WO1998019715A1 - Procede de production d'une seringue sterile pre-remplie - Google Patents

Procede de production d'une seringue sterile pre-remplie Download PDF

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Publication number
WO1998019715A1
WO1998019715A1 PCT/EP1997/006258 EP9706258W WO9819715A1 WO 1998019715 A1 WO1998019715 A1 WO 1998019715A1 EP 9706258 W EP9706258 W EP 9706258W WO 9819715 A1 WO9819715 A1 WO 9819715A1
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
stopper
prefilled
producing
sterile
Prior art date
Application number
PCT/EP1997/006258
Other languages
German (de)
English (en)
Inventor
Frank Schnegotzki
Original Assignee
Schering Aktiengesellschaft
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 Schering Aktiengesellschaft filed Critical Schering Aktiengesellschaft
Priority to AU53210/98A priority Critical patent/AU5321098A/en
Publication of WO1998019715A1 publication Critical patent/WO1998019715A1/fr

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons
    • 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

Definitions

  • the invention relates to a method for producing prefilled syringes which are terminally sterilized.
  • the focus here is in particular on the problem-free insertion of the plunger into the syringe body.
  • These syringes are preferably provided for the use of injectable diagnostic agents, in particular contrast media, which are injected, for example, into blood vessels, organs, organ parts, cavities and other vessels or which have an imaging effect there.
  • injectable diagnostic agents in particular contrast media
  • Publication EP 0 227 401 describes a method for producing a filled, terminally sterilized plastic syringe.
  • the syringe has a cylinder with a distal end with a syringe outlet.
  • the syringe outlet piece is sealed by a closure.
  • the syringe is closed with a flexible rubber stopper that is slidable in the cylinder.
  • the process begins with removing debris or other contaminants from the closure and the plunger. Microbial contaminants on the cap and piston are destroyed.
  • the cylinder is washed with a variety of water jets to remove pyrogens and waste particles.
  • silicone oil is applied to the inner wall of the syringe.
  • the closure is placed on the syringe outlet piece.
  • the contrast medium is filled into the syringe through the proximal end of the syringe.
  • the syringe is then closed with the stopper. Inserting the stopper involves evacuating air from the cylinders using a vacuum system so that the stopper can be inserted into the proximal end of the cylinder with a selected amount of inert gas above the level of the liquid content.
  • a vacuum system so that the stopper can be inserted into the proximal end of the cylinder with a selected amount of inert gas above the level of the liquid content.
  • EP 0 553 926 describes a terminal sterilization process for prefilled syringes, in which no autoclave is used, but only a pressure-resistant stenciling chamber is used.
  • the distally or proximally filled syringe is introduced into this plunger chamber.
  • the chamber is heated by means of heating gas This heating gas also ensures a pressure that is intended to compensate for the pressure rise in the syringe.
  • water vapor may also be introduced in addition to the heating gas.It is represented in the property right that the same safety with regard to sterilization occurs, as can be achieved with an autoclave
  • WO 95/12482 describes a method for producing prefilled plastic syringes that are filled with a contrast agent.
  • the syringes consist of a cylinder, a syringe outlet piece at the distal end, which is prepared for a cannula attachment. Furthermore, the syringe comprises a stopper that slides in the cylinder can He seals the proximal end of the syringe.
  • the syringe has been manufactured using a process that leads to pyrogen-free objects. There are also no more particles.
  • the syringe is filled through the proximal end, and the syringe outlet piece is sealed with a closure.
  • the filled syringe is then with that Plug closed
  • the particle status of the premises corresponds to the conditions of class 100
  • the syringe parts come out of the mold, they are blown off with gas to remove particles.
  • the syringe is then washed.
  • the syringe is then sterilized so that the syringe can be processed, stored or can be transported
  • the stopper usually consists of an elastic rubber material. This stopper is pushed into the interior of the pre-filled body. For this purpose, it is necessary that a compression device specially made for this purpose compresses the stopper with respect to the cylinder wall.
  • a compression device specially made for this purpose compresses the stopper with respect to the cylinder wall.
  • plugs are also suitable which have a modulus of elasticity which is significantly larger than the modulus of elasticity of rubber
  • the residual air quantity in the syringe is said to be so be in such a way that a disability does not occur during the stabilization and the application.
  • the stopper should have a higher modulus of elasticity than conventional rubber stoppers
  • the first three alternative forms of the solution differ only in the point in time at which the negative pressure is created. A partial evacuation before filling the medium is preferred
  • the object is achieved by a method for producing a prefilled, sterile syringe made of glass or plastic or a mixture of glass and plastic, furthermore a glass syringe with an associated plastic film and a plastic syringe with an associated glass coating, which includes Syringe a cylindrical tip body with a closable proximal and a closable distal end a syringe outlet piece at the distal end a closure sealing the syringe outlet piece, a stopper which is slidable in the syringe body, the stopper being movable by a plunger, and a fluid and a gaseous medium, the fluid medium being a liquid, a solution, a
  • a suspension or an emulsion comprising the following steps:
  • the stopper which is free from germs, pyrogens and / or endotoxins and is low in particles, application of a lubricant, - creating a negative pressure, the negative pressure being built up in a setting tube (17) which lies sealingly against the syringe body (1), which is connected to a vacuum system and which can be sealed by the stopper (11) at its end pointing away from the syringe,
  • An alternative embodiment consists of a method for producing a prefilled, sterile syringe made of glass or plastic or a mixture of glass and plastic, furthermore a glass syringe with an associated plastic film and a plastic syringe with an associated glass coating, the syringe comprising a cylindrical syringe body with a closable proximal and a closable distal end, a syringe outlet piece at the distal end, a closure sealing the syringe outlet piece, a stopper which is slidable in the syringe body, the stopper being movable by a plunger, and a fluid and a gaseous medium, the fluid medium being a liquid, a solution, a
  • a suspension or an emulsion comprising the following steps:
  • a negative pressure the negative pressure being built up in a setting tube (17) which lies sealingly against the syringe body (1), which is connected to a negative pressure system and which can be sealed by the stopper (11) at its end pointing away from the syringe the syringe through the proximal end sealing the proximal end by inserting the stopper into the syringe body,
  • a third embodiment consists in a method for producing a prefilled, sterile syringe made of glass or plastic or a mixture of
  • Plastic film and a plastic syringe with a glass coating connected to it comprising a cylindrical syringe body with a closable proximal and a closable distal end, a syringe outlet piece at the distal end, a closure sealing the syringe outlet piece, a stopper which is slidable in the syringe body, the stopper being movable by a plunger, and a fluid and a gaseous medium, the fluid medium being a liquid, a solution, a
  • a suspension or an emulsion comprising the following steps:
  • the setting tube comprises a filling opening with which the syringe can be filled.
  • the methods according to the invention are advantageous for all stopper shapes and stopper materials. Through this procedure, the residual air in the filled syringe kept to a minimum. This has considerable advantages both for terminal sterilization and for later application. Air residues are always a hindrance when a syringe content is to be injected into a patient. Residual air in a syringe with thermal sterilization always leads to an increased pressure, the sum of which consists of the partial pressure which is attributable to the water vapor and a gas partial pressure which is brought about by the residual volume of the gas in the syringe.
  • Syringe plugs can be made of very different materials. In the case of small volumes, the aforementioned rubber-elastic stoppers are preferred. However, if larger pressures are applied to the stopper during application, undesirable deformations of the rubber-elastic stopper may occur. Therefore, plugs made of a less elastic material are preferred. More preferred are plugs which have a relatively inelastic, plate-shaped core, made of a plastic material with a coating of rubber-elastic material. Such plugs can be designed in several pieces. The solid core consists of a cylindrical disc, which sits in a rubber-elastic plug hollowed out on the inside.
  • the rubber-elastic part has a relatively thin wall thickness, which guarantees a tight fit of the stopper against the inner wall of the syringe.
  • compression devices for rubber stoppers can no longer be used. Either the applied compression pressures are no longer sufficient, or the stoppers are no longer reversible.
  • syringe includes the terms cartridge (large-volume syringe with a volume of at least 100 ml), ampoule syringes, disposable syringes, disposable syringe ampoules, disposable syringes, injection ampoules, spray ampoules, ready-to-use ampoules, cylindrical ampoules and immediate syringes.
  • proximal and distal are defined from the perspective of the treating doctor.
  • the syringe outlet piece to which, for example, the cannula or a hose leading to a cannula is connected.
  • the stopper that pushes the medium through the distal end during application.
  • the plug can be moved manually or mechanically.
  • stopper also includes pistons. For the manual actuation of the syringe, it is helpful for the operating personnel if the syringe carries finger holders at the proximal end.
  • the finger holders usually have at least one surface as an abutment for the index and middle fingers, the surface of the finger holder being essentially perpendicular to the axis of the syringe barrel.
  • Various models are known for mechanical pump devices.
  • a syringe then preferably carries one or more device holders at the preferably proximal end.
  • Such a mechanical pump is described particularly well in publication EP 0 584 531 (filing date July 21, 1993). Mixed forms of finger holder and device holder are also possible.
  • the syringes are usually rotationally symmetrical, only the finger holder and device holder and sometimes also the syringe outlet piece deviate from the symmetry. So the syringe outlet piece can be arranged eccentrically.
  • the Luer lock is particularly preferred since it is only used when contrast agents are applied when mechanical pump devices are used. Even with manual application, the Luer Lock and the tubing connected to it prevent unintentional movements of the doctor from being transmitted directly to the cannula.
  • the simple Luer approach and the record approach are also known.
  • the proximal and distal ends of the syringes must be closable. The distal end is sealed by a closure which can be placed on the syringe outlet piece.
  • the syringe outlet piece covers the ceiling of the syringe barrel.
  • the syringe outlet piece further comprises a tube leading to the needle or the hose, an end piece which is in contact with the needle or the hose and a threaded cylinder on the inside, the cylinder surrounding the end piece. there and carries a thread for a Luer lock, for example.
  • the syringe outlet piece can be single-story or multi-story.
  • the ceiling can be flat or pyramid-shaped. Mixed forms are also conceivable.
  • the stopper closes the proximal end of the syringe. It must be slidable in the cylinder and must keep the medium away from the environment. It should be as little permeable to gases and liquids as possible.
  • the stopper is usually not provided with its own stamp when the syringe is mechanically emptied. This is not mandatory. Rather, a plunger, which is part of the pump device, engages in a closure inside the stopper, so that movement of the stopper is possible without any problems (see publication EP 0 584 531).
  • the plug can be made of a material that is less elastic than the usual rubber material, especially for mechanical application. Such plugs are necessary because the pressure which is caused by the pump devices leads to a deformation of the otherwise usual rubber material. The otherwise usual rubber material evades the occurring loads, there are undesired leaks between the rubber plug and
  • a method for producing a prefilled, sterile syringe is preferred, the syringe being filled in a steam atmosphere.
  • a method for producing a prefilled, sterile syringe is more preferred, the vapor being hotter than the fluid medium, in particular the liquid.
  • Most preferred is a method for producing a prefilled, sterile syringe, in which the difference between normal pressure and the negative pressure has a value of 800 to 970 mbar, the steam having a temperature of 20 to 70 ° C and wherein the fluid medium has a .Temperature of 20 to 70 ° C.
  • a method for producing a prefilled, sterile syringe is preferred, the sterilization chamber being an autoclave or sterilizer, with steam, hot air and / or a microwave. Such sterilization chambers are described in detail in the cited prior art.
  • the additional support pressure that can be built up in the sterilization chamber is of particular interest.
  • a method for producing a prefilled, sterile syringe is most preferred, wherein a support pressure is built up by a gas in the sterilization chamber, the pressure on the outer surface of the syringe being equal to, greater than or less than the pressure on the inner surface of the syringe.
  • the medium in the filled syringe is a mixture of a fluid medium and at least one gas.
  • the medium can be a liquid, a solution, a suspension or an emulsion.
  • Lubricants are used so that the plug can be moved within the cylinder without great effort.
  • Preferred is silicone oil, which has the following property: viscosity of at least 1000 cSt; Quality: Medical grade.
  • Figure 1 shows an unfilled syringe.
  • Figure 2 shows an unfilled syringe in a vacuum chamber
  • FIG. 3 shows a filled syringe in a vacuum chamber
  • Figure 4 shows a filled syringe in a vacuum chamber
  • Figure 5 shows a filled syringe into which the stopper is inserted and which is still in the vacuum chamber.
  • Figure 6 shows a fully filled syringe.
  • Figure 7 shows a syringe before filling.
  • FIG. 8 shows a filled syringe.
  • FIG. 9 shows a syringe with a seat tube attached and a stopper in the
  • Figure 10 shows a syringe with a set tube and a stopper in the proximal end of the syringe.
  • FIG. 1 shows a syringe according to the invention with a cylindrical syringe body 1 which has a closable proximal end 2 and a closable distal end 3.
  • a syringe outlet piece 4 is arranged at the distal end. It is sealed by a closure 5, which is preferably a tip-cap.
  • Such a syringe has previously undergone several process steps. The syringe body, closure and stopper have been cleaned or were made under sterile conditions. High temperatures when processing the plastic ensure that even pyrogens are no longer detectable. The three parts are thus freed of germs, produced without pyrogens and without endotoxins. Furthermore, they are preferably low in particles and even free of particles. In addition, a lubricant has already been applied.
  • the syringe from FIG. 1 is then transferred to a vacuum chamber 7 shown in FIG.
  • This vacuum space seals the space in which the syringe is arranged in a gas-tight manner.
  • a valve 8 is used to selectively extract gas from the vacuum chamber, or gas can also be conducted into the vacuum chamber.
  • the interior of the vacuum chamber is evacuated. A pressure of 100 mbar is built up.
  • FIG. 9 A further stage of the filling process is shown in FIG. Through an additional valve 9, liquid is filled into the lumen of the syringe 1. The filling continues until the level designated 10 is reached. Above this level there is a gas space which has a pressure of approximately 100 mbar.
  • FIG. 4 shows the step of the filling process in which the stopper 11 is transferred into the lumen of the syringe 1.
  • the plug 11 consists of a pyramid-shaped core 12 and a rubber-elastic jacket 13 which is open towards the proximal end. Through this opening of the rubber-elastic jacket 13, the relatively firm and rigid core 12 can be inserted into the jacket.
  • the plug 11 is now inserted through the proximal end 2 of the syringe 1.
  • the pressure is then increased from 100 mbar to a normal pressure atmosphere, as a result of which the stopper 11 migrates further into the syringe, so that there is only a small residual volume between the stopper 11 and the surface of the liquid, as can be seen from FIG.
  • Figure 6 shows a filled syringe, which is now outside the vacuum chamber.
  • FIGS. 7 to 10 show the preferred embodiment, different stages of the filling being shown.
  • FIG. 7 shows a syringe body 1 which is not filled with medium and whose proximal end 2 points upwards.
  • the device holder 6 points in the horizontal direction.
  • the syringe outlet piece 4 is sealed with a closure 5.
  • the distal end 3 rests in a lifting device 16.
  • FIG. 8 shows a syringe according to FIG. 7 which is filled with medium which forms an interface between liquid and air at level 10.
  • the filling process is to be controlled via a filling valve 15.
  • FIG. 9 shows the syringe body 1 which is meanwhile filled with contrast medium and which rests with its distal end 3 on a lifting device 16.
  • the lifting device 16 moves the syringe body 1 in the direction of a setting tube 17, which consists of a setting tube cylinder 18. It (18) has an inside diameter in the lower riser tube area 19 which essentially corresponds to the inside diameter of the syringe body 1.
  • the setting tube has an O-ring 22 on the downward-facing cylinder edge, which lies sealingly against the edge of the syringe body 1.
  • the riser cylinder 18 has a riser outlet 24 which is connected to a vacuum system by means of a riser valve 25.
  • the plug 11 In the lower riser pipe area 19 is the plug 11, which rests with its rubber beads on the jacket 13 sealingly against the inner edge of the riser pipe.
  • the plug 11 is transferred into its position by a holder 26, which fixes reversibly in the core 12, and held there.
  • the syringe body 1 is positioned under the setting tube 17 by means of the lifting device 16, so that the axis of the setting tube 17 coincides with the axis of the syringe body 1. Then the moves
  • FIG. 10 shows the last stage when inserting the stopper 11 into the syringe body 1.
  • the stopper is located in the proximal end 2 of the syringe body 1, a part of the stopper 11 being immersed in the contrast medium.
  • the setting tube 17 is still in sealing contact with the syringe body.
  • the holder 26 has released the core 12 of the plug.
  • the plug 11 is now in the syringe body 1, the residual volume of gas corresponding to the residual gas which is achieved in other filling processes.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un procédé de production d'une seringue stérile pré-remplie. La seringue comprend un corps de seringue (1) présentant une extrémité proximale (2) et une extrémité distale (3), une pièce d'évacuation de la seringue (4) à l'extrémité distale (3), une fermeture (5), un bouchon (11), un milieu fluide et un milieu gazeux. Le milieu fluide est un agent de contraste. Le procédé comprend les étapes suivantes: le corps de la seringue (1), la fermeture (5) et le bouchon (11) sont mis en place. La seringue est transférée dans une chambre à dépression dans laquelle on établit un vide. La seringue est ensuite remplie par l'extrémité proximale (2), et le bouchon (11) est introduit, également à cette extrémité proximale (2). La chambre à dépression est ensuite ramenée à la pression normale. Après remplissage, la seringue est stérilisée dans une chambre de stérilisation, sous une pression auxiliaire.
PCT/EP1997/006258 1996-11-05 1997-11-05 Procede de production d'une seringue sterile pre-remplie WO1998019715A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU53210/98A AU5321098A (en) 1996-11-05 1997-11-05 Method for producing a pre-filled sterile syringe

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE1996147694 DE19647694C1 (de) 1996-11-05 1996-11-05 Verfahren zur Herstellung einer vorgefüllten, sterilen Spritze
DE19647694.1 1996-11-05

Publications (1)

Publication Number Publication Date
WO1998019715A1 true WO1998019715A1 (fr) 1998-05-14

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1997/006258 WO1998019715A1 (fr) 1996-11-05 1997-11-05 Procede de production d'une seringue sterile pre-remplie

Country Status (3)

Country Link
AU (1) AU5321098A (fr)
DE (1) DE19647694C1 (fr)
WO (1) WO1998019715A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6189292B1 (en) 1998-03-13 2001-02-20 Becton Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
WO2011114061A1 (fr) * 2010-03-19 2011-09-22 Equipement Support Radio Pharmaceutique Dispositif hermetique pour la manipulation d'un liquide
US8092425B2 (en) 2006-04-21 2012-01-10 Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg Syringe cylinder
EP2995333A4 (fr) * 2013-05-10 2017-01-04 Terumo Kabushiki Kaisha Procédé de production de seringue pré-remplie, et dispositif de production de seringue pré-remplie
WO2017044112A1 (fr) * 2015-09-11 2017-03-16 West Pharmaceutical Services, Inc. Cylindre médical d'administration avec rainures et son procédé d'étanchéité
WO2020169921A1 (fr) * 2019-02-21 2020-08-27 Lyofal Contenant pour le conditionnement de matières sous atmosphère contrôlée et procédé de conditionnement utilisant un tel contenant
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US20220212822A1 (en) * 2019-05-23 2022-07-07 G.D Societa' Per Azioni Filling Unit to Fill a Container, in Particular a Cartridge, With a Liquid Product of the Pharmaceutical Industry
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19928845A1 (de) * 1999-06-24 2000-12-28 Inova Pac Systeme Gmbh Verfahren und Vorrichtung zum Befüllen von Spritzen
DE10129452A1 (de) * 2001-06-19 2003-01-09 Bosch Gmbh Robert Verfahren zum Befüllen von im wesentlichen zylinderförmigen Ampullen
FR3083721B1 (fr) * 2018-07-12 2020-12-18 Aptar France Sas Dispositif de distribution de produit fluide et son procede de remplissage et de bouchage.

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4628969A (en) * 1985-12-20 1986-12-16 Mallinckrodt, Inc. Method of producing prefilled sterile plastic syringes
DE4320098A1 (de) * 1993-06-17 1994-12-22 Groninger & Co Gmbh Verfahren zum Abfüllen

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2258866A1 (en) * 1974-01-30 1975-08-22 Merieux Inst Sterilisation of syringes, pref. contg. medicaments - which does not require high degree of precision; overpressure being accommodated without expelling contents
US4718463A (en) * 1985-12-20 1988-01-12 Mallinckrodt, Inc. Method of producing prefilled sterile plastic syringes
US5207983A (en) * 1992-01-29 1993-05-04 Sterling Winthrop Inc. Method of terminal steam sterilization
US5383858B1 (en) * 1992-08-17 1996-10-29 Medrad Inc Front-loading medical injector and syringe for use therewith
US5620425A (en) * 1993-11-03 1997-04-15 Bracco International B.V. Method for the preparation of pre-filled plastic syringes
DE4423753C1 (de) * 1994-06-27 1996-02-01 Schering Ag Mehrteilige Spritze mit einem Glaszylinder

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4628969A (en) * 1985-12-20 1986-12-16 Mallinckrodt, Inc. Method of producing prefilled sterile plastic syringes
DE4320098A1 (de) * 1993-06-17 1994-12-22 Groninger & Co Gmbh Verfahren zum Abfüllen

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE46510E1 (en) 1998-03-13 2017-08-15 Becton, Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
US6250052B1 (en) 1998-03-13 2001-06-26 Becton, Dickinson And Company Method and apparatus for assembling and packaging medical devices
US6263641B1 (en) 1998-03-13 2001-07-24 Becton, Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
US6792743B2 (en) 1998-03-13 2004-09-21 Becton, Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
US6189292B1 (en) 1998-03-13 2001-02-20 Becton Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
US8092425B2 (en) 2006-04-21 2012-01-10 Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg Syringe cylinder
WO2011114061A1 (fr) * 2010-03-19 2011-09-22 Equipement Support Radio Pharmaceutique Dispositif hermetique pour la manipulation d'un liquide
FR2957592A1 (fr) * 2010-03-19 2011-09-23 Equip Support Radio Pharma Dispositif hermetique pour la manipulation d'un liquide
EP2995333A4 (fr) * 2013-05-10 2017-01-04 Terumo Kabushiki Kaisha Procédé de production de seringue pré-remplie, et dispositif de production de seringue pré-remplie
CN108025136A (zh) * 2015-09-11 2018-05-11 西医药服务有限公司 具有凹槽的医疗施用筒和密封其的方法
WO2017044112A1 (fr) * 2015-09-11 2017-03-16 West Pharmaceutical Services, Inc. Cylindre médical d'administration avec rainures et son procédé d'étanchéité
US10603434B2 (en) 2015-09-11 2020-03-31 West Pharmaceutical Services, Inc. Medical administration barrel with grooves and method of sealing same
US11027065B2 (en) 2015-09-11 2021-06-08 West Pharmaceutical Services, Inc. Medical administration barrel with grooves and method of sealing same
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US10918754B2 (en) 2017-03-27 2021-02-16 Regeneron Pharmaceuticals, Inc. Sterilisation method
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
WO2020169921A1 (fr) * 2019-02-21 2020-08-27 Lyofal Contenant pour le conditionnement de matières sous atmosphère contrôlée et procédé de conditionnement utilisant un tel contenant
FR3093088A1 (fr) * 2019-02-21 2020-08-28 Lyofal Contenant pour le conditionnement de matières sous atmosphère contrôlée et procédé de conditionnement utilisant un tel contenant
US20220212822A1 (en) * 2019-05-23 2022-07-07 G.D Societa' Per Azioni Filling Unit to Fill a Container, in Particular a Cartridge, With a Liquid Product of the Pharmaceutical Industry
US11801956B2 (en) * 2019-05-23 2023-10-31 G.D Societa' Per Azioni Filling unit to fill a container, in particular a cartridge, with a liquid product of the pharmaceutical industry
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery

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