Delayed leak detection method for small-capacity injection

Abstract

The invention discloses a delayed leak detection method for a small-volume injection, and relates to the technical field of medicament detection. The method comprises the following steps: S1, filling a liquid medicine into a corresponding packaging container to form a small-capacity finished injection, and removing the finished injection which is visible to naked eyes and has obvious leakage; s2, putting the finished injection which is invisible to the naked eyes and permeates into the leak detection box body, and sealing the leak detection box body through a sealing mechanism; s3, vacuumizing the interior of the leak detection box body through a vacuum pump, and monitoring the air pressure in the leak detection box body in real time through a pressure recorder communicated with the leak detection box body until the air pressure in the leak detection box body is reduced to a pressure threshold value sufficient to gasify the medicament; and S4, after the leak detection box body is kept in the closed state for a certain preset time, monitoring the air pressure in the leak detection box body at the moment through a pressure recorder. The small-volume injection micro-leakage detection device has the beneficial effects that the small-volume injection with micro-leakage can be accurately and conveniently detected, and the occurrence probability of liquid medicine pollution is greatly reduced.

Description

Technical Field

[0001] The invention relates to the technical field of drug detection, in particular to a delayed leakage detection method for small-volume injections. Background Art

[0002] Small-volume injections usually refer to sterilized preparations with a volume of less than 50 ml, usually packaged in glass bottles and plastic bottles. During the production, packaging, and delivery of small-volume injections, some packaging experiences may have micropores or microcracks due to accidental factors, resulting in leakage of the drug solution. These tiny leaks are difficult to detect with the naked eye, but this "micro-leakage" will still cause the drug solution in the package to be connected to the outside world, allowing various pathogenic microorganisms, bacteria or viruses to enter the drug solution, causing drug solution contamination and physical damage to patients. The number of people harmed by drug solution contamination every year is very alarming. Therefore, in order to reduce patient damage caused by drug solution contamination, it is very necessary to promptly and accurately detect small-volume injections with leaks, especially "micro-leaks". Summary of the invention

[0003] The technical problem to be solved by the present invention is to provide a delayed leak detection method for small-volume injections in response to the above-mentioned technical deficiencies, which can accurately and conveniently detect small-volume injections with slight leaks, greatly reducing the probability of drug solution contamination.

[0004] The technical solution adopted by the present invention is: to provide a delayed leak detection method for a small-volume injection, comprising the following steps:

[0005] S1. Fill the liquid medicine into the corresponding packaging container to form a small-volume finished injection, excluding the finished injection with obvious leakage visible to the naked eye;

[0006] S2. Put the finished injection with invisible permeability into the leak detection box, and seal the leak detection box through the sealing mechanism;

[0007] S3, evacuating the inside of the leak detection box by a vacuum pump, and monitoring the air pressure inside the leak detection box in real time by a pressure recorder connected to the leak detection box, until the air pressure inside the leak detection box is reduced to a pressure threshold sufficient to gasify the agent;

[0008] S4. After the leak detection box remains sealed for a certain preset time, the air pressure inside the leak detection box is monitored by a pressure recorder;

[0009] S5. Compare the actual air pressure value recorded by the pressure recorder with the air pressure value required by the standard. The liquid inside the finished injection with leakage will leak through the micropores and gasify inside the leak detection box, causing the air pressure inside the leak detection box to rise significantly beyond the standard value range;

[0010] S6. After the current finished injection is tested, the above steps are repeated to complete the leak testing operation on the small-volume injections in sequence.

[0011] To further optimize the technical solution, the interior of a leak detection box of a delayed leak detection method for small-volume injections is divided into multiple detection chambers by partitions, and the air pressure of each detection chamber is monitored by a corresponding pressure recorder.

[0012] To further optimize the technical solution, a vacuum pump of a delayed leak detection method for small-volume injections has an exhaust port connected to a vacuum pipe; the exhaust pipes are connected to corresponding detection cavities through exhaust branch pipes; and exhaust check valves are installed on the exhaust pipes.

[0013] To further optimize the technical solution, a delayed leak detection method for small-volume injections has a detection cavity with access ports on the outside; the sealing mechanism includes a bracket fixed to the outside of the leak detection box; a plurality of telescopes are fixed on the bracket; the telescopes correspond to the access ports one by one; and a sealing plug corresponding to the access port is fixed to the telescopic end of the telescope.

[0014] To further optimize the technical solution, a pressure recorder for a delayed leak detection method for small-volume injections transmits pressure change values ​​to a data monitoring system in real time via a network.

[0015] The beneficial effects of the present invention are:

[0016] By placing the finished injection in a sealed leak detection box, evacuating the leak detection box with a vacuum pump, and reducing the air pressure inside the leak detection box to a pressure threshold sufficient to vaporize the medicine, even if the penetration of the packaging container of the finished injection is very small, the pressure difference between the inside and outside of the packaging container will accelerate the penetration of the medicine liquid and the gas in the packaging container. In addition, by reducing the air pressure in the leak detection box to a sufficient pressure threshold, it is enough to vaporize the infiltrated medicine liquid. After a period of placement, the vaporized medicine liquid will accumulate to a certain level, causing the air pressure inside the leak detection box to rise significantly. The pressure recorder will monitor this change, thereby realizing leak detection and identification of small-volume injections. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a structural schematic diagram of the detection box in the present invention;

[0018] Figure 2 It is a schematic diagram of the structure when the detection box is in a sealed state.

[0019] In the figure, 1. leak detection box; 2. pressure recorder; 3. vacuum pump; 4. partition; 5. detection chamber; 6. support frame; 7. exhaust pipe; 8. exhaust branch pipe; 9. exhaust check valve; 10. access port; 11. bracket; 12. telescope; 13. sealing plug. DETAILED DESCRIPTION

[0020] The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0021] like Figure 1-2 As shown, a delayed leak detection method for a small volume injection comprises the following steps:

[0022] S1. Fill the liquid medicine into the corresponding packaging container to form a small-volume finished injection, excluding the finished injection with obvious leakage visible to the naked eye. The packaging container used can be either a glass ampoule or a plastic ampoule;

[0023] S2, placing the finished injection with invisible permeation into the leak detection box 1, and sealing the leak detection box 1 through a sealing mechanism;

[0024] S3, evacuating the inside of the leak detection box 1 by means of the vacuum pump 3, and monitoring the air pressure inside the leak detection box 1 in real time by means of the pressure recorder 2 connected to the leak detection box 1, until the air pressure inside the leak detection box 1 is reduced to a pressure threshold sufficient to gasify the agent;

[0025] S4, after the leak detection box 1 remains in a sealed state for a certain preset time, the air pressure inside the leak detection box 1 is monitored by the pressure recorder 2;

[0026] S5. Compare the actual air pressure value recorded by the pressure recorder 2 with the air pressure value required by the standard. The liquid inside the finished injection with leakage will leak through the micropores and gasify inside the leak detection box 1, causing the air pressure inside the leak detection box 1 to rise significantly beyond the standard value range.

[0027] S6. After the current finished injection is tested, the above steps are repeated to complete the leak testing operation on the small-volume injections in sequence.

[0028] In the above steps, after the finished injection to be tested is placed in the leak detection box 1, the leak detection box 1 is sealed and then vacuumed. Of course, the vacuuming process only requires the vacuum pump 3 to reduce the internal air pressure of the leak detection box 1 to a pressure threshold that satisfies the vaporization of the liquid medicine (which can be set separately according to the needs of different liquid medicines). When the leak detection box 1 is placed, the air pressure inside it will slowly increase. If there is no leakage in the finished injection, then the amplitude of the air pressure increase after a specified time will usually be in a relatively standard numerical range (this numerical range can be determined by experiment). If there is a slight leak in the finished injection, the leaked liquid medicine gradually vaporizes and accumulates in the leak detection box 1. After a specified time, the pressure value monitored by the pressure recorder 2 will obviously exceed the standard numerical range, thereby achieving accurate leak detection of small-volume injections.

[0029] In the present technical scheme, after the leak detection box 1 is evacuated, it is placed for a period of time to reflect whether the small-volume injection is leaking through the change in air pressure value. This method is called the delayed leak detection measure in the present scheme. The specific length of this delay is also obtained through experiments based on the type, capacity, external temperature and other conditions of the medicine, and is set accordingly according to the actual situation.

[0030] like Figure 2 As shown, the interior of the leak detection box 1 is divided into multiple detection chambers 5 by a partition 4, and each detection chamber 5 monitors the air pressure through a corresponding pressure recorder 2. Multiple detection chambers 5 are conducive to leak detection of multiple finished injections at the same time, improving the efficiency of leak detection. In order to facilitate the negative pressure to act more comprehensively on various parts of the finished injection, a support bracket 6 can be fixed in the middle of the detection chamber 5, and the finished injection can be suspended in the detection chamber 5.

[0031] like Figure 2 As shown, the air extraction port of the vacuum pump 3 is connected to an air extraction pipe 7; the air extraction pipe 7 is connected to the corresponding detection chamber 5 through an air extraction branch pipe 8; and an air extraction check valve 9 is installed on the air extraction pipe 7. The setting of the air extraction branch pipe 8 is conducive to the vacuuming of each detection chamber 5, and the setting of the air extraction check valve 9 can prevent the outside air from flowing back into the detection chamber 5 through the air extraction branch pipe 8, thereby ensuring the accuracy of the detection. The air extraction check valve 9 can be an electromagnetic valve, which is convenient for remote control to vacuumize each detection chamber 5 in turn, so that the air extraction work does not interfere with each other.

[0032] like Figure 1-2 As shown, the detection cavity 5 is provided with an access port 10 on the outside; the sealing mechanism includes a bracket 11 fixed to the outside of the leak detection box 1; a plurality of retractors 12 are fixed on the bracket 11; the retractors 12 correspond to the access ports 10 one by one; and a sealing plug 13 corresponding to the access port 10 is fixed at the retractable end of the retractor 12. The retractor 12 controls the sealing and separation of the sealing plug 13 and the access port 10 by retracting, and the access port 10 facilitates the taking and placing of the finished injection.

[0033] The pressure recorder 2 transmits the pressure change value to the data monitoring system in real time through the network. In addition to being able to visually observe the air pressure value inside the leak detection box 1, the data monitoring system can also easily reflect the specific process of air pressure change to assist in judging the leak detection work. For example, if the air pressure value changes significantly during a period of time, it may be that the leak detection box 1 is not tightly sealed, the injection packaging container is broken, and other unexpected problems may occur at this time, which helps the staff to deal with them in time.

[0034] It is to be understood that the present invention is described by some embodiments, and it is known to those skilled in the art that various changes or equivalent substitutions may be made to these features and embodiments without departing from the spirit and scope of the present invention. In addition, under the teachings of the present invention, these features and embodiments may be modified to adapt to specific circumstances and materials without departing from the spirit and scope of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed herein, and all embodiments falling within the scope of the claims of this application are within the scope of protection of the present invention.

Claims

1. A time-delayed leak detection method for small-volume injections, characterized in that: The following steps are involved: S1. Fill the liquid medicine into the corresponding packaging container to form a small-volume finished injection, excluding the finished injection with obvious leakage visible to the naked eye; S2, placing the finished injection with no visible permeation into the leak detection box (1), and sealing the leak detection box (1) by means of a sealing mechanism; S3, evacuating the interior of the leak detection box (1) by means of a vacuum pump (3), and monitoring the air pressure inside the leak detection box (1) in real time by means of a pressure recorder (2) connected to the leak detection box (1), until the air pressure inside the leak detection box (1) is reduced to a pressure threshold value sufficient to vaporize the reagent; S4, after the leak detection box (1) remains in a sealed state for a certain preset time, the air pressure inside the leak detection box (1) is monitored by the pressure recorder (2); S5. Compare the actual air pressure value recorded by the pressure recorder (2) with the air pressure value required by the standard. If there is leakage, the liquid inside the finished injection will leak through the micropores and vaporize inside the leak detection box (1), causing the air pressure inside the leak detection box (1) to rise significantly beyond the standard value range. S6. After the current finished injection is tested, the above steps are repeated to complete the leak testing operation on the small-volume injections in sequence.

2. The delayed leak detection method for a small volume injection according to claim 1, characterized in that: The interior of the leak detection box (1) is divided into a plurality of detection chambers (5) by a partition (4), and each detection chamber (5) monitors the air pressure through a corresponding pressure recorder (2).

3. The delayed leak detection method for a small volume injection according to claim 2, characterized in that: The suction port of the vacuum pump (3) is connected to a suction pipe (7); the suction pipes (7) are connected to corresponding detection chambers (5) via suction branch pipes (8); and suction check valves (9) are installed on the suction pipes (7).

4. The delayed leak detection method for a small volume injection according to claim 2, characterized in that: The detection chamber (5) is provided with an access opening (10) on the outside; the sealing mechanism comprises a bracket (11) fixed on the outside of the leak detection box (1); a plurality of retractors (12) are fixed on the bracket (11); the retractors (12) correspond to the access openings (10) one by one; and a sealing plug (13) corresponding to the access opening (10) is fixed at the retractable end of the retractor (12).

5. The delayed leak detection method for a small volume injection according to claim 1, characterized in that: The pressure recorder (2) transmits the pressure change value to the data monitoring system in real time via the network.

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