An Equivalent Detection Device Based on Ethylene Oxide Sterilizer EPCD

Abstract

This invention discloses an equivalent detection device for an EPCD (Electronic Power Distribution Device) in an ethylene oxide sterilizer, relating to the field of medical device sterilization technology. The device includes an EPCD placement chamber, a manifold, a water circulation pipeline, and a control device. The EPCD placement chamber has multiple detection units for placing the EPCD. The manifold precisely controls gas flow via a pneumatic control valve, and the water circulation pipeline maintains a stable temperature within the detection units, consistent with the temperature inside the ethylene oxide sterilizer. The control device monitors gas concentration and pressure using sensors and controls the operation of various components. This device achieves equivalent monitoring of the EPCD's status at multiple time points within the sterilizer, reflecting the sterilization status at various time points. It is easy to operate, has high detection efficiency, and has broad application prospects. By placing the EPCD within an equivalent environment sterilization monitoring device, this invention enables monitoring of the sterilization process at multiple points, eliminating the need to wait until sterilization is complete before detection. This significantly reduces the risk of sterilization failure and improves sterilization efficiency.

Description

Technical Field

[0001] This invention belongs to the field of medical device sterilization technology, and in particular relates to an EPCD equivalent detection device based on an ethylene oxide sterilizer. Background Technology

[0002] Ethylene oxide sterilization is a broad-spectrum sterilization method with characteristics such as strong penetration, low sterilization temperature, and minimal damage to products (compared to irradiation sterilization). It is one of the main sterilization methods for medical devices, especially disposable medical devices.

[0003] During the ethylene oxide sterilization validation process, we have already obtained the relationship between IPCD and EPCD. Therefore, during routine sterilization, as long as the EPCD sterilization test is qualified, the sterilized product can be considered to have reached the required sterility assurance level.

[0004] However, during conventional sterilization, deviations in actual parameters cannot guarantee that every sterilization process will be successful. We can only obtain the EPCD (Epoxy Processing Disc) after sterilization by actually testing the disc inside the sterilizer. This significantly extends product release time. If sterilization fails, the entire sterilization cycle and BI (Biochemical Incubation) must be completed before any action can be taken, requiring a second sterilization. This further prolongs product release and market launch times, increases the risk of excessive residue levels, and impacts production and sales. There is an urgent need for equipment that can monitor the EPCD status during sterilization, allowing for early prediction of sterilization status and intervention within the sterilization cycle to ensure successful sterilization in cases of potential failure. Summary of the Invention

[0005] The purpose of this invention is to provide an equivalent detection device based on an ethylene oxide sterilizer EPCD. By placing the EPCD inside the equivalent environmental sterilization monitoring device, the sterilization process can be monitored in real time, eliminating the need to wait until sterilization is complete before testing. This significantly reduces the risk of sterilization failure and improves sterilization efficiency.

[0006] To solve the above-mentioned technical problems, the present invention is achieved through the following technical solution: This invention relates to an EPCD equivalent detection device based on an ethylene oxide sterilizer. The device is installed outside the ethylene oxide sterilizer and connected to the sampling port of the ethylene oxide sterilizer, comprising: An EPCD placement cavity is divided into several parallel and independent detection units. An EPCD is placed inside each detection unit, and an air inlet and an exhaust outlet are provided on each detection unit. The manifold is equipped with a main air inlet pipe, a main air return pipe and a main exhaust pipe. The main air inlet pipe is connected to the sampling port of the ethylene oxide sterilizer via a pneumatic diaphragm pump. The main air return pipe is connected to the inner cavity of the ethylene oxide sterilizer. A vacuum generator is connected to the outside of the main exhaust pipe. The main intake pipe, main return pipe, and main exhaust pipe are each equipped with an intake branch pipe, a return branch pipe, and an exhaust branch pipe that are connected to the detection unit one by one. The intake branch pipe, the return branch pipe, and the exhaust branch pipe are all connected to a pneumatic control valve. The pneumatic control valve is connected to the intake port and the exhaust port on the detection unit to control the gas circulation. The water circulation pipeline connecting the ethylene oxide sterilizer and the EPCD placement chamber is used for hot water circulation. The water circulation pipeline includes a circulation inlet pipe and a circulation outlet pipe. A pneumatic ball valve and a hot water circulation pump are installed on the water circulation pipeline. The control device is used to control various electronic components of the entire device, and can provide multi-stage parameter recording and process control.

[0007] As a preferred embodiment of the present invention, the EPCD placement cavity includes a container shell, which is divided into 12 parallel detection units. The water circulation pipeline passes through the detection units in sequence, and a heat insulation layer is provided inside the container shell.

[0008] As a preferred embodiment of the present invention, the detection unit is provided with an EPCD loading inlet, the EPCD loading inlet is provided with a sealing plug, and the container shell is provided with temperature and humidity sensors corresponding to the detection units.

[0009] As a preferred embodiment of the present invention, the pneumatic control valve is provided with valve core A, valve core B, valve core C, valve core D and interfaces 1, 2, 3, 4, 5 and 6. The front sides of valve core A and valve core B are connected to interface 1, which is connected to the air inlet on the detection unit. The front sides of valve core C and valve core D are connected to interface 2, which is connected to the exhaust port on the detection unit. The rear sides of valve core A, valve core B, valve core C and valve core D correspond one-to-one with interfaces 3, 4, 5 and 6, respectively. Interface 3 is connected to the air inlet branch pipe, interface 5 is connected to the air return branch pipe, interface 6 is connected to the exhaust branch pipe, and interface 4 is connected to external air.

[0010] As a preferred embodiment of the present invention, an EO concentration sensor and a pressure sensor are provided on the main intake pipe.

[0011] As a preferred embodiment of the present invention, the control device includes a touch screen and a PLC control circuit.

[0012] The present invention has the following beneficial effects: 1. Convenient to retrieve and place: Ordinary EPCDs are placed on the surface of the product loading area and can only be retrieved after sterilization by opening the sterilization cabinet. This device is located outside the sterilization cabinet and has multiple channels. It can be used to retrieve the BI directly without opening the sterilization cabinet during the sterilization process by selecting to close a certain channel.

[0013] 2. Saves time and costs: It can achieve the sterilization effect of different forms of EPCD at different sterilization times in the same sterilization cycle, thereby reducing the number of short-cycle sterilizations, increasing the first-time success rate of validation, and thus shortening the entire sterilization validation time cycle and reducing validation costs.

[0014] 3. Sampling at different time points within the same sterilization cycle: This is used for preliminary confirmation of the half-cycle time. Typically, the sterilization time for a half-cycle is 8-16 times the D value. With this device, a sterilization cycle can be performed at a D value of 16 times. By sampling at different times, the effectiveness of the 8-16 times D value can be monitored.

[0015] 4. Positioning Comparison: By adjusting the position of the pipe inserted into the sterilizer, this device can monitor any desired location within the sterilizer. This allows for positioning comparison, ensuring more accurate monitoring results.

[0016] 5. Deviation Handling: In normal sterilization batches, if parameter deviations occur, the sterilization effect can be preliminarily predicted through the BI monitoring results within this device. This allows for a rapid response and a more timely and appropriate handling plan when problems are detected. Of course, any product implementing this invention does not necessarily need to achieve all the advantages described above simultaneously. Attached Figure Description

[0017] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, 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.

[0018] Figure 1 This is a schematic diagram of the overall structure of the device; Figure 2 This is a schematic diagram of the EPCD placement cavity in this device; Figure 3 This is a schematic diagram of the pneumatic control valve in this device; The components represented by each number in the attached diagram are listed below: 1-Sterilizer water jacket; 2-Sterilizer chamber; 3-EPCD test housing; 4-Pneumatic diaphragm pump; 5-Vacuum generator; 6-Manifold; 7-EO concentration sensor; 8-Pressure sensor; 9-Pneumatic control valve; 10-EPCD placement chamber; 11-Temperature and humidity sensor; 12-Pneumatic ball valve; 13-Control device; 14-Hot water circulation pump; 15-Circulating water inlet pipe; 16-Temperature sensor interface; 17-Container shell; 18-EPCD inlet; 19-EPCD; 20-Circulating water return pipe; 21-Air inlet; 22-Exhaust outlet; 23-Insulation layer. Detailed Implementation

[0019] 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. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] In the description of this invention, it should be understood that the terms "opening", "upper", "lower", "thickness", "top", "middle", "length", "inner", "around", etc., which indicate orientation or positional relationship, are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the components or elements referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting this invention.

[0021] like Figure 1As shown: An equivalent detection device based on an EPCD of an ethylene oxide sterilizer is installed outside the ethylene oxide sterilizer and connected to the sampling port of the ethylene oxide sterilizer. The device includes: an EPCD placement chamber 10, which is divided into several parallel and independent detection units, each containing an EPCD 19. Each detection unit has an air inlet 21 and an exhaust outlet 22; a manifold 6, which contains a main air inlet pipe, a main air return pipe, and a main exhaust pipe. The main air inlet pipe is connected to the sampling port of the ethylene oxide sterilizer via a pneumatic diaphragm pump 4. The main air return pipe is connected to the inner cavity of the ethylene oxide sterilizer. A vacuum generator 5 is connected to the outside of the main exhaust pipe. The main air inlet pipe, main air return pipe, and main exhaust pipe are respectively... The device is equipped with an inlet branch pipe, a return branch pipe, and an exhaust branch pipe, each corresponding to a detection unit. All three branches are connected to a pneumatic control valve 9, which is connected to the inlet 21 and exhaust 22 on the detection unit to control gas circulation. A water circulation pipeline connecting the ethylene oxide sterilizer and the EPCD placement chamber 10 is used for hot water circulation. The water circulation pipeline includes a circulation inlet pipe 15 and a circulation outlet pipe, and is equipped with a pneumatic ball valve 12 and a hot water circulation pump 14. A control device 13 is used to control various electronic components of the entire device. The EPCD placement chamber 10, the manifold 6, the pneumatic control valve 9, and the water circulation pipeline are all integrated onto the EPCD test housing 3.

[0022] In this embodiment, the core component of the device is the EPCD placement chamber 10. This EPCD placement chamber 10 is cleverly divided into multiple parallel and independent detection units, each containing an EPCD19. This design allows us to test the sterilization effect of EPCD19 at different stages within the same sterilization cycle, reducing the number of short-cycle sterilizations, increasing the first-time success rate of validation, thereby shortening the overall sterilization validation time cycle and reducing validation costs. Another key component of the device is the manifold 6. Its internal structure includes a main intake pipe, a main return pipe, and a main exhaust pipe. Each of the main intake pipe, main return pipe, and main exhaust pipe is equipped with an intake branch pipe, a return branch pipe, and an exhaust branch pipe that are connected to each detection unit. Multiple sets of pipelines are connected to the ethylene oxide sterilizer, and the gas circulation between the EPCD placement chamber 10 and the sterilizer cavity is realized through the pneumatic diaphragm pump 4, ensuring that the environment of the two is consistent and that the gas can be effectively exchanged between the various units. The inlet branch pipe, return branch pipe and exhaust branch pipe are all connected to the pneumatic control valve 9. Through the precise regulation of the control valve, we can achieve precise control of gas circulation.

[0023] To maintain stable system operation, the device is also designed with a water circulation pipeline that connects the ethylene oxide sterilizer to the EPCD placement chamber 10. This water circulation pipeline includes a circulation inlet pipe 15 and a circulation outlet pipe, which together are responsible for the circulation supply of hot water. The water in the heating jacket of the ethylene oxide sterilizer is used to heat the EPCD equivalent device, thus ensuring that the two temperatures are consistent.

[0024] Finally, the entire operation of the device relies on the support of the control device 13. This control device 13, composed of various electronic components, is responsible for monitoring the device's operating status and making corresponding adjustments based on actual conditions. Through the precise control of the control device 13, we can ensure the device operates stably under various environments, providing reliable safety assurance for the ethylene oxide sterilization process.

[0025] like Figure 2 As shown: The EPCD placement cavity 10 includes a container shell 17, which is divided into 12 parallel detection units. A water circulation pipeline passes through each detection unit in sequence. An insulation layer 23 is installed inside the container shell 17. Each detection unit is equipped with an EPCD loading inlet 18, which is fitted with a sealing plug. Several temperature and humidity sensors 11, corresponding to each detection unit, are installed on the outside of the container shell 17.

[0026] In this embodiment, the EPCD placement chamber 10 is divided into 12 independent detection units, each with an air inlet 21 and an exhaust outlet 22. Each detection unit has an external temperature and humidity sensor interface 16 connected to a temperature and humidity sensor 11 for monitoring ambient temperature and humidity. Inside the EPCD placement chamber 10, there are multiple circulating water pipe networks. The main circulating water inlet pipe 15 and circulating water return pipe 20 are connected to the inlet and outlet of the sterilizer's hot water circulation system, providing the device with the same heating method and heat as the sterilizer. The outer end of the EPCD placement chamber 10 is covered with insulation material. Each detection unit in the EPCD placement chamber 10 has an EPCD loading port 18, which is sealed with a threaded plug. Before sterilization, EPCDs 19 need to be placed into the chamber unit and the plug tightened. This device can hold a total of 12 EPCDs 19 simultaneously.

[0027] The hot water circulation in the EPCD placement chamber 10 is controlled by a pneumatic ball valve 12, and the hot water circulation pump provides power for the hot water circulation in the water jacket of the EPCD equivalent detection device and the sterilizer.

[0028] In summary, the EPCD placement chamber 10 is a meticulously designed container, with its core component being the container shell 17. The unique feature of this container shell 17 is that it is divided into 12 parallel detection units, each with its own water circulation pipeline. These pipelines pass sequentially through the detection units, ensuring the uniformity and stability of the internal temperature. To maintain the EPCD 19 in an optimal temperature environment for testing, an insulation layer 23 is also installed inside the container shell 17. The insulation layer 23 uses advanced thermal insulation materials, effectively reducing the impact of external temperature fluctuations on the internal environment of the container, thereby ensuring the stability and reliability of the EPCD. Each detection unit has an EPCD loading port 18, designed for both ease of operation and airtightness. To ensure the airtightness of the loading port, a sealing plug is installed at the loading port, effectively preventing the intrusion of external impurities and ensuring the cleanliness of the detection unit. Furthermore, to monitor the internal temperature and humidity environment of the container in real time, several temperature and humidity sensors 11, corresponding to each detection unit, are installed on the outside of the container shell 17. These sensors can accurately measure the temperature and humidity of each detection unit, providing operators with real-time and accurate environmental data. This ensures that the EPCD in the equivalent detection device is consistent with the EPCD environment inside the cabinet. During routine sterilization, 12 EPCDs are placed into the EPCD placement cavity unit before sterilization and the plug is tightened. Based on experience, we can divide the sterilization exposure stage into several stages. Several EPCDs are taken out and cultured in each stage. This allows us to understand the sterilization status of multiple stages without opening the sterilizer cabinet door, and then determine whether to continue sterilization or take other measures.

[0029] like Figure 1 and Figure 3 As shown, the pneumatic control valve 9 is equipped with valve cores A, B, C, and D, and interfaces 1, 2, 3, 4, 5, and 6. The front sides of valve cores A and B are connected to interface 1, which in turn connects to the air inlet 21 on the detection unit. The front sides of valve cores C and D are connected to interface 2, which in turn connects to the exhaust port 22 on the detection unit. The rear sides of valve cores A, B, C, and D correspond one-to-one with interfaces 3, 4, 5, and 6, respectively. Interface 3 connects to the intake branch pipe, interface 5 connects to the return branch pipe, interface 6 connects to the exhaust branch pipe, and interface 4 connects to external air. EO concentration sensors 7 and 8, and pressure sensors, are installed on the main intake pipe.

[0030] In this embodiment, during actual use, the pneumatic control valve 9 controls the EPCD placement chamber 10 to perform vacuuming, drug dosing, circulation, and exhaust functions. When valve cores A and C of the pneumatic control valve 9 are open, and valve cores B and D are closed, interfaces 3 and 5 are connected to the inlet and return air branches of the manifold 6, respectively, and are connected to the sampling port of the sterilizer through pipelines. A pneumatic diaphragm pump 4 is installed between the sterilizer sampling port and the manifold 6. In this state, when the sterilizer is evacuated and dosing chemicals, the EPCD placement chamber 10 is also evacuated and dosing chemicals. The gas in the sterilizer and the gas in the EPCD placement chamber 10 are circulated and replaced by the pneumatic diaphragm pump 4 to achieve the purpose of consistent gas composition and environment. A vacuum generator 5 is installed at the external exhaust port 22 of the main exhaust pipe of the manifold 6. When valve cores B and D of the pneumatic control valve 9 are open and valve cores A and C are closed, the interfaces 4 and 6 are connected to the air port and the exhaust branch pipe of the manifold 6, respectively. The gas in the EPCD placement chamber 10 is drawn to the outside by the vacuum generator 5 to achieve the exhaust function, reducing the possibility of operators being exposed to ethylene oxide and increasing equipment safety.

[0031] The manifold 6 contains a main intake pipe, a main return pipe, and a main exhaust pipe. Each main pipe is divided into 12 branches, each connected to a corresponding interface of the pneumatic control valve 9. An 8-pressure sensor and an ethylene oxide concentration sensor are installed on the main intake pipe of the system circulation to monitor the pressure and concentration and compare them with the sterilizer, ensuring that the internal environment of the EPCD equivalent detection device is consistent with the internal environment of the sterilizer. The pneumatic control valve 9 can achieve multi-channel on / off control, switching between gas circulation and air intake / exhaust functions. Multiple sets of temperature and humidity sensors 11, concentration sensors, and pressure sensors 8 are used to monitor the equivalent EPCD environment to ensure it closely approximates the environment inside the ethylene oxide sterilizer cabinet. This patented device, when used in conventional sterilization processes, can effectively reduce the risk of sterilization failure, significantly improve sterilization efficiency, and accelerate product time-to-market.

[0032] like Figure 1 As shown: The control device 13 includes a control chip and a touch screen. The control system can set any EPCD retrieval time to obtain the desired result. The control device 13 is controlled by a touch screen and a PLC, and has diverse functions and stable performance.

[0033] In the description of this specification, the references to terms such as "an embodiment," "example," "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. The preferred embodiments of the present invention disclosed above are merely for the purpose of illustrating the present invention. The preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific embodiments described. Obviously, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the present invention, thereby enabling those skilled in the art to better understand and utilize the present invention. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A detection device based on an EPCD equivalent of an ethylene oxide sterilizer, the device being installed outside the ethylene oxide sterilizer and connected to the sampling port of the ethylene oxide sterilizer, characterized in that, include: An EPCD placement cavity is divided into several parallel and independent detection units. An EPCD is placed inside each detection unit, and an air inlet and an exhaust outlet are provided on each detection unit. The manifold is equipped with a main air inlet pipe, a main air return pipe and a main exhaust pipe. The main air inlet pipe is connected to the sampling port of the ethylene oxide sterilizer via a pneumatic diaphragm pump. The main air return pipe is connected to the inner cavity of the ethylene oxide sterilizer. A vacuum generator is connected to the outside of the main exhaust pipe. The main intake pipe, main return pipe, and main exhaust pipe are each equipped with an intake branch pipe, a return branch pipe, and an exhaust branch pipe that are connected to the detection unit one by one. The intake branch pipe, the return branch pipe, and the exhaust branch pipe are all connected to a pneumatic control valve. The pneumatic control valve is connected to the intake port and the exhaust port on the detection unit to control the gas circulation. The water circulation pipeline connecting the ethylene oxide sterilizer and the EPCD placement chamber is used for hot water circulation. The water circulation pipeline includes a circulation inlet pipe and a circulation outlet pipe. A pneumatic ball valve and a hot water circulation pump are installed on the water circulation pipeline. The control device is used to control various electronic components of the entire device, and can provide multi-stage parameter recording and process control.

2. The EPCD equivalent detection device based on an ethylene oxide sterilizer according to claim 1, characterized in that, The EPCD placement cavity includes a container shell, which is divided into 12 parallel detection units. The water circulation pipeline passes through the detection units in sequence, and an insulation layer is provided inside the container shell.

3. The EPCD equivalent detection device based on an ethylene oxide sterilizer according to claim 2, characterized in that, The detection unit is equipped with an EPCD loading inlet, which is fitted with a sealing plug. The container shell is equipped with temperature and humidity sensors that correspond one-to-one with the detection unit.

4. The EPCD equivalent detection device based on an ethylene oxide sterilizer according to claim 1, characterized in that, The pneumatic control valve is equipped with valve core A, valve core B, valve core C, valve core D and interfaces 1, 2, 3, 4, 5 and 6. The front sides of valve cores A and B are connected to interface 1, which is connected to the air inlet on the detection unit. The front sides of valve cores C and D are connected to interface 2, which is connected to the exhaust port on the detection unit. The rear sides of valve cores A, B, C, and D correspond one-to-one with interfaces 3, 4, 5, and 6, respectively. Interface 3 is connected to the air inlet branch pipe, interface 5 is connected to the air return branch pipe, interface 6 is connected to the exhaust branch pipe, and interface 4 is connected to external air.

5. The EPCD equivalent detection device based on an ethylene oxide sterilizer according to claim 1, characterized in that, An EO concentration sensor and a pressure sensor are installed on the main intake pipe.

6. The EPCD equivalent detection device based on an ethylene oxide sterilizer according to claim 1, characterized in that, The control device includes a touch screen and a PLC control circuit.

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