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WO2010089388A1 - Enceinte de confinement pour bouteilles, flacons et autres récipients - Google Patents

Enceinte de confinement pour bouteilles, flacons et autres récipients Download PDF

Info

Publication number
WO2010089388A1
WO2010089388A1 PCT/EP2010/051485 EP2010051485W WO2010089388A1 WO 2010089388 A1 WO2010089388 A1 WO 2010089388A1 EP 2010051485 W EP2010051485 W EP 2010051485W WO 2010089388 A1 WO2010089388 A1 WO 2010089388A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
containment
bottle
retaining insert
vial
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/EP2010/051485
Other languages
English (en)
Inventor
Thomas Schlieper
Boris Schwab
Douwe Hoekstra
Michael Spettl
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.)
Sandoz AG
Original Assignee
Sandoz AG
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 Sandoz AG filed Critical Sandoz AG
Publication of WO2010089388A1 publication Critical patent/WO2010089388A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/048—Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical
    • B65D77/0486—Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical the inner container being coaxially disposed within the outer container
    • B65D77/0493—Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical the inner container being coaxially disposed within the outer container and retained at a distance of the inner side-wall of the outer container, e.g. within a bottle neck

Definitions

  • the invention concerns a containment for bottles, vials and like containers in accordance with the pre-characterizing clause of claim 1.
  • cyto-toxic substances In pharmaceutical and clinical applications very often toxic and cyto-toxic substances must be handled. Usually such substances are contained in bottles, vials and like containers made of glass. Bottles containing e.g. cyto-toxic substances usually in liquid form constitute a considerable risk for unprotected personnel and, therefore, in many countries there are very strict rules for the handling and/or transportation of such substances. Cyto-toxic substances usually are not administrated in their original concentrations in which they are provided in bottles or vials from the manufacturer. For administration to a patient they are typically diluted and/or combined with other substances. During handling of the substances, care must be taken to avoid that the handling personnel be contaminated with these substances.
  • the equipment and the environment of the laboratory must be protected from getting contaminated with these substances, since otherwise the expense for carefully cleaning such equipment and environment is very high. Contamination may occur, for example, when these substances are spilled and/or when the exterior of the bottle or vial is soiled. Also, contamination may occur when a bottle or vial breaks allowing the toxic or cytotoxic substance to escape from the bottle or vial.
  • WO 02/46060 In order to avoid contamination of the handling personnel, in WO 02/46060 it has been suggested to accommodate a bottle containing a hazardous liquid - such as a toxic or cytotoxic liquid - in an exterior container with a closure cap for tightly closing the container.
  • the container and the closure cap are provided with spacer ribs distributed over their respective interior circumferences for supporting the body and the neck of the bottle.
  • the spacer ribs in the container are supposed to clampingly seat the received bottle.
  • the specific design of the container with closure cap is supposed to prohibit breakage of the bottle. Even in case the bottle breaks the contents thereof are collected in the closed container and thus do not contaminate the environment.
  • the container of WO 02/46060 is also supposed to assist in preventing the handling personnel from coming into contact with the exterior of the bottle which during handling may have been soiled with the toxic or cyto-toxic substance contained in the bottle.
  • the neck of the bottle projects above the upper rim of the container.
  • a containment for such bottles, vials and like containers for hazardous contents, such as e.g. toxic or cyto-toxic liquids, which substantially eliminates the danger of contamination during transport and handling.
  • a containment shall be provided which ensures safe transport and handling and which may be suitable for accommodating bottles or vials of different sizes.
  • a containment for bottles, vials or the like with toxic, cytotoxic contents or the like which comprises a container having an open end for receiving a bottle, vial or the like and a closure cap for tightly closing the container.
  • the containment comprises a separate retaining insert which can be securely attached to the container in the vicinity of the open end thereof and which has a central opening for a neck portion of the bottle, vial and the like.
  • the separate retaining insert serves for securely retaining a bottle, vial or the like which is accommodated in the container.
  • the central opening of the retaining insert is large enough to allow the neck of the bottle, vial or the like to protrude therethrough, but too small for the rest of the bottle, vial or the like to slip through.
  • the retaining insert is securely attached thereto, and the closure cap is then mounted to the container, e.g. by screwing it onto the container.
  • the closure cap is later on removed the bottle, vial or the like cannot fall out of the container even if the latter is turned upside down.
  • the bottle, vial or the like rests with its shoulder against the retaining insert, but is retained inside the container.
  • handling of the containment and of the therein accommodated bottle, vial or the like is improved.
  • the risk of the bottle, vial or the like falling out of the container, of breakage and of contamination of the environment is at least greatly reduced if not eliminated.
  • the containment protects the bottle, vial or the like accommodated therein during transport. In case a breakage occurs, the hazardous contents are retained inside the hermetically closed container/closure cap arrangement.
  • the containment consists of only three components, namely the container, the closure cap, and the retaining insert, which are easy and cheap to manufacture and can be easily assembled. The components may be mass-manufactured in the desired size without departing from the basic concept according to the invention.
  • the sterile containment is placed in a glove-box the interior of which also contains a sterile environment, and the containment can then be opened with the gloves of the glove-box and its contents be accessed under sterile conditions. After that, the containment can be re-closed again under sterile conditions in the glove-box and the containment (closed under sterile conditions) can then be placed in the refrigerator.
  • any extra sterilisation can be dispensed with.
  • the retaining insert may be glued or welded to the container
  • the container along an interior circumference thereof is provided with protrusions for securing the retaining insert in place.
  • the container in close vicinity to the circumferentially arranged protrusions is provided with a circumferentially running shoulder such, that the attached retaining insert is secured in between that annular shoulder and the circumferentially arranged protrusions.
  • the safety of the containment is even further improved.
  • the retaining insert is mounted to the container only once. Thus, a wearing down of the locking protrusions, which might occur in a detachable assembly, is avoided.
  • this embodiment of the invention in which the retaining insert may only be removed by destroying the assembly, allows an easy detection of any unauthorized manipulation, in which the bottle, vial or the like was removed from the container.
  • the retaining insert may be provided with resilient radial flaps which are distributed about its circumference with the free ends thereof delimiting the central opening. In the assembled state the radial flaps press against the neck and shoulder of the bottle, vial or the like and enhance its secure retainment within the container. The resilient flaps also serve for a slight absorption and compensation of impacts which might occur during transport and handling, thus protecting the bottles, vials and the like from breaking.
  • the container may be provided with spacer ribs which are distributed about its interior circumference. The spacer ribs enhance the rigidity and stability of the container and serve for better fixation of the bottle, vial and the like inside the container. In addition, the spacer ribs protect the bottle, vial and the like from the consequences of impacts, e.g. in case the containment accidentally falls down.
  • the container is made of a transparent or translucent plastic material.
  • the closure cap and/or the retaining insert are also made from a transparent or translucent plastic material.
  • Preferred materials for the container and/or the closure cap and/or the retaining insert include polyolefines, e.g. polypropylene, laminates and co-extrusions of transparent and translucent plastic materials.
  • An alternative preferred material is polyethyleneter- ephthalate (PET). The properties of these materials are well known and they have proved their suitability in mass manufacturing processes. Suitable manufacturing processes for the containment or the components thereof, respectively, include blow molding processes, injection molding processes, or a deep drawing processes.
  • the container and the closure cap may be releasably attached to each other by various means.
  • the container and closure cap are provided with mating threads or like fastening elements.
  • the container has a greater axial length than the bottle, vial or the like to be accommodated therein.
  • This embodiment provides for additional safety against breakage of the bottle, vial or the like in case that e.g. the opened container accidentally falls down, topples over, or in case an article is accidentally dropped upon the open container.
  • Fig. 1 shows an exploded view of an embodiment of the containment according to the invention
  • Fig. 2 shows a sectional view of the assembled containment of Fig. 1 ;
  • Fig. 3 shows a sectional view of the assembled containment of Fig. 2 with a bottle held in place;
  • Fig. 4 is a perspective view from above showing the container of the containment of Fig. 1 with a retaining insert in place;
  • Fig. 5 is a perspective view from above into the container of the containment of Fig. 1 without the retaining insert;
  • Fig. 6 is an enlarged view of the separate retaining insert of the embodiment of the containment of Fig. 1.
  • FIG. 1 an embodiment of a containment for bottle, vials or the like with toxic, cyto-toxic contents or the like is generally designated with reference numeral 1.
  • the transport containment comprises an elongated container 2 having a closed bottom 3 and an open end 4.
  • a closure cap 5 is releasably attachable to the container 2 for tightly closing it.
  • the container 2 in vicinity of its open end 4 and the closure cap 5 are provided with mating threads 6 or the like fastening elements.
  • the closure cap 5 has a circumferential inwardly projecting rim 50 radially abutting against the inner wall of the container at the upper end of the container, and the rim at the open end of the container 2 abuts against the inner surface of the closure cap 5.
  • the closure cap 5 is provided with a protruding bar-like rib 51 or the like to facilitate gripping thereof.
  • An annular retaining insert 8 is provided, which is adapted to be attached securely inside the container for holding an inserted bottle, vial or the like safely in place.
  • the retaining insert 8 is provided with a central opening 10 for the neck portion of a bottle, vial or the like.
  • Fig. 2 shows the containment 1 of Fig. 1 in the assembled state, with the closure cap 5 screwed onto the open end of the container 2.
  • the mating threads on the outside of the container 2 and on the inside of the closure cap 5 are designated with reference numerals 6 and 7, respectively.
  • the retaining insert 8 is attached to the inside of the container 2 in the vicinity of the open end 4 thereof and is secured in place in between an annular shoulder 1 1 of the container 2 and protrusions 12 which are provided at an interior circumference of the container.
  • the annular retaining insert 8 is formlockingly secured in place inside the container 2.
  • Fig. 3 is a perspective sectional view of the containment 1 , with the container 2 accommodating a bottle 20 which may contain a toxic, cyto-toxic or the like substance.
  • the bottle 20 is secured in between the closed bottom 3 of the container 2 and the annular retaining insert 8 which is formlockingly attached to the interior circumference of the container 2.
  • the annular retaining insert 8 is non-detachably secured inside the container 2.
  • the retaining insert 8 is provided with resilient radial flaps 9 which are distributed about its circumference and which project essentially radially inwardly. The free ends of the flaps 9 delimit the central opening 10 and are pressing against the neck 21 of the bottle 20.
  • the inserted bottle 20 is axially firmly secured.
  • the radial flaps 9 are slightly curved towards the open end 4 of the container 2, thus enabling a better abutment against the neck 21 of the bottle 20. Due to the flexibility of the radial flaps 9 axial impacts are dampened and are mostly compensated.
  • spacer ribs 13 are provided along the interior circumference of the container 2. As shown in Fig. 3, the container 2 may have a greater axial length than the bottle 20 accommodated therein. This provides for additional safety against breakage of the bottle 20, in case that e.g. the opened container 2 accidentally falls down, topples over, or an article falls upon the open container 2 (closure cap 5 unscrewed).
  • Fig. 4 shows a view from above into the opened container 2.
  • the annular retaining insert 8 is firmly held in place by the protrusions 12 which are distributed about the interior circum- ference of the container 2.
  • the resilient radial flaps 9 of the annular retaining insert 8 delimit the central opening 10 thereof.
  • the annular retaining insert 8 (see Fig. 4) is not shown. This allows a better view of the annular shoulder 11 of the container 2 and of the protrusions 12, which are located along an interior circumference and close to the open end 4 of the container 2.
  • the axial distance between the annular shoulder 11 and the protrusions 12 is such, that the outer rim of the annular retaining insert 8 is easily accommodated therebetween but is firmly secured.
  • Reference numeral 13 designates the spacer ribs which are distributed along the interior circumference of the container 2. The spacer ribs 13 may extend across the closed bottom 3 of the container 2.
  • the container 2 On the outer surface of its wall the container 2 is provided with indentations which simplifies gripping the container 2, for example if gloves are worn by the personnel when handling the containment.
  • FIG. 6 the annular retaining insert 8 is depicted. From a circumferentially extending rim a number of resilient radial flaps 9 extend essentially radially inwardly towards the center of the retaining insert 8. The free ends of the radial flaps 9 delimit the central opening 10. The radial flaps 9 are separated from each other by radially extending slots which widen towards the circumferential rim, thus enhancing the flexibility of the radial flaps 8.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)

Abstract

Une enceinte de confinement (1) pour bouteilles (20), flacons ou autres comportant un contenu toxique ou cytotoxique ou autre comprend un récipient (2) possédant une extrémité ouverte (4) destinée à recevoir une bouteille un flacon ou autre et un bouchon de fermeture (5) destiné à fermer de manière étanche le récipient (2). L'enceinte de confinement comprend en outre un insert de retenue distinct (8), qui peut être fixé solidement au récipient (2) à proximité de l'extrémité ouverte (4) de celui-ci et qui possède une ouverture centrale (10) pour une partie goulot (21) de la bouteille (20), du flacon et autres.
PCT/EP2010/051485 2009-02-09 2010-02-08 Enceinte de confinement pour bouteilles, flacons et autres récipients Ceased WO2010089388A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09152414.0 2009-02-09
EP09152414A EP2216265A1 (fr) 2009-02-09 2009-02-09 Contenu pour bouteilles, flacons et récipient similaires

Publications (1)

Publication Number Publication Date
WO2010089388A1 true WO2010089388A1 (fr) 2010-08-12

Family

ID=40456816

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/051485 Ceased WO2010089388A1 (fr) 2009-02-09 2010-02-08 Enceinte de confinement pour bouteilles, flacons et autres récipients

Country Status (2)

Country Link
EP (1) EP2216265A1 (fr)
WO (1) WO2010089388A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013088970A1 (fr) 2011-12-15 2013-06-20 テルモ株式会社 Instrument médical

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013049178A2 (fr) * 2011-09-27 2013-04-04 The Board Of Regents Of The University Of Texas System Mélangeur de perfusion robotique et cartouche transportable
HUP1100675A2 (en) * 2011-12-09 2013-06-28 Dezsoe Matyi Packaging for bottles
CA2955469A1 (fr) 2017-01-20 2018-07-20 Robert Kamen Dispositif de transport de matieres presentant un danger biologique

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3246999A1 (de) * 1982-11-10 1984-05-10 Institut Virion AG, 8803 Rüschlikon Verpackung
WO2002046060A1 (fr) 2000-12-06 2002-06-13 Ebewe Pharma Ges.M.B.H. Nfg.Kg Emballage pour transport de bouteilles
US20070108205A1 (en) * 2005-11-03 2007-05-17 Bristol-Myers Squibb Company Protective outer enclosure for pharmaceutical vial
DE102007029587A1 (de) * 2007-06-27 2009-01-08 Stada Arzneimittel Ag Schutzbehälter für Behälter aus zerbrechlichem Material

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3246999A1 (de) * 1982-11-10 1984-05-10 Institut Virion AG, 8803 Rüschlikon Verpackung
WO2002046060A1 (fr) 2000-12-06 2002-06-13 Ebewe Pharma Ges.M.B.H. Nfg.Kg Emballage pour transport de bouteilles
US20070108205A1 (en) * 2005-11-03 2007-05-17 Bristol-Myers Squibb Company Protective outer enclosure for pharmaceutical vial
DE102007029587A1 (de) * 2007-06-27 2009-01-08 Stada Arzneimittel Ag Schutzbehälter für Behälter aus zerbrechlichem Material

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013088970A1 (fr) 2011-12-15 2013-06-20 テルモ株式会社 Instrument médical
US9480621B2 (en) 2011-12-15 2016-11-01 Terumo Kabushiki Kaisha Medical instrument

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Publication number Publication date
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