JP5683129B2 - Vial stopper and seal member used therefor - Google Patents
Vial stopper and seal member used therefor Download PDFInfo
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- JP5683129B2 JP5683129B2 JP2010105555A JP2010105555A JP5683129B2 JP 5683129 B2 JP5683129 B2 JP 5683129B2 JP 2010105555 A JP2010105555 A JP 2010105555A JP 2010105555 A JP2010105555 A JP 2010105555A JP 5683129 B2 JP5683129 B2 JP 5683129B2
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- vial
- flange portion
- opening
- compression
- seal member
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- 230000006835 compression Effects 0.000 claims description 62
- 238000007906 compression Methods 0.000 claims description 62
- 238000007789 sealing Methods 0.000 claims description 36
- 230000002093 peripheral effect Effects 0.000 claims description 27
- 239000000463 material Substances 0.000 claims description 9
- 238000002360 preparation method Methods 0.000 claims description 8
- 229920003002 synthetic resin Polymers 0.000 claims description 7
- 239000000057 synthetic resin Substances 0.000 claims description 7
- 229920003051 synthetic elastomer Polymers 0.000 claims description 6
- 239000005061 synthetic rubber Substances 0.000 claims description 6
- 238000009423 ventilation Methods 0.000 claims description 5
- 239000007788 liquid Substances 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 3
- 229920002725 thermoplastic elastomer Polymers 0.000 claims description 3
- 230000006641 stabilisation Effects 0.000 claims description 2
- 238000011105 stabilization Methods 0.000 claims description 2
- 230000000087 stabilizing effect Effects 0.000 claims description 2
- 238000003825 pressing Methods 0.000 description 20
- 238000012986 modification Methods 0.000 description 17
- 230000004048 modification Effects 0.000 description 17
- 238000009777 vacuum freeze-drying Methods 0.000 description 10
- 238000002347 injection Methods 0.000 description 7
- 239000007924 injection Substances 0.000 description 7
- 230000001012 protector Effects 0.000 description 5
- 238000004108 freeze drying Methods 0.000 description 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 3
- 229910052782 aluminium Inorganic materials 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 229920005549 butyl rubber Polymers 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 239000005060 rubber Substances 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 229910001873 dinitrogen Inorganic materials 0.000 description 1
- 239000011261 inert gas Substances 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 238000005304 joining Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Images
Classifications
-
- 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
Description
本発明はバイアルに用いる栓体とこれに用いるシール部材に関し、更に詳しくは、簡単な構造でありながら、バイアルの全高やシール部材のフランジ部の厚さ等に寸法公差があっても、バイアルの開口部をシール部材で確実に密封できる、バイアル用栓体とこれに用いるシール部材に関する。 The present invention relates to a stopper used for a vial and a seal member used for the same, and more specifically, even if there is a dimensional tolerance in the overall height of the vial, the thickness of the flange portion of the seal member, etc., even though the structure is simple, The present invention relates to a vial stopper that can securely seal an opening with a seal member and a seal member used therefor.
医薬品や各種検査用試薬を収容する有底筒状のバイアルに対し、その開口部を密封する栓体としては、アルミ材料からなるプロテクタの上面に、破断部を介して合成樹脂製キャップが固定され、上記のプロテクタの内面にバイアル上面の開口部を密封するシール部材が嵌着されたものがある。上記のバイアル内に収容された薬剤を凍結乾燥する場合は、上記のシール部材を上記の開口部から浮き上がらせた半打栓姿勢にしておき、この状態で上記のバイアルを真空凍結乾燥装置内に収容し、凍結乾燥したのち上記のシール部材を全打栓姿勢に切り換えて上記の開口部を密封し、次いで真空凍結乾燥装置から取り出して、上記のプロテクタの裾部を捲締機で巻き締めする。 A cap made of a synthetic resin is fixed to the upper surface of a protector made of an aluminum material via a fractured portion as a stopper for sealing the opening of a bottomed cylindrical vial containing medicines and various test reagents. In some cases, a seal member for sealing the opening of the upper surface of the vial is fitted to the inner surface of the protector. When freeze-drying the drug contained in the vial, the sealing member is placed in a half-plugged position that is lifted from the opening, and in this state, the vial is placed in a vacuum freeze-drying apparatus. After storing and freeze-drying, the sealing member is switched to the full plugging position to seal the opening, and then taken out from the vacuum freeze-drying device, and the skirt of the protector is wound with a clamping machine. .
しかし、上記のアルミ材料製プロテクタを用いたバイアルは、構成材料がガラス、アルミニウム、合成樹脂、ゴムの４種類からなり、廃棄の際に分別が容易でない問題がある。また上記の真空凍結乾燥装置から大気中に取り出したバイアルは内部が減圧状態となっているのに対し、上記のシール部材は、上記のプロテクタが巻き締めされるまでの間、未だ確りと固定されていないためバイアル内の気密性の確保が容易でない問題もある。 However, the vial using the above-described protector made of aluminum material has four kinds of constituent materials of glass, aluminum, synthetic resin, and rubber, and there is a problem that separation is not easy at disposal. The vials taken out from the vacuum freeze-drying apparatus into the atmosphere are in a reduced pressure state, whereas the seal member is still securely fixed until the protector is tightened. Therefore, there is a problem that it is not easy to ensure airtightness in the vial.
上記の問題点を解消するため、従来のバイアル用栓体には、合成樹脂製の筒部と上壁とを備えたキャップ内にシール部材を装着してあり、このバイアル用栓体をバイアルに半打栓姿勢で装着しておき、凍結乾燥後にその真空凍結乾燥装置内でバイアル用栓体を全打栓姿勢へ切り換えることで、上記のキャップにより上記のシール部材をバイアルの開口部周縁へ確りと固定する、バイアル用栓体が提案されている(例えば、特許文献１参照。)。 In order to solve the above problems, a conventional vial stopper has a sealing member mounted in a cap provided with a synthetic resin cylinder and an upper wall, and this vial stopper is attached to the vial. Installed in a semi-plugging position, and after freeze-drying, switching the vial stopper to the full-plugging position in the vacuum freeze-drying device ensures that the sealing member is secured to the periphery of the vial opening by the cap. A vial stopper has been proposed (see, for example, Patent Document 1).
即ちこの従来技術は、上記の合成樹脂製キャップが、通針用窓部を設けた上壁と、この上壁の外周縁部から垂下した筒部とを備えており、このキャップ内に、上記の上壁とバイアルの開口部周縁に形成された鍔部の上面との間を密封するシール部材が嵌着してある。また上記の筒部の内面には、上記のキャップとこれに嵌着したシール部材を全打栓姿勢に保持する係止手段が設けてある。 That is, in this prior art, the above-mentioned synthetic resin cap is provided with an upper wall provided with a needle passing window portion, and a cylindrical portion suspended from the outer peripheral edge portion of the upper wall. A sealing member for sealing between the upper wall and the upper surface of the flange formed on the peripheral edge of the opening of the vial is fitted. Moreover, the inner surface of said cylinder part is provided with the latching means which hold | maintains said cap and the sealing member fitted to this in the whole stoppering attitude | position.
上記のバイアル用栓体は、上記のキャップとこれに内嵌した上記のシール部材を真空凍結乾燥装置内で半打栓姿勢から全打栓姿勢に切り換えると、上記の係止手段が上記のバイアルの鍔部の下面に係止し、これにより、このキャップの上壁が上記のシール部材を鍔部の上面へ確りと押圧する状態に保持される。 When the cap for the vial and the seal member fitted therein are switched from the half-plugging position to the full-plugging position in the vacuum freeze-drying apparatus, the locking means is used for the vial. The upper wall of the cap is held in a state of firmly pressing the sealing member against the upper surface of the collar.
上記のバイアル用栓体は、上記の真空凍結乾燥装置内で棚間隔を狭めることにより上方の棚板に押圧されて、半打栓姿勢から全打栓姿勢に切り換えられる。このとき、全打栓姿勢に切り換える押圧力は、過剰に高くするとバイアルを破損する虞があり、例えば６０Ｎ以下に設定される。しかしながら、バイアル全高やシール部材のフランジ部の厚さ、真空凍結乾燥装置の棚板の水平レベル、多段となった棚板間の高さ等に、寸法のバラツキがある。例えば、シール部材のフランジ部の厚さは、寸法公差が例えば±０.３ｍｍに設定される。特にバイアルが硝子製の場合は、その全高の寸法公差が例えば±０.５ｍｍと大きい。このため、例えば６０００本などの多数のバイアルに対し、上記の棚板を一定寸法移動させてバイアル用栓体を全打栓姿勢に切り換えようとすると、全てのバイアルについて確実に打栓する、ということができない虞や、キャップの上壁でシール部材を確りと押圧することができず、シール不良を生じたり、気密保持性が低下したりする虞がある。 The vial stopper is pressed by the upper shelf plate by narrowing the shelf interval in the vacuum freeze-drying apparatus, and is switched from the half-plugging posture to the full-plugging posture. At this time, if the pressing force for switching to the full stoppering posture is excessively high, the vial may be damaged, and is set to 60 N or less, for example. However, there are variations in dimensions such as the overall height of the vial, the thickness of the flange portion of the seal member, the horizontal level of the shelf plate of the vacuum freeze-drying apparatus, and the height between the shelf plates in multiple stages. For example, the thickness tolerance of the flange portion of the seal member is set to, for example, ± 0.3 mm. In particular, when the vial is made of glass, the overall dimensional tolerance is as large as ± 0.5 mm. For this reason, for example, if a plurality of vials such as 6000 are moved by a certain size to switch the vial stoppers to the full stoppering posture, all the vials are reliably stoppered. There is a possibility that the sealing member cannot be pressed firmly with the upper wall of the cap, and there is a possibility that a sealing failure may occur or the airtightness may be lowered.
本発明の技術的課題は上記の問題点を解消し、簡単な構造でありながら、バイアルの全高やシール部材のフランジ部の厚さ等に寸法公差があっても、バイアルの開口部をシール部材で確実に密封できる、バイアル用栓体を提供することにある。 The technical problem of the present invention is to solve the above-mentioned problems, and even if there is a dimensional tolerance in the overall height of the vial, the thickness of the flange portion of the seal member, etc. while having a simple structure, the opening portion of the vial is sealed. It is an object of the present invention to provide a vial stopper that can be reliably sealed.
本発明は上記の課題を解決するため、例えば本発明の実施の形態を示す図１から図１４に基づいて説明すると、次のように構成したものである。
すなわち、本発明１はバイアル用栓体に関し、バイアル(２)の上端に開口された開口部(６)を密封するバイアル用栓体であって、上記の開口部(６)の周囲に鍔部(７)が形成してあり、上記の開口部(６)を覆う状態に装着されるゴム弾性を備えたシール部材(８)と、このシール部材(８)を上記の鍔部(７)の上面へ押圧して固定する合成樹脂製キャップ(９)とを有し、上記のキャップ(９)は、上記のフランジ部(10)の上方に配置した上壁(15)と、この上壁(15)の外周縁部から垂下した筒部(16)と、この筒部(16)の内方に配置され上記の鍔部(７)の下面へ係止可能な係止部(18)とを備え、上記のシール部材(８)は上記の鍔部(７)の上面に載置されるフランジ部(10)を有し、このフランジ部(10)の上面に、平面視でそのフランジ部(10)の外周縁と接し、且つ、この外周縁に沿って連続した若しくは不連続の環状に、圧縮用凸部(29)を形成したことを特徴とする。
In order to solve the above-described problems, the present invention is configured as follows, for example, based on FIGS. 1 to 14 showing an embodiment of the present invention.
That is, the
また本発明２はシール部材に関し、上記の本発明１のバイアル用栓体(１)に用いるシール部材であって、円板状のフランジ部(10)と、そのフランジ部(10)の下面中央部から垂下した脚部(11)とを備え、上記のフランジ部(10)の上面に、平面視でそのフランジ部(10)の外周縁と接し、且つ、この外周縁に沿って連続した若しくは不連続の環状に、圧縮用凸部(29)を形成したことを特徴とする。
The
上記のバイアル用栓体を全打栓姿勢に切り換えると、上記の上壁により、上記のシール部材のフランジ部がバイアルの開口の周囲の上面に押圧される。このとき、上記のシール部材は、上記の上壁により最初に上記の圧縮用凸部が押圧され、この圧縮用凸部が偏平化されたのち、その他の部位のフランジ部が上壁で押圧される。 When the vial stopper is switched to the full stoppering posture, the flange portion of the seal member is pressed against the upper surface around the opening of the vial by the upper wall. At this time, in the sealing member, the compression convex portion is first pressed by the upper wall, and after the compression convex portion is flattened, the flange portions of other portions are pressed by the upper wall. The
上記の圧縮用凸部はフランジ部全体の一部に過ぎないので、フランジ部全体を押圧する場合に比べて、低い押圧力で上壁により圧縮される。そしてこの圧縮用凸部が押圧されると、この圧縮用凸部を介してその下方のフランジ部が上記のバイアルの開口部の周囲の上面に押圧される。上記の圧縮用凸部はフランジ部の外周縁に沿った環状に形成されているので、上記のバイアル上面へのフランジ部の押圧により、上記の開口部が密封される。即ち、各部材の寸法公差に基づくバラツキがあっても、その寸法のバラツキがこの圧縮用凸部で緩和され、例えば１本あたり５０Ｎ以下の、好ましくは３０Ｎ程度の低い押圧力で打栓しても、バイアルの開口部が確実に密封される。 Since the above-mentioned compression convex portion is only a part of the entire flange portion, it is compressed by the upper wall with a lower pressing force than when the entire flange portion is pressed. When the compression convex portion is pressed, the lower flange portion is pressed against the upper surface around the opening of the vial via the compression convex portion. Since the compression convex portion is formed in an annular shape along the outer peripheral edge of the flange portion, the opening portion is sealed by pressing the flange portion against the upper surface of the vial. That is, even if there is a variation based on the dimensional tolerance of each member, the variation in the size is alleviated by this compression convex portion, and for example, it is plugged with a pressing force as low as 50 N or less, preferably about 30 N per piece. Also, the vial opening is securely sealed.
上記の圧縮用凸部は、平面視でフランジ部の外周縁と接する状態に形成してあるので、フランジ部上面で最も広い範囲に形成されている。このため、押圧力が良好に分散され、フランジ部が均一に押圧されるうえ、キャップの上壁を介して真空凍結乾燥装置の棚板等で押圧する場合に、シール部材の上面が水平状態に安定良く維持され、このシール部材が適正な姿勢でバイアルの開口部へ打栓される。 Since the compression convex portion is formed so as to be in contact with the outer peripheral edge of the flange portion in plan view, it is formed in the widest range on the upper surface of the flange portion. For this reason, when the pressing force is well dispersed, the flange portion is pressed uniformly, and when pressing with the shelf plate of the vacuum freeze-drying device through the upper wall of the cap, the upper surface of the seal member is in a horizontal state. It is maintained stably and this seal member is plugged into the opening of the vial in an appropriate posture.
またシール部材のフランジ部の周側面は、圧縮用凸部を形成した分、上下方向へ長く形成される。シール部材をバイアルの開口部に半打栓姿勢で装着すると、上記のフランジ部がバイアル上面から離隔した状態となっているが、この半打栓姿勢で、このシール部材の外側に上記のキャップを装着する際、キャップの筒部が、このフランジ部の上下に長い周側面で容易に案内される。これにより、キャップは半打栓姿勢のシール部材の周囲に、筒部の中心軸が垂直方向となった適正な姿勢で容易に装着される。 In addition, the peripheral side surface of the flange portion of the seal member is formed longer in the vertical direction as much as the compression convex portion is formed. When the seal member is attached to the opening of the vial in a half-plugging posture, the flange portion is separated from the top surface of the vial. In this half-plugging posture, the cap is placed outside the seal member. When mounting, the cylindrical portion of the cap is easily guided by the long peripheral side surface above and below the flange portion. As a result, the cap is easily mounted around the seal member in the half-plugging posture in an appropriate posture in which the central axis of the cylindrical portion is in the vertical direction.
上記の圧縮用凸部は、平面視でフランジ部の外周縁と接し、且つ、この外周縁に沿った環状に形成してあればよく、特定の寸法や形状のものに限定されないが、不連続の環状に形成すると、圧縮用凸部で囲まれた空間が不連続部で外部と連通するので、このシール部材を半打栓姿勢でバイアルに装着する場合や、それまでのハンドリングの際に、装着手段やハンドリング装置、その他の他物へ吸着することが防止されて好ましい。 The compression convex portion is not limited to a specific size or shape as long as it is in contact with the outer peripheral edge of the flange portion in plan view and formed in an annular shape along the outer peripheral edge. Since the space surrounded by the compression convex portion communicates with the outside at the discontinuous portion, when this seal member is attached to the vial in a half-plugging posture, or when handling up to that time, It is preferable that it is prevented from adsorbing to the mounting means, the handling device, and other objects.
上記の圧縮用凸部が不連続の環状に形成されている場合、即ち、上記のフランジ部の外周縁に沿って複数形成してある場合、例えば各圧縮用凸部は点状に形成されてもよいが、各圧縮用凸部が径方向内側に延びる形状であると、上壁により圧縮されることにより、その下方のフランジ部を広い範囲に亘ってバイアルの開口部の周囲の上面に押圧することができ、その開口部をより確実に密封できて好ましい。 When the above-mentioned compression convex portions are formed in a discontinuous annular shape, that is, when a plurality of compression convex portions are formed along the outer peripheral edge of the above flange portion, for example, each compression convex portion is formed in a dot shape. However, when each of the compression convex portions has a shape extending radially inward, it is compressed by the upper wall so that the lower flange portion is pressed against the upper surface around the opening of the vial over a wide range. This is preferable because the opening can be more reliably sealed.
上記のキャップは特定の形状や構造のものに限定されないが、このキャップの上壁の下面のうち、上記の開口部の内径よりも大きい環状部分であって、上記の圧縮用凸部の径方向内側に、下方へ突出した受止用突起部が形成してあると、上記の圧縮用凸部がこの受止用突起部に受け止められて、上記のフランジ部は縮径方向へずれ動くことが阻止される。この結果、シール部材の中央部に大気圧が加わっても周縁のフランジ部がずれ動いたり薄肉に変形したりすることを防止でき、シール不良の発生を低減して、気密保持性能を向上することができる。 The cap is not limited to a specific shape or structure, but the lower surface of the upper wall of the cap is an annular portion larger than the inner diameter of the opening, and the radial direction of the compression convex portion If a receiving protrusion protruding downward is formed on the inner side, the compression protrusion is received by the receiving protrusion, and the flange portion may be displaced in the reduced diameter direction. Be blocked. As a result, even if atmospheric pressure is applied to the central part of the seal member, it is possible to prevent the peripheral flange part from shifting or deforming into a thin wall, reducing the occurrence of seal failure, and improving the airtight holding performance. Can do.
しかもこの場合には、フランジ部が上記のキャップの上壁とバイアルの上面との間に確りと保持されるので、バイアルに収容された収容物を取り出すためシール部材の中央部へ注射針等を刺通する際、その注射針等の押圧力でシール部材がバイアル内へ押し込まれることを防止でき、また、注射針の先端が誤ってシール部材の脚部に突き刺さっても、脚部を介してフランジ部がバイアル内へ引き込まれることを防止できるので、シール部材にその注射針等を確実に刺通できる効果もある。 In this case, the flange portion is securely held between the upper wall of the cap and the upper surface of the vial. Therefore, an injection needle or the like is inserted into the central portion of the seal member to take out the contents contained in the vial. When piercing, the seal member can be prevented from being pushed into the vial by the pressing force of the injection needle, etc., and even if the tip of the injection needle is accidentally stuck into the leg of the seal member, Since the flange portion can be prevented from being pulled into the vial, there is also an effect that the injection needle and the like can be reliably pierced through the seal member.
なお、上記の受止用突起部は特定の形状や寸法に限定されないが、平面視で上記の開口部を取り囲む環状に形成してあると、開口部周囲の全周に亘って上記の圧縮用凸部を効果的に受け止めることができて好ましい。この場合、上記の開口部を取り囲む環状は、周方向に不連続であってもよいが、周方向に連続した環状であると、フランジ部が縮径方向へずれ動くことを一層良好に阻止できて、さらに好ましい。 The receiving protrusion is not limited to a specific shape or size. However, if the receiving protrusion is formed in an annular shape surrounding the opening in a plan view, the above-described receiving protrusion is compressed over the entire periphery of the opening. The convex portion can be received effectively, which is preferable. In this case, the annular shape surrounding the opening may be discontinuous in the circumferential direction, but if the annular shape is continuous in the circumferential direction, the flange portion can be further prevented from shifting in the reduced diameter direction. And more preferable.
上記の圧縮用凸部の高さは、特定の寸法に限定されないが、上記のこの圧縮用凸部が形成されていない部位でのフランジ部の厚さの１０〜６０％の寸法であると、各部材の寸法公差による寸法のバラツキを良好に緩和することができ、低い押圧力で開口部をシール部材で確実に密封できるので好ましく、フランジ部の厚さの２０〜５０％の寸法であるとさらに好ましい。 The height of the compression convex portion is not limited to a specific size, but when the height is 10 to 60% of the thickness of the flange portion at the portion where the compression convex portion is not formed, The variation in dimensions due to the dimensional tolerance of each member can be eased satisfactorily, and the opening can be reliably sealed with a seal member with a low pressing force, which is preferable, and the dimension is 20 to 50% of the thickness of the flange portion. Further preferred.
上記のシール部材は特定の材質のものに限定されず、例えば合成ゴム材料や熱可塑性エラストマーを主原料とすると、優れたシール性能のシール部材を安定した品質で製造することができて、好ましい。 The sealing member is not limited to a specific material. For example, a synthetic rubber material or a thermoplastic elastomer is preferably used as a main raw material because a sealing member having excellent sealing performance can be manufactured with stable quality.
なお、上記のバイアル内に収容される収容物は特定のものに限定されず、例えば粉末製剤や液剤等であってもよいが、特に凍結乾燥製剤であると、真空凍結乾燥装置内でバイアル用栓体を半打栓姿勢から全打栓姿勢へ容易に切換えできるので、好ましい。 The contents contained in the vial are not limited to specific ones, and may be, for example, powder preparations or liquid preparations. In particular, in the case of a freeze-dried preparation, It is preferable because the stopper can be easily switched from the half-plugging position to the full-plugging position.
本発明のバイアル用栓体とこれに用いるシール部材は、上記のように構成され作用するので次の効果を奏する。 The vial stopper of the present invention and the seal member used therefor have the following effects because they are configured and act as described above.
(１)上記の圧縮用凸部は低い押圧力で圧縮でき、これにより、その下方のフランジ部をバイアルの開口部の周囲の上面に押圧できるので、フランジ部上面の周縁部に圧縮用凸部を設けるだけの簡単な構造で、上記の開口部を確実に密封でき、例えば１本あたり５０Ｎ以下の低い押圧力で確実に打栓できるうえ、各部材の寸法公差に基づくバラツキがあっても、シール不良を低減して気密保持性能を向上することができる。 (1) The above-mentioned compression convex portion can be compressed with a low pressing force, so that the lower flange portion can be pressed against the upper surface around the opening of the vial. The above-mentioned opening can be reliably sealed with a simple structure, for example, can be plugged reliably with a low pressing force of 50 N or less per piece, and even if there is variation due to dimensional tolerance of each member, The sealing failure can be reduced and the airtight holding performance can be improved.
(２)圧縮用凸部は、平面視でフランジ部の外周縁と接する状態に形成してあるので、真空凍結乾燥装置の棚板等で打栓する際に、キャップの上壁による押圧力を広い面積で受けることができ、この押圧力を良好に分散して、フランジ部を均一に押圧できる。しかも押圧力を広い面積で受けるので、シール部材の上面を水平状態に容易に維持でき、このシール部材を適正な姿勢でバイアルの開口部へ打栓することができる。 (2) Since the compression convex portion is formed so as to be in contact with the outer peripheral edge of the flange portion in a plan view, when pressing with a shelf board of a vacuum freeze-drying device, the pressing force by the upper wall of the cap is applied. It can be received over a wide area, and this pressing force can be well dispersed to uniformly press the flange portion. Moreover, since the pressing force is received over a wide area, the upper surface of the seal member can be easily maintained in a horizontal state, and the seal member can be plugged into the opening of the vial in an appropriate posture.
(３)圧縮用凸部を形成した部位では、シール部材のフランジ部の周側面は上下方向へ長く形成されることから、半打栓姿勢のシール部材の外側にキャップを装着する際、キャップの筒部をこのフランジ部の上下に長い周側面で容易に案内することができ、キャップを適正な姿勢で装着することができる。 (3) Since the peripheral side surface of the flange portion of the seal member is formed long in the vertical direction at the site where the convex portion for compression is formed, when the cap is attached to the outside of the seal member in the half-plugging posture, The cylindrical portion can be easily guided on the upper and lower sides of the flange portion with long peripheral side surfaces, and the cap can be mounted in an appropriate posture.
以下、本発明の実施の形態を図面に基づき説明する。
図１から図８は本発明の実施形態を示し、図１はバイアル用栓体(１)が半打栓姿勢(Ｙ)で装着されたバイアル(２)の縦断面図である。このバイアル(２)は、有底筒状の胴部(３)を備え、その胴部(３)内に収容部(４)が形成してある。医薬品などの収容物はこの収容部(４)内に収容される。上記の胴部(３)の上方には首部(５)が延設してあり、この首部(５)の上端に開口部(６)が形成してある。この開口部(６)の周囲には、径方向外側へ膨出した鍔部(７)が形成してある。
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
1 to 8 show an embodiment of the present invention, and FIG. 1 is a longitudinal sectional view of a vial (2) in which a vial stopper (1) is mounted in a half-plugging posture (Y). The vial (2) is provided with a bottomed cylindrical body (3), and a housing part (4) is formed in the body (3). Containers such as medicines are stored in the storage section (4). A neck portion (5) extends above the trunk portion (3), and an opening (6) is formed at the upper end of the neck portion (5). Around the opening (6), a flange (7) bulging outward in the radial direction is formed.
上記のバイアル用栓体(１)は、上記の開口部(６)を覆う状態に装着される、例えばブチルゴム製などのゴム弾性を備えた合成ゴム製シール部材(８)と、このシール部材(８)へ被せた状態に装着される合成樹脂製キャップ(９)とを有する。 The vial stopper (1) is mounted so as to cover the opening (6), and a synthetic rubber sealing member (8) having rubber elasticity such as butyl rubber, and the sealing member ( 8) and a synthetic resin cap (9) to be mounted on the cover.
上記のシール部材(８)は、上記の鍔部(７)の上面に載置される円板状のフランジ部(10)と、そのフランジ部(10)の下面中央部から垂下した円筒状の脚部(11)とを備える。この脚部(11)には、下端から上下方向の中間部まで切欠部(12)が形成してある。この切欠部(12)の上端は、図１に示す半打栓姿勢(Ｙ)では上記の開口部(６)よりも上方に位置しており、上記の収容部(４)内はこの開口部(６)と切欠部(12)との間を介して外部空間に連通している。この脚部(11)の外径は上記の開口部(６)の内径よりも僅かに大径であり、やや圧縮されてその開口部(６)に挿入される。 The sealing member (8) includes a disc-shaped flange portion (10) placed on the upper surface of the flange portion (7), and a cylindrical shape that hangs down from the center of the lower surface of the flange portion (10). And a leg (11). The leg (11) is formed with a notch (12) from the lower end to the middle in the vertical direction. The upper end of the notch (12) is located above the opening (6) in the half-plugging position (Y) shown in FIG. 1, and the inside of the housing (4) is the opening. It communicates with the external space through the space between (6) and the notch (12). The outer diameter of the leg (11) is slightly larger than the inner diameter of the opening (6), and is slightly compressed and inserted into the opening (6).
上記のキャップ(９)は、キャップ本体(13)とその上方に固定した蓋部(14)とを備える。このキャップ本体(13)は、上記のフランジ部(10)の上方に配置した上壁(15)とその外周縁部から垂下した筒部(16)と、この筒部(16)の内面に装着した環状の係止部材(17)とを備えている。この係止部材(17)の上端には係止部(18)が形成してあり、また、上記の上壁(15)の中央部には通針用窓部(19)が開口してある。上記の蓋部(14)の下面中央部には、円筒状の封止部(20)が上記の通針用窓部(19)へ挿通する状態に垂下してある。 The cap (9) includes a cap body (13) and a lid (14) fixed above the cap body (13). The cap body (13) is attached to the upper wall (15) disposed above the flange portion (10), the cylindrical portion (16) suspended from the outer peripheral edge thereof, and the inner surface of the cylindrical portion (16). And an annular locking member (17). A locking portion (18) is formed at the upper end of the locking member (17), and a needle passing window portion (19) is opened at the center of the upper wall (15). . A cylindrical sealing portion (20) hangs down from the center of the lower surface of the lid portion (14) so as to be inserted into the needle passing window portion (19).
上記のバイアル用栓体(１)は、バイアル(２)内の収容物が真空凍結乾燥されたのち、上方から押圧され、図２に示す全打栓姿勢(Ｘ)に切り換わる。この全打栓姿勢(Ｘ)では、キャップ(９)の上壁(15)により、シール部材(８)のフランジ部(10)がバイアル(２)の開口部(６)の周囲の上面に確りと押圧され、これにより上記の開口部(６)が密封される。このとき、上記の係止部(18)がバイアル(２)の上記の鍔部(７)の下面へ係止されるので、上記のキャップ(９)が全打栓姿勢(Ｘ)に保持される。また上記の封止部(20)の下端は、上記のシール部材(８)の上面へ食い込み、これによりこのシール部材(８)の上面中央部が外部空間から気密状に遮断される。 The vial stopper (1) is pressed from above after the contents in the vial (2) are freeze-dried and switched to the full stoppering posture (X) shown in FIG. In this all-plugging posture (X), the upper wall (15) of the cap (9) ensures that the flange portion (10) of the seal member (8) is firmly positioned on the upper surface around the opening (6) of the vial (2). And the opening (6) is sealed. At this time, since the locking portion (18) is locked to the lower surface of the flange (7) of the vial (2), the cap (9) is held in the full stoppering posture (X). The Further, the lower end of the sealing part (20) bites into the upper surface of the sealing member (8), whereby the central part of the upper surface of the sealing member (8) is shut off from the external space in an airtight manner.
図３と図４に示すように、上記のキャップ本体(13)の上面には、２か所に射出成型用ゲートのための凹部(21)が形成してあり、また、上記の通針用窓部(19)を取り囲む状態に、環状の凹溝(22)が形成してある。一方、上記の蓋部(14)の下面には４か所に接合突起(23)が突設してあり、この接合突起(23)の先端を上記の凹溝(22)の内面に溶着することで、この蓋部(14)をキャップ本体(13)の上面に固定してある。 As shown in FIGS. 3 and 4, the upper surface of the cap body (13) has recesses (21) for injection molding gates formed at two locations. An annular groove (22) is formed so as to surround the window (19). On the other hand, there are four projections (23) on the lower surface of the lid (14), and the tip of the junction projection (23) is welded to the inner surface of the concave groove (22). Thus, the lid (14) is fixed to the upper surface of the cap body (13).
図４に示すように、上記の係止部材(17)は、上記の筒部(16)の内周面に形成された嵌合突条(24)に嵌着してある。この係止部材(17)には、上記の係止部(18)が複数、所定間隔をあけて、縮径方向の斜め上方に向けて突設してある。各係止部(18)は基部にヒンジ(25)が形成してあり、上端を拡径方向へ偏移可能に構成してある。上記の係止部材(17)の内周面には、各係止部(18)間に通気溝(26)が形成してある。図１に示す上記の半打栓姿勢(Ｙ)では、上記の開口部(６)と切欠部(12)との間と、上記の通気溝(26)とを順に介して、上記の収容部(４)内が外部空間に連通している。 As shown in FIG. 4, the locking member (17) is fitted to a fitting protrusion (24) formed on the inner peripheral surface of the cylindrical portion (16). The locking member (17) is provided with a plurality of the locking portions (18) protruding obliquely upward in the diameter reducing direction at a predetermined interval. Each locking portion (18) has a hinge (25) formed at the base, and is configured such that the upper end can be shifted in the diameter increasing direction. On the inner peripheral surface of the locking member (17), a ventilation groove (26) is formed between the locking portions (18). In the half-plugging posture (Y) shown in FIG. 1, the accommodating portion is interposed between the opening (6) and the notch (12) and the ventilation groove (26) in this order. (4) The inside communicates with the external space.
図２や図４に示すように、上記のキャップ本体(13)の上壁(15)下面には、上記の開口部(６)の内径よりも大きく、且つ上記のシール部材(８)のフランジ部(10)の外径よりも小さい環状部分に、下方へ突出した受止用突起部(27)が形成してある。この受止用突起部(27)は、平面視で上記の開口部(６)を取り囲む、連続した環状に形成してある。この受止用突起部(27)の、開口部(６)の中心軸(28)を通過する垂直方向の断面形状は、図５に示すように、下端が９０度以下に、例えば４５度となるように形成してある。またこの断面形状は、径方向外側の表面が上記の中心軸(28)と平行な垂直に形成してある。この受止用突起部(27)の高さ(Ｌ)は、例えば０.５ｍｍに設定してある。 As shown in FIG. 2 and FIG. 4, the lower surface of the upper wall (15) of the cap body (13) is larger than the inner diameter of the opening (6) and the flange of the seal member (8). A receiving projection (27) projecting downward is formed in an annular portion smaller than the outer diameter of the portion (10). The receiving projection (27) is formed in a continuous annular shape surrounding the opening (6) in plan view. As shown in FIG. 5, the vertical sectional shape of the receiving projection (27) passing through the central axis (28) of the opening (6) is 90 degrees or less, for example, 45 degrees. It is formed so that This cross-sectional shape is formed such that the radially outer surface is perpendicular to the central axis (28). The height (L) of the receiving projection (27) is set to 0.5 mm, for example.
一方、上記のシール部材(８)は、図６から図８に示すように、上記のフランジ部(10)の上面に、平面視でそのフランジ部(10)の外周縁と接し、且つこの外周縁に沿った環状に、圧縮用凸部(29)が形成してある。この圧縮用凸部(29)は、平面視でフランジ部(10)の外周縁と接する状態に形成してあるので、例えば図７や図８に示すように、フランジ部(10)の周側面は上下方向に長い。この結果、図１に示す半打栓姿勢(Ｙ)でキャップ(９)をシール部材(８)の外側に装着する際、キャップ(９)の筒部(16)がこのフランジ部(10)の上下に長い周側面で案内され、筒部(16)の中心軸が垂直方向となった適正な姿勢でキャップ(９)が装着される。 On the other hand, the sealing member (8) is in contact with the outer peripheral edge of the flange portion (10) in plan view on the upper surface of the flange portion (10) as shown in FIGS. A compression convex portion (29) is formed in an annular shape along the periphery. Since this compression convex part (29) is formed in the state which contact | connects the outer periphery of the flange part (10) by planar view, as shown, for example in FIG.7 and FIG.8, the surrounding side surface of a flange part (10) Is long in the vertical direction. As a result, when the cap (9) is mounted on the outside of the seal member (8) in the half-plugging posture (Y) shown in FIG. 1, the cylindrical portion (16) of the cap (9) is attached to the flange portion (10). The cap (9) is mounted in an appropriate posture guided by a long peripheral side surface in the vertical direction and the central axis of the cylindrical portion (16) being in the vertical direction.
上記の圧縮用凸部(29)には、周方向の４か所に不連続部(30)が形成してあり、圧縮用凸部(29)で囲まれた空間がこの不連続部(30)を介して外部と連通している。このため、このシール部材(８)を半打栓姿勢(Ｙ)でバイアル(２)に装着する場合や、それまでのハンドリングや洗浄、滅菌等の処理の際に、装着手段やハンドリング装置、各種処理装置、或いはその他の他物へ、このシール部材(８)が吸着されることを効果的に防止できる。なお、上記のフランジ部(10)の上面には、中央部分に刺通用凹部(31)が凹設してある。また上記の実施形態では、上記の不連続部(30)を圧縮用凸部(29)の周方向の４か所に形成した。しかし本発明ではこの不連続部を、周方向の３か所以下に形成してもよく、或いは５か所以上に形成してもよい。 In the compression convex portion (29), discontinuous portions (30) are formed at four locations in the circumferential direction, and a space surrounded by the compression convex portion (29) is defined as the discontinuous portion (30). ) To communicate with outside. For this reason, when this seal member (8) is attached to the vial (2) in the half-plugging posture (Y), or during the handling, washing, sterilization, etc., the attachment means, handling device, This seal member (8) can be effectively prevented from being adsorbed to the processing device or other objects. A piercing recess (31) is provided in the center of the upper surface of the flange (10). In the above embodiment, the discontinuous portion (30) is formed at four locations in the circumferential direction of the compression convex portion (29). However, in the present invention, the discontinuous portions may be formed at three or less locations in the circumferential direction, or may be formed at five or more locations.
図１に示すように、上記の受止用突起部(27)はこの圧縮用凸部(29)の径方向内側に形成してあり、シール部材(８)が径方向内側へずれ動こうとしたり、変形したりしようとすると、上記の受止用突起部(27)で上記の圧縮用凸部(29)を受け止めるようにしてある。この圧縮用凸部(29)の高さ(ｈ)は、例えば０.８ｍｍに設定してあり、上記の圧縮用凸部(29)が形成されていない部位でのフランジ部(10)の厚さ(ｔ)が、例えば３.５ｍｍであると、このフランジ部(10)の厚さ(ｔ)の約２３％の寸法に設定されている。 As shown in FIG. 1, the receiving projection (27) is formed radially inside the compression projection (29), and the seal member (8) tries to move radially inward. Or the deformation projection (27) receives the compression projection (29). The height (h) of the compression convex portion (29) is set to, for example, 0.8 mm, and the thickness of the flange portion (10) at the portion where the compression convex portion (29) is not formed. When the thickness (t) is, for example, 3.5 mm, the dimension is set to about 23% of the thickness (t) of the flange portion (10).
図１に示す半打栓姿勢(Ｙ)で上記のバイアル用栓体(１)を装着したバイアル(２)は、図示しない真空凍結乾燥装置内に収容され、減圧下で凍結乾燥されたのち、棚板で上方から押圧されて、バイアル用栓体(１)が図２に示す全打栓姿勢(Ｘ)に切り換わる。このとき、上記のシール部材(８)は、キャップ本体(13)の上壁(15)により、最初に上記の圧縮用凸部(29)が押圧されて圧縮され、この圧縮用凸部(29)が偏平化されたのち、その他の部位のフランジ部(10)が押圧され圧縮される。このとき、上記の受止用突起部(27)は、図２に示すように、上記のフランジ部(10)の上面に食い込んだ状態となっており、従って、フランジ部(10)は縮径方向へずれ動くことが阻止され、上記のキャップ(９)の上壁(15)とバイアル(２)の上面との間に確りと保持される。 The vial (2) equipped with the above-described vial stopper (1) in the half-plugging posture (Y) shown in FIG. 1 is accommodated in a vacuum freeze-drying apparatus (not shown) and lyophilized under reduced pressure. The vial stopper (1) is switched to the full stoppering posture (X) shown in FIG. 2 by being pressed from above by the shelf. At this time, the sealing member (8) is compressed by first pressing the compression projection (29) by the upper wall (15) of the cap body (13). ) Is flattened, and the flange portion (10) of the other part is pressed and compressed. At this time, as shown in FIG. 2, the receiving protrusion (27) is in a state of being bitten into the upper surface of the flange (10). Therefore, the flange (10) has a reduced diameter. It is prevented from moving in the direction and is securely held between the upper wall (15) of the cap (9) and the upper surface of the vial (2).
上記の圧縮用凸部(29)はフランジ部(10)全体の一部に過ぎないので、低い押圧力で容易に圧縮され、この圧縮用凸部(29)を介してその下方のフランジ部(10)がバイアル(２)の開口部(６)の周囲の上面に押圧される。この圧縮用凸部(29)はフランジ部(10)の外周縁に沿った環状に形成されているので、上記のバイアル(２)上面へのフランジ部(10)の押圧により、上記の開口部(６)が外部空間に対し密封される。またこの圧縮用凸部(29)は、各部材の寸法公差に基づくバラツキがあっても、そのバラツキが充分に緩和できる高さに設定してあり、例えば１本あたり３０Ｎ程度の低い押圧力で打栓しても、バイアル(２)の開口部(６)が確実に密封される。 The compression convex portion (29) is only a part of the entire flange portion (10), so it is easily compressed with a low pressing force, and the lower flange portion ( 10) is pressed against the upper surface around the opening (6) of the vial (2). Since the convex portion for compression (29) is formed in an annular shape along the outer peripheral edge of the flange portion (10), the opening portion is formed by pressing the flange portion (10) against the upper surface of the vial (2). (6) is sealed against the external space. Further, even if there is a variation based on the dimensional tolerance of each member, the compression convex portion (29) is set to a height that can sufficiently reduce the variation, for example, with a low pressing force of about 30 N per piece. Even if it is stoppered, the opening (6) of the vial (2) is securely sealed.
上記の圧縮用凸部(29)は、平面視でフランジ部(10)の外周縁と接する状態に形成してあり、フランジ部(10)上面で最も広い範囲に形成されていることから、上記のキャップ(９)による押圧力が良好に分散され、フランジ部(10)が均一に押圧される。しかも、キャップ(９)の上壁(15)で押圧される際、シール部材(８)の上面が水平状態に安定良く維持され、このシール部材(８)が適正な姿勢でバイアル(２)の開口部(６)へ打栓される。 The compression convex portion (29) is formed in a state in contact with the outer peripheral edge of the flange portion (10) in a plan view, and is formed in the widest range on the upper surface of the flange portion (10). The pressing force by the cap (9) is well dispersed, and the flange portion (10) is pressed uniformly. Moreover, when pressed by the upper wall (15) of the cap (9), the upper surface of the seal member (8) is stably maintained in a horizontal state, and the seal member (8) is placed in an appropriate posture in the vial (2). It is plugged into the opening (6).
上記のバイアル用栓体(１)で密封されたバイアル(２)からは、用時に次の手順で収容物が取り出される。
最初に、上記のキャップ(９)の蓋部(14)が、上記の接合突起(23)の破断によりキャップ本体(13)から取り外され、シール部材(８)の刺通用凹部(31)が上記の通針用窓部(19)から外方に露出される。次いで、この刺通用凹部(31)に注射針が刺通され、溶解液等がバイアル(２)の収容部(４)内へ注入されて収容物が液状にされたのち、注射針を介してその収容物が取り出される。
From the vial (2) sealed with the above-described vial stopper (1), the contents are taken out by the following procedure at the time of use.
First, the lid portion (14) of the cap (9) is removed from the cap body (13) due to the breaking of the joining projection (23), and the piercing recess (31) of the seal member (8) is It is exposed to the outside through the needle passage window (19). Next, the injection needle is pierced into the piercing recess (31), and a solution or the like is injected into the container (4) of the vial (2) to make the container liquid. The contents are removed.
このとき、上記の受止用突起部(27)がシール部材(８)のフランジ部(10)の上面に食い込んでおり、また、上記の圧縮用凸部(29)がこの受止用突起部(27)に受け止められているので、上記のフランジ部(10)が縮径方向へずれ動くことがない。この結果、上記の注射針を上記の刺通用凹部(31)へ刺通する際に、シール部材(８)が開口部(６)からバイアル(２)内へ押し込まれることが防止され、また、注射針の先端が誤ってシール部材の脚部に突き刺さっても、脚部を介してフランジ部がバイアル内へ引き込まれることが防止されるので、このシール部材(８)に上記の注射針を確実に刺通することができる。 At this time, the receiving projection (27) bites into the upper surface of the flange (10) of the seal member (8), and the compression projection (29) is the receiving projection. Since it is received by (27), the flange portion (10) does not move in the direction of diameter reduction. As a result, it is possible to prevent the seal member (8) from being pushed into the vial (2) from the opening (6) when the needle is pierced into the piercing recess (31), and Even if the tip of the injection needle is accidentally pierced into the leg portion of the seal member, the flange portion is prevented from being pulled into the vial through the leg portion, so that the above-described injection needle is securely attached to the seal member (8). Can be pierced.
上記の実施形態では、上記の受止用突起部(27)の断面形状は、径方向外側の表面が上記の開口部(６)の中心軸(28)と平行な垂直方向に形成してある。しかし、本発明の受止用突起部の断面は特定の形状に限定されない。
例えば図９に示す変形例１では、受止用突起部(27)の、開口部の中心軸を通過する垂直方向の断面形状は、下端の角度を約６０度に設定してある。また、径方向外側の表面と、上記の下端から上方に延びる垂直線との間に形成される挟角(α)が、例えば３０度など、４５度以下に設定してある。
In the embodiment described above, the cross-sectional shape of the receiving projection (27) is such that the radially outer surface is formed in a vertical direction parallel to the central axis (28) of the opening (6). . However, the cross section of the receiving projection of the present invention is not limited to a specific shape.
For example, in the first modification shown in FIG. 9, the angle of the lower end of the cross-sectional shape in the vertical direction passing through the central axis of the opening of the receiving projection (27) is set to about 60 degrees. The included angle (α) formed between the radially outer surface and the vertical line extending upward from the lower end is set to 45 degrees or less, for example, 30 degrees.
図１０は本発明の実施形態の変形例２を示し、上記の係止部材(17)の内周面のうち、上記の係止部(18)間の通気溝(26)に、姿勢安定用リブ(32)が上下方向に形成してある。この姿勢安定用リブ(32)の内端を結ぶ仮想円の直径は、上記のバイアル(２)の鍔部(７)の外径と略同径であるか、僅かに小径に設定してある。このため、この係止部材(17)を備えたキャップ(９)を上記のバイアル(２)に装着すると、筒部(16)の中心軸がバイアル(２)の開口部(６)の中心軸(28)と一致した、適正な半打栓姿勢(Ｙ)でバイアル(２)に装着される。 FIG. 10 shows a second modified example of the embodiment of the present invention. In the inner peripheral surface of the locking member (17), a ventilation groove (26) between the locking portions (18) is provided for posture stabilization. Ribs (32) are formed in the vertical direction. The diameter of the imaginary circle connecting the inner ends of the posture stabilizing ribs (32) is substantially the same as or slightly smaller than the outer diameter of the collar (7) of the vial (2). . For this reason, when the cap (9) provided with the locking member (17) is attached to the vial (2), the central axis of the cylinder (16) is the central axis of the opening (6) of the vial (2). Installed in vial (2) with proper half-plugging posture (Y) consistent with (28).
上記のシール部材(８)に形成した圧縮用凸部(29)は、例えば図１１から図１４に示す変形例のように、必要に応じて様々な形状に形成することができる。
即ち図１１に示す変形例３では、圧縮用凸部(29)を切れ目のない連続した環状に形成してある。なお、この圧縮用凸部(29)の複数個所には、他の部位よりも低い低位部(33)が形成してあり、圧縮用凸部(29)で囲まれた空間がこの低位部(33)の上方を介して、外部と連通できるように構成し、このシール部材(８)が他物へ吸着されることを防止してある。
The compression projections (29) formed on the seal member (8) can be formed in various shapes as necessary, as in the modifications shown in FIGS. 11 to 14, for example.
That is, in the third modification shown in FIG. 11, the compression convex portion (29) is formed in a continuous annular shape without a break. In addition, a plurality of lower portions (33) lower than the other portions are formed at a plurality of locations of the compression convex portion (29), and the space surrounded by the compression convex portions (29) is the lower portion ( The seal member (8) is prevented from being adsorbed to other objects so that it can communicate with the outside via the upper part of 33).
図１２に示す変形例４では、上記の変形例３と同様、圧縮用凸部(29)を切れ目のない連続した環状に形成してあるが、変形例３の低位部(33)に代えて、他物への付着を防止するための付着防止用凸部(34)が、圧縮用凸部(29)の上面に形成してある。圧縮用凸部(29)で囲まれた空間は、この付着防止用凸部(34)の周囲の空間を介して、外部と連通することができる。 In the fourth modification shown in FIG. 12, the compression convex portion (29) is formed in a continuous annular shape without any break as in the third modification, but instead of the lower portion (33) in the third modification. Further, an adhesion preventing projection (34) for preventing adhesion to other objects is formed on the upper surface of the compression projection (29). The space surrounded by the compression convex portion (29) can communicate with the outside through the space around the adhesion prevention convex portion (34).
図１３に示す変形例５では、圧縮用凸部(29)を平面視で環状に並べた点状に形成してあり、この圧縮用凸部(29)よりも低い環状部(35)で、この圧縮用凸部(29)を互いに連結してある。 In the modified example 5 shown in FIG. 13, the convex portions for compression (29) are formed in the shape of dots arranged in an annular shape in plan view, and the annular portion (35) lower than the convex portions for compression (29) The compression convex portions (29) are connected to each other.
図１４に示す変形例６では、圧縮用凸部(29)をフランジ部(10)の外周縁に沿って複数形成してあり、各圧縮用凸部(29)は平面視で径方向内側に延びる長円状に形成してある。この変形例６の場合は、キャップの上壁で圧縮されると、その下方のフランジ部(10)が広い範囲に亘ってバイアルの上面に押圧される。 In the sixth modification shown in FIG. 14, a plurality of compression projections (29) are formed along the outer peripheral edge of the flange portion (10), and each compression projection (29) is radially inward in plan view. It is formed in an elongated oval shape. In the case of this modified example 6, when compressed by the upper wall of the cap, the lower flange portion (10) is pressed against the upper surface of the vial over a wide range.
上記の実施形態や変形例で説明したバイアル用栓体は、本発明の技術的思想を具体化するために例示したものであり、各部の形状や寸法、材質などを、この実施形態や変形例のものに限定するものではなく、本発明の特許請求の範囲内において種々の変更を加え得るものである。 The vial stoppers described in the above embodiments and modifications are illustrated to embody the technical idea of the present invention, and the shape, dimensions, materials, and the like of each part are described in this embodiment and modifications. The present invention is not limited to those described above, and various modifications can be made within the scope of the claims of the present invention.
例えば上記の実施形態や変形例では、キャップの上壁の下面に受止用突起部を形成したが、本発明ではこの受止用突起部を省略してもよい。 For example, in the above-described embodiment or modification, the receiving protrusion is formed on the lower surface of the upper wall of the cap. However, in the present invention, the receiving protrusion may be omitted.
また、上記の実施形態では、上記の係止部を筒部とは別体の係止部材に形成した。しかし本発明ではこの係止部を、上記の筒部に一体に形成したものであってもよい。さらにこの筒部には、バイアルの収容部内を外部空間に連通する通気孔やスリットを形成したものであってもよい。 In the above embodiment, the locking portion is formed on a locking member that is separate from the cylindrical portion. However, in the present invention, the locking portion may be formed integrally with the cylindrical portion. Further, the cylindrical portion may be formed with a vent hole or a slit that communicates the inside of the vial housing portion with the external space.
上記の実施形態では、上記のキャップ本体の上壁に設けた針通用窓部を上記の蓋部で蓋し、接合突起を破断することでこの蓋部を取り外すように構成したので、開封済みのバイアルと未開封のバイアルとを容易に峻別することができる。しかし本発明ではこの針通用窓部を、例えば再シール不能な封止用フィルムなどで覆い、上記の蓋部を省略することも可能である。 In the above embodiment, the needle passing window provided on the upper wall of the cap body is covered with the lid, and the lid is removed by breaking the joint protrusion. Vials and unopened vials can be easily distinguished. However, in the present invention, it is also possible to cover the needle passing window with a sealing film that cannot be resealed, and to omit the lid.
また上記の実施形態では、例えばブチルゴムなどの合成ゴム材料を用いた。しかし本発明では他の合成ゴムや熱可塑性エラストマーなどを主原料とする材料で形成したものであってもよい。
さらに上記の実施形態では、収容物を真空凍結乾燥する場合について説明した。しかし本発明を用いるバイアルには、粉末製剤や液剤など、他の収容物を、真空凍結乾燥することなく収容するものであってもよい。
また上記のバイアル内は、真空状態や減圧状態以外に陽圧状態であってもよく、窒素ガスなど、収容物に対し不活性なガスを充填したものであってもよい。
上記の受止用突起部や圧縮用凸部の断面形状や寸法等は、上記の実施形態のものに限定されないことは、いうまでもない。
In the above embodiment, a synthetic rubber material such as butyl rubber is used. However, in this invention, you may form with the material which uses other synthetic rubbers, thermoplastic elastomers, etc. as a main raw material.
Furthermore, in the above embodiment, the case where the contents are freeze-dried by vacuum has been described. However, the vial using the present invention may contain other items such as powder preparations and liquids without vacuum lyophilization.
Further, the inside of the vial may be in a positive pressure state other than a vacuum state or a reduced pressure state, and may be filled with an inert gas such as nitrogen gas with respect to the contents.
Needless to say, the cross-sectional shape, dimensions, and the like of the above-described receiving projections and compression projections are not limited to those of the above-described embodiment.
本発明のバイアル用栓体とこれに用いるシール部材は、簡単な構造でありながら、バイアルの全高やシール部材のフランジ部の厚さ等に寸法公差があっても、バイアルの開口部をシール部材で確実に密封できるので、真空凍結乾燥製剤を収容したバイアルを密封する栓体として特に好適であるが、他の収容物を収容したバイアルにも好適である。 The vial stopper of the present invention and the seal member used therefor have a simple structure, but even if there are dimensional tolerances in the overall height of the vial, the thickness of the flange of the seal member, etc., the opening of the vial is sealed. Therefore, it is particularly suitable as a stopper for sealing a vial containing a vacuum freeze-dried preparation, but is also suitable for a vial containing other contents.
１…バイアル用栓体
２…バイアル
６…開口部
７…鍔部
８…シール部材
９…キャップ
10…フランジ部
11…脚部
15…上壁
16…筒部
18…係止部
27…受止用突起部
29…圧縮用凸部
ｈ…圧縮用凸部(29)の高さ
ｔ…フランジ部(10)の厚さ
DESCRIPTION OF
10… Flange part
11 ... Leg
15… Upper wall
16 ... Cylinder part
18 ... Locking part
27 ... Reception protrusion
29: Convex part for compression h: Height of convex part for compression (29) t: Thickness of flange part (10)
Claims (7)
上記の開口部(６)の周囲に鍔部(７)が形成してあり、
上記の開口部(６)を覆う状態に装着されるゴム弾性を備えたシール部材(８)と、このシール部材(８)を上記の鍔部(７)の上面へ押圧して固定する合成樹脂製キャップ(９)とを有し、
上記のシール部材（８）は上記の鍔部(７)の上面に載置される円板状のフランジ部(10)を有し、
上記のキャップ(９)は、上記のフランジ部(10)の上方に配置した上壁(15)と、この上壁(15)の外周縁部から垂下した筒部(16)と、この筒部(16)の内方に配置され上記の鍔部(７)の下面へ係止可能な係止部(18)とを備え、
上記フランジ部(10)の上面に、平面視で上記フランジ部(10)の外周縁と接し、且つ、この外周縁に沿って連続した若しくは不連続の環状に、圧縮用凸部(29)を形成したバイアル用栓体において、
上記の筒部(16)の内面に環状の係止部材(17)が装着され、当該係止部材(17)には所定間隔をあけて複数の係止部(18)が斜め上方に向けて突設されるとともに各係止部(18)の間には通気溝(26)が形成され、上記フランジ部(10)の下面中央部には円筒状の脚部(11)が垂下され、当該脚部(11)の下端から上下方向の中間部には切欠部(12)が形成され、半打栓姿勢（Ｙ）では、上記開口部(６)と切欠部(12)との間と、上記通気溝(26)とを介してバイアル(２)の胴部（３）内の収容部（４）が外部空間に連通しており、上記係止部材(17)の上下方向に姿勢安定用リブ(32)が形成され、当該姿勢安定用リブ(32)の内端を結ぶ仮想円の直径は鍔部(７)の外径と略同径であるか、僅かに小径であることを特徴とする、バイアル用栓体。 A vial stopper for sealing the opening (6) opened at the upper end of the vial (2),
A collar (7) is formed around the opening (6),
A rubber-sealed seal member (8) mounted in a state of covering the opening (6), and a synthetic resin that presses and fixes the seal member (8) to the upper surface of the flange (7) A cap (9) ,
Said sealing member (8) has a disk-shaped flange portion which is mounted on the upper surface of the flange portion (7) to (10),
The cap (9) includes an upper wall (15) disposed above the flange portion (10), a cylindrical portion (16) suspended from the outer peripheral edge of the upper wall (15), and the cylindrical portion. A locking portion (18) that is disposed inward of (16) and can be locked to the lower surface of the collar portion (7) ,
The upper surface of the flange portion (10) in contact with the outer peripheral edge of the flange portion (10) in plan view, and, in a continuous or discontinuous annular along the outer circumferential edge, the compression projection (29) In the formed vial stopper,
An annular locking member (17) is mounted on the inner surface of the cylindrical portion (16), and the locking member (17) has a plurality of locking portions (18) obliquely upward at predetermined intervals. A ventilation groove (26) is formed between the locking portions (18) and protruded, and a cylindrical leg (11) is suspended from the center of the lower surface of the flange portion (10). A notch (12) is formed in the middle part in the vertical direction from the lower end of the leg (11), and in the half-plugging position (Y), between the opening (6) and the notch (12), The container (4) in the body (3) of the vial (2) communicates with the external space via the ventilation groove (26), and is used for posture stabilization in the vertical direction of the locking member (17). A rib (32) is formed, and the diameter of a virtual circle connecting the inner ends of the posture stabilizing rib (32) is substantially the same as or slightly smaller than the outer diameter of the flange (7). A vial stopper.
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2010105555A JP5683129B2 (en) | 2010-04-30 | 2010-04-30 | Vial stopper and seal member used therefor |
| EP20110003090 EP2383199B1 (en) | 2010-04-30 | 2011-04-12 | Closure device for a container, and seal member for the device |
| CN201110111651.4A CN102259723B (en) | 2010-04-30 | 2011-04-27 | Closing appliance for container and the sealing element for this device |
| US13/097,178 US8978909B2 (en) | 2010-04-30 | 2011-04-29 | Closure device for a container, and seal member for the device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2010105555A JP5683129B2 (en) | 2010-04-30 | 2010-04-30 | Vial stopper and seal member used therefor |
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| Publication Number | Publication Date |
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| JP2011230839A JP2011230839A (en) | 2011-11-17 |
| JP5683129B2 true JP5683129B2 (en) | 2015-03-11 |
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| Application Number | Title | Priority Date | Filing Date |
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| JP2010105555A Active JP5683129B2 (en) | 2010-04-30 | 2010-04-30 | Vial stopper and seal member used therefor |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2014079373A (en) * | 2012-10-16 | 2014-05-08 | Sumitomo Rubber Ind Ltd | Medical rubber plug sealed by cap |
| WO2015029580A1 (en) * | 2013-09-02 | 2015-03-05 | 大成化工株式会社 | Cap for vial |
| EP2862587A1 (en) | 2013-10-15 | 2015-04-22 | Becton Dickinson France | Tip cap assembly for closing an injection system |
| CA2985439A1 (en) * | 2015-06-29 | 2017-01-05 | Antonio Mutterle | Closing assembly for a bottle, associated bottle and assembly method |
| JP7016519B2 (en) * | 2017-11-20 | 2022-02-07 | 内外化成株式会社 | Medical cap and its manufacturing method |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5664961A (en) * | 1979-11-01 | 1981-06-02 | Fujisawa Pharmaceutical Co | Plug body for vial |
| JPH052182Y2 (en) * | 1985-07-15 | 1993-01-20 | ||
| JPH0721564U (en) * | 1993-09-24 | 1995-04-18 | 株式会社ニッショー | Vial closure |
| JP2001245956A (en) * | 2000-03-03 | 2001-09-11 | Ohtsu Tire & Rubber Co Ltd :The | Rubber plug for medical treatment |
| JP2003128095A (en) * | 2001-10-24 | 2003-05-08 | Ohtsu Tire & Rubber Co Ltd :The | Medicinal rubber stopper and production method therefor |
| JP5116279B2 (en) * | 2006-02-14 | 2013-01-09 | 紀伊産業株式会社 | Resin cap and container with resin cap using the same |
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| JP2011230839A (en) | 2011-11-17 |
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