[go: up one dir, main page]

WO2017188949A1 - Joint d'étanchéité inviolable pour flacon de médicament - Google Patents

Joint d'étanchéité inviolable pour flacon de médicament Download PDF

Info

Publication number
WO2017188949A1
WO2017188949A1 PCT/US2016/029675 US2016029675W WO2017188949A1 WO 2017188949 A1 WO2017188949 A1 WO 2017188949A1 US 2016029675 W US2016029675 W US 2016029675W WO 2017188949 A1 WO2017188949 A1 WO 2017188949A1
Authority
WO
WIPO (PCT)
Prior art keywords
skirt
vial
tamper evident
seal
score line
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.)
Ceased
Application number
PCT/US2016/029675
Other languages
English (en)
Inventor
Phil HUMPHREY
Markus Vor Dem Esche
Xia Zhao
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.)
West Pharmaceutical Services Inc
Original Assignee
West Pharmaceutical Services 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 West Pharmaceutical Services Inc filed Critical West Pharmaceutical Services Inc
Priority to PCT/US2016/029675 priority Critical patent/WO2017188949A1/fr
Publication of WO2017188949A1 publication Critical patent/WO2017188949A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
    • 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
    • B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
    • B65D41/32—Caps or cap-like covers with lines of weakness, tearing-strips, tags, or like opening or removal devices, e.g. to facilitate formation of pouring openings
    • B65D41/40—Caps or cap-like covers adapted to be secured in position by permanent deformation of the wall-engaging parts
    • B65D41/44—Caps or cap-like covers adapted to be secured in position by permanent deformation of the wall-engaging parts made of metallic foil or like thin flexible material

Definitions

  • the present invention relates generally to a closure for containers, for example, pharmaceutical vials, and more particularly to a closure for containers that indicates whether the closure has been tampered with or previously opened or accessed.
  • Containers such as, for example, pharmaceutical vials, often contain contents that may be compromised once exposed to the environment, or even if merely unsealed. Such contents, for example, may be intended for single use consumption only. In such applications, it is important for a user, such as, for example, a health care worker, to be able to determine whether the contents within a container have been previously exposed and are therefore no longer suitable for use, or dispensing, or whether the contents have not been previously accessed or exposed and are suitable for use.
  • the invention provides tamper evident closures for containers, particularly, tamper evident closures for containers having an open end for assembling with a closure.
  • one aspect of the present invention is directed to a combination drug vial and tamper evident seal.
  • the vial includes an internal chamber for storing a material and has a neck with an opening therethrough in fluid communication with the internal chamber.
  • a cap is detachably and sealingly coupled to the vial and includes a top covering the opening.
  • a skirt extends around the perimeter and away from the top while surrounding at least a portion of the neck.
  • the skirt has a proximal end adjacent the top and a distal end opposite the proximal end.
  • At least one frangible score line extends from the proximal end of the skirt toward, but terminating prior to, the distal end of the skirt. The at least one frangible score line is configured to break when the cap is detached from the vial.
  • the vial includes an internal chamber for storing a material and has a neck with an opening therethrough in fluid communication with the internal chamber.
  • a cap is detachably and sealingly coupled to the vial and includes a top covering the opening.
  • a skirt having a first section and a second section extends around the perimeter of the cap. The skirt extends away from the top and surrounds at least a portion of the neck. The skirt has a proximal end adjacent the top and a distal end opposite the proximal end.
  • a frangible score line extends circumferentially around at least a portion of the skirt between the first section and the second sections.
  • FIG. 1 is a side perspective view of a vial and tamper evident seal in accordance with one embodiment of the present invention
  • FIG. 2 is an isolated side perspective view of the tamper evident seal of Fig. 1 ;
  • Fig. 3 is a side perspective view of a vial and tamper evident seal in accordance with another embodiment of the present invention;
  • Fig. 4 is a side perspective view of the vial and tamper evident seal of Fig. 3 with a different score line.
  • the present invention relates to a tamper evident seal for a container generally designated 10 as shown in Figs. 1-2.
  • the seal 10 is coupled to a vial 12 or other container to provide a closure for the container 12.
  • the vial 12 includes a body 14 and a neck 16.
  • the body 14 includes an internal chamber 12a for storing material such as liquid drugs or medicament.
  • An opening 12b shown in phantom on Fig. 1 , extends through the neck to establish fluid communication with the internal chamber 12a.
  • a cap 18 is detachably coupled to the vial 12 and seals the vial opening 12b to provide a hermetic seal on the vial 12.
  • the cap 18 includes an upper portion or top 20 and a skirt 22.
  • the upper portion 20 has an outer diameter at least slightly larger than the diameter of the skirt 22.
  • the skirt 22 extends around the perimeter of the upper portion 20 or top of the cap 18 and surrounds at least a portion of the vial neck 16.
  • the skirt 22 has a proximal end 22a adjacent the top 20 of the cap 18 and a lower or distal end 22b opposite the proximal end 22a.
  • a shoulder 24 is formed where the upper portion 20 meets the skirt 22.
  • the upper portion 20 and skirt 22 can have the same diameter and no shoulder is needed (not shown).
  • the skirt 24 can have a larger diameter than the upper portion 20.
  • the skirt 22 is preferably manufactured from a thin rigid material (e.g. metal) that can retain its shape when the skirt 22 is crimped around the neck 16 of the container 12 such that a lower edge 26 of the skirt 22 is secured below a lip (not shown) on the neck 16.
  • One or more and preferably five spaced apart score lines 28 are formed on the skirt 22 which are frangible and designed to fracture as the skirt 22 is pulled away from the neck 18 and the cap 18 is removed or partially removed from the vial 12.
  • Each score line 28 can be a segment having a reduced thickness compared to the rest of the skirt 22 with an indentation formed on an outer surface of the skirt 22 and extending toward, but terminating prior to, an inner surface of the skirt 22.
  • the score lines 28 may be a different material than the rest of the skirt 22 with a lower yield strength such that one or more of the score lines 28 are fractured before the rest of the skirt 22 as explained in greater detail below.
  • the score lines 28 may be the same material and/or thickness as the rest of the skirt 22 but may be chemically or physically treated such that the score lines 28 fracture before the rest of the skirt 22.
  • the score lines 28 extend generally vertically in the embodiment of Figs. 1 -2 and generally horizontally in the embodiment shown in Figs. 3-4. Alternatively, the score lines 28 could extend at an angle and may not extend completely around the skirt 22.
  • the score lines 28 of Figs. 1 -2 terminate at least 0.5 millimeters from the distal end of the skirt 22.
  • the skirt 22 is transitionable between an expanded pre-crimped state and a crimped state as shown in Fig. 1.
  • the score lines 28 may be formed prior to crimping or may be scored during or after crimping the skirt 22 to the vial 12. Although the score lines 28 of Fig. 1 are shown as generally having the same length, one or more score lines 28 may have different lengths.
  • a seal line 30 is created toward the distal end of the skirt 22 which forms the hermetic seal between the skirt 22 and the vial 12.
  • the score lines 28 extend above and beyond the seal line 30 in Fig. 1. Although five score lines are shown in Figs. 1 -2. any number of score lines 28 could be used.
  • the score line 28 of Fig. 3 is a generally horizontal dashed line which extends circumferentially around at least a portion of the skirt 22 and may extend completely around. Furthermore, more than one score line (not shown) could be used or one score line 28 could extend spirally around the skirt 22 completing more than one revolution.
  • the score line of Fig. 4 is a generally horizontal line with a scalloped pattern with peaks 32 and troughs 34 and the troughs are proximate to the distal end 22b of the skirt 22.
  • a zigzag pattern or any other desired pattern could be adopted for the score line 28 provided that the score line is adapted to fracture prior to the rest of the skirt 22.
  • the horizontal score line 28 is proximal to the seal line 30 such that the hermetic seal is destroyed when the score line 28 fractures.
  • a user receives the vial 12 with liquid medicament within the internal chamber.
  • the user visually inspects the skirt 22 to determine if a score line 28 is fractured which would indicate that the contents of the internal chamber may have been tampered with. If none of the score lines 28 is fractured, the user knows the vial 10 has not been tampered with or previously opened so the user removes the cap 18 and skirt 22 from the vial 12.
  • the skirt 22 is removed one or more of the score lines 28 fracture as shown in Fig. 2. At least one of the score lines 28 fractures when the cap 18 is removed but not all the score lines 28 are required to fracture. Similarly, it is not required that the entire horizontal score line 28 fractures when the skirt 22 of the embodiment of Figs. 3 and 4 is removed.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)

Abstract

La présente invention concerne une combinaison de flacon de médicament et de jusqu'à inviolable qui comprend une chambre interne (12) pour stocker un matériau et comporte un col avec une ouverture traversant celui-ci en communication fluidique avec la chambre interne. Un capuchon (18) est couplé de façon amovible et étanche au flacon et comprend une partie supérieure recouvrant l'ouverture. Une jupe (22) s'étend autour du périmètre et à l'écart de la partie supérieure tout en entourant au moins une partie du col (16). La jupe comporte une extrémité proximale adjacente à la partie supérieure et une extrémité distale opposée à l'extrémité proximale. Au moins une ligne de coupe cassable (28) s'étend de l'extrémité proximale de la jupe vers, mais se termine avant, l'extrémité distale de la jupe. Les une ou plusieurs lignes de coupe cassables sont configurées pour se rompre lorsque le capuchon est détaché du flacon.
PCT/US2016/029675 2016-04-28 2016-04-28 Joint d'étanchéité inviolable pour flacon de médicament Ceased WO2017188949A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2016/029675 WO2017188949A1 (fr) 2016-04-28 2016-04-28 Joint d'étanchéité inviolable pour flacon de médicament

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2016/029675 WO2017188949A1 (fr) 2016-04-28 2016-04-28 Joint d'étanchéité inviolable pour flacon de médicament

Publications (1)

Publication Number Publication Date
WO2017188949A1 true WO2017188949A1 (fr) 2017-11-02

Family

ID=55953428

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2016/029675 Ceased WO2017188949A1 (fr) 2016-04-28 2016-04-28 Joint d'étanchéité inviolable pour flacon de médicament

Country Status (1)

Country Link
WO (1) WO2017188949A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20230086975A (ko) * 2021-12-09 2023-06-16 주식회사 골든바이오텍 검체 용기

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3480171A (en) * 1966-12-30 1969-11-25 West Co Container closure
US3870184A (en) * 1973-07-09 1975-03-11 Owens Illinois Inc Easy open metal closure
US4149647A (en) * 1976-08-27 1979-04-17 Gebruder Seidel Kg Metal tear off cap
US6371317B1 (en) * 1998-08-07 2002-04-16 Kerr Group, Inc. Tamper indicating closure with foldable tab
US20050150858A1 (en) * 2004-01-08 2005-07-14 Simport Plastics Ltd. Controllable tamper proof closure for a vial
GB2492586A (en) * 2011-07-07 2013-01-09 Alan Christie Double Tamper Evident Seal

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3480171A (en) * 1966-12-30 1969-11-25 West Co Container closure
US3870184A (en) * 1973-07-09 1975-03-11 Owens Illinois Inc Easy open metal closure
US4149647A (en) * 1976-08-27 1979-04-17 Gebruder Seidel Kg Metal tear off cap
US6371317B1 (en) * 1998-08-07 2002-04-16 Kerr Group, Inc. Tamper indicating closure with foldable tab
US20050150858A1 (en) * 2004-01-08 2005-07-14 Simport Plastics Ltd. Controllable tamper proof closure for a vial
GB2492586A (en) * 2011-07-07 2013-01-09 Alan Christie Double Tamper Evident Seal

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20230086975A (ko) * 2021-12-09 2023-06-16 주식회사 골든바이오텍 검체 용기
KR102684545B1 (ko) 2021-12-09 2024-07-12 주식회사 골든바이오텍 검체 용기

Similar Documents

Publication Publication Date Title
US11484152B2 (en) Container apparatus
CN103459257B (zh) 用于容器的闭合件和具有这种闭合件的容器
JP6309890B2 (ja) 閉鎖装置及びその装置を有する容器
DE602004016197D1 (de) Flasche für fluidprodukte, insbesondere pharmazeutische, medizinische und kosmetische produkte
JP2001517585A (ja) 容器用クロージャーシステム
EP2452890B1 (fr) Bouteille améliorée pour produits fluides, en particulier des produits pharmaceutiques, médicamenteux ou cosmétiques
NZ548279A (en) Needleless access vial
US10675217B2 (en) Spherical pill container with domed lid
JP5385157B2 (ja) プラスティック製アンプル
EP1981771B1 (fr) Dispositif de recipient muni de moyens d'inviolabilité
ES2976289T3 (es) Sistema de cierre para un envase de medicamento y envase de medicamento con un sistema de cierre
US7175057B2 (en) Dropper bottle
CN107735335A (zh) 显窃启封闭件
AU594144B2 (en) Tamper-resistant package
WO2017188949A1 (fr) Joint d'étanchéité inviolable pour flacon de médicament
WO2012033472A1 (fr) Récipient destiné à la mise sous emballage de deux composants
EP2423122B1 (fr) Flacons de médicaments pour l'extraction d'un produit de remplissage présenté en morceaux
EP3083435B1 (fr) Capsule inviolable pour contenants
KR20100004811U (ko) 실링구조를 갖는 화장품 용기
EP3307115A1 (fr) Embout buccal pour boire directement aux canettes de boisson
EP3738900B1 (fr) Récipient, en particulier pour médicaments
CN109715513A (zh) 封盖
KR200266715Y1 (ko) 성분이 다른 두 종류의 내용물을 분리 보관 및 혼합사용이 가능한 포장용 용기
HK1077793B (en) Dropper bottle
JP2003312705A (ja) スリットバルブを備える容器

Legal Events

Date Code Title Description
NENP Non-entry into the national phase

Ref country code: DE

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16721598

Country of ref document: EP

Kind code of ref document: A1

122 Ep: pct application non-entry in european phase

Ref document number: 16721598

Country of ref document: EP

Kind code of ref document: A1