WO2000002795A1 - Dual vial connecting system - Google Patents

Dual vial connecting system Download PDF

Info

Publication number
WO2000002795A1
WO2000002795A1 PCT/EP1998/004290 EP9804290W WO0002795A1 WO 2000002795 A1 WO2000002795 A1 WO 2000002795A1 EP 9804290 W EP9804290 W EP 9804290W WO 0002795 A1 WO0002795 A1 WO 0002795A1
Authority
WO
WIPO (PCT)
Prior art keywords
glass vial
plastic bottle
connection
neck
closing
Prior art date
Application number
PCT/EP1998/004290
Other languages
French (fr)
Inventor
Franck Moisio
Franz A. Klug
Original Assignee
Pentapharm 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 Pentapharm Ag filed Critical Pentapharm Ag
Priority to PCT/EP1998/004290 priority Critical patent/WO2000002795A1/en
Priority to AU88601/98A priority patent/AU8860198A/en
Publication of WO2000002795A1 publication Critical patent/WO2000002795A1/en

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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3205—Separate rigid or semi-rigid containers joined to each other at their external surfaces
    • B65D81/3211—Separate rigid or semi-rigid containers joined to each other at their external surfaces coaxially and provided with means facilitating admixture
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end

Definitions

  • the present invention concerns a dual vial connecting system for temporary connection of two containers, namely a glass vial and a plastic bottle, for the purpose of reconstituting a lyophilized or powder product contained in the glass vial or plastic container with a corresponding solvent product contained in the plastic bottle, the connecting system having tubular closing and connecting means with a lower portion for connection to the neck of the glass vial, an upper portion having an internal thread for screwing connection with of the plastic bottle and sealing means being perforable by the orifice reducer of the plastic bottle when screwed into the upper portion of the closing and connecting means.
  • the two products are kept and stored in separate containers prior to their immediate use.
  • the two containers are hermetically closed.
  • the closing and connecting means is constituted by a cylindrical ring which is combined with a rubber stopper for tightness and connection between the glass vial and the plastic bottle.
  • a rubber stopper for tightness and connection between the glass vial and the plastic bottle.
  • the orifice reducer perforates a membrane.
  • the plastic bottle is compressed in order to transfer the solvent into the glass vial.
  • a solution is formed when shaking the assembly. By inverting the assembly, the solution is caused to return into the plastic bottle when squeezed.
  • N° PCT/EP 97/04660 in which a dual vial connecting system is described which operates without a rubber stopper and is characterized by sealing rings to ensure tightness of closure and connection.
  • the aim of the present invention is a dual container connect-, ing system, which may or may not have a rubber stopper but ensures a tight closure of the glass vial containing the lyophilized product as well as a tight connection between the glass vial and the solvent bottle and at the same time is more flexible in the choice of resins, colorants and applications .
  • the upper portion and the lower portion of the closing and connecting means being two separate pieces, the upper piece having an essentially tubular shape fitting onto the upper portion of the rubber stopper and/or the glass vial neck and having a threaded interior surface for accomodating the threaded neck portion and the orifice reducer of the plastic bottle and a flanged lower rim resting on the opening of the glass vial, the lower piece being constituted by a sleeve fitting over the flange of the upper piece and the glass vial neck to hold the upper piece on top of the glass vial.
  • the glass vial is closed in a conventional manner by a rubber stopper held by an aluminum ring.
  • the sleeve fits over both the tubular upper piece as well as the rubber stopper and the aluminum ring.
  • Fig. 1 shows a schematic representation of one preferred embodiment of the dual vial connecting system according to the invention
  • Fig. 2 shows another preferred embodiment of the dual vial connecting system according to the invention
  • a glass vial 1 contains a solid product such as a lyophili- sate 2.
  • the glass vial shown in Fig.1 is closed by a rubber stopper 3 which is held in place by an aluminum cramping ring 4.
  • this substance has to be mixed or redissolved with a solvent stored separately in a second container 5 made of a flexible material such as plastic.
  • the two containers have to be connected in such a way that the solvent may be transferred into the glass vial containing the lyophilisate and where the mixing and reconstitution takes place.
  • An upper piece 6 of a plastic closing and connecting means has a tubular shape and is provided with a threaded inner surface 7 and a flange 8 at its lower end.
  • the flange 8 has a conical upper surface.
  • Upper piece 6 is placed on top of the rubber stopper 3 and ring 4 and is held in place by a sleeve 9 which due to conical internal surfaces exerts pressure onto the flange 8 of upper piece 6.
  • a sleeve 9 which due to conical internal surfaces exerts pressure onto the flange 8 of upper piece 6.
  • FIG. 2 The embodiment shown in Fig. 2 is very similar to one embodiment of co-pending international patent application N° PCT/EP 97 04660 which is hereby incorporated by reference. The following description mainly emphasizes the distinctions rather than repeating the features already described in the reference.
  • the glass vial 1 is not closed by a rubber stopper but is directly closed by the upper piece 6 of a closure and connecting means.
  • the upper piece 6 has an integral membrane 12 and sealing rings 16, 17. Similar to the embodiment of Fig. 1 the upper piece 6 has a threaded internal surface 14 and a flange 13 at its lower rim.
  • a skirt 15 extends downwardly from the membrane 12 and has an outer diameter fitting into the inner bottle neck.
  • the skirt 15 is an integral part of the upper piece 6, i.e. it is molded in one piece with the latter.
  • the second means for effecting tightness is the elastomer sealing ring 16 placed around the skirt 15, thus being positioned between the flange 13 and the vial neck. Inside the upper piece 6 is located the sealing ring 17 to guarantee complete sealing.

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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
  • Package Specialized In Special Use (AREA)

Abstract

For temporary connection of two containers (1, 5) such as vials, bottles, etc., with guaranteed tightness thanks to a two piece tubular connecting device (6, 9) having either a perforable plastic membrane (12) located between its upper piece (6) and the lower piece (9) including a first sealing ring (16) fixed around a plastic skirt (15) located under the bottom of the upper piece, and a second sealing ring (17) fixed inside the upper piece, or alternatively, a rubber stopper (3) in the vial neck covered by the two piece tubular connecting device, the whole assuring complete tightness of the system when stored and when used for reconstitution of the products.

Description

DUAL VIAL CONNECTING SYSTEM
The present invention concerns a dual vial connecting system for temporary connection of two containers, namely a glass vial and a plastic bottle, for the purpose of reconstituting a lyophilized or powder product contained in the glass vial or plastic container with a corresponding solvent product contained in the plastic bottle, the connecting system having tubular closing and connecting means with a lower portion for connection to the neck of the glass vial, an upper portion having an internal thread for screwing connection with of the plastic bottle and sealing means being perforable by the orifice reducer of the plastic bottle when screwed into the upper portion of the closing and connecting means.
For reasons of stability, freshness, marketing aspects etc. the two products (respective contents of the two containers) are kept and stored in separate containers prior to their immediate use. During storage the two containers are hermetically closed.
In a commonly used prior art system the closing and connecting means is constituted by a cylindrical ring which is combined with a rubber stopper for tightness and connection between the glass vial and the plastic bottle. For connecting two containers of this type it is known to screw the plastic bottle containing the solvent into the upper internal threaded portion of the closing and connecting ring snapped on the glass vial containing the product. When screwing in the solvent bottle, the orifice reducer perforates a membrane. The plastic bottle is compressed in order to transfer the solvent into the glass vial. A solution is formed when shaking the assembly. By inverting the assembly, the solution is caused to return into the plastic bottle when squeezed. Reference is made to co-pending international patent application N° PCT/EP 97/04660 in which a dual vial connecting system is described which operates without a rubber stopper and is characterized by sealing rings to ensure tightness of closure and connection.
The aim of the present invention is a dual container connect-, ing system, which may or may not have a rubber stopper but ensures a tight closure of the glass vial containing the lyophilized product as well as a tight connection between the glass vial and the solvent bottle and at the same time is more flexible in the choice of resins, colorants and applications .
According to the invention this is achieved by the upper portion and the lower portion of the closing and connecting means being two separate pieces, the upper piece having an essentially tubular shape fitting onto the upper portion of the rubber stopper and/or the glass vial neck and having a threaded interior surface for accomodating the threaded neck portion and the orifice reducer of the plastic bottle and a flanged lower rim resting on the opening of the glass vial, the lower piece being constituted by a sleeve fitting over the flange of the upper piece and the glass vial neck to hold the upper piece on top of the glass vial.
According to another preferred embodiment of the invention the glass vial is closed in a conventional manner by a rubber stopper held by an aluminum ring. In this embodiment the sleeve fits over both the tubular upper piece as well as the rubber stopper and the aluminum ring.
The various measures known in the prior art or contained in the above-mentioned co-pending patent application for improving tightness may of course be combined with the present invention.
In the following preferred embodiments of the invention are described with regard to the accompanying drawings, wherein : Fig. 1 shows a schematic representation of one preferred embodiment of the dual vial connecting system according to the invention and
Fig. 2 shows another preferred embodiment of the dual vial connecting system according to the invention
A glass vial 1 contains a solid product such as a lyophili- sate 2. The glass vial shown in Fig.1 is closed by a rubber stopper 3 which is held in place by an aluminum cramping ring 4. In order to obtain a ready to use solution, this substance has to be mixed or redissolved with a solvent stored separately in a second container 5 made of a flexible material such as plastic. For the mixing and reconstitution process, the two containers have to be connected in such a way that the solvent may be transferred into the glass vial containing the lyophilisate and where the mixing and reconstitution takes place. After shaking the solution contained in the glass vial 1 , the system is inverted, having now the glass vial on top so that the solution may be retransferred into the plastic bottle by squeezing the plastic bottle 5. During this entire process, no liquid must be lost and no leakage must occur.
An upper piece 6 of a plastic closing and connecting means has a tubular shape and is provided with a threaded inner surface 7 and a flange 8 at its lower end. The flange 8 has a conical upper surface. Upper piece 6 is placed on top of the rubber stopper 3 and ring 4 and is held in place by a sleeve 9 which due to conical internal surfaces exerts pressure onto the flange 8 of upper piece 6. Thus, secure and tight connection between the upper piece 6 and the vial 1 is ensured.
When the solvent plastic bottle 5 is screwed into the thread of the upper piece 6 its orifice reducer 10 perforates a membrane on top of the rubber stopper 3 and assures tightness by being in contact with the wall of the center hole of the stopper 3. The two containers are now connected and the transfer of the solvent contained in the plastic bottle 5 into the glass vial 1 containing the lyophilisate 2 may be effected by squeezing the plastic bottle 5. After reconstitution, the solution may be sucked back into the plastic bottle 5 by inverting the assembly. The whole procedure can be made without any spilling or leakage.
The embodiment shown in Fig. 2 is very similar to one embodiment of co-pending international patent application N° PCT/EP 97 04660 which is hereby incorporated by reference. The following description mainly emphasizes the distinctions rather than repeating the features already described in the reference.
In the embodiment of Fig. 2 the glass vial 1 is not closed by a rubber stopper but is directly closed by the upper piece 6 of a closure and connecting means. The upper piece 6 has an integral membrane 12 and sealing rings 16, 17. Similar to the embodiment of Fig. 1 the upper piece 6 has a threaded internal surface 14 and a flange 13 at its lower rim.
Tightness between the upper piece 6 and the vial neck is ensured by two cooperating features: A skirt 15 extends downwardly from the membrane 12 and has an outer diameter fitting into the inner bottle neck. The skirt 15 is an integral part of the upper piece 6, i.e. it is molded in one piece with the latter. The second means for effecting tightness is the elastomer sealing ring 16 placed around the skirt 15, thus being positioned between the flange 13 and the vial neck. Inside the upper piece 6 is located the sealing ring 17 to guarantee complete sealing.
The major advantage of this second embodiment is its special suitability for fully automatical lyophilisation process, as described in detail in the referenced co-pending patent specification .
In addition to the two embodiments described above various combinations of prior art systems may easily be combined with the essential features of the present invention without exceeding the scope of the invention.

Claims

1. A connecting system for temporary connection of two containers, namely a glass vial and a plastic bottle, for the purpose of reconstituting a product contained in the glass vial with a corresponding solvent product contained in the plastic bottle, the connecting system having tubular closing and connecting means with a lower portion having inwardly directed projections for snapping connection to the neck of the glass vial, an upper portion having an internal thread for screwing connection with of the plastic bottle and an integrated membrane being perforable by the orifice reducer of the plastic bottle when screwed into the upper portion of the closing and connecting means, characterised by the closing and connecting means being constituted by an essentially tubular connection and closure piece fitting onto the glass vial neck and having an upwardly extending annular collar for accommodating the threaded neck portion and the orifice reducer of the plastic bottle and a lower flanged portion for resting on the opening of the glass vial, and a separate sleeve fitting over the flanged portion of the the glass vial neck to hold the connection and closure piece on top of the glass vial.
PCT/EP1998/004290 1998-07-10 1998-07-10 Dual vial connecting system WO2000002795A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/EP1998/004290 WO2000002795A1 (en) 1998-07-10 1998-07-10 Dual vial connecting system
AU88601/98A AU8860198A (en) 1998-07-10 1998-07-10 Dual vial connecting system

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP1998/004290 WO2000002795A1 (en) 1998-07-10 1998-07-10 Dual vial connecting system

Publications (1)

Publication Number Publication Date
WO2000002795A1 true WO2000002795A1 (en) 2000-01-20

Family

ID=8166997

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/004290 WO2000002795A1 (en) 1998-07-10 1998-07-10 Dual vial connecting system

Country Status (2)

Country Link
AU (1) AU8860198A (en)
WO (1) WO2000002795A1 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005068320A1 (en) * 2004-01-19 2005-07-28 Taisei Kako Co., Ltd. Mixing container set in use
US20200369454A1 (en) * 2017-12-08 2020-11-26 Unipharma, Llc Container and method for reconstitution of substances
GB2589347A (en) * 2019-11-27 2021-06-02 Fluorogenics Ltd Freeze-drying apparatus and method
JP2022503384A (en) * 2018-10-19 2022-01-12 コラダン エスエイエス A device that temporarily connects two containers

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2188565A5 (en) * 1972-06-13 1974-01-18 Semco Emballage Conditio
FR2427960A1 (en) * 1978-06-06 1980-01-04 Dehais Claude Polypropylene adaptor for linking two bottles - with an integral diaphragm for sterile protection
EP0283629A1 (en) * 1987-03-24 1988-09-28 Semco Packaging for extemporaneous preparations
FR2682088A1 (en) * 1991-10-04 1993-04-09 Emballages Conditionnement Package for the extemporaneous preparation of medicinal products
EP0793954A1 (en) * 1996-03-04 1997-09-10 Charles Manni Packaging unit for freeze-dried preparations

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2188565A5 (en) * 1972-06-13 1974-01-18 Semco Emballage Conditio
FR2427960A1 (en) * 1978-06-06 1980-01-04 Dehais Claude Polypropylene adaptor for linking two bottles - with an integral diaphragm for sterile protection
EP0283629A1 (en) * 1987-03-24 1988-09-28 Semco Packaging for extemporaneous preparations
FR2682088A1 (en) * 1991-10-04 1993-04-09 Emballages Conditionnement Package for the extemporaneous preparation of medicinal products
EP0793954A1 (en) * 1996-03-04 1997-09-10 Charles Manni Packaging unit for freeze-dried preparations

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005068320A1 (en) * 2004-01-19 2005-07-28 Taisei Kako Co., Ltd. Mixing container set in use
US20200369454A1 (en) * 2017-12-08 2020-11-26 Unipharma, Llc Container and method for reconstitution of substances
JP2022503384A (en) * 2018-10-19 2022-01-12 コラダン エスエイエス A device that temporarily connects two containers
JP7368387B2 (en) 2018-10-19 2023-10-24 コラダン エスエイエス A device that temporarily connects two containers
US11925601B2 (en) 2018-10-19 2024-03-12 Coradin Sas Device for temporarily connecting two containers
GB2589347A (en) * 2019-11-27 2021-06-02 Fluorogenics Ltd Freeze-drying apparatus and method

Also Published As

Publication number Publication date
AU8860198A (en) 2000-02-01

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