Thermoplastic polymer packaging material for medical equipment and preparation method of thermoplastic polymer packaging material
By accurately controlling the composition ratio and processing technology of thermoplastic polymer packaging materials, the problem of qualitative change in medical device packaging materials during sterilization is solved, and packaging materials that are adapted to various sterilization methods are realized, ensuring the safety and integrity of medical devices.
Patent Information
- Application Number
- CN202411953010.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-27
- Publication Date
- 2025-03-25
AI Technical Summary
Existing medical device packaging materials are prone to qualitative changes during the sterilization process, resulting in the inability to ensure the integrity and safety of medical devices, and it is difficult to adapt to a variety of sterilization methods.
The preparation method of thermoplastic polymer packaging materials is adopted, and the ratio of polypropylene random copolymer or polyethylene to white color masterbatch, antioxidant, antibacterial agent and light stabilizer is accurately controlled, and high-speed mixing and plasticizing film formation are carried out to form packaging materials that are suitable for a variety of sterilization methods.
The thermoplastic polymer packaging materials of medical devices prepared by this method can maintain good stability in a variety of sterilization methods, ensure the integrity and safety of medical devices, and improve antibacterial ability and sterilization stability.
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Abstract
Description
Technical Field
[0001] The invention relates to a method for preparing a medical device packaging material, in particular to a medical device thermoplastic polymer packaging material and a method for preparing the same. Background Art
[0002] Medical device packaging plays a key role in protecting the integrity and safety of medical devices, especially precision medical devices, during transportation and storage. Specifically, medical device packaging is required to have sufficient toughness and strength to withstand impact and extrusion during transportation, and should also have good barrier properties to prevent external factors such as oxygen, moisture, and bacteria from affecting medical devices. At the same time, most medical devices need to be sterilized, and the packaging enters the sterilization process together with the medical devices. If the packaging material undergoes qualitative changes during the sterilization process, the integrity and safety of the medical device will not be guaranteed. Therefore, the selection of packaging materials requires the ability to adapt to a variety of different sterilization methods. This application aims to propose a method for preparing medical device packaging materials that can adapt to a variety of sterilization methods. Summary of the invention
[0003] In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide a medical device thermoplastic polymer packaging material and a preparation method thereof, so that it has the advantage of being adaptable to a variety of different sterilization methods.
[0004] To achieve the above objectives and other related objectives, on the one hand, the present invention provides the following technical solutions:
[0005] A method for preparing a thermoplastic polymer packaging material for medical devices, characterized by comprising:
[0006] S1. Measuring and material selection: The weighing system is used to accurately control the weight of component A, which accounts for 97.5%, and component B, which accounts for 2.5%. Component A is a random copolymer of polypropylene or polyethylene, and component B includes a white masterbatch, which accounts for 80%, an antioxidant, a 5% antibacterial agent, and a 8% light stabilizer.
[0007] S2, high-speed mixing: Put the component A and component B whose proportions are precisely controlled after step S1 into the mixer at the same time for high-speed mixing;
[0008] S3, plasticizing and film forming: feeding the mixed material after step S2 into the screw, controlling the temperature at 220-240 degrees to form a melt, and shaping it into an initial sheet of a preset size through a mold and a three-roll calender;
[0009] S4, trimming the scrap edges of the initial sheet in step S3 to obtain a finished sheet and then rolling it up for packaging.
[0010] Preferably, the mixing speed in step S2 is controlled at 1350 rpm.
[0011] In another aspect, the present invention provides a medical device thermoplastic polymer packaging material, which is prepared by any of the above-mentioned methods for preparing a medical device thermoplastic polymer packaging material.
[0012] In summary, the present invention provides a medical device thermoplastic polymer packaging material and a preparation method thereof, which have the following beneficial effects:
[0013] The invention provides a medical device thermoplastic polymer packaging material and a preparation method thereof, the preparation method comprising the following steps: S1, metering and material selection: accurately controlling a component A with a weight proportion of 97.5% and a component B with a weight proportion of 2.5% through a weighing system, wherein the component A is a polypropylene random copolymer or polyethylene, and the component B comprises a white masterbatch with a weight proportion of 80%, an antioxidant of 7%, an antibacterial agent of 5% and a light stabilizer of 8%; S2, high-speed mixing: putting the component A and the component B with a weight proportion accurately controlled after step S1 into a mixer at the same time for high-speed mixing; S3, plasticizing and film forming: feeding the mixed material after step S2 into a screw, controlling the temperature at 220 degrees to 240 degrees to form a melt, and shaping it into an initial sheet of a preset size through a mold and a three-roll calender; S4, performing waste edge trimming treatment on the initial sheet of step S3 to obtain a finished sheet and performing winding and packaging; the medical device thermoplastic polymer packaging material prepared by the above preparation method has the advantage of being adaptable to a variety of different sterilization methods. DETAILED DESCRIPTION
[0014] The following is a description of the implementation of the present invention by means of specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.
[0015] Embodiment 1
[0016] A method for preparing a thermoplastic polymer packaging material for medical devices, comprising:
[0017] S1. Measuring and material selection: The weighing system is used to accurately control the weight of component A, which accounts for 97.5%, and component B, which accounts for 2.5%. Component A is a random copolymer of polypropylene, and component B includes a white masterbatch, which accounts for 80% by weight, an antioxidant, a 5% antibacterial agent, and a 8% light stabilizer;
[0018] Among them, antioxidants and light stabilizers enhance the stability during the sterilization process, effectively reducing or even avoiding discoloration during the sterilization process; at the same time, they are combined with antibacterial agents to improve the overall antibacterial ability.
[0019] S2, high-speed mixing: Put the component A and the component B whose proportions are precisely controlled after step S1 into the mixer at the same time for high-speed mixing. Preferably, the material speed is controlled at 1350 rpm;
[0020] S3, plasticizing and film forming: feeding the mixed material after step S2 into the screw, controlling the temperature at 220-240 degrees to form a melt, and shaping it into an initial sheet of a preset size through a mold and a three-roll calender;
[0021] S4, trimming the scrap edges of the initial sheet in step S3 to obtain a finished sheet and then rolling it up for packaging.
[0022] A medical device thermoplastic polymer packaging material is prepared by the preparation method.
[0023] Comparative Example 1:
[0024] The difference between Comparative Example 1 and Example 1 is that the weight proportion of component A is 97%, and the weight proportion of component B is 3%.
[0025] Comparative Example 2:
[0026] The difference between Comparative Example 2 and Example 1 is that the weight proportion of component A is 98%, and the weight proportion of component B is 2%.
[0027] Comparative Example 3:
[0028] The difference between Comparative Example 3 and Example 1 is that the weight proportion of component A is 97.7%, and the weight proportion of component B is 2.3%.
[0029] Table 1 lists the test results of Example 1 and Comparative Examples 1, 2, and 3 in terms of various properties.
[0030] Table 1:
[0031]
[0032] From the comparison results of various performance indicators in Table 1, it can be seen that comparative examples 1, 2, and 3 all have unqualified items in various indicators, while embodiment 1 has excellent performance in various indicators.
[0033] Embodiment 2
[0034] A method for preparing a thermoplastic polymer packaging material for medical devices, comprising:
[0035] S1. Measuring and material selection: The weighing system is used to accurately control the weight of component A, which accounts for 97.5%, and component B, which accounts for 2.5%. Component A is polyethylene, and component B includes white masterbatch, which accounts for 80%, antioxidant, antibacterial agent, and light stabilizer, which accounts for 7%, 5%, and 8% respectively.
[0036] Among them, antioxidants and light stabilizers enhance the stability during the sterilization process, effectively reducing or even avoiding discoloration during the sterilization process; at the same time, they are combined with antibacterial agents to improve the overall antibacterial ability.
[0037] S2, high-speed mixing: Put the component A and the component B whose proportions are precisely controlled after step S1 into the mixer at the same time for high-speed mixing. Preferably, the material speed is controlled at 1350 rpm;
[0038] S3, plasticizing and film forming: feeding the mixed material after step S2 into the screw, controlling the temperature at 220-240 degrees to form a melt, and shaping it into an initial sheet of a preset size through a mold and a three-roll calender;
[0039] S4, trimming the scrap edges of the initial sheet in step S3 to obtain a finished sheet and then rolling it up for packaging.
[0040] A medical device thermoplastic polymer packaging material is prepared by the preparation method.
[0041] Comparative Example 4:
[0042] The difference between Comparative Example 4 and Example 2 is that the weight proportion of component A is 97%, and the weight proportion of component B is 3%.
[0043] Comparative Example 5:
[0044] The difference between Comparative Example 5 and Example 2 is that the weight proportion of component A is 98%, and the weight proportion of component B is 2%.
[0045] Comparative Example 6:
[0046] The difference between Comparative Example 6 and Example 2 is that the weight proportion of component A is 97.7%, and the weight proportion of component B is 2.3%.
[0047] Table 2 lists the test results of Example 2 and Comparative Examples 4, 5, and 6 in various properties.
[0048] Table 2:
[0049]
[0050]
[0051] From the comparison results of various performance indicators in Table 2, it can be seen that comparative examples 4, 5, and 6 all have unqualified items in various indicators, while embodiment 2 has excellent performance in various indicators.
[0052] The medical device thermoplastic polymer packaging material prepared by the preparation method of the medical device thermoplastic polymer packaging material provided by the present invention can maintain good stability in a variety of sterilization methods and meet the requirements of the medical device sterilization process.
[0053] The above embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. Anyone familiar with the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by a person of ordinary skill in the art without departing from the spirit and technical concept disclosed by the present invention shall still be covered by the claims of the present invention.
Claims
1. A method for preparing a thermoplastic polymer packaging material for medical devices, characterized in that: include: S1. Measuring and material selection: The weighing system is used to accurately control the weight of component A, which accounts for 97.5%, and component B, which accounts for 2.5%. Component A is a random copolymer of polypropylene or polyethylene, and component B includes a white masterbatch, which accounts for 80%, an antioxidant, a 5% antibacterial agent, and a 8% light stabilizer. S2, high-speed mixing: Put the component A and component B whose proportions are precisely controlled after step S1 into the mixer at the same time for high-speed mixing; S3, plasticizing and film forming: feeding the mixed material after step S2 into the screw, controlling the temperature at 220-240 degrees to form a melt, and shaping it into an initial sheet of a preset size through a mold and a three-roll calender; S4, trimming the scrap edges of the initial sheet in step S3 to obtain a finished sheet and then rolling it up for packaging.
2. The method for preparing a thermoplastic polymer packaging material for medical devices according to claim 1, characterized in that: The mixing speed in step S2 is controlled at 1350 rpm.
3. A thermoplastic polymer packaging material for medical devices, characterized in that: The medical device thermoplastic polymer packaging material is prepared by the preparation method of the medical device thermoplastic polymer packaging material as claimed in claim 1 or 2.