JPH02258325A - Manufacture of plastic container stopper for liquid transfusion - Google Patents

Abstract

PURPOSE:To manufacture easily and prevent chemical liquid from getting polluted by cuttings at the time of sticking by using a rubber stopper manufactured by integrally laminating specified super-molecular weight PC films at the time of vulcanization molding and integrating with a stopper constituting body mechanically and airtightly. CONSTITUTION:A rubber stopper 14 is manufactured by overlapping super-high molecular weight PC film 15 of 2 million to 5 million molecular weight, and the melting point of 130 - 140 deg.C equivalent to rubber vulcanizing temperature or lower, and density of 0.93 - 0.94g/cm<3> and a rubber such as IR, BR, IIR or EPT, compression molding at the rubber vulcanizing temperature of 140 - 185 deg.C and integrally laminating by one vulcanization molding without using a bonding agent. A stopper 10, consisting a top cover section of PE cylindrical stopper main body 13 and a disc-shaped rubber stopper 14 with the film 15 as its inner surface fusion welded to said cover, covers the rubber stopper 14 and the outer surface of the cylindrical main body 13 and compresses the rubber stopper 14 to strengthen elasticity, which welds a PC cap 16 on the outer periphery of the PC cylindrical stopper main body 13, and the exposed surface of the rubber stopper 14 formed a surface where an injection needle such as bottle needle is stuck. Content of chemical liquid can be sealed and retained by said arrangement, and the injection needle can easily be stuck and rubber or plastic chip is not mixed into a container.

Description

Detailed Description of the Invention Field of Application This invention is a plastic container for infusions made of polyethylene (hereinafter referred to as PE) or polypropylene (hereinafter referred to as PP) whose opening is sealed and made of a rubber material that can be pierced with a syringe needle. It relates to a container stopper having a stopper and a method for manufacturing the same, and in particular, to mechanically and airtightly integrate the stopper structure with a rubber stopper in which a specific ultra-high molecular weight PE film is laminated and integrated during vulcanization molding. The present invention relates to a plastic container stopper for infusions that is easy to manufacture and prevents contamination of drug solutions by cuttings during piercing, and a method for manufacturing the same.

Conventional technology The conventional structure of a plastic container stopper for infusion is PE,
A resin that can be welded and sealed to the opening of a container such as PP using methods such as heat or ultrasonic waves, and a plug structure that is usually made of the same resin as the container, has a disc shape that can be pierced with a syringe needle, or It has a built-in rubber stopper with a circular shape with a rim, that is, one side of the rubber stopper is exposed to the outside and the other side is sealed inside the container by fitting it together or loading it into a mold. It is constructed by injection molding, so-called insert molding.

The rubber stopper used for the stopper is usually made of a rubber material that passes the Japanese Pharmacopoeia infusion rubber stopper test method and has a low eluate content. For example, isoprene rubber (hereinafter referred to as IR)
, butadiene rubber (hereinafter referred to as BR), butyl rubber (hereinafter referred to as IIR), ethylene propylene rubber (hereinafter referred to as EP)
) and so on.

However, such rubber stoppers are mixed with various organic vulcanizing agents, inorganic fillers, and other compounding agents, and there is a risk of contaminating the chemical solution with migratory particles, volatile substances, and eluates.
In order to prevent the rubber stopper from coming into contact with the drug solution in the container, the inside of the stopper is integrated with the plastic stopper component to form a diaphragm to isolate it from the rubber stopper. was. (Unexamined Japanese Patent Publication No. 55-60463, Japanese Utility Model Publication No. 58-41964, Japanese Utility Model Publication No. 59-169
No. 835) Problems with the prior art When using an infusion in a container, it is difficult to pierce the injection needle such as a bottle needle.
That is, the rubber stopper and diaphragm are broken and the bottle is penetrated through the stopper into the container, and a bottle needle with a large diameter, such as a 15G metal needle or a plastic needle, is usually used.

If such a bottle is penetrated by a needle, there is a risk that rubber debris may fall from the rubber stopper and plastic debris may fall from the diaphragm and mix into the drug solution, as the rubber stopper and plastic diaphragm are not laminated and bonded. was there.

In addition, although the diaphragm is manufactured by injection molding, it is difficult to mold a thin one, and the thickness is usually 0.3 mm or more, making it difficult to penetrate with an injection needle, especially when using a plastic needle. For women, it requires a painful amount of penetration force, and improvements were needed.

Purpose of the Invention In view of the current situation, the present invention has been developed to seal and seal the mouth of a plastic container for infusion made of PE or PP so that the medicinal solution contained therein can be stored in a hermetically sealed manner, making it easy to pierce the injection needle during use. The aim is to develop a container closure structure and manufacturing method that prevents rubber and plastic debris from entering the container, and which has a film layer that can have a thickness of 0.1 mm or less, replacing the molded diaphragm that is the same as the conventional closure structure. The purpose is to propose rubber stoppers, container stoppers, and their manufacturing methods.

Summary of the Invention A plug body with a built-in rubber stopper consists of a rubber stopper and a plastic main body, which is welded to the mouth of a plastic container, and has a structure that does not peel off or leak gas or liquid. is necessary.

In order to guarantee the sealing performance of a plastic container filled with a chemical solution using such a stopper, it is meaningless to conduct a destructive test by sampling samples of mass-produced products and evaluate the entire loft based on the results.

In other words, in the case of plastic containers for infusions, it is necessary to guarantee that the entire volume of the mass-produced product has all of the above characteristics, but this guarantee is not achieved through testing, but rather due to errors and variations in the manufacturing method. It is important to adopt a simple and reliable production process.

Therefore, it is thought that if the rubber stopper constituting the stopper body and the stopper component are fused together using the high pressure and melting temperature of injection molding, they will surely become one piece and a uniform product can be produced at all times.

In addition, in the stopper body, the plastic diaphragm in contact with the surface facing the inside of the container of the disc-shaped or circular rubber stopper should be as thin as possible so that it can be easily penetrated by the injection needle. It is desirable that the rubber stopper is laminated with a strong covering so that it will not fall into the container even if it is cut.

In order to laminate a plastic film on the surface of the rubber stopper used for the stopper body, the conventional technique is to roughen the film surface through physical processing such as etching or sputtering, and to use a physical anchoring effect. However, the adhesive strength is insufficient and extra pre-processing is required.

Furthermore, in the method using an adhesive, there is a risk that the adhesive may migrate or the adhesive layer may ooze into the drug solution when it is pierced with an injection needle.

Further, the increase in the number of steps such as pre-treatment of the film and application of adhesive goes against quality control, which is best achieved by obtaining a uniform product using a simple method.

Therefore, the present invention has a plug structure that securely seals with the opening of a plastic container for infusion, and does not contain rubber or plastic when the injection needle is inserted.In other words, the rubber, plastic film, and plastic plug main body are fused and integrated. As a result of various studies aimed at creating a structure with a molecular weight of 2,000,000 to 500,
10,000 non-polar ultra-high molecular weight PE films are subjected to IR at temperatures above their melting point.

It was discovered that low polarity rubbers such as BRlUR and EPT are fused at the same time as the vulcanization reaction, and by using the rubber stopper laminated with this film and performing the above-mentioned insert molding, the above object was achieved, and the present invention. This is the completed version.

Structure of the Invention This invention has a molecular weight of 2 million to 5 million, a melting point of 130 to 140°C below the rubber vulcanization temperature, and a density of 0.93 to 0.94 g.
/ cm3 ultra-high molecular weight PE film and IR, BR,
Layer with rubber such as IIR, EPT, etc. and heat at 140℃ to 185℃
This is a rubber stopper for plastic container stoppers for infusions, which is compression molded at a rubber vulcanization temperature of It is characterized by a plug body using a mass plug.

In other words, the present invention uses PE in the cap of the stopper component when injection molding the cylindrical stopper main body, and uses rubber such as IR, BRlIIR, EPT, etc., in which an ultra-high molecular weight PE film is laminated and integrated during vulcanization molding of the rubber. Load the stopper into the mold with the film inside, and 17
Each plug component and the film are fused at an injection molding temperature of 0 to 250°C to mechanically and airtightly integrate the rubber plug made of ultra-high molecular weight PE film laminated and integrated with the PE plug component. It is a plastic container stopper for infusion liquid, and the P of the stopper is
When injection molding a cylindrical stopper main body inside a P cap, a rubber stopper such as IR, BRlIIR, EPT, etc., in which an ultra-high molecular weight PE film is laminated and integrated during rubber vulcanization molding, is molded with the film inside. Fill the mold with ethylene-propylene copolymer resin or ethylene-propylene copolymer resin and P.
A material mixed and modified with E of 30/70 to 70/30 is injection molded at 170 to 250°C, each stopper structure is fused through the film, and the rubber stopper and each stopper structure are machined. It is a plastic container stopper for infusion fluid that is integrated and airtight.

In this invention, the ultra-high molecular weight PE film has a molecular weight (viscosity method ASTM D2857) of 2 million to 500
10,000, melting point (ASTMD2117); 130-140
°C, density (ASTMD1505); 0.93-0.
Ultra-high molecular weight PE with a crystallinity of 94 g/cm3 and a crystallinity of approximately 62% exhibits flexibility even at temperatures above the melting point of 130-140°C, unlike other thermoplastics. It has a very high viscosity, has only high elasticity and low fluidity, and has an MFR value of almost 0 at 190°C. This resin is manufactured under the trade name Sunfine U.
, manufactured by Asahi Kasei Corporation, HIZEX MILLION, manufactured by Mitsui Petrochemical Company, etc.

To the vulcanization mold for the rubber stopper for the stopper, IR, BR, IIRlE
A low polar rubber compound such as PT and the non-polar ultra-high molecular weight P
Pile and charge films with a thickness of 30 to 150 pm,
When compression molding is performed at a rubber vulcanization temperature of 140 to 185°C, the rubber fills into the mold cavity and softens the film.The film stretches into a shape that fits the cavity, and at the same time softens the film before vulcanization. This causes fusion with the rubber.

When the rubber is vulcanized and removed from the mold, a continuous element of the rubber plug is obtained, one side of which is covered with PE film and strongly fused.This is then individually cut into desired shapes by punching, cutting, etc. By separating the two, a rubber stopper for a stopper can be obtained.

Normally, the main body of the PE stopper is made by injection molding, but for example, when placed in a position that corresponds to the canopy of the mold cavity,
If the rubber plug is loaded so that the film-covered surface meets the injected molten resin, the film and the injected resin will be fused, and after being removed from the mold, the cylindrical plug main body and the rubber plug will be separated. It is possible to obtain a plug body that has high mechanical strength and is fused together in an airtight manner without leakage of gas or liquid.

When the plastic container for infusion is made of PE, if the same PE material is used for the main body of the cylindrical stopper, the opening of the plastic container can be reliably sealed by a welding method such as heat or ultrasonic waves.

If the plastic container is made of PP, ethylene-propylene copolymer or ethylene-propylene copolymer
When a cylindrical stopper main material made of a mixed and modified R of 30/70 to 70/30 is injection molded at a temperature of 170 to 250"C, the cylindrical stopper main body and the film of the rubber stopper are fused together. Moreover, the structure including the rubber stopper and the PP cap can be mechanically and airtightly integrated.

In addition, in this invention, there is the following method for making a cylindrical stopper structure, and as shown in the example, the film of the cylindrical stopper main body and the rubber stopper is fused and integrated, and then taken out from the entire injection molding mold. After that, there is a method in which a separately molded cap is placed on the cylindrical stopper main body and welded by heat or other suitable means at the circular flanges of both the cylindrical stopper main body and the cap.

DISCLOSURE OF THE INVENTION BASED ON THE DRAWINGS Figures a and b of FIGS. 1 and 2 are longitudinal cross-sectional explanatory views showing the manufacturing process of a rubber stopper according to the present invention.

3 to 6 are explanatory longitudinal cross-sectional views of a plastic container stopper for infusion, showing the container stopper according to the present invention.

The rubber plug vulcanization mold shown in Figures 1 and 2 consists of an upper mold and a lower mold, which are vulcanized and compression-molded into a cavity of the desired shape to sandwich a rubber sheet and form a rubber plug. It is something to do.

For example, in the case of Fig. 1a, there is a flat upper mold (1) and a lower mold (2) in which a large number of required circular cavities (3) are arranged, and in the case of Fig. 2a, there are respective predetermined cavities ( 7X9
) A rubber sheet (4) and the ultra-high molecular weight PE film (5) having a thickness of 30 to 150 pm, preferably 50 to 1100 pm are placed between the upper mold (6) and the lower mold (8) having .

At this time, the ultra-high molecular weight PE film (5) is placed on the side of the rubber stopper of the product that comes into contact with the chemical solution.

The mold (IX2X6X8) is preferably heated to the rubber vulcanization temperature in advance, but this film (5) is
At a rubber vulcanization temperature of 0 to 185°C, the rubber retains its elasticity and softens, but does not melt or burst.

Next, the upper mold (IX6) and lower mold (2X8) filled with the film (5) and the rubber sheet (4) are placed in a compression press.
The rubber is heated and pressure molded at a temperature of 140 to 185° C. and a pressure of about 30 to 80 kg/cm 2 , preferably about 40 kg/cm 2 for a vulcanization time of 3 to 10 minutes.

After vulcanization, when taken out from the mold, a continuous element of rubber plug is obtained, as shown in FIGS. ) Rubber (4) is welded and covered with such strength that it cannot be peeled off by external force.

This continuous element of the rubber stopper can be individually separated and finished by a suitable method such as punching or cutting to obtain a rubber stopper for the stopper.

The ultra-high molecular weight PE film used does not require any pre-treatment such as adhesive application, etching or sputtering.
Any material that maintains a clean surface free of oil, fat, dust, etc. is fine.

The material of the rubber stopper is low polarity IR, BR, IIR1EP.
It is desirable that the material be made of I' and have a composition with a low amount of impurity elution that passes the Japanese Pharmacopoeia's rubber stopper test method for infusions.
Examples of formulations are shown in Tables 1 and 2.

Margin below Table 1 Table 2 Examples of the plug according to the present invention will be explained below.

The plug body (10) shown in FIG.
) A disk-shaped rubber stopper (14) is fused to the canopy of the cylindrical stopper (14) with an ultra-high molecular weight PE film (15) on the inner surface, and further covers the outer surface of the rubber stopper (14) and the cylindrical stopper main body (13). In order to compress the rubber plug (14) and strengthen its elasticity, a PE cap (16) is welded to the outer periphery of the PE cylindrical plug main body (13). The combination of the cylindrical stopper main body and the cap constitutes a structural body.

This cap (16) supports the outer surface along the outer periphery of the rubber stopper (14), and the diameter of the rubber stopper (14) is 2 to 8.
It is preferable that the rubber stopper (14) has a dimension that compresses toward the center of the circle, and the outer surface of the central portion of the rubber stopper (14) near the center of the circle is exposed. The exposed surface of this rubber stopper (14) becomes a surface through which an injection needle such as a bottle needle is pierced.

In addition, the bottom of the cap (16) becomes a circular flange with an enlarged diameter, and the same part forms the mouth edge (12) of the container (11).
It is welded by heat, ultrasonic heating, etc.

The surface of the rubber stopper (14) facing the inside of the stopper is made of ultra-high molecular weight P.
E film (15) is coated, and the film (15) is fused to the cylindrical plug main body (13) by insert molding, and the cylindrical plug main body (13) is also fused to the cap (16), and all parts are machined. It is integrated in an airtight manner.

When the stopper (10) having such a configuration is used for infusion, etc., a syringe needle such as a bottle needle is pierced through the central exposed surface of the rubber stopper (14), and the rubber stopper (14) and the ultra-high molecular weight PE film are inserted. (15
) into the inside of the stopper.

At this time, the film (15) is torn, but since the film (15) is covered and welded to the surface of the rubber stopper (14), the chips will not fall into the container. In addition, the top surface of the rubber stopper (14) may be scraped by the injection needle and rubber debris may be generated.
The film (15) prevents rubber debris from falling into the container.

The plug shown in Figures 4, 5, and 6 (20X30X40
) are all equivalent to the configuration shown in Figure 3 above, and PE
PE cylindrical plug main body (23X33X) for sealing the mouth of a plastic infusion container (21X31X41)
43) A rubber plug (
24X34X44) and cap (26X36X46)
) with the outer periphery fixed.

In the case of FIG. 4, the shape of the rubber stopper (24) is a cross-shaped cross section with a circular edge, and the exposed surface forms the same flat surface as the cap (26).

In the case of FIG. 5, the rubber stopper (34) in a circular shape with a rim fits into the cylindrical main body (33) and the cap (36), and the bottom of the cylindrical main body (33) has a circular flange with an enlarged diameter, which forms the rim of the container (31) (
32) and are welded by heat, ultrasonic heating, or other methods.

Next, a method for manufacturing the plug shown in FIGS. 3 to 5 will be described in detail.

PE cap (16cm) pre-molded by regular injection molding
Ultra-high molecular weight PE film (15X25)
A rubber stopper (14 x 24 x 34) laminated with a rubber plug (14 x 24 x 34) is fitted into the opening position as shown.

Next, this fitted body was attached to each cylindrical plug main body (13×23
X33) is inserted into an injection mold with a cavity that can be molded, and from a gate positioned according to the mold structure, a high-density PE such as Mitsubishi Yuka UJ 990, density 0 is inserted.
．． 937g/cm3, melting point 127℃ MFR35g/10
m1n is injection molded into a cavity at a temperature of 190° C. to 250° C. to produce a cylindrical plug main body (13×23×33).

Through this insert molding, a rubber stopper (14 x 24 x 34) and an ultra-high molecular weight PE film (15
X25X35), PE cap (16X26) (36
) are fused and integrated by the cylindrical plug main body (13 x 23 x 33).

If the plastic container is PE, a PE cap (16
(26 x 36) and the cylindrical main body (13 x 23 x 33) may be the above PE.

If the plastic container is PP, the main body is a cylindrical stopper (13X2
3X33) is an ethylene-propylene copolymer resin (e.g. Mitsubishi Yuka 8400, melting point 150°C, MFR 17g/1
0mln) or PE (e.g. Mitsubishi Yuka UJ 990) and ethylene-propylene copolymer resin (e.g. Mitsubishi Yuka 8400) at 30/70 to 70/3.
A PE cap (
By using 16X26>(36), each member can be welded and integrated.

To explain the manufacturing method of the plug body (40) shown in FIG.
4) into an injection molding mold having a cavity that forms the cylindrical plug main body (43), and the rubber plug (44), ultra-high molecular weight PE film (45), and tube are formed by the injection molding described above. The shaped main body (43) is fused and molded together.

This composite body is made of PE pre-fabricated using a normal injection molding method.
Extrapolate the manufactured cap (46).

Thereafter, the flange formed at the lower part of the cylindrical plug main body (43) and the cap (46) are fused together by a secondary processing method such as an ultrasonic welding method.

In this case, whether the plastic container (41) is PE or P
Depending on whether P is used or not, the material of the cylindrical plug main body (43) is adjusted in the same manner as in the previous embodiment.

[Brief explanation of drawings]

Figures a and b in Figs. 1 and 2 are longitudinal sectional views showing the manufacturing process of the rubber stopper according to the present invention. 3 to 6 are explanatory longitudinal cross-sectional views of a plastic container stopper for infusion, showing the container stopper according to the present invention. 1.6...upper mold, 2,8...lower mold, 3,7.9...
・Cavity, 4...Rubber sheet, 5...Ultra high polymer jtPE film, 10.20,30,40...Plug body, 11,21,31.41...Container, 12.22,3
2.42... Mouth rim, 13, 23, 33.43...
Cylindrical plug main body, 14.24, 34.44...Rubber plug,
15,25,35.45...Ultra high molecular weight PE film, 16,26,36.46...Cap.

Claims (1)

[Scope of Claims] 1. In order to seal the opening of a plastic container for infusion made of PE, a rubber stopper such as IR, BR, IIR, EPT, etc. that can be pierced with a syringe needle is used with a PE cap and a cap made of PE. The plastic container stopper for infusion, which is placed between the PE cylindrical stoppers that are welded inside, has a molecular weight of 2 million to 5 million, a melting point of 130 to 140°C, which is below the rubber vulcanization temperature, and a density of 0.93. ~0.94g/c
1. A plastic container stopper for infusions, characterized in that the rubber of the rubber stopper and each of the above-mentioned stopper components are welded and integrated without an adhesive by sandwiching an ultra-high molecular weight PE film having a property of m^3. 2. Molecular weight is 2 million to 5 million, melting point is 130 to 140°C below the rubber vulcanization temperature, and density is 0.93 to 0.94 g/c.
A rubber stopper for a plastic container stopper for infusions, characterized in that it is made of rubber such as IR, BR, IIR, EPT, etc., which is made by laminating an ultra-high molecular weight PE film of m^3 during rubber vulcanization molding. 3. Molecular weight is 2 million to 5 million, melting point is 130 to 140°C below the rubber vulcanization temperature, and density is 0.93 to 0.94 g/c.
m^3 ultra-high molecular weight PE film, IR, BR, II
Rubbers such as R, EPT, etc. are layered and compression molded at a rubber vulcanization temperature of 140°C to 185°C, and the ultra-high molecular weight PE film is laminated and integrated in one vulcanization molding without using adhesives. A method for manufacturing a rubber stopper for a plastic container stopper for infusion. 4. Rubber stoppers such as IR, BR, IIR, and EPT, in which PE is used in the cap of the stopper component and the main body of the cylindrical stopper is injection molded, and an ultra-high molecular weight PE film is laminated and integrated during rubber vulcanization molding. was loaded into a mold with the film inside, and 17
Each plug component and the film are fused at an injection molding temperature of 0 to 250°C to mechanically and airtightly integrate the rubber plug made of ultra-high molecular weight PE film laminated and integrated with the PE plug component. 2. The method for manufacturing a plastic container stopper for infusion according to claim 1. 5. To seal the opening of a plastic container for infusion made of PP, a rubber stopper such as IR, BR, IIR, EPT, etc. that can be pierced with a syringe needle is attached to a PP cap and a tube welded inside the cap. In the plastic container stopper for infusion disposed between the cylindrical stopper main bodies, the cylindrical stopper main body is made of an ethylene-propylene copolymer resin or a material obtained by mixing and modifying the copolymer resin and PE in a ratio of 30/70 to 70/30, Laminated and integrated on the required surface of the rubber stopper, the molecular weight is 2 million to 5 million and the melting point is 130 to 140, which is below the rubber vulcanization temperature.
℃, and a density of 0.93 to 0.94 g/cm^3, and the rubber of the rubber stopper and each of the above-mentioned stopper components were welded and integrated without an adhesive. A plastic container stopper for infusions characterized by: 6. When injection molding the main body of the cylindrical stopper inside the PP cap of the stopper, use rubber stoppers such as IR, BR, IIR, and EPT, which are made by laminating an ultra-high molecular weight PE film during rubber vulcanization molding.
A mold is loaded with the film inside, and a material obtained by mixing and modifying ethylene-propylene copolymer resin or ethylene-propylene copolymer resin and PE in a ratio of 30/70 to 70/30 is injection molded at 170 to 250°C. Claim 5, characterized in that the rubber stopper and each stopper structure are mechanically and airtightly integrated by welding each stopper structure through the film.
The method for producing the plastic container stopper for infusion described above.