JPH11244356A - Method for making ampul - Google Patents

Abstract

PROBLEM TO BE SOLVED: To easily form an outlet for use and to give transferability and heat deformation resistance by forming a projection at a belly section or a shoulder section made of a fixed form blow-molding resin and by forming an outlet for a medical fluid after cutting the projection. SOLUTION: After filling a medical fluid from an upper opening, an ampul 1 is formed with a fixed form blow-molding resin for sealing the opening. A projection 11 is formed at a shoulder section of the ampul 1. When the projection 11 is cut out, an outlet 12 for a medical fluid for use is formed. A projecting loop section 13 is provided around the outlet 12, and a seal member 14 is attached as a lid member to liquid-tightly cover the outlet 12. Thereby it is easy to form, to seal, and to open the outlet 12.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for producing a plastic ampule, and more particularly, to a method for producing an ampule which is subjected to high-pressure steam sterilization and contains a liquid medicine for injection in a liquid-tight manner. It is about.

[0002]

2. Description of the Related Art Generally, ampules are made of glass. The ampoule is molded from a cylindrical tube and the molding is sealed at one end to the bottom, consisting of a body, shoulder, neck, and a sealed tip of the fill opening. And the conveyance, filling and sealing lines in the production of ampules are automated. Recently,
The glass ampule has a problem that glass fragments are mixed in from the neck when the ampule is opened. Further, glass ampules are easily broken, and there is a problem that safety during transportation and handling is lacking. Further, there is a problem that it takes time to dispose after use. Therefore, commercialization of plastic ampules has recently been expected.

[0003]

However, if a plastic ampule is to be adapted to a conventional glass ampoule production line for transporting, filling, and sealing, the following problems occur. When using the ampoule, it is necessary to open the upper sealed opening. Providing an easy-open mechanism at the mouth involves difficulties on the production line. It is also desirable that the body of the plastic ampule be cylindrical, like the glass ampule. Causes trouble. On the other hand, after filling the ampoule with the chemical solution, the filling port is sealed. Then, the ampule is subjected to high-pressure steam sterilization. However, during the high-pressure steam sterilization process, the plastic ampule has a positive pressure / negative pressure relationship between the inside of the ampule and the inside of the sterilizer. However, there is a problem that the ampule does not take the form of a product. Accordingly, an object of the present invention is to provide a method for manufacturing a plastic ampule that can easily provide an outlet when the ampule is used and has transportability and heat-resistant deformation resistance.

[0004]

According to the present invention, there is provided a method for producing an ampoule comprising a blow-resin molded article having a fixed shape, wherein a chemical solution is filled from an upper opening and the opening is sealed, and a body of the molded article is formed. An object of the present invention is to provide a method for producing an ampoule, wherein a projecting portion is formed on a portion or a shoulder portion, and the projecting portion is cut to be used as an outlet for the above-mentioned chemical solution at the time of use.

[0005] The blow resin molded product may be a direct blow molded product or an injection blow molded product.
The blow port of the molded product is formed of an opening filled with a chemical solution, and is sealed after filling with the chemical solution. As the resin material for blow molding, general-purpose resins such as polyolefin resin, vinyl chloride, vinylidene chloride resin, polyester resin, polyvinyl alcohol resin, polyacrylonitrile resin, polyacrylic acid resin, and polyamide resin are used. Further, the resin container may be formed in a single layer or a multilayer. The innermost layer that comes into contact with the drug in the container is preferably a resin layer that does not affect the contained liquid and does not generate elutes. As such a resin, a polyolefin-based resin is desirable, and examples thereof include low-, middle-, and high-density lower-grade olefin resins such as polyethylene and polypropylene.

The thickness of the body wall of the blow molded product is 0.5 to 5.
It is desirable to be in the range of 0 mm. When it is in the above range, the moldability is sufficiently exhibited, and the gas barrier property can be enhanced. If the body wall has a fixed shape, handling during use is safe and the transfer operation to a syringe or the like becomes easy.
In addition, if the gas barrier property of the body wall is high, the solution in the ampoule is prevented from being deteriorated by oxygen or the like permeating from the outside during storage. The opening of the blow molded product is sealed in a production line after filling with a chemical solution. In particular, in the case of sealing, a conventional glass ampule sealing line can be used, which is preferable. The chemical solution filled through the opening is subjected to steam sterilization after sealing, and thus is surely sterilized. Steam sterilization is performed at a temperature of 100 ° C to 140 ° C, especially 105 ° C to 1 ° C.
It is desirable to perform steam sterilization at a temperature of 15 ° C. At a sterilization temperature below the above range, it takes time and sterilization may be insufficient. On the other hand, if the sterilization temperature is higher than the above range, the molded product is undesirably deformed by heat or deteriorated by heat.

[0007] The above-mentioned blow-resin molded article forms a projection on its body or shoulder during molding and cuts the projection. Since the formation of the projection is performed at the same time as the blow molding, it can be made extremely simple. Then, when the projection is cut, a through hole can be formed in the wall surface of the trunk or the shoulder, and this can be used as an outlet. Therefore, in such a manufacturing method, a boring process can be easily performed on the body or shoulder of the ampoule container body, and such a portion can be used as a discharge port. Then, by attaching a sealing lid made of a peelable lid or a plug to the outlet, an easy-opening mechanism can be easily attached, and the conventional filling and filling can be performed.
It can be put on the manufacturing process.

According to a second aspect of the present invention, in the method for producing an ampoule according to the first aspect, a projecting annular portion is provided around the discharge port, and a peelable lid material is attached to the annular portion. The outlet is liquid-tightly covered. The peripheral surface of the outlet is a cut surface of the protruding portion, and a lid material (such as a resin sheet) can be removably attached to such a portion, and should be liquid-tight enough to withstand high-pressure steam sterilization. Can be. Further, in order to safely maintain the bonding state between the lid member and the peripheral surface, it is desirable to further form the above-mentioned annular portion around the periphery. That is, when the top surface of the annular portion of the lid member and the container wall is provided as a contact adhesive portion with the lid material and the double-sided attaching surface is provided, safety during high-pressure steam sterilization is enhanced. Further, the formation of the annular portion on the container wall can be easily formed at the time of blow molding.

According to a third aspect of the present invention, in the method for producing an ampoule according to the first or second aspect, the shoulder and the bottom of the body of the molded product are formed in a cylindrical shape, and the center of the body is formed. The portion is formed in a rectangular cylindrical shape, and the corner at the central portion of the rectangular cylindrical shape is formed to be angular so as to fit within the cylindrical outer diameters of the shoulder and the bottom. The above-mentioned blow-resin molded product has a shoulder portion and a bottom portion in the body portion formed in a cylindrical shape, and a central portion in the body portion formed in a square tube shape. The central portion may be a square tube, a hexagonal tube, an octagonal tube, or another polygonal tube. The central cylindrical corner is angular so as to fit within the outer diameter of the shoulder and the bottom of the cylinder. Then, the ampoule body itself is made of a fixed-shaped blown resin molded product. The central part of the above-mentioned square tube is 1
/ 5 or more, particularly preferably in the range of 1/3 to 4/5. Within the above range, thermal deformation of the trunk itself during high-pressure steam sterilization can be prevented.

In the method for manufacturing the ampoule thus formed, since both ends of the body have a cylindrical shape, the rollability and the alignment can be maintained. Can be adapted. On the other hand, at the time of high-pressure steam sterilization, if the entire body is cylindrical, a part of the body can be easily deformed. This is often found in containers of polyolefin resins such as polyethylene and propylene. However, since the central portion of the trunk is a polygonal tube as in the ampoule according to the present invention, even if some tension occurs in the trunk wall at the time of heating, when the temperature returns to room temperature, it differs from the cylindrical shape, and the normal trunk Return to the wall, do not lose its commercial value, and increase its mechanical strength.

[0011]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, preferred embodiments of the method for producing an ampule according to the present invention will be described in detail with reference to the accompanying drawings. FIG. 1 is a front view of an ampule used in the method for producing an ampule according to the first embodiment. FIG. 2 shows I- of the ampoule of the first embodiment.
It is sectional drawing along the I line. FIGS. 3A and 3B are side sectional views showing a step of forming a discharge port of the ampule of the first embodiment. FIGS. 4 and 5 are cross-sectional views showing a modification of the trunk portion of the first embodiment.

As shown in FIGS. 1 to 3, an ampoule 1 in an ampoule manufacturing method according to the present embodiment is filled with a chemical solution 3 from an upper opening 2 and the opening 2 is sealed. Consists of A protrusion 11 is formed on the shoulder of the molded product of the ampoule 1, and the protrusion 11 is cut to form the outlet 12 for the chemical solution 3 at the time of use. A projecting ring 13 is provided around the outlet 12, and a peelable sealing material (lid material) 14 is attached to the ring 13 to cover the outlet 12 in a liquid-tight manner. Shoulder 5 in body 4 of the molded article
And the bottom portion 6 is formed in a cylindrical shape, and the central portion 7 in the body portion 4 is formed in a rectangular cylindrical shape, and the corner 7 in the rectangular cylindrical central portion 7 is formed.
A is formed to be angular so as to fit within the cylindrical outer diameter A of the shoulder portion 5 and the bottom portion 6. The upper opening 2 is sealed by heating, and the chemical solution 3 is subjected to high-pressure steam sterilization together with the main body.

The method of manufacturing the ampule 1 of this embodiment will be further described. As shown in FIGS. 1 to 3, the main body of the ampule 1 is manufactured by blow molding of polypropylene. The blow molded product is formed in the shape of a quadrangular cylinder at the center of the body 4, and the shoulder 5
And the bottom part 6 is formed in a cylindrical shape. The protrusion of the corner A of the central portion 7 is formed so as to fit within the cylindrical outer diameter A of the shoulder portion 5 and the bottom portion 6. The average thickness of the wall of the body 4 is 3.0 mm, which has a fixed shape. A protrusion 11 and a ring 13 are formed on the side of the shoulder 5. The chemical solution 3 is filled from the blowout opening 2 of the blow molded product, and the opening 2 is sealed. Next, a discharge port 12 having a diameter of 3 mm capable of communicating with the inside by fusing the protrusion 11 is formed by cutting. Cover the outlet 12 with a sealing material 14,
The sealing material 1 is applied to the cut surface of the periphery of the discharge port 12 and the annular portion 13.
4 is thermally welded so as to be peelable. Thereby, the outlet 12 is sealed. Next, the ampoule 1 is subjected to high-pressure steam sterilization at a temperature of 110 ° C. Then, as shown in FIG. 1, a product of the ampule 1 is obtained.

According to the method of manufacturing the ampoule 1 having such a configuration, high-pressure steam sterilization is performed at the time of manufacturing. In this case, since almost the entire body 4 of the ampoule 1 is formed in the shape of a square tube, even when the ampule 1 is exposed to a negative pressure or a positive pressure against the outside during such processing, the wall of the body 4 is kept Although it may undergo thermal deformation once, it tends to return to its normal shape after processing. For this reason, the deformation due to the processing is smaller than that of the conventional body having a cylindrical shape as a whole, and the commercial value is not impaired. In addition, since the shoulder portion 5 and the bottom portion 6 of the body portion 4 are formed in a cylindrical shape in the transporting and setting process, it can be easily mounted on a conventional glass ampule production line. Therefore, it can be mounted on the production line without any trouble. Further, the filling opening 2 of the chemical solution 3 can be sealed in the same manner as in the conventional ampoule process and placed on a conventional line, and the discharge port 12 can be formed and the discharge port 12 can be easily formed with a sealing material 14 or the like. An opening mechanism can be easily provided. Further, when the seal material 14 is used,
By peeling off, the outlet 12 is easily opened, and the insertion of the injection needle or the like is simplified.

In the above embodiment, the body 7 is a square pillar, but the body 7 may be a hexagonal pillar as shown in FIG. 4, or the body 7 may be an octagonal pillar as shown in FIG. The ampoule thus configured has the same operation and effect as the ampoule 1 of the first embodiment.

[0016]

According to the method for producing an ampoule according to the present invention, a projection is formed on the body or shoulder of the molded product, and the projection is cut and used as an outlet for the chemical solution when used. A discharge port at the time of use of the ampoule can be easily provided, and a plastic ampule having transportability and heat deformation resistance can be manufactured.

[Brief description of the drawings]

FIG. 1 is a front view of a first embodiment of an ampule according to the present invention.

FIG. 2 is a cross-sectional view of the ampule of the first embodiment taken along line II.

FIGS. 3A and 3B are side sectional views showing a step of forming a discharge port of the ampule according to the first embodiment.

FIG. 4 is a cross-sectional view showing a modification of the trunk of the first embodiment.

FIG. 5 is a cross-sectional view showing a modification of the trunk portion of the first embodiment.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Ampoule 2 Opening 3 Chemical liquid 4 Body 5 Shoulder 6 Bottom 11 Projection 12 Outlet 13 Ring section 14 Sealing material

Claims (3)

[Claims] 1. A method of manufacturing an ampoule, wherein a chemical solution is filled from an upper opening and the opening is sealed, and a main body is formed of a blown resin molded product having a fixed shape. A method for producing an ampoule, wherein the ampoule is formed, and the projection is cut to form an outlet for the chemical solution during use. 2. The discharge port according to claim 1, wherein a protruding ring section is provided around the discharge port, and a detachable lid material is attached to the ring section to cover the discharge port in a liquid-tight manner. How to make an ampoule. 3. A shoulder and a bottom of a body of the molded product are formed in a cylindrical shape, and a center of the body is formed in a rectangular tube shape. 3. The method for producing an ampule according to claim 1 or 2, wherein the ampule is formed so as to be angular so as to fit within the outer diameter of the cylinder at the bottom.