U.S. patent application number 12/245681 was filed with the patent office on 2009-04-16 for method for formulating and aseptically filling liquid products.
Invention is credited to Daniel Py.
Application Number | 20090098250 12/245681 |
Document ID | / |
Family ID | 40526713 |
Filed Date | 2009-04-16 |
United States Patent
Application |
20090098250 |
Kind Code |
A1 |
Py; Daniel |
April 16, 2009 |
METHOD FOR FORMULATING AND ASEPTICALLY FILLING LIQUID PRODUCTS
Abstract
An apparatus and method are provided for formulating and
aseptically filling liquid products. A first liquid source includes
at least one first liquid component; a second liquid source
includes at least one second liquid component; and a container
includes a body defining an empty, sterile storage chamber therein
that is sealed with respect to ambient atmosphere. The container is
introduced into a sterile filling chamber. A first filling member
coupled in fluid communication with the first liquid source is
placed in fluid communication with the storage chamber of the
container located in the sterile filling chamber, and the first
liquid component is aseptically introduced through the first
filling member and into the storage chamber. A second filling
member coupled in fluid communication with the second liquid source
is placed in fluid communication with the storage chamber of the
container located in the sterile filling chamber, and the second
liquid component is aseptically introduced through the second
filling member and into the storage chamber and, in turn, the first
and second liquid components are combined into a liquid product
formulation within the sterile chamber of the container. The first
and second filling members are withdrawn from fluid communication
with the storage chamber of the container located within the
sterile filling chamber, and the filled storage chamber is sealed
with respect to ambient atmosphere to hermetically seal the liquid
product formulation within the storage chamber of the
container.
Inventors: |
Py; Daniel; (Larchmont,
NY) |
Correspondence
Address: |
MCCARTER & ENGLISH LLP;CITYPLACE I
185 ASYLUM STREET
HARTFORD
CT
06103
US
|
Family ID: |
40526713 |
Appl. No.: |
12/245681 |
Filed: |
October 3, 2008 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60997675 |
Oct 4, 2007 |
|
|
|
Current U.S.
Class: |
426/62 ; 426/106;
426/234; 426/399; 426/580; 426/599; 426/61; 426/66 |
Current CPC
Class: |
A23L 2/46 20130101; B65B
55/10 20130101; A23L 3/22 20130101; B65B 55/025 20130101; A23L 3/04
20130101; B65B 3/04 20130101; B65B 55/12 20130101 |
Class at
Publication: |
426/62 ; 426/399;
426/234; 426/61; 426/599; 426/580; 426/66; 426/106 |
International
Class: |
B65B 55/04 20060101
B65B055/04; B65B 55/08 20060101 B65B055/08; A23L 1/29 20060101
A23L001/29; A23L 1/28 20060101 A23L001/28; A23L 2/02 20060101
A23L002/02; A23C 9/20 20060101 A23C009/20; A23L 2/00 20060101
A23L002/00; B65D 85/72 20060101 B65D085/72; B65D 85/80 20060101
B65D085/80 |
Claims
1. A method of formulating and aseptically filling liquid products,
comprising: providing a first liquid source including at least one
first liquid component; providing a second liquid source including
at least one second liquid component; providing a container
including a body defining an empty, sterile storage chamber therein
that is sealed with respect to ambient atmosphere; introducing the
container into a sterile filling chamber; placing a first filling
member coupled in fluid communication with the first liquid source
in fluid communication with the storage chamber of the container
located in the sterile filling chamber, and aseptically introducing
the least one first liquid component through the first filling
member and into the storage chamber; placing a second filling
member coupled in fluid communication with the second liquid source
in fluid communication with the storage chamber of the container
located in the same or a different sterile filling chamber, and
aseptically introducing the least one second liquid component
through the second filling member and into the storage chamber and,
in turn, combining the at least one first and at least one second
liquid components into a liquid product formulation within the
sterile chamber of the container; and withdrawing the first and
second filling members from fluid communication with the storage
chamber of the container located within the sterile filling chamber
and sealing the filled storage chamber with respect to ambient
atmosphere to hermetically seal the liquid product formulation
within the storage chamber of the container.
2. A method as defined in claim 1, further comprising the steps of
providing a container including at least one needle penetrable and
thermally resealable portion in fluid communication with the
storage chamber; penetrating the at least one needle penetrable and
thermally resealable portion of the container with a first filling
needle; penetrating the at least one needle penetrable and
thermally resealable portion of the container with a second filling
needle; withdrawing the first and second filling needles from the
needle penetrable and thermally resealable portion of the container
and leaving at least one resulting needle hole therein; and
applying laser radiation to the at least one resulting needle hole
to thermally reseal the needle penetrable and thermally resealable
portion and, in turn, hermetically seal the liquid product
formulation within the storage chamber.
3. A method as defined in claim 1, further comprising sterilizing
the at least one first liquid component and separately sterilizing
the at least one second liquid component.
4. A method as defined in claim 3, wherein at least one of the
first and second liquid components is heat labile, and the
sterilizing step does not damage, destroy or decompose the heat
labile components.
5. A method as defined in claim 3, wherein at least one of the
first and second liquid components is heat labile, and the
sterilizing of the at least one heat labile component is by
filtration.
6. A method as defined in claim 3, wherein the at least one first
liquid component is heat labile, the at least one second liquid
component is not heat labile, the at least one first liquid
component is sterilized by filtration, and the at least one second
liquid component is thermally sterilized.
7. A method as defined in claim 3, wherein the at least one first
liquid component and the at least one second liquid component are
sterilized prior to introducing the first and second liquid
components into the storage chamber.
8. A method as defined in claim 6, wherein the at least one first
liquid component is a micronutrient.
9. A method as defined in claim 8, wherein the micronutrient is
selected from the group including minerals, vitamins, hormones,
growth factors, nucleotides, polynucleotides, biopolymers, and
mixtures of at least one of proteins, carbohydrates and
nucleotides.
10. A method as defined in claim 6, wherein the at least one first
liquid component is a living organism.
11. A method as defined in claim 10, wherein the living organism is
selected from the group including probiotics, bacteriophages,
yeasts, molds and fungi.
12. A method as defined in claim 6, wherein the at least one first
liquid component is selected from the group including a flavoring
and an aroma.
13. A method as defined in claim 6, wherein the at least one second
liquid component is selected from the group including water,
proteins, carbohydrates and lipids.
14. A method as defined in claim 13, wherein the proteins are
selected from the group including milk, vegetable proteins,
fractions of milk proteins, fractions of milk protein fractions,
and hydrolyzed forms of any of the foregoing.
15. A method as defined in claim 13, wherein the carbohydrates are
selected from the group including lactose, glucose, sucrose,
maltodextrins, galactooligosaccharides, glucooligosaccharides,
fructooligosaccharides, and other oligosaccharides known to provide
explicit physiological benefits or to be present in human or other
mammalian milks.
16. A method as defined in claim 13, wherein the lipids are
selected from the group including lipids of animal, plant or
microbial origin.
17. A method as defined in claim 1, further comprising mounting the
sealed, empty container on a conveyor; transmitting a fluid
sterilant onto at least an exposed portion of the container and, in
turn, sterilizing with the fluid sterilant at least such exposed
portion of the container; transmitting a heated gas onto the
portion of the container exposed to the fluid sterilant, flushing
away with the heated gas the fluid sterilant from the exposed
portion of the container and, in turn, placing at least one of the
first and second filling members in fluid communication with the
sterile storage chamber of the container at the sterilized exposed
portion of the container; and moving the conveyor through the
sterile filling chamber.
18. A method as defined in claim 1, wherein the at least one first
liquid component is selected from the group including a heat labile
component, a flavoring and an aroma, and the at least one second
liquid component defines a base.
19. A method as defined in claim 18, wherein the base is selected
from the group including water, milk, a milk-based beverage, soy, a
soy-based beverage, a dairy product, and a fruit juice.
20. A method as defined in claim 18, further comprising first
introducing the at least one first liquid component, and then
introducing the base to facilitate mixing the first and second
liquid components.
21. A method as defined in claim 1, further comprising introducing
the at least one first liquid component and the at least one second
liquid component into the storage chamber by pumping each liquid
component through the first and second filling members,
respectively.
22. A method as defined in claim 21, further comprising selecting
at least one of speed, flow rate and time of operation of a pump to
control the volume of each of the first and second liquid
components introduced into the storage chamber.
23. A method as defined in claim 22, further comprising providing a
first pump drivingly coupled to the first filling member, and a
second pump drivingly coupled to the second filling member.
24. A method as defined in claim 23, wherein each pump is a
positive displacement pump.
25. A method as defined in claim 24, further comprising reversing
the direction of at least one positive displacement pump upon
terminating introducing a respective first or second liquid
component to prevent dripping of the component from the respective
filling member into the storage chamber.
26. A method as defined in claim 1, wherein a substantially
hermetic seal is maintained between the storage chamber and ambient
atmosphere during filling thereof.
27. A method as defined in claim 1, wherein the container includes
at least one filling valve coupled in fluid communication with the
storage chamber, and the first and second filling members fill the
storage chamber through the valve.
28. A method as defined in claim 27, wherein the filling members
are cannulas.
29. A method as defined in claim 27, wherein the filling member is
a needle, the container includes a needle penetrable and thermally
resealable portion, and a substantially hermetic seal is maintained
between the filling needle and needle penetrable and thermally
resealable portion during filling therethrough.
30. A method as defined in claim 1, further comprising the step of
providing an overpressure of sterile gas in the sterile chamber
during filling therein.
31. A liquid product made in accordance with the following method:
providing a first liquid source including at least one first liquid
component; providing a second liquid source including at least one
second liquid component: providing a container including a body
defining at least one empty, sterile storage chamber therein that
is sealed with respect to ambient atmosphere; introducing the
container into a sterile filling chamber; placing a first filling
member coupled in fluid communication with the first liquid source
in fluid communication with the storage chamber of the container
located in the sterile filling chamber, and aseptically introducing
the least one first liquid component through the first filling
member and into the storage chamber; placing a second filling
member coupled in fluid communication with the second liquid source
in fluid communication with the storage chamber of the container
located in the same or a different sterile filling chamber,
aseptically introducing the least one second liquid component
through the second filling member and into the storage chamber and,
in turn, combining the at least one first and at least one second
liquid components into a liquid product formulation within the
sterile chamber of the container; and withdrawing the first and
second filling members from fluid communication with the storage
chamber of the container located within the sterile filling chamber
and sealing the filled storage chamber with respect to ambient
atmosphere to hermetically seal the liquid product formulation
within the storage chamber of the container.
32. A liquid product made in accordance with the method of claim
31, further comprising the following steps: providing a container
including a body defining an empty, sterile storage chamber
therein, and at least one needle penetrable and thermally
resealable portion in fluid communication with the storage chamber;
penetrating the at least one needle penetrable and thermally
resealable portion of the container with a first filling needle
coupled in fluid communication with the first liquid source, and
aseptically introducing the least one first liquid product through
the first filling needle and into the storage chamber; penetrating
the at least one needle penetrable and thermally resealable portion
of the container with a second filling needle coupled in fluid
communication with the second liquid source, and aseptically
introducing the least one second liquid product through the second
filling needle and into the storage chamber and, in turn, combining
the at least one first and at least one second liquid products into
a liquid product formulation; withdrawing the first and second
filling needles from the needle penetrable and thermally resealable
portion of the container and leaving at least one resulting needle
hole therein; and applying laser radiation to the at least one
resulting needle hole to thermally reseal the needle penetrable and
thermally resealable portion and, in turn, hermetically seal the
liquid product formulation within the storage chamber.
Description
CROSS-REFERENCE TO PRIORITY AND RELATED APPLICATIONS
[0001] This patent application claims priority under 35 U.S.C.
.sctn. 119 on prior U.S. provisional patent application Ser. No.
60/997,675, filed Oct. 4, 2007, entitled "Apparatus And Method For
Formulating And Aseptically Filling Liquid Products", which is
hereby incorporated by reference in its entirety as part of the
present disclosure. In addition, this patent application contains
subject matter related to the co-pending U.S. patent application
filed in the name of the same inventor, on even date herewith,
entitled "Apparatus for Formulating and Aseptically Filling Liquid
Products."
FIELD OF THE INVENTION
[0002] The present invention relates to methods for formulating
and/or filling products, and more particularly, to methods for
aseptically formulating and/or filling liquid products.
BACKGROUND INFORMATION
[0003] Sterility and shelf-life are important considerations in the
manufacture of many liquid food products, such as liquid nutrition
products and beverages. Food manufacturing practices must achieve
final products with assured microbial safety, e.g., sterility.
Traditionally, this means products must be heat processed to reduce
any potential microbial contamination to meet or exceed the levels
of sterility prescribed for such products in national and
international legislation. In addition, products typically must be
stored for extended periods of time and hence unstable components
cannot be included without deterioration or must be over-dosed to
ensure that minimal quantities remain at point of consumption. For
many products, such as infant formulas and other liquid nutrition
products, it is desirable that the products contain certain
essential nutrients, such as all of the essential nutrients needed
for human infant growth and development in the case of infant
formula.
[0004] A prerequisite to an infant formula is that the final
product must be microbiologically safe, and for that reason
traditional processing mandates that the final product be
adequately heat processed. Thus, products in liquid form are
subject to a rigorous heat treatment typically by exposure to high
temperatures for short time (UHT--aseptic process) or by retorting.
The retort sterilization has been recommended for products used in
hospitals to feed premature and term newborn babies.
[0005] While these thermal treatments can be successful in assuring
microbial safety, they can adversely affect the molecular
components and structures that are ingredients in infant formulas
and other liquid nutrition products. Invariably, heat-treating
complex infant formula mixtures leads to various reactions of
individual molecules and to interactions between different
components. One prior art strategy to resolve the losses caused by
these destructive reactions with respect to the final quantities of
components of formula is to include a sufficient excess of the
ingredients as a quantitative function of the instability to ensure
that sufficient levels of essential nutrients remain in the final
product. The strategy of using excess nutrients prior to processing
the formula ignores the potential implications to the user of
consuming thermal reaction products formed during processing. Thus,
although necessary, the thermal processing of nutritional
components can generate compounds or intermediates that may have
undesirable nutritional consequences.
[0006] Another drawback of thermal processing is that it can
generate advanced glycation end products (AGEs). Through the
Maillard reaction, certain amino acids such as lysine can react
with aldehyde groups of glucose to first create Schiff bases and
then rearrange to Amadori products. These reactions produce various
glycoxidation and lipoxidation products which are collectively
known as AGEs. AGEs are formed by the Maillard reaction during food
processing when, for example, mixtures containing protein and
carbohydrates are heated. However, AGEs also may be formed
endogenously in the body and are thought to contribute to the
natural aging process.
[0007] AGEs are end-products that in general retain little chemical
reactivity. They are formed via complex chemical reactions which
may include oxidation reactions and the formation of reactive
intermediates. Thus, AGEs can be considered markers for the
formation of these reactive intermediates. These intermediates
include glyoxal, methylglyoxal, 3-deoxyglucosone, glyceraldehyde,
and others. Examples of AGEs are lactuloselysine,
hydroxymethylfurfural, oxalic acid monolysinylamide, and
carboxymethyllysine.
[0008] It has been suggested that AGEs may be linked to chronic low
level inflammation. This is due in part to oxidative stress caused
by AGEs. Chronic low level inflammation has been linked to a number
of diseases. For example, it is hypothesized that chronic low level
inflammation may be linked to diabetes, cardiovascular disease,
Alzheimer, cancer, and even weight gain and aging. A reduction in
AGEs in the diet may lead to an extension of life span;
prevention/reduction of weight gain; prevention of insulin
resistance; prevention of heart disease; and improvement of
oxidative stress. Many scientific papers have been written
postulating links between AGEs and various disease states. One such
paper is entitled "Advanced Glycation Endproducts" by Wauthier and
Guillasseau, Diabetes Metab (Paris) 2001, 27, 535-542. See also
International Patent Publication No. WO 2006/029298 A1 entitled
"Nutritional Products Having Improved Quality And Methods And
Systems Regarding Same". The foregoing paper and published patent
application are hereby incorporated by reference in their
entireties as part of the present disclosure.
[0009] Typically, infant formula and other liquid nutrition
products must be pre-processed to achieve the final composition and
to uniformly disperse and solubilize all formula ingredients
(proteins, carbohydrates, lipids and other nutrients) and to
produce a homogenous emulsion. The emulsion is further processed by
high pressure homogenizations and heating to assure homogeneity and
reduce bacterial load. If a ready-to-feed liquid is desired, the
emulsion is filled into appropriate packaging and subjected to a
further heat treatment. The heat treatment may be applied either
before filling in which case filling is carried out under aseptic
conditions or the filled containers may themselves be heat treated
in a retort process. In addition, some infant formulas are produced
and packaged for the first feeding in hospitals. Many such
hospital-targeted products are produced in ready-to-feed liquid
form in small bottles called nursettes, and are sterilized in such
containers by retort processing.
[0010] The majority of destructive reactions and of undesirable
Maillard reactions that lead to various decomposition and
polymerization products including AGEs occur when proteins, lipids
and carbohydrates are heated in a liquid phase. This intensive
heating is also a factor that leads to the decomposition of various
heat labile nutrients. Once they begin during the heating process,
many chemical reactions continue, although at slower reaction
rates, throughout the storage of either liquid or dry products at
room temperature. It should also be noted that under factory
conditions it may be necessary for batches of liquid product to be
kept in holding tanks at various stages in the manufacturing
process for reasons such as unplanned work on necessary processing
equipment. Any delays occurring in this way will increase the
potential for AGE formation.
[0011] Formulations containing whey proteins, bioactive compounds
and other nutritional components found in human milk can be
necessary for infant formula, especially for low birth weight
infants when feeding with human milk is not an option. The heat
lability and reactivity of some of these components makes it
particularly difficult to incorporate some of them into liquid
formulas which are thermally sterilized. As indicated above,
conventional thermal processes can result in nutrient degradation,
loss of functionality, reduction of shelf-life and the development
of unwanted by products. In order to improve the product quality it
is necessary to produce the formula in a manner that minimizes the
exposure of those components to excessive heating. Sterilizing such
components using cold sterilization processes or less severe heat
processes would allow the development of formulas with improved
qualities and that more closely approximate human breast milk.
[0012] It is an object of the present invention to overcome one or
more of the above-described drawbacks and/or disadvantages of the
prior art.
SUMMARY OF THE INVENTION
[0013] In accordance with a first aspect, the present invention is
directed to a method of formulating and aseptically filling liquid
products. The method comprises the following steps:
[0014] (i) providing a first liquid source including at least one
first liquid component;
[0015] (ii) providing a second liquid source including at least one
second liquid component;
[0016] (iii) providing a container including a body defining an
empty, sterile storage chamber therein that is sealed with respect
to ambient atmosphere;
[0017] (iv) introducing the container into a sterile filling
chamber;
[0018] (v) placing a first filling member coupled in fluid
communication with the first liquid source in fluid communication
with the storage chamber of the container located in the sterile
filling chamber, and aseptically introducing the least one first
liquid component through the first filling member and into the
storage chamber;
[0019] (vi) placing a second filling member coupled in fluid
communication with the second liquid source in fluid communication
with the storage chamber of the container located in the same or a
different sterile filling chamber, and aseptically introducing the
least one second liquid component through the second filling member
and into the storage chamber and, in turn, combining the at least
one first and at least one second liquid components into a liquid
product formulation within the sterile chamber of the container;
and
[0020] (vii) withdrawing the first and second filling members from
fluid communication with the storage chamber of the container and
sealing the filled storage chamber with respect to ambient
atmosphere to hermetically seal the liquid product formulation
within the storage chamber of the container.
[0021] In accordance with some embodiments of the present
invention, the method comprises the following steps:
[0022] (i) providing a container including a needle penetrable and
thermally resealable portion in fluid communication with the
storage chamber;
[0023] (ii) penetrating the needle penetrable and thermally
resealable portion of the container with a first filling needle or
other injection member coupled in fluid communication with the
first liquid source, and aseptically introducing the least one
first liquid component through the first filling needle and into
the storage chamber;
[0024] (iii) penetrating the needle penetrable and thermally
resealable portion of the container with a second filling needle or
other injection member coupled in fluid communication with the
second liquid source, and aseptically introducing the least one
second liquid component through the second filling needle and into
the storage chamber and, in turn, combining the at least one first
and at least one second liquid components into a liquid product
formulation;
[0025] (iv) withdrawing the first and second filling needles from
the needle penetrable and thermally resealable portion of the
container and leaving at least one resulting needle hole therein;
and
[0026] (v) applying laser radiation to the at least one resulting
needle hole to thermally reseal the needle penetrable and thermally
resealable portion and, in turn, hermetically seal the liquid
product formulation within the storage chamber.
[0027] The currently preferred embodiments of the present invention
further comprise sterilizing the at least one first liquid
component and separately sterilizing the at least one second liquid
component. In some embodiments of the present invention, at least
one of the first and second liquid components is heat labile, and
the sterilizing step does not damage, destroy or decompose the heat
labile components. In some such embodiments, at least one of the
first and second liquid components is heat labile, and such heat
labile components are sterilized by filtration. In some such
embodiments, the at least one first liquid component is heat
labile, the at least one second liquid component is not heat
labile, the at least one first liquid component is sterilized by
filtration, and the at least one second liquid component is
thermally sterilized. In some such embodiments, the at least one
first liquid component and the at least one second liquid component
are sterilized prior to introducing the first and second liquid
components into the storage chamber.
[0028] In some embodiments of the present invention, the at least
one first liquid component is a micronutrient. In some such
embodiments, the micronutrient is selected from the group including
minerals, vitamins, hormones, growth factors, nucleotides,
polynucleotides, biopolymers, and mixtures of at least one of
proteins, carbohydrates and nucleotides. In some embodiments, the
at least one first liquid component is a living organism. In some
such embodiments, the living organism is selected from the group
including probiotics, bacteriophages, yeasts, molds and fungi. In
some embodiments, the at least one first liquid component is
selected from the group including a flavoring and an aroma. In some
embodiments, the at least one second liquid component is selected
from the group including water, proteins, carbohydrates and lipids.
In some such embodiments, the proteins are selected from the group
including milk, vegetable proteins, fractions of milk proteins,
fractions of milk protein fractions, and hydrolyzed forms of any of
the foregoing; the carbohydrates are selected from the group
including lactose, glucose, sucrose, maltodextrins,
galactooligosaccharides, glucooligosaccharides,
fructooligosaccharides, and other oligosaccharides known to provide
explicit physiological benefits or to be present in human or other
mammalian milks; and the lipids are selected from the group
including lipids of animal, plant or microbial origin.
[0029] In accordance with another aspect, the method further
comprises the steps of: (i) mounting the sealed, empty container on
a conveyor; (ii) transmitting a fluid sterilant onto at least an
exposed portion of the container and, in turn, sterilizing with the
fluid sterilant at least such exposed portion of the container;
(iii) transmitting a heated gas onto the portion of the container
exposed to the fluid sterilant, flushing away with the heated gas
the fluid sterilant from the exposed portion of the container and,
in turn, forming an exposed portion of the container substantially
free of fluid sterilant; and (iv) moving the conveyor with the
container thereon through the sterile filling chamber.
[0030] In some embodiments of the present invention, the at least
one first liquid component is a heat labile component, a flavoring
and/or an aroma, and the at least one second liquid component
defines a base. In some such embodiments, the base is a liquid
beverage, such as water, milk, a milk based beverage, soy, a soy
based beverage, a dairy product, or a fruit juice. Some embodiments
of the present invention further comprise first introducing the at
least one first liquid component, and then introducing the base to
facilitate mixing the first and at least second liquid
components.
[0031] Some embodiments of the present invention further comprise
introducing the at least one first liquid component and the at
least one second liquid component into the storage chamber by
pumping each liquid component through first and second filling
members or needles, respectively. Some such embodiments further
comprise selecting the speed, flow rate and/or time of operation of
the pump to control the volume of each of the first and second
liquid components introduced into the storage chamber. Some
embodiments of the present invention further comprise providing a
first driving system or pump drivingly coupled to the first filling
member, and a second driving system or pump drivingly coupled to
the second filling member. Some such embodiments further comprise
reversing the direction of at least one driving system or pump upon
terminating introducing a respective first or second liquid
component to prevent dripping of the component from the respective
filling member into the storage chamber.
[0032] In accordance with another aspect, the present invention is
directed to an apparatus for formulating and aseptically filling
liquid products. The apparatus comprises a first liquid source
including at least one first liquid component; at least a second
liquid source including at least one second liquid component; a
container including a body defining an empty, sterile storage
chamber therein that is sealed with respect to ambient atmosphere;
and a sterile filling chamber. A first filling member is coupled in
fluid communication with the first liquid source, is movable
relative to the container located within the sterile filling
chamber, and is connectable in fluid communication with the sealed,
sterile storage chamber of the container for aseptically
introducing the least one first liquid component through the first
filling member and into the storage chamber. A second filling
member is coupled in fluid communication with the second liquid
source, is movable relative to the container located within the
same or a different sterile filling chamber, and is connectable in
fluid communication with the sealed, empty sterile chamber of the
container. The least one second liquid component is aseptically
introduced through the second filling member and into the storage
chamber, and is combined with the at least one first liquid
component into a liquid formulation that is hermetically sealed
with respect to ambient atmosphere within the sterile storage
chamber of the container
[0033] In some embodiments of the present invention, the container
includes a needle penetrable and thermally resealable portion in
fluid communication with the storage chamber. A first filling
needle or like injection member is coupled in fluid communication
with the first liquid source, and is movable relative to the needle
penetrable and thermally resealable portion of the container for
aseptically introducing the least one first liquid component
through the first filling needle and into the storage chamber. A
second filling needle or like injection member is coupled in fluid
communication with the second liquid source and is movable relative
to the needle penetrable and thermally resealable portion of the
container for aseptically introducing the least one second liquid
component through the second filling needle and into the storage
chamber and, in turn, combining the at least one first and at least
one second liquid components into a liquid product formulation. A
laser source is connectable in thermal communication with the
needle penetrable and thermally resealable portion for applying
laser radiation to at least one needle hole resulting from
withdrawal of the first and second filling needles from the needle
penetrable and thermally resealable portion to hermetically seal
the liquid product formulation within the storage chamber.
[0034] In some embodiments of the present invention, the apparatus
further comprises first means for sterilizing the at least one
first liquid component, and second means for separately sterilizing
the at least one second liquid component. In some such embodiments,
at least one of the first and second liquid components is heat
labile, and the respective first or second means does not damage,
destroy or decompose the heat labile components. In some such
embodiments, the at least one first liquid component is heat
labile, the at least one second liquid component is not heat
labile, the first means is a filter, and the second means is a
thermal sterilization apparatus.
[0035] In some embodiments of the present invention, the at least
one first liquid component is heat labile, the at least one second
liquid component is not heat labile, and the apparatus further
comprises (i) a filtration sterilization apparatus coupled in fluid
communication with the first liquid source for sterilizing the at
least one first liquid component by filtration prior to introducing
the at least one first liquid component through the first filling
needle or other filling member, and (ii) a thermal sterilization
apparatus for thermally sterilizing the at least one second liquid
component prior to introducing the at least one second liquid
component through the second filling needle or other filling
member.
[0036] In some embodiments of the present invention, the apparatus
further comprises at least one first filling station including at
least one first filling needle or other filling member, and at
least one second filling station including at least one second
filling needle or other filling member. Preferably, the apparatus
further comprises at least one pump drivingly coupled to the first
and second filling needles or other filling members for pumping the
components therethrough. In some such embodiments, the apparatus
comprises a first pump drivingly coupled to the first filling
member, and a second pump drivingly coupled to the second filling
member. In some such embodiments, each of the first and second
filling stations includes a filling manifold including a plurality
of filling members spaced relative to each other and movable
relative to a container support for penetrating or otherwise being
placed in fluid communication with a plurality of containers
mounted on the support, filling the containers through the filling
members, and withdrawing the filling members from the filled
containers. In such embodiment including containers with needle
penetrable and thermally resealable portions, the apparatus
preferably further comprises a plurality of laser assemblies. Each
laser assembly is connectable to a source of laser radiation, and
is focused substantially on a penetration spot on the needle
penetrable and thermally resealable portion of a respective
container for applying laser radiation thereto and resealing the
respective penetration aperture(s).
[0037] In some embodiments of the present invention, the apparatus
further comprises a housing defining an inlet end, an outlet end,
and at least one sterile chamber located between the inlet and
outlet ends. A conveyor is located at least partially within the
sterile chamber and defines a plurality of container positions
thereon for supporting and moving containers in a direction from
the inlet end toward the outlet end through the sterile chamber. In
some such embodiments, a fluid sterilant station is located within
the sterile zone and is coupled in fluid communication with a
source of fluid sterilant for transmitting fluid sterilant onto at
least an exposed portion of a respective container supported on the
conveyor within the fluid sterilant station, and sterilizing at
least the exposed portion of the respective container. Such
embodiments further comprise at least one sterilant removing
station located within the sterile chamber between the fluid
sterilant station and the outlet end of the housing, and coupled in
fluid communication with a source of heated gas for transmitting
the heated gas onto a container supported on the conveyor within
the at least one sterilant removing station to flush away fluid
sterilant on the container. In some such embodiments, the filling
members, and laser optic assemblies when employed, are located
within the sterile chamber between the at least one sterilant
removing station and the outlet end of the housing for receiving
the sterilized containers therefrom. In some such embodiments, the
fluid sterilant is hydrogen peroxide. Some embodiments further
comprise a source of sterile gas coupled in fluid communication
with the sterile chamber for creating an over pressure of sterile
gas within the sterile chamber, and means for directing a flow of
sterile gas substantially in a direction from the outlet end toward
the inlet end of the housing to thereby prevent fluid sterilant
from flowing onto containers located adjacent to the filling
members.
[0038] In some embodiments of the present invention, the conveyor
includes a plurality of pivotally mounted container supports that
engage opposing sides of a respective container supported thereon
relative to each other, and substantially isolate a sterile portion
of the container located above the container supports relative to a
portion of the container located below the container supports to
thereby prevent any contamination on the lower portion of the
container from contaminating the sterile upper portion of the
container. In those embodiments with containers that are needle
penetrable and thermally resealable, the sterile portion of the
container located above the supports includes the needle penetrable
and thermally resealable portion.
[0039] In some embodiments of the present invention, the penetrable
and thermally sealable portion of the container is a thermoplastic
elastomer that is heat sealable to hermetically seal the
penetration aperture(s) by applying laser radiation at a
predetermined wavelength and power thereto, and defines (i) a
predetermined wall thickness, (ii) a predetermined color and
opacity that substantially absorbs the laser radiation at the
predetermined wavelength and substantially prevents the passage of
the radiation through the predetermined wall thickness thereof, and
(iii) a predetermined color and opacity that causes the laser
radiation at the predetermined wavelength and power to hermetically
seal the penetration aperture formed in the penetrable region
thereof in a predetermined time period of less than or equal to
about 5 seconds and substantially without burning the penetrable
region.
[0040] In some embodiments of the present invention, the penetrable
and thermally sealable portion of the container is a thermoplastic
elastomer that is heat sealable to hermetically seal the
penetration aperture by applying laser radiation at a predetermined
wavelength and power thereto, and includes (i) a styrene block
copolymer; (ii) an olefin; (iii) a predetermined amount of pigment
that allows the penetrable portion to substantially absorb laser
radiation at the predetermined wavelength and substantially prevent
the passage of radiation through the predetermined wall thickness
thereof, and hermetically seal the penetration aperture(s) formed
in the penetrable portion in a predetermined time period of less
than or equal to about 5 seconds; and (iv) a predetermined amount
of lubricant that reduces friction forces at an interface of the
filling member and penetrable portion.
[0041] In some embodiments of the present invention, the penetrable
and thermally sealable portion of the container is a thermoplastic
elastomer that is heat sealable to hermetically seal the
penetration aperture(s) by applying laser radiation at a
predetermined wavelength and power thereto, and includes (i) a
first polymeric material in an amount within the range of about 80%
to about 97% by weight and defining a first elongation; (ii) a
second polymeric material in an amount within the range of about 3%
to about 20% by weight and defining a second elongation that is
less than the first elongation of the first polymeric material;
(iii) a pigment in an mount that allows the second material portion
to substantially absorb laser radiation at the predetermined
wavelength and substantially prevent the passage of radiation
through the predetermined wall thickness thereof, and hermetically
seal a penetration aperture formed in the penetrable region thereof
in a predetermined time period of less than or equal to about 5
seconds; and (iv) a lubricant in an amount that reduces friction
forces at an interface of the filling member and penetrable portion
during penetration thereof.
[0042] In accordance with another aspect, the present invention is
directed to an apparatus for formulating and aseptically filling
liquid products. The apparatus comprises first means for supplying
at least one first liquid component; second means for supplying at
least one second liquid component; a container including a body
defining an empty, sterile storage chamber therein that is sealed
with respect to ambient atmosphere; a sterile filling chamber;
third means coupled in fluid communication with the first means and
movable relative to the container located within the sterile
filling chamber for connecting the first means in fluid
communication with the sterile storage chamber and aseptically
introducing the least one first liquid component therethrough and
into the storage chamber; and fourth means coupled in fluid
communication with the second means and movable relative to the
container located within the same or a different sterile filling
chamber for connecting the second means in fluid communication with
the sterile storage chamber and aseptically introducing the least
one second liquid component therethrough and into the storage
chamber and, in turn, combining the at least one first and at least
one second liquid components into a liquid formulation sealed with
respect to ambient atmosphere within the storage chamber.
[0043] In some embodiments of the present invention, the container
includes a penetrable and thermally resealable portion in fluid
communication with the storage chamber. The third means are coupled
in fluid communication with the first means and movable relative to
the container for penetrating the penetrable and thermally
resealable portion of the container and aseptically introducing the
least one first liquid component therethrough and into the storage
chamber. The fourth means are coupled in fluid communication with
the second means and movable relative to the container for
penetrating the penetrable and thermally resealable portion of the
container, and aseptically introducing the least one second liquid
component therethrough and into the storage chamber and, in turn,
mixing the at least one first and at least one second liquid
components into a liquid product formulation. In these embodiments,
fifth means are connectable in thermal communication with the
penetrable and thermally sealable portion of the container for
thermally sealing the penetration aperture(s) to hermetically seal
the liquid product formulation within the storage chamber. In some
embodiments of the present invention, the first means is a first
liquid chamber, the second means is a second liquid chamber, the
third means is a first filling member, such as a filling needle,
the fourth means is a second filling member, such as a filling
needle, and the fifth means is a laser.
[0044] One advantage of the present invention is that heat labile
components can be sterilized at cold or ambient temperatures, and
thus the apparatus and method of the present invention can overcome
the drawbacks and disadvantages associated with thermal
sterilization encountered in the prior art. Yet another advantage
of the present invention is that the components that are not heat
labile can be thermally sterilized, and the separately sterilized
components can be aseptically filled and combined into a desired
liquid formulation in the storage chamber.
[0045] Other objects and advantages of the present invention,
and/or of the currently preferred embodiments thereof, will become
more readily apparent in view of the following detailed description
of currently preferred embodiments and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] FIG. 1 is a schematic illustration of a first embodiment of
an apparatus embodying the present invention.
[0047] FIG. 2 is a schematic illustration of a second embodiment of
an apparatus embodying the present invention.
DETAILED DESCRIPTION OF CURRENTLY PREFERRED EMBODIMENTS
[0048] In FIG. 1, an apparatus embodying the present invention is
indicated generally by the reference numeral 10. The apparatus 10
comprises a first liquid source 12 including at least one first
liquid component, and a second liquid source 14 including at least
one second liquid component. A plurality of containers 16 are
mounted on a conveyor 18 and transported by the conveyor through
the apparatus. Each container 16 includes a body 20 defining an
empty, sterile storage chamber 22 therein, and a penetrable and
thermally resealable portion 24 in fluid communication with the
storage chamber. The apparatus 10 includes a housing 26 defining a
barrier enclosure for receiving therein sealed, empty sterile
containers 16 transported on the conveyor 18, sterilizing the
exterior portions of the containers, aseptically filling the
containers with the first and second liquid components (and other
components if desired) and combining the liquid components within
the storage chambers 22 of the containers into a liquid product
formulation, and laser sealing the penetration aperture(s) formed
in the penetrable and thermally resealable portions 24 to seal the
liquid product formulation within the containers.
[0049] The housing 26 includes a plurality of stations through
which the conveyor 18 transports the containers 16 for processing.
The containers are provided to the apparatus 10 in a sealed, empty
sterile condition, i.e., the sealed empty chambers 22 of the
containers are sterile. However, the exterior surfaces of the
containers may not be sterile. Accordingly, the apparatus 10
includes a first station 28 that sterilizes at least the penetrable
and thermally resealable portions 24 of the containers 16 with a
fluid sterilant, such as vaporized hydrogen peroxide ("VHP"),
provided by a fluid sterilant source 30. A second station 32
transmits a heated gas 34 onto the surfaces of the containers to
evaporate the fluid sterilant and, in turn, provide dry sterile
containers 16 for subsequent filling and sealing. If desired, other
sterilizing mechanisms equally may be employed, such as ebeam,
gamma or other irradiation.
[0050] A third station 36 has mounted therein at least one first
filling member 38, such as a filling needle, coupled in fluid
communication with at least one first liquid component(s) source
12. As indicated by the arrows in FIG. 1, each first filling member
38 is drivingly mounted and movable relative to the needle
penetrable and thermally resealable portions 24 of the containers
16 received in the third station 36 for aseptically introducing the
first liquid component(s) 12 through the first filling member 38
and into the storage chamber 22 of the respective containers. A
cold sterilization apparatus 40 and a pump 42 are coupled in fluid
communication with the first liquid component source 12 and first
filling member 38. In the illustrated embodiment, the cold
sterilization apparatus 40 is a microfilter, such as a 0.2 micron
filter, and the pump 42 is a positive displacement pump.
Accordingly, the first liquid component(s) is/are pumped through
the cold sterilization apparatus 40 and the resulting sterile
liquid component(s) is/are aseptically introduced through the first
filling member 38 into the sterile storage chamber 22 of a
respective container.
[0051] A fourth station 44 has mounted therein at least one second
filling member 46, such as a filling needle, coupled in fluid
communication with at least one second liquid component(s) source
14. As indicated by the arrows in FIG. 1, each second filling
member 46 is drivingly mounted and movable relative to the needle
penetrable and thermally resealable portions 24 of the containers
16 received in the fourth station 44 for aseptically introducing
the second liquid component(s) 14 through the second filling member
46 and into the storage chamber 22 of the respective containers. A
thermal sterilization apparatus 47 and a pump 48 are coupled in
fluid communication to the second liquid component source 14 and
second filling member 46. In the illustrated embodiment, the
thermal sterilization apparatus 47 is of a type known to those of
ordinary skill in the pertinent art for thermally sterilizing
liquid food products, and the pump 48 is a positive displacement
pump. Accordingly, the second liquid component(s) is/are are
thermally sterilized in the thermal sterilization apparatus 47 and
the resulting sterile liquid component(s) is/are pumped through the
second filling needle 46 and aseptically introduced into the
sterile storage chamber 22 of the respective containers.
[0052] A fifth station 50 includes at least one laser optic
assembly 52 optically coupled to at least one laser source 54 and
connectable in thermal communication with the needle penetrable and
thermally resealable portions 24 of the containers 16 passing
through the fifth station. The laser optic assembly 52 transmits
laser radiation from the laser source 54 to the needle hole(s)
resulting from withdrawal of the first and second filling members
38 and 46, respectively, from the needle penetrable and thermally
resealable portion 24 of the respective containers to hermetically
seal the aseptic liquid product formulation within the storage
chambers.
[0053] A source of pressurized sterile gas 56 is coupled in fluid
communication with at least the third, fourth and fifth stations to
provide an overpressure (or laminar flow) of sterile gas and, in
turn, maintain the sterility of the penetrable and thermally
resealable surfaces 24 of the containers and of the filling members
38 and 46 within the barrier enclosure. A sixth station 58 is
provided to optically detect the temperature of the resealed
portions of the containers (or this can be performed within the
laser resealing station 50, if desired, or more practicable), and
otherwise to perform the desired quality control operations on the
aseptically filled and sealed containers prior to their discharge
from the apparatus 10.
[0054] The sixth station 58 includes one or more optical sensors 60
for optically detecting the temperatures of the sealed portions of
the containers and associated electronics and displays 62 for
recording and displaying the date and otherwise providing
notification and enabling discarding of any containers that are out
of specification.
[0055] In FIG. 2, another apparatus embodying the present invention
is indicated generally by the reference numeral 110. The apparatus
110 is substantially similar to the apparatus 10 described above
with reference to FIG. 1, and therefore like reference numerals
preceded by the numeral "1" are used to indicate like elements. As
can be seen, the apparatus 110 includes first and second stations
128 and 132, respectively, for sterilizing the filling surfaces of
the containers, such as the penetrable and resealable stoppers, or
filling valves, and for transmitting a heated gas onto such
surfaces in the event a fluid sterilant is employed. A third
station 136 includes a plurality of first liquid component sources
112 (numbered "1" through "4" in the figure) mounted in series
relative to each other over the conveyor 118, and a fourth station
144 includes at least one second liquid component source 114
mounted over the conveyor 118. A fifth station 150 includes a laser
source 152, and a sixth station 158 includes devices for quality
control, tamper-evident capping and labeling. As shown at the inlet
to the housing 126, the container bodies 120 are formed by blow
molding (or other type of molding, such as injection molding) and
septum capping with the penetrable and resealable septums 124, or
capping with filling valves (not shown) (i.e., as can be seen, each
body 120 may start out as a perform which is blow molded into the
final body shape and capped with the penetrable and resealable
septum, or capped with a filling valve, etc.). This approach may be
particularly desirable for achieving the benefits of "just in time"
manufacturing (i.e., molding and filling). If desired, the bodies
120 and caps 124 may be aseptically molded in accordance with the
teachings of the co-pending patent applications incorporated by
reference below to form containers 116 with sealed, empty, sterile
chambers 122 ready for aseptic filling. Alternatively, the sealed
empty containers may be non-aseptically assembled and sterilized in
a more conventional manner, such as by subjecting the sealed empty
containers to gamma radiation.
[0056] Each sealed, empty, sterile container 116 may be filled in
the apparatus 110 with any of a variety of different liquid
components, in any of a variety of different orders of filling the
different liquid components, to create any of a variety of
different liquid product formulations. In one embodiment, the first
liquid component source 112 numbered "1" contains a first nutrient,
the second liquid component source 112 numbered "2" contains a
second nutrient, the first liquid component source 112 numbered "3"
contains a flavor "A", the first liquid component source 112
numbered "4" contains a flavor "B", and the second liquid component
source 114 numbered "5" contains a base liquid. The apparatus 110
includes a programmable controller that is programmable to control
the apparatus to fill any desired combination of the liquid
component sources to form any of a variety of different liquid
product formulations. For example, one batch of containers may be
filled with the first liquid component nutrient "1", the flavor
"B", and then the base "5". Alternatively, these same components
may be filled in a different order by moving the conveyor 118
forwardly and then backwardly, or vice versa. Other product
formulations may be aseptically created and filled in the same
manner. As described further below, any of numerous different
product formulations may be aseptically filled in the apparatus 10
or 110. In the illustrated embodiment, after each container is
filled with the desired liquid components to create the desired
liquid product formulations, the septums 124 are sealed in the
station 150, such as by laser resealing, and as indicated by the
arrow in FIG. 2, an over cap is applied to the sealed septum, such
as a tamper-evident over cap, and labeling is applied, in the
station 158. If a filling valve is used instead of the needle
penetrable septum, the laser resealing step may be eliminated.
[0057] As may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, the apparatus 10 and
110 may take any of numerous different configurations involving any
of numerous different types of stations and components that are
currently known, or that later become known, including any of
numerous different devices or methods for sterilizing the external
surfaces of the containers; any of numerous different types of
filling members, needles or other injection members; any of
numerous different numbers of filling members, needles or other
injection members; any of numerous different types of hot or cold
sterilization apparatus or processes; any of numerous different
types of pumps; any of numerous different configurations of liquid
component sources, sterilization apparatus and/or pumps; any of
numerous different liquid components, any desired number of such
components, and any desired combination of components forming any
of a variety of different product formulations; and any of numerous
different sealing devices or processes, including chemical sealing
devices or processes, or thermal sealing devices or processes, such
as laser sealing devices, or sealing devices that apply other forms
of energy to thermally reseal penetration aperture(s), such as
electrical, radiofrequency, microwave, ultrasonic, or ultrasound
energy application devices. For example, the sterilization
apparatus 40 and 47 may be either cold or thermal sterilization
apparatus.
[0058] The method and apparatus of the invention also may be
employed to make any of numerous different liquid product
formulations that are currently known, or that later become known,
including without limitation the following exemplary
formulations:
[0059] Water Plus Formulations
[0060] Exemplary "water plus" formulations include "vitamin
waters", i.e., waters with vitamins added to them, and/or waters
with flavorings, such as fruit flavorings added to them. Exemplary
prior art products of this type are produced using a "hot fill"
process (i.e., a fill temperature within the range of about 170-185
F). One of the drawbacks of the prior art hot fill approach is that
it requires a relatively heavy weight bottle to withstand
temperature and vacuum conditions upon cooling.
[0061] In the exemplary "water plus" formulations of the present
invention, a base or water is introduced into the container at one
filling station and the "plus" (e.g., vitamins and/or flavorings)
is introduced in another filling station. The base (water) is
processed in any of numerous different ways that are currently
known, or that later become known, including hot or cold
sterilization prior to being aseptically filled into the container
at about ambient temperature. The "plus" components, on the other
hand, are cold sterilized, such as by cold sterile filtration
(e.g., 0.2 micron filtration), and introduced into the container in
a separate filling member, needle or fill station to thereby allow
for improved quality with minimal heat degeneration. If desired,
the "plus" may be introduced into the containers prior to
introducing the water (or "base"), or the order of injecting the
components may be selected, in order to facilitate desired mixing
of the components into the resulting liquid product
formulation.
[0062] One advantage of the currently preferred embodiments of the
present invention is that the apparatus can include any number of
filling members, needles or associated filling stations. For
example, the apparatus can include any desired number of "base"
filling needles, members or associated stations for filling the
base component(s), such as water (or, for example, milk, non-dairy
creamer or soy, as described below), and any desired number of
"plus" filling members, needles or associated stations, such as
different filling members, needles or stations for filling
different flavorings, vitamins, nutritional supplements, other
ingredients and/or aromas. As a result, different product
formulations can be made by simply employing different filling
needles, members or stations of the same apparatus, and thus can be
made without the downtime and associated system cleaning and
sterilization required when changing over prior art filling lines
from one product or product configuration to another. Yet another
advantage of the present invention is the provision of a closed,
sterilized container that eliminates the need for rinsing before
filling and thus can significantly reduce the overall water and
waste requirements for a bottling facility in comparison to the
prior art. Yet another advantage of some currently preferred
embodiments of the present invention is that space allocations for
the rinsing of bottles or other containers can be minimized to a
"receiving" area only, thus further reducing the requirements and
associated costs in comparison to the prior art.
[0063] Yet another advantage is that the present invention can
enable more streamlined and/or efficient distribution of liquid
product formulations. Apparatus of the present invention can be
significantly smaller and more simplified in comparison to prior
art aseptic filling systems, thus requiring smaller facilities in
comparison to the prior art. As a result, manufacturers and/or
distributors can set up apparatus of the present invention in
different geographic locations relatively widely spaced from each
other, such as different locations throughout a country, so that
containers can be filled at or very close to desired points of
distribution, such as points of regional or local distribution,
thus reducing distribution costs (such as shipping and inventory
costs) in comparison to the prior art. Further, the apparatus and
methods of the invention, and the ability to fill closer to
distribution points, facilitate "just in time" or "fill to order"
formulation and filling, as opposed to "filling to stock" whereby
relatively large inventories of filled products are maintained
and/or such relatively large inventories are maintained at
centrally located bottling facilitates and/or distribution centers.
A still further advantage is that the empty containers can be
manufactured at one or more relatively large and/or centrally
located facilities, and the empty containers can be shipped to the
regional, local or otherwise more geographically diverse filling
facilities to reduce the costs otherwise associated with shipping
filled containers and/or maintaining inventories of such filled
containers.
[0064] Dairy Formulations
[0065] As indicated above, prior art dairy based products are
typically processed through a UHT (ultra high temperature) system.
A typical such heat sterilization process involves injecting steam
directly into the product to subject the product to high
temperature sterilization (e.g., about 298 F for about 5 seconds)
which can cause browning and degradation of flavors and vitamins.
Another drawback of such prior art processes is that the water
added during steam injection must be removed by vacuum which can,
in turn, lead to further loss of flavors by vacuum.
[0066] The exemplary dairy formulations of the present invention
allow for the introduction of heat sensitive components via a
different needle or other filling member (or associated filling
station) than the non heat or oxygen sensitive components. As with
the previous example, such heat sensitive components may be cold
filtered through, for example, a 0.2 micron filter, in order to
sterilize the components prior to filling.
[0067] In some exemplary embodiments of the present invention, one
or more "base" filling stations are provided for filling the base
product. In some such examples, the base is a dairy creamer,
non-dairy creamer or soy containing liquid product formulation that
includes non heat sensitive components and may be thermally
sterilized. One or more other "plus" filling stations are provided
for filling various "plus" components, such as different
flavorings, supplements, aromas, and/or other ingredients. For
example, in the context of coffee creamers, the plus station may
include different flavorings, such as hazelnut, vanilla,
cappuccino, etc. Different product formulations can be made by
selectively filling the containers in different plus filling
stations. For example, a hazelnut flavored coffee creamer can be
made by filling a hazelnut flavoring and then filling the base
creamer (e.g., a base dairy creamer, non-dairy creamer or soy
containing liquid formulation). Other flavored creamers can be made
in the same apparatus by filling other flavorings in different
filling stations with the same base creamer, thus allowing any of a
variety of different products to be formulated and filled in the
same apparatus without breaking down and cleaning the apparatus
between different product fills as encountered in the prior art. In
other exemplary embodiments, the products may be dairy based
beverages including a base dairy product, such as a milk based
product, provided in one or more first filling stations, and a
variety of "plus" products, such as flavorings (e.g., chocolate,
strawberry, blueberry, banana, cappuccino, coffee aroma, etc.)
and/or nutritional supplements, provided in a plurality of "plus"
filling stations. Yet another advantage of the present invention is
that it enables separate cold sterilization and filling of heat
labile components to further improve taste and/or quality in
comparison to the prior art.
[0068] As in the previous example, one advantage of the currently
preferred embodiments of the present invention is that the plural
filling members, needles and/or stations allow for switching from
one product formulation or variation to another without requiring
the system cleaning, sterilization and/or downtime associated with
prior art dairy filling systems. Yet another advantage of the
present invention is that the heat sensitive or reactive
components, such as flavors and vitamins, can be cold sterilized,
and aseptically filled apart from the non heat sensitive or
reactive components, thus avoiding the browning and degradation,
and/or loss of flavors, vitamins, and other heat sensitive or
reactive components as encountered in the prior art.
[0069] Infant Formulations
[0070] In the currently preferred embodiments of the present
invention, heat labile or reactive components of the infant formula
are prepared in separate solutions which are sterilized by
microfiltration or other cold sterilization processes and are later
aseptically combined in the sterile storage chambers of the
containers with the remainder of the formula previously sterilized
by thermal sterilization, such as conventional UHT sterilization.
Exemplary heat labile components include water soluble vitamins,
such as vitamin C, folic acid, vitamin B1, and any other vitamins
which are affected by thermal processing. Exemplary proteins
include whey, alpha-lactalbumin and other protein fractions that
are denatured by heat. Exemplary carbohydrates include lactose or
other sugars as well as prebiotics which undergo Maillard browning.
The heat labile components also may include bioactive nutrients
including Lactoferrin, Lysozyme, Lactoperoxidase, and other
bioactive nutrients that have health benefits and cannot withstand
thermal processing. The reactive components include the trace
elements such as iron and copper which by processing separately can
result in improved fat and vitamin stability.
[0071] The cold sterilized heat labile and/or reactive components
can be mixed in an aseptic environment with the previously heat
sterilized non heat labile or reactive components, and the
resulting mixture can be aseptically filled into the containers.
Or, preferably, the cold sterilized components are first mixed and
cold sterilized, or cold sterilized separately and then mixed in an
aseptic holding tank, and the cold sterilized components are
injected through the respective filling member(s) or needle(s) into
the sterile storage chambers of the containers. Then, or prior to
injecting the cold sterilized components, the non heat labile
and/or non reactive components are mixed and heat sterilized, or
heat sterilized and then mixed in an aseptic holding tank, and the
heat sterilized components are injected through the respective
filling member(s) or needle(s) into the storage chambers of the
containers. The cold sterilized and heat sterilized products are
thus combined in the sterile chambers of the containers to thereby
form sterile filled liquid product formulations that may exhibit in
comparison to the prior art improved quality with respect to
vitamin and/or flavor content, and/or improved quality with respect
to the content of other components or ingredients that are heat
labile or reactive.
[0072] An exemplary infant formula includes a protein blend having
an approximately 60:40 Whey:Casein ratio similar to human milk
where the whey includes, if desired, a blend of alpha-lactalbumin
and whey protein concentrate. The alpha-lactalbumin solution is
sterilized by microfiltration or other cold sterilization
processing, and therefore the denaturation encountered in prior art
thermal processing is avoided. The water soluble vitamins that
degrade during thermal processing likewise can be included in the
alpha-lactalbumin solution to further minimize any vitamin loss
that otherwise would occur during thermal processing. In one such
embodiment, vitamin C is cold sterilized as part of the
alpha-lactalbumin solution. A significant advantage of the present
invention is that it can enable manufacturers of infant formulas to
consistently meet predetermined or established minimum amounts of
Vitamin C and maximum amounts of by-products produced through the
breakdown of Vitamin C.
[0073] Table 1 below sets forth an exemplary infant formulation
including ingredients that are separately cold sterilized and heat
sterilized as indicated, and then injected through respective
filling needles, other filling members, or associated filling
stations into the sterile chambers of the containers. The term
"cold sterilized" as used herein does not mean that the components
are necessarily chilled, but rather contemplates any type of
sterilization that does not thermally sterilize (i.e., heat) the
components, and thus "cold sterilization" may be performed at
ambient temperature, or at a temperature above or below ambient
temperature.
TABLE-US-00001 TABLE 1 % range Ingredients (approximate) Cold
Filtered Portion (approximately 1.5% of formula) Water for Cold
Filter Solution 1.200-1.500 Alpha-Lactalbumin 0.150-0.50 Vitamin C
Sodium Ascorbate 0.0060-0.04 Vitamin Calcium Pantothenate
0.00025-0.0005 Vitamin B1 Thiamin Mononitrate 0.00003-0.0002
Vitamin Folic Acid 0.00001-0.000025 Thermally Processed Portion
(approximately 98.5% of formula) Water for Thermal Processed
Portion 84.0-86.0 Milk Nonfat Dry 1.50-2.50 Whey Protein
Concentrate 1.00-1.60 Lactose 3.0-4.0 Maltodextrin 2.0-3.0
Vegetable Oils (Palm Olein, Soy, Coconut, 2.20-4.00 High Oleic
Safflower) Soy lecithin 0.025-1.00 DHA Oil and ARA Oil 0.05-0.100
Carrageenan 0-0.025 Calcium Citrate tetrahydrate 0.062-0.09 Calcium
Phosphate 0.009-0.014 Ferrous Sulfate heptahydrate 0.00048-0.0095
Magnesium Chloride heptahydrate 0.005-0.015 Zinc Sulfate
0.0022-0.015 Copper Sulfate pentahydrate 0.00015-0.00025 Manganese
Sulfate monohydrate 0.000003-0.00003 Potassium Citrate 0-0.10
Potassium Chloride 0-0.10 Sodium Chloride 0-0.020 Potassium Iodide
0.0055-0.009 Sodium Selenate decahydrate 0.000005-0.00004 Inositol
0.0025-0.0035 L-Carnitine 0.0008-0.0015 Taurine 0.0025-0.0078
Choline Bitartrate 0.015-0.05 Vitamin Biotin 0.00028-0.0004 Vitamin
E-DL Alpha Tocopheryl Acetate 0.0014-0.003 Vitamin Riboflavin
0.00007-0.00013 Vitamin Pyridoxine HCl 0.000025-0.000050 Vitamin A
Acetate 325,000 IU/g 0.0005-0.0015 Vitamin D3 100,000 IU/gram
0.00025-0.00065 Vitamin K1 0.000004-0.000006 Vitamin B12
0.00000025-0.0000015 Nucleotides 0.0025-0.005
[0074] Table 2 below sets forth in further detail an exemplary
infant formulation including ingredients that are separately cold
sterilized and heat sterilized as indicated, and then injected
through respective filling needles, other filling members, or
associated filling stations into the sterile chambers of the
containers.
TABLE-US-00002 TABLE 2 Ingredients % (approximate) Cold Sterilized
Components (approximately 1.53% of formula) Water for Cold Filter
Solution 1.2000 Alpha-Lactalbumin (Whey Protein), Bio Pure Davisco
0.3000 Vitamin C Sodium Ascorbate 0.025000 Vitamin Calcium
Pantothenate 0.000265 Vitamin B1 Thiamin Mononitrate 0.000100
Vitamin Folic Acid 0.000016 Heat Sterilized Components
(approximately 98.47% of formula) Water for Heat Processed Portion
85.646100 Milk Nonfat Dry 1.9800 Whey CONC Dry 35, Daritek 1.3000
Lactose 3.6000 Maltodextrin 2.2200 Vegetable Oils (Palm Olein, Soy,
Coconut, 3.2180 High Oleic Safflower) Soy lecithin 0.0750 DHASCO
DHA Oil (40-45% DHA), Martek 0.029000 ARASCO ARA (38-44% ARA),
Martek 0.0580 Carrageenan SeaKem CM 615 0.010000 Calcium
Citrate*4H2O 0.0750 Calcium Phosphate Micro 0.011200 Ferrous
Sulfate*7H2O 0.005100 Magnesium Chloride 0.012500 Zinc Sulfate
0.001300 Copper Sulfate 5H2O 0.000210 Manganese Sulfate 1H2O
0.000026 Potassium Citrate 0.0550 Potassium Chloride 0.028919
Sodium Chloride 0.006800 Potassium Iodide 0.005944 Sodium
Selenate*10H2O 0.000008 Inositol 0.002810 L-Carnitine 0.001200
Taurine 0.050000 Choline Bitartrate 0.0375 Vitamin Biotin 1%
0.036049 Vitamin E-DL Alpha Tocopheryl acetate 0.002672 Vitamin
Riboflavin 0.000083 Vitamin Pyridoxine HCl 0.000052 Vitamin A
Acetate 325,000 IU 0.000892 Vitamin D3 100,000 IU/gram 0.000582
Vitamin K1 1% SD 0.000446 Vitamin B12 0.1% SD 0.000259 Cytidine 5'
Monophosphate 0.001500 Disodium Uridine 5' Monophosphate 0.001000
Niacinamide 0.000877 Adenosine 5' Monophosphate 0.000330 Disodium
Guanosine 5'' Monophosphate 0.000200 Calculated total per 100 grams
100.000 Specifications Specific Gravity 1.036 Whey % of Protein
60.0 Casein % of Protein 39.5 .alpha. Lactalbumin % of Protein 27.9
LNAA: Tryptophan 14.11 DHA % of fat 0.337 ARA % Of Fat 0.641
Calcium: Phosphorus 1.741
[0075] The currently preferred embodiments of the present invention
not only involve separate filling of cold sterilized and heat
sterilized ingredients, but also involve, if desired, filling heat
sterilized ingredients separately from each other and/or filling
cold sterilized ingredients separately from each other. The thermal
processing of proteins and carbohydrates together can give rise to
Maillard reactions, and thus it may be desirable to thermally
sterilize such ingredients (and/or other ingredients) separately in
order to avoid Maillard and/or other undesirable chemical
reactions. Such separately thermally sterilized ingredients can be
combined prior to filling, or may be separately filled into the
containers through separate filling needles or other filling
members. In addition, iron can react with vitamin C and cause
vitamin C loss. Accordingly, it may be desirable to separate
certain iron-containing ingredients (such as iron and copper
containing ingredients) into one fluid source, and to separate
vitamin C containing ingredients (such as vitamin C and other
vitamins) into another fluid source. These different fluid sources
can be filled into the containers through separate filling needles
or other filling members to avoid combining such ingredients prior
to filling, and therefore to further reduce or eliminate the loss
of vitamin C or other vitamins through undesirable reaction with
iron or other ingredients in the other fluid source. Further, it
may be desirable to separately fill calcium or calcium containing
ingredients separately from protein or protein-containing
ingredients to substantially prevent or eliminate protein
precipitation that can occur when calcium is combined with protein.
Accordingly, the currently preferred embodiments of the present
invention can involve any of numerous different liquid or other
sources of components that are separately sterilized, aseptically
filled through separate filling needles or other filling members
into one or more sterile chambers of containers, and combined
therein into desired liquid product formulations.
[0076] Another advantage of the present invention is that it can
enable the production of an infant formula that is more similar to
human milk and that has enhanced nutritional quality in comparison
to prior art infant formulas. Another advantage of currently
preferred embodiments of the present invention is that reduced
vitamin losses and therefore reduced over dosage of vitamins for
cost benefit can be achieved. Another advantage is that improved
protein quality with less denaturation and therefore closer to
protein quality of human milk and potentially improved stability
with less protein sedimentation and gelation can be achieved. Yet
another advantage of the present invention is that it can enable
less oxidation of the vitamins and fats for improved nutritional
and sensory qualities in comparison to the prior art. A further
advantage of the present invention is that it can minimize other
reactions such as Maillard Browning that otherwise would result in
poorer nutritional quality of protein and vitamin loss. A still
further advantage of the present invention is that it can increase
the feasibility of creating a composition closer to human milk with
the addition of heat labile nutrients that cannot be added using
conventional thermal sterilization.
[0077] The Containers and Filling Apparatus
[0078] The sterile, empty container and closure assemblies 16 may
take the form of any of numerous different containers that are
currently known, or that later become known, and may be filled and
thermally resealed, or aseptically filled with other filling
members and sealed within the containers, with any of numerous
different apparatus in any of numerous different ways that are
currently known, or that later become known, including any of the
containers and apparatus and methods for filling disclosed in any
of the following patent applications and patents that are hereby
incorporated by reference in their entireties as part of the
present disclosure: U.S. patent application Ser. No. 11/949,097,
filed Dec. 3, 2007, entitled "Device with Needle Penetrable and
Laser Resealable Portion and Related Method," similarly-titled U.S.
patent application Ser. No. 11/933,300, filed Oct. 31, 2007, both
of which are continuations of similarly-titled U.S. patent
application Ser. No. 11/879,485, filed Jul. 16, 2007, which is a
continuation of U.S. application Ser. No. 11/408,704, filed Apr.
21, 2006, entitled "Medicament Vial Having a Heat-Sealable Cap, and
Apparatus and Method for Filling the Vial," now U.S. Pat. No.
7,243,689, which is a continuation of U.S. patent application Ser.
No. 10/766,172 filed Jan. 28, 2004, entitled "Medicament Vial
Having A Heat-Sealable Cap, And Apparatus and Method For Filling
The Vial", now U.S. Pat. No. 7,032,631, which is a
continuation-in-part of similarly titled U.S. patent application
Ser. No. 10/694,364, filed Oct. 27, 2003, which is a continuation
of similarly titled co-pending U.S. patent application Ser. No.
10/393,966, filed Mar. 21, 2003, which is a divisional of similarly
titled U.S. patent application Ser. No. 09/781,846, filed Feb. 12,
2001, now U.S. Pat. No. 6,604,561, issued Aug. 12, 2003, which, in
turn, claims the benefit of similarly titled U.S. Provisional
Application Ser. No. 60/182,139, filed Feb. 11, 2000; similarly
titled U.S. Provisional Patent Application No. 60/443,526, filed
Jan. 28, 2003; similarly titled U.S. Provisional Patent Application
No. 60/484,204, filed Jun. 30, 2003; U.S. patent application Ser.
No. 11/933,272, filed Oct. 31, 2007, entitled "Sealed Containers
And Methods Of Making And Filling Same," which is a continuation of
similarly-titled U.S. patent application Ser. No. 11,515,162, filed
Sep. 1, 2006, which is a continuation of similarly-titled U.S.
patent application Ser. No. 10/655,455, filed Sep. 3, 2003, now
U.S. Pat. No. 7,100,646, U.S. patent application Ser. No.
10/983,178 filed Nov. 5, 2004, entitled "Adjustable Needle Filling
and Laser Sealing Apparatus and Method; U.S. patent application
Ser. No. 11/901,467, filed Sep. 17, 2007, entitled "Apparatus and
Method for Needle Filling and Laser Resealing," which is a
continuation of similarly-titled U.S. patent application Ser. No.
11,510,961, filed Aug. 28, 2006, which is a continuation of
similarly-titled U.S. patent application Ser. No. 11/070,440 filed
Mar. 2, 2005; U.S. patent application Ser. No. 11/074,513 filed
Mar. 7, 2005, entitled "Apparatus for Molding and Assembling
Containers with Stoppers and Filling Same; U.S. patent application
Ser. No. 11/074,454 filed Mar. 7, 2005, entitled "Method for
Molding and Assembling Containers with Stoppers and Filling Same";
U.S. patent application Ser. No. 11/339,966, filed Jan. 25, 2006,
entitled "Container Closure With Overlying Needle Penetrable And
Thermally Resealable Portion And Underlying Portion Compatible With
Fat Containing Liquid Product, And Related Method"; and U.S. patent
application Ser. No. 11/786,206, filed Apr. 10, 2007 entitled
"Ready To Drink Container With Nipple And Needle Penetrable And
Laser Resealable Portion, And Related Method"; U.S. patent
application Ser. No. 11/650,102, filed Jan. 5, 2007, entitled
"One-Way Valve, Apparatus and Method of Using the Valve," which is
a continuation of similarly-titled U.S. patent application Ser. No.
11/295,274, filed Dec. 5, 2005, entitled; U.S. patent application
Ser. No. 12/021,115, filed Jan. 28, 2008, entitled "Method of Using
One-Way Valve and Related Apparatus," which is a continuation of
U.S. patent application Ser. No. 11/295,251, filed Dec. 5, 2005,
entitled "One-Way Valve, Apparatus and Method of Using the
Valve".
[0079] Further, the filling assemblies may take any of numerous
different configurations that are currently known, or that later
become known for filling containers. For example, the filling
assemblies may have any of numerous different mechanisms for
sterilizing, feeding and/or aseptically filling the liquid
components into the sealed empty chamber(s) of the containers. In
addition, rather than use the penetrable and resealable stopper,
the containers may employ filling valves and filling members for
filling through the filling valves as disclosed, for example, in
the following patent and patent applications which are hereby
incorporated by reference in their entireties as part of the
present disclosure: U.S. Application Serial No. 12,025,362, filed
Feb. 4, 2008, entitled "Dispenser and Apparatus and Method for
Filling a Dispenser," which is a continuation of similarly-titled
U.S. application Ser. No. 11/349,873, filed Feb. 8, 2006, which is
a continuation of similarly-titled U.S. application Ser. No.
10/843,902, filed May 12, 2004, now U.S. Pat. No. 6,997,219, issued
Feb. 14, 2006; U.S. application Ser. No. 11/938,103, filed Nov. 9,
2007, entitled "Device with Chamber and First and Second Valves in
Communication Therewith, and Related Method," which is a divisional
of U.S. application Ser. No. 10/976,349, filed Oct. 28, 2004,
titled "Container and Valve Assembly for Storing and Dispensing
Substances, and Related Method". In such alternative embodiments, a
first valve is formed or otherwise mounted on the container in
fluid communication with the storage chamber to fill the storage
chamber therethrough. In addition, the container may include a
second valve formed on or otherwise mounted on the container for
allowing gas to flow out of the storage chamber during filling
thereof, or to allow drawing or evacuation of gas from the storage
chamber during filling thereof. Still further, the pumps may take
the form of any of numerous different pumps that are currently
known, or that later become known. For example, rather than a
positive displacement pump or other type of electrical,
electro-mechanical or mechanical pump, the apparatus may employ a
peristaltic pump or a pressure fill, such as where a tank
containing the liquid to be filled is pressurized with gas, a
valve, such as a timing valve, or a valve in combination with a
flow meter and feedback valve control, is coupled between the tank
and filling member to meter the amount of liquid that flows through
the filling member and into a respective storage chamber. In
addition, the containers may include any desired number of sealed
empty chambers, including, for example, a first chamber for
receiving one or more first liquid components, and a second chamber
for receiving one or more second liquid components. In some such
embodiments, the first and second chambers are initially sealed
with respect to each other to maintain the first and second liquid
components separate from each other during, for example, the shelf
life of the product. Then, when the product is ready to be
dispensed or used, the container includes a mechanism to allow the
first and second chambers to be placed in fluid communication with
each other to allow mixing of the first and second liquid
components at the time of use, or shortly before use. Exemplary
containers that may be used in connection with the methods and
apparatus of the present invention include those described in the
following patent applications: U.S. Provisional Patent Application
Ser. No. 60/983,153, filed Oct. 26, 2007, entitled "Ready to Feed
Container with Drinking Dispenser and Sealing Member, and Related
Method"; U.S. patent application Ser. No. 11/339,966, filed Jan.
25, 2006, entitled "Container Closure With Overlying Needle
Penetrable And Thermally Resealable Portion And Underlying Portion
Compatible With Fat Containing Liquid Product, And Related Method";
U.S. patent application Ser. No. 11/786,206, filed on Apr. 10,
2007, entitled "Ready to Drink Container with Nipple and Laser
Resealable Portion, and Related Method," which claims priority to
similarly-titled U.S. Provisional Patent Application Ser. No.
60/790,684, filed Apr. 10, 2006; U.S. Provisional Patent
Application Ser. No. 60/981,107, filed Oct. 11, 2007, entitled
"Container Having a Closure and Removable Resealable Stopper for
Sealing a Substance Therein and Related Method."
[0080] Further, the filling machines of the present invention may
take any of numerous different configurations that are currently
known, or that later become known for filling containers. For
example, the filling machines may have any of numerous different
mechanisms for sterilizing, feeding and/or aseptically filling the
liquid components into the sealed empty chamber(s) of the
containers. In addition, rather than use the penetrable and
resealable stopper, the containers may employ filling valves and
filling members for filling through the filling valves as disclosed
in the following patents and patent applications that are hereby
incorporated by reference in their entireties as part of the
present disclosure: U.S. application Ser. No. 10/843,902, filed May
12, 2004, titled "Dispenser and Apparatus and Method for Filling a
Dispenser", now U.S. Pat. No. 6,997,219, issued Feb. 14, 2006; U.S.
application Ser. No. 11/349,873, filed Feb. 8, 2006, titled
"Dispenser and Apparatus and Method for Filling a Dispenser"; U.S.
application Ser. No. 10/976,349, filed Oct. 28, 2004, titled
"Container and Valve Assembly for Storing and Dispensing
Substances, and Related Method"; U.S. patent application Ser. No.
11/487,386, filed Jul. 17, 2006, entitled "Container with Valve
Assembly for Filling and Dispensing Substances, and Apparatus and
Method for Filling," which is a continuation of similarly-titled
U.S. patent application Ser. No. 10/833,371, filed Apr. 28, 2004,
now U.S. Pat. No. 7,077,176, claims priority to U.S. Provisional
patent Application Nos. 60/471,592, filed May 19, 2003, 60/469,67,
filed May 12, 2003, and 60/465,992, filed Apr. 28, 2003.
[0081] In such alternative embodiments, a valve is formed or
otherwise mounted on the container in fluid communication with the
storage chamber to fill the storage chamber therethrough. In
addition, the container may include a second valve formed on or
otherwise mounted on the container for allowing gas to flow out of
the storage chamber during filling thereof, or to allow drawing or
evacuation of gas from the storage chamber during filling thereof.
The "dome-spring" valve disclosed in the above-mentioned patent and
application may allow for venting gas out of the chamber during
filling of the chamber therethrough. Still further, the pumps may
take the form of any of numerous different pumps that are currently
known, or that later become known. For example, rather than a
positive displacement pump or other type of electrical,
electro-mechanical or mechanical pump, the apparatus may employ a
peristaltic pump or a pressure fill, such as where a tank
containing the liquid to be filled is pressurized with gas, a
valve, such as a timing valve, or a valve in combination with a
flow meter and feedback valve control, is coupled between the tank
and filling member to meter the amount of liquid that flows through
the filling member and into a respective storage chamber.
[0082] If desired, the container closure may be molded in the same
mold as the container body, or may be molded in adjacent molding
machines, and at least one of the container closure and the body
may be assembled within or adjacent to the mold in accordance with
the teachings of U.S. patent application Ser. Nos. 11/074,454 and
11/074,513 incorporated by reference above; U.S. Provisional Patent
Application Ser. No. 60/727,899 filed Oct. 17, 2005, entitled
"Sterile De-Molding Apparatus And Method"; and U.S. patent
application Ser. No. 11/582,291, filed Oct. 17, 2006, titled
"Sterile De-molding Apparatus and Method", each of which is hereby
incorporated by reference in its entirety as part of the present
disclosure. One advantage of this approach is that the container is
closed to define a sealed, empty sterile chamber at essentially the
time of formation, and the container is never opened (through
filling, resealing, and during shelf life) until the product is
dispensed. Accordingly, a significantly high level of sterility
assurance can be achieved. Alternatively, as described above, the
sealed empty containers may be sterilized in any of numerous
different ways that are currently known, or that later become
known, such as by applying radiation, such as beta or gamma
radiation, or by applying a fluid sterilant thereto, such as
VHP.
[0083] The term "sterile" should be understood to mean that the
product in question complies with the respective microbiological
standard prescribed for products of that type in national and
international legislation. For example, the components in
embodiments of the present invention can be rendered sterile by
techniques which are explicitly designed to reduce or eliminate
interactions and heat reactions of proteins and lipids, proteins
and carbohydrates and/or to reduce damage to or decomposition of
heat labile macro- and micronutrients, such as nucleotides,
vitamins, probiotics, long chain polyunsaturated fatty acids, etc.
A variety of suitable techniques are available. Some of these
techniques rely on the application of heat (i.e., thermally
sterilized), for example, such as retorting and aseptic processing.
Other non-heat or "cold sterilization" techniques include, for
example, bacterial filtration or microfiltration, high pressure
sterilization and irradiation. These techniques may be selected and
combined as appropriate in the production of specific formulas or
products according to the intended use of the formulas or products
of the present invention.
[0084] As may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, numerous changes may
be made to the above-described and other embodiments without
departing from the scope of the invention as defined in the
appended claims. For example, the apparatus and method may involve
the use of any of numerous different types of containers and/or
different product formulations, including containers having plural
needle penetrable and thermally resealable portions. In addition,
the containers need not include a penetrable and thermally
resealable portion, but rather may include other means for
aseptically filling the sealed empty sterile storage chambers of
the containers, such as filling valves, and/or filling valves and
venting valves, and that are filled with the associated filling
members as described in the above-mentioned co-pending patents and
patent applications and incorporated herein. In addition, the term
container is used herein to mean any device that includes one or
more chambers for receiving the filled liquids, and including
without limitations containers with or without valves or other
dispensing devices, and/or containers with fixed or variable-volume
storage chambers. Accordingly, this detailed description of
currently preferred embodiments is to be taken in an illustrative
as opposed to a limiting sense.
* * * * *