Positive and negative pressure test support for pre-filled needle medicine

Abstract

The utility model belongs to the field of container sealing integrity testing, and particularly discloses a pre-filling needle medicine positive and negative pressure testing support which comprises a support fixing seat and pre-filling needle supports, the pre-filling needle supports are evenly distributed on the periphery of the support fixing seat and connected with the support fixing seat, and a clamping seat can freely move up and down along a trapezoidal guide rail and can be adjusted to a proper position. The position of the clamping seat is locked and fixed through the second knurled screw, the device can adapt to pre-filling needle medicines with different liquid loading quantities, the testing universality and flexibility are improved, the position of the clamping seat is fixed through the second knurled screw, operation is easy and convenient, the position of the pre-filling needle push rod is easy to adjust and fix, the testing efficiency and convenience are improved, and the testing efficiency is improved. The support fixing seat can test a plurality of pre-needle-filling drugs at a time, and the combined and installed support is integrally placed in a closed container for detection, so that the detection efficiency is greatly improved, and the time and the labor cost are saved.

Description

Technical Field

[0001] This utility model relates to the field of container airtightness integrity testing technology, specifically a pre-filled needle drug positive and negative pressure testing bracket. Background Technology

[0002] When assessing the airtightness of pharmaceutical products, especially sterile injectable products such as pre-filled syringes, different processes and pharmaceutical formulations present different risks. Therefore, long-term airtightness testing is particularly important. For example, sterile injectable products (small-volume pre-filled syringes) consist of three parts: a rubber stopper, a glass vial, and a push rod (the push rod may be omitted during testing). Whether this pharmaceutical packaging system will change within a certain storage period requires periodic testing. In this case, non-destructive testing is crucial. Utilizing the pressure difference between the inside and outside of the drug can effectively assess the airtightness of pre-filled syringes and analyze the airtightness over a period of time. Below is a brief explanation of positive and negative pressure testing for drug airtightness.

[0003] First, the vial is placed in a sealed pressure chamber within the equipment, and a vacuum or increased pressure is applied. The vacuum causes gas to escape through a leakage path, while increased pressure, conversely, causes liquid medication to leak out when the vacuum level is below the liquid's vapor pressure. Therefore, the increased pressure within the sealed chamber is due to leakage from the pharmaceutical packaging, and this pressure is detected by one or more sensors within the sealed chamber. If pre-filled syringes are placed directly into the pressure chamber for testing, the pressure difference can cause the stopper to shift, potentially contaminating the medication (because after the stopper shifts, the previously exposed vial wall will be in the same space as the liquid medication).

[0004] To reduce the risk of contamination and address the low efficiency and high cost of individual tests, a pre-filled needle drug positive and negative pressure test bracket is provided. The bracket is designed with a pre-filled needle holder that can move freely on the guide rod, making it suitable for pre-filled needle drugs with different liquid volumes. Multiple pre-filled needle drugs can be tested at once using the bracket fixing seat. Utility Model Content

[0005] The purpose of this invention is to provide a pre-filled needle drug positive and negative pressure test bracket to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, this utility model provides the following technical solution: a pre-filled needle drug positive and negative pressure test bracket, including a bracket fixing base and a pre-filled needle bracket, wherein the pre-filled needle bracket is evenly distributed around the bracket fixing base and connected to the bracket fixing base;

[0007] The bracket fixing seat includes several columns arranged vertically in a uniform manner, a fixing plate and a base plate connecting the upper and lower ends of the columns, several U-shaped grooves arranged uniformly along the outer edge of the fixing plate, a dovetail groove set on the upper surface of the U-shaped groove, and a knurled screw set on the lower surface of the U-shaped groove and passing through the U-shaped groove.

[0008] The pre-charge needle bracket includes a base connected to a U-shaped groove, a trapezoidal guide rail vertically mounted above the base, a card holder that slides vertically along the trapezoidal guide rail, and two knurled screws connecting the card holder and the trapezoidal guide rail. A U-shaped groove is provided on one side of the base, and the pre-charge needle push rod is inserted into the U-shaped groove from one side, with the upper end of the pre-charge needle push rod inserted into the opening on one side of the card holder.

[0009] Preferably, a dovetail boss is provided on the outer periphery of the bottom of the base. The dovetail boss is slidably inserted into the dovetail groove, and the knurled screw passes through the dovetail groove to lock the dovetail boss. The dovetail groove and the dovetail boss are matched.

[0010] Preferably, after the dovetail protrusion is inserted into the dovetail groove, the semicircular arc of the U-shaped groove and the semicircular arc of the U-shaped groove form a circular hole. The test sample bottle body sleeved on the pre-filling needle push rod is located at this circular hole. A rubber stopper is provided at the mouth of the test sample bottle, and the pre-filling needle push rod passes through the rubber stopper.

[0011] Preferably, the card holder has two layers on one side where the pre-charge needle push rod is located, forming a lower chamber. The lower layer has a side opening, and the upper end of the pre-charge needle push rod is inserted into the side opening along the side, with its upper end located in the lower chamber.

[0012] Preferably, the trapezoidal guide rail is located on the side of the card holder away from the pre-charge needle push rod, the position of the second knurled screw corresponds to the position of the trapezoidal groove, and the second knurled screw passes through the trapezoidal groove of the card holder to lock the trapezoidal guide rail.

[0013] Preferably, the surface of the base plate is provided with a plurality of screw through holes II, and the surface of the fixing plate is provided with a plurality of screw through holes I.

[0014] Compared with the prior art, the beneficial effects of this utility model are:

[0015] 1. The card holder can move freely up and down along the trapezoidal guide rail and be adjusted to a suitable position. The position of the card holder is fixed by locking it with two knurled screws. It can adapt to pre-filled needle drugs with different liquid volumes, which improves the versatility and flexibility of the test.

[0016] 2. The position of the card holder is fixed by knurled screws, which is simple and convenient to operate and easy to adjust and fix the position of the pre-charge needle push rod, thus improving the efficiency and convenience of testing;

[0017] 3. The bracket holder can test multiple pre-filled needle drugs at once. The assembled and installed bracket is placed into a sealed container for testing, which greatly improves testing efficiency and saves time and labor costs. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the structure of the bracket fixing seat of this utility model;

[0019] Figure 2 This is a schematic diagram of the pre-filled needle holder of this utility model;

[0020] Figure 3 This is a schematic diagram of the structure of the bracket fixing seat and the pre-filled needle bracket after installation.

[0021] In the diagram: 1. Base plate; 2. Fixing plate; 3. Support column; 4. Knurled screw one; 5. Base; 6. Card holder; 7. Knurled screw two; 8. Pre-charge pin push rod; 9. U-shaped groove; 10. Dovetail groove; 11. Screw through hole one; 12. Screw through hole two; 13. Trapezoidal guide rail; 14. Trapezoidal groove; 15. Lower chamber; 16. Dovetail boss; 17. U-shaped groove. Detailed Implementation

[0022] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0023] In the description of this utility model, it should be noted that the terms "vertical", "up", "down", "horizontal", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0024] In the description of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0025] Please see Figure 1-3 This utility model provides a technical solution: a pre-filled needle drug positive and negative pressure test bracket, including a bracket fixing base and a pre-filled needle bracket, wherein the pre-filled needle bracket is evenly distributed around the bracket fixing base and connected to the bracket fixing base;

[0026] The bracket fixing seat includes several vertically arranged columns 3, a fixing plate 2 and a base plate 1 connecting the upper and lower ends of the columns 3, several U-shaped grooves 9 evenly arranged along the outer edge of the fixing plate 2, a dovetail groove 10 set on the upper surface of the U-shaped groove 9, and a knurled screw 4 set on the lower surface of the U-shaped groove 9 and passing through the U-shaped groove 9.

[0027] The pre-charge needle bracket includes a base 5 connected to a U-shaped groove 9, a trapezoidal guide rail 13 vertically mounted above the base 5, a card holder 6 that slides vertically along the trapezoidal guide rail 13, and a knurled screw 7 connecting the card holder 6 and the trapezoidal guide rail 13. A U-shaped groove 17 is provided on one side of the base 5, and a pre-charge needle push rod 8 is inserted into the U-shaped groove 17 from one side, with the upper end of the pre-charge needle push rod 8 inserted into the opening on one side of the card holder 6.

[0028] Furthermore, a dovetail boss 16 is provided on the bottom periphery of the base 5. The dovetail boss 16 is slidably inserted into the dovetail groove 10. The knurled screw 4 passes through the dovetail groove 10 to lock the dovetail boss 16. The dovetail groove 10 matches the dovetail boss 16.

[0029] Furthermore, after the dovetail boss 16 is inserted into the dovetail groove 10, the semicircular arc of the U-shaped groove 9 and the semicircular arc of the U-shaped groove 17 form a circular hole. The test sample bottle body fitted on the pre-filling needle push rod 8 is located at this circular hole. A rubber stopper is provided at the mouth of the test sample bottle, and the pre-filling needle push rod 8 passes through the rubber stopper.

[0030] Furthermore, the card holder 6 has two layers on one side where the pre-charge needle push rod 8 is located, forming a lower chamber 15. The lower layer has a side opening, and the upper end of the pre-charge needle push rod 8 is inserted into the side opening along the side, with its upper end located in the lower chamber 15.

[0031] Furthermore, the trapezoidal guide rail 13 is located on the side of the card holder 6 away from the pre-charge needle push rod 8, and the position of the knurled screw 7 corresponds to the position of the trapezoidal groove 14. The knurled screw 7 passes through the trapezoidal groove 14 of the card holder 6 to lock the trapezoidal guide rail 13.

[0032] Furthermore, the surface of the base plate 1 is provided with several screw through holes 12, and the surface of the fixing plate 2 is provided with several screw through holes 11.

[0033] Working principle:

[0034] The pre-filled needle push rod 8 is fixed by connecting the base 5 and the card holder 6, preventing the pre-filled needle push rod 8 from moving during the test and causing the rubber stopper to shift. This effectively avoids the situation where the rubber stopper shifts and the medicine is contaminated during the test. The U-shaped groove 9 of the fixing plate 2 and the U-shaped groove 17 of the base 5 combine to form a round hole for fixing the pre-filled needle bottle body, ensuring that the medicine bottle will not fall off the bracket. The dovetail groove 10 positions the base 5, and the pre-filled needle bracket is tightened by the knurled screw 4 to prevent it from falling off the bracket fixing seat.

[0035] The holder 6 can move freely up and down along the trapezoidal guide rail 13 to be adjusted to a suitable position. The position of the holder 6 is locked and fixed by the knurled screw 7. It can adapt to pre-filled needle drugs with different liquid contents, thus improving the versatility and flexibility of the test.

[0036] The position of the retainer 6 is fixed by the knurled screw 27, which is simple and convenient to operate and easy to adjust and fix the position of the pre-charge needle push rod, thus improving the efficiency and convenience of testing.

[0037] The stand holder can test multiple pre-filled needle drugs at once. The assembled and installed stand is placed in a sealed container for testing, which greatly improves testing efficiency and saves time and labor costs.

[0038] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A pre-filled needle drug positive and negative pressure testing bracket, characterized in that: It includes a support base and a pre-charged needle bracket, with the pre-charged needle bracket evenly distributed around the support base and connected to the support base; The bracket fixing seat includes several vertically arranged pillars (3), a fixing plate (2) connecting the upper and lower ends of the pillars (3) and a base plate (1), several U-shaped grooves (9) evenly arranged along the outer edge of the fixing plate (2), a dovetail groove (10) set on the upper surface of the U-shaped groove (9), and a knurled screw (4) set on the lower surface of the U-shaped groove (9) and passing through the U-shaped groove (9). The pre-charge needle bracket includes a base (5) connected to a U-shaped groove (9), a trapezoidal guide rail (13) vertically mounted above the base (5), a card holder (6) that slides vertically along the trapezoidal guide rail (13), and a knurled screw (7) connecting the card holder (6) and the trapezoidal guide rail (13). A U-shaped groove (17) is provided on one side of the base (5), and a pre-charge needle push rod (8) is inserted into the U-shaped groove (17) from one side, with the upper end of the pre-charge needle push rod (8) inserted into the opening on one side of the card holder (6).

2. The pre-filled needle drug positive and negative pressure test bracket according to claim 1, characterized in that: The base (5) has a dovetail boss (16) on its bottom periphery. The dovetail boss (16) is slidably inserted into the dovetail groove (10). The knurled screw (4) passes through the dovetail groove (10) to lock the dovetail boss (16). The dovetail groove (10) matches the dovetail boss (16).

3. The pre-filled needle drug positive and negative pressure test bracket according to claim 2, characterized in that: After the dovetail protrusion (16) is inserted into the dovetail groove (10), the semicircular arc of the U-shaped groove (9) and the semicircular arc of the U-shaped groove (17) form a circular hole. The test sample bottle body fitted on the pre-filling needle push rod (8) is located at the circular hole. A rubber stopper is provided at the mouth of the test sample bottle, and the pre-filling needle push rod (8) passes through the rubber stopper.

4. The pre-filled needle drug positive and negative pressure test bracket according to claim 1, characterized in that: The card holder (6) has two layers on one side where the pre-charge needle push rod (8) is located. The two layers form a lower chamber (15). The lower layer has a side opening. The upper end of the pre-charge needle push rod (8) is inserted into the side opening along the side, and its upper end is located in the lower chamber (15).

5. The pre-filled needle drug positive and negative pressure test bracket according to claim 4, characterized in that: The trapezoidal guide rail (13) is located on the side of the card holder (6) away from the pre-charge needle push rod (8). The position of the second knurled screw (7) corresponds to the position of the trapezoidal groove (14). The second knurled screw (7) passes through the trapezoidal groove (14) of the card holder (6) to lock the trapezoidal guide rail (13).

6. The pre-filled needle drug positive and negative pressure testing bracket according to claim 1, characterized in that: The base plate (1) has several screw through holes (12) on its surface, and the fixing plate (2) has several screw through holes (11) on its surface.

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