JPH0663105A - Plug body for infusion with pulltop and method for manufacturing the same - Google Patents

Abstract

PURPOSE:To eliminate pinholes in a score part around a pull-top by previously molding an upperside lid body with the pulltop, inserting therein a laminated rubber plug after inspecting the absence of the pinholes in the score part with an automatic detecting machine or the like and then injection molding a lower side lid body to melt mold integrally with the rubber plug. CONSTITUTION:A plastic film 1 to be laminated and an unvulcanized rubber 2 are put between upper and lower metal molds and heat pressed to make the vulcanized rubber 2' adhere to the plastic film 1 and form a sheet-like laminated rubber plug which is stamped to form the laminated rubber plug 3. An upper side lid body with a pulltop of the plastic outline part of the plug body is prepared by an injection molding method to detect the presence of pinholes in a score part. After the intermediate inspection, the upper side lid body 4 with the pulltop having no pinholes and the laminated rubber plug 3 are inserted and the lower side lid body 8 is formed by the injection molding while the outer part is fixed to the surface of the metal mold, so that a highly air tight, sanitary plug body is obtained even after being pierced by a needle.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an infusion plug with a pull-up stopper, which is applied to the mouth of a plastic container for infusion. According to the present invention, a high quality, highly safe and highly practical plug body that conforms to or conforms to the standards of the plastic container test method for infusion and the rubber stopper test method for infusion according to the 12th revised Japanese Pharmacopoeia Can provide well.

[0002]

2. Description of the Related Art Infusion plugs having an external support made of plastic are those in which the top surface of the plug is made of a rubber stopper, and the upper lid with a pull-up cover already covers the top surface of the plug. There is. The former plug must be fused to the mouth of the plastic infusion container, and then a film or the like must be sealed and fused to the top of the plug. The latter stopper is widely used because it is not necessary to seal and seal the top surface of the stopper with such a film after being fused to the mouth of the plastic infusion container.

Further, the film portion is made of a film or sheet having a thickness of about 0.1 to 0.2 mm for the purpose of preventing coring and cracking from the plastic film portion existing on the lower lid at the time of needle stick. Constituted plug (actual fair 3-19
877), and in the same manner, the membrane portion is made of a film or sheet and has a plug-in plug for infusion (actual open flat plate 3).
-94234).

Further, there is an infusion solution plug body (Japanese Patent Laid-Open No. 2-1275) in which a rubber plug laminated with a plastic film (hereinafter referred to as a laminated rubber plug) is used in place of the film portion of the lower lid. However, Japanese Patent Laid-Open No. 12275/1990 does not disclose a plug for infusion with a pull-up stopper. Furthermore, there is a method of producing a plug for infusion with a pull-up stopper made of a laminated rubber plug (JP-A-3-205141). According to this Japanese Patent Laid-Open No. 3-205141, a laminated rubber plug is fitted into the outer tubular portion at the first stage, and an inner tubular portion is formed at the subsequent second stage to manufacture a plug body integrated with the outer shell. The method is characterized in that the assembly step of the laminated rubber plug and the plastic outer shell is omitted.

[0005]

When using a pull-top, a part of the upper lid layer is designed thin on the top surface of the plug with the root of the pull-top as the base point for the purpose of lowering the opening force. It is designed on the lid. This score part is likely to have pinholes during molding. The presence of pinholes naturally causes the problem of contamination of the infusion solution due to invasion of bacteria. However, only the destructive test can be used for the pinhole inspection of the score part around the plug top with the final finished plug body, and it has been desired to perform an intermediate inspection for the absence of pinholes only in the upper cover with the plug top.

Since the manufacturing method of Japanese Patent Laid-Open No. 3-205141 is characterized by omitting the assembly step as described above, it cannot be inspected in advance that there is no pinhole in the score portion around the push-up.

An object of the present invention is to eliminate the pinhole in the score part around the top-up lid in the upper lid, and to eliminate the membrane part in the lower lid so that coring from the membrane and cracking of the membrane do not occur at the time of needle stick. The present invention provides a plug for infusion with a pull-up, which is made of a laminated rubber plug, and a method for manufacturing the same.

[0008]

SUMMARY OF THE INVENTION According to the present invention, a rubber laminated on at least a part of its surface with a plastic film is attached to an upper lid having a pull-top structure preliminarily inspected for pinholes in the score portion around the pull-up. A gist of a plug body for infusion with a pull-up is characterized in that a stopper is fitted and a lower lid is melt-molded integrally with a laminated portion of a rubber stopper surface and an upper lid.

Further, in order to manufacture the stopper of the present invention, an upper lid having a pull-up structure is molded, and it is inspected that there is no pinhole in the score portion around the pull-up of the upper lid, and then the upper lid. Insert the lid into the mold, then insert the rubber stopper with at least a part of the surface laminated with plastic film into the mold, and finally injection-mold the lower lid to obtain the upper lid.・ The feature is that the laminated part on the surface of the rubber plug and the lower lid are integrated by melt molding.

[0010]

According to the present invention, the upper lid with the pull-up cap is preliminarily formed, and it is preliminarily inspected by an automatic inspection machine or the like that there is no pinhole in the score portion, and a laminated rubber stopper is fitted therein.
After this assembling step, the lower lid is injection-molded to be melt-molded and integrated to obtain a plug top with infusion plug. Therefore, it is possible to confirm that there is no pinhole in the state of only the upper lid with the pull-up, between the above-mentioned upper lid molding and the assembly process, that is,
It is a feature of the present invention that an intermediate inspection can be performed.

[0011]

Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 is an explanatory view of a manufacturing procedure of a laminated rubber stopper according to the present invention, FIG. 2 is an explanatory view of an inspection procedure of an upper lid body with a pull-up according to the present invention, and FIGS. 3 and 4 are sectional views showing an embodiment of the present invention in process order. It is a figure.

(1) Manufacture of Laminated Rubber Plug As shown in FIG. 1 (A), a laminating plastic film 1 and an unvulcanized rubber 2 are provided between an upper mold and a lower mold in which a large number of rubber plug shapes are engraved. 1B, heat and pressure are applied to bond the vulcanized rubber 2'and the plastic film 1 to form a sheet-shaped laminated rubber stopper as shown in FIG. Figure 1
A laminated rubber stopper 3 as shown in (D) is made.

The laminating plastic film used here is polyethylene, polypropylene, a copolymer film thereof, vinyl chloride or the like, and is arbitrarily selected depending on the material of the upper lid and the infusion container.

The surface of the rubber plug to be laminated may be either one surface or the entire surface. The heating / pressurizing conditions are as follows:
165 ° C, time 5-20 minutes, pressure 50-100kg
f / cm ² G.

(2) Molding of upper lid with pull-up and pinhole inspection of score portion In the present invention, the upper lid with pull-up, which is the plastic outer portion of the plug, is injection-molded in the form shown in FIG. 2 (A). Made by. Then, as shown in FIG. 2 (B), electrodes 6 and 7 are brought close to the position of 1 to 2 mm from the score part 5 of the upper lid 4 with the pull-up to apply a high DC voltage of 10 to 20 kv. If there is no pinhole in the score part 5 of the upper lid 4, no current flows between both electrodes, but if there is a pinhole, discharge occurs through the pinhole,
The presence of pinholes is inspected by detecting this.

(3) Molding of the lower lid by injection molding and formation of the plug for infusion with pull-up stopper The upper lid with pull-up stopper 4 having no pinhole and the laminated rubber stopper after the intermediate inspection made as described above. 3 is inserted as shown in FIG. Next, after the assembly of the laminated rubber stopper 3 and the upper lid 4, the lower lid 8 as shown in FIG. 3B is formed by injection molding with the outside fixed with the mold surface. This lower lid 8 is a place to be attached to the mouth of the main body of the plastic container for medicines.

At this time, the laminated rubber plug 3 is inserted so that at least one surface thereof faces the lower lid 8. Lower lid 8
By injection molding, the lower lid 8 is melt-bonded to the surface of the laminated rubber plug 3 and the upper lid 4 to obtain the infusion plug 9 with a pull-up stopper. The plug body manufactured by such a manufacturing method is called a one-color insert product.

By being melt-bonded in this way,
It is possible to obtain a sanitary plug having high airtightness even after needle stick.

The method of molding the lower lid 8 is as follows.
A two-color insert molding method may be used. That is, as shown in FIG. 4 (A), the lower presser 10 is formed by primary molding injection, and the upper lid 4 with the pull-up without pinhole and the laminated rubber stopper 3 after the intermediate inspection, which is formed as described above, are formed on the lower presser 10. Is inserted into the mold as shown in FIG.
A lower lid 8'as shown in Fig. 2 is made by secondary molding injection. At this time, the laminated rubber plug 3 is inserted so that at least one surface thereof faces the lower lid 8 '.

By injecting the lower lid 8'by secondary molding, the lower lid 8'is melt-bonded to the surface of the laminated rubber plug 3, the upper lid 4 and the lower presser 10, and a plug for infusion with a pull-up stopper. Obtain body 9 '(two-color insert).

By thus melt-adhering, it becomes possible to obtain a sanitary plug having high airtightness even after needle stick.

Further, in the two-color insert molding method, the rubber stopper 3 is pre-compressed by the lower presser 10, so that a further excellent stopper body which is less likely to leak liquid can be obtained.

The materials for injection molding are polyethylene, polypropylene and their copolymers, and any material suitable for the material of the infusion container is arbitrarily selected.

(4) Evaluation of Plug Body A performance test was carried out on the plug body for infusion with a pull-top obtained in the present invention by changing the material of the rubber plug, the material of the laminate and the thickness of the laminate. The results are shown in Table 1.

[0025]

[Table 1]

In the case where the rubber stopper was not laminated and a film was used instead of the laminate (Comparative Examples 1 and 2), and the intermediate inspection for the pinhole of the score part was not performed (Comparative Examples 2 and 3). The results are shown in Table 2.

[0027]

[Table 2]

In the evaluation of the plug body, the rubber / laminate (film) adhesiveness is indicated by ◯ when it is adhered even a little, by X when it is not adhered at all, and ◯ when no coring occurs. Those that occur with a frequency of ~ 50% are indicated by △, and the liquid leakage resistance shows leakage of the liquid when the needle is pulled out by leaving the needle in a container with a stopper filled with the liquid for 3 hours. Those with 0.2 cc or less are shown with ◯, those with no pinholes are shown with ◯, and those in which defective products are seen at a frequency of 0.1% or more are shown with Δ. IR / BR / in Tables 1 and 2
PP / PE means isoprene rubber / butyl rubber / polypropylene / polyethylene.

As is clear from Tables 1 and 2, the plugs for infusion containers with pull-ups obtained in the present invention are excellent in pinhole performance, liquid leakage resistance, and rubber / laminate adhesion. On the other hand, in Comparative Examples 2 and 3, the insert molding method is different, so that it is not possible to perform an intermediate inspection on the pinholes, and thus it is not possible to prevent the occurrence of pinholes.

[0030]

As described above, the plug for infusion with a pull-top obtained in the present invention is excellent in pinhole performance, liquid leakage resistance, and rubber / laminate adhesion. In addition, since the top surface is already covered because it is equipped with a pull-up, it is not necessary to seal the seal on the top surface of the stopper body with a film or the like after fusing the stopper to the container, which is advantageous in streamlining the process.

[Brief description of drawings]

FIG. 1 is an explanatory view of a procedure for manufacturing a laminated rubber stopper according to the present invention.

FIG. 2 is an explanatory diagram of an inspection procedure for the upper lid with the pull-up according to the present invention.

FIG. 3 is a cross-sectional view showing an embodiment of the present invention in process order.

FIG. 4 is a cross-sectional view showing another embodiment of the present invention in process order.

[Explanation of symbols]

 1 Plastic film 2 Unvulcanized rubber 3 Laminated rubber stopper 4 Upper lid 5 Score part 6 Electrode 7 Electrode 8 Lower lid 9 Infusion plug with pluto-top 10 Lower presser

Claims (2)

[Claims] 1. A rubber stopper having at least a part of its surface laminated with a plastic film is fitted into an upper lid having a pull-top structure preliminarily inspected for pinholes in a score portion around the pluto-top, and the lower lid is fitted into the upper lid. An infusion plug body with a pull-up, wherein the side lid body is melt-molded integrally with the laminating portion on the surface of the rubber stopper and the upper lid body. 2. An upper lid having a push-top structure is molded, and after checking that there is no pinhole in the score part around the top-up of the upper lid, the upper lid is inserted into a mold. Then, insert a rubber stopper, at least a part of the surface of which is laminated with plastic film, into the mold, and finally by injection molding the lower lid, the upper lid and the laminated portion of the rubber stopper surface A method for producing a plug for infusion with a pull-up, wherein the side lid is integrated by melt molding.