EP0028411B1 - Stopper for vials - Google Patents

Stopper for vials Download PDF

Info

Publication number
EP0028411B1
EP0028411B1 EP80106715A EP80106715A EP0028411B1 EP 0028411 B1 EP0028411 B1 EP 0028411B1 EP 80106715 A EP80106715 A EP 80106715A EP 80106715 A EP80106715 A EP 80106715A EP 0028411 B1 EP0028411 B1 EP 0028411B1
Authority
EP
European Patent Office
Prior art keywords
cap
inner cap
flange
stopper
rubber plug
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.)
Expired
Application number
EP80106715A
Other languages
German (de)
French (fr)
Other versions
EP0028411A1 (en
Inventor
Hisatomi Fukuoka
Seizou Sunago
Kiyonori Okada
Shinji Nakashima
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fujisawa Pharmaceutical Co Ltd
Original Assignee
Fujisawa Pharmaceutical Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Fujisawa Pharmaceutical Co Ltd filed Critical Fujisawa Pharmaceutical Co Ltd
Priority to AT80106715T priority Critical patent/ATE5958T1/en
Publication of EP0028411A1 publication Critical patent/EP0028411A1/en
Application granted granted Critical
Publication of EP0028411B1 publication Critical patent/EP0028411B1/en
Expired legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs
    • 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
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/241—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying means

Definitions

  • This invention relates to a stopper for vials, and more particularly to a stopper for sealing off a vial by a simplified procedure without necessitating the step of crimping an aluminum cap.
  • US-A-3 587 897 discloses a container closure comprising a cap of a cuplike form adapted to hold a stopper or liner in place in a container, said cap having a top including inner and outer portions. While the outer portion, i.e. a cover member may be made of a pliable material, such as plastic, the inner portion, i.e. the closure for holding the stopper in place has a generally cuplike form and is made out of sheet material such as aluminum.
  • DE-A-2 405 169 describes a dropping dispenser to be fixed to a bottle by the user of the bottle.
  • This dropping dispenser comprises two elements, i.e. an inner dropping insert to be introduced into the bottle opening and an outer cup for sealing the opening of the dropping insert.
  • a stopper for vials is known as well, which comprises an aluminum outer cap for holding the stopper in place.
  • Such so-called “flip-off caps” of aluminum are widely used for vials containing pharmaceutical preparations, especially powders or the like for preparing injection solutions.
  • Such raps are costly since they are made of aluminum and, moreover, have the drawback of requiring a cumbersome vial closing process because the aluminum cap must be fitted to the vial by crimping after the vial has been sealed with a rubber plug pressed against the flange of the vial.
  • Subject matter of this invention therefore is a stopper for a vial having a flange at its opening portion comprising a rubber plug having a top plate fittable to the flange in pressing contact therewith, an inner cap for receiving the rubber plug and having an upper wall formed with a hole in its center and an outer cap made of a flexible plastic fittable over the inner caps (as known from US-A-3587897), which is characterized in that the side wall of the inner cap comprises at least one projection on the inner peripheral surface thereof, the projection being fittable to the lower face of the flange with the top plate of the rubber plug held between the upper wall of the inner cap and the flange and at least one projection engageable with the top plate of the rubber plug on the inner surface of the inner cap side wall at its upper end; in that the outer cap has a side wall provided on its inner peripheral surface with a projection engageable with the outer peripheral surface of the inner cap side wall; and in that the inner cap is made of a flexible plastic.
  • the stopper of this invention comprises an outer cap 1, an inner cap 2 and a rubber plug 3.
  • the outer cap 1 includes an upper wall 1 a and a side wall 1 b integral therewith and formed with a projection 4 on its inner peripheral surface.
  • the projection 4 is engageable with the outer periphery of the side wall 2b of the inner cap 2 to hold the outer cap 1 thereon.
  • the inner cap 2 includes an upper wall 2a integral with the above-mentioned side wall 2b.
  • the upper wall 2a is formed in its center with a hole 5 for permitting an injection needle to penetrate the rubber plug 3.
  • Formed on the inner peripheral surface of the side wall 2b are two projections 6 which are fittable to the lower face of the flange 11 a of a vial 11 with the top plate 3a of the rubber plug 3 positioned between the upper wall 2a and the flange 11 a.
  • Four projections 7 are provided on the inner surface of the side wall 2b at its upper end for engaging the top plate 3a of the rubber plug 3 to retain the plug 3 in the inner cap 2.
  • the rubber plug 3 which is a rubber stopper heretofore used for vials, comprises the above-mentioned top plate 3a serving as a packing, and two legs 3b. Each of the legs has on its outer surface a projection 8 engageable with the opening portion of the vial 11.
  • the outer cap 1 and the inner cap 2 are made of a flexible plastic, which is preferably polypropylene, polyethylene, polycarbonate or the like.
  • the projection 4 on the outer cap 1 and the projections 6 and 7 on the inner cap 2 are not limitative in their arrangement but can be provided as desired insofar as they are serviceable as contemplated.
  • the projections 6 on the inner cap 2 may be in the form of a continuous projection extending over the entire inner periphery of the inner cap side wall 2b like the projection 4 on the outer cap 1, or may be in the form of dots resembling the projections 7 on the inner cap 2.
  • the stopper of this invention will be used in the following manner, for example, for a vial 11 for containing a freeze-dried preparation for injection.
  • the inner cap 2 is fitted in the outer cap 1 in engagement with the projection 4, with the rubber plug 3 engaged with the projections 7 on the inner cap 2.
  • the stopper is then placed on the vial 11 containing an aqueous solution S of the preparation so that the projections 8 on the rubber plug 3 bear on the opening portion of the vial 11 as seen in Fig. 7.
  • the projections 6 on the inner cap 2 strike the upper edge of the flange 11 a on the vial 11, thereby forcing the side wall 2b of the inner cap 2 radially outward at its lower portion, and thereafter come into fitting engagement with the lower face of the flange 11 a, whereupon the inner cap side wall 2b restores itself.
  • the vial 11 containing the powder P is completely sealed off as shown in Fig. 8.
  • the vial stopper of this invention for which no aluminum material is used, can be manufactured at a low cost.
  • the stopper is easy to use since it seals off the vial completely when simply pressed on. Because the sealing step can be performed subsequent to freeze-drying within a freeze-drying chamber in a continuous operation, the stopper is very useful for providing pharmaceutical products free from foreign matter and having an extremely low water content and a high quality.

Abstract

A stopper for sealing off vials having a flange at their opening portion without using any aluminum material and without resorting to the crimping step needed for aluminum caps comprising a rubber plug (3) having a top plate (3a) fittable to the flange (11a) in pressing contact therewith, a flexible inner cap (2) for receiving the rubber plug (3) therein and an outer cap (1) fittable over the inner cap (2), the inner cap (2) having an upper wall (2a) formed with a hole (5) in its center and a side wall (26) formed with at least one projection (6) on the inner peripheral surface thereof, the projection (6) being fittable to the lower face of the flange (11a) with the top plate (3a) of the rubber plug (3) held between the upper wall (2a) and the flange (11a).

Description

  • This invention relates to a stopper for vials, and more particularly to a stopper for sealing off a vial by a simplified procedure without necessitating the step of crimping an aluminum cap.
  • US-A-3 587 897 discloses a container closure comprising a cap of a cuplike form adapted to hold a stopper or liner in place in a container, said cap having a top including inner and outer portions. While the outer portion, i.e. a cover member may be made of a pliable material, such as plastic, the inner portion, i.e. the closure for holding the stopper in place has a generally cuplike form and is made out of sheet material such as aluminum.
  • DE-A-2 405 169 describes a dropping dispenser to be fixed to a bottle by the user of the bottle. This dropping dispenser comprises two elements, i.e. an inner dropping insert to be introduced into the bottle opening and an outer cup for sealing the opening of the dropping insert.
  • From DE-B-2 361 350 a stopper for vials is known as well, which comprises an aluminum outer cap for holding the stopper in place.
  • Such so-called "flip-off caps" of aluminum are widely used for vials containing pharmaceutical preparations, especially powders or the like for preparing injection solutions. Such raps are costly since they are made of aluminum and, moreover, have the drawback of requiring a cumbersome vial closing process because the aluminum cap must be fitted to the vial by crimping after the vial has been sealed with a rubber plug pressed against the flange of the vial.
  • According to the present invention these drawbacks are overcome by providing a stopper for sealing off vials without using any aluminum material and also without resorting to the cumbersome crimping step needed for aluminum caps.
  • Subject matter of this invention therefore is a stopper for a vial having a flange at its opening portion comprising a rubber plug having a top plate fittable to the flange in pressing contact therewith, an inner cap for receiving the rubber plug and having an upper wall formed with a hole in its center and an outer cap made of a flexible plastic fittable over the inner caps (as known from US-A-3587897), which is characterized in that the side wall of the inner cap comprises at least one projection on the inner peripheral surface thereof, the projection being fittable to the lower face of the flange with the top plate of the rubber plug held between the upper wall of the inner cap and the flange and at least one projection engageable with the top plate of the rubber plug on the inner surface of the inner cap side wall at its upper end; in that the outer cap has a side wall provided on its inner peripheral surface with a projection engageable with the outer peripheral surface of the inner cap side wall; and in that the inner cap is made of a flexible plastic.
  • The subclaim covers a preferred embodiment of the stopper of the invention as defined above and in claim 1.
  • A vial stopper embodying this invention will be described below with reference to be accompanying drawings, in which:
    • Fig. 1 is a view in vertical section of an outer cap 1;
    • Fig. 2 is a bottom view of the same;
    • Fig. 3 is a view in vertical section of an inner cap 2;
    • Fig. 4 is a bottom view of the sa.ne;
    • Fig. 5 is a view in vertical section of a rubber plug 3;
    • Fig. 6 is a bottom view of the same;
    • Fig. 7 is a view in vertical section showing the stopper placed on the vial before the sealing step; and
    • Fig. 8 is a view in vertical section showing the stopper after the sealing step.
  • The stopper of this invention comprises an outer cap 1, an inner cap 2 and a rubber plug 3.
  • The outer cap 1 includes an upper wall 1 a and a side wall 1 b integral therewith and formed with a projection 4 on its inner peripheral surface. The projection 4 is engageable with the outer periphery of the side wall 2b of the inner cap 2 to hold the outer cap 1 thereon.
  • The inner cap 2 includes an upper wall 2a integral with the above-mentioned side wall 2b. The upper wall 2a is formed in its center with a hole 5 for permitting an injection needle to penetrate the rubber plug 3. Formed on the inner peripheral surface of the side wall 2b are two projections 6 which are fittable to the lower face of the flange 11 a of a vial 11 with the top plate 3a of the rubber plug 3 positioned between the upper wall 2a and the flange 11 a. Four projections 7 are provided on the inner surface of the side wall 2b at its upper end for engaging the top plate 3a of the rubber plug 3 to retain the plug 3 in the inner cap 2.
  • The rubber plug 3, which is a rubber stopper heretofore used for vials, comprises the above-mentioned top plate 3a serving as a packing, and two legs 3b. Each of the legs has on its outer surface a projection 8 engageable with the opening portion of the vial 11.
  • The outer cap 1 and the inner cap 2 are made of a flexible plastic, which is preferably polypropylene, polyethylene, polycarbonate or the like.
  • The projection 4 on the outer cap 1 and the projections 6 and 7 on the inner cap 2 are not limitative in their arrangement but can be provided as desired insofar as they are serviceable as contemplated.
  • For example, the projections 6 on the inner cap 2 may be in the form of a continuous projection extending over the entire inner periphery of the inner cap side wall 2b like the projection 4 on the outer cap 1, or may be in the form of dots resembling the projections 7 on the inner cap 2.
  • The stopper of this invention will be used in the following manner, for example, for a vial 11 for containing a freeze-dried preparation for injection.
  • The inner cap 2 is fitted in the outer cap 1 in engagement with the projection 4, with the rubber plug 3 engaged with the projections 7 on the inner cap 2. The stopper is then placed on the vial 11 containing an aqueous solution S of the preparation so that the projections 8 on the rubber plug 3 bear on the opening portion of the vial 11 as seen in Fig. 7. When the stopper is pressed against the vial after the solution S has been freeze-dried to powder P, the projections 6 on the inner cap 2 strike the upper edge of the flange 11 a on the vial 11, thereby forcing the side wall 2b of the inner cap 2 radially outward at its lower portion, and thereafter come into fitting engagement with the lower face of the flange 11 a, whereupon the inner cap side wall 2b restores itself. Thus the vial 11 containing the powder P is completely sealed off as shown in Fig. 8.
  • The vial stopper of this invention, for which no aluminum material is used, can be manufactured at a low cost. The stopper is easy to use since it seals off the vial completely when simply pressed on. Because the sealing step can be performed subsequent to freeze-drying within a freeze-drying chamber in a continuous operation, the stopper is very useful for providing pharmaceutical products free from foreign matter and having an extremely low water content and a high quality.

Claims (2)

1. A stopper for a vial (11) having a flange (11 a) at its opening portion comprising a rubber plug (3) having a top plate (3a) fittable to the flange (11 a) in pressing contact therewith, an inner cap (2) for receiving the rubber plug (3) and having an upper wall (2a) formed with a hole (5) in its center and an outer cap (1) made of a flexible plastic fittable over the inner cap, characterized in that the side wall (2b) of the inner cap (2) comprises at least one projection (6) on the inner peripheral surface thereof, the projection (6) being fittable to the lower face of the flange (11a) with the top plate (3a) of the rubber plug (3) held between the upper wall (2a) of the inner cap (2) and the flange (11a) and at least one projection (7) engageable with the top plate (3a) of the rubber plug on the inner surface of the inner cap side wall (2b) at its upper end; in that the outer cap (1) has a side wall (1 b) provided on its inner peripheral surface with a projection (4) engageable with the outer peripheral surface of the inner cap side wall (2b); and in that the inner cap (2) is made of a flexible plastic.
2. The stopper as defined in claim 1, characterized in that the outer cap (1) and the inner cap (2) are made of polypropylene, polyethylene or polycarbonate.
EP80106715A 1979-11-01 1980-10-31 Stopper for vials Expired EP0028411B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT80106715T ATE5958T1 (en) 1979-11-01 1980-10-31 STOPPER FOR BOTTLES.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP14261279A JPS5664961A (en) 1979-11-01 1979-11-01 Plug body for vial
JP142612/79 1979-11-01

Publications (2)

Publication Number Publication Date
EP0028411A1 EP0028411A1 (en) 1981-05-13
EP0028411B1 true EP0028411B1 (en) 1984-01-25

Family

ID=15319368

Family Applications (1)

Application Number Title Priority Date Filing Date
EP80106715A Expired EP0028411B1 (en) 1979-11-01 1980-10-31 Stopper for vials

Country Status (5)

Country Link
EP (1) EP0028411B1 (en)
JP (1) JPS5664961A (en)
AT (1) ATE5958T1 (en)
DE (1) DE3066308D1 (en)
ES (1) ES265665Y (en)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2516480B1 (en) * 1981-11-13 1986-03-07 Lyonnaise Bouchage MEANS FOR SEALING A CONTAINER CONTAINING PRODUCTS FOR INJECTION
US4554125A (en) * 1983-03-17 1985-11-19 Schering Corporation Method of making a stopper for a sterile fluid container
US4465200A (en) * 1983-06-06 1984-08-14 Becton, Dickinson And Company Low contamination closure for blood collection tubes
JPS6096260U (en) * 1983-12-05 1985-07-01 第一製薬株式会社 medicinal bottle lid
JPS61178344U (en) * 1985-04-24 1986-11-07
US4697717A (en) * 1986-08-18 1987-10-06 Becton, Dickinson And Company Rubber/plastic stopper composite with mechanical adhesive joints
JPS63180556U (en) * 1987-05-12 1988-11-22
CA2074505A1 (en) * 1990-01-26 1991-07-27 David M. Wong Sanitary sampling system
CA2067691C (en) * 1991-05-13 1995-12-12 James A. Burns Stopper-shield combination closure
US5823379A (en) * 1993-10-20 1998-10-20 Amersham International Plc Sealed container for hazardous material
ATE195697T1 (en) 1995-10-18 2000-09-15 Daikyo Seiko Ltd PLASTIC CAP AND METHOD FOR PRODUCING SAME
US5718348A (en) * 1996-09-12 1998-02-17 Comar, Inc. Overcap assembly for gear finish vial
GB2312207B (en) * 1996-10-25 1998-08-26 Massmould Holdings Plug closure assembly
US20060134354A1 (en) * 2004-12-16 2006-06-22 Walters Jay M Calibration vial stopper with improved security features
US7543188B2 (en) * 2005-06-29 2009-06-02 Oracle International Corp. Browser based remote control of functional testing tool
FR2912384B1 (en) * 2007-02-09 2009-04-10 Biocorp Rech Et Dev Sa CLOSURE DEVICE FOR A CONTAINER, CONTAINER EQUIPPED WITH SUCH A DEVICE AND METHOD FOR CLOSING A LOT OF SUCH A CONTAINER
JP5479029B2 (en) * 2009-10-30 2014-04-23 株式会社大協精工 Combination of rubber stopper (B) for vial and plastic cap (C)
JP5683129B2 (en) * 2010-04-30 2015-03-11 大和特殊硝子株式会社 Vial stopper and seal member used therefor
FI20116059A (en) * 2011-10-28 2013-04-29 Thermo Fisher Scientific Oy Reagent bottle, system, method and apparatus for handling closures and the like
WO2019125223A1 (en) * 2017-12-21 2019-06-27 Акционерное общество "Елатомский приборный завод" Vacuum test tube

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1949902A (en) * 1930-11-05 1934-03-06 Owens Illinois Glass Co Bottle closure
US3092278A (en) * 1957-09-20 1963-06-04 Astra Apotekarnes Kem Fab Cap for a container for an injection liquid
US3073471A (en) * 1960-03-17 1963-01-15 Aluminum Co Of America Closure device for sealed packages
US3746196A (en) * 1971-01-29 1973-07-17 Green Cross Corp Coated plastic container for liquid medicine
BE794248A (en) * 1972-02-22 1973-05-16 Baxter Laboratories Inc IMPROVEMENTS TO STERILE CLOSURES FOR SOLUTION BOTTLES OR VIALS
US3888377A (en) * 1973-05-30 1975-06-10 Reinhard Stadler Closure cap for an infusion flask
DE2361350B1 (en) * 1973-12-08 1975-05-28 Matthias Faensen, Kleinmetallwarenfabrikation, 5190 Stolberg Closure for pharmaceutical bottles
DE2405169A1 (en) * 1974-02-04 1975-08-07 Sanner Kg Friedr Dropper insert for medicine bottles - has hollow bottle stopper with dropper tube fitting and cylindrical cap with inner bead
NL7707814A (en) * 1976-08-03 1978-02-07 Abbott Lab PLASTIC HOLDERS.
US4211333A (en) * 1978-06-05 1980-07-08 Merck & Co., Inc. Tamperproof container

Also Published As

Publication number Publication date
ES265665U (en) 1983-02-01
EP0028411A1 (en) 1981-05-13
JPS5664961A (en) 1981-06-02
DE3066308D1 (en) 1984-03-01
ES265665Y (en) 1983-07-16
ATE5958T1 (en) 1984-02-15

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