Packaging system sealing test device based on helium mass spectrum
By designing a packaging system sealing performance testing device based on helium mass spectrometry, the problem of testing the sealing performance of pharmaceutical packaging systems under low temperature conditions was solved, enabling effective testing of the sealing performance of pharmaceutical packaging systems and ensuring the quality and safety of pharmaceuticals under low temperature conditions.
Patent Information
- Application Number
- CN202520223158.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-02-12
- Publication Date
- 2026-02-10
- Estimated Expiration
- 2035-02-12
AI Technical Summary
Existing technologies lack effective testing methods for the sealing performance of pharmaceutical packaging systems in low-temperature environments. Physical changes in packaging components at low temperatures affect the integrity of the seal, making testing difficult.
Design a helium mass spectrometry-based packaging system sealing test device, including a cryogenic device, a sample testing device, and a helium mass spectrometer detector. The sealing performance of the packaging system is evaluated by detecting the leakage rate of helium gas at cryogenic conditions. Helium gas is supplied using a helium tank and an air compressor, and real-time monitoring and analysis are performed using a temperature sensor and a data processor.
It enables effective testing of the sealing performance of pharmaceutical packaging systems at low temperatures, ensuring the quality and safety of pharmaceuticals in low-temperature environments and providing reliable quality control support.
Smart Images
Figure CN223896984U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of pharmaceutical packaging testing technology, and in particular to a packaging system sealing test device based on helium mass spectrometry. Background Technology
[0002] In the field of medical device technology, pharmaceutical packaging systems play a crucial role in the quality and safety of pharmaceuticals. These systems must maintain good sealing throughout the entire shelf life. Container seal integrity is essential for the preservation of the contents, prevention of microbial intrusion, and barrier against gases or other substances, ensuring that the pharmaceuticals continue to meet safety and quality requirements. Container seal integrity checks aim to detect leaks in the packaging, including determining the size and location of leaks. (USP) <1207> We advocate for a lifecycle approach to testing, covering all stages including product development, production, and shelf life.
[0003] Helium mass spectrometry leak detection is an effective detection method with two modes: sniffing and vacuum. The vacuum mode uses quantitative detection, in which the sample to be tested, filled with helium, is placed in a vacuum chamber, and the leaking helium is detected by mass spectrometer and converted into a leakage rate. This method has high detection sensitivity, wide applicability, and can detect leaks in non-porous, rigid or flexible packaging.
[0004] However, low temperatures can affect the integrity of packaging seals. Many biomolecular products are stored in the range of 20°C to -80°C. At low temperatures, packaging components undergo physical changes. The different coefficients of thermal expansion of elastomers and glass can cause changes in material length, affecting component fit and thus affecting the integrity of container seals. For example, when the temperature drops from room temperature (20°C) to -80°C, the stopper volume shrinks significantly, and the glass bottle volume shrinks by less than 1%.
[0005] Currently, there is a lack of testing devices for the sealing of packaging systems during cryogenic storage. Against this backdrop, it is of great practical significance and urgent need to provide a packaging system sealing test device based on helium mass spectrometry. Utility Model Content
[0006] The purpose of this invention is to address the shortcomings of existing technologies by providing a packaging system sealing performance testing device based on helium mass spectrometry.
[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:
[0008] A helium mass spectrometry-based packaging system sealing test device includes: a cryogenic device, a sample testing device disposed inside the cryogenic device, and a helium mass spectrometer detector;
[0009] The sample testing device includes an upper component and a lower component that is detachably disposed at the bottom of the upper component.
[0010] The upper component has a first cavity in the middle of its bottom, and a first positioning hole in each of the four corners of its top. The first positioning hole penetrates the upper component, and a first through hole is provided in the side wall of the upper component. The first through hole communicates with the first cavity.
[0011] The lower component has a second cavity in the middle of its top, and second positioning holes are respectively opened at the four corners of the top of the lower component. The lower component has a second through hole at its bottom, and the second through hole communicates with the second cavity. A temperature sensor is fixedly installed in the second cavity.
[0012] Wherein, the first positioning hole matches the second positioning hole, the first cavity matches the second cavity coaxially, the first cavity and the second cavity together form a third cavity, and a sample bottle is provided in the third cavity;
[0013] Furthermore, when the upper component and the lower component are relatively fixed, the first cavity is connected only to the first through hole and the second cavity, but not to the external environment; the second cavity is connected only to the first cavity and the second through hole, but not to the external environment.
[0014] The first through hole is connected to the detection helium channel of the helium mass spectrometer, and the second through hole is connected to the injection helium channel of the helium mass spectrometer.
[0015] Furthermore, the shape of the third cavity matches the shape of the sample vial.
[0016] Furthermore, the side of the upper component opposite to the lower component is coated with vacuum silicone grease.
[0017] Furthermore, it also includes: helium tanks and air compressors;
[0018] The helium tank is connected to the helium port pipeline of the helium mass spectrometer, and the outlet of the air compressor is connected to the compressed air port pipeline of the helium mass spectrometer, providing compressed gas for driving the helium mass spectrometer's drive valve.
[0019] Furthermore, the temperature sensor is a low-temperature resistant sensor.
[0020] Furthermore, the helium mass spectrometer detector is electrically connected to the data processor.
[0021] Furthermore, a sealing groove is provided on the top of the lower component along the outer circumference of the second cavity, and a rubber sealing gasket is provided in the sealing groove.
[0022] Furthermore, it also includes: fixing screws, which pass through the first positioning hole and the second positioning hole in sequence to fix the upper component and the lower component relative to each other.
[0023] The present invention adopts the above technical solution and has the following technical effects compared with the prior art:
[0024] This invention can effectively test the sealing performance of packaging systems at low temperatures, providing strong support for the quality control of pharmaceutical packaging. Attached Figure Description
[0025] Figure 1 This is a schematic diagram of the axial structure of the third cavity in this utility model, after the upper and lower components are fastened together, in which a sample bottle is placed.
[0026] Figure 2 This is a schematic diagram of the axial side structure of the third cavity without a sample bottle placed after the upper and lower components are fastened together in this utility model.
[0027] Figure 3 This is a schematic diagram of the structure of this utility model;
[0028] Figure 4 This is a schematic diagram of the axial structure of the upper component in this utility model;
[0029] Figure 5 This is a cross-sectional view of the upper component in this utility model;
[0030] Figure 6 This is a schematic diagram of the axial structure of the lower component in this utility model;
[0031] Figure 7 This is a cross-sectional view of the lower component of this utility model.
[0032] The reference numerals in the attached figures are:
[0033] 3. Cryogenic device; 1. Sample testing device; 4. Helium mass spectrometer detector; 17. Helium tank; 16. Air compressor; 11. Upper component; 12. Lower component; 111. First cavity; 112. First positioning hole; 113. First through hole; 121. Second cavity; 122. Second through hole; 123. Temperature sensor; 124. Third cavity; 2. Sample bottle; 5. Sealing groove. Detailed Implementation
[0034] 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.
[0035] It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.
[0036] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, but this is not intended to limit the present invention.
[0037] Example
[0038] This embodiment provides a packaging system sealing test device based on helium mass spectrometry, including: a cryogenic device 3, a sample testing device 1 disposed inside the cryogenic device 3, a helium mass spectrometer detector 4, a helium tank 17, and an air compressor 16;
[0039] The sample testing device 1 includes an upper component 11 and a lower component 12 that is detachably disposed at the bottom of the upper component 11.
[0040] The upper component 11 has a first cavity 111 at the bottom center, and a first positioning hole 112 at each of the four corners of the top of the upper component 11. The first positioning hole 112 penetrates the upper component 11, and a first through hole 113 is provided on the side wall of the upper component 11, which communicates with the first cavity 111.
[0041] The lower component 12 has a second cavity 121 in the middle of its top, and second positioning holes 122 are respectively opened at the four corners of the top of the lower component 12. The lower component 12 has a second through hole 123 at its bottom, which communicates with the second cavity 121. A temperature sensor 124 is fixedly installed in the second cavity 121.
[0042] Wherein, the first positioning hole 112 matches the second positioning hole 122, the first cavity 111 matches the second cavity 121 coaxially, the first cavity 111 and the second cavity 121 together form a third cavity 13, a sample bottle 2 is provided in the third cavity 13, and the shape of the third cavity 13 matches the shape of the sample bottle 2.
[0043] The shape of the second cavity 121 matches the shape of the bottle mouth of the sample bottle 2. The second cavity 121 and the bottle mouth of the sample bottle 2 are connected by threads. The connection between the two is also equipped with a sealing ring, so that after the upper part 11 and the lower part 12 are fixed, the second through hole 123 communicates only with the interior of the sample bottle 2, thereby isolating the interior space of the sample bottle 2 from the first cavity 111, so that when helium is introduced, helium only enters the sample bottle 2.
[0044] Among them, the top of the lower component 12 is provided with a sealing groove 5 along the outer circumference of the second cavity 121, and a rubber sealing gasket is provided in the sealing groove 5.
[0045] The fixing screws pass through the first positioning hole 112 and the second positioning hole 122 in sequence to fix the upper part 11 and the lower part 12.
[0046] Furthermore, when the upper component 11 and the lower component 12 are relatively fixed, the first cavity 111 is connected only to the first through hole 113 and the second cavity 121, but not to the external environment; the second cavity 121 is connected only to the first cavity 111 and the second through hole 123, but not to the external environment.
[0047] The first through-hole 113 is connected to the detection helium channel of the helium mass spectrometer 4, and the second through-hole 123 is connected to the injection helium channel of the helium mass spectrometer 4.
[0048] Vacuum silicone grease is applied to the side of the upper component 11 opposite to the lower component 12.
[0049] Among them, the helium tank 17 is connected to the helium port pipeline of the helium mass spectrometer 4, and the outlet of the air compressor 16 is connected to the compressed air port pipeline of the helium mass spectrometer 4.
[0050] As a preferred embodiment, unless otherwise stated, all pipe connections in this application are sealed pipe connections.
[0051] In a preferred embodiment, the temperature sensor 124 is a low-temperature resistant sensor. The temperature sensor 124 monitors the temperature inside the third cavity 13 in real time and transmits the temperature data to the data processor so as to record and analyze the effect of temperature on the packaging seal.
[0052] In a preferred embodiment, the helium mass spectrometer 4 is electrically connected to the data processor. The helium mass spectrometer 4 converts the detected helium signal into an electrical signal and transmits it to the data processor, which is electrically connected to it, for analysis and processing. The data processor calculates the helium leakage rate according to a preset algorithm, thereby determining whether the sealing performance of the sample bottle 2 packaging system is up to standard.
[0053] In use, select the sample vial 2 whose sealing performance needs to be tested, place it in the second cavity 121 at the top of the lower component 12, align the upper component 11 with the lower component 12, and precisely align the first positioning hole 112 with the second positioning hole 122. Then, use fixing screws to pass through the first positioning hole 112 and the second positioning hole 122 in sequence to fix the upper component 11 and the lower component 12 relative to each other. At this time, the first cavity 111 and the second cavity 121 together form the third cavity 13, and the internal space of the sample vial 2 is connected to the second through hole 123. Then, connect the upper component 11 and the lower component 12 to the tubing of the helium mass spectrometer detector 4, and ensure the sealing performance of the tubing. Place the fixed upper component 11 and the lower component 12 in the cryogenic device 3.
[0054] The air compressor 16 is started to provide compressed gas for driving the valve of the helium mass spectrometer 4. Then, the helium mass spectrometer 4 and the helium tank 17 are turned on. The vacuum pump located in the helium mass spectrometer 4 is started at the same time to evacuate the third chamber 13. When the third chamber 13 reaches a suitable vacuum level, helium is filled into the sample bottle 2 through the helium injection channel of the helium mass spectrometer 4 and through the second through hole 123. After the helium is filled, if the helium leaks from the packaging system of the sample bottle 2, it will enter the first through hole 113 through the first chamber 111 and be detected by the helium mass spectrometer 4. The helium mass spectrometer 4 converts the detected helium signal into an electrical signal and transmits it to the data processor that is electrically connected to it for analysis and processing. The data processor calculates the helium leakage rate according to the preset algorithm, thereby determining whether the sealing performance of the packaging system of the sample bottle 2 is qualified.
[0055] In summary, this method can effectively test the sealing performance of packaging systems at low temperatures, providing strong support for the quality control of pharmaceutical packaging.
[0056] The above description is only a preferred embodiment of the present utility model and does not limit the implementation method and protection scope of the present utility model. Those skilled in the art should realize that all solutions obtained by equivalent substitutions and obvious changes made based on the description and illustrations of the present utility model should be included within the protection scope of the present utility model.
Claims
1. A packaging system sealing performance testing device based on helium mass spectrometry, characterized in that, include: The cryogenic device (3), the sample testing device (1) disposed inside the cryogenic device (3), and the helium mass spectrometer detector (4); The sample testing device (1) includes an upper component (11) and a lower component (12) detachably disposed at the bottom of the upper component (11). The upper component (11) has a first cavity (111) in the middle of its bottom, and a first positioning hole (112) is opened at each of the four corners of the top of the upper component (11). The first positioning hole (112) penetrates the upper component (11), and a first through hole (113) is opened on the side wall of the upper component (11). The first through hole (113) communicates with the first cavity (111). The lower component (12) has a second cavity (121) in the middle of its top, and a second positioning hole (122) is provided at each of the four corners of the top of the lower component (12). The lower component (12) has a second through hole (123) at its bottom. The second through hole (123) communicates with the second cavity (121). A temperature sensor (124) is fixedly installed in the second cavity (121). Wherein, the first positioning hole (112) matches the second positioning hole (122), the first cavity (111) matches the second cavity (121) coaxially, the first cavity (111) and the second cavity (121) together form a third cavity (13), and a sample bottle (2) is provided in the third cavity (13); Furthermore, when the upper component (11) and the lower component (12) are relatively fixed, the first cavity (111) is connected only to the first through hole (113) and the second cavity (121) without being connected to the external environment, and the second cavity (121) is connected only to the first cavity (111) and the second through hole (123) without being connected to the external environment; The first through hole (113) is connected to the detection helium channel of the helium mass spectrometer (4), and the second through hole (123) is connected to the injection helium channel of the helium mass spectrometer (4).
2. The packaging system sealing performance testing device based on helium mass spectrometry according to claim 1, characterized in that, The shape of the third cavity (13) matches the shape of the sample bottle (2).
3. The packaging system sealing performance testing device based on helium mass spectrometry according to claim 1, characterized in that, The upper component (11) is coated with vacuum silicone grease on the side opposite to the lower component (12).
4. The packaging system sealing performance testing device based on helium mass spectrometry according to claim 1, characterized in that, Also includes: Helium tank (17) and air compressor (16); The helium tank (17) is connected to the helium port pipeline of the helium mass spectrometer (4), and the outlet of the air compressor (16) is connected to the compressed air port pipeline of the helium mass spectrometer (4).
5. The packaging system sealing performance testing device based on helium mass spectrometry according to claim 1, characterized in that, The temperature sensor (124) is a low-temperature resistant sensor.
6. The packaging system sealing performance testing device based on helium mass spectrometry according to claim 1, characterized in that, The helium mass spectrometer detector (4) is electrically connected to the data processor.
7. The packaging system sealing performance testing device based on helium mass spectrometry according to claim 1, characterized in that, A sealing groove (5) is provided on the top of the lower component (12) along the outer circumference of the second cavity (121), and a rubber sealing gasket is provided in the sealing groove (5).
8. The packaging system sealing performance testing device based on helium mass spectrometry according to claim 1, characterized in that, Also includes: A fixing screw is provided, which passes through the first positioning hole (112) and the second positioning hole (122) in sequence to fix the upper component (11) and the lower component (12) relative to each other.