Package including a sealed contact area containing a nonwoven fabric having a binding surface with an embossed stamped pattern.

Abstract

To provide an improved package for providing a closed internal environment that can be sterilized, and a gas-permeable fibrous nonwoven sheet structure suitable for use therein. The present invention relates to a package for providing a closed internal environment that can be sterilized, and to a gas-permeable fibrous nonwoven sheet structure useful in such a structure, the structure having at least one surface with a pre-sealed embossed imprint pattern and a particle barrier permeability of less than 10%, a Gurley Hill porosity of 40 seconds or less, and a gas permeability of 3500 g / m 2 and a gas-permeable fibrous nonwoven sheet structure having a water vapor transport rate of at least 1 / day.

Description

[Technical Field]

[0001] The present invention relates to an improved package for providing a sterilizable enclosed internal environment, and a gas-permeable fibrous nonwoven sheet structure suitable for use therein. [Background technology]

[0002] U.S. Patent No. 6,034,008, granted to Lim et al., discloses a sheet material suitable for use in filtration and sterile packaging, which has at least equal strength, weight and barrier properties to TYVEK® spunbond olefin nonwoven sheet materials conventionally used for such applications, but also has considerably improved air and liquid permeability.

[0003] In particular, Lim et al. have found that the entire surface has a smooth paper feel, which is commonly used in several applications, including sterile packaging. Conclusion The resulting "hard structure" product has a more fabric-like feel for apparel applications. Conclusion The report discloses a "soft structure" product which is also softened.

[0004] As disclosed by Lim et al., the entire surface of the “hard structure” flashspun sheet product Conclusion This is thought to reduce the high surface area plexifilamentous fibers of the sheet, and sequentially widen the pores between the fibers. Therefore, "hard structure" sheet products generally have higher water vapor permeability and higher hydrostatic head values ​​compared to "soft structure" sheet products. This more permeable material has been found to have great utility in sterile packaging materials, where the increased permeability allows the material to perform its function in a more efficient manner.

[0005] Fibrous nonwoven sheets are useful in packages that can be sterilized, as they allow manufacturers to first package items and then sterilize the items in the package using gases, such as steam, ethylene oxide, or a combination of some of these. Sterilizing gases can penetrate the package through the fibrous nonwoven sheet, sterilizing the enclosed interior of the package. A suitable fibrous nonwoven sheet also provides a barrier against contaminants, preventing sterilized packaged items from becoming contaminated before the package is opened.

[0006] It is not uncommon for sterile packages to be opened in a sterile environment, and one desirable feature of fibrous nonwoven sheets is that when the sheet is removed, it can be peeled from the package without excessive tearing of the nonwoven sheet surface. Some believe that the rupture of the nonwoven sheet surface during peeling, which is fibrous tearing, can potentially contaminate the sterile environment in which the package is opened. [Overview of the project] [Problems that the invention aims to solve]

[0007] Since most sterile packaging is used in health-related situations such as operating rooms, any improvements that facilitate the prevention or reduction of any possible contamination are desirable. In packaging, any improvements to the release properties, particularly of fibrous nonwoven structures, are highly desirable. [Means for solving the problem]

[0008] The present invention relates to a package for providing a sterilizable enclosed internal environment, comprising a gas-permeable fibrous nonwoven sheet structure, a polymer tie layer, and a package substrate, wherein the nonwoven sheet structure has a first surface and a second surface, and the enclosed internal environment is formed by sealing a contact area between the first surface of the nonwoven sheet structure and the package structure, the sealed contact area is formed by the polymer tie layer, and the first surface of the nonwoven sheet structure has an embossed pattern at least within the sealed contact area. ConclusionThis concerns the packaging.

[0009] The present invention relates to a fibrous nonwoven sheet structure suitable for use in sterile packaging, wherein the sheet structure is gas permeable and has a first surface and a second surface, the first surface having an embossed pattern Conclusion The second surface is printable, the sheet structure has a particle barrier penetration of less than 10%, a Gurley Hill porosity of less than 40 seconds, and a density of 3500 g / m². 2 / day or more Water vapor transmission rate This also relates to a fibrous nonwoven sheet structure having the following characteristics. [Brief explanation of the drawing]

[0010] [Figure 1] Here are some examples of embossed stamp patterns. [Figure 2] Here are some examples of embossed stamp patterns. [Figure 3] These are examples of several packaging substrates that show a sealed area. [Figure 4] These are examples of several packaging substrates that show a sealed area. [Figure 5] This is an example of the placement of four samples for determining the sealing strength of the package. [Modes for carrying out the invention]

[0011] The present invention provides a package for providing a sterilizable enclosed internal environment, and a gas-permeable fibrous nonwoven sheet structure useful in such a structure, with an embossed printing pattern in front Conclusion It has at least one surface that is subjected to particle barrier penetration of less than 10%, Gurley Hill porosity of 40 seconds or less, and 3500 g / m². 2 / day or more Water vapor transmission rate This invention relates to a gas-permeable fibrous nonwoven sheet structure having the following characteristics:

[0012] Surprisingly, it has an embossed stamp pattern. ConclusionA nonwoven sheet structure having a surface has been found to be usable in a sealed package having a sterilizable internal environment. (1) The embossed nonwoven surface can provide a good seal to the package structure, and also (2) the resulting package has an excellent level of peel performance when the package is opened, which is better in more cases than a smooth surface Conclusion It is surprising that the package has an excellent level of peel performance when opened, which is better in more cases than a smooth surface

[0013] Any package used and opened in a sterile environment should provide "aseptic peel / presentation", a term used in the medical industry to mean the requirement that the package has "clean peel" or can be opened and the contents can be presented to the sterile environment without the risk of contamination. As used herein, this excellent opening performance is determined by the use of the "fiber tearing" criterion. Surprisingly, the use of a nonwoven sheet structure having at least one surface embossed with an embossing pattern in contact with a polymer tie layer can provide a package with clean peel and very low fiber tearing, or actually no fiber tearing. Conclusion The use of a nonwoven sheet structure having at least one surface embossed with an embossing pattern in contact with a polymer tie layer can provide a package with clean peel and very low fiber tearing, or actually no fiber tearing.

[0014] Even more remarkable is that this excellent level of peel performance is achieved without any additional coating layer on the fibrous nonwoven sheet structure. The use of a nonwoven coating can provide improved peel, but the mere use of such a coating can generate other loose particles that pose a risk to aseptic presentation.

[0015] A package for providing a sterilizable enclosed internal environment includes a gas-permeable fibrous nonwoven sheet structure, a polymer tie layer, and a package substrate.

[0016] The packaging substrate can be any material that forms a packaging in the form of a flexible or semi-rigid package, such as a pouch, bag, sheath or blister pack. A package containing the packaging substrate generally serves to protect the packaged item and, in the case of sterile packaging, promotes maintaining the packaged item in a non-contaminated state until it can be used. In one practical application, the item to be packaged is placed within the packaging substrate and then sealed using a polymer tie layer and a gas-permeable fibrous non-woven sheet structure to form an enclosed environment. Then, if desired, the package with the enclosed item can be sterilized using a suitable sterilizing gas. In some embodiments, the packaging substrate includes polyamides (especially nylon), polypropylene, polyesters (especially polyethylene terephthalate) and any combination thereof.

[0017] The package includes a polymer tie layer to seal the contact area between the non-woven sheet structure and the package structure. The polymer tie layer is preferably any flexible or semi-rigid film that is compatible with both the packaging substrate and the non-woven sheet structure and properly seals the non-woven sheet structure to the packaging substrate. Being compatible means that the polymer tie layer does not react adversely with either the non-woven sheet or the packaging substrate and has a suitable shelf life to maintain the package sealed until its intended use. In some preferred embodiments, the polymer tie layer is integral with the packaging substrate. As shown in FIGS. 3 and 4, the sealed regions 15 and 17 illustrate one embodiment of the region where the polymer tie layer forms a sealed contact area where the package substrate and the fibrous non-woven sheet structure contact.

[0018] The polymer tie layer is preferably in the form of a film. The composition of the polymer tie layer can include compositions including, for example, polyethylene containing low density polyethylene, ethylene vinyl acetate and any combination thereof.

[0019] In some preferred embodiments, the polymer tie layer and the packaging substrate are integral. In some embodiments, they are combined in the same film. In this case, as used herein, the packaging substrate is defined as the “structural material,” which is integrally combined with a polymer useful as the polymer tie layer in the film. For example, some useful structural materials include polyamides (especially nylon), polypropylene, polyesters (especially polyethylene terephthalate), and any combination thereof. Particularly desirable structural material / polymer tie layer combinations that can be used when the packaging substrate and the polymer tie layer are integral include polyamide / polyethylene, polyester / polyethylene, polypropylene / polyethylene, polypropylene / ethylene vinyl acetate, polyamide-polypropylene / polyethylene, and the like.

[0020] The fibrous nonwoven sheet structure is gas permeable, meaning that sterilizing gases such as ethylene oxide and / or steam can pass through the sheet without the use of excessive pressure. In particular, the fibrous nonwoven sheet structure has a Gurley porosity (also known as Gurley-Hill porosity) of 40 seconds or less. This porosity is a measure of how long it takes for a certain volume of gas to pass through a region of the material where a particular pressure gradient exists; therefore, a lower number means the material is more gas permeable, and a higher number means the material is less permeable. In some embodiments, the fibrous nonwoven sheet structure has a Gurley porosity of 10 seconds or less. In some embodiments, the fibrous nonwoven sheet structure has a Gurley porosity of 5 seconds or less, and in some of the most preferred embodiments, the fibrous nonwoven sheet structure has a Gurley porosity of 3 seconds or less.

[0021] Another indicator of permeability is a measurement of water vapor transport, with higher values ​​indicating greater permeability. This is particularly important when steam is used as part of a sterilization process. The fibrous nonwoven sheet structure has a permeability of at least 3500 g / m². 2 / day or more Water vapor transmission rateIt has. In some preferred embodiments, the fibrous nonwoven sheet structure has a density of at least 7500 g / m². 2 / day or more Water vapor transmission rate It has. In some embodiments, the fibrous nonwoven sheet structure has a density of at least 9000 g / m². 2 / day or more Water vapor transmission rate It has the following characteristics. Preferably, the fibrous nonwoven sheet structure is uncoated, allowing for a more permeable sheet structure. The use of coatings for improved adhesion tends to seal the surface of the nonwoven sheet structure, reducing the rate at which sterilizing gases can pass through the structure.

[0022] The fibrous nonwoven sheet structure has a first surface and a second surface, the first surface having an embossed pattern Conclusion When used herein, the phrase "embossed stamp pattern" is used. Conclusion "is done" means that the surface has at least two properties, the first being that the fibrous material on the surface is Conclusion "is made" means that the fibrous material is substantially strengthened and stabilized by the heat and pressure applied to the sheet from a heat source such as a roll, and additionally, the surface has an embossed imprint pattern that leaves a visual texture on the surface. When used herein, the word "is made" means that the fibrous material is substantially strengthened and stabilized by the heat and pressure applied to the sheet from a heat source such as a roll, and additionally, the surface has an embossed imprint pattern that leaves a visual texture on the surface. Conclusion The use of "embossed" means that the fibrous nonwoven sheet structure has been embossed before being incorporated into any package.

[0023] In one embodiment, the embossed pattern on the sheet is provided by calendering the nonwoven sheet in a nip between a heated metal roll and an elastomer backup roll, where the pattern is provided with a raised region or a boss extending radially outward from the surface of the roll. In some preferred embodiments, the raised region or boss extends 0.008 to 0.020 inches (0.20 to 0.50 mm) from the rest of the roll surface. In some other embodiments, the raised region or boss may have a width of 0.005 to 0.025 inches (0.12 to 0.64 mm). In some preferred embodiments, the width of the raised region or boss may be 0.005 to 0.015 inches (0.12 to 0.38 mm).

[0024] When a fibrous nonwoven sheet is pressed in a nip between a heated metal roll with raised regions or bosses and an elastomer backup roll, the nonwoven sheet is left with an embossed imprint pattern having dimensions and essentially uniform depth to the bosses. Figures 1 and 2 provide examples of two potentially useful and desirable embossed imprint patterns, Figure 1 referred to as the linen pattern and Figure 2 referred to as the dogbone pattern.

[0025] One preferred method for embossing a nonwoven sheet is to thermally emboss the sheet using a modified machine similar to the one shown in Figure 2 of U.S. Patent No. 5,972,147 granted to Janis. Conclusion That is what it is. In the preheating section of the modified machine, Conclusion Each side of the embossed nonwoven sheet is placed in contact with a plurality of preheating rolls. In some preferred embodiments for the embossed nonwoven sheet described herein, the Janis machine ensures that the sheet has sufficient surface Conclusion The four heated rolls in this section are modified to operate at a temperature sufficient to essentially provide the desired effect. ConclusionThe process depends on the melting point of the material being embossed. After preheating the rolls, the sheet passes through preferably only one of several embossing stations, which are designated to apply the embossing pattern to preferably only one surface of the sheet. On each embossing station, there is an embossing roll that can be pressed onto a backup roll to form a nip. The pressure between the embosser and the backup roll is expressed in pounds per line inch (pli). The backup roll is typically covered with an elastomer covering and cooled internally with a recirculating cooling medium. The nonwoven sheet is then transferred to several cooling rolls, where the temperature of the sheet material is reduced, and then wound onto the rolls. The use of multiple preheating rolls operating at high temperatures allows the first surface of the nonwoven sheet to be embossed to... Conclusion Not only does it promote doing so, but also Conclusion A second surface on the opposite side is also provided. This second surface is preferably printable. Furthermore, it is preferable that the second surface has a smooth surface without any embossing for best printability. Many packages require very specific barcodes and other subtle, small markings, which require a very uniform, flat surface without the texture provided by embossing.

[0026] Instead, the sheet has a first surface Conclusion It is then rolled up, then rolled back up, embossed on one side, and embossed with an embossed stamp pattern. Conclusion A first surface can be provided which has an embossed pattern. Other embossing processes can also be used to create embossed patterns. Conclusion This is possible insofar as it provides a fibrous nonwoven sheet having at least a first surface. Preferably, the process provides a second surface that can be printed on. Preferably, the second surface is uniform and has no embossed pattern.

[0027] In some embodiments, the fibrous nonwoven sheet structure has good barrier properties against contaminants and adequate resistance to withstand general handling without damage to or contamination of the packaged contents. Therefore, the fibrous nonwoven sheet structure having an embossed pattern preferably has a particle barrier permeability of less than 10%, as determined by a TSI 8130 instrument. This particle barrier test is considered useful in determining the degree of barrier the sheet provides against contaminants, which may include bacteria in reality. Furthermore, the fibrous nonwoven sheet structure having an embossed pattern preferably has a Mullen burst strength of more than 500 kPa and a measured Elmendorf tear strength of more than 2 N / m.

[0028] Fibrous nonwoven sheet structures include nonwoven fabrics that can provide a stabilized surface having an embossed imprint pattern for use in contact with a polymer tie layer on a package. Such nonwoven sheet structures may include flashspun nonwoven sheet structures, spunbond nonwoven sheets, meltblown sheets, electroblown sheets, and any combination thereof. Fibrous means that the material in the nonwoven sheet has some fibrous properties. This fibrous property may be given by staple fibers, continuous or semi-continuous fibers and / or plexifila fibrous structures, etc. Fibrous material may include multiple materials, either as a single material or as a combination of different fibers, or as a combination of similar fibers composed of different materials. The term “nonwoven” means that a planar sheet structure includes at least one web of randomly distributed fibrous material relative to a woven or knitted fabric made of woven yarn or interlocked yarn loops. In some preferred embodiments, the fibrous material in the nonwoven sheet is a synthetic polymer, and in some embodiments, the synthetic polymer is a thermoplastic polymer. In some preferred embodiments, the fibrous material in the nonwoven sheet structure is bonded in the sheet by melting of the fiber intersections in the sheet structure without the addition of an added binder, i.e., the fibrous material is bonded in the sheet by melting of the fiber intersections in the sheet structure without the addition of an additional binder compound to the sheet.

[0029] In some embodiments, the fibrous nonwoven sheet structure has a basis weight of less than 55 grams per square meter. In some more preferred embodiments, the fibrous nonwoven sheet structure has a basis weight of less than 50 grams per square meter, and in some most preferred embodiments, the fibrous nonwoven sheet structure has a basis weight of less than 45 grams per square meter.

[0030] A preferred fibrous material in fibrous nonwoven sheet structures is plexifilamentous. As used herein, the terms plexifilamentous and plexifilament refer to a three-dimensional, integrated network structure of multiple thin, ribbon-like film-fibrils of random length, with an average fibril thickness of less than about 4 micrometers and a median width of less than about 25 micrometers. In plexifilamentous structures, the film-fibrils are generally aligned coaxially with the longitudinal axis of the structure and intermittently coalesce and separate at irregular intervals throughout the length, width, and thickness of the structure to form a continuous three-dimensional network structure. Such structures are described in further detail in U.S. Patent Nos. 3,081,519 and 3,227,794.

[0031] A preferred method for producing a fibrous nonwoven sheet structure having a plexifila-like fibrous material is by flash spinning. The resulting fibrous nonwoven sheet structure containing a plexifila-like film-fibril element is also known as a flash-spun plexifila-like sheet.

[0032] Therefore, further Conclusion And preferred fibrous nonwoven sheets suitable for embossing can be produced using general flash spinning techniques as described in U.S. Patent No. 3,227,794 granted to Anderson and U.S. Patent No. 3,860,369 granted to Brethauer et al. Conclusion Particularly preferred fibrous nonwoven sheets suitable for embossing can be produced using a spinning solution containing high-density polyethylene and a hydrocarbon spinning agent, as described in, for example, U.S. Patent Nos. 6,010,970, 7,338,916, 8,048,513 and 6,034,008. Preferably, a sheet with improved permeability and barrier strength characteristics is obtained by flash spinning the sheet from a hydrocarbon-based spinning solution composed of 12% to 20% by weight of polyethylene and maintained at a temperature above 180°C before flashing. Conclusion This is a fibrous nonwoven sheet suitable for [the purpose], and in some embodiments, the temperature is 185-195°C before flashing.

[0033] The fibrous material in the nonwoven sheet is preferably a polyolefin. Polyolefins may include polyethylene, polypropylene, polymethylpentene, polybutylene, and combinations thereof. Preferably, the polyolefin is polyethylene. Polyethylene includes not only homopolymers of ethylene but also copolymers in which at least 85% of the repeating units are derived from ethylene. Preferred polyethylene has an upper limit of the melting range of about 130.0 to 137.0°C and a viscosity of 0.94 to 0.98 g / cm³. 3 This is linear high-density polyethylene having a density in the range of and a melt index of 0.1 to 100, preferably 0.1 to 4 (as defined in ASTM D-1238-57T, condition E). Polypropylene includes not only propylene homopolymers but also copolymers in which at least 85% of the repeating units are derived from propylene units.

[0034] The package, comprising a gas-permeable fibrous nonwoven sheet structure, a polymer tie layer, and a package substrate, provides a closed internal environment that can be sterilized. The closed environment is frontal with an embossed printing pattern. Conclusion The contact area between the first surface of the nonwoven sheet and the package structure is formed by sealing it with a polymer tie layer.

[0035] In some embodiments, the package may be of the type of pouch made from a film having a cavity for the material being packaged, with a fibrous nonwoven sheet sealing the package. In this embodiment, the polymer tie layer is preferably integral with the film of the pouch, and the tie layer is a film exposed inside the pouch to be in contact with the fibrous nonwoven sheet.

[0036] Alternatively, in some embodiments, the package may be of the blister package type, where the package substrate has a thermoformed blister cavity for the material being packaged, and a fibrous nonwoven sheet structure provides a lid for the package. Again, in a preferred embodiment, a polymer tie layer is integral and is the inner surface of the thermoformed cavity, in contact with the fibrous nonwoven sheet to seal the cavity along the lip of the package.

[0037] Plan views of two package substrates having cavities 16 and 18 are shown in Figures 3 and 4, respectively, and the package substrates have sealing regions 15 and 17 surrounding the cavities, respectively. When the cavities are sealed, the fibrous nonwoven sheet structure covers both the sealing regions and the cavities. A polymer tie layer is placed in the sealing region and positioned between the package substrate containing the cavities and the fibrous nonwoven sheet material. The polymer tie layer may be integral with the packaging substrate, which is preferable. In some embodiments, the package, together with the polymer tie layer, forms the desired package substrate, fills the cavities with the material to be packaged, and then has an embossed printing pattern in contact with the polymer tie layer. Conclusion It is manufactured by applying a nonwoven sheet structure that is then sealed. In some embodiments, the nonwoven sheet structure may be a component that forms a lid for a blister pack. The package is then sealed by heat, pressure, or a combination of both.

[0038] In some embodiments, the components are heat-sealed, typically using a heated platen. While the cavity containing the items to be packaged is completely sealed, some other areas on the package do not need to be completely sealed, as required, to provide a starting point for peeling off the fibrous nonwoven sheet structure before removing the product. If the fibrous nonwoven sheet structure is not pre-printed before sealing, the nonwoven sheet structure may be printed immediately before or after heat sealing.

[0039] While preferred packaging embodiments are pouch or blister-type packaging, any flexible or semi-rigid packaging, including packaging in the form of a sack, bag or sheath, may have an embossed printing pattern as a gas-permeable feature. Conclusion It is understood that a fibrous nonwoven sheet structure may be used.

[0040] The formed package has a closed internal environment for the packaged item, formed by sealing the contact area between the first surface of the nonwoven sheet structure and the package substrate, the sealed contact area being a polymer tie layer, and the first surface of the nonwoven sheet structure being embossed with a printed pattern at least within the sealed contact area. Conclusion In some embodiments, the formed package has a closed internal environment which includes the packaged item, formed by sealing the contact area between the first surface of the nonwoven sheet structure and the package substrate, the sealed contact area being a polymer tie layer, and the first surface of the nonwoven sheet structure being embossed with a printing pattern at least within the sealed contact area. Conclusion It is being done.

[0041] In some embodiments, the formed package is a heat-sealed, peelable package. As defined herein, the phrase “peeled package” means that the sheet structure is sealed in the package by a “peeled seal.” As defined herein, the phrase “peeled seal” means that the sheet structure sealed in the package has an average peak load sealing strength of at least 0.5 pound-per-inch and a maximum of 4 pound-per-inch. This means that the sheet structure can be removed by hand from the sealed package by exerting a seal of at least 0.5 pound-per-inch and a maximum of 4 pound-per-inch. In some preferred embodiments, the maximum average peak load sealing strength is 3 pound-per-inch or less. Furthermore, the fibrous nonwoven sheet structure is such that it has an embossed pattern. Conclusion Because it has at least one surface that is, Conclusion Embossed patterns can be used to create packaging and "removable seals."

[0042] One measure of sealing integrity is characterized by a dye permeability test as described in ASTM F1929-12. Surprisingly, in the embossed stamp pattern Conclusion Furthermore, it was found that packages made of a nonwoven sheet structure, which is attached to the polymer tie layer by an embossed surface in the sealed area, had no negative impact whatsoever on the dye permeability test.

[0043] The formed package has excellent sealing and release properties. Surprisingly, in contact with the polymer tie layer, the embossed printing pattern is applied to the front. Conclusion The use of a fibrous nonwoven sheet structure having at least one surface can provide a package with clean release and very low fiber tearing, or even no fiber tearing at all. Surprisingly, when the surface of the nonwoven sheet having an embossed pattern is sealed to the film, the release properties are improved.

[0044] The improved peeling properties are indicated by both a reduction in the percentage of packages exhibiting fiber tearing and / or a reduction in the severity of fiber tearing. Specifically, when compared with non-embossed materials, fibrous nonwoven sheet structures having at least one surface with an embossed imprinting pattern were found to have a substantial reduction in packages that do not provide clean peeling. In particular, the use of embossed sheet structures was found to provide at least a 25 percent reduction, preferably at least a 30 percent reduction, or even higher, in packages with visible fiber tearing when compared with non-embossed structures.

[0045] Furthermore, sealing strength was found to be improved compared to the use of a non-embossed fibrous nonwoven sheet structure, as measured under both average intermediate and average peak loads. In other words, both sealing strength and peel quality are improved by the use of an embossed surface on the surface of the fibrous nonwoven sheet structure in contact with the polymer tie layer.

[0046] Test method Basis weight. Basis weight is measured according to ASTM D3776 (2009).

[0047] Gurley Hill porosity (or simply "Gurley porosity"; terms used interchangeably herein) is a measure of the permeability of a sheet material to gaseous materials. Specifically, it is a measure of how long it takes for a certain volume of gas to pass through a region of the material in the presence of a particular pressure gradient. Gurley-Hill porosity is measured according to TAPPI T-460 OM-88 using a Lorentzen & Wettre Model SE 166 or 516 from Lorentzen & Wettre, Kista, Sweden. This test measures the time required for 100 cubic centimeters of air to pass through a 28.7 mm diameter sample (with an area of ​​1 square inch) under a water pressure of approximately 1.21 kPa (4.9 inches). The results are often expressed in seconds, referred to as Gurley seconds. The reported value represents the average of at least 12 individual measurements.

[0048] Water vapor transmission rate (MVTR). Water vapor transmission rate (MVTR) is measured according to EN ISO 12572, Hygrothermal performance of building materials and products, Climate C, 2001. The measurement is performed using a multilayer method with a cup-level relative humidity of 100% and an airflow of 2.5 m / s over the sample, with a measurement interval of 30 minutes. The obtained MVTR is measured based on the loss of water in the sample. The reported value represents the average of at least one measurement. The measurement is performed using a Gintronic Gravitest 6400 with an ES 420A balance from MRS Seitter, Lenning-Bruck, Germany.

[0049] Particle penetration. Particle penetration is measured using a TSI 8130 instrument from TSI Incorporated, Shoreview, MN, United States. TSI 8130 This instrument is used for measurements according to NIOSH procedure numbers RCT-APR-STP-57, 58, and 59. For analysis, the TSI 8130 instrument is used with sodium chloride particle generation at a flow rate of 2.3 liters per minute. To achieve a flow rate of 2.3 liters per minute, the control valve is closed and the airflow is derived from air passing only through the downstream photometer. The sodium chloride particle distribution has a count median diameter of 0.075 μm, a mass mean diameter of 0.3 μm, and a geometric standard deviation of 1.8. Measurements are performed with a rise time of 25 seconds and a measurement time of 4 seconds. Transmission is measured based on the difference in light intensity by the upstream and downstream photometers. The reported transmission is the average of at least six measurements. Particle transmission is instead given by the following formula: LRV-TSI 8130=-log10(transmission[%] / 100) It can be expressed as a logarithmically decreasing value based on [a certain principle].

[0050] Elmendorf tear resistance. Elmendorf tear resistance is measured according to ISO 1974:1990; Paper - Determination of tearing resistance (Elmendorf method). Elmendorf is measured using an 09 ED tear tester from Lorentzen & Wettre, Kista, Sweden. Elmendorf tear resistance is measured in both the longitudinal (MD) and transverse (XD) directions.

[0051] Mullen bursting strength. Mullen bursting strength is measured according to ISO 2758:2001. Paper - Determination of bursting strength. Mullen bursting is measured using a Lorenzen & Wettre Model 519L from Lorentzen & Wettre, Kista, Sweden, integrated into an Autoline 400 from Lorentzen & Wettre, Kista, Sweden.

[0052] Sealing strength. Sealing strength is measured according to ASTM F88 / F88M Appendix C in “free tail” mode. As shown in Figure 5, four strips per test package 25 are cut at specified positions with a width of 1 inch to test the seal 20. The ends of the strips are clean-cut and perpendicular to the direction of the seal. The hardest part of the seal is placed on the upper clamp. The manufactured nonwoven sheet is the hardest part of the seal and is therefore placed on the upper clamp. The seal was tested at a grip separation rate of 300 mm / min. The number of measurements per test item is equal to at least 24. Sealing strength is reported both as the average of the average load sealing strength and the average of the peak load sealing strength in pounds per inch, lbf / in.

[0053] Dye penetration. Dye penetration is performed according to ASTM F1929-12 “Standard Test method for Detecting Seal Leaks in Porous Mechanical packaging by Dye Penetration”. ASTM F1929-12 specifies a procedure for detecting and locating leaks equal to or greater than the groove formed by a 50 μm (0.002 inch) wire in the package end seal formed between the transparent material and the porous sheet material. The dye penetration solution is applied locally to the seal end where the leak is being tested. After contact with the dye penetration solution for a specified time of 5 seconds, the package is visually inspected for dye penetration. If no groove is visually visible, the dye penetration test for the package is considered “passed”.

[0054] Printing. Nonwoven sheets are printed with line barcodes or 2D data matrices. Testing of line barcodes is carried out according to ISO 15416, and testing of 2D data matrices is carried out as described in ISO 15415.

[0055] Fiber tearing. Fiber tearing is performed by visual inspection of the package being opened. The package is opened by hand in the following manner: The nonwoven sheet is held in one hand, and the film is held in the other. The time to open one package is approximately 1 second. The package is not opened until it reaches the bottom edge seal. In other words, the package is not opened completely except for the top seal and the two side seals. After each package is opened, the surface of the nonwoven sheet sealed against the film is inspected. The surface should be uniform and continuous without the presence of delamination and tearing of the nonwoven sheet. If there is delamination or tearing of the nonwoven sheet, the package has fiber tearing. The above procedure is performed for at least 50 packages. The percentage of packages showing fiber tearing is determined by dividing the number of packages showing fiber tearing by the total number of packages opened. Alternatively, fiber tearing may be performed according to EN 868-5(2009), Appendix E. However, this standard does not count some smaller-length visual fibers. As shown in the examples and as defined herein, a “package showing fiber tearing” is one that, after opening, has attached fibers of any length that could be seen with the unassisted eye. [Examples]

[0056] Examples 1 and 2 further Conclusion Unfinished fibrous nonwoven sheets for embossing were prepared from a spinning solution containing high-density polyethylene and an n-pentane hydrocarbon spinning agent, using a general flash spinning process as described in Examples 9-15 of U.S. Patent No. 6,034,008 granted to Lim et al., except that the polymer concentration in the spinning solution was 17% by weight and the spinning temperature was 195°C. The polyethylene had a melt flow index (measured by ASTM D1238-13) at approximately 0.75 g / 10 / 2.16 kg / 190°C. Nonwoven sheets of two different basis weights were prepared.

[0057] Next, the unfinished fibrous nonwoven sheet is subjected to an embossed pattern by partial modification to the process described in U.S. Patent No. 5,972,147 granted to Janis, particularly by modification of the apparatus shown in Figure 2 of the patent. Conclusion In the process shown in the figure, the sheet is wrapped alternately and preheated by a single set of two preheating rolls, and then the first set of rolls turns one side of the sheet. Conclusion And the second set of rolls on the other side of the sheet Conclusion Two sets of sheets at the nip of two calendar rolls Conclusion This was followed by cooling of the sheet by a single set of two cooling rolls. In particular, Janis's process was partially modified to use an additional set of preheating rolls, and such a sheet was wound alternately around four preheating rolls (compared to two) without any nipping between the rolls. Furthermore, only the second set of calendar rolls nipped the sheet, operating at a nipping pressure of approximately 200 pounds per line inch. The first set of calendar rolls was left open and did not nip the sheet. This was followed by cooling of the sheet by two sets of two cooling rolls (compared to a single set of two).

[0058] The specific apparatus configuration involved the lower part of the sheet being wrapped around the first preheating roll (PH1), the upper part of the sheet being wrapped around the second preheating roll (PH2), followed by the lower part of the sheet being wrapped around the third preheating roll (PH3), and then the upper part of the sheet being wrapped around the second preheating roll (PH4). The first set of calendar rolls did not nip the sheet, so the upper surface of the sheet was not embossed. The second set of calendar rolls embossed the lower surface of the sheet. Conclusion Then, a linen-patterned design, as shown in Figure 1, was embossed onto the surface of the sheet.

[0059] The sheets were then transferred to a cooling section and subsequently wound onto rolls. The temperatures of the preheating rolls and embossing machine are shown in Table 1, and the resulting sheet characteristics are summarized in Table 2.

[0060] [Table 1]

[0061] [Table 2]

[0062] Comparative Example A further Conclusion Unfinished fibrous nonwoven sheets for embossing were prepared from a spinning solution containing high-density polyethylene and an n-pentane hydrocarbon spinning agent using a general flash spinning process as described in Examples 9-15 of U.S. Patent No. 6,034,008 granted to Lim et al., except that the polymer concentration in the spinning solution was 17% by weight and the spinning temperature was 185°C. The polyethylene had a melt flow index (measured by ASTM D1238-13) of 2.16 kg / 190°C at approximately 0.7 g / 10.

[0063] Next, the unfinished fibrous nonwoven sheet is processed using a steam pressure of 66.7 psia, as generally described in U.S. Patent No. 3,532,589 granted to David. Conclusion This is the process described in U.S. Patent No. 6,034,008 granted to Lim et al. for producing a “hard structure” nonwoven sheet. In this process, the nonwoven sheet is then heated on both sides of the material by passing it over a heating drum, followed by a cooling drum, then another heating drum and cooling drum. Conclusion The heating drum is kept at a temperature that causes partial melting of the nonwoven sheet. Conclusion This induces [the desired effect]. The resulting sheet characteristics are summarized in Table 3.

[0064] [Table 3]

[0065] Example 3 Each of them weighs 44 grams / meter 2Nonwoven sheets obtained from Example 1 and Comparative Example A, having the specified basis weight, were then used to produce medical packages using a Multivac R535 apparatus. The Multivac R535 apparatus produced four packages on one substrate, each package having a length of 200 mm in the longitudinal direction, approximately 95 mm in the transverse direction, and a sealing width of approximately 7.5 mm as shown as dimension 5 in Figure 3. The nonwoven sheets were attached to the package substrate when sealing the contact area using two different tie film materials. Film 1 was Multifol GA Tyvek®, a 100 μm polyamide / polyethylene peelable film from Suedpack Verpackungen GmbH&Co.KG, Ochsenhausen, Germany. Film 2 was Wipak® ML E 135 TF PEEL, a polyethylene / polyamide / polyethylene film from Wipak, Nastola, Finland.

[0066] In all cases, Conclusion The nonwoven surface from the nonwoven sheet of Example 1, which was embossed with a linen pattern, was sealed against the film. All packages were made with a sealing pressure of 6.5 bar and a residence time of 1.2 seconds. The sealing temperature was set to at least two levels—resulting in different sealing strengths—for each film. The packages were then opened by peeling the nonwoven sheet from the tie film.

[0067] The sealing temperatures and the resulting sealing strength values ​​are shown in Table 4. With increasing sealing temperatures, the average peak sealing strength and average intermediate sealing strength increased for individual films. Furthermore, at higher sealing strengths, the percentage of packages exhibiting fiber tearing increased. However, in all cases, nonwoven sheets with embossed patterns exhibited both improved fiber tearing (peeling) and sealing performance, with the percentage reduction in fiber tearing ranging from 32% to 73%.

[0068] [Table 4]

[0069] Example 4 and Comparative Example B 47g / m² with the same embossed linen pattern 2 Example 2 was repeated using a nonwoven sheet having the basis weight, however, the unfinished sheet was embossed using the embossing conditions shown in Table 5. Conclusion I did. I got Conclusion The nonwoven sheet had a Gurley porosity of 3.6 seconds.

[0070] For Comparative Example B, the process was repeated using the same basis weight sheet and the temperature conditions shown in Table 5, but without embossing the bottom of the sheet. (The sheet was not nipped in the calender roll.) The resulting nonwoven sheet was obtained without any embossing. Conclusion It had a Gurley porosity of 2 seconds.

[0071] [Table 5]

[0072] Conclusion The obtained nonwoven sheet having a surface embossed with a linen pattern and a nonwoven sheet without any embossing. ConclusionThe nonwoven sheet was then used to produce medical packages using an Autovak M320 machine in Hong Kong, China. The Autovak machine simultaneously produced two packages with lengths of approximately 190 mm in the longitudinal direction and 127 mm in the transverse direction, and a sealing width of 10 mm as indicated by dimension 10 in Figure 4. The nonwoven sheet was attached to the package substrate when sealing the contact area using a 135 μm thick polyamide / polyethylene peelable tie film code UGBLGV340C from Xiangfu (Zhongshan) Film Packaging Co., LTD, 180, Zhongshan 5th Rd, Guandong, China. The film was preheated in the forming zone. The temperature of the forming zone was set to 105°C, and the residence time was set to 1.0 second. The sealing temperature for all packages was set to 120°C. The residence time was adjusted to vary the sealing strength obtained for the packages. The sealing time and sealing strength are shown in Table 6. Next, the package was opened by peeling the nonwoven sheet from the tie film. As shown in Table 6, Conclusion Packages using nonwoven sheets that were only embossed but not processed exhibited higher sealing strength characteristics but showed overall unacceptable fiber tearing performance, while packages using embossed nonwoven sheets exhibited acceptable sealing strength characteristics and excellent fiber tearing (peeling) performance.

[0073] [Table 6]

[0074] Examples 5, 6, and 7 These examples show that embossing is applied to nonwoven sheets. Conclusion This illustrates how it can later be applied to nonwoven sheets as a separate process. Conclusion However, comparative example B, which is not embossed, was repeated using two different nonwoven sheet basis weights. Conclusion The sheet was rolled up. Next, ConclusionThe roll of nonwoven sheet was then unwound, and the sheet was embossed onto one surface by nipping it with a set of heated calender rolls. In this case, the embossed surface of the sheet was a dogbone pattern, as shown in Figure 2, rather than a linen pattern. Conclusion The conditions for the subsequent embossing process are shown in Table 7. As in Example 4, a package was made using the same tie film with an embossed surface in contact with the tie film. The results are shown in Table 8.

[0075] [Table 7] (* - Not measured)

[0076] [Table 8]

[0077] Next, the package was opened by peeling the nonwoven sheet from the tie film. As shown in Table 8, the package using the embossed nonwoven sheet exhibited excellent peeling performance.

[0078] Example 8 The nonwoven sheet structures with embossed printing patterns used in Examples 1 to 7 were tested for barrier and mechanical properties. All of these sheet structures of the present invention had an Elmendorf tear strength of over 2.0 N and a Mullen burst strength of over 500 kPa. All of the sheet structures of the present invention had a particle barrier permeability of less than 10% using a TSI 8130 apparatus operating at a flow rate of 2.3 L / min. The non-embossed side of each nonwoven structure allows printing in the form of line barcodes and 2D data matrices with good visual results. Next, preferred embodiments of the present invention will be shown. 1. A package for providing a sterilizable enclosed internal environment, comprising a gas-permeable fibrous nonwoven sheet structure, a polymer tie layer, and a package substrate, The nonwoven sheet structure has a first surface and a second surface, The enclosed internal environment is formed by sealing the contact region between the first surface of the nonwoven sheet structure and the package structure, and the sealed contact region is formed by the polymer tie layer. A package wherein the first surface of the nonwoven sheet structure is pre-bonded with an imprinted pattern at least within the sealed contact area. 2. The package according to item 1, wherein the polymer tie layer is integral with the package substrate. 3. The package according to item 1 above, wherein the polymer tie layer and the package substrate are combined in a film. 4. The package according to any one of items 1 to 3 above, wherein the fibrous nonwoven sheet structure is in the form of a plexifilament. 5. The package according to item 4 above, wherein the fibrous nonwoven sheet structure includes polyethylene plexifilaments. 6. A fibrous nonwoven sheet structure suitable for use in sterile packaging, which is gas permeable and has a first surface and a second surface, The first surface is bonded with an embossed pattern, and the second surface is printable. The aforementioned sheet structure has a particle barrier permeability of less than 10%, a Gurley Hill porosity of less than 40 seconds, and a density of 3500 g / m². 2 A fibrous nonwoven sheet structure with a water vapor transmission rate of more than / day. A fibrous nonwoven sheet structure as described in 6 above, having a Gurley Hill porosity of 7.10 seconds or less. 8.7500g / m 2 A fibrous nonwoven sheet structure according to 6 or 7 above, having a water vapor transmission rate of 1 / day or more. 9.9000g / m 2 The fibrous nonwoven sheet structure described in item 8 above, having a water vapor transmission rate of 1 / day or more. 10. A fibrous nonwoven sheet structure according to any one of 6 to 9 above, which is in the form of a plexifilament. 11. The fibrous nonwoven sheet structure described in 10 above, comprising polyethylene plexifila.

Claims

1. A roll made by winding up a nonwoven sheet containing a fibrous material, The aforementioned nonwoven sheet is reversible and its surface can be embossed. The nonwoven sheet has a first surface and a second surface, The fibrous material on the first surface is surface-bonded, and the first surface has an embossed pattern. The second surface may be printable, and the second surface may not have any embossed patterns. The aforementioned nonwoven sheet is a roll that possesses all of the following physical properties: (1), (2), and (3). (1) Particle barrier penetration is less than 10% as measured by NIOSH procedure numbers RCT-APR-STP-57, 58, and 59 using a TSI 8130 instrument manufactured by TSI Corporation, USA. (2) The Gurley Hill porosity, measured according to TAPPI T-460 OM-88 using a Lorenzen & Wettre Model SE 166 or 516 from Lorenzen & Wettre, Sweden, is 40 seconds or less. (3) The water vapor transmission rate measured in accordance with EN ISO 12572 is 3500 g / m³. 2 / day or more.

2. The roll according to claim 1, wherein the nonwoven sheet has a Gurley Hill porosity of 10 seconds or less, as measured according to TAPPI T-460 OM-88 using a Lorenzen & Wettre Model SE 166 or 516 manufactured by Lorenzen & Wettre, Sweden.

3. The aforementioned nonwoven sheet has a water vapor transmission rate of 7500 g / m², as measured according to EN ISO 12572. 2 The roll according to claim 1 or 2, wherein the length is 1 day or more.

4. The roll according to any one of claims 1 to 3, wherein the nonwoven sheet is in the form of a plexifilament.

5. The roll according to claim 1, wherein the nonwoven sheet has a flash-spun nonwoven sheet structure.

6. The roll according to claim 1, wherein the fibrous material is a thermoplastic polymer.

7. The roll according to claim 1, wherein the fibrous material is free of added binder.

8. The roll according to claim 1, wherein the fibrous material is polyethylene, polypropylene, polymethylpentene, polybutylene, or a combination thereof.

9. The roll according to claim 8, wherein the fibrous material is polyethylene.

10. The fibrous material has an upper limit of the melting range of 130.0 to 137.0°C and a concentration of 0.94 to 0.98 g / cm³. 3 The roll according to claim 8, having a density in the range of , and having a melt flow index of 0.1 to 100 as defined by ASTM D-1238-57T, condition E.

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