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CN-121989531-A - High-temperature sterilization sterile barrier packaging material

CN121989531ACN 121989531 ACN121989531 ACN 121989531ACN-121989531-A

Abstract

The invention relates to the technical field of packaging materials, in particular to a high-temperature sterilization sterile barrier packaging material which comprises a breathable base material, and a microfiber supporting layer, a nanofiber barrier layer and a reentrant structure surface layer which are sequentially attached to the surface of the breathable base material. The solution air spinning technology is adopted, so that the high-efficiency ventilation is ensured, the microorganism seepage path is cut off, the bead-shaped reentrant structure is constructed on the surface, and the material is endowed with excellent super-hydrophobic anti-wetting performance. The invention solves the technical problems that the ventilation and the blocking of the existing sterile packaging material are difficult to be compatible, the thermal shrinkage deformation is easy to occur and the wet package is easy to occur under the high-temperature steam sterilization environment.

Inventors

  • ZHANG JUN
  • WU HUIHONG

Assignees

  • 太仓合翔包装材料有限公司

Dates

Publication Date
20260508
Application Date
20260126

Claims (9)

  1. 1. The high-temperature sterilization sterile barrier packaging material is characterized by comprising a breathable base material, and a microfiber supporting layer, a nanofiber barrier layer and a reentrant structure surface layer which are sequentially attached to the surface of the breathable base material.
  2. 2. The high temperature sterilized sterile barrier packaging material of claim 1, wherein the high temperature sterilized sterile barrier packaging material is prepared by a process comprising the steps of: Step S1, polyvinylidene fluoride-hexafluoropropylene is selected as matrix resin and is dissolved in a mixed solvent of N, N-dimethylformamide and acetone to respectively prepare a high-concentration spinning solution, a medium-concentration spinning solution and a low-concentration spinning solution; s2, placing the breathable base material on a receiving device, and spraying the high-concentration spinning solution obtained in the step S1 on the surface of the breathable base material under the condition of low air pressure by utilizing a solution air spinning process to form a micrometer fiber supporting layer with the average diameter of 1-3 mu m; Step S3, spraying the medium-concentration spinning solution obtained in the step S1 onto the surface of the microfiber support layer obtained in the step S2 under the high-pressure condition to form a nanofiber barrier layer with the average diameter of 100-200 nm; step S4, spraying the low-concentration spinning solution obtained in the step S1 onto the surface of the nanofiber barrier layer obtained in the step S3, and inducing to generate beaded fibers to form a surface layer with a reentrant structure, thereby obtaining an uncrosslinked composite film; And S5, placing the uncrosslinked composite film obtained in the step S4 under an electron beam accelerator, and carrying out electron beam irradiation treatment with the dose of 50-80kGy to form a crosslinked network by PVDF-HFP molecular chains in the film layer, thereby obtaining the high-temperature sterilization sterile barrier packaging material.
  3. 3. The high temperature sterilization sterile barrier packaging material according to claim 1, wherein the average fiber diameter of the microfiber support layer is 1-3 μm, the average fiber diameter of the nanofiber barrier layer is 100-200nm, and the thickness of the nanofiber barrier layer is 20-30 μm.
  4. 4. The high temperature sterilization sterile barrier packaging material according to claim 1, wherein the fibers of the surface layer of the reentrant structure have a beaded morphology, are formed by microspheres connected in series on nanofibers, and have a water contact angle of greater than 150 ° and a roll angle of less than 10 °.
  5. 5. The high-temperature sterilized aseptic barrier packaging material according to claim 2, wherein in step S1, the concentration of the high concentration spinning solution is 18wt%, the concentration of the medium concentration spinning solution is 14wt%, and the concentration of the low concentration spinning solution is 10-12wt%; In the step S2, the low-pressure condition is that the air pressure is 0.1MPa; In the step S3, the high air pressure condition is air pressure of 0.5-0.6MPa.
  6. 6. A high temperature sterilized sterile barrier packaging material according to claim 2, wherein in step S1 the polyvinylidene fluoride-hexafluoropropylene has a weight average molecular weight of greater than 400000; the volume ratio of N, N-dimethylformamide to acetone in the mixed solvent is 6:4, and the spinning solution is also added with a polyfunctional monomer TAIC as a sensitizer.
  7. 7. The high temperature sterilized sterile barrier packaging material of claim 1, wherein the high temperature sterilized sterile barrier packaging material has an area shrinkage of less than 2% after 30 minutes of treatment in a saturated steam environment at 135 ℃.
  8. 8. A high temperature sterilized barrier packaging material according to claim 2 wherein the process employs a multi-stage tandem SBS spray system; in steps S2 to S4, the breathable substrate is moved within the multi-stage tandem SBS spray system, sequentially through different spray areas, thereby achieving continuous deposition of the microfiber support layer, the nanofiber barrier layer, and the reentrant structure surface layer.
  9. 9. A sterilized sterile barrier packaging material according to claim 2, wherein the electron beam irradiation treatment of step S5 is performed in an oxygen-free or controlled atmosphere; The cross-linked network is a C-C covalent bond network formed by breaking C-H bonds and C-F bonds on PVDF-HFP molecular chains under irradiation to generate free radicals, and then combining adjacent molecular chains.

Description

High-temperature sterilization sterile barrier packaging material Technical Field The invention relates to the technical field of packaging materials, in particular to a high-temperature sterilization sterile barrier packaging material. Background In the field of modern medical devices, sterile barrier systems are critical lines of defense that ensure that the medical device remains sterile after sterilization until use. In various sterilization modes, high-temperature high-pressure steam sterilization is widely applied because of being nontoxic and environment-friendly and having strong penetrating power. However, this sterilization mode is extremely harsh, requiring the packaging material to have both a dual function of having sufficient breathability to allow rapid ingress and egress of the sterilizing medium (steam) and to balance the large pressure differential created by the pulsating vacuum phase to prevent bursting of the package, and a dense micro-porous structure to absolutely block microbial ingress. In addition, the material is required to withstand high temperature thermal shock and high humidity environment, and avoid thermal deformation or bacterial penetration caused by condensate wetting. At present, the medical packaging materials commonly used in clinic mainly comprise medical dialyzing paper and flash evaporation polyethylene materials. Although the cost of medical dialyzing paper is lower, the mechanical strength is obviously reduced in a wet state, fiber particles are easy to generate, and the risk of cleanliness exists. The flash evaporation method polyethylene material has excellent comprehensive performance, but the production process is extremely complex, the equipment investment is huge, the melting point of the material is relatively close to the upper limit temperature of high-temperature steam sterilization, and under the long-time or extremely high-temperature sterilization procedure, the hidden danger of thermal shrinkage or dimensional deformation exists, so that the integrity of the sterile barrier can be damaged. In recent years, nanofiber membranes have been considered as ideal microbial barrier materials due to their high specific surface area and tortuous pore passages. However, the current mainstream technology for preparing nanofibers, i.e. the electrospinning technology, faces a number of bottlenecks in industrial applications. The electrostatic spinning relies on a high-voltage electric field, has potential safety hazards for a system using flammable organic solvents, is sensitive to the conductivity of polymer solutions, limits the application of partial high-performance polymers, and most importantly, has extremely low yield of a single nozzle of the electrostatic spinning, and is difficult to meet the high-flux production requirements of a large number of packaging materials. In addition, in the material structural design, the existing porous medium often has difficulty in combining the contradictory indexes of high ventilation and high barrier. Although the uniform and compact nanofiber layer can effectively resist bacteria, the fluid resistance is too high, so that pressure residues and package breakage in the sterilization process are easy to cause. Meanwhile, the surface of the existing material lacks a specific anti-wetting design, and wetting is easy to occur when steam condensate water is encountered, so that a wet-packing phenomenon is caused, and the risk that bacteria penetrate through a barrier through a liquid bridge is increased. Therefore, we propose a high temperature sterilized sterile barrier packaging material to solve the above problems. Disclosure of Invention The invention aims to solve the defects in the prior art, and provides a high-temperature sterilization sterile barrier packaging material. In order to achieve the above purpose, the present invention adopts the following technical scheme: a high-temperature sterilization sterile barrier packaging material comprises a breathable base material, and a microfiber supporting layer, a nanofiber barrier layer and a reentrant structure surface layer which are sequentially attached to the surface of the breathable base material. As a preferable technical scheme: The high-temperature sterilization sterile barrier packaging material is prepared by a process comprising the following steps: Step S1, polyvinylidene fluoride-hexafluoropropylene is selected as matrix resin and is dissolved in a mixed solvent of N, N-dimethylformamide and acetone to respectively prepare a high-concentration spinning solution, a medium-concentration spinning solution and a low-concentration spinning solution; s2, placing the breathable base material on a receiving device, and spraying the high-concentration spinning solution obtained in the step S1 on the surface of the breathable base material under the condition of low air pressure by utilizing a solution air spinning process to form a micrometer fiber supporting layer