WO2015113035A1

WO2015113035A1 - Aseptic filtration process

Info

Publication number: WO2015113035A1
Application number: PCT/US2015/013045
Authority: WO
Inventors: Gul Konuklar; Timothy LAPLANTE
Original assignee: Abbott Laboratories
Priority date: 2014-01-27
Filing date: 2015-01-27
Publication date: 2015-07-30

Abstract

A non-thermal sterilization process for nutritional compositions is provided. The process includes aseptically filtering a nutritional composition at room temperature prior to filling the nutritional composition into its packaged form.

Description

ASEPTIC FILTRATION PROCESS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and any benefit of U.S. Provisional Application

No. 61/931 ,940, filed January 27, 2014, the content of which is incorporated herein by reference in its entirety.

FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to a process for aseptically filtering a nutritional composition. Particularly, the present disclosure relates to a sterilization process including aseptically filtering a nutritional composition at room temperature prior to filling the nutritional composition into its packaged form.

BACKGROUND

[0003] Nutritional products must be sterilized to remove pathogenic microorganisms and to meet food grade standards prior to packaging. Conventional commercial scale sterilization techniques for liquid nutritional products typically involve high heat (UHT) and/or high pressure (HPP) processing to kill pathogenic microorganisms. However, the high heat, high pressure, or both utilized in such processes causes degradation of the flavor in the final product due to the heat sensitivity of certain ingredients.

SUMMARY

[0004] The present disclosure is directed to a non-thermal sterilization process for nutritional compositions. The process disclosed herein includes aseptically filtering a nutritional composition at an ambient temperature prior to filling the nutritional composition into its packaged form.

[0005] In accordance with one embodiment, a process for sterilizing a nutritional composition at a temperature from about 0 °C to about 100 °C is disclosed. The process includes adding at least one micronutrient to a continuous stream of the nutritional composition, the nutritional composition comprising at least one macronutrient. The continuous stream is thereafter sterilized via aseptic filtration and filled into its packaged form.

[0006] In accordance with the preceding and other embodiments, a process for sterilizing a nutritional composition is disclosed. The process includes aseptically filtering a continuous product stream of a complete formulation of a nutritional composition at a temperature from about 0 °C to about 100 °C to sterilize the stream.

[0007] In accordance with the preceding and other embodiments, a process for sterilizing a nutritional composition is disclosed. The process includes adding at least one micronutrient to a continuous stream of the nutritional composition, the nutritional composition comprising at least one macronutrient. The at least one micronutrient and the continuous stream are then mixed and pumped through a sterile filter. The continuous stream is then conveyed into a sterile aseptic holding tank, and thereafter filled into its packaged form.

[0008] In accordance with the preceding and other embodiments, a nutritional composition including micro and macronutrients is disclosed. The nutritional composition is sterilized via aseptic filtration at room temperature prior to packaging.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a diagram of an aseptic filtration process according to the embodiments disclosed herein.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0010] A non-thermal process for sterilizing a nutritional composition is described in detail herein. The process includes an aseptic filtration step at ambient temperature upstream from a package filling step. These and other features of the sterilization process, as well as some of the many optional variations and additions, are described in detail hereafter.

Definitions [0011] All percentages, parts, and ratios as used herein are by weight of the total formulation, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore, do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified.

[0012] The various embodiments of the nutritional compositions of the present disclosure may also be substantially free of any optional or selected essential ingredient or feature described herein, provided that the remaining formulation still contains all of the required ingredients or features as described herein. In this context, and unless otherwise specified, the term "substantially free" means that the selected formulation contains less than a functional amount of the optional ingredient, typically less than 0.1% by weight, and also includes zero percent by weight of such optional or selected essential ingredient.The nutritional compositions and corresponding manufacturing methods of the present disclosure can comprise, consist of, or consist essentially of the essential elements of the disclosure as described herein, as well as any additional or optional element described herein or which is otherwise useful in nutritional compositions.

[0013] All combinations of method or process steps as used herein can be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made.

[0014] The term "infant," as used herein, unless otherwise specified, refers to a human about 12 months of age or younger. The term "toddler," as used herein, unless otherwise specified, refers to a human about 12 months of age to about 3 years of age. The term "child," as used herein, unless otherwise specified, refers to a human about 3 years of age to about 18 years of age. The term "adult, " as used herein, unless otherwise specified, refers to a human about 18 years of age or older.

[0015] The term "nutritional composition" as used herein, unless otherwise specified, refers to nutritional products in various forms including, but not limited to, liquids, solids, powders, semi-solids, semi-liquids, nutritional supplements, and any other nutritional food product known in the art. A nutritional composition in powder form may be reconstituted upon addition of water or another liquid to form a liquid nutritional composition prior to administration to (e.g., prior to providing to or consumption by) a subject. As discussed below, in certain embodiments disclosed herein, the nutritional compositions comprise at least one of a source of carbohydrate, a source of protein, or a source of fat. The nutritional compositions disclosed herein are generally suitable for oral consumption by a human.

[0016] The term "majority" as used herein, unless otherwise specified, means more than

50%, including at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95% , at least 99%, and up to and including 100%.

[0017] The term "oral rehydration solution" as used herein, unless otherwise specified, refers to a nutritional composition used to prevent or treat dehydration. Oral rehydration solutions may include, but are not limited to, a source of carbohydrate and a source of sodium. Oral rehydration solutions may further include a source of a galactooligosaccharide.

[0018] Numerical ranges as used herein are intended to include every number and subset of numbers within that range, whether specifically disclosed or not. Further, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 2 to 8, from 3 to 7, from 5 to 6, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

[0019] All references to singular characteristics or limitations of the present disclosure shall include the corresponding plural characteristic or limitation, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made.

Process for Sterilizing A Nutritional Composition

[0020] Disclosed herein is a process for sterilizing a nutritional composition. In accordance with the process disclosed herein, at least one micronutrient is added to a continuous stream of a nutritional composition. In certain embodiments, the at least one micronutrient comprises one or more minerals, one or more vitamins, or combinations thereof. In particular embodiments, the at least one micronutrient may be heat sensitive. [0021] The continuous stream of the nutritional composition comprises at least one macronutrient. In certain embodiments, the macronutrient comprises at least one of a fat, a protein, or a carbohydrate. In certain preferred embodiments, the macronutrient is a carbohydrate.

[0022] The at least one micronutrient and the nutritional composition comprising at least one macronutrient are then mixed. In certain embodiments, the micro and macronutrients are mixed in a mixing tank. In certain embodiments, the continuous outlet stream from the mixing tank comprises a complete nutritional composition. In one particular embodiment, the continuous outlet stream from the mixing tank is an oral rehydration solution.

[0023] After mixing, the continuous stream is aseptically filtered at a temperature between about 0 °C and about 100 °C. In certain embodiments, the stream is aseptically filtered at a temperature between about 10 °C and about 90 °C. In certain embodiments, the stream is aseptically filtered at a temperature between about 15 °C and about 80 °C. In certain embodiments, the stream is aseptically filtered at a temperature between about 18 °C and about 25 °C. In certain embodiments, the stream is aseptically filtered at about room temperature. Generally, any aseptic filtration method known for use in food processing at ambient temperatures may be utilized in the process disclosed herein. In certain embodiments, the aseptic filtration step includes pumping the continuous stream through a sterile filter. In certain preferred embodiments, the sterile filter comprises an about 0.1 micron to about 0.5 micron filter. In one particular embodiment, the sterile filter is a 0.2 micron filter. In certain embodiments, the continuous stream is thereafter pumped into a sterile aseptic holding tank; however, it should be understood that the aseptic holding tank is not necessary to achieve aseptic filtration. In certain embodiments utilizing the aseptic holding tank, the continuous stream resides in the aseptic holding tank for about 5 minutes to about 2 days. It should be understood that the aseptic filtration step disclosed herein is not limited to the above embodiments. For example, in certain embodiments, the continuous stream may pass through multiple sterile filters having the same or different pore sizes.

[0024] After aseptic filtration, the sterilized continuous stream is filled into its packaged form. In certain embodiments, the sterilized stream may be packaged in an aseptic container such as a glass or plastic bottle, a plastic pouch, or a paper-based carton. In certain embodiments, the sterilized stream may be packaged in a container that includes an oxygen barrier, an oxygen scavenger, an ultraviolet radiation barrier, or combinations thereof. In certain embodiments, the nutritional composition may be filled and packaged in non-liquid forms. In certain embodiments, the nutritional composition may be packaged as a gel containing one or more gelling agents. In other embodiments, the nutritional composition may be packaged as a frozen solution in the form of ice cubes, ice on a stick (i.e. "freezer pop"), crushed ice, or shaved ice.

[0025] In certain embodiments, the aseptic filtration process disclosed herein achieves at least a 5-log reduction of microorganisms in the nutritional composition. In certain embodiments, the aseptic filtration process disclosed herein achieves "commercial sterility," which unless otherwise indicated herein refers to a 12-D Clostridium botulinum reduction.

[0026] FIG. 1 should not be construed as limiting, but is provided for purposes of illustration. FIG. 1 illustrates a process wherein at least one micronutrient 1 is added to a continuous stream 2 of a nutritional composition. Preferably, the continuous stream 2 comprises at least one macronutrient. After mixing 3, the continuous stream is sterilized via aseptic filtration at room temperature. In accordance with certain embodiments, the aseptic filtration step includes conveying the continuous stream through an aseptic filter 4 and optionally into a sterile aseptic holding tank 5. After aseptic filtration, the continuous stream is filled 6 into its packaged form.

[0027] In the process disclosed herein, a nutritional composition is sterilized without the use of high temperature or high pressure. Unlike conventional thermal-based sterilization methods, this non-thermal process provides the requisite reduction in microorganisms to a continuous stream of a nutritional composition as a whole. This process simplifies the previous high heat (UHT) sterilization methods, while still achieving requisite FDA standards for food safety. Moreover, this non-thermal process reduces the energy and equipment costs associated with standard thermal sterilization processes.

[0028] As discussed above, the nutritional compositions sterilized by the process disclosed herein include at least one micronutrient. In certain exemplary embodiments, the micronutrient comprises sodium. The sodium may be present as a cation of a salt. Examples of suitable sodium sources include sodium ch loride, sodium phosphate, sodium citrate, sodium carbonate, sodium bicarbonate, sodium hydroxide, and combinations thereof.

[0029] In certain other embodiments, the micronutrient may comprise a source of potassium or potassium ions. The potassium may be present as an ion, and may be in equilibrium with a salt. Examples of potassium salts include potassium chloride, potassium phosphate, potassium citrate, potassium carbonate, potassium bicarbonate, potassium hydroxide, and combinations thereof.

[0030] In certain other embodiments, the micronutrient may comprise a source of chloride. The chloride may be present as an ion, and may be in equilibrium with a salt. Examples of suitable chloride salts include, but are not limited to sodium chloride, potassium chloride, calcium chloride, ma o^gnesium chloride, and combinations thereof.

[0031] in certain other embodiments, the micronutrient may comprise a source of zinc.

Any zinc salt suitable for human consumption may be used in the process disclosed herein. Examples of suitable zinc sources include zinc gluconate, zinc sulfate, zinc chloride, zinc citrate, zinc bicarbonate, zinc carbonate, zinc hydroxide, zinc lactate, zinc acetate, zinc fluoride, zinc bromide, zinc sulfonate, and combinations thereof.

[0032] In certain embodiments, the micronutrient may comprise any of a variety of vitamins or related nutrients, non-limiting examples of which include vitamin A, vitamin E, vitamin D2, vitamin D3, vitamin A palmitate, vitamin E acetate, vitamin C palmitate (ascorbyl palmitate), vitamin K, thiamine, riboflavin, pyridoxine, vitamin Bi₂, carotenoids (e.g., beta- carotene, zeaxanthin, lutein, lycopene), niacin, folic acid, pantothenic acid, vitamin C, choline, inositol, salts and derivatives thereof, and combinations thereof.

[0033] In certain embodiments, the micronutrient may comprise one or more heat sensitive ingredients. In some exemplary embodiments, the heat sensitive ingredients may comprise one or more of a flavor, bioactive peptides, bioactive enzymes, heat sensitive vitamins, or polyphenols including EGCg, cocoa polyphenols, and anthocyanins. [0034] In addition to the at least one micronutrient, the nutritional composition sterilized by the process disclosed herein further includes at least one macronutrient. This macronutrient may comprise a source of carbohydrate, a source of protein, a source of fat, or combinations thereof.

[0035] Carbohydrates suitable for use in the process disclosed herein may be simple, complex, variations, or combinations thereof. Any source of carbohydrate may be used so long as it is suitable for use in nutritional compositions and is otherwise compatible with any other selected ingredients or features present in the nutritional composition. Non-limiting examples of a source of carbohydrate suitable for use in the nutritional compositions disclosed herein include but are not limited to, polydextrose, maltodextrin; hydrolyzed or modified starch or cornstarch; glucose polymers; corn syrup; corn syrup solids; rice-derived carbohydrate; sucrose; glucose; fructose; lactose; high fructose corn syrup; honey; sugar alcohols (e.g., maltitol, erythritol, sorbitol); isomaltulose; sucromalt; pullulan; potato starch; and other slowly-digested carbohydrates; dietary fibers including, but not limited to, fructooligosaccharides (FOS), galactooligosaccharides (GOS), oat fiber, soy fiber, gum arabic, sodium carboxymethylcellulose, methylcellulose, guar gum, gellan gum, locust bean gum, konjac flour, hydroxypropyl methylcellulose, tragacanth gum, karaya gum, gum acacia, chitosan, arabinoglactins, glucomannan, xanthan gum, alginate, pectin, low methoxy pectin, high methoxy pectin, cereal beta-glucans (e.g., oat beta-glucan, barley beta-glucan), carrageenan and psyllium, digestion resistant maltodextrin (e.g., Fibersol™, a digestion-resistant maltodextrin, comprising soluble dietary fiber); soluble and insoluble fibers derived from fruits or vegetables; other resistant starches; and combinations thereof. The nutritional compositions described herein may include any individual source of carbohydrate or combination of the various sources of carbohydrate listed above. In certain exemplary embodiments, the at least one macronutrient comprises dextrose. In other exemplary embodiments, the at least one macronutrient further comprises fructose or sucrose in addition to dextrose

[0036] In certain embodiments, the nutritional composition comprises protein from one or more sources. Generally, any source of protein may be used so long as it is suitable for oral nutritional compositions and is otherwise compatible with any other selected ingredients or features in the nutritional composition. Suitable sources of protein may include, but are not limited to, intact, hydrolyzed, and partially hydrolyzed protein, which may be derived from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (e.g., rice, corn), vegetable (e.g., soy, potato, pea), and combinations thereof. The protein may also include a mixture of amino acids (often described as free amino acids) known for use in nutritional products or a combination of such amino acids with the intact, hydrolyzed, or partially hydrolyzed proteins described herein. The amino acids may be naturally occurring or synthetic amino acids.

[0037] More particular examples of suitable protein (or sources thereof) used in the nutritional composition disclosed herein include, but are not limited to, whole cow's milk, partially or completely defatted milk, milk protein concentrates, milk protein isolates, nonfat dry milk, condensed skim milk, whey protein concentrates, whey protein isolates, acid caseins, sodium casemates, calcium casemates, potassium casemates, legume protein, soy protein concentrates, soy protein isolates, pea protein concentrates, pea protein isolates, collagen proteins, potato proteins, rice proteins, wheat proteins, canola proteins, quinoa, insect proteins, earthworm proteins, fungal (e.g., mushroom) proteins, hydrolyzed yeast, gelatin, bovine colostrum, human colostrum, glycomacropeptides, mycoproteins, proteins expressed by microorganisms (e.g., bacteria and algae), and combinations thereof. The nutritional compositions described herein may include any individual source of protein or combination of the various sources of protein listed above.

[0038] In addition, the proteins for use herein can also include, or be entirely or partially replaced by, free amino acids known for use in nutritional products, non-limiting examples of which include L-tryptophan, L-glutamine, L-tyrosine, L-methionine, L-cysteine, taurine, L- arginine, L-carnitine, and combinations thereof.

[0039] In certain embodiments, the nutritional composition described herein include a protein component that consists of only intact or partially hydrolyzed protein; that is, the protein component is substantially free of any protein that has a degree of hydrolysis of 25% or more. In this context, the term "partially hydrolyzed protein" refers to proteins having a degree of hydrolysis of less than 25%, including less than 20%>, including less than 15%, including less than 10%), and including proteins having a degree of hydrolysis of less than 5%. The degree of hydrolysis is the extent to which peptide bonds are broken by a hydrolysis chemical reaction. To quantify the partially hydrolyzed protein component of these embodiments, the degree of protein hydrolysis is determined by quantifying the amino nitrogen to total nitrogen ratio (AN/TN) of the protein component of the selected nutritional composition. The amino nitrogen component is quantified by USP titration methods for determining amino nitrogen content, while the total nitrogen component is determined by the Tecator® Kjeldahl method. These analytical methods are well known.

[0040] Suitable source of fats used in the process disclosed herein include any fat or fat source that is suitable for use in an oral nutritional composition and is compatible with the essential elements and features of such composition. In certain embodiments, the nutritional composition comprises fat from one or more sources including, but not limited to, coconut oil, fractionated coconut oil, soy oil, high oleic soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT (medium chain triglycerides) oil, high gamma linolenic (GLA) safflower oil, sunflower oil, high oleic sunflower oil, palm oil, palm kernel oil, palm olein, canola oil, high oleic canola oil, marine oils, fish oils, algal oils, borage oil, cottonseed oils, fungal oils, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), arachidonic acid (ARA), conjugated linoleic acid (CLA), alpha-linolenic acid, rice bran oil, wheat bran oil, interesterified oils, transesterified oils, structured lipids, and combinations thereof. The nutritional compositions can include any individual source of fat or combination of the various sources of fat listed above.

Sterilized Nutritional Compositions

[0041] In some exemplary embodiments, nutritional compositions manufactured by the process disclosed herein may meet one or more of the following target parameters:

Table 1 : Nutritional Composition Target Parameters

Chloride Ion Concentration 1000 - 1500 mg per 1 kg of nutritional product

Total Solids (by weight of the 2.8 - 3.5 %

total product)

GOS Concentration 0.2 -0.4 g per 100 g of nutritional product

[0042] In the above table, the "sediment" value is a measure of the amount of insoluble material which settles to the bottom of the container. This material generally consists of minerals and insoluble proteins. Excessive sedimentation may give the product an unacceptable appearance, and may make nutrients which appear on the label unavailable for consumption.

[0043] As discussed above, the nutritional compositions sterilized by the process disclosed herein may comprise an oral rehydration solution. In certain embodiments, the oral rehydration solution includes a source of carbohydrate and a source of sodium, and may further include a source of galactooiigosaccharide. In certain embodiments, the oral rehydration solution comprises water, dextrose, zinc, sodium ions, potassium ions, chloride ions, beta-GOS, and citrate ions. In certain embodiments, the oral rehydration solution is a clear liquid having an acidic pH.

[0044] In certain embodiments, the nutritional composition may be a nutritional liquid.

Non-limiting examples of nutritional liquids include snack and meal replacement products, hot or cold beverages, carbonated or non carbonated beverages, juices or other acidified beverages, shakes, coffees, teas, and so forth. Generally, the nutritional liquids are formulated as suspensions or emulsions, but the nutritional liquids can also be formulated in any other suitable forms such as clear liquids, solutions, liquid gels, liquid yogurts, and so forth.

[0045] In other embodiments, the nutritional composition may be formulated as semisolid or semi-liquid compositions (e.g., puddings, gels, yogurts, etc.). In other embodiments, the nutritional composition may be in the form of lozenges, tablets (e.g., chewable, coated, etc.), pastes, gels, or yogurts.

[0046] In accordance with certain embodiments, the nutritional composition may formulated as a clear liquid having a pH of 2 to 5, and also having no more than 0.5% fat by weight of the nutritional composition. The limited amount of fat contributes to the desired clarity and the desired pH of the nutritional composition. Typically, liquid nutritional compositions desired to be clear, or at least substantially translucent, are substantially free of fat. As used herein "substantially free of fat" refers to nutritional compositions containing less than 0.5%, and including less than 0.1% fat by weight of the total composition. "Substantially free of fat" also may refer to nutritional compositions disclosed herein that contain no fat, i.e., zero fat. Furthermore, embodiments of liquid nutritional compositions that have a desired acidic pH in the range of 2 to 5 {e.g., juices, fruit juices, fruit-flavored beverages, etc.) are typically substantially free of fat. Liquid nutritional compositions that are both clear and have a pH ranging from 2 to 5 are also typically substantially free of fat. In certain of the preceding embodiments, the pH of the nutritional composition may be from 2.5 to 4.5, including a pH of 3 to 3.5. In those embodiments of the nutritional compositions that are substantially free of fat but have some amount of fat present, the fat may be present as a result of being inherently present in another ingredient {e.g., a source of protein) or may be present as a result of being added as one or more separate sources of fat.

[0047] In certain embodiments, the nutritional composition is formulated as an aqueous emulsion. The emulsion generally comprises at least one source of protein, at least one source of carbohydrate, and at least one source of fat. The emulsions are flowable or drinkable liquids at from about 1 to about 25 °C and are typically in the form of oil-in-water, water-in-oil, or complex aqueous emulsions, although such emulsions are most typically in the form of oil-in- water emulsions having a continuous aqueous phase and a discontinuous oil phase. The emulsion may have a pH ranging from 3 to 8, but is generally formulated with a pH in a range of from 5 to 8, including from 6 to 8, and also including from 6.5 to 7.5.

[0048] The inventive concepts have been described above both generically and with regard to various exemplary embodiments. Although the general inventive concepts have been set forth in what is believed to be exemplary illustrative embodiments, a wide variety of alternatives known to those of skill in the art can be selected within the generic disclosure.

Examples

[0049] The following examples illustrate certain exemplary embodiments of the nutritional compositions and methods described herein. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the general inventive concepts, as many variations thereof are possible without departing from the spirit and scope of the general inventive concepts.

Examples 1 & 2

[0050] Examples 1 and 2 illustrate the sensory performance of exemplary embodiments of a nutritional product sterilized by the process disclosed herein.

[0051] Example 1 examined a liquid nutritional product including a grape flavor system.

A control grape liquid nutritional product (Control A) was prepared using a traditional heat sterilization process. A comparative grape liquid nutritional product (Sample 1) was sterilized by the process disclosed herein. The "comparative" samples examined herein constituted samples having an identical formulation of nutritional composition as each respective control sample, wherein only the method of sterilization differed.

[0052] Table 2: Grape Flavor System

[0053] Example 2 examined a liquid nutritional product including a cherry flavor system.

A control cherry liquid nutritional product (Control B) was prepared using a traditional heat sterilization process. A comparative cherry liquid nutritional product (Sample 2) was sterilized by the process disclosed herein.

Table 3 : Cherry Flavor System

[0054] All samples prepared by the process disclosed herein passed a micro analysis and were released for sensory evaluation.

[0055] The samples of Examples 1 and 2 were tasted by three certified sensory scientists, who are specifically trained in sensory evaluation and flavor profiling. Several parameters were evaluated, including sweet, sour, puckery, protein pH mouthfeel (pph mf), and drying/tannin. Each sample was given a score based on a flavor profile scale of 0 to 3 (i.e., 0, 1/2, 1, 1 1/2, 2, 2 1/2, and 3). Panelists were given the sterilized liquid nutritional products and asked to rate the astringency of the samples according to the flavor profile scale. The flavor profile scale is detailed in Table 4. Each number on the scale represents a degree. For example, an astringency rating of 2 1/2 is 1 degree different than an astringency rating of 2 or 3.

Table 4: Flavor Profile Scale

[0056] The results of the sensory evaluations for the samples in Examples 1 and 2 are summarized below. As used in the below tables, the designation "typical" indicates a flavor profile similar to a current commercial nutritional product sterilized via traditional heat sterilization.

Table 5: Grape Flavor System Sensory Evaluation

Sweet 2 2

Salt 1/2 1/2

Citrus 1/2 1/2

Musty 1/2 1/2

Sour 1 1/2 1 1/2

Mineral Salt 1/2 1/2

Saline/Serumy Mouthfeel 1 1

sss 1 1

Bitter 1/2 1/2

Drying 1 1

Astringent 1 1

Grape (Concord, Candy) 2 2

Mixed Berry

Red Berry

Cherry 1 1/2 (benzaldehyde,candy)

Table 6: Cherry Flavor System Sensory Evaluation

sss 1 1

Bitter

Drying 1 1

Astringent 1 1

Salivating 1 1

Mouth Irritation 1 1

Tongue Tingle

Cherry

(benzaldehyde,candy) 2 2

[0057] Overall, the scientists found that any differences between the aseptically filtered samples tested in the grape flavor system and the cherry flavor system were likely to have a minimal impact on the acceptance of the product. More particularly, the Grape Flavor System showed that when the nutritional composition is not heated, more berry notes are present in the nutritional product. This is reflective of the impact that traditional heat sterilization has on the flavor of the final nutritional product. The sterilization process disclosed herein allows for a final product having a flavor that closely reflects the actual flavor ingredients used. The impact of the aseptic filtration process on the flavor in the Cherry Flavor System appears to be minor. Thus, based on these results, it can be said that the aseptic filtration of a nutritional composition does not negatively impact the flavor of the nutritional product, and in some flavors, actually makes the flavor of the nutritional product more representative of the flavor ingredients used. Furthermore, neither Sample 1 nor Sample 2 exhibited a difference in serum mouth feel from the respective control samples, which is the principle factor identified in consumer acceptance of the product.

[0058] As used in the description of the invention and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. To the extent that the term "includes" or "including" is used in the specification or the claims, it is intended to be inclusive in a manner similar to the term "comprising" as that term is interpreted when employed as a transitional word in a claim. Furthermore, to the extent that the term "or" is employed (e.g., A or B) it is intended to mean "A or B or both." When the applicants intend to indicate "only A or B but not both" then the term "only A or B but not both" will be employed. Thus, use of the term "or" herein is the inclusive, and not the exclusive use. Also, to the extent that the terms "in" or "into" are used in the specification or the claims, it is intended to additionally mean "on" or "onto." Furthermore, to the extent the term "connect" is used in the specification or claims, it is intended to mean not only "directly connected to," but also "indirectly connected to" such as connected through another component or components.

[0059] Unless otherwise indicated herein, all sub-embodiments and optional embodiments are respective sub-embodiments and optional embodiments to all embodiments described herein. While the present application has been illustrated by the description of embodiments thereof, and while the embodiments have been described in considerable detail, it is not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. Therefore, the application, in its broader aspects, is not limited to the specific details, the representative process, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of the applicant's general disclosure herein.

Claims

What is claimed is:

1. A process for sterilizing a nutritional composition, the process comprising: adding at least one micronutrient to a continuous stream of the nutritional composition, the nutritional composition comprising at least one macronutrient; aseptically filtering the continuous stream to sterilize the stream; and filling the stream into its packaged form, wherein the process for sterilization occurs at a temperature from about 0 °C to about 100

°C.

2. The process of claim 1, wherein the process for sterilization occurs at a temperature from about 15 °C to about 80 °C.

3. The process of claim 1, wherein the process for sterilization occurs at about room temperature.

4. The process of claim 1, wherein the at least one micronutrient comprises one or more minerals, one or more vitamins, or combinations thereof.

5. The process of claim 1, wherein the at least one macronutrient comprises at least one of a fat, a protein, or a carbohydrate.

6. The process of claim 1, wherein the nutritional composition is an oral rehydration solution.

7. The process of claim 1, wherein the continuous stream includes the complete nutritional composition.

8. The process of claim 1, wherein the aseptic filtration step further comprises conveying the stream through a sterile filter.

9. The process of claim 8, wherein the sterile filter comprises an about 0.1 micron to about 0.5 micron filter.

10. A process for sterilizing a nutritional composition, the process comprising: aseptically filtering a continuous product stream of a complete formulation of the nutritional composition at a temperature from about 0 °C to about 100 °C to sterilize the stream.

11. A process for sterilizing a nutritional composition, the process comprising: adding at least one micronutrient to a continuous stream of the nutritional composition, the nutritional composition comprising at least one macronutrient; mixing the at least one micronutrient and the continuous stream; pumping the continuous stream through a sterile filter; conveying the continuous stream into a sterile aseptic holding tank; and filling the stream into its packaged form.

12. The process of claim 11, wherein the continuous stream is aseptically filtered at about room temperature.

13. The process of any of claims 1-12, wherein the step of aseptic filtration achieves at least a 5 -log reduction of microorganisms in the nutritional composition.

14. A nutritional composition made by the process of any of claims 1-13.

15. An oral rehydration solution made by the process of any of claims 1-13.