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WO2014187779A1 - Procédé de stérilisation superficielle d'une seringue prête à l'emploi - Google Patents

Procédé de stérilisation superficielle d'une seringue prête à l'emploi Download PDF

Info

Publication number
WO2014187779A1
WO2014187779A1 PCT/EP2014/060248 EP2014060248W WO2014187779A1 WO 2014187779 A1 WO2014187779 A1 WO 2014187779A1 EP 2014060248 W EP2014060248 W EP 2014060248W WO 2014187779 A1 WO2014187779 A1 WO 2014187779A1
Authority
WO
WIPO (PCT)
Prior art keywords
functional packaging
sterilization
primary container
drug
materials
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2014/060248
Other languages
German (de)
English (en)
Inventor
Andreas Kalitzki
Heiko Kranz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Pharma AG
Original Assignee
Bayer Pharma 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 Bayer Pharma AG filed Critical Bayer Pharma AG
Publication of WO2014187779A1 publication Critical patent/WO2014187779A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • 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
    • 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
    • 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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • A61L2103/05—
    • 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
    • A61L2202/18—Aseptic storing means
    • A61L2202/181—Flexible packaging means, e.g. permeable membranes, paper
    • 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
    • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
    • 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
    • B65B2220/00—Specific aspects of the packaging operation
    • B65B2220/16—Packaging contents into primary and secondary packaging

Definitions

  • the invention relates to a protein syringe in a Sterilbarrieresystem for sterilization with a gas, further the surface sterilization of a protein syringe with hydrogen peroxide or ethylene oxide, and a measuring method for process control of surface sterilization (a blistered syringe) with hydrogen peroxide or ethylene oxide.
  • the present invention enables the surface sterilization of a primary container incl. Maintaining this sterility at least over the life.
  • the primary container is introduced into a functional packaging.
  • the functional packaging enables sterilization and maintains sterility at least over the life of the product.
  • the functional packaging is developed according to ISO 1 1607-1 and -2.
  • the functional packaging completely encloses the primary container and may consist of one or two or more materials which are firmly connected or closed against each other, eg sealed. At least one of the materials is permeable to gases, particularly sterilization gases (such as hydrogen peroxide or ethylene oxide). On the other hand, this material is germ-impermeable.
  • gases particularly sterilization gases (such as hydrogen peroxide or ethylene oxide).
  • this material is germ-impermeable.
  • Such a gas-permeable but germ-impermeable material may be, for example: polyethylene flow (PE flow, for example, trademark Tyvek) or paper or modifications of the aforementioned materials.
  • biological indicators can be introduced, which are spore-coated carrier.
  • the functional packaging may be a flexible package (pouch) or a rigid package (blister).
  • the primary container is contained in a functional packaging (as described above) which allows external sterilization of the primary container and ensures sterility at least over its lifetime.
  • the primary container may be, for example, prefilled syringes (glass or plastic, see ISO 1 1040-4, ISO 1 1040-6) or cartridges (see ISO 13926-1), which are then packaged secondarily in the functional packaging.
  • the primary container is suitable for medicinal products, including biological medicinal products (eg aflibercept (Eylea) or ranibizumab (Lucentis)) and medical devices.
  • the surface sterilization of the primary container in the functional packaging is carried out with a suitable sterilization method, typically by means of vaporous hydrogen peroxide or ethylene oxide.
  • a suitable sterilization method typically by means of vaporous hydrogen peroxide or ethylene oxide.
  • vapor or hydrogen peroxide or ethylene oxide sterilization also allows for the external sterilization of primary packaging (e.g., pre-filled syringes) with temperature sensitive drugs, e.g. biological drug molecules (especially aflibercept (Eylea) and ranibizumab (Lucentis)), using gentle sterilization conditions, since the method at low temperatures of 15- 40 ° C, especially at 17 ° C-30 ° C, preferably at 20-25 ° C and low pressures can be performed.
  • the functional packaging may have a shape that ensures that the primary container remains in position and also prevents pressure fluctuations, e.g. B. during transport by air or sterilization, flexible components, such. B. the plug of the syringe, move.
  • the subject of this invention is a process for surface sterilization with vaporous hydrogen peroxide or ethylene oxide of a primary container, which
  • (B) has been incorporated into a functional packaging made up of one or more materials, of which at least one of the materials is permeable to gases.
  • the process is characterized in that it is carried out at low temperatures of 15-40 ° C.
  • Pre-filled syringes sterilized by ethylene oxide or hydrogen peroxide have a germ-free outer surface.
  • the process can achieve a Sterility Assurance Level (SAL) of at least 10 "6 , especially 10 " 9, preferably O "12 or higher.
  • SAL Sterility Assurance Level
  • the described containers are delimited by a sterile outer surface of the primary container.
  • the sterility of the primary container is ensured by a validated sterilization process with a 12-log germ reduction.
  • the success of the sterilization process is unequivocally proven in the process by biological indicators, which are introduced into the sterilization chamber or the functional packaging before the sterilization process, for example.
  • the biological indicators are spore-coated carriers such as Geobacillus stearothermophilusis or Bacillus subtilis, which are proven to be suitable for sterilization with gases such as ethylene oxide and hydrogen peroxide.
  • the bioindicators used eg, as a disk or ribbon type from Mesa Labs or bioindicators from Skan
  • the bioindicators are introduced into the secondary packaging in such a way that the spore-loaded part is free during sterilization and from the gas on all sides is introduced into the functional packaging.
  • the bioindicators can be fixed to the functional packaging.
  • the primary container consists of a cylindrical body made of glass or plastic (e.g., cycloolefin or polypropylene).
  • the cylindrical body has an internal volume of 0.3 ml to 1 ml.
  • the cylindrical part may be formed as a Luer cone at the front end.
  • the cylindrical part may be flanged at the rear end.
  • the cylindrical part can be coated with a lubricant.
  • the cylindrical part can be printed with a scale or a dose mark.
  • the primary container is sealed at the front end (for drug delivery) with a closure that is (but not necessarily complete) made of an elastomer (such as butyl or polyisoprene) or a
  • Thermoplastic elastomer exists.
  • This closure may include other features such as a security lock or a luer lock adapter.
  • the primary tank is sealed at the rear end with a closure that is (but not necessarily complete) made of an elastomer (such as butyl, polyisoprene or polyisobutylene) or a thermoplastic elastomer.
  • This rear seal may be wholly or partly coated, e.g.
  • the rear end seal may be constructed of several materials, such as e.g. a plastic core with thread and a softer shell.
  • a linkage may be fitted in the seal at the rear end (eg via a thread or other fitting connection). However, the linkage can also be introduced without a fixed connection for sealing at the rear end. By means of this linkage, the seal can be moved and the syringe drained via the front end.
  • This flange can be made of plastic.
  • Figure 1 a shows an example of a primary container.
  • Figure 1 b shows an example of a primary container in a functional
  • FIG. 1 c shows a biological indicator introduced into the functional packaging.

Landscapes

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

Abstract

L'invention concerne une seringue de protéine dans un système de barrière stérile destiné à la stérilisation au moyen d'un gaz, ainsi que la stérilisation superficielle d'une seringue de protéine au peroxyde d'hydrogène ou à l'oxyde d'éthylène et une méthode de mesure pour contrôler le processus de stérilisation superficielle (d'une seringue sous blister) au peroxyde d'hydrogène ou à l'oxyde d'éthylène.
PCT/EP2014/060248 2013-05-24 2014-05-19 Procédé de stérilisation superficielle d'une seringue prête à l'emploi Ceased WO2014187779A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13169083.6 2013-05-24
EP13169083 2013-05-24

Publications (1)

Publication Number Publication Date
WO2014187779A1 true WO2014187779A1 (fr) 2014-11-27

Family

ID=48536710

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2014/060248 Ceased WO2014187779A1 (fr) 2013-05-24 2014-05-19 Procédé de stérilisation superficielle d'une seringue prête à l'emploi

Country Status (1)

Country Link
WO (1) WO2014187779A1 (fr)

Cited By (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD788937S1 (en) 2016-03-01 2017-06-06 Baxalta Incorporated Packaging unit for single medical device
USD788936S1 (en) 2016-03-01 2017-06-06 Baxalta Incorporated Packaging unit for single medical device
WO2018215580A1 (fr) 2017-05-24 2018-11-29 Formycon Ag Procédé de stérilisation de seringues en plastique pré-remplies contenant un antagoniste du vegf
WO2018217995A1 (fr) 2017-05-24 2018-11-29 Formycon Ag Conditionnements pharmaceutiques pré-remplis stérilisables comprenant une formulation liquide d'un antagoniste du vegf
WO2018218013A2 (fr) 2017-05-24 2018-11-29 Sio2 Medical Products, Inc. Conditionnement pharmaceutique stérilisable pour formulations ophtalmiques
EP3708204A4 (fr) * 2018-11-16 2020-10-21 KORTUC Inc. Seringue appropriée pour une solution de peroxyde d'hydrogène et nécessaire
USD906102S1 (en) 2019-07-29 2020-12-29 Regeneron Pharmaceuticals, Inc. Packaging
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
WO2021021925A1 (fr) * 2019-07-29 2021-02-04 Regeneron Pharmaceuticals, Inc. Emballage de dispositif médical et procédés associées
WO2021046070A1 (fr) * 2019-09-03 2021-03-11 Amgen Inc. Dispositif d'injection destiné à l'administration de médicament et emballage destiné au dispositif d'injection
CN112739307A (zh) * 2018-09-24 2021-04-30 吴制药有限公司 输注系统
USD961376S1 (en) 2020-07-29 2022-08-23 Regeneron Pharmaceuticals, Inc. Packaging
USD961377S1 (en) 2020-07-29 2022-08-23 Regeneron Pharmaceuticals, Inc. Packaging
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
EP4077157A1 (fr) * 2019-12-18 2022-10-26 Janssen Pharmaceutica NV Systèmes d'emballage pour dispositifs d'administration de médicaments et kits d'emballage
WO2022259217A1 (fr) 2021-06-11 2022-12-15 Cilag Gmbh International Seringues stérilisables au gaz ayant des ouvertures couvertes par des barrières perméables au gaz pour permettre l'entrée et la sortie de gaz de stérilisation tout en empêchant la fuite de matières fluides
EP4202055A1 (fr) 2021-12-21 2023-06-28 Bayer Aktiengesellschaft Indicateurs enzymatiques pour la commande des processus de stérilisation
USD1035436S1 (en) 2022-08-26 2024-07-16 Regeneron Pharmaceuticals, Inc. Packaging
USD1042107S1 (en) 2022-08-26 2024-09-17 Regeneron Pharmaceuticals, Inc. Packaging
USD1047700S1 (en) 2022-08-26 2024-10-22 Regeneron Pharmaceuticals, Inc. Packaging
US12201816B2 (en) 2019-03-29 2025-01-21 Kortuc Inc. Hydrogen peroxide solution-prefilled syringe with excellent hydrogen peroxide preservation due to silicone oil included in oil composition
US12233177B2 (en) 2019-09-16 2025-02-25 Amgen Inc. Method for external sterilization of drug delivery device

Citations (8)

* Cited by examiner, † Cited by third party
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EP0302420A2 (fr) * 1987-07-30 1989-02-08 JOHNSON & JOHNSON MEDICAL, INC. Système de stérilisation par la vapeur de peroxyde d'hydrogène à basse pression
US6228324B1 (en) * 1997-11-28 2001-05-08 Seikagaku Corporation Sterilizing method for medical sterilization packaging and injection pack
US20050268573A1 (en) * 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
US20070084144A1 (en) * 2005-10-14 2007-04-19 Atrium Medical Corporation Packaging and sterilization of medical devices
EP1864909A1 (fr) * 2006-06-06 2007-12-12 Aesculap AG & Co. KG Emballage en cyanoacrylate stérilisé
WO2008077155A1 (fr) * 2006-12-21 2008-06-26 Genentech, Inc. Stérilisation d'objets contenant des molécules biologiques
JP2010057597A (ja) * 2008-09-02 2010-03-18 Earekkusu:Kk プレフィルドシリンジの除染方法
US20120114524A1 (en) * 2009-07-14 2012-05-10 Juergen Sigg Surface Decontamination of Prefilled Containers in Secondary Packaging

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0302420A2 (fr) * 1987-07-30 1989-02-08 JOHNSON & JOHNSON MEDICAL, INC. Système de stérilisation par la vapeur de peroxyde d'hydrogène à basse pression
US6228324B1 (en) * 1997-11-28 2001-05-08 Seikagaku Corporation Sterilizing method for medical sterilization packaging and injection pack
US20050268573A1 (en) * 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
US20070084144A1 (en) * 2005-10-14 2007-04-19 Atrium Medical Corporation Packaging and sterilization of medical devices
EP1864909A1 (fr) * 2006-06-06 2007-12-12 Aesculap AG & Co. KG Emballage en cyanoacrylate stérilisé
WO2008077155A1 (fr) * 2006-12-21 2008-06-26 Genentech, Inc. Stérilisation d'objets contenant des molécules biologiques
JP2010057597A (ja) * 2008-09-02 2010-03-18 Earekkusu:Kk プレフィルドシリンジの除染方法
US20120114524A1 (en) * 2009-07-14 2012-05-10 Juergen Sigg Surface Decontamination of Prefilled Containers in Secondary Packaging

Cited By (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD788936S1 (en) 2016-03-01 2017-06-06 Baxalta Incorporated Packaging unit for single medical device
USD788937S1 (en) 2016-03-01 2017-06-06 Baxalta Incorporated Packaging unit for single medical device
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
WO2018215580A1 (fr) 2017-05-24 2018-11-29 Formycon Ag Procédé de stérilisation de seringues en plastique pré-remplies contenant un antagoniste du vegf
WO2018217995A1 (fr) 2017-05-24 2018-11-29 Formycon Ag Conditionnements pharmaceutiques pré-remplis stérilisables comprenant une formulation liquide d'un antagoniste du vegf
WO2018218013A2 (fr) 2017-05-24 2018-11-29 Sio2 Medical Products, Inc. Conditionnement pharmaceutique stérilisable pour formulations ophtalmiques
US20200237997A1 (en) * 2017-05-24 2020-07-30 Formycon Ag Sterilizable pre-filled pharmaceutical packages comprising a liquid formulation of a vegf-antagonist
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
CN112739307A (zh) * 2018-09-24 2021-04-30 吴制药有限公司 输注系统
CN112739307B (zh) * 2018-09-24 2024-11-01 吴制药有限公司 输注系统
EP4461334A2 (fr) 2018-11-16 2024-11-13 KORTUC Inc. Seringue pour stocker une solution de peroxyde d'hydrogène, seringue pré-remplie et kit la comprenant
IL282203B1 (en) * 2018-11-16 2025-12-01 Kortuc Inc A syringe suitable for hydrogen peroxide solution, and a kit
EP3708204A4 (fr) * 2018-11-16 2020-10-21 KORTUC Inc. Seringue appropriée pour une solution de peroxyde d'hydrogène et nécessaire
AU2019378353B2 (en) * 2018-11-16 2022-11-17 Kortuc Inc. Syringe suitable for hydrogen peroxide solution, and kit
US12201816B2 (en) 2019-03-29 2025-01-21 Kortuc Inc. Hydrogen peroxide solution-prefilled syringe with excellent hydrogen peroxide preservation due to silicone oil included in oil composition
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
JP2025015780A (ja) * 2019-07-29 2025-01-30 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 医療機器の包装および関連する方法
CN114450232A (zh) * 2019-07-29 2022-05-06 里珍纳龙药品有限公司 医疗装置包装及相关方法
TWI888395B (zh) * 2019-07-29 2025-07-01 美商里珍納龍藥品有限公司 醫療器材封裝及相關之方法
JP2022544039A (ja) * 2019-07-29 2022-10-17 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 医療機器の包装および関連する方法
US11160918B2 (en) 2019-07-29 2021-11-02 Regeneran Pharmaceuticals, Inc. Medical device packaging and related methods
JP7592691B2 (ja) 2019-07-29 2024-12-02 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 医療機器の包装および関連する方法
AU2020323937B2 (en) * 2019-07-29 2025-09-25 Regeneron Pharmaceuticals, Inc. Medical device packaging and related methods
WO2021021925A1 (fr) * 2019-07-29 2021-02-04 Regeneron Pharmaceuticals, Inc. Emballage de dispositif médical et procédés associées
IL290063B1 (en) * 2019-07-29 2025-12-01 Regeneron Pharma Medical device packaging and associated methods
US11793926B2 (en) 2019-07-29 2023-10-24 Regeneron Pharmaceuticals, Inc. Medical device packaging and related methods
CN114450232B (zh) * 2019-07-29 2024-06-07 里珍纳龙药品有限公司 医疗装置包装及相关方法
USD934069S1 (en) 2019-07-29 2021-10-26 Regeneron Pharmaceuticals, Inc. Packaging
USD906102S1 (en) 2019-07-29 2020-12-29 Regeneron Pharmaceuticals, Inc. Packaging
JP7774696B2 (ja) 2019-07-29 2025-11-21 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 医療機器の包装および関連する方法
US12458746B2 (en) 2019-07-29 2025-11-04 Regeneron Pharmaceuticals, Inc. Medical device packaging and related methods
US12059555B2 (en) 2019-09-03 2024-08-13 Amgen Inc. Injection device for drug delivery and packaging for the injection device
WO2021046070A1 (fr) * 2019-09-03 2021-03-11 Amgen Inc. Dispositif d'injection destiné à l'administration de médicament et emballage destiné au dispositif d'injection
US12233177B2 (en) 2019-09-16 2025-02-25 Amgen Inc. Method for external sterilization of drug delivery device
EP4077157A1 (fr) * 2019-12-18 2022-10-26 Janssen Pharmaceutica NV Systèmes d'emballage pour dispositifs d'administration de médicaments et kits d'emballage
USD961376S1 (en) 2020-07-29 2022-08-23 Regeneron Pharmaceuticals, Inc. Packaging
USD961377S1 (en) 2020-07-29 2022-08-23 Regeneron Pharmaceuticals, Inc. Packaging
WO2022259217A1 (fr) 2021-06-11 2022-12-15 Cilag Gmbh International Seringues stérilisables au gaz ayant des ouvertures couvertes par des barrières perméables au gaz pour permettre l'entrée et la sortie de gaz de stérilisation tout en empêchant la fuite de matières fluides
EP4202055A1 (fr) 2021-12-21 2023-06-28 Bayer Aktiengesellschaft Indicateurs enzymatiques pour la commande des processus de stérilisation
WO2023117876A1 (fr) 2021-12-21 2023-06-29 Bayer Aktiengesellschaft Indicateurs enzymatiques pour mettre en oeuvre un contrôle de processus sur des processus de stérilisation
USD1047700S1 (en) 2022-08-26 2024-10-22 Regeneron Pharmaceuticals, Inc. Packaging
USD1042107S1 (en) 2022-08-26 2024-09-17 Regeneron Pharmaceuticals, Inc. Packaging
USD1035436S1 (en) 2022-08-26 2024-07-16 Regeneron Pharmaceuticals, Inc. Packaging

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