the packages. The disclosed solid
pharmaceutical product packaging solutions utilize fewer machines
and processing steps in order to form an overall solid
pharmaceutical product package. In accordance with the preferred
exemplary embodiments of the present invention, the manufacturing
processing steps associated with the formation of the blister
members in the clear plastic sheets is integrated in line with
manufacturing of the backing material.
Inventors: |
Siegel, Todd; (Clearwater,
FL) ; Bagley, Stuart; (Clearwater, FL) ;
Rosenbaum, Ron; (Clearwater, FL) |
Correspondence
Address: |
ROBERT J. DEPKE LEWIS T. STEADMAN
HOLLAND & KNIGHT LLC
131 SOUTH DEARBORN
30TH FLOOR
CHICAGO
IL
60603
US
|
Family ID: |
32297505 |
Appl. No.: |
10/298669 |
Filed: |
November 18, 2002 |
Current U.S.
Class: |
53/452 ;
53/558 |
Current CPC
Class: |
B65D 75/323 20130101;
B65B 11/50 20130101; B65D 75/327 20130101; B65B 9/045 20130101;
B65B 5/103 20130101; B29L 2031/7164 20130101 |
Class at
Publication: |
053/452 ;
053/558 |
International
Class: |
B65B 043/00 |
Claims
We claim:
1. A method of forming a product package comprising steps of:
forming holes in first and second portions of support board;
applying a sheet of plastic material to the cover the holes formed
in the first portion of the support board; applying a temporary
covering material to holes formed in the second portion of the
support board; and further wherein all the steps occur in a
continuous process
2. The method of claim 1, wherein the support board is formed of
cardboard.
3. The method of claim 1, further comprising a step of forming
cavity members in the sheet of plastic material covering the holes
in the first portion of the support board in the same in-line
manufacturing process.
4. The method of claim 1, wherein the support board is formed of
plastic.
5. The method of claim 1, wherein the temporary cover material is
formed of foil.
6. An in-line manufacturing machine for forming a product package
comprising: means for forming holes in first and second portions of
support board; means for applying a sheet of plastic material to
cover the holes formed in the first portion of the support board;
and means for applying a temporary covering material to holes
formed in the second portion of the support board.
7. The machine of claim 6, wherein the support board is formed of
cardboard.
8. The machine of claim 6, further comprising a means for forming
cavity members in the sheet of plastic material covering the holes
in the first portion of the support board in the same in-line
machine.
9. The machine of claim 6, wherein the support board is formed of
plastic.
10. The machine of claim 6, wherein the temporary cover material is
formed of foil.
11. A method of forming a product package comprising steps of:
forming holes in first a support board; applying a sheet of plastic
material to the cover the holes formed in the support board; and
further wherein all the steps occur in a continuous process.
12. The method of claim 1 1, further comprising a step of forming
blister cavities in the plastic material at the locations of the
holes.
13. The method of claim 12, further comprising a step of filling
the blister cavities with a product.
14. The method of claim 13, further comprising a step of applying a
backing material to seal the cavities.
15. The method of claim 14, wherein the backing material is a foil
material.
16. The method of claim 14, wherein the backing material is a foil
material that is secured to a cardboard support with holes formed
therein.
17. The method of claim 12, wherein the step of forming the blister
cavities is performed at a forming station that is separated from a
manufacturing machine which performs any preceding manufacturing
steps.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates generally to field of
pharmaceutical product packaging systems and methods. More
specifically, the present invention is directed to systems and
methods for automatically forming the blister portions of a solid
pharmaceutical product package and the corresponding packaging
support members for an overall pharmaceutical product package. The
two distinct portions are preferably formed in a single in-line
process into a unitary package member.
[0003] 2. Description of the Related Art
[0004] Currently in the field of pharmaceutical product packaging
systems and methods, typical conventional solutions for the
manufacture of the solid pharmaceutical product packaging include
clear plastic sheets with blister package cavities formed into the
plastic sheets. The cavities formed into the clear plastic sheets
are sealed with either foil or paper or cardboard backing that is
adhesively secured to the perimeter around the cavities formed in
the plastic sheets. In the typical conventional manufacturing
solutions for these products, the cardboard backing members are
produced by punching out portions of cards on in-line flexographic
presses or in sheet fed die cutting machines. The process is
typically initiated with 10-20 point cardboard.
[0005] In a series of steps, through the use of an in-line machine,
the cardboard is coated, printed and die cut. The unwanted die cut
portion is then removed, glue or adhesive is applied to one side of
the remaining portion of the cardboard sheets and foil or other
backing material is laminated on the adhesive backed side of the
punch card material. Subsequently, the products are sheeted at the
end of the press into, for example, twelve by nine inch punch
cards. A variety of different sizes are possible for the output
depending upon the size of the original stock.
[0006] In an alternate approach, more manual processing is
utilized. In this more manual approach, sheet fed offset printing
is applied and a separate die cutting machine is utilized.
Windowing machinery is thereafter used to laminated the punch card
with the foil. This processing is performed at individual distinct
processing stations rather than through the use of the in-line
process described above.
[0007] Regardless of the type of initial processing, clear plastic
sheets with blister members formed therein are later inserted into
the punch cards. This is typically performed by the customer or
during packaging or manufacturing when the individual blister
packages are filled with solid pharmaceutical products. The punch
cards advantageously have openings in the card member that
correspond to each of the blister cavities formed in the sheet of
clear plastic material. The card member is typically utilized to
provide both support and sealing of the cavity portions formed into
the clear plastic sheets.
[0008] In one conventional application, the blister members that
are formed in the sheet of clear plastic material are subsequently
inserted into the holes formed in the punch cards. The cards are
produced with a portion that folds over and simultaneously seals a
plurality of blister cavities. A foil material is typically
utilized for sealing and also allowing easy access to the solid
pharmaceutical cavity. Specifically, in one particular design
twelve by nine inch punch cards are folded over such that the total
package size ultimately is six by nine inches.
[0009] In yet another alternate application that is known as form
fill and seal, plastic sheet material is processed to form cavities
from roll stock and thereafter the cavities are filled with drug
product. The filled cavities are then sealed with foil. If a
cardboard punch card is desired for the finished product then a
previously manufactured cardboard backing is added at a later
station in the form fill and seal machine or in a secondary process
that occurs off-line.
[0010] One significant shortcoming of the conventional systems and
methods for forming these pharmaceutical product package members is
that multiple machines and corresponding manufacturing processes
are required in order to form each of the separate portions of the
overall package. In particular, one or more machines or processing
steps are required in order to form the blisters in the sheets of
clear plastic material. Additionally, separate machines and
processing is required in order to produce the backing material for
the product package which, as noted above, is typically formed from
cardboard.
[0011] Yet another shortcoming and deficiency is that the plastic
sheets with the blister cavities formed therein consume a
significant amount of space and therefore require larger storage
space.
[0012] Accordingly, there remains a need in the field for improved
systems and methods for forming pharmaceutical product packaging
members that utilize fewer machines and processing steps in order
to form the overall solid pharmaceutical product package. In light
of the foregoing, one object and advantage of the present invention
is to provide improved systems and methods for more efficiently
forming both backing and support members as well as forming the
blister portions for solid pharmaceutical product packages. Other
objects and advantages of the present invention will be apparent in
light of the following Summary and Detailed Description of the
Presently Preferred Embodiments.
SUMMARY OF THE INVENTION
[0013] Systems and methods are provided for more efficiently
forming both backing and support members of a solid pharmaceutical
product package as well as the blister cavity portions for the
packages. The solid pharmaceutical product packaging solutions of
the present invention utilize fewer machines and processing steps
in order to form an overall solid pharmaceutical product
package.
[0014] Specifically, in accordance with the preferred exemplary
embodiments of the present invention, the manufacturing processing
steps associated with the formation of the blister members in the
clear plastic sheets is integrated in-line with manufacturing of
the cardboard support material. In accordance with one of the
preferred exemplary embodiments, as one portion of a first side of
the cardboard backing material is laminated with foil, the other
side is laminated with a thermoplastic material. Each side is
preferably previously punched or die cut and the unwanted material
is removed in order to form openings therein prior to the
lamination step in the same in-line processing.
[0015] The preferred thermoplastic material is polyethylene but
other suitable plastic materials will also perform satisfactory
results. In a preferred exemplary embodiment, a polyethylene
coextrusion or one that is coated or laminated with Saran material
or other clear plastic may be utilized. The most preferred material
is medical packaging film manufactured by Dow Chemical Corporation
known as MPF 2005 or Saranex which is readily available. The
lamination can be achieved either with conventional glue lamination
or through the use of heat and pressure as in an alternate
embodiment.
[0016] In a subsequent step or stage, additional heat is applied to
the plastic material in order to soften the material. Those skilled
in the art will appreciate that a variety of different processing
techniques and/or mechanisms may be utilize for applying heat to
the material, such as, for example, passing the material through a
heater or wrapping it around a hot roller. Alternatively, in yet
another alternate exemplary embodiment, conventional cold forming
may be utilized.
[0017] The material is then preferably run through a rotary
male-female matched set of punches that indents each blister in
line prior to sheeting into separate individual punch cards. It is
believed that processing speeds of 100 feet per minute or greater
can be achieved through utilization of the systems and methods of
the present invention. In accordance with the systems and methods
of the present invention, greater manufacturing efficiency is
achieved with fewer manufacturing steps and less machinery.
Accordingly, as a result, utilization of the systems and methods of
the present invention provide a significant economic advantage over
previous approaches to the formation of solid pharmaceutical
product packaging.
[0018] Those skilled in the art will appreciate that a variety of
different processing techniques may be utilized in order to achieve
the results of the present invention. More specifically, it should
be recognized that it is not necessary to immediately form the
blister or cavity portions of the package member during the in-line
process. Those skilled in the art will recognize that the cavity
member may also be subsequently formed when the solid
pharmaceutical products are being inserted into the package. In
this alternate embodiment, shipping of the package material is
easier because less volume is required.
[0019] In an alternate preferred exemplary embodiment, a
male-female punch that is preferably of a rotary design may not be
utilized in the original in-line manufacturing process. In this
alternate approach, a flat bed forming station maybe used. In this
exemplary embodiment, the material is routed through an accumulator
after the preferably clear plastic material has been laminated to
the board or backing material. Thereafter, the combined structure
is passed to an intermittent forming station where the material can
be heated and then intermittently formed in a vacuum or pressure
former. This approach is not the preferred approach due to the
anticipated reduced productivity in the overall process but it
should be recognized that this approach may ultimately prove easier
to functionally achieve.
[0020] This intermittent forming station is preferably integrated
into the in-line manufacturing process. Those skilled in the art
will appreciate that it is unnecessary to utilize such a machine in
this manner. As an alternate approach, the plastic material may be
secured to the cardboard backing with the holes formed therein.
Sheets of this material can be accumulated and the formation of the
actual blister may be made at a later time.
[0021] In yet a further alternate exemplary embodiment, the blister
portion of the package is not formed in-line. In this alternate
exemplary approach, after the preferably clear plastic material has
been laminated, the punch card would continue in the process
through the sheeter mechanism. As a result this intermediate
product has a flat sheet of preferably clear plastic material on
one side and a flat sheet of foil on the other. The material is
then desirably formed off-line in a secondary machine. This can be
done alternately in a dedicated machine designed to thermoform
material or in a packaging machine where the preferably clear
plastic laminated punch card is introduced into the packaging
machine as is known in the art. The card is preferably pre-heated
in one station and thereafter the blisters are vacuum or pressure
formed with or without male-female flat tooling. Finally the card
is filled with medications, folded over and sealed in order to form
finished package.
[0022] Those skilled in the art will readily appreciate that the
punch card does not have to be of a fold-over style and the foil
backing can be produced separately and subsequently added to the
clear plastic laminated member after it has been filled with
medication. Although the preferred embodiment has been described
with reference to utilization of the thermoplastic or other heat
formable material, it should be readily recognized that any
formable plastic or similar material may be formed with the
application of heat as described above in order to achieve the
desired product. Those skilled in the art should also appreciate
that cold forming materials may also be utilized.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 illustrates a top plan view of the finished blister
pack formed in accordance with an exemplary embodiment of the
present invention;
[0024] FIG. 2 illustrates a side view of the finished blister pack
formed in accordance with an exemplary embodiment of the present
invention;
[0025] FIG. 3 illustrates an alternate view of the finished blister
pack formed in accordance with an exemplary embodiment of the
present invention;
[0026] FIG. 4 is an exploded illustration of the separate portions
of a solid pharmaceutical package formed in accordance with an
exemplary embodiment of the present invention;
[0027] FIG. 5 illustrates the placement of the sheet of clear
plastic material on a cardboard member in accordance with an
exemplary embodiment of the present invention;
[0028] FIG. 6 illustrates step in the manufacturing process in
accordance with an exemplary intermittent embodiment of the present
invention;
[0029] FIG. 7 illustrates step in the manufacturing process in
accordance with an exemplary intermittent embodiment of the present
invention;
[0030] FIG. 8 illustrates further step in the manufacturing process
in accordance with an exemplary embodiment of the present
invention;
[0031] FIG. 9 illustrates further step in the manufacturing process
in accordance with an exemplary embodiment of the present
invention;
[0032] FIG. 10 illustrates further step in the manufacturing
process in accordance with an exemplary embodiment of the present
invention;
[0033] FIG. 11 illustrates further step in the manufacturing
process in accordance with an exemplary embodiment of the present
invention; and
[0034] FIG. 12 illustrates an alternate exemplary embodiment.
DETAILED DESCRIPTION OF THE PRESENT PREFERRED EMBODIMENTS
[0035] FIG. 1 illustrates a top plan view of the finished blister
pack formed in accordance with an exemplary embodiment of the
present invention that is shown generally at 10. The overall
package is comprised of a support member 12 that incorporates a
plurality of openings 14 for receiving individual doses of solid
pharmaceutical products 16. The solid pharmaceutical products are
secured via a clear plastic material 18. This material is
preferably thermoplastic material such as polyethylene but other
suitable plastic materials will also perform satisfactory results.
In a preferred exemplary embodiment, polyethylene co-extruded with
saran or other clear plastic material may be utilized. The most
preferred material is medical packaging film manufactured by Dow
Chemical Corporation known as MPF 2005 or Saranex which is readily
available.
[0036] The product displayed in FIGS. 1 and 2 represents the
overall finished product that is formed in the manufacturing
process described below. FIG. 2 is a side view that illustrates the
finished blister pack of FIG. 1 formed in accordance with an
exemplary embodiment of the present invention. FIG. 3 is a
perspective view that illustrates the finished blister pack formed
in accordance with an exemplary embodiment of the present
invention. FIGS. 2 and 3 more clearly illustrates the fact that the
support member is actually comprised of an upper portion 21 and a
backing or lower portion 22 between which the plastic material 18
is secured.
[0037] FIG. 4 is an exploded illustration of the separate portions
of a solid pharmaceutical package formed in accordance with an
exemplary embodiment of the present invention. In particular, FIG.
4 more clearly illustrates the fact that both the upper and lower
portion 21, 22 of the support member 12 includes openings 14 for
receiving one or more individual solid pharmaceutical medications.
Additionally, the illustration of FIG. 4 clearly shows the
preferably clear plastic material 18 placed adjacent the upper
member and the sheet of foil backing material 24 secured to the
lower backing or support member 22. The backing material 24 may be
formed from either foil or thin paper or any other suitable product
which may be easily punctured or torn in order to provide access to
the cavity. During the filling process, medications are located
between the sheet of preferably clear plastic material 18 and the
foil or paper backing 24 in registration with the corresponding
holes in the respective sides of the backing or support member.
FIG. 5 illustrates an intermediate stage in the manufacturing
process wherein preferably clear plastic material sheet 18 and the
backing foil or paper sheet 24 have been laminated to the
respective sides of the support members 21, 22.
[0038] FIGS. 6 and 7 illustrate the formation of the blister
protrusion in the preferably clear plastic material sheet 18. This
stage in the processing can actually be performed at an
intermittent stage wherein roll fed material is temporarily
accumulated in order to allow the use of an intermittent process in
the formation of the cavities. Prior to this stage in the process,
the preferably clear plastic material has been heated. Plug assist
vacuum forming is preferably utilized although those skilled in the
art will appreciate the other alternate approaches may be utilized
as well. For example, pressure and vacuum forming without the use
of male plugs may be used as an alternate solution. Heating is
preferred in order to increase the ease with which the material can
be stretched. As shown in FIG. 6, male blister forming members 32
are located in registration above female blister forming members
33. The male and female members are in registration with the
corresponding openings in the sheet of material that has not been
shown in this illustration for the sake of convenience. The male
blister forming members 32 are moved toward the corresponding
female members 33 and push through the sheet of preferably clear
plastic material in order to form the blister members 35 as shown
in FIG. 7. Those skilled in the art will appreciate that vacuum
forming with plug assist is preferably utilized in the formation of
the blister portions. However, it should be recognized that this is
not necessary.
[0039] FIG. 7 illustrates a stage in the process wherein the upper
male blister forming members have been moved away from the female
members and the product package, thus leaving the blisters 35 in
the packaging material. In accordance with the preferred exemplary
embodiment, the male blister forming members are preferably located
on a rotary member in order to provide continuous processing of the
overall package. This preferred process is in contrast to the
intermittent processing shown in FIGS. 6 and 7. This arrangement
provides for the greatest degree of output. As noted above, it is
anticipated that manufacturing speeds in excess of 100 linear feet
per minute can be achieved. Additionally, as also noted in the
summary, it is possible to have rows of male and female members or
plates with multiple rows that stamp the blisters during the
manufacturing process as shown in FIGS. 6 and 7. The preferred
embodiment is, however, a rotary mechanism.
[0040] FIG. 8 illustrates the filling process for placement of one
or more individual solid pharmaceutical products into each of the
respective blister openings in the overall package. As shown in
FIG. 8, the medications are located in package templates 42 and one
or more sliding plates allows an opening in at least one of the
plates to drop the medications into the desired blister package
openings at the appropriate time. This is a conventional processing
step and is not necessary for utilization of the present invention
during the in-line process. This step actually preferably takes
place at a later point in time and even at a different location
than the original manufacturing process.
[0041] FIG. 9 illustrates the completed package with individual
solid pharmaceutical members located within the blister portions of
the overall package. The individual solid pharmaceutical products
can be accessed by pushing on the blister portions against the
solid pharmaceutical products to push the solid pharmaceutical
products through the backing material for access.
[0042] This is the typical way of the solid pharmaceutical products
are accessed through similar packaging materials. The advantages to
utilization of the system methods of the present invention are
primarily achieved in the overall efficiencies provided in the
manufacturing process. Yet another additional advantage inherent in
the systems and methods of the present invention is that the
material that is used preferably shrinks around the pharmaceutical
product thereby allowing more efficient storage of the product
packaging material.
[0043] FIG. 12 illustrates the portions of the manufacturing
process of the preferred exemplary embodiment directed to the
formation of blister members and the lamination of the preferably
clear plastic material to the cardboard backing. As shown in FIG.
12, the lamination portion of the process entails matching the
preferably clear plastic material 18 to the cardboard member over
the corresponding holes in the cardboard. Heated rollers 42, 44 are
utilized in order to raise the temperature of the preferably clear
plastic material 18 to a desired temperature. Heating is preferable
because it enables the material to be more easily formed. Male and
female rollers 46, 48 rotate such that rows of male members engage
corresponding rows of female members to simultaneously form a
plurality of blister portions. This facilitates more rapid
processing in an in-line or continuous roll fed machine. This
approach eliminates the need for temporary accumulation of the roll
fed materials which would be necessary if an intermittent forming
station is used as detailed above.
[0044] The finished product 48 passes from the rows of male and
female members located on the rollers 46, 48 to further processing
stations were about material is subsequently cut to the desired
size. Additionally, as recognized above, the rollers 46, 48 could
be replaced with stamp members that incorporate rows of male and
female members that are engaged for the purpose of forming the
blister portions intermittently.
[0045] Those skilled in the art will appreciate that the preferred
exemplary embodiment has been described with respect to the
formation of support members wherein one side of the cardboard
material has holes which are covered by the formable plastic
material and the other side has holes covered by foil. It should be
recognized that in an alternate embodiment, a single sheet of
cardboard material may be formed with the process according to the
invention wherein a single sheet has holes formed therein and a
formable plastic material is applied thereto. Subsequent to, or
simultaneously with this processing, the blister members may be
formed into the formable plastic material and a backing may be
applied. Preferably this backing may be foil material. A solid
pharmaceutical or other similar product is inserted into the
blister cavity. Those skilled in the art will appreciate that the
backing material may be applied directly to the cardboard support
member upon which the plastic material has been applied and within
which the blisters have been formed. This alternate approach would
eliminate the need for a further cardboard support portion.
* * * * *