Medical packaging blue film for 134°C pressure steam sterilization and preparation method thereof

Abstract

The present invention discloses a medical packaging blue film for 134°C pressure steam sterilization and a preparation method thereof, belonging to the field of medical sterilization packaging technology. The blue film is composed of the following layers: a 29-29.5% polyester layer, a 2.5-3% glue layer, a corona layer, a 40.5-41% intermediate layer, and a heat seal layer; the mass ratio of the corona layer, intermediate layer, and heat seal layer is 1:3:1; the intermediate layer is composed of the following components: 74.6-88.6% homopolypropylene, 3-5% blue transparent masterbatch, 5-15% elastomer, 2-6% nucleating agent, and 0.3-0.5% antioxidant; the elastomer is DF810 or DF940, and the nucleating agent is NAM-98 masterbatch; the heat seal layer is composed of the following components: 79-94% copolymerized polypropylene, 5-20% elastomer, and 0.5-1% lubricant. The present invention can achieve clean separation of the blue film from medical dialysis paper and reduce the probability of bag bursting during pressure steam sterilization.

Description

Technical Field

[0001] The present invention relates to the technical field of medical sterilization packaging, in particular to a medical packaging blue film for 134° C. pressure steam sterilization and a preparation method thereof. Background Art

[0002] With the continuous improvement of medical technology, doctors and patients are paying more and more attention to infection control. Medical high-temperature paper-plastic bags are commonly used packaging materials in hospital disinfection supply centers or third-party disinfection and sterilization agencies. They have the following advantages: medical staff can operate them easily, the color change of the chemical indicator card in the bag can be clearly seen through the film, and they can effectively block air and bacteria to ensure the sterility of surgical instruments for 180 days.

[0003] Chinese invention patent CN111941983A discloses a composite film for medical paper-plastic bags and a medical paper-plastic bag. The composite film includes: a heat-resistant layer and a heat-sealing layer. The heat-sealing layer is composed of a composite layer, an intermediate layer and a heat-sealing layer. The heat-resistant layer and the composite layer are connected by an adhesive layer. The composite layer: 30-50 parts by weight of random copolymer polypropylene, 20-40 parts by weight of maleic anhydride grafted polypropylene, and 0.5-1 part by weight of an anti-aging agent; the intermediate layer: 60-80 parts by weight of block copolymer polypropylene, 20-30 parts by weight of random copolymer polypropylene, 1-1.5 parts by weight of an anti-aging agent, and 1-1.5 parts by weight of an antistatic agent; and the heat-sealing layer: 30-50 parts by weight of homopolypropylene, 20-28 parts by weight of LDPE, 10-20 parts by weight of random copolymer polypropylene, 1-1.5 parts by weight of a slip agent, 0.8-1.2 parts by weight of an anti-aging agent, and 1-1.5 parts by weight of an antistatic agent.

[0004] The medical high-temperature paper-plastic bags disclosed in the aforementioned patents and the common medical high-temperature paper-plastic bags currently on the market have the following problems: 1. Lining often occurs when the composite film is removed after sterilization, causing secondary contamination of surgical instruments and increasing the risk of infection for patients; 2. These bags often burst during pressure steam sterilization, leading to sterilization failure and increasing the workload of medical staff. Therefore, it is particularly important to develop a medical packaging blue film with a certain heat-seal strength that can not only prevent the bag from breaking during high-temperature sterilization, but also prevent linting and shedding when removed. Summary of the Invention

[0005] The technical problem to be solved by the present invention is: to overcome the shortcomings of the existing technology and provide a medical packaging blue film for 134°C pressure steam sterilization and a preparation method thereof. When packaging surgical instruments, it can ensure that the blue film and medical dialysis paper have a certain heat sealing strength, and after sterilization, the blue film and medical dialysis paper can be cleanly peeled off without linting, thereby reducing the probability of patient infection; and the probability of bag bursting during saturated pressure steam sterilization can be reduced.

[0006] The technical solution of the present invention is:

[0007] In one aspect, the present invention provides a medical packaging blue film for 134°C pressure steam sterilization, which is composed of the following layers arranged in sequence in the following mass percentages:

[0008] Polyester layer 29-29.5%

[0009] Glue layer 2.5-3%

[0010] corona layer

[0011] Middle layer 40.5-40.8%

[0012] heat seal layer;

[0013] The mass ratio of the corona layer, the middle layer and the heat seal layer is 1:3:1;

[0014] The middle layer is composed of the following components by mass percentage: homopolypropylene 74.6-88.6%, blue transparent masterbatch 3-5%, elastomer 5-15%, nucleating agent 2-6%, and antioxidant 0.3-0.5%; wherein the elastomer of the middle layer is DF810 or DF940 produced by Mitsui Chemicals, and the nucleating agent is NAM-98 masterbatch produced by Chenghe Technology Co., Ltd.;

[0015] The heat sealing layer is composed of the following components in percentage by mass: 79-94% copolymerized polypropylene, 5-20% elastomer, and 0.5-1% lubricant.

[0016] Adding a certain amount of elastomer to the heat-seal layer not only improves the mechanical properties of the CPP film but also enhances the peelability of the film from medical dialysis paper. This is because the addition of a certain amount of elastomer to the PP particles creates an "island structure" at the interface when hot-sealing the film with the medical dialysis paper. This can be simply understood as not fully sealing the film and the paper, thus improving the peelability of the film from the paper. However, the higher the elastomer addition, the better. When the elastomer addition is too high, the seal is likely to be loose, and the resulting paper-plastic bag is prone to bursting during the sterilization process. When the elastomer is omitted or the addition is too low, the seal is prone to blocking. Therefore, the amount of elastomer added is crucial. In the present invention, an elastomer addition of 5-20% in the heat-seal layer achieves excellent results for paper-plastic bags, ensuring good peelability between the film and medical dialysis paper (reducing the probability of bursting during sterilization) while also preventing linting and shedding when the paper-plastic bag is torn open after sterilization.

[0017] Preferably, the polyester layer is a 12 μm thick biaxially oriented polyester film for composite use produced by Fuwei Film (Shandong) Co., Ltd.

[0018] Preferably, the glue layer adopts AB type solvent-free polyurethane glue produced by Kangda New Materials (Group) Co., Ltd.

[0019] Preferably, the corona layer is made of random copolymer polypropylene, such as F800EDF produced by Sinopec Shanghai Petrochemical Co., Ltd.

[0020] Preferably, the homopolymer polypropylene of the middle layer is HD601CF produced by Borealis; and the blue transparent masterbatch is BL0122 masterbatch produced by Shandong Luyan Masterbatch Co., Ltd.

[0021] Preferably, the antioxidants of the intermediate layer are 1010 and 168 produced by BASF.

[0022] Preferably, the copolymer polypropylene of the heat sealing layer is CF309 produced by Hanwha Total Petrochemical or DY-W0723F produced by PetroChina Dushanzi Petrochemical Company.

[0023] Preferably, the lubricant of the heat seal layer is oleamide produced by Korea Paiswell or Croda Corporation or erucamide masterbatch produced by Shandong Haiman Tuobang Chemical Technology Co., Ltd.

[0024] Preferably, the elastomer of the heat sealing layer is DF810 or DF940 produced by Mitsui Chemicals.

[0025] The resin raw materials, functional additives and processing additives used in the present invention all meet food grade requirements, and the produced blue film can be used for packaging of medical devices.

[0026] On the other hand, the present invention also provides a preparation method for the above-mentioned medical packaging blue film for 134°C pressure steam sterilization. After the raw materials of the corona layer, the intermediate layer and the heat sealing layer are evenly mixed, the three-layer co-extruded cast film equipment is subjected to an extrusion process, a cooling and shaping process, a thickness measurement process, a corona process, a deflection process, a trimming and winding process and an aging process to obtain a three-layer co-extruded cast CPP film. The CPP film has uniform thickness, good flatness, no crystal points, low haze and high transparency; the CPP film and the polyester layer are composited with a glue layer on a solvent-free composite equipment to obtain a medical packaging blue film for 134°C pressure steam sterilization.

[0027] The corona layer of the CPP film produced by the present invention has a dyne value of ≥38 through corona treatment. By adding a blue transparent masterbatch to the intermediate layer, a blue transparent film can be obtained in a one-step casting process, eliminating the need to add color powder to adjust the film color during subsequent dry lamination. By adding elastomers, nucleating agents, and antioxidants, the toughness, strength, transparency, and service life of the film can be effectively improved. By adding a lubricant and an elastomer to the heat-sealing layer, it can be heat-pressed with medical dialysis paper in a bag-making machine to produce a medical high-temperature paper-plastic bag with a certain heat-sealing strength, which can ensure that the bag will not break during high-temperature sterilization and will not cause linting when the blue film is removed, allowing for clean separation between the two.

[0028] When the blue film of the present invention is used to prepare medical high-temperature paper-plastic bags, the prepared blue film is cut according to size and then hot-stitched with medical dialysis paper through a bag-making machine to obtain medical high-temperature paper-plastic bags.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] The medical packaging blue film of the present invention can ensure that the blue film and the medical dialysis paper have a certain heat sealing strength when packaging surgical instruments. After sterilization, the blue film and the medical dialysis paper can be cleanly peeled off without linting, which is convenient for medical staff to package and take surgical instruments, meets the requirements of hospital sterilization applications, and can reduce the probability of patient infection. In addition, the prepared CPP film has good temperature resistance. At the same time, by optimizing the preparation method, the peeling force between the blue film and the medical dialysis paper is increased, thereby reducing the probability of the medical packaging blue film bursting during saturated pressure steam sterilization. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a schematic structural diagram of the medical packaging blue film of the present invention.

[0032] In the figure, 1. Medical packaging blue film; 2. CPP film; 3. Polyester layer; 4. Glue layer; 5. Corona layer; 6. Middle layer; 7. Heat seal layer. DETAILED DESCRIPTION

[0033] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention.

[0034] Example 1

[0035] The preparation method of the medical packaging blue film 1 for 134°C pressure steam sterilization in this embodiment is as follows: the components of the corona layer 5, the intermediate layer 6 and the heat-sealing layer 7 shown in Table 1 are mixed and evenly blended, and then subjected to an extrusion process, a cooling and shaping process, an automatic thickness measurement process, a corona process, a deflection process, a trimming and winding process, and an aging process on a three-layer co-extrusion cast film equipment (Guangdong Shicheng Plastic Machinery Co., Ltd.) to obtain a CPP film 2. The CPP film 2 is composited with a polyester layer 3 using a solvent-free glue on a solvent-free composite equipment, and then the composite is aging to obtain a medical packaging blue film 1 (structure as shown in FIG. Figure 1 As shown). The glue amount is 1.5g / m 2 The curing temperature is 40℃, the curing humidity is 50%, and the curing time is 48h.

[0036] Table 1 Components and mass percentages of each layer of the medical packaging blue film 1 of Example 1

[0037]

[0038] Example 2

[0039] The difference between this embodiment and embodiment 1 is that the components of each layer of the medical packaging blue film 1 and their mass percentages are shown in Table 2.

[0040] Table 2 Components and mass percentages of each layer of the medical packaging blue film 1 of Example 2

[0041]

[0042] Example 3

[0043] The difference between this embodiment and embodiment 1 is that the components of each layer of the medical packaging blue film 1 and their mass percentages are shown in Table 3.

[0044] Table 3 Components and mass percentages of each layer of the medical packaging blue film 1 of Example 3

[0045]

[0046] Example 4

[0047] The difference between this embodiment and embodiment 1 is that the components of each layer of the medical packaging blue film 1 and their mass percentages are shown in Table 4.

[0048] Table 4 Components and mass percentages of each layer of the medical packaging blue film 1 of Example 4

[0049]

[0050] Example 5

[0051] The difference between this embodiment and embodiment 1 is that the components of each layer of the medical packaging blue film 1 and their mass percentages are shown in Table 5.

[0052] Table 5 Components and mass percentages of each layer of the medical packaging blue film 1 of Example 5

[0053]

[0054] Comparative Example 1

[0055] The difference from Example 2 is that no elastomer is added to the intermediate layer 6 and the heat-sealing layer 7 .

[0056] Comparative Example 2

[0057] The difference from Example 2 is that no nucleating agent is added to the intermediate layer 6 .

[0058] Comparative Example 3

[0059] The difference from Example 2 is that the elastomer of the intermediate layer 6 and the heat-sealing layer 7 and the nucleating agent of the intermediate layer 6 are not added.

[0060] The performance of the CPP film 2 in Examples 1-5 and Comparative Examples 1-3 was tested, and the test results are shown in Table 6:

[0061] Table 6 Performance test results of CPP film 2 in Examples 1-5 and Comparative Examples 1-3

[0062]

[0063] The performance of the medical packaging blue film 1 of Examples 1-5 and Comparative Examples 1-3 was tested, and the test results are shown in Table 7:

[0064] Table 7 Performance test results of medical packaging blue film 1 of Examples 1-5 and Comparative Examples 1-3

[0065]

[0066] Among them, the test conditions of 180° peel force in Table 6 and Table 7 are shown in Table 8:

[0067] Table 8 Test conditions for 180° peel strength

[0068]

[0069] As shown in Tables 6-7, by comparing Comparative Example 1 with Example 2, it can be seen that by adding an elastomer to the intermediate layer 6 and the heat seal layer 7 of the CPP film 2, the tensile strength and elongation at break of the CPP film 2 are greatly improved, that is, the mechanical properties of the CPP film 2 are improved, thereby also improving the mechanical properties of the medical packaging blue film 1. By comparing Comparative Example 2 with Example 2, the haze of the CPP film 2 is reduced and the light transmittance is increased, that is, by adding a nucleating agent, the optical properties of the CPP film 2 are improved, thereby also improving the optical properties of the medical packaging blue film 1. This is because the nucleating agent can accelerate the crystallization rate, increase the crystallization density, and promote the miniaturization of the grain size by changing the crystallization behavior of the resin, thereby shortening the molding cycle and improving the transparency of the product. By comparing Comparative Example 3 with Example 2, it can be seen that by adding a nucleating agent to the intermediate layer 6 of the CPP film 2 and adding an elastomer to the intermediate layer 6 and the heat seal layer 7, the optical properties and mechanical properties of the CPP film 2 are improved, and the optical properties and mechanical properties of the medical packaging blue film 1 are also improved.

[0070] Furthermore, Comparative Examples 1 and 3 show that, while no elastomer is added, Comparative Example 1 adds a nucleating agent to the intermediate layer 6. As shown in Table 6, the mechanical properties of Comparative Example 1, such as tensile strength and elongation at break, are superior to those of Comparative Example 3. This demonstrates that the addition of a nucleating agent to the intermediate layer 6 according to the present invention can improve the mechanical properties of the CPP film 2 to a certain extent. Similarly, Comparative Examples 2 and 3 show that, while no nucleating agent is added, Comparative Example 2 adds an elastomer to the intermediate layer 6 and the heat-sealing layer 7. As shown in Table 6, the haze of Comparative Example 2 is lower than that of Comparative Example 3, while the light transmittance is higher than that of Comparative Example 3. This demonstrates that the addition of an elastomer to the intermediate layer 6 and the heat-sealing layer 7 according to the present invention can also improve the optical properties of the CPP film 2 to a certain extent. A comparison of Comparative Examples 1-2 with Example 2 shows that the addition of both a nucleating agent and an elastomer results in superior mechanical and optical properties to those obtained with either a nucleating agent or an elastomer alone. Therefore, the nucleating agent added in the present invention can play a certain synergistic role with the elastomer, and can improve the mechanical properties and optical properties of the film to a certain extent.

[0071] Furthermore, from the comparison of Examples 2-5, it can be seen that with the increase in the mass percentage of the nucleating agent in the intermediate layer 6 of the CPP film 2 and the elastomer in the intermediate layer 6 and the heat-sealing layer 7, the optical and mechanical properties of the CPP film 2 are also getting higher and higher, thereby also making the optical and mechanical properties of the medical packaging blue film 1 higher and higher.

[0072] The temperature resistance (heat shrinkage) of the CPP film 2 in Examples 1-5 and Comparative Examples 1-3 was tested using the following method: The length and width of the film roll correspond to the longitudinal and transverse directions of the sample, respectively. Five 100mm x 100mm square specimens were cut from the sample in a direction parallel to the longitudinal direction, with the sides of the squares parallel to the longitudinal direction of the film roll and marked in the longitudinal and transverse directions. Two straight lines parallel to the sides of the square and passing through the center of the square were drawn as markers, and the lengths of the two lines were accurately measured. The sample was placed flat on a stainless steel plate in the center of the sterilizer chamber in a pulsating vacuum pressure steam sterilizer. A fabric sterilization program was run. After the program was completed, the sample was removed and cooled to the test ambient temperature. The lengths of the longitudinal and transverse marked lines were measured to the nearest 0.5mm. The CPP film 2 was placed in the pressure steam sterilizer and sterilized at 134°C. The average heat shrinkage of the film was measured. The calculated results are shown in Table 9:

[0073] Table 9 Thermal shrinkage of CPP film 2 in Examples 1-5 and Comparative Examples 1-3

[0074]

[0075] After the heat shrinkage test, it was found that the heat shrinkage of the CPP film 2 in the embodiment of the present invention is smaller than that of the commercially available sample. This is because the raw material resins selected for the film are different. The Vicat softening point of the cast-grade PP resin used in the present invention is higher than or close to 134°C. Therefore, after 134°C pressure steam sterilization, the heat shrinkage of the film is smaller, that is, the film has better high temperature resistance.

Claims

1. Medical packaging blue film for 134℃ pressure steam sterilization, characterized by: It is composed of the following layers in the following mass percentages arranged in sequence: Polyester layer (3) 29-29.5% Glue layer (4) 2.5-3% Corona layer (5) Middle layer (6) 40.5-40.8% heat seal layer (7); The mass ratio of the corona layer (5), the intermediate layer (6) and the heat sealing layer (7) is 1:3:1; The intermediate layer (6) is composed of the following components in percentage by mass: homopolypropylene 74.6-88.6%, blue transparent masterbatch 3-5%, elastomer 5-15%, nucleating agent 2-6%, antioxidant 0.3-0.5%; wherein the elastomer of the intermediate layer (6) is DF810 or DF940, and the nucleating agent is NAM-98 masterbatch; The heat sealing layer (7) is composed of the following components in percentage by mass: copolymerized polypropylene 79-94%, elastomer 5-20%, and lubricant 0.5-1%; The elastomer of the heat sealing layer (7) is DF810 or DF940.

2. The medical packaging blue film for 134°C pressure steam sterilization according to claim 1, characterized in that: The polyester layer (3) is a composite biaxially oriented polyester film.

3. The medical packaging blue film for 134°C pressure steam sterilization according to claim 1, characterized in that: The glue layer (4) adopts solvent-free polyurethane glue.

4. The medical packaging blue film for 134°C pressure steam sterilization according to claim 1, characterized in that: The corona layer (5) is made of random copolymer polypropylene.

5. The medical packaging blue film for 134°C pressure steam sterilization according to claim 1, characterized in that: The homopolymer polypropylene of the intermediate layer (6) is HD601CF; the blue transparent masterbatch is BL0122 masterbatch.

6. The medical packaging blue film for 134°C pressure steam sterilization according to claim 1, characterized in that: The antioxidants of the intermediate layer (6) are 1010 and 168.

7. The medical packaging blue film for 134°C pressure steam sterilization according to claim 1, characterized in that: The copolymerized polypropylene of the heat sealing layer (7) is CF309 or DY-W0723F.

8. The medical packaging blue film for 134°C pressure steam sterilization according to claim 1, characterized in that: The lubricant of the heat seal layer (7) is oleamide or erucamide masterbatch.

9. The method for preparing a medical packaging blue film for 134°C pressure steam sterilization according to any one of claims 1 to 8, characterized in that: After the raw materials of the corona layer (5), the middle layer (6) and the heat-sealing layer (7) are uniformly mixed, the three-layer co-extruded cast CPP film (2) is obtained by extrusion, cooling and shaping, thickness measurement, corona, deflection, trimming and winding, and aging on a three-layer co-extruded cast film device; and the CPP film (2) and the polyester layer (3) are laminated with a glue layer (4) on a solvent-free laminating device to obtain a medical packaging blue film (1) for 134°C pressure steam sterilization.

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