Sterilization packaging material, method for producing the same, and use thereof

Abstract

The application discloses a sterilization packaging material and a preparation method and application thereof. The sterilization packaging material comprises a non-woven fabric and a functional layer; the functional layer is closely attached to at least one side of the non-woven fabric; and the functional layer is selected from at least one of polymers containing sulfonic acid groups. The non-woven fabric is modified in the application, so that the non-woven fabric can effectively adsorb aluminum impurities reaching the surface of the sterilization packaging in a plasma sterilization process, greatly reduces contamination of objects in the sterilization packaging, and reduces the risk of health and life safety caused by the contamination.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of non-woven fabrics, and further relates to a sterilization packaging material and a preparation method and application thereof. BACKGROUND

[0002] Plasma sterilization technology is widely used in the sterilization and disinfection of surgical instruments due to its characteristics of no need for high temperature, no chemical residues, no damage to instruments, and short sterilization time. Non-woven fabric, also known as non-woven fabric, is an ideal sterilization packaging material due to its antibacterial and antiseptic properties, moisture resistance, air permeability, flexibility, lightness, and low cost, and is widely used in plasma sterilization. Currently, for medical instruments with large volume and heavy weight, such as various endoscopes used in surgery, non-woven fabric sterilization packaging is mainly used for sterilization. The present inventors have recently found that plasma sterilization technology has aluminum contamination, which comes from the inner wall of the sterilization cavity. Currently, the cavity of the commonly used plasma sterilizer on the market is mostly made of aluminum alloy inner wall. During the plasma sterilization process, high-speed charged particles bombard the inner wall of the cavity, sputtering aluminum atoms on the surface. Although the medical instruments are sealed in the sterilization packaging throughout the sterilization process, these free aluminum can penetrate the sterilization packaging and adhere to the surface of the medical instruments, forming aluminum contamination. During the use of these sterilized medical instruments, the aluminum contamination on the surface can enter the human body, threatening people's health and safety.

[0003] Therefore, it is necessary to solve the problem of aluminum contamination on the surface of medical instruments subjected to sterilization treatment. SUMMARY

[0004] To solve the problems in the prior art, the present application provides a sterilization packaging material and a preparation method and application thereof. The non-woven fabric is modified in the present application, so that it can effectively adsorb aluminum impurities reaching the surface of the sterilization packaging during plasma sterilization, greatly reducing the contamination of the objects in the sterilization packaging. Therefore, the non-woven fabric provided by the present application is particularly suitable for packaging medical instruments in plasma sterilization.

[0005] One of the purposes of the present application is to provide a sterilization packaging material comprising a non-woven fabric and a functional layer.

[0006] The functional layer is tightly attached to at least one side of the non-woven fabric.

[0007] The functional layer is selected from at least one of polymers containing sulfonic acid groups.

[0008] In the present application, the functional layer is present on one side of the non-woven fabric or on both sides of the non-woven fabric.

[0009] In the sterilization packaging material described in the present application, preferably,

[0010] The material of the non-woven fabric is selected from polypropylene or polyester; preferably, it is a medical non-woven fabric.

[0011] In the sterilization packaging material according to the present application, preferably,

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

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

[0014] In the sterilization packaging material according to the present application, preferably,

[0015] The thickness of the functional layer is 0.1-100 μm, preferably 0.5-50 μm.

[0016] In the sterilization packaging material according to the present application, preferably,

[0017] The ion exchange capacity of the polymer containing sulfonic acid group is 0.4-2.5 mmol / g, preferably 0.5-2.0 mmol / g; further preferably 0.9-2.0 mmol / g.

[0018] The second object of the present application is to provide a method for preparing a sterilization packaging material, comprising the following steps:

[0019] (1) dissolving a functional layer material in a solvent to prepare a dispersion;

[0020] (2) coating the dispersion on at least one surface of the non-woven fabric, drying to prepare a sterilization packaging material;

[0021] Preferably used for preparing the sterilization packaging material according to the first object of the present application.

[0022] In the method for preparing the sterilization packaging material according to the present application, preferably,

[0023] In step (1),

[0024] The solvent is selected from a mixture of alcohol and water; and / or,

[0025] The concentration of the dispersion is 1-20 wt%;

[0026] The functional layer material is selected from at least one of polymer containing sulfonic acid group;

[0027] Preferably,

[0028] The alcohol is selected from at least one of methanol, ethanol, n-butanol; and / or,

[0029] The volume ratio of alcohol to water in the solvent is (1-10):1; and / or,

[0030] The functional layer is selected from at least one of perfluorosulfonic acid resin, sulfonated polymer; further preferably,

[0031] The sulfonated polymer is selected from at least one of sulfonated polyether ketone or sulfonated polyether sulfone.

[0032] In the method for preparing the sterilization packaging material according to the present application, preferably,

[0033] In step (2),

[0034] The coating method is dip coating; preferably, the dip coating time is 10-300 s, further preferably 30-120 s, and still further preferably 60-120 s; and / or,

[0035] The drying temperature is 40-80℃.

[0036] A third object of the present application is to provide the use of the sterilization packaging material according to any one of the first object of the present application or the method according to the second object of the present application as an outer packaging material in sterilization treatment; preferably, as an outer packaging material in plasma sterilization treatment.

[0037] In the use of the sterilization packaging material according to the present application, preferably,

[0038] After the sterilization object is wrapped with the sterilization packaging material as an outer packaging material, it is put into a plasma sterilizer for sterilization treatment.

[0039] Further preferably, the sterilization object and the sterilization indicator are wrapped with a sterilization packaging material of appropriate size and sealed with adhesive tape, and the outside is further wrapped with another sterilization packaging material of the same kind and sealed with adhesive tape. Then a label with the sterilization indicator is attached to the outer sterilization packaging material. Finally, it is put into a plasma sterilizer for sterilization.

[0040] The polymer containing sulfonic acid groups according to the present application can form a film on non-woven fabric, which has a barrier effect on aluminum ions. Moreover, the sulfonic acid groups can chelate aluminum ions, which has an adsorption effect on aluminum ions. The two effects together can significantly reduce the contamination of medical devices in sterilization packaging by aluminum ions.

[0041] The endpoints of the ranges and any values disclosed herein are not limited to the precise values recited as implicitly split by the language of the specification. The endpoints of the ranges and any values are to be construed as specifically included. The language of the specification is intended to be broad and expansive and is intended to be construed in a manner consistent with the scope of the disclosure. The disclosure contemplates various combinations and sub-combinations of the disclosed features and alternatives.

[0042] Compared with the prior art, the present application has at least the following advantages:

[0043] The sterilization packaging material of the present application can greatly reduce the aluminum contamination of the sterilized objects, and reduce the risk of health and life safety. BRIEF DESCRIPTION OF DRAWINGS

[0044] Figure 1 The results of the distribution of the aluminum atom concentration near the surface of the silicon wafer A, the silicon wafer G and the silicon wafer I with depth;

[0045] Figure 2 The results of the distribution of the aluminum atom concentration near the surface of the silicon wafer B, the silicon wafer H and the silicon wafer E with depth;

[0046] Figure 3 The results of the distribution of the aluminum atom concentration near the surface of the silicon wafer C, the silicon wafer G and the silicon wafer I with depth;

[0047] Figure 4 The results of the distribution of the aluminum atom concentration near the surface of the silicon wafer D, the silicon wafer G and the silicon wafer I with depth;

[0048] Figure 5 The results of the distribution of the aluminum atom concentration near the surface of the silicon wafer E, the silicon wafer G and the silicon wafer I with depth;

[0049] Figure 6 The results of the distribution of the aluminum atom concentration near the surface of the silicon wafer F, the silicon wafer G and the silicon wafer I with depth;

[0050] Figure 7 The results of the distribution of the aluminum atom concentration near the surface of the silicon wafer J, the silicon wafer G and the silicon wafer I with depth. DETAILED DESCRIPTION

[0051] The following will describe the present application in detail in conjunction with specific embodiments. It is necessary to point out here that the following embodiments are only used to further illustrate the present application and cannot be understood as limiting the protection scope of the present application. Some non-essential improvements and adjustments of the present application made by those skilled in the art according to the content of the present application still fall within the protection scope of the present application.

[0052] It should be further noted that each specific technical feature described in the following detailed description can be combined in any suitable manner, without contradiction, unless otherwise indicated. In order to avoid unnecessary repetition, the present application will not be described again for each possible combination.

[0053] Furthermore, any combination of various embodiments of the present application can be made, as long as it does not deviate from the idea of the present application, and the technical solution thus formed belongs to the original disclosure of the present specification and falls within the protection scope of the present application.

[0054] Raw material sources:

[0055] Nafion D521 (ion exchange capacity of perfluorosulfonic acid resin is 0.92 mmol / g, concentration is 5 wt%; solvent is a mixture of isopropyl alcohol and water with a volume ratio of 5:1; purchased from Alpha Aesar;

[0056] Nafion D520 (ion exchange capacity of perfluorosulfonic acid resin is 1.2 mmol / g, concentration is 20 wt%; solvent is a mixture of isopropyl alcohol and water with a volume ratio of 5:1; purchased from Alpha Aesar;

[0057] Sulfonated polyether ketone (ion exchange capacity is 1.95 mmol / g) purchased from Tianjin Yanzhijun Technology Co., Ltd.;

[0058] Sulfonated polyether sulfone (ion exchange capacity is 1.80 mmol / g) purchased from Tianjin Yanzhijun Technology Co., Ltd.

[0059] Example 1

[0060] A commercially available sterilization non-woven fabric W1 made of polypropylene was selected, and two pieces were cut from it, each with a size of 20 cm*20 cm. The non-woven fabric was immersed in the Nafion D521 dispersion liquid for 60 s (the concentration of the perfluorosulfonic acid-based polymer resin was 5 wt%), and was dried at 60°C to obtain a sterilization packaging material W2. The thickness of the functional layer on one side of W2 was 10 μm. A 1 cm square silicon wafer A was cut from a silicon wafer S and was cleaned. A was first packaged with one W2 and a sterilization indicator, and was sealed with a medical adhesive tape. Then, A was wrapped with another W2 and was sealed with a medical adhesive tape, and a label with a sterilization indicator was attached. A wrapped with double-layer W2 was placed in a plasma sterilizer, and was sterilized in a short cycle mode. The plasma treatment time was 660 s, the temperature was 53°C, and the pressure was 150 Pa. After sterilization, the sterilization indicator showed that the sterilization was qualified.

[0061] The distribution of aluminum concentration near the surface of A with depth was measured by secondary ion mass spectrometry, as shown in Figure 1 .

[0062] Example 2

[0063] Two sheets of commercially available sterilization nonwoven fabric W3 made of PET were selected, each having a size of 20 cm * 20 cm. The nonwoven fabric was immersed in a Nafion D520 dispersion liquid (20 wt% of a perfluorosulfonic acid-based polymer resin) for 60 s, and dried at 60°C to produce sterilization packaging material W4. The functional layer side of W4 had a thickness of 20 μm. A 1 cm square silicon wafer B was cut from a silicon wafer S and washed. The silicon wafer B and a sterilization indicator were first packaged with one sheet of W4 and sealed with medical tape, and then wrapped with another sheet of W4 and sealed with medical tape, and a label with a sterilization indicator was attached. The B wrapped with the double sheets of W4 was placed in a plasma sterilizer, and sterilized under the same conditions as in Example 1. After sterilization, the sterilization indicator showed that the sterilization was successful.

[0064] The distribution of aluminum concentration near the surface of B with depth was measured by secondary ion mass spectrometry, and is shown in Figure 2 .

[0065] Example 3

[0066] Two sheets of commercially available sterilization nonwoven fabric W1 made of polypropylene were selected, each having a size of 20 cm * 20 cm. A 15 wt% sulfonated polyether ketone dispersion liquid was prepared by dissolving the sulfonated polyether ketone in a mixture of isopropyl alcohol and water (volume ratio of isopropyl alcohol to water = 3:1). The nonwoven fabric was immersed in the sulfonated polyether ketone dispersion liquid for 60 s, and dried at 60°C to produce sterilization packaging material W5. The functional layer side of W5 had a thickness of 18 μm. A 1 cm square silicon wafer C was cut from a silicon wafer S and washed. The silicon wafer C and a sterilization indicator were first packaged with one sheet of W5 and sealed with medical tape, and then wrapped with another sheet of W5 and sealed with medical tape, and a label with a sterilization indicator was attached. The C wrapped with the double sheets of W5 was placed in a plasma sterilizer, and sterilized under the same conditions as in Example 1. After sterilization, the sterilization indicator showed that the sterilization was successful.

[0067] The distribution of aluminum concentration near the surface of C with depth was measured by secondary ion mass spectrometry, and is shown in Figure 3 .

[0068] Example 4

[0069] Two pieces of commercially available sterilization nonwoven fabric W1 made of polypropylene were selected, each having a size of 20 cm*20 cm. Sulfonated polyether ketone was dissolved in a mixture of isopropyl alcohol and water (volume ratio of isopropyl alcohol to water was 5:1) to prepare a 5wt% sulfonated polyether ketone dispersion; the nonwoven fabric was immersed in the sulfonated polyether ketone dispersion for 120 s and dried at 80°C to prepare sterilization packaging material W6. The thickness of the functional layer of W6 was 12 μm. A 1 cm square piece of silicon wafer D was cut from a piece of silicon wafer S and washed. The silicon wafer D and sterilization indicator were first packaged with one piece of W6 and sealed with medical tape, and then wrapped with another piece of W6 and sealed with medical tape, and a label with a sterilization indicator was attached. The D wrapped with double layers of W6 was placed in a plasma sterilizer, and sterilized under the same conditions as in Example 1. After sterilization, the sterilization indicator showed that the sterilization was qualified.

[0070] The distribution of aluminum concentration near the surface of D with depth was measured by secondary ion mass spectrometry, as shown in Figure 4 .

[0071] Example 5

[0072] Two pieces of commercially available sterilization nonwoven fabric W1 made of polypropylene were selected, each having a size of 20 cm*20 cm. Sulfonated polyether ketone was dissolved in a mixture of isopropyl alcohol and water (volume ratio of isopropyl alcohol to water was 5:1) to prepare a 5wt% sulfonated polyether ketone dispersion; the nonwoven fabric was immersed in the sulfonated polyether ketone dispersion for 120 s and dried at 80°C to prepare sterilization packaging material W6. The thickness of the functional layer of W6 was 12 μm. A 1 cm square piece of silicon wafer D was cut from a piece of silicon wafer S and washed. The silicon wafer D and sterilization indicator were first packaged with one piece of W6 and sealed with medical tape, and then wrapped with another piece of W6 and sealed with medical tape, and a label with a sterilization indicator was attached. The D wrapped with double layers of W6 was placed in a plasma sterilizer, and sterilized under the same conditions as in Example 1. After sterilization, the sterilization indicator showed that the sterilization was qualified.

[0073] The distribution of aluminum concentration near the surface of D with depth was measured by secondary ion mass spectrometry, as shown in Figure 5 .

[0074] Example 6

[0075] Two pieces of commercially available sterilization nonwoven fabric W1 made of polypropylene were selected, each having a size of 20 cm x 20 cm. The nonwoven fabric was immersed in a mixed dispersion liquid of Nafion D521 (the same material as used in Example 1) and sulfonated polyether ketone (the same material as used in Example 4) for 60 seconds (mass ratio of Nafion D521, a perfluorosulfonic acid-based polymer resin, to sulfonated polyether ketone was 1:1, and the solvent was a mixed liquid of isopropyl alcohol and water at a volume ratio of 5:1; the concentration of the mixed dispersion liquid was 10 wt%, and the mixed dispersion liquid was dried at 60°C to prepare sterilization packaging material W8. The functional layer of W8 had a thickness of 13 μm. A piece of silicon wafer S was cut into a 1 cm square silicon piece F and washed. The silicon piece F and sterilization indicator were packaged with one piece of W8 and sealed with medical tape, and then the packaged silicon piece F was wrapped with another piece of W8 and sealed with medical tape, and a label with a sterilization indicator was attached. The silicon piece F wrapped with the double-layer W8 was placed in a plasma sterilizer, and sterilized under the same conditions as in Example 1. After sterilization, the sterilization indicator showed that the sterilization was qualified.

[0076] The distribution of aluminum concentration near the surface of F with depth was measured by secondary ion mass spectrometry, and is shown in Figure 6 .

[0077] Comparative Example 1

[0078] Two pieces of W1 were cut, each having a size of 20 cm x 20 cm. Another piece of silicon wafer S was cut into a 1 cm square silicon piece G and washed. The silicon piece G and sterilization indicator were packaged with one piece of W1 and sealed with medical tape, and then the packaged silicon piece G was wrapped with another piece of W1 and sealed with medical tape, and a label with a sterilization indicator was attached. The silicon piece G wrapped with the double-layer W1 was placed in a plasma sterilizer, and sterilized under the same conditions as in Example 1. After sterilization, the sterilization indicator showed that the sterilization was qualified.

[0079] The distribution of aluminum concentration near the surface of G with depth was measured by secondary ion mass spectrometry, and is shown in Figure 1 and Figures 3-7 .

[0080] Comparative Example 2

[0081] Two pieces of W3 were cut, each having a size of 20 cm x 20 cm. Another piece of silicon wafer S was cut into a 1 cm square silicon piece H and washed. The silicon piece H and sterilization indicator were packaged with one piece of W3 and sealed with medical tape, and then the packaged silicon piece H was wrapped with another piece of W3 and sealed with medical tape, and a label with a sterilization indicator was attached. The silicon piece H wrapped with the double-layer W3 was placed in a plasma sterilizer, and sterilized under the same conditions as in Example 1. After sterilization, the sterilization indicator showed that the sterilization was qualified.

[0082] The distribution of aluminum concentration near the surface of H with depth was measured by secondary ion mass spectrometry, and is shown inFigure 2 .

[0083] Comparative Example 3

[0084] A 1 cm square silicon wafer I was cut from the silicon wafer S and washed.

[0085] The distribution of aluminum concentration near the surface of I with depth was measured by secondary ion mass spectrometry, shown in Figures 1-7 .

[0086] Comparative Example 4

[0087] A commercially available sterilization nonwoven fabric W1 made of polypropylene was selected, and two pieces of the nonwoven fabric each having a size of 20 cm*20 cm were cut. The nonwoven fabric was immersed in sulfosalicylic acid (5 wt%) for 60 s, and dried at 60°C to obtain a sterilization packaging material W9. A 1 cm square silicon wafer J was cut from the silicon wafer S and washed. J and a sterilization indicator were packaged with one piece of W9 and sealed with a medical adhesive tape, and then wrapped with another piece of W9 and sealed with a medical adhesive tape, and a label with a sterilization indicator was attached. J wrapped with the double-layered W9 was placed in a plasma sterilizer, and sterilized under the same conditions as in Example 1. After sterilization, the sterilization indicator showed that the sterilization was qualified.

[0088] The distribution of aluminum concentration near the surface of J with depth was measured by secondary ion mass spectrometry, shown in Figure 7 .

[0089] As can be seen from Figures 1-7 , the aluminum concentration on the surface of the silicon wafer wrapped with the commercially available sterilization nonwoven fabric was significantly increased after plasma sterilization, and the highest concentration reached 4.2E19 / cm 3 . The aluminum concentration on the surface of the silicon wafer wrapped with the sterilization packaging material provided by the present application was significantly reduced after sterilization under the same conditions, and the highest concentration was only 9.5E18 / cm 3 , which was very close to the aluminum concentration on the surface of the silicon wafer without sterilization (i.e. the original aluminum concentration in the silicon wafer). However, the adsorption of aluminum by the sterilization packaging material modified with sulfosalicylic acid as an organic compound containing a sulfonic acid group was not obvious, as shown in Figure 7 , and the aluminum concentration on the surface of the silicon wafer J was not significantly reduced, but was close to the aluminum concentration on the surface of the silicon wafer G.

[0090] From the above results, it can be seen that the sterilization packaging material provided by the present application can effectively adsorb aluminum generated in the cavity during plasma sterilization, thereby avoiding contamination of the contents in the sterilization package, and solving the problem of aluminum contamination in the prior art. Therefore, the sterilization packaging material provided by the present application is particularly suitable for packaging medical devices in plasma sterilization.

[0091] The present application is illustrated by the detailed description and examples, but these are not to be construed as limiting the application. Those skilled in the art will appreciate that various modifications, adaptations or improvements to the present application and its implementations can be made without departing from the spirit and scope of the present application, which are to be determined by the appended claims. The scope of the present application is defined by the appended claims.

[0092] All publications, patent applications, patents and other references mentioned in this specification are herein incorporated by reference. Unless otherwise defined, all technical and scientific terms used in this specification are to be given their conventional meaning as is commonly understood by one of ordinary skill in the art. In case of conflict between the definitions in the specification and those in the appended claims, the definitions in the claims are intended to prevail.

[0093] When the specification states that a material, substance, method, step, apparatus or component etc. is "known to those of ordinary skill in the art", "prior art", or the like, the disclosure is intended to incorporate by reference any current or future publications known to those of ordinary skill in the art that may affect the interpretation of the phrase one of ordinary skill in the art.

[0094] In the context of this specification, except where otherwise indicated, any unrecited matter or item not explicitly stated is to be taken directly from those known in the art without any need for modification.

Claims

1. A sterilization packaging material comprising a nonwoven fabric and a functional layer; the functional layer is closely adhered to at least one side of the nonwoven fabric; the functional layer is selected from at least one of a sulfonic acid group-containing polymer; the functional layer is selected from at least one of a perfluorosulfonic acid resin, a sulfonated polymer; the sulfonated polymer is selected from at least one of a sulfonated polyether ketone or a sulfonated polyether sulfone; after a sterilized article is wrapped with the sterilization packaging material as an outer packaging material, the sterilization packaging material is put into a plasma sterilizer for sterilization treatment; the sterilization packaging material can reduce aluminum contamination to the sterilized article.

2. The sterilization packaging material according to claim 1, wherein: the material of the nonwoven fabric is selected from polypropylene or polyester.

3. The sterilization packaging material according to claim 2, wherein: the material of the nonwoven fabric is a medical nonwoven fabric.

4. The sterilization packaging material according to claim 1, wherein: the thickness of the functional layer is 0.1-100 μm.

5. The sterilization packaging material according to claim 4, wherein: the thickness of the functional layer is 0.5-50 μm.

6. The sterilization packaging material according to claim 1, wherein: the ion exchange capacity of the sulfonic acid group-containing polymer is 0.4-2.5 mmol / g; the ion exchange capacity of the sulfonic acid group-containing polymer is 0.5-2.0 mmol / g; the ion exchange capacity of the sulfonic acid group-containing polymer is 0.9-2.0 mmol / g.

7. A method for preparing the sterilization packaging material according to any one of claims 1-8, comprising the steps of: (1) dissolving a functional layer material in a solvent to prepare a dispersion; (2) coating the dispersion on at least one surface of a nonwoven fabric, drying to prepare the sterilization packaging material.

10. The method for preparing the sterilization packaging material according to claim 9, wherein: in step (1), the solvent is selected from a mixture of alcohol and water; and / or, the concentration of the dispersion is 1-20 wt%; the functional layer material is selected from at least one of a sulfonic acid group-containing polymer.

11. The method for preparing the sterilization packaging material according to claim 10, wherein: the alcohol is selected from at least one of methanol, ethanol and n-butanol; and / or, the volume ratio of alcohol to water in the solvent is (1-10):1; and / or, the functional layer is selected from at least one of a perfluorosulfonic acid resin, a sulfonated polymer.

12. The method for preparing the sterilization packaging material according to claim 11, wherein: the sulfonated polymer is selected from at least one of a sulfonated polyether ketone or a sulfonated polyether sulfone.

13. The method for preparing the sterilization packaging material according to claim 9, wherein: in step (2), the coating method is dip coating; and / or, the drying temperature is 40-80°C.

14. The method for preparing the sterilization packaging material according to claim 13, wherein: the dip coating time is 10-300 s; the dip coating time is 30-120 s; the dip coating time is 60-120 s. ​ ​ 7. The sterilization wrap material of claim 6, wherein: ​ 8. The sterilization wrap material of claim 7, wherein: ​ 9. A method for the production of a sterilization packaging material, characterized in that ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 15. The method of producing a sterilization wrap material according to claim 14, characterized by: ​ 16. The method of producing a sterilization wrap material according to claim 15, characterized by: ​ 17. Use of a sterilization wrapper according to any one of claims 1-8 as an overwrap material in a sterilization process.

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