A nitrogen replacement protection control system for isolators
Patent Information
- Application Number
- CN202522300314.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-10-30
- Publication Date
- 2026-09-01
- Estimated Expiration
- 2035-10-30
AI Technical Summary
[0003]现有技术中隔离器在生产阶段需要持续注入氮气且排风系统持续运行,以维持内部负压及氧浓度维持在设定值下;在生产过程中需要消耗大量氮气
[0021]利用在使用顶部进气底部排气方式,使设备既能快速达到低氧环境,氧浓度传感器设置于隔离器下方,保障隔离器最差位置氧浓度符合要求;
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Figure CN224700191U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of isolator technology, and more specifically, to an isolator nitrogen replacement protection control system. Background Technology
[0002] In modern pharmaceutical production, isolators are increasingly used to process powdered drugs. Many drugs are easily oxidized by oxygen, which affects their efficacy. Drugs that are prone to reacting with air are generally handled in isolators under inert gas protection.
[0003] In the existing technology, the isolator requires continuous injection of nitrogen and continuous operation of the exhaust system during the production stage to maintain the internal negative pressure and oxygen concentration at the set value; a large amount of nitrogen is consumed during the production process.
[0004] In conclusion, how to effectively reduce nitrogen consumption during the production stage is a problem that urgently needs to be solved by those skilled in the art. Utility Model Content
[0005] In view of this, the purpose of this utility model is to provide a nitrogen replacement protection control system for isolators, which can quickly exhaust the air inside the isolator, provide a low-oxygen environment, protect the medicine from oxidation, rely on the high sealing performance of the isolator and the negative pressure formed by the exhaust fan to reduce the leakage of medicine, protect the operators and the environment, and at the same time greatly reduce the nitrogen consumption through the internal circulation pipeline.
[0006] To achieve the above objectives, this utility model provides the following technical solution:
[0007] A nitrogen replacement protection control system for an isolator includes an isolator, with an air inlet at the upper end of the isolator in the height direction and an exhaust port at the lower end of the isolator in the height direction. A circulation pipeline is connected between the air inlet and the exhaust port outside the isolator.
[0008] The other inlet of the air inlet is also connected to an air intake assembly, and the other outlet of the exhaust port is also connected to an exhaust assembly.
[0009] Preferably, the intake assembly includes:
[0010] A nitrogen cylinder, wherein an air inlet pipe is connected between the outlet of the nitrogen cylinder and the air inlet, and the air inlet pipe is equipped with a pressure regulator for adjusting the ammonia pressure.
[0011] Preferably, the pressure regulating component includes a pressure reducing valve, a pressure sensor, and a first valve sequentially disposed on the air intake pipe.
[0012] Preferably, the pressure reducing valve is a filter pressure reducing valve.
[0013] Preferably, the pressure sensor is equipped with an alarm unit so that it can issue an alarm when it detects a pressure deviation from a set value.
[0014] Preferably, the exhaust assembly includes an exhaust pipe disposed at the exhaust port, and a second valve and an exhaust fan are sequentially disposed on the exhaust pipe.
[0015] Preferably, a filter element is provided on the exhaust pipe between the second valve and the air inlet.
[0016] Preferably, the filter element includes a medium-efficiency filter and a high-efficiency filter arranged sequentially along the exhaust direction on the exhaust pipe.
[0017] Preferably, a third valve and a circulating fan are sequentially arranged on the circulation pipeline from the air inlet to the exhaust outlet, and the end of the circulation pipeline opposite to the air inlet is connected to the output end of the filter element.
[0018] Preferably, the bottom of the isolator is provided with an oxygen concentration sensor for monitoring the oxygen content inside the isolator, and the top of the isolator is provided with a differential pressure sensor for monitoring the internal pressure difference.
[0019] The nitrogen replacement protection control system for isolators provided by this utility model utilizes an air intake component to introduce nitrogen into the isolator, and works in conjunction with an exhaust component to replace the gas inside the isolator, thereby rapidly reducing the oxygen concentration below a set oxygen concentration. After a delay following the oxygen concentration dropping below the set value, the system enters production mode. In production mode, both the air intake and exhaust components are shut off, and the air inside the isolator is maintained in an internal circulation state through a circulation pipeline, continuously maintaining a negative pressure state. When the oxygen concentration inside the isolator is about to exceed the standard, the replacement mode is activated again. This cycle repeats continuously, ensuring that the oxygen concentration inside the isolator remains below the set value while effectively reducing nitrogen consumption.
[0020] The further solutions provided in this application can also achieve at least one of the following beneficial technical effects:
[0021] By using a top-intake and bottom-exhaust method, the equipment can quickly reach a low-oxygen environment. The oxygen concentration sensor is located below the isolator to ensure that the oxygen concentration at the worst point of the isolator meets the requirements.
[0022] The production process adopts an internal gas circulation method, which ensures that the pressure difference inside the chamber is negative while greatly reducing nitrogen consumption and saving energy.
[0023] The exhaust system uses a two-stage filtration system of medium-efficiency and high-efficiency filters, which can greatly extend the service life of the exhaust system and reduce operating costs.
[0024] By using a differential pressure sensor to continuously adjust and provide feedback on the differential pressure of the isolator, the differential pressure of the isolator is kept stable. Attached Figure Description
[0025] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.
[0026] Figure 1 This is a schematic diagram of the nitrogen replacement protection control system for the isolator in this embodiment.
[0027] The reference numerals in the figures include:
[0028] 1. Isolator; 2. Pressure reducer; 3. Pressure sensor; 4. First valve; 5. Third valve; 6. Circulating fan; 7. Medium-efficiency filter; 8. High-efficiency filter; 9. Second valve; 10. Exhaust fan; 11. Differential pressure sensor; 12. Oxygen concentration sensor. Detailed Implementation
[0029] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.
[0030] Unless otherwise defined, the technical or scientific terms used in this application shall have the ordinary meaning understood by one of ordinary skill in the art to which this utility model pertains. The terms "first," "second," and similar words used in this utility model do not indicate any order, quantity, or importance. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. Terms such as "upper," "lower," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly. This application discloses an isolator nitrogen replacement protection control system.
[0031] The core of this utility model is to provide a nitrogen replacement protection control system for isolators.
[0032] Please refer to Figure 1 .
[0033] The isolator nitrogen replacement protection control system provided by this utility model includes an isolator 1, with an air inlet at the upper end of the isolator 1 in the height direction and an exhaust port at the lower end of the isolator 1 in the height direction. A circulation pipeline is connected between the air inlet and the exhaust port outside the isolator 1. The other inlet of the air inlet is also connected to an air intake component, and the other outlet of the exhaust port is also connected to an exhaust component.
[0034] Specifically, isolator 1 is a pharmaceutical device that achieves high isolation between the inside and outside of isolator 1. Along the height direction of isolator 1, based on the density difference between nitrogen and air, an air inlet for nitrogen is opened at its top, and an air outlet for air is opened at its bottom. These outlets work in conjunction with air intake and exhaust components to achieve nitrogen intake and oxygen-containing air exhaust. A circulation pipeline is also provided between the air inlet and exhaust outlet, which is opened after the air intake and exhaust components are closed to achieve internal gas circulation within isolator 1.
[0035] Furthermore, after isolator 1 completes the leak detection and passes the inspection, the control system enters the replacement mode, opens the intake and exhaust components and closes the circulation path. Nitrogen is introduced into isolator 1 through the intake component and the oxygen-containing air at the bottom of isolator 1 is discharged through the exhaust component, thereby quickly replacing the air inside isolator 1 and rapidly reducing the oxygen concentration in the air to below the set oxygen concentration. After the oxygen concentration drops below the set value and remains below it for a period of time, the control system enters the production mode, closes the intake and exhaust components, and opens the circulation pipeline to maintain the air inside isolator 1 in an internal circulation state. At this time, isolator 1 maintains a negative pressure state. When the oxygen concentration inside isolator 1 is about to exceed the set value, the circulation pipeline is closed and the intake and exhaust components are opened simultaneously. The replacement mode described above is repeated to maintain the oxygen concentration inside isolator 1 below the set value. In the replacement mode, PID control can be used to adjust the pressure difference between the inside and outside of isolator 1 to maintain stability.
[0036] The aforementioned isolator nitrogen replacement protection control system can quickly exhaust the air inside the isolator, providing a low-oxygen environment to protect the medicine from oxidation. Relying on the high sealing performance of the isolator and the negative pressure formed by the exhaust components, it reduces the leakage of medicine, protecting operators and the environment. At the same time, through the circulation pipeline, it greatly reduces the amount of nitrogen consumed.
[0037] The nitrogen replacement protection control system for isolators provided by this utility model will be described in more detail below with reference to the accompanying drawings and specific embodiments.
[0038] In one specific implementation, reference is made to... Figure 1 The air intake assembly includes a nitrogen cylinder, and an air intake pipe is connected between the outlet of the nitrogen cylinder and the air intake port. The air intake pipe is equipped with a pressure regulator for adjusting the ammonia pressure.
[0039] Specifically, the nitrogen cylinder is a container for storing nitrogen gas, typically made of high-strength steel to ensure storage safety. Other containers suitable for storing ammonia may also be used in other embodiments. The inlet pipe connects the nitrogen cylinder to the inlet of isolator 1 and is generally made of corrosion-resistant metal or plastic. A pressure regulator is installed between the nitrogen cylinder and the inlet to adjust the nitrogen pressure entering isolator 1, ensuring that the nitrogen pressure inside isolator 1 remains within the set requirements.
[0040] Furthermore, the pressure regulating component includes a pressure reducing valve 2, a pressure sensor 3, and a first valve 4, which are sequentially arranged on the intake pipe.
[0041] Specifically, the pressure reducing valve 2, the pressure sensor 3, and the first valve 4 are sequentially arranged on the intake pipe along the nitrogen intake direction. The pressure reducing valve 2 is used to adjust the intake pressure according to the nitrogen pressure monitored by the pressure sensor 3, while the first valve 4 is used to open and close the entire intake pipe.
[0042] Based on any of the above embodiments, refer to Figure 1 Pressure reducing valve 2 is a filter pressure reducing valve. The filter pressure reducing valve can not only regulate the pressure, but also filter the incoming nitrogen gas to remove any impurities that may be present, ensuring the purity of the nitrogen gas entering the isolator.
[0043] Based on any of the above embodiments, the pressure sensor 3 is equipped with an alarm unit to issue an alarm when it detects a pressure deviation from a set value. This ensures that the nitrogen pressure entering the isolator is stable and meets requirements. For example, excessively high pressure may damage the isolator; while excessively low pressure may prevent rapid gas replacement. When the pressure sensor 3 detects a pressure deviation from the set value, it will issue an alarm. For instance, when the pressure exceeds the set upper or lower limit, the alarm unit will alert the operator with sound or light to allow for timely adjustment.
[0044] Based on any of the above embodiments, refer to Figure 1 The exhaust assembly includes an exhaust pipe located at the exhaust port, and a second valve 9 and an exhaust fan 10 are sequentially installed on the exhaust pipe.
[0045] Specifically, the exhaust assembly includes an exhaust pipe located at the exhaust port, with a second valve 9 and an exhaust fan 10 sequentially arranged along the gas discharge direction on the exhaust pipe. The exhaust pipe, in conjunction with the exhaust fan 10, discharges the gas from the isolator 1 and is typically made of a corrosion-resistant material similar to the intake pipe. The second valve 9 controls the opening and closing of the exhaust pipe; when the system is in purging mode, the second valve 9 is opened and nitrogen purging begins. The exhaust fan 10 provides the power for exhaust, accelerating the discharge speed of the gas from the isolator 1.
[0046] Based on any of the above embodiments, refer to Figure 1 A filter is installed on the exhaust pipe between the second valve 9 and the air inlet.
[0047] Specifically, during the exhaust process, the gas is filtered through filters, which can greatly extend the service life of the exhaust components and effectively reduce operating costs.
[0048] Furthermore, the filter elements include a medium-efficiency filter 7 and a high-efficiency filter 8 sequentially arranged along the exhaust direction on the exhaust pipe. The medium-efficiency filter 7 can filter out larger particulate impurities, while the high-efficiency filter 8 can further filter out fine particles and harmful substances, ensuring that the exhaust gas meets environmental protection requirements. This two-stage filtration extends the service life of the high-efficiency filter and reduces operating costs. The high-efficiency filter 8 is preferably an H14 high-efficiency filter (filtration efficiency: 99.993%).
[0049] Based on any of the above embodiments, refer to Figure 1 The circulation pipeline is equipped with a third valve 5 and a circulation fan 6 in sequence from the air inlet to the air outlet. The end of the circulation pipeline away from the air inlet is connected to the output end of the filter element.
[0050] Specifically, a third valve 5 and a circulating fan 6 are sequentially installed on the circulation pipeline from the air inlet to the air outlet. The end of the circulation pipeline opposite to the air inlet is connected to the output end of the filter element. When the oxygen concentration in the isolator drops to the set value, the valves and fan related to the air inlet and exhaust are closed, and the third valve 5 and the circulating fan 6 are opened, allowing the gas in the isolator to circulate internally through the circulation pipeline. This reduces nitrogen consumption while maintaining a negative pressure state within the isolator. Simultaneously, the filter element effectively extends the service life of the circulating fan.
[0051] Based on any of the above embodiments, refer to Figure 1 An oxygen concentration sensor 12 is installed at the bottom of the isolator 1 to monitor the oxygen content inside the isolator 1, and a differential pressure sensor 11 is installed on the isolator 1 to monitor the internal pressure difference.
[0052] Specifically, due to the density difference between nitrogen and air, the oxygen concentration is highest at the bottom of isolator 1. Therefore, an oxygen concentration sensor 12 is installed at the point of highest oxygen concentration within isolator 1 to monitor the oxygen content, ensuring that the oxygen concentration inside isolator 1 meets the requirements. The preferred range of the oxygen concentration sensor is 0-25%. When the oxygen concentration is about to exceed the limit, the system will activate the intake and exhaust equipment to perform nitrogen replacement again. The differential pressure sensor 12 is used to monitor the pressure difference between the inside of isolator 1 and the outside environment, ensuring that isolator 1 maintains negative pressure inside during production mode. Throughout the process, the differential pressure sensor 12 participates in the adjustment and feedback of the external pressure difference of isolator 1, maintaining the stability of the external pressure difference of isolator 1. The preferred range of the differential pressure sensor 11 is -500 Pa to 500 Pa.
[0053] It should be noted in this embodiment that the first valve 4, the second valve 9, the third valve 5, etc., can be automatically controlled by a conventional automated control system to achieve automatic control of the isolator nitrogen replacement protection control system.
[0054] Based on any of the above embodiments, a vortex guide shroud (not shown in the figure) is provided at the top of the sealed chamber and between the air inlet and the pressure reducing valve 2. The vortex guide shroud can change the airflow pattern of nitrogen entering the isolator 1. It has spiral guide vanes inside, and the pitch of the spiral guide vanes decreases from top to bottom. This causes the nitrogen to form a vortex when entering the isolator 1, allowing it to be more evenly distributed within the isolator 1 and improving the efficiency of gas replacement.
[0055] The implementation principle of the nitrogen replacement protection control system for an isolator according to this application embodiment is as follows: The isolator 1 is first subjected to leak detection. After passing the leak detection, the control system enters the replacement mode, opening the first valve 4, the second valve 9, and the exhaust fan 10. Nitrogen gas enters the isolator 1 from the nitrogen cylinder through the inlet pipe, while air inside the isolator 1 is discharged through the exhaust pipe. When the oxygen concentration sensor 12 detects that the oxygen concentration inside the isolator 1 has reached the set value, after a delay, the first valve 4, the second valve 9, and the exhaust fan 10 are closed, and the third valve 5 and the circulating fan 6 are opened to allow internal circulation of the gas inside the isolator 1. When the oxygen concentration sensor 12 detects that the oxygen concentration is about to exceed the limit, the first valve 4, the second valve 9, and the exhaust fan 10 are opened again to perform nitrogen replacement. In this way, a low-oxygen environment inside the isolator can be maintained, nitrogen consumption can be reduced, and the differential pressure sensor 11 assists in maintaining a negative pressure state inside the isolator, protecting operators and the environment.
[0056] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.
[0057] The above provides a detailed description of the isolator nitrogen replacement protection control system provided by this utility model. Specific examples have been used to illustrate the principle and implementation of this utility model. The descriptions of the embodiments above are only for the purpose of helping to understand the method and core idea of this utility model. It should be noted that for those skilled in the art, several improvements and modifications can be made to this utility model without departing from the principle of this utility model, and these improvements and modifications also fall within the protection scope of this utility model.
Claims
1. An isolator nitrogen replacement guard control system, comprising: a housing; a nitrogen source; a valve; a pressure sensor; a controller; and a pressure regulator. Includes an isolator (1), with an air inlet at the upper end of the isolator (1) in the height direction and an exhaust port at the lower end of the isolator (1) in the height direction. A circulation pipeline is connected between the air inlet and the exhaust port outside the isolator (1). The other inlet of the air inlet is also connected to an air intake assembly, and the other outlet of the exhaust port is also connected to an exhaust assembly.
2. The isolator nitrogen-purge guard control system of claim 1, wherein, The air intake assembly includes: A nitrogen cylinder, wherein an air inlet pipe is connected between the outlet of the nitrogen cylinder and the air inlet, and the air inlet pipe is equipped with a pressure regulator for adjusting the ammonia pressure.
3. The isolator nitrogen-purge guard control system of claim 2, wherein, The pressure regulating component includes a pressure reducing valve (2), a pressure sensor (3), and a first valve (4) sequentially disposed on the air intake pipe.
4. The isolator nitrogen-purge guard control system of claim 3, wherein, The pressure reducing valve (2) is a filter pressure reducing valve.
5. The isolator nitrogen-purge guard control system of claim 3, wherein, The pressure sensor (3) is equipped with an alarm unit so that it can issue an alarm when it detects a pressure that deviates from the set value.
6. The isolator nitrogen-purge guard control system of claim 1, wherein, The exhaust assembly includes an exhaust pipe disposed at the exhaust port, and a second valve (9) and an exhaust fan (10) are sequentially disposed on the exhaust pipe.
7. The isolator nitrogen-purge guard control system of claim 6, wherein, A filter element is provided on the exhaust pipe between the second valve (9) and the air inlet.
8. The isolator nitrogen-purge guard control system of claim 7, wherein, The filter element includes a medium-efficiency filter (7) and a high-efficiency filter (8) arranged sequentially on the exhaust pipe along the exhaust direction.
9. The isolator nitrogen-purge guard control system of claim 7, wherein, A third valve (5) and a circulating fan (6) are sequentially arranged on the circulation pipeline from the air inlet to the exhaust outlet. The end of the circulation pipeline away from the air inlet is connected to the output end of the filter element.
10. The isolator nitrogen-purge guard control system of any one of claims 1-9, wherein, The bottom of the isolator (1) is provided with an oxygen concentration sensor (12) for monitoring the oxygen content inside the isolator (1), and the top of the isolator (1) is provided with a differential pressure sensor (11) for monitoring the internal pressure difference of the isolator (1).