A leak detection device for vials combining TDLAS technology and gas reflection pool

Abstract

The invention provides a vial leak detection device combining TDLAS technology and a gas reflection pool, which is used to detect the sealing of a vial. The device is characterized in that it comprises: a laser emitting unit, which is used to emit laser light within a certain wavelength range, and comprises a semiconductor laser and a laser controller; an external long optical path gas reflection pool, which comprises a collimator, a vial base, a mounting frame and two plane reflectors; a laser detection unit, which is used to detect a transmission light intensity signal transmitted through the vial and convert it into an electrical signal; and a signal processing unit, which is used to process the electrical signal and generate a gas leakage coefficient, wherein the laser controller is connected to the semiconductor laser, the collimator is connected to the laser emitting unit, and is arranged on the mounting frame, and is used to collimate the laser beam so that the laser beam is horizontally projected into the external long optical path gas reflection pool, the vial base is used to place the vial, and the plane reflectors are arranged in parallel on both sides of the vial base through the mounting frame, and are used to increase the optical path of the laser passing through the vial.

Description

Technical Field

[0001] The invention relates to the field of vial detection, and in particular to a vial leak detection device combining TDLAS technology and a gas reflection pool. Background Art

[0002] Vials are widely used in the packaging of lyophilized powder injections of antibiotics such as beta-lactams and quinolones because of their advantages such as easy transportation, storage and use. However, due to cracks and fissures in the vials during the packaging process and the loose assembly between the stopper and the bottle, air can penetrate into the vials, where water vapor and oxygen in the air react with the drugs in a series of chemical reactions, causing the drugs to deteriorate and denature. If the vials are not leak-checked in time, it will have a great impact on the health of patients. Therefore, it is particularly important to conduct non-interference, rapid and high-precision testing of the sealing of vials.

[0003] Traditional vial leak detection methods cannot meet the requirements of high precision, rapidity, and non-interference. For example, the electronic micropore leak detection method requires that the drug being tested has conductivity; the microbial invasion method cannot achieve rapid online detection and will contaminate the drugs; the colored water leak detection method is destructive and relies on manual judgment; the desktop headspace analyzer developed by the American Lighthouse Company for vial leak detection, although it can achieve high-precision gas concentration detection, has a long detection time, with the measurement time for a single bottle ranging from 1s to 5s, and is less efficient.

[0004] Tunable semiconductor laser absorption spectroscopy (TDLAS) has the advantages of fast time response and no interference with the detection object, and is widely used in gas concentration and temperature measurement. The existing patent (ZL201810980524.X) proposes a vial leak detection device and a measurement method based on dual-wavelength-TDLAS technology. This method achieves online leak detection by measuring the water vapor leakage coefficient of the vial and comparing it with the threshold. However, lyophilized powder injections (drugs) are hygroscopic after low-temperature freeze-drying. Therefore, the vial leak detection device based on water vapor dual-wavelength TDLAS technology cannot accurately determine the leakage of the vial. Summary of the invention

[0005] The present invention is made to solve the above problems, and its purpose is to provide a vial leak detection device combining TDLAS technology and a gas reflection pool. To this end, the present invention provides the following technical solutions:

[0006] The invention provides a vial leak detection device combining TDLAS technology and a gas reflection pool, which is used to detect the sealing of a vial. The device is characterized in that it comprises: a laser emitting unit, which is used to emit laser light within a certain wavelength range, and comprises a semiconductor laser and a laser controller; an external long optical path gas reflection pool, which comprises a collimator, a vial base, a mounting frame and two plane reflectors; a laser detection unit, which is used to detect a transmission light intensity signal transmitted through the vial and convert it into an electrical signal; and a signal processing unit, which is used to process the electrical signal and generate a gas leakage coefficient, wherein the laser controller is connected to the semiconductor laser and is used to control the temperature and current of the semiconductor laser; the collimator is connected to the laser emitting unit and is arranged on the mounting frame and is used to collimate the laser beam so that the laser beam is horizontally projected into the external long optical path gas reflection pool; the vial base is used to place the vial; and the plane reflectors are arranged in parallel on both sides of the vial base through the mounting frame and are used to increase the optical path of the laser passing through the vial.

[0007] The vial leak detection device combining TDLAS technology and a gas reflection pool provided by the present invention may also have the following features: wherein the vial base has an inclination angle, which is set to 8° to suppress the influence of the standard tool effect on the gas transmission light intensity signal.

[0008] The vial leak detection device combining the TDLAS technology and the gas reflection pool provided by the present invention may also have the following features: wherein the vial base has a positioning groove, the inner diameter of which is 2.74 cm, for fixing the position of the vial.

[0009] The vial leak detection device combining TDLAS technology and a gas reflection pool provided by the present invention may also have such features, and also include: a reflection and focusing component, which is arranged between the external long optical path gas reflection pool and the laser detection part, and is used to reflect and focus the outgoing light, including a spherical reflector and a convex lens.

[0010] The vial leak detection device combining the TDLAS technology and the gas reflection pool provided by the present invention may also have the following feature: wherein the laser detection unit adopts a photoelectric detector.

[0011] The vial leak detection device combining TDLAS technology and a gas reflection pool provided by the present invention may also have the following features: wherein the signal processing unit includes an acquisition card and a computer, the acquisition card is electrically connected to the photoelectric detector for collecting electrical signals, and the computer is electrically connected to the acquisition card for performing data processing and calculating the gas leakage coefficient.

[0012] The vial leak detection device combining the TDLAS technology and the gas reflection pool provided by the present invention may also have the following characteristics: wherein the wavelength of the laser covers the absorption peak of oxygen, and the gas leakage coefficient is the oxygen leakage coefficient.

[0013] Functions and Effects of the Invention

[0014] The vial leak detection device combined with TDLAS technology and gas reflection pool involved in the present invention comprises a laser emission unit, an external long optical path gas reflection pool, a laser detection unit and a signal processing unit. These structures have the following effects:

[0015] The laser emitting unit includes a semiconductor laser and a laser controller. The laser controller is connected to the semiconductor laser and can control the temperature and current of the semiconductor laser so that the semiconductor laser can emit laser light within a certain wavelength range.

[0016] The external long optical path gas reflection pool includes a collimator, a vial base, a mounting frame, and two plane reflectors. The collimator is connected to the laser emission unit and is mounted on the mounting frame. It can collimate the laser beam so that it can be horizontally projected into the external long optical path gas reflection pool, so that the beam can pass through the diameter direction of the vial as much as possible. The vial base can hold the vial, and the plane reflectors are arranged in parallel on both sides of the vial base through the mounting frame. The laser beam collimated by the collimator can be focused and reflected multiple times between the two reflectors, thereby increasing the optical path of the beam passing through the vial and improving the measurement accuracy of low-concentration gas in the vial.

[0017] The laser detection unit can detect the transmission light intensity signal that is transmitted through the vial after being partially absorbed by the gas of a specific wavelength in the vial, and convert the attenuated transmission light intensity signal into an electrical signal.

[0018] The signal processing unit can further collect and process the electrical signals to accurately and quickly obtain the gas leakage coefficient of the vial, thereby judging the leakage status of the vial.

[0019] Therefore, the vial leak detection device combined with the TDLAS technology and the gas reflection pool involved in the present invention can study and determine the leakage of the vial by measuring the gas leakage coefficient. It adopts the laser transmission method and does not come into direct contact with the medicine in the vial to avoid contaminating the medicine. It can be used to detect the sealing of vials of water-absorbing freeze-dried powder injections and other medicines, and achieves the detection requirements of high precision, rapidity, and interference-free that cannot be met by traditional vial leak detection methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a schematic structural diagram of a vial leak detection device combining TDLAS technology and a gas reflection pool in an embodiment of the present invention; and

[0021] Figure 2 Schematic diagram of the structure of the long optical path gas reflection cell in the embodiment of the present invention. DETAILED DESCRIPTION

[0022] In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the following embodiments and accompanying drawings specifically illustrate the vial leak detection device combining TDLAS technology and a gas reflection pool of the present invention.

[0023] <Example>

[0024] Figure 1 It is a schematic structural diagram of a vial leak detection device combining the TDLAS technology and a gas reflection pool in an embodiment of the present invention.

[0025] like Figure 1 As shown, the vial leak detection device 100 combining the TDLAS technology and the gas reflection pool includes a laser emitting unit 10 , an external long optical path gas reflection pool 20 , a reflection focusing assembly 30 , a laser detection unit 40 and a signal processing unit 50 .

[0026] The laser emitting unit 10 is used to emit laser light in a certain wavelength range, and includes a semiconductor laser 11 and a laser controller 12. The laser controller 12 is connected to the semiconductor laser 11 and is used to control the temperature and current of the semiconductor laser 11. In this embodiment, the semiconductor laser 11 is a tunable semiconductor laser, and the wavelength of the laser emitted by the laser emitting unit 10 can cover the absorption peak of oxygen.

[0027] Figure 2 Schematic diagram of the structure of the long optical path gas reflection cell in the embodiment of the present invention.

[0028] like Figure 2 As shown, the external long optical path gas reflection pool 20 includes a collimator 21, a vial base 22, a mounting frame 23 and two plane reflectors 24. The collimator 21 is connected to the semiconductor laser 11 and is arranged on the mounting frame 23, and is used to collimate the laser beam so that it is horizontally projected into the external long optical path gas reflection pool 20. The vial base 22 is used to place the vial. The vial base 22 in this embodiment has an inclination angle, which is set to 8°, and is used to suppress the influence of the standard tool effect on the gas transmission light intensity signal. A positioning groove 221 is also provided on the vial base 22 for fixing the position of the vial. The inner diameter of the positioning groove 221 is adapted to the outer diameter of the vial. In this embodiment, the outer diameter of the vial to be measured is 2.7 cm, and the inner diameter of the positioning groove 221 is 2.74 cm. The plane reflectors 24 are arranged in parallel on both sides of the vial base 22 through the mounting frame 23, and are used to increase the optical path of the laser passing through the vial. In this embodiment, the two plane reflectors 24 are both silver-plated plane reflectors customized by Edmund Company, with an average reflectivity of more than 96%, so that the light beam can be focused and reflected 11 times between the two plane reflectors 24, with a total optical path of about 50 cm and a theoretical effective optical path of about 32 cm.

[0029] The reflection and focusing assembly 30 is arranged between the external long optical path gas reflection pool 20 and the laser detection unit 40, and is used to reflect and focus the outgoing light, and includes a spherical reflector 31 and a convex lens 32. In this embodiment, the spherical reflector 31 adopts a gold-plated spherical reflector. The spherical reflector 31, the collimator 21 and the two plane reflectors 24 are all arranged on the same straight line. The spherical reflector 31 is arranged outside the plane reflector 24 where the laser is emitted, and the convex lens 32 is arranged between the spherical reflector 31 and the laser detection unit 40.

[0030] The laser detection unit 40 is used to detect the intensity signal of the light transmitted through the vial and convert it into an electrical signal. In this embodiment, the laser detection unit 40 is a photoelectric detector.

[0031] The signal processing unit 50 is used to process the electrical signal and generate a gas leakage coefficient. In this embodiment, the gas leakage coefficient is an oxygen leakage coefficient. The signal processing unit 50 includes an acquisition card 51 and a computer 52. The acquisition card 51 is electrically connected to the photoelectric detector for collecting electrical signals. The computer 52 is electrically connected to the acquisition card 51 for data processing and calculating the gas leakage coefficient.

[0032] In this embodiment, data collection and processing are performed in LabVIEW software. After further signal processing and analysis, the oxygen leakage coefficient k of the vial is obtained. The definition of k is:

[0033] k=-In(I t / I0)

[0034] Among them, I t is the transmitted light intensity signal received by the photodetector; I0 is the incident light intensity, that is, the baseline obtained by polynomial fitting by selecting the unabsorbed area at both ends of the oxygen absorption peak. According to the oxygen leakage coefficient k value of the vial to be tested, the leakage state of the vial is analyzed and judged by comparing it with the threshold.

[0035] The following is combined with Figures 1-2 The specific use process and method of the vial leak detection device 100 of the present invention combining the TDLAS technology and the gas reflection pool are described as follows:

[0036] Step 1: Control the operating temperature of the semiconductor laser 11 to remain constant through the laser controller 12, and modulate the wavelength of the laser output by the semiconductor laser 11 by means of a tuning current, so that the semiconductor laser 11 outputs laser light within a desired wavelength range;

[0037] Step 2: The laser beam collimated by the collimator 21 is horizontally incident on the external long optical path gas reflection pool 20, and the laser is focused and reflected between two plane reflectors 24, passing through the vial to be tested placed on the vial base 22 for multiple times;

[0038] Step 3: The outgoing light is reflected and focused by the spherical reflector 31 and the convex lens 32 and then concentrated on the laser detection unit 40;

[0039] Step 4: The laser detection unit 40 detects the transmission light intensity signal transmitted through the vial after being partially absorbed by the oxygen in the vial, and converts the attenuated transmission light intensity signal into an electrical signal;

[0040] Step 5: The acquisition card 51 acquires the electrical signal, and the computer 52 processes the data, and finally obtains the oxygen leakage coefficient of the tested vial, and analyzes and determines the leakage state of the vial by comparing it with the threshold.

[0041] Functions and Effects of the Embodiments

[0042] The vial leak detection device combined with TDLAS technology and gas reflection pool involved in this embodiment includes a laser emission unit, an external long optical path gas reflection pool, a reflection focusing component, a laser detection unit and a signal processing unit. These structures have the following effects:

[0043] The laser emitting unit includes a semiconductor laser and a laser controller. The laser controller is connected to the semiconductor laser and can control the temperature and current of the semiconductor laser so that the semiconductor laser can emit laser light in a certain wavelength range. The semiconductor laser of this embodiment is a tunable semiconductor laser, and the wavelength of the laser emitted by the laser emitting unit can cover the absorption peak of oxygen.

[0044] The external long optical path gas reflection pool includes a collimator, a vial base, a mounting frame and two plane reflectors. The collimator is connected to the semiconductor laser and is arranged on the mounting frame. It can collimate the laser beam so that it can be horizontally shot into the external long optical path gas reflection pool, so that the beam can pass through the diameter direction of the vial as much as possible. The vial base can hold the vial. The vial base in this embodiment has an inclination angle of 8°, which can suppress the influence of the standard tool effect on the gas transmission light intensity signal, making the measurement result more accurate. A positioning groove is also provided on the vial base for fixing the position of the vial, and the inner diameter of the positioning groove is adapted to the outer diameter of the vial. In this embodiment, the outer diameter of the vial to be measured is 2.7 cm, and the inner diameter of the positioning groove is 2.74 cm, so that the vial can be just placed in the positioning groove, and the position of the vial is not easy to change, so as to prevent the light path from changing with the placement position of the vial, thereby improving the overall accuracy of the device. The two plane reflectors 24 of this embodiment are both silver-plated plane reflectors custom-made by Edmund Company, with an average reflectivity of more than 96%, so that the light beam can be focused and reflected 11 times between the two plane reflectors 24, with a total optical path of about 50 cm and a theoretical effective optical path of about 32 cm. The plane reflectors are arranged in parallel on both sides of the vial base through a mounting frame, which can effectively increase the optical path of the laser passing through the vial and improve the measurement accuracy of low-concentration oxygen in the vial.

[0045] The reflective focusing assembly is arranged between the external long optical path gas reflection pool and the laser detection unit, and includes a spherical reflector and a convex lens. The spherical reflector adopts a gold-plated spherical reflector, which can achieve a better focusing and reflection effect. The spherical reflector, the collimator and the two plane reflectors are arranged on the same straight line, which is convenient for accurate control and detection of the laser. The spherical reflector is arranged on the outside of the plane reflector from which the laser emerges, and the convex lens is arranged between the spherical reflector and the laser detection unit. The reflective focusing assembly can further reflect and focus the outgoing light to ensure that the outgoing laser is fully received by the laser detection unit.

[0046] The laser detection part is a photoelectric detector, which can detect the transmission light intensity signal transmitted through the vial after being partially absorbed by the oxygen in the vial, and convert the attenuated transmission light intensity signal into an electrical signal.

[0047] The signal processing unit includes an acquisition card and a computer, which can process the electrical signal and generate a gas leakage coefficient. The gas leakage coefficient of this embodiment is the oxygen leakage coefficient. The acquisition card is electrically connected to the photodetector and can collect electrical signals. The computer is electrically connected to the acquisition card, and data processing can be performed through LabVIEW software to accurately and quickly obtain the oxygen leakage coefficient of the vial, and compare it with the threshold value to analyze and judge the leakage state of the vial, timely screen out the leaking vial, and ensure the safety and reliability of the drugs in the vial.

[0048] Therefore, the vial leak detection device combined with the TDLAS technology and the gas reflection pool involved in the present invention can study and determine the leakage of the vial by measuring the gas leakage coefficient. It adopts the laser transmission method and does not come into direct contact with the medicine in the vial to avoid contaminating the medicine. It can be used to detect the sealing of vials of water-absorbing freeze-dried powder injections and other medicines, and achieves the detection requirements of high precision, rapidity, and interference-free that cannot be met by traditional vial leak detection methods.

[0049] The above-mentioned embodiments are preferred examples of the present invention and are not intended to limit the protection scope of the present invention.

Claims

1. A vial leak detection device combining TDLAS technology and a gas reflection pool, used to detect the sealing of vials, characterized in that: include: A laser emitting unit, used for emitting laser light within a certain wavelength range, including a semiconductor laser and a laser controller; External long optical path gas reflection cell, including collimator, vial base, mounting frame and 2 flat mirrors; A laser detection unit, used to detect the transmitted light intensity signal transmitted through the vial and convert it into an electrical signal; as well as A signal processing unit, used for processing the electrical signal and generating a gas leakage coefficient, Wherein, the laser controller is connected to the phase and is used to control the temperature and current of the semiconductor laser, The collimator is connected to the laser emitting unit and is arranged on the mounting frame, and is used to collimate the laser beam so that it can be horizontally emitted into the external long optical path gas reflection pool. The vial base is used to place the vial. The plane reflector is arranged in parallel on both sides of the vial base through a mounting frame, so as to increase the optical path of the laser passing through the vial.

2. The vial leak detection device combining TDLAS technology and gas reflection pool according to claim 1 is characterized in that: in, The base of the vial has an inclination angle, The tilt angle is set to 8° to suppress the influence of the etalon effect on the gas transmission light intensity signal.

3. The vial leak detection device combining TDLAS technology and gas reflection pool according to claim 1, characterized in that: in, The base of the vial has a positioning groove. The inner diameter of the positioning groove is 2.74 cm, and is used to fix the position of the vial.

4. The vial leak detection device combining TDLAS technology and gas reflection pool according to claim 1, characterized in that: Also includes: The reflection and focusing assembly is arranged between the external long optical path gas reflection pool and the laser detection unit, and is used for reflecting and focusing the outgoing light, and comprises a spherical reflector and a convex lens.

5. The vial leak detection device combining TDLAS technology and gas reflection pool according to claim 1, characterized in that: in, The laser detection unit adopts a photodetector.

6. The vial leak detection device combining TDLAS technology and gas reflection pool according to claim 5 is characterized in that: in, The signal processing unit includes an acquisition card and a computer. The acquisition card is electrically connected to the photoelectric detector and is used to acquire the electrical signal. The computer is electrically connected to the acquisition card and is used for data processing and calculating the gas leakage coefficient.

7. The vial leak detection device combining TDLAS technology and gas reflection pool according to claim 1, characterized in that: in, The wavelength of the laser covers the absorption peak of oxygen, The gas leakage coefficient is an oxygen leakage coefficient.

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