Sealing device and sterilization device

By designing a sealing device for thermal penetration test for injection sterilization, the problem of drug liquid leakage caused by poor sealing in the prior art is solved, and the high sealing and temperature data of the liquid container are accurately collected.

CN222757099UActive Publication Date: 2025-04-15YANGTZE RIVER PHARM GRP CO LTD
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Patent Information

Application Number
CN202421622904.3
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-07-09
Publication Date
2025-04-15
Estimated Expiration
2034-07-09

AI Technical Summary

Technical Problem

In the prior art, when conducting sterilization heat penetration tests for injections, sealing with raw material tape and high-temperature glass glue may lead to leakage of the drug liquid in the container and the actual temperature penetration of the sterilized preparation cannot be accurately monitored.

Method used

A sealing device is designed, including a cylinder, a first sealing cover and a support base, and a liquid storage container is accommodated through the cylinder, and the first sealing cover and the liquid storage container are clamped with each other by using the first sealing cover and support base to increase the sealing force of the sealing member and prevent liquid leakage.

Benefits of technology

It realizes a high sealing of the liquid container to prevent liquid leakage, ensures that the temperature probe can accurately collect data, and accurately monitor the temperature penetration of the sterilized preparation.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

The utility model discloses a sealing device and a sterilization device, the sealing device comprises: a cylinder, which is arranged to accommodate a liquid container and has a first end and a second end opposite to each other, and the first end is provided with a first port communicated with the inner cavity of the cylinder; the first sealing cover is matched with the first end of the cylinder body to cover and shield the first port, the first sealing cover is provided with a through hole communicated with the inner cavity of the cylinder body, and the through hole is arranged to allow the probe to penetrate through and extend into the inner cavity, so that the probe can enter the liquid container through the sealing element to collect data; the supporting base is arranged at the second end of the cylinder body, and the first sealing cover and the supporting base are arranged to be capable of being matched with each other to clamp the sealing piece and the liquid container so as to limit the sealing piece to be separated from the liquid container.
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Description

Technical Field

[0001] The utility model relates to the technical field of heat penetration experimental instruments, in particular to a sealing device and a sterilizing device. Background Art

[0002] Sterilization of injections is one of the important process steps that affects drug quality and ensures drug safety. The sterilization process needs to be verified. Usually, temperature probes are inserted into the drug bottles and evenly arranged in the sterilization chamber to collect and analyze the heat penetration temperature data to evaluate whether the process and regulatory requirements are met.

[0003] Currently, the industry uses raw tape and high-temperature glass glue to seal the mouth of the ampoule for thermal penetration testing. Due to the high sterilization temperature and pressure, this method may cause leakage of the drug solution in the container during sterilization verification, and cannot monitor the actual temperature penetration of the sterilized preparation. Utility Model Content

[0004] The utility model provides a sealing device 100 and a sterilizing device, which can highly seal a liquid container 41 to prevent liquid leakage.

[0005] The utility model provides a sealing device 100 for sealing a liquid container 41 having an open end, wherein the open end is configured to be covered by a sealing member 42; the sealing device 100 comprises:

[0006] The barrel 1 is configured to accommodate the liquid container 41 and has a first end 11 and a second end 12 opposite to each other, wherein the first end 11 is provided with a first port 101 communicating with the inner cavity 10 of the barrel 1;

[0007] A first sealing cover 2 is matched with the first end 11 of the cylinder 1 to cover the first port 101. The first sealing cover 2 is provided with a through hole 20 communicating with the inner cavity 10 of the cylinder 1. The through hole 20 is configured to allow a probe to pass through and extend into the inner cavity 10, so that the probe can enter the liquid container 41 through the sealing member 42 to collect data;

[0008] The support base 3 is disposed at the second end 12 of the cylinder 1 , and the first sealing cover 2 and the support base 3 are configured to cooperate with each other to clamp the sealing member 42 and the liquid container 41 to limit the sealing member 42 from being separated from the liquid container 41 .

[0009] In an exemplary embodiment, the second end 12 of the barrel 1 is provided with a second port 102 communicating with the inner cavity 10 of the barrel 1 , and the support base 3 includes a second sealing cover 30 that cooperates with and covers the second port 102 and shields the second port 102 .

[0010] In an exemplary embodiment, the sealing device 100 also includes the seal 42; at least one of the first sealing cover 2 and the second sealing cover 30 is configured to be able to adjust the covering depth based on the cylinder 1 to adjust the sealing compression force applied to the seal 42; and / or the first sealing cover 2 and the first end 11 are covered by threaded screwing, and the second sealing cover 30 and the second end 12 are covered by threaded screwing.

[0011] In an exemplary embodiment, the outer end surface of the first sealing cover 2 is provided with a boss 22 for positioning the probe, and the through hole 20 passes through the boss 22; the body of the cylinder 1 is provided with one or more liquid-permeable holes 13 spaced along its circumference; and / or the side wall of the cylinder 1 is provided with an anti-roll bracket 14.

[0012] In an exemplary embodiment, the support base 3 includes a base 31 and a lifting mechanism connected to the base 31, the base 31 is arranged in the cylinder 1 and can cooperate with the first sealing cover 2 to clamp the seal 42 and the liquid container 41, and the lifting mechanism is configured to drive the base 31 to rise and fall in the cylinder 1 to adapt to liquid containers 41 of different specifications and / or adjust the sealing compression force applied to the seal 42.

[0013] In an exemplary embodiment, the first sealing cover 2 is provided with a first groove 21 for positioning the top of the sealing member 42; and / or the base 31 is provided with a second groove 311 for positioning the bottom of the liquid container 41; the base 31 is made of a soft material.

[0014] In an exemplary embodiment, the lifting mechanism includes a turntable 32, a first threaded member 320 provided on the turntable 32, a second threaded member 310 provided on the base 31, and a limit member 33; the second threaded member 310 is threadedly engaged with the first threaded member 320, and the limit member 33 is configured to limit the rotation of the second threaded member 310 or the base 31, so that the rotation of the turntable 32 can drive the base 31 to move linearly up and down.

[0015] In an exemplary embodiment, the support base 3 further includes a second sealing cover 30 that cooperates with and covers the second port 102 of the cylinder 1, and the second sealing cover 30 is provided with a through hole 301 for the first threaded member 320 and / or the second threaded member 310 to pass through;

[0016] The limiting member 33 is axially arranged between the base 31 and the second sealing cover 30 along the cylinder 1 , and the limiting member 33 is provided with a special-shaped hole 332 that matches the shape of the second threaded member 310 and allows the second threaded member 310 to pass through.

[0017] In an exemplary embodiment, a concave cavity 302 communicating with the through hole 301 is provided on the inner side of the second sealing cover 30, and a buckling portion 321 located in the concave cavity 302 is provided on the first threaded member 320;

[0018] The lifting mechanism also includes a clamping member 5 that cooperates with the holding portion 321, and the clamping member 5 is configured to limit the axial movement of the turntable 32 along the cylinder 1; the limiting member 33 includes a disk body 330, and a hollow connecting body 331 extending from the disk body 330 into the concave cavity 302 and cooperating with the concave cavity 302.

[0019] The utility model further provides a sterilization device, characterized in that it comprises: the sealing device 100 as described above, and a liquid container 41 arranged in the sealing device 100 .

[0020] Compared with the related art, the sealing device of the utility model provides a cylinder to accommodate a liquid container, and provides a first sealing cover and a supporting base that can cooperate to press the liquid container and the seal, apply pressure to the seal, increase the sealing force of the seal on the liquid container, limit the seal from detaching from the liquid container, achieve a high degree of sealing of the liquid container, and prevent liquid leakage.

[0021] The sealing device of the utility model is designed with a base and a lifting mechanism, and the height of the base is adjusted by the lifting mechanism, so that the sealing device can adapt to the testing of liquid containers of various specifications.

[0022] Other features and advantages of the utility model will be described in the following description, and partly become apparent from the description, or understood by implementing the utility model. The purpose and other advantages of the utility model can be realized and obtained through the structures particularly pointed out in the description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying drawings are used to provide a further understanding of the technical solution of the utility model and constitute a part of the specification. Together with the embodiments of the utility model, they are used to explain the technical solution of the utility model and do not constitute a limitation on the technical solution of the utility model.

[0024] Figure 1 This is an overall three-dimensional diagram of a sealing device sealing a liquid container according to an embodiment of the utility model;

[0025] Figure 2 This is an overall cross-sectional view of a sealing device sealing a liquid container according to an embodiment of the utility model;

[0026] Figure 3 This is a three-dimensional exploded view of a sealing device sealing a liquid container according to an embodiment of the utility model;

[0027] Figure 4 A three-dimensional diagram of a first sealing cover of a sealing device according to an embodiment of the utility model;

[0028] Figure 5 A partial three-dimensional exploded view of a sealing device according to an embodiment of the utility model;

[0029] Figure 6 for Figure 5 Another angle view of . DETAILED DESCRIPTION

[0030] In order to make the purpose, technical solution and advantages of the utility model more clear, the embodiments of the utility model will be described in detail with reference to the accompanying drawings. It should be noted that the embodiments and features in the embodiments of the utility model can be combined with each other arbitrarily without conflict.

[0031] like Figure 1-Figure 3 As shown, the embodiment of the utility model provides a sealing device 100 for sealing a liquid container 41 having an open end, wherein the open end is configured to be covered by a sealing member 42. The sealing device 100 comprises a cylinder 1, a first sealing cover 2 and a supporting base 3.

[0032] The barrel 1 is configured to accommodate a liquid container 41 and has a first end 11 and a second end 12 opposite to each other. The first end 11 is provided with a first port 101 communicating with the inner cavity 10 of the barrel 1 (see Figure 3 , which cannot be fully shown due to the direction of the figure). The first sealing cover 2 is matched with the first end 11 of the cylinder 1 to cover and shield the first port 101. The first sealing cover 2 is provided with a through hole 20 communicating with the inner cavity 10 of the cylinder 1. The through hole 20 is configured to allow a probe (not shown) to pass through and extend into the inner cavity, so that the probe can enter the liquid container 41 through the through hole 20 and the sealing member 42 to collect data. The support base 3 is provided at the second end 12 of the cylinder 1. The first sealing cover 2 and the support base 3 are configured to cooperate with each other to clamp the liquid container 41 and the sealing member 42 to prevent the sealing member 42 from being separated from the liquid container 41.

[0033] The opening of the liquid container 41 is arranged at the top, and the seal 42 is used to preliminarily seal the opening of the liquid container 41. The first sealing cover 2 and the support base 3 of the sealing device 100 cooperate with each other to increase the sealing pressure of the seal 42, so as to prevent the liquid from expanding due to heat during the test, resulting in sealing failure of the seal 42 and leakage.

[0034] It should be noted that: Figure 2 The perforation 20 is magnified in the figure, and the specific size of the perforation is determined according to the size of the probe and is not limited here.

[0035] The sealing device 100 of the embodiment of the utility model is provided with a cylinder 1 to accommodate a liquid container 41, and a first sealing cover 2 and a supporting base 3 are provided to cooperate to press the liquid container 41 and the sealing member 42, apply pressure to the sealing member 42, increase the sealing force of the sealing member 42 on the liquid container 41, limit the sealing member 42 from being separated from the liquid container 41, and achieve a high sealing effect on the liquid container 41 to prevent liquid leakage.

[0036] like Figure 1 , Figure 3 As shown, the barrel 1 in the embodiment of the utility model is provided with one or more liquid-permeable holes 13 arranged at intervals along its circumference, and the liquid-permeable holes 13 are in the shape of long strips extending along its axial direction. One or more liquid-permeable holes 13 can allow liquid to enter the inner cavity 10 of the barrel 1, thereby improving the efficiency of heat conduction. The barrel 1 in the embodiment of the utility model is made of high-temperature resistant material, such as 305 stainless steel, to meet the requirements of high-temperature environment experiments.

[0037] The specific shape and size of the liquid permeable hole 13 in the embodiment of the utility model can be designed according to actual conditions and are not limited here.

[0038] For example, when a heat penetration test is performed on the fluid in the liquid container 41, the sealing device 100 with the liquid container 41 is placed in the fluid, and the liquid in the liquid container 41 is heated by heating the fluid. By providing the liquid permeable holes 13, the fluid can directly transfer heat to the liquid container 41, thereby improving the heat transfer efficiency. The fluid can be a liquid or a gas.

[0039] like Figure 1 As shown, the side wall of the cylinder 1 is provided with an anti-rolling bracket 14, which can prevent the sealing device 100 from rolling along its circumferential direction when the sealing device 100 is placed for testing.

[0040] The probe described in the embodiment of the utility model is used to collect liquid data in the liquid container 41. For example, when performing a heat penetration test on the liquid in the liquid container 41, the probe can be a temperature probe, which is used to collect, analyze and evaluate the heat penetration temperature data of the liquid container 41 when the liquid container 41 is tested.

[0041] The liquid contained in the liquid container 41 of the embodiment of the utility model can be medicine, chemical reagent, etc. The embodiment of the utility model is described in detail by taking the liquid container 41 as an ampoule bottle and the liquid contained as medicine as an example.

[0042] like Figure 3 , Figure 4As shown, the first sealing cover 2 can adjust the covering depth based on the barrel 1 to apply a sealing pressure to the sealing member 42 at the top of the liquid container 41. The first sealing cover 2 has an external thread, and the first end 11 of the barrel 1 has an internal thread adapted to the external thread of the first sealing cover 2. The first sealing cover 2 and the first end 11 are screwed together to cover by screwing, so as to adjust the pressure on the sealing member 42.

[0043] The adjustment of the covering depth direction described in the embodiment of the utility model refers to adjusting the first sealing cover 2 along the axial direction of the cylinder 1. Figure 1 The middle arrow indicates direction.

[0044] like Figure 2 , Figure 4 As shown, the inner end surface of the first sealing cover 2 is provided with a first groove 21 , and the first groove 21 is used to position the sealing member 42 of the liquid container 41 .

[0045] like Figure 2 As shown, the sealing device 100 of the embodiment of the utility model further includes a sealing member 42 adapted to the first groove 21 and used for sealing the opening of the liquid container 41 .

[0046] In the embodiment of the present invention, the seal 42 has a T-shaped appearance. The specific shape of the seal 42 is not limited, but it is necessary to ensure that the upper end of the seal 42 can be installed in the first groove 21, and the lower end must be sized to the open end of the liquid container 2 to seal the open end of the liquid container 3. It should be noted that the sealing device 100 of the embodiment of the present invention includes the seal 42 for the convenience of users; of course, it may not be included, and users can prepare suitable seals 42 by themselves.

[0047] In the embodiment of the utility model, the diameter range of the portion of the seal 42 positioned in the first groove 21 is: 1.2cm~1.5cm, and the size of the lower end matches the size of the opening end of the liquid container 41. The specific size of the seal 42 can be set according to actual conditions and is not limited here.

[0048] The sealing member 42 of the present invention is made of a soft high temperature resistant material with a heat resistance temperature of more than 100 degrees, such as silicone, EPDM, polytetrafluoroethylene, perfluoroethylene propylene, ethylene-tetrafluoroethylene, coated rubber plugs, etc., all of which have good sealing and heat resistance. Generally, the sealing device 100 of the present invention embodiment can withstand a sterilization temperature between 120 degrees and 135 degrees. In this temperature range, the properties of the sealing member 42 are guaranteed not to change, so as to achieve the effect of accurate sterilization.

[0049] When the material of the sealing member 42 allows the probe to pass through more easily, there is no need to set a through hole for the probe to pass through; conversely, when the material of the sealing member 42 does not allow the probe to pass through more easily, the sealing member 42 may be provided with a through hole for the probe to pass through to prevent damage to the probe.

[0050] like Figure 2 As shown, the outer end surface of the first sealing cover 2 is provided with a boss 22 for positioning the probe, and the through hole 20 passes through the boss 22 and is connected to the first groove 21. The boss 22 can be used to protect the probe from breaking and verify the positioning of the temperature measurement point. During use, the probe of the probe will be inserted into the liquid medicine through the through hole 20 in the boss 22, so that the probe of the probe can be placed in the boss 22 and inserted into the bottle, thereby preventing the probe from being deformed and broken due to the rotation of the device or the objects inside the device squeezing the probe during use. At the same time, the height of the boss 22 can be designed according to the actual situation or a sleeve can be added to ensure that the probe temperature measurement point is placed in the liquid medicine when the probe is inserted.

[0051] Some sterilization cabinets rotate during the sterilization process, and the temperature measuring point of the probe (such as a platinum resistor or a thermocouple) may be displaced, resulting in the inability to accurately detect the temperature at the worst point inside the container. The constant movement of the probe will also cause hardware damage, data loss and other problems. The embodiment of the utility model provides a boss 22 for the probe to extend into and position the probe, thereby preventing the probe from breaking during testing. Specifically, the probe tip of the probe is inserted into the liquid container 41 through the perforation 20 in the boss 22, the temperature measuring point is placed in the liquid, and the probe tip is not exposed to the outside, thereby avoiding the probe tip from being hit / squeezed by the loaded items during the rotation process and causing it to break.

[0052] In an exemplary embodiment, when verifying the sterilization process of the liquid in the liquid container 41, the sealing device 100 can seal the liquid container 41 and fix the temperature probe, thereby effectively avoiding leakage of liquid inside the sterilization liquid container 41 due to high temperature and high pressure during the sterilization process and breaking of the probe due to equipment operation, and then stably detecting the temperature inside the liquid container 41 to achieve accurate confirmation of the sterilization effect inside the liquid.

[0053] The protrusion 22 in the embodiment of the utility model is a cylinder with a length range of 0.8 cm to 1.5 cm and a diameter range of 0.5 cm to 0.8 cm. The diameter of the through hole 20 is about 0.2 cm and passes through the first sealing cover 2. The depth of the first groove 21 is about 0.2 cm and the inner diameter is 1.2 cm to 1.5 cm. The actual size of the first groove 21 can be determined according to the sealing member 42.

[0054] like Figure 2-Figure 6 As shown, the second end 12 of the cylinder 1 is provided with a second port 102, and the support base 3 includes a second sealing cover 30 that shields the second port 102. In the embodiment of the utility model, the second sealing cover 30 is matched with the second end 102. The second sealing cover 30 can adjust the covering depth based on the cylinder 1 to apply a sealing pressure to the liquid container 41 and the sealing member 42.

[0055] In the above solution, the support base 3 includes a second sealing cover 30 which is assembled separately from the cylinder 1. In other embodiments, the support base 3 can also be an integrated structure with the cylinder 1, which can also support the sealed container 41 and cooperate with the first sealing cover 2 to clamp the seal 42 and the sealed container 41.

[0056] In an exemplary embodiment, the second sealing cover 30 has an external thread, and the second end 12 of the cylinder 1 has an internal thread adapted to the external thread of the second sealing cover 30. The second sealing cover 30 and the second end 12 are screwed together to adjust the pressing force on the sealing member 42.

[0057] In some embodiments, Figure 2-Figure 6 As shown, the support base 3 also includes a base 31 and a lifting mechanism connected to the base 31. The base 31 is arranged in the cylinder 1 and is used to support the bottom end of the liquid container 41, and can cooperate with the first sealing cover 2 to clamp the sealing member 42 and the liquid container 41.

[0058] The lifting mechanism is configured to drive the base 31 to rise and fall in the cylinder 1, so that the sealing device 100 can adapt to different specifications of liquid containers 41. The lifting mechanism is configured to also be able to adjust the position of the base 31 to apply sealing pressure to the liquid container 41.

[0059] It is understandable that, since the base 31 can support the liquid container 41, it can also cooperate with the first sealing cover 2 to clamp the sealing member 42 and the sealed container 41. Therefore, in other embodiments, the supporting base 3 may not include the second sealing cover 30, and the base 31 may be set to a size that matches the inner cavity of the cylinder 1, so as to have the function of sealing the cylinder 1.

[0060] like Figure 5 As shown, the base 31 is provided with a second groove 311 for positioning the bottom of the liquid container 41. The second groove 311 can prevent the liquid container 41 from moving, and keep the pressure of the first sealing cover 2 and the supporting base 3 accurately applied to the sealing member 42.

[0061] like Figure 5 , Figure 6 As shown, the lifting mechanism includes a turntable 32 , a first threaded member 320 disposed on the turntable, a second threaded member 310 disposed on the base, and a stopper 33 .

[0062] The first threaded member 320 and the second threaded member 310 are screwed together; the stopper 33 limits the rotation of the second threaded member 310 or the base 32 to achieve the linear lifting movement of the base 31. In the embodiment of the utility model, the first threaded member 310 is a shaft with external threads, and the second threaded member 320 is a sleeve with internal threads.

[0063] The sealing device 100 of the embodiment of the utility model is designed with a base 31 and a lifting mechanism, and the height position of the base 31 is adjusted by the lifting mechanism, so that the sealing device 100 can adapt to the testing of liquid containers 41 of various specifications.

[0064] The base 31 in the embodiment of the utility model can be made of soft materials, such as silicone pads, etc., which can prevent damage to the ampoule bottle 3. Of course, other soft materials can also be used, which is not limited here.

[0065] like Figure 5 , Figure 6 As shown, the turntable 32 is arranged on the outer side of the second sealing cover 30 for the user to operate. The second sealing cover 30 is provided with a through hole 301 for the first threaded member 320 and / or the second threaded member 310 to pass through. The second sealing cover 30 can adjust the covering depth to apply a clamping force to the bottom end of the liquid container 41, thereby tightening the sealing member 42 at the top end of the liquid container 41 to achieve a sealing effect.

[0066] The inner side described in the embodiment of the utility model refers to the side close to the cylinder 1, and the outer side refers to the side away from the cylinder 1. The inner side and the outer side of the same component are relative to each other.

[0067] like Figure 5 , Figure 6 As shown, the inner side of the second sealing cover 30 is provided with a concave cavity 302 connected to the through hole 301, and the rotating shaft 60 of the rotating disk 32 is provided with a buckling portion 321 located in the concave cavity 302. The lifting mechanism also includes a clamping member 5 that is buckled with the buckling portion 321, and the clamping member 5 is configured to limit the axial movement of the rotating disk 32 along the cylinder 1. In the embodiment of the utility model, the buckling portion 321 is a fixed notch, and the clamping member 5 can be a retaining spring.

[0068] During installation, the first threaded member 320 with external threads is inserted into the concave cavity 302 from the outside of the second sealing cover 30, and the clamping member 5 is clamped into the fixing notch 321. After the second sealing cover 30 is tightened, the first threaded member 320 and the second threaded member 310 are assembled. The diameter of the clamping member 5 is larger than the diameter of the through hole 301, so that the rotating disk 32 is fixed in the axial direction and can still rotate in the circumferential direction, thereby allowing the rotating disk 32 to rotate.

[0069] The limiting member 33 includes a disk body 330, and a hollow connector 331 extending from the disk body 330 into the concave cavity 302 and connected with the concave cavity 302. In the embodiment of the utility model, the disk body 330 and the concave cavity 302 are fixed by threaded connection. The disk body 330 is provided with a special-shaped hole 332 for the second threaded member 310 of the base 31 to pass through. The special-shaped hole 332 matches the shape of the second threaded member 310 of the base 31 and limits the circumferential rotation of the second threaded member 310 of the base 31. The concave cavity 302 is provided with an internal thread, and the hollow connector 331 is provided with an external thread adapted to the internal thread of the concave cavity 302. The special-shaped hole 332 is generally a non-circular hole.

[0070] When in use, the support base 3 can be assembled and installed to the second end 12 of the cylinder 1. Next, the bottom of the liquid container 41 plugged with the seal 42 is positioned in the second groove 311 of the base 31, and the first sealing cover 2 is covered so that the top of the seal 42 is positioned in the first groove 21, and the first sealing cover 2 is tightened. Then, the first threaded member 320 and the second threaded member 310 are driven to move in coordination by rotating the turntable 32. Since the circumferential movement of the second threaded member 310 is restricted and can only move linearly, the base 31 can only move up and down. The rotating turntable 32 drives the liquid container 41 to rise, and the seal 42 is more tightly embedded in the first groove 21. The turntable 32 is continuously rotated until it is tightened to achieve a high degree of sealing. When the model of the liquid container 41 is different, the base 31 can still be strengthened by lifting and lowering the base 31 by rotating the turntable 32.

[0071] The sealing device 100 of the utility model embodiment can be tightened towards the top and bottom of the liquid container 41 by providing the first sealing cover 2 and the second sealing cover 30, thereby achieving a high degree of sealing of the liquid container 41. In order to adapt to the testing of multiple specifications of products, the sealing device 100 is designed with a height-adjustable base 31.

[0072] It is understandable that the sealing device 100 of the embodiment of the utility model can achieve the application of sealing force to the seal 42 and the liquid container 41 through a variety of combination schemes. Scheme 1: The first sealing cover 2 and the second sealing cover 30 cooperate with each other to achieve the application of sealing force to the seal 42 and the liquid container 41. Scheme 2: The first sealing cover 2 is combined with the base 31 and the lifting mechanism to achieve the application of sealing force to the seal 42 and the liquid container 41. Scheme 3: The first sealing cover 2 is combined with the second sealing cover 30, and the base 31 and the lifting mechanism to achieve the application of sealing force to the seal 42 and the liquid container 41.

[0073] The sealing member 42 in the embodiment of the utility model is installed in the open end of the liquid container 41, and is used to cover the open end of the liquid container 41. The inner side of the first sealing cover 2 has a first groove 21 that can be embedded with the sealing member 42, which can be used to constrain the liquid container 41 to be centered. The sealing device 100 strengthens the seal, which can prevent the liquid in the liquid container 41 from expanding due to heat during the experiment, pushing open the sealing member 42, and causing liquid leakage.

[0074] The sealing device 100 of the embodiment of the utility model can effectively protect the probe, and at the same time ensure that there will be no leakage of liquid medicine during the entire sterilization process, resulting in untrue data, thereby accurately determining whether the inside of the sterilized product has achieved the expected effect.

[0075] The sealing device 100 of the embodiment of the utility model, its cylinder 1, first sealing cover 2, second sealing cover 30 and support base 3 are all made of high temperature resistant materials; or the sealing device 100 of the embodiment of the utility model is made of high temperature resistant materials as a whole, so that it is not easy to be damaged during the thermal radiation experiment. The sealing device 100 of the embodiment of the utility model has a compact structure, is small and portable.

[0076] Test Example 1: Heat penetration test (all samples are emulsion injection in ampoules)

[0077] In the application of thermal penetration test for small volume injection, the inventors conducted comparative tests on samples sealed by the sealing device 100 protected by the utility model, samples sealed by glass glue (the existing solution in the industry, i.e. after the ampoule is opened, a probe is inserted, and the gap between the probe and the bottle mouth is sealed with tape and glue), and samples in a thermal distribution state. As shown in Table 1: the inventors selected 4 samples sealed by the sealing device 100, 4 samples sealed by glass glue, and 4 samples in a thermal distribution state (without inserting the probe into the product). When preparing the samples sealed by the sealing device 100 protected by the utility model, the probe is inserted into the sealing device from the convex column 20, and the probe is inserted into the ampoule, and the temperature measurement point is placed in the liquid at about 1 / 4 of the bottom of the bottle. When preparing samples for glass glue sealing (existing solutions in the industry), insert the probe into the inside of the ampoule, seal the bottle mouth with glass glue that can withstand high temperatures (leave it overnight to allow the glass glue to dry naturally), insert the probe into the ampoule, and place the temperature measurement point in the liquid at about 1 / 4 of the distance from the bottom of the bottle. For samples in a heat distribution state, just place the probe outside the ampoule.

[0078] Reference test standards: First: visually inspect whether the product leaks after sterilization; Second: sterilization time (12-14) min after sterilization is completed.

[0079] During the experiment, a cold spot was selected for testing, and one sample sealed by the sealing device 100 protected by the utility model, one sample sealed by glass glue, and one sample in a heat distribution state were placed. The test program was started at 121°C for 12 minutes. The sterilization program was run, and the sterilization conditions were: 121°C for 12 minutes. In order to achieve the accuracy of the experiment, the inventor conducted a four-cabinet experiment.

[0080] Table 1

[0081]

[0082] The test results show that:

[0083] (1) Comparison of test data between samples sealed by the sealing device 100 protected by the present invention (i.e., samples with the probe inserted into the product through the sealing device 100) and samples in a heat distribution state (i.e., samples with the probe not inserted into the product): ① During the test, the time for samples sealed by the sealing device 100 to enter sterilization (the time actually measured to reach the process temperature of 121°C) was up to 50 seconds later than that of samples in a heat distribution state; ② During the test, the time for samples sealed by the sealing device 100 to exit sterilization (the time to exit the process temperature of 121°C) was up to 30 seconds later than that of samples in a heat distribution state; ③ During the overall sterilization process, the sterilization time (the time spent at the required process sterilization temperature of 121°C) of samples sealed by the sealing device 100 was shorter than that of samples in a heat distribution state, which was 20 seconds shorter in the worst case of the four tests. (2) Comparison of test data of samples sealed by the sealing device 100 protected by the present invention (i.e., samples in which the probe is inserted into the interior of the product through the sealing device 100) and samples sealed by glass glue (the existing solution in the industry, i.e., after the ampoule is opened, the probe is inserted, and the gap between the probe and the bottle mouth is sealed with tape and glue): ① During the test, the time for samples sealed by the sealing device 100 to enter sterilization (the actual measured time to reach the process temperature of 121°C) was up to 50 seconds later than that of samples sealed by glass glue; ② During the test, the time for samples sealed by the sealing device 100 to exit sterilization (the time to exit the process temperature of 121°C) was up to 40 seconds later than that of samples sealed by glass glue; ③ During the overall sterilization process, the sterilization time (the time spent at the required process sterilization temperature of 121°C) of samples sealed by the sealing device 100 was shorter than that of samples sealed by glass glue, with the worst case being 20 seconds less in four tests.

[0084] In summary:

[0085] For samples in heat distribution state, the probe is not inserted into the product (it is placed next to the product). The test data can only represent the sterilization data of the space, but cannot represent the temperature inside the test product and the actual data during the sterilization process.

[0086] For samples sealed with glass glue, the probe was inserted into the ampoule, and the bottle mouth was sealed with glass glue that can withstand high temperatures (left overnight to allow the glass glue to dry naturally). The probe was inserted into the ampoule, and the temperature measurement point was placed in the liquid at about 1 / 4 of the distance from the bottom of the bottle. However, during the actual test, the glass glue would crack due to excessive pressure in the bottle, and the sealing was poor, which was prone to damage and leakage. After sterilization, the product capacity was about 1 / 3 of the original, and the measured data could not effectively represent the real data of the product during the sterilization process;

[0087] For a sample sealed by the sealing device 100 protected by the utility model, the probe is inserted into the sealing device through the convex column 20, and the probe is inserted into the ampoule bottle. The temperature measuring point is placed in the liquid medicine at about 1 / 4 of the distance from the bottom of the bottle. This not only ensures the sealing of the sample, but also realizes the accurate positioning of the probe, thereby accurately testing the internal temperature of the product and the real data of the sterilization process, ensuring that when the product is sterilized, the sterilization time and temperature control meet the process requirements, and ensuring the actual sterilization effect of the product.

[0088] Test Example 2: Sterilization Process Validation

[0089] As shown in Table 2, the inventors used heat distribution and heat penetration tests to verify the sterilization process. Test conditions: The sterilization process is 121°C, 12 minutes, the acceptable standard of sterilization temperature is 121°C to 123°C, and the acceptable standard of sterilization time is 720s to 960s.

[0090] Table 2

[0091]

[0092] In summary, the test results of this experiment all meet the set test objectives, so the use of sealing device 100 for sealing verification will not affect the sterilized ampoule product.

[0093] In the description of the present invention, it should be noted that the terms "upper", "lower", "one side", "the other side", "one end", "the other end", "side", "relative", "four corners", "periphery", "mouth-shaped structure" and the like 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 structure referred to has a specific orientation, is constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0094] In the description of the embodiments of the present utility model, unless otherwise clearly specified and limited, the terms "connection", "direct connection", "indirect connection", "fixed connection", "installation", and "assembly" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; the terms "installation", "connection", and "fixed connection" can be a direct connection, or an indirect connection through an intermediate medium, or the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0095] Although the implementation methods disclosed in the utility model are as above, the above contents are only implementation methods adopted to facilitate the understanding of the utility model, and are not used to limit the utility model. Any technician in the field to which the utility model belongs can make any modifications and changes in the form and details of implementation without departing from the spirit and scope disclosed in the utility model, but the scope of patent protection of the utility model shall still be defined by the attached claims.

Claims

1. A sealing device (100), characterized in that: Used to seal a liquid container (41) having an open end, wherein the open end is configured to be covered by a sealing member (42); the sealing device (100) comprises: A barrel (1) configured to accommodate the liquid container (41) and having a first end (11) and a second end (12) opposite to each other, wherein the first end (11) is provided with a first port (101) communicating with the inner cavity (10) of the barrel (1); a first sealing cover (2) which cooperates with the first end (11) of the cylinder (1) to cover and shield the first port (101); the first sealing cover (2) is provided with a through hole (20) which is in communication with the inner cavity (10) of the cylinder (1); the through hole (20) is arranged to allow a probe to pass through and extend into the inner cavity (10), so that the probe can enter the liquid container (41) through the sealing member (42) to collect data; A support base (3) is arranged at the second end (12) of the cylinder (1), and the first sealing cover (2) and the support base (3) are configured to cooperate with each other to clamp the sealing member (42) and the liquid container (41) to prevent the sealing member (42) from being separated from the liquid container (41).

2. The sealing device (100) according to claim 1, characterized in that: The second end (12) of the cylinder (1) is provided with a second port (102) communicating with the inner cavity (10) of the cylinder (1), and the support base (3) comprises a second sealing cover (30) cooperating with the second port (102) and shielding the second port (102).

3. The sealing device (100) according to claim 2, characterized in that: The sealing device (100) further comprises a sealing member (42); At least one of the first sealing cover (2) and the second sealing cover (30) is configured to be able to adjust the covering depth based on the cylinder (1) so as to adjust the sealing pressing force applied to the sealing member (42); And / or the first sealing cover (2) and the first end (11) are screwed together and covered by threads, and the second sealing cover (30) and the second end (12) are screwed together and covered by threads.

4. The sealing device (100) according to any one of claims 1 to 3, characterized in that: The outer end surface of the first sealing cover (2) is provided with a convex column (22) for positioning the probe, and the through hole (20) passes through the convex column (22); the body of the cylinder (1) is provided with one or more liquid permeable holes (13) arranged at intervals along its circumference; and / or the side wall of the cylinder (1) is provided with an anti-roll bracket (14).

5. The sealing device (100) according to any one of claims 1 to 3, characterized in that: The support base (3) comprises a base (31) and a lifting mechanism connected to the base (31); the base (31) is arranged in the cylinder (1) and can cooperate with the first sealing cover (2) to clamp the sealing member (42) and the liquid container (41); the lifting mechanism is configured to drive the base (31) to rise and fall in the cylinder (1) to adapt to liquid containers (41) of different specifications and / or adjust the sealing pressure applied to the sealing member (42).

6. The sealing device (100) according to claim 5, characterized in that: The first sealing cover (2) is provided with a first groove (21) for positioning the top of the sealing member (42); and / or the base (31) is provided with a second groove (311) for positioning the bottom of the liquid container (41); the base (31) is made of a soft material.

7. The sealing device (100) according to claim 5, characterized in that: The lifting mechanism comprises a turntable (32), a first threaded member (320) provided on the turntable (32), a second threaded member (310) provided on the base (31), and a limit member (33); the second threaded member (310) is threadedly engaged with the first threaded member (320), and the limit member (33) is configured to limit the rotation of the second threaded member (310) or the base (31), so that the rotation of the turntable (32) can drive the base (31) to perform a linear lifting motion.

8. The sealing device (100) according to claim 7, characterized in that: The support base (3) further comprises a second sealing cover (30) which cooperates with and covers the second port (102) of the cylinder (1); the second sealing cover (30) is provided with a through hole (301) for the first threaded member (320) and / or the second threaded member (310) to pass through; The limiting member (33) is axially arranged between the base (31) and the second sealing cover (30) along the cylinder (1), and the limiting member (33) is provided with a special-shaped hole (332) that matches the outer shape of the second threaded member (310) and allows the second threaded member (310) to pass through.

9. The sealing device (100) according to claim 8, characterized in that: The inner side of the second sealing cover (30) is provided with a concave cavity (302) communicating with the through hole (301), and the first threaded member (320) is provided with a buckling portion (321) located in the concave cavity (302); The lifting mechanism also includes a clamping member (5) that is engaged with the holding portion (321), and the clamping member (5) is configured to limit the axial movement of the turntable (32) along the cylinder (1); the limiting member (33) includes a disk body (330), and a hollow connecting body (331) extending from the disk body (330) into the concave cavity (302) and engaged with the concave cavity (302).

10. A sterilization device, characterized in that: include: A sealing device (100) as claimed in any one of claims 1 to 9, and a liquid container (41) arranged in the sealing device (100).