WO1994013328A1 - Procedes de production de dispositifs preremplis d'administration de liquides sans contamination externe ni interne - Google Patents

Procedes de production de dispositifs preremplis d'administration de liquides sans contamination externe ni interne Download PDF

Info

Publication number
WO1994013328A1
WO1994013328A1 PCT/US1993/011959 US9311959W WO9413328A1 WO 1994013328 A1 WO1994013328 A1 WO 1994013328A1 US 9311959 W US9311959 W US 9311959W WO 9413328 A1 WO9413328 A1 WO 9413328A1
Authority
WO
WIPO (PCT)
Prior art keywords
delivery device
prefilled
sterile
secondary package
exterior
Prior art date
Application number
PCT/US1993/011959
Other languages
English (en)
Inventor
Ronald W. Hagen
Original Assignee
Mallinckrodt Medical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mallinckrodt Medical, Inc. filed Critical Mallinckrodt Medical, Inc.
Priority to JP6514391A priority Critical patent/JPH08504350A/ja
Priority to AU58987/94A priority patent/AU5898794A/en
Priority to EP94905354A priority patent/EP0673261A4/fr
Publication of WO1994013328A1 publication Critical patent/WO1994013328A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • 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
    • 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
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • 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
    • A61L2/08—Radiation
    • A61L2/10—Ultraviolet radiation
    • 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
    • A61L2/14—Plasma, i.e. ionised gases
    • 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
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases

Definitions

  • the present invention relates generally to prefilled delivery devices, such as syringes, for the in vivo delivery of fluids and, more specifically, to methods of producing sterile, prefilled delivery devices without exterior or interior contamination.
  • Prefilled delivery devices such as prefilled syringes are known in the art for use in various medical procedures.
  • a delivery device is prefilled with the fluid to be dispensed and the entire assembly, including the delivery device and its contents, is then sterilized and supplied for end use.
  • prefilled sterile syringes of this type are disclosed in U.S. Patent Nos. 4,628,969 and 4,718,463.
  • Contamination of the exterior of a delivery device in an otherwise sterile environment could possibly cause serious illness, perhaps even death.
  • Critical medical procedures are typically carried out in sterile environments to ensure that patients are not exposed to infectious agents.
  • the exterior of a delivery device were contaminated with an infectious agent and if that delivery device were used during a critical medical procedure, the likelihood that a patient would be exposed to and be infected by an infectious agent would greatly increase.
  • An infection in a vulnerable patient undergoing such a medical procedure would clearly affect his ability to recover quickly or, perhaps, to recover at all.
  • methods of producing prefilled, sterile delivery devices without exterior or interior contamination include preparing an assembled and sealed prefilled delivery device, sterilizing the assembled and sealed prefilled delivery device and its contents, and aseptically placing the prefilled delivery device in a sterile secondary package which provides a sterile barrier surrounding the delivery device.
  • the prefilled delivery device can be non-aseptically placed in a secondary package after sterilization and then the exterior surfaces of the delivery device and the interior of the secondary package can be sterilized while the delivery device is in the secondary package which provides a sterile barrier surrounding the delivery device.
  • Another option would be to place the prefilled delivery device in a secondary package prior to sterilization, thus permitting the sterilization of the exterior and interior of the delivery device as well as the interior of the secondary package during the initial autoclaving procedure, thereby eliminating the need for further sterilization.
  • Fig. 1 is a sectional view of a prefilled sterile delivery device produced in accordance with the invention.
  • Fig. 2 is a sectional view of a prefilled sterile delivery device in a secondary package which provides a sterile barrier surrounding the delivery device in accordance with the invention.
  • a prefilled, sterile delivery device for injecting fluid materials indicated generally at 10 and produced in accordance with one embodiment of the present invention includes a housing portion 12 having an opening or passageway 14 at one end which is closed by a sealed tip portion 16. An open end 18 of housing portion 12 is closed and sealed by a rubber piston 20 which can be operated by a handle 22 for expelling the contents 24 through opening or passageway 14.
  • the housing portion 12 is produced by a suitable plastic-forming process such as injection molding of a suitable polymer such as polypropylene, or a co-polymer process of polypropylene and polyethylene.
  • sealed tip portion 16 including suitable sealing means such as a cap 15 and piston 20 may likewise be produced by injection molding a suitable elastomeric plastic or rubber material to the desired shapes.
  • the contents 24 can be any medicinal or diagnostic fluid material including, but not limited to, contrast media.
  • the term fluid means a medical fluid and encompasses liquids, gases, or combinations thereof, comprising or containing pharmaceutical media.
  • a prefilled delivery device is prepared.
  • the prefilled delivery device is a syringe.
  • the parts of the delivery device can be individually manufactured and assembled later.
  • the delivery device can be assembled and prefilled by any suitable means.
  • the parts of the delivery device are manufactured individually, cleaned, and assembled; the assembled delivery device is prefilled; and then the piston 20 is inserted into the open end 18 of the housing portion 12 so as to form a prefilled delivery device and to seal the fluid contents 24 in the delivery device.
  • the assembly of the piston 20 includes the evacuation of air from the housing portion 12 via a vacuum system so that the piston 20 can be inserted within the open end 18 of the housing portion 12 with a maximum amount of oxygen- free gas above the level of the fluid contents 24.
  • the housing portion 12, opening or passageway 14, and sealed tip portion 16 can be manufactured in a single unit, thus obviating the need for assembling these parts.
  • This single unit can be prefilled and then piston 20 can be inserted into open end 18 of housing portion 12 so as to form a prefilled delivery device as described above.
  • the assembled and prefilled delivery device is sterilized by any suitable means.
  • the assembled and prefilled delivery device can be placed in an autoclave where the prefilled delivery device and its contents can be heated under pressure in a steam/air mixture autoclave.
  • the sterile, prefilled delivery device 10 can be aseptically handled by any suitable means including, but not limited to, handling the delivery device with sterile instruments, wearing sterile gloves and/or clothing and the like in a sterile environment, or using sterile solutions after handling the delivery device, and can be placed in any suitable sterile secondary package 30 which provides a sterile barrier surrounding the delivery device so as to provide a sterile, prefilled delivery device without exterior or interior contamination as is depicted in Fig. 2.
  • the sterile, prefilled delivery device can be non-aseptically handled and placed in a secondary package 30 which provides a sterile barrier surrounding the delivery device.
  • the exterior surface of the prefilled delivery device and the interior of the secondary package may possibly be contaminated from the non-aseptic handling thereof, while the interior surface of the delivery device and the fluid contents therein remain in a sterile condition.
  • the prefilled delivery device and the secondary package 30 can then be sterilized by any suitable means so as to eliminate any contamination which might be present on the exterior surfaces of the prefilled delivery device or the interior of the secondary package 30 so as to provide a sterile delivery device without exterior or interior contamination as is depicted in Fig. 2.
  • suitable means for sterilizing the prefilled delivery device while it is in the secondary package include, but are not limited to, using hydrogen peroxide, electron beam irradiation, gamma irradiation, ultraviolet irradiation, ethylene oxide, ozonization, gas plasma, peracetic acid, para formaldehyde, glutaraldehyde, or beta propiolactone.
  • any suitable breathable or nonbreathable package can be used.
  • sterilization agents which require that the sterilizing agent be allowed access to the interior of the secondary package are used, only a suitable breathable package may be used as the secondary package.
  • the breathable package must be of such construction that it has pores or openings which are large enough to let the sterilizing agent enter into the interior of the secondary package, while the pores are also small enough to prevent contaminants, pyrogens and the like from entering into the secondary package.
  • TyvekTM which is made by Du Pont.
  • the exterior surface of the prefilled delivery device and the interior of the secondary package 30 can be sterilized by autoclaving.
  • the secondary package 30 is made of a resincus material which can withstand the autoclaving prccess so as to allow the exterior surface of the prefilled delivery device and the secondary package 30 to be sterilized under autoclaving conditions which are not severe enough to affect the amount or composition of the contents 24 of the delivery device i.e., the conditions are not severe enough to cause movement of the fluid contents 24 and/or the piston 20.
  • the secondary package 30 when sterilization of the delivery device in the secondary package 30 occurs through autoclaving, that the secondary package is transparent so as to allow quick and easy quality control inspection of the sterile delivery device without exterior or interior contamination, where one of the purposes of the quality control inspection is to ensure that no substantial movement of piston 20 and/or fluid contents 24 occurred during autoclaving which would affect the volume of fluid in the delivery device.
  • the prefilled delivery device can be non- aseptically placed in any suitable secondary package 30 which provides a sterile barrier surrounding the delivery device.
  • the prefilled delivery device in the secondary package 30 can then be sterilized by any suitable means, such as autoclaving, so that the exterior and interior surfaces of the prefilled delivery device, the fluid contents 24 therein, and the secondary package 30 are all sterilized during the initial sterilization procedure so as to provide a sterile, prefilled delivery device without exterior or interior contamination as is depicted in Fig. 2. Accordingly, no later sterilization procedures need to be undertaken in this embodiment.
  • the prefilled delivery device and the secondary package 30 are made of materials which would permit sterilization of the prefilled delivery device without allowing movement of the fluid contents 24 and/or piston 20 during the autoclaving process. It is further preferred that the secondary package 30 is also transparent for the reasons stated above.
  • this delivery device can easily be transported to the point of end use and stored in such a manner that the sterility of the delivery device can be maintained so that at the time of end use, the delivery device will be without exterior or interior contamination. That is, at the time of end use, the delivery device of the present invention can be handled by a "gloved" physician in a totally sterile environment without any contact with a possibly contaminated exterior surface of the delivery device.
  • this invention provides unique methods of producing sterile, prefilled delivery devices for injection of fluid. The combination of steps forming the methods described above is able to produce sterile, prefilled delivery devices without exterior or interior contamination which have heretofore been impossible to produce utilizing standard production procedures.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Packages (AREA)

Abstract

Procédés de production de dispositifs (10) d'administration de liquides préremplis stériles, sans contamination externe ni interne, qui consiste à préparer un dispositif (10) d'administration prérempli assemblé et scellé, à stériliser ledit dispositif (10) et son contenu (24) et à placer aseptiquement ledit dispositif (10) d'administration prérempli dans un emballage secondaire (30) qui constitue une barrière stérile entourant le dispositif (10) d'administration. Eventuellement, ledit dispositif (10) d'administration prérempli peut être placé non aseptiquement dans un emballage secondaire (30) après stérilisation. Les surfaces extérieures du dispositif (10) d'administration et l'intérieur de l'emballage secondaire (30) peuvent alors être stérilisés tandis que le dispositif (10) d'administration se trouve dans l'emballage secondaire (30). Eventuellement encore, le dispositif (10) d'administration prérempli peut être placé dans un emballage secondaire (30) avant stérilisation, permettant ainsi la stérilisation de l'extérieur et de l'intérieur du dispositif (10) d'administration, ainsi que de l'intérieur de l'emballage (30) secondaire pendant la procédure initiale de passage à l'autoclave, ce qui rend donc superflue une stérilisation ultérieure.
PCT/US1993/011959 1992-12-14 1993-12-09 Procedes de production de dispositifs preremplis d'administration de liquides sans contamination externe ni interne WO1994013328A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP6514391A JPH08504350A (ja) 1992-12-14 1993-12-09 内外部に汚染のない既充填放出装置の製法
AU58987/94A AU5898794A (en) 1992-12-14 1993-12-09 Methods of producing prefilled delivery devices without exterior or interior contamination
EP94905354A EP0673261A4 (fr) 1992-12-14 1993-12-09 Procedes de production de dispositifs preremplis d'administration de liquides sans contamination externe ni interne.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US98826492A 1992-12-14 1992-12-14
US07/988,264 1992-12-14

Publications (1)

Publication Number Publication Date
WO1994013328A1 true WO1994013328A1 (fr) 1994-06-23

Family

ID=25533985

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1993/011959 WO1994013328A1 (fr) 1992-12-14 1993-12-09 Procedes de production de dispositifs preremplis d'administration de liquides sans contamination externe ni interne

Country Status (5)

Country Link
EP (1) EP0673261A4 (fr)
JP (1) JPH08504350A (fr)
AU (1) AU5898794A (fr)
MX (1) MX9307952A (fr)
WO (1) WO1994013328A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0739638A1 (fr) * 1994-08-19 1996-10-30 Eiken Chemical Co., Ltd. Procede de sterilisation de medicaments dans des seringues pre-remplies
WO1997044068A1 (fr) * 1996-05-23 1997-11-27 Schering Ag Procede de sterilisation terminale de seringues remplies
WO1998005366A1 (fr) * 1996-08-02 1998-02-12 Schering Aktiengesellschaft Procede de sterilisation terminale de seringues remplies sous une pression d'appoint
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
EP1285672A1 (fr) * 2001-08-10 2003-02-26 Seikagaku Corporation Emballage d'injecteur pré-empli et son procédé de stérilisation ou de désinfection
US6648859B2 (en) 1997-09-29 2003-11-18 Becton Dickinson And Company Disposable, pre-filled drug cartridge
US9072781B2 (en) 2013-03-14 2015-07-07 Becton, Dickinson France S.A.S. Morphine formulations
US9248229B2 (en) 2013-03-14 2016-02-02 Becton, Dickinson France S.A.S. Packaging system for oxygen-sensitive drugs

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3831505B2 (ja) * 1997-12-26 2006-10-11 生化学工業株式会社 医療用滅菌包装における滅菌方法
JP4503953B2 (ja) * 2003-08-11 2010-07-14 テルモ株式会社 プレフィルドシリンジの製造方法
JP3845110B2 (ja) * 2006-01-06 2006-11-15 生化学工業株式会社 医療用滅菌包装における滅菌方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3891779A (en) * 1970-07-08 1975-06-24 Rosini Donald A Aseptic packaging of foods
US4628969A (en) * 1985-12-20 1986-12-16 Mallinckrodt, Inc. Method of producing prefilled sterile plastic syringes
US4878903A (en) * 1988-04-15 1989-11-07 Mueller Louis H Prefilled catheter tip syringe kit
US5031762A (en) * 1987-10-07 1991-07-16 Heacox Albert E Three envelope package for sterile specimens
US5033252A (en) * 1987-12-23 1991-07-23 Entravision, Inc. Method of packaging and sterilizing a pharmaceutical product

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3891779A (en) * 1970-07-08 1975-06-24 Rosini Donald A Aseptic packaging of foods
US4628969A (en) * 1985-12-20 1986-12-16 Mallinckrodt, Inc. Method of producing prefilled sterile plastic syringes
US5031762A (en) * 1987-10-07 1991-07-16 Heacox Albert E Three envelope package for sterile specimens
US5033252A (en) * 1987-12-23 1991-07-23 Entravision, Inc. Method of packaging and sterilizing a pharmaceutical product
US4878903A (en) * 1988-04-15 1989-11-07 Mueller Louis H Prefilled catheter tip syringe kit

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0673261A4 *

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0739638A4 (fr) * 1994-08-19 1997-12-10 Eiken Chemical Procede de sterilisation de medicaments dans des seringues pre-remplies
EP0739638A1 (fr) * 1994-08-19 1996-10-30 Eiken Chemical Co., Ltd. Procede de sterilisation de medicaments dans des seringues pre-remplies
WO1997044068A1 (fr) * 1996-05-23 1997-11-27 Schering Ag Procede de sterilisation terminale de seringues remplies
WO1998005366A1 (fr) * 1996-08-02 1998-02-12 Schering Aktiengesellschaft Procede de sterilisation terminale de seringues remplies sous une pression d'appoint
US6161364A (en) * 1996-08-02 2000-12-19 Scherring Aktiengesellschaft Terminal sterilization process for filled syringes under an auxiliary pressure
US6648859B2 (en) 1997-09-29 2003-11-18 Becton Dickinson And Company Disposable, pre-filled drug cartridge
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
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
US6250052B1 (en) 1998-03-13 2001-06-26 Becton, Dickinson And Company Method and apparatus for assembling and packaging medical devices
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
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
EP1285672A1 (fr) * 2001-08-10 2003-02-26 Seikagaku Corporation Emballage d'injecteur pré-empli et son procédé de stérilisation ou de désinfection
US9248229B2 (en) 2013-03-14 2016-02-02 Becton, Dickinson France S.A.S. Packaging system for oxygen-sensitive drugs
US9192608B2 (en) 2013-03-14 2015-11-24 Becton Dickinson France S.A.S. Morphine formulations
US9545473B2 (en) 2013-03-14 2017-01-17 Fresenius Kabi Deutschland Gmbh Packaging system for oxygen-sensitive drugs
US9072781B2 (en) 2013-03-14 2015-07-07 Becton, Dickinson France S.A.S. Morphine formulations
US10213424B2 (en) 2013-03-14 2019-02-26 Fresenius Kabi Deutschland Gmbh Morphine formulations
US10214338B2 (en) 2013-03-14 2019-02-26 Fresenius Kabi Deutschland Gmbh Packaging system for oxygen-sensitive drugs
US10781027B2 (en) 2013-03-14 2020-09-22 Fresenius Kabi Deutschland Gmbh Packaging system for oxygen-sensitive drugs
US11214426B2 (en) 2013-03-14 2022-01-04 Fresenius Kabi Deutschland Gmbh Packaging system for oxygen-sensitive drugs

Also Published As

Publication number Publication date
JPH08504350A (ja) 1996-05-14
EP0673261A4 (fr) 1997-11-26
AU5898794A (en) 1994-07-04
MX9307952A (es) 1994-08-31
EP0673261A1 (fr) 1995-09-27

Similar Documents

Publication Publication Date Title
US20200246533A1 (en) Medical apparatus and method for sterilizing medical apparatus
EP1940476B1 (fr) Procede de sterilisation d'articles d'etancheite elastomeres
US8540693B2 (en) Device for substantially germ-free provision of a fluid medium
EP0553926B1 (fr) Procédé pour la stérilisation terminale à la vapeur
EP2846754B1 (fr) Systèmes de conteneur prérempli
US5496302A (en) Method for sterilizing
JP2019088811A (ja) 制御された非分離充填器具および方法
US10207046B2 (en) Aseptic assembling of pharmaceutical containers
US11958647B2 (en) Methods for manufacturing non-glass prefilled syringes
KR20120034103A (ko) 이차 포장 내의 사전충전된 용기의 표면 오염제거 방법
EP0673261A1 (fr) Procedes de production de dispositifs preremplis d'administration de liquides sans contamination externe ni interne
EP0901380A1 (fr) Procede de sterilisation terminale de seringues remplies
US20220133981A1 (en) Syringe pack and method of packing a prefilled syringe
US20230310681A1 (en) Prefilled syringe and method of preparing a prefilled syringe
US20200297919A1 (en) Prefilled syringe and method of preparing a prefilled syringe
JPH1085306A (ja) 医療用容器

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AU CA JP

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FR GB GR IE IT LU MC NL PT SE

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 1994905354

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 1994905354

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: CA

WWW Wipo information: withdrawn in national office

Ref document number: 1994905354

Country of ref document: EP