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WO2015113035A1 - Procédé de filtration aseptique - Google Patents

Procédé de filtration aseptique Download PDF

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Publication number
WO2015113035A1
WO2015113035A1 PCT/US2015/013045 US2015013045W WO2015113035A1 WO 2015113035 A1 WO2015113035 A1 WO 2015113035A1 US 2015013045 W US2015013045 W US 2015013045W WO 2015113035 A1 WO2015113035 A1 WO 2015113035A1
Authority
WO
WIPO (PCT)
Prior art keywords
nutritional composition
stream
nutritional
continuous stream
micronutrient
Prior art date
Application number
PCT/US2015/013045
Other languages
English (en)
Inventor
Gul Konuklar
Timothy LAPLANTE
Original Assignee
Abbott Laboratories
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abbott Laboratories filed Critical Abbott Laboratories
Publication of WO2015113035A1 publication Critical patent/WO2015113035A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23B—PRESERVATION OF FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES; CHEMICAL RIPENING OF FRUIT OR VEGETABLES
    • A23B2/00—Preservation of foods or foodstuffs, in general
    • A23B2/70—Preservation of foods or foodstuffs, in general by treatment with chemicals
    • A23B2/725—Preservation of foods or foodstuffs, in general by treatment with chemicals in the form of liquids or solids

Definitions

  • the present disclosure relates to a process for aseptically filtering a nutritional composition.
  • 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.
  • 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.
  • UHT high heat
  • HPP high pressure
  • 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.
  • 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.
  • a process for sterilizing a nutritional composition at a temperature from about 0 °C to about 100 °C 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.
  • a process for sterilizing a nutritional composition 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.
  • a process for sterilizing a nutritional composition 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.
  • a nutritional composition including micro and macronutrients is disclosed.
  • the nutritional composition is sterilized via aseptic filtration at room temperature prior to packaging.
  • Figure 1 is a diagram of an aseptic filtration process according to the embodiments disclosed herein.
  • 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.
  • 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.
  • 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.
  • infant refers to a human about 12 months of age or younger.
  • toddler refers to a human about 12 months of age to about 3 years of age.
  • child refers to a human about 3 years of age to about 18 years of age.
  • adult refers to a human about 18 years of age or older.
  • 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.
  • 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.
  • oral rehydration solution 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.
  • 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.
  • At least one micronutrient is added to a continuous stream of a nutritional composition.
  • the at least one micronutrient comprises one or more minerals, one or more vitamins, or combinations thereof.
  • the at least one micronutrient may be heat sensitive.
  • the continuous stream of the nutritional composition comprises at least one macronutrient.
  • the macronutrient comprises at least one of a fat, a protein, or a carbohydrate. In certain preferred embodiments, the macronutrient is a carbohydrate.
  • the at least one micronutrient and the nutritional composition comprising at least one macronutrient are then mixed.
  • the micro and macronutrients are mixed in a mixing tank.
  • the continuous outlet stream from the mixing tank comprises a complete nutritional composition.
  • the continuous outlet stream from the mixing tank is an oral rehydration solution.
  • 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.
  • the aseptic filtration step includes pumping the continuous stream through a sterile filter.
  • the sterile filter comprises an about 0.1 micron to about 0.5 micron filter.
  • the sterile filter is a 0.2 micron filter.
  • 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.
  • 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.
  • the continuous stream may pass through multiple sterile filters having the same or different pore sizes.
  • the sterilized continuous stream is filled into its packaged form.
  • 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.
  • the sterilized stream may be packaged in a container that includes an oxygen barrier, an oxygen scavenger, an ultraviolet radiation barrier, or combinations thereof.
  • the nutritional composition may be filled and packaged in non-liquid forms.
  • the nutritional composition may be packaged as a gel containing one or more gelling agents.
  • 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.
  • 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.
  • 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.
  • the continuous stream 2 comprises at least one macronutrient.
  • the continuous stream is sterilized via aseptic filtration at room temperature.
  • 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.
  • a nutritional composition is sterilized without the use of high temperature or high pressure.
  • 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.
  • UHT high heat
  • this non-thermal process reduces the energy and equipment costs associated with standard thermal sterilization processes.
  • the nutritional compositions sterilized by the process disclosed herein include at least one micronutrient.
  • the micronutrient comprises sodium.
  • the sodium may be present as a cation of a salt.
  • suitable sodium sources include sodium ch loride, sodium phosphate, sodium citrate, sodium carbonate, sodium bicarbonate, sodium hydroxide, and combinations thereof.
  • 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.
  • potassium salts include potassium chloride, potassium phosphate, potassium citrate, potassium carbonate, potassium bicarbonate, potassium hydroxide, and combinations thereof.
  • the micronutrient may comprise a source of chloride.
  • the chloride may be present as an ion, and may be in equilibrium with a salt.
  • suitable chloride salts include, but are not limited to sodium chloride, potassium chloride, calcium chloride, ma o g nesium chloride, and combinations thereof.
  • the micronutrient may comprise a source of zinc.
  • any zinc salt suitable for human consumption may be used in the process disclosed herein.
  • 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.
  • 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 Bi 2 , carotenoids (e.g., beta- carotene, zeaxanthin, lutein, lycopene), niacin, folic acid, pantothenic acid, vitamin C, choline, inositol, salts and derivatives thereof, and combinations thereof.
  • vitamins or related nutrients 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 Bi 2 , carotenoids (e.g., beta- carotene, zeaxanthin, lutein
  • the micronutrient may comprise one or more heat sensitive ingredients.
  • 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.
  • 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.
  • 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, karay
  • the nutritional compositions described herein may include any individual source of carbohydrate or combination of the various sources of carbohydrate listed above.
  • the at least one macronutrient comprises dextrose.
  • the at least one macronutrient further comprises fructose or sucrose in addition to dextrose
  • the nutritional composition comprises protein from one or more sources.
  • 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.
  • the nutritional compositions described herein may include any individual source of protein or combination of the various sources of protein listed above.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 l
  • nutritional compositions manufactured by the process disclosed herein may meet one or more of the following target parameters:
  • 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.
  • the nutritional compositions sterilized by the process disclosed herein may comprise an oral rehydration solution.
  • the oral rehydration solution includes a source of carbohydrate and a source of sodium, and may further include a source of galactooiigosaccharide.
  • the oral rehydration solution comprises water, dextrose, zinc, sodium ions, potassium ions, chloride ions, beta-GOS, and citrate ions.
  • the oral rehydration solution is a clear liquid having an acidic pH.
  • 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.
  • 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.
  • the nutritional composition may be formulated as semisolid or semi-liquid compositions (e.g., puddings, gels, yogurts, etc.).
  • the nutritional composition may be in the form of lozenges, tablets (e.g., chewable, coated, etc.), pastes, gels, or yogurts.
  • 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.
  • liquid nutritional compositions desired to be clear, or at least substantially translucent, are substantially free of fat.
  • 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.
  • 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.
  • the pH of the nutritional composition may be from 2.5 to 4.5, including a pH of 3 to 3.5.
  • 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.
  • 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.
  • 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 1 and 2 illustrate the sensory performance of exemplary embodiments of a nutritional product sterilized by the process disclosed herein.
  • 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.
  • Example 2 examined a liquid nutritional product including a cherry flavor system.
  • Control B was prepared using a traditional heat sterilization process.
  • a comparative cherry liquid nutritional product was sterilized by the process disclosed herein.
  • Example 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.

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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Chemical & Material Sciences (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

L'invention concerne un procédé de stérilisation non thermique pour des compositions nutritionnelles. Ce procédé comprend la filtration aseptique d'une composition nutritionnelle à température ambiante avant le transfert de la composition nutritionnelle dans son emballage.
PCT/US2015/013045 2014-01-27 2015-01-27 Procédé de filtration aseptique WO2015113035A1 (fr)

Applications Claiming Priority (2)

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US201461931940P 2014-01-27 2014-01-27
US61/931,940 2014-01-27

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WO2015113035A1 true WO2015113035A1 (fr) 2015-07-30

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA029693B1 (ru) * 2016-09-29 2018-04-30 Общество С Ограниченной Ответственностью "Научно-Технологическая Фармацевтическая Фирма "Полисан" Способ получения стабильной фармацевтической композиции в виде водного раствора для внутривенного введения

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JPH03112471A (ja) * 1989-09-26 1991-05-14 Hisaka Works Ltd 液体食品の滅菌装置
US5152900A (en) * 1990-02-07 1992-10-06 House Food Industrial Co., Ltd. Method for preparing packaged sterilized mineral water, method for producing sterilized container for packaging the same and packaged sterilized mineral water
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WO2000018258A2 (fr) * 1998-09-29 2000-04-06 The Procter & Gamble Company Boissons a faible teneur en acide enrichies en sources nutritionnelles calciques
US20100323066A1 (en) * 2006-09-25 2010-12-23 Robert Lawrence Comstock Process for Solubilization of Flavor Oils
US20110256272A1 (en) * 2010-01-29 2011-10-20 Johns Paul W Aseptically Packaged Nutritional Liquids Comprising HMB
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JPH03112471A (ja) * 1989-09-26 1991-05-14 Hisaka Works Ltd 液体食品の滅菌装置
US5152900A (en) * 1990-02-07 1992-10-06 House Food Industrial Co., Ltd. Method for preparing packaged sterilized mineral water, method for producing sterilized container for packaging the same and packaged sterilized mineral water
US5242595A (en) * 1991-04-25 1993-09-07 U.S. Filter/Illinois Water Treatment, Inc. Bacteria removal by ceramic microfiltration
WO2000018258A2 (fr) * 1998-09-29 2000-04-06 The Procter & Gamble Company Boissons a faible teneur en acide enrichies en sources nutritionnelles calciques
US20100323066A1 (en) * 2006-09-25 2010-12-23 Robert Lawrence Comstock Process for Solubilization of Flavor Oils
US20110256272A1 (en) * 2010-01-29 2011-10-20 Johns Paul W Aseptically Packaged Nutritional Liquids Comprising HMB
CN203194491U (zh) * 2013-03-22 2013-09-18 湖南恒辉膜技术有限公司 一种酱油陶瓷膜过滤澄清灭菌装置

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Publication number Priority date Publication date Assignee Title
EA029693B1 (ru) * 2016-09-29 2018-04-30 Общество С Ограниченной Ответственностью "Научно-Технологическая Фармацевтическая Фирма "Полисан" Способ получения стабильной фармацевтической композиции в виде водного раствора для внутривенного введения

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