CN216746634U - Package sealing performance detection system - Google Patents
Package sealing performance detection system Download PDFInfo
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- CN216746634U CN216746634U CN202220432186.8U CN202220432186U CN216746634U CN 216746634 U CN216746634 U CN 216746634U CN 202220432186 U CN202220432186 U CN 202220432186U CN 216746634 U CN216746634 U CN 216746634U
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Abstract
The utility model relates to a package tightness detection system which comprises a vacuum leak detection cabinet, a vacuum control system, a compressed air control system, a pneumatic control system, a drainage system, a PLC (programmable logic controller) control system, a purified water tank, a color water tank, a water pump, a water circulation vacuum pump, a pipeline, a valve, a filter, a sensor, a detector and an actuator. The vacuum leak detection cabinet is respectively connected with the vacuum control system and the compressed air control system through pipelines and valves, the color water tank and the purification water tank are connected with the vacuum leak detection cabinet through pipelines, valves and a water pump, and the PLC control system is connected with the systems and the components through lines. The method can be used for detecting the sealing property of a liquid preparation packaged by plastic, and can also be used for detecting leakage of glass package and performing online steam sterilization. The internal structure of vacuum leak detection cabinet box adopts the fillet design, no dead angle, easy washing accord with GMP requirement, and the look water can also recycle, and this packing leakproofness detecting system is one set of quick, effective, reliable, economic look water method leak hunting equipment.
Description
Technical Field
The utility model relates to the technical field of production equipment in the pharmaceutical industry, in particular to a system for detecting the packaging tightness of liquid preparations such as injection/inhalant after the liquid preparations are produced and filled.
Background
The sealability of a packaging system, also called the integrity of the container seal, refers to the ability of the packaging system to prevent the loss of contents, the invasion of microorganisms, and the entry of gases (oxygen, air, water vapor, etc.) or other substances, and to ensure that the pharmaceutical product continuously meets the requirements of safety and quality. The package system leak test, or container seal integrity test, refers to a package leak test (including physical, chemical, or microbiological test methods) that detects any breaks or gaps.
After the injection/inhalant is filled and sealed, the tightness of a packaging system needs to be detected, namely leakage detection, and common packages comprise glass penicillin bottles, ampoule bottles, plastic infusion bottles/bags and the like. The preparation in the plastic ampoule bottle is usually prepared by aseptic filling of blowing, filling and sealing integrated process equipment at one time. The liquid preparations are aseptically filled and sterilized after filling, i.e. both aseptically filled and sterilized preparations, and the tightness of their packages is examined.
In the conventional probabilistic method for detecting the sealing performance of the package, a color water method is a method capable of performing qualitative and semi-quantitative determination (semi-quantitative determination by adopting a UV method), and the method is still a common method in the actual production at present on the basis of visual and reliable detection result, simplicity and convenience in operation, low cost and high cost performance.
However, the existing color water method leak detection equipment on the market is only suitable for detecting glass ampoule bottles generally, and color water leak detection equipment aiming at plastic ampoule bottles is not available. The plastic ampoule preparation obtained by aseptic filling of the blowing, filling and sealing integrated equipment needs to be subjected to leakage detection, but high-temperature final sterilization is not required, and the preparation is subjected to filtration sterilization to achieve sterility; in addition, liquid preparations packaged in plastic bags which are commonly used in clinic are not required to be subjected to high-temperature final sterilization, and only leakage detection is required, so that suitable equipment is required for leakage detection of the plastic packaging preparations.
Therefore, the sealing detection system of the injection/inhalation package, especially the plastic ampoule, and the liquid preparation packaged by the plastic bag needs to be improved based on the prior art.
The utility model adds the supporting facilities and equipment on the basis of the sterilization cabinet, and a series of improvements are carried out to obtain a set of packaging tightness detection system.
SUMMERY OF THE UTILITY MODEL
The utility model aims to solve the defects of the prior art and provides a quick, effective, reliable and economic package tightness detection system.
In order to achieve the purpose, the utility model adopts the following technical scheme: a package tightness detection system comprises a vacuum leak detection cabinet 1; a spray device 11; a temperature detector 12; a validation port 13; a vacuum control system 2; a check valve 21; a safety valve 22; a water circulation vacuum pump 26; a compressed air control system 3; a filter 31; a pneumatic control system 4; a pressure-regulating filter 41; the air-operated valve 42; a door ring 43; a pure steam interface 5; a drinking water interface 6; a purified water tank 7; a purified water interface 70; a water pump 71; a color water tank 8; a showering water sampling port 9; a drainage system 10; a PLC control system 100; a detector and actuator 101; a low water level sensor E1; high water level sensor E2.
The vacuum leak detection cabinet 1 is respectively connected with a vacuum control system 2 and a compressed air control system 3 through pipelines and valves, a pneumatic control system 4 is respectively connected with the vacuum control system 2 and the compressed air control system 3, the vacuum control system 2 is connected with a drinking water interface 6 through a water circulation vacuum pump 26 and the pipelines and valves, a pure steam interface 5 is connected with the vacuum leak detection cabinet 1 through the pipelines and valves, a purified water interface 70 is connected with a color water tank 8 and a purified water tank 7 through the pipelines and valves, the purified water tank 7 is connected with the color water tank 8 and the purified water tank 7 through the pipelines and valves, the water pump 71 is connected with the vacuum leak detection cabinet 1, the color water tank 8 is connected with the vacuum leak detection cabinet 1 through a pipeline and a valve, the leaching water sampling port 9 is connected with the vacuum leak detection cabinet 1 through a pipeline and a valve, and the vacuum leak detection cabinet 1, the vacuum control system 2, the color water tank 8 and the purified water tank 7 are respectively connected with the drainage system 10.
Preferably, the internal structure of the vacuum leak detection cabinet box adopts a fillet design, and is provided with a low water level sensor E1 and a high water level sensor E2, and the upper part is provided with a spraying device 11.
Preferably, the vacuum leak detection cabinet 1 is provided with a detector and actuator 101 on the outside.
Preferably, the bottom of the vacuum leak detection cabinet 1 is provided with a temperature detector 12.
Preferably, the vacuum leak detection cabinet 1 is provided with a verification port 13 on the side.
Preferably, the vacuum control system 2 is provided with a check valve 21, a safety valve 22.
Preferably, the compressed air control system 3 is provided with a filter 31.
Preferably, the pneumatic control system 4 is provided with a pressure regulating filter 41, an air-operated valve 42, a gate 43, a detector and an actuator 101.
Preferably, the vacuum leak detection cabinet 1, the purified water tank 7 and the color water tank 8 are all provided with a low water level sensor E1 and a high water level sensor E2.
Preferably, the compressed air control system 3, the pure steam interface 5 and the purified water tank 7 can be connected with the vacuum leak detection cabinet 1 through the same interface.
Preferably, the systems, the tank, the pump, the valve, the sensor, the detector and the actuator are integrated into the PLC control system 100 through a line.
The utility model has the beneficial effects that: the internal structure of the vacuum leak detection cabinet box adopts a fillet design, has no dead angle and is easy to clean, and completely meets the requirements of GMP (good manufacturing practice) on the production quality management standard of medicines for equipment. The package tightness detection system can be used for liquid preparations packaged by glass materials and tightness detection of liquid preparations packaged by plastic materials, meets the leakage detection requirements of different packages, can complete leakage detection and perform online steam sterilization when used for the liquid preparations packaged by the glass materials, and can monitor the sterilization temperature online. Namely, the package tightness detection system can be simultaneously suitable for a sterilization preparation and a sterile preparation. In addition, each device and each component can be subjected to parameter setting and online real-time monitoring through the PLC control system, and the color water can be recycled, so that the cost is saved, and the efficiency is improved.
Drawings
FIG. 1 is a schematic structural diagram of the present invention.
In the figure: 1-vacuum leak detection cabinet; 11-a spraying device; 12-a temperature detector; 13-a validation port; 2-a vacuum control system; 21-a one-way valve; 22-safety valve; 26-water circulation vacuum pump; 3-a compressed air control system; 31-a filter; 4-a pneumatic control system; 41-pressure regulating filter; 42-pneumatic valves; 43-door ring; 5-pure steam interface; 6-drinking water interface; 7-a purified water tank; 70-purified water interface; 71-a water pump; 8-color water tank; 9-a leaching water sampling port; 10-a drainage system; 100-a PLC control system; 101-detector and actuator; e1-low water level sensor; e2-high water level sensor.
Detailed Description
The utility model is further illustrated by the following figures and examples.
Examples
As shown in fig. 1, in a liquid preparation packaging tightness detection system, when a packaging tightness detection operation is performed, a door of a vacuum leak detection cabinet 1 is opened, a positive sample and a sample to be detected are firstly put in, the vacuum leak detection cabinet is started, and the door is closed to perform a door sealing operation; preparing colored water with a certain concentration in a colored water tank 8 by using a required indicator and purified water; setting parameters such as pressure, holding time, balance time, soaking time, leaching time and the like in a PLC (programmable logic controller) control system 100, starting to execute a program, vacuumizing a vacuum leakage detection cabinet 1 by a vacuum control system 2, simultaneously conveying color water prepared in advance in a color water tank 8 into the vacuum leakage detection cabinet 1 through a pipeline, immersing a sample in the color water, keeping the pressure for b seconds when the vacuum leakage detection cabinet 1 is vacuumized to the pressure of a kPa, releasing the pressure of the vacuum leakage detection cabinet 1 to c kPa by a compressed air control system 3, balancing for d seconds under the condition of c kPa, and discharging the color water of the vacuum leakage detection cabinet 1 back to the color water tank 8 for detection of a next batch of samples; (the process of the color water discharge color water tank is that when the color water in the vacuum leakage detection cabinet 1 needs to be discharged, a valve of a pipeline at the bottom of the vacuum leakage detection cabinet 1 and a valve of a pipeline at the bottom of the color water tank 8, which is connected with a drain pipe 10, are opened, compressed air is conveyed to the vacuum leakage detection cabinet 1 through a compressed air control system 3, the color water flows back into the color water tank 8 through the pipeline at the bottom of the vacuum leakage detection cabinet 1 and the pipeline at the bottom of the color water tank 8 under pressure for next use), then, purified water in a purified water tank 7 is pumped into the vacuum leakage detection cabinet 1 through a water pump through a pipeline, the water is emptied after being fully soaked for e seconds, the outer wall of a sample is rinsed and cleaned by purified water through a spraying device 11 for f seconds, when rinsing is finished, the sample is sampled at a rinsing water sampling port 9, then the water in the vacuum leakage detection cabinet 1 is emptied, after the above procedures are finished, the finishing procedures in the PLC control system 100 and printing is finished, the hatch of the vacuum leak detection cabinet 1 is then opened to pull out all samples. The procedure was repeated for the next batch of samples. After the operation is finished, detecting and visually observing the positive sample and the leaching water by using an ultraviolet-visible spectrophotometry verified by methodology, setting an acceptable standard, visually observing the sample to be detected, and judging the packaging sealing integrity of the sample to be detected according to the acceptable standard. Wherein, the values of the parameters such as the vacuum pumping pressure a, the holding time b, the releasing pressure c, the balancing time d, the soaking time e, the leaching time f and the like are set according to the actual situation.
The packaging sealing performance detection system can also be used for sterilization, when in sterilization operation, parameters such as temperature, pressure, sterilization time and the like are set in the PLC control system 100, pure steam is introduced from the pure steam interface 5, sterilization is finished after a certain time, the compressed air control system 3 is opened to exhaust, when the pressure in the vacuum leak detection cabinet 1 is reduced to normal pressure, the cabin door of the vacuum leak detection cabinet 1 is opened to pull out all samples, and sterilization is finished.
The present invention has been described in connection with the accompanying drawings, and it is to be understood that the utility model is not limited to the specific embodiments described above, but is intended to cover various modifications, which may be made by the method and technical solution of the present invention, or may be applied to other fields without modification.
Claims (7)
1. A package tightness detection system is characterized by comprising a vacuum leak detection cabinet, a vacuum control system, a compressed air control system, a pneumatic control system, a drainage system, a PLC control system, a purified water tank, a color water tank, a water pump, a water circulating vacuum pump, a pipeline, a valve, a filter, a sensor, a detector and an actuator, wherein the vacuum leak detection cabinet is respectively connected with the vacuum control system and the compressed air control system through the pipeline and the valve, the pneumatic control system is respectively connected with the vacuum control system and the compressed air control system, the vacuum control system is connected with a drinking water interface through the water circulating vacuum pump and the pipeline and the valve, the vacuum leak detection cabinet is connected with a pure steam interface through the pipeline and the valve, the color water tank and the purified water tank are connected with the purified water interface through the pipeline and the valve, and the purified water tank is connected with the purified water interface through the pipeline and the valve, The water pump is connected with the vacuum leak detection cabinet, the color water tank is connected with the vacuum leak detection cabinet through a pipeline and a valve, the leaching water sampling port is connected with the vacuum leak detection cabinet through a pipeline and a valve, the vacuum leak detection cabinet, a vacuum control system, the color water tank and a purified water tank are respectively connected with a drainage system, a PLC control system is respectively connected with the vacuum leak detection cabinet through a circuit, the vacuum control system, a compressed air control system, a pneumatic control system, a drainage system, the purified water tank, the color water tank, the water pump, a water circulation vacuum pump, a valve, a filter, a sensor, a detector and an actuator.
2. The system for detecting the tightness of the package according to claim 1, wherein the vacuum leak detection cabinet is designed with a round angle inside and is provided with a low water level sensor and a high water level sensor, a spraying device is arranged on the upper portion, a detector and an actuator are arranged on the outside, a temperature detector is arranged on the bottom, and an equipment verification port is arranged on the side.
3. The system of claim 1, wherein the vacuum control system comprises a check valve, a safety valve, a water circulation vacuum pump, a valve and a pipeline.
4. The package hermeticity detection system of claim 1 wherein the compressed air control system includes filters, valves and tubing.
5. The system of claim 1, wherein the pneumatic control system comprises pressure regulating filters, pneumatic valves, valve collars, detectors and actuators, valves, and piping.
6. The system of claim 1, wherein the purified water tank and the color water tank are each provided with a low water level sensor and a high water level sensor.
7. The system for detecting the tightness of a package according to claim 1, wherein the compressed air control system, the pure steam interface and the purified water tank are connected with the vacuum leak detection cabinet through the same interface.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202220432186.8U CN216746634U (en) | 2022-03-02 | 2022-03-02 | Package sealing performance detection system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202220432186.8U CN216746634U (en) | 2022-03-02 | 2022-03-02 | Package sealing performance detection system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN216746634U true CN216746634U (en) | 2022-06-14 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202220432186.8U Active CN216746634U (en) | 2022-03-02 | 2022-03-02 | Package sealing performance detection system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN216746634U (en) |
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- 2022-03-02 CN CN202220432186.8U patent/CN216746634U/en active Active
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