U.S. patent application number 14/351511 was filed with the patent office on 2014-08-21 for liner-based shipping and dispensing containers for the substantially sterile storage, shipment, and dispense of materials.
The applicant listed for this patent is Advanced Technology Materials, Inc.. Invention is credited to Alfredo Daniel Botet.
Application Number | 20140231427 14/351511 |
Document ID | / |
Family ID | 48082464 |
Filed Date | 2014-08-21 |
United States Patent
Application |
20140231427 |
Kind Code |
A1 |
Botet; Alfredo Daniel |
August 21, 2014 |
LINER-BASED SHIPPING AND DISPENSING CONTAINERS FOR THE
SUBSTANTIALLY STERILE STORAGE, SHIPMENT, AND DISPENSE OF
MATERIALS
Abstract
A liner-based assembly including an overpack, a liner disposed
within the overpack, and a filling connector securable to at least
one of the overpack and the liner and ineloding a membrane for
substantially aseptic filling. The membrane may be an elastomeric
stopper, which may be configured, for re-sealing with or without
the assistance of heat The liner-based assembly may further include
a dispense connector that is operably connected with the overpack
and/or the liner. The dispense connector may comprise or be
operably connected to a one-way valve, the one-way valve having
--an elastomeric portion defining an opening and generally operably
coupled with a plug member positioned within the--opening. In a
closed position, the elastomeric portion may be sealed against the
plug member, and when a pressure is applied against the elastomeric
portion, the elastomeric portion may flex in a manner configured
--to permit only one--way flow through the opening.
Inventors: |
Botet; Alfredo Daniel;
(Avon, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Advanced Technology Materials, Inc. |
Danbury |
CT |
US |
|
|
Family ID: |
48082464 |
Appl. No.: |
14/351511 |
Filed: |
October 12, 2012 |
PCT Filed: |
October 12, 2012 |
PCT NO: |
PCT/US2012/059865 |
371 Date: |
April 11, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61546678 |
Oct 13, 2011 |
|
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|
61590164 |
Jan 24, 2012 |
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Current U.S.
Class: |
220/62.21 |
Current CPC
Class: |
B67D 1/0462 20130101;
B65D 25/18 20130101; B65D 25/14 20130101; B65D 77/06 20130101; A61J
1/05 20130101; B65D 77/0486 20130101; A61J 1/16 20130101 |
Class at
Publication: |
220/62.21 |
International
Class: |
B65D 25/14 20060101
B65D025/14 |
Claims
1. A liner-based assembly for use with pressure dispense
comprising: an overpack; a liner disposed within the overpack; and
a filling connector that is securable to at least one of the
overpack and the liner, the connector including a membrane for
substantially aseptic filling.
2. The liner-based assembly of claim 1, wherein the membrane
comprises a re-sealable elastomeric stopper.
3. The liner-based assembly of claim 2, wherein the re-sealable
elastomeric stopper is configured for re-sealing with the
assistance of heat.
4. The liner-based assembly of claim 2, wherein the liner and
overpack are irradiated.
5. The liner-based assembly of claim 1, further comprising a
dispense connector operably connected with at least one of the
overpack and the liner, over the filling connector, the dispense
connector at least one of comprising or operably connected to a
one-way valve.
6. The liner-based assembly of claim 5, wherein the liner is
collapsible away from the overpack.
7. The liner-based assembly of claim 6, further comprising a
portable pressure source for pressurizing an annular space between
the overpack and liner for collapsing the liner and dispensing the
contents thereof.
8. The liner-based assembly of claim 5, wherein the one-way valve
comprises an elastomeric portion defining an opening and generally
operably coupled with a plug member positioned within the opening,
the plug member being relatively stiff as compared to the
elastomeric portion, wherein in a closed position, the elastomeric
portion is sealed against the plug member, and wherein when a
pressure is applied against the elastomeric portion, the
elastomeric portion is flexes in a manner configured to permit only
one-way flow through the opening.
9. A method for providing a sterile transporting and pressure
dispense system, the method comprising: providing an overpack and a
liner disposed within the overpack; irradiating the overpack and
liner for sterility; and securing a connector to at least one of
the overpack and the liner, the connector including a membrane for
substantially aseptic filling.
10. The method of claim 9, wherein the membrane comprises a
re-sealable elastomeric stopper.
11. The method of claim 10, further comprising filling the liner by
piercing the elastomeric stopper with a needle and passing a
material through the needle into the liner.
12. The method of claim 11, further comprising removing the needle
upon completion of filling and applying heat to assist in
re-sealing the elastomeric stopper.
13. The method of claim 11, further comprising removing headspace
gas from the interior of the liner upon completion of filling the
liner.
14. The method of claim 13, wherein the connector comprises a
one-way valve for permitting headspace gas to pass in one direction
out of the liner.
15. The method of claim 9, further comprising providing a dispense
connector that is operably connected with at least one of the
overpack and the liner, the dispense connector at least one of
comprising or operably connected to a one-way valve.
16. The method of claim 15, wherein providing a dispense connector
comprises providing a portable pressure source for pressurizing an
annular space between the overpack and liner.
17. The method of claim 16, wherein the portable pressure source
comprises a disposable compressed gas cartridge.
18. A liner-based assembly for use with pressure dispense
comprising: an overpack; a liner disposed within the overpack, the
liner configured for collapsing away from the overpack upon the
introduction of a gas or fluid into an annular space between the
overpack and liner; and a dispense connector that is securable to
at least one of the overpack and the liner, the dispense connector
comprising a passage in fluid communication with the annular space
and at least one of comprising or operably connected to a one-way
dispense valve in fluid communication with an interior of the
liner.
19. The liner-based assembly of claim 18, wherein the one-way valve
comprises an elastomeric portion defining an opening and generally
operably coupled with a plug member positioned within the opening,
the plug member being relatively stiff as compared to the
elastomeric portion, wherein in as closed position, the elastomeric
portion is sealed against the plug member, and wherein when a
pressure is applied against the elastomeric portion, the
elastomeric portion is flexes in a manner configured to permit only
one-way flow through the opening.
20. The liner-based assembly of claim 8, wherein the liner and
overpack irradiated.
Description
FIELD OF THE INVENTION
[0001] The present disclosure relates to novel and advantageous
shipping and dispensing systems. Particularly, the present
disclosure relates to novel and advantageous liner-based systems
for the substantially sterile storage, shipment, and dispense of
materials used in the biotechnology and pharmaceutical industries,
and which, in some cases, may be completely or substantially
disposable.
BACKGROUND OF THE INVENTION
[0002] Numerous materials, such as culture media, buffers, reagents
and other biological materials, for example, are used extensively
by biotech companies, for example, in research and development,
vaccine creation and usage, protein production and purification,
and the development of other biologics. To be safe and effective
for their intended use, as well as to he in compliance with various
rules and regulations, these materials must be pure and
sterile,
[0003] Container systems may be used in the biopharmaceutical, and
other Industries, for storing, shipping, mixing, reacting,
processing, and/or dispensing materials such as those described
above. Such materials are often fragile and/or expensive, and/or
must be maintained in a sterile environment, Accordingly, any
container system used with such materials must be substantially
air-tight to prevent contamination and to prevent escape of the
material into the outside environment. Further a container system
must be safe, sterile, reliable and leak proof, such that it may
withstand the stresses of shipping and dispense.
[0004] Container systems that are used to store and dispense the
types of materials described, above, as well as other liquid-based
contents, typically include a container of some kind, and/or a
Liner, a cap that may be used to seal and protect the contents of
the storage system when the contents are not being dispensed, and a
connector that may be used to dispense the contents from the
container. However, traditional storage and dispense container
systems are typically not configured to permit for the safe and
secure shipment of the types of materials described, particularly
not in a disposable container system. Specifically, such
traditional dispensers may not adequately maintain or ensure the
purity of the contents of the dispenser and, for example, are
unable to keep gas or other contaminants from getting into the
contents stored in the liner. Similarly, in cases where the
material being transferred is noxious or harmful, with traditional
storage and dispense container systems not configured to permit for
the safe and secure shipment, the user may be undesirably exposed
to the material during transfer,
[0005] Accordingly, there is a need for a dispenser that limits or
substantially eliminates contamination and/or degradation of the
contents of the dispenser. Further yet, a need exists for isolating
the contents of a dispenser from the environment from the point of
filling to final dispense of the contents.
BRIEF SUMMARY OF THE INVENTION
[0006] The present disclosure, in one embodiment, relates to a
liner-based assembly for use with pressure dispense. The
liner-based assembly may include an overpack, a liner disposed
within the overpack, and a filling connector that is securable to
at least one of the overpack and the liner, the connector including
a membrane for substantially aseptic filling. The membrane, in some
eases, may be a re-sealable elastomeric stopper which may be
configured for re-scaling with or without the assistance of heat.
The liner and overpack could be irradiated for sterility. The
liner-based assembly may further include a dispense connector that
is operably connected with the overpack and/or the liner, over the
filling connector. The dispense connector may comprise or be
operably connected to a one-way valve. The one-way valve may have
an elastomeric portion defining an opening and generally operably
coupled with it plug member positioned within the opening. The plug
member may he relatively stiff as compared to the elastomeric
portion. In a closed position, the etastomeric portion may be
sealed against the plug member, and when a pressure is applied
against the elastomeric portion, the elastomeric portion may flex
in a manner configured to permit only one-way flow through the
opening. The liner may be configured to collapsible away from the
overpack during pressure dispense. Furthermore, the liner-based
assembly may include a portable pressure source for pressurizing an
annular space between the overpack overpack and liner for
collapsing the liner and dispensing the contents thereof.
[0007] The present disclosure, in another embodiment, relates to a
method for providing a sterile transporting and pressure dispense
system. The method includes providing an overpack and a liner
disposed within the overpack; irradiating the overpack and liner
for sterility; and securing as connector at least one of the
overpack and the liner, the connector including a membrane, which
in some cases may be an elastomeric stopper, for substantially
aseptic filling. Again, the membrane may be a re-sealable
elastomeric stopper. The method may further include filling the
liner by piercing the elastomeric stopper with a needle and passing
a material through the needle into the liner. Upon completion of
filling, the needle may be removed, and in some cases heat may be
applied to assist in re-sealing the elastomeric stopper. Also upon
completion of filling the liner, headspace gas may be removed from
the interior of the liner. A one-way valve may be provided on the
connector for permitting headspace gas to pass in one direction out
of the liner. The method may also include providing dispense
connector that is operably connected with the overpack and/or the
liner, the dispense connector comprising or operably connected to a
one-way valve. A portable pressure source may be provided for
pressurizing an annular space between the overpack and liner. The
portable pressure source may be, for example, a disposable
compressed gas cartridge.
[0008] In another embodiment, the present disclosure relates to a
liner-based assembly for use with pressure dispense. The
liner-based assembly may include an overpack, a liner disposed
within the overpack, the liner configured for collapsing away from
the overpack upon the introduction of a gas or fluid into an
annular space between the overpack and liner, and a dispense
connector that is securable to at least one of the overpack and the
liner, the dispense connector comprising a passage in fluid
communication with the annular space and comprising or operably
connected to a one-way dispense valve in fluid communication with
an interior of the liner. The one-way valve may include an
elastomeric portion defining an opening and generally operably
couple with a plug member positioned within the opening, the plug
member being relatively stiff as to the elastomeric portion. In a
closed position, the elastomeric portion may be sealed against the
plug member, and when a pressure is applied against the elastomeric
portion, the elastomeric portion may flex in a manner configured to
permit only one-way flow through the opening. In some embodiments,
the liner and overpack may be irradiated.
[0009] While multiple embodiments are disclosed, still other
embodiments of the present disclosure will become apparent to those
skilled in the art from the following detailed description, which
shows and describes illustrative embodiments of the disclosure. As
will be realized, the various embodiments of the present disclosure
are capable of modifications in various obvious aspects, all
without departing from the spirit and scope of the present
disclosure. Accordingly, the drawings and detailed description are
to be regarded as illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] While the specification concludes with claims particularly
pointing out and distinctly claiming the subject matter that is
regarded as forming the various embodiments of the present
disclosure, it is believed that the disclosure will be better
understood from the following description taken in conjunction with
the accompanying Figures, in which:
[0011] FIG. 1 is a cross-sectional view of a shipping and
dispensing system according to one embodiment of the present
disclosure.
[0012] FIG. 2 is a cross-sectional view of a outlet valve of a
dispense connector according to one embodiment of the present
disclosure.
[0013] FIG. 3 is a dispense system schematic according to one
embodiment of the present disclosure.
[0014] FIG. 4 is a dispense system schematic according to another
embodiment of the present disclosure.
[0015] FIG. 5 shows a shipping and storage system for use with
indirect pressure dispense according to one embodiment of the
present disclosure.
[0016] FIG. 6 shows statistics related to the indirect pressure
dispense method shown in FIG. 5 provided in graphical form in
accordance with one embodiment of the present disclosure.
[0017] FIG. 7 is a cross-sectional view of a shipping and
dispensing system including a packaging element according to one
embodiment of the present disclosure that.
DETAILED DESCRIPTION
[0018] The present disclosure relates to novel and advantageous
shipping and dispensing systems. More particularly, the present
disclosure relates to novel and advantageous liner-based systems
for use, in some embodiments, with materials that must maintain
their purity, or some high level of purity during shipping and/or
dispense, wherein, in some cases, the liner-based system may be
completely or substantially disposable. For example, the shipping
and dispense system of the present disclosure, in one aspect, may
be configured for a single use and/or remain substantially
air-tight for use in industries that use materials that must remain
substantially pure, uncontaminated, and/or sterile, such as many
materials used in, for example, the biopharmaceutical manufacturing
and analytical processes industries. Examples of some of the types
of materials that may be used with embodiments of the present
disclosure include, but are not limited to, reagents, buffers, cell
culture media, or other sterile media. Applications may include,
but are not limited to, sterile media transfer, vaccine
manufacture, filling and formulation, bioreactors feed and harvest,
pharmaceutical process fluid transfer, high containment operations,
in-process pooling, and transferring buffers. It is, however,
recognized that embodiments of the present disclosure may also be
used with as variety of materials to a variety of different
industries. For example, dispensers of the present disclosure may
contain, but are not limited in use to: ultrapure liquids, such as
acids, solvents, bases, photoresists, slurries, detergents,
cleaning formulations, dopants, inorganic, organic, metalorganics,
TEOS, and biological solutions, DNA and RNA solvents and reagents,
pharmaceuticals, nanomaterials (including for example, fullerenes,
inorganic nanoparticles, sol-gels, and other ceramics), and
radioactive chemicals; pesticides/fertilizers;
paints/glosses/solvents/coating-materials etc.; power washing
fluids; lubricants for use in the automobile or aviation industry,
for example; food products, such as but not limited to, condiments,
cooking oils, and soft drinks, for example; reagents or other
materials for use in the biomedical or research industry; hazardous
materials used by the military, for example; polyurethanes;
agrochemicals; industrial chemicals; cosmetic chemicals; petroleum
and lubricants; adhesives; sealants; health and oral hygiene
products and toiletry products; or any other material that may be
dispensed by pressure dispense, for example. Materials that may be
used with embodiments of the present disclosure may have any
viscosity, including high viscosity and low viscosity fluids. Those
skilled in the art will recognize the benefits of the disclosed
embodiment and therefore will recognize the suitability of the
disclosed embodiments to various industries and for the
transportation and dispense of various products.
[0019] The use creation, and/or storage of some materials that may
he used with embodiments of the present disclosure may be subject
to various rules, regulations, and/or standards. Accordingly, in
some embodiments of the present disclosure, the liner-based system
and/or the use of the liner-based system may meet guidelines set by
the United States Pharmacopeia ("USP"). Specifically, some
embodiments of the present disclosure may be suitable to meet Class
VI USP guidelines to ensure biocompatibility with plastics. USP's
official Reference Standards are highly characterized specimens of
drug substances, excipients, impurities, degradation products,
dietary supplements, compendial reagents, and performance
calibrators. They are specified for use in conducting official
USP-NF tests and assays. USP also provides Reference Standards
specified in the Food Chemicals Codex as well as authentic
substances, high-quality chemical samples, as a service to
analytical, clinical, pharmaceutical, and research laboratories.
USP's Reference Standards are used in more than 130 countries
around the world. USP Reference Standards that are based directly
on official monographs in the USP-NF, whose standards and
procedures are enforceable by the U.S. Food and Drug Administration
(FDA), are recognized as official standards in the U.S., and their
use is effective in demonstrating compliance with statutory
requirements.
[0020] In other embodiments, various components or all components
of the shipping and dispensing systems of the present disclosure
the liner may be, or may also be, animal derived component free
("ADCF"). Using ADCF materials may be important, for example,
because bovine spongiform encephalopathy ("BSE"), and its potential
to affect humans has emerged as a serious concern. Accordingly,
suppliers of many essential animal-sourced components used in cell
culture and fermentation processes, for example, became concerned
about the potential for material contamination with prions. Viruses
also can be present in raw materials derived from animal origins.
Many important drug and vaccine products are made by mammalian cell
culture or bacterial fermentation, so their biological safety is
paramount. However, it is very difficult to ensure that any
material from an animal source carries no infection. Even the
rigorous cleaning methods designed to minimize carry-over of
biohazards from one batch to the next is no guarantee of safety.
Thus the use of ACDF materials for storing, shipping and dispensing
biological and/or biopharmaceutical media may be advantageous.
[0021] The liner-based systems of the present disclosure may hold
up to approximately 200 liters, in some embodiments. Alternatively,
the liner-based systems may hold up to approximately 20 liters,
Alternatively, the liner-based systems may hold. approximately 1 to
5 liters, or less. It will be appreciated that the referenced
container sizes are examples only and that the liner-based systems
of the present disclosure may be readily adapted for use with a
wide variety of sized and shaped shipping, and dispensing
containers. The entire liner-based system of the present disclosure
may be used a single-time and then disposed of, in some
embodiments. In other embodiments, the overpack, for example, may
be reused while the liner and/or any connectors may be used only a
single time.
[0022] FIG. 1 illustrates one embodiment of a liner-based shipping
and dispense system 100 of the present disclosure. In some
embodiments, the shipping and dispense system 100 may include an
overpack 102, a liner 104, and one or more connectors or connector
assemblies, which may be, for example, a filling connector and/or a
dispensing connector or connector assembly, as will be described in
further detail below.
[0023] The overpack 102 may include an overpack wall 106, an
interior cavity 108, and a mouth 110. The overpack 102 may be
comprised of any suitable material or combination of materials, for
example but not limited to one or more polymers, including
plastics, nylons, EVOH, polyolefins, or other natural or synthetic
polymers. In further embodiments, the overpack 102 may be
manufactured using polyethylene terephthalate (PET), polyethylene
naphthalate (PEN), poly(butylene 2,6-naphthalate) (PBN),
polyethylene (PE), linear low-density polyethylene (LLDPE),
low-density polyethylene (LDPE), medium-density polyethylene
(MDPE), high-density polyethylene (HDPE), polypropylene (PP),
and/or fluoropolymer, such as but not limited to,
Polychlorotrifluoroethylene (PCTFE), polytetrafluoroethylene
(PTFE), fluorinated ethylene propylene (FEP), and perfluoroalkoxy
(PFA). The overpack 102 may be of any suitable shape or
configuration, such as, but not limited to, a bottle, a can, a
drum, etc.
[0024] As described above, the shipping and dispense system 100 may
include a liner 104, which may be disposed within the overpack 102.
The liner 104 may include a liner wall 112, an interior cavity 114,
and a mouth 116. The mouth 116 of the liner 104 may include a
fitment portion 118. The fitment portion 118 may be made of the
same or different material than the rest of the liner 104 and may
be harder, more resilient, and/or less flexible than the rest of
the liner. The fitment portion 118 may include threads 120 that may
couple with complementary threads on a connector or connector
assembly (discussed more fully below). It is appreciated, however,
that the fitment portion 118 may alternatively or additionally
include any other means for coupling with a connector, such as but
not limited to, snap-fit or friction-fit means, bayonet means, or
any other suitable mechanism or combination of mechanisms for
coupling, as will be appreciated by those skilled in the art. In
some embodiments, a connector or connector assembly may couple to,
or may also couple to, the mouth 110 of the overpack 102.
[0025] In some embodiments, the liner 104 may be a collapsible
liner that is substantially flexible, while in other embodiments
the liner may be somewhat rigid but still collapsible, e.g., a
rigid collapsible liner. The liner 104 may be manufactured using
any suitable material or combination of materials, such as but not
limited to, any of the materials or combination of materials listed
above with respect to the overpack 102, However, the overpack 102
and liner 104 need not be manufactured from the same materials. In
some embodiments, the material or materials selected and the
thickness of that material or those materials may determine the
rigidity of the liner 104. The liner 104 may have one or more
layers and may have any desirable thickness. A liner 104 may have a
thickness of, for example, from about 0.05 mm to about 3 mm, or any
other suitable thickness.
[0026] The liner 104 may be configured to comprise any desirable
shape that is appealing to the user, and/or assists in the collapse
of the liner. The liner 104, in some embodiments, may be
dimensioned and shaped to substantially conform to the interior of
the overpack 102. As such, the liner 102 may have a relatively
simplistic design with a generally smooth outer surface, or the
liner may have a relatively complicated design including, for
example but not limited to, indentations and/or protrusions, In
some embodiments, the liner wall 112 may include a generally
textured surface in order to minimize adhesion. For example, in
some embodiments, the surface may include a plurality of bumps,
scales, or projections, which may each have any appropriate size,
for example, but not limited to, from about 0.5-100 .mu.m.
Texturizing features may be spaced any suitable distance from one
another. In some embodiments, the texturizing may comprise a
framework, such as a lattice or scaffold, for example. Examples of
some suitable texturizing features are described in greater detail
in U.S. Provisional Patent Appln. No. 61/334,006, titled, "Fluid
Processing Components with Textured Surface for Decreased Adhesion
and Related Methods," filed May 12, 2010, which is hereby
incorporated by reference herein in its entirety. The liner 104 may
have a relatively thin liner wall 112, as compared to the thickness
of the overpack wall 106. In some embodiments, the liner 102 may be
flexible such that the liner wall 112 may be readily collapsed,
such as by vacuum through the mouth 116 or by pressure between the
liner wall 112 and overpack wall 106, referred to herein as the
annular space therebetween.
[0027] The liner 104, in a further embodiment, may have a shape,
when inflated or filled, that is different from, but complimentary
with, the shape of the overpack 102 such that it may be disposed
therein. In some embodiments, the liner 104 may be removably
attached to the interior of the overpack wall 102. The liner 104
may provide a barrier, such as a gas barrier, against drive gas
migration from the annular space between the liner wall 112 and the
overpack wall 106. Accordingly, the liner 104 may generally ensure
and/or maintain the purity of the contents within the liner.
[0028] In some embodiments, particularly where sterility of the
contents of the liner must be substantially maintained, the liner
102 may be comprised of a material that may help ensure or maintain
as sterile environment for the contents disposed in the liner. For
example, in some embodiments the liner may be comprised of TK8
manufactured by ATMI of Danbury, Conn., or any other suitable
material. As noted above, in some embodiments, the liner 104 may
comprise multiple layers. The multiple layers may comprise one or
more different polymers or other suitable materials. In some
embodiments, the thickness, ply, and/or the composition of the
liner and/or the layers of the liner may allow for the secure and
substantially uncontaminated shipment of the contents of the
liner-based system of the present disclosure by limiting or
eliminating typical weaknesses or problems associated with
traditional liners or packages, such as, for example weld tears,
pin holes, gas entrainment and/or any other means of contamination.
Similarly, or in addition, the liner 104 may also contribute to the
secure and substantially uncontaminated shipment of the contents of
the shipping and dispense system 100 of the present disclosure b
configuring the liner to substantially conform to the shape of the
overpack when the liner is filled, thereby reducing the amount of
movement of the contents during shipping. Further, in embodiments
where the liner substantially conforms to the shape of the
overpack, the amount of movement of the liner during shipment may
be reduced or substantially reduced, advantageously reducing or
eliminating the occurrence of pin holes.
[0029] The overpack 102 and liner 104 may each be manufactured
using any suitable manufacturing process, such as but not limited
to, injection blow molding, injection stretch blow molding,
extrusion, etc., and may each be manufactured as a single component
or may be a combination of multiple components. To some
embodiments, the overpack 102 and liner 104 may be blow molded in a
nested fashion, also referred to herein as co-blow molded. Examples
of liner-based systems and methods utilizing co-blow molding
techniques have been described in greater detail in U.S. Prov.
Appl. No. 61/506,807, titled "Nested Blow Molded Liner and Overpack
and Methods of Making Same," filed Jul. 12, 2011, which is hereby
incorporated herein by reference in its entirety. In some
embodiments a liner may be blow molded into an already formed
overpack, whereby the overpack may function as the mold for the
liner, and may be referred to herein as "dual blow molding," which
is described in further detail in U.S. Prov. Appl. No. 61/703,996,
titled "Liner-based Shipping and Dispensing Systems," filed Sep.
21, 2012, which is hereby incorporated herein by reference in its
entirety. In such embodiments, the overpack may be manufactured by
any suitable process.
[0030] Examples of the type of liners and overpacks that may be
used are disclosed in more detail in: International PCT Appl. No.
PCT/US11/55558, titled, "Substantially Rigid Collapsible Liner,
Container and/or Liner for Replacing Glass Bottles, and Enhanced
Flexible Liners," filed Oct. 10, 2011; International PCT Appl, No
PCP/US11/55560, titled, "Nested Blow Molded Liner and Overpack and
Methods of Making Same," filed Oct. 10, 2011; International PCT
Appl. No. PCT/US11/64141, titled "Generally Cylindrically-Shaped
Liner for Use in Pressure Dispense Systems and Methods of
Manufacturing the Same," filed Dec. 9, 2011; U.S. Prov. Appl. No.
61/468,832, titled "Liner-Based Dispenser," filed Mar. 29, 2011;
U.S. Prov. Appl. No. 61/525,540, titled "Liner-Based Dispensing
Systems," filed Aug. 19, 2011; U.S. Prov. Appl. No, 61/703,996,
titled "Liner-based Shipping and Dispensing Systems," filed Sep.
21, 2012; U.S. Pat. Appl. No. 11/915,996, titled "Fluid Storage and
Dispensing Systems and Processes," filed Jun. 5, 2006;
International PCT Appl. No. PCT/US10/51786, titled "Material
Storage and Dispensing System and Method With Degassing Assembly,"
filed Oct. 7, 2010, international PCT Appl, No. PCT/US10/41629,
U.S. Pat. No. 7,335,721, U.S. Pat. Appl. No. 11/912,629, U.S. Pat.
Appl. No. 12/302,287 and International PCT Appl. No.
PCT/US08/85264, each of which is hereby incorporated by reference
herein in its entirety. The overpack 102 and liner 104 for use with
the shipping and dispense system 100 of the present disclosure may
include any of the embodiments, features, and/or enhancements
disclosed in any of the above noted applications, including, but
not limited to, flexible, rigid collapsible, 2-dimensional,
3-dimensional, welded, molded, gusseted, and/or non-gusseted
liners, and/or liners that contain folds and/or liners that
comprise methods for limiting or eliminating choke-off and linen
sold under the brand name NOWpak.RTM. by ATMI, Inc. for
example.
[0031] As described above, the liner 104 may include a fitment
portion 118, which may include coupling means, such as but not
limited to, threads 120, for coupling with complementary threads on
a connector or connector assembly. Various types of connectors or
connector assemblies may be utilized with the shipping and
dispensing system 100 of the present disclosure. In one embodiment,
the shipping and dispensing system 100 may include one or both of a
shipping and filling connector and a dispense connector assembly,
each of which is described more fully below.
[0032] As illustrated in FIG. 1, a shipping and filling connector
122 of the present disclosure, in some embodiments, may include
complementary threads 124 that may couple with threads 120 on the
fitment portion 118 of the liner 104. As with fitment portion 118,
it is appreciated, however, that the connector 122 may
alternatively or additionally include any other means for coupling
with one or more portions of the liner based system, such as but
not limited to, snap-fit or friction-fit means, bayonet means, or
any other suitable mechanism or combination of mechanisms for
coupling, as will be appreciated by those skilled, in the art.
[0033] In some embodiments, the connector 122 may be configured for
aseptic filling of the interior cavity 114 of the liner 104. In
some embodiments, connector 122 may include a membrane 126 through
which aseptic filling may be accomplished. The membrane 126 may be,
for example, a re-sealable stopper made from an elastomeric
material, such that a filling tube or needle, such as but not
limited to a non-coring needle, may be passed through the membrane
for filling the liner 104. Upon removal of the filling tube or
needle, the elastomeric material of the membrane 126 may reseal,
thereby eliminating or substantially eliminating germ ingress to
the liner 104. In some embodiments, the membrane 126 resealing may
be assisted with the use of heat, such as by laser. Such a
connector 122 permitting aseptic filling can eliminate the need for
costly and complex isolators. Rather, the shipping and dispense
system 100, or more particularly, the overpack 102 and/or liner 104
may be sterile and irradiated, thereby themselves becoming the
isolators. In general, with some such embodiments of connector 122,
at no time during filling and shipping of the filled liner are the
contents within the interior cavity 114 of the liner 104 exposed to
the external environment, completely or substantially preventing
contamination of the contents. In one embodiment, the shipping and
filling connector 122 may be, or may be similar to, filling
connectors sold under the brand name Intact.TM. Sterile Filling
System by Medical Instill Technologies, Inc, of New Milford, Conn.
While a connector having a membrane of an elastomeric substance is
described, it will be understood that any suitable Class VI
plastic, or combinations thereof, for example, may be used to
provide a sterile connector within the spirit and scope of the
present disclosure.
[0034] A dispense connector or assembly may, or may also be used
with embodiments of the present disclosure. In some cases, the
dispense assembly may comprise a dispense connector, features for
dispensing by pressure dispense, and/or a one-way dispense valve.
In some embodiments, a dispense connector may include dispensing
features, as well as features for filling such as those described
above, thereby allowing the same connector to be used for both
filling and dispense, while in other cases, the dispense connector
may be a separate connector from the connector used to fill the
liner based system. Accordingly, the dispense connector may be
directly coupled to or over the connector 122 used to fill and/or
ship the container in some embodiments. In other embodiments where
the dispense connector is separate from the connector 122 used to
fill and/or ship, some or all of the fill and/or shipping connector
may be removed from the liner and overpack system before coupling
the dispense connector thereto. The dispense connector may be
comprised of any suitable material, such as metal, plastic, or any
other material or combination of materials. In some embodiments,
the dispense connector may be comprised of a material that may be
suitable for use in a sterile environment, such as those listed
above, or any other suitable material, or combination of
materials.
[0035] The dispense assembly may also include features used to
dispense the contents of the liner based system. In some
embodiments, the dispense assembly may be configured to work with
existing static systems, for instance existing pressure-dispense
systems that may not be portable. In other embodiments, the
dispense system may be configured to be substantially completely
portable. Generally, dispensing features of the dispense assembly
may include a pressurizing gas inlet that generally permits a gas
pressure in-line to be inserted through or coupled with the
dispense connector and be in fluid communication with the annular
space between the liner 104 and the overpack 102. In such a system,
a fluid, gas, or other suitable substance may be introduced into
the annular space, thereby pushing the contents of the filled liner
104 out of the liner 104. The dispense assembly may also include
one or more ports that may include dip tubes that may extend any
suitable distance into the interior of the liner 104 that may be
used, for example, to puncture the membrane 126 on the fill
connector 122 in embodiments where the dispense connector may be
coupled to or over the fill connector 122.
[0036] The dispense assembly may also include a one-way dispense
valve 200 as shown in FIG. 2. In some embodiments the dispense
valve 200 may act as a non-contamination barrier, protecting the
contents of the liner during dispense from air, moisture, bacteria
and/or any other harmful contaminants. The one-way valve 200 may
generally only allow material to flow in one direction, i.e. out of
the valve and not back into the liner, during dispense. In this
way, the one-way valve 200 functions similarly to the arterial
valve in the cardiovascular system. The one-way valve 200 may
include an elastomeric portion 202 that may be coupled to and abut
up against a plug 204 of the valve. The plug 204 may be relatively
stiff as compared to the elastomeric portion 202. As may be seen in
FIG. 2, in some embodiments the elastomeric portion 202 may
generally surround an outlet tube 206, for example. The elastomeric
portion 202 may generally taper to provide a relatively smaller
dispense opening 210, in which the plug 204 may be positioned. The
plug 204 may generally seal the dispense end of the elastomeric
portion 202 when contents are not being dispensed. In use, the
one-way valve 200 may be used to dispense materials in a
substantially aseptic manner. During pressure dispense, the
contents of the liner may be directed toward the one-way valve 200,
thereby creating pressure on the valve 200. The pressure created by
the force of the material on the valve 200 may cause the
elastomeric portion 202 to open. The material may then pass through
the valve 200 as a result of the pressure applied to the material,
ensuring that there is direct flow in only the dispense direction
220. As the desired amount of material is dispensed, the pressure
source may be lessened, and eventually may be turned off, causing
the elastomeric portion 202 to close in on itself beginning with
the thicker portion at the base 208, thereby allowing no ingress,
and squeezing out the remaining material in the valve 200. In one
embodiment, the dispense connector may be, or may be similar to,
dispense connectors or dispense valves sold under the brand name
Pure-Dose.TM. One-Way Visco-Elastic Valve by Medical Instill
Technologies, Inc. of New Milford, Conn. In other embodiments, the
valve may be comprised of any other suitable material, including
any other plastic or combination of plastics or other
materials.
[0037] Filling connectors and dispense connectors and/or valves,
such as those like the connectors sold under the brand names
Intact.TM. Sterile Filling System and Pure-Dose.TM. One-Way
Visco-Elastic Valve by Medical Instill Technologies, Inc., are
further described in detail in: U.S. Pat. No. 7,997,447; U.S. Pat.
No. 7992,597; U.S. Pat. No. 7,980,276; U.S. Pat. No. 7,975,453;
U.S. Pat. No. 7,967034; U.S. Pat. No. 7,966,746; U.S. Pat. No.
7,954,521; U.S. Pat. No. 7,886,937; U.S. Pat. No. 7,874,129; U.S.
Pat. No. 7,861,750; U.S. Pat. No. 7,850,051; U.S. Pat. No.
7,845,517; U.S. Pat. No. 7,810,677; U.S. Pat. No. 7,798,185; U.S.
Pat. No. 7,780,023; U.S. Pat. No. 7,779,609; U.S. Pat. No.
7,726,357; U.S. Pat. No. 7,678,089; U.S. Pat. No. 7,669,390; U.S.
Pat. No. 7,665,923; U.S. Pat. No. 7,651,291; U.S. Pat. No.
7,637,401; U.S. Pat. No. 7,637,400; U.S. Pat. No. 7,628,184; U.S.
Pat. No. 7,568,509; U.S. Pat. No. 7,556,066; U.S. Pat. No.
7,410,050; U.S. Pat. No. 7,331,944; U.S. Pat. No. 7,322,491; U.S.
Pat. No. 7,270,158; and U.S. Pat. No. 7,077,176; U.S. Pat. No.
7,000,806, each of which is hereby incorporated by reference herein
in its entirety.
[0038] The liner-based system may also include features for helping
prevent or limit choke-off. Generally speaking, choke-off may be
described as what occurs when a liner ultimately collapses on
itself, or a structure internal to the liner, to form a choke point
disposed above a substantial amount of liquid. When choke-off
occurs, it may preclude complete utilization of the liquid disposed
within the liner, which can be a significant problem, as many
materials used in the biotechnology and/or pharmaceutical industry,
for example, can be very expensive. A variety of ways of preventing
or handling choke-off are described in PCT Application Number
PCT/US08/52506, entitled, "Prevention Of Liner Choke-off In
Liner-based Pressure Dispensation System," with an international
filing date of Jan. 30, 2008, which is hereby incorporated herein
by reference in its entirety. Additional ways of preventing or
handling choke-off are described in International PCT Appl. No.
PCT/US11/55558, titled, "Substantially Rigid Collapsible Liner,
Container and/or Liner for Replacing Glass Bottles, and Enhanced
Flexible Liners," filed Oct. 10, 2011, which was previously
incorporated herein by reference in its entirety.
[0039] In use, in some embodiments, as liner-based system may
arrive at a first filling site, for example, with the system fully
assembled including an overpack 102, liner 104, and filling
connector 122. In some cases, the overpack 102, liner 104, and/or
the connector may be irradiated and sterilized at a manufacturing
site, such that that the sterilization process may not need to be
performed at the filling site. As part of the sterilization
process, the liner may be evacuated and therefore may be in a
collapsed state and may include substantially no gases and be ready
for filling upon arrival, for example, at the fill site. In other
embodiments, the filling connector may be provided at the till site
and/or the overpack 102, liner 104, and/or filling connector may be
irradiated and/or sterilized at the fill site prior to filling.
[0040] At the fill site, the filling connector 122 may be used to
aseptically fill the contents of the liner. As explained above, in
some embodiments the filling connector may be configured to
comprise a closed needle that may puncture a membrane that may seal
the liner. Once the needle has passed through the membrane, the
needle may open to allow material to be introduced into the liner
in a sterile manner. After the fill is complete, in some
embodiments, any headspace may be removed from the liner. Headspace
generally refers to any gas space in a liner, for example, that may
exist above the material stored in the liner. Headspace may be
undesirable because it may allow for some of the headspace gas to
enter the material, thereby contaminating the material. Limiting or
eliminating headspace may be particularly important for systems
that may be transported. The movement of the material in the liner
that may occur when headspace is present may cause foaming,
bubbling, stress, protein damage, and/or gas contamination of the
material, for example, which can be highly undesirable when
maintaining the purity of the contents of the system is crucial.
The headspace may be removed by introducing a suitable gas or fluid
into the annular space between the liner and the overpack. The
increased pressure in the annular space may push the liner in upon
itself, thereby forcing out any excess gas in the liner. This may
be accomplished in some embodiments by including a sterile outlet
valve, for example, as part of the connector 122 that may allow any
headspace to be removed and captured in an isolated part of the
fill connector 122, for example. In some embodiments, the outlet
valve may be a one-way valve that may only allow headspace gas to
move out of the liner and may not allow it back into the liner. In
other embodiments headspace may be removed at the dispense location
prior to dispense.
[0041] Once the liner has been filled, and in some embodiments, the
headspace has been substantially removed, the filling connector may
reseal, as described above, thereby aseptically sealing the liner
104. In some cases, the system 100 may then be shipped to a second
site, while in other cases, the filled system may be stored at the
first site prior to dispense at a subsequent time at the first
site.
[0042] Prior to dispense, dispense connector or dispense connector
assembly may be coupled to the system 100. In some embodiments, the
headspace gas may be removed at the dispense site just prior to
dispense, for example, substantially in the same manner as
explained above. Depending on the embodiment being used, in some
cases the fill connector may also include features used for
dispense, and therefore another connector may not need to be added
to the system for dispense. In other embodiments, however, some
portion, or all of the fill connector may be removed from the liner
and overpack and the dispense connector and/or assembly may be
coupled thereto for dispense. In still other embodiments, a
dispense connector and/or dispense assembly may be coupled to or
over the fill connector. In embodiments where the dispense
connector may be coupled to or over the fill connector, a portion
of the dispense connector may puncture the fill connector membrane
126 so as to allow access to the material of the liner for
dispense. Once the dispense connector and/or dispense assembly have
been operably coupled to the liner 104 and/or overpack 102,
dispense may occur. Dispense may be by pressure dispense, as
discussed in more detail below.
[0043] In some embodiments, after dispense, the dispense connector
and/or assembly, the liner, and/or the overpack may be disposed of.
However, in other embodiments, one or more of the dispense
connector/assembly, liner, or overpack may be cleaned, sterilized,
and reused in another cycle.
[0044] FIG. 3 generally shows how the system of the present
disclosure may operate during liquid dispense, specifically
pressure dispense, according to one embodiment. One end of a gas
pressure in-line 306 may be connected to the pressurizing gas inlet
fitting of a dispense connector 360, while the other end may be
connected to a pressurized gas or fluid source 340. In one
embodiment, the gas or fluid source 340 may be regulated to push
pressurized gas or fluid into the area in the annular space between
the inside wall of the container 320 and the outside wall of the
liner 310. As can be seen, as the amount of gas or fluid increases
in the space between the wall of the container 320 and the wall of
the liner 310, the collapsible liner 312 will begin to collapse in
upon itself, which will force the contents M of the liner 312 up
through the dispense connector 360. In some embodiments, the
dispense connector 360 may include a one-way dispense valve, while
in other embodiments, a one-way outlet valve 362 may be distant
from, but operably coupled to, the dispense connector 360.
Pressurized gas or fluid may continue to be added until
substantially all of the contents M of the liner 312 have been
dispensed. Once liquid dispense has been completed and/or the liner
312 has been substantially emptied, the gas pressure in-line 306
may be removed from the pressurizing gas inlet of the dispense
connector 360, which in some embodiments may also release the
pressure gas in the annular space between the inside wall of the
container 320 and the inside wall of the liner 310. As discussed
above, in some embodiments, the liner and/or the connector may be
removed and disposed of while the overpack may be cleaned,
sterilized, and reused. In other embodiments the overpack may also
be disposed of after a single use.
[0045] In some embodiments, the controlled and varied introduction
of pressurized gas or liquid into the annular space between the
inside of the container wall 320 and the outside of the liner wall
310 may be used to mix the contents of the liner. In some such
embodiments, headspace may not be removed prior to mixing so as to
allow room for mixing. A controlled cycle of pressurization and
depressurization resulting in compression and relaxation of the
liner may cause the contents of the liner to mix, for example. In
use, this embodiment would allow for the sterile mixing of the
contents of the liner without the need for impellers or paddles.
Because introducing objects into the interior of the liner may
increase the risk of contamination, not needing to introduce
impellers or paddles into the liner may advantageously help
minimize the risk of contamination. In other embodiments two
containers may be used for mixing two or more materials.
[0046] The use of pressure dispense may he advantageous over
methods currently used in relevant industries, such as dispense by
peristaltic pumps. The use of pumps to dispense the contents of a
liner may cause bubbling and stress on the material and the system,
which may be undesirable because the purity of the contents of the
liner may be crucial. The use of pressure dispense may help avoid
or eliminate these problems. Further, in some cases a higher rate
of dispense may be achieved by pressure dispense as opposed to pump
dispense.
[0047] As explained above, in some embodiments, the entire storage
and dispense system may be configured to be portable, as shown in
FIG. 4. In some embodiments of a portable storage and dispense
system 400 a pressure source 460 may be included as part of the
dispense assembly 420. The pressure source 460 may be used to
pressure dispense the contents of the liner 412 by forcing a gas,
for example, into the annular space between the inner wall of the
overpack 420 and the outer wall 410 of the liner 412. The pressure
source 460, in some embodiments, may be connected directly to, or
be integral with the dispense connector as shown in FIG. 4 by any
suitable manner, while in other embodiments, the pressure source
may be remotely connected to the dispense connector via any
suitable means, for example tubing or hosing. In some embodiments,
the pressure source 460 may comprise a carbon dioxide (CO.sub.2),
nitrogen (N.sub.2), or other disposable compressed gas cartridge,
for example. In still other embodiments, the pressure source may be
generally directly detachably connected or integrally connected to
the dispense assembly. While particular embodiments have been
described herein, it will be understood that the pressure source
may be positioned at any suitable place on and/or near the
dispenser by any suitable means. While the pressure source has been
discussed as a disposable cartridge for use with a disposable
system, in other embodiments the pressure source may be any
suitable or known pressure source to which the dispenser may be
operably connected. In some embodiments, a user may activate the
dispensing system by activating the pressure source. The pressure
source may be activated, or turned "on," in a variety of suitable
ways, for example but not limited to, via as button, flip-switch,
sliding switch, or any other suitable actuator or combination of
actuators. In some embodiments, such as in a fully disposable
and/or recyclable embodiment, wherein the pressure source may
comprise, for example, a CO.sub.2, N.sub.2, or other disposable
compressed gas cartridge, the pressure source may be activated by
activating the compressed gas cartridge as would be understood by
those skilled in the art. In some embodiments, activating the
pressure source may cause the contents of the liner or dispensing
system to be dispensed. In still further embodiments, the contents
of the liner or dispensing system may be dispensed continuously
until the pressure source is deactivated or in the case of a
compressed gas cartridge, for example, until the contents of the
pressure source are entirely or substantially depleted, and/or
until the contents of the liner are substantially depleted or are
otherwise down to a desired level. In some embodiments the one-way
dispense valve 480, as described above, may be coupled to the
dispense connector 420, while in other embodiments the one-way
dispense valve 480 may be remote from the dispense connector 420
but may be operably coupled thereto by any suitable means, such as
tubing, for example,
[0048] In one embodiment, the portable pressure source 460 may be,
or may be similar to, the portable pressure source and dispense
systems sold under the brand name Tap-A-Draft by Sturman B G, LLC
of Woodland Park, Colo., which have traditionally been used to
maintain and dispense carbonated beverages. Generally, as the
liquid stored in the container to which the Tap-A-Draft system is
attached is poured through the Tap-A-Draft dispense connector, gas,
such as CO.sub.2, Nitrous, or Argon, is allowed to enter the
container to maintain the pressure within the container. Such
portable pressure source and dispense systems, like the pressure
dispense assemblies sold under the brand name Tap-A-Draft by
Sturman B G, LLC, are further described in detail in U.S. Pat. No.
5,395,012; U.S. Pat. No. 5,443,186; U.S. Pat. No. 5,979,713; U.S.
Pat. No. 6,036,054; U.S. Pat. No. 7845,522; U.S. Pat. No. D582,722;
U.S. Publ. No. 2009/0242044; and U.S. Publ. No. 2011/0147406, each
of which is hereby incorporated by reference herein in its
entirety.
[0049] In another embodiment, the liner may first be filled with a
solid material, for example, but not limited to, a peptide, API,
etc. The solid may take up relatively little space within the
liner. The liner-based system may then be stored, or in other
cases, shipped to another site, whereupon the liner may be filled
with a sterile liquid. In order to dissolve the solid in the
liquid, the liner may be shaken or otherwise moved. The contents of
the liner may then be dispensed or shipped to another location for
dispense. In use, such an embodiment may be substantially similar
to the embodiments described above. Using such an embodiment would
allow a user to avoid having to transfer the solid material to a
new container for sterile mixing, thereby minimizing the risk of
contamination and saving time, labor, act any associated costs, for
example. Alternatively, two or more containers may be used to mix
the contents of one or more liners.
[0050] In some embodiments, a dispenser as disclosed herein may
include more than one liner that my contain different materials.
The dispense assembly may include a connector/cover that may
connect to or align with the fitments of each of the liners.
Alternatively, one liter may comprise two or more compartments that
may contain different materials. The dispense assembly may draw the
material from some or all of the liners and may mix the material
prior to or at the time the material is dispensed from the
dispenser, for example, such that the resulting material that is
dispensed out of the dispenser may be a mixture of the contents of
all or some of the liners. In some such embodiments, the one or
more liners may not be completely filled, and/or headspace may not
be removed, and/or headspace may be introduced into the liners to
allow for mixing room in one or more liners.
[0051] This embodiment may also be advantageously used with
substances that may be unstable and require a catalyst to cure.
Accordingly, one liner may contain the substance and another liner
may contain the catalyst, thereby allowing a mixture of both to be
applied. In multiple liner embodiments, the ratio of the material
of each liner that is included in the mixture may be controlled by
a variety of means, for example, by varying the pressure applied,
by varying the size of a terminal apparatus configured as a nozzle,
by varying the size of the channels through the connector/cover, by
varying the size of any diptube(s) used, or any other suitable
method or combination of methods.
[0052] In some dispenser embodiments, the liner, overpack, and/or
connectors may be configured for high flow dispense or dispense of
contents of relatively higher viscosity. In one embodiment, such
high flow or high viscous dispense can be achieved by providing
larger orifice sizes in the liner, overpack, and/or dispensing
assembly, which would allow for higher flow rates or the larger
flow paths for materials with relatively higher viscosity.
[0053] Embodiments of liners of the present disclosure, in some
cases, may be dispensed at pressures less than about 100 psi, or
more preferably at pressures less than about 50 psi, and still more
preferably at pressures less than about 20 psi, In some cases, the
contents of the liners of some embodiments, however, may be
dispensed at significantly lower pressures, as may be desirable,
depending on the intended use or application involved.
[0054] In additional embodiments, a dispense assembly, including
the connector, may also include control components to control the
incoming gas and outgoing liquid. For example, a controller can be
operably coupled to control components to control the dispense of
the liquid from the liner. One or more transducers may also be
included in some embodiments to sense the inlet and/or outlet
pressure. In this regard, such control components may be utilized
to detect when the liner is near empty. Means for controlling such
dispense of fluid from the liner and determining when a liner nears
empty are described for example in U.S. Pat. No. 7,172,096,
entitled "Liquid Dispensing System," issued Feb. 6, 2007 and PCT
Application Number PCT/US07/70911, entitled "Liquid Dispensing
Systems Encompassing Gas Removal," with an international filing
date of Jun. 11, 2007, each of which is hereby incorporated herein
by reference in its entirety, and International Patent Application
No. PCT/US2011/055558, previously incorporated by reference in its
entirety.
[0055] In an additional or alternative embodiment, shown in FIG. 5,
an empty detect mechanism may include a liner and overpack system
502 that may be operably connected to an indirect pressure
dispensing assembly 504. The dispense assembly 504 may include a
pressure transducer or sensor 506, as pressure solenoid or other
control valve 508, and a vent solenoid or other control valve 510.
A microcontroller may he used to control the pressure solenoid 508
and/or the vent solenoid 510. The outlet liquid pressure may be
read and measured by the pressure transducer 506. If the pressure
is too low, i.e. lower than a set value, the pressure solenoid 508
may be turned on for a period a time (P.sub.on), thereby causing
more pressurizing gas or other substance to be introduced into the
annular space between the overpack and liner and raising the outlet
liquid pressure. If the pressure is too high, i.e. higher than a
predetermined value, the vent solenoid 510 may be turned on for a
period of time (P.sub.vent), somewhat relieving the pressure in the
annular space between the overpack and liner, and thus the outlet
liquid pressure. As may be seen in FIG. 6, as the contents of the
liner near empty, the liquid pressure drops 610. The drop in liquid
pressure triggers the pressure solenoid to turn on for a longer
period of time. The increase in the time that the pressure solenoid
is turned on (P.sub.on) rises rapidly as the liner nears empty 612.
Accordingly, the amount of time that the pressure valve is on
(P.sub.on) may be used to determine when the endpoint of the
dispense has been reached.
[0056] Alternatively or additionally, the frequency of the on/off
switching of the inlet pressure solenoid may be monitored. As
indicated above, as the liner approaches empty, the inlet pressure
will need to increase in order to maintain the constant liquid
outlet pressure. The inlet pressure solenoid may thus switch on/off
at a higher frequency as the liner nears empty to permit the
required amount of pressurized gas into the annular space between
the liner and the container. This frequency of the on/off switching
can be a useful empty detect indicator. Empty detect mechanisms
such as those disclosed herein, may help save time and energy, and
consequently money.
[0057] After dispense is completed or substantially completed and
the liner is empty or substantially empty, the end-user may dispose
of the liner-based system, and/or recycle or reuse some or all of
the liner-based system, including some or all of the
closure/connector assembly. In order to assist in making the
dispensers described herein more sustainable, the dispensers or one
or more components thereof, including any overpack, liner(s),
handles, etc., may be manufactured from biodegradable materials or
biodegradable polymers, including but not limited to:
polyhydroxyalkanoates (PHAs), like poly-3-hydroxybutyrate (PHB),
polyhydroxyvalerate (PHV), and polyhydroxyhexanoate (PHH);
polylactic acid (PLA); polybutylene succinate (PBS);
polycaprolactone (PCL); polyanhydrides; polyvinyl alcohol; starch
derivatives; cellulose esters, like cellulose acetate and
nitrocellulose and their derivatives (celluloid); etc. Similarly,
in some embodiments, and if suitable for the industry application,
the dispensers or one or more components thereof may be
manufactured from materials that can be recycled or recovered, and
in some embodiments, used in another process by the same or a
different end user, thereby allowing such end user(s) to lessen
their impact on the environment or lower their overall emissions.
For example, in one embodiment, the dispensers or one or more
components thereof may be manufactured from materials that may be
incinerated, such that the heat generated therefrom may be captured
and incorporated or used in another process by the same or
different end user. In general the dispensers or one or more
components thereof may be manufactured from materials that can be
recycled, or that may be converted into raw materials that may be
used again.
[0058] In one embodiment of the present disclosure a storage and
dispense system 700 may include an additional optional packaging
element 720, in which the liner and overpack 702 may be positioned.
The packaging element 720 may be used to store, transport, and/or
carry the liner and overpack 702, in some cases relatively easily.
The packaging element 720 may generally be a box configured from a
corrugated material, such as but not limited to cardboard. However,
in other embodiments, the packaging element 720 may be comprised of
any suitable material or combination of materials including paper,
wood, metal, glass, or plastic, for example. The packaging element
720 may include one or more reinforcing elements 730 that may
provide support and/or stability for the liner and overpack 702
disposed therein. A reinforcing element 730 may be positioned at
any appropriate or desired height in the packaging element 720. For
example, as may be seen in FIG. 7, one reinforcing element 730 may
be provided near the top of the body of the overpack and liner 702.
However, in other embodiments, one or more reinforcing elements may
be positioned at other areas of the overpack, for example at the
bottom of the overpack, or the middle of the overpack. In still
another embodiment, the reinforcing element may generally fill
substantially all of, or some portion of the space not taken up by
the liner and overpack. The reinforcing element(s) 730 may be
comprised of any suitable material or combination of materials,
such as but not limited to the materials listed above for the
packaging element. In some embodiments, the reinforcing element(s)
730 may be comprised of the same material as the remainder of the
packaging element 720, although use of the same materials is not
necessary. The packaging element 720 may also have one or more
handles or handle slots/openings 740 that may make the packaging
element 720 relatively easy to move and/or carry. The packaging
element 720 may be any desired shape, and in some cases may be a
generally rectangular box, as shown. A plurality of systems, such
as those shown in FIG. 7, may be easily and conveniently packed for
storage and/or shipping due to the rectangular box shape of the
packaging element. Additionally, the packaging element may further
protect the liner and overpack disposed therein from exposure, such
as exposure to potentially harmful UV rays.
[0059] In some embodiments including a packaging element 720, the
liner and overpack system may not include a handle or chime because
the storage unit 720 may provide handle slots/openings and the
support otherwise provided by the chime. Accordingly, a cost
associated with the liner and overpack related to the handle and/or
chime may be reduced or eliminated in such embodiments.
Nonetheless, in other embodiments, the liner and overpack may still
include a handle and/or chime in embodiments including a packaging
element.
[0060] In still further embodiments, co-blow molded or nested
preforms and liners, such as those described in International PCT
Appl. No. PCT/US11/55560, titled, "Nested Blow Molded Liner and
Overpack and Methods of Making Same," filed Oct. 10, 2011, which
was previously incorporated herein, may be used to manufacture a
dispenser having greater than two layers. Two or more separate
materials may be filled into the spaces between the layers. The
dispenser may be configured to mix the separate materials upon
dispense.
[0061] In other embodiments, the dispensers of the present
disclosure may include baffles, baffling features, or other
discontinuities in the interior surface(s) thereof to retard
settling of the suspended solids contained therein during storage
and/or transportation.
[0062] The dispensers described herein may be configured as any
suitable shape, including but not limited to square, rectangular,
triangular or pyramidal, cylindrical, or any other suitable polygon
or other shape. Differently shaped dispensers can improve packing
density during storage and/or transportation, and may reduce
overall transportation costs. Additionally, differently shaped
dispensers can be used to differentiate dispensers from one
another, such as to provide an indicator of the contents provided
within the dispensers or to identify for which application or
applications the contents are to be used, etc. In still further
embodiments, the dispensers described herein may be configured as
any suitable shape in order to "retrofit" the dispensers with
existing dispense assemblies or dispense systems.
[0063] In some embodiments, the dispensers described herein may
include symbols and/or writing that is molded into the dispensers
or one or more components thereof. Such symbols and/or writing may
include, but is not limited to names, logos, instructions,
warnings, etc. Such molding may be done during or after the
manufacturing process of the dispensers or one or more components
thereof. In one embodiment, such molding may be readily
accomplished during the fabrication process by, for example,
embossing the mold for the dispensers or one or more components
thereof. The molded symbols and/or writing may be used, for
example, to differentiate products.
[0064] In some embodiments, one or more colors and/or absorbant
materials may be added to the materials of the dispensers or one or
more components thereof during or after the manufacturing process
to help protect the contents of the dispensers from the external
environment, to decorate the dispensers, or to use as an indicator
or identifier of the contents within the dispensers or otherwise to
differentiate multiple dispensers, etc. Colors may be added using,
for example, dyes, pigments, nanoparticles, or any other suitable
mechanism. Absorbant materials may include materials that absorb
ultraviolet light, infrared light, and/or radio frequency signals,
etc.
[0065] Similarly, in some embodiments, the dispensers or one or
more components thereof may be provided with different textures or
finishes. As with color and molded symbols and/or writing, the
different textures or finishes may he used to differentiate
products, to provide an indicator of the contents provided within
the dispensers, or to identify for which application or
applications the contents are to be used etc. In one embodiment,
the texture or finish may be designed to be a substantially
non-slip texture or finish or the like, and including or adding
such a texture or finish, to the dispensers or one or more
components thereof may help improve graspability or handling of the
packaging system, and thereby reduce or minimize the risk of
dropping of the dispensers. The texture or finish may be readily
accomplished during the fabrication process by, for example,
providing a mold for the dispensers or one or more components
thereof with the appropriate surface features. In other
embodiments, the molded dispensers may be coated with the texture
or finish. In some embodiments, the texture or finish may be
provided on substantially the entire dispenser or substantially the
entirety of one or more components thereof. However, in other
embodiments, the texture or finish may be provided on only a
portion of the dispenser or a portion of one or more components
thereof.
[0066] Similarly, in some embodiments, the exterior and/or interior
walls of the dispensers or one or more components thereof may have
any suitable coating provided thereon. The coating may increase
material compatibility, decrease permeability, increase strength,
increase pinhole resistance, increase stability, provide
anti-static capabilities or otherwise reduce static, etc. Such
coatings can include coatings of polymers or plastic, metal, glass,
adhesives, etc. and may be applied during the manufacturing process
by, for example coating a preform used in blow-molding, or may be
applied post manufacturing, such as by spraying, dipping, filling,
etc.
[0067] In some embodiments, the dispensers may include one or more
handles. The one or more handles can be of any shape or size, and
may be located at any suitable position of the dispensers. Types of
handles can include, but are not limited to, handles that are
located at the top and/or sides; are ergonomic; are removable or
detachable; are molded into the dispensers or are provided after
fabrication of the dispensers (such as by, for example, snap fit,
adhesive, riveting, screwed on, bayonet-fit, etc.); etc. Different
handles and/or handling options can be provided and may depend on,
for example but not limited to, the anticipated contents of the
dispensers, the application for the dispensers, the size and shape
of the dispensers, the anticipated dispensing system for the
dispensers, etc.
[0068] In some embodiments, the dispensers may include two or more
layers, such as an overpack and a liner, multiple overpacks, or
multiple liners. In further embodiments, a dispenser may include at
least three layers, which may help ensure enhanced containment of
the contents therein, increase structural strength, and/or decrease
permeability, etc. Any of the layers may be made from the same or
different materials, such as but not limited to, the materials
previously discussed herein.
[0069] In some embodiments, and if suitable for the industry
application, the dispensers or one or more components thereof may
be manufactured from materials that can be recycled or recovered,
and in some embodiments, used in another process by the same or a
different end user, thereby allowing such end user(s) to lessen
their impact on the environment or lower their overall emissions.
For example, in one embodiment, the dispensers or one or more
components thereof may be manufactured from materials that may be
incinerated, such that the heat generated therefrom may be captured
and incorporated or used in another process by the same or
different end user. In general the dispensers or one or more
components thereof may be manufactured from materials that can be
recycled, or that may be converted into raw materials that may be
used again.
[0070] In some embodiments, structural features may be designed
into the dispensers that add strength and integrity to the
dispensers or one or more components thereof. For example, the base
(or chime in some embodiments), top, and sides of the dispensers
may all be areas that experiences increased shake and external
forces during filling, transportation, installation, and use (e.g.,
dispensing). Accordingly, in one embodiment, added thickness or
structural edifices e.g., bridge tressel design) may be added to
support stressed regions of the dispensers, which can add strength
and integrity to the dispensers. Furthermore, any connection region
in the dispensers may also experience increased stress during use.
Accordingly, any of these such regions may include structural
features that add strength through, for example, increased
thickness and/or specifically tailored designs. In further
embodiments, the use of triangular shapes could be used to add
increased strength to any of the above described structures;
however, other designs or mechanical support features may be
used.
[0071] In some embodiments, the dispensers or one or more
components thereof, including any overpack or liner(s), may include
reinforcement features, such as but not limited to, a mesh,
fiber(s), epoxy, or resin, etc. that may be integrated or added to
the dispensers or one or more components thereof, or portions
thereof, in order to add reinforcement or strength. Such
reinforcement may assist in high pressure dispense applications, or
in applications for dispensing high viscosity contents or corrosive
contents.
[0072] In some embodiments, the dispensers may include level
sensing features or sensors. Such level sensing features or sensors
may use visual, electronic, ultrasonic, or other suitable
mechanisms for identifying, indicating, or determining the level of
the contents stored in the dispensers. For example, in one
embodiment, the dispensers or a portion thereof may be made from a
substantially translucent or transparent material that may be used
to view the level of the contents stored therein.
[0073] In further embodiments, flow metering technology may be
integrated into or operably coupled with the connectors for a
direct measurement of material being delivered from the packaging
system to a down stream process. A direct measurement of the
material being delivered could provide the end user with data which
may help ensure process repeatability or reproducibility. In one
embodiment, the flow meter may provide an analog or digital readout
of the material flow. The flow meter, or other component of the
system, can take the characteristics of the material (including but
not limited to viscosity and concentration) and other flow
parameters into consideration to provide an accurate flow
measurement, Additionally, or alternatively, the flow meter can be
configured to work with, and accurately measure, a specific
material stored and dispensed from the dispenser. In one
embodiment, the inlet pressure can be cycled, or adjusted, to
maintain a substantially constant outlet pressure or flow rate.
[0074] The various shipping and dispensing system embodiments of
the present disclosure have several advantages over traditional
packaging systems. Many of the advantages have been noted
throughout the application and include, but are not limited to:
sterility of the contents from the time of fill to complete
dispense; substantially reduced or eliminated germ ingress during
filling; longer shelf life of the contents of the liner; portable
dispense; enables sterile dispense automation; easier portable
dispense, which can eliminate hand-pump dispense. Other advantages
will be recognized by those skilled in the art and may vary from
industry application to industry application.
[0075] In the foregoing description various embodiments of the
invention have been presented for the purpose of illustration and
description. They are not intended to be exhaustive or to limit the
invention to the precise form disclosed. Obvious modifications or
variations are possible in light of the above teachings. The
embodiments were chosen and described to provide the best
illustration of the principals of the invention and its practical
application, and to enable one of ordinary skill in the art to
utilize the invention in various embodiments and with various
modifications as are suited to the particular use contemplated. All
such modifications and variations are within the scope of the
invention as determined by the appended claims when interpreted in
accordance with the breadth they are fairly, legally, and equitably
entitled.
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