Eye washing liquid disinfection and sterilization method and liquid preparation system

Abstract

The invention relates to the technical field of medicine manufacturing, in particular to an eye washing liquid disinfection and sterilization method and a liquid preparation system. Comprising the following steps: SS1, presetting and setting a liquid preparation system, dividing the interior of the liquid preparation system into a liquid phase sterilization cavity and a gas phase sterilization cavity, filling purified deionized water in the liquid phase sterilization cavity, heating to 121 + / -0.5 DEG C through an electric heating jacket, maintaining the working pressure of 20psi, introducing saturated steam at 124 DEG C into the gas phase sterilization cavity, controlling the steam flow rate to be 0.3-0.5 m / s, and sterilizing for 2-3 hours; the microcontroller is linked with the temperature probe and the pressure release valve to realize pressure closed-loop regulation and control, the eye wash to be disinfected is filled in the sterilization container, and the filled sterilization container is clamped on the liquid preparation system. The device has the beneficial effects that core sterilization efficiency breakthrough is realized through double-medium alternate sterilization and multi-motion system linkage, and the problem of incomplete sterilization caused by obstruction of an existing single-medium sterilization barrier film and spore dormancy is solved.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical manufacturing technology, specifically to a method for disinfecting and sterilizing eye wash solution and a solution preparation system. Background Technology

[0002] As a care product that comes into direct contact with the mucous membranes of the eyes, the sterility of eye wash directly determines the user's eye health and safety. If bacterial spores, E. coli, or other microorganisms remain in the product, it can easily cause eye infections such as conjunctivitis and keratitis, and may even lead to more serious damage to eye tissues. Therefore, sterilization is an indispensable core step in the production process of eye wash. Currently, the mainstream sterilization technology for eye wash in the industry mainly relies on single-media sterilization schemes, including high-temperature superheated water liquid-phase sterilization and saturated steam gas-phase sterilization. Although these can meet basic sterilization requirements, in actual industrial production, due to limitations in the technical principles, many technical problems still exist, as follows: Existing single-phase liquid and gas-phase sterilization devices form a stable barrier film on the surface of eyewash storage containers, which significantly reduces heat transfer efficiency, resulting in thorough surface sterilization but insufficient internal sterilization. The most difficult microorganism to treat in eyewash sterilization is bacterial spores. The calcium pyridine dicarboxylate protective layer contained in the core of the spores has extremely strong heat resistance and stability. Under a single constant high temperature environment, this protective layer can maintain the dormant state of the spores. The temperature and action mode of existing single-media sterilization technology cannot destroy the protective layer structure, causing the spores to always be in a heat-resistant dormant state. Dormant spores are easy to reactivate and contaminate. Based on this, the present invention provides a method for disinfecting and sterilizing eye wash solution and a solution preparation system to solve the problems mentioned in the background art. Summary of the Invention

[0003] This invention addresses the technical problems existing in the prior art by providing a method for disinfecting and sterilizing eye wash solution and a solution preparation system. This solves the problem that existing single liquid-phase and gas-phase sterilization devices form a stable barrier film on the surface of the eye wash solution storage container, which significantly reduces heat transfer efficiency, resulting in thorough surface sterilization but insufficient internal sterilization.

[0004] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: A method for disinfecting and sterilizing eye wash solution, comprising the following steps: SS1, Preset: Set up the liquid preparation system, which is divided into a liquid phase sterilization chamber and a gas phase sterilization chamber. The liquid phase sterilization chamber is filled with purified deionized water, which is heated to 121℃±0.5℃ by an electric heating jacket and maintained at a working pressure of 20psi. The gas phase sterilization chamber is saturated with 124℃ steam, and the steam flow rate is controlled at 0.3-0.5m / s. The pressure is controlled in a closed loop by linking the temperature probe and the pressure relief valve through a microcontroller. The eyewash solution to be sterilized is filled into the sterilization container, and the filled sterilization container is clamped onto the liquid dispensing system. The tank body and tank cover of the liquid preparation system are opened and closed by an electric actuator, and fluororubber sealing rings are provided on the sealing surfaces of the tank cover and the tank body. SS2, sterilization: A variable amplitude vibration, revolution and rotation mechanism is set in the liquid preparation system to cause the sterilization container to alternately enter the liquid phase sterilization chamber and the gas phase sterilization chamber and generate variable amplitude vibration, revolution and rotation simultaneously. The single residence time of the sterilization container in the liquid phase sterilization chamber and the gas phase sterilization chamber is 90±5s, and the number of cycles is ≥40. During the switching process, the liquid level probe monitors the liquid medium height in real time to ensure that the sterilization container is completely immersed in superheated water or exposed to the steam environment. SS3. After sterilization, restore the tank to normal pressure and temperature, and fully drain the deionized water and saturated steam. Drive the tank lid to open and close via the electric actuator, allowing the sterilization container to leak out of the tank. Then, remove the sterilization containers one by one to complete the unloading operation.

[0005] A liquid dispensing system includes a tank body and a tank cover. Two electric actuators are installed between the tank body and the tank cover. The tank body is divided into a liquid phase sterilization chamber and a gas phase sterilization chamber from bottom to top. A transmission system is provided on the tank body. A reciprocating frame and a rotating orbiting frame are connected to the transmission system. The reciprocating frame is slidably connected to the tank cover. A vibrating support frame is provided below the reciprocating frame. An amplitude-changing vibration drive assembly for driving the vibrating support frame to circulate and change amplitude is provided between the reciprocating frame and the vibrating support frame. A liquid level probe is installed on the vibrating support frame. The orbiting frame is rotatably connected to the vibrating support frame. A rotating shaft is installed on the bottom surface of the orbiting frame. A spiral stirring blade and a stirring blade assembly are installed on the rotating shaft from top to bottom. Six mounting systems are provided on the orbiting frame. The mounting system includes a sterilization container, a swing frame rotatably connected to a rotating frame, a rotating sleeve rotatably mounted on the swing frame, the rotating sleeve being rotatably connected to the rotating frame, a reciprocating spiral tube rotatably mounted on the swing frame, and a torsion spring being provided at the rotatable connection between the two. A threaded connector is rotatably connected to the mouth of the sterilization container, the threaded connector being threadedly connected to the reciprocating spiral tube, and a one-way valve being installed inside the threaded connector. The reciprocating rack is driven by a transmission system, causing the sterilization containers to alternately enter the liquid phase sterilization chamber and the gas phase sterilization chamber. It also includes a drive system, a condenser tank, and an exhaust system connected to the reciprocating spiral tube. The drive system drives the swing frame to reciprocate within ±35° as the orbital frame rotates, and synchronously drives the reciprocating spiral tube to rotate in both directions. A condenser coil is installed inside the condenser tank. The exhaust port of the exhaust system is connected to the condenser coil. The liquid outlet port of the condenser coil is connected to a detection tube, and a laser detection module is installed on the detection tube.

[0006] Based on the above technical solution, the present invention can be further improved as follows.

[0007] As a preferred technical solution of the present invention, it further includes an equipment rack, which is fixedly connected to the tank body. The condenser is fixedly installed on the equipment rack. A microcontroller is installed on the end face of the equipment rack. A pressure relief valve and a pressure gauge are respectively installed on the tank cover. A temperature probe with a measurement and control end extending to the liquid phase sterilization chamber is installed at the bottom of the tank body. An electric heating jacket is provided on the tank body. The electronic control end of the pressure relief valve, the laser detection module, the pressure gauge, the temperature probe, and the liquid level probe are all connected to the microcontroller.

[0008] As a preferred technical solution of the present invention, a drain valve is provided at the bottom of the detection tube, and a wastewater storage tank is provided on the equipment frame at a position directly below the drain valve.

[0009] As a preferred embodiment of the present invention, the transmission system includes a transmission motor mounted on a device frame, a fixed shaft rotatably connected to the device frame, and a movable shaft and a cam shaft rotatably connected to the can lid. The output shaft of the transmission motor is connected to a synchronous toothed belt. The fixed shaft is connected to the synchronous toothed belt. The fixed shaft has a first synchronous groove with an open top and slidably connected to the movable shaft. The cross-sections of the first synchronous groove and the movable shaft are both regular hexagonal. The movable shaft and the cam shaft are each equipped with a first bevel gear. The two first bevel gears mesh orthogonally. An eccentric cam is mounted on the cam shaft. A follower wheel is rotatably mounted on the reciprocating frame. The wheel surface of the eccentric cam rolls in contact with the wheel surface of the follower wheel. A return spring is mounted on the reciprocating frame. The other end of the return spring is fixedly connected to the can lid.

[0010] As a preferred technical solution of the present invention, the transmission system further includes a hexagonal shaft rotatably connected to the bottom of the tank body. The hexagonal shaft is connected to a synchronous toothed belt. The shaft has a second synchronous groove with a bottom opening and slidably connected to the hexagonal shaft. The cross-sections of the second synchronous groove and the hexagonal shaft are both regular hexagons.

[0011] As a preferred embodiment of the present invention, the variable amplitude vibration drive assembly includes a synchronous shaft rotatably connected to the vibration support frame, a vibrating wheel rotatably connected to the reciprocating frame, a reversing shaft, and a differential outer shaft. A differential inner shaft is rotatably mounted on the differential outer shaft. The differential inner shaft has a third synchronous groove with a bottom opening and slidably connected to the synchronous shaft. A second bevel gear is mounted on both the differential inner shaft and the differential outer shaft. A third bevel gear is mounted on the reversing shaft. Both second bevel gears are drive-connected to the third bevel gear. A fourth bevel gear is mounted on both the vibrating wheel and the differential outer shaft. The two fourth bevel gears mesh orthogonally. The vibrating wheel has three alternating transmission tooth segments and three toothless reset areas. A rack plate is mounted on the vibration support frame. The three transmission tooth segments alternately mesh with the rack plate, and the transmission stroke of the three transmission tooth segments to the rack plate is different. Two T-shaped guide rods are mounted on the vibration support frame. Both T-shaped guide rods are slidably connected to the reciprocating frame. A return spring is sleeved on both T-shaped guide rods.

[0012] As a preferred technical solution of the present invention, the cross-sections of the third synchronous groove and the synchronous shaft are both regular hexagonal, the two second bevel gears are respectively disposed on both sides of the third bevel gear, the reciprocating frame is provided with two guide grooves, and guide sliders are installed on the can cover at positions corresponding to the two guide grooves, and the two guide sliders are slidably connected to the two guide grooves respectively.

[0013] As a preferred technical solution of the present invention, the exhaust system includes a one-way exhaust valve installed on the tank cover, airflow channels are provided on both the differential inner shaft and the synchronous shaft, and a cavity communicating with the airflow channels is provided on the revolution frame. The cavity is connected to the one-way exhaust valve through the airflow channels. A flexible hose is connected to the outlet port of the one-way exhaust valve, and the other end of the flexible hose is connected to the condenser coil. A corrugated connecting pipe is rotatably connected to the top of each reciprocating spiral tube, and the other end of the corrugated connecting pipe is connected to the cavity.

[0014] As a preferred technical solution of the present invention, the drive system includes a swing bevel gear mounted on the swing frame, a rotating bevel gear mounted on the sleeve, and a fifth bevel gear mounted on both the sleeve and the reciprocating rotating tube. The two fifth bevel gears mesh orthogonally. The vibration support frame is equipped with four rotating sector gear segments adapted to mesh with the rotating bevel gear, nine forward sector gear segments, and nine reverse sector gear segments. The forward and reverse sector gear segments alternately mesh with the swing bevel gear as the revolution frame rotates. A first reset area is provided on the vibration support frame at the position corresponding to each adjacent rotating sector gear segment. The nine forward and nine reverse sector gear segments are arranged alternately in pairs on the vibration support frame. A second reset area is provided on the vibration support frame at the position corresponding to each forward sector gear segment and the adjacent reverse sector gear segment. The forward and reverse sector gear segments are respectively located on the upper and lower sides of the swing bevel gear.

[0015] The beneficial effects of this invention are: 1. This invention achieves a breakthrough in core sterilization efficiency through dual-media alternating sterilization and multi-motion system linkage, solving the problems of incomplete sterilization caused by barrier membranes and spore dormancy in existing single-media sterilization. First, the liquid-phase sterilization chamber and the gas-phase sterilization chamber are divided by the tank. Driven by the transmission system, the sterilization container is alternately driven into the two chambers by a reciprocating frame. When switching from gas to liquid phase, superheated water uses high shear force to peel off the vapor condensate film on the outer wall of the container and dissolve the solidified liquid film at the bottle mouth. When switching from liquid to gas phase, the steam quickly evaporates the residual superheated water, avoiding the formation of a static liquid film. At the same time, the steam flow penetrates deep into the container's graduation lines, bottle shoulders, and other dead corners, forming a basic membrane-breaking mechanism for alternating media flushing. The variable amplitude vibration drive component, drive system and transmission system form a motion linkage. The variable amplitude vibration breaks the stable membrane structure under the traditional single medium through dynamic impact, which improves the heat transfer efficiency. The ±35° oscillation makes the eye wash liquid periodically shake, eliminating the film accumulation in the depression dead corner. The bidirectional rotation of the reciprocating tube avoids the liquid film following the movement. Combined with the medium disturbance of the spiral stirring blade, it realizes the full-dimensional enhancement of membrane breaking, heat transfer and dead corner coverage. In addition, the difference in heat exchange rate between the two media and the variable amplitude vibration form a harmless temperature micro-fluctuation of 121°C plus ±3°C, which precisely destroys the calcium pyridine dicarboxylate protective layer of bacterial spores, promotes the transformation of dormant spores into reproductive bodies, and improves the spore killing rate.

[0016] 2. This invention achieves real-time control of sterilization quality through exhaust, condensation, laser detection, and electronic control linkage, solving the problems of lagging sterilization detection and batch risk in existing technologies. Existing technologies rely on sampling and testing after sterilization. If microbial residues are found, the entire batch of products must be destroyed, resulting in serious lag and cost waste. This invention constructs a real-time monitoring and dynamic control linkage system to achieve real-time monitoring and detection of the sterilization process. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the overall structure of an equipment rack and tank cover in a liquid preparation system. Figure 2 for Figure 1 A structural diagram from another perspective; Figure 3 for Figure 2 A schematic diagram of the cross-sectional structure; Figure 4 for Figure 3 A magnified schematic diagram of the partial structure at point A in the middle; Figure 5 for Figure 3 A magnified schematic diagram of the local structure at point B; Figure 6 This is a schematic diagram of the cross-sectional structure of the condenser. Figure 7 This is a schematic diagram of the follower wheel and the return spring. Figure 8 This is a structural schematic diagram of the forward transmission sector tooth section and the vibration bearing frame; Figure 9 This is a schematic diagram of a one-way exhaust valve; Figure 10 for Figure 9 A magnified schematic diagram of the structure at point C in the middle; Figure 11 This is a flowchart of the present invention.

[0018] The attached diagram lists the components represented by each number as follows: 1. Tank body; 2. Tank lid; 3. Electric actuator; 4. Liquid phase sterilization chamber; 5. Gas phase sterilization chamber; 6. Reciprocating rack; 7. Revolution rack; 8. Vibration support rack; 9. Liquid level probe; 10. Rotating shaft; 11. Spiral agitator blades; 12. Agitator blade assembly; 13. Sterilization container; 14. Swing rack; 15. Reciprocating rotary tube; 16. Torsion spring; 17. Threaded connector; 18. Sleeve; 19. Condenser; 20. Condenser coil; 21. Detection tube; 22. Laser detection module; 23. Equipment rack; 24. Microcontroller; 25. Temperature probe; 26. Heating clamp 27. Wastewater storage tank; 28. Drive motor; 29. ​​Fixed shaft; 30. Movable shaft; 31. Cam shaft; 32. Eccentric cam; 33. Follower wheel; 34. Return spring; 35. Hexagonal shaft; 36. Synchronous shaft; 37. Vibrating wheel; 38. Differential outer shaft; 39. Differential inner shaft; 40. Drive gear section; 41. Rack plate; 42. T-shaped guide rod; 43. Return spring; 44. One-way exhaust valve; 45. Airflow channel; 46. Corrugated connecting pipe; 47. Rotating sector gear section; 48. Forward sector gear section; 49. Reverse sector gear section; 50. Reversing shaft. Detailed Implementation

[0019] The principles and features of the present invention are described below with reference to the accompanying drawings. The examples given are only for explaining the present invention and are not intended to limit the scope of the present invention.

[0020] The present invention provides the following preferred embodiments. like Figure 1 As shown, a method for disinfecting and sterilizing eye wash includes the following steps: SS1, Preset, set up the liquid preparation system, and divide the liquid preparation system into liquid phase sterilization chamber 4 and gas phase sterilization chamber 5; The liquid phase sterilization chamber 4 is filled with purified deionized water, which is heated to 121°C by the electric heating jacket 26 and maintained at a working pressure of 20psi. The gas phase sterilization chamber 5 is saturated with 124°C steam, and the steam flow rate is controlled at 0.4m / s. The pressure is controlled in a closed loop by linking the temperature probe 25 and the pressure relief valve through the microcontroller 24. The eye wash solution to be sterilized is filled into the sterilization container 13, and the sterilization container 13 is clamped onto the liquid dispensing system. The tank body 1 and the tank cover 2 of the liquid preparation system are opened and closed by electric push rod 3. Fluororubber sealing rings are set on the sealing surfaces of the tank cover 2 and the tank body 1 to ensure that the cavity leakage rate is ≤0.5% / min during the sterilization process. SS2, sterilization: A variable amplitude vibration, revolution and rotation motion mechanism is set in the liquid preparation system to cause the sterilization container 13 to alternately enter the liquid phase sterilization chamber 4 and the gas phase sterilization chamber 5 and generate variable amplitude vibration, revolution and rotation motion simultaneously. The single residence time of the sterilization container 13 in the liquid phase sterilization chamber 4 and the gas phase sterilization chamber 5 is 90s, and the number of cycle switching is ≥40 times. During the switching process, the liquid level probe 9 monitors the liquid medium height in real time to ensure that the sterilization container 13 is completely immersed in superheated water or exposed to the steam environment. SS3. After sterilization, restore the pressure and temperature inside the tank 1 to normal and fully drain the deionized water and saturated steam. Drive the tank lid 2 to open and close via the electric push rod 3, allowing the sterilization container 13 to leak out of the tank 1. Then, remove the sterilization containers 13 one by one to complete the unloading operation.

[0021] like Figure 1-10 As shown, a liquid dispensing system includes a tank body 1 and a tank cover 2, with two electric actuators 3 installed between the tank body 1 and the tank cover 2; A sealing ring is installed on the lower surface of the can lid 2, and a sealing ring groove that matches the sealing ring is opened on the top surface of the can body 1. The interior of tank 1 is divided into a liquid phase sterilization chamber 4 and a gas phase sterilization chamber 5 from bottom to top; It also includes an equipment rack 23, which is fixedly connected to the tank body 1; The condenser 19 is fixedly installed on the equipment rack 23. A microcontroller 24 is installed on the end face of the equipment rack 23. A pressure relief valve and a pressure gauge are installed on the tank cover 2. A temperature probe 25 with its control end extending to the liquid phase sterilization chamber 4 is installed at the bottom of the tank body 1. An electric heating jacket 26 is provided on the tank body 1. The electric control end of the pressure relief valve, the laser detection module 22, the pressure gauge, the temperature probe 25 and the data end of the liquid level probe 9 are all connected to the microcontroller 24. The electric heating jacket 26 adopts a PID temperature control module, and the microcontroller 24 adjusts the heating power according to the feedback signal of the temperature probe 25, with a temperature control accuracy of ±0.5℃; In a preferred embodiment, during sterilization, the liquid phase sterilization chamber 4 is filled with deionized water, and the filling height of the deionized water is flush with the height of the liquid phase sterilization chamber 4. The microcontroller 24 maintains the temperature of the deionized water in the tank 1 at 121°C through the linkage control of the electric heating jacket 26 and the pressure relief valve, maintains the saturated steam in the gas phase sterilization chamber 5 at 124°C, and maintains the pressure in the inner cavity of the tank 1 at 20 psi. The microcontroller 24 can receive data from the temperature probe 25, pressure gauge and liquid level probe 9 in real time, and maintain the superheated water temperature by controlling the heating power of the electric heating jacket 26 through linkage. At the same time, it adjusts the opening and closing degree of the pressure relief valve to balance the pressure in the tank 1, and ensures that the medium parameters of the liquid phase sterilization chamber 4 and the gas phase sterilization chamber 5 are accurately matched. This solution enables independent temperature and pressure control of superheated water and saturated steam, providing a stable medium environment for the sterilization container 13 to alternately enter the two layers, thus avoiding incomplete sterilization caused by temperature and pressure fluctuations. The tank body 1 is equipped with a transmission system, and the transmission system is connected to a reciprocating frame 6 and a rotating orbital frame 7. The reciprocating frame 6 is slidably connected to the tank cover 2. Two guide grooves are provided on the reciprocating frame 6. Guide sliders are installed on the can cover 2 at positions corresponding to the two guide grooves. The two guide sliders are slidably connected to the two guide grooves respectively. Below the reciprocating frame 6 is a vibrating support frame 8. Between the reciprocating frame 6 and the vibrating support frame 8 is an amplitude-changing vibration drive assembly that drives the vibrating support frame 8 to circulate and change amplitude. A liquid level probe 9 is installed on the vibrating support frame 8. The orbital frame 7 is rotatably connected to the vibrating support frame 8. A rotating shaft 10 is installed on the bottom surface of the orbital frame 7. A spiral stirring blade 11 and a stirring blade assembly 12 are installed on the rotating shaft 10 from top to bottom. Six mounting systems are provided on the orbital frame 7. The mounting system includes a sterilization container 13 and a swing frame 14 rotatably connected to a rotating frame 7. A rotating sleeve 18 is rotatably fitted on the swing frame 14 and is rotatably connected to the rotating frame 7. A reciprocating spiral tube 15 is rotatably mounted on the swing frame 14, and a torsion spring 16 is provided at the rotatable connection between the two. A threaded connector 17 is rotatably connected to the mouth of the sterilization container 13. The threaded connector 17 is threadedly connected to the reciprocating spiral tube 15, and a one-way valve is installed inside the threaded connector 17. The reciprocating rack 6 is driven by a transmission system, causing the sterilization container 13 to alternately enter the liquid phase sterilization chamber 4 and the gas phase sterilization chamber 5; In a preferred embodiment, the sterilization container 13 is made of 304 stainless steel, the height of the sterilization container 13 is 15cm, and the capacity of the sterilization container 13 is 2L. The height of both the liquid phase sterilization chamber 4 and the gas phase sterilization chamber 5 is 40cm. The 304 stainless steel sterilization container 13 is sealed to the reciprocating spiral tube 15 via the bottle mouth threaded connector 17. The internal one-way valve can prevent the sterilization medium from flowing back into the sterilization container 13 and contaminating the eye wash solution. The 15cm height design ensures that when the container alternately enters the liquid phase, the superheated water can fully wrap the sterilization container 13. The 2L capacity is suitable for the single processing volume requirements of common eye wash batch production. The 304 stainless steel material is resistant to high temperature of 121℃ and steam corrosion, which can avoid the problem of impurity leaching after long-term sterilization of traditional materials and extend the service life of sterilization container 13. The combination of threaded seal and check valve ensures the airtightness of the sterilization process and prevents external contamination. The matching of 15cm height and 2L capacity not only takes into account the efficiency of mass production, but also ensures that the dual media can fully act on the inside and outside of the sterilization container 13, eliminating the heat transfer dead zone caused by improper size of the sterilization container 13, and providing a structural basis for subsequent barrier membrane breaking and efficient sterilization. The transmission system includes a drive motor 28 mounted on the equipment frame 23, a fixed shaft 29 rotatably connected to the equipment frame 23, and a movable shaft 30 and a convex shaft 31 rotatably connected to the can cover 2. The output shaft end of the drive motor 28 is connected to a synchronous toothed belt. The fixed shaft 29 is connected to the synchronous toothed belt. The fixed shaft 29 has a first synchronous groove with an opening at the top and is slidably connected to the movable shaft 30. The cross-sections of the first synchronous groove and the movable shaft 30 are both regular hexagonal. Both the movable shaft 30 and the cam shaft 31 are equipped with first bevel gears, and the two first bevel gears mesh orthogonally. An eccentric cam 32 is installed on the cam shaft 31, and a follower wheel 33 is rotatably installed on the reciprocating frame 6. The wheel surface of the eccentric cam 32 and the wheel surface of the follower wheel 33 are in rolling contact. A return spring 34 is installed on the reciprocating frame 6, and the other end of the return spring 34 is fixedly connected to the can cover 2.

[0022] The drive motor 28 drives the fixed shaft 29 to rotate via a synchronous toothed belt. The first synchronous groove of the regular hexagon drives the movable shaft 30 to rotate synchronously. The first bevel gear on the movable shaft 30 meshes and drives the cam shaft 31 to rotate. The eccentric cam 32 of the cam shaft 31 pushes the reciprocating frame 6 to slide up and down along the guide slider of the can lid 2 via the follower wheel 33. The reset spring 34 assists the reciprocating frame 6 to return smoothly to its original position. Finally, the reciprocating frame 6 drives the sterilization container 13 to circulate up and down, alternately entering the liquid phase sterilization chamber 4 and the gas phase sterilization chamber 5. Traditional sterilization equipment often relies on a single medium to form a persistent barrier film, including a static liquid film in the liquid phase and a condensate film in the gas phase. This barrier film hinders heat transfer to the core of the eyewash solution, resulting in incomplete surface sterilization but insufficient internal sterilization. The circulating lifting mechanism, through medium switching and physical flushing, forms a closed-loop mechanism to break down the barrier film. When switching from gas phase to liquid phase, the 121°C superheated water in the liquid phase sterilization chamber 4 directly washes the outer wall of the container, using the high shear force of the liquid to peel off the continuous barrier film of the vapor condensate attached in the gas phase stage, while dissolving the solidified liquid film remaining at the container opening. When switching from liquid to gas phase, the saturated steam in the gas phase sterilization chamber 5 quickly evaporates the superheated water remaining on the outer wall of the sterilization container 13, avoiding the formation of a new static liquid film. At the same time, the flow characteristics of the steam can penetrate deep into the dead corners such as the scale lines and the shoulder of the sterilization container 13, washing away the concave film that is difficult to reach by traditional equipment.

[0023] This cyclical effect directly shortens the core heating time of the eye wash solution; The heat transfer characteristics of the liquid phase and the gas phase are naturally complementary. The liquid phase has a high heat transfer coefficient, while the gas phase has strong latent heat penetration. Bacterial spores are most heat-resistant at constant high temperatures, while temperature fluctuations can destroy their core protective layer of calcium pyridine dicarboxylate. The cyclical rise and fall utilizes the difference in heat exchange rates between the two media to form harmless micro-fluctuations. Unlike traditional intermittent sterilization equipment, this fluctuation does not require cooling to room temperature, but directly activates dormant spores in a high-temperature environment, transforming them into easily killed vegetative cells, ultimately increasing the spore kill rate. In a preferred embodiment, the residence time of sterilization container 13 in both liquid phase sterilization chamber 4 and gas phase sterilization chamber 5 is 90s in one cycle. The transmission system also includes a hexagonal shaft 35 rotatably connected to the bottom of the tank 1. The hexagonal shaft 35 is connected to the synchronous toothed belt drive. The shaft 10 has a second synchronous groove with a bottom opening and sliding connection with the hexagonal shaft 35. The cross-sections of the second synchronous groove and the hexagonal shaft 35 are both regular hexagonal. Synchronous toothed belt synchronously drives the hexagonal shaft 35 at the bottom of the tank 1 to rotate. The regular hexagonal second synchronous groove drives the rotating shaft 10 to rotate. The spiral stirring blade 11 and stirring blade assembly 12 on the rotating shaft 10 rotate with the rotating shaft 10. At the same time, the revolution frame 7 moves with the vibration bearing frame 8 to achieve revolution, ultimately forming a variable amplitude vibration of revolution and rotation, revolution and rotation motion. The hexagonal structure of the hexagonal shaft 35 and the second synchronous groove allows the rotating shaft 10 to rise and fall with the reciprocating frame 6 while transmitting rotational power, thus achieving motion coordination between lifting and rotation. The rotation of the spiral stirring blade 11 and the stirring blade assembly 12 can disturb the liquid and gaseous media around the sterilization container 13, break the static media layer, improve the heat transfer efficiency, and, in conjunction with the revolution motion, make multiple sterilization containers 13 evenly contact the dual media, avoiding uneven local media temperature. The variable amplitude vibration drive assembly includes a synchronous shaft 36 rotatably connected to the vibration support frame 8, a vibrating wheel 37 rotatably connected to the reciprocating frame 6, a reversing shaft 50, and a differential outer shaft 38. A differential inner shaft 39 is rotatably mounted on the differential outer shaft 38. The differential inner shaft 39 has a third synchronous groove with a bottom opening and is slidably connected to the synchronous shaft 36. The cross-sections of the third synchronous groove and the synchronous shaft 36 are both regular hexagonal. A second bevel gear is installed on both the inner differential shaft 39 and the outer differential shaft 38, and a third bevel gear is installed on the reversing shaft 50. Both second bevel gears are connected to the third bevel gear in a transmission manner, and the two second bevel gears are respectively located on both sides of the third bevel gear. Both the vibrating wheel 37 and the differential outer shaft 38 are equipped with fourth bevel gears. The two fourth bevel gears mesh orthogonally. The vibrating wheel 37 is alternately provided with three transmission tooth segments 40 and three toothless reset areas. The vibrating support frame 8 is equipped with a rack plate 41. The three transmission tooth segments 40 alternately mesh with the rack plate 41, and the transmission stroke of the three transmission tooth segments 40 to the rack plate 41 is different. The vibrating support frame 8 is equipped with two T-shaped guide rods 42. Both T-shaped guide rods 42 are slidably connected to the reciprocating frame 6. Both T-shaped guide rods 42 are fitted with return springs 43. In a preferred embodiment, the central angles corresponding to the three transmission tooth segments 40 are 20°, 30° and 40° respectively, and the central angles corresponding to the three toothless reset areas are all 90°. The transmission strokes of the three transmission tooth segments 40 to the rack plate 41 are 1cm, 1.5cm and 2cm respectively; Synchronous shaft 36 drives differential inner shaft 39 to rotate through hexagonal third synchronous groove. Differential inner shaft 39 and differential outer shaft 38 mesh together to drive reversing shaft 50. Differential outer shaft 38 drives vibrating wheel 37 to rotate through fourth bevel gear. The transmission tooth segments 40 with center angles of 20°, 30° and 40° on vibrating wheel 37 alternately mesh with rack plate 41. Together with T-shaped guide rod 42 and return spring 43, they drive vibration bearing frame 8 to generate cyclic amplitude vibration with different strokes of 1cm, 1.5cm and 2cm. Amplitude vibration creates a dynamic relative interaction between the liquid and the bottle wall, using shear force and impact turbulence to break the static liquid film of the cooking liquid and the barrier film of steam condensate on the surface of the container, thereby improving the barrier film breaking rate. At the same time, the vibrations of different strokes cause slight temperature fluctuations in the eyewash solution inside the bottle, which can activate dormant spores to transform into easily killable vegetative cells, thus increasing the spore killing rate. It also includes a drive system, a condenser tank 19, and an exhaust system connected to the reciprocating spiral tube 15. The drive system drives the swing frame 14 to reciprocate within ±35° as the revolution frame 7 rotates, and synchronously drives the reciprocating spiral tube 15 to rotate in both directions. A condenser coil 20 is installed inside the condenser tank 19. The exhaust port of the exhaust system is connected to the condenser coil 20. The liquid outlet port of the condenser coil 20 is connected to a detection tube 21. A laser detection module 22 is installed on the detection tube 21. A drain valve is provided at the bottom of the detection tube 21. A wastewater storage tank 27 is provided on the equipment frame 23 and at the position directly below the drain valve.

[0024] The condenser coil 20 condenses the steam discharged from the exhaust system into liquid, which flows into the detection tube 21 and is then detected by the laser detection module 22 for microbial residue, thereby monitoring the sterilization progress in real time. After the test is completed, open the drain valve at the bottom of the test tube 21 to discharge the bacteria-containing wastewater into the wastewater storage tank 27 below for centralized treatment. The laser detection module 22 enables real-time quality monitoring of the sterilization process, avoiding the lag of traditional post-sterilization sampling and testing, and can promptly detect sterilization failures, reducing the risk of batch contamination. The combination of the drain valve and the wastewater storage tank 27 realizes the closed-loop treatment of unqualified wastewater, prevents environmental pollution, and indirectly reflects the sterility status of the sterilization environment inside the tank through condensate detection, forming a full-process control of sterilization, detection and drain, and improving the overall sterility assurance level. The laser detection module 22 has a built-in semiconductor laser emitter. The stable parallel laser output through the straight lens penetrates the sample. Microorganisms deflect the laser due to Mie scattering, and a small amount is absorbed at the same time. The scattered light and transmitted light detectors on both sides of the detection tube 21 convert the light signal into a current signal, which is then amplified, filtered, and transmitted to the signal processing unit. The signal processing unit calculates the number of colonies per unit volume by the number of scattered light pulses, and compares it with the preset threshold after light intensity correction. If it passes the threshold, it operates normally; if it fails the threshold, it sends a signal to the microcontroller 24 to trigger an alarm and adjust the sterilization parameters, while recording the data. The exhaust system includes a one-way exhaust valve 44 installed on the tank cover 2, air guide channels 45 are provided on the differential inner shaft 39 and the synchronous shaft 36, and a cavity is provided on the orbital frame 7 that communicates with the air guide channels 45. The cavity is connected to the one-way exhaust valve 44 through the air guide channels 45. The outlet port of the one-way exhaust valve 44 is connected to a hose, and the other end of the hose is connected to the condenser coil 20. The top end of each reciprocating rotary tube 15 is rotatably connected to a corrugated connecting pipe 46, and the other end of the corrugated connecting pipe 46 is connected to the cavity.

[0025] Excess steam and gas in the sterilization container 13 enter the cavity of the rotating frame 7 through the corrugated connecting pipe 46 at the top of the reciprocating spiral tube 15. They are then gathered in the airflow channel 45 of the synchronous shaft 36 and the differential inner shaft 39 to the one-way exhaust valve 44. The one-way exhaust valve 44 controls the gas to be discharged in one direction to the hose, and finally enters the condenser coil 20 for condensation. The corrugated connecting pipe 46 can adapt to the movement deviation of the orbital frame 7 and the reciprocating spiral pipe 15, ensuring that the airflow channel is always unobstructed and avoiding the breakage or leakage of traditional rigid pipes due to movement. One-way exhaust valve 44 prevents outside air from flowing back in; The integrated design of the airflow channel 45 integrates the exhaust system with the moving structure, without taking up extra space inside the tank, ensuring that multiple sterilization containers 13 are arranged in an orderly manner, improving the space utilization of the equipment, and at the same time ensuring the sealing and stability of the dual-media sterilization environment. The drive system includes a swing bevel gear mounted on the swing frame 14, a rotating bevel gear mounted on the sleeve 18, and a fifth bevel gear mounted on both the sleeve 18 and the reciprocating tube 15. The two fifth bevel gears mesh orthogonally. The vibration support frame 8 is equipped with four rotating sector gear segments 47 that mesh with the rotating bevel gear, nine forward sector gear segments 48, and nine reverse sector gear segments 49. The forward sector gear segments 48 and reverse sector gear segments 49 alternately mesh with the swing bevel gear as the revolution frame 7 rotates. A first reset area is provided on the vibration support frame 8 at the position corresponding to each adjacent rotating sector gear segment 47. The nine forward sector gear segments 48 and nine reverse sector gear segments 49 are arranged alternately in pairs on the vibration support frame 8. A second reset area is provided on the vibration support frame 8 at the position corresponding to each forward sector gear segment 48 and the adjacent reverse sector gear segment 49. The forward sector gear segments 48 and reverse sector gear segments 49 are respectively located on the upper and lower sides of the swing bevel gear.

[0026] Specifically, the forward transmission sector gear segment 48 is located above the oscillating bevel gear, and the reverse transmission sector gear segment 49 is located below it; When the orbital frame 7 rotates, the swing bevel gear on the swing frame 14 alternately meshes with the forward transmission sector gear section 48 and the reverse transmission sector gear section 49 of the vibration bearing frame 8, driving the swing frame 14 to swing back and forth within ±35°. At the same time, the rotating bevel gear on the rotating sleeve 18 meshes with the rotating sector gear section 47, driving the reciprocating rotating tube 15 to rotate in both directions. After the auxiliary bevel gears of the first reset area and the second reset area disengage, they reset. The ±35° reciprocating oscillation causes the sterilization container 13 to sway obliquely, and the contact position between the liquid and the bottle wall changes periodically. This can impact the dead corners such as the bottle shoulder and graduation lines to accumulate film. Combined with the rotation of the reciprocating rotary tube 15, it forms a two-degree-of-freedom amplitude vibration of oscillation and rotation, revolution and rotation, to achieve 360° omnidirectional coverage without dead corners and avoid the liquid film following the movement caused by a single rotation. The alternating arrangement of forward-transmission sector tooth section 48 and reverse-transmission sector tooth section 49 matches the motion rhythm with the alternating cycle of the two media, further enhancing the membrane breaking mechanism of flushing and evaporation.

[0027] Traditional unidirectional rotation can easily cause the barrier membrane to follow the movement. The barrier membrane rotates synchronously with the sterilization container 13 without falling off. Reciprocating rotation achieves precise breaking through alternating directions and instantaneous shearing. Traditional unidirectional rotation can only form a unidirectional vortex, and uneven heating of the liquid can easily produce local low temperature zones, leading to false sterilization. Reciprocating rotation improves thermal uniformity through bidirectional vortex mixing. Reciprocating rotation not only acts on the liquid, but also assists in the discharge of residual air in the container and the verification of the seal integrity, forming a synergistic function of sterilization and detection.

[0028] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A method for disinfecting and sterilizing eyewash solution, characterized in that, Includes the following steps: SS1, Preset, set up the liquid preparation system, and divide the liquid preparation system into a liquid phase sterilization chamber (4) and a gas phase sterilization chamber (5). The liquid phase sterilization chamber (4) is filled with purified deionized water, which is heated to 121℃±0.5℃ by the electric heating jacket (26) and maintained at a working pressure of 20psi. The gas phase sterilization chamber (5) is filled with 124℃ saturated steam, and the steam flow rate is controlled at 0.3-0.5m / s. The pressure is controlled in a closed loop by linking the temperature probe (25) and the pressure relief valve through the microcontroller (24). The eye wash solution to be sterilized is filled into the sterilization container (13), and the sterilization container (13) after filling is clamped onto the liquid preparation system. The tank body (1) and the tank cover (2) of the liquid preparation system are driven to open and close by an electric push rod (3), and a fluororubber sealing ring is provided on the sealing surface of the tank cover (2) and the tank body (1); SS2, sterilization: A variable amplitude vibration, revolution and rotation mechanism is set in the liquid preparation system to cause the sterilization container (13) to alternately enter the liquid phase sterilization chamber (4) and the gas phase sterilization chamber (5) and generate variable amplitude vibration, revolution and rotation simultaneously. The single stay time of the sterilization container (13) in the liquid phase sterilization chamber (4) and the gas phase sterilization chamber (5) is 90±5s, and the number of cycles is ≥40. During the switching process, the liquid phase medium height is monitored in real time by the liquid level probe (9) to ensure that the sterilization container (13) is completely immersed in superheated water or exposed to steam environment. SS3. After sterilization, restore the pressure and temperature inside the tank (1) to normal and fully drain the deionized water and saturated steam. Drive the tank cover (2) to open and close through the electric push rod (3) so that the sterilization container (13) leaks out of the tank (1). Then, remove the sterilization container (13) in sequence to complete the unloading operation.

2. A solution preparation system, characterized in that, The tank includes a tank body (1) and a tank cover (2). Two electric actuators (3) are installed between the tank body (1) and the tank cover (2). The tank body (1) is divided into a liquid phase sterilization chamber (4) and a gas phase sterilization chamber (5) from bottom to top. A transmission system is provided on the tank body (1). A reciprocating frame (6) and a rotating orbital frame (7) are connected to the transmission system. The reciprocating frame (6) is slidably connected to the tank cover (2). A vibration bearing frame (8) is provided below the reciprocating frame (6). An amplitude-changing vibration drive assembly is provided between the vibration support frame (8) and the vibration support frame (8) to drive the vibration support frame (8) to circulate and change amplitude vibration. A liquid level probe (9) is installed on the vibration support frame (8). The orbital frame (7) is rotatably connected to the vibration support frame (8). A rotating shaft (10) is installed on the bottom surface of the orbital frame (7). A spiral stirring blade (11) and a stirring blade assembly (12) are installed on the rotating shaft (10) from top to bottom. Six mounting systems are provided on the orbital frame (7). The mounting system includes a sterilization container (13) and a swing frame (14) rotatably connected to a rotating frame (7). A rotating sleeve (18) is rotatably fitted on the swing frame (14), and the rotating sleeve (18) is rotatably connected to the rotating frame (7). A reciprocating spiral tube (15) is rotatably installed on the swing frame (14), and a torsion spring (16) is provided at the rotatable connection between the two. A threaded connector (17) is rotatably connected to the mouth of the sterilization container (13), and the threaded connector (17) is threadedly connected to the reciprocating spiral tube (15). The reciprocating rack (6) is driven by the transmission system and causes the sterilization container (13) to alternately enter the liquid phase sterilization chamber (4) and the gas phase sterilization chamber (5). It also includes a drive system, a condenser (19) and an exhaust system connected to the reciprocating spiral tube (15). The drive system drives the swing frame (14) to reciprocate within ±35° as the orbital frame (7) rotates and synchronously drives the reciprocating spiral tube (15) to rotate in both directions. A condenser coil (20) is installed inside the condenser (19). The exhaust port of the exhaust system is connected to the condenser coil (20). The liquid outlet port of the condenser coil (20) is connected to a detection tube (21). A laser detection module (22) is installed on the detection tube (21).

3. The solution preparation system according to claim 2, characterized in that, It also includes an equipment rack (23), which is fixedly connected to the tank body (1). The condenser (19) is fixedly installed on the equipment rack (23). A microcontroller (24) is installed on the end face of the equipment rack (23). A pressure relief valve and a pressure gauge are installed on the tank cover (2). A temperature probe (25) with its measurement and control end extending to the liquid phase sterilization chamber (4) is installed at the bottom of the tank body (1). An electric heating jacket (26) is provided on the tank body (1). The data terminals of the pressure relief valve, the laser detection module (22), the pressure gauge, the temperature probe (25), and the liquid level probe (9) are all connected to the microcontroller (24).

4. The solution preparation system according to claim 3, characterized in that, The bottom end of the detection tube (21) is provided with a drain valve, and a wastewater storage tank (27) is provided on the equipment frame (23) at the position directly below the drain valve.

5. A solution preparation system according to claim 3, characterized in that, The transmission system includes a drive motor (28) mounted on the equipment frame (23), a fixed shaft (29) rotatably connected to the equipment frame (23), and a movable shaft (30) and a convex shaft (31) rotatably connected to the can lid (2). The output shaft end of the drive motor (28) is connected to a synchronous toothed belt. The fixed shaft (29) is connected to the synchronous toothed belt. The fixed shaft (29) has a first synchronous groove with an opening at the top and is slidably connected to the movable shaft (30). The first synchronous groove and the movable shaft (31) are connected to the convex shaft (21). The cross-section of 0) is a regular hexagon. The movable shaft (30) and the cam shaft (31) are both equipped with first bevel gears. The two first bevel gears mesh orthogonally. An eccentric cam (32) is installed on the cam shaft (31). A follower wheel (33) is rotatably installed on the reciprocating frame (6). The wheel surface of the eccentric cam (32) and the wheel surface of the follower wheel (33) are in rolling contact. A return spring (34) is installed on the reciprocating frame (6). The other end of the return spring (34) is fixedly connected to the can lid (2).

6. A solution preparation system according to claim 5, characterized in that, The transmission system also includes a hexagonal shaft (35) rotatably connected to the bottom of the tank (1). The hexagonal shaft (35) is connected to a synchronous toothed belt. The shaft (10) has a second synchronous groove with a bottom opening and sliding connection with the hexagonal shaft (35). The cross-sections of the second synchronous groove and the hexagonal shaft (35) are both regular hexagons.

7. A solution preparation system according to claim 6, characterized in that, The variable amplitude vibration drive assembly includes a synchronous shaft (36) rotatably connected to the vibration support frame (8), a vibrating wheel (37) rotatably connected to the reciprocating frame (6), a reversing shaft (50), and a differential outer shaft (38). A differential inner shaft (39) is rotatably mounted on the differential outer shaft (38). The differential inner shaft (39) has a third synchronous groove with a bottom opening and sliding connection with the synchronous shaft (36). A second bevel gear is mounted on both the differential inner shaft (39) and the differential outer shaft (38). A third bevel gear is mounted on the reversing shaft (50). Both second bevel gears are connected to the third bevel gear in a transmission manner. The vibrating wheel (37) and The differential outer shaft (38) is equipped with a fourth bevel gear, and the two fourth bevel gears mesh orthogonally. The vibrating wheel (37) is alternately provided with three transmission tooth segments (40) and three toothless reset areas. The vibration bearing frame (8) is equipped with a rack plate (41). The three transmission tooth segments (40) alternately mesh with the rack plate (41), and the transmission stroke of the three transmission tooth segments (40) to the rack plate (41) is different. The vibration bearing frame (8) is equipped with two T-shaped guide rods (42). The two T-shaped guide rods (42) are slidably connected to the reciprocating frame (6). The two T-shaped guide rods (42) are fitted with return springs (43).

8. A solution preparation system according to claim 7, characterized in that, The cross-sections of the third synchronous groove and the synchronous shaft (36) are both regular hexagons. The two second bevel gears are respectively set on both sides of the third bevel gear. The reciprocating frame (6) has two guide grooves. The can cover (2) is equipped with guide sliders at the positions corresponding to the two guide grooves. The two guide sliders are slidably connected to the two guide grooves respectively.

9. A solution preparation system according to claim 6, characterized in that, The exhaust system includes a one-way exhaust valve (44) installed on the can cover (2). The differential inner shaft (39) and the synchronous shaft (36) are provided with air guide channels (45). The orbital frame (7) is provided with a cavity that communicates with the air guide channels (45). The cavity is connected to the one-way exhaust valve (44) through the air guide channels (45). The outlet port of the one-way exhaust valve (44) is connected to a hose. The other end of the hose is connected to the condenser coil (20). The top end of each reciprocating spiral tube (15) is rotatably connected to a corrugated connecting pipe (46). The other end of the corrugated connecting pipe (46) is connected to the cavity. A one-way valve is installed in the threaded joint (17).

10. A solution preparation system according to claim 2, characterized in that, The drive system includes a swing bevel gear mounted on the swing frame (14), a rotating bevel gear mounted on the sleeve (18), and a fifth bevel gear mounted on both the sleeve (18) and the reciprocating rotary tube (15). The two fifth bevel gears mesh orthogonally. The vibration bearing frame (8) is equipped with four rotating sector gear segments (47) adapted to mesh with the rotating bevel gears, nine forward sector gear segments (48), and nine reverse sector gear segments (49). The forward sector gear segments (48) and the reverse sector gear segments (49) rotate with the revolution frame (7). Alternating meshing with the oscillating bevel gear, a first reset area is provided on the vibration bearing frame (8) and at the position corresponding to the position between two adjacent rotating sector gear segments (47). Nine forward sector gear segments (48) and nine reverse sector gear segments (49) are arranged alternately in pairs on the vibration bearing frame (8). A second reset area is provided on the vibration bearing frame (8) and at the position corresponding to each forward sector gear segment (48) and the adjacent reverse sector gear segment (49). The forward sector gear segments (48) and the reverse sector gear segments (49) are respectively located on the upper and lower sides of the oscillating bevel gear.

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