CN108698741B - 灭菌用包装材料 - Google Patents
灭菌用包装材料 Download PDFInfo
- Publication number
- CN108698741B CN108698741B CN201780011533.1A CN201780011533A CN108698741B CN 108698741 B CN108698741 B CN 108698741B CN 201780011533 A CN201780011533 A CN 201780011533A CN 108698741 B CN108698741 B CN 108698741B
- Authority
- CN
- China
- Prior art keywords
- nonwoven fabric
- packaging material
- sterilization
- fabric layer
- laminated
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 230000001954 sterilising effect Effects 0.000 title claims abstract description 67
- 238000004659 sterilization and disinfection Methods 0.000 title claims abstract description 66
- 239000005022 packaging material Substances 0.000 title claims abstract description 65
- 239000004745 nonwoven fabric Substances 0.000 claims abstract description 137
- 239000000835 fiber Substances 0.000 claims abstract description 77
- 229920001410 Microfiber Polymers 0.000 claims abstract description 10
- 239000011148 porous material Substances 0.000 claims description 29
- 230000035699 permeability Effects 0.000 claims description 20
- 238000012360 testing method Methods 0.000 claims description 12
- 229920000728 polyester Polymers 0.000 claims description 4
- 239000004744 fabric Substances 0.000 claims description 3
- 239000004750 melt-blown nonwoven Substances 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 53
- 238000012545 processing Methods 0.000 abstract description 6
- 230000008859 change Effects 0.000 abstract description 2
- 229920005989 resin Polymers 0.000 description 47
- 239000011347 resin Substances 0.000 description 47
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- 229920000139 polyethylene terephthalate Polymers 0.000 description 31
- 239000005020 polyethylene terephthalate Substances 0.000 description 31
- 238000009987 spinning Methods 0.000 description 25
- 229920005992 thermoplastic resin Polymers 0.000 description 17
- 239000000523 sample Substances 0.000 description 16
- 241000894006 Bacteria Species 0.000 description 15
- 239000007788 liquid Substances 0.000 description 14
- -1 polyethylene Polymers 0.000 description 14
- 239000007789 gas Substances 0.000 description 12
- 239000000463 material Substances 0.000 description 11
- 230000004888 barrier function Effects 0.000 description 10
- 238000002844 melting Methods 0.000 description 10
- 230000008018 melting Effects 0.000 description 10
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- 239000004743 Polypropylene Substances 0.000 description 8
- 230000000052 comparative effect Effects 0.000 description 8
- 238000005259 measurement Methods 0.000 description 8
- 238000001179 sorption measurement Methods 0.000 description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 8
- 239000002657 fibrous material Substances 0.000 description 7
- 239000002245 particle Substances 0.000 description 7
- 239000005871 repellent Substances 0.000 description 7
- 239000000843 powder Substances 0.000 description 6
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- 229920001155 polypropylene Polymers 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- WSSSPWUEQFSQQG-UHFFFAOYSA-N 4-methyl-1-pentene Chemical compound CC(C)CC=C WSSSPWUEQFSQQG-UHFFFAOYSA-N 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 3
- 238000001816 cooling Methods 0.000 description 3
- 230000007423 decrease Effects 0.000 description 3
- 239000000428 dust Substances 0.000 description 3
- 229920000573 polyethylene Polymers 0.000 description 3
- 238000009736 wetting Methods 0.000 description 3
- LIKMAJRDDDTEIG-UHFFFAOYSA-N 1-hexene Chemical compound CCCCC=C LIKMAJRDDDTEIG-UHFFFAOYSA-N 0.000 description 2
- KWKAKUADMBZCLK-UHFFFAOYSA-N 1-octene Chemical compound CCCCCCC=C KWKAKUADMBZCLK-UHFFFAOYSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 239000012298 atmosphere Substances 0.000 description 2
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- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
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- VXNZUUAINFGPBY-UHFFFAOYSA-N 1-Butene Chemical compound CCC=C VXNZUUAINFGPBY-UHFFFAOYSA-N 0.000 description 1
- 229920001817 Agar Polymers 0.000 description 1
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 229920010126 Linear Low Density Polyethylene (LLDPE) Polymers 0.000 description 1
- 239000004734 Polyphenylene sulfide Substances 0.000 description 1
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- 229920005674 ethylene-propylene random copolymer Polymers 0.000 description 1
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- 239000000203 mixture Substances 0.000 description 1
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- TVMXDCGIABBOFY-UHFFFAOYSA-N n-Octanol Natural products CCCCCCCC TVMXDCGIABBOFY-UHFFFAOYSA-N 0.000 description 1
- 239000005026 oriented polypropylene Substances 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- 229920003207 poly(ethylene-2,6-naphthalate) Polymers 0.000 description 1
- 229920000058 polyacrylate Polymers 0.000 description 1
- 229920001707 polybutylene terephthalate Polymers 0.000 description 1
- 229920001225 polyester resin Polymers 0.000 description 1
- 239000004645 polyester resin Substances 0.000 description 1
- 239000011112 polyethylene naphthalate Substances 0.000 description 1
- 229920013716 polyethylene resin Polymers 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920005672 polyolefin resin Polymers 0.000 description 1
- 229920000069 polyphenylene sulfide Polymers 0.000 description 1
- 229920005630 polypropylene random copolymer Polymers 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
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- 238000010998 test method Methods 0.000 description 1
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- 239000004416 thermosoftening plastic Substances 0.000 description 1
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- 239000004711 α-olefin Substances 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00072—Packaging of dressings
-
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- B32B5/02—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by structural features of a fibrous or filamentary layer
- B32B5/022—Non-woven fabric
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
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- B32B27/00—Layered products comprising a layer of synthetic resin
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- B32B5/22—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed
- B32B5/24—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer
- B32B5/26—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer another layer next to it also being fibrous or filamentary
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- B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
- B32B7/04—Interconnection of layers
- B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
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- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D65/00—Wrappers or flexible covers; Packaging materials of special type or form
- B65D65/38—Packaging materials of special type or form
- B65D65/40—Applications of laminates for particular packaging purposes
-
- D—TEXTILES; PAPER
- D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
- D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
- D04H3/00—Non-woven fabrics formed wholly or mainly of yarns or like filamentary material of substantial length
- D04H3/08—Non-woven fabrics formed wholly or mainly of yarns or like filamentary material of substantial length characterised by the method of strengthening or consolidating
- D04H3/16—Non-woven fabrics formed wholly or mainly of yarns or like filamentary material of substantial length characterised by the method of strengthening or consolidating with bonds between thermoplastic filaments produced in association with filament formation, e.g. immediately following extrusion
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- B32B2262/0253—Polyolefin fibres
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- B32B2262/02—Synthetic macromolecular fibres
- B32B2262/0276—Polyester fibres
- B32B2262/0284—Polyethylene terephthalate [PET] or polybutylene terephthalate [PBT]
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- B32B2307/306—Resistant to heat
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- B32B2307/7244—Oxygen barrier
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- B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
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Abstract
提供一种新型灭菌用包装材料,其具有作为包装材料的加工适性,适应于高温条件等所有的灭菌处理方法,形状、尺寸的变化也少,可以维持内部的灭菌状态。本发明的灭菌用包装材料由包含无纺布层(I)和无纺布层(II)的至少2层以上的层叠无纺布构成,所述无纺布层(I)由具有平均纤维直径5~30μm的连续长纤维构成,所述无纺布层(II)由具有平均纤维直径0.1~4μm的超细纤维构成。
Description
技术领域
本发明涉及例如用于医疗器具的灭菌的灭菌用包装材料。
背景技术
关于医疗器具,已知为了防止感染症而实施灭菌处理来使用,作为实施该处理的器具,具体而言,可列举出探针(Sonde)、手术刀(mes)、镊子(pincette)、剪子等。作为灭菌处理的方法,使用高温高压蒸气法、环氧乙烷气体法等,使用适于处理方法的器具的包装材料。适于灭菌用包装材料的纤维质的片材需要:透气性良好、开孔直径和泡点微小且阻隔性良好、具有热封性、起毛性良好等。
通常,作为灭菌用包装材料,使用以浆粕系、聚乙烯为代表的合成纤维原料的无纺布、薄膜,近年,为了看见内部,存在组合无纺布和透明的树脂薄膜等以形成袋状体的方式粘结来使用的包装材料。
例如以下的专利文献1中报告了作为医疗领域中使用的纤维质片材使用了聚乙烯树脂的闪蒸纺丝法的无纺布。利用闪蒸纺丝时,丝直径不均匀、在平均纤维直径2μm以下的领域不能制造、单位面积重量分散性也不好、另外需要使用溶剂等,因此从安全性方面考虑也不实用。
另外,以下的专利文献2中报告了浆粕系的灭菌纸,记载了通过将灭菌纸和合成树脂薄膜层压从而得到热封性。但是,通常的灭菌包装材料使用浆粕系的纸的情况下,与长纤维系无纺布相比,纤维1根1根不连续,加工时纸粉飞散,作为医疗器具成为致命的问题。另外,在频繁使用醇、水等的环境下,浆粕系灭菌纸非常脆,作为包装材料是不合格的。
现有技术文献
专利文献
专利文献1:日本特开2014-237478号公报
专利文献2:日本特开平7-238449号公报
发明内容
发明要解决的问题
鉴于以上的现有技术,本发明的目的在于,提供一种新型灭菌用包装材料,其具有作为包装材料的加工适性,适应于高温条件等所有的灭菌处理方法,形状、尺寸的变化也少,可以维持内部的灭菌状态。
用于解决问题的方案
本发明人等为了解决上述问题而进行深入研究并重复实验,结果发现,通过使用以下列举出的特定结构的无纺布,得到更高生产、更高性能的灭菌用包装材料,从而完成了本发明。即,本发明如以下所述。
[1]一种灭菌用包装材料,其由包含无纺布层(I)和无纺布层(II)的至少2层以上的层叠无纺布构成,所述无纺布层(I)由具有平均纤维直径5~30μm的连续长纤维构成,所述无纺布层(II)由具有平均纤维直径0.1~4μm的超细纤维构成。
[2]根据前述[1]所述的灭菌用包装材料,其中,在2层的前述无纺布层(I)之间存在包含前述无纺布层(II)的中间层。
[3]根据前述[1]或[2]所述的灭菌用包装材料,其中,前述无纺布层(II)由熔喷无纺布构成。
[4]根据前述[1]~[3]中任一项所述的灭菌用包装材料,其中,前述层叠无纺布的平均流量孔径为0.1~30μm、且泡点为0.5~50μm。
[5]根据前述[1]~[4]中任一项所述的灭菌用包装材料,其中,前述层叠无纺布的单位面积重量为8.0~100g/m2、且厚度为0.03~0.2mm。
[6]根据前述[1]~[5]中任一项所述的灭菌用包装材料,其中,在格利型透气性试验中由100ml的空气通过前述层叠无纺布的时间得到的透气性为1~100秒/100ml。
[7]根据前述[1]~[6]中任一项所述的灭菌用包装材料,其中,前述层叠无纺布的拉伸强度为10~300N/25mm宽度、且刺穿强度为70~700N。
[8]根据前述[1]~[7]中任一项所述的灭菌用包装材料,其中,前述层叠无纺布由聚酯构成。
[9]根据前述[1]~[8]中任一项所述的灭菌用包装材料,其中,前述层叠无纺布的比表面积为0.01~10m2/g。
发明的效果
本发明的灭菌用包装材料通过使用具有特定的结构、高度控制了孔径的层叠无纺布,能够适应于蒸气灭菌等所有的灭菌方法,可以以稳定的加工工序、成品率良好地低成本地生产,进而由于具有适当的透气性和孔径,可以维持包装材料内部的灭菌状态的细菌阻隔性非常好,由于纸粉等的飞散也少、品质稳定性优异,因此性能高、品质高。
具体实施方式
以下对于本发明的实施方式进行详细说明。
本实施方式的灭菌用包装材料为包含超细纤维层的至少2层以上的层叠无纺布。包含超细纤维层的无纺布具有微小的孔径,纤维表面的比表面积增大,良好的透气性、细菌阻隔性升高。
无纺布层(I)由具有纤维直径5~30μm的纤维构成。若纤维直径为30μm以下则纤维的直径不会过粗,可以得到均匀的纤维之间距离,因此可以得到致密且均匀的无纺布层叠体,将无纺布层(I)和无纺布层(II)以互相接触的方式层叠的情况下,构成无纺布层(II)的超细纤维更均匀地配置于构成无纺布层(I)的纤维之间。由此,可以使层叠无纺布的孔径均匀,意味着最大孔径的泡点减小,可以达成良好的细菌阻隔性。根据需要,无纺布层(II)可以形成2层以上。另一方面,若构成无纺布层(I)的纤维的纤维直径为5μm以上则单丝强度增强,层叠无纺布可以达成充分的拉伸、刺穿强度,加工性也稳定。在该意义上,构成无纺布层(I)的无纺布的纤维直径优选为7~20μm、更优选9~18μm。
无纺布层(II)由具有纤维直径0.1~4μm的超细纤维构成。若纤维直径为4μm以下则纤维之间距离不会过大,因此可以达成微小孔径,可以具有良好的细菌阻隔性。若不足0.1μm则对于无纺布而言,基材的孔径过小,认为透气性变差。若超过4μm则致密性、孔径均匀性降低,细菌阻隔性显著降低。在该意义上,构成无纺布层(II)的无纺布的纤维直径更优选处于0.3~3μm的范围内、进一步优选处于0.5~2.5μm的范围内。
为了更稳定地制造本实施方式的灭菌用包装材料,优选在2层的无纺布层(I)之间存在作为中间层的无纺布层(I)的3层的层叠无纺布。若层叠无纺布的两面为无纺布层(I)则在加工时对于无纺布表面施加外力时,可以抑制起毛、回丝的产生,另外,生产时可以抑制表面起毛主要原因的不良,可以期待使剥离性良好,作为灭菌用包装材料可以得到优质的无纺布。
本实施方式的灭菌用包装材料的无纺布层(I)由连续长纤维无纺布构成。长纤维指的是纤维长为15mm以上。连续长纤维的丝与短纤维相比连续,因此单丝强度强,作为结果,可以达成布强度、生产工序的稳定化。
本实施方式的灭菌用包装材料优选通过热塑性合成树脂构成。例如可以为聚烯烃系树脂、聚酯系树脂、聚苯硫醚系树脂,具体而言,作为乙烯、丙烯、1-丁烯、1-己烯、4-甲基-1-戊烯、1-辛烯等α-烯烃的均聚物或共聚物的高压法低密度聚乙烯、线型低密度聚乙烯(LLDPE)、高密度聚乙烯、聚丙烯(丙烯均聚物)、聚丙烯无规共聚物、聚1-丁烯、聚4-甲基-1-戊烯、乙烯·丙烯无规共聚物的聚烯烃、聚酯(聚对苯二甲酸乙二醇酯、聚对苯二甲酸丁二醇酯、聚萘二甲酸乙二醇酯)。另外,也优选为以这些树脂作为主体的共聚物或混合物。特别是通过使用由熔点140℃以上的树脂构成的无纺布,也可以是适应于蒸气灭菌等需要高温条件的灭菌处理。更优选为聚酯系、或聚丙烯的聚合物。使用这些树脂的情况下,特别是耐热性高、在医院内频繁使用的高压蒸气灭菌处理中,与以往相比,能够实现高温处理,因此可以减少处理时间,能够进行有效的灭菌处理。此时,可以维持由超细纤维构成的致密的孔结构,灭菌处理后也能够有效地防止细菌的侵入。
对于各无纺布层的制造方法没有限定。无纺布层(I)的制法可以优选为纺粘法、干式法、湿式法等。从生产率良好的观点考虑,进一步优选为纺粘法。无纺布层(II)的制法可以优选为使用超细纤维的干式法、湿式法等制法、或静电纺丝法、熔喷法等。从可以容易地致密地形成超细无纺布的观点考虑,进一步优选为熔喷法。
对于无纺布层(I)与无纺布层(II)的层叠·一体化的方法没有特别限定。具体而言,作为热的接合,可列举出利用轧光机进行的加工、以及利用高温的热风进行的一体化(热风(air through)方式),作为化学的接合,可列举出涂布聚丙烯酸酯或聚氨酯树脂等的乳液化物的方法等。特别是热的接合可以维持无纺布的拉伸、刺穿的强度和弯曲柔软性,不使用粘合剂,就可以形成多层无纺布层,作为拒绝杂质混入的医疗用包装材料非常优选。特别优选的热的接合方法为利用轧光机进行的加工。轧光加工为通过使用了压花、绉纹组织花纹等具有凹凸的金属辊、或者具有平滑性的平滑辊的热辊进行压接的方法。具有表面凹凸性的辊的表面花纹若可以将纤维之间粘合则没有特别限定。通过该工序,也可以有助于易剥离性。热粘接工序可以在与热塑性树脂(优选热塑性树脂长纤维)的熔点相比低50~120℃的温度下以线压力100~1000N/cm进行。若热粘接工序中的线压力不足100N/cm则难以表现出充分的强度。另外,若超过1000N/cm则表观密度增大,平均流量孔径过小,有可能损害必要的透气性。
本实施方式的灭菌用包装材料的平均流量孔径优选为0.1~30μm。不足0.1μm时,纤维间隙过度狭窄,因此透气性降低,灭菌处理未浸渗至包装材料内部,是不合适的。若超过30μm则纤维之间距离过大,细菌阻隔性降低,允许细菌类的侵入,难以维持灭菌状态。在该意义上,更优选处于0.3~20μm的范围内、进一步优选处于0.5~15μm的范围内。
泡点也存在同样的考虑,泡点越接近于平均流量孔径的数值则越具有孔径均匀性。优选处于0.5~50μm的范围内、更优选处于2.0~40μm的范围内、进一步优选处于3.0~50μm的范围内。
本实施方式的灭菌用包装材料的单位面积重量优选处于8.0~100g/m2的范围内。若不足8g/m2则拉伸、刺穿的强度不充分,难以作为包装材料进行加工,从生产率等考虑不合适。在该意义上,更优选处于10~90g/m2的范围内、进一步优选处于15~80g/m2的范围内。厚度优选处于0.03~1.0mm的范围内。不足0.03mm时,层叠体的密度升高、透气性降低。若超过1.0mm则无纺布层之间的剥离强度降低,难以维持层叠体。在该意义上,更优选处于0.05~0.20mm的范围内、进一步优选处于0.08~0.15的范围内。
本实施方式的灭菌用包装材料的透气性优选在格利型透气性试验中由100ml的空气通过层叠无纺布的时间为1~100秒/100ml。若不足1秒/100ml则得不到微小平均流量孔径,细菌阻隔性低,作为灭菌包装材料不优选。若超过100秒/100ml则气体的透气性差,不能发挥作为灭菌包装材料的功能。在该意义上,该透气性更优选处于1.0~80秒/100ml的范围内、进一步优选处于1.5~70秒/100ml的范围内。
本实施方式的灭菌用包装材料的拉伸强度优选为10~300N/25mm宽度。若不足10N/25mm宽度则在生产工序中,不能耐加工工序上的张力,形成包装材料时也容易产生变形,不能发挥作为灭菌包装材料的功能。若超过300N/25mm宽度则灭菌包装材料过于具有张力而操作性差,不能发挥作为灭菌包装材料的功能,在该意义上,更优选处于10~280N/25mm宽度的范围内、进一步优选处于15~260N/25mm宽度的范围内。关于刺穿强度,也与此相同,优选处于70~700N的范围内、更优选处于15~650N的范围内、进一步优选处于20~600N的范围内。
本实施方式的灭菌用包装材料的比表面积优选为0.01~10m2/g。作为细菌被无纺布捕集的机理,认为有纤维间隙、孔径等物理的捕集和静电、分子间力等吸附捕集。有效地利用纤维表面的捕集方法为后者。此时,能够在维持高的透气性的状态下,有效地捕集进入到包装材料内部的细菌,能够兼具高的灭菌效率和细菌阻隔性。若比表面积不足0.01m2/g则吸附面积减小、细菌阻隔性降低,允许细菌进入到包装材料内部。另一方面,若超过10m2/g则现实上形成透气性极低的无纺布,难以兼具灭菌效率和阻隔性,因此比表面积更优选处于0.05~9m2/g的范围内、进一步优选处于0.10~8m2/g的范围内。
对于处于上述比表面积范围内的无纺布的制造方法没有限定。由于增加纤维界面的面积为目的,因此例如通过适当调整所构成的纤维的纤维直径,能够控制比表面积。但是,对于熔喷等长纤维系溶融纺丝而言,通常刚自喷嘴喷出之后,更接近的纤维立即接触、热粘,表观上大多产生包含数根的纤维束,难以得到比表面积,因此通过适当调整关于聚合物的喷出、冷却、捕集的各种条件(喷出量、温度、风量、风向等),可以制作高比表面积的无纺布。另外进行层叠·一体化时,例如若利用轧光加工等过度施加热量、压力则诱发纤维热粘,比表面积降低,因此适当调整热量、压力,在维持设计时的纤维形状的状态下进行一体化是重要的。
灭菌用包装材料通常存在仅利用无纺布等的透气性而形成灭菌用包装材料的情况、或者将透气性基材和透明的薄膜等非透气性基材组合来使用的情况,因此,对于基材有时要求热封性。本实施方式的层叠无纺布由热塑性树脂构成,容易得到热封性。特别是通过单面采用熔点低的树脂材料等,表现出优异的热封强度。若具有热封性则使用层叠无纺布,不仅灭菌包装材料、而且缝制手术用手术衣等时也可以采用热压接缝制。
本实施方式的灭菌用包装材料优选实施拒水·拒醇处理。对于拒水·拒醇处理的方法没有限定。例如可以使用涂布具有拒水性的材料的涂覆方法、利用具有拒水·拒醇性的气体等使纤维表面活化而实施表面处理的气体处理方法。作为具有拒水·拒醇性的材料、或者气体的种类没有限定,可列举出氟系、硅系等。
实施例
以下列举出实施例对于本发明进行具体说明,但是本发明不被这些实施例所限定。
(1)超细纤维的平均纤维直径(μm)的测定
将无纺布切割为10cm×10cm,对于上下60℃的铁板以0.30MPa的压力加压90秒后,用铂蒸镀无纺布。使用SEM装置(JSM-6510日本电子株式会社制),在加速度电压15kV、工作距离21mm的条件下进行拍摄。对于拍摄倍率而言,平均纤维直径不足0.5μm的丝设为10000倍、平均纤维直径0.5μm以上且不足1.5μm的丝设为6000倍、1.5μm以上的丝设为4000倍。对于各拍摄倍率下的拍摄视野而言,10000倍时设为12.7μm×9.3μm、6000倍时设为21.1μm×15.9μm、4000倍时设为31.7μm×23.9μm。随机拍摄100根以上纤维,拍摄全部纤维直径。但是,将在丝长方向热粘的纤维之间自测长对象排除。通过以下的式子求出的重均纤维直径(Dw)作为平均纤维直径:
Dw=ΣWi·Di=Σ(NiDi2)/(Ni·Di)
{式中,Wi=纤维直径Di的重量分数=Ni·Di/ΣNi·Di。}
(2)单位面积重量(g/m2)
根据JIS L-1906中规定的方法,对于纵20cm×横25cm的试验片,试样的宽度方向每1m采集3个部位、总计每1m×1m 9个部位,测定质量,将其平均值换算为单位面积的质量来求出。
(3)厚度(μm)的测定
根据JIS L-1906中规定的方法,每宽度1m测定10个部位的厚度,求出其平均值。
(4)表观密度(g/cm3)的测定
使用上述(2)中测得的单位面积重量(g/m2)、上述(3)中测得的厚度(μm),通过以下的式子算出:
表观密度=(单位面积重量)/(厚度)
(5)孔隙率(%)的测定
使用上述(4)中计算的表观密度(g/cm3),通过以下的式子算出:
孔隙率={1-(表观密度)/(树脂密度}}/100
(6)无纺布的平均孔径的测定
作为测定装置,使用PMI公司制的Perm-Porometer(型号:CFP-1200AEX)。对于该测定装置,将无纺布作为试样,在预先已知表面张力的浸液中浸渍无纺布,由无纺布全部细孔被浸液的膜覆盖的状态对于无纺布施加压力,测定由浸液的液膜被破坏的压力和浸液的表面张力计算的细孔的孔径。作为浸液,使用PMI公司制的Silwick,将无纺布浸渍于浸液、充分脱气后使用下述式:
d=C·r/P
{式中,d(单位:μm)为过滤器的孔径、r(单位:N/m)为浸液的表面张力、P(单位:Pa)为该孔径的液膜被破坏的压力、C为浸液的润湿张力、利用接触角等规定的常数求出孔径。
测定对于浸渍于浸液的过滤器施加的压力P自低压向高压连续地变化时的流量(润湿流量、单位L/分钟)。该测定方法中,某压力P时的润湿流量除以该压力时的干燥流量得到的值称为累积过滤器流量(单位%)。累积过滤器流量为50%的压力下被破坏的液膜的流量作为平均流量孔径。另外,初期的压力由于即使是最大的细孔的液膜也不会被破坏,因此流量为0。若升高压力则最大的细孔的液膜被破坏,产生流量,该细孔径称为泡点。
(7)比表面积
使用装置型号Gemini2360株式会社岛津制作所制。
将无纺布卷成圆筒状、装入比表面积测定用槽(cell)。此时投入的样品重量优选为0.20~0.60g左右。将投入有样品的槽在60℃的条件下干燥30分钟后,进行10分钟冷却。然后,在上述比表面积测定装置安装槽,通过氮气对样品表面的吸附,适用下述BET的下述式:
P/(V(P0-P))=1/(Vm×C)+((C-1)/(Vm×C))(P/P0)
{式中,P0:饱和水蒸气压(Pa)、Vm:单分子层吸附量(mg/g)、C:关于吸附热等的参数(-)<0,本关系式特别是在P/P0=0.05~0.35的范围内良好地成立。},
求出比表面积值。BET式指的是恒定温度下为吸附平衡状态时、表示吸附平衡压力P与该压力下的吸附量V的关系的式子。
(8)拉伸张力(N/25mm)的测定
根据JIS 8113中规定的方法,除了无纺布的各端部10cm之外,以夹具之间的距离为100mm的方式固定宽度25mm×长度200mm的试验片,以十字头速度20mm/分钟进行测定。无纺布的宽度方向每1m分别采集5个部位。施加负荷直至试验片断裂,求出机械方向(MD)和宽度方向(CD)的试验片的最大负荷时的强度的平均值。
(9)格利透气性(秒/100ml)
使用格利式密度计(株式会社安田精机制作所制、“B”型),室温下进行100ml的空气的透过时间(单位、s/100ml)的测定。对于一个无纺布样品,对于各不同的位置,进行5点的测定,其平均值作为透气性。
(10)刺穿强度(N)
在台式精密万能机(岛津制作所社制的AGS-1000D型)安装直径φ25mm、前端的半径12.5mm的针,以温度23±2℃、针的移动速度50mm/分钟进行刺穿试验。对于一个无纺布样品,对于各不同的位置,进行5点的测定,其平均值作为刺穿强度。
(11)热封性
在适当的温度下热封时的热封强度根据JIS L 1086通过以下的方法测定。将长度10cm、宽度3cm的试样片2张重叠,准备与试样片的宽度方向平行地将自端部2cm的部分热封而成的试样5个。对于热封而言,利用具有用聚四氟乙烯涂布的上下一对压接棒(宽度1cm、长度30cm)的热压机,在表面压力98N/cm2下热封1秒。接着使用台式精密万能机(株式会社岛津制作所制的AGS-1000D型),以夹持间隔7cm在卡盘之间以粘接部成为中央的方式安装样品,以拉伸速度10cm/分钟进行剥离,由剥离时示出的极大值大的情况取3个、由极小值小的情况取3个,总计6个的平均值作为热封性。
(12)剥离性
利用适当的方法在实施例1~14中得到的包装材料上粘结片材(利用T模头法得到的无延伸聚丙烯),在高压蒸气灭菌处理后,将片材自灭菌纸剥离,此时的剥离性通过肉眼判定剥离后转移到片材的起毛的量来判断。比较例4、5的高压蒸气灭菌处理后的剥离性作为◎、差的情况作为○、进一步差的情况作为×,以2等级进行评价。
(13)耐水压
除了实施例1~14中得到的包装材料的两端部10cm之外,在CD方向5等分、在MD方向3等分,关于总计15点,取样20cm见方的试验片,根据JIS L 1092测定,由该测定值的平均值算出耐水压。
(14)热收缩率
对于样品,在长度300mm、宽度210mm的试样形成80mm×80mm的正方形的记号,测定尺寸。将形成有正方形记号的试样停留于设定于温度125℃的干热机内15分钟,测定正方形的尺寸,与装入到干热机之前进行比较,算出收缩率。
(15)细胞特性评价
根据一次性医疗用具包装材料自主标准的遮菌性试验法进行。对于干燥微粉土,取河边等的并非砂状的土,避开热、日光进行自然干燥后,用乳钵形成微粉末。进行过滤测定,使用含有环境菌群104个/g以上的物质。制作具有可以容纳直径9cm浅型培养皿的尺寸的3方密封的灭菌包装材料6个,预先杀菌。杀菌方法采用不会由于灭菌处理而产生袋的变质的方法。取利用常规方法制成的琼脂平板培养基的盖,装入并密封。将3方密封材料的3个作为试样、剩余3个作为对照试样。对照试验中,用24号针(外径0.54~0.58mm)分别开3处孔。将含有菌的干燥微粉土约10g装入到减压干燥器的底部,装入到装入有培养皿的试样和对照材料各3个干燥器中,设为560mmHg的真空度(由大气压-200mmHg),保持约3分钟后,突然全开阀门导入空气,使微粉土充分飞舞,恢复到大气压。然后将试样和对照试样自干燥器取出,37度培养48小时时,在对照物试样中发现可见菌落,确认试样中是否发现可见菌落。没有确认的情况作为○、确认的情况作为×,以2等级进行判断。
(16)大气灰尘捕集效率
设为测定面积78.5cm2(直径10cm)、风速23.0L/分钟,捕集通过测定机前后的大气,用颗粒计数器(RION制)测定捕集大气中的1μm的颗粒(尘埃),通过下式求出。
大气灰尘捕集效率(%)=[1-(下游颗粒数/上游颗粒数)]×100
[实施例1~7]
使用聚对苯二甲酸乙二醇酯(以下PET)树脂,利用纺粘法,在纺丝温度300℃下将长丝的长纤维组向着移动的捕集网上挤出,以纺丝速度4500m/分钟进行纺丝,利用电晕带电,带电3μC/g左右,充分进行开纤,在捕集网上形成热塑性树脂长纤维网片。在前述制作的SB无纺布之上利用以下的MB法喷出网片。作为纤维原材料,使用PET树脂,自纺口喷嘴直径0.30mm的纺口喷嘴,挤出利用挤出机熔融的PET树脂。适当选择挤出机中的PET树脂的熔融温度、纺丝气体温度、熔融树脂的单孔喷出量等,将热塑性树脂牵引细化。进而在该MB无纺布之上喷出同样的SB无纺布,由此制作SB-MB-SB层叠无纺布。然后对于所得到的网片进行轧光加工,得到灭菌用包装材料。
[实施例8]
使用PET树脂,利用纺粘法,在纺丝温度300℃下将长丝的长纤维组向着移动的捕集网上挤出,以纺丝速度4500m/分钟进行纺丝,利用电晕带电,带电3μC/g左右,充分进行开纤,在捕集网上形成热塑性树脂长纤维网片。在前述制作的SB无纺布之上利用以下的MB法喷出网片。作为纤维原材料,使用PET树脂,自纺口喷嘴直径0.30mm的纺口喷嘴,挤出利用挤出机熔融的PET树脂。适当选择挤出机中的PET树脂的熔融温度、纺丝气体温度、熔融树脂的单孔喷出量等,将热塑性树脂牵引细化,由此制作SB-MB层叠无纺布。然后对于所得到的网片进行轧光加工,得到灭菌用包装材料。
[实施例9~12]
使用聚丙烯(以下PP)树脂,利用纺粘法,在纺丝温度230℃下将长丝的长纤维组向着移动的捕集网上挤出,以纺丝速度4500m/分钟进行纺丝,利用电晕带电,带电3μC/g左右,充分进行开纤,在捕集网上形成热塑性树脂长纤维网片。在前述制作的SB无纺布之上利用以下的MB法喷出网片。作为纤维原材料,使用PET树脂,自纺口喷嘴直径0.30mm的纺口喷嘴,挤出利用挤出机熔融的PET树脂。适当选择挤出机中的PP树脂的熔融温度、纺丝气体温度、熔融树脂的单孔喷出量等,将热塑性树脂牵引细化。进而在该MB无纺布之上喷出同样的SB无纺布,由此制作SB-MB-SB层叠无纺布。然后对于所得到的网片进行轧光加工,得到灭菌用包装材料。
[实施例13]
使用PET树脂,利用纺粘法,在纺丝温度300℃下将长丝的长纤维组向着移动的捕集网上挤出,以纺丝速度4500m/分钟进行纺丝,利用电晕带电,带电3μC/g左右,充分进行开纤,在捕集网上形成热塑性树脂长纤维网片。在前述制作的SB无纺布之上利用以下的MB法喷出网片。作为纤维原材料,使用PET树脂,自纺口喷嘴直径0.30mm的纺口喷嘴,挤出利用挤出机熔融的PET树脂。适当选择挤出机中的PET树脂的熔融温度、纺丝气体温度、熔融树脂的单孔喷出量等,将热塑性树脂牵引细化。进而在该MB无纺布之上喷出同样的SB无纺布,由此制作SB-MB-SB层叠无纺布。然后对于所得到的网片进行轧光加工,利用适当方法进行涂布氟系的拒水剂的拒水加工处理。
[实施例14]
使用PET树脂和CO-PET树脂,利用纺粘法,在纺丝温度300℃下将长丝的长纤维组向着移动的捕集网上挤出,以纺丝速度4500m/分钟进行纺丝,利用电晕带电,带电3μC/g左右,充分进行开纤,在捕集网上形成热塑性树脂长纤维网片,制作2成分纤维的无纺布。在前述制作的SB无纺布之上利用以下的MB法喷出网片。作为纤维原材料,使用PET树脂,自纺口喷嘴直径0.30mm的纺口喷嘴,挤出利用挤出机熔融的PET树脂。适当选择挤出机中的PET树脂的熔融温度、纺丝气体温度、熔融树脂的单孔喷出量等,将热塑性树脂牵引细化。进而在该MB无纺布之上喷出同样的SB无纺布,由此制作SB-MB-SB层叠无纺布。然后对于所得到的网片进行轧光加工,得到灭菌用包装材料。
[实施例15~22]
与实施例1~7同样地,使用聚对苯二甲酸乙二醇酯(以下PET)树脂,利用纺粘法,在纺丝温度300℃下将长丝的长纤维组向着移动的捕集网上挤出,以纺丝速度4500m/分钟进行纺丝,利用电晕带电,带电3μC/g左右,充分进行开纤,在捕集网上形成热塑性树脂长纤维网片。在前述制作的SB无纺布之上利用以下的MB法喷出网片。作为纤维原材料,使用PET树脂,自纺口喷嘴直径0.30mm的纺口喷嘴,挤出利用挤出机熔融的PET树脂。适当选择挤出机中的PET树脂的熔融温度、纺丝气体温度、熔融树脂的单孔喷出量等,将热塑性树脂牵引细化。进而在该MB无纺布之上喷出同样的SB无纺布,由此制作SB-MB-SB层叠无纺布。关于喷出时的喷出、冷却、捕集的各种条件从抑制热粘的观点考虑分别设定。另外,然后对于所得到的网片,利用从保持纤维形状的观点考虑、辊硬度最合适化了的轧光辊,在适当条件下进行轧光加工,得到灭菌用包装材料。
[实施例23]
与实施例1~7同样地,使用聚丙烯(以下PP)树脂,利用纺粘法,在纺丝温度230℃下将长丝的长纤维组向着移动的捕集网上挤出,以纺丝速度4500m/分钟进行纺丝,利用电晕带电,带电3μC/g左右,充分进行开纤,在捕集网上形成热塑性树脂长纤维网片。在前述制作的SB无纺布之上利用以下的MB法喷出网片。作为纤维原材料,使用PET树脂,自纺口喷嘴直径0.30mm的纺口喷嘴,挤出利用挤出机熔融的PET树脂。适当选择挤出机中的PP树脂的熔融温度、纺丝气体温度、熔融树脂的单孔喷出量等,将热塑性树脂牵引细化。进而在该MB无纺布之上喷出同样的SB无纺布,由此制作SB-MB-SB层叠无纺布。关于喷出时的喷出、冷却、捕集的各种条件从抑制热粘的观点考虑分别设定。另外,然后对于所得到的网片,利用从保持纤维形状的观点考虑、辊硬度最合适化了的轧光辊,在适当条件下进行轧光加工,得到灭菌用包装材料。
[比较例1]
将由PET树脂构成的利用SB法的无纺布(丝直径16μm、单位面积重量25g/m2)喷出到网上,利用平滑辊以线压力260N/cm、温度190℃热粘接后,利用轧光辊,以线压力294N/cm、温度245℃进行加工,得到层叠无纺布。
[比较例2]
将由PET树脂构成的MB无纺布(丝直径2μm、单位面积重量25g/m2)喷出到网上,利用平滑辊以线压力260N/cm、温度120℃热粘接后,利用轧光辊,以线压力340N/cm、温度40℃进行加工,得到层叠无纺布。
[比较例3]
将由PET树脂构成的MB无纺布(丝直径1.0μm、单位面积重量25g/m2)喷出到网上,利用轧光辊,以线压力340N/cm、温度40℃进行加工,得到层叠无纺布。
[比较例4]
通常使用的由聚乙烯闪纺法制作的无纺布的灭菌包装材料(丝直径5μm、单位面积重量75g/m2)
[比较例5]
通常使用的由聚乙烯闪纺法制作的无纺布的灭菌包装材料(丝直径4μm、单位面积重量63g/m2)
[比较例6]
通常使用的浆粕短纤维的灭菌纸(丝直径4μm、单位面积重量63g/m2)
实施例1~23、比较例1~6的无纺布结构以及所得到的无纺布的各种特定如以下的表1~4所示。
[表1]
[表2]
[表3]
[表4]
产业上的可利用性
本发明的层叠无纺布,对于探针(Sonde)、手术刀(mes)、镊子(pincette)、剪子等为了防止感染症能够作为医疗领域中的灭菌用包装材料合适地利用。
Claims (8)
1.一种灭菌用包装材料,其由包含无纺布层(I)和无纺布层(II)的至少2层以上的层叠无纺布构成,所述无纺布层(I)由具有平均纤维直径5~30μm的连续长纤维构成,所述无纺布层(II)由具有平均纤维直径0.1~4μm的超细纤维构成,
所述层叠无纺布的比表面积为0.10~10m2/g,
所述无纺布层(II)的比表面积为1.8~15.1m2/g。
2.根据权利要求1所述的灭菌用包装材料,其中,在2层的所述无纺布层(I)之间存在包含所述无纺布层(II)的中间层。
3.根据权利要求1或2所述的灭菌用包装材料,其中,所述无纺布层(II)由熔喷无纺布构成。
4.根据权利要求1或2所述的灭菌用包装材料,其中,所述层叠无纺布的平均流量孔径为0.1~30μm、且泡点为0.5~50μm。
5.根据权利要求1或2所述的灭菌用包装材料,其中,所述层叠无纺布的单位面积重量为8.0~100g/m2、且厚度为0.03~0.2mm。
6.根据权利要求1或2所述的灭菌用包装材料,其中,在格利型透气性试验中由100ml的空气通过所述层叠无纺布的时间得到的透气性为1~100秒/100ml。
7.根据权利要求1或2所述的灭菌用包装材料,其中,所述层叠无纺布的拉伸强度为10~300N/25mm宽度、且刺穿强度为70~700N。
8.根据权利要求1或2所述的灭菌用包装材料,其中,所述层叠无纺布由聚酯构成。
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