A fill simulation system for sterilization equipment space within load optimization
By leveraging the synergistic effect of standardized matrix units and pressure regulating components, the problems of uneven sterilization chambers and fixed volume adaptability in sterilization equipment are solved, enabling flexible filling and pressure stability of the sterilization equipment, thereby improving sterilization efficiency and energy saving.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- DONGGUAN MAIJIE BIOTECHNOLOGY CO LTD
- Filing Date
- 2025-05-23
- Publication Date
- 2026-05-29
AI Technical Summary
When processing small batches of medical devices, traditional sterilization equipment creates ineffective spaces inside the sterilization chamber, resulting in uneven heat distribution, humidity distribution, and sterilizing agent concentration, which affects the consistency of sterilization effect. Furthermore, the fixed volume structure is difficult to adapt to the loading requirements of products of different specifications, leading to energy waste and extended sterilization cycles.
A filling simulation system employing standardized matrix units and pressure regulating components works synergistically. By dynamically adjusting the pressure through a nitrogen replacement component, combined with a vacuum pump group and an automatic pressure relief valve, flexible filling and pressure stability of the sterilizer chamber are achieved. A nano-scale hydrophobic coating is used to reduce the adsorption of sterilizing agents.
It enables flexible filling of the sterilization cabinet cavity, reduces the amount of sterilizing agent used, saves operation time, ensures the stability of the sterilization environment, prevents backflow of contaminated gas, improves sterilization efficiency and reduces energy consumption.
Smart Images
Figure CN224292274U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of ethylene oxide sterilization technology, and more specifically, to a filling simulation system for optimizing the loading within the space of sterilization equipment. Background Technology
[0002] In the field of ethylene oxide sterilization technology, traditional sterilization equipment, when processing small batches of medical devices, is prone to creating ineffective spaces inside the sterilization chamber due to insufficient loading capacity. This results in uneven heat distribution, humidity distribution, and sterilizing agent concentration distribution, which seriously affects the consistency of sterilization effect.
[0003] Conventionally, cotton fabrics and plastic products are used to fill the unloaded sterilization chambers. However, cotton fabrics and plastic products have significant adsorption properties for ethylene oxide, which not only increases the consumption of sterilizing agent but also requires additional replenishment frequency.
[0004] Furthermore, existing sterilizers are mostly designed with a fixed volume structure, and their built-in filling modules are difficult to adapt to the combined loading requirements of products of different specifications, especially when dealing with medium-sized products (such as the HMQ-30 model, with a volume of 30m³). 3 ) and large-scale sterilization equipment (such as the HMQ-100 model, with a volume of 100m³) 3 In low-load operation scenarios, fixed filling structures lead to low space utilization, resulting in energy waste and prolonged sterilization cycles. These problems are particularly prominent in the biomedical industry, necessitating technological innovation to achieve dynamic optimization of sterilization space configuration. Utility Model Content
[0005] This invention provides a filling simulation system for optimizing the loading within the space of sterilization equipment. Through the synergistic effect of standardized base units and dynamic pressure adjustment components, it solves the problems of mismatch between the fixed volume of sterilization cabinets and actual loading requirements, and low adaptability of filling modules in the prior art.
[0006] The technical solution adopted by this utility model to solve its technical problem is:
[0007] A filling simulation system for optimizing the loading within a sterilization device space, comprising:
[0008] At least one standardized matrix unit, the matrix unit being a hollow box structure, the surface of the matrix unit being coated with a nanoscale hydrophobic coating;
[0009] The pressure regulating assembly includes an adjustable pressure regulating chamber, a pressure sensor, a controller, and a pressure gauge; the pressure sensor, in conjunction with the controller, adjusts the nitrogen charging and discharging rate within the substrate unit in real time; the pressure regulating chamber is used to maintain a stable pressure difference between the substrate unit and the sterilizer chamber; and the pressure gauge provides visual pressure feedback within the substrate unit.
[0010] The nitrogen replacement assembly integrates a vacuum pump unit, a nitrogen filling device controlled by a two-way solenoid valve, and an automatic pressure relief valve; the vacuum pump unit is used to evacuate the base unit; the nitrogen filling device and the automatic pressure relief valve are used to balance the internal and external pressure difference between the base unit and the sterilizer.
[0011] The substrate unit is dynamically connected to the chamber of the sterilizer via a nitrogen replacement component.
[0012] Preferably, the base unit has transverse ribs along its long side and longitudinal ribs along its short side, and both the transverse ribs and the longitudinal ribs are welded to the base unit as a whole.
[0013] Preferably, the corners of the base unit are all rounded.
[0014] Preferably, the base unit is provided with a sealing cover, the sealing cover is connected to the unit by a flange, and a sealing ring is provided on the end of the sealing cover connected to the base unit.
[0015] Preferably, in the combined state, the interiors of the multiple base units are interconnected, adjacent base units are welded together, and the combined base units include connecting base units, which are connected to the pressure regulating component and the nitrogen replacement component.
[0016] Preferably, the base unit has an air extraction port and a safety port on its side wall, and the air extraction pipeline of the vacuum pump unit is connected to the air extraction port through a corrugated pipe; the pressure relief port of the automatic pressure relief valve is connected to the safety port through a flexible pipeline; the air inlet channel of the bidirectional solenoid valve is connected to the nitrogen charging device through a quick-release clamp, and the exhaust channel of the bidirectional solenoid valve is connected to the safety port through a pressure relief pipeline, and the pressure relief pipeline is equipped with a check valve structure.
[0017] Preferably, the base unit is provided with a sealing flange, and the flange interface of the adjustable pressure regulating chamber is connected to the sealing flange via a double ferrule connector, and a sealing gasket is provided inside the double ferrule connector; the pressure sensor is communicatively connected to the controller; the base unit is provided with a pressure measuring port, and a capillary tube is connected to the pressure gauge, with both ends of the capillary tube fixedly connected to the pressure sensor and the pressure measuring port, respectively.
[0018] Preferably, the structural dimensions of the base unit are 100×120×145cm, and the base unit can be freely combined.
[0019] The beneficial effects of this utility model are as follows:
[0020] 1. By combining standardized base units with a detachable welded frame, the sterilization cabinet cavity can be flexibly filled; at the same time, the internal pressure can be dynamically adjusted by a nitrogen replacement component to ensure the stability of the sterilization environment.
[0021] 2. The pressure inside the substrate unit is monitored in real time by a pressure sensor. The controller adjusts the nitrogen charging and discharging rate according to the set threshold. The pressure gauge provides visual feedback, which can reduce manual intervention and save more operation time in the sterilization cycle. At the same time, the pressure difference fluctuation is controlled within ±20kPa, which can avoid uneven sterilization temperature or concentration caused by pressure changes.
[0022] 3. The three-stage linkage of vacuum pump group for vacuuming, nitrogen filling device for quantitative nitrogen filling, and overpressure protection of automatic pressure relief valve can ensure the inert environment inside the base unit. Nitrogen replacement reduces ethylene oxide residue, thereby reducing the amount of agents required for sterilization.
[0023] 4. By dynamically maintaining the pressure inside the substrate unit slightly lower than the pressure inside the sterilizer chamber through the nitrogen replacement component, it is possible to prevent the backflow of contaminated gas inside the sterilizer, thereby effectively maintaining a local sterile environment.
[0024] 5. The grid support structure formed by the transverse ribs on the long side and the longitudinal ribs on the short side can improve the compressive strength in the combined state to adapt to the mechanical stress of frequent start-stop of the sterilizer, while filling the gaps in the frame and reducing leakage of the combined unit. Attached Figure Description
[0025] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the present invention will be further described below in conjunction with the accompanying drawings and embodiments. The drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0026] Figure 1 This is a schematic diagram of the overall structure after the base unit is assembled according to the embodiment of this application.
[0027] Figure 2 These are three views of the base unit assembly in the embodiments of this application. Detailed Implementation
[0028] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, a clear and complete description will be provided below in conjunction with the technical solutions in the embodiments of this utility model. Obviously, the described embodiments are some, but not all, of the embodiments of this utility model. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.
[0029] The preferred embodiment of this utility model is as follows: Figure 1 and Figure 2 As shown, a filling simulation system for optimizing the loading within a sterilization equipment space includes a matrix unit, a pressure regulating component, and a nitrogen replacement component.
[0030] The surface of the substrate unit is coated with a nano-scale hydrophobic coating; the nano-hydrophobic coating is a fluorocarbon modified coating with a contact angle ≥150° and a sterilizing agent adsorption rate <0.01%. As an optional embodiment, the substrate unit is made of SUS304 stainless steel, with a temperature tolerance range of -10℃ to 80℃ and a pressure tolerance range of -90kPa to +90kPa; it can support 1500 sterilization cycles with performance degradation <5%. The substrate unit has structural dimensions of 100×120×145cm and can be freely combined according to actual sterilization requirements. As an optional embodiment, the substrate unit is compatible with sterilizers HMQ-12, HMQ-20, HMQ-25, HMQ-30, HMQ-50, and HMQ-100.
[0031] The base unit has transverse ribs along its long side and longitudinal ribs along its short side. Both transverse and longitudinal ribs are welded integrally with the base unit, enhancing its strength. The corners of the base unit are rounded to reduce stress concentration. A sealing cover is provided on the base unit, connected to the unit by a flange, and a sealing ring is fitted onto the circumferential surface of the cover where it contacts the base unit.
[0032] In the combined state, the interiors of multiple base units are interconnected, and adjacent base units are welded together. The combined base units include connecting base units, which are connected to the pressure regulating component and the nitrogen replacement component.
[0033] The pressure regulation assembly includes an adjustable pressure regulation chamber, a pressure sensor, a controller, and a pressure gauge; the pressure sensor, in conjunction with the controller, adjusts the nitrogen charging and discharging rate in real time; the pressure regulation chamber is used to maintain a stable pressure difference between the substrate unit and the sterilizer chamber; and the pressure gauge provides visual pressure feedback.
[0034] The base unit is equipped with a sealing flange. The flange interface of the adjustable pressure regulating chamber is connected to the sealing method through a double compression fitting. A sealing gasket is installed inside the double compression fitting. The pressure sensor is connected to the controller. The base unit is equipped with a pressure measuring port. A capillary tube is connected to the pressure gauge. The two ends of the capillary tube are fixed to the pressure sensor and the pressure measuring port, respectively.
[0035] The nitrogen purging assembly integrates a vacuum pump unit, a nitrogen filling device controlled by a two-way solenoid valve, and an automatic pressure relief valve. The vacuum pump unit can evacuate the base unit to -36.5 kPa gauge pressure. The nitrogen filling device controls the nitrogen filling rate via a two-way solenoid valve. The overpressure protection threshold set on the automatic pressure relief valve is ±10% of the working pressure. The nitrogen purging assembly has a three-stage pressure regulation mechanism: the vacuum pump unit evacuates the base unit to -36.5 kPa gauge pressure; the two-way solenoid valve controls the nitrogen filling rate from 0.5 to 2 m³ / s. 3 / h adjustable; the automatic pressure relief valve trigger threshold is ±10% of the set working pressure.
[0036] The base unit has an air extraction port and a safety port on its side wall. The air extraction pipeline of the vacuum pump unit is connected to the air extraction port through a corrugated pipe. The pressure relief port of the automatic pressure relief valve is connected to the safety port through a flexible pipeline. The air inlet channel of the two-way solenoid valve is connected to the nitrogen charging device through a quick-release clamp. The exhaust channel of the two-way solenoid valve is connected to the safety port through a pressure relief pipeline, and the pressure relief pipeline is equipped with a check valve.
[0037] The substrate unit is dynamically connected to the sterilizer chamber via a nitrogen purging assembly. During sterilization, the pressure inside the substrate unit is maintained within a range of -5 kPa to +5 kPa relative to the sterilizer chamber pressure.
[0038] The volume of the substrate unit can be dynamically adjusted. By adjusting the number of substrate units, the available sterilization volume can be effectively adjusted, i.e., the number of sterilization cabinets can be adjusted. At the same time, using substrate units for filling can reduce the adsorption of sterilizing agents, thereby reducing the energy consumption of sterilizing agents.
[0039] During the sterilization process, the number of substrate units required is first calculated based on the sterilization cabinet's capacity and the actual sterilization load. The substrate units are then sealed after being evacuated by a vacuum pump and pre-assembled. The assembled substrate units are then placed into the sterilization cabinet, and the nitrogen replacement component is activated to balance the internal and external pressure difference. Pressure changes within the substrate units are monitored, and nitrogen is replenished as needed.
[0040] As an optional embodiment, in the case of a large ethylene oxide sterilizer not being fully loaded, the scenario is set to 30m. 3 The sterilizer can hold 10 trays of sterilized products. Two trays of medical devices need to be sterilized, which means the total capacity is 20%. The number of products to be sterilized is less than the number of trays that can be held. The configuration can be set up to fill the remaining 8 trays of sterilized products with 8 standard base units, so that the internal volume of the sterilizer chamber is filled to full capacity.
[0041] As an optional embodiment, 30m 3 The sterilizer was verified to have a maximum usable volume of 21m³. 3The required sample quantity for validation is 41 samples per cycle. Actual validation requirement (loading quantity): 2 pallets (approximately 3.4m³). 3 The initial validation sample requirement was 12 samples per cycle. However, by using a standard simulator, the number of validation samples can be reduced.
[0042] The implementation principle of a filling simulation system for optimizing the loading within a sterilization equipment space, as described in this application, is as follows: Flexible filling of the sterilization chamber is achieved through a combination of a standardized base unit and a detachable welded frame. Simultaneously, the internal pressure is dynamically adjusted by a nitrogen replacement component to ensure the stability of the sterilization environment. A pressure sensor monitors the pressure within the base unit in real time, and a controller adjusts the nitrogen charging and discharging rate according to a set threshold. A pressure gauge provides visual feedback, reducing manual intervention and saving operation time during the sterilization cycle. Furthermore, controlling pressure fluctuations within ±20 kPa avoids uneven sterilization temperature or concentration caused by pressure changes. A three-stage linkage system—vacuum pumping, quantitative nitrogen charging, and overpressure protection by an automatic pressure relief valve—ensures an inert environment within the base unit. Nitrogen replacement reduces ethylene oxide residue, thereby reducing the amount of chemicals required for sterilization. The nitrogen replacement component dynamically maintains the pressure within the base unit slightly lower than the sterilization chamber pressure, preventing contaminated gases from flowing back into the base unit and effectively maintaining a localized sterile environment. The grid support structure formed by the transverse ribs on the long side and the longitudinal ribs on the short side can improve the compressive strength in the combined state to adapt to the mechanical stress of frequent start-stop of the sterilizer, while filling the gaps in the frame and reducing leakage of the combined unit.
[0043] It should be understood that those skilled in the art can make improvements or modifications based on the above description, and all such improvements and modifications should fall within the protection scope of the appended claims.
Claims
1. A filling simulation system for optimizing the loading within the space of a sterilization device, characterized in that, include: At least one standardized matrix unit, the matrix unit being a hollow box structure, the surface of the matrix unit being coated with a nanoscale hydrophobic coating; The pressure regulating assembly includes an adjustable pressure regulating chamber, a pressure sensor, a controller, and a pressure gauge; the pressure sensor, in conjunction with the controller, adjusts the nitrogen charging and discharging rate within the substrate unit in real time; the pressure regulating chamber is used to maintain a stable pressure difference between the substrate unit and the sterilizer chamber; and the pressure gauge provides visual pressure feedback within the substrate unit. The nitrogen replacement assembly integrates a vacuum pump unit, a nitrogen filling device controlled by a two-way solenoid valve, and an automatic pressure relief valve; the vacuum pump unit is used to evacuate the base unit; the nitrogen filling device and the automatic pressure relief valve are used to balance the internal and external pressure difference between the base unit and the sterilizer. The substrate unit is dynamically connected to the chamber of the sterilizer via a nitrogen replacement component.
2. The filling simulation system for optimizing the loading within the space of a sterilization equipment according to claim 1, characterized in that, The base unit has transverse ribs along its long side and longitudinal ribs along its short side. Both the transverse ribs and the longitudinal ribs are welded to the base unit as a whole.
3. A filling simulation system for optimizing the loading within the space of a sterilization device according to claim 1, characterized in that, The corners of the base unit are all rounded.
4. A filling simulation system for optimizing the loading within the space of a sterilization device according to claim 1, characterized in that, The base unit is provided with a sealing door cover, which is connected to the unit by a flange, and a sealing ring is provided on the end of the sealing door cover that is connected to the base unit.
5. A filling simulation system for optimizing the loading within the space of a sterilization device according to claim 1, characterized in that, In the combined state, the interiors of the multiple base units are interconnected, and the adjacent base units are welded together. The combined base units include connecting base units, which are connected to the pressure regulating component and the nitrogen replacement component.
6. A filling simulation system for optimizing the loading within the space of a sterilization device according to claim 1, characterized in that, The base unit has an air extraction port and a safety port on its side wall. The air extraction pipeline of the vacuum pump unit is connected to the air extraction port through a corrugated pipe. The pressure relief port of the automatic pressure relief valve is connected to the safety port through a flexible pipeline. The air inlet channel of the bidirectional solenoid valve is connected to the nitrogen charging device through a quick-release clamp. The exhaust channel of the bidirectional solenoid valve is connected to the safety port through a pressure relief pipeline, and the pressure relief pipeline is equipped with a check valve.
7. A filling simulation system for optimizing the loading within the space of a sterilization device according to claim 1, characterized in that, The base unit is provided with a sealing flange, and the flange interface of the pressure regulating chamber is connected to the sealing flange through a double ferrule connector, and a sealing gasket is provided inside the double ferrule connector; the pressure sensor is communicatively connected to the controller; the base unit is provided with a pressure measuring port, and a capillary tube is connected to the pressure gauge, with both ends of the capillary tube fixedly connected to the pressure sensor and the pressure measuring port, respectively.
8. A filling simulation system for optimizing the loading within the space of a sterilization device according to claim 1, characterized in that, The structural dimensions of the base unit are 100×120×145cm, and the base unit can be freely combined.