Modified paper-plastic material for plasma sterilization against aluminum contamination and preparation method and application thereof

Abstract

This invention discloses a modified paper-plastic material for plasma sterilization that prevents aluminum contamination, its preparation method, and its application. The modified paper-plastic material of this invention comprises a paper-plastic layer and a functional layer tightly adhered to the outside of the paper-plastic layer to prevent aluminum contamination; the functional layer is selected from at least one polymer containing sulfonic acid groups. This invention modifies the paper-plastic layer to effectively adsorb aluminum impurities reaching the surface of the sterilized packaging during plasma sterilization, significantly reducing contamination of items inside the sterilized packaging and mitigating the resulting health and safety risks.

Description

Technical Field

[0001] This invention relates to the technical field of paper-plastic layers, and more specifically, to modified paper-plastic materials for plasma sterilization that prevent aluminum contamination, their preparation methods, and applications. Background Technology

[0002] Plasma sterilization technology is particularly suitable for medical devices that are sensitive to moisture and heat, and is therefore widely used in the sterilization and disinfection of surgical instruments.

[0003] Medical paper-plastic composites are commonly used sterilization packaging materials. Medical paper-plastic bags made from them can be used in hospital sterilization centers (CSSD), supply rooms, operating rooms, and dental departments for sterilization and for packaging sterilized medical devices after sterilization.

[0004] Recent research by the inventors has revealed that plasma sterilization technology suffers from aluminum contamination. This contamination originates from the inner wall of the sterilization chamber, primarily because most commercially available plasma sterilizers use aluminum alloy inner walls. During plasma sterilization, high-speed charged particles bombard the inner wall of the chamber, sputtering aluminum atoms from its surface. Although medical devices are sealed in sterilization packaging throughout the sterilization process, this free aluminum can penetrate the medical paper and plastic packaging materials, adhering to the surface of the medical devices and forming aluminum contamination. During use, this surface-contaminated aluminum can enter the human body, threatening people's health and safety.

[0005] Therefore, it is necessary to further modify existing medical paper-plastic materials to reduce the amount of aluminum generated during plasma sterilization that can penetrate medical paper-plastic and other sterilization packaging materials, adhere to the surface of medical devices, and contaminate them. Summary of the Invention

[0006] To address the problems in existing technologies, this invention proposes a modified paper-plastic material for plasma sterilization that prevents aluminum contamination, along with its preparation method and applications. This invention modifies the paper-plastic layer to effectively adsorb aluminum impurities reaching the surface of the sterilization packaging during plasma sterilization. This reduces the amount of aluminum generated during plasma sterilization penetrating medical paper-plastic and other sterilization packaging materials, significantly minimizing contamination of the items inside the sterilization packaging. Therefore, the paper-plastic layer provided by this invention is particularly suitable for packaging medical devices during plasma sterilization.

[0007] To achieve the above objectives, the present invention adopts the following technical solution:

[0008] One of the objectives of this invention is to provide a modified paper-plastic material for plasma sterilization that is resistant to aluminum contamination. The modified paper-plastic material includes a paper-plastic layer and a functional layer that is tightly adhered to the outside of the paper-plastic layer to prevent aluminum contamination.

[0009] The functional layer is selected from at least one polymer containing sulfonic acid groups.

[0010] In this invention, the modified paper-plastic layer is used for packaging medical devices and other items that need to be sterilized during plasma sterilization; the outer side of the paper-plastic layer refers to the side that does not wrap the medical device, that is, during plasma sterilization, the structure from the outside to the inside should be the functional layer / paper-plastic layer / medical device that prevents aluminum contamination.

[0011] In the modified paper-plastic material for plasma sterilization with aluminum contamination prevention described in this invention, preferably,

[0012] The functional layer is selected from at least one of perfluorosulfonic acid resin and sulfonated polymer; preferably,

[0013] The sulfonated polymer is selected from at least one of sulfonated polyether ketone and sulfonated polyether sulfone.

[0014] In the modified paper-plastic material for plasma sterilization with aluminum contamination prevention described in this invention, preferably,

[0015] The paper-plastic layer refers to commonly used medical paper-plastic materials (i.e., materials that are essentially plastic but have the texture and feel of paper), preferably selected from medical breathable membrane materials; more preferably, polyethylene medical breathable membranes; and / or,

[0016] The thickness of the functional layer is 0.05–10 μm, preferably 0.1–5 μm.

[0017] The second objective of this invention is to provide a method for preparing a modified paper-plastic material for plasma sterilization that is resistant to aluminum contamination, comprising the following steps:

[0018] (1) Dissolve the functional layer material in a solvent to obtain a dispersion;

[0019] (2) The dispersion is sprayed onto the outer surface of the paper-plastic layer and dried to obtain a modified paper-plastic material for plasma sterilization that is resistant to aluminum contamination.

[0020] The modified paper-plastic material for plasma sterilization that is resistant to aluminum contamination, as described in one of the objectives of this invention, is preferably used.

[0021] In the preparation method of the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to the present invention, preferably,

[0022] In step (1),

[0023] The solvent is selected from a mixture of alcohol and water; and / or,

[0024] The concentration of the dispersion is 0.1–10 wt%.

[0025] The functional layer material is selected from at least one polymer containing sulfonic acid groups.

[0026] In the preparation method of the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to the present invention, preferably,

[0027] The alcohol is selected from at least one of methanol, ethanol, isopropanol, and n-butanol; and / or,

[0028] The volume ratio of alcohol to water in the solvent is (5–20):1; preferably (5–15):1; and / or,

[0029] The functional layer is selected from at least one of perfluorosulfonic acid resin and sulfonated polymer; more preferably,

[0030] The sulfonated polymer is selected from at least one of sulfonated polyether ketone and sulfonated polyether sulfone.

[0031] In the preparation method of the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to the present invention, preferably,

[0032] The ion exchange capacity of the polymer containing sulfonic acid groups is 0.2–3 mmol / g, preferably 0.25–2.0 mmol / g; more preferably 0.5–2.0 mmol / g.

[0033] In the preparation method of the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to the present invention, preferably,

[0034] In step (2),

[0035] The spraying time is 15–45 s, preferably 20–30 s; and / or,

[0036] The drying temperature is 40–80℃.

[0037] A third objective of this invention is to provide an application of the modified paper-plastic material described in any one of the objectives of this invention or the modified paper-plastic material prepared by the method described in any one of the objectives of this invention as an outer packaging material in sterilization treatment; preferably, its application as an outer packaging material in plasma sterilization treatment.

[0038] In the application of the modified paper-plastic material for plasma sterilization with aluminum contamination prevention as described in this invention, preferably,

[0039] After wrapping the items to be sterilized with the modified paper-plastic material for plasma sterilization (which is designed to prevent aluminum contamination), the items are placed in a plasma sterilizer for sterilization.

[0040] More preferably, the object to be sterilized and the sterilization indicator are wrapped in a piece of appropriately sized, aluminum-resistant modified paper-plastic material for plasma sterilization, and a label with the sterilization indicator attached is affixed. After packaging, the object is placed in a plasma sterilizer and sterilized using a short-cycle mode. After sterilization is complete, the sterilization indicator shows that sterilization is successful.

[0041] In this invention, the sterilization conditions can be the commonly used plasma sterilization conditions, preferably a plasma treatment time of 660s, a temperature of 55℃, and a pressure of 130Pa.

[0042] The polymer containing sulfonic acid groups of this invention can form a film on the paper-plastic layer, which has a barrier effect against aluminum ions. Furthermore, the sulfonic acid groups can chelate aluminum ions, thus adsorbing them. Together, these effects significantly reduce the contamination of medical devices within the sterile packaging by aluminum ions.

[0043] The endpoints and any values ​​of the ranges disclosed in this invention are not limited to the precise ranges or values; these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed herein. In the following, various technical solutions can, in principle, be combined with each other to obtain new technical solutions, which should also be considered as specifically disclosed herein.

[0044] Compared with the prior art, the present invention has at least the following advantages:

[0045] The modified paper-plastic material for plasma sterilization that prevents aluminum contamination of the present invention can greatly reduce aluminum contamination of sterilized objects, thereby reducing the health and safety risks associated with it. Detailed Implementation

[0046] The present invention will now be described in detail with reference to specific embodiments. It should be noted that the following embodiments are only used to further illustrate the present invention and should not be construed as limiting the scope of protection of the present invention. Some non-essential improvements and adjustments made by those skilled in the art based on the content of the present invention are still within the scope of protection of the present invention.

[0047] It should also be noted that the various specific technical features described in the following embodiments can be combined in any suitable manner without contradiction. To avoid unnecessary repetition, the various possible combinations will not be described separately in this invention.

[0048] Furthermore, various embodiments of the present invention can be combined in any way, as long as they do not violate the spirit of the present invention. The resulting technical solutions are part of the original disclosure of this specification and also fall within the protection scope of the present invention.

[0049] Raw material source:

[0050] Perfluorosulfonic acid resins were purchased from DuPont or Burson-Pure.

[0051] Sulfonated polyether ketone (ion exchange capacity of 1.95 mmol / g) was purchased from Tianjin Yanjin Technology Co., Ltd.

[0052] Sulfonated polyethersulfone (ion exchange capacity of 1.80 mmol / g) was purchased from Tianjin Yanjin Technology Co., Ltd.

[0053] The paper-plastic bag W1 was purchased from Shandong Xinhua Medical Equipment Co., Ltd.; the material is polyethylene.

[0054] The paper-plastic bag W3 was purchased from Anhui Yiren Medical Packaging Co., Ltd.; the material is polyethylene.

[0055] Test method:

[0056] The aluminum concentration on the surface of a silicon wafer was measured using secondary ion mass spectrometry.

[0057] Example 1

[0058] A commercially available sterile paper-plastic bag, W1, was selected. A 6 wt% Nafion dispersion was prepared by dissolving Nafion (ion exchange capacity of 0.8 mmol / g) in a mixture of isopropanol and water (volume ratio of isopropanol to water: 5:1). The dispersion was sprayed onto the outer surface of W1 for 20 seconds and dried at 60°C to obtain the paper-plastic bag W2. The functional layer thickness of W2 was 2 μm.

[0059] Application Example 1

[0060] A 1 cm square silicon wafer A was cut from a silicon wafer S and cleaned. A and a sterilization indicator were placed together in W2, which was then sealed and labeled with the sterilization indicator. The packaged wafer A was placed in a plasma sterilizer and sterilized using a short-cycle mode. The plasma treatment time was 660 s, the temperature was 55℃, and the pressure was 130 Pa. After sterilization, the sterilization indicator showed that sterilization was successful. The aluminum concentration on the surface of A was measured using secondary ion mass spectrometry; the specific results are shown in Table 1.

[0061] Example 2

[0062] Another commercially available sterile paper-plastic bag, W3, was selected. A 5 wt% Nafion dispersion was prepared by dissolving Nafion (ion exchange capacity of 1.1 mmol / g) in a mixture of isopropanol and water (volume ratio of isopropanol to water 10:1). The dispersion was sprayed onto the outer surface of W3 for 30 seconds and dried at 60°C to obtain paper-plastic bag W4. The functional layer thickness of W4 was 5 μm.

[0063] Application Example 2

[0064] Cut a 1 cm square silicon wafer B from S and wash it. Place B and the sterilization indicator together into W4 and seal W4, affixing a label with the sterilization indicator attached. Place the packaged B in W4 into a plasma sterilizer and sterilize under the same conditions as in Application Example 1. After sterilization, the sterilization indicator shows that sterilization is successful.

[0065] The aluminum concentration on surface B was measured using secondary ion mass spectrometry, and the specific results are shown in Table 1.

[0066] Example 3

[0067] A commercially available sterile paper-plastic bag, W1, was selected. Sulfonated polyethersulfone was dissolved in a mixture of isopropanol and water (volume ratio of isopropanol to water was 15:1) to prepare a 10 wt% sulfonated polyethersulfone dispersion. The dispersion was sprayed onto the outer surface of W1 for 15 seconds and dried at 60°C to obtain the paper-plastic bag W5. The functional layer thickness of W5 was 3 μm.

[0068] Application Example 3

[0069] A 1 cm square silicon wafer C was cut from a silicon wafer S and cleaned. C and the sterilization indicator were placed together in W5, which was then sealed and labeled with the sterilization indicator. The wafer A packaged in W5 was placed in a plasma sterilizer and sterilized using a short-cycle mode under the same conditions as in Application Example 1. After sterilization, the sterilization indicator showed that sterilization was successful. The aluminum concentration on the surface of C was measured using secondary ion mass spectrometry; the results are shown in Table 1.

[0070] Example 4

[0071] A commercially available sterile paper-plastic bag, W1, was selected. Sulfonated polyetherketone was dissolved in a mixture of isopropanol and water (volume ratio of isopropanol to water was 5:1) to prepare a 5 wt% sulfonated polyetherketone dispersion. The dispersion was sprayed onto the outer surface of W1 for 45 seconds and dried at 60°C to obtain paper-plastic bag W6. The functional layer thickness of W6 was 8 μm.

[0072] Application Example 4

[0073] A 1 cm square silicon wafer D was cut from a silicon wafer S and cleaned. D and a sterilization indicator were placed together in a container W6, which was then sealed and labeled with the sterilization indicator. The packaged D was placed in a plasma sterilizer and sterilized using a short-cycle mode under the same conditions as in Application Example 1. After sterilization, the sterilization indicator showed that sterilization was successful. The aluminum concentration on the surface of D was measured using secondary ion mass spectrometry; the results are shown in Table 1.

[0074] Comparative Example 1

[0075] Alternatively, select a paper-plastic bag W1.

[0076] Cut out another 1 cm square silicon wafer E from S and wash it. Place E and the sterilization indicator together into W1 and seal W1, affixing a label with the sterilization indicator attached. Place the packaged E from W1 into a plasma sterilizer and sterilize under the same conditions as in Application Example 1. After sterilization, the sterilization indicator shows that sterilization is successful.

[0077] The aluminum concentration on surface E was measured using secondary ion mass spectrometry, and the specific results are shown in Table 1.

[0078] Comparative Example 2

[0079] Alternatively, choose a paper-plastic bag W3.

[0080] Cut out another 1 cm square silicon wafer F from S and wash it. Place F and the sterilization indicator together into W3 and seal W3, affixing a label with the sterilization indicator attached. Place F, packaged in W3, into a plasma sterilizer and sterilize under the same conditions as in Application Example 1. After sterilization, the sterilization indicator shows that sterilization is successful.

[0081] The aluminum concentration on the F surface was measured using secondary ion mass spectrometry, and the specific results are shown in Table 1.

[0082] Comparative Example 3

[0083] Cut out a 1 cm square silicon wafer G from S and clean it.

[0084] The aluminum concentration on the surface of G was measured using secondary ion mass spectrometry, and the specific results are shown in Table 1.

[0085] Comparative Example 4

[0086] Commercially available sterilization paper-plastic layer W1 made of polypropylene was selected. A 6wt% sulfosalicylic acid dispersion was prepared by dissolving it in a mixture of isopropanol and water (volume ratio of isopropanol to water is 5:1). The dispersion was sprayed onto the outer surface of W1 under the same conditions as in Example 1 and dried at 60°C to obtain paper-plastic bag W7.

[0087] A 1 cm square silicon wafer H was cut from a silicon wafer S and cleaned. The silicon wafer H, wrapped by W7, was placed in a plasma sterilizer and sterilized under the same conditions as in Application Example 1. After sterilization, the sterilization indicator showed that sterilization was successful.

[0088] The aluminum concentration on the H surface was measured using secondary ion mass spectrometry, and the specific results are shown in Table 1.

[0089] Table 1

[0090] Application Example 1: Silicon Wafer A 9.5E18 Application Example 2 Silicon Wafer B 9.9E18 Application Example 3 Silicon Wafer C 1.5E19 Application Example 4: Silicon Wafer D 8.9E18 Comparative Example 1 Silicon Wafer E 8.5E19 Comparative Example 2 Silicon Wafer F 8.8E19 Comparative Example 3 Silicon Wafer G 7.7E18 Comparative Example 4 Silicon Wafer H 8.3E19

[0091] As can be seen from the comparison of the results of Application Examples 1-4 and Comparative Examples 1-3 in Table 1, the aluminum concentration on the surface of silicon wafers packaged with commercially available unmodified paper-plastic layers increased significantly after plasma sterilization. Silicon wafers packaged with the modified paper-plastic material for plasma sterilization provided by this invention, which prevents aluminum contamination, showed a significant decrease in aluminum concentration on the surface after sterilization under the same conditions. Furthermore, compared to the surface aluminum concentration of unsterilized silicon wafers (i.e., the original aluminum concentration in the silicon wafer), the aluminum concentration did not increase significantly.

[0092] As can be seen from Application Example 1 and Comparative Example 4 in Table 1, the adsorption effect of aluminum on paper-plastic materials after modification with organic compounds containing sulfonic acid groups, such as sulfosalicylic acid, is not obvious; only the polymer containing sulfonic acid groups of the present invention has a more obvious effect on the modification of paper-plastic materials.

[0093] The above results demonstrate that the modified paper-plastic material for plasma sterilization, designed to prevent aluminum contamination, provided by this invention can effectively adsorb aluminum generated within the plasma sterilization chamber, preventing contamination of items within the sterilization packaging and thus solving the aluminum contamination problem existing in the prior art. Therefore, the modified paper-plastic material for plasma sterilization, designed to prevent aluminum contamination, provided by this invention is particularly suitable for packaging medical devices during plasma sterilization.

[0094] The present invention has been described in detail above with reference to specific embodiments and exemplary examples; however, these descriptions should not be construed as limiting the present invention. Those skilled in the art will understand that various equivalent substitutions, modifications, or improvements can be made to the technical solutions and embodiments of the present invention without departing from the spirit and scope of the invention, and all such modifications and improvements fall within the scope of the present invention. The scope of protection of the present invention is defined by the appended claims.

[0095] All publications, patent applications, patents, and other references mentioned in this specification are incorporated herein by reference. Unless otherwise defined, all technical and scientific terms used in this specification have the meanings commonly understood by those skilled in the art. In case of conflict, the definitions in this specification shall prevail.

[0096] When this specification uses the prefixes “known to those skilled in the art,” “prior art,” or similar terms to derive materials, substances, methods, steps, apparatus, or components, the objects derived from such prefixes cover those commonly used in the art at the time of this application, but also include those that are not currently commonly used but will become generally recognized in the art as suitable for similar purposes.

[0097] In the context of this specification, except where expressly stated otherwise, any matters or issues not mentioned shall apply directly to those known in the art without any modification.

Claims

1. A modified paper-plastic material for plasma sterilization that prevents aluminum contamination, characterized in that: The modified paper-plastic material includes a paper-plastic layer and a functional layer that prevents aluminum contamination, which is tightly adhered to the outside of the paper-plastic layer. The functional layer is selected from at least one polymer containing sulfonic acid groups; the paper-plastic layer is selected from medical plastic film. After wrapping the items to be sterilized with the modified paper-plastic material that prevents aluminum contamination as the outer packaging material, the items are placed in the plasma sterilizer for sterilization. The functional layer is selected from at least one of perfluorosulfonic acid resin and sulfonated polymer; The sulfonated polymer is selected from at least one of sulfonated polyether ketone and sulfonated polyether sulfone.

2. The modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to claim 1, characterized in that: The paper-plastic layer is selected from polyethylene medical plastic film; and / or, The thickness of the functional layer is 0.05~10µm.

3. The modified paper-plastic material for plasma sterilization, free from aluminum contamination according to claim 2, characterized in that: The thickness of the functional layer is 0.1~5µm.

4. A process for the preparation of modified paper-plastic material for plasma sterilization against aluminum contamination, characterized by, Includes the following steps: (1) Dissolve the functional layer material in a solvent to obtain a dispersion; (2) The dispersion is sprayed onto the outer surface of the paper-plastic layer and dried to obtain a modified paper-plastic material for plasma sterilization that is resistant to aluminum contamination. Used to prepare the modified paper-plastic material for plasma sterilization with aluminum contamination prevention as described in any one of claims 1-3.

5. The method for preparing the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to claim 4, characterized in that: In step (1), The solvent is selected from a mixture of alcohol and water; and / or, The concentration of the dispersion is 0.1~10wt%; The functional layer material is selected from at least one polymer containing sulfonic acid groups.

6. The method for preparing the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to claim 5, characterized in that: The alcohol is selected from at least one of methanol, ethanol, isopropanol, and n-butanol; and / or, The volume ratio of alcohol to water in the solvent is (5~20):1; and / or, The functional layer is selected from at least one of perfluorosulfonic acid resin and sulfonated polymer.

7. The method for preparing the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to claim 6, characterized in that: The volume ratio of alcohol to water in the solvent is (5~15):1; and / or, The sulfonated polymer is selected from at least one of sulfonated polyether ketone and sulfonated polyether sulfone.

8. The method for preparing the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to claim 5, characterized in that: The ion exchange capacity of the polymer containing sulfonic acid groups is 0.2~3 mmol / g.

9. The method for preparing the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to claim 8, characterized in that: The ion exchange capacity of the polymer containing sulfonic acid groups is 0.25~2.0 mmol / g.

10. The method for preparing the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to claim 9, characterized in that: The ion exchange capacity of the polymer containing sulfonic acid groups is 0.5~2.0 mmol / g.

11. The method for preparing the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to claim 4, characterized in that: In step (2), The spraying time is 15-45 seconds; and / or, The drying temperature is 40~80℃.

12. The method for preparing the modified paper-plastic material for plasma sterilization with aluminum contamination prevention according to claim 11, characterized in that: In step (2), The spraying time is 20-30 seconds.

13. The application of a modified paper-plastic material according to any one of claims 1-3 or a modified paper-plastic material prepared by the method according to any one of claims 4-12 as an outer packaging material in sterilization treatment.

14. The application according to claim 13, characterized in that: Application as an outer packaging material in plasma sterilization processes.