KR20200090444A - Outer pouch film for infusion solution bag - Google Patents

Abstract

The present invention relates to an outer pouch film for an infusion solution bag, which has improved transparency while satisfying basic physical properties such as heat resistance, tearing property, and moisture reduction rate of an existing outer pouch for an infusion solution bag. The present invention also relates to an outer pouch for an infusion solution bag comprising the same. The film according to the present invention satisfies the requirements as an outer pouch for an infusion solution bag, and ensures improved transparency, so that it is easy to detect foreign substances or residues contained in the infusion solution bag.

Description

Film for outer pouch {Outer pouch film for infusion solution bag}

This specification describes the film for the exterior pouch of the sap bag with improved transparency.

The sap bag generally used in the medical field requires a higher level of oxygen and moisture barrier properties, flexibility, printability, and rigidity than a container for storing a normal liquid. Polyvinyl chloride (PVC)-based resins have been commonly used as the plastic material used for the sap bag, but endocrine disrupting substances (environment hormones) are generated in the PVC sap bag, and a large amount of dioxin is generated during incineration. As confirmed, the development of a non-PVC sap bag to replace it is being made.

The non-PVC-based sap bag that has been recently used has a polyolefin-based multi-layer structure, but in most cases, there is a limitation in sterilization heat resistance, lack of flexibility and moldability, and requires an external pouch (secondary pouch) to store it. do.

In the case of the conventional universal sap bag exterior pouch, it is composed of a combination of a high-density polyethylene copolymer and a linear low-density polyethylene, so the tearability due to external force is good, but it has an opaque appearance, which makes it possible for the sap bag stored inside. It has a problem that it is difficult to detect impurities after filling.

In recent years, as the amount of fluid used has increased, claims have been generated in hospitals or medical facilities that use it without checking foreign matter in the fluid, or when foreign matter is detected after opening the external pouch. This is a part directly related to medical stability, and it is required to develop a transparent packaging film that can be detected in advance by visually confirming the above problems.

Republic of Korea Utility Model Publication No. 20-0471558 relates to a tube-type pouch film made of a high-density polyethylene resin, which has an opaque appearance characteristic, and thus has a problem in that it is difficult to detect impurities after filling the sap bag. Republic of Korea Patent Publication No. 10-1014196 relates to the manufacture of a transparent sap outer pouch produced by an inflation method using as a main component a polypropylene resin having excellent transparency and heat resistance, and the polymer chain is induced in orientation in the machine direction to tear The back is excellent, but there is a problem that transparency is poor when crumpled by external force.

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

In one aspect, the problem to be solved by the present invention is to satisfy the basic properties such as heat resistance, tear resistance, and moisture reduction rate of the existing sap bag exterior pouch at the same level, and improve the transparency of the sap bag exterior pouch film and sap containing the same It is to provide a bag exterior pouch.

In one aspect, the present invention is an outer layer comprising a biaxially stretched polypropylene; An adhesive layer comprising a solventless polyurethane; And an inner layer, which is a sealant layer comprising a 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 exterior pouch of an infusion bag.

In another aspect, the present invention is a space portion in which the sap bag is stored inside the film formed by overlapping the two sheets; And it provides a sap bag exterior pouch comprising an input portion formed on one surface of the edge of the space portion and a sealing portion formed on the other surface except for the input portion.

In one aspect, the film according to the present invention is excellent in heat resistance, tear resistance, moisture reduction rate, etc., and satisfies the requirements as a pouch for storing the sap, but improves transparency, making it easy to detect foreign substances or residues contained in the sap bag. In addition, two foreign substance detection steps, which are generally performed before manufacture and sterilization of the pouch and before shipment, can be reduced to one step, thereby eliminating the overlapping process.

1 is a schematic view showing the layer structure of the film for the exterior pouch of the sap bag according to an embodiment of the present invention.
Figure 2 is a schematic view showing a cross-section of the exterior pouch of the sap 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.

Figure 1 shows an exemplary form of the present invention. Referring to Figure 1, the film according to one embodiment is for the outer pouch of the sap bag, the outer layer 10 comprising a biaxially stretched polypropylene, the adhesive layer 20 containing a solvent-free polyurethane, and a non-stretched heat-resistant poly It may include an inner layer 30 that is a sealant layer containing propylene. Or the film according to one embodiment is to be composed of an outer layer 10 comprising a biaxially stretched polypropylene, an adhesive layer 20 containing a solvent-free polyurethane, and an inner layer 30 which is a sealant layer comprising an unstretched heat-resistant polypropylene. 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 containing unstretched propylene by including bi-axially oriented polypropylene (BOPP). Accordingly, wrinkles due to high heat may be prevented during the production of the film, and the external pouch manufactured using the film maintains strength so that tearing can be more smoothly performed when opening by applying an external force to a tear line. Can. In one embodiment, the thickness of the outer layer may be 30 to 50㎛. If the thickness exceeds 50㎛, it is easy to process the pouch, but there is a problem that flexibility is reduced and it is difficult to tear.If the thickness is less than 30㎛, the bottom side when sealing both sides and bottom of the pouch with high heat when processing the pouch using the film The heat transfer rate to the sealant layer is increased, and appearance defects in which wrinkles are generated 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 subject having a hydroxyl group and an isocyanate curing agent. The subject is a polyol. In the polyurethane polymer, a urethane bond (-NHCOO-) is formed by reaction of a hydroxyl group (-OH) and an isocyanate group (-NCO), and the outer layer and the inner layer can be effectively bonded through a reaction between each functional group. . In addition, the oily adhesive is not suitable for medical packaging materials such as fluids, because the transparency of the film decreases upon lamination and requires thorough management of the solvent remaining after aging, whereas the present invention provides a solvent-free polyurethane polymer that does not use an organic solvent. Since it is included as an adhesive, it is possible to improve the transparency of the film, making it suitable as a material for external pouch for infusion. The solvent-free polyurethane may be, for example, a solvent-free polyurethane polymer formed by mixing a subject having a hydroxyl group and an isocyanate curing agent in a weight ratio of 10:7 to 9.9, and more specifically, a subject having a hydroxyl group and an isocyanate 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, curing may not be properly performed, which may result in deterioration of physical properties due to the residual of uncured reactants. As an embodiment, the thickness of the adhesive layer may be 1 μm to 5 μm, and more specifically 2 μm to 4 μm. The thickness is the thickness of the final adhesive layer on which the adhesive is applied to the film, dried and aged, and if the thickness is less than 1 μm, the film interlayer may be peeled due to low adhesive strength, and when the thickness is more than 5 μm, coating may be difficult. .

As an embodiment, the sealant layer as the inner layer may include a non-stretched polypropylene (CPP) having improved heat resistance. Since non-stretched polypropylene is excellent in transparency and moisture resistance, it is suitable as a material for external pouch for infusion. Conventionally, unstretched polypropylene has been used as a heat-adhesive layer, but as a skin layer, ter-polypropylene (Ter-PP) or random polypropylene (Random PP) is used, and a low thermal melting (melting point) of up to 145~150℃ ) It has a temperature, it fills the sap bag during manufacturing as an external pouch, and when it undergoes a sterilization process, the sap bag and the blocking bag having the same polypropylene material at a high temperature of 121°C and 30 minutes (actual chamber residence time is 2 hours) are blocked. There is a problem that the quality of the product is deteriorated by generating adhesion.

In order to improve this, the sealant layer according to an embodiment of the present invention may include a triple layer stacked in the order of a homo polypropylene layer, a homo polypropylene layer, and a mixture of homo propylene and random polypropylene from the adhesive layer. The middle layer consists of a coextrusion structure. The homo polypropylene is composed of only a single bond of propylene and has excellent tensile strength, tear strength, etc., and has a high melting point of 160° C., but has heat resistance, but does not have sealing properties, for example, heat adhesion. Accordingly, according to the present invention, by stacking a mixed layer of homo propylene and random polypropylene in a certain ratio on the innermost layer of a film of an external pouch in which a sap bag is embedded, the sap bag is embedded with a high heat resistance, and when it undergoes a sterilization process, anti-reaction with the sap bag is prevented. It has a blocking function and 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 homo propylene and random polypropylene are mixed in a weight ratio of 3 to 5: 5 to 7. The inner layer may be produced using a casting or browning facility as an embodiment. As an embodiment, the thickness of the inner layer (sealant layer) may be 30 to 50 μm. The thicker the thickness of the inner layer compared to the total thickness of the film, the better the flexibility, but there is a problem that the work has to be performed at a higher temperature than during normal pouch processing according to the use of a heat-resistant resin. It should be sealed at about 180~190℃ by raising the temperature of about 20~30℃ compared to the current working level, but this high temperature may cause wrinkles to be generated in the pouch.

As an embodiment, the mixed layer may further include an anti-blocking agent, and the anti-blocking agent may include, without limitation, as long as it is commonly used in films 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 a silicone oil, and in this case, the slip property is improved, so that when the sap bag is filled in the external pouch, the input can be made smoothly. . The slip agent may be included without limitation as long as it is commonly used in films in the technical field of the present invention. The slip agent and the silicone oil are likely to cause migration when added in excess, and preferably, may be included at a concentration of 1000 ppm or less, more specifically 700 to 900 ppm.

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

As an embodiment, the tensile strength of the film for the exterior pouch 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 Traverse Direction (TD) in the unwinding direction. Can be

As an embodiment, the tear strength of the film for the exterior pouch may be 0.1 to 1 Kgf for the mechanical direction (MD), and 2 to 3 Kgf for the vertical direction (TD) of the unwinding direction. .

In the case of the external pouch (outer bag) of the normal sap bag, the moisture reduction rate is about 5 to 7 days in a thermo-hygrostat at 60°C, RH25% after packing the normal sap bag in the outer pouch and storing it. By comparison, when the degree of water loss of the sap solution is confirmed, generally 5 g/m ² is required when the sap is 1 L. This is because, if there is a lot of water loss, the concentration of the sap becomes darker, and problems may occur when it is injected into the human body. As an embodiment, the moisture permeability of the film for the exterior pouch 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 a sap bag exterior pouch, and the attached FIG. 2 shows an exemplary form of the sap bag exterior pouch of the present invention. Referring to FIG. 2, the sap bag exterior pouch according to an embodiment includes a space portion 100 in which a sap bag is stored inside a film formed by overlapping two films; And a non-sealing portion 101 formed on one side of the edge of the space portion and a sealing portion 102, 103, and 104 formed on the other side except for the input portion 101. In this case, the film may be a film for the sap bag exterior pouch described above.

In one embodiment, the outer pouch is not limited in its shape as long as it is an envelope capable of filling or embedding the sap bag, for example, it may be in the form of a square envelope. For example, when the shape of the external pouch is a square envelope shape, the pouch may be in the form of an envelope in which three sides of the edge of the space portion, that is, both side and bottom portions are sealed, as shown in FIG. 2. The present invention provides an external pouch in the form of an envelope as an embodiment, thereby making it possible to omit the bag processing process of the sap bag manufacturer, thereby reducing process costs and eliminating risk factors such as uneven sealing that may occur during inline bag production. Can.

As one embodiment, the input portion 101 of the exterior 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 sap bag therein, an external force is applied in the vertical direction of the input part, so that the pouch can be easily torn, and opening is easy. In addition, if the width of the sealing portion is too thin, the volume of the external pouch may be large, while the force withstanding the weight of the filled sap bag may be weak, and if the width is too thick, there is a problem that the filling operation of the sap bag is not easy. The width of the sealing portion may be adjusted according to the volume of the exterior pouch or the size or weight of the sap bag to be embedded. For example, when the total volume of the exterior pouch is 1 L, a sealing strength of about 2 kgf/15 mm or more is required, and at this time, the width of the sealing portion may be about 5 to 7 mm.

As an embodiment, the exterior 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 tear lines may be included in the input portion 101 and/or the opposite sealing portion 103 of the input portion 101.

As an embodiment, the method of manufacturing the exterior pouch for the sap bag includes: manufacturing an outer layer including biaxially stretched polypropylene and an inner layer that is a sealant layer including unstretched 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 sheets of the prepared film and sealing the remaining surface except one surface of the edge.

The film according to the above embodiments of the present invention has improved transparency while satisfying the same level of physical properties in terms of basic properties such as heat resistance, tear resistance, and moisture reduction rate, compared to an opaque film applied to an existing sap bag exterior pouch. It is easy to visually observe foreign substances and remnants contained in the sap to be built in the furnace. Specifically, by laminating the outer layer containing the biaxially stretched polypropylene and the inner layer (silent layer) containing the non-stretched polypropylene, the inner layer contacting the sap bag is provided in a three-layer structure including a heat-resistant copolymer resin. , It removes the blocking (sticking) that occurs in the sterilization process at high temperature and high pressure with the sap bag (inner bag) containing the sap and improves transparency, and it is easily torn by fabricating the pouch in the direction of the fabric, that is, the release direction of the film You can implement

Hereinafter, the present invention will be described in detail with reference to Examples, Comparative Examples and Test Examples. These are only provided by way of example to explain the present invention in more detail, the scope of the present invention is not limited by these examples, comparative examples and test examples for those skilled in the art It will be self-evident.

[Example 1]

The sap bag exterior pouch film according to one embodiment of the present invention was prepared according to the following method.

First, a sealant film including a biaxially oriented polypropylene (BOPP) film and a heat-resistant reinforced non-stretched polypropylene (CPP) was prepared to prepare a film for an exterior pouch. The sealant layer was manufactured by casting a homo-polypropylene layer as a casting method, a homo-polypropylene layer as an intermediate layer, and a triple layer in which a homo-propylene and random polypropylene mixed layer was laminated as the innermost layer.

Then, a non-solvent (non-solvent type) polyurethane adhesive was applied to the sealant film 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 produced 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 sap bag exterior pouch according to the embodiment of the present invention was manufactured according to the following method.

The film for the exterior pouch prepared in Example 1 was sealed in the form of a square envelope by sealing both ends and the bottom, except for the upper part, by using a heat-sealing mold manufactured according to the exterior pouch standard of a 1000 mL sap bag. Then, two notches were processed at the input and the bottom, respectively, to prepare an external pouch for the sap bag as shown in FIG. 2.

[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, thereby preparing an exterior pouch having the same shape as in Example 2.

[Test Example]

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

Haze

The transparency was measured by transmitting from the outside of the film to the inside using a haze meter.

The tensile strength

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

Tear strength

Tear was measured by pulling both ends of the film on the clip using a tear strength meter (UTM).

Moisture permeability

Using an OTR (Oxygen transmission rate) facility of Mocon, the amount of oxygen permeated from the outside to the inside of the film was measured.

Moisture reduction

The amount of water loss is a value indicating the degree of water loss in the fluid during long-term storage at constant temperature. In the case of a product with a small capacity, the sodium content in the fluid increases, which may increase the concentration of the entire fluid, which may cause defects. In this experiment, an external pouch was filled with an infusion bag containing 1000 mL of sap and stored at 60°C for 5 days, and the amount of water reduction was evaluated by weighing and comparing the degree of moisture reduction of the sap 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/㎡ 3.4 g 3.1g

According to the above table, Example 2 according to an embodiment of the present invention maintains a level similar to Comparative Example 1 in both tear strength, water permeability, and water loss, while maintaining the level of transparency and tensile strength in the vertical direction (TD) of the annealing direction. It can be confirmed that it has significantly improved. This means that the film according to one embodiment of the present invention is not only usable in the entire specification (1L, 500mL, 250mL, 100mL) of the sap bag when the external pouch for the sap bag is manufactured, but also has better properties than the existing external pouch. .

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

Claims (15)

An outer layer comprising biaxially stretched polypropylene;
An adhesive layer comprising a solventless polyurethane; And
It includes an inner layer that is a sealant layer comprising a non-stretched heat-resistant polypropylene,
The adhesive layer is formed between the outer layer and the inner layer,
Film for exterior pouch of infusion bag. The film according to claim 1, wherein the solvent-free polyurethane is a solvent-free polyurethane polymer formed by mixing a main group having a hydroxyl group and an isocyanate curing agent in a weight ratio of 10:7 to 9.9. According to claim 1, wherein the sealant layer,
A film comprising a homo-polypropylene layer, a homo-polypropylene layer, and a triple layer laminated in a homo-propylene and random polypropylene mixed layer order from the adhesive layer. The film of claim 3, wherein the random polypropylene layer further comprises an anti-blocking agent. The film of claim 3, wherein the random polypropylene 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 thickness of the inner layer is 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 solventless polyurethane; And
It consists of an inner layer, which is a sealant layer comprising a non-stretched heat-resistant polypropylene,
The adhesive layer is formed between the outer layer and the inner layer,
Film for exterior pouch of infusion bag. The method of claim 10, wherein the sealant layer,
The film which is a triple layer laminated|stacked from the adhesive layer in the order of a homo polypropylene layer, a homo polypropylene layer, and a homo propylene and a random polypropylene mixed layer. A space part in which the sap bag is stored inside the film formed by overlapping two films; And
Includes an input portion formed on one surface of the edge of the space portion and a sealing portion formed on the remaining surface excluding the input portion,
The film is a film of any one of claims 1 to 11, the sap bag exterior pouch. The sap bag exterior pouch of claim 12, wherein the sealing portion width for a volume of 1 L of the exterior pouch is 5 to 7 mm. The sap bag exterior pouch of claim 12, wherein the input part is formed in a mechanical direction (MD) and a transverse direction (TD) of the film. The sap bag exterior pouch according to claim 14, wherein the input part includes a tear line shown in an unwinding direction of the film.

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