Device for measuring rubber plug depth and label position of high-throughput prefilled syringe
By designing a high-throughput pre-filled syringe stopper depth and label position measurement device, the problems of low detection efficiency and high cost were solved, and multi-sample synchronous high-precision measurement was achieved, improving detection efficiency and accuracy.
Patent Information
- Application Number
- CN202521085830.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-05-29
- Publication Date
- 2026-05-15
- Estimated Expiration
- 2035-05-29
AI Technical Summary
In existing technologies, the detection efficiency of pre-filled syringe stopper depth and label position is low and the cost is high. Manual detection is easily affected by subjective factors, while automated equipment is expensive and environmentally sensitive.
A high-throughput pre-filled syringe stopper depth and label position measurement device was designed. It adopts a modular expansion architecture, including an upper frame, a lower frame, a measuring rod, a fixing unit, and a label positioning component. It supports simultaneous detection of multiple channels, is compatible with various syringe specifications, and achieves high-precision measurement of stopper depth and label position.
It significantly improves detection efficiency and accuracy, reduces costs, enables simultaneous measurement of multiple samples, simplifies the operation process, and increases detection throughput and accuracy.
Smart Images
Figure CN224246950U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of pharmaceutical packaging testing technology, and in particular to a high-throughput pre-filled syringe stopper depth and label position measuring device. Background Technology
[0002] Prefilled syringes (PFS) are increasingly used in the development of biologics as a novel drug formulation. As a key sealing component that directly contacts the drug solution, the positioning accuracy of the rubber stopper directly affects drug stability and the airtightness of the packaging system, requiring precise process control of its assembly position.
[0003] In the PFS filling process, stopper depth testing is a core quality indicator for evaluating the stability of the stoppering process in production equipment. This parameter is particularly significant for products with the potential to develop autoinjectors: it is both a critical quality attribute (CQA) for production process control and a core design parameter that must be validated during the design phase of device-pharmaceutical combination products.
[0004] Currently, automated inspection equipment, such as laser rangefinders or vision inspection systems, can achieve non-contact measurement, improving speed and accuracy. However, automated equipment is relatively expensive and sensitive to environmental conditions. For feasibility studies regarding post-production inspection and release of PFS (Production Sample Foundry) and its development phase, current methods mainly rely on manual sampling measurements using depth micrometers or vernier calipers. Each operation takes approximately 30 seconds per piece, and the operator must continuously hold the micrometer and PFS, resulting in low efficiency and fatigue during batch inspections.
[0005] In addition, pre-filled syringes must be labeled with product information, and in clinical applications, a blinding label is also required to implement a blinding design. Especially in autoinjectors, label placement outside the tolerance range directly affects the stability of the assembly process, leading to assembly failure. For products requiring blinding, label positioning deviations may allow patients to observe the drug characteristics through the syringe window, thus undermining the effectiveness of the blinding design. Furthermore, inconsistencies in label placement can easily lead to negative perceptions of product quality among users. Label placement compliance is primarily determined using online visual inspection systems or manual visual inspection. The former has higher equipment costs, while the latter lacks clear judgment criteria, is easily influenced by subjective factors, and has low inspection efficiency.
[0006] Therefore, there is a need in the field for a high-throughput device for measuring the stopper depth and label position of pre-filled syringes, which can support simultaneous measurement of multiple samples at low cost and significantly improve the detection efficiency of stopper depth and label position. Utility Model Content
[0007] To solve the above-mentioned technical problems, this utility model provides the following technical solution:
[0008] A high-throughput pre-filled syringe stopper depth and label position measuring device includes an upper frame, a lower frame, a measuring rod, a first fixing unit, and a second fixing unit. The upper frame is detachably mounted on the top of the lower frame. The first fixing unit is disposed within the upper frame, and the second fixing unit is disposed within the lower frame. Multiple first and second fixing units are provided, and the number of first and second fixing units is equal. The measuring rod has graduation lines and is slidably mounted within the first fixing unit. A pre-filled syringe adapter is disposed within the second fixing unit. The bottom surface of the measuring rod is flush with the top surface of the pre-filled syringe adapter. A label positioning component is disposed on one side of the lower frame.
[0009] In one specific embodiment, the upper frame consists of two upper frame vertical plates and an upper frame horizontal plate fixed between the two upper frame vertical plates. The first fixing unit is a plurality of first circular holes opened on the upper frame horizontal plate. The measuring rod is fitted with the first circular holes with a clearance and is slidably installed in the first circular holes.
[0010] In one specific embodiment, the lower frame consists of two lower frame vertical plates and a lower frame horizontal plate fixed parallel to the two lower frame vertical plates. The second fixing unit is a plurality of second circular holes opened on the upper lower frame horizontal plate, and the second circular holes are coaxially arranged with the first circular holes.
[0011] In one specific embodiment, a pre-filled syringe adapter is detachably installed in the second circular hole. The pre-filled syringe adapter is used to accommodate pre-filled syringes of various sizes. The pre-filled syringe adapter is a cylindrical body with a small hole at the center of the cylindrical body for accommodating pre-filled syringes of various sizes. A clearance fit is formed between the cylindrical body and the second circular hole. The upper surface of the cylindrical body extends horizontally and forms a circular surface with a diameter larger than the inner diameter of the second circular hole.
[0012] In one specific embodiment, multiple measuring rods are provided, the graduation accuracy of the scale lines of the measuring rods is 0.1mm, the bottom of the measuring rods is flush with the top surface of the pre-filled syringe adapter, and the 0 point of the scale line is flush with the upper frame horizontal plate. The scale line is set vertically upward from the plane where the top surface of the upper frame horizontal plate is located.
[0013] In one specific embodiment, the label positioning component includes two crossbars disposed on the side of the lower frame, and the inner side of the lower frame is provided with mutually symmetrical hollow slots. The two crossbars are parallel to each other and are independently slidably installed in the hollow slots.
[0014] In one specific embodiment, the two ends of the crossbar are screwed with knobs, the knobs have threaded holes inside, and the two ends of the crossbar are respectively provided with external threads that mate with the threaded holes. The knobs are screwed to the two ends of the crossbar.
[0015] In one specific embodiment, a scale line is provided on the outer side of the hollow groove, and the graduation accuracy of the scale line is 0.1mm.
[0016] In one specific embodiment, a level bubble is provided at the bottom center of the lower frame, the level bubble is used to adjust the level of the lower frame, and leveling nuts are provided at the four corners of the bottom of the lower frame.
[0017] In one specific embodiment, the top of the lower frame is provided with a plurality of protrusions, and the bottom of the upper frame is provided with a groove corresponding to the protrusions. The upper frame and the lower frame are connected by the cooperation of the protrusions and the groove.
[0018] The beneficial effects of this utility model include:
[0019] 1. The high-throughput pre-filled syringe stopper depth and label position measuring device provided by this utility model adopts a modular expansion architecture through the setting of multiple first fixing units and second fixing units, supports simultaneous detection of multiple channels, and can be flexibly configured according to actual detection needs during use to improve detection throughput and detection efficiency.
[0020] 2. The high-throughput pre-filled syringe stopper depth and label position measuring device provided by this utility model, through the setting of pre-filled syringe adapter and label positioning component, can not only adapt to pre-filled syringes of various specifications and sizes, but also simultaneously complete the label position determination, integrating the effects of both stopper depth measurement and label positioning technologies, thus significantly improving the functionality of the device.
[0021] 3. The high-throughput pre-filled syringe stopper depth and label position measuring device provided by this utility model achieves high-precision detection by setting a scale line with a graduation accuracy of 0.1mm. In practice, the two crossbars can be fixed in advance at the boundary position of the qualified range according to the preset label position parameters. During the detection process, the accuracy of the label position can be judged directly by comparing the relative positions of the crossbars and the label. The operation is simple and the results are accurate. Attached Figure Description
[0022] Figure 1 A schematic diagram of the overall structure of the high-throughput pre-filled syringe stopper depth and label position measuring device provided by this utility model;
[0023] Figure 2A schematic diagram of the upper frame and measuring rod of the high-throughput pre-filled syringe stopper depth and label position measuring device provided by this utility model;
[0024] Figure 3 A schematic diagram of the lower frame of the high-throughput pre-filled syringe stopper depth and label position measuring device provided by this utility model;
[0025] Figure 4 A schematic diagram of the pre-filled syringe and adapter for the high-throughput pre-filled syringe stopper depth and label position measuring device provided by this utility model;
[0026] Figure 5 This is a partial structural diagram showing the relative position of the scale line of the measuring rod with respect to the upper and lower frames of the high-throughput pre-filled syringe stopper depth and label position measuring device provided by this utility model.
[0027] In the diagram, 1. Upper frame; 2. Lower frame; 3. Measuring rod; 4. First fixing unit; 5. Second fixing unit; 6. Pre-filled syringe adapter; 7. Label positioning assembly; 8. Spirit bubble; 9. Leveling nut; 10. Measuring rod 0 point. Detailed Implementation
[0028] The technical solution of this utility model will be clearly and completely described below. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.
[0029] Example 1
[0030] like Figure 1-4 As shown in the figure, this embodiment illustrates a high-throughput pre-filled syringe stopper depth and label position measuring device, which includes an upper frame 1, a lower frame 2, a measuring rod 3, a first fixing unit 4, and a second fixing unit 5. The top of the lower frame 2 is provided with multiple bosses, and the bottom of the upper frame 1 is provided with grooves corresponding to the bosses. The upper frame 1 and the lower frame 2 are connected by the bosses and grooves.
[0031] The first fixing unit 4 is located within the upper frame 1, and the second fixing unit 5 is located within the lower frame 2. Multiple units of both the first fixing unit 4 and the second fixing unit 5 are provided, and the number of each is equal. The measuring rod 3 has graduations and is slidably mounted within the first fixing unit 4. A pre-filled syringe adapter 6 is located within the second fixing unit 5. The bottom surface of the measuring rod 3 is flush with the top surface of the pre-filled syringe adapter. A label positioning component 7 is located on one side of the lower frame 2. The first fixing unit 4 and the second fixing unit 5 correspond one-to-one, integrating the pre-filled syringe to be tested and the measuring rod 3 into a single measuring module. This multi-modal expansion design increases the throughput of testing, allowing multiple measuring rods 3 to simultaneously measure the stopper depth of multiple pre-filled syringes.
[0032] The upper frame 1 consists of two upper frame vertical plates and an upper frame horizontal plate fixed between the two upper frame vertical plates. The first fixing unit 4 consists of multiple first circular holes opened on the upper frame horizontal plate. The measuring rod 3 is clearance-fitted with the first circular holes and is slidably installed in the first circular holes. The lower frame 2 consists of two lower frame vertical plates and a lower frame horizontal plate fixed parallel to the two lower frame vertical plates. The second fixing unit 5 consists of multiple second circular holes opened on the upper lower frame horizontal plate, and the second circular holes are coaxially arranged with the first circular holes.
[0033] Multiple measuring rods 3 can be installed, made of nylon, ensuring a weight not exceeding 3.5g to achieve lightweight design, reduce component weight, and prevent rubber stopper displacement due to gravity, thus avoiding impact on detection accuracy. In a specific embodiment, a truncated cone can be installed at the top of the measuring rod 3 to form a self-locking structure with the upper frame 1, preventing excessive displacement of the measuring rod 3. The graduation accuracy of the scale lines of the measuring rod 3 is 0.1mm. The bottom of the measuring rod 3 is flush with the top surface of the pre-filled syringe adapter 6, and the 0 point of the scale line is flush with the horizontal plate of the upper frame. The scale lines are set vertically upwards from the plane containing the top surface of the horizontal plate of the upper frame. When in use, the operator aligns the measuring rod 3 with the inside of the pre-filled syringe needle and lets the measuring rod 3 fall freely. If the friction is too great and affects the free fall of the measuring rod 3, the operator can apply a downward force to the measuring rod 3 by hand. The measuring rod 3 moves downward along the first circular hole until the bottom of the measuring rod 3 reaches the top surface of the rubber stopper. At this time, the depth of the rubber stopper can be judged according to the difference in the scale of the movement.
[0034] A pre-filled syringe adapter 6 is detachably installed inside the second circular hole to accommodate pre-filled syringes of various sizes. The pre-filled syringe adapter 6 has a cylindrical body with a small hole at its center to accommodate pre-filled syringes of various sizes. A clearance fit is formed between the cylindrical body and the second circular hole. The upper surface of the cylindrical body extends horizontally and forms a circular surface with a diameter larger than the inner diameter of the second circular hole. The pre-filled syringe adapter 6 can be manufactured using 3D printing technology to make plastic, for example, for 1mL and 2.25mL pre-filled syringes. The adapter provided in this embodiment can be quickly adapted. By replacing the adapter module with the corresponding size, compatible assembly of syringes of different sizes on a universal fixing device is achieved, effectively improving equipment reusability and reducing spare parts management costs.
[0035] The label positioning component 7 includes two crossbars located on the side of the lower frame 2. The inner side of the lower frame 2 has symmetrically arranged perforated slots. The two crossbars are parallel to each other and slide independently within the perforated slots. The outer side of the perforated slots has graduation lines with a graduation accuracy of 0.1mm. Knobs are threaded to both ends of the crossbars. Each knob has a threaded hole, and both ends of the crossbars have external threads that mate with the threaded holes. In use, the two ends of the crossbars are first inserted into the perforated slots, and then the knobs are rotated to lock the ends of the crossbars. According to the product standard, the two crossbars are fixed in the corresponding positions according to the graduation lines on the perforated slots, such as the upper and lower limits of the label position tolerance. After placing the pre-filled syringe to be tested, it can be visually determined whether the label position meets the standard requirements.
[0036] A level bubble 8 is installed at the bottom center of the lower frame 2. The level bubble 8 is used to adjust the level of the lower frame 2. Leveling nuts 9 are installed at the four corners of the bottom of the lower frame 2. Before use, the leveling nuts 9 should be adjusted according to the position of the level bubble 8 to ensure that the bubble of the level bubble 8 is centered.
[0037] The scale lines on measuring rod 3 and the hollowed-out groove are all made using high-precision laser engraving technology. The linear scale range is selectable from 0-60mm, with a graduation accuracy of 0.1mm. The scale lines are marked every 1mm and thickened every 0.5mm. The calibration method can be selected from laser micro-engraving process, with a line width of 0.05mm±0.01mm and an engraving depth of 0.1mm.
[0038] During the measurement process, the scale is observed using auxiliary devices such as optical magnifying glasses.
[0039] The measurement process of the high-throughput pre-filled syringe stopper depth and label position measuring device shown in this embodiment is as follows:
[0040] 1. Place the device in a room temperature and natural light environment. Use the leveling nut 9 to adjust the lower frame 2 to a horizontal state, i.e., the bubble in the leveling bubble 8 should be centered. 2. Select a suitable pre-filled syringe adapter 6 according to the specifications of the pre-filled syringe to be tested, and install the pre-filled syringe adapter 6 into the second fixing unit 5. Complete the corresponding number of combinations according to the measurement requirements. 3. First, embed both ends of the crossbar into the hollow grooves, then rotate the knob to lock both ends of the rod. According to the product standard, fix the two crossbars in the corresponding positions according to the scale lines on the hollow grooves. The positions of the two crossbars correspond to the upper and lower limits of the label position tolerance, respectively. 4. Place the sample to be tested into the pre-filled syringe adapter 6 and observe whether the rubber stopper depth or label position is within the range of the label positioning component 7. If the label has bubbles, wrinkles, curled edges, or uneven edges, treat it as a problematic sample and do not perform position determination. 5. When measuring the rubber stopper depth, refer to... Figure 5 The measuring rod 0.10 is flush with the upper frame horizontal plate, and the bottom surface of the measuring rod 3 is flush with the top surface of the pre-filled syringe. The operator aligns the measuring rod 3 with the inside of the pre-filled syringe needle tube, and the measuring rod 3 falls freely. If the friction is too great and affects the free fall of the measuring rod 3, the operator can apply a downward force to the measuring rod 3 by hand. The measuring rod 3 moves downward along the first circular hole until the bottom surface of the measuring rod 3 contacts the top surface of the rubber stopper. At this time, the depth of the rubber stopper can be judged according to the scale difference generated by the movement. In some embodiments, it is necessary to consider the influence of the flange thickness of the pre-filled syringe on the reading value. At this time, the depth of the rubber stopper is the sum of the reading value and the flange thickness. Finally, the depth of the rubber stopper can be measured by calculation. The label position can be determined by observing the relative position relationship between the label and the label positioning component 7 with a magnifying glass or the naked eye.
[0041] In summary, the above embodiments are merely preferred embodiments of the present utility model and are not intended to limit the scope of protection of the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the scope of protection of the present utility model.
Claims
1. A device for measuring the stopper depth and label position of a high-throughput pre-filled syringe, characterized in that, The high-throughput pre-filled syringe stopper depth and label position measuring device includes an upper frame, a lower frame, a measuring rod, a first fixing unit, and a second fixing unit. The upper frame is detachably mounted on the top of the lower frame. The first fixing unit is located inside the upper frame, and the second fixing unit is located inside the lower frame. Multiple first and second fixing units are provided, and the number of first and second fixing units is equal. The measuring rod is provided with scale lines and is slidably mounted inside the first fixing unit. A pre-filled syringe adapter is provided inside the second fixing unit. The bottom surface of the measuring rod is flush with the top surface of the pre-filled syringe adapter. A label positioning component is provided on one side of the lower frame.
2. The high-throughput pre-filled syringe stopper depth and label position measuring device according to claim 1, characterized in that, The upper frame consists of two upper frame vertical plates and an upper frame horizontal plate fixed between the two upper frame vertical plates. The first fixing unit is a plurality of first circular holes opened on the upper frame horizontal plate. The measuring rod is fitted with the first circular holes with a clearance and is slidably installed in the first circular holes.
3. The high-throughput pre-filled syringe stopper depth and label position measuring device according to claim 2, characterized in that, The lower frame consists of two lower frame vertical plates and a lower frame horizontal plate fixed parallel to the two lower frame vertical plates. The second fixing unit is a plurality of second circular holes opened on the upper lower frame horizontal plate, and the second circular holes are coaxially arranged with the first circular holes.
4. The high-throughput pre-filled syringe stopper depth and label position measuring device according to claim 3, characterized in that, A pre-filled syringe adapter is detachably installed in the second circular hole. The pre-filled syringe adapter is used to accommodate pre-filled syringes of various sizes. The pre-filled syringe adapter has a cylindrical body with a small hole in the center. The small hole is used to accommodate pre-filled syringes of various sizes. The cylindrical body and the second circular hole form a clearance fit. The upper surface of the cylindrical body extends horizontally and forms a circular surface with a diameter larger than the inner diameter of the second circular hole.
5. The high-throughput pre-filled syringe stopper depth and label position measuring device according to claim 2, characterized in that, Multiple measuring rods are provided, and the graduation accuracy of the scale lines of the measuring rods is 0.1mm. The bottom of the measuring rod is flush with the top surface of the pre-filled syringe adapter, and the 0 point of the scale line is flush with the upper frame horizontal plate. The scale line is set vertically upward from the plane where the top surface of the upper frame horizontal plate is located.
6. The high-throughput pre-filled syringe stopper depth and label position measuring device according to claim 1, characterized in that, The label positioning component includes two horizontal bars disposed on the side of the lower frame. The inner side of the lower frame is provided with symmetrical hollow slots. The two horizontal bars are parallel to each other and are independently slidably installed in the hollow slots.
7. The high-throughput pre-filled syringe stopper depth and label position measuring device according to claim 6, characterized in that, The two ends of the crossbar are screwed with knobs, each knob having a threaded hole inside. The two ends of the crossbar are respectively provided with external threads that mate with the threaded holes, and the knobs are screwed to the two ends of the crossbar.
8. The high-throughput pre-filled syringe stopper depth and label position measuring device according to claim 6, characterized in that, The outer side of the hollow groove is provided with scale lines, and the graduation accuracy of the scale lines is 0.1mm.
9. The high-throughput pre-filled syringe stopper depth and label position measuring device according to claim 1, characterized in that, A level bubble is provided at the bottom center of the lower frame, which is used to adjust the level of the lower frame. Leveling nuts are provided at the four corners of the bottom of the lower frame.
10. The high-throughput pre-filled syringe stopper depth and label position measuring device according to claim 1, characterized in that, The lower frame has multiple protrusions at its top, and the upper frame has grooves at its bottom corresponding to the protrusions. The upper frame and the lower frame are connected by the protrusions and grooves.