WO1997044068A1 - Procede de sterilisation terminale de seringues remplies - Google Patents

Procede de sterilisation terminale de seringues remplies Download PDF

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Publication number
WO1997044068A1
WO1997044068A1 PCT/EP1997/002641 EP9702641W WO9744068A1 WO 1997044068 A1 WO1997044068 A1 WO 1997044068A1 EP 9702641 W EP9702641 W EP 9702641W WO 9744068 A1 WO9744068 A1 WO 9744068A1
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
manufacturing
stopper
ampoules
syringes
Prior art date
Application number
PCT/EP1997/002641
Other languages
German (de)
English (en)
Inventor
Johannes Tack
Thomas Schurreit
Jörg ZÜRCHER
Original Assignee
Schering Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Schering Ag filed Critical Schering Ag
Priority to EP97923989A priority Critical patent/EP0901380A1/fr
Priority to AU29602/97A priority patent/AU2960297A/en
Priority to JP09541568A priority patent/JP2000510740A/ja
Publication of WO1997044068A1 publication Critical patent/WO1997044068A1/fr

Links

Classifications

    • 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
    • A61L2/208—Hydrogen peroxide
    • 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
    • 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
    • A61L2/12—Microwaves
    • 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
    • A61L2/202—Ozone
    • 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
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/122—Chambers for sterilisation

Definitions

  • the invention relates to a method for the terminal sterilization of filled syringes.
  • the focus is on a pyrogen-free and germ-free surface of the syringes.
  • These syringes are preferably provided for the use of injectable diagnostics, 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.
  • the patent specification AT-E 68 979 describes a method for producing a filled, terminally sterilized syringe.
  • the syringe is made of plastic.
  • the syringe has a barrel 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 contamination on the closure and the piston are destroyed.
  • the cylinder is washed with a variety of water jets to remove pyrogens and waste particles. Then silicone oil is applied to the inner wall of the syringe.
  • the closure is then 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.
  • This assembled and filled syringe is sterilized in an autoclave.
  • an additional support pressure is generated in the autoclave. As a result, the pressure on the outer surface of the syringe becomes equal to or greater than the pressure on the inner surface of the syringe.
  • a terminal sterilization of prefilled syringe vials is known from the publication by Venten and Hoppert (E. VENTEN and J. HOPPERT (1978) Pharm. Ind. Vol. 40, No. 6, pages 665 to 671).
  • the spray ampoules which have a stopper at the proximal end, are filled distally through the rolled rim.
  • the rolled edge is then sealed by a sealing washer, whereby a flanged cap fixes the sealing washer on the rolled edge.
  • the prefilled syringe vials are then transferred to an autoclave.
  • This autoclave can be regulated in terms of temperature and pressure. So that the sealing washer a support pressure is generated in the autoclave. The support pressure is built up by an additional gas. This makes it possible to keep the pressure on the inside of the sealing disk approximately equal to the pressure on the outside of the sealing disk. This also avoids movement of the plunger used. to be sterilized terminally without an inadmissible plug movement or sealing disk leakage occurring
  • Finnish patent application FI 93 0405 describes a method for the periodic sterilization of a prefilled plastic syringe or glass syringe, the syringe containing a contrast agent.
  • the syringe consists of a syringe barrel which has a syringe outlet piece at the distal end Venten and Hoppert form described
  • the syringes have an open proximal end which can be closed by a stopper which is slidable in the syringe.
  • the stopper is connected with a stamp
  • the stopper When the syringe or syringe ampoule is filled, the stopper is first inserted into the proximal end of the syringe or syringe ampoule and then filled through the distal end. The distal end is then sealed by a closure.
  • a sealing washer In the case of the tip ampoules, a sealing washer is fixed to the rolled edge with a brothel cap.
  • the syringes or syringe ampoules are then sterilized, using a support pressure. The pressure on the outer surface of the syringe is therefore less than that Pressure held on the inside surface of the syringe or spray ampoule. With the spray ampoules, the pressure in the autoclave is the same, greater or less than the pressure in the spray ampoule.
  • WO 95/12418 describes a terminal stencilization process for prefilled syringes, in which no autoclave is used, but only a pressure-resistant sterilization chamber is used. The distally or proximally filled syringe is introduced into this sterilization 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 increase in the syringe. In order to avoid evaporation of liquid that penetrates through the plastic, water vapor is also introduced in addition to the heating gas. It is described in the protection law that the same safety as in an autoclaving should be achieved 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 hub.
  • the syringe further includes a stopper that can slide in the barrel. It seals the proximal end of the syringe.
  • the syringe is made using a process that results in pyrogen-free objects. There are also no more particles.
  • the syringe is filled through the proximal end, the syringe outlet piece being sealed with a closure. The filled syringe is closed with the stopper.
  • 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 in order to remove particles. The syringe is then washed. The syringe is then sterilized, so that the syringe can optionally be further processed, stored or transported.
  • the task is to offer a syringe which is pre-filled with a medium, the medium being permanently in the syringe without any loss of quality.
  • Particularly high demands are to be placed on safety with regard to sterility and low particle content inside and outside the syringe.
  • the object is achieved by a manufacturing method of a prefilled, sterile syringe made of glass or plastic or a mixture of glass and plastic, furthermore a glass syringe with an associated plastic oil 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 , wherein the fluid medium is a liquid, a solution, a suspension or an emulsion, the method comprising the following steps: Providing the syringe body which is free from germs, pyrogens and / or endotoxins and is low in particles,
  • syringe includes the terms cartridge (large-volume syringe with a volume of at least 100 ml), ampoule syringes, disposable syringes, disposable syringe ampoules, disposable syringe ampoules, disposable syringes, injection ampoules syringe ampoules, ready-to-use ampoules, cylindrical ampoules, double-chamber syringes, two-chamber syringes, two-chamber syringes Disposable syringe and immediate syringe
  • COC cycloolefin copolymer with the brand name CZ (manufacturer Nihon Zeon) are preferred and TOPAS (manufacturer Mitsui Chemicals and Hoechst)]
  • proximal and distal are defined from the point of view of the attending physician.
  • the syringe outlet piece to which, for example, the cannula or a hose leading to a channel is connected.
  • the stopper that passes the medium through the The distal end prints during application. The movement of the stopper can take place manually or mechanically.
  • the expression stopper also includes pistons.
  • the syringe For the manual actuation of the syringe, it is helpful for the operating personnel if the syringe carries finger holders on the proximal end the finger holders usually have at least one surface as an abutment for the index finger and middle finger, the surface of the finger holder being essentially perpendicular to the axis of the syringe barrel.
  • Different models are known for mechanical pumping devices.
  • a syringe then preferably carries one or more device holders on the two Such a mechanical pump is particularly well described in EP 0 584 531 (Reilly et al. filing date 21 07 1993). Mixed forms of finger holder and device holder are also possible
  • the syringes are usually rotationally symmetrical, only the finger mounts and device mounts and sometimes also the syringe outlet piece deviate from the symmetry.
  • the syringe outlet piece can be arranged eccentrically.
  • the Luer lock is particularly preferred because it is used exclusively when contrast agents are applied then comes into play when mechanical pumping devices are used. Also in the manual application cation, the Luer lock and the tubing connected to it prevent unintentional movements of the doctor from being transmitted directly to the cannula. Furthermore, the simple Luer approach and also the record approach are known.
  • a syringe outlet piece has a predetermined breaking point, which allows the syringe outlet piece to be opened easily before use.
  • the proximal and the distal end of the syringe must be closable.
  • the distal end is sealed by a closure which can be placed on the syringe outlet piece.
  • the syringe outlet piece comprises the top of the syringe barrel.
  • the syringe outlet piece comprises a tube which leads 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 and carrying a thread for a Luer lock, for example. It can
  • Syringe outlet piece can be in one piece or in several pieces.
  • the ceiling can be curved, 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 reliably retain the medium from the environment as little permeability as possible for gases and liquids Even temperature fluctuations must be absorbed without malfunction.
  • the stopper is not provided with its own stamp during the mechanical emptying of the syringes. Instead, a stopper, which is part of the pumping device, engages in a closure inside the stopper, so that movement of the stopper is possible without problems (cf. EP 0 584 531)
  • 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.
  • contrast agents with the generic names Ami- dotrizoic acid, gadopentetic acid, gadobutrol, gadolinium EOB-DTPA, lopamidol, lopromid, lotrolan and lotroxinic acid.
  • a syringe must be cleaned of foreign objects.
  • Foreign bodies are all the particles that are not made of the material of the syringe and the medium and the detached fragments of the syringe.
  • Pyrogens are substances that, as fragments of bacteria, provoke an immune response in humans. In particular, they are lipopolysaccharides.
  • the process with hydrogen peroxide is particularly preferred.
  • Sterilization with high-energy radiation is also possible.
  • Gamma rays and X-rays are known.
  • Neutron rays, beta rays and alpha rays are also used
  • Lubricants are used so that the plug can be moved within the cylinder without great effort.
  • Silicone oil is preferred, which has the following properties: viscosity at least 1000 cSt; Quality: medical grade
  • the parts of the syringe are sterile packed in bacteria-proof but gas-permeable film or aluminum.
  • the sterilization is carried out with the aid of thermal and / or chemical sterilization, with gamma rays or X-rays, neutron rays or Beta rays or a mixture of the aforementioned rays, treatment with hydrogen peroxide or ozone / steam mixture is preferred
  • the syringe body is then filled through the distal or proximal end, with either the stopper or the closure sealing the opposite end.
  • the filling opening is then closed by the closure or the stopper
  • the distal end is closed with a closure or by welding the distal end.
  • the distal end has a predetermined breaking point proximal to the welding. As a result, the distal end can be opened without problems after the welding
  • the syringe or cartridge is thermally sterilized in the autoclave or sterilizer with hot air or using a microwave
  • the pressure on the outer surface of the syringe being greater than or less than the pressure on the inner surface of the syringe pressure is to be defined as the pressure which corresponds to the sum of the partial pressures in the control room minus the partial pressure of the steam
  • stopper is readjusted after sterilization. This ensures that the stopper is in an optimal position. Sometimes the friction between stopper and cylinder is so great that the stopper is set in the stable position that there is no pressure difference between the inside and outside of the syringe does not take place independently
  • the filled and terminally filled syringe is packaged in sterile plastic film and / or aluminum film under optionally aseptic conditions. It is advantageous here that the syringe is packed in possibly sterile blisters, where aseptic conditions may prevail.
  • the syringe lying in the container is then externally sterilized again by treating the syringe with ethylene oxide, propan-3-olide and / or diethyl dicarbonate.
  • FIG. 1 A preferred embodiment is shown below by way of example.
  • a syringe according to the invention is shown in FIG. 1 as a perspective drawing.
  • FIG. 3 shows a flow chart in which the process of manufacture, sterilization, filling and terminal sterilization is shown.
  • FIG. 1 and 2 show a plastic syringe 100, which consists of a syringe body 1 with a syringe barrel 2.
  • the syringe 100 has a proximal end 3, which is closed by a stopper 4.
  • the stopper has a pyramid-shaped distal stopper part 5 and a cylindrical proximal stopper part 6, which lies sealingly against the inner wall of the syringe barrel 2. The contact between the proximal stopper part 6 and the inner wall of the cylinder takes place via a plurality of rubber beads 7.
  • Device holders 8 which consist of a device holder ring 9 and two device holder projections 10 and 10 ′, are arranged on the proximal end of the device cylinder Clamping the syringe in a mechanical pumping device.
  • a pyramid-shaped syringe outlet piece 12 which comprises a tube 13 and an end piece 14.
  • the pyramid-shaped distal stopper part 5 fits complementarily into the pyramid-shaped syringe outlet piece 12.
  • the conically tapering tube 13 is arranged centrally from the syringe outlet piece 12 that ends in the tail 14.
  • This end piece 14 is surrounded by a cylinder 15 which carries a thread 16 for a Luer lock on the inside.
  • the end piece 14 can be closed either by a tip closure part in the form of a tip cap or by a syringe closure part with a Luer lock.
  • the syringe closure part is in not shown in the drawing
  • FIG. 1 A flow chart is shown in FIG.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un procédé de fabrication d'une seringue stérile préremplie. Cette seringue comprend un corps de pompe, avec une extrémité proximale et une extrémité distale, une pièce de sortie située à l'extrémité distale, un obturateur, un bouchon et une substance fluide et un milieu gazeux. La substance fluide est un liquide. Ce procédé comprend les étapes suivantes: préparer le corps de pompe, l'obturateur et le bouchon, qui sont exempts de germes et/ou de d'endotoxines et ont une teneur réduite en particules. Un lubrifiant est appliqué. L'extrémité proximale étanchéifiée par introduction du bouchon dans le corps de pompe. La seringue est remplie par l'extrémité distale. La pièce de sortie de la seringue est étanchéifiée avec l'obturateur. La seringue est stérilisée dans une chambre de stérilisation, puis est emballée et le récipient d'emballage la contenant est ensuite à nouveau stérilisé.
PCT/EP1997/002641 1996-05-23 1997-05-23 Procede de sterilisation terminale de seringues remplies WO1997044068A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP97923989A EP0901380A1 (fr) 1996-05-23 1997-05-23 Procede de sterilisation terminale de seringues remplies
AU29602/97A AU2960297A (en) 1996-05-23 1997-05-23 Method of terminally sterilizing filled syringes
JP09541568A JP2000510740A (ja) 1996-05-23 1997-05-23 充填した注射器の最終滅菌方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19622283.4 1996-05-23
DE1996122283 DE19622283A1 (de) 1996-05-23 1996-05-23 Verfahren zur terminalen Sterilisierung von befüllten Spritzen

Publications (1)

Publication Number Publication Date
WO1997044068A1 true WO1997044068A1 (fr) 1997-11-27

Family

ID=7796041

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1997/002641 WO1997044068A1 (fr) 1996-05-23 1997-05-23 Procede de sterilisation terminale de seringues remplies

Country Status (5)

Country Link
EP (1) EP0901380A1 (fr)
JP (1) JP2000510740A (fr)
AU (1) AU2960297A (fr)
DE (1) DE19622283A1 (fr)
WO (1) WO1997044068A1 (fr)

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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
EP2869813A1 (fr) 2012-07-03 2015-05-13 Novartis AG Seringue
CN106176215A (zh) * 2016-06-28 2016-12-07 宋占涛 一种卡式瓶制品干燥性和稳定性的保持方法
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
EP3777834B1 (fr) 2012-06-01 2022-02-16 Novartis AG Seringue
CN114177325A (zh) * 2021-11-23 2022-03-15 欧冬妹 一种医疗用无针注射器顶端消毒装置
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
US11519020B2 (en) 2018-05-25 2022-12-06 Regeneron Pharmaceuticals, Inc. Methods of associating genetic variants with a clinical outcome in patients suffering from age-related macular degeneration treated with anti-VEGF
US11769597B2 (en) 2015-12-03 2023-09-26 Regeneron Pharmaceuticals, Inc. Methods of associating genetic variants with a clinical outcome in patients suffering from age-related macular degeneration treated with anti-VEGF

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FR2813797B1 (fr) * 2000-09-12 2006-02-10 Lagarde Procede de debacterisation d'un produit sec et produit sec obtenu
FR2813795B1 (fr) * 2000-09-12 2003-03-14 Lagarde Procede de debacterisation d'un produit sec et produit sec obtenu
US20020172615A1 (en) * 2001-03-08 2002-11-21 Archie Woodworth Apparatus for and method of manufacturing a prefilled sterile container
JP5729838B2 (ja) * 2009-07-09 2015-06-03 オンファーマ， インコーポレイテッド 緩衝溶液カートリッジを滅菌および保持する方法およびデバイス
AR078060A1 (es) * 2009-07-14 2011-10-12 Novartis Ag Descontaminacion de superficie de contenedores previamente llenados en empaque secundario
DE102010026104B3 (de) * 2010-07-05 2011-12-01 Fresenius Medical Care Deutschland Gmbh Verfahren zur Sterilisation wenigstens eines Gegenstandes, Sterilisationsvorrichtung sowie Verwendung hierzu
US20130280346A1 (en) * 2012-04-19 2013-10-24 C. R. Bard, Inc. Infusates with Enhanced pH Stability Under Ethylene Oxide Sterilization
KR102558984B1 (ko) 2020-08-25 2023-07-25 김용현 프리필드 약액 펌핑 어셈블리의 제조방법, 프리필드 약액 펌핑 어셈블리, 및 프리필드 약액 주입 장치
JP2023539254A (ja) * 2020-08-25 2023-09-13 ヨンヒョン キム プレフィルド薬液ポンピングアセンブリの製造方法、プレフィルド薬液ポンピングアセンブリ及びプレフィルド薬液注入装置
WO2023163243A1 (fr) * 2022-02-23 2023-08-31 김용현 Méthode de fabrication d'un ensemble de pompage de liquide médicinal pré-rempli, ensemble de pompage de liquide médicinal pré-rempli et ensemble d'injection de liquide médicinal pré-rempli

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EP0901380A1 (fr) 1999-03-17

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