JPS62253068A - Infusion container made of synthetic resin - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION Field of Application This invention relates to improvements in synthetic resin infusion containers such as infusion bottles and bags, and in particular to improvements in stoppers and mouths for sealing the mouths of containers, including ultrasonic welding, It prevents contamination of chemicals, etc. by fine particles generated from pressure welding parts such as friction welding, and does not cause pressure welding defects that tend to occur during heat welding.It is easy to assemble, can be fully automated, and is manufactured at low cost. The present invention relates to a synthetic resin infusion container having a spout and a stopper with a simple structure.

BACKGROUND ART Synthetic resin infusion containers for storing medical solutions such as medical injections are
It is becoming the mainstream infusion container, replacing the conventional glass bottle with a rubber stopper and wrapped with an aluminum cap.It is lightweight, difficult to break, and eliminates the need for air introduction needles, etc. , it has the advantage of being easy to handle.

Synthetic resin infusion containers have a container body made of thermoplastic synthetic resin (
PE, PC, PP, PVC, etc.) or semi-hard synthetic resins, such as blow-molded bottles, or soft PVC, EVA.

A so-called bag having an opening made of a thermoplastic film material such as polyurethane or polyolefin is filled with the drug solution, and a flange of a stopper made of various synthetic resins is attached to the rim of the opening. The container is sealed by pressure welding, and the whole container is sterilized by heating, for example, in a high-pressure sterilization pot. When the container is used, a liquid sampling needle is inserted through the stopper at the mouth to mix the liquid with the small waves or draw out the medicinal liquid.

Therefore, the mouth and stopper of the infusion container must be able to completely seal the mouth of the infusion container, prevent volatilization and evaporation of the drug solution, and prevent contamination from the outside, and that the stopper in particular does not elute harmful substances; ■Heat sterilization The stopper must have enough strength to withstand the heat and internal pressure inside the container; ■The stopper must be flexible enough to allow the liquid collection needle to be inserted relatively easily, and the stopper must be able to securely hold the liquid collection needle. It is required that each of the following properties be satisfied.

Generally, the stopper that is pressure-welded to the opening of the infusion container is strong enough to withstand the pressure during heat sterilization, and is made of rubber (NR, IR, I
IR, SIR, etc.), a synthetic resin partition material that prevents contact between the rubber stopper and the chemical solution, and a thermoplastic synthetic resin (PE) that covers and holds the entire body.

It consists of a combination with a covering member made of (PC, PP, PVC, etc.).

For example, the container shown in FIG.
The mouth part and the stopper body of the above publication are obtained by fitting a rubber stopper (3) with an H-shaped cross section into a cap body (2) having a bull ring (1) for separating and removing the required part, and making contact with the chemical solution. the end plug (4) so that the components of the rubber plug (3) do not elute.
The rubber plug (3), which is fitted into the groove provided on the inner circumference of the flange of the cap body (2) and provides the main strength, is attached to the cap body (2).
2) are shaped so that they fit together to obtain strength from both, and the flanges of the cap body (2) and the end plug (4) are connected to the flanged opening of the container opening (5). The edge portion (6) is sealed by pressure welding such as high frequency, ultrasonic, or thermal welding.

In addition to the configuration in which the brim-like mouth edge of the part to be welded is provided at the opening end, for example, a container with a scale (1986-419
The mouth and stopper of No. 64) have a concave shape with the container mouth provided below the flange, and the stopper has a shape that can fit into this concave, and is coated with a sealing material that separates it from the drug solution. The rubber stopper, which mainly has high strength, is fitted and held in a ring-shaped covering member having an inner circumferential protrusion that fits into an annular fitting groove provided at the center of the outside, and the covering member and partition sealing material are connected to the flange. It is configured to be pressure welded to the part.

In the process of forming, filling with drug solution, sealing, and sterilizing, the infusion container with the above-mentioned structure is first washed thoroughly after forming, and is further cleaned to prevent foreign matter and living organisms such as bacteria from adhering to the inner and outer surfaces. , are lined up with their mouths facing up and moved on a conveyor or rotary table to receive the chemical solution.
If necessary, the air inside the container is replaced with an inert gas such as nitrogen, and then the stopper is placed on the mouth. Depending on the material of the container, etc., heat welding, high frequency welding, Using a pressure welding method such as sonic welding or friction welding, the container's rim or flange is pressure welded to the flange of the stopper to seal the container's mouth, and then heat sterilized in a high-pressure cooker, etc. It is processed.

Conventional infusion containers are filled with drug solution through the process described above, but there is a problem in that fine particles generated during ultrasonic welding and friction welding enter the container and contaminate the drug solution. It has been desired that such an infusion container has a structure that prevents the fine particles from easily penetrating into the container.

In addition, in the case of an infusion container configured to replace the air inside the container with an inert gas and seal the rim of the container and the flange of the stopper using a heat welding method, welding to the pressure melt detector Defective parts sometimes occurred, but this problem could not be solved with conventionally configured infusion containers.

Purpose of the Invention In view of the above-mentioned problems, the present invention aims to improve the shape and structure of the mouth and stopper for sealing the mouth of a synthetic resin infusion container, and to improve the shape and structure of the mouth and the stopper for sealing the mouth of a synthetic resin infusion container. Prevents contamination of chemical solutions, etc. by fine particles generated by melting inspectors,
The object of the present invention is to provide a synthetic resin infusion container having a spout and a stopper with a simple structure that can be easily manufactured and assembled at a low cost without causing welding defects during thermal welding, and can be manufactured and assembled easily and completely automatically.

Structure and Effects of the Invention The present invention has been made as a result of various studies aimed at creating a stopper for a synthetic resin infusion container that has a simple structure that can be easily and fully automated in production and assembly, and can be manufactured at low cost. We focused on the fact that because the rim of the flange to be welded is on the same level as the opening of the mouth, fine particles generated from the flange during welding easily enter the mouth and contaminate the chemical solution. By placing the flange of the container, which is the pressure welding point, below the opening of the mouth, a cylindrical part is formed from the upper part of the flange of the container to the opening end, and the stopper is also attached accordingly. The flange is formed through the cylindrical part that is in close contact with the cylindrical part, and when the flange parts are pressure welded together, the cylindrical parts are in close contact with each other. Therefore, when pressure welding occurs due to ultrasonic waves or friction, noise generated from the flange part. It was discovered that there is an advantage that fine particles are prevented from entering in the direction of the opening.

In addition, in the case of an infusion container configured to replace the air inside the container with an inert gas and seal the rim of the container and the flange of the stopper by heat welding, welding to the pressure Defective parts may occur.

That is, as shown in Fig. 4, after being cleaned, the containers are lined up with their mouths (5) facing upward, and moved on a conveyor or rotary table to be filled with chemical solution, and the air inside the containers is filled with nitrogen, etc. Next, after the stopper is placed on the mouth, the mouth edge of the container and the flange of the stopper are pressure welded by heat welding, but this will be discussed in detail. As a result, the fourth
As shown in the figure, a common method is to heat the mouth edge (6) before the gas replacement. According to this method, when the container moves toward the device for placing the stopper, the replacement gas is heated. It was discovered that leakage occurs in the opposite direction to the moving direction, locally cooling the heated mouth edge (6) and causing a welding failure. It has been found that by installing 6) as a flange below the opening of the mouth, there is no need for cooling by the replacement gas, and there is an advantage that uniform thermal welding can be achieved.

That is, the present invention provides a synthetic resin infusion container in which the opening of the container made of synthetic resin is sealed by pressure welding the flanges of the container with a stopper made of synthetic resin or the like. This is a synthetic resin infusion container characterized in that the flange of the container is located below the opening.

In addition, by adopting the structure according to the present invention, the shape and fitting shape of each member of the mouth and stopper of the infusion container can be made extremely simple, and the above-mentioned properties (1) to (4) are satisfied, It has the advantage that molding and assembly of each member is extremely easy, assembly can be completely automated, and manufacturing can be done at low cost.

゛Preferred embodiment of the invention The infusion container according to the present invention may be a bottle or bag of any shape and material, and the flange of the container, which is the pressure welding part, is placed below the opening. As a feature,
The flange of the stopper may also have a shape that corresponds to the flange of the container, and the flange of the container mouth is placed below the opening to form a cylindrical part from above the flange to the opening end. Accordingly, if the flange is formed through a cylindrical part that is in close contact with the cylindrical part, and the cylindrical parts are in close contact with each other when the flange parts are pressure welded, the flange of the container mouth part The plug body can be applied in any configuration, and the material of each part and the shape of the flange can be adjusted depending on the conditions such as the type of liquid to be filled and the usage.

It is advisable to select the configuration appropriately.

Preferably, as shown in FIGS. 1 and 2 of the embodiment,
The flange provided below the mouth opening of the container is formed into an inclined surface that expands toward the container body, and the flange of the stopper is fitted into the flange of the container, that is, the shapes match as shown in FIG. Alternatively, as shown in Figure 2, the entire container flange is formed into an inclined shape that fits into the flange of the stopper, so that the flange can be identified as fitting together, thereby increasing the pressure welding area. A synthetic resin infusion container can be obtained which has various advantages such as an improved effect of preventing the intrusion of fine particles and no leakage of replacement gas before pressure welding.

Preferably, as shown in FIGS. 1 and 2 of the embodiment,
By adopting a sealed structure in which the cylindrical part from the upper part of the flange of the container to the opening end is fitted into the stopper body, it has an even better effect of preventing the intrusion of fine particles, and also has an effect of preventing the displacement gas from leaking before pressure welding. A resin infusion container is obtained.

Furthermore, the stopper is constructed from an integral molding made of synthetic resin that does not elute harmful components upon contact with the drug solution, and a rubber part for holding the pierced liquid sampling needle is enclosed in the stopper and opened. By fitting into the interior, a synthetic resin infusion container can be obtained which has an excellent effect of preventing the intrusion of fine particles and an effect of preventing the displacement gas from leaking before pressure welding.

The stopper used in the infusion container of the present invention includes at least a rubbery part through which a liquid collection needle is pierced to draw out a drug solution and for holding the same, and a rubbery part that prevents harmful components from leaching out from the rubbery part. It is sufficient that the main body has a flange that holds and encloses the rubber part and the partition and can be pressure-welded to the container flange, and these can be assembled, injection molded, etc. It is preferable to manufacture the product by simultaneous molding, and it may have any other configurations, such as having various shapes of covering materials and adhesion components, depending on the required function.

DISCLOSURE OF THE INVENTION BASED ON DRAWINGS FIG. 1 is a vertical cross-sectional view and a top view showing the opening of a synthetic resin infusion container according to the present invention, and FIG. 2 is a synthetic resin infusion container showing another embodiment according to the invention. FIG.

The infusion container shown in FIG. 1 consists of a container main body (10) and a stopper (20) that can be fitted into its mouth (11), and the mouth (11) has a cylindrical shape. 11) A flange (12) with a triangular cross section that expands toward the container body (10) is provided on the outer peripheral surface of the lower part, and a cylindrical portion (13) extends from the upper end of the flange (12) to the opening end of the mouth. It is formed.

The stopper (20) fitted into the mouth (11) of the container body (10) is a so-called cap-shaped integrally molded headed cylindrical body made of synthetic resin that does not elute harmful components upon contact with the drug solution. The inner circumferential part on the opening side has a tapered shape inclined toward the head, and the same product constitutes a plug body flange (21) that fits and abuts on the inclined outer circumferential surface of the flange (12), In addition, a hole is provided in the center of the head, and a substantially disc-shaped rubber part (22) is enclosed in the hole. A seal groove (23) is provided around the outer periphery of the rubber part (22), and the seal groove (23) wall and the inner surface of the head cover the rubber part (22) and the drug solution filled in the container body (10). It serves as a partition (24) between the two.

The fitting between the opening (11) and the stopper (20) is achieved by fitting the opening (11)
) is the sealing groove (23) of the stopper (20).
By fitting the rubber part (22) into the partition part (
24) into the mouth (11), and the plug body flange (
21) is configured to come into close contact with the flange (12) of the mouth (11).

When filling the drug solution, the container body (10), which has been washed and cleaned in advance, is held and moved by a conveyor, and the container body (20), which has been washed and cleaned, is filled with the drug solution. (10) is fitted into the mouth part (11), and then the plug flange part (21) and the flange part (12) of the mouth part (11) are fitted tightly together.
) and pressure welding using ultrasonic welding, friction welding, etc.
It is then heated and sterilized to complete the filling of the chemical solution.

In the container according to the present invention, the stopper flange (21) to be pressure welded and the flange (12) of the mouth (11) are located below the opening end of the mouth (11), and the cylindrical part (13) is Since it is a sealing part, it is possible to make the container airtight before pressure welding, and fine particles generated during welding such as ultrasonic welding and friction welding do not enter the container body (11).

Furthermore, when used in a hospital or the like, the rubber part (22) of the stopper (20) has a structure in which the main part is contained in the stopper (20) and is held by being fitted into the mouth part (11). Therefore, even if the rubber part (22) is thinner than before, it can exhibit sufficient strength to hold the liquid sampling needle, and the liquid sampling needle can be easily penetrated.

Further, while heating the flange (12) of the container body (10),
When filling the remaining space with the chemical solution and filling with inert gas, and then thermally welding it to the stopper flange (21), the container body (1
The infusion container according to the present invention shown in FIG. 2 is capable of sealing by uniform heat welding without locally cooling the flange (12) with the filling gas when moving the infusion container (12), as shown in FIG. It has the same structure as the container, but there is a groove (25) in the stopper flange (21).
is provided around the body to form a recessed portion by the plug flange portion (21), and the flange shape is determined so that the entire flange portion (14) of the mouth portion (11) can fit into this recessed portion, Container body (1
When fitting the stopper (20) into the mouth (11) of 0), by pushing the stopper (20) strongly, the two can be firmly fitted and fixed, and a higher degree of airtightness can be achieved before pressure welding. It is possible to achieve this, and it is possible to prevent contamination of foreign objects, etc., and to prevent leakage of filling gas.

[Brief explanation of drawings]

FIG. 1 is a longitudinal cross-sectional view and a top view showing the mouth of a synthetic resin infusion container according to the present invention, and FIG. 2 is a longitudinal cross-sectional view showing the mouth of a synthetic resin infusion container according to another embodiment of the present invention. It is an explanatory diagram. FIG. 3 is a vertical cross-sectional view showing the opening of a conventional synthetic resin infusion container. FIG. 4 is a perspective explanatory view showing the opening of a conventional synthetic resin infusion container. 10... Container body, 11... Mouth part, 12.14...
- Flange part, 13... Cylindrical part, 20... Plug body, 21...
- Plug body flange, 22... rubbery part, 23... seal groove, 24... partition, 25... groove.

Claims (1)

[Scope of Claims] 1. In a synthetic resin infusion container in which the opening of the container made of synthetic resin is sealed by pressure welding the flanges of both sides with a stopper made of synthetic resin, etc., at the pressure welded point. 1. A synthetic resin infusion container, characterized in that a flange of the container is located below the opening. 2. The flange provided below the mouth opening of the container is an inclined surface that expands toward the container body, and the flange of the stopper has an inclined shape that fits into the flange of the container. A synthetic resin infusion container according to claim 1. 3. The flange provided below the mouth opening of the container is an inclined surface that expands toward the container body, and the container flange fits into the flange inside the stopper, making it possible to fit and fix the container. A synthetic resin infusion container according to claim 1. 4. The synthetic resin infusion liquid according to claim 1, 2, or 3, wherein the cylindrical portion from the upper part of the flange to the open end of the container has a sealed structure that fits into the stopper. container. 5. The plug body is made of an integrally molded synthetic resin that does not elute harmful components upon contact with the drug solution, and a rubbery part for holding the pierced liquid sampling needle is enclosed in the plug body and fits into the opening. 5. A synthetic resin infusion container according to claim 4, which comprises: