CN205562163U - Pinhole patency testing arrangement - Google Patents

Abstract

The utility model discloses a pinhole patency testing device, which comprises a communication path, a first opening of the communication path communicates with an amplification device, and a second opening of the communication path communicates with a syringe to be tested; Correspondingly, measuring tools are provided, and the amplification device includes an amplification container containing a solution, a piston is arranged in the amplification container, and a weight is arranged on the top of the piston. The utility model has high test result precision and fully meets product quality control requirements. The utility model has economical purchasing cost and high cost performance. The utility model has the advantages of simple structure and convenient operation. On the premise of satisfying the national standard, the utility model has accurate measurement results in the whole testing process, greatly improves the testing efficiency, has a simple structure, and reduces the testing cost.

Description

Pinhole patency test device

technical field

The utility model belongs to the field of production detection of prefilled syringes, and relates to a testing device for the patency of pinholes of stainless steel needles used for prefilled syringes.

Background technique

Prefilled syringes have the characteristics of no-cleaning, no-disinfection, and no-installation in clinical use, which minimizes the labor and cost from production to use. Therefore, the market demand for them has greatly increased.

Testing the quality of prefilled syringes mainly needs to test the patency of the needle holes of the syringes. The existing testing devices for the patency of the needle holes of prefilled syringes are very immature, and there is no perfect mechanism to accurately detect prefilling. The patency of the stainless steel needle of the sealed syringe hinders the promotion of product quality control, and ultimately brings hidden dangers to the actual application of the product.

Utility model content

The purpose of this utility model is to overcome the deficiencies of the above-mentioned prior art, in order to ensure the quality of the prefilled syringe, according to the standard requirements for the prefilled syringe in the Chinese Pharmacopoeia (2015), to provide a simple structure, low cost, high Efficient prefilled syringe pinhole patency testing device.

In order to achieve the above object, the utility model adopts the following technical solutions:

The pinhole patency testing device includes a communication path, the first opening of the communication path communicates with the amplification device, and the second opening of the communication path communicates with the syringe to be tested; a measuring tool is correspondingly arranged under the syringe to be tested, and the expansion device The increasing device comprises an expanding container containing solution, a piston is arranged in the expanding container, and a weight is arranged on the upper part of the piston. The expansion container contains a certain volume of water, and the heavy object produces a certain amount of water pressure on the water of a certain volume in the expansion container. patency.

Further, the communication path is further provided with a third opening connected to a pressure measuring device; the pressure testing device tests the water pressure in the expansion container.

Preferably, a spherical container is provided in the middle of the communication path; the solution in the amplification container will not directly flow into the syringe to be tested, and enter the syringe to be tested after staying at the spherical container, so that the solution flowing into the syringe can be activated. to a certain degree of control.

The spherical container communicates with the first opening, the second opening and the third opening.

Or further, the expansion container is connected to a pressure measuring device; the pressure testing device tests the water pressure in the expansion container.

Preferably, a spherical container is provided in the middle of the communicating passage.

The spherical container communicates with both the first opening and the second opening.

The pressure measuring device is a pressure gauge.

The weight is a weight.

The device also includes a timer; recording the time of the testing process.

The pinhole patency testing device includes a communication path, the first opening of the communication path communicates with the amplification device, and the second opening of the communication path communicates with the syringe to be tested; a measuring tool is correspondingly arranged under the syringe to be tested, and the expansion device The increasing device includes an expanding container containing solution, and a piston is arranged in the expanding container, and the piston is connected with the power device through a push rod. A piston is arranged in the expansion container, and the piston is connected with a power device through a push rod, and the power device drives the push rod to move downward. The expansion container contains a certain volume of water, and the push rod generates a certain amount of water pressure for the quantitative volume of water in the expansion container. patency.

Further, the power device is connected with the electronic control unit; the operation of the power device is controlled by the electronic control unit, and the stability of the internal pressure of the syringe is adjusted by adjusting the speed of the motor push rod, so as to facilitate the control of the internal pressure of the syringe.

Further, the communication passage or the amplification container is connected with a pressure sensor, and the pressure sensor communicates with the electronic control unit; the pressure sensor indirectly detects the pressure inside the syringe.

Further, the communication path is connected with a flow sensor, and the flow sensor communicates with the electronic control unit; the flow sensor tests the liquid flow through the pinhole.

The beneficial effects of the utility model are:

(1) The test result of the utility model has high precision and fully meets the requirements of product quality control.

(2) The utility model has economical purchasing cost and high cost performance.

(3) The utility model has the advantages of simple structure and convenient operation.

(4) Under the premise of meeting the national standard, the utility model has accurate measurement results during the whole test process, greatly improves the test efficiency, has a simple structure, and reduces the test cost.

(5) The utility model is equipped with an electronic control unit, a power device, a push rod and other devices, and the electronic control unit can control the pressure in the syringe, detect the pressure in the syringe, and detect the flow of liquid flowing through the pinhole, and can test the needle automatically. The patency of the hole, without manual operation, improves the test efficiency and accuracy.

Description of drawings

Fig. 1 is the utility model testing device structural representation;

Fig. 2 is another embodiment of the utility model test device structure diagram;

In the figure, 1 tee connector, 2 amplification container, 3 weight, 4 piston, 5 pressure test device, 6 syringe to be tested, 7 measuring tool, 8 push rod, 9 motor, 10 electronic control unit, 11 pressure sensor, 12 flow sensors, 13 communicating paths.

detailed description

Below in conjunction with accompanying drawing and embodiment the utility model is further described.

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings that need to be used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings in the following description are only some implementations of the present invention. For example, those of ordinary skill in the art can also obtain other drawings based on these drawings on the premise of not paying creative efforts.

Example 1:

As shown in FIG. 1 , the pinhole patency device for prefilled syringes includes a three-way connector 1 , and the three-way connector 1 is connected to an amplification device, a pressure test device 5 , and a syringe 6 to be tested. A time recording tool is also included to record the time of the testing process.

The amplification device ensures that the amount of water flowing through the sample to be tested is sufficient. The amplification device comprises an amplification container 2, a weight 3 and a piston 4, and the expansion container 2 accommodates a quantitative volume of water; the weight 3 produces a quantitative hydraulic pressure for the water of a quantitative volume in the amplification container 2; Undertake water pressure.

The pressure testing device 5 tests the water pressure in the expansion container. The pressure testing device 5 is not limited to be connected to the three-way connector 1 , it can also be connected to the amplification container 2 .

The syringe 6 to be tested is connected to the three-way connector 1, and the syringe 6 to be tested is placed with a measuring tool 7, and the measuring tool 7 measures the amount of water flowing out of the syringe 6 to be tested within a certain period of time.

The three-way connector 1 is not limited to having three interfaces, and the positions of the interfaces are not limited to those shown in FIG. 1 .

The test principle of the needle hole patency device for prefilled syringes is as follows:

Pour a sufficient amount of water into the expansion container 2, the amount of water is greater than or equal to 50ml, and try to empty the air in the expansion container 2. Fix the syringe 6 to be tested on the three-way connector 1, and place the measuring tool 7 under the syringe 6 to be tested.

Place the weight 3 on the upper end of the piston 4, and generate a certain pressure on the piston 4 through the gravitational action of the weight 3, and the pressure is transmitted to the water in the amplification container 2 to generate water pressure, which can be tested on the pressure test device 5 show. The water volume recorded by the time recording tool for a period of time is measured by the gauge 7, and the ratio of the water volume to time is the flow rate passing through the sample to be tested under a certain pressure. Replace the sample to be tested with a standard needle, and perform the same operation to obtain the flow rate of the standard needle. According to the standard requirements for prefilled syringes in the Chinese Pharmacopoeia (2015): "Take an appropriate amount of this product, and the needle specified in Table 4 can pass freely or the flow rate should not be less than the same outer diameter and length under the water pressure of not more than 100KPa. And the needle tube with the smallest inner diameter specified in Table 4, 80% of the flow rate under the same conditions.” Compare whether the sample to be tested meets the standard requirements.

Example 2:

As shown in Figure 2, the fully automatic pinhole patency testing device includes a communication path 13, the first opening of the communication path 13 communicates with the amplification device, and the second opening of the communication path 13 communicates with the syringe 6 to be tested; A measuring tool 7 is correspondingly arranged below the syringe 6 , and the amplification device includes an amplification container 2 containing a solution, and a piston 4 is arranged in the amplification container 2 , and the piston 4 is connected to a motor 9 through a push rod 8 . The motor 9 drives the push rod 8 to move downwards to expand the volume, and the volume 2 contains a certain volume of water. The push rod 8 generates a certain amount of water pressure for the water of a certain volume in the expansion container 2. The piston 4 receives the water pressure, and the measuring tool 7 Measure the water volume of the syringe to be tested during the test, and then compare the patency of the needle of the syringe to be tested.

The push rod 8 is an electric push rod, the push rod 8 is vertically connected with the motor 9, and the motor 9 and the push rod 8 are connected through a worm gear; or the motor 9 and the push rod 8 can be connected in parallel, and the motor 9 and the push rod 8 are connected through a gear; Or the motor 9 is connected in parallel with the push rod 8, and the motor 9 and the push rod 8 are connected through a timing belt.

The motor 9 is connected with the electronic control unit 10; the operation of the motor 9 is controlled by the electronic control unit 10, and the stability of the internal pressure of the syringe is adjusted by adjusting the speed of the motor push rod, which facilitates the control of the internal pressure of the syringe. The electronic control unit 10 can automatically perform timing.

The amplification container 2 is connected with a pressure sensor 11 , and the pressure sensor 11 communicates with the electronic control unit 10 ; the pressure sensor 11 indirectly detects the pressure inside the syringe 6 . The pressure sensor 11 may also be provided in connection with the communication path 13 .

A flow sensor 12 is arranged on the communication path 13, and the flow sensor 12 communicates with the electronic control unit 10; the flow sensor 12 tests the flow of the liquid passing through the pinhole.

The test principle of the automatic pinhole patency test device:

The motor 9 is connected to the push rod 8, which can drive the push rod 8 to move telescopically. The speed is controlled by the electronic control unit 10, and the stability of the internal pressure of the syringe is adjusted by adjusting the speed of the motor push rod; the pressure sensor 11 is directly or indirectly connected to the amplification container 2 , can detect the pressure inside the syringe 6, the motor 9, the pressure sensor 11, and the electronic control unit 10 form an effective closed-loop control; the amplification container 2 is connected to the flow sensor 12, and an electronic flowmeter can be selected, and the electronic flowmeter is connected to the syringe 6, The electronic flowmeter is used to test the liquid flow through the pinhole; the motor 9, pressure sensor 11, and flow sensor 12 are all connected to the electronic control unit 10, and the electronic control unit realizes the collection and control of the above signals to realize fully automatic testing.

Although the specific implementation of the utility model has been described above in conjunction with the accompanying drawings, it does not limit the protection scope of the utility model. Those skilled in the art should understand that on the basis of the technical solution of the utility model, those skilled in the art do not need to Various modifications or deformations that can be made with creative efforts are still within the protection scope of the present utility model.

Claims (10)

1. The pinhole patency test device is characterized in that it includes a communication path, the first opening of the communication path communicates with the amplification device, and the second opening of the communication path communicates with the syringe to be tested; A measuring instrument is set, and the amplification device includes an amplification container containing a solution, a piston is arranged in the amplification container, and a weight is arranged on the upper part of the piston. 2. The testing device according to claim 1, characterized in that, the communicating passage is further provided with a third opening connected to a pressure measuring device. 3 . The testing device according to claim 2 , wherein a spherical container is provided in the middle of the communicating path; and the spherical container communicates with the first opening, the second opening, and the third opening. 4 . 4. The testing device of claim 1, wherein the expansion vessel is connected to a pressure measuring device. 5 . The testing device according to claim 4 , wherein a spherical container is provided in the middle of the communicating path; and the spherical container communicates with both the first opening and the second opening. 5 . 6. The testing device of claim 1, further comprising a timer. 7. The pinhole patency test device is characterized in that it includes a communication path, the first opening of the communication path communicates with the amplification device, and the second opening of the communication path communicates with the syringe to be tested; the lower part of the syringe to be tested corresponds to Measuring tools are set, and the expansion device includes an expansion container containing a solution, a piston is arranged in the expansion container, and the piston is connected with the power device through a push rod. 8. The test device according to claim 7, wherein the power device is connected to an electronic control unit. 9. The test device according to claim 8, wherein the communication path or the expansion vessel is connected to a pressure sensor, and the pressure sensor communicates with the electronic control unit. 10. The test device according to claim 8, characterized in that, the communication path is connected to a flow sensor, and the flow sensor communicates with the electronic control unit.