Sterilization device for producing lactulose raw material medicine and use method of sterilization device

Abstract

The invention discloses a sterilization device for producing lactulose raw material medicine and a using method thereof, and relates to the technical field of biological pharmacy, the sterilization device comprises a filtering cavity and a filtering module, a feeding port is formed in the upper end of the filtering cavity, a discharging port is formed in the lower end of the filtering cavity, and the filtering module is arranged in the filtering cavity; the filtering module is used for filtering microorganisms in liquid flowing in from the feeding port, and it can be guaranteed that thick liquid passes through the filtering module at the normal flow speed. The method has the advantages that the problem of membrane blockage caused by high viscosity can be actively and intelligently resisted, so that the filtering flux of a filtering membrane and the production efficiency of a product are guaranteed.

Description

Technical Field

[0001] This application relates to the technical field of biopharmaceuticals, and in particular to a sterilization apparatus for producing lactulose raw material and a method of using the same. Background Technology

[0002] In the production process of lactulose raw materials, the final sterilization process is a key step to ensure product sterility and medication safety. However, the traditional sterilization process usually uses high-temperature steam. Since lactulose will degrade and isomerize when exposed to high temperatures for a long time, aseptic filtration can be used to sterilize lactulose raw materials.

[0003] Existing sterile filters typically include a stainless steel shell and an internal filter element. The internal filter element is equipped with a filter membrane that can filter microorganisms in the solution. The solution enters the shell from the inlet at the top of the shell, and after being filtered by the filter membrane, it flows out from the outlet at the bottom of the shell, thus completing the sterilization process of the solution.

[0004] However, due to the relatively high viscosity of lactulose raw materials, a very high driving pressure is required when the fluid passes through a filter membrane with micron-sized pores. Under high pressure, the concentration of solute molecules on the membrane surface increases sharply, forming a so-called concentration polarization phenomenon, which quickly develops into a dense gel layer. This gel layer is the main source of filtration resistance. It can quickly clog the membrane pores, causing a sharp drop in filtration flux, extending the production batch time, or even making filtration impossible. Summary of the Invention

[0005] The purpose of this application is to provide a sterilization device and its method for producing lactulose raw materials, which can actively and intelligently combat membrane clogging caused by high viscosity, thereby ensuring the filtration flux of the filter membrane and the production efficiency of the product.

[0006] Firstly, the sterilization apparatus for producing lactulose raw materials provided in this application adopts the following technical solution: A filter chamber, wherein a feed inlet is provided at the upper end of the filter chamber and a discharge outlet is provided at the lower end of the filter chamber; A filtration module is disposed within the filtration chamber. The filtration module is used to filter microorganisms in the liquid flowing in from the feed inlet and can ensure that viscous liquids pass through the filtration module at a normal flow rate.

[0007] Optionally, the filtering module includes: A mounting bracket is disposed within the filter chamber, and a filter membrane for filtering microorganisms in the liquid is disposed on the mounting bracket; A shape memory alloy mesh is mounted on a mounting bracket. The shape memory alloy mesh is located at the upper end of the filter membrane and maintains a preset micro gap with the surface of the filter membrane. A heated vibration assembly is used to instantaneously heat a shape memory alloy mesh and cause the shape memory alloy to vibrate to enhance the fluidity of the liquid.

[0008] Optionally, the shape memory alloy mesh is composed of multiple shape memory alloy wires, which are tensioned and fixed in a low-temperature martensitic state and have a tendency to recover their nonlinear shape when heated to a high-temperature austenitic state, thereby generating mechanical micro-vibrations under constrained conditions.

[0009] Optionally, the heating vibration component is a pulse power controller, which is electrically connected to the shape memory alloy mesh. The pulse power controller is used to apply a pulse current to the shape memory alloy mesh to drive the shape memory alloy mesh to generate heat and mechanical micro-vibration, thereby locally heating and dynamically turbulentizing the liquid near the surface of the filter membrane.

[0010] Optionally, the filter chamber is provided with a monitoring component for monitoring the pressure difference across the filter membrane. The monitoring component is electrically connected to the pulse power controller. The pulse power controller adaptively adjusts the frequency or amplitude of the pulse current according to the pressure difference change monitored by the monitoring component.

[0011] Optionally, the filter membrane is configured as an elastic filter membrane, and each focal point of the shape memory alloy wire in the shape memory alloy grid is provided with a protrusion, the protrusion being in contact with the upper surface of the filter membrane.

[0012] Optionally, the mounting bracket is provided with a detachable connector for easy replacement of the filter membrane.

[0013] Secondly, the present application provides a practical method for using a sterilization device, comprising the following steps: S1: Inject the lactulose raw material solution to be sterilized through the feed port of the filter chamber; S2: Activate the heating vibration component, apply electrical energy to the shape memory alloy mesh, so that it generates mechanical micro-vibration by utilizing the phase change effect under constrained state, and at the same time locally heat the lactulose raw material solution near the surface of the filter membrane; S3: Adjust the electrical energy application parameters of the heating vibration component to synergistically utilize the dynamic turbulence and viscosity reduction effects generated by the mechanical micro-vibration and local heating to actively manage the fluid boundary layer state on the surface of the filter membrane, thereby achieving aseptic filtration of the lactulose raw material solution while ensuring filtration flux. S4: When the filter membrane needs to be replaced, the filter membrane can be replaced individually by operating the detachable connector on the mounting bracket.

[0014] In summary, this application includes at least one of the following beneficial technical effects: 1. This invention fundamentally solves the problems of concentration polarization and gel layer clogging commonly found in traditional filtration of high-viscosity lactulose solutions by introducing shape memory alloy dynamic cleaning technology onto the filter membrane surface. Through the synergistic effect of micro-vibration turbulence generated by the shape memory alloy mesh and precise local heating, the membrane surface can be continuously maintained in a clean and low-viscosity state. This allows for a significantly higher filtration flux and longer operating cycle than existing technologies at lower operating pressures. Simultaneously, precise local heating avoids prolonged high-temperature exposure of the main feed solution, maximizing the protection of lactulose quality stability. This achieves efficient, stable, and aseptic filtration of high-viscosity fluids, significantly improving product quality and production reliability. 2. This invention uses a shape memory alloy mesh with several protrusions to transform the static filter membrane into a dynamic one. This allows the blockages inside the filter membrane pores to be rubbed and expelled from the pores, reducing the probability of filter membrane clogging and improving product quality. More importantly, this vibration enables the filter membrane to self-clean, and the filter membrane remains in self-cleaning mode as long as the equipment is in operation, greatly reducing the number of times the equipment needs to be disassembled and cleaned and reducing the workload of the staff. 3. This invention introduces an upstream and downstream differential pressure monitoring component and links it with a pulse power controller, transforming the filter from a passive separation device into an intelligent device capable of actively sensing its own state and self-regulating. The system can automatically adjust the cleaning intensity (pulse frequency or amplitude) of the shape memory alloy mesh according to the real-time degree of membrane fouling, always keeping the filtration process within the optimal operating range. This closed-loop feedback control not only maximizes filtration efficiency but also avoids premature clogging due to insufficient cleaning intensity or energy waste caused by excessive intensity, greatly enhancing the process's adaptability to viscosity fluctuations of different batches of materials. 4. This invention fundamentally optimizes the cumbersome and high-risk filter replacement process of traditional filters by designing a detachable mounting bracket and integrating the filter membrane with a shape memory alloy mesh into a filter module. Operators can quickly and conveniently replace the core components without opening the heavy stainless steel casing or performing complex internal operations. This not only reduces replacement time from hours to minutes, but more importantly, it eliminates the risks of cross-contamination and installation errors that may be introduced during traditional manual replacement, greatly improving the reliability of aseptic production and GMP compliance. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the overall structure of Embodiment 1 of this application; Figure 2yes Figure 1 A magnified view of part A in the middle; Figure 3 This is an exploded structural diagram of Embodiment 1 of this application; Figure 4 yes Figure 3 A magnified view of part B in the middle section; Figure 5 This is a schematic diagram of the mounting bracket in Embodiment 1 of this application; Figure 6 This is an exploded structural diagram of the mounting bracket in Embodiment 1 of this application; Figure 7 yes Figure 6 A magnified view of part C in the middle; Figure 8 This is a partial structural cross-sectional view of Embodiment 1 of this application; Figure 9 yes Figure 8 A magnified view of part D in the middle; In the diagram, 1. Filter chamber; 11. Inlet; 12. Outlet; 13. Semi-annular groove; 2. Filter module; 21. Mounting bracket; 211. Annular groove; 212. Semi-annular groove; 22. Ring frame; 23. Filter membrane; 24. Shape memory alloy mesh; 231. Protrusion; 3. Heating vibration assembly; 4. Monitoring assembly; 5. Detachable connector; 51. Replacement block; 52. Sealing ring; 53. Buckle. Detailed Implementation

[0016] The following is in conjunction with the appendix Figure 1-7 This application will be described in further detail below. Example 1

[0017] A sterilization apparatus for producing lactulose raw materials, referring to Figure 1-9 It includes a filter chamber 1 and a filter module 2.

[0018] Reference Figure 1 In this embodiment, the filter chamber 1 includes a cylinder and a head. The upper end face of the cylinder is detachably connected to the head by bolts. The head is provided with a feed port 11. A bracket is fixedly connected to the side wall of the cylinder, and a discharge port 12 is provided on the lower end face of the bottom of the cylinder. Pressure gauge interfaces are provided on both the head and the bottom. In this embodiment, both the cylinder and the head are made of 316L stainless steel.

[0019] Reference Figure 1 , Figure 3 , Figure 4 , Figure 5 and Figure 6 In this embodiment, the filter module 2 includes a mounting bracket 21, a shape memory alloy mesh 24, and a heating vibration assembly 3.

[0020] The mounting frame 21 is a ring frame, also made of 316L stainless steel. The mounting frame 21 is coaxially fixedly installed on the inner wall of the filter chamber 1. The filter membrane 23 is coaxially fixedly connected to the mounting frame 21. In this embodiment, the filter membrane 23 is made of polyvinylidene fluoride, which is currently the mainstream 0.22μm sterilization-grade filter membrane on the market. It has excellent mechanical strength and toughness. The shape memory alloy mesh 24 is fixedly installed on the mounting frame 21, and the shape memory alloy mesh 24 is located above the filter membrane 23. A small gap is maintained between the shape memory alloy mesh 24 and the filter membrane 23. In this embodiment, the preferred distance is 1cm. The heating vibration component 3 is located outside the filter chamber 1. The heating vibration component 3 is electrically connected to the shape memory alloy mesh 24 through a wire. In this embodiment, the heating vibration component 3 is used to instantaneously heat the shape memory alloy mesh 24 and cause the shape memory alloy to vibrate.

[0021] When sterilization of lactulose raw material is required, the lactulose raw material solution is continuously poured into the filter chamber 1 through the inlet 11 on the filter chamber 1 by an external feeding device. The lactulose raw material solution will fall under the action of gravity and come into contact with the filter membrane 23 in the filter chamber 1. After the lactulose raw material solution passes through the filter membrane 23, the filter membrane 23 filters out the microorganisms in the lactulose raw material solution. Then the clean lactulose raw material solution falls to the bottom of the filter chamber 1 and is discharged into other containers or filled from the outlet 12 on the bottom of the filter chamber 1.

[0022] However, due to the relatively high viscosity of the lactulose raw material solution, according to the Hagen-Poiseuille law in fluid mechanics, the flow rate (Q) of a liquid through a thin tube (which can be approximated as a membrane pore) is directly proportional to the pressure difference (ΔP), but inversely proportional to the viscosity (μ) of the liquid (Q≈ΔP / μ). This means that when the viscosity (μ) is very high, to maintain an acceptable flow rate (Q), a very large pressure difference (ΔP) must be applied to forcibly push apart these entangled molecules and force them through the membrane pores. That is, as the external feeding device continuously adds lactulose raw material solution into the feed inlet 11, relatively little lactulose raw material solution passes through the filter membrane 23. Therefore, a large amount of lactulose raw material solution accumulates in the filter chamber 1 above the filter membrane 23, causing the pressure in the filter chamber 1 above the filter membrane 23 to increase. Under high pressure, a large amount of liquid (water and lactulose raw material) is pushed towards the membrane surface as a whole. This is a non-selective process. Water and lactulose raw material arrive at the membrane together. The filter membrane 23 allows water molecules (solvent) to pass through the membrane pores relatively easily and flow to the lower side of the filter membrane 23. At the same time, most of the lactulose raw material (solute) cannot pass through the membrane pores due to its size and interaction with the membrane, and is retained on the upper side of the membrane. As the retained lactulose raw material (solute) accumulates in the area near the upper surface of the filter membrane 23, a concentration gradient phenomenon (concentration polarization) is formed from the upper surface of the membrane to the bulk solution (lactulose raw material solution). When the local concentration on the upper surface of the filter membrane 23 exceeds its solubility limit or a certain critical gelation concentration due to concentration polarization, the solute (lactulose raw material) molecules will change from a dissolved state to a semi-solid, highly hydrated, viscous gel state, and rapidly develop into a dense gel layer. This gel layer is the main source of filtration resistance, which will quickly clog the membrane pores and cause a sharp drop in filtration flux.

[0023] Therefore, when the external feeding device begins to pour the lactulose raw material solution into the filter chamber 1 through the inlet 11, the heating vibration component 3 can be activated simultaneously. The heating vibration component 3 can instantly heat the shape memory alloy mesh 24 and cause it to vibrate. Firstly, the distance between the shape memory alloy mesh 24 and the upper surface of the filter membrane 23 is very close. When the shape memory alloy mesh 24 vibrates, it generates strong local turbulence and shear waves. This energy, like countless micro-stirring paddles, continuously agitates and refreshes the lactulose raw material solution on the upper surface of the filter membrane 23. The forced convection generated by the vibration greatly enhances… Mass transfer forcibly rolls up the high-concentration lactulose raw material molecules enriched on the membrane surface and remixes them into the lactulose raw material bulk solution with a faster flow rate and relatively lower concentration. This prevents the solute from accumulating to a dangerous concentration on the membrane surface. Even if a small amount of gelation begins to occur, the physical vibration of the shape memory alloy mesh 24 can break and peel off the lactulose raw material molecules through mechanical force before they are tightly adhered to the filter membrane 23, preventing them from forming a continuous and dense coating layer. Therefore, the solute (lactulose raw material) molecules cannot condense into a gel layer, which greatly reduces the probability of the filter membrane 23 pores being blocked.Furthermore, since the viscosity of liquids is extremely sensitive to temperature, especially solutions like syrups, a slight increase in temperature weakens the intermolecular binding forces and intensifies molecular motion, macroscopically manifesting as an exponential decrease in viscosity. Therefore, when the heating vibration component 3 instantaneously heats the shape memory alloy mesh 24, because the shape memory alloy mesh 24 is close to the upper surface of the filter membrane 23, it only heats the most important boundary layer fluid, the one with the highest viscosity, which is about to pass through the membrane pores. This makes it thinner and more fluid at the moment of passing through the membrane pores. According to the above formula, when the viscosity (μ) is significantly reduced by heating, the required driving pressure (ΔP) can be greatly reduced while maintaining the same flow rate (Q). The reduced driving pressure means that the force pushing the solute (lactulose raw material molecules) towards the upper surface of the filter membrane 23 is weakened, thus slowing down the movement of the solute (lactulose raw material molecules) on the upper surface of the filter membrane 23 from the source. The increased stacking speed allows more time and space for vibration to take effect. Therefore, in summary, the interaction between the vibration of the shape memory alloy mesh 24 and the heat emitted by it ensures that the upper surface of the filter membrane 23 remains clean and the solution concentration is relatively low. This prevents the formation of a gel layer on the upper surface of the filter membrane 23, thus maintaining a stable filtration flux and ensuring the production effect of lactulose raw materials. Simultaneously, the pressure difference between the filter chamber 1 above and below the filter membrane 23 remains relatively low, meaning that the space in the filter chamber 1 above the filter membrane 23 does not require excessive pressure. Therefore, the feeding assembly does not need to consume excessive energy to increase the pressure inside the filter chamber 1. Furthermore, the reduced pressure in the filter chamber 1 also lowers the pressure on the walls and internal components, thereby reducing the probability of equipment damage and increasing the equipment's service life.

[0024] There are generally three methods in the prior art for solving the problem of viscous liquid clogging the filter membrane 23. The first is to increase the pump pressure to force the liquid through the clogged membrane. The second is to briefly stop forward filtration and use clean liquid to back-impact the filter membrane 23 from the filtrate side to try to wash away the contaminant layer on the membrane surface. The third is to shut down the entire filtration system and use a specific chemical cleaning agent (circulating for several hours to dissolve or degrade the clogging material) when physical methods are ineffective. All of these prior art methods address the problem after it occurs, and then try to solve it through other means. In contrast, the method in this embodiment is preventative, meaning that before the filter membrane 23 becomes clogged, the shape memory alloy mesh 24 vibrates and dissipates heat, preventing the formation of a gel layer on the upper surface of the filter membrane 23, thus avoiding clogging. Furthermore, compared to the methods in the prior art, the solution in this embodiment does not require shutdown, which greatly improves production efficiency. At the same time, the solution in this embodiment does not cause excessive damage to the filter membrane 23, greatly increasing its service life and reducing equipment operating costs.

[0025] In this embodiment, the shape memory alloy mesh 24 is composed of multiple shape memory alloy wires. The shape memory alloy wires are made of nickel-titanium alloy with a phase transformation point of 60-65℃. In this embodiment, the shape memory alloy wires are wavy in the high-temperature austenitic state. During assembly, the shape memory alloy wires in the low-temperature martensitic state are slightly straightened and fixed on the mounting bracket 21. In this embodiment, the diameter of the shape memory alloy wires is set to 100 micrometers.

[0026] In this embodiment, the heating vibration component 3 is a pulse power controller and an external power supply system electrically connected to the pulse power controller. The pulse power controller is installed on the outer wall of the filter chamber 1 and is electrically connected to the shape memory alloy mesh 24 through a wire. A hole is opened on the outer wall of the filter chamber 1 for the power supply wire to pass through. When the wire passes through the hole, the hole is sealed. The pulse power controller can provide periodic power supply.

[0027] When the pulse power controller is in the pulse period, it is in the on state. Current flows through the pulse power controller and reaches the shape memory alloy wire. The shape memory alloy wire itself can be regarded as a resistor. Therefore, the temperature of the shape memory alloy wire begins to rise after the current passes through it. When the temperature of the shape memory alloy wire rises instantaneously above the phase transformation point, its internal crystal structure will rapidly transform from martensite to austenite. After the shape memory alloy wire becomes austenite, it will desperately try to recover its memorized wavy shape. However, because its two ends are fixed, it cannot complete the macroscopic contraction. This strong, unreleased internal recovery stress will... The entire wire is excited to generate high-frequency transverse micro-vibrations. When the pulse power controller is in the intermittent period, the current is interrupted, the shape memory alloy wire quickly dissipates heat and cools down, reverses back to the martensitic state, the stress disappears, the vibration stops, and it prepares for the next excitation. Therefore, as the pulse power controller changes continuously between the pulse period and the intermittent period, the shape memory alloy wire continuously vibrates, causing the lactulose raw material molecules on the upper surface of the filter membrane 23 to form a gel layer. By adjusting the amplitude (current / voltage magnitude) and frequency of the pulse, we can precisely control the heat and vibration intensity generated by the shape memory alloy wire, just like adjusting the volume and pitch of an audio device.

[0028] It should be noted that lactulose raw material molecules undergo significant degradation when continuously heated above 70-75°C. Short-duration heating within the 55-70°C range (on the order of minutes) is acceptable for industrial production, meaning that lactulose raw material molecules will not undergo significant degradation. In this embodiment, by adjusting the pulse amplitude (current / voltage magnitude) and frequency, the temperature of the shape memory alloy wire can be controlled to only rise to 60-65°C. This temperature is precisely the phase transition point of the shape memory alloy wire and does not exceed the degradation temperature of the lactulose raw material molecules. Therefore, there is no need to worry about high temperatures causing chemical changes in the lactulose raw material. Furthermore, the diameter of the shape memory alloy wire in this embodiment is set to 100 micrometers. The mass and volume of a single wire are extremely small, therefore its heat capacity is also very small. According to the formula Q = ... The amount of heat (Q) required to heat an object with a very small heat capacity (mc) to a specified temperature rise (ΔT) is very small. Due to its small heat capacity, even a small current can cause the temperature of the shape memory alloy wire to rise rapidly within milliseconds (ms). Similarly, because the surface area to volume ratio of the shape memory alloy wire is extremely large, when the current is interrupted, it can also dissipate heat rapidly within milliseconds through contact with the surrounding flowing lactulose raw material solution, thus achieving instantaneous temperature change of the shape memory alloy wire and enabling high-frequency vibration of the shape memory alloy wire. Furthermore, the instantaneous temperature change prevents the shape memory alloy wire from continuously heating the lactulose raw material solution, further reducing the probability of degradation of lactulose raw material molecules.

[0029] In this embodiment, the filter chamber 1 is equipped with a monitoring component 4 for monitoring the pressure difference between the upstream and downstream of the filter membrane 23. The monitoring component 4 in this embodiment consists of two pressure gauges, which correspond one-to-one with the pressure gauge interfaces at the end cap and the bottom. The pressure gauges are installed at the pressure gauge interfaces. The pressure gauge at the end cap monitors the pressure upstream of the filter membrane 23, and the pressure gauge at the bottom monitors the pressure downstream of the filter membrane 23. The equipment in this embodiment is equipped with a control center, which is a PLC. The two pressure gauges, the pulse power controller, the external power supply system, etc. are all electrically connected to the control center.

[0030] Two pressure gauges continuously monitor the pressure upstream and downstream of the filter membrane 23 and transmit the pressure values ​​to the control center. The control center analyzes the pressure difference between the upstream and downstream of the filter membrane 23 (i.e., pressure difference), and then adjusts the pulse amplitude (current / voltage magnitude) and frequency at any time based on the difference, thereby changing the vibration frequency and temperature of the shape memory alloy wire, thus achieving precise energy control as a whole and greatly reducing the average energy consumption of the equipment.

[0031] Reference Figure 5 , Figure 6 , Figure 7 and Figure 8 In this embodiment, the shape memory alloy mesh 24 is formed by interlacing multiple shape memory alloy wires. Each connection point of the shape memory alloy wires is provided with a protrusion 231. In this embodiment, the protrusion 231 is hemispherical, and all protrusions 231 are located on the lower end face of the shape memory alloy mesh 24. All protrusions 231 abut against the filter membrane 23. All protrusions 231 in this embodiment are made of polycarbonate, which has good electrical insulation, thermal insulation, shock resistance, and a smooth surface. Therefore, electricity and heat on the shape memory alloy mesh 24 cannot be transferred to the filter membrane 23 through the protrusions 231 (in conjunction with...). Figure 9 ).

[0032] When the shape memory alloy wire is vibrating, it drives all the protrusions 231 on the shape memory alloy mesh 24 to vibrate. During the vibration, the protrusions 231 periodically squeeze the filter membrane 23. When the filter membrane 23 is squeezed by the protrusions 231, the membrane surface undergoes dynamic deformation. When the filter membrane 23 is not squeezed, due to the elasticity of the filter membrane 23 itself, the filter membrane 23 will return to its previous state. Therefore, the entire filter membrane 23 is always in a state of dynamic deformation. This state will produce a mechanical squeezing and kneading effect on the particles blocking the membrane pore inlet, helping them to detach or pass through. This greatly reduces the probability of membrane pore blockage, thereby further improving the production efficiency of the equipment and ensuring the normal operation of the equipment.

[0033] In this embodiment, the mounting bracket 21 is provided with a detachable connector 5 for easy replacement of the filter membrane 23.

[0034] Reference Figure 3 , Figure 4 and Figure 9 In this embodiment, a semi-annular replacement block 51 is fitted into the outer wall of the filter chamber 1. A buckle 53 is provided between the replacement block 51 and the outer wall of the filter chamber 1. The buckle 53 is prior art and will not be described in detail here. When the buckle 53 is opened and the replacement block 51 is removed, half of the outer peripheral wall of the mounting bracket 21 is exposed. An annular groove 211 is provided on the inner wall of the mounting bracket 21. A ring frame 22 is placed in the annular groove 211, and the filter membrane 23 is coaxially fixed on the ring frame 22. A semi-annular groove 212 communicating with the annular groove 211 is provided on the exposed peripheral wall of the mounting bracket 21. The ring frame 22 can pass through the semi-annular groove 212 and then be inserted into the annular groove 211. After the ring frame 22 is inserted into the annular groove 211, the replacement block 51 is embedded into the outer wall of the filter chamber 1. At this time, the replacement block 51 abuts against the outer peripheral wall of the mounting frame 21 and the outer peripheral wall of the ring frame 22, so that the ring frame 22 cannot move. Then the buckle 53 is closed, so that the replacement block 51 cannot move. Therefore, the operator does not need to disassemble the entire filter chamber 1 to replace the filter membrane 23. The detachable connector 5 in this embodiment allows the filter membrane 23 to be replaced separately and the replacement process is simpler.

[0035] To ensure the airtightness of the filter chamber 1, a sealing ring 52 is also provided between the replacement block 51 and the outer wall of the filter chamber 1 to ensure that the normal pressure can be maintained inside the filter chamber 1 when the equipment is working. Example 2

[0036] A practical method for using a sterilization apparatus, based on a sterilization apparatus for producing lactulose raw material described in Example 1, includes the following steps: S1: Inject the lactulose raw material solution to be sterilized through the feed port 11 of the filter chamber 1; S2: Activate the heating vibration component 3, apply electrical energy to the shape memory alloy mesh 24, so that it generates mechanical micro-vibration by utilizing the phase change effect under constrained state, and at the same time locally heat the lactulose raw material solution near the surface of the filter membrane 23. S3: Adjust the electrical energy application parameters of the heating vibration component 3 to synergistically utilize the dynamic turbulence and viscosity reduction effects generated by the mechanical micro-vibration and local heating to actively manage the fluid boundary layer state on the surface of the filter membrane 23, thereby achieving aseptic filtration of the lactulose raw material solution while ensuring filtration flux. S4: When it is necessary to replace the filter membrane 23, the filter membrane 23 can be replaced individually by operating the detachable connector 5 on the mounting bracket 21.

[0037] The embodiments described in this specific implementation are preferred embodiments of this application and are not intended to limit the scope of protection of this application. Identical components are represented by the same reference numerals. Therefore, all equivalent changes made to the structure, shape, and principle of this application should be covered within the scope of protection of this application.

Claims

1. A sterilization apparatus for producing lactulose raw material, characterized in that, include: The filter chamber (1) has an inlet (11) at the upper end and an outlet (12) at the lower end. The filter module (2) is located inside the filter chamber (1). The filter module (2) is used to filter microorganisms in the liquid flowing in from the feed inlet (11) and can ensure that the viscous liquid passes through the filter module (2) at a normal flow rate.

2. The sterilization apparatus for producing lactulose raw material according to claim 1, characterized in that, The filtering module (2) includes: Mounting bracket (21) is disposed inside the filter chamber (1), and a filter membrane (23) for filtering microorganisms in the liquid is disposed on the mounting bracket (21). A shape memory alloy mesh (24) is disposed on a mounting bracket (21). The shape memory alloy mesh (24) is located at the upper end of the filter membrane (23) and maintains a preset small gap with the surface of the filter membrane (23). A heating vibration assembly (3) is used to instantaneously heat the shape memory alloy mesh (24) and cause the shape memory alloy to vibrate to enhance the fluidity of the liquid.

3. A sterilization apparatus for producing lactulose raw materials according to claim 2, characterized in that, The shape memory alloy mesh (24) is composed of multiple shape memory alloy wires. The shape memory alloy wires are tensioned and fixed in the low-temperature martensitic state and have a tendency to recover nonlinear shape when heated to the high-temperature austenitic state, thereby generating mechanical micro-vibration under the constrained state.

4. A sterilization apparatus for producing lactulose raw materials according to claim 3, characterized in that, The heating vibration component (3) is a pulse power controller. The pulse power controller is electrically connected to the shape memory alloy mesh (24). The pulse power controller is used to apply a pulse current to the shape memory alloy mesh (24) to drive the shape memory alloy mesh (24) to generate heat and mechanical micro-vibration, thereby locally heating and dynamically turbulentizing the liquid near the surface of the filter membrane (23).

5. A sterilization apparatus for producing lactulose raw materials according to claim 4, characterized in that, The filter chamber (1) is provided with a monitoring component (4) for monitoring the pressure difference across the filter membrane (23). The monitoring component (4) is electrically connected to the pulse power controller. The pulse power controller adaptively adjusts the frequency or amplitude of the pulse current according to the pressure difference change monitored by the monitoring component (4).

6. A sterilization apparatus for producing lactulose raw materials according to claim 3, characterized in that, The filter membrane (23) is configured as an elastic filter membrane (23), and each focal point of the shape memory alloy wire in the shape memory alloy mesh (24) is provided with a protrusion (231), and the protrusion (231) is in contact with the upper surface of the filter membrane (23).

7. A sterilization apparatus for producing lactulose raw materials according to claim 2, characterized in that, The mounting bracket (21) is provided with a detachable connector (5) for easy replacement of the filter membrane (23).

8. A practical method for using a sterilization apparatus, based on the sterilization apparatus for producing lactulose raw materials as described in any one of claims 1-7, comprising the following steps: S1: Inject the lactulose raw material solution to be sterilized from the feed port (11) of the filter chamber (1); S2: Start the heating vibration assembly (3), apply electrical energy to the shape memory alloy mesh (24) to generate mechanical micro-vibration by using phase change effect under constrained state, and at the same time locally heat the lactulose raw drug solution near the surface of the filter membrane (23); S3: Adjust the electrical energy application parameters of the heating vibration component (3) to utilize the dynamic turbulence and viscosity reduction effect generated by the mechanical micro-vibration and local heating to actively manage the fluid boundary layer state on the surface of the filter membrane (23), thereby achieving sterile filtration of the lactulose raw material solution while ensuring filtration flux. S4: When it is necessary to replace the filter membrane (23), the filter membrane (23) can be replaced individually by operating the detachable connector (5) on the mounting bracket (21).

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