WO2003045477B1 - System for filling and assembling pharmaceutical delivery devices - Google Patents

System for filling and assembling pharmaceutical delivery devices

Info

Publication number
WO2003045477B1
WO2003045477B1 PCT/CA2002/001772 CA0201772W WO03045477B1 WO 2003045477 B1 WO2003045477 B1 WO 2003045477B1 CA 0201772 W CA0201772 W CA 0201772W WO 03045477 B1 WO03045477 B1 WO 03045477B1
Authority
WO
WIPO (PCT)
Prior art keywords
piston
sleeve
assembly
rimmed
syringe
Prior art date
Application number
PCT/CA2002/001772
Other languages
French (fr)
Other versions
WO2003045477A1 (en
Inventor
David L Reynolds
Original Assignee
Duoject Inc
David L Reynolds
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 Duoject Inc, David L Reynolds filed Critical Duoject Inc
Priority to CA002505162A priority Critical patent/CA2505162A1/en
Priority to DE60230915T priority patent/DE60230915D1/en
Priority to EP20020779077 priority patent/EP1455865B1/en
Priority to AU2002342479A priority patent/AU2002342479A1/en
Publication of WO2003045477A1 publication Critical patent/WO2003045477A1/en
Publication of WO2003045477B1 publication Critical patent/WO2003045477B1/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
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • A61L2/06—Hot gas
    • A61L2/07—Steam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/206—Ethylene oxide
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2821—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers applying plugs or threadless stoppers
    • 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
    • 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
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A61M5/31505—Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit
    • A61M2005/31506—Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit formed as a single piece, e.g. moulded
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/04—Tools for specific apparatus
    • A61M2209/045—Tools for specific apparatus for filling, e.g. for filling reservoirs
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/53—Means to assemble or disassemble
    • Y10T29/53313—Means to interrelatedly feed plural work parts from plural sources without manual intervention
    • Y10T29/53322—Means to assemble container
    • Y10T29/53339—Hypodermic syringe

Abstract

A system is provided which permits syringe barrels of prefilled disposable syringes to be filled and capped on standard vial filling equipment, and which permits the syringe body and piston comprising the barrel to be simultaneously sterilized by a sterilizing gas. The system provides means for stabilizing syringe barrels so they can be conveyed upright on their bases without tipping through vial filling and capping equipment. Preferably, the stabilizing means comprises a cylindrical sleeve into which the lower end of the syringe body is inserted, thereby stably supporting it against tipping. The system also provides means by which the piston is retained in close proximity to the lower end of the syringe body, but slightly separated therefrom to permit access to all surfaces of the piston by a sterilizing gas. Preferably, the piston is retained directly below the lower end of the syringe body, and substantially centred therewith, to permit the piston to be inserted into the lower end of the body merely by pushing the body and piston together.

Claims

30AMENDED CLAIMSReceived by the International Bureau on 26 May 2003 (26.05.2003) original claims 1-32 replaced by amended claims 1-31.
1. An assembly for forming a barrel of a pre-filled syringe, comprising:
(a) a syringe body having a generally cylindrical side wall with an inner surface and an outer surface, the side wall extending between a neck end and an open rimmed end;
(b) a generally cylindrical elastome ic piston having an upper surface, a side surface adapted to form a hermetic seal with the inner surface of the cylindrical side wall when inserted into the open rimmed end of the syringe body, and a lower surface opposite the upper surface, the upper surface of the piston being closer to the neck end than the lower surface when the piston is inserted into the open rimmed end of the syringe body;
(c) a generally cylindrical sleeve having a base end and a top end, wherein said syringe body is received inside the top end of the sleeve in a close fit with the rimmed end of the syringe body located intermediate the top end and the base end of the sleeve;
(d) piston support means in contact with the sleeve, said piston support means having a support surface on which the piston is supported with its upper surface spaced from the rimmed end of the syringe body and substantially concentric therewith, such that a gap exists between the upper surface of the piston and the rimmed end of the syringe body, thereby permitting sterilization of the syringe body and the piston by a sterilizing gas.
2. The assembly of claim 1, wherein the base end of the sleeve has an outwardly projecting flange.
3. The assembly of claim 2, wherein the flange has a substantially flat radially outwardly facing wall which is substantially vertical when the assembly is standing upright. 31
4. The assembly of claim 1, wherein the sleeve has an inwardly projecting portion intermediate the base end and the top end for supporting the rimmed end of the syringe body.
5. The assembly of claim 4, wherein the inwardly projecting portion comprises a detent of sufficient shape and size to retain the rimmed end of the syringe body intermediate the top end and the base end of the sleeve in the absence of a force which pushes the rimmed end of the syringe body and the base end of the sleeve toward one another, but which permits the rimmed end and the base end to be pushed toward one another in response to a predetermined force.
6. The assembly of claim 1 , wherein the piston support means is integrally formed with the sleeve, and comprises a piston support surface located radially inwardly of the inner surface of the syringe body side wall.
7. The assembly of claim 6, wherein the piston support surface is annular with a central aperture through which the piston can be engaged by a plunger.
8. The assembly of claim 7, wherein the piston support surface is positioned relative to the base end of the sleeve such that the piston is supported above the base end of the sleeve when the assembly is standing upright.
9. The assembly of claim 8, wherein the piston support surface is spaced inwardly from the inner surface of the sleeve by a distance substantially equal to a thickness of the syringe body side wall, thereby forming an annular recess between the piston support surface and the inner surface of the sleeve, the annular recess having a bottom wall intermediate the piston support surface and the lower surface of the base end, such that when a force is applied to push the rimmed end of the syringe body into the annular recess until it engages the bottom wall, the piston becomes fully inserted in the syringe body with its side surface forming a hermetic seal with the syringe body side wall.
10. The assembly of claim 1, wherein the piston support means comprises a. stabilization cap comprising a hollow cylindrical portion with an upper end and a lower end adapted to fit inside the syringe body, with the upper end of the cylindrical portion forming a piston support surface for engagement with the lower surface of the piston, the stabilization cap further comprising a finger flange projecting radially outwardly at the lower end of the adapter ring.
11. The assembly of claim 10, wherein the finger flange fits inside the base end of the sleeve.
12. The assembly of claim 1, wherein a plurality of said piston support rneans are arranged on a tray.
.
13. The assembly of claim 6, wherein a plurality of said integrally formed sleeves and piston support means are arranged on a tray.
14. The assembly of claim 2 additionally comprising a second cylindrical leeve having an upper end, a lower end and an outer surface extending therebetween, wherein said syringe body is received inside the lower end of the second sleeve in a close fit, the second sleeve having a cylindrical collar defining an annular gap between the collar and the outer surface of the second sleeve, said annular gap being open towards the lower end of the second sleeve and closed toward the upper end of the second sleeve.
15. The assembly of claim 14 wherein said collar has an outer diameter substantially equal to that of the outwardly projecting flange.
16. A method for producing a pre-filled syringe barrel for a pre-filled syringe, the syringe barrel comprising a body and a piston, the body having a generally cylindrical side wall with an inner surface and an outer surface, the side wall extending between a neck end and an open rimmed end of the body, the piston being generally cylindrical and formed of an elasto eric material with an upper surface, a side surface adapted to form a hermetic seal with the 33
inner surface of the body when inserted into the open rimmed end of the body, and a lower surface opposite the upper surface, the method comprising:
(a) forming a first assembly comprising said elastomeric piston, a generally cylindrical sleeve having an inner surface, an outer surface, a base end and a top end, and piston support means in contact with the sleeve and having a piston support surface on which the piston is supported with its lower surface engaging the piston support surface, the piston support surface being spaced radially inwardly of the inner surface of the sleeve;
(b) forming a second assembly by inserting the rimmed end of the body into the top end of the sleeve to a sufficient depth that the body is stably supported in the sleeve, and such that the rimmed end is located intermediate the top end and the base end of the sleeve with a gap between the upper surface of the piston and the rimmed end of the barrel;
(c) sterilizing the second assembly with a sterilizing gas;
(d) applying a force to the second assembly to cause relative movement of the body toward the base end of the sleeve, causing insertion of the piston into the barrel such that the side surface of the piston forms a hermetic seal with the inner surface of the body and seals the rimmed end of the body;
(e) filling said body with a medicament or a component thereof through the neck end using equipment for filling and capping pharmaceutical vials; and
(f) capping the neck end of the body using said equipment for filling and capping pharmaceutical vials; wherein, subsequent to insertion of the piston in step (d), said second assembly is conveyed through at least a portion of said 34
equipment for filling and capping pharmaceutical vials while freestanding in an upright position.
17. The method of claim 16, wherein the medicament is in the form of a liquid when filled into the body in step (e) and wherein the method further comprises lyophilization of the medicament between steps (e) and (f).
18. The method of claim 16, wherein the sleeve is removed from the syringe barrel after step (f).
19. The method of claim 18, wherein the pre-filled syringe barrel further comprises an adapter ring which forms said piston support means and comprises a hollow cylindrical portion with an upper end and a lower end, the upper end of the hollow cylindrical portion forming a piston support surface for engagement with the lower surface of the piston, the adapter ring further comprising a finger flange projecting radially outwardly at the lower end of the adapter ring, and wherein during step (d) the hollow cylindrical portion of the adapter ring becomes received inside the body, with the rimmed end of the body engaging the finger flange.
20. The method of claim 19, wherein the cylindrical portion of the adapter ring forms a snap fit with the rimmed end of the body.
21. A method for producing a barrel for use in a pre-filled syringe, said barrel to be pre-filled with at least one component of a pharmaceutical medicament, the barrel comprising a body and a piston, the body having a generally cylindrical side wall with an inner surface and an outer surface, the side wall extending between a neck end and an open rimmed end of the body, the piston being generally cylindrical and formed of an elastomeric material with an upper surface, and side surface adapted to form a hermetic seal with the inner surface of the barrel when inserted into the open rimmed end of the barrel, and a lower surface opposite the upper surface, the method comprising: 35
(a) forming a first assembly comprising said elastomeric piston, a generally cylindrical sleeve having an inner surface, and outer surface, a base end and a top end, and piston support means in contact with the sleeve and having a piston support surface on which the piston is supported with its lower surface engaging the piston support surface, the piston support surface being spaced radially inwardly of the inner surface of the sleeve;
(b) forming a second assembly by inserting the rimmed end of the body into the top end of the sleeve to a sufficient depth that the body is stably supported in the sleeve, and such that the rimmed end is located intermediate the top end and the base end of the sleeve with a gap between the upper surface of the piston and the rimmed end of the body;
(c) sterilizing the second assembly with a sterilizing gas;
(d) applying a force to the second assembly to cause relative movement of the body toward the base end of the sleeve, causing insertion of the piston into the body such that the side surface of the piston forms a hermetic seal with the inner surface of the body and seals the rimmed end of the body; and
(e) maintaining said second assembly in a sterile environment until it is ready to be filled through the neck of the body with at least one medicament or a component thereof and capped, while being conveyed through at least a portion of equipment for filling and capping pharmaceutical vials while freestanding in an upright position.
22. The method of claim 21 additionally comprising, after step (e), the steps of: 36
(f) filling the body with a medicament or a component thereof through the neck end using equipment for filling and capping pharmaceutical vials; and
(g) capping the neck end of the body using equipment for filling and capping pharmaceutical vials.
23. The method of claim 22 additionally comprising, after step (g), the step qf sterilizing the barrel.
-|4. The method of claim 21 additionally comprising, before sterilization, the step of packaging a plurality second assemblies on a tray.
25. The method of claim 24 additionally comprising, after forming a plurality pf second assemblies on a tray and either before or after sterilizing, the step of overwrapping the second assemblies and the tray with an overwrap material to maintain sterility.
?6. The method as claimed in claim 25 additionally comprising, after step (e), the additional steps of:
(f) removing the overwrap;
(g) filling the plurality of bodies with a medicament or a component thereof through their neck ends using equipment for filling and capping pharmaceutical vials; and
(h) capping the neck ends of the bodies using equipment for filling and capping pharmaceutical vials.
27, The method of claim 26 additionally comprising, before step (g), the 'step of removing the plurality of bodies from the tray.
!28. The method of claim 22 wherein the medicament is in the form of a liquid when filled into the body in step (f) and wherein the method further comprises lyophilization of the medicament between steps (f) and (g). 37
^9. The method of claim 22, wherein the sleeve is removed from the syringe barrel after step (g).
30. The method of claim 29, wherein the syringe barrel further comprises an adapter ring which forms said piston support means and comprises a hollow cylindrical portion with an upper end and a lower end, the upper end of Ijhe hollow cylindrical portion forming a piston support surface for engagement th the lower surface of the piston, the adapter ring further comprising a fjnger flange projecting radially outwardly at the lower end of the adapter ring,
II j^nd wherein during step (d) the hollow cylindrical portion of the adapter ring
I becomes received inside the body, with the rimmed end of the body engaging the finger flange.
31. The method of claim 30, wherein the cylindrical portion of the adapter j-ing forms a snap fit with the rimmed end of the body.
PCT/CA2002/001772 2001-11-23 2002-11-22 System for filling and assembling pharmaceutical delivery devices WO2003045477A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CA002505162A CA2505162A1 (en) 2001-11-23 2002-11-22 System for filling and assembling pharmaceutical delivery devices
DE60230915T DE60230915D1 (en) 2001-11-23 2002-11-22 SYSTEM FOR FILLING AND MOUNTING PHARMACEUTICAL DISPENSERS
EP20020779077 EP1455865B1 (en) 2001-11-23 2002-11-22 System for filling and assembling pharmaceutical delivery devices
AU2002342479A AU2002342479A1 (en) 2001-11-23 2002-11-22 System for filling and assembling pharmaceutical delivery devices

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/993,299 US6802828B2 (en) 2001-11-23 2001-11-23 System for filling and assembling pharmaceutical delivery devices
US09/993,299 2001-11-23

Publications (2)

Publication Number Publication Date
WO2003045477A1 WO2003045477A1 (en) 2003-06-05
WO2003045477B1 true WO2003045477B1 (en) 2003-07-10

Family

ID=25539361

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2002/001772 WO2003045477A1 (en) 2001-11-23 2002-11-22 System for filling and assembling pharmaceutical delivery devices

Country Status (7)

Country Link
US (2) US6802828B2 (en)
EP (1) EP1455865B1 (en)
AT (1) ATE420684T1 (en)
AU (1) AU2002342479A1 (en)
CA (1) CA2505162A1 (en)
DE (1) DE60230915D1 (en)
WO (1) WO2003045477A1 (en)

Families Citing this family (100)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7544189B2 (en) * 2000-10-10 2009-06-09 Meridian Medical Technologies, Inc. Needle and hub assembly for automatic injector
US6802828B2 (en) 2001-11-23 2004-10-12 Duoject Medical Systems, Inc. System for filling and assembling pharmaceutical delivery devices
FR2860978B1 (en) * 2003-10-20 2006-03-03 Valois Sas TANK SUPPORT DEVICE AND STERILIZATION ASSEMBLY HAVING SUCH A DEVICE.
IL161660A0 (en) 2004-04-29 2004-09-27 Medimop Medical Projects Ltd Liquid drug delivery device
US7199375B2 (en) * 2004-10-12 2007-04-03 Bard Brachytherapy, Inc. Radiation shielding container that encloses a vial of one or more radioactive seeds
US7731678B2 (en) 2004-10-13 2010-06-08 Hyprotek, Inc. Syringe devices and methods for mixing and administering medication
AU2005312310A1 (en) * 2004-12-03 2006-06-08 Duoject Medical Systems Inc. Cartridge, device and method for pharmaceutical storage, mixing and delivery
AU2005313993A1 (en) * 2004-12-09 2006-06-15 West Pharmaceutical Services, Inc. Breech loaded fixed needle syringe and automatic injection device having the same
EP1904125B1 (en) 2005-07-18 2018-10-17 West Pharmaceutical Services, Inc. Auto-injection syringe having vent device
DK1919432T3 (en) 2005-08-11 2012-01-30 Medimop Medical Projects Ltd Liquid Medication Transfer Devices for Safe Safe Resting Connection on Medical Vials
CN101365503B (en) * 2005-11-09 2012-02-29 海浦德科公司 Syringe devices, components of syringe devices, and methods of forming components and syringe devices
US7988675B2 (en) 2005-12-08 2011-08-02 West Pharmaceutical Services Of Delaware, Inc. Automatic injection and retraction devices for use with pre-filled syringe cartridges
KR100683280B1 (en) * 2006-07-11 2007-02-16 메디칸(주) Syringe using in fat transplantation
WO2008082711A2 (en) * 2006-08-24 2008-07-10 Areva Federal Services Llc Transportation container and assembly
US8012413B2 (en) * 2006-12-21 2011-09-06 Depuy Spine, Inc. Gaseous sterilization of impermeable containers through use of porous material
IL182605A0 (en) 2007-04-17 2007-07-24 Medimop Medical Projects Ltd Fluid control device with manually depressed actuator
CN101918074B (en) 2007-09-18 2013-02-27 麦迪麦珀医疗工程有限公司 Medicament mixing and injection apparatus
IL186290A0 (en) 2007-09-25 2008-01-20 Medimop Medical Projects Ltd Liquid drug delivery devices for use with syringe having widened distal tip
US9522097B2 (en) 2007-10-04 2016-12-20 Hyprotek, Inc. Mixing/administration syringe devices, protective packaging and methods of protecting syringe handlers
US8002737B2 (en) 2007-10-04 2011-08-23 Hyprotek, Inc. Mixing/administration syringe devices, protective packaging and methods of protecting syringe handlers
US8435217B2 (en) * 2008-04-11 2013-05-07 Applied Silicone Corporation Gas sterilizable two-part polymer delivery system
DE102008030038A1 (en) * 2008-06-12 2009-12-17 Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg Apparatus for testing the intended positioning of a plug in a syringe or carpule having a hollow body
DE102008030271A1 (en) * 2008-06-19 2009-12-31 Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg Device and method for testing the tightness of caps on medical hollow bodies
DE102008030268B3 (en) * 2008-06-19 2010-02-04 Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg Method for filling dual-chamber systems in pre-sterilizable carrier systems and pre-sterilisable carrier system
USD641080S1 (en) 2009-03-31 2011-07-05 Medimop Medical Projects Ltd. Medical device having syringe port with locking mechanism
US8393357B2 (en) 2009-07-08 2013-03-12 Medtronic Minimed, Inc. Reservoir filling systems and methods
US8167846B2 (en) * 2009-07-08 2012-05-01 Medtronic Minimed, Inc. Reservoir filling systems and methods
IL199767A0 (en) * 2009-07-09 2010-04-15 Medimop Medical Projects Ltd Medical device for use with cartridge and vial
IL201323A0 (en) 2009-10-01 2010-05-31 Medimop Medical Projects Ltd Fluid transfer device for assembling a vial with pre-attached female connector
IL202069A0 (en) 2009-11-12 2010-06-16 Medimop Medical Projects Ltd Fluid transfer device with sealing arrangement
IL202070A0 (en) 2009-11-12 2010-06-16 Medimop Medical Projects Ltd Inline liquid drug medical device
CH702668B1 (en) * 2010-02-04 2015-04-15 Christian Schütz Set packaging comprising a plurality of vial or a plurality of vial closures.
BR112012021134B1 (en) 2010-02-24 2020-01-21 Medimop Medical Projects Ltd fluid transfer set for use with a first vial and a second vial for reconstitution and liquid drug delivery
CN102781396B (en) 2010-02-24 2015-01-07 麦迪麦珀医疗工程有限公司 Liquid drug transfer device with vented vial adapter
TW201216948A (en) * 2010-07-19 2012-05-01 Sanofi Aventis Deutschland Medicament cartridges with non-standard dimensions
AU2011286179B2 (en) * 2010-08-06 2016-05-05 Hospira Australia Pty Ltd Vial preparation method and system
AU2011295037B2 (en) * 2010-08-27 2015-05-14 Sanofi-Aventis Deutschland Gmbh Packaging system for multi-component medical products
USD669980S1 (en) 2010-10-15 2012-10-30 Medimop Medical Projects Ltd. Vented vial adapter
IL209290A0 (en) 2010-11-14 2011-01-31 Medimop Medical Projects Ltd Inline liquid drug medical device having rotary flow control member
IL212420A0 (en) 2011-04-17 2011-06-30 Medimop Medical Projects Ltd Liquid drug transfer assembly
US10723497B2 (en) 2014-11-03 2020-07-28 Vanrx Pharmasystems Inc. Apparatus and method for monitoring and controlling the filling of a container with a pharmaceutical fluid in an aseptic environment
WO2013043889A1 (en) 2011-09-21 2013-03-28 Medrad, Inc. System and assembly method for a fluid pump device for a continuous multi-fluid delivery system
IL215699A0 (en) 2011-10-11 2011-12-29 Medimop Medical Projects Ltd Liquid drug reconstitution assemblage for use with iv bag and drug vial
EP3045188B1 (en) 2011-10-14 2020-12-23 Amgen Inc. Injector and method of assembly
SG192310A1 (en) * 2012-02-02 2013-08-30 Becton Dickinson Holdings Pte Ltd Adaptor for coupling to a medical container
USD720451S1 (en) 2012-02-13 2014-12-30 Medimop Medical Projects Ltd. Liquid drug transfer assembly
USD674088S1 (en) 2012-02-13 2013-01-08 Medimop Medical Projects Ltd. Vial adapter
USD737436S1 (en) 2012-02-13 2015-08-25 Medimop Medical Projects Ltd. Liquid drug reconstitution assembly
IL219065A0 (en) 2012-04-05 2012-07-31 Medimop Medical Projects Ltd Fluid transfer device with manual operated cartridge release arrangement
US10780228B2 (en) 2012-05-07 2020-09-22 Medline Industries, Inc. Prefilled container systems
IL221634A0 (en) 2012-08-26 2012-12-31 Medimop Medical Projects Ltd Universal drug vial adapter
IL221635A0 (en) 2012-08-26 2012-12-31 Medimop Medical Projects Ltd Drug vial mixing and transfer device for use with iv bag and drug vial
EP2872100B1 (en) 2012-09-13 2017-03-29 Medimop Medical Projects Ltd Telescopic female drug vial adapter
USD734868S1 (en) 2012-11-27 2015-07-21 Medimop Medical Projects Ltd. Drug vial adapter with downwardly depending stopper
BR112015024282B1 (en) 2013-03-22 2022-05-17 Amgen Inc Injector and injector mounting method
IL225734A0 (en) 2013-04-14 2013-09-30 Medimop Medical Projects Ltd Ready-to-use drug vial assemblages including drug vial and drug vial closure having fluid transfer member, and drug vial closure therefor
JP6199483B2 (en) 2013-05-10 2017-09-20 メディモップ・メディカル・プロジェクツ・リミテッド Medical device comprising a vial adapter having an in-line dry drug module
ITRM20130457A1 (en) * 2013-08-05 2015-02-06 Orofino Pharmaceuticals Group Srl INTERMEDIATE PRODUCT FOR THE PREPARING OF SYRINGES OR CARTRIDGES WITH DOUBLE CHAMBER AND PRODUCTION PROCEDURE OF SUCH INTERMEDIATE PRODUCT
USD767124S1 (en) 2013-08-07 2016-09-20 Medimop Medical Projects Ltd. Liquid transfer device with integral vial adapter
CN205626622U (en) 2013-08-07 2016-10-12 麦迪麦珀医疗工程有限公司 Liquid transfer device that is used together with infusion container
USD765837S1 (en) 2013-08-07 2016-09-06 Medimop Medical Projects Ltd. Liquid transfer device with integral vial adapter
TW201900137A (en) * 2013-08-16 2019-01-01 加拿大商凡爾克斯醫藥系統公司 Method, device and system for filling and lyophilizing drug containers
AU2014340171B2 (en) 2013-10-24 2019-05-30 Amgen Inc. Injector and method of assembly
EP3177359B1 (en) * 2014-08-04 2020-04-01 F. Hoffmann-La Roche AG Apparatus and methods for sealing a medicament within a medical delivery device
USD757933S1 (en) 2014-09-11 2016-05-31 Medimop Medical Projects Ltd. Dual vial adapter assemblage
EP3009354A1 (en) 2014-10-15 2016-04-20 F. Hoffmann-La Roche AG Method for providing in a primary packaging container a dried solid product containing an active pharmaceutical ingredient
WO2016110838A1 (en) 2015-01-05 2016-07-14 Medimop Medical Projects Ltd Dual vial adapter assemblages with quick release drug vial adapter for ensuring correct usage
EP3242649A4 (en) 2015-01-09 2019-01-09 Bayer Healthcare LLC Multiple fluid delivery system with multi-use disposable set and features thereof
US20170354784A1 (en) * 2015-01-12 2017-12-14 Sanofi-Aventis Deutschland Gmbh Packaging for pre-filled drug cartridges with peg for pushing cartridge stopper for priming purposes
FR3036969A1 (en) * 2015-06-02 2016-12-09 Biocorp Prod PROCESS FOR MANUFACTURING AT LEAST ONE TANK ASSEMBLY, INJECTABLE PRODUCT TANK ASSEMBLY FOR INJECTOR PEN AND INJECTOR PEN EQUIPPED WITH SUCH ASSEMBLY
JP6560042B2 (en) * 2015-07-14 2019-08-14 株式会社松風 Piston that can be easily mounted on a cartridge and its insertion method
CN113143759B (en) 2015-07-16 2024-01-30 西部制药服务以色列有限公司 Liquid drug transfer device for secure telescopic snap-fit on an injection vial
USD801522S1 (en) 2015-11-09 2017-10-31 Medimop Medical Projects Ltd. Fluid transfer assembly
CN108366905A (en) 2015-11-25 2018-08-03 西部制药服务以色列有限公司 Include double bottle commutator components of the vial adapter of the inlet valve with automatic-sealed
IL245803A0 (en) 2016-05-24 2016-08-31 West Pharma Services Il Ltd Dual vial adapter assemblages including vented drug vial adapter and vented liquid vial adapter
IL245800A0 (en) 2016-05-24 2016-08-31 West Pharma Services Il Ltd Dual vial adapter assemblages including identical twin vial adapters
US20170349313A1 (en) * 2016-06-01 2017-12-07 Centurion Medical Products Corporation Methods for manufacturing non-glass prefilled syringes
IL246073A0 (en) 2016-06-06 2016-08-31 West Pharma Services Il Ltd Fluid transfer devices for use with drug pump cartridge having slidable driving plunger
IL247376A0 (en) 2016-08-21 2016-12-29 Medimop Medical Projects Ltd Syringe assembly
US10926025B2 (en) * 2016-09-15 2021-02-23 Tandem Diabetes Care, Inc. Vial supporter for medicament pump
USD832430S1 (en) 2016-11-15 2018-10-30 West Pharma. Services IL, Ltd. Dual vial adapter assemblage
IL249408A0 (en) 2016-12-06 2017-03-30 Medimop Medical Projects Ltd Liquid transfer device for use with infusion liquid container and pincers-like hand tool for use therewith for releasing intact drug vial therefrom
IL251458A0 (en) 2017-03-29 2017-06-29 Medimop Medical Projects Ltd User actuated liquid drug transfer devices for use in ready-to-use (rtu) liquid drug transfer assemblages
EP3427781A3 (en) * 2017-07-11 2019-05-01 Pharma Resources GmbH Drug and device system for pressurized aerosol therapies into a mammalian hollow space
IL254802A0 (en) 2017-09-29 2017-12-31 Medimop Medical Projects Ltd Dual vial adapter assemblages with twin vented female vial adapters
JP1630477S (en) 2018-07-06 2019-05-07
EP3669911A1 (en) * 2018-12-18 2020-06-24 SHL Medical AG Medicament delivery device
USD923812S1 (en) 2019-01-16 2021-06-29 West Pharma. Services IL, Ltd. Medication mixing apparatus
JP1648075S (en) 2019-01-17 2019-12-16
JP7101900B2 (en) 2019-01-31 2022-07-15 ウェスト・ファーマ・サービシーズ・アイエル・リミテッド Liquid transfer device
CN109761183B (en) * 2019-02-01 2021-07-06 楚天科技股份有限公司 Double-head encapsulation method and system
IL277446B2 (en) 2019-04-30 2024-02-01 West Pharma Services Il Ltd Liquid transfer device with dual lumen iv spike
US20220379040A1 (en) * 2019-10-08 2022-12-01 Novo Nordisk A/S Dose sensing module with friction enhancing means
USD956958S1 (en) 2020-07-13 2022-07-05 West Pharma. Services IL, Ltd. Liquid transfer device
CN111924783A (en) * 2020-09-02 2020-11-13 焦明惠 Electronic tobacco tar filling device
CN111924782A (en) * 2020-09-02 2020-11-13 焦明惠 Electronic tobacco tar filling method
BE1028884B1 (en) * 2020-12-14 2022-07-12 Cenexi Laborathoires Thissen METHOD FOR ASSEMBLING AND FILLING CONTAINERS FOR A NEEDLELESS INJECTION DEVICE
FR3117459B1 (en) * 2020-12-14 2022-12-16 Cenexi Laborathoires Thissen METHOD FOR ASSEMBLING AND FILLING CONTAINERS FOR A NEEDLELESS INJECTION DEVICE
US20240025578A1 (en) * 2020-12-14 2024-01-25 Cenexi-Laborathoires Thissen Method for assembling and filling containers for a needleless injection device
CN115231013B (en) * 2022-07-22 2023-08-18 江西生物制品研究所股份有限公司 Antisera preparation filling system with CIP, SIP function

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2453590A (en) * 1946-11-04 1948-11-09 Noel J Poux Hypodermic syringe
US2660635A (en) * 1948-12-08 1953-11-24 Ite Circuit Breaker Ltd Air operated circuit breaker
US2860635A (en) * 1957-03-20 1958-11-18 Edgar H Wilburn Sterilizable and sterilized hypodermic syringe assemblies
US3967759A (en) * 1971-11-11 1976-07-06 Mpl, Inc. Syringe assembly with contained pop-out elastic plug seal
BE791340A (en) * 1972-01-06 1973-03-01 Becton Dickinson Co NEW METHOD AND APPARATUS FOR TAKING A CULTURE AND IDENTIFYING MICRO-ORGANISMS OF MOODS
US4014331A (en) * 1975-12-30 1977-03-29 Head James E Syringe barrel with protective plastic cover
US4091812A (en) * 1976-01-19 1978-05-30 Alcon Laboratories, Inc. Operator means for syringe cartridges
US4620863A (en) * 1981-07-02 1986-11-04 Rensselaer Polytechnic Institute Radiation coloration resistant glass
US4794086A (en) * 1985-11-25 1988-12-27 Liquid Air Corporation Method for measurement of impurities in liquids
US4718463A (en) * 1985-12-20 1988-01-12 Mallinckrodt, Inc. Method of producing prefilled sterile plastic syringes
US4886495A (en) * 1987-07-08 1989-12-12 Duoject Medical Systems Inc. Vial-based prefilled syringe system for one or two component medicaments
US5554125A (en) * 1987-07-08 1996-09-10 Reynolds; David L. Prefilled vial syringe
US5364369A (en) * 1987-07-08 1994-11-15 Reynolds David L Syringe
GB2249727A (en) 1989-11-16 1992-05-20 Duoject Inc Syringe vial
DE4107665A1 (en) * 1991-03-09 1992-09-10 Basf Ag PARTLY NETWORKED PLASTIC MATERIAL FROM PROPYLENE AND ETHYLENE POLYMERS
US5387195A (en) * 1992-12-23 1995-02-07 Hicks; Charles D. No share syringe
DK39293D0 (en) * 1993-04-01 1993-04-01 Novo Nordisk As DISPENSES PROTECTED FOR RECYCLING
JPH08164205A (en) 1993-12-30 1996-06-25 Eisai Co Ltd Prefilled syringe and gasket falling-off preventing jig and sterilization method using the jig
US5597530A (en) * 1994-08-18 1997-01-28 Abbott Laboratories Process for prefilling and terminally sterilizing syringes
JP3208525B2 (en) * 1995-01-05 2001-09-17 電気化学工業株式会社 Sodium hyaluronate solution injection and container for injection
US5836917A (en) * 1995-01-10 1998-11-17 Specialized Health Products, Inc. Self retracting medical needle apparatus and methods
PT928182E (en) * 1996-01-11 2002-10-31 Duoject Inc DISTRIBUTION SYSTEM FOR PHARMACEUTICAL PRODUCTS PACKED IN PHARMACEUTICAL BOTTLES
US5880380A (en) * 1997-04-29 1999-03-09 Goldschmidt; Norman High containment sampler
JPH11155951A (en) * 1997-12-01 1999-06-15 Kaken Pharmaceut Co Ltd Decompression syringe and manufacture thereof
EP1061975B1 (en) 1998-03-13 2004-02-11 Becton, Dickinson and Company Method for assembling and packaging medical devices
SE9802938D0 (en) * 1998-09-01 1998-09-01 Astra Ab Improved stability for injection solutions
US6802828B2 (en) * 2001-11-23 2004-10-12 Duoject Medical Systems, Inc. System for filling and assembling pharmaceutical delivery devices

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US6802828B2 (en) 2004-10-12
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CA2505162A1 (en) 2003-06-05
ATE420684T1 (en) 2009-01-15

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