CN113203532A - Preparation method of injection packaging integrity testing tool based on vacuum attenuation method - Google Patents
Preparation method of injection packaging integrity testing tool based on vacuum attenuation method Download PDFInfo
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- CN113203532A CN113203532A CN202110407448.5A CN202110407448A CN113203532A CN 113203532 A CN113203532 A CN 113203532A CN 202110407448 A CN202110407448 A CN 202110407448A CN 113203532 A CN113203532 A CN 113203532A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- G01M3/00—Investigating fluid-tightness of structures
- G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
- G01M3/26—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors
- G01M3/32—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for containers, e.g. radiators
- G01M3/34—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for containers, e.g. radiators by testing the possibility of maintaining the vacuum in containers, e.g. in can-testing machines
Abstract
The invention provides a preparation method of an injection packaging integrity test tool based on a vacuum attenuation method. The invention also provides an injection packaging integrity testing tool based on the vacuum attenuation method and a testing method for the injection product packaging integrity. The 3D printing technology is an integrated printing manufacturing mode, so that defects such as pores and the like caused by various reasons in the process of machining a casting mold by a machine tool are avoided, and time and cost are saved. In addition, the test mould which is manufactured by the 3D printing manufacturing method and adopts the vacuum attenuation method to test the package integrity of the injection product can freely control the space size of the cavity. Based on the advantages, the 3D printing manufacturing method of the tool for testing the package integrity by adopting the vacuum attenuation method can be rapidly popularized, so that the development of the injection industry is promoted.
Description
Technical Field
The invention relates to the field of package integrity testing, in particular to a preparation method of an injection package integrity testing tool based on a vacuum attenuation method.
Background
The broad definition of package Integrity (CCI) is: the ability of a container to prevent loss of contents and external contamination, in particular, for pharmaceutical products, the integrity of the packaging container means that the pharmaceutical product is not subject to leakage, which may lead to the risk of contaminants entering the pharmaceutical product or causing loss of the pharmaceutical product. The tightness of the containers of the packaging material in direct contact with the pharmaceutical products should ensure that the packaging system of the pharmaceutical products is closed or sealed to prevent contamination or loss of pharmaceutical content. USP <1> injections and implants (parenteral administration) -product quality tests specifically indicate that "the packaging system should be closed or sealed to prevent contamination or loss of drug content. Verification of the integrity of the container must be able to prove the absence of the ingress of microbial contamination, or some assurance that the necessary chemical or physical parameters of the product have not increased or decreased ". There are many types of test methods for package integrity, and currently, none of the package leak test or package seal quality test methods are applicable to all pharmaceutical packaging systems. In recent years, the testing method of container integrity is continuously mature and perfect, and a plurality of nondestructive quantitative testing methods such as a vacuum attenuation method, a high-voltage discharge method, a liquid tracing method and the like are developed in succession abroad.
The vacuum attenuation method is characterized in that a packaging container is placed in a special test cavity, the test cavity is vacuumized, the pressure difference between the inside and the outside of the container enables the gas in the container to leak into the test cavity through a leakage hole, a host pressure sensor monitors the change of pressure, the pressure change value is compared with a reference value, the pressure increase indicates that leakage exists, and whether the sealing integrity of the container is checked or not is judged. The vacuum decay method is a deterministic leakage test method, is loaded in United states Pharmacopeia USP 1207 and is a method for obtaining the approval of the United states FDA, and can be used for nondestructively, rapidly and quantitatively monitoring the tightness of a pharmaceutical container. At present, the tool for testing the product packaging integrity by the method is a hollow metal mold which mainly comprises a base and an outer cover, and after the base and the outer cover are sealed, a cavity is arranged in the middle of the base and can be used for placing the tested injection product.
However, since products in the pharmaceutical market have packages of different shapes and sizes, if a machine tool is used to machine the mold test container, each different form of package requires a new work of molding or the like. The small gaps at the metal joints may cause errors in the experimental data. And the machine tool processes the mould casting work to waste time and energy, and the cost is huge. The inspection mechanism may face different manufacturers and different sizes of products, and it is not favorable to research the inspection speed if each of the manufacturers needs to machine the mold, and it is a waste to test such many molds at one time. Therefore, for the detection mechanism, the machine tool machining die is not suitable for quickly and conveniently detecting various packages.
In view of different packaging forms and sizes of the pharmaceutical preparations, the method for testing the leakage of the pharmaceutical preparation lossless packaging container by the vacuum attenuation method has unique advantages. The invention mainly solves the problems that the time and labor are wasted and the cost is high because the required tool material is used for testing, the mould is manufactured by the original machine tool, and then the corresponding tool material is produced. At present, the 3D scanning and printing integrated technology is improved and adopted, so that a fast, convenient and reasonable manufacturing process is established.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides a preparation method of a tool for testing the package integrity of injections (particularly small-volume injection containers) based on a vacuum attenuation method.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention provides a preparation method of an injection packaging integrity test tool based on a vacuum attenuation method, which comprises the following specific steps:
and 3, 3D printing is carried out according to the 3D model of the testing tool by adopting a 3D printing technology, and the injection packaging integrity testing tool is obtained.
Further, the appearance size of the step 1 comprises the height, the outer diameter length, the inner diameter length, the bottom radian and the chamfer angle of the sample to be detected.
Further, the 3D modeling software of step 2 is selected from one of 3DMAX, UG, SketchUp, or other 3D modeling software.
Further, the material used for 3D printing in step 3 is one or more of metal, plastic, glass, or other elastic materials.
The second aspect of the present invention is a vacuum decay method-based injection packing integrity test tool manufactured according to the above manufacturing method.
Furthermore, the structure of the testing tool comprises an upper gland and a lower base which are detachably connected, wherein an upper cavity is arranged at the bottom of the upper gland, a lower cavity corresponding to the upper cavity is arranged at the top of the lower base, and the lower cavity is matched with the upper cavity to form a cavity for placing a sample to be tested.
Further, the cavity varies according to the apparent size of the sample to be studied, and the outer wall of the sample and the inner cavity wall of the mould keep proper gaps, so that the air flow freely passes through the cavity.
Furthermore, the bottom of the upper gland is provided with at least one annular groove positioned on the outer side of the upper cavity, the annular groove and the upper gland are of a concentric circle structure, the top of the lower base is provided with at least one boss corresponding to the annular groove, and the boss is of a certain gradient.
Further, the annular groove is provided with a sealing gasket.
Furthermore, the top of the upper gland is provided with a handle, and the side wall of the upper gland is provided with three upper reinforcing handles; the lateral wall of the lower base is provided with three lower reinforcing handles corresponding to the upper reinforcing handles, and the reinforcing handles are connected with the corresponding upper reinforcing handles in a buckling manner.
Further, the test tool comprises a vacuum attenuator, a micro-flow meter and an air flow channel; the vacuum attenuator and the micro flow meter are communicated with the cavity through a hose and an airflow channel, and the outer end point of the airflow channel is provided with a thread.
Further, the connection part of the hose and the airflow channel is a metal structure with a thread on the outer wall matched with the thread.
The third aspect of the invention provides a method for testing the package integrity of an injection product by using an injection package integrity testing tool based on a vacuum attenuation method, which specifically comprises the following steps of putting the injection product to be tested into a testing cavity, keeping the outside of a mould sealed, and then carrying out the following operations on a vacuum attenuation instrument host: vacuumizing; maintaining the pressure; and (6) testing.
Compared with the prior art, the preparation method of the injection packaging integrity testing tool based on the vacuum attenuation method provided by the invention has the following beneficial effects:
1. the 3D printing manufacturing method is an integrated printing manufacturing mode, so that defects such as pores and the like caused by various reasons in the process of machining a casting mold by a machine tool are avoided.
2. The 3D printing manufacturing method only needs about one week from modeling to finished product production, and the time consumption is short; meanwhile, the 3D scanning technology is used for rapidly and accurately scanning and measuring various samples with complex appearances, the mold can be continuously optimized according to the actual condition of research, a three-dimensional effect graph can be rapidly formed, and then the graph model can be converted into a graph model for 3D printing.
3. The 3D printing manufacturing method has the advantages that manufacturing cost is saved by manufacturing the mold;
4. the test mould which is manufactured by the 3D printing manufacturing method and adopts a vacuum attenuation method to test the packaging integrity of the injection product can freely control the space size of the cavity;
5. based on the advantages, the 3D printing manufacturing method can be used for rapidly carrying out technical popularization, so that the development of the injection industry is promoted.
Drawings
Fig. 1 is a cross-sectional view of an injection packing integrity test tool based on the vacuum decay method according to the present invention.
Fig. 2 is a left side view of the injection packing integrity test tool based on the vacuum decay method according to the present invention.
Wherein: 1-a handle; 2, pressing a gland; 3-lower base; 4-a cavity; 5-a groove; 6-sealing gaskets; 7-a boss; 8-an airflow channel; 9-thread; 10-lower reinforced handle; 11-a micro flow meter; 12-vacuum attenuator; and 13-reinforcing a handle.
Detailed Description
The present invention will be described in detail and specifically with reference to the following examples and drawings so as to provide a better understanding of the invention, but the following examples do not limit the scope of the invention.
The following examples provide a method for preparing a vacuum decay method based injection package integrity test tool and a test procedure of the vacuum decay method based injection package integrity test tool prepared by the preparation method (refer to fig. 1 and 2).
Embodiment A3D printing method for manufacturing test tool
This example provides a production process of a test mold for testing the integrity of an injection product package by a vacuum decay method, and integrated manufacturing is performed by a 3D printing technique after measurement according to the external dimensions of the tested drug package. The method mainly comprises the following steps:
and 3, 3D printing is carried out according to the 3D model of the testing tool by adopting a 3D printing technology, and the injection packaging integrity testing tool is obtained.
EXAMPLE two test procedure
The basic steps of the testing tool for testing the package integrity of the injection product by adopting the vacuum attenuation method to test the package integrity of the injection product are that the injection product to be tested is placed in a testing cavity, and after the outside of a mould is kept sealed, the following operations are carried out on a vacuum attenuation instrument host: vacuumizing; maintaining the pressure; and (6) testing.
The test method can judge the leakage degree of the package according to the vacuum degree or the pressure difference value, and provides test methods for a plurality of specific injection products for the following specific embodiments.
The integrity of the package of the injection packed by the glass/penicillin bottle combination is tested, and the method comprises the following specific steps:
putting the injection packaged by the glass/penicillin bottle combination into a test cavity, closing the box, keeping the outside of the mould sealed, and performing the following operations on a vacuum attenuation instrument host:
1. vacuumizing: in the vacuumizing stage, if the actual vacuum degree cannot reach the reference vacuum degree within the specified vacuumizing time, a large leakage is packaged.
2. Pressure maintaining: in the pressure maintaining stage, if the actual vacuum degree can not reach the reference vacuum degree within the specified pressure maintaining time, the packaging bag is filled with the middle leakage.
3. And (3) testing: in the test phase, if the actual pressure mbar variation dp value is greater than the reference pressure mbar variation dp value, a small leak is packaged.
4. Carrying out methodology verification: and carrying out methodology verification such as accuracy and precision.
Application example two
The method for testing the package integrity of the polypropylene infusion bottle comprises the following specific steps:
putting a polypropylene infusion bottle into a test cavity, closing the box, keeping the external seal of the mould, and performing the following operations on a vacuum attenuation instrument host machine:
1. vacuumizing: in the vacuumizing stage, if the actual vacuum degree cannot reach the reference vacuum degree within the specified vacuumizing time, a large leakage is packaged.
2. Pressure maintaining: in the pressure maintaining stage, if the actual vacuum degree can not reach the reference vacuum degree within the specified pressure maintaining time, the packaging bag is filled with the middle leakage.
3. And (3) testing: in the test phase, if the actual pressure mbar variation dp value is greater than the reference pressure mbar variation dp value, a small leak is packaged.
4. Carrying out methodology verification: and carrying out methodology verification such as accuracy and precision.
The above embodiment illustrates that the test tool for testing the integrity of the package of the injection product by using the vacuum attenuation method, which is manufactured by the 3D printing manufacturing method, can freely control the size of the space of the cavity, and the printing technology avoids defects such as pores and the like caused by various reasons in the process of machining a casting mold by a machine tool, saves time and cost, and can quickly carry out technical popularization, thereby promoting the development of the injection industry.
The embodiments of the present invention have been described in detail, but the embodiments are merely examples, and the present invention is not limited to the embodiments described above. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be covered by the present invention.
Claims (10)
1. The preparation method of the injection packaging integrity test tool based on the vacuum attenuation method is characterized by comprising the following steps of:
step 1, 3D scanning is carried out on an injection sample to be detected, and appearance size data of the injection sample is measured;
step 2, establishing a 3D model of a testing tool according with the injection sample through 3D modeling software according to the measured appearance size data;
and 3, performing 3D printing by adopting a 3D printing technology according to the test tool 3D model to obtain an injection package integrity test tool.
2. The method for preparing the injection package integrity test tool according to claim 1, wherein the external dimensions in step 1 include height of the sample to be tested, outer diameter length, inner diameter length, bottom radian and chamfer.
3. The method for preparing an injection package integrity test tool according to claim 1, wherein the 3D modeling software of step 2 is selected from one of 3DMAX, UG, SketchUp or other 3D modeling software.
4. The method for preparing the injection packaging integrity test tool according to claim 1, wherein the material used for 3D printing in step 3 is one or more of metal, plastic, glass or other elastic materials.
5. The injection packing integrity test tool based on the vacuum decay method prepared by the method of claim 1 comprises an upper gland (2) and a lower base (3) which are detachably connected, wherein an upper cavity is arranged at the bottom of the upper gland (2), a lower cavity corresponding to the upper cavity is arranged at the top of the lower base (3), and the lower cavity and the upper cavity are matched to form a cavity (4) for placing a sample to be tested.
6. The vacuum attenuation method-based injection packing integrity test tool according to claim 5, characterized in that the bottom of the upper gland (2) is provided with at least one annular groove (5) located outside the upper cavity; the top of the lower base (3) is provided with at least one boss (7) corresponding to the annular groove (5).
7. The vacuum attenuation method-based injection packaging integrity test tool according to claim 5, characterized in that the annular groove (5) is provided with a sealing gasket (6).
8. The vacuum attenuation method-based injection packing integrity test tool according to claim 5, wherein the top of the upper gland (2) is provided with a handle (1), and the side wall is provided with three upper reinforcing handles (13); the side wall of the lower base (3) is provided with three lower reinforcing handles (10) corresponding to the upper reinforcing handles (13), and the reinforcing handles (10) are connected with the corresponding upper reinforcing handles (13) in a buckling mode.
9. The testing tool for testing the package integrity of injection products by vacuum decay method according to claim 5, further comprising a vacuum attenuator (10), a micro flow meter (11) and an air flow channel (8), wherein the vacuum attenuator (10) and the micro flow meter (11) are communicated with the cavity (4) through a hose and the air flow channel (8), and the outer end point of the air flow channel is provided with a thread (9).
10. A method for testing the package integrity of an injection product by using a testing tool according to any one of claims 5 to 9, wherein the method comprises the following steps of placing the injection product to be tested into a testing cavity, keeping the exterior of the mold sealed, and then performing the following operations on a vacuum attenuation instrument host machine: vacuumizing; maintaining the pressure; and (6) testing.
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