U.S. patent application number 10/654662 was filed with the patent office on 2005-03-03 for disposable single-use container with indicia bearing portion.
Invention is credited to Poynter, Richard Q..
Application Number | 20050045667 10/654662 |
Document ID | / |
Family ID | 34194680 |
Filed Date | 2005-03-03 |
United States Patent
Application |
20050045667 |
Kind Code |
A1 |
Poynter, Richard Q. |
March 3, 2005 |
DISPOSABLE SINGLE-USE CONTAINER WITH INDICIA BEARING PORTION
Abstract
A container and storage apparatus with an attached, but
functionally separate, labeling portion is provided. The apparatus
has a primary chamber containing a predetermined agent separated
from the labeling portion. An optional contamination barrier region
may increase the separation. A preferred embodiment may be formed
by a blow-fill-seal method from thermoplastic, allowing one piece
molding of the apparatus. A removable cap allows a dispensing point
to be opened into the primary chamber for removal of the agent.
Indicia may be formed in or on the labeling portion, which may be
smaller, larger, or the same in size and shape as the primary
chamber. Inks, adhesives or other substances incidental to the
indicia will be less likely to migrate across the apparatus wall
and into the primary chamber due to the functional separation
provided between the primary chamber and labeling portion.
Inventors: |
Poynter, Richard Q.;
(Crystal Lake, IL) |
Correspondence
Address: |
CARDINAL HEALTH
7000 CARDINAL PLACE
LEGAL DEPARTMENT - INTELLECTUAL PROPERTY
DUBLIN
OH
43017
US
|
Family ID: |
34194680 |
Appl. No.: |
10/654662 |
Filed: |
September 3, 2003 |
Current U.S.
Class: |
222/541.9 ;
222/130 |
Current CPC
Class: |
B65D 25/205 20130101;
B01L 3/545 20130101; A61J 1/067 20130101; B65D 2203/00 20130101;
B65D 1/09 20130101; A61J 2205/20 20130101; A61J 2205/30 20130101;
A61J 2205/40 20130101; A61J 1/00 20130101 |
Class at
Publication: |
222/541.9 ;
222/130 |
International
Class: |
B65D 035/22 |
Claims
We claim:
1. A disposable single-use container and storage apparatus
containing a predetermined agent, wherein the apparatus has a
proximal end and a distal end, comprising: a primary chamber,
having at least one interior surface in contact with the agent and
at least one exterior surface in contact with a surrounding
environment; a removable cap, releasably attached to the primary
chamber and substantially near the distal end of the apparatus,
having at least one gripping surface, such that a dispensing point
capable of placing the inner surface of the primary chamber in
fluid communication with a surrounding environment is formed when
the removable cap is removed from the apparatus; and a labeling
portion, attached to the apparatus which comprises at least one
interior surface, at least one exterior surface and at least one
pressure equalization channel wherein said equalization channel
allows the surrounding environment to be in fluid contact with said
at least one interior surface of the labeling portion.
2. The apparatus of claim 1, wherein the removable cap further
includes at least one cap chamber wherein the cap chamber is in
fluid communication with the primary chamber across a frangible
break line, such that the dispensing point is formed when the
removable cap is removed from the apparatus at the frangible break
line.
3. The apparatus of claim 1, wherein the labeling portion is
substantially cylindrical in shape.
4. The apparatus of claim 1, further including at least one indicia
located on the labeling portion.
5. The apparatus of claim 4, wherein the at least one indicia is
formed in the labeling portion.
6. The apparatus of claim 4, wherein the at least one indicia is
integral to at least one shrink-wrap sleeve that is mounted to the
labeling portion.
7. The apparatus of claim 1, further including a contamination
barrier region formed between the labeling portion and the primary
chamber.
8. The apparatus of claim 1, made by a blow-fill-seal method.
9. The apparatus of claim 1, wherein the apparatus is formed in a
color associated with the predetermined agent.
10. The apparatus of claim 1, wherein the apparatus is formed in a
shape associated with the predetermined agent.
11. The apparatus of claim 1, wherein the apparatus is formed from
a thermoplastic.
12. The apparatus of claim 11, wherein the thermoplastic is
selected from a group consisting of polycarbonate, polyethylene,
polyester, polystyrene, polypropylene, polysulfone, polyurethane,
polyvinyl chloride, and ethylene-vinyl-acetate.
13. The apparatus of claim 1, wherein the labeling portion is
attached to the primary chamber substantially near the proximal end
of the apparatus.
14. The apparatus of claim 1, wherein the labeling portion is
attached to the removable cap substantially near the distal end of
the apparatus.
15. A storage apparatus containing a predetermined agent, wherein
the apparatus has a proximal end and a distal end, comprising: a
primary chamber, having at least one interior surface in contact
with the agent and at least one exterior surface in contact with a
surrounding environment; a removable cap, integrally molded to the
primary chamber and substantially near the distal end of the
apparatus, having at least one gripping surface, such that a
dispensing point capable of placing the inner surface of the
primary chamber in fluid communication with the surrounding
environment is formed when the removable cap is removed from the
apparatus, wherein the removable cap further includes at least one
cap chamber wherein the cap chamber is in fluid communication with
the primary chamber across a frangible break line, such that the
dispensing point is formed when the removable cap is removed from
the apparatus at the frangible break line; and a labeling portion,
attached to the apparatus, having at least one interior surface and
at least one exterior surface; and a contamination barrier region
formed between the labeling portion and the primary chamber.
16. The apparatus of claim 15, wherein the labeling portion is
substantially cylindrical in shape.
17. The apparatus of claim 15, further including at least one
indicia located on the labeling portion.
18. The apparatus of claim 17, wherein the at least one indicia is
formed in the labeling portion.
19. The apparatus of claim 17, wherein the at least one indicia is
integral to at least one shrink-wrap sleeve that is mounted to the
labeling portion.
20. The apparatus of claim 15, made by a blow-fill-seal method.
21. The apparatus of claim 15, wherein the apparatus is formed in a
color associated with the predetermined agent.
22. The apparatus of claim 15, wherein the apparatus is formed in a
shape associated with the predetermined agent.
23. The apparatus of claim 15, wherein the apparatus is formed from
a thermoplastic.
24. The apparatus of claim 23, wherein the thermoplastic is
selected from a group consisting of polycarbonate, polyethylene,
polyester, polystyrene, polypropylene, polysulfone, polyurethane,
polyvinyl chloride, and ethylene-vinyl-acetate.
25. The apparatus of claim 15, wherein the labeling portion is
attached to the primary chamber substantially near the proximal end
of the apparatus.
26. The apparatus of claim 15, wherein the labeling portion is
attached to the removable cap substantially near the distal end of
the apparatus.
27. A disposable single-use container and storage apparatus made by
a blow-fill-seal method, containing a predetermined agent, wherein
the apparatus has a proximal end and a distal end, comprising: a
primary chamber, having at least one interior surface in contact
with the agent and at least one exterior surface in contact with a
surrounding environment; a removable cap, integrally molded to the
primary chamber and substantially near the distal end of the
apparatus, having at least one gripping surface, such that a
dispensing point capable of placing the inner surface of the
primary chamber in fluid communication with the surrounding
environment is formed when the removable cap is removed from the
apparatus, wherein the removable cap further includes at least one
cap chamber wherein the cap chamber is in fluid communication with
the primary chamber across a frangible break line, such that the
dispensing point is formed when the removable cap is removed from
the apparatus at the frangible break line; and a labeling portion,
substantially cylindrical in shape, attached to the apparatus,
having at least one interior surface and at least one exterior
surface, and including at least one pressure equalization channel
allowing the surrounding environment to be in fluid contact with
the at least one interior surface of labeling portion; and a
contamination barrier region formed between the labeling portion
and the primary chamber.
Description
FIELD OF THE INVENTION
[0001] The instant invention relates to a container and storage
apparatus; particularly, a blow-fill-seal container formed with an
indicia bearing labeling portion.
BACKGROUND OF THE INVENTION
[0002] Glass containers, with their inherent fragility, sharp edges
after fracture, and possibility of introducing fragments into the
contents of the container, are increasingly being replaced by
plastic containers. Containers made of such materials as
polyethylene, polypropylene, and polyvinyl chloride are frequently
utilized, and are generally produced by a process of
"blow-fill-seal" (BFS), in which the containers are mechanically
blow molded, filled, and then sealed in a continuous operation.
[0003] BFS containers typically comprise a main chamber, holding
the desired contents, and a head portion. A relatively narrow neck
forms an outlet channel from the main chamber into the head
portion, and this outlet channel is sealed by a frangible membrane
that is typically formed by placing a crimp across the head portion
during the molding and sealing process. At the time of use, the
head portion is broken away from the main chamber portion, thus
opening the outlet channel and allowing removal of the contents. A
prototypical example of a BFS container is seen in U.S. Pat. No.
4,995,519 to Rose, et al. Alternatively, other methods of sealing
the container, such as a foil membrane with a pull-tab, may be used
to s al the container, as seen in U.S. Pat. No. 6,357,626 to Zhang,
et al.
[0004] BFS containers, since they are not typically resealable,
have found special application in dispensing unit dose contents,
particularly unit dose liquid medicaments. Typical of such use is
U.S. Pat. No. 6,241,124 to Hoyt. The '124 device is specifically
designed to handle sterile, preservative-free formulations, such as
those used in single dose eye drop applications.
[0005] While representing a definite advance in packaging, BFS
containers as they are currently manufactured share a number of
drawbacks. As they are generally designed to handle unit dose, or
otherwise small quantities of material, they are generally small,
slippery, and difficult to handle. Their small size makes it very
difficult to engrave or affix indicia that adequately describe the
contents in a size that may readily be discerned by the human eye.
In particular, persons with presbyopia or diminished vision
generally have a very difficult time reading the small print
generally present on such containers. Additionally, the materials
from which these containers are compounded are often permeable to
inks, adhesives, or other substances such that labeling indicia
cannot be imprinted on the container, or even sometimes on labels
affixed to the container, without potentially contaminating the
contents. Because of the commonality of many BFS container designs,
these containers tend to look very much alike, creating dangerous
points of confusion in utilizing such containers.
[0006] Recent developments in safety labeling have compounded some
of the problems associated with BFS containers. There is an
increasing trend toward labeling various materials, in particular
drugs, with machine-readable codes, more commonly known as bar
codes.
[0007] A typical system of utilizing bar codes to track, in this
case, drugs, is seen in U.S. Pat. No. 5,845,264 to Nelhaus. In the
'264 device, machine readable bar codes are placed on various
medications, which may be read by a scanner and compared with a
computer database of drug information. When combined with bar codes
associated with individual persons, pharmacies, or caregivers,
discernment and comparison of the various bar codes can be used to
generate a plurality of information regarding drug administration.
In particular, drug administration can be regulated to minimize the
chances of incorrect drug administration, which is widely
recognized to be a significant factor in medical treatment related
morbidity and mortality.
[0008] However, attaching bar codes to BFS containers has proven
problematic. The BFS containers are themselves often small, and it
is difficult to encode sufficient machine-readable code in a small
space to be useful. This is compounded by the necessity of sharing
space on the container with visually discernable printing, which
must not be covered or otherwise obscured by the machine-readable
code. The attachment of an opaque, or even translucent, label, may
tend to obscure the contents of the container. Because of the
problems of substance migration through BFS packaging, it is often
not practical to print bar codes directly on the containers, or
even on labels affixed directly to the containers, and heretofore
there has been no other practical place to put such code.
[0009] Accordingly, what the art has needed is a single-use
container and storage apparatus design d to incorporate a lab ling
portion to safely and reliably bear indicia, without minimizing or
obscuring the labeling on such containers. The labeling portion
should be functionally separated from those parts of the walls of
the BFS container which enclose the contents of the container in
order to prevent migration of substances incidental to labeling
through the walls of the BFS container and into the container
contents, and yet be physically part of the BFS container in order
to prevent separation of the labeling from the container. The
containers should be distinctive in appearance, and should be
simple and inexpensive to manufacture with a minimum of fabrication
steps. The instant invention answers these, and other, needs.
SUMMARY OF THE INVENTION
[0010] In its most general configuration, the present invention
advances the state of the art with a variety of new capabilities
and overcomes many of the shortcomings of prior devices in new and
novel ways. In its most general sense, the present invention
overcomes the shortcomings and limitations of the prior art in any
of a number of generally effective configurations.
[0011] In one of the simplest configurations, the instant invention
provides a disposable single-use container and storage apparatus
containing a predetermined agent. The apparatus has a primary
chamber, a labeling portion that is functionally separated from the
primary chamber, and a removable cap.
[0012] The primary chamber is closed by a removable cap releasably
attached to the primary chamber such that a dispensing point
capable of placing the inner surface of the primary chamber in
fluid communication with a surrounding environment is formed when
the removable cap is removed. The removable cap may be made of a
dissimilar material from the apparatus, such as a foil cap that is
heat-sealed to the apparatus. Alternatively, the removable cap may
be integrally formed and further include at least one cap chamber
wherein the cap chamber is in fluid communication with the primary
chamber across a frangible break line. In such an embodiment, the
dispensing point is formed when the removable cap is removed from
the apparatus at the frangible break line.
[0013] The shortcomings of the prior art devices are addressed by
the inventive apparatus in providing a labeling portion
functionally separated from the primary chamber. The functional
separation may be accomplished by placing a contamination barrier
region between the primary chamber and the labeling portion. The
labeling portion may be placed in any practical spatial
relationship to the primary chamber; and, in a preferred
embodiment, is placed proximally and close to the primary chamber.
In alternate embodiments, it may be placed distal to the cap and
relatively far from the primary chamber, or may even be lateral to
the primary chamber.
[0014] The labeling portion may be attached by any number of
methods, including, in a preferred embodiment, being integrally
formed with the apparatus. Such integral formation may be by a
number of methods, and includes, as would be understood by one
skilled in the art, casting or molding, and in particular, by a
blow-fill-seal method of fabrication. Additionally, the labeling
portion may be attached to the primary chamber with an adhesive, or
by any of a number of material joining techniques, including by way
of example and not limitation, chemical, mechanical, thermal, or
other joining technologies.
[0015] The labeling portion may be formed of a solid material, or
in a preferred embodiment, may have at least one interior surface
and at least one exterior surface. In those embodiments having at
least one interior surface and at least one exterior surface, the
labeling portion may be configured to have at least one pressure
equalization channel allowing the surrounding environment to be in
fluid contact with the at least one interior surface of the
labeling portion. The pressure equalization channel minimizes the
adverse effects associated with a closed gas-filled space. For
example, variations in atmospheric pressure would not tend to crush
or expand a labeling portion with an open pressure equalization
channel. A substantially hollow labeling portion allows the
apparatus to be made of less material (lighter weight), is less
expensive, and easily suited to blow-fill-seal manufacturing
techniques. Further, the addition of a labeling portion gives such
an apparatus additional gripping surfaces which make handling and
opening of the apparatus easier.
[0016] The apparatus may be formed in a wide variety of shapes and
sizes, including, but not limited to, a labeling portion being
substantially cylindrical in shape. Similarly, the primary chamber
may be formed in virtually any size and shape. In order to
facilitate identification of the contents, the apparatus may bear
at least one indicia located on the labeling portion. The indicia
may be formed in the material of the apparatus, an adhesive indicia
label may be affixed to the exterior surface of the labeling
portion, or a shrink-wrap sleeve may be mounted to the labeling
portion. An optional contamination barrier region, formed between
the labeling portion and the primary chamber, may help to
functionally isolate the primary chamber from the labeling portion
and thus make any solvents, inks, or other substances incidental to
the indicia less likely to migrate from the labeling portion across
the wall of the primary chamber and to contaminate the contents of
the apparatus. The apparatus may be formed by a blow-fill-seal
method, well known to those skilled in the art, and may be formed
of a thermoplastic, such as, by way of example and not limitation,
polycarbonate, polyethylene, polyester, polystyrene, polypropylene,
polysulfone, polyurethane, polyvinyl chloride and
ethylene-vinyl-acetate. Certain materials, such as polyethylene,
provide additional qualities to the invention, such as
compressibility of the walls of the vial, which allows the walls to
tend to collapse as fluid is being withdrawn with a syringe. This
tends to prevent the establishment of a vacuum within the vial, and
lessens the tendency for non-sterile ambient air to be drawn into
the interior of the vial.
[0017] While the labeling portion may be, in one embodiment,
substantially cylindrical in order to facilitate labeling, the
apparatus may be formed in virtually any shape, size, or color. In
alternate embodiments, the apparatus may be formed to have a
certain shape or color associated with a certain predetermined
agent, such that users will tend to associate a distinctive shape
or color of the apparatus with certain known agents.
[0018] Thus, there is disclosed a disposable single-use container
and storage apparatus containing a predetermined agent, wherein the
apparatus has a proximal end and a distal end, comprising:
[0019] a primary chamber, having at least one interior surface in
contact with the agent and at least one exterior surface in contact
with a surrounding environment;
[0020] a removable cap, releasably attached to the primary chamber
and substantially near the distal end of the apparatus, having at
least one gripping surface, such that a dispensing point capable of
placing the inner surface of the primary chamber in fluid
communication with a surrounding environment is formed when the
removable cap is removed from the apparatus; and
[0021] a labeling portion, attached to the apparatus which
comprises at least one interior surface, at least one exterior
surface and at least one pressure equalization channel wherein said
equalization channel allows the surrounding environment to be in
fluid contact with said at least one interior surface of the
labeling portion.
[0022] There is further disclosed a storage apparatus containing a
predetermined agent, wherein the apparatus has a proximal end and a
distal end, comprising:
[0023] a primary chamber, having at least one interior surface in
contact with the agent and at least one exterior surface in contact
with a surrounding environment;
[0024] a removable cap, integrally molded to the primary chamber
and substantially near the distal end of the apparatus, having at
least one gripping surface, such that a dispensing point capable of
placing the inner surface of the primary chamber in fluid
communication with the surrounding environment is formed when the
removable cap is removed from the apparatus, wherein the removable
cap further includes at least one cap chamber wherein the cap
chamber is in fluid communication with the primary chamber across a
frangible break line, such that the dispensing point is formed when
the removable cap is removed from the apparatus at the frangible
break line; and
[0025] a labeling portion, attached to the apparatus, having at
least one interior surface and at least one exterior surface;
[0026] and a contamination barrier region formed between the
labeling portion and the primary chamber.
[0027] There is also disclosed a disposable single-use container
and storage apparatus made by a blow-fill-seal method, containing a
predetermined agent, wherein the apparatus has a proximal end and a
distal end, comprising:
[0028] a primary chamber, having at least one interior surface in
contact with the agent and at least one exterior surface in contact
with a surrounding environment;
[0029] a removable cap, integrally molded to the primary chamber
and substantially near the distal end of the apparatus, having at
least one gripping surface, such that a dispensing point capable of
placing the inner surface of the primary chamber in fluid
communication with the surrounding environment is formed when the
removable cap is removed from the apparatus, wherein the removable
cap further includes at least one cap chamber wherein the cap
chamber is in fluid communication with the primary chamber across a
frangible break line, such that the dispensing point is formed when
the removable cap is removed from the apparatus at the frangible
break line; and
[0030] a labeling portion, substantially cylindrical in shape,
attached to the apparatus, having at least one interior surface and
at least one exterior surface, and including at least one pressure
equalization channel allowing the surrounding environment to be in
fluid contact with the at least one interior surface of labeling
portion; and
[0031] a contamination barrier region formed between the labeling
portion and the primary chamber.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] Without limiting the scope of the present invention as
claimed below and referring now to the drawings and figures:
[0033] FIG. 1 shows an elevated perspective view, not to scale, of
one embodiment of the apparatus of the instant invention in its
sealed state;
[0034] FIG. 2 shows an elevated perspective view, not to scale, of
the embodiment of FIG. 1 with the removable cap removed and placed
next to the apparatus;
[0035] FIG. 3 shows a top plan view, not to scale, of the
embodiment of FIG. 1;
[0036] FIG. 4 shows a side plan view, not to scale, of the
embodiment of FIG. 1;
[0037] FIG. 5 shows a section view, not to scale, of the embodiment
of FIG. 3, taken along section line 5-5;
[0038] FIG. 6 shows a section view, not to scale, of the embodiment
of FIG. 5, shown with the removable cap removed;
[0039] FIG. 7 shows a top plan view, not to scale, of an
alternative embodiment of the apparatus of the instant
invention;
[0040] FIG. 8 shows a top plan view, not to scale, of another
alternative embodiment of the apparatus of the instant
invention;
[0041] FIG. 9 shows a section view, not to scale, of the embodiment
of FIG. 7, taken along section line 9-9;
[0042] FIG. 10 shows a section view, not to scale, of the
embodiment of FIG. 8, taken along section line 10-10;
[0043] FIG. 11 shows an elevated perspective view, not to scale, of
one embodiment of the apparatus of the instant invention in its
sealed state; and
[0044] FIG. 12 shows an elevated perspective view, not to scale, of
the embodiment of FIG. 11 with the removable cap removed and placed
next to the apparatus.
DETAILED DESCRIPTION OF THE INVENTION
[0045] The container and storage apparatus of the instant invention
enables a significant advance in the state of the art. The
preferred embodiments of the apparatus accomplish this by new and
novel arrangements of elements that are configured in unique and
novel ways and which demonstrate previously unavailable but
preferred and desirable capabilities.
[0046] The detailed description set forth below in connection with
the drawings is intended merely as a description of the presently
preferred embodiments of the invention, and is not intended to
represent the only form in which the present invention may be
constructed or utilized. The description sets forth the designs,
functions, means, and methods of implementing the invention in
connection with the illustrated embodiments. It is to be
understood, however, that the same or equivalent functions and
features may be accomplished by different embodiments that are also
intended to be encompassed within the spirit and scope of the
claimed invention.
[0047] Referring generally to FIGS. 1 through 10, the instant
invention includes an integrally molded disposable single-use
container and storage apparatus 50, a labeling portion 100, a
primary chamber 200, and a removable cap 300. The apparatus 50 has
a proximal end 52 and a distal end 54, as seen in FIG. 1 and FIG.
2. The primary chamber 200, seen in FIGS. 1 through 8, has at least
on interior surface 210 in contact with the stored material (i.e. a
liquid pharmaceutical) and at least one exterior surface 220 in
contact with a surrounding environment. This is best seen in FIG.
5.
[0048] The primary chamber 200 is closed by a removable cap 300,
seen in FIGS. 1 through 8, releasably attached to the primary
chamber 200 and substantially near the distal end 54 of the storage
apparatus 50. The removable cap 300 has at least one gripping
surface 310, such that a dispensing point 230, seen in FIG. 6,
capable of placing the inner surface 210 of the primary chamber 200
in fluid communication with the surrounding environment is formed
when the removable cap 300 is removed from the apparatus 50 (the
container is opened). The removable cap 300, by way of example and
not limitation, may be made of a material dissimilar from the
storage apparatus 50. For example, a foil cap may be heat sealed to
the storage apparatus 50. Alternatively, and in a preferred
embodiment, seen in FIG. 5, the removable cap 300 further includes
at least one cap chamber 320 wherein the cap chamber 320 is in
fluid communication with the primary chamber 200 across a frangible
break line 330, such that the dispensing point 230, as seen in FIG.
6, is formed when the removable cap 300 is removed from the storage
apparatus 50 at the frangible break line 330.
[0049] Further shortcomings of the prior art storage apparatuses
are addressed by the apparatus 50 having a labeling portion 100,
attached to the apparatus 50, seen in FIGS. 1 through 12. The
labeling portion 100 may be placed in any practical spatial
relationship to the primary chamber 200; and, in a preferred
embodiment, as seen in FIGS. 1-10 the labeling portion 100 may be
placed proximally and close to the primary chamber 200. In
alternate embodiments, as seen in FIGS. 11 and 12, the labeling
portion 100 may be placed distal to the cap chamber 320 and
relatively far from the primary chamber 200, or may even be lateral
to the primary chamber. The labeling portion 100 may be separated
from the primary chamber 200 by a contamination barrier region 150
formed between the labeling portion 100 and the primary chamber
200, as seen in FIGS. 1-10. In alternate embodiments, seen in FIGS.
11 and 12, the contamination barrier region 150 may separate the
cap chamber 320 from the labeling portion 100. The labeling portion
100 may be formed of a solid material, or in a preferred
embodiment, may have at least one interior surface 110 and at least
one exterior surface 120.
[0050] In those embodiments having at least one interior surface
110 and at least one exterior surface 120, the labeling portion 100
may be configured to have at least one pressure equalization
channel 130 allowing the surrounding environment to be in fluid
contact with the at least one interior surface 110 of the labeling
portion 100. The pressure equalization channel 130 minimizes the
adverse effects associated with a closed gas-filled space in the
labeling portion 100. A substantially hollow labeling portion 100
allows the apparatus 50 to be made of less material and with a
lighter weight, is less expensive, and more feasibly suited to
blow-fill-seal manufacturing techniques.
[0051] The apparatus 50, may formed in a wide variety of shapes and
sizes, including, but not limited to, a labeling portion 100 being
substantially cylindrical in shape, as seen in FIGS. 3 through 6.
Alternative shapes of the labeling portion 100, by way of example
and not limitation, include substantially square profiles, as seen
in FIGS. 7 and 9, and polyhedral profiles, illustrated by a
substantially triangular profile in FIGS. 8 and 10. Similarly, the
primary chamber 200 may be formed in virtually any size and
shape.
[0052] In order to facilitate identification of the contents, the
apparatus 50 may bear at least one indicia 140 located on the
labeling portion 100, seen in FIGS. 3, 4, and 7. The indicia 140
may be carried on the apparatus 50 in a wide variety of manners. In
one embodiment, indicia 140 is formed in the material of the
apparatus 50. In another, seen in FIG. 7, an adhesive indicia label
144 is affixed to the exterior surface 120 of the labeling portion
100. In a preferred embodiment, seen in FIG. 4, the at least one
indicia 140 is integral to at least one shrink-wrap sleeve 142 that
is mounted to the labeling portion 100. The contamination barrier
region 150, seen well in FIGS. 6 and 7, formed, in this embodiment,
between the labeling portion 100 and the primary chamber 200, helps
to insure that any solvents, inks, or other substances incidental
to the indicia 140 are less likely to migrate across the wall of
the primary chamber 200 and to contaminate the contents of the
apparatus 50.
[0053] Studies were undertaken in one embodiment wherein the
apparatus was fabricated of low density polyethylene (LDPE), to
assess the potential for migration of volatile compounds from the
indicia 140 and the shrink-wrap sleeve 142, into the primary
chamber 200. In summary of the protocol, potential migrants were
identified from both shrink-wrap sleeves 142 and from the primary
chambers 200 of unlabeled samples of the apparatus 50. Any migrants
eventually detected in the contents of the primary chamber 200,
which corresponded to migrants detected in the indicia 140 bearing
shrink-wrap sleeves 142, but which did not correspond to migrants
detected in the primary chamber 200 contents of unlabeled
experimental examples of the apparatus 50, may be presumed to be
migrants that passed from the indicia 140, across the walls of the
primary chamber 200, and into the primary chamber 200 contents.
Other detected compounds may migrate from the LDPE material of the
apparatus 50.
Test 1
Extraction of Compounds from Indicia and Shrink-Wrap Sleeves
[0054] As a first step, a direct extraction and analysis of one
embodiment of the indicia 140 bearing shrink-wrap sleeves 142
according to one embodiment was carried out to determine potential
migrants that might later be detected in the primary chamber 200
contents. Indicia 140 was imprinted on shrink-wrap sleeves 142, and
the shrink-wrap sleeves 142 bearing indicia 140 themselves had
weight and surface area determined for the loose, that is, not
affixed to apparatus 50, shrink-wrap sleeves 142. Indicia 140
bearing shrink-wrap sleeves 142 were found to weigh, on average,
175 mg each, and had a one-side surface area of 11.25 cm.sup.2.
Four indicia 140 bearing shrink-wrap sleeves 142 were combined for
extraction. The indicia 140 bearing shrink-wrap sleeves 142 were
placed in a 50-ml borosilicate glass test tube sealed with a
polytetrafluoroethylene-lined screw cap closure along with 40 ml of
10% ethanol (ETOH) in distilled water. The tube was tightly closed
and incubated at 40.degree. C. for 14 hours with constant
agitation. Following incubation, the tube was cooled to room
temperature and the indicia 140 bearing shrink-wrap sleeves 142
were removed. Internal standard (anthracene-d.sub.10) at a
concentration equivalent to 100 PPB (parts per billion) (w/v)
relative to the 10% ETOH extraction solvent was spiked into the
tube along with 5.0 ml of methylene chloride. The solution was
extracted and then centrifuged at 2000 RPM for 30 minutes to
promote complete phase separation. The lower methylene chloride
layer was transferred to a 5 ml, conical bottomed vial, and
concentrated under a gentle stream of nitrogen at room temperature
to a final volume of approximately 100 .mu.l. The concentrated
extract was then analyzed by gas chromatography-mass spectrometry
(GC-MS). A method analysis blank was performed and analyzed
alongside the indicia 140 bearing shrink-wrap sleeves 142 and
consisted of all reagents and work up procedure except for the
absence of indicia 140 bearing shrink-wrap sleeves 142. Triplicate
analyses were performed. The compounds detected in the direct
extracts of the indicia 140 bearing shrink-wrap sleeves 142 were
used to compile a target list of indicia 140 bearing shrink-wrap
sleeve 142 borne extractables to check for as potential migrants in
the primary chamber 200 contents. Table 1 is a summary of the
indicia 140 bearing shrink-wrap sleeve 142 direct extraction
results, and lists the compound detected in the 10% ETOH direct
extract of the labels. The concentration data is expressed in parts
per billion (PPB) w/w in the 10% ETOH extraction solvent. The mean
and standard deviation values for the three replicate
determinations are given.
1TABLE 1 Compounds Detected in Direct Extraction of Labels (Indicia
and Shrink-Wrap Sleeves) Concentration Compound (Mean +/- S.D.)(PPB
w/w) Unknown compound 142 m.w., 1.66 +/- 0.14 monochlorinated
2,6-di-t-butylbenzoquin- one 0.54 +/- 0.37
2,6,di-t-butyl-p-hydroxyanisole (BHT 3.79 +/- 0.37 methyl ether)
Unknown compound 154 mw. 0.95 +/- 0.34 Butylated hydroxyl toluene
(BHT) 0.18 +/- 0.03 Neopentyl glycol-adipic acid cyclic 17.94 +/-
0.77 diester (NPG-adiapte) cis-isophorone diisocyanate (cis-IDPI)
1.03 +/- 0.32 Trans-isophorone diisocyanate (trans 6.46 +/- 1.36
IPDI) Tripropylene glycol (TPG) 2.38 +/- 1.21
2,6-di-t-butyl-p-ethylphen- ol (lonol II) 0.40 +/- 0.14
Dibutylphthalate 1.44 +/- 0.23 methyl abietate 0.46 +/- 0.04 di-(EG
adipate) 92.95 +/- 11.76 EG, NPG-diadipate 87.34 +/- 9.18 di-(NPG
adipate) 25.38 +/- 3.83 Ethylene glycol terephthalate oligomer 1.17
+/- 1.42 I (EG-terephthalate) Ethylene glycol terephthalate
oligomer 19.94 +/- 4.97 II (EG-terephthalate) Tri-(EG-adipate)
35.65 +/- 10.24 EG-NPG adipate (3:1:3 oligomer) 31.91 +/- 6.82
EG-NPG-adipate (2:2:3) oligomer) 18.33 +/- 1.62 Total Direct
Indicia Bearing Shrink- 355.75 +/- 36.43 Wrap Sleeve 10% ETOH
Extractables
[0055] The analytical data on direct label extractables is in
agreement with the reported composition of the base polymer
shrink-wrap sleeves 142 and composition of the indicia 140 as
reported for the particular embodiment studied. The base polymer of
the shrink-wrap sleeve 142 in the particular embodiment was PET-G,
which is a polyester based on polyethylene terephthalate. The
direct label extractables found at highest concentration are all
short chain polyester oligomers including ethylene glycol
terephthalic acid esters and esters of ethylene glycol and
neopentyl glycol with adipic acid. Two common polyurethane-type
monomers were detected (cis and trans-isophorone diisocyanate) were
detected, indicating the use of polyurethane-based inks in the
printing of the indicia 140. Other monomer compounds included
hindered-phenol type antioxidants, traces of plasticizers, and some
rosin ester.
Test 2
Extraction from Unlabeled Samples of Apparatus
[0056] Next, an analysis of potential migrants derived from the
material of the apparatus 50 was performed to identify potential
migrants from the structural material of the apparatus 50 itself
that might later be detected in the primary chamber 200 contents.
Should such migrants be detected in the primary chamber 200
contents, and not be present in the direct extracts from the
indicia 140 bearing shrink-rap sleeves 142 as detailed in Table 1,
it would be inferred that such compounds had originated from the
body of the apparatus 50, rather than from the indicia 140 bearing
shrink-wrap sleeves 142.
[0057] A total of 30 unlabeled examples of the apparatus 50 each
containing 5 ml of 0.9% normal saline (NS) were stored at
40.degree. and 60.degree. C. for ten days in constant temperature
chambers at 75% relative humidity (RH) and were then analyzed to
establish a baseline for organic extractable components. The
apparatus 50 contents were analyzed in triplicate. For each
replicate, the contents from 10 examples of the apparatus 50 were
pooled together and poured into a 70-ml size borosilicate glass
test tube sealed with a polytetrafluoroethylene-lined screw cap
closure. Internal standard (antracene-d.sub.10) at a concentration
equivalent to 10 PPB (w/w) relative to the 0.9% normal saline
solution was spiked into the tube along with 5.0 ml of methylene
chloride. The saline solution was extracted and centrifuged at 2000
RPM for 30 minutes to promote complete phase separation. The lower
methylene chloride layer was transferred to a 5-ml conical bottomed
vial and concentrated under a gentle stream of nitrogen at room
temperature to a final volume of approximately 10.0 .mu.l. The
concentrated extract was then analyzed by GC-MS as previously
described.
[0058] Tables 2 and 3 list the compounds detected in the methylene
chloride extracts of the saline solution contents of the unlabeled
examples of the apparatus 50. Concentration data is expressed units
of parts per billion (PPB) w/w in the saline solution. In each case
the mean and standard deviation values for the three replicate
determinations are given.
2TABLE 2 Compounds Detected in Normal Saline Solution of Unlabeled
Samples of the Apparatus Stored at 40.degree. C., 75% RH, for 10
Days Concentration Compound (Mean +/- S.D.)(PPB w/w)
2-butoxyethanol (Butyl Cellosolve) 0.92 +/- 0.21 Nonanal 0.52 +/-
0.04 2-ethyhexanoic acid 0.83 +/- 0.46 octanoic acid 0.87 +/- 0.12
2-phenoxy-1-propanol 3.09 +/- 0.50 caprolactam 14.89 +/- 8.60
nonanoic acid 28.07 +/- 7.70 p-isoamylphenol 3.02 +/- 0.31 Surfynol
104 0.27 +/- 0.15 2,6-di-t-butyl-phydroxyanisole (BHT 0.90 +/- 0.26
methyl ether) Butylated hydroxyl toluene (BHT) 0.31 +/- 0.06
o-hydroxybiphenyl 2.94 +/- 0.43 diethylphthalate (DEP) 137.17 +/-
48.55 Unknown 184 m.w. substance 0.74 +/- 0.43 ethylene
glycol-adipic acid monoester 0.96 +/- 0.24 (EG-adipate) lauramide
0.79 +/- 0.69 dibutylphthalate 6.03 +/- 7.08 myristamide 1.30 +/-
0.43 palmitoleamide 0.40 +/- 0.27 palmitamide 1.59 +/- 1.26
oleamide 0.28 +/- 0.16 stearamide 0.79 +/- 0.19
di-2-ethylhexylphthalate (DEHP) 2.39 +/- 2.42 Erucamide 3.48 +/-
2.60 Mixture of short chain polyethylene 3.07 +/- 2.82 oligomers
(long chain hydrocarbons) Total Methylene Chloride Extractables
215.63 +/- 59.00
[0059]
3TABLE 3 Compounds Detected in Normal Salin Solution of Unlabeled
Samples of the Apparatus Stored at 60.degree. C., 75% RH, for 10
Days Concentration Compound (Mean +/- S.D.)(PPB w/w) Phenol 1.04
+/- 0.40 2-butoxyethanol (Butyl Cellosolve) 0.81 +/- 0.34 nonanal
0.62 +/- 0.43 2-ethylhexanoic acid 2.59 +/- 0.60 diethylene glycol,
monobutyl ether 15.63 +/- 5.73 octanoic acid 0.74 +/- 0.11
2-phenoxy-1-propanol 0.62 +/- 0.18 caprolactam + nonanoic acid
11.21 +/- 5.05 p-isoamylphenol 0.27 +/- 0.12 Surfynol 104 0.06 +/-
0.06 2,6-di-t-butyl-p-hydroxyanisole (BHT 1.04 +/- 0.75 methyl
ether) butylated hydroxyl toluene (BHT) 0.38 +/- 0.09
o-hydroxybiphenyl 41.33 +/- 26.44 diethylphthalate (DEP) 441.47 +/-
85.87 unknown 184 m.w. 0.95 +/- 0.58 ethylene glycol-adipic acid
monoester 0.84 +/- 0.55 (EG-Adipate) Lauramide 1.07 +/- 1.27
mixture of nonylphenol isomers 3.95 +/- 2.05 (decomposition
products of trisnonylphenylphosphite, TNPP stabilizer)
Diisobutylphthalate 0.14 +/- 0.02 Dibutylphthalate 0.37 +/- 7.25
Myristamide 1.19 +/- 0.57 Palmitoleamide 6.47 +/- 4.92 Palmitamide
35.72 +/- 15.60 Oleamide 0.31 +/- 0.16 Stearamide 0.09 +/- 0.05
di-2-ethylhexylphthalate (DEHP) 0.15 +/- 0.07 erucamide 1.08 +/-
0.51 mixture of short chain polyethylene 2.24 +/- 1.28 oligomers
(long chain hydrocarbons) Total Methylene Chloride Extractables
577.10 +/- 102.94
[0060] Trace levels of organic extractables were detected in the
unlabeled samples. The compounds are mostly plastic migrants
resulting from exposure of the saline to various polymeric
materials it is processing history. They include antioxidants,
plasticizers, slip additives (fatty acid amide derivatives), which
are added to plastics as mold release agents or to reduce the
coefficient of friction during processing, plastic oxidation
products, solvents, surfactants, and monomers such as caprolactam
(Nylon monomer) and short chain polyethylene oligomers. The
profiles of the 40.degree. and 60.degree. C. samples were very
similar with only several exceptions. The 60.degree. C. samples
contained some isomeric nonylphenols, which are decomposition
products of a common plastic stabilizer called tris-(nonylphenyl)
phosphate (TNPP). The 60.degree. C. samples also uniquely contained
traces of phenol, diisobutylphthalate and diethylene glycol,
monobutyl ether. Several compounds found in both the direct label
extracts (Table 1) and the unlabeled apparatus 50 sample primary
chamber 200 contents (Tables 2 and 3) were the plasticizer
dibutylphthalate and the two hindered-phenol type antioxidants BHT
and BHT methyl ether. The level of these three components were very
low in all samples, and as they were present in both the direct
indicia 140 bearing shrink-wrap sleeve 142 extracts and the
unlabeled apparatus 50 sample primary chamber 200 contents (Tables
2 and 3), they were disregarded as potential indicia 140 bearing
shrink-wrap sleeve 142 migrants.
Test 3
Extraction from Apparatus Labeled According to an Embodiment of the
Instant Invention
[0061] After the list of potential migrants that might arise from
the indicia 140 bearing shrink-wrap sleeves 142 of the experimental
embodiment, as detailed in Table 1; and the material of the
apparatus 50 itself, as detailed in Tables 2 and 3, was assembled,
a comparison was undertaken to measure compounds appearing in the
primary chamber 200 of the experimental apparatus 50 to identify
those compounds which had migrated into the primary chamber 200
from the indicia 140 bearing shrink-wrap sleeves 142. In short,
knowing which migrants might originate in the labels, and knowing
which migrants may originate from the walls of the apparatus 50,
allows a deduction as to the origin of any migrant eventually
detected in the primary chamber 200.
[0062] A total of 30 labeled examples of the apparatus 50, each
bearing indicia 140 printed on a shrink-wrap sleeve 142 according
to one embodiment of the instant invention, and each containing 5
ml of 0.9% normal saline (NS) were examined for the presence of any
compounds detected in both the direct extracts of the indicia 140
and shrink-wrap sleeves 142 and which were not present in the
extractables found in unlabeled examples of the apparatus 50. The
extraction and analysis protocol was the same as that used in Test
2. Extremely trace levels of two indicia 140 bearing shrink-wrap
sleeve 142 migrants (polyester oligomers) were detected in the
extracts of the labeled examples of the apparatus 50. A third
adipate was detected only in those samples stored at 60.degree. C.
The concentration of these oligomers is summarized in Table 4.
These compounds were presumptively identified, therefore, as having
migrated into the primary chamber 200 contents from the indicia 140
bearing shrink-wrap sleeves 142.
4TABLE 4 Indicia and Shrink-wrap Sleeve Migrants Detected in
Sterile Saline Solution Contents of Labeled Example of the
Apparatus Stored at 40.degree. C. and 60.degree. C., 75% RH, for 10
Days Concentration of Migrant in Saline Solution in PPB w/w (Mean
+/- S.D.) ethylene glycol ethylene glycol terephthalate oligomer
ethylene glycoladipic Sample terephthalate oligomer 2 (EG- acid
dimer Identification 1 (EG-Terephthalate) Terephthalate)
di-(EG-Adipate) Labeled 2.78 +/- 1.43 0.64 +/- 0.29 N.D.* Samples
Stored at 40.degree. C., 75% RH, 10 Days Labeled 1.71 +/- 0.67 0.49
+/- 0.25 0.11 +/- 0.02 Samples Stored at 60.degree. C., 75% RH, 10
Days *Compound not detected in samples at this storage level
temperature
Test 4
Extraction from Apparatus with Indicia and Shrink-wrap Label on
Primary Chamber Ext rior Surface ("Double-Labeled")
[0063] One of the experimental hypotheses of the instant invention
is that there may be value, in reducing migration, of imposing a
physical separation between the labeling portion 100 and the
primary chamber 200 of the apparatus 50. To test this hypothesis,
examples of the apparatus 50 were prepared with a second indicia
140 bearing shrink-wrap sleeve 142 covering the primary chamber
200, in addition to the indicia 140 bearing shrink-wrap sleeve 142
in the normal location of the preferred embodiment, that is,
covering the labeling portion 100 of the apparatus 50. In this
experiment, therefore, an indicia 140 bearing shrink-wrap sleeve
142 was placed directly on the primary chamber exterior surface
220. Accordingly, as with conventionally labeled prior art designs
of this type, any migrant could reach the interior surface 210 of
the primary chamber 200 by passage across the relatively thin wall
separating the chamber interior surface 210 from the chamber
exterior surface 220. This is to be contrasted with the design of
the preferred embodiment, as seen in FIGS. 1-8, where, in order for
a migrant to pass from the indicia 140 bearing shrink-wrap sleeve
142 to the interior surface 210 of the primary chamber 200, such
migrant would have to traverse the physical separation between the
labeling portion 100 and the primary chamber 200, including, in
some embodiments, the contamination barrier region 150.
[0064] The experimental hypothesis was that such "double-labeled"
apparatus 50, resembling prior art labeling, would display an
increased level of migrants, as compared to the "single labeled"
apparatus 50, as intended by the instant invention, as discussed
above, and as detailed in Table 4. Additionally, it was
hypothesized that the increase in migrants would be out of
proportion to the approximate doubling in size of the labeled area
of the apparatus 50, that is, the increase in level of migrants
would not be linearly related to the increase in the labeled
surface area caused by adding a second label. Accordingly,
double-labeled apparatus 50 were prepared by placing a second
indicia 140 bearing shrink-wrap sleeve 142 over the primary chamber
200. Storage, extraction, and analysis methodology exactly matching
that of the single labeled samples, as detailed above and in Table
4, was performed. The results are summarized in Table 5.
5TABLE 5 Indicia and Shrink-wrap Sleeve Migrants Detected in
Sterile Saline Solution Contents of Double-Labeled Example of the
Apparatus Stored at 40.degree. C. and 60.degree. C., 75% RH, for 10
Days Double-Labeled Double-Labeled Apparatus Apparatus 10 Days,
40.degree. C., 75% RH 10 Days, 60.degree. C., 75% RH Compound (Mean
+/- S.D.)(PPB w/w) (Mean +/- S.D.)(PPB w/w) Unknown 142 m.w. 3.25
+/- 0.44 2.37 +/- 0.31 NPG-Adipate 33.78 +/- 5.25 43.79 +/- 2.92
TPG 5.92 +/- 0.69 5.88 +/- 1.04 di-(EG-adipate) 30.55 +/- 2.99
140.12 +/- 21.74 EG/NPG-Adipate 15.22 +/- 0.87 87.82 +/- 8.55
di-(NPG-adipate) 2.32 +/- 0.91 9.97 +/- 1.87 EG-terephthalate
oligomer 1 0.40 +/- 0.14 0.55 +/- 0.09 EG-terephthalate oligomer 2
0.57 +/- 0.04 4.98 +/- 1.65 tri-(EG-adipate) N.D.* 7.46 +/- 2.52
EG-NPG-adipate (3:1:3) N.D.* 5.60 +/- 1.38 *Compound not detected
in samples at this storage level temperature
[0065] Comparison of the results seen in Table 5 for the
double-labeled apparatus 50 are in marked contrast to those of the
preferred embodiment apparatus 50 summarized in Table 4. Placing a
second indicia 140 bearing shrink-wrap sleeve 142 on the apparatus
50 resulted in migration of six additional compounds being detected
at 40.degree. C. storage temperatures, and in seven additional
compounds being detected at 60.degree. C. storage conditions.
[0066] Additionally, as to levels of the three migrant compounds
that were detected at 60.degree. C. storage conditions, in the
preferred embodiment as seen in Table 4, there were some
significant differences in some of these migrants as present in the
double-labeled samples. For example, although there was little
difference in the levels of EG-terephthalate oligomers seen as
migrants in the single labeled and double-labeled specimens stored
at 40.degree. C., there was approximately a two and half times
increase in these oligomers in the double-labeled samples stored at
60.degree. C., (Table 5, sum of EG-terephthalate oligomer 1 and
oligomer 2=5.53 PPB/mean), as compared to the single labeled
samples stored at 60.degree. C. (Table 4, sum of EG-terephthalate
oligomer 1 and oligomer 2=2.20 PPB/mean). Even more remarkable was
the difference in migration of di-(EG-adipate), which increased
from 0.11 PPB .+-.0.02 (Table 4) in the single labeled sample, to a
mean of 140.12.+-.21.74 (Table 5) in the double-labeled sample, a
more than one thousand fold increase.
[0067] Six compounds that were either not present, or below
detection thresholds, in single labeled samples, were detected in
the double-labeled samples stored at 40.degree. C. (Unknown 142
m.w. substance, NPG-Adipate, TPG di-(EG-adipate), EG/NPG-Adipate,
and di-(NPG-adipate).
[0068] Additionally, in addition to these five, two compounds that
were either not present, or below detection thresholds, in single
labeled samples, were detected in the double-labeled samples stored
at 60.degree. C., tri-(EG-adipate) and EG-NPG-adipate (3:1:3).
[0069] In summary, the results of this series of experiments using
a single embodiment of the instant invention, showed that migration
of various compounds across the wall of the apparatus 50 could be
mitigated by the design of the instant invention. It is to be noted
that these experiments involved only a single embodiment of the
instant invention, and that different design details, materials,
and functional aspects of the instant invention may be incorporated
in differing embodiments.
[0070] For example, the apparatus 50 may be formed by a number of
blow-fill-seal and other methods, well know to those skilled in the
art, and may be formed of a thermoplastic, such as, by way of
example and not limitation, polycarbonate, polyethylene, polyester,
polystyrene, polypropylene, polysulfone, polyurethane, polyvinyl
chloride, and ethylene-vinyl-acetate. Certain materials, such as
polyethylene, provide additional qualities to the invention, such
as compressibility of the walls of the vial, which allows the walls
to tend to collapse as fluid is being withdrawn with a syringe.
This tends to prevent the establishment of a vacuum within the
vial, and lessens the tendency for non-sterile ambient air to be
drawn into the interior of the vial.
[0071] While the labeling portion 100 is, in one embodiment,
substantially cylindrical in order to facilitate labeling, the
apparatus 50 may be formed in virtually any shape, size, or color.
The labeling portion 100 and the primary chamber 200 may be
approximately the same size or shape as one another, or may be
radically different in size and shape from each other. In alternate
embodiments, the apparatus 50, or parts of the apparatus 50, may be
formed to have a certain shape or color associated with a certain
predetermined agent, such that users will tend to associate a
distinctive shape or color of the apparatus 50 with certain known
agents. By way of example and not limitation, topical agents could
be manufactured in containers of a certain shape or color, while
parenteral agents could be manufactured in a different shape or
color. High hazard agents, such as chemotherapeutics or narcotics,
could be packaged in especially distinctive colors or shapes. All
such package coding would serve to decrease errors in agent
identification.
[0072] Numerous alterations, modifications, and variations of the
preferred embodiments disclosed herein will be apparent to those
skilled in the art and they are all anticipated and contemplated to
be within the spirit and scope of the claimed instant invention.
For example, although specific embodiments have been described in
detail, those with skill in the art will understand that the
preceding embodiments and variations can be modified to incorporate
various types of substitute and/or additional or alternative
materials, relative arrangement of elements, and dimensional
configurations.
[0073] Accordingly, even though only few variations of the present
invention are described herein, it is to be understood that the
practice of such additional modifications and variations and the
equivalents thereof, are within the spirit and scope of the
invention as defined in the following claims.
Industrial Applicability
[0074] The system and method answers a long felt need for a
container and storage apparatus wherein a labeling portion is
attached to, and yet functionally separated from, the agent
containing chamber. Particularly in the manufacture of plastic
containers, where small size of the container, or the migration of
labeling indicia and associated substances across the wall of the
apparatus, may restrict lab ling options, the instant invention
provides a safe and secure location for the placement of
indicia.
* * * * *