EP0564037B1 - Abrasion resistant stopper to prevent generation of particles by piercing - Google Patents

Abrasion resistant stopper to prevent generation of particles by piercing Download PDF

Info

Publication number
EP0564037B1
EP0564037B1 EP93200885A EP93200885A EP0564037B1 EP 0564037 B1 EP0564037 B1 EP 0564037B1 EP 93200885 A EP93200885 A EP 93200885A EP 93200885 A EP93200885 A EP 93200885A EP 0564037 B1 EP0564037 B1 EP 0564037B1
Authority
EP
European Patent Office
Prior art keywords
stopper
spike
abrasion
fluid
elastomeric
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 - Lifetime
Application number
EP93200885A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0564037A1 (en
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
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 filed Critical Nycomed Imaging AS
Publication of EP0564037A1 publication Critical patent/EP0564037A1/en
Application granted granted Critical
Publication of EP0564037B1 publication Critical patent/EP0564037B1/en
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 wall of the vial as the spike rolls and drags the fragments during penetration.
  • an abrasion resistant stopper for a medical vial containing a fluid therein, the stopper being adapted to be pierced by an infusion spike and comprising a stopper body of an elastomeric material having a head portion and a fluid contacting leg portion, said leg portion being adapted to be inserted into said medical vial to hermetically seal said fluid therein, said head portion having a bottom, fluid-contacting surface and a top having a central pierceable portion, said central portion having a spike-receiving surface.
  • Silicone lubricant applied to the top of the stopper body head portion provides abrasion resistance.
  • silicone does reduce particle generation from the spiking procedure it also increases the risk of product contamination from its own composition.
  • 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.
  • the present invention is characterised in that said spike-receiving surface is coated with an abrasion resistant film, said film being adapted to conform to the edges of a hole created by an infusion spike upon said spike piercing the stopper and providing a barrier between the spike and the elastomeric material, thereby preventing mechanical contact between the spike and the elastomeric material and the consequent generation of elastomeric particles by abrasion, said abrasion-resistant film being selected from the group consisting of polystyrene, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, copolymer of polyvinyl chloride and polyvinylidine chloride, polymethylene oxide, polyphenylene oxide, polyphenylene sulfone, polyethylene terephthalate, polycarbonate, copolyesters and polycaprolactam.
  • the top of the head portion has a region surrounding the coated central portion which is not coated.
  • 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.
  • the present invention provides a method of preventing the generation of elastomeric particles by abrasion between an infusion spike and an abrasion resistant stopper as defined above, wherein during piercing of the stopper by the infusion spike the abrasion resistant film of the stopper provides a barrier between the infusion spike and the elastomeric material of the stopper thereby preventing mechanical contact between the infusion spike and the elastomeric material and the consequent generation of elastomeric particles by abrasion.
  • 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.
  • 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 a stopper (which could be the stopper of FIGS. 1-3 or that of FIGS. 4-6) 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 the stopper 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.
  • the elastomeric material 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: polystyrene, polyvinyl acetate (PVA), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), a copolymer of PVC and PVDC, polymethylene oxide, polyphenylene oxide, polyphenylene sulphone, polyethylene terephthalate (PET), polycarbonate, copolyesters and polycaprolactam (Nylon 6).
  • 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.

Landscapes

  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
  • Polishing Bodies And Polishing Tools (AREA)
  • Drilling Tools (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Physical Or Chemical Processes And Apparatus (AREA)
  • Radiation-Therapy Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Heating, Cooling, Or Curing Plastics Or The Like In General (AREA)
  • Glass Compositions (AREA)
  • Tires In General (AREA)
  • Materials For Medical Uses (AREA)
  • Wrappers (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Passenger Equipment (AREA)
  • Arc Welding In General (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP93200885A 1992-04-02 1993-03-27 Abrasion resistant stopper to prevent generation of particles by piercing Expired - Lifetime EP0564037B1 (en)

Applications Claiming Priority (2)

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

Publications (2)

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

Family

ID=25337719

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93200885A Expired - Lifetime EP0564037B1 (en) 1992-04-02 1993-03-27 Abrasion resistant stopper to prevent generation of particles by piercing

Country Status (20)

Country Link
EP (1) EP0564037B1 (enExample)
JP (1) JPH0639017A (enExample)
KR (1) KR930021174A (enExample)
AT (1) ATE156088T1 (enExample)
AU (1) AU666910B2 (enExample)
BR (1) BR9301388A (enExample)
CA (1) CA2091020C (enExample)
CZ (1) CZ54393A3 (enExample)
DE (1) DE69312545T2 (enExample)
DK (1) DK0564037T3 (enExample)
ES (1) ES2108205T3 (enExample)
FI (1) FI931501A7 (enExample)
HU (1) HUT67955A (enExample)
IL (1) IL105247A (enExample)
MX (1) MX9301044A (enExample)
MY (1) MY131318A (enExample)
NO (1) NO931288L (enExample)
NZ (1) NZ247323A (enExample)
SK (1) SK27493A3 (enExample)
TW (1) TW227523B (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1078880B1 (en) 1999-08-05 2003-03-19 The Procter & Gamble Company Dispensing device comprising a reservoir and attachment means provided with protected piercing means
US6386392B1 (en) 1999-11-02 2002-05-14 The Procter & Gamble Company Reservoirs for use with cleaning devices
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
AR040977A1 (es) * 2002-08-16 2005-04-27 Glaxosmithkline Biolog Sa Disposicion de cierre para un frasco para uso farmaceutico, el frasco, y procedimiento para su llenado y cerrado
WO2004026695A2 (en) * 2002-09-03 2004-04-01 Medical Instill Technologies, Inc. Sealed containers and methods of making and filling same
US20090196798A1 (en) * 2008-02-06 2009-08-06 Robert Sassa Barrier with Low Extractables and Resealing Properties
CN102283776B (zh) * 2011-07-07 2013-09-04 海南卫康制药(潜山)有限公司 免穿刺瓶塞及其使用方法
DE102012101509A1 (de) * 2012-02-24 2013-08-29 Krones Aktiengesellschaft Durchstechbarer Kunststoffverschluss zum Verschließen von Behältnissen
USD713931S1 (en) 2013-01-09 2014-09-23 Central Garden & Pet Company Sprayer
EP3906114B1 (en) * 2019-01-04 2025-08-20 Instrumentation Laboratory Company Container stopper for high pierce count applications
US12434889B2 (en) 2022-12-09 2025-10-07 Instrumentation Laboratory Company Sealing systems

Family Cites Families (4)

* 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
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
JP2545540B2 (ja) * 1987-05-29 1996-10-23 株式会社 大協精工 両面ラミネ−トゴム栓
DE8906346U1 (de) * 1989-05-23 1989-09-14 Pharma-Gummi Wimmer West Gmbh, 5180 Eschweiler Verschluß für Medikamentenflaschen

Also Published As

Publication number Publication date
JPH0639017A (ja) 1994-02-15
EP0564037A1 (en) 1993-10-06
DK0564037T3 (da) 1997-09-29
NO931288D0 (no) 1993-04-02
SK27493A3 (en) 1993-11-10
AU666910B2 (en) 1996-02-29
CA2091020C (en) 2005-01-25
MY131318A (en) 2007-08-30
HUT67955A (en) 1995-05-29
FI931501A0 (fi) 1993-04-02
KR930021174A (ko) 1993-11-22
BR9301388A (pt) 1993-10-13
IL105247A0 (en) 1993-08-18
NZ247323A (en) 1996-03-26
CA2091020A1 (en) 1993-10-03
DE69312545T2 (de) 1998-02-19
FI931501L (fi) 1993-10-03
ATE156088T1 (de) 1997-08-15
NO931288L (no) 1993-10-04
FI931501A7 (fi) 1993-10-03
HU9300971D0 (en) 1993-06-28
AU3280593A (en) 1993-10-07
TW227523B (enExample) 1994-08-01
MX9301044A (es) 1993-10-01
ES2108205T3 (es) 1997-12-16
CZ54393A3 (en) 1995-11-15
IL105247A (en) 1997-04-15
DE69312545D1 (de) 1997-09-04

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