JP2017044542A - Quantitative method for gaseous leakage, and flexible bag - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a quantitative method for gaseous leakage capable of facilitating comparison and quantitation of a gaseous leakage regardless of the form or size of a specimen, and a flexible bag used in the quantitative method.SOLUTION: A quantitative method for gaseous leakage includes the steps of: putting a specimen 9 into a transparent and flexible bag 1 including an air injection section 5, and sealing the flexible bag 1 in a state where air in a space part 10 of the flexible bag is extracted; injecting a constant amount of air from the air injection section 5, and making gas in the space part 10 uniform; collecting a constant amount of uniform gas in the space part 10; and analyzing concentration of a component in the collected gas.SELECTED DRAWING: Figure 1D

Description

  The present invention relates to a method for quantifying gaseous leakage and a flexible bag used in the quantification method.

  Conventionally, methods for inspecting leakage of volatile substances and gases have been proposed. For example, Patent Document 1 sucks a gas in a case containing a plurality of containers, detects a gas resulting from the contents of the container from the sucked gas, and a detection result in the process. And a step of determining suitability of airtightness of a plurality of containers accommodated in the case.

JP 2008-8626 A

However, in the method described in Patent Document 1, the presence or absence of gas leakage can be detected, but the volume of the space in the case varies depending on the form and size of the test object (container), so the amount of gas leakage is compared. It is difficult to quantify.
SUMMARY OF THE INVENTION An object of the present invention is to provide a method for quantitatively determining a gaseous leak that can be easily compared and quantified regardless of the form and size of the test object, and a flexible bag used in this quantitative method. Is to provide.

  Another object of the present invention is to provide a gaseous leak that can easily perform comparison and quantification of gaseous leaks during a drug collection operation from a drug container, regardless of the form and size of the test object. An object of the present invention is to provide a quantitative method for an object and a flexible bag used for the quantitative method.

  In order to achieve the above-mentioned object, the invention according to claim 1 is such that a test object is placed in a transparent flexible bag having an air injection site, and the air in the space of the flexible bag is expelled. A step of sealing, a step of injecting a certain amount of air from the air injection site to make the gas in the space portion uniform, a step of collecting a certain amount of gas in the space portion that has become uniform, and And a step of analyzing the concentration of the components in the gas.

  According to this method, after putting the test object in the flexible bag, the air in the space is once expelled and sealed, and then a certain amount of air is injected to make the gas in the space uniform. Regardless of the form and size of the specimen, the volume of the space of the flexible bag can be made substantially constant. Therefore, since the leakage amount of gaseous leakage from the test object can be measured under the same conditions, comparison and quantification of gaseous leakage can be easily performed.

  The invention according to claim 2 is a step of putting a test object and a gas sampling container in a transparent flexible bag having an air injection site, and sealing in a state in which air in the space portion of the flexible bag is expelled. And a step of injecting a certain amount of air from the air injection portion to make the gas in the space portion uniform, and a step of enclosing a certain amount of the gas in the space portion into the gas sampling container, And a step of analyzing the concentration of the component in the gas sealed in the gas sampling container.

  According to this method, after putting the test object in the flexible bag, the air in the space is once expelled and sealed, and then a certain amount of air is injected to make the gas in the space uniform. Regardless of the form and size of the specimen, the volume of the space of the flexible bag can be made substantially constant. Therefore, since the leakage amount of gaseous leakage from the test object can be measured under the same conditions, comparison and quantification of gaseous leakage can be easily performed. Moreover, since the gas in the space is collected by the gas sampling container in the flexible bag and the gas is analyzed, it is possible to prevent the gas from leaking and decreasing in the process from gas sampling to analysis. be able to. As a result, it is possible to accurately compare and quantify gaseous leakages.

The invention according to claim 3 is a flexible bag used in the determination method according to claim 1 or 2, wherein the air injecting portion is provided on a wall of the bag body of the flexible bag, and is injected. It is a flexible bag containing the elastic body which can pierce a needle.
According to this configuration, since the injection and collection of air (gas) can be performed using the injection needle of a syringe, which is a conventional instrument, no special instrument is required, and the above quantitative method can be easily performed. Can be introduced.

The invention according to claim 4 is the flexible bag according to claim 3, wherein the bag body is formed of a hardly adsorbing plastic.
According to this configuration, it is possible to suppress the gaseous leakage leaking into the bag body from being adsorbed by the bag body. As a result, the quantitative accuracy of the gaseous leakage can be improved.
The invention according to claim 5 is the flexible bag according to claim 3 or 4, further comprising at least one finger insertion portion formed inward of the bag body.

According to this configuration, it becomes easy to hold a container or the like housed in the bag body, so that when it becomes necessary to hold a test object or the like when quantifying gaseous leakage, the workability is improved. Can be made.
The invention according to claim 6 is the flexible bag according to claim 5, wherein the finger insertion portion is integrally formed by utilizing a part of the bag body.

According to this configuration, since the joint between the finger insertion portion and the bag body can be eliminated, it is possible to prevent gas from leaking from such a joint.
According to the seventh aspect of the present invention, an elastic sealing body capable of inserting an injection needle as a test object in a transparent flexible bag having an air injection portion made of an elastic body capable of inserting the injection needle. A step of sealing the medicine container sealed with, sealing in a state in which the air in the space of the flexible bag is expelled, and inserting the injection needle of a syringe containing a certain amount of air into the air injection site, After injecting a certain amount of air into the flexible bag, and subsequently performing an operation of collecting the medicine in the medicine container by inserting the needle into the elastic sealing body of the medicine container. , Removing the injection needle from the elastic sealing body and the air injection site, and making the gas in the space portion uniform after a certain period of time, and collecting a certain amount of gas in the space portion that has become uniform And analyzing the concentration of components in the collected gas, It is a quantitative method for gaseous leaking substance during drug collection operation from agent container.

  According to this method, after the test object (drug container) is put in the flexible bag, the air in the space is once expelled and sealed, and then the space in the flexible bag into which a certain amount of air has been injected. Since the gas is made uniform after a certain period of time after sampling the drug, the volume of the space portion of the flexible bag can be made almost constant regardless of the form and size of the test object. . Therefore, since the leakage amount of the gaseous leakage at the time of the medicine collecting operation from the medicine container can be measured under the same conditions, the comparison and quantification of the gaseous leakage can be easily performed.

According to an eighth aspect of the present invention, in the step of collecting a certain amount of the gas in the space in the flexible bag, a gas collection container accommodated in the flexible bag together with the medicine container is provided. The method for quantifying gaseous leakage according to claim 7, which is used.
According to this method, the gas in the space is collected by the gas collection container in the flexible bag and the gas is analyzed, so that gas leaks in the process from gas collection to analysis and the amount decreases. This can be suppressed. As a result, it is possible to accurately compare and quantify gaseous leakages.

FIG. 1A is a diagram for explaining a quantitative method of gaseous leakage according to an embodiment of the present invention in the order of steps. FIG. 1B is a diagram showing a step subsequent to FIG. 1A. FIG. 1C is a diagram showing a step subsequent to FIG. 1B. FIG. 1D is a diagram showing a step subsequent to FIG. 1C. FIG. 1E is a diagram showing a step subsequent to FIG. 1D. FIG. 1F is a diagram showing a step subsequent to that in FIG. 1E. FIG. 2A is a diagram showing a flexible bag containing a relatively large test object. FIG. 2B is a diagram showing a flexible bag containing a relatively small test object. FIG. 3A is a diagram for explaining a quantitative method of gaseous leakage according to another embodiment of the present invention in the order of steps. FIG. 3B is a diagram showing a step subsequent to FIG. 3A. FIG. 3C is a diagram showing a step subsequent to FIG. 3B. FIG. 3D is a diagram showing a step subsequent to FIG. 3C. FIG. 3E is a diagram showing a step subsequent to that in FIG. 3D. FIG. 3F is a diagram showing a step subsequent to that in FIG. 3E. FIG. 4A is a diagram for explaining a quantitative method of gaseous leakage according to still another embodiment of the present invention in the order of steps. FIG. 4B is a diagram showing a step subsequent to FIG. 4A. FIG. 4C is a diagram showing a step subsequent to FIG. 4B. FIG. 4D is a diagram showing a step subsequent to FIG. 4C. FIG. 4E is a diagram showing a step subsequent to that in FIG. 4D. FIG. 4F is a diagram showing a step subsequent to that in FIG. 4E. FIG. 4G is a diagram showing a step subsequent to FIG. 4F. 4H is a diagram showing a step subsequent to that in FIG. 4G. FIG. 5 is a view showing a modification of the flexible bag.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
FIG. 1A to FIG. 1F are diagrams for explaining a method for quantitatively determining a gaseous leakage according to an embodiment of the present invention in the order of steps.
First, as shown in FIG. 1A, a transparent flexible bag 1 is prepared.
The flexible bag 1 includes, for example, a flat bag body 2, and a space 10 is defined inside the bag body 2. The shape of the flat bag body 2 may be, for example, a quadrangle as shown in FIG. 1A, but may be a triangle, a circle, or an indefinite shape. The bag body 2 is preferably made of a hardly adsorptive plastic film. The hardly adsorbing plastic film includes, for example, a substance that is difficult to adsorb gaseous leakage, and specifically, a single layer or multilayer film including a film such as a cyclic polyolefin, polyamide, or an inorganic vapor deposition film can be suitably employed. Thereby, since it can suppress that a gaseous leak is adsorb | sucked to the film inner surface of the bag main body 2, the fixed quantity precision of a gaseous leak can be improved.

  Sealing means for sealing the bag body 2 is provided at a part of the periphery of the bag body 2. The sealing means may be, for example, a rail fastener 3 formed by using the peripheral edge of the bag body 2 as shown in FIG. 1A, or provided separately from the bag body 2. It may be a fastener (not shown) such as a clip that closes the peripheral edge of the clip. In this embodiment, one side of the bag body 2 is a sealing port 4 with a rail fastener 3, and a test object 9 (described later) can be taken in and out from the sealing port 4.

  An air injection part 5, a gas collection part 6, and an air discharge part 7 are provided in part of the periphery of the bag body 2. In this embodiment, the air injection part 5, the gas sampling part 6 and the air discharge part 7 are arranged in this order from the side of the sealing port 4 on one of a pair of side sides of the bag body 2 facing each other. This arrangement form has the following advantages. For example, when the air discharge part 7 is disposed opposite to the sealing port 4, when the air in the space 10 of the bag body 2 is pushed out to the opposite side of the sealing port 4 with the flat bag body 2 held by the palm, There is a possibility that the film of the bag body 2 that is being pressed is displaced and the rail fastener 3 of the sealing opening 4 is opened. However, by arranging the air discharge portion 7 on the side of the bag body 2 as in this embodiment, such problems are less likely to occur and workability during air discharge can be improved.

  Moreover, it is preferable that the air injection | pouring site | part 5 is arrange | positioned away from the air discharge site | part 7, as shown to FIG. 1A. In this embodiment, the air injection part 5 is arranged at the end of the side of the bag body 2 on the side of the sealing port 4, and the air discharge part 7 is arranged at the opposite end. By keeping the air injection part 5 away from the air discharge part 7, the operator can touch the air discharge part 7 when injecting a certain amount of air from the air injection part 5 into the space 10 of the bag body 2. Since this can be avoided, it is possible to prevent a certain amount of injected air from leaking out of the air discharge site 7 by mistake.

  As the air injection part 5, for example, an elastic body (for example, rubber, elastomer, etc.) that can be pierced with an injection needle can be suitably employed. The shape of the air injection part 5 in that case is a columnar shape, a flat plate shape, or the like, and is not particularly limited. Moreover, the attachment method can also employ | adopt well-known methods, such as adhesion | attachment and welding suitably. In addition, the structure which provided the air inlet using the peripheral part of the bag main body 2, and was equipped with the check valve in the inlet may be sufficient. In addition, when an elastic body is employ | adopted as the air injection | pouring site | part 5, it is preferable that the said elastic body is comprised by the three-dimensional structure by the hard port etc. Thereby, it can prevent that a hole is opened in the flexible bag 1 at the time of piercing operation of an injection needle.

For example, an elastic body (for example, rubber, elastomer, or the like) that can be pierced with an injection needle can be suitably used as the gas collection portion 6, for example, as in the preferred example of the air injection portion 5.
The air discharge part 7 has a configuration in which an air discharge port is provided using the peripheral edge of the bag body 2 and a check valve 8 is provided at the discharge port, as in the other examples of the air injection part 5. May be.
In addition, said gas collection | recovery site | part 6 and air discharge site | part 7 are not an essential structure. For example, even if the gas collection part 6 is omitted, the gas in the space 10 of the bag body 2 can be collected through the air injection part 5 and the air discharge part 7. Even if the air discharge part 7 is omitted, the air can be discharged from the air injection part 5 with an injection needle or the like.

Next, as shown in FIG. 1B, the test object 9 is accommodated in the flexible bag 1. As the test object 9, for example, various things such as a gas cylinder and a vial containing a volatile drug can be used.
Next, after closing the sealing port 4 of the flexible bag 1, as shown in FIG. 1C, the air in the space 10 of the bag body 2 is expelled. In this embodiment, after closing the sealing port 4, the bag body 2 is pressed by the palm of the hand and air is discharged from the air discharge portion 7. The air can be discharged by other methods. For example, after the test object 9 is put in the flexible bag 1, the sealing port 4 may be closed while pushing out the bag body 2 with a palm to expel air. Alternatively, the test object 9 may be placed in the flexible bag 1 and the sealing port 4 may be closed, and then an injection needle may be inserted into the air injection site 5 and air may be sucked out with a syringe.

  Next, as shown to FIG. 1D, a fixed amount of air is inject | poured from the air injection | pouring site | part 5, and the gas of the space part 10 of the bag main body 2 is made uniform. For example, an injection needle of a syringe containing a certain amount of air may be pierced through the air injection site 5 to inject air, and then left for a certain period of time to make the gas uniform, or the flexible bag 1 may be pressed from the outside By doing so, the air in the flexible bag 1 may be agitated to make the gas uniform.

  Next, as shown to FIG. 1E, a fixed amount of gas of the space part 10 of the bag main body 2 which became uniform is extract | collected. For example, as shown in FIG. 1E, the injection needle 12 of the syringe 11 may be pierced through the gas collection site 6 and a certain amount of gas may be sucked while being measured by the scale of the syringe 11. Further, an aspirator such as a pump may be connected to the gas sampling part 6 to the gas sampling part 6 and a certain amount of gas may be sucked from the space 10 by the suction unit.

Next, as shown to FIG. 1F, the density | concentration of the component in the extract | collected gas is analyzed. The analysis method is not particularly limited, and a certain amount of gas collected in FIG. 1E can be put into a sample tube 13 for an analytical instrument and analyzed with a known analytical instrument suitable for the purpose. For example, gas chromatography, mass spectrometry, or a combination thereof can be suitably employed.
Next, a description will be given of the operational effects of this embodiment. For example, as shown in FIGS. 2A and 2B, when comparing a relatively large test object 9 </ b> A and a test object 9 </ b> B that is relatively smaller than the test object 9 </ b> A, in the flexible bag 1. When the test objects 9A and 9B are put in the flexible bag 1, the volume (shaded portion) of the space 10 of the flexible bag 1 containing the test object 9A accommodates the test object 9B. The volume of the space portion 10 of the flexible bag 1 is smaller. Therefore, even if the same amount of gas in the space 10 is collected from this state and analyzed for concentration, the volume of the space 10 serving as a base is different, so the amount of gaseous leakage is accurately compared and quantified. I can't.

  However, according to the method of this embodiment, after putting the test object 9 in the flexible bag 1, the air in the space 10 is once expelled and sealed (FIG. 1C), and then a certain amount of air is injected. Since the gas in the space portion 10 is made uniform (FIG. 1D), the volume of the space portion 10 of the flexible bag 1 can be made substantially constant regardless of the form and size of the test object 9. Therefore, since the leakage amount of the gaseous leakage from the test object 9 can be measured under the same conditions, comparison and quantification of the gaseous leakage can be easily performed. As a result, it is possible to easily compare the degree of leakage of a plurality of test objects 9 having different shapes and sizes, such as the test objects 9A and 9B.

In addition, since the injection (injection) of air (gas) can be performed using the injection needle 12 of the syringe 11 which is a conventional instrument, no special instrument is required and the above quantification method is easily introduced. be able to.
FIG. 3A to FIG. 3F are views for explaining a method for quantitatively determining a gaseous leak according to another embodiment of the present invention in the order of steps. 3A to 3F, the same components as those shown in FIGS. 1A to 1F are denoted by the same reference numerals, and the description thereof is omitted.

In this embodiment, first, as shown to FIG. 3A, the flexible bag 1 is prepared. In this flexible bag 1, the gas collection part 6 is omitted, and an air injection part 5 and an air discharge part 7 are respectively provided at the side end of the bag body 2 on the side of the sealing port 4 and the opposite end thereof. Is provided.
Next, as shown in FIG. 3B, the gas sampling container 14 in which the test object 9 and the lid 17 are attached to the flexible bag 1 is accommodated together. As the gas sampling container 14, for example, the above-described sample tube 13 for an analytical instrument can be suitably used.

Next, after closing the sealing port 4 of the flexible bag 1, the air in the space 10 of the bag body 2 is expelled as shown in FIG. 3C. The air discharging method may be the same as the method described with reference to FIG. 1C described above.
Next, as shown to FIG. 3D, a fixed amount of air is inject | poured from the air injection | pouring site | part 5, and the gas of the space part 10 of the bag main body 2 is made uniform. The method of injecting air to make it uniform may be the same as the method described above with reference to FIG. 1D.

  Next, as shown in FIG. 3E, a certain amount of gas in the space 10 of the bag body 2 that has become uniform is enclosed in a gas sampling container 14. For example, as a first step, the injection needle 16 of the syringe 15 is pierced through the air injection site 5 and a certain amount of gas in the space 10 is sucked while being measured by the scale of the syringe 15. Next, as a second step, with the injection needle 16 pierced through the flexible bag 1 (without removing the injection needle 16), the lid 17 is removed in the space 10 and a certain amount measured by the syringe 15 is removed. Gas is put into the gas sampling container 14.

Next, as shown in FIG. 3F, the mouth of the gas collection container 14 from which a certain amount of gas has been collected is sealed with a lid 17, and the concentration of the components in the gas is analyzed with an analytical instrument (gas chromatography or the like). .
According to the method of this embodiment, after the test object 9 is placed in the flexible bag 1, the air in the space 10 is once expelled and sealed (FIG. 3C), and then a certain amount of air is injected to fill the space. Since the gas in the portion 10 is made uniform (FIG. 3D), the volume of the space portion 10 of the flexible bag 1 can be made almost constant regardless of the form and size of the test object 9. Therefore, since the leakage amount of the gaseous leakage from the test object 9 can be measured under the same conditions, comparison and quantification of the gaseous leakage can be easily performed. Moreover, the gas in the space portion 10 is collected by the gas collection container 14 in the flexible bag 1 (FIG. 3E), and the lid 17 is also detached and attached in the space portion 10 to analyze the gas (FIG. 3F). The gas can be prevented from leaking out of the flexible bag 1 and decreasing in the process from gas sampling to analysis. As a result, since the error between the amount of gas measured by the syringe 15 and the amount of gas put in the gas sampling container 14 can be reduced, comparison and quantification of gaseous leakage can be performed with high accuracy.

4A to 4H are views for explaining a method for quantitatively determining a gaseous leakage according to another embodiment of the present invention in the order of steps. 4A to 4H, the same components as those shown in FIGS. 1A to 1F and 3A to 3F are denoted by the same reference numerals, and the description thereof is omitted.
In this embodiment, first, as shown in FIG. 4A, a flexible bag 1 is prepared. In this flexible bag 1, the gas collection part 6 is omitted, and an air injection part 5 and an air discharge part 7 are respectively provided at the side end of the bag body 2 on the side of the sealing port 4 and the opposite end thereof. Is provided.

Next, as shown in FIG. 4B, the gas sampling container 14 in which the test object 18 and the lid 17 are attached to the flexible bag 1 is accommodated together. As the test object 18, for example, a medicine container (such as a vial) sealed with an elastic sealing body 19 that can be pierced with an injection needle can be suitably employed. The drug 20 accommodated in the test object 18 may be, for example, a volatile drug such as an anticancer drug.
Next, after closing the sealing port 4 of the flexible bag 1, the air in the space 10 of the bag body 2 is expelled as shown in FIG. 4C. The air discharging method may be the same as the method described with reference to FIG. 1C described above.

Next, as shown in FIG. 4D, a certain amount of air is injected from the air injection portion 5. For example, the injection needle 22 of the syringe 21 is pierced into the air injection site 5, and a certain amount of air is injected while being measured with the scale of the syringe 15.
Next, as shown in FIG. 4E, the medicine 20 is collected from the test object 18 using the syringe 15 used for air injection. For example, while the injection needle 22 is pierced through the flexible bag 1 (without removing the injection needle 22), the object 18 is grasped through the flexible bag 1 and the injection needle 22 is inserted into the elastic sealing body 19. Pierce. Next, a certain amount of the medicine 20 in the test object 18 is sucked while being measured by the scale of the syringe 21.

Next, as shown to FIG. 4F, the injection needle 22 is extracted from the elastic sealing body 19 and the air injection | pouring site | part 5, and it passes for a fixed time, and makes the gas of the space part 10 uniform.
Next, as shown in FIG. 4G, a certain amount of gas in the space 10 of the bag body 2 that has become uniform is sealed in the gas sampling container 14. For example, as a first step, an injection needle 24 of a syringe 23 different from the syringe 21 used for collecting the medicine 20 is pierced through the air injection site 5 and a certain amount of gas in the space 10 is measured with the scale of the syringe 23. While sucking up. Next, as a second stage, with the injection needle 24 pierced through the flexible bag 1 (without removing the injection needle 24), the lid 17 is removed in the space 10 and a certain amount measured by the syringe 23 is removed. Gas is put into the gas sampling container 14.

Next, as shown in FIG. 4H, the mouth of the gas sampling container 14 from which a certain amount of gas has been collected is sealed with a lid 17, and the concentration of the components in the gas is analyzed with an analytical instrument (gas chromatography or the like). .
According to the method of this embodiment, after putting the test object 18 in the flexible bag 1, the air in the space portion 10 is once expelled and sealed (FIG. 4C), and then the space portion into which a certain amount of air has been injected. After the medicine 20 is collected at 10 (FIGS. 4D and 4E), the gas in the space 10 is made uniform after a certain period of time (FIG. 4F). Therefore, the volume of the space portion 10 of the flexible bag 1 can be made substantially constant regardless of the form and size of the test object 18. Therefore, since the leakage amount of the gaseous leak when collecting the medicine 20 from the test object 18 can be measured under the same conditions, the comparison and quantification of the gaseous leak can be easily performed.

  In the first place, with the conventional method, it is impossible to measure the amount of leakage of gaseous leakage at the time of drug collection operation, but using the method of this embodiment, for example, a relatively thick injection needle, When the medicine 20 is collected with a thin needle and an intermediate thickness needle, it is possible to accurately determine which syringe needle is likely to generate a gaseous leak. Further, it is very useful for discriminating the type of the elastic sealing body 19 in which a gaseous leak is easily generated or hardly generated.

  Further, in this embodiment, the gas in the space portion 10 is collected in the gas collection container 14 in the flexible bag 1 (FIG. 4G), and the lid 17 is also detached and attached in the space portion 10 to analyze the gas. Therefore (FIG. 4H), it can suppress that gas leaks out of the flexible bag 1 in the process from gas collection to analysis, and the quantity decreases. As a result, since the error between the amount of gas measured by the syringe 23 and the amount of gas put in the gas sampling container 14 can be reduced, comparison and quantification of gaseous leakage can be performed with high accuracy.

As mentioned above, although embodiment of this invention was described, this invention can also be implemented with another form.
For example, as shown in FIG. 5, the flexible bag 1 may further include at least one glove-like finger insertion portion 25 formed inward of the bag body 2. As shown in FIG. 5, the finger insertion portion 25 may be integrally formed by using a part of the bag body 2, or by processing the bag body 2, Gloves may be provided later on.

  Thereby, since it becomes easy to hold | maintain the container (For example, test object 9,18, the gas sampling container 14, etc.) accommodated in the bag main body 2, when quantifying a gaseous leak, When the necessity to hold | maintain the gas collection container 14 grade | etc., Arises, the workability | operativity can be improved. Moreover, if the finger insertion part 25 is integral with the bag main body 2, since the joint of the finger insertion part 25 and the bag main body 2 can be eliminated, it can prevent that gas leaks from such a joint. .

Although not shown, when two rail fasteners 3 are provided to increase the sealing degree of the flexible bag 1 and the space between the two rail fasteners 3 is used as a buffer space, the gas sampling container 14 is taken out. In addition, once confined in the buffer space, it is possible to suppress leakage of the leaked material in the flexible bag 1 as much as possible.
In addition, various design changes can be made within the scope of matters described in the claims.

DESCRIPTION OF SYMBOLS 1 Flexible bag 2 Bag main body 3 Rail fastener 4 Sealing port 5 Air injection | pouring site | part 6 Gas sampling part 7 Air discharge | emission part 8 Check valve 9 Test object 9A Test object 9B Test object 10 Space part 11 Syringe 12 Injection needle DESCRIPTION OF SYMBOLS 13 Sample tube 14 Gas collection container 15 Syringe 16 Injection needle 17 Cover 18 Test object 19 Elastic sealing body 20 Drug 21 Syringe 22 Injection needle 23 Syringe 24 Injection needle 25 Finger insertion part

Claims (8)

Putting a test object in a transparent flexible bag having an air injection site, and sealing the state in which the air in the space of the flexible bag is expelled;
Injecting a certain amount of air from the air injection site to make the gas in the space uniform;
Collecting a certain amount of gas in the space portion that has become uniform;
And a step of analyzing the concentration of components in the collected gas. Putting a test object and a gas sampling container in a transparent flexible bag provided with an air injection site, and sealing in a state in which the air in the space of the flexible bag is expelled;
Injecting a certain amount of air from the air injection site to make the gas in the space uniform;
Enclosing a certain amount of gas in the space portion that has become uniform in the gas sampling container;
Analyzing the concentration of the component in the gas sealed in the gas sampling container. A flexible bag used in the quantitative method according to claim 1 or 2,
A flexible bag, wherein the air injection portion includes an elastic body provided on a wall of a bag body of the flexible bag and capable of being pierced with an injection needle.   The flexible bag according to claim 3, wherein the bag body is made of a hardly adsorbing plastic.   The flexible bag according to claim 3 or 4, further comprising at least one finger insertion portion formed inward of the bag body.   The flexible bag according to claim 5, wherein the finger insertion portion is integrally formed using a part of the bag body. A drug container that is sealed with an elastic sealing body that can be pierced with an injection needle as a test object in a transparent flexible bag having an air injection portion made of an elastic body that can be pierced with an injection needle. Putting and sealing in a state in which the air in the space of the flexible bag is expelled;
The injection needle of a syringe containing a certain amount of air is pierced through the air injection site, a certain amount of air is injected into the flexible bag, and then the injection needle is further elastically sealed in the drug container. After performing an operation of piercing the body and collecting the medicine in the medicine container, the injection needle is removed from the elastic sealing body and the air injecting portion, and the gas in the space portion is made uniform after a certain period of time. And the process of
Collecting a certain amount of gas in the space portion that has become uniform;
And a method of analyzing the concentration of components in the collected gas, and a method for quantifying a gaseous leak during a drug collecting operation from a drug container.   The gas according to claim 7, wherein in the step of collecting a certain amount of gas in the space in the flexible bag, a gas collection container accommodated in the flexible bag is used together with the medicine container. Quantitative method for spilled material

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