Laser headspace measuring device for transparent container

Abstract

The utility model discloses a transparent container laser headspace measuring device, which comprises a measuring device lower cavity and a measuring device upper cavity, the measuring device lower cavity supports the measuring device upper cavity, a vertical lifting motor subsystem is arranged on the measuring device lower cavity, a support frame cavity is arranged in the measuring device lower cavity, a measuring tool is arranged above the support frame cavity, and the vertical lifting motor subsystem is arranged on the measuring device lower cavity. The vacuum blood collection tube is arranged on the measuring tool, a strip-shaped through hole is formed in the side wall of the lower cavity of the measuring device, the vertical lifting motor subsystem penetrates through the strip-shaped through hole and is connected with the supporting frame cavity, and the vertical lifting motor subsystem controls the supporting frame cavity to move up and down. An optical adjusting frame platform and a photoelectric detector are respectively fixed on the opposite sides of the measuring device upper cavity, an optical adjusting frame is connected to the optical adjusting frame platform through bolts, an optical fiber collimator is arranged in the optical adjusting frame, and a light through hole is formed in the supporting frame cavity. By arranging the measuring tool, penicillin bottles / ampoule bottles / blood collection tubes of different sizes and specifications can be replaced.

Description

Technical Field

[0001] The utility model relates to the technical field of transparent container laser headspace measurement, in particular to a transparent container laser headspace measurement device. Background Art

[0002] Sterile drug packaging systems must maintain adequate sealing to prevent microbial contamination. To ensure drug quality and safety, damaged or defective products must be accurately detected and removed during the final inspection process to prevent contaminated or ineffective drugs from entering the market due to seal integrity defects. In 1998, the US FDA first proposed that sterile drug packaging integrity testing could be used as an alternative to sterility testing methods during sterile drug stability studies. In 2008, the EU Good Manufacturing Practices (GMP) also issued requirements for sterile product integrity testing. In May 2018, the latest edition of the United States Pharmacopoeia (USP) <1207.2> outlined 10 seal integrity testing methods, including probabilistic methods such as microbial challenge and deterministic methods such as vacuum decay, high-voltage discharge, and laser.

[0003] The pharmaceutical industry is increasingly using freeze-dried packaging for pharmaceuticals, with vials being a widespread option. Annual demand in the domestic market alone reaches tens of billions. However, due to factors such as unstable stoppering and capping, and damage to the packaging material itself, the seal integrity of vials is easily compromised, causing drug deterioration or denaturation, which can pose a serious threat to life. Unlike atmospheric pressure aqueous ampoules, which can be leak-tested using vacuum decay and high-voltage discharge techniques, freeze-dried vials contain powdered drugs in a high-vacuum state, making currently established leak detection techniques like vacuum decay and high-voltage discharge inapplicable.

[0004] Laser absorption spectroscopy (TDLAS) is an emerging gas analysis technology that uses a narrowband laser to scan the absorption lines of gas molecules. By analyzing the gas's absorption of the laser, parameters such as the concentration, temperature, and pressure of the gas to be measured can be obtained. It has the advantages of non-destructive in-situ online detection, high measurement accuracy, and fast response. It has been widely used in the field of gas detection.

[0005] Currently, the headspace environmental measurement and analysis of transparent sealed containers of pharmaceutical packaging materials (vials / ampoules / blood collection tubes, etc.) mostly uses destructive measurement methods, which have disadvantages such as low measurement accuracy and easy misjudgment.

[0006] In order to solve the above problems, the present utility model is hereby proposed. Utility Model Content

[0007] The purpose of the utility model is to provide a transparent container laser headspace measurement device, which adopts tunable diode laser absorption spectroscopy technology (TDLAS) to build a measurement device compatible with various types of pharmaceutical packaging materials (vials / ampoules / blood collection tubes, etc.), and realizes non-destructive and full life cycle detection of sample bottles of transparent sealed containers of pharmaceutical packaging materials, without the need for nitrogen purging. The measuring device has strong compatibility and high integration.

[0008] The purpose of the utility model can be achieved through the following technical solutions:

[0009] A transparent container laser head space measuring device comprises a measuring device lower cavity and a measuring device upper cavity, the measuring device lower cavity supports the measuring device upper cavity, a vertical lifting motor subsystem is provided on the measuring device lower cavity, a support frame cavity is provided in the measuring device lower cavity, a measuring tool is installed above the support frame cavity, a vacuum blood collection tube is placed on the measuring tool, a strip through hole is provided on the side wall of the measuring device lower cavity, the vertical lifting motor subsystem is connected to the support frame cavity through the strip through hole, the vertical lifting motor subsystem controls the support frame cavity to move up and down, an optical adjustment frame platform and a photoelectric detector are fixed on opposite sides of the measuring device upper cavity, an optical adjustment frame is connected to the optical adjustment frame platform by bolts, a fiber optic collimator is provided inside the optical adjustment frame, and a light hole is provided inside the support frame cavity.

[0010] Preferably, the vertical lifting motor subsystem consists of a stepper motor, a connecting guide rail, a stepper motor guide rail bracket and a guide rail slider. The output shaft of the stepper motor is connected to the stepper motor guide rail bracket, the guide rail slider is connected to the stepper motor guide rail bracket, a connecting guide rail is installed on the stepper motor, the guide rail slider is located on the connecting guide rail, the stepper motor guide rail bracket is connected to the bottom support frame by bolts, and the bottom support frame is connected to the support frame cavity.

[0011] Preferably, a photoelectric switch is provided on the surface of the lower cavity of the measuring device, and the stepping motor guide rail bracket is connected to the photoelectric switch via bolts to trigger it.

[0012] Furthermore, the measuring tool is mounted on the support frame cavity in a bayonet form.

[0013] Beneficial technical effects:

[0014] The utility model is provided with a measuring tool, which can be replaced according to different sizes of vials / ampoules / blood collection tubes, thereby achieving the installation of different transparent sealed containers, and the measuring device has strong compatibility. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The present invention will be further described below with reference to the accompanying drawings.

[0016] Figure 1 This is a schematic structural diagram of the transparent container laser headspace measurement device of the utility model.

[0017] Figure 2 This is a side view of the transparent container laser headspace measurement device of the utility model.

[0018] Figure 3 This is a cross-sectional view of the transparent container laser headspace measurement device of the utility model.

[0019] Figure 4 This is a schematic diagram of the internal structure of the transparent container laser headspace measurement device of the utility model.

[0020] Figure 5 This is an internal side view of the transparent container laser headspace measurement device of the utility model.

[0021] In the figure: 1. Optical adjustment frame platform; 2. Optical adjustment frame; 3. Laser beam; 4. Vacuum blood collection tube; 5. Measuring tool; 6. Upper cavity of measuring device; 7. Photoelectric detector; 8. Stepper motor guide rail bracket; 9. Stepper motor; 10. Photoelectric switch; 11. Photoelectric switch trigger; 12. Lower cavity of measuring device; 13. Connecting rail; 14. Bottom support frame; 15. Support frame cavity. DETAILED DESCRIPTION

[0022] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0023] like Figure 1-5 As shown, a transparent container laser head space measurement device includes a measuring device lower chamber 12 and a measuring device upper chamber 6. The measuring device lower chamber 12 supports the measuring device upper chamber 6. A vertical lifting motor subsystem is provided on the measuring device lower chamber 12. A support frame cavity 15 is provided in the measuring device lower chamber 12. A measuring tool 5 is installed above the support frame cavity 15. A vacuum blood collection tube 4 is placed on the measuring tool 5. A strip through hole is provided on the side wall of the measuring device lower chamber 12. The vertical lifting motor subsystem is connected to the support frame cavity 15 through the strip through hole. Next, the vertical lifting motor subsystem controls the up and down movement of the support frame cavity 15. The optical adjustment frame platform 1 and the photodetector 7 are fixed on the opposite sides of the upper cavity 6 of the measuring device. The optical adjustment frame 2 is connected to the optical adjustment frame platform 1 by bolts. The optical adjustment frame 2 is provided with a fiber collimator inside. The fiber collimators of different bands can be replaced according to the measurement requirements. A light hole is provided inside the support frame cavity 15. The height and cylindrical diameter of the support frame cavity 15 are compatible with various transparent sealed containers for pharmaceutical packaging materials, such as vials / ampoules / blood collection tubes, etc.

[0024] When the transparent sealed container laser head space measurement device is working, the laser beam 3 passes through the vacuum blood collection tube 4 through the light hole and hits the target surface of the photodetector 7 for signal collection. The laser light intensity can be used to determine whether the position of the vacuum blood collection tube 4 is appropriate, and the support frame cavity 15 can be adjusted through the vertical lifting motor subsystem.

[0025] Measuring fixture 5 can accommodate different sizes of blood collection tubes, vials, and ampoules, ensuring system compatibility. The vertical lift motor subsystem automatically adjusts the lift height to adjust the position of the sample, providing a high degree of automation. Using TDLAS, non-destructive, full-lifecycle testing of sample bottles is possible.

[0026] The vertical lifting motor subsystem consists of a stepper motor 9, a connecting guide rail 13, a stepper motor guide rail bracket 8 and a guide rail slider. The output shaft of the stepper motor 9 is connected to the stepper motor guide rail bracket 8, and the guide rail slider is connected to the stepper motor guide rail bracket 8. The stepper motor 9 is equipped with a connecting guide rail 13, and the guide rail slider is located on the connecting guide rail 13 to ensure that the guide rail slider moves in the vertical direction. The stepper motor guide rail bracket 8 is connected to the bottom support frame 14 by bolts, and the bottom support frame 14 is connected to the support frame cavity 15. The bottom support frame 14 supports the support frame cavity 15 to ensure its vertical lifting.

[0027] A photoelectric switch 10 is provided on the surface of the lower cavity 12 of the measuring device. The stepping motor guide rail bracket 8 is connected to the photoelectric switch trigger 11 through bolts. The photoelectric switch trigger 11 covers the photoelectric switch 10 during the movement of the stepping motor guide rail bracket 8 and plays a zero point and limit role.

[0028] During use, the vacuum blood collection tube 4 is installed on the measuring tool 5. The measuring tool 5 can replace blood collection tubes / vials / ampoules of different sizes, etc. The vacuum blood collection tube 4 can replace various medicine packaging materials. The measuring tool 5 is installed on the support frame cavity 15 in a bayonet form to play a supporting and lifting role.

[0029] The utility model can be widely used in measuring the headspace components of all kinds of transparent sealed containers and has the characteristics of high degree of automation and strong versatility.

[0030] The utility model has the following advantages:

[0031] 1. Transparent container laser headspace measurement device. The measuring tooling can be replaced according to the different sizes of vials / ampoules / blood collection tubes to achieve the installation of different transparent sealed containers. The measuring device has strong compatibility. The entire test platform uses automated equipment to analyze the laser measurement position to prevent the drug in the container from being blocked by light, ensuring the accuracy of the measurement position. The system has a high degree of automation and integration, which facilitates headspace analysis and accurately obtains measurement data.

[0032] 2. The entire device integrates a stepper motor subsystem, which can automatically adjust the laser light transmission position of transparent sealed containers (blood collection tubes, vials, ampoules, etc.) according to parameters such as laser transmission intensity, photoelectric switches and module data.

[0033] 3. The headspace gas analysis in transparent sealed containers uses laser absorption spectroscopy measurement, which can achieve non-destructive and full life cycle detection of sample bottles. It does not require nitrogen purging, has a stable device structure, and the design has multiple functions and uses, high integration, and a small size.

[0034] In addition, it should be understood that although this specification is described in terms of implementation methods, not every implementation method contains only one independent technical solution. This narrative method of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other implementation methods that can be understood by those skilled in the art.

Claims

1. A transparent container laser headspace measurement device, characterized in that: It includes a lower cavity and an upper cavity of the measuring device. The lower cavity of the measuring device supports the upper cavity of the measuring device. A vertical lifting motor subsystem is arranged on the lower cavity of the measuring device. A support frame cavity is arranged in the lower cavity of the measuring device. A measuring tool is installed above the support frame cavity. The vacuum blood collection tube is placed on the measuring tool. A strip through hole is arranged on the side wall of the lower cavity of the measuring device. The vertical lifting motor subsystem is connected to the support frame cavity through the strip through hole. The vertical lifting motor subsystem controls the up and down movement of the support frame cavity. An optical adjustment frame platform and a photoelectric detector are fixed on opposite sides of the upper cavity of the measuring device respectively. An optical adjustment frame is connected to the optical adjustment frame platform by bolts. A fiber optic collimator is arranged inside the optical adjustment frame, and a light hole is arranged inside the support frame cavity.

2. The transparent container laser head space measurement device according to claim 1, characterized in that: The vertical lifting motor subsystem consists of a stepper motor, a connecting guide rail, a stepper motor guide rail bracket and a guide rail slider. The output shaft of the stepper motor is connected to the stepper motor guide rail bracket, the guide rail slider is connected to the stepper motor guide rail bracket, a connecting guide rail is installed on the stepper motor, the guide rail slider is located on the connecting guide rail, the stepper motor guide rail bracket is connected to the bottom support frame by bolts, and the bottom support frame is connected to the support frame cavity.

3. The transparent container laser head space measurement device according to claim 2, characterized in that: A photoelectric switch is provided on the surface of the lower cavity of the measuring device, and the stepping motor guide rail bracket is connected to the photoelectric switch through bolts to trigger it.

4. The transparent container laser head space measurement device according to claim 3, characterized in that: The measuring tool is mounted on the support frame cavity in a bayonet manner.

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