JP2010105714A - External bag - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an external bag that prevents contents from being soiled during excessive bleeding out of a slipping agent, and prevents a roll from being soiled during filling, and excels in oxygen barrier property. <P>SOLUTION: The external bag is formed by heat-fusing peripheral edges of opposed heat fusible layers of a packaging material in which each heat-fusible layer is laid, via an adhesive layer, over a single or laminated film that has oxygen barrier properties. In the external bag, the heat fusible layer is formed of a polyolefin resin, and contains ethylenebis oleic acid amide and a silica antiblocking agent. The thickness of the external bag is 50 to 90 μm and slippage is smaller than 0.5. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to an outer bag having an oxygen barrier property used for storing a packaging bag filled with an easily oxidizable content, and particularly for storing a soft bag filled with a chemical solution such as infusion in the medical and pharmaceutical fields. It is related with the exterior bag used suitably as.

  In the medical and pharmaceutical fields, various qualities that are not available in general packaging bags are required as exterior bags for storing soft bags filled with chemical solutions such as amino acid infusions, sugar / electrolyte infusions, and Ringer's solutions. Examples include hygiene without the attachment of harmful substances and bacteria, oxygen barrier properties to protect the contents from oxidation, non-migration to prevent foreign matter from transferring to the contents, non-contamination in the filling line, low-temperature sealability, Quality such as easy filling (sliding). In particular, strict standards are imposed on non-migration due to the nature of the contents.

  A conventional exterior bag is a laminated packaging bag in which at least an oxygen barrier layer and a heat-sealing layer are laminated, and the heat-sealing layer is represented by a phenol-based or phosphorus-based compound that prevents thermal oxidation during film formation. Anti-oxidant, anti-blocking agent (hereinafter abbreviated as AB agent) typified by silica and synthetic zeolite, which prevents the adhesion (blocking) between the packaging materials at the time of winding, and imparts bag-making suitability and filling suitability Therefore, it is made of a polyolefin resin containing various additives such as a slip agent typified by fatty acid amide and a heat stabilizer typified by calcium stearate.

  Most slip agents impart slipperiness by moving through the polymer and moving to the surface of the heat-fusible layer that contacts the contents. Conventionally, erucic acid amide, an unsaturated fatty acid monoamide, has been widely used as a slip agent, but erucic acid amide has a melting point of 82 ° C. and can easily move in a polymer even at a relatively low temperature. It is known that the liquid may be transferred from the surface of the layer to an infusion bag as a stored item, and may further move to the content liquid by moving through the packaging material of the infusion bag. An excessive bleed out of erucic acid amide has a problem that it may cause contamination of the inner solution, laminating process, and roll contamination on the filling line, as well as lamination inhibition and sealing inhibition.

  In order to solve the above problems, the amount of fatty acid amide is reduced as much as possible, a large amount of AB agent is added to supplement conventional slipperiness, the type of AB agent is changed, and the density of polyolefin is increased. Things have been implemented. However, there are concerns that increasing the AB agent may result in inferior transparency of the heat-welded layer, weak physical strength, and weak seal strength. Furthermore, raising the density of the polyolefin causes problems that the low-temperature sealability is lowered and the filling line suitability is deteriorated.

The polyethylene-based laminate for laminating described in Patent Document 1 is a laminate that is used as a heat-sealing layer by being bonded to a base, and has been proposed for the purpose of improving slipperiness and low-temperature sealability. As described in the claims, this laminate is a laminate formed into a multilayer by a coextrusion method having a sealant layer on one side and a laminate surface on the opposite side of the sealant layer, the Young's modulus of the laminate is at 1500 kgf / cm ² or more, a range sealant layer the average density of 0.880~0.915g / cm ³ of the laminate, more than 50% by weight of the resin constituting the sealant layer A layer composed of a linear low density polyethylene resin, and a layer in which the average density is 0.915 g / cm ³ or more and 50% by weight or more is a linear low density polyethylene resin is laminated in the structure of the laminate. It is the polyethylene-type laminated body for lamination characterized by the above-mentioned. In Examples of Patent Document 1, 0.15 parts by weight of erucic acid amide, 0.15 parts by weight of ethylenebisoleic acid amide with respect to polyethylene-based resin 100 as a sealant layer, 1.0 AB agent (average particle size 8 μm, spherical, synthetic zeolite) is used. Part by weight added. It is described that 0.15 parts by weight of erucic acid amide and 0.15 parts by weight of ethylenebisoleic acid amide are added to the intermediate layer 100 based on the polyethylene resin 100.

Moreover, the polyethylene-type laminated body for laminating described in Patent Document 2 is a laminated body used as a heat-sealing layer by being bonded to a base, similarly to the laminated body described in Patent Document 1, and similarly slippery. It has been proposed for the purpose of improving the low temperature sealability. As described in the claims, this laminate is a polyethylene-based film formed in multiple layers by a coextrusion method having a sealant layer on one side and a laminate layer on the opposite side of the sealant layer. A laminate comprising a resin, wherein the laminate has a Young's modulus of 1500 kgf / cm ² or more, and the sealant layer of the laminate has an average density of 0.880 g / cm ^{3 to} 0.915 g / cm ³ . , more than 50 wt% of the resin constituting the sealant layer is a linear low density polyethylene resin, also polyethylene resin layer other than the sealant layer, at an average density of 0.920 g / cm ³ or more, The sum of the thicknesses is 50% to 90% of the total thickness of the laminate, and all layers other than the laminate layer have at least 100 weight of each polyethylene resin as an organic additive. Erucic acid amide 0.5 parts by weight and ethylenebisoleic acid amide 2.0 parts by weight are added, and the laminate surface of the laminate has a surface wettability of 38 dyne / cm or more by surface treatment. It is the polyethylene-type laminated body for lamination characterized by the above-mentioned.

Since the polyethylene-based laminates described in Patent Document 1 and Patent Document 2 both have sufficient slipperiness and waist strength, they have good filling suitability and sealing properties. Although it is useful as a packaging bag, there is a risk of excessive bleedout due to the excessive amount of slip agent, especially erucamide, and strict standards such as outer packaging bags for pharmaceuticals. It does not conform to.
JP 11-198323 A Japanese Patent No. 3882682

  The subject of this invention is providing the exterior bag excellent in oxygen barrier property which does not produce the contamination of the contents which generate | occur | produce by excessive bleed-out of a slip agent, and the roll dirt at the time of filling.

  As means for solving the above-mentioned problems, the invention according to claim 1 is directed to heat fusion of a packaging material in which a heat-sealing layer is laminated on a single layer or laminated film having oxygen barrier properties via an adhesive layer. An outer packaging bag in which peripheral portions are heat-sealed with facing layers facing each other, the heat-sealing layer is made of a polyolefin-based resin, contains ethylene bisoleic acid amide and a silica-based antiblocking agent, and has a thickness of It is an exterior bag characterized by being 50-90 micrometers and sliding property being less than 0.5.

  The invention according to claim 2 is characterized in that the contents of ethylenebisoleic acid amide and silica-based antiblocking agent contained in the heat-fusible layer are 1000 ppm or less and 20000 ppm or less, respectively. 1. The exterior bag according to 1.

  Further, in the invention according to claim 3, the adhesive forming the adhesive layer is a two-component urethane resin adhesive, and the adhesive layer is cured by warm curing the laminated packaging material, and ethylene The outer bag according to claim 1 or 2, wherein bleed-out of bisoleic acid amide to the surface of the heat-fusible layer is promoted.

  The outer bag according to the present invention has a peripheral layer heat-sealed by facing the heat-sealing layers of a packaging material in which a heat-sealing layer is laminated on a single layer or laminated film having an oxygen barrier property via an adhesive layer. A heat-seal layer made of a polyolefin resin, containing an ethylenebisoleic acid amide and a silica antiblocking agent, having a thickness of 50 to 90 μm and a slipperiness of 0.5. It is an exterior bag characterized by being less than, and since it can avoid excessive use of erucamide that is easy to bleed as a slip agent, it can avoid various problems caused by bleed out of the slip agent It becomes possible.

  In addition, since there is a single layer or laminated film having an oxygen barrier property on the opposite side of the heat fusion surface of the heat fusion layer, the slip agent cannot move through this layer, and heat fusion Since the bleed-out is concentrated on the surface of the layer, even if a small amount is added, the function can be sufficiently exerted, and the amount of the slip agent added can be small. Furthermore, since the thickness of the heat-sealing layer is set to 50 to 90 μm, the absolute amount of slip agent contained in the heat-sealing layer is reduced, and it is essential to avoid problems caused by excessive slip agent bleed-out. Is possible.

  Moreover, blocking at the time of winding of the packaging material film by addition of the silica-based AB agent and blocking of the heat-fusible layers after bag making were prevented, and the slipping property of the heat-fusible layer was less than 0.5. As a result, various aptitudes in the filling line can be satisfied.

  In addition, when the contents of ethylenebisoleic acid amide and silica-based antiblocking agent contained in the heat-fusible layer are 1000 ppm or less and 20000 ppm or less, respectively, extremely severe, represented by an outer bag of a pharmaceutical soft bag For applications that require quality standards, it is possible to stably satisfy the required standards.

  In addition, the adhesive that bonds the heat fusion layer and the oxygen barrier layer is a two-component urethane resin adhesive, and the adhesive layer is cured by warm curing the laminated packaging material, and the ethylene bisoleic acid amide In an outer bag characterized by accelerating bleed-out to the surface of the heat-sealing layer, warm curing can almost completely complete the adhesive layer and intensive bleed-out of the slip agent. As a result, the lead time from production to shipment of the packaging material can be shortened. Further, there is little change in quality over time after shipment, and a product with stable quality can be supplied.

  Hereinafter, the best mode for carrying out the outer bag according to the present invention will be specifically described with reference to the drawings. FIG. 1 is a schematic cross-sectional view showing one embodiment of a packaging material used for an exterior bag according to the present invention. As the printing substrate layer 1, stretched films for packaging materials marketed by various companies such as polyethylene terephthalate resin film (PET), stretched polypropylene resin film (OPP), stretched nylon film (ONy), and the like can be used. Although there is no restriction | limiting in particular about the thickness of various films, About 30 micrometers or less are appropriate for a PET film, About 20-40 micrometers for an OPP film, About 10-30 micrometers for an ONy film are suitable. The surface of the printing substrate layer 1 can be subjected to printing that represents a pattern or information related to the contents.

The oxygen barrier layer 2 may be a gas barrier film that exhibits a gas barrier property by depositing a metal oxide such as aluminum oxide or silicon oxide on the same film as the film used for the printing substrate layer 1. A single gas barrier film such as an ethylene-vinyl alcohol copolymer film (EVOH) or a polyvinyl alcohol film (PVA) may be used. These single barrier films have excellent barrier properties against oxygen, but water vapor permeates, whereas gas barrier films deposited with metal oxides also have excellent barrier properties against water vapor. It can be preferably used for applications requiring this standard.

  In addition, the gas barrier film deposited with metal oxide has a high effect of blocking the migration of the slip agent used for the heat fusion layer, and the slip agent added to the heat fusion layer is concentrated on the heat fusion surface side. This is more preferable because it has the effect of bleeding out.

  In the embodiment shown in FIG. 1, the printing base material layer 1 and the oxygen barrier layer 2 are separate films and are laminated by the adhesive layer 4. It may also serve as a role.

  Examples of the heat fusion layer 3 include unstretched polyolefin resins such as a low density polyethylene resin film (LDPE), a linear low density polyethylene resin film (LLDPE), a medium density polyethylene resin film (MDPE), and a polypropylene resin film (PP). Film can be used. In addition, ethylene resins such as ethylene / vinyl acetate copolymer, ethylene / α-olefin copolymer, propylene / ethylene random copolymer, propylene / ethylene block copolymer, propylene / α-olefin copolymer, etc. Polypropylene resin films can also be used.

  It is desirable that at least ethylene bisoleic acid amide is added as a slip agent to these heat fusion layers 3 at 100 ppm or more and 1000 ppm or less, more preferably 250 ppm or more and 750 ppm or less. If it is less than 100 ppm, the slip property may be insufficient, and if it is more than 1000 ppm, the bleed-out amount of the slip agent to the surface of the heat-fusible layer is too large, and sufficient laminate strength in the lamination process with the oxygen barrier layer. There is a case where a lamination hindrance that does not occur occurs, a seal hindering that a sufficient sealing strength does not occur during the bag making process, or a roll contamination due to a slip agent occurs during the laminating process or filling process. Furthermore, the slip agent may shift to the soft bag content liquid, which is an internal solution, and cause contamination of the content liquid. Since the molecular weight of ethylenebisoleic acid amide is about 1.5 times that of erucic acid amide, which is widely used as a slip agent, the diffusion rate in the polymer is slow, so the above problem is unlikely to occur. Special care must be taken when using it as an external bag for medical soft bags.

  In addition, it is preferable to add 2000 ppm to 20000 ppm of a silica-based AB agent to the heat fusion layer 3, and more preferably 5000 ppm to 15000 ppm. If the AB agent is less than 2000 ppm, the anti-blocking effect may be insufficient, and blocking may occur depending on the storage conditions. On the other hand, when it exceeds 20000 ppm, there is a risk that the lamination is hindered or the seal strength is insufficient. As the AB agent, when a commonly used porous material such as zeolite is used, the slip agent may be selectively trapped in the internal space, and the effect of the slip agent may be hindered. It is desirable to use a system AB agent.

  The thickness of the heat sealing layer 3 is preferably 50 μm or more and 90 μm or less, and the slipperiness is preferably less than 0.5. The slip property is a numerical value represented by tan θ by a test method based on JIS P8174. If the slip property is 0.5 or more, the slip property may be insufficient and a problem may occur in filling suitability. If the thickness of the heat-fusible layer 3 is less than 50 μm, it is difficult to make the slip property less than 0.5, and if the thickness exceeds 90 μm, the absolute amount of the slip agent increases. Slip agent bleed-out can be excessive, possibly leading to contamination of the contents.

For the adhesive layers 4 and 5, one liquid or two generally used for dry lamination
A liquid curable urethane-based adhesive can be used, and the coating amount during drying is preferably about ² to 3 g / m ² from the viewpoint of adhesive strength and good slipperiness. If the coating amount is too small, the adhesive strength is insufficient, and problems such as delamination may occur in the bag making process. Moreover, when there is too much application quantity, the slip agent contained in a heat sealing | fusion layer is absorbed by an adhesive bond layer, and there exists a possibility that slipperiness may not fully be exhibited.

  Since the adhesive strength gradually increases with time (aging) after processing as a characteristic of urethane adhesives, after dry lamination, store in an environment of 40 ° C to 50 ° C for about 1 to 2 days for warm curing It is desirable to do. By performing the warm curing, the curing of the adhesive layer is promoted and the bleed out of the slip agent is promoted. Therefore, at the end of the warm curing, the original packaging material in terms of laminate strength, slipperiness, etc. The performance is almost exhibited, and thereafter, the change in performance over time is reduced, so that a product with stable quality can be obtained.

  When warm curing is not performed, especially at low temperatures such as in winter, if the lead time from production of packaging materials to use is not sufficient, slipperiness associated with the development of laminate strength and bleed-out of slip agent May be delayed, causing problems in the bag making process and filling process.

  As the most preferable embodiment of the outer bag according to the present invention, a thin heat-sealing layer to which a small amount of slip agent is added is used, and it is included in the heat-sealing layer by performing warm curing. By promoting the bleed-out of the slip agent, the necessary minimum amount of the slip agent can be concentrated on the surface of the heat-sealing layer to ensure the necessary slip and at the same time prevent the slip agent from transferring to the contents. It becomes possible.

  FIG. 2 is a schematic view showing a usage pattern of the outer bag according to the present invention. The outer bag 10 according to the present invention is a seal portion 9 in which the heat sealing layer surfaces of the packaging material 7 as shown in FIG. In this example, after the soft bag 8 which is the contents is stored, the opening is heat-sealed to obtain a finished product.

  When the contents are stored (filled) in the outer bag, if the inner surface of the outer bag does not have a certain level of slipperiness, the suitability (fillability) will be inferior. It is necessary to add a slip agent to the layer. However, the outer surface of the soft bag 8 is in direct contact with the surface of the heat-sealing layer 10 which is the inner surface of the outer bag 10. Therefore, if additives such as slip agents are present at a high concentration on the surface of the heat-sealing layer, depending on the storage conditions. This additive may penetrate the soft bag packaging material and reach the inner solution, which is a big problem.

  Since the slip agent that has reached the inner solution exists as insoluble fine particles in the inner solution, it can be easily detected by a fine particle measuring device (particle counter).

Hereinafter, based on an Example and a comparative example, the exterior bag concerning the present invention is explained still more concretely. The basic configurations of the packaging materials in the examples and comparative examples 1 to 5 are common, and in the comparative examples 1 to 4, only the specifications of the heat-sealing layer are different. Moreover, in the comparative example 5, the specification of AB agent is different.
(Basic configuration) Printing substrate layer / adhesive layer / oxygen barrier layer / adhesive layer / heat-bonding layer Printing substrate layer: OPP, FORM manufactured by Futamura Chemical Co., Ltd., thickness 30 μm
Oxygen barrier layer: Transparent vapor deposition gas barrier film, Toppan Printing Co., Ltd. GL-E, PET12
μm base adhesive layer: two-component curable urethane adhesive, manufactured by Mitsui Chemicals Polyurethanes Co., Ltd. A525 / A52 Dry coating amount 3 g / m ²
Thermal fusion layer: Metallocene LLDPE, Evolue SP202 manufactured by Prime Polymer Co., Ltd.
0, density 0.915 g / cm ³ , MFR 2.2 g / 10 min, thickness 60 μm
Slip agent: Ethylene bisoleic acid amide, Nippon Oil & Fats Co., Ltd. Alflow AD-28
1-F, 500 ppm
AB agent: Silica, Silica manufactured by Fuji Gel Sales Co., Ltd., average particle diameter of 2-3 μm, 10,000
ppm

The specification was based on the basic structure of the packaging material.
Hereinafter, for the comparative example, only the specifications different from the basic configuration or the noticeable specifications will be described.
<Comparative Example 1>
Thermal fusion layer thickness: 60 μm
Slip agent: No addition <Comparative Example 2>
Thermal fusion layer thickness: 60 μm
Slip agent: erucic acid amide (Nippon Yushi Co., Ltd. Alflow P-10), 500 ppm <Comparative Example 3>
Thermal fusion layer thickness: 40 μm
Slip agent: Same as basic configuration <Comparative Example 4>
Thermal fusion layer thickness: 100 μm
Slip agent: Same as basic composition <Comparative Example 5>
Thermal fusion layer thickness: 60 μm
Slip agent: Same as basic composition AB agent: Synthetic zeolite, average particle size 8μm, spherical shape

Using the packaging materials of Example 1 and Comparative Examples 1 to 5, an exterior bag for an infusion bag having an unsealed opening was prepared, and the following items were evaluated.
<Evaluation items and evaluation methods>
(Measurement of slipperiness): Static friction coefficient of heat sealing layer surface of packaging material, inclination angle method according to JIS P8174, no tan θ aging, after aging at 23 ° C. × 7 days, and after aging at 50 ° C. × 2 days . Aging at 50 ° C. × 2 days corresponds to warm curing.
(Evaluation of filling suitability): The filling suitability of a sample subjected to aging at 50 ° C for 2 days was evaluated in an actual infusion bag filling line.
○: No problem, Δ: Less than 10% filling failure occurred, X: More than 10% filling failure occurred (insoluble fine particle measurement): For a sample subjected to aging at 50 ° C. × 2 days, a commercially available infusion bag (Otsuka) Aminotripa No. 2 manufactured by Pharmaceutical Factory Co., Ltd. was housed and stored for 6 months in an environment of 40 ° C. and 75% RH, and then insoluble fine particles in the liquid content were measured with a particle counter. The number of specimens was n = 3.
Measuring instrument: Light blocking automatic particle measuring device KL-04
Fine particle limit: Number of fine particles of 10 μm or more: 25 particles / mL or less
Number of fine particles of 25 μm or more: 3 particles / mL or less Comparative Example 1 was used as a blank, and the difference from this was also used as a criterion.
○: All specimens were below the limit value. △: Only one specimen out of the three specimens was below the limit value. It was.

According to the results shown in Table 1, the outer bag of Example 1 had a slipperiness of 0.5 or less after warm curing and showed good filling suitability. Insoluble fine particles were also below the limit value in all samples. In Comparative Example 1 in which the slip agent is not added, tan θ indicating the static friction coefficient is 0.6 or more and the slipperiness is poor, so there is a problem in filling suitability. However, insoluble fine particles are naturally below the limit value. .
In Comparative Example 2 in which the type of slip agent was changed to erucic acid amide, the slip agent has the property of easily bleeding out, so the slipperiness is 0.5 or less regardless of the presence or absence of aging, and the filling suitability is good However, in the measurement of insoluble fine particles, it exceeded the standard and failed. In Comparative Example 3 in which the thickness of the heat-fusible layer was 40 μm, the slip agent was insufficient because the absolute amount of the slip agent was insufficient, and the filling suitability was poor. In Comparative Example 4 in which the thickness of the heat-sealing layer was 100 μm, the absolute amount of the slip agent was too large, and a sample exceeding the limit value in insoluble fine particle measurement was generated. Further, in Comparative Example 5 in which the AB agent was changed to zeolite, the slip agent was adsorbed by the AB agent and was insufficient, so that the slipperiness was inferior and there was a slight problem in filling suitability.

It is the cross-sectional schematic diagram which showed one embodiment of the packaging material used for the exterior bag which concerns on this invention. It is the schematic diagram which showed the usage pattern of the exterior bag which concerns on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Printing base material layer 2 ... Oxygen barrier layer 3 ... Heat-fusion layer 4 ... Adhesive layer 5 ... Adhesive layer 6 ... Laminated film 7 ... Packaging material 8 ... Soft bag 9 ... Seal 10 ... Exterior bag

Claims (3)

  An outer packaging bag in which a thermal fusion layer of a packaging material in which a thermal fusion layer is laminated via an adhesive layer on a single layer or laminated film having an oxygen barrier property, the thermal fusion layers of the packaging material are opposed to each other and the peripheral portion is thermally fused. The heat-sealing layer is made of a polyolefin-based resin, contains ethylene bisoleic acid amide and a silica-based antiblocking agent, has a thickness of 50 to 90 μm, and has a sliding property (inclination angle: tan θ JIS P8174 compliant) of 0. The exterior bag characterized by being less than 5.   2. The exterior bag according to claim 1, wherein the contents of the ethylenebisoleic acid amide and the silica-based antiblocking agent contained in the heat-fusible layer are 1000 ppm or less and 20000 ppm or less, respectively.   The adhesive that forms the adhesive layer is a two-component urethane resin adhesive, and by curing the laminated packaging material warmly, the adhesive layer is cured and the ethylenebisoleic acid amide heat sealing layer surface The bleed-out of the outer bag according to claim 1 or 2, wherein the bleed-out is promoted.

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