Patent Application
20180065768
The present invention relates to a gas substitution apparatus.
A vial is filled with contents such as medicine, and then the vial is sealed by coupling a cover to an opening of the vial. However, the cover may be coupled in a state in which oxygen remains in a headspace which is an upper space in the vial. If oxygen remains in the headspace of the vial, the contents accommodated in the vial is oxidized, which may cause deterioration in quality. In particular, in the case of an injection solution which is accommodated in the vial and used, a main component of the injection solution may be oxidized by only a small amount of oxygen in the headspace, and decomposition products may be generated.
To prevent the occurrence of the decomposition products, oxygen in the headspace is substituted with an inert gas before the cover is coupled after the vial is filled with the contents.
In general, oxygen in the vial is substituted with an inert gas by using a nozzle having a needle shape. However, such a substitution method cannot meet the expectation of a substitution rate. Therefore, there is a need for the development of a gas substitution apparatus capable of more assuredly substituting oxygen remaining in the headspace of the vial.
The present invention has been made in an effort to provide a gas substitution apparatus capable of more assuredly substituting oxygen in a vial.
The present invention has also been made in an effort to provide a gas substitution apparatus capable of improving a substitution rate of substitution gas by sealing a gas substitution section in a vial.
The exemplary embodiment according to the present invention may be used to achieve other objects that are not specifically mentioned in addition to the aforementioned objects.
An exemplary embodiment of the present invention provides a gas substitution apparatus including: a first gas substitution unit which seals a periphery of an opening of a vial disposed in a gas substitution section, and guides a flow of a first substitution gas to be supplied into the vial; and a second gas substitution unit which is coupled to an upper side of the first gas substitution unit, and guides a flow of a second substitution gas to be supplied directly into the vial.
The first gas substitution unit may include a plurality of gas tunnel portions which extend in the gas substitution section in a direction in which the vial is conveyed, and the plurality of gas tunnel portions may include: a first gas tunnel portion which is installed in a straight section in the gas substitution section; and a second gas tunnel portion which is connected to one end of the first gas tunnel portion. The first gas tunnel portion may include: a first tunnel body which is opened at a lower side thereof and formed straight; and a first tunnel connecting portion which is coupled to one side of the first tunnel body. The second gas tunnel portion may include: a second tunnel body which is opened at a lower side and a part of a lateral side thereof, and has a curved shape; and a second tunnel connecting portion which is coupled to an upper side of the second tunnel body. The second tunnel body of the second gas tunnel portion may be installed in a curved section of the gas substitution section. The first gas tunnel portion and the second gas tunnel portion may be integrally formed. The gas substitution section may be set from a section in which the vial is filled with contents to a section in which the opening of the vial is covered.
The second gas substitution unit may include: a body portion which has a hermetic internal space, and is coupled to the first tunnel body; an auxiliary connecting portion which is coupled to one side of the body portion; and a nozzle unit which is disposed in the first tunnel body, and has an inlet which is coupled to a lower side of the body portion, and a length such that an outlet of the nozzle unit is adjacent to the opening of the vial. A nozzle inner diameter of the nozzle unit may be set to 3.5 mm to 25 mm.
According to the exemplary embodiment of the present invention, it is possible to reduce consumption of gas to be substituted in the gas substitution section of the vial, and to improve a substitution rate of substitution gas, thereby reducing oxidation of injection products.
The technical terms used herein are merely for the purpose of describing a specific exemplary embodiment, and are not intended to limit the present invention. Singular expressions used herein include plural expressions unless they have definitely opposing meanings. The terms “comprises” and/or “comprising” used in the specification specify particular features, regions, integers, steps, operations, elements, or components, but do not preclude the presence or addition of other particular features, regions integers, steps, operations, elements, or components, and/or groups thereof.
Unless otherwise defined, all terms used herein including technical or scientific terms have the same meanings as meanings which are generally understood by those skilled in the art. Terms which are usually used and defined in dictionaries shall be construed such that they have meanings matching those in the context of a related art, and shall not be construed in ideal or excessively formal meanings unless they are clearly defined as such in the present application.
Hereinafter, an exemplary embodiment of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the technical field to which the present invention pertains may easily carry out the exemplary embodiment. However, the present invention may be implemented in various different ways, and is not limited to exemplary embodiments described herein. A gas substitution apparatus according to an exemplary embodiment of the present invention seals a periphery of an opening of a vial which is disposed in a gas substitution section of the vial. Further, a gas filling space in the vial may be easily filled with a substitution gas.
The first gas substitution unit 100 is disposed in a gas substitution section of a vial 10. The vial 10 has a gas filling space 14 positioned above a portion in which contents 12 are accommodated through an opening of the vial 10. Here, the contents 12 accommodated in the vial 10 may include an injection solution. During a period in which the injection solution is stored, related substances with an unsubstituted formulation may be created in the gas filling space 14 which is an upper space in the vial 10. The amount of related substances with an unsubstituted formulation is increased in proportion to the amount of oxygen in the vial 10. Therefore, the amount of oxygen in the gas filling space 14 of the vial 10 filled with the injection solution needs to be managed so that the amount of oxygen is at most 1% or less. Further, the gas filling space 14 refers to a space which is formed above the contents 12 accommodated in the vial 10, that is, a space which is filled with a gas. The gas filling space 14 may be called a headspace.
The first gas substitution unit 100 has gas substitution spaces 116 and 126 (see
The plurality of gas tunnel portions may include a first gas tunnel portion 110 which is installed in a straight section of the gas substitution section, and a second gas tunnel portion 120 which is connected to one end of the first gas tunnel portion 110. The first gas tunnel portion 110 and the second gas tunnel portion 120 may be integrally formed. The first gas tunnel portion 110 and the second gas tunnel portion 120 may have different shapes.
One end of each of the connecting portions 114, 124, and 204 is connected to a gas storage unit (not illustrated) which stores the substitution gas to be supplied to the gas filling space 14 and the gas substitution spaces 116 and 126, and the other end of each of the connecting portions 114, 124, and 204 is connected to the first gas substitution unit 100. Each of the connecting portions 114, 124, and 204 may include a hose and a connecting tube. Meanwhile, the connecting tube may include a single conduit coupled to the first gas tunnel portion 110 and the second gas tunnel portion 120. However, the connecting tube may include a plurality of conduits. Therefore, the present invention is not limited to the configuration in which the connecting tube includes a single conduit, and the connecting tube may include one or more conduits.
In
Referring to
The gas substitution apparatus according to the exemplary embodiment of the present invention may further include the second gas substitution unit 200 which is disposed in the gas substitution section and guides a flow of the substitution gas to be supplied directly into the gas filling space 14 of the vial 10. The second gas substitution unit 200 includes a body portion 202, an auxiliary connecting portion 204, and a nozzle unit 206.
The body portion 202 has a hermetic internal space, and the body portion 202 is coupled to the first tunnel body 112. The auxiliary connecting portion 204 is coupled to one side of the body portion 202 and guides a flow of the substitution gas to the interior of the body portion 202. An inlet of the nozzle unit 206 is coupled to a lower side of the body portion 202. Further, an outlet of the nozzle unit 206 has a length such that the outlet of the nozzle unit 206 is adjacent to the opening of the vial 10, and the outlet of the nozzle unit 206 is disposed in the first tunnel body 112. The nozzle unit 206 supplies the substitution gas, which is supplied into the body portion 202, to the gas filling space 14 through the opening of the vial 10. A nozzle inner diameter of the nozzle unit 206 may be set to 3.5 mm to 25 mm. Here, the nozzle inner diameter of the nozzle unit 206 may be 12 mm. If the nozzle inner diameter of the nozzle unit 206 is smaller than 3.5 mm, the amount of substitution gas, which is supplied directly into the opening of the vial 10, may be rapidly increased. Therefore, the substitution gas may interfere with oxygen in the vial 10, such that the substitution gas may not be discharged to the outside of the vial 10 in some cases. Then, gas substitution efficiency deteriorates, such that it may be difficult to reduce the amount of oxygen in the vial 10. If the nozzle inner diameter of the nozzle unit 206 is larger than 25 mm, a pressurized atmosphere formed at an upper side of the vial 10 may deteriorate. The range of the nozzle inner diameter of the nozzle unit 206 is not limited to the exemplary embodiment of the present invention. The nozzle inner diameter of the nozzle unit 206 may be design-varied and implemented in various forms in accordance with a size of the opening of the vial 10. In this case, the nozzle inner diameter of the nozzle unit 206 may be larger than the size of the opening of the vial 10.
The first gas tunnel portion 110 and the second gas substitution unit 200, which are disposed in the straight substitution section, may be manufactured such that the substitution gas is injected directly into the vial 10 from the nozzle unit 206. That is, in the straight substitution section, the interior of the first gas tunnel portion 110 may be formed to have a substitution gas tunnel environment. Further, in the straight substitution section, the substitution gas may be supplied directly into the vial 10. Therefore, the substitution gas tunnel environment, which is filled with the substitution gas, may be made while the vial 10 is conveyed along the conveying line. In addition, the substitution gas may be supplied directly to the gas filling space 14 in the vial 10 in a state in which the gas tunnel environment is formed. Therefore, it is possible to further improve efficiency in pushing oxygen which remains in the gas filling space 14 in the vial 10 to the outside of the vial 10.
A curved portion of the second tunnel body 122 of the second gas tunnel portion 120 may at least be installed in a curved section of the gas substitution section. The second gas tunnel portion 120, which is disposed in the curved substitution section, may have a substitution gas tunnel environment having an interior filled with the substitution gas. That is, the gas tunnel environment may be made such that a state in which the substitution gas is substituted in the gas filling space 14 of the vial 10 is easily maintained while the vial 10 is capped with the cover in the curved substitution section. Therefore, oxygen remaining in the gas filling space 14 in the vial 10 may be substituted with the substitution gas through the second gas tunnel portion 120 continuously connected to the first gas tunnel portion 110 which is the straight substitution section. Further, the peripheral of the vial 10 may be continuously maintained in the substitution gas tunnel environment until the vial 10 is capped with the cover.
As described above, in the exemplary embodiment of the present invention, the substitution gas is supplied to the first gas substitution unit 100 and the second gas substitution unit 200 through the gas storage unit and the connecting portion. Further, oxygen in the gas filling space 14 in the vial 10 is pushed away by injecting or blowing the substitution gas supplied through the first gas substitution unit 100 and the second gas substitution unit 200. In addition, the gas substitution may be implemented by filling the gas filling space 14 in the vial 10 with the substitution gas. The vial 10 is capped with the cover after the substitution gas is injected. It is possible to set conditions (a nozzle size, pressure, and substitution time) for ensuring that the amount of oxygen in the gas filling space 14 in the vial 10 is equal to or less than 1%. More detailed experimental results for ensuring that the amount of oxygen in the gas filling space 14 in the vial 10 is equal to or less than 1% will be described with reference to the following experimental examples.
In Experimental Example 1 of the present invention, a first substitution gas was supplied to the first gas substitution unit 100, and a second substitution gas was supplied to the second gas substitution unit 200. Under this experimental condition, the experiment was performed while changing a size and a filling capacity of the vial 10 and a nozzle inner diameter of the nozzle unit 206. The results are shown in the following Table 1. For example, 15 ml vials were filled with gases at 5 ml and 10 ml, respectively, and 20 ml vials were filled with gases at 5 ml, 10 ml, and 15 ml, respectively. The examples were classified based on the dimensions of the nozzle inner diameter (3.5 mm and 12 mm) of the nozzle unit 206 provided above the vial 10. Therefore, the amount of oxygen (%) in the vial 10 was measured by using a dual supply structure including the first gas substitution unit 100 and the second gas substitution unit 200.
As shown in Table 1, in a case in which the dual supply structure including the first gas substitution unit 100 and the second gas substitution unit 200 is used, the amount of oxygen in the vial 10 was equal to or less than 0.4%, such that a very high substitution rate was obtained. When Examples 1-1 to 1-10 are evaluated in accordance with various sizes and filling capacities of the vial 10 and various nozzle inner diameters of the nozzle unit 206, all of the Examples 1-1 to 1-10 have excellent gas substitution rates. When the vials 10 have the same size and the same filling capacity, a slightly higher gas substitution rate is implemented as the nozzle inner diameter of the nozzle unit 206 is increased. However, all of the examples have almost assured gas substitution rates within the aforementioned range of nozzle inner diameters.
In Experimental Example 2 of the present invention, no first substitution gas was supplied to the first gas substitution unit 100. The experiment was performed while changing the size and the filling capacity of the vial 10 and the nozzle inner diameter of the nozzle unit 206 under a condition in which the second substitution gas was supplied to the second gas substitution unit 200. The results are shown in the following Table 2. For example, 15 ml vials were filled with gases at 5 ml and 10 ml, respectively, and 20 ml vials were filled with gases at 5 ml, 10 ml, and 15 ml, respectively. The examples were classified based on the dimensions of the nozzle inner diameter (3.5 mm and 12 mm) of the nozzle unit 206 provided above the vial 10. Then, the amount of oxygen (%) in the vial 10 was measured when only the supply structure of the second gas substitution unit 200 was used.
As shown in Table 2, the second substitution gas was supplied only by using the second gas substitution unit 200 without using the first gas substitution unit 100. In this case, it was confirmed that an amount of oxygen which is much larger than the amount of oxygen in Examples 1-1 to 1-10 in Table 1 remained in the vial 10 because the first gas substitution unit 100 was not used. Therefore, it was confirmed that a larger amount of oxygen remained in the vial 10 and an effect of improving the gas substitution rate deteriorated in the case in which the second substitution gas was supplied only by using the second gas substitution unit 200 without using the first gas substitution unit 100 in comparison with the case in which the dual supply structure including the first gas substitution unit 100 and the second gas substitution unit 200 was used.
In Experimental Example 3 of the present invention, the experiment was performed under a condition in which the second substitution gas was supplied to a general nozzle without using the dual supply structure including the first gas substitution unit 100 and the second gas substitution unit 200. The results are shown in the following Table 3. For example, 15 ml vials were filled with gases at 5 ml and 10 ml, respectively, and 20 ml vials were filled with gases at 5 ml, 10 ml, and 15 ml, respectively. Further, the amount of oxygen (%) in the vial 10 was measured by using only the supply structure using the general nozzle in a state in which an inner diameter of the general nozzle provided at the upper side of the vial 10 was set to 4.2 mm.
As shown in Table 3, the second substitution gas was supplied only by using the general nozzle without using the first gas substitution unit 100 and the second gas substitution unit 200. In this case, it was confirmed that an amount of oxygen which is larger than the amount of oxygen shown in Tables 1 and 2 remained in the vial 10. Therefore, it was confirmed that a larger amount of oxygen remained in the vial 10 and an effect of improving the gas substitution rate significantly deteriorated in the case in which the second substitution gas was supplied only by using the general nozzle without using the first gas substitution unit 100 and the second gas substitution unit 200 in comparison with the other experimental examples.
It can be seen from the experimental examples that it is difficult to improve the substitution rate of oxygen only by using the general nozzle or the separate substitution structure. Further, it is possible to considerably decrease the amount of oxygen remaining in the vial 10 by sealing the upper side of the vial 10 in a tunnel shape by using the first gas substitution unit 100 and the second gas substitution unit 200 and by using the dual supply structure.
Further, it is possible to maintain the interior of the gas filling space 14 at a high pressure by increasing the amount of substitution gas to be supplied. By maintaining the interior of the gas filling space 14 at a high pressure, it is possible to prevent a flow of outside air that may be introduced into the gas filling space 14 from the outside of the vial 10. In addition, it is possible to more easily discharge oxygen remaining in the gas filling space 14 of the vial 10 to the outside of the vial 10 from the interior of the gas filling space 14. Here, it is not necessary to limit the supply of the substitution gas to a configuration in which the substitution gas is injected at a high pressure. A supply pressure of the substitution gas may be set to a pressure condition in which a substitution flow of the substitution gas may be easily generated and the interior of the vial 10 may be easily filled with the substitution gas outside the vial 10.
A process of substituting oxygen accommodated in the gas filling space 14 of the vial 10 with preset substitution gas in the gas substitution section will be described with reference to
First, the vial 10 is positioned in the gas substitution section. Then, the periphery of the upper side of the vial 10 is surrounded by the substitution gas due to an influence of the substitution gas accommodated in the first gas substitution unit 100 and the second gas substitution unit 200. The interiors of the first gas substitution unit 100 and the second gas substitution unit 200 are supplied with the substitution gas through the connecting portions from the gas storage unit, and filled with the substitution gas. The substitution gas is supplied at least at a high pressure. Therefore, it is possible to prevent outside air remaining outside the vial 10 from being introduced into the gas filling space 14 of the vial 10. In addition, since the substitution gas is supplied at a high pressure, oxygen remaining in the gas filling space 14 of the vial 10 may be discharged to the outside of the vial 10.
For reference, the first gas substitution unit 100 has the plurality of gas tunnel portions, that is, the first gas tunnel portion 110 and the second gas tunnel portion. Therefore, it is possible to more easily fill the vial 10 with the substitution gas. When the vial 10 is moved through the first gas tunnel portion 110 and the second gas tunnel portion 120, the vial 10 is affected by the gas filling space 14 and the gas substitution spaces 116 and 126 which are surrounded by the substitution gas. That is, oxygen is discharged from the gas filling space 14 of the vial 10. Further, oxygen is substituted with the substitution gas, and the space from which the oxygen is discharged is filled with the substation gas. In particular, the first gas tunnel portion 110 and the second gas tunnel portion 120 are formed such that the substitution gas is supplied to an upper region including the opening of the vial 10. Therefore, when the vial 10 passes through the first gas tunnel portion 110 and the second gas tunnel portion 120, oxygen in the gas filling space 14 is disturbed, and as a result, the gas substitution may be promoted. In addition, the substitution gas is supplied into the first gas tunnel portion 110 and the second gas tunnel portion 120. Therefore, it is possible to easily prevent outside air remaining outside the vial 10 from being introduced into the gas filling space 14 of the vial 10.
The first gas tunnel portion 110 and the second gas tunnel portion 120 are structured to minimize an opened portion of the shape of the tunnel, and surround the vial 10. The first gas tunnel portion 110 and the second gas tunnel portion 120 reduce an area of a gap with the outside, thereby maintaining an almost sealed space. Therefore, an almost sealed state of the interiors of the first and second gas tunnel portions 110 and 120 is maintained, and as a result, no air containing oxygen is introduced from the outside.
Although the preferred exemplary embodiments of the present invention have been described above, the present invention is not limited thereto, and various modifications can be made and carried out within the scope of the claims, the detailed description of the invention, and the accompanying drawings, and also fall within the scope of the invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10- 2015-0032999 | Mar 2015 | KR | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/KR2016/002189 | 3/4/2016 | WO | 00 |
