SINGLE SIDED HYDROPHILIC NONWOVEN FABRIC WITH HIGH TENSIBLE STRENGTH AND CSR WRAP MADE THEREFROM

Abstract

The present application discloses a single sided hydrophilic nonwoven fabric with high tensile strength and a CSR wrap made therefrom, wherein the single sided hydrophilic nonwoven fabric has a spunbonded/meltblown/spunbonded (SMS) structure consisting of a top spunbonded layer, a middle meltblown layer and a bottom spunbonded layer, wherein one side of the nonwoven fabric is hydrophilic, and the other side of the nonwoven fabric is hydrophobic.

Claims

1. A single sided hydrophilic nonwoven fabric, having a structure comprising (i) a top spunbonded layer including one or more spunbond layers, (ii) a middle meltblown layer including one or more meltblown layers, and (iii) a bottom spunbonded layer including one or more spunbond layers, wherein one side of the nonwoven fabric is hydrophilic and the other side thereof is hydrophobic.

2. (canceled)

3. The single sided hydrophilic nonwoven fabric according to claim 1, wherein the single sided hydrophilic nonwoven fabric comprises (i) 60 wt % to 95 wt % of spunbonded fibers, (ii) 5 wt % to 40 wt % of meltblown fibers, or (iii) both (i) and (ii).

4-9. (canceled)

10. The single sided hydrophilic nonwoven fabric according to claim 1, wherein the middle meltblown layer is composed of two meltblown layers.

11. The single sided hydrophilic nonwoven fabric according to claim 1, wherein a tensile enhancer is added to the top spunbonded layer and the bottom spunbonded layer, and wherein the tensile enhancer is added in an amount of from 1 wt % to 10 wt %, based on the total weight of the top spunbonded layer and the bottom spunbonded layer.

12. (canceled)

13. The single sided hydrophilic nonwoven fabric according to claim 1, wherein the middle meltblown layer accounts for 10% to 30% of the weight of the whole single sided hydrophilic nonwoven fabric.

14. The single sided hydrophilic nonwoven fabric according to claim 13, wherein the middle meltblown layer has meltblown fibers having a diameter between 0.5 ?m and 10 ?m.

15. The single sided hydrophilic nonwoven fabric according to claim 1, wherein the top spunbonded layer is a hydrophilic spunbonded layer, and the bottom spunbonded layer is a hydrophobic spunbonded layer.

16. The single sided hydrophilic nonwoven fabric according to claim 15, wherein the weight of the hydrophilic spunbonded layer accounts for 30% to 50% of the weight of the whole single sided hydrophilic nonwoven fabric.

17. (canceled)

18. The single sided hydrophilic nonwoven fabric according to claim 15, wherein the weight of the hydrophobic spunbonded layer accounts for 30% to 50% of the weight of the whole single sided hydrophilic nonwoven fabric.

19. (canceled)

20. The single sided hydrophilic nonwoven fabric according to claim 15, wherein a hydrophilic masterbatch is added to the top spunbonded layer.

21. The single sided hydrophilic nonwoven fabric according to claim 20, wherein the hydrophilic masterbatch is a glyceride of fatty acid.

22. The single sided hydrophilic nonwoven fabric according to claim 20, wherein the hydrophilic masterbatch is added in an amount of from 1 wt % to 10 wt %, based on the total weight of the top spunbonded layer.

23-26. (canceled)

27. The single sided hydrophilic nonwoven fabric according to claim 1, wherein a tensile strength of the single sided hydrophilic nonwoven fabric in the longitudinal direction and transverse direction, as determined in accordance with EN ISO 1924-2, are each in the range of 1.2 KN/m to 5.0 kN/m.

28. The single sided hydrophilic nonwoven fabric according to claim 1, wherein a longitudinal tensile strength of the single sided hydrophilic nonwoven fabric, as determined in accordance with EN ISO 1924-2, is in the range of 2 KN/m to 5.0 KN/m.

29. The single sided hydrophilic nonwoven fabric according to claim 1, wherein a longitudinal elongation of the single sided hydrophilic nonwoven fabric, as determined in accordance with EN ISO 1924-2, is in the range of 50% to 120%.

30. The single sided hydrophilic nonwoven fabric according to claim 1, wherein a transverse tensile strength of the single sided hydrophilic nonwoven fabric, as determined in accordance with EN ISO 1924-2, is in the range of 1.5 KN/m to 3.5 KN/m.

31. The single sided hydrophilic nonwoven fabric according to claim 1, wherein a transverse elongation of the single sided hydrophilic nonwoven fabric, as determined in accordance with EN ISO 1924-2, is in the range of 50% to 150%.

32. The single sided hydrophilic nonwoven fabric according to claim 1, wherein the single sided hydrophilic nonwoven fabric has (i) a water absorption capacity of the single sided hydrophilic nonwoven fabric, as determined in accordance with the GB/T 1540 method, is from 10 g/m.sup.2 to 30 g/m.sup.2, (ii) a microbial barrier of the single sided hydrophilic nonwoven fabric, as determined in accordance with EN868, is maintained for 180 days or longer, or (iii) both (i) and (ii).

33. (canceled)

34. A central supply room (CSR) wrap made from the single sided hydrophilic nonwoven fabric according to claim 1.

35. A method of sterilizing a medical device, comprising: (i) enclosing the medical device within a central supply room (CSR) wrap comprising a single sided hydrophilic nonwoven fabric according to claim 1 to provide an enclosed medical device, and (ii) subjecting the enclosed medical device to a steam sterilization operation.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0035] The following drawings attached to the specification illustrate preferred embodiments of the present application by way of examples, and are used in conjunction with the detailed description of the present application given below to enable the technical concepts of the present application to be further understood, and therefore, the contents of such drawings should not be used alone to explain the present application.

[0036] FIG. 1 is a schematic view of the single sided hydrophilic nonwoven fabric according to a preferred embodiment of the present application.

[0037] FIG. 2 is a schematic view of the single sided hydrophilic nonwoven fabric according to another preferred embodiment of the present application.

DETAILED DESCRIPTION

[0038] Hereinafter, various embodiments of the present application will be described in detail with reference to the drawings. However, the present application may be implemented in many different forms and should not be construed to be limited to the embodiments set forth herein.

[0039] The terminology used herein is for the purpose of describing specific exemplary embodiments only, and is not intended to be limiting. The singular forms a, an and the as used herein may be intended to include the plural forms as well, unless clearly indicated otherwise in the context. The terms comprise(s), contain(s), include(s) and have/has are inclusive, thus specifying the presence of the stated features, integers, steps, operations, elements and/or components, but not excluding the presence or addition of one or more other features, integers, steps, operations, elements, components and/or groups thereof. The method steps, processes and operations described herein should not be interpreted as necessarily requiring them performing in the particular order discussed or illustrated, unless specifically identified as an order of performing. It should also be understood that additional or alternative steps may be taken.

[0040] The single sided hydrophilic nonwoven fabric in the present application refers to a nonwoven fabric with spunbonded/meltblown/spunbonded (SMS) structure, where S represents single or multiple spunbonded beam(s), and M represents single or multiple meltblown beam(s). The single sided hydrophilic nonwoven fabric of the present application is a laminate composed of a top spunbonded layer, a middle meltblown layer and a bottom spunbonded layer, wherein any one of the top spunbonded layer, the middle meltblown layer and the bottom spunbonded layer may be composed of one or more layers. Therefore, the term SMS structure used in the meaning of the present application not only means an S-M-S laminate composed of a spunbonded layer, a meltblown layer and another spunbonded layer, but also may mean a laminate with structures such as S-S-M-S, S-M-M-S, and S-M-S-S, etc. For example, in one embodiment, the middle meltblown layer may be composed of two layers.

[0041] In one embodiment, the single sided hydrophilic nonwoven fabric may have a basis weight of from 20 gsm to 100 gsm, preferably from 40 gsm to 80 gsm, and more preferably from 50 gsm to 70 gsm.

[0042] In the present application, the raw material for each of the spunbonded layers and the middle meltblown layer of single sided hydrophilic nonwoven fabric may comprise a polyethylene homopolymer or a copolymer thereof, or a polypropylene homopolymer or a copolymer thereof, and polypropylene resin is particularly preferred. Polypropylene resin is widely used in the manufacture of non-woven fabrics with SMS structure.

[0043] The melt flow rate of polypropylene resin suitable for the middle meltblown layer in the present application may be between 800 g/10 min and 1800 g/10 min, preferably between 1200 g/10 min and 1600 g/10 min, especially about 1400 g/10 min.

[0044] The melt flow rate of polypropylene resin suitable for each of the spunbonded layers in the present application may be between 35 g/10 min and 40 g/10 min, for example, about 35 g/10 min.

[0045] In addition, during the formation of the middle meltblown layer and each of the spunbonded layers, color masterbatches of various colors, such as white, yellow, blue, green, purple, pink, etc., can also be added, in order to allow the single sided hydrophilic nonwoven fabric of the present application to be colored.

[0046] In one embodiment, a color masterbatch may be added to the middle meltblown layer and the bottom spunbonded layer. The color masterbatch may be added in an amount of from 1 wt % to 10 wt %, and preferably from 1.5 wt % to 8 wt %, based on the total weight of the middle meltblown layer. Additionally, the color masterbatch may be added in an amount of from 1 wt % to 10 wt %, and preferably from 1.5 wt % to 8 wt %, based on the total weight of the bottom spunbonded layer.

[0047] The single sided hydrophilic nonwoven fabric according to the present application has high tensile strength and/or elongation. High tensile strength and/or elongation make the single sided hydrophilic non-woven fabric not easy to be damaged when accommodating or wrapping medical devices, thus effectively preventing the occurrence of damaged packs.

[0048] According to one aspect of the present application, the single sided hydrophilic nonwoven fabric may include 60 wt % to 95 wt % of spunbonded fibers, which may provide sufficient tensile strength. Preferably, the single sided hydrophilic nonwoven fabric may include spunbonded fibers ranging from 70 wt % to 90 wt %, and more preferably ranging from 75 wt % to 85 wt %. When the content of the spunbonded fibers in the single sided hydrophilic nonwoven fabric is less than 60 wt %, the tensile strength of the nonwoven fabric may be insufficient, and when the content of spunbonded fibers is higher than 95%, the sterile barrier performance may be unfavorably decreased.

[0049] In addition, a tensile enhancer may be added to the top spunbonded layer and/or the bottom spunbonded layer to further improve the tensile strength of the single sided hydrophilic nonwoven fabric. In one embodiment, a tensile enhancer may be added to both the top spunbonded layer and the bottom spunbonded layer.

[0050] In the present application, the types of the tensile enhancer are not limited, as long as it is a material that can increase the crystallization percentage of spunbonded materials. The tensile enhancer may be added in an amount of between 1 wt % and 10 wt %, preferably between 1 wt % and 8 wt %, and more preferably between 2 wt % and 5 wt %, based on the total weight of each of the spunbonded layers.

[0051] In one embodiment, the tensile strengths of the single sided hydrophilic nonwoven fabric in the longitudinal direction (i.e., machine direction, MD) and the transverse direction (i.e., cross direction, CD), as determined in accordance with EN ISO 1924-2, may each be in the range of 1.2 KN/m to 5.0 KN/m.

[0052] In one embodiment, the longitudinal tensile strength of the single sided hydrophilic nonwoven fabric, as determined in accordance with EN ISO 1924-2, may be in the range of 2 KN/m to 5.0 KN/m, for example, in the range of 2.5 KN/m to 4.0 KN/m.

[0053] In one embodiment, the longitudinal elongation of the single sided hydrophilic nonwoven fabric, as determined in accordance with EN ISO 1924-2, may be in the range of 50% to 120%, for example, in the range of 70% to 100%.

[0054] In one embodiment, the transverse tensile strength of the single sided hydrophilic nonwoven fabric, as determined in accordance with EN ISO 1924-2, may be in the range of 1.5 KN/m to 3.5 KN/m, for example, in the range of 1.6 KN/m to 3.0 KN/m.

[0055] In one embodiment, the transverse elongation of the single sided hydrophilic nonwoven fabric, as determined in accordance with EN ISO 1924-2, may be in the range of 50% to 150%, for example, in the range of 70% to 100%.

[0056] In an embodiment according to the present application, the single sided hydrophilic nonwoven fabric has at least two spunbonded layers, wherein at least one of the spunbonded layers is a hydrophilic spunbonded layer so as to absorb the condensed water after steam sterilization, and at least one of the spunbonded layers is a hydrophobic spunbonded layer so as to provide a barrier to prevent the penetration of bacteria. Therefore, when the single sided hydrophilic nonwoven fabric of the present application is used as a CSR wrap, the occurrence of wet packs can be effectively prevented.

[0057] In one embodiment according to the present application, one spunbonded layer of the single sided hydrophilic nonwoven fabric is designed to be hydrophilic. In one embodiment, only the top spunbonded layer in the single sided hydrophilic nonwoven fabric is designed to be a hydrophilic spunbonded layer, and the bottom spunbonded layer is designed to be a hydrophobic spunbonded layer. When the top spunbonded layer is composed of two or more layers, only the outermost spunbonded layer may be designed to be hydrophilic, or the whole top spunbonded layer may be designed to be hydrophilic.

[0058] In one embodiment of the present application, the weight of the hydrophilic spunbonded layer may account for 30% to 50% of the weight of the whole single sided hydrophilic nonwoven fabric. In the hydrophilic spunbonded layer, the diameter of the fibers may be between 10 ?m and 30 ?m, and preferably between 15 ?m and 25 ?m, and the average diameter of the fibers may be about 17-21 ?m. In a preferred embodiment, the diameter of the fibers in the hydrophilic spunbonded layer may be between 15 ?m and 25 ?m, and the average diameter of the fibers may be about 19 ?m.

[0059] In one embodiment of the present application, the weight of the hydrophobic spunbonded layer may account for 30% to 50% of the weight of the whole single sided hydrophilic nonwoven fabric. In the hydrophobic spunbonded layer, the diameter of the fibers may be between 10 ?m and 30 ?m, and preferably between 15 ?m and 25 ?m, and the average diameter of the fibers may be about 17-21 ?m. In a preferred embodiment, the diameter of the fibers in the hydrophobic spunbonded layer may be between 15 ?m and 25 ?m, and the average diameter of the fibers may be about 19 ?m.

[0060] Preferably, a hydrophilic masterbatch may be added to the top spunbonded layer to make it hydrophilic. The types of the hydrophilic masterbatch are not limited, as long as it can make the spunbonded layer hydrophilic without impairing the physical properties of the spunbonded layer. In a preferred embodiment, the hydrophilic master batch may be, for example, a glyceride of fatty acids. Examples of glycerides of fatty acids may include, but are not limited to, tributyrin, tricaprylin, myristin, and glycerol 2-ethylcaproate, etc. In one embodiment, the hydrophilic masterbatch may be added in an amount of from 1 wt % to 10 wt %, preferably from 1 wt % to 5 wt %, and more preferably from 2 wt % to 5 wt %, based on the total weight of the spunbonded fibers for the hydrophilic spunbonded layer.

[0061] Since one side of the single sided hydrophilic nonwoven fabric of the present application is hydrophilic, the condensed water may be absorbed after steam sterilization. In one embodiment, the water absorption capacity of the single sided hydrophilic nonwoven fabric, as determined in accordance with GB/T 1540 method, may be from 10 g/m.sup.2 to 30 g/m.sup.2, for example, from 15 g/m.sup.2 to 25 g/m.sup.2.

[0062] The single sided hydrophilic nonwoven fabric of the present application further comprises a middle meltblown layer located between the top spunbonded layer and the bottom spunbonded layer. The single sided hydrophilic nonwoven fabric may contain 5 wt % to 40 wt % of meltblown fibers, which will provide high barrier properties to prevent the penetration of microorganisms and bacteria. For example, the weight of the middle meltblown layer can account for 10% to 30% of the weight of the whole single sided hydrophilic nonwoven fabric.

[0063] When the content of meltblown fibers contained in the single sided hydrophilic nonwoven fabric is less than 5 wt %, sufficient barrier properties may not be provided, and when the content of meltblown fibers is more than 40 wt %, the tensile strength of the obtained nonwoven fabric may be insufficient.

[0064] Referring to FIG. 1, which shows a schematic view of the single sided hydrophilic nonwoven fabric according to a preferred embodiment of the present application.

[0065] As shown in FIG. 1, the single sided hydrophilic nonwoven fabric according to the present application sequentially includes a top spunbonded layer, a middle meltblown layer and a bottom spunbonded layer from top to bottom.

[0066] In the embodiment shown in FIG. 1, the top spunbonded layer may be designed to be a hydrophilic spunbonded layer. In this top spunbonded layer, the diameter of the fibers may be 15 ?m to 25 ?m, and the average diameter of the fibers may be about 19 ?m. The top spunbonded layer may absorb 10 g/m.sup.2 to 30 g/m.sup.2 of condensed water. In addition, the weight of the top spunbonded layer may account for 30% to 50% of the weight of the whole nonwoven fabric. As an inner layer in the CSR wrap, this top spunbonded layer can absorb condensed water after steam sterilization due to its hydrophilicity, thus avoiding the occurrence of wet packs problems.

[0067] The bottom spunbonded layer may be designed to be a hydrophobic spunbonded layer. In this bottom spunbonded layer, the diameter of the fibers may be from 15 ?m to 25 ?m, and the average diameter of the fibers may be about 19 ?m. In addition, the weight of the bottom spunbonded layer may account for 30% to 50% of the weight of the whole nonwoven fabric.

[0068] The middle meltblown layer located between the top spunbonded layer and the bottom spunbonded layer is also hydrophobic. In the middle meltblown layer, the diameter of the fibers may range from 0.5 ?m to 10 ?m, and the average diameter of the fibers may be about 2 ?m. In addition, the weight of the bottom spunbonded layer may account for 30% to 50% of the weight of the whole nonwoven fabric.

[0069] The single sided hydrophilic nonwoven fabric of the present application comprises both a top spunbonded layer and a bottom spunbonded layer, wherein the spunbonded fibers may account for 60 wt % to 95 wt % of the weight of the single sided hydrophilic nonwoven fabric, thereby providing sufficient tensile strength to accommodate medical devices.

[0070] In addition, since both the middle meltblown layer and the bottom spunbonded layer are hydrophobic, they can provide an effective barrier to prevent the penetration of bacteria.

[0071] FIG. 2 is a schematic view of the single sided hydrophilic nonwoven fabric according to another preferred embodiment of the present application. As shown in FIG. 2, the single sided hydrophilic nonwoven fabric differs from the single sided hydrophilic nonwoven fabric shown in FIG. 1 only in that its middle meltblown layer is composed of two meltblown layers.

[0072] The manufacture of the nonwoven fabrics with SMS structure is known in the art, wherein the spunbonded and meltblown equipment or beams are used in combination, and the formed fiber layer is consolidated by thermal bonding consolidation technology. For example, for a nonwoven fabric with the structure shown in FIG. 1, a spunbonded bottom layer may be formed from spunbonded fibers in the No. 1 beam, and the fibers may be meltblown onto the bottom spunbonded layer in the No. 2 beam, and then another layer of spunbonded fibers may be spread on the meltblown layer in the No. 3 beam. After that, the resulting multilayer structure may be bonded and consolidated by calendering, thereby obtaining a nonwoven fabric with SMS structure.

[0073] In particular, the single sided hydrophilic nonwoven fabric according to the present application has high tensile strength, and one side thereof is hydrophilic and the other side is hydrophobic, and the benefits it can achieve include, but are not limited to: [0074] Hydrophilic spunbonded layer absorbs the condensed water after steam sterilization [0075] Hydrophobic meltblown and spunbonded layers provide a barrier to prevent the penetration of bacteria [0076] High tensile strength may decrease the possibility of damage to the wrap

[0077] According to another aspect of the present application, there is also provided a sterilized CSR wrap formed by the above single sided hydrophilic nonwoven fabric, which has the following characteristics, including but not limited to: [0078] Allow sterilizing agents to penetrate [0079] Allow air to penetrate [0080] Allow to load a given weight of medical devices without breaking [0081] Allow to absorb a given weight of condensed water [0082] Resistance to microbial pass-through [0083] Resistance to water penetration [0084] Wear resistance

[0085] The single sided hydrophilic CSR wrap according to the present application may be used as sterilization packaging for medical devices. CSR wrap are designed to be used by utilizing the following sterilization methods: Steam sterilization, EO sterilization, Hydrogen peroxide sterilization, and Formaldehyde sterilization. CSR wrap are designed and manufactured to meet EN 868.2 standardPackaging for terminally sterilized medical devices, Section 2: sterilization wrap-requirements and test methods, and YY/T 0698.2 standardPackaging materials for terminal sterilized medical devices, Section 2: sterilized wrapping materials-requirements and test methods.

Examples

[0086] Hereinafter, preferred embodiments will be provided to better understand the present invention. However, the following examples are only for illustrative purposes and for a better understanding of the present disclosure by those skilled in the art. Trade names sold by corresponding chemical companies may be presented in the following examples. According to the teachings of the present invention, the corresponding components or products can be obtained by those skilled in the art through purchasing approaches based on the names of the commercial chemicals provided. In addition, the corresponding components can be also synthesized or manufactured by those skilled in the art based on the teachings of the present invention. Therefore, the present invention should not be limited by these examples.

Example 1

[0087] Raw Materials: [0088] Polypropylene resin 3155E5 used in spunbonded process has an MFR of 35 g/10 min; [0089] Polypropylene resin HP461Y used in meltblown process has an MFR of 1400 g/10 min; [0090] Hydrophilic masterbatch MB-4031-TS, with an MFR of 550 g/10 min, was only added to the top spunbonded layer at the level of 3%; [0091] Blue masterbatches PCB377BN and PCB377CN, added to the middle meltblown layer and the bottom spunbonded layer, wherein PCB377BN and PCB377CN was added in an amount of 1.5% and 6.5%, respectively; [0092] Tensile enhancer TE 1096, added to both the top spunbonded layer and the bottom spunbonded layer, and was added in an amount of 3%; [0093] A laminate with S-M-M-S structure was obtained by using the above raw materials in accordance with the spunbonded-meltblown-meltblown-spunbonded process, and the laminate with S-M-M-S structure was consolidated by calendering, thereby obtaining an S-M-M-S wrapping material, which is Whi #BL15 S-M-M-S with a basis weight of 60 gsm.

[0094] 1. Physical Characteristics of S-M-M-S Wrapping Materials

[0095] Physical properties of S-M-M-S wrapping materials, including basis weight, tensile strength, elongation and tearing resistance in the longitudinal direction (i.e., machine direction, MD), tensile strength, elongation and tearing resistance in the transverse direction (i.e., cross direction, CD), bursting strength, air permeability, hydrostatic pressure (HSH) and water absorption capacity, were measured in accordance with the testing methods listed in Table 1 below. The results are shown in Table 1 below.

TABLE-US-00001 TABLE 1 Characteristic Unit Test Method Average EN868-2 Requirement conformity Basis Weight g/m.sup.2 EN ISO 536 60.4 (+0.6%) with in ?5% Pass Tensile Strength-MD KN/m EN ISO 1924-2 3.2 not less than 1 KN/m Pass Elongation-MD % EN ISO 1924-2 89.92 not less than 5% Pass Tensile Strength-CD KN/m EN ISO 1924-2 1.82 not less than 0.65 KN/m Pass Elongation-CD % EN ISO 1924-2 84.2 not less than 7% Pass Tearing Resistance -MD mN EN ISO 1974 5233 not less than 750 mN Pass Tearing Resistance -CD mN EN ISO 1974 11929 not less than 1000 mN Pass Bursting Strength Kpa EN ISO 2758 314 not less than 130 kPa Pass Air Permeability L/min/100 cm.sup.2 ASTM D 737 119.4 N/A N/A HSH mbar EN20811 55.08 N/A N/A Water Absorption Capacity g/m.sup.2 GB/T 1540 19.87 N/A N/A

[0096] 2. Determination of Microbial Barrier

[0097] In order to show compliance to ISO 11607-1:2019-02, Section 5.1.6 a) microbial barrier, the above materials were examined according to ISO 11607-1:2019-02, Section 5.2.3 test method DIN 58953-6:2016-12, Section 3 (germ proofness test under humidity) and Section 4 (germ proofness test with air permeance).

[0098] 2.1 Determination of Germ Proofness Under Humidity

[0099] A sample material was examined according to DIN 58953-6, Section 3, wherein both sides (side A and side B) of the sample material were contaminated with the test germ, and each was sterilized by steam at 134? C. for 4 minutes. The results are shown in Table 2 below.

TABLE-US-00002 TABLE 2 Sterilization -- Number of CFU/agar plate Test side 1 2 3 4 5 ? Steam 134? C. Side A 0 0 0 0 0 0 Steam 134? C. Side B 0 0 0 0 0 0 CFU = colony forming unit

[0100] 2.2 Determination of Germ Proofness with Air Permeance

[0101] A sample material was examined according to DIN 58953-6, Section 4, in which both sides (side A and side B) of the sample material were contaminated with the test germ, and each was sterilized by steam at 134? C. for 4 min. The results are shown in Table 3 below.

TABLE-US-00003 TABLE 3 Sterilization -- Number of CFU/Specimem Test side 1 2 3 4 5 6 7 8 9 10 ? Steam 134? C. 0 0 0 0 0 0 0 0 0 0 0 Side A Steam 134? C. 0 0 0 0 0 0 0 0 0 0 0 Side B

[0102] The evaluation of microbial barrier was conducted.

[0103] The germ proofness under humidity and air permeance of the sample material were examined after sterilization by steam (134? C./4 min). The results show that the S-M-M-S wrapping material has sufficient barrier for germ proof according to DIN 58953-6, Section 3.8 and Section 4.8.6.

[0104] 3. Stability Testing

[0105] The stability testing was used to demonstrate that the sterile barrier system maintains integrity over time per ISO 11607-1:2019. Following accelerated aging test, protocols were used with reference of ASTM F1980-21, with a temperature of 65? C. and a relative humidity of 80%?5%. The accelerated aging time (7 days) is equivalent to the real aging time (180 days) under room temperature condition. The results are shown in Table 4 below.

TABLE-US-00004 TABLE 4 The Growth of Microorganisms (Growth/Test tube) Test Group Aerobe Anaerobion Fungus Pre-sterilization control group 5/5 5/5 5/5 After sterilization before storage 0/5 0/5 0/5 After sterilization stored 7 days 0/5 0/5 0/5

[0106] The sample material was able to maintain package sterility for 180 days under controlled environmental conditions during the accelerated aging test.

[0107] Although the exemplary embodiments of the present application have been described in detail, the scope of the present application is not limited thereto. Various modifications and improvements made by those skilled in the art through adopting the basic concept of the present application as defined in the claims also fall within the scope of the present application.