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 PDFInfo
- 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
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
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
- A61L2/0094—Gaseous substances
-
- 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
-
- 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
- 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
- A61L2202/20—Targets to be treated
- A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- General Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Diabetes (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (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.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP13169083 | 2013-05-24 | ||
EP13169083.6 | 2013-05-24 |
Publications (1)
Publication Number | Publication Date |
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WO2014187779A1 true WO2014187779A1 (fr) | 2014-11-27 |
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ID=48536710
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2014/060248 WO2014187779A1 (fr) | 2013-05-24 | 2014-05-19 | Procédé de stérilisation superficielle d'une seringue prête à l'emploi |
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WO (1) | WO2014187779A1 (fr) |
Cited By (17)
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 |
WO2018218013A2 (fr) | 2017-05-24 | 2018-11-29 | Sio2 Medical Products, Inc. | Conditionnement pharmaceutique stérilisable pour formulations ophtalmiques |
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 |
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 |
USD961377S1 (en) | 2020-07-29 | 2022-08-23 | Regeneron Pharmaceuticals, Inc. | Packaging |
USD961376S1 (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 |
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 |
Citations (8)
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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 |
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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 |
-
2014
- 2014-05-19 WO PCT/EP2014/060248 patent/WO2014187779A1/fr active Application Filing
Patent Citations (8)
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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 |
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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 (26)
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 |
US10918754B2 (en) | 2017-03-27 | 2021-02-16 | Regeneron Pharmaceuticals, Inc. | Sterilisation method |
US10905786B2 (en) | 2017-03-27 | 2021-02-02 | Regeneron Pharmaceuticals, Inc. | Sterilisation method |
WO2018218013A2 (fr) | 2017-05-24 | 2018-11-29 | Sio2 Medical Products, Inc. | Conditionnement pharmaceutique stérilisable pour formulations ophtalmiques |
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 |
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 |
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 |
US11439758B2 (en) | 2019-06-05 | 2022-09-13 | Regeneron Pharmaceuticals, Inc. | Devices and methods for precision dose delivery |
US11160918B2 (en) | 2019-07-29 | 2021-11-02 | Regeneran 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 |
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 |
USD934069S1 (en) | 2019-07-29 | 2021-10-26 | Regeneron Pharmaceuticals, Inc. | Packaging |
USD906102S1 (en) | 2019-07-29 | 2020-12-29 | Regeneron Pharmaceuticals, Inc. | Packaging |
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 |
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 |
USD961377S1 (en) | 2020-07-29 | 2022-08-23 | Regeneron Pharmaceuticals, Inc. | Packaging |
USD961376S1 (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 |
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