JPH07325000A - Device measuring pressure in sealed vessel - Google Patents

Abstract

PURPOSE:To quantitatively and easily measure pressure inside a sealed vessel and to improve the reliability at a quality inspection. CONSTITUTION:The pressure-measuring device 10 measuring pressure in a sealed vessel 2 having a rubber-like elastic part 4, is constituted of a pressure gauge part 11 and a measuring needle part 13 which is inserted into the rubber-like elastic part 4 into the sealed vessel 2 and has a passage communicating the interior of the sealed vessel 2 with the pressure gauge part 11.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a pressure measuring device in a sealed container for measuring the pressure in a vial container as a sealed container containing a freeze-dried product or a liquid.

[0002]

2. Description of the Related Art Conventionally, as shown in FIG. 5, a sealed product 1 in which a lyophilized product or liquid of a drug solution such as an injection or a diagnostic agent is contained in a vial container as a hermetically sealed container is used. It is manufactured through the steps of freezing → vacuum → drying (when it is stored as a liquid, the following steps are performed as a liquid) → repressurization → plugging. Each step will be described below.

In the freezing process, the inside and outside of the hermetically sealed container 2 are in communication with the opening 3 of the hermetically sealed container 2 in which the chemical liquid C is stored, and the rubber stopper 4 as a rubber-like elastic body is in communication. By disposing the thus prepared state in the freeze dryer 5, the chemical liquid C in the sealed container 2 is frozen.

In the vacuum / drying process, the freeze dryer 5 is provided with a vacuum pump 6 as a vacuum device, and the chemical liquid C is supplied by the vacuum pump 6.
Freeze-dried product C ′ is obtained by directly sublimating the water in the frozen state and drying.

In the recompression process, the freeze-dryer 5 is provided with a gas cylinder 7 in order to fill the gas in the sealed container 2 to recompress the gas, and the gas which is set to a desired pressure by the regulator 8 is supplied from the gas cylinder 7. It is filled in the sealed container 2 to restore the pressure.

In the stoppering process, the rubber stopper 4 is completely driven by the stopper 9 so that the rubber stopper 4 in the half-pressed state is sealed.

[0007] The manufacturing technology know-how in the above-mentioned pressure-recovering step may include two points: (1) type of filling gas and (2) setting of pressure of filling gas.

As the filling gas of (1), dehumidified air or inert nitrogen gas is mainly used. Therefore, the filling gas in the hermetically sealed container 2 is evaluated by measuring the dissolved oxygen in the hermetically sealed container 2 using a dissolved oxygen meter by a destructive test on the finished hermetically sealed product. It is quantified and evaluated based on that value.

The pressure setting in the double pressure of (2) includes normal pressure, slightly reduced pressure, complete vacuum and the like. The measurement of the pressure in the sealed container 2 of the freeze-dried product C ′ after the pressure restoration by these pressure settings is very important for obtaining the validation data of the manufacturing process and guaranteeing the quality of the product.

[0010]

However, since a device for directly measuring the pressure inside the hermetically sealed container 2 has not been commercialized, gas filling before sealing the rubber container 4 at the opening 3 of the hermetically sealed container 2 is performed. It was estimated from the measured pressure of the filling gas at that time. There is a problem in that reliability is poor in terms of quality inspection because the measured value in the sealed container 2 of the sealed product 1 thus completed is not a measured value.

The present invention has been made to solve the above-mentioned problems of the prior art, and its object is to make it possible to quantitatively and easily measure the pressure in a sealed container and to perform quality inspection. An object of the present invention is to provide a pressure measuring device in a sealed container which can improve reliability.

[0012]

In order to achieve the above object, according to the present invention, in a pressure measuring device in a sealed container for measuring a pressure in a sealed container having a rubber-like elastic body portion, a pressure gauge And a measuring needle portion that is inserted into the rubber-like elastic body portion facing the inside of the hermetically sealed container and has a passage through which the inside of the hermetically sealed container and the pressure gauge portion communicate with each other.

Further, the rubber-like elastic body portion may be a plug body for closing the opening of the hermetically sealed container constituted by the rubber stopper in a hermetically sealed state.

[0014]

In the pressure measuring device in the hermetically-sealed container having the above structure, the rubber-like elastic body is provided so as to face the hermetically-sealed container with the measuring needle portion having the passage through which the hermetically-sealed container and the pressure gauge portion communicate with each other. Measure the pressure inside the sealed container by inserting it into the chamber. In other words, since the outer peripheral surface of the inserted measuring needle portion is sealed by the elastic force of the rubber-like elastic body portion, the pressure in the sealed container acts on the pressure gauge portion via the passage of the measuring needle portion. The pressure in the sealed container is directly measured by looking at the value on the pressure gauge section at this time.

Further, since the hole of the rubber-like elastic body portion after the measuring needle portion is pulled out after measuring the pressure is closed by the elastic force of the rubber-like elastic body portion, it can be kept in a sealed state.

[0016]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below with reference to illustrated embodiments. First, what is measured by the pressure measuring device in the sealed container according to the embodiment of the present invention will be described with reference to FIGS. 5 and 6. This is a sealed product containing a freeze-dried drug solution or a liquid such as an injection or a diagnostic agent in a vial container as a sealed container. The manufacturing process of this sealed product 1 is the same as that shown in the prior art, and its manufacturing process is as shown in FIG. The process of is performed as a liquid.) → Repressurization → Plugging. Each step will be described below. The same components as those of the conventional technique will be described with the same reference numerals.

First, a description will be given of the hermetically-sealed container 2 forming the hermetically-sealed product 1 and the rubber stopper 4 as a stopper that hermetically closes the opening 3 of the hermetically-sealed container 2 as a rubber-like elastic body. The sealed container 2 has a cylindrical shape with a bottom, a small diameter on the side of the opening 3, and an outward flange portion 3 on the peripheral edge of the end of the opening 3.
Have one. The rubber plug 4 is composed of a plug portion 41 that is press-fitted into the inner periphery of the opening 3 of the sealed container 2 in a sealed state, and a disk portion 42 that is in close contact with the flange portion 31 of the opening 3. The plug portion 41 has a columnar shape and has a slit 43 that opens on the opposite side of the disc portion 42.
It penetrates in the radial direction.

In the freezing step, the stopper portion 41 of the rubber stopper 4 can be communicated with the inside and outside of the hermetically sealed container 2 through the slit 43 at the inner circumference of the opening 3 of the hermetically sealed container 2 in which the chemical solution C is stored. As described above, a so-called half-pressed state of the rubber plug 4 is placed in the freeze dryer 5 to freeze the chemical liquid C in the sealed container 2 (see FIG. 5A).

In the vacuum / drying process, the freeze dryer 5 is provided with a vacuum pump 6 as a vacuum device, and the chemical liquid C is supplied by the vacuum pump 6.
Freeze-dried product C ′ is obtained by directly sublimating water in the frozen state and drying it (see FIG. 5 (b)).

In the pressure regaining step, the lyophilizer 5 is provided with a gas cylinder 7 in order to fill the gas (for example, nitrogen as an inert gas) into the hermetically sealed container 2 to restore the pressure. Then, the gas having a desired pressure is filled in the sealed container 2 to restore the pressure (see FIG. 5C).

In the plugging step, the rubber stopper 4 having a half-punched state is sealed by the plugging machine 9 into the opening 3 of the hermetically sealed container 2 so that the rubber stopper 4 has an inverted T-shape. The disk portion 42 of the rubber stopper 4 is driven in until it comes into close contact with the end face of the outward flange portion 31 of the opening 3 of the sealed container 2 (see FIG. 5D).

The sealed product 1 is manufactured by advancing the steps as described above.

Next, the structure and function of the pressure measuring device for measuring the pressure in the hermetically sealed container 2 constituting the hermetically sealed product 1 provided by the present invention will be described in detail. It should be noted that although illustrated for convenience, the present invention is not limited to the shapes of the device and parts.

FIG. 1 shows a hermetically sealed container 2 according to an embodiment of the present invention.
FIG. 3 is a front view showing a configuration example of a pressure measuring device in a vial container as the above.

A pressure measuring device (hereinafter abbreviated as measuring device) 10 in the sealed container 2 of FIG. 1 includes a pressure gauge portion 11 for measuring and displaying the pressure and a rubber stopper 4 facing the sealed container 2.
An injection needle portion 13 as a measuring needle portion having a passage 12 through which the inside of the sealed container 2 and the pressure gauge portion 11 communicate with each other.
And a joint portion 14 for connecting the pressure gauge portion 11 and the injection needle portion 13.

The pressure gauge section 11 can be used with various scales of pressure gauges, such as a negative pressure type, a positive pressure type, and both pressure ranges, depending on the pressure range to be measured. As the pressure gauge section 11, there is a generally used Bourdon tube pressure gauge as shown in the figure, and the pressure is measured by looking at the scale 11B indicated by the pointer 11A. Of course, the pressure gauge unit 11 is not limited to this Bourdon tube pressure gauge, and may be another pressure gauge such as a bellows type pressure gauge depending on the sealed container to be measured. Further, the display is an analog type in the present embodiment, but the display is not limited to this and may be a digital type.

The injection needle portion 13 has a passage 12 therein for communicating the inside of the sealed container 2 and the pressure gauge portion 11. Further, the injection needle portion 13 passes through the rubber stopper 4 and passes through the sealed container 2
If the sealed container 2 is a vial container as in this embodiment, the thickness is 0.1 to 5 mm, preferably 0.3 to 2 mm. Especially preferably, it is 0.4 to 1.2 mm. As a structure of the tip of the injection needle portion 13, as shown in FIG. 2, the passage 12 is opened by obliquely cutting it.

The joint portion 14 is a nut portion 14 screwed into a screw portion 11C provided on the pressure gauge portion 11.
It is composed of A and a projecting portion 14B provided substantially at the center of one end of the nut portion 14A, and the inner end of the injection needle portion 13 is fixed to the projecting portion 14B. At this time, since the inside of the joint portion 14 and the protruding portion 14B is hollow, the hollow portion and the passage 12 are communicated with each other.

Then, the joint portion 14 is screwed into the thread portion 11C of the pressure gauge portion 11, whereby the injection needle portion 13 and the pressure gauge portion 11 are connected.

Next, a method of using the measuring device 10 having the above structure will be described with reference to FIG.

First, the injection needle portion 13 is pierced and penetrated into the rubber stopper 4 so as to face the inside of the hermetically sealed container 2 of the hermetically sealed product 1. At this time, the outer peripheral surface of the pierced injection needle portion 13 is sealed by the elastic force of the rubber stopper 4 (see FIG. 4B). In this way, by connecting the inside of the sealed container 2 and the pressure gauge part 11 while maintaining the hermeticity of the inside of the sealed container 2, the pressure inside the sealed container 2 is increased through the passage 12 of the injection needle part 13. The pressure in the sealed container 2 is measured by observing the value of the pressure gauge portion 11 at this time.

Further, the hole 15 of the rubber stopper 4 after the injection needle portion 13 is pulled out after measuring the pressure is closed by the elastic force of the rubber stopper 4 (see FIG. 4 (c)).

In the measuring device having the above-mentioned structure, the pressure in the sealed container 2 can be directly measured simply by inserting the injection needle portion 13 into the sealed container 2 and inserting it into the rubber stopper 4. The pressure in 2 can be measured quantitatively and easily.

Since the measurement result is a value obtained by directly measuring the pressure in the sealed container 2, the reliability of the quality inspection is dramatically improved.

Further, after measuring the pressure, the injection needle portion 13
Since the hole 15 of the rubber plug 4 after the removal is closed by the elastic force of the rubber plug 4, it can be kept in a sealed state, and foreign matter such as impurities does not enter the sealed container 2, There is no adverse effect on the sealed product 1.

FIG. 3 shows the structure of the other tip of the injection needle portion. The injection needle portion 13A has a passage 12 inside.
A is a type in which the distal end of the injection needle portion 13A is processed into a conical shape, and the distal end of the injection needle portion 13A is of a lateral hole type. The injection needle portion 13A can prevent the freeze-dried product C ′ from flowing into the passage 12A when the injection needle portion 13A is inserted into the sealed container 2.

In the above-mentioned embodiment, the so-called vial container for accommodating a drug solution or the like is described as an example of the hermetically sealed container 2. However, the hermetically sealed container 2 is not limited to the vial container and may be a hermetically sealed container for accommodating other things. good.

Further, as the rubber-like elastic body, a plug body for closing the opening 3 of the hermetically sealed container 2 constituted by the rubber stopper 4 in a sealed state has been described as an example. It is possible to provide a portion into which the measuring needle portion, which is the injection needle portion 13 of the measuring device, can be inserted in a hermetically sealed container that does not have an opening and is not closed, and that portion can be a rubber-like elastic body portion.

Further, the rubber stopper 4 has been described as an example in which it is press-fitted into the opening portion 3 of the hermetically sealed container 2 by the stoppering machine 9 and hermetically sealed. However, the present invention is not limited to this and the rubber stopper 4 is hermetically capped with a screw. The same thing can be applied.

[0040]

Industrial Applicability The present invention has the above-described structure and operation, and has a rubber-like elastic body so that the measuring needle portion having a passage for communicating the inside of the sealed container and the pressure gauge portion faces the inside of the sealed container. Since the pressure in the sealed container can be measured simply by inserting it into the portion, the pressure in the sealed container can be quantitatively and easily measured.

Moreover, since the measured value is a value obtained by directly measuring the pressure in the sealed container, the reliability of the quality inspection is dramatically improved.

[Brief description of drawings]

FIG. 1 is a front view of a pressure measuring device in a vial container as a hermetically sealed container according to an embodiment of the present invention.

FIG. 2 is an enlarged view of a main part showing a structure of a tip of an injection needle portion of the measuring device of FIG.

FIG. 3 is an enlarged view of a main part showing a structure of a tip of an injection needle portion of another aspect of the measuring apparatus of FIG.

FIG. 4 is a schematic diagram showing how to use the measuring device of FIG. 1, where FIG. 4 (a) shows the injection needle portion before the rubber stopper is pierced, and FIG. 4 (b) shows the injection needle. The figure shows a state in which the part is pierced facing the inside of the vial container.
Shows the state after the injection needle part is pulled out from the rubber stopper.

FIG. 5 is a schematic diagram showing a manufacturing process of a sealed product, wherein FIG. 5A shows a freezing process, FIG. 5B shows a vacuum / drying process, and FIG. c) shows the pressure restoration process, and FIG. 7 (d) shows the plugging process.

FIG. 6 (a) is a perspective view of a rubber plug portion of a hermetically sealed product, and FIG. 6 (b) is a perspective view of the rubber plug portion before the rubber plug is sealed.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Sealed product 2 Sealed container (vial container) 3 Opening 31 Flange part 4 Rubber stopper (rubber-like elastic body part) 41 Plug part 42 Disc part 43 Slit 5 Freeze dryer 6 Vacuum pump 7 Gas cylinder 8 Regulator 9 Closure machine 91 Rubber stopper 10 Pressure measuring device 11 Pressure gauge 11A Pointer 11B Scale 11C Thread 12,12A Passage 13,13A Injection needle (measurement needle) 14 Joint 14A Nut 14B Projection 15 Hole

Claims (2)

[Claims] 1. A pressure measuring device in a hermetic container for measuring a pressure in a hermetic container having a rubber-like elastic body, comprising: a pressure gauge part; A pressure measuring device in a sealed container, comprising: a measuring needle part having a passage that allows the inside of the sealed container to communicate with the pressure gauge part. 2. The pressure measuring device in the hermetically sealed container according to claim 1, wherein the rubber-like elastic member is a stopper that hermetically closes an opening of the hermetically sealed container formed of a rubber stopper.