EP0564037A1 - Bouchon résistant à l'abrasion pour éviter la formation de particules lors de la perforation - Google Patents

Bouchon résistant à l'abrasion pour éviter la formation de particules lors de la perforation Download PDF

Info

Publication number
EP0564037A1
EP0564037A1 EP93200885A EP93200885A EP0564037A1 EP 0564037 A1 EP0564037 A1 EP 0564037A1 EP 93200885 A EP93200885 A EP 93200885A EP 93200885 A EP93200885 A EP 93200885A EP 0564037 A1 EP0564037 A1 EP 0564037A1
Authority
EP
European Patent Office
Prior art keywords
stopper
coating
top surface
fluid
spike
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.)
Granted
Application number
EP93200885A
Other languages
German (de)
English (en)
Other versions
EP0564037B1 (fr
Inventor
Richard T. c/o STERLING WINTHROP INC. Liebert
Neil H. Sterling Winthrop Inc. Brown
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.)
GE Healthcare AS
Original Assignee
Nycomed Imaging AS
Sterling Winthrop Inc
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 Nycomed Imaging AS, Sterling Winthrop Inc filed Critical Nycomed Imaging AS
Publication of EP0564037A1 publication Critical patent/EP0564037A1/fr
Application granted granted Critical
Publication of EP0564037B1 publication Critical patent/EP0564037B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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

Definitions

  • This invention relates to a stopper for a container and, more particularly, to an improved stopper for a container of parenteral solutions which is suitable for infusion spike penetration without producing unacceptable amounts of particulate matter.
  • Stopper systems for vials, bottles and the like are made of materials that are resistant to chemicals and pharmaceuticals such as corrosive materials, reagents, parenteral solutions and solid formulations reconstitutable with a solvent prior to use.
  • the most commonly used stopper system for such products has been glass or plastic bottles and vials equipped with rubber stoppers made of elastomeric materials. The system appears to provide for good hermetical seal, safe storage and easy access to the content through the elastomeric stopper via the use of an infusion spike when withdrawal of the content is desired.
  • the elastomeric stopper used comprises an elastomeric base, such as natural or synthetic rubber and an inert coating covering at least some portions of the stopper.
  • the coating used heretofore includes chlorobutyl rubber, polymeric fluorocarbon resins such as polytetrafluoroethylene (TEFLON) and various thermoplastic films.
  • the coating is intended to insulate the elastomeric stopper base from the content of the container in order to prevent contact and possible chemical reactions therebetween.
  • untreated elastomeric stoppers offer a high degree of resistance against the exterior surface of the spike as the spike is being pushed into the penetration area.
  • stopper fragments are generated, they are the result of the elastomeric portion of the stopper being abraded off the upper surface of the stopper as it conforms to the shape of the penetrating spike. The fragments are then transported into the interior of the vial as the spike rolls and drags the fragments during penetration.
  • the present invention addresses the need to eliminate or at least greatly reduce the particle generation from surface erosion of the stopper during spike penetration.
  • the invention reduces the risk of the push-through and blow-out tendency by minimizing frictional drag and residual elastic tension during spike penetration.
  • this invention provides an abrasion-resistant stopper for a medical vial for containing a fluid therein comprising: a stopper body of an elastomeric material having a head portion and a fluid contactable leg portion, said leg portion being adapted to be inserted into said medical vial for hermetically sealing said fluid therein, and said head portion comprising a top surface to receive a coating thereon, said top surface being coated with an abrasion-resistant coating to prevent generation of particles upon piercing of the stopper by a spike or a hypodermic needle.
  • the coating covers at least the centre, pierceable portion of the top surface for spike or needle penetration of the stopper when withdrawal of fluid is desired.
  • the coating on the top surface of the stopper conforms to the deformation of the stopper caused by the spike penetration procedure. It appears that, upon piercing, the spike is not in contact with the elastomeric stopper body but only with the abrasion-resistant coating thereby circumventing abrasion and eliminating the formation of elastomeric particulate materials.
  • numeral 10 shows one embodiment of the stopper of the present invention comprising: a head portion 20 and a leg portion 30.
  • Head portion 20 comprises a flange 22 which is adapted to cover a corresponding planar, circular mouth portion of a medical vial, while leg portion 30 is adapted for insertion into the neck of the vial to tightly seal the content therein.
  • Numeral 40 shows an abrasion-resistant film mounted on the centre part of the head portion 20 which serves as the piercing area for insertion and withdrawal of a spike or hypodermic needle.
  • numeral 10' shows another embodiment of the stopper of the present invention comprising: a head portion 20' and a leg portion 30'.
  • Head portion 20' comprises a flange 22' which is adapted to cover a corresponding planar, circular mouth portion of a medical vial, while leg portion 30' is adapted for insertion into the neck of the vial to tightly seal the content therein.
  • Numeral 40' shows an abrasion-resistant film mounted on the top part of the head portion 20'.
  • recess 32' extends toward the top surface of the head portion 20' forming a thin portion 34' in head portion 20' for facilitating piercing of the stopper by a spike.
  • FIG. 7 illustrates a stopper 10 having an abrasion-resistant film 40 covering vial 1.
  • Vial 1, containing an injectable fluid 5, is sealed by stopper (10 or 10') by inserting leg portion 30 of the stopper into the neck 7 of the vial 1.
  • Flange portion 22 of head portion 20 tightly seals the mouth 8 of vial 1.
  • a thin metal foil 9 is crimped over head portion 20 and flange portion 22 of stopper (10 or 10') to tightly seal and securely hold the stopper in vial 1.
  • the elastomeric material of the stopper body must be a fluid-impervious, resilient and inert material without leachable additives therein in order to prevent any alteration of the product contained in the vial. It may be of a single component or a blend of components. Examples of materials include synthetic or natural rubber, such as butyl rubber, isoprene rubber, butadiene rubber, silicone rubber, halogenated rubber, ethylene propylene therpolymer and the like.
  • a synthetic elastomeric rubber examples include the CH2CF2-C3F6(C3F5H) and the C2F4-C2F3OCF3 series of elastomers made by duPont under the trade names of VITON® and CARLEZ®; the fluoro-silicone rubbers, such as those made by Dow Corning under the name of SILASTIC®; and polyisobutylenes, such as VISTANEX MML-100 and MML-140; and halogenated butyl rubber, such as CHLOROBUTYL 1066, made by Exxon Chemical Company.
  • elastomers may be made into the desired stopper configuration by known methods. Such methods conventionally include the use of a curing agent, a stabilizer and a filler and comprise a primary and secondary curing step at elevated temperatures.
  • the abrasion-resistant coating for covering the top portion of the stopper, but at least the centre, pierceable portion thereof, may be: a polyvinyl, such as polystyrene, polyvinyl acetate (PVA), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), a copolymer of PVC and PVDC, polyvinyl fluoride, polyvinylidene fluoride, polychlorotrifluoroethylene and polytetrafluoroethylene ; a polyolefine, such as polypropylene and polymethylpentene; an ether, such a polymethylene oxide, polyphenylene oxide and polyphenylene sulphone; an ester, such as polyethylene terephthalate (PET), polycarbonate and copolyesters; an ester, such as polycaprolactam (Nylon 6), polyhexamethylene adipamide (Nylon 66) and polyundecanoamide (Nylon 11).
  • the abrasion-resistant coating covering at least the centre, pierceable portion of the top surface of the stopper is preferably polytetrafluoroethylene sold under the trade name TEFLON by duPont.
  • the coating thickness will be in the range of about 0.002 to 1.0 mm, and preferably about 0.02 to 0.5 mm.
  • the coating may be applied or bonded to the stopper body in any suitable manner known in the art, such as, but not limited to, by the use of adhesives, solvents, spray applications, radio waves, infrared, microwaves, ultrasonics and heat or a combination thereof.
  • the preferred stopper of the present invention comprising an elastomeric material and a TEFLON coating on the top centre portion thereof was tested against another stopper of the same elastomeric material but without the TEFLON coating thereon.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Radiation-Therapy Devices (AREA)
  • Drilling Tools (AREA)
  • Polishing Bodies And Polishing Tools (AREA)
  • Heating, Cooling, Or Curing Plastics Or The Like In General (AREA)
  • Physical Or Chemical Processes And Apparatus (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Glass Compositions (AREA)
  • Tires In General (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Wrappers (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Arc Welding In General (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Passenger Equipment (AREA)
EP93200885A 1992-04-02 1993-03-27 Bouchon résistant à l'abrasion pour éviter la formation de particules lors de la perforation Expired - Lifetime EP0564037B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US862120 1986-05-12
US86212092A 1992-04-02 1992-04-02

Publications (2)

Publication Number Publication Date
EP0564037A1 true EP0564037A1 (fr) 1993-10-06
EP0564037B1 EP0564037B1 (fr) 1997-07-30

Family

ID=25337719

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93200885A Expired - Lifetime EP0564037B1 (fr) 1992-04-02 1993-03-27 Bouchon résistant à l'abrasion pour éviter la formation de particules lors de la perforation

Country Status (20)

Country Link
EP (1) EP0564037B1 (fr)
JP (1) JPH0639017A (fr)
KR (1) KR930021174A (fr)
AT (1) ATE156088T1 (fr)
AU (1) AU666910B2 (fr)
BR (1) BR9301388A (fr)
CA (1) CA2091020C (fr)
CZ (1) CZ54393A3 (fr)
DE (1) DE69312545T2 (fr)
DK (1) DK0564037T3 (fr)
ES (1) ES2108205T3 (fr)
FI (1) FI931501A (fr)
HU (1) HUT67955A (fr)
IL (1) IL105247A (fr)
MX (1) MX9301044A (fr)
MY (1) MY131318A (fr)
NO (1) NO931288L (fr)
NZ (1) NZ247323A (fr)
SK (1) SK27493A3 (fr)
TW (1) TW227523B (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004018317A3 (fr) * 2002-08-16 2004-05-27 Glaxosmithkline Biolog Sa Nouveau dispositif
CN102283776A (zh) * 2011-07-07 2011-12-21 海南卫康制药(潜山)有限公司 免穿刺瓶塞及其使用方法
EP2546152A3 (fr) * 2002-09-03 2014-03-26 Medical Instill Technologies, Inc. Contenants hermétiques et procédés de fabrication et de remplissage de ceux-ci
EP2817237A2 (fr) * 2012-02-24 2014-12-31 Krones AG Bouchon en matière plastique perforable destiné à fermer des contenants
WO2020142592A1 (fr) * 2019-01-04 2020-07-09 Instrumentation Laboratory Company Bouchon de récipient pour applications à nombre de perforation élevé

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6386392B1 (en) 1999-11-02 2002-05-14 The Procter & Gamble Company Reservoirs for use with cleaning devices
EP1078880B1 (fr) 1999-08-05 2003-03-19 The Procter & Gamble Company Dispositif de distribution comprenant un récipient et une embase de réception munie de moyens de perçage protégés
US6321941B1 (en) 2000-04-20 2001-11-27 The Procter & Gamble Company Consumer safe fitment for connecting a reservoir to a dispensing appliance
JP4601127B2 (ja) * 2000-06-06 2010-12-22 住友ゴム工業株式会社 医療用ゴム栓
US20090196798A1 (en) * 2008-02-06 2009-08-06 Robert Sassa Barrier with Low Extractables and Resealing Properties
USD713931S1 (en) 2013-01-09 2014-09-23 Central Garden & Pet Company Sprayer

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4499148A (en) * 1983-01-10 1985-02-12 Canton Bio-Medical Products, Inc. Composite materials of silicone elastomers and polyolefin films, and method of making
EP0294127A2 (fr) * 1987-05-29 1988-12-07 Daikyo Gomu Seiko Ltd. Bouchon de caoutchouc laminé de résine
DE8906346U1 (de) * 1989-05-23 1989-09-14 Pharma-Gummi Wimmer West Gmbh, 5180 Eschweiler Verschluß für Medikamentenflaschen

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3628681A (en) * 1969-10-06 1971-12-21 Plastics Consulting And Mfg Co Stopper

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4499148A (en) * 1983-01-10 1985-02-12 Canton Bio-Medical Products, Inc. Composite materials of silicone elastomers and polyolefin films, and method of making
EP0294127A2 (fr) * 1987-05-29 1988-12-07 Daikyo Gomu Seiko Ltd. Bouchon de caoutchouc laminé de résine
DE8906346U1 (de) * 1989-05-23 1989-09-14 Pharma-Gummi Wimmer West Gmbh, 5180 Eschweiler Verschluß für Medikamentenflaschen

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8960242B2 (en) 2000-02-11 2015-02-24 Medinstill Development Llc Sealed containers and methods of filling and resealing same
US9637251B2 (en) 2000-02-11 2017-05-02 Medinstill Development Llc Sealed containers and methods of filling and resealing same
US9051064B2 (en) 2000-02-11 2015-06-09 Medinstill Development Llc Resealable containers and methods of making, filling and resealing same
US7946437B2 (en) 2002-08-16 2011-05-24 Aseptic Technologies S.A. Closure system for a vial, vial, method of closing and filling a vial and stand for a vial
WO2004018317A3 (fr) * 2002-08-16 2004-05-27 Glaxosmithkline Biolog Sa Nouveau dispositif
EP2006213A3 (fr) * 2002-08-16 2008-12-31 GlaxoSmithKline Biologicals S.A. Ampoule et mécanisme de fermeture pour une ampoule
CN100347052C (zh) * 2002-08-16 2007-11-07 葛兰素史密丝克莱恩生物有限公司 封盖系统、小瓶、封闭和填充小瓶的方法以及小瓶封盖
EP2546152A3 (fr) * 2002-09-03 2014-03-26 Medical Instill Technologies, Inc. Contenants hermétiques et procédés de fabrication et de remplissage de ceux-ci
CN102283776A (zh) * 2011-07-07 2011-12-21 海南卫康制药(潜山)有限公司 免穿刺瓶塞及其使用方法
EP2817237A2 (fr) * 2012-02-24 2014-12-31 Krones AG Bouchon en matière plastique perforable destiné à fermer des contenants
WO2020142592A1 (fr) * 2019-01-04 2020-07-09 Instrumentation Laboratory Company Bouchon de récipient pour applications à nombre de perforation élevé
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
US11319122B2 (en) 2019-01-04 2022-05-03 Instrumentation Laboratory Company Container stopper for high pierce count applications

Also Published As

Publication number Publication date
IL105247A (en) 1997-04-15
TW227523B (fr) 1994-08-01
BR9301388A (pt) 1993-10-13
EP0564037B1 (fr) 1997-07-30
JPH0639017A (ja) 1994-02-15
FI931501A0 (fi) 1993-04-02
AU666910B2 (en) 1996-02-29
SK27493A3 (en) 1993-11-10
AU3280593A (en) 1993-10-07
NZ247323A (en) 1996-03-26
CZ54393A3 (en) 1995-11-15
MX9301044A (es) 1993-10-01
NO931288L (no) 1993-10-04
ES2108205T3 (es) 1997-12-16
HU9300971D0 (en) 1993-06-28
FI931501A (fi) 1993-10-03
KR930021174A (ko) 1993-11-22
HUT67955A (en) 1995-05-29
NO931288D0 (no) 1993-04-02
CA2091020A1 (fr) 1993-10-03
IL105247A0 (en) 1993-08-18
DE69312545D1 (de) 1997-09-04
ATE156088T1 (de) 1997-08-15
DE69312545T2 (de) 1998-02-19
DK0564037T3 (da) 1997-09-29
CA2091020C (fr) 2005-01-25
MY131318A (en) 2007-08-30

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