KR102181170B1 - Outer pouch film for infusion solution bag - Google Patents

Abstract

The present invention relates to a film for an infusion bag exterior pouch with improved transparency while satisfying basic physical properties such as heat resistance, tearing property, and moisture reduction rate of the existing infusion bag exterior pouch at the same level, and an infusion bag exterior pouch including the same. The film according to the present invention satisfies the requirements as an outer pouch of the infusion bag, and improves transparency, so that it is easy to detect foreign substances or residues contained in the infusion bag.

Description

Outer pouch film for infusion solution bag}

This specification describes a film for an external pouch of an infusion bag with improved transparency.

Infusion bags generally used in the medical field require higher levels of oxygen and moisture barrier properties, flexibility, printability, rigidity, etc. than containers that store general liquids. Conventionally, polyvinyl chloride (PVC)-based resin has been widely used as a plastic material used in the infusion bag, but endocrine disrupting substances (environmental hormones) are generated in the PVC-based infusion bag, and a large amount of dioxin is generated when incinerated. As it was confirmed, development of a non-PVC sap bag to replace it is being made.

The recently used non-PVC infusion bag has a polyolefin-based multilayer structure, but in most cases, it has limitations such as poor sterilization heat resistance, lack of flexibility and moldability, and requires an external pouch (second pouch) to store it. do.

Conventional infusion bag exterior pouch is composed of a combination of high-density polyethylene copolymer and linear low-density polyethylene, so it has good tearability by external force, but has an opaque appearance. It has a problem that it is difficult to detect impurities after filling.

In recent years, as the amount of infusion used has increased, a large number of claims have been generated, such as using it without checking foreign matter in the infusion solution in hospitals or medical facilities using it, or detecting foreign matter after opening the outer pouch. This is a part directly connected to medical stability, and development of a transparent packaging film capable of detecting the above problems with the naked eye is required.

Republic of Korea Utility Model Publication No. 20-0471558 relates to a tube-type pouch film made of a high-density polyethylene resin, and has a problem that it is difficult to detect impurities after filling an infusion bag due to its opaque appearance. Republic of Korea Patent Publication No. 10-1014196 relates to the manufacture of a transparent sap outer pouch manufactured by the inflation method using polypropylene resin having excellent transparency and heat resistance as a main component. The back is excellent, but there is a problem that the transparency is inferior when it is crumpled by an external force.

Republic of Korea Utility Model Publication No. 20-0471558 Korean Patent Publication No. 10-1014196

In one aspect, the problem to be solved by the present invention is a film for an infusion bag outer pouch with improved transparency while satisfying the basic physical properties such as heat resistance, tearing property, and moisture reduction rate of the existing infusion bag outer pouch at the same level, and an infusion solution containing the same. It is to provide an outer pouch.

In one aspect, the present invention is an outer layer comprising a biaxially stretched polypropylene; An adhesive layer comprising a solvent-free polyurethane; And an inner layer that is a sealant layer including non-stretched heat-resistant polypropylene, wherein the adhesive layer is formed between the outer layer and the inner layer, and provides a film for an outer pouch of an infusion bag.

In another aspect, the present invention is a space unit in which the infusion bag is stored in the inside formed by overlapping the two films; And it provides an infusion bag external pouch including an injection portion formed on one side of the edge of the space portion and a sealing portion formed on the other surface except for the injection portion.

In one aspect, the film according to the present invention is excellent in heat resistance, tearing property, moisture reduction rate, etc., and satisfies the requirements as a pouch for storing the infusion solution, but has improved transparency, making it easy to detect foreign matter or residue contained in the infusion bag. In addition, two foreign matter detection steps, which are generally performed after manufacturing and sterilization of a pouch, and before shipping, can be reduced to one step, and thus, there is an advantage in that redundant processes can be omitted.

1 is a schematic diagram showing a layer structure of a film for an external pouch of an infusion bag according to an embodiment of the present invention.
2 is a schematic diagram showing a cross-section of an external pouch of an infusion bag according to an embodiment of the present invention.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

1 shows an exemplary form of the present invention. Referring to FIG. 1, the film according to an embodiment is for an exterior pouch of an infusion bag, and an outer layer 10 comprising biaxially stretched polypropylene, an adhesive layer 20 comprising a solvent-free polyurethane, and a non-stretched heat-resistant poly It may include an inner layer 30 which is a sealant layer containing propylene. Alternatively, the film according to an embodiment is composed of an outer layer 10 comprising biaxially stretched polypropylene, an adhesive layer 20 comprising a solvent-free polyurethane, and an inner layer 30 that is a sealant layer comprising non-stretched heat-resistant polypropylene. I can. The outer layer 20 is a layer in contact with the outside, and the adhesive layer 20 may be formed between the outer layer 10 and the inner layer 30.

As an embodiment, the film of the outer layer included in the present invention may exhibit improved tensile strength than a film including non-stretched propylene by including Bi-axially oriented polypropylene (BOPP). Accordingly, the occurrence of wrinkles due to high heat during the manufacture of the film can be prevented, and the outer pouch manufactured using the film applies an external force to the notch to maintain strength so that tearing can be made more smoothly when opened. I can. As an embodiment, the thickness of the outer layer may be 30 to 50㎛. If the thickness exceeds 50 μm, the pouch is easy to process, but the flexibility is reduced and tearing is difficult. If the thickness is less than 30 μm, when the pouch is processed using the film, both sides and bottom of the pouch are sealed with high heat. As the heat transfer rate to the sealant layer of is increased, appearance defects in which wrinkles occur in the pouch may occur.

As an embodiment, the adhesive layer included in the present invention may include a non-yellowing two-component adhesive, and the non-yellowing two-component adhesive may be a non-solvent type polyurethane. Specifically, the adhesive layer may include a solvent-free polyurethane polymer formed by mixing a main agent having a hydroxyl group and an isocyanate curing agent. At this time, the subject is polyol. In the polyurethane polymer, a urethane bond (-NHCOO-) is formed by the reaction of a hydroxyl group (-OH) and an isocyanate group (-NCO), and the outer layer and the inner layer can be effectively bonded through the reaction between each functional group. . In addition, oil-based adhesives are not suitable for medical packaging materials such as sap because the transparency of the film decreases during lamination and requires thorough management of the solvent remaining after aging, whereas the present invention uses a solvent-free polyurethane polymer that does not use an organic solvent. Since it is included as an adhesive, the transparency of the film can be improved, and it is suitable as a material for an exterior pouch for infusion solutions. The solvent-free polyurethane may be, for example, a solvent-free polyurethane polymer formed by mixing a base material having a hydroxyl group and an isocyanate curing agent in a weight ratio of 10:7 to 9.9, and more specifically, a base material and an isocyanate having a hydroxyl group. The blending ratio of the curing agent may be 10:8.5 to 9.5. When the ratio of the isocyanate curing agent is low, the curing is not performed properly, and thus properties may be deteriorated due to the remaining uncured reactants. As an embodiment, the thickness of the adhesive layer may be 1 μm to 5 μm, more specifically 2 μm to 4 μm. The thickness is the thickness of the final adhesive layer after applying, drying and aging the adhesive to the film, and if the thickness is less than 1 μm, the interlayer of the film may be peeled due to low adhesion, and if the thickness exceeds 5 μm, coating may be difficult. .

As an embodiment, the inner layer, the sealant layer, may include cast polypropylene (CPP) having improved heat resistance. Non-stretched polypropylene has excellent transparency and moisture-proof properties, so it is suitable as a material for external pouch for sap. Conventionally, non-stretched polypropylene has been generally used as a heat-adhesive layer, but ter-polypropylene (Ter-PP) or random polypropylene (Random PP) is used as the skin layer, so low heat melting (melting point) of up to 145~150℃ ) It has a temperature, so when it is manufactured as an external pouch, when the infusion bag is filled and then goes through the sterilization process, the infusion bag made of the same polypropylene material and blocking (drop-in) under the conditions of a high temperature of 121℃ and 30 minutes (actual chamber residence time is 2 hours). There is a problem of deteriorating the quality of the product by causing sticking, adhesion phenomenon).

In order to improve this, the sealant layer according to an embodiment of the present invention may include a triple layer stacked in order from an adhesive layer to a homo polypropylene layer, a homo polypropylene layer, and a homopropylene and random polypropylene mixture layer, and the 3 The middle layer consists of a coextrusion structure. The homopolypropylene is composed of a single bond of propylene only, has excellent tensile strength, tear strength, etc., and has a high melting point of 160°C, so it has heat resistance, but does not have sealing properties, for example, thermal adhesion. Therefore, the present invention is a mixture layer of homopropylene and random polypropylene blended in a certain ratio on the innermost layer of the film of the outer pouch in which the infusion bag is embedded, so that the infusion bag is anti-invasive when the infusion bag is embedded and then undergoes a sterilization process. While having a blocking function, it is implemented to have a level of heat adhesion that can be processed as an external pouch. As an embodiment, the innermost layer may be a layer in which homopropylene and random polypropylene are mixed in a weight ratio of 3 to 5: 5 to 7. The inner layer can be produced using casting or brown equipment as an embodiment. As an embodiment, the thickness of the inner layer (the sealant layer) may be 30 to 50 μm. As the thickness of the inner layer increases compared to the total thickness of the film, the flexibility is better, but there is a problem that the work must be performed at a higher temperature than when processing a general pouch according to the use of heat-resistant resin. The sealing work should be done at about 180~190℃ by raising the temperature by about 20~30℃ compared to the current working level, but such high heat may cause wrinkles to be formed in the pouch.

As an embodiment, the mixed layer may further include an anti-blocking agent, and the anti-blocking agent may be included without limitation as long as it is commonly used in a film in the technical field of the present invention. In addition, as an embodiment, the mixed layer may further include at least one of a slip agent and silicone oil, and in this case, the slip property is improved, so that when the infusion bag is filled into the outer pouch, the injection can be smoothly performed. . The slip agent may be included without limitation as long as it is commonly used in a film in the technical field of the present invention. When the slip agent and the silicone oil are added in an excessive amount, migration may occur, and may be included in a concentration of preferably 1000 ppm or less, more specifically 700 to 900 ppm.

As an embodiment, the haze of the external pouch film may be 0.1 to 10%.

As an embodiment, the tensile strength of the outer pouch film is 3 to 7 Kgf/mm in the case of the unwinding direction (Mechanical Direction, MD), and 10 to 20 Kgf/mm in the case of the vertical direction (Traverse Direction, TD) of the unwinding direction. Can be

As an embodiment, the tear strength of the outer pouch film may be 0.1 to 1 Kgf in the case of a mechanical direction (MD) and 2 to 3 Kgf in the case of a traverse direction (TD) in the unwinding direction. .

In the case of the external pouch (outer bag) of the general infusion bag, the moisture reduction rate is determined by filling the general infusion bag into the external pouch and storing it in a thermo-hygrostat at about 60℃ and RH25% for about 5 to 7 days. When comparing the degree of water loss of the infusion solution, in general, about 5 g/m ² is required when the infusion solution is 1L. This is because if there is a lot of water loss, the concentration of the sap becomes thick, which can cause problems when introduced into the human body. In one embodiment, the moisture permeability of the outer pouch film may be 1 to 4 g/m ² day, and the moisture reduction amount may be 2 to 4 g/m ² .

According to another embodiment, the present invention relates to an infusion bag external pouch, and FIG. 2 shows an exemplary form of the infusion bag external pouch of the present invention. Referring to FIG. 2, the infusion bag outer pouch according to an embodiment includes: a space unit 100 in which the infusion bag is stored in an interior formed by overlapping two films; And a non-sealing portion 101 formed on one surface of the edge of the space portion and a sealing portion 102, 103, 104 formed on the other surface except for the inlet portion 101, and , In this case, the film may be the film for the infusion bag exterior pouch described above.

In one embodiment, the external pouch is not limited in shape as long as it is a bag capable of filling or embedding an infusion bag, and may be, for example, a square bag. For example, when the shape of the outer pouch is a square bag, the pouch may be in the form of an envelope in which three sides of the space portion, that is, both sides and lower ends, are sealed as shown in FIG. 2. The present invention provides an external pouch in the form of a bag as an embodiment, thereby making it possible to omit the bag processing process of the infusion bag manufacturer, thereby reducing process costs and eliminating risk factors such as sealing unevenness that may occur when manufacturing inline bags. I can.

As an embodiment, the input portion 101 of the outer pouch is a non-sealing portion, and may be formed in a mechanical direction (MD) and a vertical direction (TD) of the film. In this case, after filling the infusion bag inside, the pouch can be easily torn by applying an external force in the vertical direction of the input unit, so that opening is easy. In addition, if the width of the sealing part is too thin, the volume of the external pouch may be wide while the strength to withstand the weight of the filled infusion bag may be weak.If the width is too thick, there is a problem that the filling operation of the infusion bag is not easy. The width of the sealing part may be adjusted according to the volume of the external pouch or the size or weight of the infusion bag to be embedded. For example, when the total volume of the outer pouch is 1L, a sealing strength of about 2kgf/15mm or more is required, and the width of the sealing portion may be about 5 to 7mm.

As an embodiment, the outer pouch may include a tear line 105 shown in the mechanical direction (MD) of the film, that is, a notch. For example, one or more of the tear lines may be included in the input unit 101 and/or the sealing unit 103 on the opposite side of the input unit 101.

In one embodiment, a method of manufacturing an outer pouch for an infusion bag includes: preparing an outer layer comprising biaxially stretched polypropylene and an inner layer that is a sealant layer comprising non-stretched heat-resistant polypropylene; Forming a film by forming an adhesive layer between the outer layer and the inner layer; It may include the step of overlapping the two prepared films and sealing the remaining surfaces except for one of the edges.

The film according to the embodiments of the present invention satisfies the same level of physical properties in terms of basic physical properties such as heat resistance, tearing property, and moisture reduction rate compared to the opaque film applied to the existing external pouch for infusion bag, while improving transparency. It is easy to visually observe foreign substances and residues contained in the internal sap during manufacture. Specifically, by laminating an outer layer comprising biaxially stretched polypropylene and an inner layer (sealing layer) comprising unstretched polypropylene as described above, and providing an inner layer contacting the sap bag in a three-layer structure comprising a heat-resistant copolymer resin , Blocking (sticking) that occurs in the sterilization process under high temperature and high pressure conditions with the infusion bag (inner bag) containing the sap was removed, and transparency was improved, and the pouch was made in the direction of the fabric, that is, the unwinding direction of the film, making it easy to tear. Can be implemented.

Hereinafter, the present invention will be described in detail with reference to Examples, Comparative Examples and Test Examples. These are only illustratively presented to explain the present invention in more detail, and that the scope of the present invention is not limited by these Examples, Comparative Examples, and Test Examples, for those of ordinary skill in the art. It will be self-evident.

[Example 1]

A film for an infusion bag outer pouch according to an embodiment of the present invention was prepared according to the following method.

First, a sealant film including a biaxially oriented polypropylene (BOPP) film and non-stretched heat-resistant polypropylene (CPP) reinforced with heat resistance was prepared to prepare a film for an exterior pouch. The sealant layer was formed by casting a homopolypropylene layer, a homopolypropylene layer as an intermediate layer, and a triple layer in which a homopropylene and random polypropylene mixture layer was stacked as an innermost layer.

Then, a non-solvent type polyurethane adhesive was applied on the sealant film by using a gravure cylinder using a gravure coating method, and the BOPP film was laminated thereon to prepare a film for an exterior pouch.

In the final manufactured film, the thickness of the BOPP film is 40 μm, the thickness of the adhesive layer is 3 μm, and the thickness of the sealant film is 40 μm.

[Example 2]

The infusion bag outer pouch according to an embodiment of the present invention was manufactured according to the following method.

The film for the outer pouch prepared in Example 1 was manufactured in the form of a square bag by sealing both sides and the bottom excluding the input part at the top using a heat-adhesive mold manufactured according to the outer pouch standard of a 1000 mL infusion bag. Then, by notch processing two at each of the input portion and the lower end, an external pouch for an infusion bag as shown in FIG. 2 was manufactured.

[Comparative Example 1]

As a comparative example of the present invention, a film (HDPE80) made of a single layer of high-density polyethylene and having a thickness of 80 μm was prepared, and an exterior pouch having the same shape as in Example 2 was prepared.

[Test Example]

The physical properties of Example 2 and Comparative Example 1 were compared and shown in Table 1.

Haze

Using a haze meter, the film was transmitted from the outside to the inside to measure the transparency.

The tensile strength

Using a tensile strength meter (UTM), the film was cut to a length according to a specific standard, and the both ends of 15mm X 40-50mm were hung with a clip, and the tensile strength or degree of fracture was measured.

Tear strength

Tear strength measuring instrument (UTM) was used to measure the tear while pulling both ends of the film to the clip.

Moisture permeability

Using Mocon's OTR (Oxygen transmission rate) equipment, the amount of oxygen transmitted from the outside to the inside centered on the film was measured.

Moisture reduction

Moisture reduction is a number indicating the degree of water loss in the sap during long-term storage at constant temperature. In the case of a product with a low volume, the sodium content in the sap increases, which can increase the concentration of the total sap, which can cause defects. In this experiment, an infusion bag containing 1000 mL of infusion solution was filled in an external pouch and stored at 60° C. for 5 days, and the amount of moisture reduction was evaluated by measuring and comparing the moisture reduction degree of the infusion solution contained in the infusion bag.

Item unit Comparative Example 1 (HDPE80) Example 2 Haze % 65 5 The tensile strength Kgf/mm 3(MD,TD) 5(MD), 15(TD) Tear strength Kgf 0.5(MD), 2(TD) 0.5(MD), 2.4(TD) Moisture permeability g/㎡.day 2.5g 2.2g Moisture reduction g/㎡ 3.4g 3.1g

According to the table above, in Example 2 according to an embodiment of the present invention, the tear strength, moisture permeability, and moisture reduction amount all maintained similar levels as in Comparative Example 1, while the transparency and tensile strength in the vertical direction (TD) in the unwinding direction were It can be seen that the remarkably improved. This means that when manufacturing an external pouch for an infusion bag with a film according to an embodiment of the present invention, it can not only be used in all sizes (1L, 500mL, 250mL, 100mL) of the infusion bag, but also has superior characteristics than the existing external pouch. .

10: outer layer
20: adhesive layer
30: inner floor
100: space
101: input
102, 103 and 104: sealing portion
105: tear line

Claims (15)

An outer layer comprising biaxially stretched polypropylene;
An adhesive layer comprising a solvent-free polyurethane; And
Including an inner layer that is a sealant layer comprising non-stretch heat-resistant polypropylene,
The adhesive layer is a film formed between the outer layer and the inner layer,
The solvent-free polyurethane is a solvent-free polyurethane polymer formed by mixing a main agent having a hydroxyl group and an isocyanate curing agent in a weight ratio of 10:7 to 9.9,
The sealant layer comprising the non-stretch heat-resistant polypropylene includes a triple layer stacked in order from an adhesive layer to a homopolypropylene layer, a homopolypropylene layer, and a homopropylene and random polypropylene mixture layer,
The film,
(i) Tensile strength is 3 to 7 Kgf/mm in the unwinding direction (Mechanical Direction, MD) and 10 to 20 Kgf/mm in the vertical direction (Traverse Direction, TD) of the unwinding direction;
(ii) Tear strength is 0.1 to 1 Kgf in the unwinding direction (Mechanical Direction, MD), and 2 to 3 Kgf in the traverse direction (TD) of the unwinding direction;
(iii) water permeability of 1 to 4 g/m ² ·day; And
(iv) the amount of water reduction is 2 to 4 g/m ² ;
A film that satisfies at least one of, for an external pouch of an infusion bag. delete delete The film of claim 1, wherein the homopropylene and random polypropylene mixed layer further comprises an anti-blocking agent. The film of claim 1, wherein the homopropylene and random polypropylene mixed layer further comprises a slip agent and a silicone oil. The film of claim 1, wherein the outer layer has a thickness of 30 to 50 μm. The film of claim 1, wherein the adhesive layer has a thickness of 1 to 5 μm. The film of claim 1, wherein the inner layer has a thickness of 30 to 50 μm. The film of claim 1, wherein the film has a haze of 0.1 to 10%. An outer layer comprising biaxially stretched polypropylene;
An adhesive layer comprising a solvent-free polyurethane; And
It is composed of an inner layer that is a sealant layer containing non-stretched heat-resistant polypropylene,
The adhesive layer is a film formed between the outer layer and the inner layer,
The solvent-free polyurethane is a solvent-free polyurethane polymer formed by mixing a main agent having a hydroxyl group and an isocyanate curing agent in a weight ratio of 10:7 to 9.9,
The sealant layer comprising the non-stretch heat-resistant polypropylene is a triple layer stacked in order from an adhesive layer to a homo polypropylene layer, a homo polypropylene layer, and a homopropylene and random polypropylene mixture layer,
The film,
(i) Tensile strength is 3 to 7 Kgf/mm in the unwinding direction (Mechanical Direction, MD) and 10 to 20 Kgf/mm in the vertical direction (Traverse Direction, TD) of the unwinding direction;
(ii) Tear strength is 0.1 to 1 Kgf in the unwinding direction (Mechanical Direction, MD), and 2 to 3 Kgf in the traverse direction (TD) of the unwinding direction;
(iii) water permeability of 1 to 4 g/m ² ·day; And
(iv) the amount of water reduction is 2 to 4 g/m ² ;
A film that satisfies at least one of, for an external pouch of an infusion bag. delete A space unit in which an infusion bag is stored in an interior formed by overlapping two films; And
Including an input portion formed on one side of the edge of the space portion and a sealing portion formed on the other surface excluding the input portion,
The film is the film of any one of claims 1 and 4 to 10, infusion bag exterior pouch. The infusion bag exterior pouch of claim 12, wherein the width of the sealing part with respect to the volume of 1L of the exterior pouch is 5 to 7mm. The infusion bag outer pouch according to claim 12, wherein the input unit is formed in a mechanical direction (MD) and a transverse direction (TD) of the film. The infusion bag outer pouch according to claim 14, wherein the input part comprises a tear line shown in the unwinding direction of the film.

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