JPH07291301A - Packaging bag for container for medical application - Google Patents

Abstract

PURPOSE:To facilitate the manufacturing processes of a packaging material for multiple packaging by forming a multiple packaging bag to wrap a sealed container containing a medical solution in such a manner that a tube-form film which is obtained by inflation-forming is overlapped at least two times to form the multiple packaging bag. CONSTITUTION:A multiple packaging bag which is applied when a transfusion solution being easy to denature by the effect of oxygen such as an amino acid preparation, fat emulsion, etc., is preserved under a condition wherein the transfusion solution is almost totally shielded from the outside air is manufactured in such a manner that a tube-form film which is obtained by inflation-forming is overlapped at least two times to form the multiple packaging bag. By this method, the manufacturing processes when a packaging of double or more is performed are facilitated. That is, in the case of double packaging, the package is conventionally manufactured by putting 4 sheets of a film together, but when a tube-form film is applied, two sheets are fed as one surface of a multiple packaging bag, and a multiple packaging bag with an excellent pin hole resistance can be obtained with less labor.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a multiple packaging bag used for packaging a container for containing a liquid medicine or the like.

[0002]

2. Description of the Related Art Infusion solutions such as amino acid preparations and fat emulsions that are easily transformed by the action of oxygen must be stored in a state of being almost shielded from the outside air.

On the other hand, the infusion container is often made of a soft polymer such as soft polyvinyl chloride, low density polyethylene, ethylene vinyl acetate copolymer, polypropylene and the like, all of which are poor in oxygen gas barrier property, and therefore, as described above. When the drug solution is contained, it is inevitably packaged and enclosed with a gas barrier packaging material.

In addition, it is important to keep the outer surface clean even in the case of a container for storing an infusion solution other than the above or a container for storing blood components, and it is also common to wrap it with a packing material.

The problem here is the occurrence of pinholes in the packaging material against vibrations and drops during transportation and handling, and various methods have been adopted. Typical examples are a method of increasing the thickness of the packaging material (sheet or film) to increase the strength of the packaging material, and a method of double packaging.

However, the cost is high,
Not only does it reduce the operability during use (particularly openability), but it also increases the amount of waste after use.

In the method (1), even if the packaging material is relatively thin, the probability that pinholes communicating with the outside air will be reduced by making it more than double (that is, if the total thickness is the same, it is advantageous to divide into several pieces). In addition, the gap between the packaging materials acts as a cushion, and the occurrence of pinholes is suppressed, so that the performance is excellent, but the packaging material manufacturing process and packaging process cannot be complicated.

[0008]

Among the problems of the prior art described above, the object of the present invention is to improve the production particularly in the method of double packaging (described above). Is.

[0009]

SUMMARY OF THE INVENTION The gist of the present invention is a multi-packaging bag for containing a sealed container for containing a medicinal solution, wherein a tubular film obtained by inflation molding is provided at least twice. It is a packaging bag for medical containers characterized by being overlapped. With such a configuration, it is possible to simplify the manufacturing process when packaging is double or more.

That is, taking double packaging as an example, in the conventional case, it is necessary to stack four films, but since the tubular film is used in the structure of the present invention, two sheets are a multiple packaging bag. Since it is provided as one side, it is possible to provide a multiple packaging bag having excellent pinhole resistance with less labor than conventionally.

The material of the drug solution container to be contained in the multi-packaging bag of the present invention is appropriately selected, but as a commonly used material, soft poly is used in view of its flexibility and transparency. It is selected from vinyl chloride, low density polyethylene, ethylene-vinyl acetate copolymer, soft polypropylene and the like.

The thickness of the sheet used for the above-mentioned container varies depending on the items required for the use of the medical container, but is generally 0.15 to 0.50 mm, more preferably 0.20 to 0. About 45 mm is suitable.

As liquids contained in the container to be contained, there are physiological saline, electrolyte solution, dextran preparation, fat emulsion, mannitol preparation, saccharide preparation, amino acid preparation and the like.

A container for storing a blood component as a medical container can be an object to be included in the multiple packaging bag of the present invention.

The inflation film used in the multi-packaging bag of the present invention can be obtained by a generally known method, but its mechanical properties, transparency, gas barrier property and sealing property (bag forming property).
From the balance of the above, a multilayer film is generally used.

As the material constituting the film, low density polyethylene, high density polyethylene, ethylene vinyl acetate copolymer, polypropylene, polyvinyl chloride, nylon 6, polybutylene terephthalate, polyethylene terephthalate, etc. or other copolymers containing these as the main components Polymers selected from gas barrier polymers such as polyvinylidene chloride, ethylene vinyl alcohol copolymer, polyacrylonitrile, and polymethaxylylene adipamide are used in appropriate combination.

Points to be noted in the constitution of the film selected from the above materials are strength, transparency, flexibility, tearability, pinhole resistance, gas barrier property, heat sealability, etc. Is selected as appropriate depending on the type of the product, required performance, and the like.

The thickness of the "tube" of the tubular film used in the multiple packaging bag of the present invention is 0.03-0.
20 mm, more preferably 0.05 to 0.15 mm is suitable.

An increase in the thickness of the film is effective in improving the pinhole resistance, but the above range may be appropriate in view of the balance between flexibility and transparency.

The method of manufacturing the multiple packaging bag according to the present invention will be described below.

The medical container contained in the multi-packaging bag of the present invention means a container for storing and storing a liquid to be treated in the medical treatment such as blood and medical liquid (infusion). Such a product is generally known. Method (extrusion molding, blister molding, etc.)
The tubular film used as a base material for the multiple packaging bag of the present invention is also produced by a generally known inflation molding.

The multiple packaging bag of the present invention is formed by stacking tubular films at least twice and cutting them into a predetermined size to insert a medical container. The stacking method at this time is the center line of stacking. It goes without saying that the folding line may be parallel to the axial direction or may be folded perpendicularly to the axial direction, but the opening direction (though this is due to the stretching direction of the film) and the size and shape of the contents It is decided based on the balance of.

Therefore, as compared with the conventional manufacturing of multiple packaging bags, it is possible to simplify the manufacturing process of the packaging material for multiple packaging and avoid the complication of the process in multiple packaging, and to manufacture it as a series of continuous steps. It is easily possible to bag and package.

The medical container can be packaged using the multiple packaging bag of the present invention either before or after sterilization, but it is generally packaged after sterilization. It is also possible to adopt a method of sterilizing in a multi-packaging bag, sterilizing without sealing, and then sealing.

As the sterilization method, any of commonly used methods such as high pressure steam sterilization and gamma ray sterilization may be used.

In the packaging method of the present invention, a hot plate sealing method is generally used as a sealing method for the tubular film, but any of an impulse sealing method, a high frequency sealing method, an ultrasonic sealing method and the like may be used.

The multi-packaging bag of the present invention exerts a great effect in enclosing a medical container, such as an amino acid preparation and a fat emulsion, which needs to be stored particularly in a state in which it is almost shielded from the outside air.

[0028]

The present invention will be described in more detail with reference to the following examples, but the present invention is not limited thereto.

1. Preparation of Evaluation Sample (Common to Examples and Comparative Examples) 1-1. A medical container (infusion container) linear low density polyethylene (density 0.920 g / cm ³⁾
It is made of a sheet (thickness 0.32 mm). The shape of the container is flat (dimensions 40 × 180 × 130 mm), and a cylindrical waste liquid port made of high-density polyethylene with a rubber stopper attached to one end is fixed. Infusion agent 500 m consisting of an aqueous solution containing about 12 W / V% amino acid in this container
1 was dispensed.

The above container was placed in a high-pressure steam sterilizer, and the temperature was 115 ° C. and the gauge pressure was 1.8 kg / c in a nitrogen atmosphere.
The sample container was sterilized by m ² for 30 minutes.

1-2. Film for packaging container Table 1 shows the structure of a film for a container for enclosing a container containing a medical liquid.

The film forming conditions are as follows:
A die having a diameter of 100 mm was used in Comparative Example 1, and a die having a diameter of 100 mm was used in Comparative Example 1. In both cases, the die temperature was 220 ° C., the take-up speed was 10 m / min, and the water cooling method was used for both cooling.

[0033]

[Table 1]

1-3. Packaging An infusion container prepared by using the film of Table 1 was included, and 4 sides for Example 1 and Comparative Example 1 and 3 sides for Example 2 were sealed with a hot plate sealing method (sealing temperature 170 ° C.) of a width of 10 mm. Sealed with.

2. Pinhole resistance measurements, results (Table 2):
The prepared sample container (the number of samples: 100) was allowed to drop naturally on a concrete floor from a height of 150 cm in an atmosphere of 10 ° C. and 40% RH with the infusion port facing upward. Next, after leaving it to stand naturally in an atmosphere of 23 ° C. and 60% RH for 100 days, the result of observing the color change of the content liquid is shown in Table 2.

[0036]

[Table 2]

3. Conclusion As shown in Table 2, even if the total thickness of the packaging material was the same, the double-wrapped form showed much better pinhole resistance.

Further, both the four-way sealed product and the three-way sealed product had excellent pinhole resistance.

[0039]

As described above, the packaging bag of the present invention is a multiple packaging body in which tubular films obtained by the inflation method are superposed at least twice, and simplifies the manufacturing process of the packaging material for multiple packaging. Its industrial value is high because it is easy.

Claims (1)

[Claims] 1. A multi-packaging bag for enclosing a sealed container for containing a medicinal solution, characterized in that tubular films obtained by inflation molding are superposed at least twice. Packaging bag for containers.