CN221099989U - Test device for detecting sealing integrity of container - Google Patents
Test device for detecting sealing integrity of container Download PDFInfo
- Publication number
- CN221099989U CN221099989U CN202322331707.8U CN202322331707U CN221099989U CN 221099989 U CN221099989 U CN 221099989U CN 202322331707 U CN202322331707 U CN 202322331707U CN 221099989 U CN221099989 U CN 221099989U
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- sealing
- test device
- flexible bag
- container
- fitting
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- 238000007789 sealing Methods 0.000 title claims abstract description 94
- 238000012360 testing method Methods 0.000 title claims abstract description 41
- 239000007788 liquid Substances 0.000 claims abstract description 10
- 241000894006 Bacteria Species 0.000 claims abstract description 8
- 239000004033 plastic Substances 0.000 claims description 5
- 239000004677 Nylon Substances 0.000 claims description 4
- 229920001778 nylon Polymers 0.000 claims description 4
- 229910001220 stainless steel Inorganic materials 0.000 claims description 3
- 239000010935 stainless steel Substances 0.000 claims description 3
- 238000013461 design Methods 0.000 claims description 2
- 239000000463 material Substances 0.000 claims 1
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 8
- 230000000813 microbial effect Effects 0.000 abstract description 6
- 244000005700 microbiome Species 0.000 abstract description 5
- 230000001954 sterilising effect Effects 0.000 abstract description 5
- 238000001514 detection method Methods 0.000 abstract description 4
- 238000000034 method Methods 0.000 abstract description 4
- 238000011109 contamination Methods 0.000 abstract description 2
- 239000007789 gas Substances 0.000 description 18
- 239000003814 drug Substances 0.000 description 6
- 238000004806 packaging method and process Methods 0.000 description 5
- 230000001580 bacterial effect Effects 0.000 description 3
- 230000002906 microbiologic effect Effects 0.000 description 3
- 238000011181 container closure integrity test Methods 0.000 description 2
- 238000007654 immersion Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- 239000003570 air Substances 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000011534 incubation Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 238000011179 visual inspection Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Landscapes
- Examining Or Testing Airtightness (AREA)
Abstract
The utility model provides a test device for detecting the sealing integrity of a container, which comprises a flexible bag and a gas power system, wherein the flexible bag is connected with the gas power system in a sealing way through a gas conduit, the flexible bag is internally provided with a container for containing bacteria liquid, the container is internally provided with a lining plate, and the lining plate is provided with holes matched with the size of a sample to be detected, so that the sample to be detected is inversely suspended in the container and soaked in the bacteria liquid. The test device provided by the utility model has the advantages of simple structure, simplicity and convenience in operation, basically operation after simple study, convenience in disinfection and sterilization, capability of improving the detection efficiency while meeting the experimental requirements of a container seal integrity microorganism challenge method (immersed), and capability of ensuring the biological safety of the whole test and effectively preventing microbial contamination.
Description
Technical Field
The utility model relates to the technical field of medicine package detection, in particular to a test device for detecting the sealing integrity of a container.
Background
In recent years, along with the transition of medicine supervision modes in China and the deep understanding of factors influencing medicine quality, the important significance of sealing integrity of a medicine packaging system on medicine safety is realized, and related supervision requirements and regulation guidelines are brought out. The packaging system tightness (PACKAGE INTEGRITY), also known as container seal integrity (container-closure integrity), refers to the ability of the packaging system to prevent loss of contents, ingress of microorganisms, and ingress of gases (oxygen, air, water vapor, etc.) or other substances, ensuring that the drug continues to meet safety and quality requirements. Packaging system leak check (PACKAGE INTEGRITY TEST), otherwise known as container-closure INTEGRITY TEST (CCIT), refers to a packaging leak test (including physicochemical or microbiological testing methods) that detects any breaks or gaps, some of which may determine the size and/or location of the leak.
The microbiological challenge test is a package leak test method that evaluates package integrity by immersing a container filled with growth-promoting medium in a bacterial suspension for exposure (liquid load challenge test), and demonstrates leaks by challenging subsequent growth of microorganisms in the package contents. Microbial challenge (submerged): the sample to be tested is filled with a sterile growth-promoting medium, then incubated and visually inspected to confirm sterility of the sample prior to microbial challenge, the sample is immersed in a bacterial suspension of a concentration for a predetermined period of time, during which the sample may be exposed to a predetermined vacuum for a predetermined period of time, then the vacuum is released, and the package is maintained immersed at atmospheric pressure for a predetermined period of time. The sample is then placed in growth promoting conditions for incubation and visual inspection or other means to check the contents of the package for microbial growth. Most of the microbiologically challenged test devices were found to be reused through investigation. The cavity containing the test sample is large and may not be placed in a conventional autoclave. A certain difficulty is brought to thorough disinfection and sterilization. Sterilization of containers used in microbiological challenge (immersion) tests has limited the development of the industry. Conventional sterilization of containers does not meet the ever-increasing demand for service.
Disclosure of utility model
In order to overcome the defects in the prior art, the utility model provides a test device for detecting the sealing integrity of a container, which is particularly suitable for a microbial challenge method (immersion type) test.
In order to achieve the above purpose, the utility model adopts the following technical scheme:
The utility model provides a test device for detecting the sealing integrity of a container, which comprises a flexible bag and a gas power system, wherein the flexible bag is connected with the gas power system in a sealing way through a gas conduit, the flexible bag is internally provided with a container for containing bacteria liquid, the container is internally provided with a lining plate, and the lining plate is provided with holes matched with the size of a sample to be detected, so that the sample to be detected is inversely suspended in the container and soaked in the bacteria liquid.
Further, the flexible bag may be elliptical, circular or polygonal in shape.
Further, the lining board is a bracket assembled by double-layer PVC hard sheets, and holes capable of fixing a sample to be tested are formed in the PVC hard sheets through cutting.
Further, the lining board is a stainless steel net frame.
Further, a sealing piece is arranged at the opening of the flexible bag; the sealing piece is a hollow reverse-U-shaped groove, a sealing ring is respectively arranged in the groove close to the inner ring wall and the outer ring wall, and a certain distance is reserved between the sealing ring and the inner ring wall; one end of the gas conduit close to the flexible bag is connected with a sealing accessory which is a plastic plate with a certain thickness, the edge of the sealing accessory is provided with a reverse-U-shaped groove with the same size as the sealing accessory, and the center of the reverse-U-shaped groove is provided with a sealing ring; the width of the sealing ring on the sealing fitting is larger than the distance between the two sealing rings arranged on the sealing fitting.
Further, the sealing ring is made of rubber.
Further, the closure and the flexible bag are of unitary design; the sealing piece is made of plastic.
Further, the outer edges of the sealing piece and the sealing fitting are respectively provided with corresponding fixing pieces, and the fixing pieces on the sealing piece and the fixing pieces on the sealing fitting are acted by fasteners, so that the sealing rings on the sealing piece and the sealing fitting are mutually extruded, and the sealing piece and the sealing fitting are in sealing connection; the number of fixtures on the closure and the closure fitment is greater than 2, preferably greater than 4, preferably symmetrically disposed, preferably at the four corners of the closure or closure fitment.
Further, one end of the gas conduit close to the flexible bag is provided with a hollow connector, and the opening of the flexible bag is bound on the outer surface of the connector through a nylon binding belt, so that the whole test device is airtight.
Further, the aerodynamic system is a vacuum pump or an air compressor.
Further, a pressure control system, preferably a tightness tester or a filter integrity tester, is arranged between the aerodynamic system and the flexible bag, and is used for controlling the negative pressure or the positive pressure within a set value range.
Compared with the prior art, the utility model has the following technical effects:
The test device provided by the utility model has the advantages of simple structure, simplicity and convenience in operation, basically operation after simple study, convenience in disinfection and sterilization, capability of improving the detection efficiency while meeting the experimental requirements of a container seal integrity microorganism challenge method (immersed), and capability of ensuring the biological safety of the whole test and effectively preventing microbial contamination.
Drawings
FIG. 1 is a schematic view showing the structure of a test device for detecting the seal integrity of a container in accordance with a preferred embodiment of the present utility model;
Wherein: 1-flexible bag, 2-container, 3-sample to be measured, 4-lining board, 5-connection port, 6-gas conduit, 7-conversion port and 8-gas power system;
FIG. 2 is a schematic view showing the structure of a closure member according to a preferred embodiment of the present utility model, wherein a hatched portion is shown as a seal ring;
fig. 3 shows a schematic structural view of a seal fitting in accordance with a preferred embodiment of the present utility model, wherein the hatched portion is shown as a sealing ring.
Detailed Description
The utility model provides a test device for detecting the sealing integrity of a container, which can improve the detection efficiency of a microorganism challenge method (immersed type). The present utility model will be described in detail and specifically by way of the following specific examples and drawings to provide a better understanding of the present utility model, but the following examples do not limit the scope of the present utility model. Herein, the relative relationships described are based on the connection state at the time of use.
The utility model provides a test device for detecting the sealing integrity of a container, which comprises a flexible bag 1 and a gas power system 8 which are in sealing connection through a gas conduit 6, wherein a container 2 for containing bacteria liquid is placed in the flexible bag, an inner lining plate 4 is arranged in the container 2, and a hole matched with the size of a sample 3 to be detected is formed in the inner lining plate, so that the sample to be detected is inversely suspended in the container and soaked in the bacteria liquid.
In a preferred embodiment of the utility model, the flexible bag 1 is a completely airtight bag with a flexible container of a size slightly larger than Cheng Jun (but not too large) which can be sterilized in an autoclave after use, and is oval, circular or polygonal in shape.
In a preferred embodiment of the utility model, the lining plate 4 is a bracket assembled by double-layer PVC hard sheets, which can be assembled by bonding, and the PVC hard sheets are provided with holes for fixing the sample to be tested by cutting. In another preferred embodiment, the inner liner 4 is a stainless steel mesh frame
In a preferred embodiment of the utility model, as shown in fig. 1-3, the flexible bag 1 and the gas conduit 6 are sealingly connected by a connection port 5. The connection port 5 comprises a closure member (see fig. 2) provided at the opening of the flexible bag 1 and a closure fitting (see fig. 3) connected to the end of the gas conduit 6 adjacent to the flexible bag. The sealing piece is a hollow reverse-U-shaped groove, a sealing ring is respectively arranged in the groove close to the inner ring wall and the outer ring wall, and a certain distance is reserved between the sealing ring and the inner ring wall; wherein the hollow interior of the closure is of a regular quadrilateral shape, which is sized such that the container (e.g. beaker) lies flat inside the flexible bag 1. The sealing fitting is a plastic plate with a certain thickness, the edge of the sealing fitting is provided with a reverse-U-shaped groove with the same size as the sealing, and the center of the reverse-U-shaped groove is provided with a sealing ring; the width of the sealing ring on the sealing fitting is larger than the distance between the two sealing rings arranged on the sealing fitting. In a preferred embodiment, the height of the sealing ring is equal to or greater than the depth of the groove. The outer edges of the sealing piece and the sealing fitting are respectively provided with corresponding fixing pieces (preferably sheet-shaped objects with holes and the same thickness as the sealing piece/the sealing fitting, the cross sections of the sheet-shaped objects can be semicircular), and the fixing pieces on the sealing piece and the fixing pieces on the sealing fitting are acted by fasteners (such as bolt and nut fittings or nylon ties) so that a sealing ring on the sealing piece and a sealing ring on the sealing fitting are mutually extruded to realize sealing connection of the sealing piece and the sealing fitting; the number of fixing elements on the sealing element and the sealing fitting is more than 2, preferably more than 4, and is preferably symmetrically arranged, preferably arranged at four corners of the sealing element or the sealing fitting.
In a preferred embodiment of the utility model, the air conduit 6 is provided with a hollow connector near one end of the flexible bag, and the opening of the flexible bag 1 is bound and attached to the outer surface of the connector through nylon ties, so that the whole test device is airtight.
In a preferred embodiment of the utility model, the gas conduit 6 is connected to a gas power system 8 via a swivel port 7. The aerodynamic system 8 is a vacuum pump or an air compressor.
In a preferred embodiment of the utility model, a pressure control system, preferably a tightness tester or a filter integrity tester, is also arranged between the aerodynamic system 8 and the flexible bag 1 for controlling the negative pressure or the positive pressure within a set value range.
When the test device provided by the utility model is used, the lining plate 4 with proper size is arranged in the container 2, and the sample 3 to be tested is inversely fixed on the lining plate; the bacterial liquid which is not passed through the sample to be measured is slowly poured into the container 2. Then slowly and stably placing the container 2 into the disposable flexible bag 1, sealing and connecting the flexible bag 1 with the gas conduit 6, and ensuring the air tightness of the bag mouth; the gas conduit 6 is connected to a gas power system 8 using an adapter 7. The power supply of the aerodynamic system 8 is turned on, and the disposable flexible bag 1 is filled with gas according to the pressure required by the test. In a preferred embodiment of the utility model, the air powered system 8 is an air compressor which is powered on and in which the pressure is initially increased, and the power is turned off after a pressure slightly above the desired pressure, and the air release switch of the air compressor is turned to allow compressed air to be fed into the disposable flexible bag 1. This step should be performed slowly and smoothly. When the flexible bag 1 is not obviously collapsed and the bag is tight, the pressure gauge of the air compressor is observed, if the pressure gauge shows that the pressure is lower than the target pressure, the power supply of the air compressor is turned on again, and the power supply is turned off after the pressure is increased to the required target pressure.
The above description of the specific embodiments of the present utility model has been given by way of example only, and the present utility model is not limited to the above described specific embodiments. It will be apparent to those skilled in the art that any equivalent modifications and substitutions of the present utility model are intended to be within the scope of the present utility model. Accordingly, equivalent changes and modifications are intended to be included within the scope of the present utility model without departing from the spirit and scope thereof.
Claims (14)
1. The test device for detecting the sealing integrity of the container is characterized by comprising a flexible bag and a gas power system, wherein the flexible bag and the gas power system are in sealing connection through a gas conduit, a container for containing bacteria liquid is placed in the flexible bag, an inner lining plate is arranged in the container, and holes matched with the size of a sample to be detected are formed in the inner lining plate and are used for enabling the sample to be detected to be inversely suspended in the container and soaked in the bacteria liquid.
2. The test device of claim 1, wherein the flexible bag is elliptical, circular, or polygonal in shape.
3. The test device according to claim 1, wherein the inner lining plate is a bracket assembled by double-layer PVC hard sheets, and holes capable of fixing a sample to be tested are formed in the PVC hard sheets through cutting.
4. The test device of claim 1, wherein the interior lining is a stainless steel mesh frame.
5. The test device of claim 1, wherein a closure member is provided at the opening of the flexible bag; the sealing piece is a hollow reverse-U-shaped groove, and sealing rings are respectively arranged in the groove and close to the inner ring wall and the outer ring wall, and have a certain distance; one end of the gas conduit, which is close to the flexible bag, is connected with a sealing accessory and is communicated with the flexible bag, the sealing accessory is a plastic plate with a certain thickness, the edge of the sealing accessory is provided with a reverse-U-shaped groove with the same size as the sealing accessory, and the center of the reverse-U-shaped groove is provided with a sealing ring; the width of the sealing ring on the sealing fitting is larger than the distance between the two sealing rings arranged on the sealing fitting.
6. The test device of claim 5, wherein the closure and flexible bag are of unitary design; the sealing piece is made of plastic materials.
7. The test device according to claim 5, wherein the outer edges of the sealing member and the sealing fitting are respectively provided with corresponding fixing members, and the fixing members on the sealing member and the fixing members on the sealing fitting are acted on by fasteners, so that the sealing ring on the sealing member and the sealing ring on the sealing fitting are mutually extruded to realize sealing connection of the sealing member and the sealing fitting; the number of the sealing pieces and the fixing pieces on the sealing fittings is more than 2.
8. The test device of claim 7, wherein the number of fasteners on the closure member and the closure fitting is greater than 4.
9. The test device of claim 7, wherein the closure member and the securing member on the closure fitting are symmetrically disposed.
10. The test device of claim 9, wherein the fasteners on the closure member and the closure fitting are symmetrically disposed at four corners of the closure member or the closure fitting.
11. The test device according to claim 1, wherein the air duct is provided with a hollow connector at one end close to the flexible bag, and the opening of the flexible bag is bound to the outer surface of the connector through a nylon tie, so that the whole test device is airtight.
12. The test device of claim 1, wherein the aerodynamic system is a vacuum pump or an air compressor.
13. The test device of claim 1, wherein a pressure control system is further disposed between the pneumatic system and the flexible bag.
14. The test device of claim 13, wherein the pressure control system is a tightness tester or a filter integrity tester for controlling the negative pressure or the positive pressure within a set value range.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202322331707.8U CN221099989U (en) | 2023-08-29 | 2023-08-29 | Test device for detecting sealing integrity of container |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202322331707.8U CN221099989U (en) | 2023-08-29 | 2023-08-29 | Test device for detecting sealing integrity of container |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN221099989U true CN221099989U (en) | 2024-06-07 |
Family
ID=91305458
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202322331707.8U Active CN221099989U (en) | 2023-08-29 | 2023-08-29 | Test device for detecting sealing integrity of container |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN221099989U (en) |
-
2023
- 2023-08-29 CN CN202322331707.8U patent/CN221099989U/en active Active
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| GR01 | Patent grant |