Manufacturing method for packaging bags

Abstract

The present invention provides a packaging bag that prevents moisture and oxygen from penetrating from the edges of the sealed portion, even when using nonwoven fabric as an intermediate material. [Solution] The packaging bag 10 of the present invention is composed of, in order from the surface, a film laminated with aluminum foil (AL) (hereinafter referred to as the "first film") 11, an intermediate partition membrane 12 made of nonwoven fabric mainly composed of high-density polyethylene (HDPE), and a film laminated with AL and provided with easy opening properties (hereinafter referred to as the "second film") 13. The intermediate partition membrane 12 has the first film 11 and the second film 13 sealed on the front and back surfaces of the peripheral edge, forming a space 17 for containing an oxygen absorber 19 with the first film 11 and a space 18 for containing a medical device 20 with the second film 13, and is melted at 180°C or higher in the sealed portion 15.

Description

Technical Field

[0001] The present invention relates to a packaging bag in which a film laminated with an aluminum foil (AL) is sealed using a non-woven fabric mainly composed of high-density polyethylene (HDPE) as an intermediate partition film.

Background Art

[0002] Medical devices implanted in the human body need to be sterilized to prevent bacteria from having a serious impact on the human body. In addition, in order to prevent the medical device from deteriorating or its function from declining due to moisture absorption or oxidation by oxygen, it is necessary to store it with a desiccant or an oxygen absorber.

[0003] Therefore, it was common to perform a primary packaging for sterilization using an HDPE-based non-woven fabric and then perform a secondary packaging for storing with an oxygen absorber using an aluminum laminate film that can be opened.

[0004] Here, in the film subjected to the secondary packaging, there is a risk of misidentifying that the outside of the non-sterilized primary packaging is sterilized. To avoid this, a packaging bag that integrates an HDPE-based non-woven fabric and an AL laminate film, forms two spaces, and after opening one space, sterilizing it, and then putting a desiccant into the other space and sealing it has been proposed (see Patent Document 1).

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Disclosure of the Invention

Problems to be Solved by the Invention

[0006] However, the proposal in Patent Document 1 uses an AL laminate film as an intermediate material, so in order to ensure breathability, it is necessary to punch out the center and seal it with an HDPE-based nonwoven fabric, which can be time-consuming to manufacture. Therefore, there has been a demand for a packaging bag that does not require this step.

[0007] On the other hand, if the intermediate material is made solely of HDPE-based nonwoven fabric, there is a concern that moisture and oxygen may penetrate from the edges of the seal with the AL laminate film due to the breathability of the nonwoven fabric, causing the contained medical devices and oxygen absorbers to absorb moisture.

[0008] The present invention aims to provide a packaging bag that can prevent moisture and oxygen from penetrating from the edges of the sealed portion, even when a nonwoven fabric is used as the intermediate material. [Means for solving the problem]

[0009] <1> A packaging bag is provided in which a nonwoven fabric mainly composed of high-density polyethylene (HDPE) is used as an intermediate partition membrane, a film laminated with aluminum foil (AL) is sealed with a space formed on both sides of the partition membrane, and at least one side of the film is provided with easy opening properties, characterized in that the portion of the partition membrane that is sealed with the film is melted.

[0010] <2> In the aforementioned space, the medical device is housed on the side of the film that is designed for easy opening, and the oxygen absorber is housed on the other side of the film. <1> This is the packaging bag described.

[0011] <3> The melting temperature of the sealed portion is 180°C or higher. <2> This is the packaging bag described.

[0012] <4> The width of the sealed portion is 5mm to 15mm. <3> This is the packaging bag described.

[0013] <5> Both the front and back films are laminated in the following order: polyethylene terephthalate (PET), low-density polyethylene (LDPE), aluminum foil (AL), low-density polyethylene (LDPE), and linear low-density polyethylene (LLDPE). <1> from <4> It is a packaging bag as described in one of the following. [Effects of the Invention]

[0014] The packaging bag of the present invention uses a nonwoven fabric mainly composed of HDPE as an intermediate partition membrane, with a space formed on both sides of the membrane, and a film laminated with aluminum foil (AL) is sealed over it. Therefore, even if the intermediate material is only nonwoven fabric, it is possible to prevent misidentification of whether or not the product has been sterilized. Furthermore, since the portion where the films on the front and back of the nonwoven fabric are sealed is melted, moisture absorption due to the penetration of water and oxygen from this portion can be prevented. [Brief explanation of the drawing]

[0015] [Figure 1] Figure 1 is a schematic cross-sectional view showing the packaging bag of the present invention. [Figure 2] Figure 2(a) is a schematic front view of the packaging bag of the present invention, and (b) is a schematic back view thereof. [Figure 3] Figure 3 is a graph showing the change in the amount of moisture absorbed by the contents when the fusion temperature of the seal portion is changed. [Figure 4] Figure 4 is a photograph showing the appearance of the adhesion prevention film when the fusion temperature of the sealing portion is changed. [Figure 5] Figure 5 shows photographs of the cross-section of the seal portion when the fusion temperature was changed. [Modes for carrying out the invention]

[0016] Embodiments of the present invention will be described with reference to the drawings. Figure 1 is a schematic cross-sectional view of the packaging bag of the present invention, Figure 2(a) is a schematic front view of the packaging bag of the present invention, and Figure 2(b) is a schematic back view thereof.

[0017] As shown in FIG. 1, the packaging bag 10 of the present invention includes, in order from the surface, a film (hereinafter referred to as "the first film") 11 laminated with an aluminum foil (AL), and a non-woven intermediate partition film 12 mainly composed of high-density polyethylene (HDPE, polyethylene with a density of 0.942 g / cm 3 or higher polyethylene), and a film (hereinafter referred to as "the second film") 13 laminated with AL and provided with easy-opening properties.

[0018] The intermediate partition film 12 is sealed with the first film 11 and the second film 13 on the front and back surfaces of the peripheral portion. By this seal portion 15, a three-sided bag is formed inside the packaging bag 10, in which a space 17 is formed by the intermediate partition film 12 and the first film 11, and a space 18 is formed by the intermediate partition film 12 and the second film 13.

[0019] As particularly shown in FIG. 2(a), an oxygen absorber 19 is accommodated in the space 17 on the front surface side, and as particularly shown in FIG. 2(b), a medical device 20 is accommodated in the space 18 on the back surface side, preferably sterilized by ethylene oxide gas (EOG). That is, the oxygen absorber 19 and the medical device 20 are enclosed in separate locations by the seal portion 15.

[0020] When the medical device 20 is used, at the seal portion 15, the second film 13 is peeled off from the interface with the intermediate partition film 12 to be opened, and the medical device 20 is taken out.

[0021] Thus, in the packaging bag 10, the oxygen absorber 19 and the medical device 20 are accommodated in separate locations, and moreover, only the medical device 20 can be taken out by opening.

[0022] The intermediate partition membrane 12 is melted at the sealing portion 15. The HDPE-based nonwoven fabric that makes up the intermediate partition membrane 12 is breathable, but because it is melted, the breathability at the sealing portion 15 is blocked, making it difficult for moisture and oxygen to penetrate into the inside of the packaging bag 10. This prevents moisture absorption by the elements contained inside, such as the oxygen absorber 19 and the medical device 20, and in particular suppresses deterioration of the medical device 20 before use.

[0023] To melt the sealing portion 15, the sealing must be performed at a temperature of 180°C or higher. If the temperature is below 180°C, the sealing portion 15 will not melt sufficiently, and moisture and oxygen will penetrate through the permeability of the intermediate partition membrane 12, making it easier for the internal elements to absorb moisture. The melting temperature during this sealing is preferably around 200°C to 250°C, and more preferably around 200°C to 220°C. Since it is sufficient for the sealing portion 15 to melt, considering the need to avoid stressing the membrane by heating and cost considerations, a temperature of around 250°C is the preferred upper limit of the temperature.

[0024] Furthermore, the pressure and time during melting can be adjusted to match the conditions for general heat sealing, but the pressure is usually 1.0 MPa or less, preferably 0.5 MPa or less, more preferably around 0.3 MPa, and the time is usually 5 seconds or less, preferably 3 seconds or less, more preferably around 1 second.

[0025] The width of the sealing portion 15 (see 1-4 in Figure 2(a)) is preferably about 5mm to 15mm, and more preferably 5mm to 10mm. A width of 5mm or more is desirable to block the permeability of the intermediate partition membrane 12, while a width of 15mm or less is desirable from a cost perspective.

[0026] The product width W and depth L of the packaging bag 10 are not particularly limited and may be adjusted to the size of the bag in which such an anti-adhesion membrane is contained. However, for example, the width W is approximately 200 mm to 300 mm and the depth L is approximately 130 mm to 210 mm, with a width of approximately 250 mm and a depth of approximately 170 mm being preferable.

[0027] The nonwoven fabric, which serves as the intermediate partition membrane 12 and is primarily composed of HDPE, may contain trace amounts of commonly used components, provided that these do not affect its properties. As a commercially available product, for example, Tyvek (registered trademark) manufactured by DuPont is preferably used.

[0028] The first film 11 and the second film 13 are preferably constructed by laminating polyethylene terephthalate (PET), low-density polyethylene (LDPE), aluminum, low-density polyethylene (LDPE), and linear low-density polyethylene (LLDPE) in that order.

[0029] Furthermore, the second film, LLDPE, is designed to be easily opened. A suitable commercially available product for this purpose is, for example, IMX-L3-A manufactured by J Film Co., Ltd.

[0030] The total thickness of each film 11,13 is not particularly limited as long as it is usable, but is usually around 50μm to 200μm.

[0031] When manufacturing these films, there are no particular restrictions; you can simply select a commonly used laminating machine and lamination method as appropriate.

[0032] The oxygen absorber is not particularly limited as long as it is a substance that absorbs oxygen and is packaged in a gas barrier material. It may be an iron-based product consisting mainly of iron powder, zeolite, salt, activated carbon, and an oxygen absorption aid, or a non-ferrous product consisting of organic substances such as vitamin C. However, from the viewpoint of preventing moisture absorption, it is preferable to have a drying function. As a commercially available product, for example, PharmaKeep® manufactured by Mitsubishi Gas Chemical Company is suitably used.

[0033] Medical devices 20 can be any device that is implanted in the human body, without any particular restrictions, and examples include pacemakers, stents, artificial joints, and adhesion prevention membranes.

[0034] These medical devices can be any commercially available product that is appropriate for the purpose of use. For example, an adhesion prevention membrane is a sheet-like medical device that is placed inside the body after surgery to inhibit adhesion formation. Since it is broken down and absorbed within the body, a sheet made of gelatin film is usually used.

[0035] As described above, the packaging bag of the present invention can be suitably used for storing medical devices in medical applications. However, it is not limited to this and can be suitably used for various applications requiring high airtightness, such as food storage. [Examples]

[0036] The following describes embodiments of the present invention, but the present invention is not limited to these embodiments.

[0037] [Production of packaging bags] A packaging bag with the configuration shown in Figures 1 and 2 was manufactured as follows.

[0038] As a film laminated with aluminum foil (AL) (hereinafter referred to as "the first film") 11, a film was prepared by extrusion lamination in the following order: polyethylene terephthalate (PET) 12 μm, low-density polyethylene (LDPE) 15 μm, AL 9 μm, low-density polyethylene (LDPE) 15 μm, and linear low-density polyethylene (LLDPE) 50 μm.

[0039] On the other hand, a second film (hereinafter referred to as "the second film") 13, to which AL is laminated and easy-open properties are provided, was prepared by extrusion lamination in the following order: polyethylene terephthalate (PET) 12 μm, low-density polyethylene (LDPE) 15 μm, AL 9 μm, low-density polyethylene (LDPE) 15 μm, and linear low-density polyethylene (LLDPE) 50 μm with easy-open properties. For the LLDPE with easy-open properties, IMX-L3-A manufactured by J Film Co., Ltd. was used.

[0040] Furthermore, an intermediate partition membrane 12 made of nonwoven fabric mainly composed of high-density polyethylene (HDPE) has a density of 64.5 g / m². 2 We prepared Tyvek (registered trademark) manufactured by DuPont.

[0041] These were cut to a size of 250 mm in width x 170 mm in depth, an intermediate partition membrane was placed between the first film and the second film, and the front and back surfaces of the periphery of both films were heat-sealed to form a sealed portion 15, thus creating a three-sided bag.

[0042] Except for the blank example, a space 17 formed on the surface side contained PharmaKeep®, manufactured by Mitsubishi Gas Chemical Company, as an oxygen absorber 19, while a sheet of adhesion prevention membrane made of gelatin film was contained as a medical device 20 in a space 18 formed on the back side, and the opening was heat-sealed.

[0043] [Measurement of moisture absorption] After preparing the packaging bags, the weight of each sample was measured as the pre-test bag weight, and then each sample was stored in a constant temperature and humidity chamber (40°C, 90% RH environment). After storage, the weight of each sample was measured weekly until 4 weeks had passed, and the amount of moisture absorbed by the contents was calculated from the weight difference before and after the test. Furthermore, after 4 weeks, assuming that the oxygen absorber was 3g and the anti-adhesion membrane was 1g, the theoretical amount of moisture absorbed by each element was calculated from the difference with the measured values. The results are shown in Table 1. Note that the width and weight of each sample were calculated by preparing multiple samples, measuring them, and then calculating the average value.

[0044] [Measurement of seal width] The film was sealed to be roughly the same width, but there were slight differences at each of the locations 1 to 4 in Figure 2(a). Therefore, the seal width at each location of each sample was measured with a ruler. The results are shown in Table 1.

[0045] <Preparation conditions for each sample> Here, each sample used was a packaging bag prepared as described above, based on the following conditions.

[0046] (Reference example 1) The first and second films were sealed to the intermediate partition membrane at a melting temperature of 160°C, 0.3 MPa, and 1.0 second. The bag was left empty without the oxygen absorber or anti-adhesion membrane.

[0047] (Comparative Example 1) In Reference Example 1, the first and second films were sealed under the same melting conditions as in Reference Example 1, except that an oxygen absorber and an anti-adhesion membrane were included.

[0048] (Reference example 2) Without using an intermediate partition membrane, the first and second films were directly sealed at a melting temperature of 200°C, 0.3 MPa, and 1.0 second, containing the oxygen absorber and the anti-adhesion membrane.

[0049] (Example 1) In Reference Example 2, an intermediate partition membrane was placed, the first and second films were sealed to it, and an oxygen absorber was placed in the space on the surface side, and an anti-adhesion membrane was placed in the space on the back side; otherwise, the procedure was the same as in Reference Example 2.

[0050] (Example 2) In Example 1, the sealing of the first and second films to the intermediate partition membrane was performed at a melting temperature of 220°C, 0.3 MPa, and 1.0 second, except that the procedure was the same as in Example 1.

[0051] In addition, Figure 3 shows graphs measuring the change in the amount of moisture absorbed by the contents during the storage period for Comparative Example 1, Example 1, and Example 2. Furthermore, Figure 4 shows photographs of the appearance of the adhesion prevention film before testing and after 4 weeks for Comparative Example 1, Reference Example 2, Example 1, and Example 2. Figure 5 shows photographs of the sealed portions of Comparative Example 1, Example 1, and Example 2, when sealed in the same manner as each example at a melting temperature of 180°C, 0.3 MPa, and 1.0 second.

[0052] [Table 1]

[0053] As can be seen from the results in Table 1 and Figure 3, in the packaging bags of Examples 1 and 2, where the melting temperature of the seal portion was 180°C or higher, the amount of moisture absorbed by the contents remained below 0.05g even after 4 weeks, indicating almost no moisture absorption. In particular, the anti-adhesion membrane actually decreased in weight, and the absorbed moisture was completely removed by the oxygen absorber. Similar results were obtained in Reference Example 1, which did not have an intermediate partition membrane. Therefore, it is judged that by setting the melting temperature of the seal portion to 180°C or higher, the breathable intermediate partition membrane melted at the seal portion, blocking its breathability in that area and preventing the penetration of moisture and oxygen.

[0054] On the other hand, in Comparative Example 1, where the melting temperature of the sealing portion was set to 160°C, the amount of moisture absorbed by the contents after one week had already exceeded that of the Examples and Reference Examples after four weeks, indicating that the melting of the sealing portion of the intermediate partition membrane was insufficient.

[0055] Furthermore, as can be seen from the photograph in Figure 4, in Comparative Example 1, where the melting temperature was 160°C, wrinkles were clearly visible in the adhesion prevention film after 4 weeks, indicating moisture absorption. In contrast, in Examples 1 and 2 and Reference Example 2, where the melting temperature was 180°C or higher, the appearance remained almost unchanged from before the test, confirming that moisture absorption was prevented.

[0056] Furthermore, as can be seen from the photograph in Figure 5, when the melting temperature is 160°C, the whiteness of the sealing portion of the intermediate partition membrane is noticeable, but when the melting temperature is 180°C, the whiteness becomes less noticeable, and when the melting temperature is 200°C or higher, the whiteness almost disappears. Therefore, it was confirmed that when the melting temperature is 180°C, the sealing portion of the intermediate partition membrane melts.

[0057] Furthermore, the fact that the moisture absorption of the contents is based on the permeability of the intermediate partition membrane was confirmed by the fact that the amount of moisture absorbed by the contents did not differ significantly between Reference Example 2, which lacked an intermediate partition membrane, and Reference Example 1, which had an intermediate partition membrane but was an empty bag without contents.

[0058] Although embodiments and examples of the present invention have been described in detail above, the packaging bag of the present invention is not limited to the above embodiments and may include any technical ideas that can be envisioned within that scope. [Industrial applicability]

[0059] This invention is applicable to the storage of medical devices implanted in the human body. [Explanation of Symbols]

[0060] 10 packaging bags 11. AL laminated film (first film) 12 Intermediate partition membrane 13. A film (second film) to which AL is laminated and which is also made easy to open. 15. Seal portion 17,18 space 19. Oxygen absorber 20 Medical devices W width of the packaging bag L Packaging bag depth

Claims

1. A packaging bag characterized in that a nonwoven fabric mainly composed of high-density polyethylene (HDPE) is used as an intermediate partition membrane, a film laminated with aluminum foil (AL) is sealed to it with a space formed on both sides of the partition membrane, and at least one side of the film is provided with easy opening properties, wherein the portion of the partition membrane that is sealed with the film is melted.

2. The packaging bag according to claim 1, wherein a medical device is contained on the side of the film that is provided with easy opening, and an oxygen absorber is contained on the other side of the film.

3. The packaging bag according to claim 2, wherein the temperature at which the sealed portion melts is 180°C or higher.

4. The packaging bag according to claim 3, wherein the width of the sealed portion is 5 mm to 15 mm.

5. The packaging bag according to any one of claims 1 to 4, wherein the front and back films are each laminated in the following order: polyethylene terephthalate (PET), low-density polyethylene (LDPE), aluminum foil (AL), low-density polyethylene (LDPE), and linear low-density polyethylene (LLDPE).

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