Decoupled manufacturing method and system for high nutritional density non-newtonian fluid products
By combining membrane sterilization and low-temperature thermal sterilization with high-pressure homogenization and pulsed electric field treatment, the problem of thermal denaturation of high-concentration protein, fat and mineral fluid systems during sterilization is solved, achieving microbial safety and nutritional stability of the product and avoiding the limitations of traditional sterilization processes.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-05-25
- Publication Date
- 2026-07-10
AI Technical Summary
Traditional sterilization processes can easily lead to thermal denaturation and chelation reactions in fluid systems with high concentrations of protein, high fat loading, and ultra-high mineral concentrations. This can cause electrostatic scaling or stratification of the product during processing, damaging the nanoscale emulsion structure and nutritional value.
The process employs membrane sterilization to treat heat-sensitive materials and low-temperature thermal sterilization to treat non-heat-sensitive materials. It also utilizes two-stage high-pressure homogenization and pulsed electric field treatment, combined with ion intensity gradient control, to achieve differentiated treatment of materials, avoid the effects of high-temperature heat, and retain the activity of nutrients.
It effectively prevents the denaturation and inactivation of heat-sensitive components, maintains the product's microbiological safety level and functional integrity, reduces steam consumption, and ensures the nutritional stability and sensory quality of the product during its shelf life.
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Figure CN122350253A_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of precision food manufacturing technology, and in particular to a decoupled manufacturing method and system for high nutrient density non-Newtonian fluid products. Background Technology
[0002] In special medical purpose formula foods, infant formula milk powder, and high-end enteral nutrition preparations, fluid systems containing high concentrations of proteins (such as whey protein and casein), high fat loadings, and extremely high mineral concentrations (such as sodium, potassium, calcium, and magnesium ions) exhibit significant shear-thinning non-Newtonian fluid characteristics and extremely high ionic strength. Traditional ultra-high temperature instantaneous sterilization or autoclave sterilization processes easily induce thermal denaturation of proteins and chelation reactions of calcium and magnesium ions. This heat-induced micro-aggregation leads to severe electroscaling or stratification during product processing, not only destroying the physical integrity of the nanoscale emulsion structure but also reducing the nutritional value of the product during its shelf life.
[0003] The above content is only used to help understand the technical solution of this application and does not represent an admission that the above content is prior art. Summary of the Invention
[0004] The main objective of this application is to provide a decoupled manufacturing method for high nutrient density non-Newtonian fluid products, aiming to solve the technical problem of how to retain the interfacial stability and bioactivity of high nutrient density fluids during product preparation.
[0005] To address the aforementioned problems, this application provides a decoupling manufacturing method for high nutrient density non-Newtonian fluid products, the method comprising: The heat-sensitive phase material in the nutrient component is subjected to membrane sterilization treatment to filter out microorganisms in the heat-sensitive phase material, and sterilized heat-sensitive phase material is obtained. The membrane sterilization treatment uses a ceramic membrane with a pore size of 0.1-0.22μm, and the temperature of the membrane sterilization treatment is less than or equal to 45°C. Based on a preset temperature and a preset time, the non-thermal-sensitive phase material in the nutrient component is subjected to thermal sterilization to obtain the sterilized non-thermal-sensitive phase material, wherein the preset temperature is 135-145°C and the preset time is 3-10 seconds. The sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material are mixed to obtain a first mixture.
[0006] In one embodiment, after the step of mixing the sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material to obtain a first mixture, the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product further includes: The first mixture is subjected to a two-stage high-pressure homogenization process to control the particle size of the first mixture within a preset particle size range, thereby obtaining a second mixture. The two-stage high-pressure homogenization process includes a high-pressure stage of 400-700 bar and a low-pressure stage of 200-300 bar. The particle size range is 100-200 nm. The high-pressure stage is used to break the droplets of the first mixture to the target particle size, and the low-pressure stage is used to prevent re-agglomeration through turbulence dissipation. Based on a preset electric field strength and pulse width, the second mixture is subjected to pulsed electric field treatment to obtain the target product, wherein the electric field strength is 25-40 kV / cm and the pulse width is 0.5-3μs.
[0007] In one embodiment, after the step of applying a pulsed electric field to the second mixture based on a preset electric field strength and pulse width to obtain the target product, the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product further includes: Real-time particle size data is collected according to a preset collection cycle, and the real-time particle size data is compared with the particle size range; The mean fluctuation range is obtained by calculating the difference between the current period's average particle size and the historical period's average particle size. When the real-time particle size data is not within the particle size range and the mean fluctuation amplitude is greater than the preset fluctuation threshold, the electric field strength and the pulse width are adjusted based on the preset adjustment value.
[0008] In one embodiment, the step of mixing the sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material to obtain a first mixture includes: Based on the target ion concentration data and the corresponding ion charge number, the first ion strength of the heat-sensitive phase material after sterilization and the second ion strength of the non-heat-sensitive phase material after sterilization are determined. Based on the first ion intensity and the second ion intensity, the ion intensity gradient difference, the rate of change of ion intensity, and the decrease in Debye length are determined; The ion intensity gradient difference, the ion intensity change rate, and the Debye length decrease are compared with their respective safety threshold ranges. If any indicator is greater than a preset safety threshold and less than a preset warning threshold, the first initial flow rate of the sterilized non-thermal phase material is adjusted based on a preset first adjustment coefficient to obtain a first target flow rate, wherein the safety threshold is less than the warning threshold. The mixing operation is performed according to the first target flow rate and the second initial flow rate corresponding to the sterilized heat-sensitive phase material.
[0009] In one embodiment, after the step of comparing the ion intensity gradient difference, the ion intensity change rate, and the Debye length decrease with corresponding safety threshold intervals, the decoupling manufacturing method of the high nutrient density non-Newtonian fluid product further includes: When any indicator is greater than or equal to the warning threshold and less than the preset over-limit threshold, the product of the second adjustment coefficient and the first initial flow rate is determined as the first target flow rate. The product of the third adjustment coefficient and the second initial flow rate corresponding to the thermosensitive phase material is determined as the second target flow rate, wherein the third adjustment coefficient is greater than the second adjustment coefficient.
[0010] In one embodiment, prior to the step of determining the first ionic strength of the sterilized thermosensitive phase material and the second ionic strength of the sterilized non-thermosensitive phase material based on ion concentration data and corresponding ion charge numbers, the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product further includes: Acquire real-time temperature, real-time pressure, and initial ion concentration data; Determine the temperature activity coefficient corresponding to the real-time temperature value and the pressure correction coefficient corresponding to the real-time pressure value; The target ion concentration data is determined by multiplying the initial ion concentration data, the temperature activity coefficient, and the pressure correction coefficient.
[0011] In one embodiment, prior to the step of performing membrane sterilization treatment on the thermosensitive phase material in the nutrient component to filter out microorganisms from the thermosensitive phase material and obtain sterilized thermosensitive phase material, the decoupling manufacturing method of the high nutrient density non-Newtonian fluid product further includes: By reviewing the component testing list of the complete nutritional raw materials, proteins, essential fatty acids, vitamins, and calcium β-hydroxy-β-methylbutyrate were classified as the heat-sensitive phase materials. The measured mineral concentration of mineral salts is obtained, and the measured mineral concentration is compared with a preset concentration threshold of 1500 mg / L. Carbohydrates and mineral salts with measured mineral concentrations greater than the concentration threshold are classified as non-thermal-sensitive phase materials.
[0012] In one embodiment, the decoupled manufacturing method for the high nutrient density non-Newtonian fluid product further includes: The real-time temperature of the material during the membrane sterilization process of the heat-sensitive phase material is obtained, and the real-time temperature of the material is compared with a preset upper temperature threshold. When the measured material temperature is greater than or equal to the upper temperature threshold, a cooling operation is performed until the measured material temperature is less than the upper temperature threshold.
[0013] In one embodiment, the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product further includes: The waste heat generated during the thermal sterilization of the non-thermal-sensitive phase material is recovered and pumped to the preheating section of the non-thermal-sensitive phase material to reduce steam consumption. The cooling requirements of the pulse electric field end processing unit after two-stage high-voltage homogenization will be thermally managed in conjunction with the cryogenic flow channel of the thermistor phase.
[0014] Furthermore, to achieve the above objectives, this application also proposes a decoupled manufacturing system for high nutrient density non-Newtonian fluid products, the system comprising: The thermosensitive phase processing module is used to perform membrane sterilization treatment on the thermosensitive phase material in the nutrient components, filter out microorganisms in the thermosensitive phase material, and obtain the sterilized thermosensitive phase material. The non-thermal phase processing module is used to perform thermal sterilization on the non-thermal phase material in the nutrient component based on a preset temperature and a preset time, so as to obtain the sterilized non-thermal phase material. The dynamic mixing and gradient introduction module is used to mix the sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material to obtain a first mixture.
[0015] Furthermore, to achieve the above objectives, this application also proposes a decoupling manufacturing apparatus for a high nutrient density non-Newtonian fluid product, the apparatus comprising: a memory, a processor, and a computer program stored in the memory and executable on the processor, the computer program being configured to implement the steps of the decoupling manufacturing method for the high nutrient density non-Newtonian fluid product as described above.
[0016] In addition, to achieve the above objectives, this application also proposes a storage medium, which is a computer-readable storage medium, on which a computer program is stored, and when the computer program is executed by a processor, it implements the steps of the decoupled manufacturing method for high nutrient density non-Newtonian fluid products as described above.
[0017] This application provides a decoupled manufacturing method for high nutrient density non-Newtonian fluid products. For heat-sensitive materials, a membrane sterilization method is used, relying on physical sieving to retain microorganisms, avoiding interference from high-temperature thermal effects, and fully preserving the internal functional active ingredients and natural physicochemical properties of the heat-sensitive phase material, preventing denaturation, inactivation, and structural damage of the heat-sensitive components. For non-heat-sensitive phase materials with good heat resistance, thermal sterilization is used. By using differentiated sterilization methods for the two types of materials, the tolerance characteristics of different materials are adapted to avoid the limitations of a single sterilization process. The two phase materials after sterilization are then uniformly mixed to prepare a first mixture, which not only improves the overall microbial safety level of the mixture, but also takes into account the functional integrity and material stability of the multi-component system. Attached Figure Description
[0018] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application.
[0019] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0020] Figure 1 A first process diagram provided for the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product of this application; Figure 2 A second process diagram provided for the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product of this application; Figure 3 This is a third process diagram for the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product of this application.
[0021] The purpose, features, and advantages of this application will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation
[0022] It should be understood that the specific embodiments described herein are merely illustrative of the technical solutions of this application and are not intended to limit this application.
[0023] To better understand the technical solution of this application, a detailed description will be provided below in conjunction with the accompanying drawings and specific implementation methods.
[0024] To achieve the above objectives, this application proposes a decoupled manufacturing method for a high nutrient density non-Newtonian fluid product. The method includes: performing membrane sterilization on a thermosensitive phase material in a nutrient component to filter out microorganisms from the thermosensitive phase material, obtaining sterilized thermosensitive phase material; performing thermal sterilization on a non-thermal sensitive phase material in the nutrient component based on a preset temperature and a preset time, obtaining sterilized non-thermal sensitive phase material; and mixing the sterilized thermosensitive phase material and the sterilized non-thermal sensitive phase material to obtain a first mixture.
[0025] In special medical purpose formula foods, infant formula milk powder, and high-end enteral nutrition preparations, fluid systems containing high concentrations of proteins (such as whey protein and casein), high fat loadings, and extremely high mineral concentrations (such as sodium, potassium, calcium, and magnesium ions) exhibit significant shear-thinning non-Newtonian fluid characteristics and extremely high ionic strength. Traditional ultra-high temperature instantaneous sterilization or autoclave sterilization processes easily induce thermal denaturation of proteins and chelation reactions of calcium and magnesium ions. This heat-induced micro-aggregation leads to severe electroscaling or stratification during product processing, not only destroying the physical integrity of the nanoscale emulsion structure but also reducing the nutritional value of the product during its shelf life.
[0026] This application provides a decoupled manufacturing method for high nutrient density non-Newtonian fluid products. For heat-sensitive materials, a membrane sterilization method is used, relying on physical sieving to retain microorganisms, avoiding interference from high-temperature thermal effects, and fully preserving the internal functional active ingredients and natural physicochemical properties of the heat-sensitive phase material, preventing denaturation, inactivation, and structural damage of the heat-sensitive components. For non-heat-sensitive phase materials with good heat resistance, thermal sterilization is used. By using differentiated sterilization methods for the two types of materials, the tolerance characteristics of different materials are adapted to avoid the limitations of a single sterilization process. The two phase materials after sterilization are then uniformly mixed to prepare a first mixture, which not only improves the overall microbial safety level of the mixture, but also takes into account the functional integrity and material stability of the multi-component system.
[0027] It should be noted that the executing entity in this embodiment can be a computing service device with network communication and program execution functions, such as a tablet computer, personal computer, or mobile phone, or an electronic device or apparatus capable of performing the above functions. The following description uses a decoupling manufacturing equipment for high nutrient density non-Newtonian fluid products as an example to illustrate this embodiment and the subsequent embodiments.
[0028] Based on this, embodiments of this application provide a decoupled manufacturing method for high nutrient density non-Newtonian fluid products, referring to... Figure 1 , Figure 1 This is a schematic flowchart of the first embodiment of the decoupled manufacturing method for high nutrient density non-Newtonian fluid products of this application.
[0029] In this embodiment, the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product includes steps S10 to S30: Step S10: Perform membrane sterilization treatment on the heat-sensitive phase material in the nutrient component to filter out microorganisms in the heat-sensitive phase material and obtain sterilized heat-sensitive phase material. The membrane sterilization treatment uses a ceramic membrane with a pore size of 0.1-0.22μm and the temperature of the membrane sterilization treatment is less than or equal to 45°C.
[0030] It should be noted that heat-sensitive phase materials refer to temperature-sensitive components such as proteins, essential fatty acids, full-spectrum vitamins (including fat-soluble and water-soluble vitamins), and calcium β-hydroxy-β-methylbutyrate (CaHMB).
[0031] In this embodiment, the total nutrient components are divided into heat-sensitive phase materials and non-heat-sensitive phase materials according to the material formulation. Based on the heat-sensitive phase flow channel and the non-heat-sensitive phase flow channel, the heat-sensitive phase materials and the non-heat-sensitive phase materials are respectively graded. For the heat-sensitive phase materials, membrane sterilization is used to sterilize the heat-sensitive phase, removing microorganisms, including spores, through physical interception.
[0032] Preferably, a ceramic membrane with a pore size of 0.1–0.22 μm is used to filter the heat-sensitive phase material. Relying on the physical barrier effect of the membrane pores, bacteria, fungi, microbial vegetative cells, and highly resistant microbial spores in the material are blocked and retained. Small molecule nutrients in the liquid phase pass through the membrane normally to form a sterile permeate, while microorganisms and spores are all retained in the concentrated phase on the membrane side. Sterilization is achieved purely physically, without relying on high-temperature heat. The spore retention rate in the heat-sensitive phase material is not less than 6 log.
[0033] Preferably, the temperature during the entire membrane sterilization process does not exceed 45°C. The thermal degradation of nutrients follows first-order reaction kinetics, and its degradation rate constant k is given by the Arrhenius equation, which is: (1) (2) (3) Where k is the degradation rate constant; A is the frequency factor; E a For activation energy, exemplarily, vitamin C is taken as 75,000 J / mol (Van Boekel 2008), and vitamin A as 110,000 J / mol (Labuza 1982); R is the ideal gas constant, with a CODATA international standard recommendation of 8.314 J / (mol·K); T is the thermodynamic temperature, T = t(°C) + 273.15; t is the heating time. This refers to the sterilization processing loss rate; The natural decay rate during shelf life is exemplified by 25% for vitamin C and 20% for vitamin A. For example, the target values for the product label at the end of the shelf life are: Vitamin C = 22.5 mg / 500 ml; Vitamin A = 300 μg RE / 500 ml; C0 is the initial addition amount.
[0034] The activation energies (Ea) for degradation and denaturation reactions of heat-sensitive components such as proteins and vitamins are generally high. According to the Arrhenius equation, k and T have an exponential relationship; the lower the temperature, the more exponentially k decreases. From the perspective of energy barriers, 45℃ (318K) is lower than the critical denaturation and degradation temperature of most heat-sensitive components, corresponding to a relatively large Ea / RT value and a high exponential term (e). Ea / RT The value of k decreases, causing the degradation rate constant k to drop to near zero. While the high temperature of the traditional UHT process (135-145℃) can quickly sterilize, it also causes the k value to soar exponentially, resulting in the degradation and inactivation of a large number of heat-sensitive components. In contrast, the low temperature environment of 45℃ keeps the heat-sensitive components below the reaction energy barrier, and the molecular kinetic energy is insufficient to cross the activation energy barrier to react, achieving a near-zero loss protection effect.
[0035] By locking the temperature of the thermosensitive phase below 45°C and utilizing the Arrhenius first-order kinetic isolation principle, the degradation rate constant of thermosensitive nutrients during the sterilization process approaches zero. The sterilization loss rate of vitamin C is less than 0.1%, corresponding to an initial addition amount approximately equal to the product of the target content and shelf-life loss compensation, eliminating the need for excessive addition to compensate for sterilization losses. The sterilization loss rate of vitamin A is less than 0.01%, corresponding to an initial addition amount approximately equal to the product of the target content and shelf-life loss compensation, also eliminating the need for excessive addition. This eliminates the catalytic pathway for the formation of dehydroascorbic acid (DHAA) due to excessive vitamin C addition, resulting in a Maillard browning reaction rate constant lower than that of autoclave sterilization (121°C). Meanwhile, because it eliminates the need for chelating agents such as citric acid and strong alkaline pH adjusters, it avoids the astringent taste of the chelating agents themselves, the bitter metallic taste of excessive mineral salts (potassium and magnesium salts), and the rancid taste from the thermal oxidation of fats. This allows the product to maintain its natural frankincense flavor without the need for any added flavorings, sweeteners, or flavor masking agents, and its sensory cleanliness meets the compliance requirements for long-term consumption. For patients with kidney disease, existing medical foods require the addition of citric acid chelating agents (to block calcium-magnesium bridges) followed by neutralization with citrate, NaOH, and KOH, resulting in an additional 384mg of sodium or 770mg of potassium per 500ml of product. Based on a daily total nutritional intake of 2100 kcal, traditionally processed products exceed the ESPEN clinical upper limit for sodium by 65% and the upper limit for potassium by 109%. While physically stable, this poses a potentially fatal physiological risk, easily inducing fatal hyperkalemia. In addition, the proteins in the heat-sensitive phase do not undergo thermal denaturation and unfolding. During the homogenization stage, they can complete the recombination of the hydrophobic water at the fat globule interface with a low activation energy, forming a stable interfacial anchoring structure.
[0036] Before step S10, steps S01 to S03 are also included: Step S01: Go through the component detection list of the complete nutritional raw materials and classify proteins, essential fatty acids, vitamins, and calcium β-hydroxy-β-methylbutyrate as the heat-sensitive phase materials.
[0037] Step S02: Obtain the measured mineral concentration of mineral salts and compare the measured mineral concentration with a preset concentration threshold.
[0038] Step S03: The carbohydrates and the mineral salts whose measured mineral concentration is greater than or equal to the concentration threshold are classified as the non-thermal sensitive phase materials.
[0039] In this embodiment, a preset list of materials for the heat-sensitive phase and a preset list of materials for the non-heat-sensitive phase are included. Optionally, the heat-sensitive phase materials include: proteins, essential fatty acids, a full spectrum of vitamins (including fat-soluble and water-soluble vitamins), calcium β-hydroxy-β-methylbutyrate, and other components that are extremely sensitive to temperature; the non-heat-sensitive phase materials include high-concentration mineral salts such as potassium, sodium, magnesium, and phosphorus, and carbohydrates, which are thermally stable. A preset concentration threshold is set; for example, the mineral concentration threshold is 1500 mg / L, which is considered a high concentration of mineral salts.
[0040] Obtain a complete list of components for testing the total nutritional raw materials. Using a pre-defined list of thermosensitive phase materials and a list of non-thermosensitive phase materials as the basis for matching, iterate through all component data line by line within the list. For each component name and category identifier obtained during the iteration, match it against the list of thermosensitive phase materials one by one. When a component category identifier completely matches any one of the categories of protein, essential fatty acids, or full-spectrum vitamins, add a thermosensitive phase attribute tag to that component. After all iterations and matching are completed, summarize all components tagged with thermosensitive phase to generate a thermosensitive phase material set, and output the thermosensitive phase classification results.
[0041] All materials categorized as potassium, sodium, magnesium, and phosphorus mineral salts are screened and locked, and real-time measured total mineral concentration values uploaded by the detection module are simultaneously collected. A preset fixed concentration threshold is retrieved, and the measured mineral concentration values are logically compared with the preset threshold. If the measured mineral concentration value is greater than or equal to the preset concentration threshold, the mineral salt is marked as a high-concentration compliant mineral component, and a non-thermal-sensitive phase attribute label is assigned to these compliant mineral salts. If the measured mineral concentration value is less than the preset threshold, the mineral salt is marked as a non-compliant component and is temporarily excluded from the non-thermal-sensitive phase range. The compliance determination dataset for mineral salts is output. All carbohydrate components in the list are identified and assigned non-thermal-sensitive phase attribute labels. Carbohydrates and high-concentration compliant mineral salts are merged and summarized to generate a non-thermal-sensitive phase material set.
[0042] Optionally, for intermediate components that do not match the thermosensitive phase material list and do not belong to the thermosensitive phase material, a preset thermal stability grading standard is obtained, including a critical temperature resistance threshold and a thermal degradation loss judgment standard. The measured critical temperature resistance temperature and measured thermal degradation loss coefficient data for each intermediate component are obtained, and the measured critical temperature resistance temperature and measured thermal degradation loss coefficient of the intermediate component are compared item by item with the preset thermal stability benchmark threshold. When the measured critical temperature resistance temperature of the intermediate component is greater than the preset high temperature tolerance threshold, and the measured thermal degradation loss coefficient is less than the preset stable loss upper limit, this type of intermediate component is determined to have good thermal stability performance and is suitable for ultra-high temperature sterilization processing environment. This type of thermally stable intermediate component is then added to the non-thermally sensitive phase material set and uniformly allocated to the non-thermally sensitive phase flow channel for processing. When the measured critical temperature of the intermediate component is less than or equal to the preset low temperature tolerance threshold, and the measured thermal degradation loss coefficient is greater than the preset loss control upper limit, it is determined that the intermediate component has temperature sensitive characteristics and cannot withstand high-intensity high-temperature heat treatment. The intermediate component of this type is then added to the thermosensitive phase material set and uniformly distributed to the thermosensitive phase flow channel for low-temperature sterile treatment.
[0043] Step S20: Based on a preset temperature and a preset time, perform thermal sterilization on the non-thermal-sensitive phase material in the nutrient component to obtain the sterilized non-thermal-sensitive phase material, wherein the preset temperature is 135-145°C and the preset time is 3-10 seconds.
[0044] It should be noted that non-thermal-sensitive phase materials refer to high-concentration mineral salts such as potassium, sodium, magnesium, and phosphorus, as well as carbohydrates. These materials have physical thermal stability.
[0045] In this embodiment, non-thermally sensitive phase materials are input into the thermosensitive phase flow channel, and ultra-high temperature instantaneous sterilization (UHT) is performed on the thermosensitive phase flow channel to ensure that all non-thermally sensitive components reach a sterile state. A preset sterilization process parameter library for the thermosensitive phase materials is used; for example, the sterilization temperature is 135~145℃, and the time is 3~10s, which can be set according to the material flow rate and the length of the heat exchange chamber. The spore inactivation target is ≥12 log, that is, the initial spore concentration is reduced by 12 orders of magnitude. The heat transfer coefficient and viscosity correction coefficient are designed for high-salt, high-carbon water systems. At the same time, the initial temperature, flow rate, viscosity, and mineral concentration data of the non-thermally sensitive phase materials in the feed section are collected to generate an initial data set of material states.
[0046] Optionally, the non-thermosensitive phase material is subjected to thermal sterilization by means of hierarchical heating. According to the feed flow rate, specific heat of the material, and initial temperature, the total heating amount required to reach the target sterilization temperature is calculated. The heating power can be distributed in such a way that the preheating section承担60–70% of the temperature rise load and the high-temperature section承担30–40% of the temperature rise load, so as to avoid thermal shock caused by one-time temperature rise. The temperature of the material after preheating is monitored in real time. If the temperature is lower than the set lower limit, the heating power of the preheating section is increased; if it is higher than the upper limit, the heating power is decreased to avoid carbonization of carbohydrates or deterioration of color caused by local overheating. In the high-temperature section, a double-pipe or plate-type ultra-high temperature heat exchanger is used to heat the material with high-pressure steam. The temperature data of the material is collected in real time through a temperature sensor, and the difference operation is performed between the measured temperature and the target temperature range. If the temperature is lower than the target lower limit, the steam pressure is increased and the heat exchange power is increased to shorten the temperature rise time; if the temperature is higher than the target upper limit, the steam pressure is automatically decreased and the bypass cooling branch of the heat exchanger is opened to avoid excessive heating of the material. When it is confirmed that the material has stably entered the sterilization temperature range of 135–145°C, it enters the insulation section. The system calculates the theoretical residence time of the material in the pipe according to the material flow rate and the effective length of the insulation pipe, t = Q / V, where V is the effective volume of the insulation pipe and Q is the volume flow rate of the material.
[0047] The initial spore concentration N0 of the non-thermosensitive phase material before sterilization and the spore concentration N of the outlet material after sterilization are collected, and the inactivation rate is calculated. The inactivation rate = log10(N0 / N). Taking the preset ≥12log as the judgment standard, if the calculation result reaches the target value, it is judged that the sterilization effect is qualified; if the inactivation rate is insufficient, the temperature of the ultra-high temperature section or the residence time of the insulation section is adjusted, and the sterilization process is re-executed until the inactivation index reaches the standard, and it is confirmed that the non-thermosensitive phase material has reached the commercial sterility state.
[0048] In a feasible implementation, the waste heat generated by subjecting the non-thermosensitive phase material to thermal sterilization is recovered and pumped to the preheating section of the non-thermosensitive phase material to reduce steam consumption; the cooling requirements of the pulse electric field terminal treatment unit after two-stage high-pressure homogenization are thermally managed with the low-temperature flow path of the thermosensitive phase. When it is judged to be qualified, the sterilized non-thermosensitive phase material is quickly cooled to the process-set temperature, and the generated waste heat is recovered and pumped to the non-thermosensitive preheating section to reduce steam consumption. The waste heat generated in the UHT section is recovered and pumped to the non-thermosensitive preheating section. At the same time, the cooling requirements of the PEF terminal treatment unit after homogenization and the low-temperature flow path of the thermosensitive phase are uniformly incorporated into the thermal management system, so that the steam consumption per ton of product is reduced by no less than 28% and the comprehensive refrigeration load is reduced by no less than 22%.
[0049] In this embodiment, through material phase separation treatment, Ca 2+ 、Mg 2+The product is physically isolated from protein components by divalent cations, eliminating the need for pH adjustment with acids, bases, or electrolyte salts, or for chelating agents such as citric acid to block the formation of divalent cation bridges. This eliminates the need for additional electrolytes introduced through strong alkali neutralization after the addition of chelating agents, achieving zero increase in sodium and potassium ions during the processing. For products used in early-stage or non-dialysis chronic kidney disease (CKD) patients, the daily sodium intake should not exceed 1800 mg and the daily potassium intake should not exceed 2000 mg, based on a daily energy intake of 2100 kcal. For products used in late-stage or dialysis-dependent CKD patients, the daily sodium intake should not exceed 2500 mg and the daily potassium intake should not exceed 2500 mg.
[0050] Step S30: Mix the sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material to obtain a first mixture.
[0051] In this embodiment, sterilized non-thermal phase materials and thermal phase materials are controlled to mix at a dynamic mixing point. By real-time monitoring of the instantaneous ion intensity gradient, a gradient introduction method is used to avoid instantaneous electrostatic shocks to protein micelles caused by high-concentration electrolytes. The instantaneous ion intensity gradient refers to the difference in ion intensity between the low-ion-intensity thermal phase material and the high-ion-intensity non-thermal phase material at the dynamic mixing interface, as well as the instantaneous rate of change of ion intensity during the mixing process. Since the electrolyte content of the two types of materials differs significantly, direct mixing can easily lead to drastic abrupt changes in ion intensity. Real-time acquisition of ion intensity parameters on both sides of the mixing region and continuous calculation of the interface gradient difference and trend are used to assess the risk of abrupt changes in the electrostatic environment of the mixing interface, providing a control basis for the controlled gradient mixing of the two materials.
[0052] The ion intensity of the two materials is collected in real time, and the instantaneous Debye length K is calculated based on the Debye-Hückel theory. -1 When K -1 When the decrease exceeds a preset threshold, the merging rate of the two material streams is automatically adjusted. According to the Debye-Hückel theory, K... -1 With ionic strength It is inversely proportional to the square root:
[0053] Wherein, I represents ionic strength, which is a quantitative indicator characterizing the total concentration and charge intensity of free charged ions in a solution.
[0054] By isolating the non-thermally sensitive phase material from the thermosensitive phase material of the protein backbone in terms of energy delivery, and by monitoring the instantaneous ion intensity gradient in real time at the dynamic mixing point, electrostatic shocks are avoided through controlled introduction, thereby protecting the spatial conformation of protein molecules.
[0055] In one feasible implementation, please refer to Figure 2 Step S30 includes steps S31 to S35: Step S31: Based on the target ion concentration data and the corresponding ion charge number, determine the first ion strength of the sterilized heat-sensitive phase material and the second ion strength of the sterilized non-heat-sensitive phase material. Step S32: Determine the ion intensity gradient difference, the ion intensity change rate, and the Debye length decrease based on the first ion intensity and the second ion intensity. Step S33: Compare the ion intensity gradient difference, the ion intensity change rate, and the Debye length decrease with their respective safety threshold ranges; Step S34: If any indicator is greater than a preset safety threshold and less than a preset warning threshold, the first initial flow rate corresponding to the sterilized non-thermal phase material is adjusted based on a preset first adjustment coefficient to obtain a first target flow rate, wherein the safety threshold is less than the warning threshold. Step S35: Perform a mixing operation according to the first target flow rate and the second initial flow rate corresponding to the sterilized heat-sensitive phase material.
[0056] In this embodiment, Debye-Hückel theory calculation parameters are pre-stored, and safety threshold parameters, material transport control parameters, and protein conformation protection parameters are pre-set. The Debye-Hückel theory calculation parameters include the dielectric constant, Avogadro's constant, electron charge, Boltzmann constant at room temperature (25°C), and the Debye length K. -1 The calculation formula includes a preset Debye length safety threshold, an ionic intensity gradient safety difference, and a protein micelle charge density stability threshold. For example, the Debye length safety threshold is 15%–20% of the original Debye length of the thermosensitive phase before mixing; exceeding this threshold indicates a risk of electrostatic shock. The ionic intensity gradient safety difference is 0.05 mol / kg. Material transport control parameters include a first transport flow rate for the non-thermal phase material, a second transport flow rate for the thermosensitive phase material, and a flow rate adjustment step size. Protein conformation protection parameters include the pH stability range and viscosity control range of the mixed system.
[0057] For both the non-thermal phase channel and the thermal phase channel, data is collected synchronously based on a preset sampling frequency. For the non-thermal phase material, data on free electrolyte ion concentration, ionic strength, material temperature, viscosity, and pressure are collected. The formula for calculating ionic strength is: ; Among them, c i Z represents the ion concentration. i This represents the ionic charge number.
[0058] For data on thermosensitive phase materials, we collect data on protein colloid concentration, protein molecule surface charge density, basic viscosity of the colloidal dispersion system, system pH value, and protein micelle size distribution. At the same time, we collect material temperature and pressure data to ensure that the temperature deviation from that of non-thermosensitive phase materials is ≤2℃, so as to avoid physicochemical fluctuations caused by temperature difference.
[0059] In this embodiment, ion concentration detection modules are respectively set in the thermosensitive phase channel and the non-thermosensitive phase channel to collect measured concentration data of various free mineral ions such as potassium, sodium, magnesium, and phosphorus according to a preset sampling frequency. A fixed parameter database is formed by preset charge constants for each ion. For example, potassium ions (K... + The charge number is 1, and the sodium ion (Na) + The charge number is +1, and the magnesium ion (Mg²⁺) + The charge number is +2, and the phosphate ion (PO4³) - The charge number is -3; store the ion type and charge number together.
[0060] Based on real-time ion concentration detection data and ion charge values, the ion intensity is obtained by substituting them into the ion intensity calculation formula. The formula for calculating ion intensity is: ; Where I is the ionic strength, c i Z represents the ion concentration. i This represents the ionic charge number.
[0061] The measured concentrations of four types of ions—non-thermal phase, thermosensitive phase, and mixed interface—were obtained. The real-time ion intensity I1 of the non-thermal phase and I2 of the thermosensitive phase were calculated using the ion intensity formula. Based on the real-time ion intensity data, the ion intensity gradient difference and rate of change were determined: ion intensity gradient difference ΔI = |I1 - I2|. The gradient differences of a preset continuous set were obtained, and the change in gradient difference per unit time was calculated to obtain the ion intensity change rate. If the change rate v ≤ a preset change rate threshold, it indicates a gentle gradient change and a stable electrostatic environment; if v > a preset change rate threshold, it indicates a drastic gradient change and a risk of sudden changes in the electrostatic environment. The gradient differences and change rates were sorted by timestamp to form a correlated dataset containing time, gradient differences, and change rates.
[0062] Determine the constants corresponding to the complete Debye-Hückel operational model, including the dielectric constant, Avogadro's constant, electron charge, Boltzmann constant, etc., at room temperature (25°C), as well as the ionic strength value. According to Debye-Hückel theory, the Debye length K... 1It is inversely proportional to the square root of the ionic strength. The instantaneous shielding distances on the non-thermal phase side, the thermal phase side, and the mixing interface are derived separately. The derived Debye length values are compared with the preset theoretical range. If they exceed the theoretical range, the derivation is considered abnormal. Ion strength data and model parameters are retrieved again for derivation until the result is acceptable.
[0063] Three indices—ionic intensity gradient difference, ionic intensity change rate, and Debye length decrease—are pre-defined with safety thresholds, warning thresholds, and over-limit thresholds to characterize the critical boundary between a stable state and the occurrence of electrostatic shock at the mixing interface. For the ionic intensity gradient difference, the safety threshold is the first gradient threshold; the warning threshold range is greater than the first gradient threshold but less than or equal to the second gradient threshold; the over-limit threshold is the second gradient threshold, which is greater than the first gradient threshold. For the ionic intensity change rate, the safety threshold is the first rate threshold; the warning threshold range is greater than the first rate threshold but less than or equal to the second rate threshold; the over-limit threshold is the second rate threshold, which is greater than the first rate threshold. For the Debye length decrease, the safety threshold is the first decrease threshold; the warning threshold range is greater than the first decrease threshold but less than or equal to the second decrease threshold; the over-limit threshold is the second decrease threshold, which is greater than the first decrease threshold.
[0064] The gradient difference, the rate of change of ion intensity, and the decrease in Debye length are compared with their corresponding safety threshold ranges. If all three indicators are within the safety threshold range, the electrostatic environment is considered safe, and the original convergence rate of the two materials is maintained, while the trend of each parameter is continuously monitored online. If any indicator exceeds the safety threshold range but does not reach the over-limit threshold, an electrostatic environment warning is issued, triggering a small-scale adjustment command to reduce the convergence rate of the non-thermal phase material, while simultaneously and continuously tracking the changes of each indicator. If any indicator exceeds the over-limit threshold, the electrostatic environment is considered high-risk, reducing the convergence rate of the non-thermal phase material and increasing the convergence rate of the thermal phase material to form a gradient buffer control until all indicators fall back to the safety threshold range.
[0065] The initial flow rates of the two materials are preset, and the flow rates are dynamically adjusted proportionally according to the risk level. When all three indicators are within the safe threshold, no adjustment is required, and the original convergence ratio and total flow rate remain stable. When any indicator enters the warning range, a smooth adjustment strategy is implemented. The flow rate of the non-thermal phase is slightly reduced by a preset first adjustment coefficient to slow down the influx of high-ionic-strength materials. The product of the first adjustment coefficient and the first initial flow rate corresponding to the non-thermal phase is determined as the first target flow rate. The first adjustment coefficient is less than 1 and close to 1 to achieve a smooth reduction. The flow rate of the thermal phase remains unchanged. After adjustment, the indicators are continuously monitored. If the indicators fall back to the safe range, the baseline flow rate is restored. When any indicator exceeds the over-limit threshold, a strong buffer adjustment strategy is implemented. The flow rate of the non-thermal phase is significantly reduced. The product of the second adjustment coefficient and the first initial flow rate is determined as the first target flow rate. The second adjustment coefficient is significantly less than 1 to limit the instantaneous influx of high-ionic-strength materials. The product of the third adjustment coefficient and the second initial flow rate corresponding to the thermal phase is determined as the second target flow rate. The third adjustment coefficient is greater than 1. By adjusting the flow rates in opposite directions, the ion intensity gradient at the mixing interface is quickly reduced, allowing the Debye length to return to a safe range.
[0066] Optionally, before step S31, the method further includes: acquiring real-time temperature value, real-time pressure value, and initial ion concentration data; determining the temperature activity coefficient corresponding to the real-time temperature value and the pressure correction coefficient corresponding to the real-time pressure value; and determining the target ion concentration data as the product of the initial ion concentration data, the temperature activity coefficient, and the pressure correction coefficient.
[0067] In this embodiment, the obtained ion strength is optimized through real-time numerical modeling. Based on temperature, pressure, and viscosity, a correlated numerical model is constructed, and the ion strength calculation results are dynamically corrected according to changes in material properties to obtain optimized real-time ion strength data.
[0068] Temperature changes alter the thermal motion rate and interionic forces of ions, thus affecting their activity coefficients. The ion activity coefficient determines the actual intensity of an ion's influence within a system. According to thermodynamic principles, the ion activity coefficient fluctuates systematically with temperature. When the temperature deviates from a baseline value, the electrostatic attraction and solvation between ions change accordingly, leading to a deviation of the effective ion concentration from the detected concentration. By pre-setting the correlation between temperature and activity coefficient, a corresponding correction coefficient is introduced to dynamically calibrate the ion activity coefficient when the material temperature changes. This compensates for deviations caused by temperature fluctuations, ensuring that the calculated ion strength value accurately reflects the actual impact of ions on the electrostatic environment of the system under different temperature conditions.
[0069] The effective activity of ions satisfies the formula: ; The formula for the temperature activity coefficient is: ; Where ai is the effective activity of the i-th ion, representing the effective concentration of the ion that actually exerts its electrostatic effect in the actual solution; γ i (T) is the ion activity coefficient of the i-th ion at temperature T, used to characterize the degree of deviation between the actual solution and the ideal solution, and it changes with temperature; c i γ is the measured molar concentration of the i-th ion, obtained online by the ion concentration detection module; i,0 Let be the standard activity coefficient of the i-th ion at the reference temperature T0, and be a preset constant; k T This is a temperature correction factor, determined by the physical properties of the material system, reflecting the sensitivity of the activity coefficient to temperature changes; ΔT = T T0 represents the temperature change, which is the difference between the current temperature and the reference temperature; T0 is the reference temperature.
[0070] Changes in pressure alter the volume of materials and the diffusion rate of ions, leading to deviations in ion concentration detection values. Increased pressure compresses the material, resulting in higher ion concentration readings; conversely, decreased pressure expands the material, leading to lower ion concentration readings. This paper establishes a pre-defined correlation between pressure and concentration conversion deviations, collects material pressure data in real time, and corrects the ion concentration detection values based on pressure changes, converting the detected values to the true ion concentration under standard pressure. The pressure correction function is as follows: g(P) = 1 + k P *ΔP; Where, k P Let ΔP be the isothermal compressibility coefficient of the solution, and ΔP be the pressure change. The current pressure value of the material in the pipeline is collected, and the difference between this pressure and the standard reference pressure is calculated to obtain the pressure change. The solution compressibility coefficient parameter is obtained, and a volume correction factor is calculated based on the pressure change. The measured concentration value output by the ion concentration detection module is multiplied by the volume correction factor to complete the pressure correction. The corrected concentration represents the true ion concentration under standard pressure, eliminating calculation errors caused by pressure fluctuations.
[0071] The ionic strength is corrected based on temperature and pressure, and the correction formula is as follows: .
[0072] Optionally, the ionic strength is corrected based on temperature and pressure, using the following formula: Temperature activity correction: γ i (T)=γ i ,0·exp(kT·ΔT); Pressure activity correction: g(P) = 1 + kP·ΔP; Where, γ i,0 is the activity coefficient at the reference temperature, kT is the temperature sensitivity coefficient, ΔT is the temperature deviation relative to the reference temperature; kP is the pressure sensitivity coefficient, ΔP is the pressure deviation relative to the reference pressure; the two work together to correct the ion strength deviation caused by temperature rise and pressure change during high-pressure homogenization.
[0073] In this embodiment, a membrane sterilization method is used for heat-sensitive materials, relying on physical sieving to trap microorganisms, avoiding interference from high-temperature heat, and fully preserving the internal functional active ingredients and natural physicochemical properties of the heat-sensitive phase material, preventing denaturation, inactivation, and structural damage of the heat-sensitive components; heat sterilization is used for non-heat-sensitive phase materials with good heat resistance; by using differentiated sterilization methods for the two types of materials, the tolerance characteristics of different materials are adapted to avoid the limitations of a single sterilization process, and the two phase materials after sterilization are uniformly mixed to prepare a first mixture, which not only improves the overall microbial safety level of the mixture, but also takes into account the functional integrity and material stability of the multi-component system.
[0074] Furthermore, high-nutrient-density medical foods contain large amounts of protein (amino acid source) and reducing sugars / carbohydrates (carbonyl source). During sterilization, the coexistence of these two components at high temperatures triggers the Maillard reaction, resulting in color and flavor damage: the formation of melanoidins, causing the product to change from milky white to a deep brown color, and the generation of aldehydes, ketones, and nitrogen / sulfur-containing volatile compounds, producing off-flavors such as burnt and cooked tastes, requiring the product to rely on flavorings to mask these odors. UHT sterilization of only the carbohydrate phase, which does not contain protein, results in the breakdown of the substrate chain in the Maillard reaction, even at high temperatures, due to the lack of amino acid donors in the system, thus preventing the formation of any melanoidin intermediates. When the protein phase enters the system via cold membrane sterilization, although the amino acid source and carbonyl source meet during the homogeneous convergence phase, they do not undergo further high-temperature processes, and the system remains below the activation energy threshold of the Maillard reaction. The combined effect of substrate separation (spatial decoupling) and temperature suppression (kinetic decoupling) fundamentally blocks the Maillard reaction.
[0075] Through a physical decoupling process, proteins undergo hydrophobic recombination at the lipid interface in their native conformation, forming a stable protein-lipid complex interfacial film. This eliminates the need for exogenous emulsifiers such as phospholipids and mono- and diglycerides (E471, mono- and diglycerides) to maintain emulsion stability. This characteristic has significant clinical applicability for special medical purpose formula foods requiring strict control of allergen sources (such as products specifically for patients with milk protein allergies), while avoiding the risk of allergen introduction from exogenous animal-derived emulsifiers and the safety hazards of exogenous synthetic emulsifiers. Based on the first embodiment of this application, in the second embodiment of this application, the content that is the same as or similar to that in the first embodiment can be referred to the above description and will not be repeated hereafter. Based on this, please refer to Figure 3 Following step S30, the decoupled manufacturing method for high nutrient density non-Newtonian fluid products further includes steps S40-S50: Step S40: The first mixture is subjected to a two-stage high-pressure homogenization process to control the particle size of the first mixture within a preset particle size range to obtain a second mixture. The two-stage high-pressure homogenization process includes a high-pressure stage of 400-700 bar and a low-pressure stage of 200-300 bar. The particle size range is 100-200 nm. The high-pressure stage is used to break the droplets of the first mixture to the target particle size, and the low-pressure stage is used to prevent re-agglomeration through turbulence dissipation.
[0076] In this embodiment, the first mixture after merging undergoes a two-stage high-pressure homogenization process to control the particle size within a preset range. Preferably, the high-pressure stage of the high-pressure homogenization process is 400–700 bar, the low-pressure stage is 200–300 bar, and the particle size range is 100–200 nm.
[0077] It should be noted that the settling velocity of spherical particles Defined by Stokes' formula:
[0078] in, Let be the particle radius. Since the settling velocity is proportional to the square of the radius, the particle size is reduced from... Reduce to Theoretically, the settlement rate will be reduced by more than 25 times. As a continuous phase viscosity, the material system exhibits non-Newtonian fluid characteristics. At low shear rates, the consistency coefficient... With flow index This determines its apparent viscosity, further suppressing the displacement of tiny particles. Decoupling processes prevent thermally induced aggregation, ensuring particles remain at the nanoscale, allowing their Brownian motion to completely counteract gravitational settling.
[0079] The first mixture enters the homogenization pre-buffer chamber, where real-time viscosity, system pressure, and temperature parameters are monitored to maintain a continuous and stable feed flow rate, preventing pressure oscillations caused by instantaneous flow fluctuations. Simultaneously, the material conveying process is kept stable to ensure a uniform colloidal dispersion structure, providing stable feeding conditions for two-stage differential pressure homogenization and preventing localized material agglomeration and uneven dispersion from affecting subsequent particle size control.
[0080] The material first enters the low-pressure homogenization unit, which has a pre-set fixed pressure range. Homogenization valves create throttling compression, high-speed jetting, and localized shearing. Under medium pressure, the loosely aggregated particles in the mixture are initially de-agglomerated and dispersed, breaking down weak bonding forces between particles, dispersing large agglomerates, reducing the overall particle size range, and eliminating localized large particle agglomerates. This low-pressure homogenization process avoids disrupting the material's original stable structure with high-intensity instantaneous mechanical action, completing the initial homogenization pretreatment of the overall particles. The low-pressure treated material is then fed into the high-pressure homogenization unit, where higher pressure levels are used to implement strong shearing, cavitation effects, and high-speed collisions. Under high pressure, the material passes through a fine valve gap at high speed, generating extremely strong fluid shearing forces and instantaneous pressure release cavitation. This process finely breaks down, tears, and reconstructs the interfaces of remaining larger particles, further compressing the particle size and optimizing the particle surface dispersion. By relying on the strong mechanical action of high pressure, the compatibility and bonding effect of the multiphase system is enhanced, so that various components are evenly dispersed, eliminating the wide range of differences in particle size distribution and achieving precise convergence of particle size.
[0081] After two-stage homogenization, the diameter distribution data of the discharged particles is collected in real time to continuously determine whether the overall particle size range meets the control requirements. If the overall particle size is too large, the intensity of the two-stage homogenization is increased and the effective homogenization time is extended; if the particle size is too small or the system is excessively sheared, the homogenization pressure parameter is appropriately reduced to weaken the mechanical action intensity. Through continuous feedback adjustment, the diameter of all particles in the homogenized discharge is stably constrained within the set target range, ensuring uniform particle size distribution and stable dispersion of the system.
[0082] Zero electrolyte increment maintains the system's ionic strength at the raw material background level, and the Debye double layer thickness κ -1 Maintaining maximum electrostatic repulsion between droplets is sufficient to resist particle aggregation; the temperature of the thermosensitive phase is controlled below 45°C, preventing protein denaturation and the formation of protein bridging, thus avoiding particle size increase due to thermal aggregation; after homogenization, PEF end interface anchoring is used to solidify the protein-lipid interface in situ; the above synergistic mechanism locks the particle size of the fat globules and protein complexes in the finished product within the 100–200 nm range. Compared to commercially available similar products (approximately 500 nm in diameter), the sedimentation rate of Stokes products with a particle size of 100–200 nm is reduced by at least 6.25 times, and the finished product shows no wall adhesion or stratification during a 12-month shelf life. The particle size locking effect is characterized by the Péclet number (Pe), calculated with a maximum particle size of 200 nm diameter (radius of 100 nm), Pe = 4π·Δρ·g·r 4 / (3·kB·T)≈ 5.0×10 -5The value is much less than 1, indicating that the system is in a spontaneously stable state dominated by Brownian motion; the Pe value is only that of a commercially available reference product (500 nm diameter, Pe≈1.95×10⁻⁶). - The fact that the product obtained in this embodiment has a significantly higher colloidal stability margin to storage temperature fluctuations and mechanical vibrations is 1 / 39 of 3).
[0083] The contribution of zero electrolyte increment to particle size stability can be quantified by the Debye length. In this example, the ionic strength of the system is approximately 0.050 mol / L, corresponding to K0. -1 ≈1.36 nm; traditional processes increase the ionic strength to approximately 0.083–0.089 mol / L due to the introduction of additional sodium or potassium salts, K -1 When compressed to approximately 1.02–1.06 nm, the double layer thickness is reduced by approximately 22%–25%, the electrostatic repulsion barrier height decreases, the tendency for particle aggregation increases, and the particle size stability deteriorates.
[0084] Step S50: Based on the preset electric field strength and pulse width, the second mixture is subjected to pulse electric field treatment to obtain the target product, wherein the electric field strength is 25-40 kV / cm and the pulse width is 0.5-3μs.
[0085] It should be noted that the main function of PEF (pulsed electric field) is to utilize Maxwell stress to induce interfacial protein Ca2+. 2+ –COO - Ion bridge crosslinking transforms the thermodynamically metastable interface film generated by homogenization into a quasi-irreversible kinetic locked state, inhibiting Ostwald ripening and droplet aggregation; and provides ≥4 log redundant inactivation protection for residual microbial vegetative cells. PEF does not target spores. Spores are controlled by the following three pre-barrier pathways: (1) Non-thermal phase UHT (135-145°C, 3-10 s) thermally inactivates spores in the non-thermal phase, with an inactivation capacity ≥12 log; (2) Thermosensitive phase membrane sterilization (pore size 0.1-0.22 μm) physically intercepts all spores in the thermosensitive phase, with a interception rate ≥6 log; (3) Homogenizer fluid contact cavity SIP in-situ steam sterilization (121°C, ≥30 min) removes existing spores in the homogenizer cavity, with an inactivation capacity ≥15 log. The three barriers target three spore sources: non-thermal phase materials, thermal phase materials, and the equipment cavity, achieving zero spore residue throughout the entire process.
[0086] In this embodiment, preset PEF processing parameters include: electric field strength, pulse width, pulse frequency, and material feed flow rate. Once it is confirmed that the material particle size has stabilized in the 100-200nm range, the PEF processing unit start command is triggered, allowing the homogenized material, i.e., the second mixture, to enter the PEF processing chamber, thus preventing substandard material from entering subsequent processes and affecting the structure locking effect.
[0087] According to the preset program, control commands are sent to the electrode components of the PEF end-processing and anchoring module to adjust the output parameters of the high-voltage pulsed electric field, ensuring that the electric field strength and pulse width remain stable within the preset range, thus avoiding parameter fluctuations that could affect the interface anchoring effect. By monitoring the discharge particle size distribution data in real time and comparing it with the preset target range, the interface anchoring effect is determined. If there are no abnormal fluctuations in the particle size distribution, and no signs of particle size increase or agglomeration, it indicates that the interface anchoring is effective, and the current electric field parameters are maintained unchanged. If abnormal particle size occurs, the pulse width and electric field strength are finely adjusted to enhance the interface molecular orientation rearrangement effect, ensuring that the thermodynamically metastable emulsion is transformed into a kinetically locked state without changing the existing particle size, thus solidifying the homogeneous nanoscale dispersion structure.
[0088] The system sets a preset nutrient inactivation criterion and collects real-time microbial detection data of the material after PEF treatment. The data is then compared with the preset standard. If the inactivation effect does not meet the standard, the pulse duration is extended and the pulse frequency is finely adjusted without changing the electric field strength and pulse width to avoid affecting interface anchoring and particle size stability. If the inactivation effect meets the standard, the current parameters are kept stable.
[0089] The system monitors the entire PEF processing flow in real time. If any abnormalities occur, such as abnormal electric field parameters, material flow fluctuations, abnormal particle size, or failure to meet inactivation standards, an early warning signal is triggered. At the same time, relevant parameters are automatically adjusted, such as pausing material conveying, fine-tuning electric field parameters, and restarting pulse output, until the abnormality is resolved. If there are no abnormalities throughout the process, the system determines that the material has passed PEF processing after the material has been processed. It then sends a command to the downstream conveying mechanism to stably convey the material with the locked structure and microbial compliance to the subsequent processes.
[0090] In one feasible implementation, after step S50, the method further includes: collecting real-time particle size data according to a preset collection cycle, comparing the real-time particle size data with the particle size range; performing a difference calculation between the current cycle average particle size and the historical cycle average particle size to obtain the average fluctuation amplitude; and adjusting the electric field strength and the pulse width based on a preset adjustment value when the real-time particle size data is not within the particle size range and the average fluctuation amplitude is greater than a preset fluctuation threshold.
[0091] In this embodiment, a fixed data acquisition cycle is preset, which matches the PEF pulse output cycle. Within each cycle, a preset group of particle size data is acquired in batches. The acquired real-time particle size data is compared group by group with a preset standard particle size range to statistically analyze the overall range of real-time particle size distribution and determine whether it falls within the standard range. The average particle size in the current cycle is calculated, and the difference is calculated with the average particle size in the previous cycle to analyze the fluctuation range of the average value. The proportion of large particles whose particle size exceeds the upper limit of the standard range is statistically analyzed to determine whether there is an aggregation trend.
[0092] If the real-time minimum particle size is not less than the lower limit of the standard interval and the real-time maximum particle size is not greater than the upper limit of the standard interval, it is determined that the overall particle size distribution falls completely within the standard interval and there is no interval shift; if the real-time maximum particle size approaches the upper limit of the standard interval but does not exceed it, it is determined that the overall particle size is approaching the critical interval and there is a potential tendency to become unstable; if the real-time maximum particle size is greater than the upper limit of the standard interval, it is determined that the particle size distribution interval has exceeded the boundary and particle size has rebounded and local structure has become loose and shifted.
[0093] The arithmetic mean of particle size in the current detection cycle and the arithmetic mean of particle size in the previous adjacent detection cycle are used to calculate the absolute value difference, thus obtaining the mean fluctuation between consecutive cycles. This fluctuation is compared with the system's preset allowable fluctuation threshold. If the mean fluctuation is less than or equal to the preset fluctuation threshold, it is determined that the average particle size changes smoothly between consecutive cycles, and the overall homogeneity of the system is stable. If the mean fluctuation is greater than the preset fluctuation threshold, it is determined that the average particle size has shifted significantly, the overall homogeneity of the particles has been disrupted, and the metastable structure exhibits obvious fluctuations.
[0094] Based on all particle size data for the current period, the number of abnormally large particle samples exceeding the upper limit of the standard range is counted, and the proportion of abnormal particles to the total number of all detected samples is calculated to obtain the real-time large particle proportion. This real-time proportion is compared with the system's preset allowable critical proportion threshold for large particles. If the real-time large particle proportion is less than or equal to the preset threshold, the abnormal particle proportion is considered controllable, with no obvious collision or aggregation behavior and no agglomeration trend. If the real-time large particle proportion is greater than the preset threshold, it is determined that large-scale particle aggregation and interface fusion have occurred, the agglomeration trend is clear, and the homogeneous nano-dispersion structure has become unstable.
[0095] When the overall particle size distribution falls within the standard range without any range shift, and the proportion of large particles is within the preset large particle proportion threshold, it is determined that there are no issues such as particle agglomeration, interface fusion, or reverse particle size increase. If the overall particle size is not within the standard range, and the average particle size fluctuation exceeds the preset fluctuation threshold, it is determined that the thermodynamically metastable emulsion structure formed by homogeneity has an unstable trend, the PEF interface anchoring strength is insufficient, and it cannot effectively constrain the interface molecular arrangement and particle movement. Therefore, adaptive compensation adjustment of the PEF working parameters is initiated. A preset PEF parameter adjustment threshold is set, and the adjusted parameters still fall within the preset PEF process range.
[0096] In this embodiment, based on the first embodiment of this application, the content that is the same as or similar to that in the first embodiment described above can be referred to the above description and will not be repeated hereafter. Based on this, after step S10, steps A10~A20 are also included: Step A10: Obtain the real-time temperature of the material during the membrane sterilization process of the thermosensitive phase material, and compare the real-time temperature of the material with the preset upper temperature threshold. Step A20: When the measured material temperature is greater than or equal to the upper temperature threshold, a cooling operation is performed until the measured material temperature is less than the upper temperature threshold.
[0097] In this embodiment, a pre-defined membrane treatment benchmark parameter library is established, storing the ceramic membrane pore size control range, the maximum constraint temperature of the material, the safe range of transmembrane pressure difference, and the threshold values for microbial and spore retention levels. Real-time continuous acquisition of data on the thermosensitive phase material feed temperature, feed flow rate, material viscosity, actual pore size feedback value of the ceramic membrane module, transmembrane pressure difference, and initial microbial and spore content detection data at the feed end forms the original measured dataset for thermosensitive phase membrane treatment. The acquired multi-dimensional raw data undergoes standardization correction and normalization operations to unify data dimensions and accuracy, eliminates fluctuating and abnormal sampling values, and generates a standardized parameter set for thermosensitive phase membrane sterilization that can be used for logical comparison and closed-loop control.
[0098] The real-time temperature of the material is compared with a preset upper temperature threshold. Preferably, the upper temperature threshold is 45°C. When the real-time temperature of the material is greater than or equal to the upper temperature threshold, the thermosensitive phase material system is stably controlled below the preset upper temperature threshold to avoid protein denaturation, vitamin decomposition, and loss of functional component activity caused by high temperature, and to maintain the original molecular conformation and physicochemical properties of the thermosensitive component.
[0099] Optionally, based on the material viscosity and feed load data in the standardized parameter set, the transmembrane pressure difference and feed flow rate required for stable operation of the ceramic membrane are dynamically calculated and matched. The throttling and conveying actuators are slightly adjusted according to the real-time material properties to ensure that the membrane module maintains stable filtration conditions and that the membrane pore structure is free from compression deformation and abnormal flux attenuation.
[0100] Real-time viscosity values and feed load data of the thermosensitive phase material are extracted from a standardized parameter set. Preset inherent parameters of the ceramic membrane module, including membrane area, membrane porosity, and membrane material tolerance threshold, are read to form a dataset relating material properties and equipment parameters. Dynamic fluctuation verification is performed on the extracted real-time viscosity values and feed load data. The amplitude of numerical fluctuations within a preset time period is calculated. If the fluctuation amplitude exceeds a preset fluctuation amplitude threshold, it is considered abnormal, and data noise reduction processing is initiated to remove extreme fluctuation values. A moving average algorithm is used to generate smoothed real-time data to avoid calculation errors caused by material property fluctuations. A preset transmembrane pressure difference (TMP) calculation model is used. This model pre-determines the correlation algorithm between viscosity, feed load, and transmembrane pressure difference. Transmembrane pressure difference is positively correlated with material viscosity and feed load, and negatively correlated with membrane porosity. The material viscosity and feed load data are quantified and calculated within the model to obtain the theoretical transmembrane pressure difference benchmark value required for stable filtration of the ceramic membrane under the current material conditions.
[0101] Obtain the preset transmembrane pressure difference safety range, compare the calculated theoretical transmembrane pressure difference benchmark value with the safety range. If the theoretical benchmark value is within the safety range, set this value as the current transmembrane pressure difference target value. If the theoretical benchmark value is lower than the lower limit of the safety range, it indicates that the feed driving force is insufficient and effective filtration cannot be achieved. Calculate and correct the target value to the lower limit of the safety range. If the theoretical benchmark value is higher than the upper limit of the safety range, it indicates that the pressure difference is too large, which can easily lead to membrane pore extrusion deformation. Calculate and correct the target value to the upper limit of the safety range, and output the transmembrane pressure difference target control value. The transmembrane pressure difference target control value is the optimal operating pressure difference of the ceramic membrane under the current operating conditions.
[0102] The feed flow rate matching calculation is performed using the output transmembrane pressure differential target control value as a constraint, combined with stabilized feed load data and material viscosity data. The ceramic membrane filtration flux formula is: Flux = Transmembrane Pressure Differential ÷ Material Viscosity × Membrane Constant. This calculation yields the theoretical feed flow rate baseline value required to maintain stable feed load under the current transmembrane pressure differential and viscosity conditions. Simultaneously, a preset membrane module flux upper limit is established to prevent excessive flux from causing membrane fouling and flux decay. Based on the membrane module flux upper limit, the theoretical feed flow rate baseline value is corrected to ensure that the filtration flux corresponding to the flow rate does not exceed the membrane module's rated flux. If the feed load changes dynamically, such as fluctuations in upstream component transport causing load increases or decreases, the load change data is captured in real time, the matching relationship between transmembrane pressure differential and feed flow rate is recalculated, and the feed flow rate target value is dynamically updated to ensure coordinated matching of feed load, transmembrane pressure differential, and feed flow rate, outputting the feed flow rate target control value.
[0103] The target control values for transmembrane pressure differential and feed flow rate are sent to the corresponding actuators. To control the transmembrane pressure difference, the outlet throttle valve of the membrane module is adjusted. By regulating the valve opening, the discharge resistance is changed, achieving precise control of the transmembrane pressure difference. When the real-time transmembrane pressure difference is lower than the target value, the valve opening is reduced, increasing the discharge resistance and raising the pressure difference; when the real-time pressure difference is higher than the target value, the valve opening is increased, reducing the resistance and lowering the pressure difference. Regarding the feed flow rate, the speed of the feed pump is adjusted. By changing the pump's output power, the feed flow rate is regulated. When the real-time flow rate is lower than the target value, the pump speed is increased, increasing the feed rate; when the real-time flow rate is higher than the target value, the pump speed is decreased, decreasing the feed rate.
[0104] This application also provides a decoupled manufacturing system for high nutrient density non-Newtonian fluid products, the aforementioned decoupled manufacturing system for high nutrient density non-Newtonian fluid products comprising: The thermosensitive phase processing module is used to perform membrane sterilization treatment on the thermosensitive phase material in the nutrient components, filter out microorganisms in the thermosensitive phase material, and obtain the sterilized thermosensitive phase material. The non-thermal phase processing module is used to perform thermal sterilization on the non-thermal phase material in the nutrient component based on a preset temperature and a preset time, so as to obtain the sterilized non-thermal phase material. The dynamic mixing and gradient introduction module is used to mix the sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material to obtain a first mixture material; The homogenization module is used to perform high-pressure homogenization on the first mixture to control the particle size of the first mixture within a preset particle size range, thereby obtaining the second mixture. The pulsed electric field end processing and anchoring module is used to process the second mixture with a pulsed electric field based on a preset electric field strength and pulse width to obtain the target product.
[0105] This application provides a decoupling manufacturing system for high nutrient density non-Newtonian fluid products, employing the decoupling manufacturing method for high nutrient density non-Newtonian fluid products described in the above embodiments. This system addresses the technical problem of preserving the interfacial stability and bioactivity of high nutrient density fluids during product preparation. Compared to existing technologies, the beneficial effects of the decoupling manufacturing system for high nutrient density non-Newtonian fluid products provided in this application are the same as those of the decoupling manufacturing method for high nutrient density non-Newtonian fluid products provided in the above embodiments. Furthermore, other technical features of the decoupling manufacturing system for high nutrient density non-Newtonian fluid products are the same as those disclosed in the methods of the above embodiments, and will not be repeated here.
[0106] The readable storage medium provided in this application is a computer-readable storage medium that stores computer-readable program instructions (i.e., a computer program) for executing the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product described above. This solves the technical problem of how to retain the interfacial stability and bioactivity of high nutrient density fluids during product preparation. Compared with the prior art, the beneficial effects of the computer-readable storage medium provided in this application are the same as those of the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product provided in the above embodiments, and will not be repeated here.
[0107] The above description is only a part of the embodiments of this application and does not limit the patent scope of this application. All equivalent structural transformations made under the technical concept of this application and using the contents of the specification and drawings of this application, or direct / indirect applications in other related technical fields, are included in the patent protection scope of this application.
Claims
1. A decoupled manufacturing method for a high nutrient density non-Newtonian fluid product, characterized in that, The decoupled manufacturing method for the high nutrient density non-Newtonian fluid product includes: The heat-sensitive phase material in the nutrient component is subjected to membrane sterilization treatment to filter out microorganisms in the heat-sensitive phase material, and sterilized heat-sensitive phase material is obtained. The membrane sterilization treatment uses a ceramic membrane with a pore size of 0.1-0.22μm, and the temperature of the membrane sterilization treatment is less than or equal to 45°C. Based on a preset temperature and a preset time, the non-thermal-sensitive phase material in the nutrient component is subjected to thermal sterilization to obtain the sterilized non-thermal-sensitive phase material, wherein the preset temperature is 135-145°C and the preset time is 3-10 seconds. The sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material are mixed to obtain a first mixture.
2. The decoupled manufacturing method for high nutrient density non-Newtonian fluid products as described in claim 1, characterized in that, After the step of mixing the sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material to obtain a first mixture, the decoupled manufacturing method of the high nutrient density non-Newtonian fluid product further includes: The first mixture is subjected to a two-stage high-pressure homogenization process to control the particle size of the first mixture within a preset particle size range, thereby obtaining a second mixture. The two-stage high-pressure homogenization process includes a high-pressure stage of 400-700 bar and a low-pressure stage of 200-300 bar. The particle size range is 100-200 nm. The high-pressure stage is used to break the droplets of the first mixture to the target particle size, and the low-pressure stage is used to prevent re-agglomeration through turbulence dissipation. Based on a preset electric field strength and pulse width, the second mixture is subjected to pulsed electric field treatment to obtain the target product, wherein the electric field strength is 25-40 kV / cm and the pulse width is 0.5-3μs.
3. The decoupled manufacturing method for high nutrient density non-Newtonian fluid products as described in claim 1, characterized in that, The step of mixing the sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material to obtain a first mixture includes: Based on the target ion concentration data and the corresponding ion charge number, the first ion strength of the heat-sensitive phase material after sterilization and the second ion strength of the non-heat-sensitive phase material after sterilization are determined. Based on the first ion intensity and the second ion intensity, the ion intensity gradient difference, the rate of change of ion intensity, and the decrease in Debye length are determined; The ion intensity gradient difference, the ion intensity change rate, and the Debye length decrease are compared with their respective safety threshold ranges. If any indicator is greater than a preset safety threshold and less than a preset warning threshold, the first initial flow rate of the sterilized non-thermal phase material is adjusted based on a preset first adjustment coefficient to obtain a first target flow rate, wherein the safety threshold is less than the warning threshold. The mixing operation is performed according to the first target flow rate and the second initial flow rate corresponding to the sterilized heat-sensitive phase material.
4. The decoupled manufacturing method for high nutrient density non-Newtonian fluid products as described in claim 3, characterized in that, Following the step of comparing the ion intensity gradient difference, the ion intensity change rate, and the Debye length decrease with their respective safety threshold ranges, the decoupling manufacturing method for high nutrient density non-Newtonian fluid products further includes: When any indicator is greater than or equal to the warning threshold and less than the preset over-limit threshold, the product of the second adjustment coefficient and the first initial flow rate is determined as the first target flow rate. The product of the third adjustment coefficient and the second initial flow rate corresponding to the thermosensitive phase material is determined as the second target flow rate, wherein the third adjustment coefficient is greater than the second adjustment coefficient.
5. The decoupled manufacturing method for high nutrient density non-Newtonian fluid products as described in claim 3, characterized in that, Before the step of determining the first ionic strength of the sterilized thermosensitive phase material and the second ionic strength of the sterilized non-thermosensitive phase material based on ion concentration data and corresponding ion charge numbers, the decoupling manufacturing method of the high nutrient density non-Newtonian fluid product further includes: Acquire real-time temperature, real-time pressure, and initial ion concentration data; Determine the temperature activity coefficient corresponding to the real-time temperature value and the pressure correction coefficient corresponding to the real-time pressure value; The target ion concentration data is determined by multiplying the initial ion concentration data, the temperature activity coefficient, and the pressure correction coefficient.
6. The decoupled manufacturing method for high nutrient density non-Newtonian fluid products as described in claim 1, characterized in that, Before the step of performing membrane sterilization treatment on the thermosensitive phase material in the nutrient component to filter out microorganisms from the thermosensitive phase material and obtain sterilized thermosensitive phase material, the decoupling manufacturing method of the high nutrient density non-Newtonian fluid product further includes: By reviewing the component testing list of the complete nutritional raw materials, proteins, essential fatty acids, vitamins, and calcium β-hydroxy-β-methylbutyrate were classified as the heat-sensitive phase materials. The measured mineral concentration of mineral salts is obtained, and the measured mineral concentration is compared with a preset concentration threshold of 1500 mg / L. Carbohydrates and mineral salts with measured mineral concentrations greater than the concentration threshold are classified as non-thermal-sensitive phase materials.
7. The decoupled manufacturing method for high nutrient density non-Newtonian fluid products as described in claim 1, characterized in that, The high nutrient density non-Newtonian fluid product is used in medical formula foods, infant formula milk or enteral nutrition preparations.
8. The decoupled manufacturing method for high nutrient density non-Newtonian fluid products as described in claim 1, characterized in that, The decoupled manufacturing method for the high nutrient density non-Newtonian fluid product further includes: The real-time temperature of the material during the membrane sterilization process of the heat-sensitive phase material is obtained, and the real-time temperature of the material is compared with a preset upper temperature threshold. When the measured material temperature is greater than or equal to the upper temperature threshold, a cooling operation is performed until the measured material temperature is less than the upper temperature threshold.
9. The decoupled manufacturing method for high nutrient density non-Newtonian fluid products as described in claim 2, characterized in that, The decoupled manufacturing method for the high nutrient density non-Newtonian fluid product further includes: The waste heat generated during the thermal sterilization of the non-thermal-sensitive phase material is recovered and pumped to the preheating section of the non-thermal-sensitive phase material to reduce steam consumption. The cooling requirements of the pulse electric field end processing unit after two-stage high-voltage homogenization will be thermally managed in conjunction with the cryogenic flow channel of the thermistor phase.
10. A decoupled manufacturing system for high nutrient density non-Newtonian fluid products, characterized in that, The decoupling manufacturing system for the high nutrient density non-Newtonian fluid product as described in claim 1 comprises: The thermosensitive phase processing module is used to perform membrane sterilization treatment on the thermosensitive phase material in the nutrient components, filter out microorganisms in the thermosensitive phase material, and obtain the sterilized thermosensitive phase material. The non-thermal phase processing module is used to perform thermal sterilization on the non-thermal phase material in the nutrient component based on a preset temperature and a preset time, so as to obtain the sterilized non-thermal phase material. The dynamic mixing and gradient introduction module is used to mix the sterilized heat-sensitive phase material and the sterilized non-heat-sensitive phase material to obtain a first mixture.