A method for testing pharmaceutical small volume glass ampoules

Abstract

A method for testing small-capacity pharmaceutical glass ampoules includes the following steps: placing the ampoules onto a conveyor belt, which passes through a testing space; a parallel light source is positioned on one side of the testing space, and a light intensity detector with an array of light intensity detectors is positioned on the other side; several testing positions are set in the testing space, and the conveyor belt sequentially places the ampoules onto each testing position; at each testing position, a positioning laser beam is set at the parallel light source corresponding to the testing position, the parallel light source is used to provide parallel light, and the light intensity detector is used to acquire the detection light intensity of the parallel light passing through the ampoule. This application uses a parallel light source to provide parallel light, then utilizes the characteristic of the ampoule as glass, uses a light intensity detector to detect the light intensity, and performs automatic ampoule testing based on the comparison of detection parameters and comparison parameters.

Description

Technical Field

[0001] This application relates to a method for testing small-capacity pharmaceutical glass ampoules. Background Technology

[0002] Injectable solutions refer to directly injectable medications that require strict aseptic conditions. Therefore, ampoules are commonly used, and since they are generally for single use, small-volume ampoules, such as 2ml, are the most widely used. Small-volume ampoules are characterized by their small size, thin walls, and fragility. Furthermore, due to the characteristics of the string-filling process, the ampoule cap is prone to defects such as charring and carbonization. This necessitates manual sampling during ampoule collection, which is unreliable, inefficient, and prone to ampoule damage. Therefore, automated ampoule testing is necessary. Automated testing can replace manual sampling with individual ampoule inspection, achieving full coverage, ensuring product quality, and improving production efficiency. Summary of the Invention

[0003] To address the aforementioned issues, this application proposes a testing method for small-capacity pharmaceutical glass ampoules, comprising the following steps: placing the ampoule onto a conveyor belt, with the conveyor belt passing through a testing space; A parallel light source is set on one side of the detection space, and a light intensity detector with several arrays of light intensity detectors is set on the other side. The detection space is provided with several detection positions, and the conveyor belt sequentially places the ampoules onto each detection position; At each detection position, a positioning laser beam is set at the parallel light source at the corresponding detection position. The parallel light source is used to provide parallel light, and the light intensity detector is used to obtain the detection light intensity of the parallel light passing through the ampoule. First, intact ampoules are selected from the ampoules to be tested for pre-testing to obtain the light intensity as a comparison parameter. Then, other ampoules are tested to obtain the light intensity as the test parameter. By comparing the test parameter with the comparison parameter, it is determined whether the ampoule needs manual testing. This application uses a parallel light source to provide parallel light and then utilizes the characteristic of ampoules as glass to detect the light intensity using a light intensity detector. Based on the comparison of the test parameter and the comparison parameter, automatic ampoule testing is performed.

[0004] Preferably, the comparison parameters are obtained in the following manner: The location of the positioning laser beam is determined by the light intensity detector as the base position L0; if the positioning laser beam is not received by the same light intensity detector, the position of the detection position is corrected until the positioning laser beam is received by the same light intensity detector. Based on this basic location L0, its surrounding adjacent locations L are obtained. 1i The light intensity E detected by the light intensity detector 1i ; Based on adjacent positions L 1i The light intensity detector is away from the secondary position L0 of the base position L0. 2j The light intensity E detected by the light intensity detector 2j ; Calculate the following parameters as comparison parameters: Calculate the surrounding adjacent positions L 1i The light intensity E of the light intensity detector 1i The average value E1 = ΣE 1i / i and the difference between the maximum and minimum values ​​E 1max Secondary position L 2j The light intensity E detected by the light intensity detector 2j The average value E2 = ΣE 2j The difference between / j and the maximum and minimum values, E 2max The rate of change λ = (E2 - E1) / E2 was obtained as a comparison parameter. Using the base position L0 as the center point, and drawing rays from the base position L0 to connect adjacent positions L... 1i Light intensity detector and secondary position L 2j The light intensity detectors are connected to form i test groups, and the rate of change of light intensity in each test group is T. i =E 2j / E 1i E in each test group 1i and E 2j On the same ray, based on T i and the corresponding adjacent position L 1i The position and orientation of the light intensity detector are plotted to obtain a contrast ring. This application sets up two contrast layers; one layer consists of simple contrast parameters, such as E. 1max E 2max The first layer is λ; the second layer is a comparison ring. The former can perform rapid comparison, while the latter performs a comprehensive comparison to ensure the reliability of automatic ampoule detection.

[0005] Preferably, the comparison between the detection parameters and the comparison parameters is performed in the following manner: First, a preliminary comparison is made between the test parameters and the comparison parameters. If the preliminary comparison fails, the ampoule markings to be tested will need to be manually tested. If the initial comparison passes, a detailed comparison will be conducted. If the detailed comparison fails, it will be marked as requiring manual inspection.

[0006] Preferably, the preliminary comparison includes the following steps: Consistent with the steps for obtaining the comparison parameters, the location of the positioning laser beam is determined using a light intensity detector as the base position L. 0T ; Based on this basic location L 0T Obtain its surrounding adjacent positions L1Ti The light intensity E detected by the light intensity detector 1iT ; Based on adjacent positions L 1iT The light intensity detector is away from the base position L 0T secondary position L 2jT The light intensity E detected by the light intensity detector 2jT ; Referring to the calculation of the comparison parameters, the difference E between the maximum and minimum values ​​is calculated respectively. 1maxT E 2maxT and λ T ; Whether manual testing is needed is determined based on parameter comparison.

[0007] Preferably, the parameter comparison is as follows: If E is satisfied 1maxT ≥2.5E 1max or E 2maxT ≥2.5E 2max or λ T If any one of the two values ​​is greater than or equal to 2λ, the initial comparison is considered unsuccessful and manual inspection is required.

[0008] Preferably, the detailed comparison is performed in the following manner: Based on the base position L 0T As the center point, based on the base position L 0T Connect adjacent positions L in the form of rays 1iT Light intensity detector and secondary position L 2jT The light intensity detectors are connected to form i test groups, and the rate of change of light intensity in each test group is T. iT =E 2jT / E 1iT E in each test group 1iT and E 2jT On the same ray; based on T iT and the corresponding adjacent position L 1iT The detection ring is obtained by plotting the position and orientation of the light intensity detector; The detection loop is compared with the comparison loop, and the maximum crossover ratio I is calculated. t , if I t A value ≥0.8 is considered passing the test; otherwise, manual inspection is required. The detection loop and comparison in this application pass the test for the maximum crossover ratio I. t The calculation is used to make a trade-off comparison. Generally, a polygon approximation method can be used, or one ring can be fixed while the other ring rotates at fixed steps until it rotates 360°. The maximum intersection-union ratio I is then calculated and compared. t .

[0009] Preferably, i is not less than 8; j is not less than 16.

[0010] Preferably, the light intensity detectors are arranged in a square array.

[0011] Preferably, the illumination intensity of the parallel light is 1000-5000 lux; The illumination intensity of the positioning laser beam is 10,000-20,000 lux.

[0012] Preferably, the transmission belt is provided with positioning grooves for positioning the ampoules so that the head and tail of the ampoules face the parallel light source and the light intensity detector, respectively.

[0013] This application can bring the following beneficial effects: 1. This application uses a parallel light source to provide parallel light, and then utilizes the characteristics of the ampoule as glass to detect the light intensity using a light intensity detector, and performs automatic detection of the ampoule based on the comparison of detection parameters and comparison parameters.

[0014] 2. This application sets up two layers of comparison. The first layer is a simple comparison parameter, such as E. 1max E 2max The first layer is λ; the second layer is a comparison ring. The former can perform rapid comparison, while the latter performs a comprehensive comparison to ensure the reliability of automatic ampoule detection.

[0015] 3. The detection loop and comparison in this application are based on the maximum crossover ratio I. t The calculation is used to make a trade-off comparison. Generally, a polygon approximation method can be used, or one ring can be fixed while the other ring rotates at fixed steps until it rotates 360°. The maximum intersection-union ratio I is then calculated and compared. t . Attached Figure Description

[0016] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings: Figure 1 This is a flowchart illustrating the process of this application; Figure 2 This is a schematic diagram of a light intensity detector. Detailed Implementation

[0017] To clearly illustrate the technical features of this solution, the following detailed description, in conjunction with the accompanying drawings, will be provided.

[0018] like Figure 1 As shown, a method for testing small-capacity pharmaceutical glass ampoules includes the following steps: S1. Place the ampoule onto the conveyor belt, which then passes through the detection space; A parallel light source is set on one side of the detection space, and a light intensity detector 2 with several arrays of light intensity detectors 1 is set on the other side; such as Figure 2 As shown, the light intensity detectors 1 are arranged in a square array. It should be noted that, in practice, a circular arrangement can also be used. If a circular arrangement is used, i and j can be selected in the same number and set accordingly.

[0019] The detection space has several detection positions, and the conveyor belt sequentially places the ampoules onto each detection position. Positioning grooves on the conveyor belt are used to position the ampoules so that their ends face the parallel light source and the light intensity detector, respectively. At least one detection position can be provided, or multiple positions can be provided; when multiple positions are provided, simultaneous detection is possible.

[0020] At each detection position, a positioning laser beam is set at a parallel light source corresponding to that position. The parallel light source provides parallel light, and the light intensity detector 2 acquires the detection light intensity of the parallel light passing through the ampoule. The illumination intensity of the parallel light is 1000-5000 lux, and the illumination intensity of the positioning laser beam is 10000-20000 lux. By observing the difference in light intensity, the position of the laser beam can be directly determined.

[0021] S2. First, select intact ampoules from the ampoules to be tested for pre-testing to obtain the test light intensity as a comparison parameter: The comparison parameters are obtained in the following manner: The location of the positioning laser beam is determined by the light intensity detector 1 as the base position L0; if the positioning laser beam is not received by the same light intensity detector 1, the position of the detection position is corrected until the positioning laser beam is received by the same light intensity detector 1. Based on this basic location L0, its surrounding adjacent locations L are obtained. 1i The light intensity E detected by light intensity detector 1 1i ; Based on adjacent positions L 1i The light intensity detector 1 is away from the secondary position L0 of the base position L0. 2j The light intensity E detected by light intensity detector 1 2j ; Calculate the following parameters as comparison parameters: Calculate the surrounding adjacent positions L 1i Light intensity E of light intensity detector 1 1i The average value E1 = ΣE 1i / i and the difference between the maximum and minimum values ​​E 1max Secondary position L 2jThe light intensity E detected by light intensity detector 1 2j The average value E2 = ΣE 2j The difference between / j and the maximum and minimum values, E 2max The rate of change λ = (E2 - E1) / E2 was obtained as a comparison parameter. Using the base position L0 as the center point, and drawing rays from the base position L0 to connect adjacent positions L... 1i Light intensity detector 1 and secondary position L 2j The light intensity detectors 1 and 1 are connected to form i test groups, and the rate of change of light intensity in each test group is T. i =E 2j / E 1i E in each test group 1i and E 2j On the same ray, based on T i and the corresponding adjacent position L 1i The position and orientation of the light intensity detector 1 are used to obtain a contrast ring. The value of i is not less than 8; the value of j is not less than 16.

[0022] S3. Test other ampoules to obtain the test light intensity as the test parameter, and determine whether the ampoule needs to be manually tested by comparing the test parameter with the comparison parameter.

[0023] The comparison between the detection parameters and the comparison parameters is performed in the following manner: First, a preliminary comparison is made between the test parameters and the comparison parameters. If the preliminary comparison fails, the ampoule markings to be tested will need to be manually tested. The preliminary comparison includes the following steps: Consistent with the steps for obtaining the comparison parameters, the location of the positioning laser beam is determined using the light intensity detector 1 as the base position L. 0T ; Based on this basic location L 0T Obtain its surrounding adjacent positions L 1Ti The light intensity E detected by light intensity detector 1 1iT ; Based on adjacent positions L 1iT Light intensity detector 1 is away from the base position L 0T secondary position L 2jT The light intensity E detected by light intensity detector 1 2jT ; Referring to the calculation of the comparison parameters, the difference E between the maximum and minimum values ​​is calculated respectively. 1maxT E 2maxT and λ T ; Whether manual testing is needed is determined based on parameter comparison.

[0024] The parameter comparison is as follows: If E is satisfied 1maxT ≥2.5E 1max or E 2maxT ≥2.5E 2max or λ T If any one of the parameters is greater than or equal to 2λ, the initial comparison is considered unsuccessful, and manual inspection is required. By expanding the comparison parameters to accommodate different situations, the above-mentioned abnormal parameters generally only occur after a problem arises with the ampoule.

[0025] If the initial comparison passes, a detailed comparison will be conducted. If the detailed comparison fails, it will be marked as requiring manual inspection.

[0026] The detailed comparison was conducted as follows: Based on the base position L 0T As the center point, based on the base position L 0T Connect adjacent positions L in the form of rays 1iT Light intensity detector 1 and secondary position L 2jT The light intensity detectors 1 and 1 are connected to form i test groups, and the rate of change of light intensity in each test group is T. iT =E 2jT / E 1iT E in each test group 1iT and E 2jT On the same ray; based on T iT and the corresponding adjacent position L 1iT The position and orientation of the light intensity detector 1 are used to obtain the detection ring; The detection loop is compared with the comparison loop, and the maximum crossover ratio I is calculated. t , if I t If the threshold is ≥, the test is considered passed. If the threshold is set to 0.8, the test is considered passed. Otherwise, the test is marked as requiring manual inspection.

[0027] The various embodiments in this specification are described in a progressive manner. Similar or identical parts between embodiments can be referred to interchangeably. Each embodiment focuses on describing the differences from other embodiments. In particular, the system embodiments are basically similar to the method embodiments, so the description is relatively simple; relevant parts can be referred to the descriptions in the method embodiments.

[0028] The above are merely embodiments of this application and are not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

Claims

1. A method for testing small-capacity pharmaceutical glass ampoules, characterized in that: Includes the following steps: The ampoule is placed on the conveyor belt, which then passes through the detection space; A parallel light source is set on one side of the detection space, and a light intensity detector with several arrays of light intensity detectors is set on the other side. The detection space is provided with several detection positions, and the conveyor belt sequentially places the ampoules onto each detection position; At each detection position, a positioning laser beam is set at the parallel light source at the corresponding detection position. The parallel light source is used to provide parallel light, and the light intensity detector is used to obtain the detection light intensity of the parallel light passing through the ampoule. First, select intact ampoules from the ampoules to be tested for pre-testing to obtain the test light intensity as a comparison parameter. Then, test other ampoules to obtain the test light intensity as the test parameter. By comparing the test parameter with the comparison parameter, determine whether the ampoule needs to be manually tested.

2. The method for detecting small-capacity pharmaceutical glass ampoules according to claim 1, characterized in that: The comparison parameters are obtained in the following manner: The location of the positioning laser beam is determined by the light intensity detector as the base position L0; if the positioning laser beam is not received by the same light intensity detector, the position of the detection position is corrected until the positioning laser beam is received by the same light intensity detector. Based on the basic position L0, its peripheral adjacent positions L 1i The light intensity E 1i detected by the light intensity detector Based on adjacent positions L 1i The light intensity detector is away from the secondary position L0 of the base position L0. 2j The light intensity E detected by the light intensity detector 2j ; Calculate the following parameters as comparison parameters: Calculate the surrounding adjacent positions L 1i The light intensity E of the light intensity detector 1i The average value E1 = ΣE 1i / i and the difference between the maximum and minimum values ​​E 1max Secondary position L 2j The light intensity E detected by the light intensity detector 2j The average value E2 = ΣE 2j The difference between / j and the maximum and minimum values, E 2max The rate of change λ = (E2 - E1) / E2 was obtained as a comparison parameter. Using the base position L0 as the center point, and drawing rays from the base position L0 to connect adjacent positions L... 1i Light intensity detector and secondary position L 2j The light intensity detectors are connected to form i test groups, and the rate of change of light intensity in each test group is T. i =E 2j / E 1i E in each test group 1i and E 2j On the same ray, based on T i and the corresponding adjacent position L 1i The position and orientation of the light intensity detector are plotted to obtain the contrast ring.

3. The method for detecting small-capacity pharmaceutical glass ampoules according to claim 2, characterized in that: The comparison between the detection parameters and the comparison parameters is performed in the following manner: First, a preliminary comparison is made between the test parameters and the comparison parameters. If the preliminary comparison fails, the ampoule markings to be tested will need to be manually tested. If the initial comparison passes, a detailed comparison will be conducted. If the detailed comparison fails, it will be marked as requiring manual inspection.

4. The method for detecting small-capacity pharmaceutical glass ampoules according to claim 3, characterized in that: The preliminary comparison includes the following steps: Consistent with the steps for obtaining the comparison parameters, the location of the positioning laser beam is determined using a light intensity detector as the base position L. 0T ; Based on this basic location L 0T Obtain its surrounding adjacent positions L 1Ti The light intensity E detected by the light intensity detector 1iT ; Based on adjacent positions L 1iT The light intensity detector is away from the base position L 0T secondary position L 2jT The light intensity E detected by the light intensity detector 2jT ; Referring to the calculation of the comparison parameters, the difference E between the maximum and minimum values ​​is calculated respectively. 1maxT E 2maxT and λ T ; Whether manual testing is needed is determined based on parameter comparison.

5. The method for detecting small-capacity pharmaceutical glass ampoules according to claim 4, characterized in that: The parameter comparison is as follows: If E is satisfied 1maxT ≥2.5E 1max or E 2maxT ≥2.5E 2max or λ T If any one of the two values ​​is greater than or equal to 2λ, the initial comparison is considered unsuccessful and manual inspection is required.

6. The method for detecting small-capacity pharmaceutical glass ampoules according to claim 3, characterized in that: The detailed comparison was conducted as follows: Based on the base position L 0T As the center point, based on the base position L 0T Connect adjacent positions L in the form of rays 1iT Light intensity detector and secondary position L 2jT The light intensity detectors are connected to form i test groups, and the rate of change of light intensity in each test group is T. iT =E 2jT / E 1iT E in each test group 1iT and E 2jT On the same ray; based on T iT and the corresponding adjacent position L 1iT The detection ring is obtained by plotting the position and orientation of the light intensity detector; The detection loop is compared with the comparison loop, and the maximum crossover ratio I is calculated. t , if I t If the value is ≥0.8, it is considered to have passed the test; otherwise, it is marked as requiring manual testing.

7. The method for detecting small-capacity pharmaceutical glass ampoules according to claim 1, characterized in that: The i is not less than 8; the j is not less than 16.

8. The method for detecting small-capacity pharmaceutical glass ampoules according to claim 1, characterized in that: The light intensity detectors are arranged in a square array.

9. The method for detecting small-capacity pharmaceutical glass ampoules according to claim 1, characterized in that: The illumination intensity of the parallel light is 1000-5000 lux; The illumination intensity of the positioning laser beam is 10,000-20,000 lux.

10. The method for detecting small-capacity pharmaceutical glass ampoules according to claim 1, characterized in that: The transmission belt has positioning grooves for positioning the ampoules so that the head and tail of the ampoules face the parallel light source and the light intensity detector, respectively.

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