Isolator based on separated hydrogen peroxide evaporation conveying system

Abstract

The invention 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 storage and weighing system is connected with an inlet of the hydrogen peroxide evaporation system; the hydrogen peroxide evaporation system heats and vaporizes liquid hydrogen peroxide, and then feeds the liquid hydrogen peroxide into the static pressure cabin through the high-efficiency filter and the 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

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and particularly relates to an isolator based on a separated hydrogen peroxide evaporation and transportation system. Background Art

[0002] In the fields of pharmacy and biotechnology, aseptic production is a core link to ensure the quality and safety of products. The control of aseptic production environment is crucial for preventing microbial contamination and ensuring the purity and efficacy of drugs. With the continuous development of the pharmaceutical industry, the requirements for aseptic production technology are also getting higher and higher.

[0003] An aseptic isolator is a device that maintains aseptic conditions in medical, pharmaceutical, biotechnological and laboratory environments. It is mainly used to isolate operators and operating items in a specific operating environment to prevent contamination by external air or microorganisms, thereby maintaining the aseptic state of the internal environment. The aseptic isolator provides a continuous aseptic environment for aseptic production and testing operations through on-line sterilization with hydrogen peroxide gas and biological decontamination.

[0004] Although the existing isolator technology plays an important role in aseptic production, there are some limitations: 1. Space limitation: In the traditional isolator design, the hydrogen peroxide evaporation system is set in the static pressure chamber, resulting in a large volume of the device, occupying a large space in the clean workshop, and having limitations in use; 2. Cleaning problem: The hydrogen peroxide weighing and transportation system is set in the clean area, increasing the difficulty of cleaning and maintenance, prone to generating sanitary dead corners, and difficult to meet the high-standard cleaning requirements of GMP for equipment in the clean area. Summary of the Invention

[0005] The present invention is to solve the technical problems that in the existing isolator, setting the hydrogen peroxide evaporation system in the static pressure chamber results in a large volume of the device, and setting the hydrogen peroxide weighing and transportation system in the clean area results in great cleaning difficulty. The purpose is to provide an isolator based on a separated hydrogen peroxide evaporation and transportation system. By designing a separated hydrogen peroxide evaporation and transportation system, the volume of the device and sanitary dead corners are reduced, and the pollution risk brought by the hydrogen peroxide evaporation device to the clean area is lowered.

[0006] The present invention is realized by the following technical solutions:

[0007] The present invention provides an isolator based on a separated hydrogen peroxide evaporation and transportation system, including a vaporized hydrogen peroxide generator, a transportation pipeline, a static pressure chamber and an operation chamber arranged inside the isolator box body. The vaporized hydrogen peroxide generator is communicated with the static pressure chamber through the transportation pipeline, and the static pressure chamber is communicated with 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 that are 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] Further, 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 arranged inside the liquid storage tank, and the electronic balance is arranged at the bottom of the hydrogen peroxide storage tank.

[0010] Further, the liquid storage tank is connected to a peristaltic pump through an infusion hose. The peristaltic pump transports the liquid hydrogen peroxide from the liquid storage tank to the hydrogen peroxide evaporation system.

[0011] Further, the hydrogen peroxide evaporation system includes an evaporation box, an evaporation tray, and heating rods. The evaporation tray is arranged inside the evaporation box, and the heating rods are located at the bottom of the evaporation tray for heating.

[0012] Further, the hydrogen peroxide evaporation system further includes a delivery fan. The delivery fan guides the hydrogen peroxide gas to be discharged from the evaporation box and transports it.

[0013] Further, a temperature control device is further arranged at the end of the delivery pipeline.

[0014] Further, the static pressure chamber is connected to a fresh air system. The fresh air system includes a fresh air fan and a fresh air filter. The fresh air fan introduces the outside air filtered by the fresh air filter into the isolator.

[0015] Further, the static pressure chamber is connected to an exhaust system. The exhaust system includes an exhaust fan and an exhaust filter. The exhaust fan discharges the gas in the isolator after filtering through the exhaust filter.

[0016] Further, a circulation fan, a temperature and humidity sensor, and a hydrogen peroxide concentration sensor are arranged inside the static pressure chamber.

[0017] Further, a uniform flow membrane is arranged inside the operation chamber.

[0018] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0019] 1. By moving the hydrogen peroxide evaporation system out of the static pressure chamber, the present invention significantly reduces the equipment volume, and at the same time solves the problem of limited reserved space in the traditional isolator liquid distribution system. Compared with the traditional isolator, the space occupation is reduced by about 50%.

[0020] 2. By moving the hydrogen peroxide weighing and conveying system out of the static pressure chamber, the present invention reduces the pollution risk brought by the hydrogen peroxide evaporation device to the clean area, reduces the sanitary dead corners, ensures the cleanliness and sterility inside the isolator, and meets the high-standard cleaning requirements of GMP for the equipment in the clean area.

[0021] 3. The present invention 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, ensure that the hydrogen peroxide gas does not condense during the conveying process, and guarantee the sterilization effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The drawings described herein are used to provide a further understanding of the embodiments of the present invention, form a part of this application, and do not constitute a limitation on the embodiments of the present invention. In the drawings:

[0023] Figure 1 is a schematic structural diagram of the present invention.

[0024] Markings in the drawings and corresponding component names:

[0025] 1 - Vaporized hydrogen peroxide generator, 2 - High-efficiency filter, 3 - Peristaltic pump, 4 - Infusion hose, 5 - Liquid storage tank, 6 - Hydrogen peroxide storage tank, 7 - Electronic scale, 8 - Leveling device, 9 - Storage and weighing system, 10 - Evaporation box, 11 - Evaporation pan, 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 - Operation chamber, 20 - Uniform flow membrane, 21 - Gloves, 22 - Temperature control device, 23 - Isolator box body, 24 - Fresh air fan, 25 - Fresh air filter, 26 - Circulation fan, 27 - Operation screen, 28 - Circulation filter, 29 - Lighting device, 30 - Fresh air system, 31 - Exhaust system. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0026] To make the objectives, technical solutions and advantages of the present invention more clear and understandable, the present invention will be further described in detail below in conjunction with the embodiments and the drawings. The illustrative embodiments and descriptions of the present invention are only used to explain the present invention and do not constitute a limitation on the present invention.

[0027] In the following description, a large number of specific details are set forth in order to provide a thorough understanding of the present invention. However, it is obvious to those of ordinary skill in the art that: the present invention does not have to employ these specific details. In other embodiments, well-known structures, circuits, materials or methods are not specifically described in order to avoid obscuring the present invention.

[0028] Throughout the specification, references to "one embodiment", "an embodiment", "one example" or "an example" mean that a particular feature, structure, or characteristic described in connection with the embodiment or example is included in at least one embodiment of the present invention. Thus, the phrases "one embodiment", "an embodiment", "one example" or "an example" appearing throughout the specification do not necessarily all refer to the same embodiment or example. In addition, the particular features, structures, or characteristics may be combined in any suitable combination and / or sub-combination in one or more embodiments or examples. Further, those of ordinary skill in the art should understand that the diagrams provided herein are for illustrative purposes only and are not necessarily drawn to scale. The term "and / or" used herein includes any and all combinations of one or more of the associated listed items.

[0029] In the description of the present invention, the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of this application is customarily placed during use, or the orientation or positional relationship commonly understood by those skilled in the art. It is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation of the present application.

[0030] Meanwhile, the terms "set", "assembled", "connected", "coupled" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0031] Embodiment 1

[0032] This Embodiment 1 provides an isolator based on a split hydrogen peroxide evaporation and transportation system, as Figure 1 shown, including a vaporized hydrogen peroxide generator 1, a transportation pipeline 15, a static pressure chamber 18 and an operation chamber 19 arranged inside an isolator box body 23. The vaporized hydrogen peroxide generator 1 is communicated with the static pressure chamber 18 through the transportation pipeline 15, and the static pressure chamber 18 is communicated with the operation chamber 19 through a circulation filter 28;

[0033] The vaporized hydrogen peroxide generator 1 includes a peristaltic pump 3, an infusion hose 4, a storage and weighing system 9, a hydrogen peroxide evaporation system 14, and a high-efficiency filter 2 that are connected in sequence. The storage and weighing system 9 stores and measures liquid hydrogen peroxide. The peristaltic pump 3 and the infusion hose 4 send 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 sent into the static pressure chamber 18 through the high-efficiency filter 2 and a delivery pipe 15.

[0034] It should be noted that the isolator of the present invention adopts full-automatic control, and the integrated control of the evaporation, delivery, and sterilization processes is realized through a PLC. Parameters such as temperature, time, and concentration operate automatically according to preset values, and an alarm is triggered when deviating from the preset range. The device is connected with an operation screen 27, which is convenient for operators to control the device.

[0035] When the present 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 starts to operate, quickly evaporating the liquid hydrogen peroxide into gas by heating. The evaporated hydrogen peroxide gas passes through the high-efficiency filter 2 to remove impurities and microorganisms in the hydrogen peroxide gas, and is continuously delivered into the static pressure chamber 18. After entering the static pressure chamber 18, sterilization treatment is carried out while maintaining the set concentration. The air flow in the static pressure chamber 18 passes through a circulation filter 28 to remove impurities and microorganisms in the hydrogen peroxide gas, further keeping the gas entering the operation chamber 19 clean and ensuring a sterile environment in the operation 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 the sterilization is completed, the hydrogen peroxide gas in the static pressure chamber 18 is discharged.

[0036] In summary, by moving the hydrogen peroxide evaporation system 14 out of the static pressure chamber 18, the present invention significantly reduces the volume of the device, and at the same time solves the problem of limited reserved space in the liquid distribution system of traditional isolators. Compared with traditional isolators, the space occupation is reduced by about 50%; by moving the peristaltic pump 3, the infusion hose 4, and the storage and weighing system 9 out of the clean area, the present invention reduces the pollution risk to the clean area, reduces the sanitary dead corners, and meets the high-standard cleaning requirements of GMP for equipment in the clean area.

[0037] Embodiment 2

[0038] This embodiment further illustrates the technical solution of the present invention on the basis of Embodiment 1.

[0039] As Figure 1As shown, 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 arranged inside the liquid storage tank 5, and the electronic scale is arranged 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, ensure the accurate measurement and storage of liquid hydrogen peroxide, and facilitate use and maintenance. A leveling device 8 is arranged at the bottom of the electronic scale 7 to level the electronic scale 7 to ensure accurate weighing.

[0040] Among them, the liquid storage tank 5 is connected to a peristaltic pump 3 through an infusion hose 4, and the peristaltic pump 3 transports liquid hydrogen peroxide from the liquid storage tank 5 to the hydrogen peroxide evaporation system 14.

[0041] Embodiment 3

[0042] This embodiment further illustrates the technical solution of the present invention on the basis of Embodiment 1.

[0043] As Figure 1 shown, the hydrogen peroxide evaporation system 14 includes an evaporation tank 10, an evaporation pan 11, and heating rods 12. The evaporation pan 11 is arranged inside the evaporation tank 10, and the heating rods 12 are located at the bottom of the evaporation pan 11 to heat and vaporize hydrogen peroxide at high temperature. The metered liquid hydrogen peroxide is sent into the evaporation pan 11 through the peristaltic pump 3, and the high temperature generated by the heating rods 12 causes hydrogen peroxide to turn into a gaseous state.

[0044] To facilitate the transportation of hydrogen peroxide gas, the hydrogen peroxide evaporation system 14 further includes a delivery fan 13. The delivery fan 13 provides the driving force for the transportation of hydrogen peroxide gas, and can guide the hydrogen peroxide gas to be discharged from the evaporation tank 10 and transported along the delivery pipeline 15.

[0045] Embodiment 4

[0046] This embodiment further illustrates the technical solution of the present invention on the basis of Embodiment 1.

[0047] As Figure 1 shown, a temperature control device 22 is further arranged at the end of the delivery pipeline 15. By arranging the temperature control device 22 at the end of the delivery pipeline 15, the temperature can be monitored in real time to ensure that the gas does not condense during transportation. The temperature control device 22 can adopt a temperature sensor, and the temperature control of the gas in the delivery pipeline 15 can be realized by transmitting the detected data to the PLC. When it deviates from the preset range, an alarm is triggered.

[0048] Embodiment 5

[0049] This embodiment further illustrates the technical solution of the present invention on the basis of Embodiment 1.

[0050] As Figure 1As shown, 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, the outside air can be sent into the isolator by the fresh air fan 24, and the fresh air filter 25 is used to filter and clean the fresh air from the outside, thus avoiding the destruction of the sterile environment inside the isolator by the environmental fresh air.

[0051] The static pressure chamber 18 is connected to an exhaust system 31. The exhaust system 31 includes an exhaust fan 16 and an exhaust filter 17. The exhaust fan 16 discharges the gas inside the isolator after filtering it through the exhaust filter 17. By setting up the exhaust system 31, the air inside the isolator can be discharged after sterilization is completed, and the exhaust filter 17 is used to remove toxic and harmful substances in the gas, avoiding environmental pollution.

[0052] A circulation fan 26, a temperature and humidity sensor, and a hydrogen peroxide concentration sensor are arranged inside the static pressure chamber 18. The hydrogen peroxide gas is made to flow inside the isolator by the circulation fan 26 to ensure that the hydrogen peroxide gas is delivered into the operation chamber 19 for sterilization. At the same time, the temperature, humidity, and hydrogen peroxide concentration inside the static pressure chamber 18 are monitored in real time by the temperature and humidity sensor and the hydrogen peroxide concentration sensor to ensure that the preset conditions are met.

[0053] Example 6

[0054] This example further illustrates the technical solution of the present invention on the basis of Example 1.

[0055] As Figure 1 shown, a uniform flow film 20, a lighting device 29, and gloves 21 are arranged inside the operation chamber 19. The uniform flow film 20 equalizes the airflow generated by the circulation fan 26 to form a vertical unidirectional flow, enabling the hydrogen peroxide gas to enter the operation chamber 19 for sterilization. Inside the operation chamber 19, when performing aseptic production operations, lighting is provided by the lighting device 29, and aseptic operation is achieved through the gloves 21.

[0056] Finally, it should be noted that: the above specific examples are only used to illustrate the purpose, technical solution, and beneficial effects of the present invention in detail. It should be understood that the above is only the specific implementation manner of the present invention and is not used to limit the protection scope of the present invention; although the present invention has been described in detail with reference to the above specific examples, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the above examples, or perform equivalent replacements or improvements on some or all of the technical features; and these modifications, equivalent replacements, and improvements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the various examples of the present invention, and they should all be covered within the scope of the claims and the description of the present invention.

Claims

1. An isolator based on a separate hydrogen peroxide evaporation and delivery system, characterized in that: The invention comprises a vaporized hydrogen peroxide generator (1), a delivery pipeline (15), a static pressure cabin (18) and an operation cabin (19) arranged inside an isolator box (23), wherein the vaporized hydrogen peroxide generator (1) is connected to the static pressure cabin (18) through the delivery pipeline (15), and the static pressure cabin (18) is connected to the operation cabin (19) through a circulation filter (28); The vaporized hydrogen peroxide generator (1) comprises a storage and weighing system (9), a hydrogen peroxide evaporation system (14) and a high-efficiency filter (2) which are connected in sequence. The storage and weighing system (9) stores and measures liquid hydrogen peroxide. The storage and weighing system (9) is connected to an 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 delivered into a static pressure cabin (18) through the high-efficiency filter (2) and a delivery pipeline (15).

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

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

4. The isolator based on the separated hydrogen peroxide evaporation delivery system according to claim 1 is characterized in that: The hydrogen peroxide evaporation system (14) comprises an evaporation box (10), an evaporation tray (11), and a heating rod (12); the evaporation tray (11) is arranged in the evaporation box (10); and the heating rod (12) is located at the bottom of the evaporation tray (11) for heating.

5. The isolator based on the separated hydrogen peroxide evaporation and delivery system according to claim 4 is characterized in that: The hydrogen peroxide evaporation system (14) further comprises a conveying fan (13), wherein the conveying fan (13) guides the hydrogen peroxide gas to be discharged from the evaporation box (10) and conveyed.

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

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

8. The isolator based on the separated hydrogen peroxide evaporation and delivery system according to claim 1, characterized in that: The static pressure cabin (18) is connected to an exhaust system (31), and the exhaust system (31) 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 the gas.

9. An isolator based on a separate hydrogen peroxide evaporation and delivery system according to any one of claims 1 to 8, characterized in that: A circulating fan (26), a temperature and humidity sensor, and a hydrogen peroxide concentration sensor are arranged in the static pressure cabin (18).

10. An isolator based on a separate hydrogen peroxide evaporation and delivery system according to any one of claims 1 to 8, characterized in that: A flow-balancing membrane (20) is arranged in the operating cabin (19).

Images