A pressure steam anti-condensation sterilization system and method

Abstract

The application discloses a pressure steam anti-condensation sterilization system and method, which comprises a steam system, a heat preservation cabin and a sterilization cabin arranged in the heat preservation cabin. Steam is introduced into the heat preservation cabin through the steam system to realize heat preservation of the sterilization cabin. An anti-condensation device is arranged in the sterilization cabin, the anti-condensation device is connected with the steam system, a plurality of shunt holes are arranged on the anti-condensation device, and a vacuum pipeline is arranged on the sterilization cabin. The heat preservation cabin is arranged, steam is introduced to perform integral heat tracing and heat preservation on the internal sterilization cabin, heat loss of the outer wall of the sterilization cabin is effectively reduced, and the problem of poor heat preservation of traditional equipment is improved from the root. During the sterilization stage, the anti-condensation device is used to continuously perform high-temperature purging and heat tracing on the surface of the biological indicator container, so that the defects of traditional equipment without condensation treatment measures and the attachment of condensate water to cause the local temperature of the surface of the biological indicator to be too low are solved.

Description

Technical Field

[0001] This invention relates to the field of steam sterilization technology, and in particular to a pressure steam anti-condensation sterilization system and method. Background Technology

[0002] High-temperature sterilization is a commonly used sterilization method in the medical, food, and biological fields. Its core principle is to create a high-temperature, high-pressure steam environment to kill microorganisms on the surface and inside of items, ensuring their sterility. Biological indicators are typically placed in the sterilization chamber and sterilized simultaneously with the process, allowing for the detection of sterilization effectiveness. The national standard GB / T 24628-2025 has strict regulations for the sterilization process of pressure steam sterilization biological indicator resistance meters, requiring short temperature rise and fall periods and a stable temperature environment during the sterilization phase. However, traditional sterilization equipment suffers from the following problems in practical use:

[0003] 1. Existing sterilization equipment suffers from poor insulation within the sterilization chamber, leading to unstable temperatures and significant temperature fluctuations (exceeding the national standard of ±0.5℃), which greatly impacts sterilization effectiveness. 2. During sterilization, condensation easily occurs on the surface of biological indicator containers such as ampoules. Areas with condensation tend to have lower surface temperatures, and existing sterilization equipment lacks measures to address this localized temperature drop caused by condensation. This results in uneven temperature distribution of the biological indicator during sterilization, significantly affecting sterilization test results. Summary of the Invention

[0004] The purpose of this invention is to solve the problems in the prior art and to provide a pressure steam anti-condensation sterilization system and method.

[0005] The objective of this invention is achieved through the following technical solution: a pressure steam anti-condensation sterilization system, comprising a steam system, an insulation chamber, and a sterilization chamber disposed within the insulation chamber. Steam is introduced into the insulation chamber through the steam system to maintain the temperature of the sterilization chamber. An anti-condensation device is installed inside the sterilization chamber and is connected to the steam system. The anti-condensation device has several diversion holes. A vacuum pipeline is installed on the sterilization chamber. During sterilization, the steam generated by the steam system is ejected through the diversion holes on the anti-condensation device and flows along the surface of the biological indicator container to inhibit condensation on the surface of the biological indicator container. At the same time, the vacuum pipeline extracts steam from the sterilization chamber to maintain a dynamic balance of steam within the sterilization chamber.

[0006] Preferably, the steam system includes a compressed air device, a steam generation chamber, a steam supply chamber, and a steam constant temperature chamber. The compressed air device is connected to the steam supply chamber via an air supply pipeline. The steam generation chamber is connected to the steam supply chamber and the steam constant temperature chamber via a first steam pipeline and a second steam pipeline, respectively. The steam supply chamber and the steam constant temperature chamber are connected via a fourth steam pipeline. The sterilization chamber is connected to the steam constant temperature chamber via a steam inlet pipeline. The anti-condensation device is connected to the steam constant temperature chamber via a micro-control temperature regulation pipeline.

[0007] Preferably, the steam generating chamber is connected to the insulation chamber via a third steam pipeline, and the steam constant temperature chamber is connected to the insulation chamber via a temperature regulating pipeline.

[0008] Preferably, the air supply pipeline is equipped with a first control valve, the first steam pipeline is equipped with a second control valve, the second steam pipeline is equipped with a third control valve, the fourth steam pipeline is equipped with a fourth control valve, the insulation chamber temperature regulation pipeline is equipped with a fifth control valve, the micro-controlled temperature regulation pipeline is equipped with a sixth control valve, the vacuum pipeline is equipped with a seventh control valve, the steam inlet pipeline is equipped with a ninth control valve, and the third steam pipeline is equipped with a tenth control valve.

[0009] Preferably, a first mass flow meter and a second mass flow meter are respectively installed on the micro-controlled temperature regulating pipeline and the vacuum pipeline.

[0010] Preferably, temperature sensors and pressure sensors are installed on the steam generation chamber, compressed air device, steam supply chamber, steam constant temperature chamber, sterilization chamber and heat preservation chamber.

[0011] Preferably, the insulated chamber is equipped with a discharge pipeline, and the discharge pipeline is equipped with an eleventh control valve; a cooling pipeline is provided between the compressed air device and the sterilization chamber, and the cooling pipeline is equipped with an eighth control valve.

[0012] Preferably, the anti-condensation device is equipped with a biological indicator rack above it for placing biological indicators. The biological indicator rack has several biological indicator placement positions, and each biological indicator placement position has a trigger switch at its bottom. The anti-condensation device includes a steam distribution chamber. The upper end of the steam distribution chamber is equipped with a steam ejector pipe corresponding to each biological indicator placement position. The steam ejector pipe has a diversion hole. Each steam ejector pipe has a movable seal below it. The movable seal is connected to a drive component via a transmission rod. The drive component drives the movable seal to move, thereby switching the opening and closing state of the diversion hole in the steam ejector pipe. Both the trigger switch and the drive component are electrically connected to the control system. When a biological indicator is placed at the biological indicator placement position, the diversion orifice in the steam ejector pipe corresponding to that biological indicator placement position is in an open state; otherwise, the diversion orifice in the steam ejector pipe corresponding to that biological indicator placement position is in a closed state.

[0013] Preferably, the driving element is an electromagnet.

[0014] A method for sterilizing with pressure steam to prevent condensation, the specific process of which is as follows: S1: Equipment preheating stage: Open the first and second control valves, and the steam generated in the steam generation chamber and the air from the compressed air device are introduced into the steam supply chamber in a certain proportion, so that the steam supply chamber reaches the preset temperature and pressure; then open the fourth control valve, and the steam in the steam supply chamber is introduced into the steam constant temperature chamber, so that the temperature in the steam constant temperature chamber is stabilized at the first preset temperature; then steam is introduced into the insulation chamber through the steam generation chamber and the steam constant temperature chamber, so that the temperature in the insulation chamber is stabilized at the second preset temperature; S2: Sterilization stage: First, the sterilization chamber is evacuated to a vacuum through the vacuum pipeline. Then, the ninth control valve is opened, and steam is introduced into the sterilization chamber from the steam constant temperature chamber to rapidly raise the temperature inside the sterilization chamber to the third preset temperature. Next, the sixth control valve is opened, and the steam from the steam constant temperature chamber is delivered to the anti-condensation device through the micro-controlled temperature regulating pipeline and sprayed out through the diversion hole. The sprayed steam flows along the surface of the biological indicator container to inhibit condensation on the surface of the biological indicator container. At the same time, the vacuum pipeline extracts steam from the sterilization chamber to maintain a dynamic balance of steam inside the sterilization chamber. S3: Sterilization end stage: Close the sixth control valve and discharge the steam in the insulation chamber and sterilization chamber to achieve rapid cooling in the sterilization chamber.

[0015] The beneficial effects of this invention are: 1. This invention features an insulated chamber with steam supplied for overall heat tracing and insulation of the internal sterilization chamber, effectively reducing heat loss from the outer wall of the sterilization chamber and fundamentally improving the poor insulation performance of traditional equipment. It can strictly control temperature fluctuations within the sterilization stage within the allowable range of ±0.5℃ specified in the national standard GB / T 24628-2025, ensuring a stable and controllable temperature environment during the constant temperature sterilization stage. Simultaneously, it optimizes the temperature rise and fall rates, meeting the national standard requirements for short-term rapid temperature increase and decrease during the rise and fall phases, thus completely solving the problems of excessive temperature fluctuations and non-compliant sterilization environments in traditional equipment.

[0016] 2. The sterilization chamber is equipped with an anti-condensation device with diversion holes. After the steam is evenly sprayed out through the diversion holes, it flows along the outer wall of the ampoule-type biological indicator container, continuously purging and heating the surface of the biological indicator container at high temperature. This actively inhibits and avoids the condensation and adhesion of water vapor on the container surface, thereby solving the defects of traditional equipment that lack condensation treatment measures and cause localized low temperatures on the surface of the biological indicator due to condensation adhesion. This ensures that the overall temperature of the biological indicator container is uniform, eliminates uneven temperature distribution, and improves the reliability of biological indicator detection results. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the pipeline of the present invention.

[0018] Figure 2 This is a schematic diagram of the anti-condensation device and the biological indicator rack.

[0019] Figure 3 A front view of the anti-condensation device and the biological indicator rack.

[0020] Figure 4 This is a cross-sectional view of the anti-condensation device.

[0021] In the diagram: 1. Steam generating chamber; 2. Compressed air device; 3. Steam supply chamber; 4. Steam constant temperature chamber; 5. Sterilization chamber; 6. Insulation chamber; 7. Air supply pipeline; 8. Vacuum pipeline; 9. Biological indicator rack; 9-1. Container limiting component; 9-2. Trigger switch; 10. Biological indicator; 11. First steam pipeline; 12. Second steam pipeline; 13. Third steam pipeline; 14. Fourth steam pipeline; 15. Cooling pipeline; 16. Micro-controlled temperature regulation pipeline; 17. Anti-condensation device; 17-1. Steam distribution chamber; 17-2. Steam ejection pipe. 17-3. Drive component; 17-4. Transmission rod; 17-5. Movable seal; 18. Temperature regulation pipeline for insulated chamber; 19. Insulation material layer; 20. Steam inlet pipeline; 21. First control valve; 22. Second control valve; 23. Third control valve; 24. Fourth control valve; 25. Fifth control valve; 26. Sixth control valve; 27. Seventh control valve; 28. Eighth control valve; 29. ​​Ninth control valve; 30. Tenth control valve; 31. Eleventh control valve; 32. Discharge pipeline; 33. Vacuum pump; 34. First mass flow meter; 35. Second mass flow meter. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0023] Those skilled in the art should understand that, in the disclosure of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the above terms should not be construed as limiting this invention.

[0024] It is understood that the term "a" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element can be one, while in another embodiment, the number of the element can be multiple, and the term "a" should not be understood as a limitation on the number.

[0025] like Figures 1 to 4 As shown, a pressure steam anti-condensation sterilization system includes a steam system, an insulation chamber 6, and a sterilization chamber 5 disposed within the insulation chamber 6. Steam is introduced into the insulation chamber 6 through the steam system to maintain the temperature of the sterilization chamber 5. An anti-condensation device 17 is installed inside the sterilization chamber 5 and is connected to the steam system. The anti-condensation device 17 has several diversion holes. A vacuum pipeline 8 is installed on the sterilization chamber 5. During sterilization, the steam generated by the steam system is ejected through the diversion holes on the anti-condensation device 17 and flows along the surface of the biological indicator container to inhibit condensation on the surface of the biological indicator container. At the same time, the vacuum pipeline 8 extracts steam from the sterilization chamber 5 to maintain a dynamic balance of steam within the sterilization chamber 5.

[0026] This invention features an insulated chamber 6, through which steam is introduced to provide overall heat tracing and insulation for the internal sterilization chamber 5. This effectively reduces heat loss from the outer wall of the sterilization chamber 5, fundamentally improving the poor insulation performance of traditional equipment. It can strictly control temperature fluctuations within the sterilization stage within the allowable range of ±0.5℃ specified in the national standard GB / T 24628-2025, ensuring a stable and controllable temperature environment during the constant temperature sterilization stage. Simultaneously, it optimizes the temperature rise and fall rates, meeting the national standard requirements for short-term rapid temperature increase and decrease during the rise and fall phases, thus completely solving the problems of excessive temperature fluctuations and non-compliant sterilization environments in traditional equipment.

[0027] The sterilization chamber 5 is equipped with an anti-condensation device 17 with diversion holes. After the steam is evenly sprayed out through the diversion holes, it flows along the outer wall of the ampoule-type biological indicator 10 container, continuously purging and heating the surface of the biological indicator container at high temperature. This actively inhibits and prevents the condensation and adhesion of water vapor on the container surface, thereby solving the defects of traditional equipment that lack condensation treatment measures and cause localized low temperatures on the surface of the biological indicator due to condensation adhesion. This ensures that the overall temperature of the biological indicator 10 container is uniform, eliminates uneven temperature distribution, and improves the reliability of the detection results of the biological indicator 10.

[0028] During the sterilization stage, while continuously supplying sterilizing steam into the sterilization chamber 5, excess steam is extracted from the chamber in real time through the vacuum pipeline 8, so that the steam pressure and temperature in the sterilization chamber 5 are always in dynamic equilibrium, and the molar mass of the inflowing and outflowing gases is kept consistent, thereby achieving a constant sterilization temperature in the sterilization chamber 5.

[0029] The steam system includes a compressed air device 2, a steam generating chamber 1, a steam supply chamber 3, and a constant-temperature steam chamber 4. The compressed air device 2 is connected to the steam supply chamber 3 via an air supply pipeline 7. The steam generating chamber 1 is connected to the steam supply chamber 3 and the constant-temperature steam chamber 4 via a first steam pipeline 11 and a second steam pipeline 12, respectively. The steam supply chamber 3 and the constant-temperature steam chamber 4 are connected via a fourth steam pipeline 14. The sterilization chamber 5 is connected to the constant-temperature steam chamber 4 via a steam inlet pipeline 20. The anti-condensation device 17 is connected to the constant-temperature steam chamber 4 via a micro-control temperature regulating pipeline 16. The steam generating chamber 1 is connected to the insulation chamber 6 via a third steam pipeline 13, and the constant-temperature steam chamber 4 is connected to the insulation chamber 6 via an insulation chamber temperature regulating pipeline 18.

[0030] Steam generation chamber 1 supplies steam independently to steam supply chamber 3, steam constant temperature chamber 4, and insulation chamber 6 via first steam pipeline 11, second steam pipeline 12, and third steam pipeline 13. The steam generated in steam generation chamber 1 has a high temperature, while the compressed air stored in compressed air device 2 has a lower temperature. The steam in steam generation chamber 1 is mixed with compressed air in a certain proportion and then introduced into steam supply chamber 3. By adjusting the ratio of steam to compressed air, the steam temperature in steam supply chamber 3 can reach the set temperature.

[0031] Meanwhile, the compressed air device 2 supplies air to the steam supply chamber 3 via the air supply pipeline 7 to stabilize the pressure. The steam supply chamber 3 is connected to the steam constant temperature chamber 4 via the fourth steam pipeline 14. As an intermediate buffer and pressure stabilizing chamber, the steam supply chamber 3 can smoothly buffer and regulate the steam pressure, suppress the shock and oscillation during the steam pressure rise and fall process, and avoid temperature runaway caused by sudden pressure changes, thereby further improving the temperature stability during the constant temperature stage.

[0032] The steam generation chamber 1 and the steam supply chamber 3 can independently supply steam to the steam constant temperature chamber 4, and by adjusting the ratio of the steam in the two chambers, the steam temperature in the steam constant temperature chamber 4 can reach the set temperature. After the steam undergoes homogenization, temperature control, and pressure stabilization in the steam constant temperature chamber 4, it is then sent to the sterilization chamber 5 through the steam inlet pipe 20; so that the sterilization steam entering the sterilization chamber 5 is itself constant temperature and steady-state steam.

[0033] The anti-condensation device 17 obtains constant temperature steam from the steam constant temperature chamber 4 separately through the micro-controlled temperature regulation pipeline 16; the steam temperature for purging the biological indicator container is precisely matched with the sterilization constant temperature, and with the flow structure attached to the wall of the diversion hole, it can continuously and stably purge the surface of the ampoule-type biological indicator container with high temperature tracing, completely preventing the re-precipitation of condensate due to deviation or fluctuation of the purging steam temperature.

[0034] The insulation chamber 6 is simultaneously connected to two steam heat sources: one source is introduced from the steam generating chamber 1 through the third steam pipe 13. The steam temperature in this source is higher, which can quickly raise the temperature inside the insulation chamber 6, thereby reducing the time it takes for the insulation chamber 6 to heat up to the target temperature; the other source is introduced from the steam constant temperature chamber 4 through the insulation chamber temperature regulating pipe 18. The temperature of the steam in this source is close to or the same as the target temperature of the insulation chamber 6. When the insulation chamber 6 is about to reach the target temperature, the steam supply from the steam generating chamber 1 is cut off, and the steam constant temperature chamber 4 supplies steam to the insulation chamber 6. The steam in the steam constant temperature chamber 4 precisely controls the temperature rise inside the insulation chamber 6 and ensures that it accurately reaches the target temperature.

[0035] An insulation material layer 19 is provided on the outside of the insulation chamber 6 to improve the insulation performance of the insulation chamber 6.

[0036] A first control valve 21 is installed on the air supply pipeline 7; a second control valve 22 is installed on the first steam pipeline 11; a third control valve 23 is installed on the second steam pipeline 12; a fourth control valve 24 is installed on the fourth steam pipeline 14; a fifth control valve 25 is installed on the insulation chamber temperature regulating pipeline 18; a sixth control valve 26 is installed on the micro-controlled temperature regulating pipeline 16; a seventh control valve 27 is installed on the vacuum pipeline 8; a ninth control valve 29 is installed on the steam inlet pipeline 20; and a tenth control valve 30 is installed on the third steam pipeline 13. These control valves allow for the control of the on / off state of the corresponding pipelines.

[0037] In this embodiment, all control valves are high-frequency solenoid valves to meet the high-frequency switching requirements.

[0038] Vacuum pump 33 and one-way valve are installed on vacuum line 8.

[0039] Furthermore, the insulated chamber 6 is equipped with a discharge pipe 32, and an eleventh control valve 31 is installed on the discharge pipe 32; a cooling pipe 15 is installed between the compressed air device 2 and the sterilization chamber 5, and an eighth control valve 28 is installed on the cooling pipe 15. The insulated chamber 6 discharges steam to the outside through the discharge pipe 32. After sterilization is completed, the eighth control valve 28 is opened to allow compressed air from the compressed air device 2 to be quickly introduced into the sterilization chamber 5, thereby achieving rapid cooling of the sterilization chamber 5.

[0040] A first mass flow meter 34 and a second mass flow meter 35 are respectively installed on the micro-controlled temperature regulating pipeline 16 and the vacuum pipeline 8. During the sterilization process, the first mass flow meter 34 and the second mass flow meter 35 can monitor the steam flow in the micro-controlled temperature regulating pipeline 16 and the vacuum pipeline 8, respectively, thereby ensuring that the molar mass of the gas flowing in and out of the sterilization chamber 5 remains balanced, and thus ensuring that the total amount of steam and the temperature in the sterilization chamber 5 are constant.

[0041] The vacuum vent is located at the bottom of the sterilization chamber or away from the anti-condensation device and the biological indicator rack. The amount of steam emitted by the anti-condensation device is precisely controlled by a first mass flow meter, and its flow rate is much smaller than the main steam intake. This ensures that the emitted steam can preferentially purge the surface of the biological indicator before mixing with the main steam in the chamber and being extracted by the vacuum pipeline, thereby achieving precise local temperature control and overall dynamic balance.

[0042] Temperature and pressure sensors are installed in the steam generation chamber 1, compressed air unit 2, steam supply chamber 3, steam constant temperature chamber 4, sterilization chamber 5, and insulation chamber 6. These sensors allow for real-time monitoring of the temperature and pressure of the medium (steam or compressed air) within the corresponding chamber or device.

[0043] Above the anti-condensation device 17 is a biological indicator rack 9 for placing biological indicators. The biological indicator rack 9 has several biological indicator placement positions, and each biological indicator placement position has a trigger switch 9-2 at its bottom. The anti-condensation device 17 includes a steam distribution chamber 17-1. The upper end of the steam distribution chamber 17-1 is provided with a steam ejection pipe 17-2 corresponding to each biological indicator placement position. The steam ejection pipe 17-2 has a diversion hole. Below each steam ejection pipe 17-2 is a movable seal 17-5. The movable seal 17-5 is connected to the drive component 17-3 through a transmission rod 17-4. The drive component 17-3 drives the movable seal 17-5 to move, thereby switching the opening and closing state of the diversion hole in the steam ejection pipe 17-2. Both the trigger switch 9-2 and the drive component 17-3 are electrically connected to the control system. When a biological indicator is placed at the biological indicator placement position, the diversion orifice in the steam ejector pipe 17-2 corresponding to the biological indicator placement position is in an open state; otherwise, the diversion orifice in the steam ejector pipe 17-2 corresponding to the biological indicator placement position is in a closed state.

[0044] When the diversion orifice in the steam ejector pipe 17-2 is open, there is a certain gap between the movable seal 17-5 and the steam ejector pipe 17-2, allowing steam in the steam distribution chamber 17-1 to be ejected outward through the steam ejector pipe 17-2. When the diversion orifice in the steam ejector pipe 17-2 is closed, the movable seal 17-5 is in close contact with the steam ejector pipe 17-2, blocking the lower end of the steam sealing pipe, thus preventing steam in the steam distribution chamber 17-1 from being ejected from the steam sealing pipe. The steam distribution chamber 17-1 is connected to the micro-controlled temperature regulating pipeline 16.

[0045] Each biological indicator placement position on the biological indicator rack 9 is provided with a corresponding container limiting member 9-1 for limiting the biological indicator 10 container.

[0046] Each placement position of the biological indicator rack 9 corresponds to a trigger switch 9-2, and each position corresponds one-to-one with the steam ejection pipe 17-2 of the anti-condensation device 17. Through the electrical connection between the trigger switch 9-2, the drive component 17-3, and the control system, on-demand control is achieved: "steam is supplied when biological indicator is present, and steam is cut off when no biological indicator is present." When no biological indicator is placed in a position, the trigger switch 9-2 is not triggered. The control system controls the drive component 17-3 to drive the movable seal 17-5 into close contact with the steam ejection pipe 17-2, blocking the lower end of the steam ejection pipe 17-2 and preventing steam from being ejected from that path. When a biological indicator is placed, the trigger switch 9-2 is triggered, and the drive component 17-3 moves the movable seal 17-5, creating a gap between the seal and the steam ejection pipe 17-2, allowing steam to be ejected normally from the diversion hole. This design solves the steam waste problem caused by the "continuous steam supply throughout the entire area" of the anti-condensation device 17. It supplies purge steam only to the location with biological indicators, which greatly reduces steam consumption and system energy consumption. At the same time, it avoids the ejection of useless steam from interfering with the temperature and pressure balance inside the sterilization chamber 5, laying the foundation for stable temperature control inside the chamber.

[0047] The steam ejector pipe 17-2 corresponds one-to-one with the biological indicator placement position. The diversion orifice is precisely aligned with the bottom and side wall of the biological indicator container (such as an ampoule). After being ejected through the diversion orifice, the steam can flow precisely along the surface of the biological indicator container, achieving one-to-one precise purging and heating. Compared with the shortcomings of traditional anti-condensation devices 17, which suffer from dispersed steam purging and incomplete purging of some biological indicators, this structure ensures that each placed biological indicator is enveloped and purged by stable and uniform constant-temperature steam, effectively suppressing condensation on the container surface. At the same time, the on-demand steam supply avoids steam disturbance in areas without biological indicators, reduces local steam convection turbulence in the chamber, further ensures uniform surface temperature of the biological indicator container, completely eliminates local low-temperature cold spots caused by condensation, ensures uniform heating during the sterilization process of the biological indicator 10, and avoids deviations in test results.

[0048] The biological indicator rack 9 has multiple placement positions, each corresponding to an independent set of steam ejector pipe 17-2, trigger switch 9-2, and movable seal 17-5, allowing multiple sets of biological indicators 10 to be placed simultaneously for synchronous sterilization testing. The anti-condensation purging of each set of biological indicators is independently controlled and does not interfere with each other, ensuring that each set of biological indicators receives accurate purging heat tracing.

[0049] The drive component 17-3 is fixed to the outer surface of the insulation chamber 6. The transmission rod 17-4 passes sequentially through the walls of the insulation chamber 6, the sterilization chamber 5, and the steam distribution chamber 17-1 before connecting to the movable seal 17-5. Because the drive component 17-3 is fixed to the outer surface of the insulation chamber 6, it is not affected by the internal steam temperature, allowing it to operate within a normal temperature range and ensuring its service life.

[0050] In this embodiment, the driving component 17-3 is an electromagnet. The electromagnet drives the transmission rod 17-4 to move axially, thereby causing the movable sealing component 17-5 to move synchronously, so as to switch the opening and closing state of the diversion hole.

[0051] A method for sterilizing with pressure steam to prevent condensation, the specific process of which is as follows: S1: Equipment preheating stage: Open the first and second control valves, and the steam generated in the steam generation chamber and the air from the compressed air device are introduced into the steam supply chamber in a certain proportion, so that the steam supply chamber reaches the preset temperature and pressure; then open the fourth control valve, and the steam in the steam supply chamber is introduced into the steam constant temperature chamber, so that the temperature in the steam constant temperature chamber is stabilized at the first preset temperature T1; then steam is introduced into the insulation chamber through the steam generation chamber and the steam constant temperature chamber, so that the temperature in the insulation chamber is stabilized at the second preset temperature T2.

[0052] In this step, the sterilization temperature T3 (i.e., the steam temperature inside the sterilization chamber) is set in advance. At the set temperature T3, the corresponding steam pressure in the sterilization chamber is P3. The steam generation chamber heats the gas source temperature to T4. ， When the pressure reaches P4, the first and second control valves are opened, and a certain proportion of compressed air and high-temperature steam from the steam generator chamber are introduced into the steam supply chamber. The preset target temperature in the steam supply chamber is T2, corresponding to the pressure P2. Due to heat loss, it is necessary to set T4 > T2 > T3, according to the ideal gas law: Given a constant volume, gas pressure and temperature are directly proportional, so P4 > P2.

[0053] By opening the fourth control valve, a large amount of gas from the steam supply chamber enters the steam constant temperature chamber; at this time, the first preset temperature of the steam constant temperature chamber is T1, T1 > T3, and the corresponding pressure is P1; by opening the tenth control valve, gas from the steam generation chamber enters the insulation chamber to heat the insulation chamber body, and based on the feedback from the temperature and pressure sensors of the insulation chamber, the tenth control valve is frequently switched on and off to achieve a rapid rise in the temperature of the insulation chamber and the entire sterilization chamber's inner wall; when approaching the upper limit of the set temperature, the tenth control valve is disconnected, and by frequently opening the fifth control valve, the temperature of the entire insulation chamber and sterilization chamber's inner wall reaches the set temperature T2 (the second preset temperature); when the temperature of the steam constant temperature chamber is lower than the set temperature T1, the steam supply chamber replenishes steam to the steam constant temperature chamber by opening the fourth and third control valves to raise its temperature.

[0054] S2: Sterilization Stage: First, the sterilization chamber is evacuated to a vacuum level through the vacuum pipeline. Then, the ninth control valve is opened, and steam is introduced into the sterilization chamber from the steam thermostat to rapidly raise the temperature to the third preset temperature T3 (i.e., the steam temperature inside the sterilization chamber). Next, the sixth control valve is opened, and the steam from the steam thermostat is delivered to the anti-condensation device through the micro-controlled temperature regulating pipeline and ejected from the diversion orifice. The ejected steam flows along the surface of the biological indicator container to inhibit condensation on the surface of the biological indicator container. At the same time, the vacuum pipeline extracts steam from the sterilization chamber to maintain a dynamic balance of steam inside the sterilization chamber. In this step, the sterilization chamber is evacuated to a vacuum level before sterilization. The temperature loss after evacuation is controlled by opening the tenth and fifth control valves. After the ninth control valve is opened, the high-temperature steam in the steam thermostat rapidly expands and enters the sterilization chamber, rapidly raising its temperature to the sterilization temperature T3. To compensate for the expansion and cooling effect, the first preset temperature T1 of the steam constant temperature chamber must be higher than the sterilization temperature T3. The specific value is determined by thermodynamic energy conservation calculations and experimental calibration to ensure that the sterilization chamber can accurately reach and stabilize at T3 after steam filling. When the steam temperature in the steam constant temperature chamber is lower than the set temperature T1, the fourth and third control valves are opened to replenish steam to the steam constant temperature chamber through the steam supply chamber and the steam generation chamber, thereby raising its temperature.

[0055] Once the sterilization temperature is reached, the first control valve is opened to introduce compressed air into the steam supply chamber, cooling the chamber and stabilizing its pressure. Based on data feedback from the temperature and pressure sensors, and the required gas temperature T5 for the steam supply chamber (T5 = T3 + pipeline temperature loss + 0.5℃), the opening time of the first control valve is controlled according to sensor feedback, thereby enabling the steam supply chamber to reach the target temperature.

[0056] It should be noted that the introduced compressed air will introduce non-condensable gases. To address this, the system uses high-precision temperature and pressure sensors to monitor the state of the mixed gas in real time, and combines this with subsequent vacuum exhaust steps to ensure that the main steam entering the sterilization chamber maintains a near-pure steam saturation level, thereby minimizing the negative impact of non-condensable gases.

[0057] During the sterilization stage, the sixth control valve is opened, and based on the data feedback from the temperature and pressure sensors of the steam constant temperature chamber, the fourth and third control valves are opened, allowing steam at the set temperature T3 to flow into the sterilization chamber. At the same time, the vacuum pump on the vacuum pipeline is turned on. Based on the feedback from the first and second mass flow meters, the opening frequency and time of the seventh control valve are controlled to ensure that the molar mass of the gas flowing into and out of the sterilization chamber remains consistent, thereby maintaining a constant sterilization temperature in the sterilization chamber.

[0058] S3: Sterilization end stage: Close the sixth control valve and discharge the steam in the insulation chamber and sterilization chamber to achieve rapid cooling in the sterilization chamber.

[0059] In this step, the sixth control valve is closed and the eighth control valve is opened. Compressed gas from the compressed air device is quickly introduced into the sterilization chamber to rapidly cool it down. At the same time, the vacuum pump is turned on to quickly evacuate the sterilization chamber to a vacuum, removing heat and achieving rapid cooling of the sterilization chamber in a short time.

[0060] This invention is not limited to the preferred embodiments described above. Anyone can derive other products in various forms under the guidance of this invention. However, regardless of any changes in shape or structure, any technical solution that is the same as or similar to this application falls within the protection scope of this invention.

Claims

1. A pressure steam anti-condensation sterilization system, characterized in that, The system includes a steam system, an insulated chamber, and a sterilization chamber located within the insulated chamber. Steam is introduced into the insulated chamber via the steam system to maintain the sterilization chamber's temperature. An anti-condensation device connected to the steam system and equipped with several diversion holes is installed inside the sterilization chamber. A vacuum pipeline is also installed on the sterilization chamber. During sterilization, steam generated by the steam system is ejected through the diversion holes on the anti-condensation device and flows along the surface of the biological indicator containers to inhibit condensation. Simultaneously, the vacuum pipeline is withdrawn from the sterilization chamber. Steam is used to maintain a dynamic balance of steam within the sterilization chamber. The steam system includes a compressed air device, a steam generation chamber, a steam supply chamber, and a steam constant temperature chamber. The compressed air device is connected to the steam supply chamber via an air supply pipeline. The steam generation chamber is connected to the steam supply chamber and the steam constant temperature chamber via a first steam pipeline and a second steam pipeline, respectively. The steam supply chamber and the steam constant temperature chamber are connected via a fourth steam pipeline. The sterilization chamber is connected to the steam constant temperature chamber via a steam inlet pipeline. The anti-condensation device is connected to the steam constant temperature chamber via a micro-control temperature regulation pipeline.

2. The pressure steam anti-condensation sterilization system according to claim 1, characterized in that, The steam generating chamber is connected to the insulation chamber via a third steam pipeline, and the steam constant temperature chamber is connected to the insulation chamber via a temperature regulating pipeline.

3. The pressure steam anti-condensation sterilization system according to claim 2, characterized in that, A first control valve is installed on the air supply pipeline, a second control valve is installed on the first steam pipeline, a third control valve is installed on the second steam pipeline, a fourth control valve is installed on the fourth steam pipeline, a fifth control valve is installed on the temperature regulation pipeline of the insulation chamber, a sixth control valve is installed on the micro-control temperature regulation pipeline, a seventh control valve is installed on the vacuum pipeline, a ninth control valve is installed on the steam inlet pipeline, and a tenth control valve is installed on the third steam pipeline.

4. The pressure steam anti-condensation sterilization system according to claim 2, characterized in that, The micro-controlled temperature regulating pipeline and the vacuum pipeline are respectively equipped with a first mass flow meter and a second mass flow meter.

5. The pressure steam anti-condensation sterilization system according to claim 1, characterized in that, Temperature sensors and pressure sensors are installed on the steam generation chamber, compressed air device, steam supply chamber, steam constant temperature chamber, sterilization chamber, and heat preservation chamber.

6. The pressure steam anti-condensation sterilization system according to claim 1, characterized in that, The insulated chamber is equipped with an exhaust pipe, and the exhaust pipe is equipped with an eleventh control valve; a cooling pipe is provided between the compressed air device and the sterilization chamber, and the cooling pipe is equipped with an eighth control valve.

7. The pressure steam anti-condensation sterilization system according to claim 1, characterized in that, Above the anti-condensation device is a biological indicator rack for placing biological indicators. The biological indicator rack has several biological indicator placement positions, and each biological indicator placement position has a trigger switch at its bottom. The anti-condensation device includes a steam distribution chamber. The upper end of the steam distribution chamber has a steam ejection pipe corresponding to each biological indicator placement position. The steam ejection pipe has a diversion hole. Below each steam ejection pipe is a movable seal. The movable seal is connected to a drive component via a transmission rod. The drive component moves the movable seal to switch the opening and closing state of the diversion hole in the steam ejection pipe. Both the trigger switch and the drive component are electrically connected to the control system. When a biological indicator is placed at the biological indicator placement position, the diversion orifice in the steam ejector pipe corresponding to that biological indicator placement position is in an open state; otherwise, the diversion orifice in the steam ejector pipe corresponding to that biological indicator placement position is in a closed state.

8. The pressure steam anti-condensation sterilization system according to claim 7, characterized in that, The driving component is an electromagnet.

9. A method for preventing condensation sterilization with pressurized steam, applied to the pressurized steam anti-condensation sterilization system according to any one of claims 1-8, characterized in that, The specific process is as follows: S1: Equipment preheating stage: Open the first and second control valves, and the steam generated in the steam generation chamber and the air from the compressed air device are introduced into the steam supply chamber in a certain proportion, so that the steam supply chamber reaches the preset temperature and pressure; then open the fourth control valve, and the steam in the steam supply chamber is introduced into the steam constant temperature chamber, so that the temperature in the steam constant temperature chamber is stabilized at the first preset temperature; then steam is introduced into the insulation chamber through the steam generation chamber and the steam constant temperature chamber, so that the temperature in the insulation chamber is stabilized at the second preset temperature; S2: Sterilization stage: First, the sterilization chamber is evacuated to a vacuum through the vacuum pipeline. Then, the ninth control valve is opened, and steam is introduced into the sterilization chamber from the steam constant temperature chamber to rapidly raise the temperature inside the sterilization chamber to the third preset temperature. Next, the sixth control valve is opened, and the steam from the steam constant temperature chamber is delivered to the anti-condensation device through the micro-controlled temperature regulating pipeline and sprayed out through the diversion hole. The sprayed steam flows along the surface of the biological indicator container to inhibit condensation on the surface of the biological indicator container. At the same time, the vacuum pipeline extracts steam from the sterilization chamber to maintain a dynamic balance of steam inside the sterilization chamber. S3: Sterilization end stage: Close the sixth control valve and discharge the steam in the insulation chamber and sterilization chamber to achieve rapid cooling in the sterilization chamber.

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