JP6243096B2 - バイアル用ゴム栓 - Google Patents
バイアル用ゴム栓 Download PDFInfo
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- JP6243096B2 JP6243096B2 JP2011250611A JP2011250611A JP6243096B2 JP 6243096 B2 JP6243096 B2 JP 6243096B2 JP 2011250611 A JP2011250611 A JP 2011250611A JP 2011250611 A JP2011250611 A JP 2011250611A JP 6243096 B2 JP6243096 B2 JP 6243096B2
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- rubber
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- plate
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- 229920001971 elastomer Polymers 0.000 title claims description 111
- 239000005060 rubber Substances 0.000 title claims description 99
- 229920005549 butyl rubber Polymers 0.000 claims description 23
- 239000005062 Polybutadiene Substances 0.000 claims description 21
- 229920002857 polybutadiene Polymers 0.000 claims description 21
- 239000004945 silicone rubber Substances 0.000 claims description 18
- 229920002379 silicone rubber Polymers 0.000 claims description 16
- 239000000806 elastomer Substances 0.000 claims description 12
- 229920003002 synthetic resin Polymers 0.000 claims description 8
- 239000000057 synthetic resin Substances 0.000 claims description 8
- 230000000994 depressogenic effect Effects 0.000 claims 1
- 239000000463 material Substances 0.000 description 35
- 238000000465 moulding Methods 0.000 description 11
- 238000012360 testing method Methods 0.000 description 10
- 239000007788 liquid Substances 0.000 description 9
- 238000000034 method Methods 0.000 description 8
- 230000004888 barrier function Effects 0.000 description 7
- 229920001577 copolymer Polymers 0.000 description 7
- 239000003814 drug Substances 0.000 description 7
- 230000002093 peripheral effect Effects 0.000 description 7
- 229920002725 thermoplastic elastomer Polymers 0.000 description 7
- 238000007789 sealing Methods 0.000 description 5
- 229920003051 synthetic elastomer Polymers 0.000 description 5
- 239000005061 synthetic rubber Substances 0.000 description 5
- 229920000459 Nitrile rubber Polymers 0.000 description 3
- 229920002367 Polyisobutene Polymers 0.000 description 3
- -1 SEBS Polymers 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000010828 elution Methods 0.000 description 3
- 229920003049 isoprene rubber Polymers 0.000 description 3
- 239000003566 sealing material Substances 0.000 description 3
- KAKZBPTYRLMSJV-UHFFFAOYSA-N Butadiene Chemical compound C=CC=C KAKZBPTYRLMSJV-UHFFFAOYSA-N 0.000 description 2
- 208000012266 Needlestick injury Diseases 0.000 description 2
- 239000002033 PVDF binder Substances 0.000 description 2
- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 description 2
- 239000004699 Ultra-high molecular weight polyethylene Substances 0.000 description 2
- CCDWGDHTPAJHOA-UHFFFAOYSA-N benzylsilicon Chemical compound [Si]CC1=CC=CC=C1 CCDWGDHTPAJHOA-UHFFFAOYSA-N 0.000 description 2
- FACXGONDLDSNOE-UHFFFAOYSA-N buta-1,3-diene;styrene Chemical compound C=CC=C.C=CC1=CC=CC=C1.C=CC1=CC=CC=C1 FACXGONDLDSNOE-UHFFFAOYSA-N 0.000 description 2
- 238000013329 compounding Methods 0.000 description 2
- 229920000840 ethylene tetrafluoroethylene copolymer Polymers 0.000 description 2
- 230000009477 glass transition Effects 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 description 2
- 229920001921 poly-methyl-phenyl-siloxane Polymers 0.000 description 2
- 229920002620 polyvinyl fluoride Polymers 0.000 description 2
- 229920002981 polyvinylidene fluoride Polymers 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 229920003048 styrene butadiene rubber Polymers 0.000 description 2
- 229920000468 styrene butadiene styrene block copolymer Polymers 0.000 description 2
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- 230000002195 synergetic effect Effects 0.000 description 2
- 229920000785 ultra high molecular weight polyethylene Polymers 0.000 description 2
- DBOFPRDNHUMHGD-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;2-methylbuta-1,3-diene;2-methylprop-1-ene Chemical compound CC(C)=C.CC(=C)C=C.C=CC1=CC=CC=C1C=C DBOFPRDNHUMHGD-UHFFFAOYSA-N 0.000 description 1
- JBAUPCNQUQGXJT-UHFFFAOYSA-N 1-ethenyl-4-methylbenzene;2-methylprop-1-ene Chemical class CC(C)=C.CC1=CC=C(C=C)C=C1 JBAUPCNQUQGXJT-UHFFFAOYSA-N 0.000 description 1
- VSKJLJHPAFKHBX-UHFFFAOYSA-N 2-methylbuta-1,3-diene;styrene Chemical compound CC(=C)C=C.C=CC1=CC=CC=C1.C=CC1=CC=CC=C1 VSKJLJHPAFKHBX-UHFFFAOYSA-N 0.000 description 1
- VQTUBCCKSQIDNK-UHFFFAOYSA-N Isobutene Chemical group CC(C)=C VQTUBCCKSQIDNK-UHFFFAOYSA-N 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 229920006465 Styrenic thermoplastic elastomer Polymers 0.000 description 1
- 206010052428 Wound Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 229920000800 acrylic rubber Polymers 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000002313 adhesive film Substances 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229920005557 bromobutyl Polymers 0.000 description 1
- 229920005556 chlorobutyl Polymers 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 238000005138 cryopreservation Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 150000001993 dienes Chemical class 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- HQQADJVZYDDRJT-UHFFFAOYSA-N ethene;prop-1-ene Chemical group C=C.CC=C HQQADJVZYDDRJT-UHFFFAOYSA-N 0.000 description 1
- 229920005560 fluorosilicone rubber Polymers 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- ZZUFCTLCJUWOSV-UHFFFAOYSA-N furosemide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC(C(O)=O)=C1NCC1=CC=CO1 ZZUFCTLCJUWOSV-UHFFFAOYSA-N 0.000 description 1
- 229920005555 halobutyl Polymers 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 238000010030 laminating Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 150000002825 nitriles Chemical class 0.000 description 1
- 125000005375 organosiloxane group Chemical group 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229920002493 poly(chlorotrifluoroethylene) Polymers 0.000 description 1
- 229920000058 polyacrylate Polymers 0.000 description 1
- 239000005023 polychlorotrifluoroethylene (PCTFE) polymer Substances 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000009257 reactivity Effects 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229920005573 silicon-containing polymer Polymers 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 229920001897 terpolymer Polymers 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- BFKJFAAPBSQJPD-UHFFFAOYSA-N tetrafluoroethene Chemical group FC(F)=C(F)F BFKJFAAPBSQJPD-UHFFFAOYSA-N 0.000 description 1
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- 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
- B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
- B29C45/14778—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles the article consisting of a material with particular properties, e.g. porous, brittle
- B29C45/14811—Multilayered articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
- B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
- B29C43/021—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles characterised by the shape of the surface
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
- B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
- B29C43/14—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles in several steps
- B29C43/146—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles in several steps for making multilayered articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
- B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
- B29C43/20—Making multilayered or multicoloured articles
- B29C43/203—Making multilayered articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/02—Transfer moulding, i.e. transferring the required volume of moulding material by a plunger from a "shot" cavity into a mould cavity
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
- B29C45/14311—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles using means for bonding the coating to the articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- 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
- B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
- B65D39/0005—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in one piece
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- 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
- B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
- B65D39/0052—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in more than one piece
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- 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
- B65D51/00—Closures not otherwise provided for
- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- 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
- B65D51/00—Closures not otherwise provided for
- B65D51/005—Closures provided with linings or internal coatings so as to avoid contact of the closure with the contents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/56—Stoppers or lids for bottles, jars, or the like, e.g. closures
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Manufacturing & Machinery (AREA)
- Closures For Containers (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Description
すなわち、脚部は、極低温下においても硬くならないエラストマーが配合されたシリコーンゴム等とし、笠部は、ガスバリア性やコアリング特性に優れたブチル系ゴム等とする等がある。
ブチル系ゴムとしては、医薬・医療用容器のシール材として一般的に使用されるブチル系ゴムやブチル系ゴムベースの配合物であれば特に限定されないが、硬度が20〜40度(JISタイプA)、ガラス転移温度が−30〜−60℃程度のものが使用される。例えば、レギュラーブチルゴム、ハロゲン化(臭素化・塩素化)ブチルゴム、臭素化イソブチレン−パラメチルスチレン、架橋イソブチレン−イソプレン−ジビニルベンゼン三元共重合体などが挙げられ、ガスバリア性、溶出特性及びコアリング特性の点からレギュラーブチルゴムやハロゲン化ブチルゴム、これらをベースにした配合ゴムが好適である。
このエラストマー配合ゴムは、硬度が40〜60度(JISタイプA)、ガラス転移温度が−100〜−150℃のものが好ましく、例えば、ベースゴムとなるシリコーンゴムやブタジエンゴム100重量部に対して、エラストマーが80〜210重量部程度、好ましくは100〜150重量部程度配合されたものが好適に使用できる。この程度の配合割合であると、極低温下におけるゴム弾性が良好に維持でき、かつゴムからの溶出特性を良好にすることができる。
熱可塑性エラストマーとしては、例えば、ポリイソブチレン系熱可塑性エラストマー(SIBS)、スチレン−ブタジエン−スチレン(SBS)系共重合体、スチレン−エチレンブチレン−スチレン(SEBS)系共重合体、スチレン−イソプレン−スチレン(SIS)系共重合体等のスチレン系エラストマーや、エチレン−プロピレン−非共役ジエンモノマー(EPDM)系共重合体、エチレン−プロピレン(EPM)系共重合体などが挙げられ、ガスバリヤ性の面からはポリイソブチレン系熱可塑性エラストマー(SIBS)が好適である。
合成ゴムとしては、アクリルゴム(ACM)、アクリロニトリルブタジエンゴム(NBR)、イソプレンゴム(IR)、ブタジエンゴム(BR)、スチレンブタジエンゴム(SBR)、ブチルゴム(IIR)などが挙げられ、シリコーンゴムとの配合特性、成形性、耐コアリング性、弾性率の向上、永久歪みや延びといった物理的特性からはブタジエンゴム(BR)が好適である。
これらの熱可塑性エラストマーや合成ゴムは、両者ともいずれか1種以上が配合されていればよい。
もちろん、上記の脚部の基端部側を構成する材質と該基端部を除く部分を構成する材質とを入れ替え、脚部の基端部側をブチル系ゴムやブチル系ゴムベースの配合体で、該基端部を除く部分をエラストマー配合シリコーンゴムやブタジエンゴム等で構成することもできる。
また、上記両ゴム材質間に、両ゴム材質を接合するために接着用フィルム、例えば、分子量100万〜700万、好ましくは150万〜600万のポリエチレンフィルム(以下、「超高分子量ポリエチレンフィルム」)を介在させることもできる。
超高分子量ポリエチレンフィルムは、薄すぎると均一な接着強度や十分なガスバリア性が確保できず、厚すぎると硬度の上昇やコアリングの発生を誘発する虞があるので、ゴム栓の用途やサイズにより、20〜200μm程度の範囲から適宜選択される。
このため、板状笠部および脚部の基端部側をエラストマーを配合したシリコーン系ゴムやブタジエンゴム等とし、脚部の基端部側を除く部分をブチル系ゴムやブチル系ゴムベースの配合物とした本発明のバイアル用ゴム栓では、強固な接合を確保できるうえ、バイアルに収容されて例えば凍結保存される極低温の液体が脚部に接触しても、その接触部分の脚部が耐寒性の高いゴム材質製であるため、ゴム栓としての機能を充分に維持することができる。
また、図示はしないが、基端部側と基端部側を除く部分との間に、これら両材質を接着させるための上記材質製のフィルムを介在させることもできる。
このフッ素樹脂フィルムとしては、例えば、テトラフルオロエチレン樹脂(PTFE)、テトラフルオロエチレン−ペルフルオロエチレンコポリマー(PFA)、テトラフルオロエチレン−ヘキサフルオロプロピレンコポリマー(FEP)、テトラフルオロエチレン−エチレンコポリマー(ETFE)、トリクロロトリフルオロエチレン(PCTFE)、ポリフッ化ビニリデン(PVDF)、ポリフッ化ビニル(PVF)などが挙げられる。
よって、一実施形態のバイアル用ゴム栓は、凍結保存される極低温の液体医薬品などを凍結保存するバイアル用ゴム栓として好適であり、この凍結保存中はもとより常温下においてもバイアル2に収容された液体医薬品中にゴム栓を構成する素材中の成分が溶出することもない。
加えて、一実施形態のバイアル用ゴム栓1は、脚部1Bの表面の合成樹脂フィルム1Dでのラミネートにより、多数が一緒に袋詰めされて保管されるような場合にも、相互に粘着することがない。
各ゴム栓の寸法は、笠部1Aの最大直径20mm、肉厚(最大肉厚)3mm、脚部1Bの最大外径15mm、脚先内径10mm、脚部1Bの突出長を含めたバイアル用ゴム栓1の高さ8mmであった。
これらゴム栓につき、剥離試験および割れ試験を下記の要領で行った。
図示しない島津製作所製オートグラフ(AG−1、ロードセル1kN)を使用し、ロードセルにセットした挟み治具に上記各ゴム栓の円板状笠部1Aを固定し、脚部1Bを試験用ペンチで挟持し、該ペンチを固定した。
この状態で、ロードセルにセットした挟み治具を速度100mm/minで、笠部1Aもしくは脚部1Bが破断するまで、または脚部1Bが笠部1Aから剥離するまで、垂直に引き上げ、引き上げ中の最大荷重を読み取り、その際のゴム栓の状況を観察した。試験数は各10個とした。結果は、表1に示す通りであった。
低温保持用と常温保持用の各ゴム栓を10個づつ、図1,図2に示す態様で、減圧雰囲気下(40Pa以下)、バイアルに打栓し、金属(アルミニウム)キャップで巻き締めた。
低温保持用の各ゴム栓で打栓した各バイアル10本は、倒立させた状態で超低温槽(−80℃)に24時間保管し、常温保持用の各ゴム栓で打栓した各バイアル10本も、倒立させた状態で常温で24時間保管した。
保管後、これらのキャップを外し、各ゴム栓に割れが発生しているか否かを観察した。結果は、表1の通りであった。
1A:円板状笠部
1B:脚部
1C:シールリング部
1D:合成樹脂フィルム
1E:ターゲットマーク
1F:ボス部
1G:リング状溝
1H:リング状溝
1J:円形凹部
2 :バイアル
2A:環状リップ部
2B:内周面
Claims (2)
- 脚部と、この脚部の基端部側に接合された板状笠部とを有するバイアル用ゴム栓であって、
前記脚部は、前記板状笠部との接合面を含む基端部側が板状笠部と同じエラストマーが配合されたシリコーンゴムまたはブタジエンゴムで構成され、前記基端部を除く部分が前記板状笠部と異なるブチル系ゴムで構成されており、
前記脚部の基端部と板状笠部との接合面は、同心円状の凹凸面であって、前記脚部の基端部には、前記板状笠部側に突出するボス部が形成され、該ボス部の周囲にはリング状溝が形成され、
前記基端部を除く部分のボス部と反対側の面に、該ボス部側へ陥没する凹部が形成され、
前記脚部の基端部を除く部分に合成樹脂フィルムが被覆されていることを特徴とするゴム栓。 - 前記ボス部の端面には、円形凹部またはリング状溝が形成されていることを特徴とする請求項1に記載のバイアル用ゴム栓。
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JP2011250611A JP6243096B2 (ja) | 2011-11-16 | 2011-11-16 | バイアル用ゴム栓 |
DK12192718.0T DK2594503T3 (en) | 2011-11-16 | 2012-11-15 | The rubber plug for a vial container |
HUE12192718A HUE026986T2 (en) | 2011-11-16 | 2012-11-15 | Rubber stopper for ampoule |
EP12192718.0A EP2594503B1 (en) | 2011-11-16 | 2012-11-15 | A rubber plug for a vial container |
ES12192718.0T ES2553649T3 (es) | 2011-11-16 | 2012-11-15 | Un tapón de caucho para un contenedor de vial |
US13/678,003 US8684206B2 (en) | 2011-11-16 | 2012-11-15 | Rubber plug for a vial container having concavo-convex connecting portions |
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JP2011250611A JP6243096B2 (ja) | 2011-11-16 | 2011-11-16 | バイアル用ゴム栓 |
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DK (1) | DK2594503T3 (ja) |
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CA151708S (en) * | 2012-12-19 | 2014-12-29 | Brita Gmbh | Carafe |
JP6179229B2 (ja) * | 2013-07-10 | 2017-08-16 | Nok株式会社 | スチレン系熱可塑性エラストマー組成物 |
ITPD20130277A1 (it) * | 2013-10-08 | 2015-04-09 | Microcell Srl | Tappo perfezionato per contenitori |
EP2862587A1 (en) | 2013-10-15 | 2015-04-22 | Becton Dickinson France | Tip cap assembly for closing an injection system |
JP6403258B2 (ja) | 2014-09-16 | 2018-10-10 | 住友ゴム工業株式会社 | 医療用ゴム栓の製造方法 |
WO2016052037A1 (ja) * | 2014-10-02 | 2016-04-07 | 住友ゴム工業株式会社 | ノズルキャップ |
CN104622689A (zh) * | 2015-01-29 | 2015-05-20 | 山东亨洁医用包装科技有限公司 | 一种一次成型式软袋接口及具有该软袋接口的输液软袋 |
CN204671572U (zh) * | 2015-05-12 | 2015-09-30 | 江苏华兰药用新材料股份有限公司 | 改型覆膜胶塞 |
CZ29602U1 (cs) * | 2015-10-20 | 2016-07-04 | Preciosa Gulf, FZCO Dubai AE | Adaptabilní zátka |
JP2020005805A (ja) * | 2018-07-05 | 2020-01-16 | 住友ゴム工業株式会社 | 医療用栓体 |
US11104489B2 (en) * | 2018-07-13 | 2021-08-31 | Aktiebolaget Skf | Annular seal having a garter spring for establishing a minimum interior diameter and seal plug including the seal |
CN113474083A (zh) * | 2019-01-04 | 2021-10-01 | 仪器实验室公司 | 用于高刺穿计数应用的容器塞子 |
USD919113S1 (en) * | 2019-09-27 | 2021-05-11 | Derek Djeu | Vial with cone bottom |
JP2021151956A (ja) * | 2020-03-24 | 2021-09-30 | 株式会社Screenホールディングス | 液体容器封止蓋および当該蓋によって封止された容器を用いた灌流装置 |
US11642280B2 (en) | 2020-11-10 | 2023-05-09 | Corning Incorporated | Glass containers and sealing assemblies for maintaining seal integrity at low storage temperatures |
EP4268789A1 (en) * | 2020-12-23 | 2023-11-01 | Daikyo Seiko, LTD. | Rubber plug |
EP4408371A1 (en) | 2021-09-30 | 2024-08-07 | Corning Incorporated | Glass containers for storing pharmaceutical compositions |
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WO2009151129A1 (ja) * | 2008-06-10 | 2009-12-17 | 株式会社大協精工 | 極低温保管容器用ゴム成形品およびそれを用いた医薬・医療用容器 |
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JP2013103755A (ja) | 2013-05-30 |
EP2594503B1 (en) | 2015-09-23 |
US20130119011A1 (en) | 2013-05-16 |
ES2553649T3 (es) | 2015-12-10 |
DK2594503T3 (en) | 2016-01-04 |
EP2594503A1 (en) | 2013-05-22 |
US8684206B2 (en) | 2014-04-01 |
HUE026986T2 (en) | 2016-08-29 |
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