Isolator based on separated hydrogen peroxide evaporation conveying system

Abstract

The utility model discloses an isolator based on a separated hydrogen peroxide evaporation conveying system, and relates to the technical field of pharmacy. Comprising a vaporized hydrogen peroxide generator, a conveying pipeline, a static pressure cabin and an operation cabin, the static pressure cabin and the operation cabin are arranged in an isolator box body, the vaporized hydrogen peroxide generator is communicated with the static pressure cabin through the conveying pipeline, and the static pressure cabin is communicated with the operation cabin through a circulating filter. The vaporized hydrogen peroxide generator comprises a storage and weighing system, a hydrogen peroxide evaporation system and a high-efficiency filter which are communicated in sequence, the storage and weighing system is used for storing and metering liquid hydrogen peroxide, and the hydrogen peroxide evaporation system is used for heating and vaporizing the liquid hydrogen peroxide; feeding into the static pressure cabin through a high-efficiency filter and a conveying pipeline; by designing the separated hydrogen peroxide evaporation conveying system, the equipment size and sanitation dead angles are reduced, and the pollution risk of a hydrogen peroxide evaporation device to a clean area is reduced.

Description

An isolator based on a separate hydrogen peroxide evaporation and delivery system Technical Field

[0001] This utility model relates to the field of pharmaceutical technology, specifically to an isolator based on a separate hydrogen peroxide evaporation and delivery system. Background Technology

[0002] In the pharmaceutical and biotechnology fields, aseptic manufacturing is a core element in ensuring product quality and safety. Controlling the aseptic manufacturing environment is crucial for preventing microbial contamination and ensuring drug purity and efficacy. As the pharmaceutical industry continues to evolve, the requirements for aseptic manufacturing technologies are becoming increasingly stringent.

[0003] A sterile isolator is a device used in medical, pharmaceutical, biotechnology, and laboratory environments to maintain sterile conditions. It is primarily used to isolate personnel and materials within a specific operating environment, preventing contamination from external air or microorganisms, thereby maintaining a sterile internal environment. Sterile isolators utilize online sterilization with hydrogen peroxide gas, followed by biological decontamination, to provide a continuous sterile environment for aseptic production and testing operations.

[0004] While existing isolator technology plays an important role in aseptic production, it has some limitations: 1. Space limitation: In traditional isolator designs, the hydrogen peroxide evaporation system is located in the static pressure chamber, resulting in a large equipment size that occupies a significant amount of space in cleanrooms, limiting its use; 2. Cleaning issues: The hydrogen peroxide weighing and conveying system is located in the clean area, increasing the difficulty of cleaning and maintenance, easily creating unsanitary areas, and making it difficult to meet the high standards of cleanliness required by GMP for equipment in clean areas. Summary of the Invention

[0005] This invention aims to address the technical problems of existing isolators where the hydrogen peroxide evaporation system is located in the static pressure chamber, resulting in large equipment volume, and the hydrogen peroxide weighing and conveying system is located in the clean area, posing significant cleaning difficulties. The purpose is to provide an isolator based on a separate hydrogen peroxide evaporation and conveying system. By designing a separate hydrogen peroxide evaporation and conveying system, the equipment volume and sanitary dead zones are reduced, thereby lowering the risk of contamination to the clean area by the hydrogen peroxide evaporation device.

[0006] This utility model is achieved through the following technical solution:

[0007] This utility model provides an isolator based on a separate hydrogen peroxide evaporation and delivery system, including a vaporized hydrogen peroxide generator, a delivery pipeline, a static pressure chamber and an operation chamber located inside the isolator housing. The vaporized hydrogen peroxide generator is connected to the static pressure chamber through the delivery pipeline, and the static pressure chamber is connected to the operation chamber through a circulation filter.

[0008] The vaporized hydrogen peroxide generator includes a storage and weighing system, a hydrogen peroxide evaporation system, and a high-efficiency filter connected in sequence. The storage and weighing system stores and measures liquid hydrogen peroxide. The storage and weighing system is connected to the inlet of the hydrogen peroxide evaporation system. The hydrogen peroxide evaporation system heats and vaporizes the liquid hydrogen peroxide to form hydrogen peroxide gas. The hydrogen peroxide gas is sent into the static pressure chamber through the high-efficiency filter and the delivery pipeline.

[0009] Furthermore, the storage and weighing system includes a liquid storage tank, a hydrogen peroxide storage tank, and an electronic scale. The hydrogen peroxide storage tank is located inside the liquid storage tank, and the electronic scale is located at the bottom of the hydrogen peroxide storage tank.

[0010] Furthermore, the storage tank is connected to a peristaltic pump via a delivery hose, and the peristaltic pump delivers liquid hydrogen peroxide from the storage tank to the hydrogen peroxide evaporation system.

[0011] Furthermore, the hydrogen peroxide evaporation system includes an evaporation chamber, an evaporation plate, and a heating rod. The evaporation plate is located inside the evaporation chamber, and the heating rod is located at the bottom of the evaporation plate for heating.

[0012] Furthermore, the hydrogen peroxide evaporation system also includes a conveying fan that guides and conveys hydrogen peroxide gas from the evaporation chamber.

[0013] Furthermore, a temperature control device is also installed at the end of the conveying pipeline.

[0014] Furthermore, the static pressure chamber is connected to a fresh air system, which includes a fresh air fan and a fresh air filter. The fresh air fan filters outside air and introduces it into the isolator.

[0015] Furthermore, the static pressure chamber is connected to an exhaust system, which includes an exhaust fan and an exhaust filter. The exhaust fan filters the gas inside the isolator and then discharges it.

[0016] Furthermore, the static pressure chamber is equipped with a circulating fan, a temperature and humidity sensor, and a hydrogen peroxide concentration sensor.

[0017] Furthermore, a flow equalization membrane is provided inside the operating chamber.

[0018] Compared with the prior art, this utility model has the following advantages and beneficial effects:

[0019] 1. This utility model significantly reduces the size of the equipment by moving the hydrogen peroxide evaporation system out of the static pressure chamber, and at the same time solves the problem of limited reserved space in the liquid preparation system of traditional isolators. Compared with traditional isolators, it reduces the space occupied by about 50%.

[0020] 2. By moving the hydrogen peroxide weighing and conveying system out of the static pressure chamber, this utility model reduces the risk of contamination to the clean area by the hydrogen peroxide evaporation device, reduces sanitary dead spots, ensures the cleanliness and sterility of the isolator, and meets the high standard cleaning requirements of GMP for equipment in the clean area.

[0021] 3. This utility model installs a temperature control device at the end of the conveying pipeline, which can monitor the temperature of the gas in the conveying pipeline in real time, ensuring that the hydrogen peroxide gas does not condense during the conveying process, so as to guarantee the sterilization effect. Attached Figure Description

[0022] The accompanying drawings, which are included to provide a further understanding of the embodiments of the present invention and form part of this application, do not constitute a limitation thereof. In the drawings:

[0023] Figure 1 is a schematic diagram of the structure of this utility model.

[0024] The attached diagram shows the markings and corresponding component names:

[0025] 1-Vaporized hydrogen peroxide generator, 2-High-efficiency filter, 3-Peristaltic pump, 4-Infusion hose, 5-Storage tank, 6-Hydrogen peroxide storage tank, 7-Electronic scale, 8-Leveling device, 9-Storage and weighing system, 10-Evaporation box, 11-Evaporation plate, 12-Heating rod, 13-Conveying fan, 14-Hydrogen peroxide evaporation system, 15-Conveying pipeline, 16-Exhaust fan, 17-Exhaust filter, 18-Static pressure chamber, 19-Operating chamber, 20-Flow equalization membrane, 21-Gloves, 22-Temperature control device, 23-Isolator housing, 24-Fresh air fan, 25-Fresh air filter, 26-Circulating fan, 27-Operating panel, 28-Circulating filter, 29-Lighting device, 30-Fresh air system, 31-Exhaust air system. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of this utility model clearer, the present utility model will be further described in detail below with reference to the embodiments and accompanying drawings. The illustrative embodiments and descriptions of this utility model are only used to explain this utility model and are not intended to limit this utility model.

[0027] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that these specific details are not necessary to implement the present invention. In other embodiments, well-known structures, circuits, materials, or methods are not specifically described in order to avoid obscuring the present invention.

[0028] Throughout this specification, references to "an embodiment," "an example," or "an example" mean that a particular feature, structure, or characteristic described in connection with that embodiment or example is included in at least one embodiment of the present invention. Therefore, the phrases "an embodiment," "an example," "an example," or "an example" appearing in various places throughout the specification do not necessarily refer to the same embodiment or example. Furthermore, specific features, structures, or characteristics can be combined in one or more embodiments or examples in any suitable combination and / or sub-combination. Moreover, those skilled in the art will understand that the illustrations provided herein are for illustrative purposes and are not necessarily drawn to scale. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0029] In the description of this utility model, the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship that the product of this application is usually placed in when in use, or the orientation or positional relationship that is commonly understood by those skilled in the art. It is only for the convenience of describing this application and simplifying the description, and is not intended to indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation of this application.

[0030] Meanwhile, the terms "set up," "assemble," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0031] Example 1

[0032] This embodiment 1 provides an isolator based on a separate hydrogen peroxide evaporation and delivery system, as shown in Figure 1. It includes a vaporized hydrogen peroxide generator 1, a delivery pipeline 15, a static pressure chamber 18 and an operation chamber 19 located inside the isolator housing 23. The vaporized hydrogen peroxide generator 1 is connected to the static pressure chamber 18 through the delivery pipeline 15, and the static pressure chamber 18 is connected to the operation chamber 19 through a circulation filter 28.

[0033] The vaporized hydrogen peroxide generator 1 includes a peristaltic pump 3, a delivery hose 4, a storage and weighing system 9, a hydrogen peroxide evaporation system 14, and a high-efficiency filter 2 connected in sequence. The storage and weighing system 9 stores and measures the liquid hydrogen peroxide. The peristaltic pump 3 and the delivery hose 4 deliver the liquid hydrogen peroxide into the hydrogen peroxide evaporation system 14. The hydrogen peroxide evaporation system 14 heats and vaporizes the liquid hydrogen peroxide to form hydrogen peroxide gas. The hydrogen peroxide gas is delivered into the static pressure chamber 18 through the high-efficiency filter 2 and the delivery pipe 15.

[0034] It should be noted that the isolator of this utility model adopts fully automatic control. It realizes integrated control of evaporation, conveying and sterilization processes through PLC. Parameters such as temperature, time and concentration operate automatically according to preset values. When it deviates from the preset range, an alarm is triggered. The equipment is connected to an operation panel 27, which makes it convenient for operators to operate the equipment.

[0035] When this invention is in use, the system is started, and the PLC controls the hydrogen peroxide evaporation system 14 to preheat to the set temperature. The hydrogen peroxide evaporation system 14 then starts operating, rapidly evaporating liquid hydrogen peroxide into gas through heating. The evaporated hydrogen peroxide gas passes through a high-efficiency filter 2 to remove impurities and microorganisms from the hydrogen peroxide gas, and is continuously transported to the static pressure chamber 18. After entering the static pressure chamber 18, the set concentration is maintained for sterilization. The airflow in the static pressure chamber 18 passes through a circulation filter 28 to remove impurities and microorganisms from the hydrogen peroxide gas, further keeping the gas entering the operating chamber 19 clean and ensuring a sterile environment in the operating chamber 19. During the sterilization process, the temperature, humidity, and hydrogen peroxide concentration in the static pressure chamber 18 are monitored in real time by sensors and fed back to the PLC. After sterilization is completed, the hydrogen peroxide gas in the static pressure chamber 18 is discharged.

[0036] In summary, this invention significantly reduces the size of the equipment by moving the hydrogen peroxide evaporation system 14 out of the static pressure chamber 18, and solves the problem of limited space reserved in the liquid preparation system of traditional isolators. Compared with traditional isolators, it reduces the space occupied by about 50%. This invention also reduces the risk of contamination to the clean area by moving the peristaltic pump 3, the infusion hose 4, and the storage and weighing system 9 out of the clean area, reduces the number of unsanitary corners, and meets the high standard of cleanliness requirements of GMP for equipment in the clean area.

[0037] Example 2

[0038] This embodiment further illustrates the technical solution of this utility model based on Embodiment 1.

[0039] As shown in Figure 1, the storage and weighing system 9 includes a liquid storage tank 5, a hydrogen peroxide storage tank 6, and an electronic scale 7. The hydrogen peroxide storage tank 6 is located inside the liquid storage tank 5, and the electronic scale 7 is located at the bottom of the hydrogen peroxide storage tank 6. The function of the storage and weighing system 9 is to integrate the storage and weighing of hydrogen peroxide, ensuring accurate measurement and storage of liquid hydrogen peroxide, while facilitating use and maintenance. The electronic scale 7 is equipped with a leveling device 8 at its bottom for leveling the scale 7 to ensure accurate weighing.

[0040] The storage tank 5 is connected to the peristaltic pump 3 via the infusion hose 4, and the peristaltic pump 3 delivers liquid hydrogen peroxide from the storage tank 5 to the hydrogen peroxide evaporation system 14.

[0041] Example 3

[0042] This embodiment further illustrates the technical solution of this utility model based on Embodiment 1.

[0043] As shown in Figure 1, the hydrogen peroxide evaporation system 14 includes an evaporation chamber 10, an evaporation plate 11, and a heating rod 12. The evaporation plate 11 is located inside the evaporation chamber 10, and the heating rod 12 is located at the bottom of the evaporation plate 11 to heat and vaporize the hydrogen peroxide at high temperature. The metered liquid hydrogen peroxide is delivered to the evaporation plate 11 by a peristaltic pump 3, and the high temperature generated by the heating rod 12 causes the hydrogen peroxide to change into a gaseous state.

[0044] To facilitate the transport of hydrogen peroxide gas, the hydrogen peroxide evaporation system 14 also includes a conveying fan 13, which provides power for transporting hydrogen peroxide gas and can guide the hydrogen peroxide gas out of the evaporation box 10 and transport it along the conveying pipeline 15.

[0045] Example 4

[0046] This embodiment further illustrates the technical solution of this utility model based on Embodiment 1.

[0047] As shown in Figure 1, a temperature control device 22 is also installed at the end of the conveying pipeline 15. By installing the temperature control device 22 at the end of the conveying pipeline 15, the temperature can be monitored in real time to ensure that the gas does not condense during the conveying process. The temperature control device 22 can be a temperature sensor, which transmits the detection data to the PLC to control the gas temperature in the conveying pipeline 15. An alarm is triggered when the temperature deviates from the preset range.

[0048] Example 5

[0049] This embodiment further illustrates the technical solution of this utility model based on Embodiment 1.

[0050] As shown in Figure 1, the static pressure chamber 18 is connected to a fresh air system 30. The fresh air system 30 includes a fresh air fan 24 and a fresh air filter 25. The fresh air fan 24 introduces outside air into the isolator after filtering it through the fresh air filter 25. By setting up the fresh air system 30, outside air can be sent into the isolator through the fresh air fan 24, while the fresh air filter 25 is used to filter and clean the fresh air from the outside, thereby preventing the ambient fresh air from damaging the sterile environment inside the isolator.

[0051] The static pressure chamber 18 is connected to an exhaust system 31, which includes an exhaust fan 16 and an exhaust filter 17. The exhaust fan 16 filters the gas inside the isolator through the exhaust filter 17 before discharging it. By setting up the exhaust system 31, the air inside the isolator can be discharged after sterilization, while the exhaust filter 17 is used to remove toxic and harmful substances from the gas, thus preventing environmental pollution.

[0052] The static pressure chamber 18 is equipped with a circulating fan 26, a temperature and humidity sensor, and a hydrogen peroxide concentration sensor. The circulating fan 26 circulates hydrogen peroxide gas within the isolator, ensuring that the hydrogen peroxide gas is delivered into the operating chamber 19 for sterilization. At the same time, the temperature and humidity sensor and the hydrogen peroxide concentration sensor monitor the temperature, humidity, and hydrogen peroxide concentration within the static pressure chamber 18 in real time to ensure that preset conditions are met.

[0053] Example 6

[0054] This embodiment further illustrates the technical solution of this utility model based on Embodiment 1.

[0055] As shown in Figure 1, the operating chamber 19 is equipped with a flow equalization membrane 20, a lighting device 29, and gloves 21. The flow equalization membrane 20 forms a vertical unidirectional flow through the airflow generated by the equalization circulating fan 26, allowing hydrogen peroxide gas to enter the operating chamber 19 for sterilization. During aseptic production operations in the operating chamber 19, lighting is provided by the lighting device 29, and aseptic operation is achieved by using gloves 21.

[0056] Finally, it should be noted that the above specific embodiments are only used to describe the purpose, technical solution, and beneficial effects of this utility model in detail. It should be understood that the above description is only a specific implementation of this utility model and is not intended to limit the protection scope of this utility model. Although this utility model has been described in detail with reference to the foregoing specific embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions or improvements can be made to some or all of the technical features. These modifications, equivalent substitutions, and improvements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model, and they should all be covered within the scope of the claims and specification of this utility model.

Claims

1. An isolator based on a separate hydrogen peroxide evaporation and delivery system, characterized in that, The system includes a vaporized hydrogen peroxide generator (1), a delivery pipeline (15), a static pressure chamber (18) and an operating chamber (19) located inside the isolator housing (23). The vaporized hydrogen peroxide generator (1) is connected to the static pressure chamber (18) via the delivery pipeline (15), and the static pressure chamber (18) is connected to the operating chamber (19) via a circulation filter (28). The vaporized hydrogen peroxide generator (1) includes a storage and weighing system (9), a hydrogen peroxide evaporation system (14), and a high-efficiency filter (2) connected in sequence. The storage and weighing system (9) stores and measures liquid hydrogen peroxide. The storage and weighing system (9) is connected to the inlet of the hydrogen peroxide evaporation system (14). The hydrogen peroxide evaporation system (14) heats and vaporizes the liquid hydrogen peroxide to form hydrogen peroxide gas. The hydrogen peroxide gas is sent into the static pressure chamber (18) through the high-efficiency filter (2) and the delivery pipeline (15).

2. The isolator based on a separate hydrogen peroxide evaporation and delivery system according to claim 1, characterized in that, The storage and weighing system (9) includes a liquid storage tank (5), a hydrogen peroxide storage tank (6), and an electronic scale (7). The hydrogen peroxide storage tank (6) is located inside the liquid storage tank (5), and the electronic scale (7) is located at the bottom of the hydrogen peroxide storage tank (6).

3. The isolator based on a separate hydrogen peroxide evaporation and delivery system according to claim 2, characterized in that, The storage tank (5) is connected to a peristaltic pump (3) via a delivery hose (4), and the peristaltic pump (3) delivers liquid hydrogen peroxide from the storage tank (5) to the hydrogen peroxide evaporation system (14).

4. The isolator based on a separate hydrogen peroxide evaporation and delivery system according to claim 1, characterized in that, The hydrogen peroxide evaporation system (14) includes an evaporation chamber (10), an evaporation plate (11), and a heating rod (12). The evaporation plate (11) is located inside the evaporation chamber (10), and the heating rod (12) is located at the bottom of the evaporation plate (11) for heating.

5. The isolator based on a separate hydrogen peroxide evaporation and delivery system according to claim 4, characterized in that, The hydrogen peroxide evaporation system (14) also includes a conveying fan (13) which guides hydrogen peroxide gas out of the evaporation chamber (10) and conveys it.

6. The isolator based on a separate hydrogen peroxide evaporation and delivery system according to claim 1, characterized in that, A temperature control device (22) is also installed at the end of the conveying pipeline (15).

7. The isolator based on a separate hydrogen peroxide evaporation and delivery system according to claim 1, characterized in that, The static pressure chamber (18) is connected to a fresh air system (30), which includes a fresh air fan (24) and a fresh air filter (25). The fresh air fan (24) filters outside air through the fresh air filter (25) and introduces it into the isolator.

8. The isolator based on a separate hydrogen peroxide evaporation and delivery system according to claim 1, characterized in that, The static pressure chamber (18) is connected to an exhaust system (31), which includes an exhaust fan (16) and an exhaust filter (17). The exhaust fan (16) filters the gas in the isolator through the exhaust filter (17) and then discharges it.

9. An isolator based on a separate hydrogen peroxide evaporation and delivery system according to any one of claims 1-8, characterized in that, The static pressure chamber (18) is equipped with a circulating fan (26), a temperature and humidity sensor, and a hydrogen peroxide concentration sensor.

10. An isolator based on a separate hydrogen peroxide evaporation and delivery system according to any one of claims 1-8, characterized in that, The operating chamber (19) is equipped with a flow equalization membrane (20).

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