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Manufacturing method of powder needle nitrogen filling device

发布日期:2019-12-27 17:10 Document serial number: 19546531Release date: 2019-12-27 17:10
Manufacturing method of powder needle nitrogen filling device

The invention relates to an inflating device, which is mainly used in a nitrogen filling device in the production of injection needles for injection.



Background technique:

In the production of sterile powder injections, for easily oxidizable powders, nitrogen is required to be filled in the powder bottles to discharge the air in the bottles, and then sealed with rubber stoppers. Oxygen reacts with the medicinal powder to cause impurities in the medicinal powder, and the color grade of the medicinal powder will rise from the original color by several grades, and the final drug effect will be reduced, which will bring about unknown negative effects. Therefore, relying on the inertness of nitrogen to alleviate the change in the color level of the drug, thereby achieving the effect of improving the stability of the drug.

There are three types of conventional nitrogen filling methods:

1. Before filling the medicine powder into the medicine bottle, turn the medicine bottle over and pre-fill with nitrogen, then inject the powder, and finally press the rubber stopper.

2. After the medicine powder is filled into the medicine bottle, the rubber stopper is pre-compressed, but the rubber stopper is left in a seam, transferred to a sealed container to evacuate, and then injected with nitrogen at normal pressure to fill the nitrogen. Finally, the rubber stopper is pressed and the aluminum lid is pressed. .

3. After filling the medicine powder into the medicine bottle, enter the nitrogen channel for nitrogen filling, and finally press the rubber stopper.

The first method is complicated in design, and the mechanical structure needs regular maintenance. In the second method, the medicine bottle needs to be transferred, and the production efficiency is low. There may be a risk of bacterial contamination during the transfer. In the current third nitrogen filling method, the residual oxygen content cannot be effectively controlled and cannot be popularized.



Technical realization elements:

The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art mentioned above and provide a powder needle nitrogen filling device.

The technical solution adopted by the present invention to solve the above technical problem is: a powder needle nitrogen filling device, comprising: a buffer tank connected to a nitrogen source and a shunt inflation mechanism, wherein the shunt inflation mechanism includes a shunt cap and an air cavity box

The air distribution cover includes: a cover plate, an air inlet pipe connected to the buffer tank through a silicone hose, and a gas distribution pipe horizontally and fixedly connected to the bottom end of the air inlet pipe. The air inlet pipe is fixed on the cover plate, There are multiple sets of first-level air-separating holes on the pipe wall;

The top of the air cavity box is an opening, and the cover plate covers the opening. The air distribution pipe is located in the middle of the cavity of the air cavity box. The bottom surface of the air cavity box is provided with a row of secondary air separation holes. Fractional pores constitute a nitrogen-filled channel.

The buffer tank includes a tank body, a gas source interface pipe protrudingly inserted at the bottom end of the tank body, and a distribution seat sealedly installed at the top of the tank body. The end of the gas source interface pipe is a nitrogen source inlet quick-release chuck. The other end of the source interface pipe is inserted into the tank with a sealing design. Two rows of air guiding holes are symmetrically opened on the side wall of the gas source interface pipe inserted into the tank. The distribution seat is inserted with an air outlet interface pipe that is inherently connected to the tank. Connect the silicone hose to the tube.

The length of the nitrogen-filling channel is not less than 350 mm, and there are thirty-nine secondary gas-dividing holes at equal intervals. The diameter of the secondary gas-dividing holes is half of the diameter of the vial.

Six air inlet ports are arranged in a row at equal intervals, and six closely arranged primary air vents form a group, and the bottom end of one air inlet port corresponds to a group of primary air vents in front and back.

The side wall of the air cavity box near the end of the nitrogen-filled channel is arranged obliquely, and the angle with the horizontal plane is 32 °.

A horizontal bracket is provided on one side of the air cavity box, a vertical bracket is connected to the bottom end of the horizontal bracket, and a long waist hole is opened on the vertical bracket. The installation height of the air cavity box is adjusted through the waist hole to make the secondary air-dividing holes. The height from the bottle mouth is 3-10mm.

A pressure regulating valve is arranged on the gas source interface pipe, and the pressure regulating valve controls the pressure of the nitrogen source to not less than 8 psi.

The front and back sides of the cover plate are bent downward to extend to form symmetrical folds, and the folds cover the opening of the air cavity box. A positioning hole is opened at one end of the plate surface of the cover plate. One side wall is provided with a threaded hole, and a second screw is used to sequentially fix the positioning hole and the threaded hole;

A U-shaped card slot is formed by inwardly folding the side of the folded edge at the other end of the cover plate, and protruding card posts are arranged on the front and rear walls of the other side of the air cavity box, and the U-shaped card slot is sleeved on the card post. .

The two ends of the pipe body of the gas separation pipe are sealed with a second screw.

Compared with the prior art, the beneficial effects of the present invention are:

The present invention is an improvement on the third nitrogen filling method. Through two-stage gas separation channels, nitrogen is evenly and slowly injected into the medicine bottle, that is, the medicine powder in the medicine bottle is not blown out, and nitrogen gas can be guaranteed to enter the medicine bottle. After the rubber stopper is sealed, it is tested by a residual oxygen detector. The average residual oxygen content is below 0.5%, and the stable production speed is 224 bottles / minute.

a. The structure is simple. It is used in conjunction with the medicine bottle conveyor belt and the rubber stopper wheel mechanism. After filling the medicine bottle with nitrogen, the residual oxygen content can be stabilized below 0.5%.

b, no mechanical transmission structure, maintenance-free, quick installation chuck and hose installation, convenient and quick;

c. Convenient debugging. By controlling the nitrogen pressure and adjusting the distance between the air hole and the bottle mouth after installation, the control index of the residual oxygen content can be reached.

d. The material gmp has high compliance and no hygienic dead corners. The shunt inflation mechanism can be disassembled only by removing the screws, which is convenient for disassembly, cleaning and high-temperature sterilization, and meets the standards for sterile pharmaceutical production.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to explain the technical solution in the embodiments of the present invention more clearly, the drawings used in the description of the embodiments will be briefly introduced below, in which:

FIG. 1 is an overall structural view of a preferred embodiment of the present invention;

2 is a sectional view of a buffer tank according to a preferred embodiment of the present invention;

3 is a perspective view of a buffer tank according to a preferred embodiment of the present invention;

4 is a perspective view of a shunt inflation mechanism according to a preferred embodiment of the present invention;

FIG. 5 is a top view of a shunt inflation mechanism according to a preferred embodiment of the present invention; FIG.

6 is a cross-sectional view of the structure in the aa direction of FIG. 5;

7 is a schematic diagram of a working state of a preferred embodiment of the present invention;

FIG. 8 is a trend diagram of the height of the nitrogen-filled channel from the bottle mouth and the amount of residual oxygen in Experiment 1;

FIG. 9 is a trend graph of the nitrogen source pressure and the residual oxygen amount in Test 2. FIG.

detailed description

The invention will be further described below with reference to the drawings and specific embodiments. The terms such as "up", "down", "left", "right", "middle", and "one" cited in the preferred embodiment are only for the convenience of description, and are not intended to limit the present invention. The scope of implementation, the change or adjustment of its relative relationship, without substantial changes in the technical content, should also be considered as the scope of the present invention.

Preferred embodiment one

Referring to FIG. 1, a powder needle nitrogen filling device designed according to a first preferred embodiment of the present invention mainly includes: a buffer tank 30 and a shunt inflation mechanism. The device is used in conjunction with a transmission belt 5 and a rubber stopper mechanism 6. The nitrogen filling of the medicine bottle is completed, and the components and connection relationships are described in detail below.

1 to 3, the buffer tank 30 includes a cylindrical tank body 31, an air source interface pipe 32 protrudingly inserted in the middle of the bottom end of the tank body 31, and a distribution seat 33 sealedly installed on the top end of the tank body 31. . The end of the gas source interface pipe 32 is a gas source inlet quick-release chuck, which is directly connected to the pipe mouth clamp of the nitrogen source. The other end of the gas source interface pipe 32 inserted into the tank 31 is sealed. Two rows of air guide holes 34 are symmetrically provided on the side wall of the interface pipe 32 inserted into the tank body 31. The gas inlet direction of the nitrogen gas and the gas outlet direction of the two air guide holes 34 are perpendicular to each other. The nitrogen gas does not directly rush to the distribution seat 33, so that the buffer tank 30 The nitrogen in it achieves the purpose of uniform diffusion. The connection end of the distribution base 33 and the tank body 31 is sealed and connected by a fixed snap ring 35. When the inside of the tank body needs to be cleaned, the distribution base 33 can be opened for inspection and cleaning. The distribution seat 33 is inserted with six air outlet interface pipes 36 communicating with the tank body 31, and the six air outlet interface pipes 36 are evenly distributed. A silicone hose 37 is inserted into the outlet interface pipe 36, and finally nitrogen flows out through the silicone hose 37.

The tank body of the buffer tank 30 is formed by double-sided welding, and the welding seam is smooth without dead ends.

Referring to FIG. 1, FIG. 4 to FIG. 6, the split-flow inflation mechanism includes a split air cover 10 and an air cavity box 20, and the split air cover 10 covers the air cavity box 20.

The air distribution cover 10 includes: a cover plate 11, an air inlet pipe 12, and a gas distribution pipe 13. The cover plate 11 is a rectangular plate and is horizontally placed. Six air inlet pipes 12 are arranged in a row at equal intervals, and are welded and inserted. On the cover plate 11, one end of the silicone hose 37 is connected to the top of the air inlet pipe 12. The gas dividing pipe 13 is horizontally fixedly connected to the bottom ends of the six air inlet pipe 12, and the two are in communication with each other. On the pipe wall of the gas distribution pipe 13, a plurality of primary gas distribution holes 14 are symmetrically provided in the front and rear. Six closely arranged primary gas distribution holes 14 form a group, and the bottom end of an air inlet pipe 12 corresponds to one group in each of the front and rear. The graded air hole 14 is composed of a gas inlet interface pipe 12, a gaseous pipe 13, and a first-stage gaseous hole 14 to form a first-stage gaseous passage. The front and back sides of the cover plate 11 are bent downward to extend to form a symmetrical fold 15. One end of the cover plate 11 is provided with a positioning hole, and the side ends of the other end of the fold 15 are recessed inward to form a U-shaped slot 16. .

The air cavity box 20 includes: a cavity structure surrounded by front, rear, left, right and bottom walls. The top of the air cavity box 20 is an opening, and thirty-nine are provided at equal intervals on the bottom surface of the air cavity box 20.二 分 气孔 21. The secondary air holes 21. Threaded holes are provided on the left and right side walls of the opening of the air cavity box 20, and protruding posts 41 are provided on the front and rear walls on the opposite side of the threaded holes.

The cover plate 11 covers the opening of the air cavity box 20, the flange 15 covers the opening, and the U-shaped slot 16 is sleeved on the card post 41. The first screw 42 is used to fix the positioning hole and the threaded hole in order, so that The gas separation cover 10 is fixedly connected to the air cavity box 20. At this time, the gas separation tube 13 is located in the middle of the cavity of the air cavity box 20. The primary air distribution hole 14, the air cavity box 20, and the secondary air distribution hole 21 constitute a secondary air distribution channel. Finally, the nitrogen gas passes through the secondary air distribution hole 21, and the medicine bottle is uniformly transported from the secondary air distribution hole 21 at one end to another through a conveyor belt. The second-stage gas separation hole 21 at one end, at this time, the distance traveled by the pill bottle is called the nitrogen filling channel. To form a nitrogen filling channel that continuously sprays nitrogen and continuously blows it out, it can be injected uniformly, stably, and slowly. Medicine bottle.

A horizontal support 23 is provided on one side of the air cavity box 20, and a vertical support 24 is connected to the bottom end of the horizontal support 23. A long waist hole is opened on the vertical support 24 to facilitate the adjustment of the air cavity box 20 by screws. Installation height. The device is mounted on one side of the conveyor belt 5 with a fixed bracket, so that the nitrogen filling channel is directly above the medicine bottle, and the height of the nitrogen filling channel from the bottle mouth can be adjusted between 3-10mm.

The two ends of the pipe body of the gas separation pipe 13 are blocked with a second screw 43, and the interior can be removed for cleaning.

The gas separation cover 10 and the air cavity box 20 are made of stainless steel 316 as a whole, and are electrolytically polished.

Please refer to FIG. 7. In order to facilitate the understanding of this solution, the working principle of the device is briefly described below:

The density of air is 1.293g / l (0 degrees Celsius, 1 standard atmosphere), and the density of nitrogen is 1.25g / l (0 degrees Celsius, 1 standard atmosphere). The density of nitrogen is 3.4% lower than the density of air, and the density is closer, so nitrogen replacement The air in the vial is continuously blown out by the nitrogen-filling channel, so that the nitrogen can be evenly, stably, and slowly injected into the vial, the air in the vial is exhausted, and a nitrogen protective area is formed between the bottle mouth and the secondary vent hole to avoid air. Enter the bottle again.

In actual use, for the use of a 15ml vial, the height of the medicine bottle is 52mm, the diameter of the bottle body is 24 ± 0.20mm, and the diameter of the bottle mouth is 12.6mm. In order to realize the replacement of the air in the vial by nitrogen, the diameter of the secondary air separation hole 21 is designed to be half of the diameter of the bottle mouth, that is, 6 mm. The length of the nitrogen-filled channel is 350mm and the width is 40mm. The side wall 22 of the air cavity box 20 is arranged obliquely near the end of the nitrogen-filled channel, and the angle between the side wall and the horizontal plane is 32 °. The plug wheel mechanism 6 enables the medicine bottle to immediately press the rubber stopper just after passing through the nitrogen filling channel, so as to shorten the connection time in the non-inflated state as much as possible.

The nitrogen filling effect is related to the nitrogen source pressure of the gas source interface tube, the height of the nitrogen filling channel from the bottle mouth, and the transfer speed of the vial. Find out the optimal parameters through experiments:

Experiment 1: Fix the nitrogen source pressure and transfer speed, and adjust the height of the nitrogen filling channel from the bottle mouth to 3mm and 5mm, respectively:

Summary: Please refer to Figure 8. The smaller the height of the nitrogen-filled channel from the bottle mouth, the lower the average value of residual oxygen. 3mm is the working physical limit. Therefore, if it is less than 3mm, there will be a problem that the medicine bottle will jump and collide with the nitrogen filling channel. Therefore, the height of the nitrogen-filled channel from the bottle mouth is determined to be 3 mm.

Experiment 2: The fixed transfer speed was 224 bottles / minute, the height of the nitrogen-filled channel from the bottle mouth was 3mm, and the relationship between the pressure of the nitrogen source and the residual oxygen value was tested:

Summary: Please refer to Figure 9. The nitrogen source pressure is from 4 to 16 psi. After 6 psi, the average residual oxygen amount is close to and stabilizes below the 0.200% baseline. Considering energy consumption and residual oxygen amount stability, the nitrogen source pressure is set at 8psi is enough. A pressure regulating valve is provided on the gas source interface pipe 32, and the pressure of the nitrogen source is controlled by setting the parameters of the pressure regulating valve.

Summary: The average residual oxygen data obtained through the tests of experiments 1 and 2, the optimal parameters are selected: the height of the nitrogen-filled channel from the bottle mouth is determined to be 3 mm, and the pressure of the nitrogen source is determined to be 8 psi.

Preferred embodiment two

A powder needle nitrogen filling method designed in the second preferred embodiment of the present invention specifically includes:

First, the nitrogen filling device described in the first embodiment is used to form a section of nitrogen filling channel that continuously emits nitrogen. The length of the nitrogen filling channel is not less than 350mm, the height of the nitrogen filling channel from the bottle mouth is 3mm, and the nitrogen source pressure of the nitrogen filling device. No less than 8psi, the powdered medicine bottle passes directly under the nitrogen filling channel at a speed of 224 bottles / minute on the conveyor belt, and the bottle is filled with nitrogen; after passing through the nitrogen filling channel, a rubber stopper wheel mechanism is used. Press the rubber stopper into the bottle mouth.

The above description is only the preferred embodiments of the present invention, and does not limit the present invention in any form. Any person skilled in the art can implement the above according to the technical essence of the present invention without departing from the scope of the technical solution of the present invention. Any introductory modifications, equivalent changes, and modifications made by the examples still fall within the scope of the technical solution of the present invention.

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