A controllable peelable heat-sealing film for sterilization packaging of medical devices and its preparation method

Abstract

The present invention discloses a controllable peelable heat-sealing film for sterilization packaging of medical devices and a preparation method thereof. The heat-sealing film can be heat-sealed with medical dialysis paper base paper or coated dialysis paper (6) to prepare a paper-plastic bag for sterilization packaging of medical devices. The opening peeling force and opening interface of the paper-plastic bag are controllable, and the integrity of the paper-plastic bag seal can be judged by the layer separation and color change on the film at the peeling position. The structure comprises: a PET plastic base film (1) having two surfaces, a front side and a back side, wherein the front side is a printable surface (2); the back side is a heat-sealing layer (3), and the heat-sealing layer (3) is composed of a primer layer (4) coated on the PET plastic base film (1) and a surface adhesive layer (5) coated on the primer layer (4). Using an anilox roller coater, the selected primer layer (4) and surface adhesive layer (5) are sequentially coated on the back side of the PET plastic base film. After passing the test, the film is cut and packaged to obtain the product.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical packaging materials, and in particular relates to a controllably peelable heat-sealing film for sterilization packaging of medical devices and a preparation method thereof. Background Art

[0002] Currently, plastic heat-sealing films used for medical device sterilization packaging are typically made by co-extruding different plastic particles and then biaxially stretching them. Other methods involve combining different plastic films using composite adhesives. The most commonly used plastic heat-sealing films for medical device sterilization packaging are composite films made of PE / PET and CPP / PET. PE / PET composite films are widely used for heat-sealing with medical dialysis paper to make bags for gas sterilization of common medical devices, and are the most important composite heat-sealing films for paper-plastic sterilization bags.

[0003] Medical dialysis paper, due to its high quality and low price, is widely used in combination with PE / PET composite films for gas sterilization packaging of medical devices. Traditionally, heat-sealing bags using composite heat-sealing films require a pre-coating of the base paper with a heat-sealing adhesive to create the coated dialysis paper. This is then heat-sealed with the PE / PET composite film. Therefore, PE / PET composite heat-sealing films and coated dialysis paper are essential components of traditional paper-plastic bags.

[0004] Although the above-mentioned composite membrane materials and coated dialysis paper are relatively mature, their shortcomings are also obvious.

[0005] First, the use of the above-mentioned traditional composite heat-sealing film, because the film contains multiple layers of plastic, is not conducive to the environmental protection requirement of reducing the amount of plastic in packaging materials. At the same time, the manufacturing equipment requirements for co-extrusion stretching or lamination are high, the process is complex, and the cost is high.

[0006] The heat sealing performance of traditional composite heat-sealing films also needs to be improved. For example, the PE plastic layer that makes up the heat sealing surface of the composite film often fluctuates in heat sealing strength and stability with the coated dialysis paper due to different specifications. This is one of the key factors that prevent the peeling effect of the heat-sealed bag from maintaining a stable and controllable state. The peeling force attenuates or increases, resulting in uncontrollable peeling effect.

[0007] Medical dialysis paper base paper used to make sterilization paper-plastic bags generally cannot be directly heat-sealed with composite film to make bags. It needs to be coated with heat-sealable adhesive that can be heat-sealed. This increases the cost of using dialysis paper. Due to the addition of the adhesive layer, the air permeability of the dialysis paper decreases, and the sterilization efficiency is reduced. In reality, it is difficult to ensure that the quality specifications of dialysis paper from different manufacturers are completely consistent. As a result, after the adhesive-coated dialysis paper and composite film are heat-sealed to make bags, defects such as paper tearing, paper scraps falling, and unclear peeling often occur when peeling, affecting normal use.

[0008] As can be seen from the above, traditional heat-sealing methods using composite heat-sealing films and coated dialysis paper suffer from the problem of uncontrollable heat-seal strength and peeling force, and the peeling interface cannot be determined. For example, peeling can occur within the adhesive layer, between the adhesive and the film, between the adhesive and the paper, or simultaneously within the adhesive layer, between the adhesive film, and between the adhesive paper. This makes the peeling interface unclear and difficult to control, and it is difficult to ensure a smooth opening to avoid paper scrap contamination.

[0009] The integrity and reliability of traditional paper-plastic bag seals are usually judged by observing traces of glue transferred to the composite film after the paper-plastic bag is peeled off. Sometimes, because the adhesion between the glue and paper is greater than the adhesion between the glue and the film, the glue on the dialysis paper cannot be completely transferred to the film, resulting in inaccurate judgment. Therefore, it is necessary to innovate the judgment method.

[0010] The invention patent with application number: CN201910794266.0 provides a new type of self-sealing and self-breaking paper-plastic packaging composite material, which is an excellent innovative packaging material. The base material involved is dialysis paper. The paper-plastic composite paper prepared by co-extrusion with other plastics has better peeling performance than the plastic coated paper used on the market. This paper-plastic heat-sealing material with dialysis paper as the base material can be used to make sterilization packaging bags for some medical consumables, which are commonly known as "paper-paper bags". Due to the limitations of material properties, this type of paper-paper bag cannot replace the paper-plastic bags used in large quantities on the market. The measures involved in improving the peeling properties cause the peeling surface to break in its own layer. Although the peeling effect is better than that of the corresponding coated paper, there is still room for improvement.

[0011] In the practice of sterilization packaging for medical devices, the requirements for packaging bags, such as peel force, opening performance, and sealing methods, are extremely specific and differ significantly from those for packaging bags in other fields. Different medical devices, sterilization bags of different shapes and sizes, and different sterilization methods all require different peel forces, often with personalized requirements requiring specific peel forces and performance. Traditional paper-plastic bags made by heat-sealing with coated dialysis paper and composite films are difficult to quantitatively design and control the peel force, and the peel interface is difficult to precisely control. Summary of the Invention

[0012] In view of the shortcomings of the existing technology, the present invention provides a controllable peeling heat-sealing film for sterilization packaging of medical devices and a preparation method thereof, which expands the scope of application. The heat-sealable dialysis paper includes not only medical dialysis paper base paper or non-hot-melt coated dialysis paper, but also traditional hot-melt coated glued dialysis paper. The paper-plastic bag made with the heat-sealable film realizes the controllable design of the peeling force of the paper-plastic bag, realizes the controllable positioning of the opening interface, achieves a smooth opening without paper breakage or paper scraps, improves the gas permeability of the traditional paper-plastic heat-sealable bag, and changes the judgment basis of the traditional paper-plastic bag on the integrity and reliability of the sealing: that is, the layer separation and color change of the film at the interlayer peeling point are used to judge whether the sealing effect of the paper-plastic bag is complete and reliable, and at the same time achieves the purpose of reducing the amount of plastic in traditional packaging materials, so that various comprehensive performances are further improved.

[0013] To achieve the above objectives, the present invention is implemented through the following technical solutions.

[0014] A controllable peelable heat-sealing film for sterilization packaging of medical devices and a preparation method thereof. The heat-sealing film can be heat-sealed with medical dialysis paper base paper or coated dialysis paper (6) to prepare a paper-plastic bag for sterilization packaging of medical devices. The opening peeling force and opening interface of the paper-plastic bag are controllable, and the integrity of the paper-plastic bag seal can be judged by the layer separation and color change on the film at the peeling position. The structure comprises: a PET plastic base film (1) having two surfaces, a front side and a back side, wherein the front side is a printable surface (2); and the back side is a heat-sealing layer (3), which is composed of a primer layer (4) coated on the PET plastic base film (1) and a surface adhesive layer (5) coated on the primer layer (4).

[0015] A controllable peelable heat-sealing film for sterilization packaging of medical devices and a preparation method thereof, wherein the primer layer (4) is formed by coating with a coating and has high adhesion to a PET plastic base film (1), wherein the adhesion resin in the coating comprises at least one of acrylic resin, polyurethane resin, polyester resin, and other grafted modified resins; the coating may or may not contain microcrystalline wax, wax emulsion, and inorganic filler; and contains at least one of a wetting agent, a leveling agent, a defoaming agent, and a rheological additive.

[0016] A controllable peelable heat-sealing film for sterilization packaging of medical devices and a preparation method thereof, wherein the surface adhesive layer (5) is coated with at least one of a solid hot-melt adhesive resin material, an organic solvent-based hot-melt adhesive resin coating, and a water-based hot-melt adhesive resin coating, and the surface adhesive layer (5) contains at least one of an inorganic filler, a pigment, and a dye.

[0017] A controllable peelable heat-sealing film for sterilization packaging of medical devices and a preparation method thereof. The coated dialysis paper (6) refers to dialysis paper with a hot-melt coating or a non-hot-melt coating coated on the surface of a medical dialysis paper base paper.

[0018] A controllable peelable heat-sealing film for sterilization packaging of medical devices and a preparation method thereof, wherein after heat-sealing the heat-sealing film and medical dialysis paper base paper or coated dialysis paper (6), the interlayer peeling force is: the peeling force F between the PET plastic base film (1) and the bottom coating (4) is 1 / 4 , the peeling force F between the primer layer (4) and the topcoat layer (5) 4 / 5 , the peeling force F between the surface adhesive layer (5) and the medical dialysis paper base paper or coated dialysis paper (6) 5 / 6 , while satisfying: F 1 / 4 >F 4 / 5 、F 5 / 6 >F 4 / 5 、F 1 / 4 ≥4N / 15mm, F 5 / 6 ≥3N / 15mm, 1.3N / 15mm≦F 4 / 5 ≦8.0N / 15mm; thus, the raw materials of the primer layer (4) and the surface adhesive layer (5) are selected to achieve a quantitative selection of the heat-sealing peeling force between the heat-sealing film and the medical dialysis paper base paper or the coated dialysis paper (6) within the range of 1.3N / 15mm to 8.0N / 15mm, thereby achieving controllable peeling force and controllable peeling interface between the primer layer (4) and the surface adhesive layer (5).

[0019] A controllable peelable heat-sealing film for sterilization packaging of medical devices and a preparation method thereof. The preparation method of the heat-sealing film can be applied to the surface of a PET plastic base film (1) by full coating or frame coating. The steps include: ① first, according to the actual needs of different medical devices and sterilization bags of different shapes and sizes, determining the target peeling force between the heat-sealing film and the selected dialysis paper heat-sealing bag, that is, the peeling force F between the base coating layer (4) and the surface adhesive layer (5) 4 / 5 The design value is in the range of 1.3N / 15mm≦F 4 / 5 ≦8.0N / 15mm;②Then according to F 4 / 5 The materials of the base coat (4) and the top coat (5) are screened to meet the requirements of F 1 / 4 >F 4 / 5 、F 5 / 6 >F 4 / 5 、F 1 / 4 ≥4N / 15mm, F 5 / 6 ≥3N / 15mm; ③ Use an anilox roller coater to apply the selected primer (4) to the reverse side of the selected PET plastic base film (1), and check the F 1 / 4 After passing the test, the selected topcoat (5) is coated on the basecoat (4) using an anilox roller coater; the basecoat (4) and the topcoat (5) can be coated once or multiple times using the corresponding coatings. ④ Check F 4 / 5 and F 5 / 6Check the value, flatness of the heat-sealed peeling area and the color change of the peeling area. After passing the test, cut and package the product.

[0020] Compared with the traditional composite heat-sealing film, the present invention has the following advantages: because the composite heat-sealing layer composed of the base coating and the surface adhesive layer is used, the peeling force between each layer can be designed by selecting the material, thereby determining the peeling strength of the overall heat-sealed bag, achieving controllable peeling force, and thus designing various paper-plastic bags that meet specific peeling requirements; because the relative size of the peeling force of each layer is designed, the peeling interface when the packaging bag is opened occurs between the base coating (4) and the surface adhesive layer (5), thereby achieving controllable peeling force and peeling interface, and the peeling interface is clean, flat, hygienic and reliable, thereby avoiding the change in interlayer peeling strength caused by the change in the type of substrate such as dialysis paper and membrane, resulting in unqualified phenomena such as unclear peeling, paper scraps falling or paper breaking. The heat-sealing film can not only be heat-sealed with the traditional hot-melt coated dialysis paper to make bags, but can also be directly heat-sealed with dialysis paper base paper and other non-hot-melt coated dialysis paper to make bags. The paper-plastic bags produced have better air permeability than traditional paper-plastic bags and have more efficient gas sterilization efficiency. The separation of layers and the change of color of the film at the interlayer peeling point can clearly determine whether the seal of the paper-plastic bag is complete and reliable, which is of great significance for the safety judgment of sterilization packaging. The heat-sealing film reduces the heat-sealing plastic layer and achieves the purpose of reducing the amount of plastic in traditional composite films. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is a schematic diagram of the structure of a heat-sealing film with controlled peeling for sterilization packaging of medical devices; Figure 2 The diagram is a structural diagram of heat sealing of a heat-sealing film and dialysis paper base paper or coated dialysis paper for sterilization packaging of medical devices with controlled peeling. DETAILED DESCRIPTION

[0022] In order to further illustrate the present invention, the present invention is described below with reference to the accompanying drawings.

[0023] like Figure 1 As shown, a controllable peelable heat-sealing film for sterilization packaging of medical devices and a preparation method thereof, the heat-sealing film can be heat-sealed with medical dialysis paper base paper or coated dialysis paper (6) to prepare a paper-plastic bag for sterilization packaging of medical devices, the opening peeling force and opening interface of the paper-plastic bag are controllable, and the integrity of the paper-plastic bag seal can be judged by the layer separation and color change on the film at the peeling position; its structure comprises: a PET plastic base film (1), divided into two surfaces, a front side and a back side, the front side being a printable side (2); the back side being a heat-sealing layer (3), the heat-sealing layer (3) consisting of a primer layer (4) coated on the PET plastic base film (1) and a surface adhesive layer (5) coated on the primer layer (4).

[0024] In the embodiment, the PET plastic base film (1) is selected from polyethylene terephthalate packaging grade film with a thickness of 0.01 to 0.015 mm. Other relevant selected materials are shown in Table 1.

[0025]

[0026] Material description in Table 1: 1. Primer: The commercially available acrylic acid system PET primer in the table is an ester-soluble primer, the commercially available polyurethane system PET primer is a water-based primer, and the commercially available polyester system PET primer is an ester-soluble primer, containing corresponding acrylic resin, polyurethane resin, polyester resin, and a wetting and leveling agent. Shanghai Wanhan PET water-based primer is a PET water-based primer produced by Shanghai Wanhan Industrial Co., Ltd., whose adhesion resin is other grafted modified resins and contains a wetting and leveling agent. 2. Surface adhesive layer (5): The A / B blended adhesive in the table is a commercially available two-component general-purpose water-based heat seal adhesive for medical device packaging (invention publication number CN108251016A) produced by Shanghai Wanhan Industrial Co., Ltd., consisting of component A adhesive and component B adhesive, with 3% by weight of blue water-based dye colorant added, and formulated according to the selected peeling force requirements. The numbers are ①, ②, and ③ respectively. The commercially available imported medical water-based heat seal adhesive is a dialysis paper heat seal adhesive from Henkel, Germany, numbered ④. The design scheme of the embodiment is shown in Table 2.

[0027]

[0028] Heat sealing film coating process: Use a gravure anilox roller coater to apply the selected primer layer (4) to the reverse side of the PET plastic base film and check the F 1 / 4 After passing the test, the selected surface adhesive layer (5) is coated on the base coating layer (4) using a gravure anilox roller coater, and the F 4 / 5 and F 5 / 6 The primer layer and the topcoat layer can be coated with the corresponding coating once or multiple times according to the value and heat seal peeling state to achieve the appropriate coating dry weight. After passing the test, the coating is cut and packaged to obtain this product.

[0029] The heat-sealing films and selected dialysis paper of the above embodiments were subjected to heat sealing tests on a heat sealing tester using the following conditions: heat sealing temperature: 160°C, heat sealing pressure: 0.5 MPa, and heat sealing time: 1 second. The heat-sealed samples were then subjected to a 180-degree peel test on a tensile tester to determine their peel strength. The test results are shown in Table 3: Performance Test Table of Various Embodiments.

[0030]

[0031] The above embodiments and accompanying drawings clearly and completely describe the concept, specific structure and technical effects of the present invention, so as to fully understand the purpose, features and effects of the present invention. The above embodiments are only preferred embodiments of the present invention and are not intended to limit the present invention. Other modifications and variations obtained by those skilled in the art without creative work are within the scope of protection of the present invention. The various technical features of the present invention can be combined interchangeably without conflict.

Claims

1. A controllable peelable heat-sealing film for sterilization packaging of medical devices, characterized in that: The heat-sealing film is heat-sealed with medical dialysis paper to prepare a paper-plastic bag for sterilization packaging of medical devices. The opening peeling force and opening interface of the paper-plastic bag are controllable, and the integrity of the paper-plastic bag seal can be judged by the layer separation and color change on the film at the peeling point. Its structure comprises: a PET plastic base film (1) having two surfaces, a front surface and a back surface, wherein the front surface is a printable surface (2) and the back surface is a heat-sealing layer (3), and the heat-sealing layer (3) is composed of a primer layer (4) coated on the PET plastic base film (1) and a surface adhesive layer (5) coated on the primer layer (4); After the heat-sealing film is heat-sealed with the base paper of the medical dialysis paper, the interlayer peeling forces are: the peeling force between the PET plastic base film (1) and the bottom coating (4) is F1 / 4, the peeling force between the bottom coating (4) and the top adhesive layer (5) is F4 / 5, and the peeling force between the top adhesive layer (5) and the base paper of the medical dialysis paper is F5 / 6; At the same time, the following conditions are satisfied: F1 / 4>F4 / 5, F5 / 6>F4 / 5, F1 / 4≥4N / 15mm, F5 / 6≥3N / 15mm, 1.3N / 15mm≦F4 / 5≦8.0N / 15mm; thus, the raw materials of the primer layer (4) and the top adhesive layer (5) are selected to achieve a quantitative selection of the heat-sealing peeling force between the heat-sealing film and the medical dialysis paper base paper within the range of 1.3N / 15mm~8.0N / 15mm, thereby achieving controllable peeling force and controllable peeling interface between the primer layer (4) and the top adhesive layer (5).

2. The controllable peelable heat-sealing film for sterilization packaging of medical devices according to claim 1, characterized in that: The primer layer (4) is formed by coating with a coating and has high adhesion to the PET plastic base film (1). The adhesion resin in the coating comprises at least one of acrylic resin, polyurethane resin, polyester resin, and other grafted modified resins; the coating may or may not contain microcrystalline wax, wax emulsion, and inorganic filler; and contains at least one of a wetting agent, a leveling agent, a defoaming agent, and a rheological additive.

3. The controllable peelable heat-sealing film for sterilization packaging of medical devices according to claim 1, characterized in that: The surface adhesive layer (5) is formed by coating at least one of a solid hot melt adhesive resin material, an organic solvent-based hot melt adhesive resin coating, and a water-based hot melt adhesive resin coating, and the surface adhesive layer (5) contains at least one of an inorganic filler, a pigment, and a dye.

4. A method for preparing a controllable peelable heat-sealing film for sterilization packaging of medical devices, for preparing the controllable peelable heat-sealing film for sterilization packaging of medical devices according to any one of claims 1 to 3, characterized in that: The heat-sealing film is coated on the surface of the PET plastic base film (1) by full coating or frame coating, comprising the following steps: ① First, according to the actual needs of different medical devices and sterilization bags of different shapes and sizes, determine the target peeling force between the heat-sealing film and the selected dialysis paper heat-sealing bag, that is, the design value of the peeling force F4 / 5 between the base coating (4) and the surface adhesive layer (5), which is in the range of 1.3N / 15mm≦F4 / 5≦8.0N / 15mm; ② Then, according to the value of F4 / 5, the materials of the base coating (4) and the top adhesive layer (5) are selected to meet the requirements of F1 / 4>F4 / 5, F5 / 6>F4 / 5, F1 / 4≥4N / 15mm, and F5 / 6≥3N / 15mm; ③ Using an anilox roller coater, apply the selected base coat (4) to the reverse side of the selected PET plastic base film (1), check F1 / 4, and after passing the test, apply the selected top coat (5) to the base coat (4) using an anilox roller coater; the base coat (4) and the top coat (5) are coated with corresponding coatings once or multiple times; ④ Check the values ​​of F4 / 5 and F5 / 6, the flatness of the heat-sealed peeling area, and the color change at the peeling area. If they meet the requirements, cut and package them. This is the product.

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