Differential pressure maintaining device

Abstract

The utility model relates to a pressure difference maintaining device which comprises a material channel arranged on a closed cavity and used for communicating the closed cavity with an external space; the negative pressure channel is communicated with the material channel; the sterilization channel is communicated with the material channel through a negative pressure channel and is communicated with the closed chamber; the exhaust fan is arranged in the negative pressure channel and used for exhausting air outwards so as to form a negative pressure environment in the negative pressure channel; the first stop valve is arranged in the negative pressure channel and used for connecting or disconnecting the negative pressure channel and the external space; and the second stop valve is arranged in the sterilization channel and is used for connecting or disconnecting the sterilization channel and the closed chamber. According to the pressure difference maintaining device designed by the utility model, the sterilization channel and the negative pressure channel are additionally arranged, so that the problems of large pressure difference fluctuation and low sterilization efficiency of an isolator cavity during material taking and conveying in related technologies are effectively solved, and the stability of the internal environment of the cavity is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of pharmaceutical equipment, in particular to a pressure difference maintaining device. Background Art

[0002] In the existing technology, with the rapid development of the biopharmaceutical industry, the requirements for safety, cleanliness and production efficiency in the drug production process are increasing. In the production process of prefilled preparations, isolator technology is widely used to prevent external contaminants from entering and ensure the quality and safety of drugs.

[0003] At present, in order to prevent external air from entering the isolator cavity, the pressure in the isolator cavity is usually set to a positive pressure state relative to the external space, and a rathole door is installed on the isolator, and a rathole baffle specially designed for the nest box to pass through is installed on the rathole door. However, in the actual production process, the nest box needs to enter the isolator cavity through the rathole door. Due to the large size of the nest box, when it partially enters the rathole opening until it completely passes through, the fresh air exhaust system in the isolator cavity will maintain the set pressure difference by increasing the speed of the exhaust fan. When the nest box completely passes through the rathole door, the ventilation area of ​​the rathole opening will suddenly increase, causing the pressure difference in the isolator cavity to drop, and the system will reduce the speed of the exhaust fan to restore the set pressure difference.

[0004] Therefore, in the actual production process, fluctuations in differential pressure may increase the risk of contamination of prefilled preparations. Summary of the invention

[0005] In order to solve the above problems, the utility model provides a pressure difference maintaining device with small pressure difference fluctuation, high sterilization efficiency and stable internal environment of the cavity.

[0006] In order to achieve the above-mentioned purpose, the pressure difference maintaining device designed by the utility model has a closed chamber, including:

[0007] A material channel is provided on the sealed chamber and is used to connect the sealed chamber with the external space;

[0008] A negative pressure channel communicated with the material channel;

[0009] A sterilization channel, connected to the material channel through the negative pressure channel, and connected to the closed chamber;

[0010] An exhaust fan is arranged in the negative pressure channel and is used to exhaust air outwards to form a negative pressure environment in the negative pressure channel;

[0011] a first stop valve, disposed in the negative pressure channel, for connecting or disconnecting the negative pressure channel from the external space;

[0012] The second stop valve is arranged in the sterilization channel, and is used to open or cut off the connection between the sterilization channel and the closed chamber; wherein the exhaust fan is configured to increase the exhaust volume when material enters and exits the material channel; when external sterilization steam is introduced into the sterilization channel, the first stop valve cuts off the connection between the negative pressure channel and the external space, and the second stop valve opens the connection between the sterilization channel and the closed chamber.

[0013] In order to solve the sealing problem of the material channel, an opening and closing cover is provided on the material channel, and the opening and closing cover is used to selectively open or cut off the connection between the material channel and the external space.

[0014] In order to facilitate operation and maintenance, a suspension column is provided on the appearance surface of the isolator, and a hanging ear matched with the suspension column is provided on the opening and closing cover.

[0015] For ease of implementation, the material channel is a tubular structure installed on the isolator, the tubular structure runs through the negative pressure channel, and air holes connected to the negative pressure channel are evenly distributed on the tube wall of the tubular structure.

[0016] In order to ensure that the exhausted air meets the emission standards, an air filter is also provided in the negative pressure channel, and the air filter is used to filter the air exhausted by the exhaust fan.

[0017] In order to optimize the channel layout, the connection position of the sterilization channel to the negative pressure channel is located between the material channel connection position and the air filter element installation position.

[0018] For the convenience of control, the first stop valve and the second stop valve are both electric butterfly valves.

[0019] In order to simply and effectively realize automatic control of the exhaust fan, a signal sensor is also included. The signal sensor is used to detect changes in the material position in the material channel. The exhaust fan is connected to the signal sensor for signal control.

[0020] The pressure difference maintaining device designed by the utility model effectively solves the problems of large pressure difference fluctuation and low sterilization efficiency in the isolator cavity when materials are taken and delivered in the related technology by adding a sterilization channel and a negative pressure channel, so as to improve the stability of the internal environment of the cavity; at the same time, the sterilization steam can effectively cover all parts to ensure better sterilization effect and improve production safety, making it more suitable for pharmaceutical production processes with high requirements on the production environment, such as intervention filling preparations, and has important practical value. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the overall structure of the isolator provided in an embodiment of the present application;

[0022] Figure 2 It is a schematic diagram of the use of the opening and closing cover provided in the embodiment of the present application;

[0023] Figure 3 is a schematic diagram of the airflow direction of each channel provided in an embodiment of the present application;

[0024] Figure 4 It is a schematic diagram of the structure of each channel provided in the embodiments of the present application.

[0025] Among them: isolator 100, closed chamber 200, material channel 10, air hole 11, negative pressure channel 20, sterilization channel 30, exhaust fan 40, first stop valve 50, second stop valve 60, opening and closing cover 70, suspension column 71, hanging ear 72, air filter element 80. DETAILED DESCRIPTION

[0026] The preferred embodiments of the present invention are described below in conjunction with the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0027] Example 1.

[0028] See also Figures 1 to 4 As shown, the pressure difference maintaining device of the isolator 100 described in this embodiment has a closed chamber 200, including:

[0029] The material channel 10 is provided on the sealed chamber 200 and is used to connect the sealed chamber 200 with the external space;

[0030] A negative pressure channel 20 communicates with the material channel 10;

[0031] The sterilization channel 30 is connected to the material channel 10 through the negative pressure channel 20 and is connected to the closed chamber 200; the exhaust fan 40 is arranged in the negative pressure channel 20 and is used to exhaust air to the outside to form a negative pressure environment in the negative pressure channel 20;

[0032] A first stop valve 50 is disposed in the negative pressure channel 20 and is used to open or close the connection between the negative pressure channel 20 and the external space;

[0033] A second stop valve 60 is disposed in the sterilization passage 30 and is used to open or close the connection between the sterilization passage 30 and the sealed chamber 200;

[0034] Among them, the exhaust fan 40 is configured to increase the exhaust volume when material enters and exits the material channel 10; when external sterilization steam is introduced into the sterilization channel 30, the first stop valve 50 cuts off the connection between the negative pressure channel 20 and the external space, and the second stop valve 60 opens the connection between the sterilization channel 30 and the closed chamber 200.

[0035] When implementing it, refer to Figure 3 and Figure 4 A detailed description is given, for example: when the isolator 100 is working normally, the pressure level in the closed chamber 200 is maintained. When the material is taken and delivered, the first stop valve 50 is opened, the negative pressure channel 20 is connected with the external space, and the material enters the closed chamber 200 through the material channel 10 for production operation. The exhaust fan 40 automatically adjusts the exhaust volume according to the change of the material position in the material channel 10 to maintain a stable pressure difference inside the closed chamber 200.

[0036] Specifically, when the material initially enters the material channel 10, the ventilation cross-sectional area in the channel decreases, and the exhaust fan 40 will increase its power and increase the exhaust volume to compensate for the pressure difference change caused by the reduction in ventilation area. After the material completely passes through the material channel 10 and enters the closed chamber 200 or the external space, the ventilation cross-sectional area in the channel returns to normal, and the exhaust fan 40 reduces its power and reduces the exhaust volume to maintain a stable pressure difference inside the closed chamber 200. That is, through this mechanism of automatically adjusting the exhaust volume, the pressure difference fluctuation caused by the material entering and exiting can be effectively prevented, and the stability of the internal environment of the closed chamber 200 can be ensured, thereby improving production safety.

[0037] In this embodiment, the exhaust fan 40 is configured to increase the exhaust volume when material enters or exits the material channel 10. To this end, a photoelectric sensor can be installed on the material channel 10. That is, when the material passes through, it will block the light beam. The sensor detects the change in the light beam and triggers a signal to the exhaust fan 40, thereby adjusting the exhaust volume.

[0038] In addition, when sterilization is required (for example, a necessary sterilization process before each production), the first stop valve 50 is closed and the second stop valve 60 is opened, and the sterilization steam can enter the closed chamber 200 through the sterilization channel 30, and enter the material channel 10 through the negative pressure channel 20, effectively covering all channels to ensure a better sterilization effect. In order to meet the sterilization requirements, the isolator 100 is provided with a quick connector 31, through which the external sterilization steam can be connected to the sterilization channel 30.

[0039] In this embodiment, refer to Figure 1 and Figure 2 As shown, the material channel 10 is provided with an opening and closing cover 70, which is used to selectively open or cut off the connection between the material channel 10 and the external space. In this way, when it is necessary to carry out material delivery operations, the opening and closing cover 70 can be opened to facilitate the material to enter and exit the closed chamber 200, and when it is not necessary to carry out material operations (or sterilization), the opening and closing cover 70 can be closed to ensure the airtightness inside the closed chamber 200 and improve production safety.

[0040] For some examples, see Figure 2As shown, a suspension column 71 is provided on the exterior surface of the isolator 100, and a hanging ear 72 adapted to the suspension column 71 is provided on the opening and closing cover 70. In this embodiment, the suspension column 71 can be used as a fixing point of the opening and closing cover 70, which is convenient for the operator to remove the opening and closing cover 70 from the material channel 10 and engage with the suspension column 71, eliminating the trouble of finding and fixing the opening and closing cover 70, and effectively avoiding the problem of loss.

[0041] In other examples, the opening and closing cover 70 may also be hinged to the isolator 100 via a hinge structure. This design allows the opening and closing cover 70 to be opened and closed naturally and smoothly, which can save operating time and energy, especially when the opening and closing cover 70 needs to be opened and closed frequently.

[0042] In some embodiments, see Figure 3 and Figure 4 As shown, the material channel 10 is a tubular structure installed on the isolator 100, the tubular structure penetrates the negative pressure channel 20, and the tube wall of the tubular structure is evenly distributed with air holes 11 connected to the negative pressure channel 20. The manufacture of the tubular structure is relatively simple, which can reduce the production cost. Since the air holes 11 connected to the negative pressure channel 20 are evenly distributed on the tube wall, it is only necessary to seal the two ends of the pipeline structure during actual manufacture, and the structure is more concise and easy to implement.

[0043] In some embodiments, see Figure 3 and Figure 4 As shown, in order to ensure that the exhausted air meets the emission standards, an air filter 80 is further provided in the negative pressure channel 20, and the air filter 80 is used to filter the air exhausted by the exhaust fan 40. The air filter 80 can filter out harmful substances such as particulate matter and impurities in the air exhausted by the exhaust fan 40, prevent them from spreading into the production environment through the exhaust system, improve production safety, and protect the health of workers.

[0044] In some embodiments, see Figure 3 As shown, the connection position of the sterilization channel 30 connected to the negative pressure channel 20 is located between the connection position of the material channel 10 and the installation position of the air filter element 80. This design can effectively prevent the sterilization steam from directly entering the air filter element 80, and avoid the air filter element 80 from being directly affected by high temperature, so that the sterilization steam first enters the negative pressure channel 20, then enters the sterilization channel 30, and finally reaches the closed chamber 200, and the other part continues to enter the material channel 10 along the negative pressure channel 20 for sterilization, which is practical and has a good sterilization effect.

[0045] In some embodiments, the first stop valve 50 and the second stop valve 60 are both electric butterfly valves. The electric butterfly valve can be precisely controlled by a motor drive combined with a control system to achieve automatic opening and closing, and the operator does not need to operate manually, which improves the convenience of operation and saves manpower.

[0046] In some embodiments, in order to simply and effectively realize the automatic control of the exhaust fan 40, a signal sensor (not shown) is also included, and the signal sensor is used to detect the change of the material position in the material channel 10, and the exhaust fan 40 is connected to the signal sensor signal control. Taking a reflective photoelectric sensor as an example, it can be installed on the side wall of the material channel 10. When the material passes through, it will reflect the light beam. The reflective photoelectric signal sensor detects the change of the light beam and triggers the signal. After receiving the signal, the control system sends a command to the exhaust fan 40, such as adjusting the speed of the exhaust fan 40 or turning on / off the exhaust fan, so as to maintain a stable pressure difference inside the cavity of the isolator 100.

[0047] The pressure difference maintaining device provided in this embodiment effectively solves the problems of large pressure difference fluctuation and low sterilization efficiency in the isolator's closed chamber 200 when materials are taken and delivered in the related technology by adding a sterilization channel and a negative pressure channel, so as to improve the stability of the internal environment of the closed chamber 200; at the same time, the sterilization steam can effectively cover all components to ensure better sterilization effect and improve production safety, making it more suitable for pharmaceutical production processes such as intervention filling preparations that have high requirements on the production environment, and has important practical value.

[0048] In the description of the present invention, it should be noted that the terms "vertical", "up", "down", "horizontal", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do 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 therefore cannot be understood as a limitation on the present invention.

[0049] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0050] Finally, it should be noted that the above description is only a preferred embodiment of the utility model and is not intended to limit the utility model. Although the utility model is described in detail with reference to the above embodiments, those skilled in the art can still modify the technical solutions recorded in the above embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the utility model shall be included in the protection scope of the utility model.

Claims

1. A pressure differential maintaining device, the isolator having a closed chamber, characterized in that: include: A material channel is provided on the sealed chamber and is used to connect the sealed chamber with the external space; A negative pressure channel communicated with the material channel; A sterilization channel, connected to the material channel through the negative pressure channel, and connected to the closed chamber; An exhaust fan is arranged in the negative pressure channel and is used to exhaust air outwards to form a negative pressure environment in the negative pressure channel; a first stop valve, disposed in the negative pressure channel, for connecting or disconnecting the negative pressure channel from the external space; The second stop valve is arranged in the sterilization channel, and is used to open or cut off the connection between the sterilization channel and the closed chamber; wherein the exhaust fan is configured to increase the exhaust volume when material enters and exits the material channel; when external sterilization steam is introduced into the sterilization channel, the first stop valve cuts off the connection between the negative pressure channel and the external space, and the second stop valve opens the connection between the sterilization channel and the closed chamber.

2. The pressure difference maintaining device according to claim 1, characterized in that: The material channel is provided with an opening and closing cover, and the opening and closing cover is used to selectively open or cut off the communication between the material channel and the external space.

3. The pressure difference maintaining device according to claim 2, characterized in that: A suspension column is arranged on the appearance surface of the isolator, and a hanging ear matched with the suspension column is arranged on the opening and closing cover.

4. The pressure difference maintaining device according to claim 1, characterized in that: The material channel is a tubular structure installed on the isolator, the tubular structure runs through the negative pressure channel, and air holes connected to the negative pressure channel are evenly distributed on the tube wall of the tubular structure.

5. The pressure difference maintaining device according to claim 1, characterized in that: An air filter is also provided in the negative pressure channel, and the air filter is used to filter the air exhausted by the exhaust fan.

6. The pressure difference maintaining device according to claim 5, characterized in that: The connection position where the sterilization channel is connected to the negative pressure channel is located between the material channel connection position and the air filter element installation position.

7. The pressure difference maintaining device according to claim 1, characterized in that: The first stop valve and the second stop valve are both electric butterfly valves.

8. The pressure difference maintaining device according to claim 1, characterized in that: It also includes a signal sensor, which is used to detect changes in the position of materials in the material channel, and the exhaust fan is connected to the signal sensor for signal control.

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