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EP4217111B1 - Composant bêta d'un système de transfert pour une zone d'isolation stérile, zone d'isolation stérile, équipement de remplissage aseptique et procédé de fonctionnement de cet équipement de remplissage - Google Patents

Composant bêta d'un système de transfert pour une zone d'isolation stérile, zone d'isolation stérile, équipement de remplissage aseptique et procédé de fonctionnement de cet équipement de remplissage

Info

Publication number
EP4217111B1
EP4217111B1 EP21778026.1A EP21778026A EP4217111B1 EP 4217111 B1 EP4217111 B1 EP 4217111B1 EP 21778026 A EP21778026 A EP 21778026A EP 4217111 B1 EP4217111 B1 EP 4217111B1
Authority
EP
European Patent Office
Prior art keywords
beta
filling
alpha
closure unit
component
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.)
Active
Application number
EP21778026.1A
Other languages
German (de)
English (en)
Other versions
EP4217111A1 (fr
Inventor
Ulrich Krauss
Patrick Holl
Markus Ilgenfritz
Andreas Bernhard
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.)
Syntegon Technology GmbH
Original Assignee
Syntegon Technology GmbH
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 Syntegon Technology GmbH filed Critical Syntegon Technology GmbH
Publication of EP4217111A1 publication Critical patent/EP4217111A1/fr
Application granted granted Critical
Publication of EP4217111B1 publication Critical patent/EP4217111B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L1/00—Enclosures; Chambers
    • B01L1/02—Air-pressure chambers; Air-locks therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/56—Labware specially adapted for transferring fluids
    • B01L3/563—Joints or fittings ; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors
    • B01L3/5635—Joints or fittings ; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors connecting two containers face to face, e.g. comprising a filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L1/00—Enclosures; Chambers
    • B01L1/02—Air-pressure chambers; Air-locks therefor
    • B01L1/025—Environmental chambers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
    • 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
    • B65B55/027—Packaging in aseptic chambers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0689—Sealing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/12—Specific details about materials
    • B01L2300/123—Flexible; Elastomeric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like

Definitions

  • the filling system is used to fill a flowable medium, which is also called product, into sealable containers.
  • the filling process takes place under sterile, germ- and contamination-free conditions.
  • isolation zone also known as an isolator
  • the isolation zone forms a closed environment with an atmosphere that meets specific requirements for purity and freedom from contamination.
  • a filling device is arranged in the isolation area. This device is designed to fill the medium or product into sealable containers using a filling needle.
  • the filling device is also referred to as the filling path.
  • the filling device or the filling path for aseptic filling in the isolation area or isolator has been set up by the operating personnel using gloves, i.e. the operating personnel mounts the filling needle in the filling needle holder of the filling device and then connects the lines connected to the filling needle via pumps to the product bag in which the medium or product to be filled is held.
  • the object is achieved by a beta component according to claim 1, by a sterile isolation area according to claim 2, a filling system according to claim 3 and a method according to claim 10.
  • Transfer systems consist of two main components, an alpha port and a beta component, which, when docked, form a double-door system.
  • the Alpha flange is often made of stainless steel.
  • the Alpha closure unit is often made of plastic.
  • the Alpha port is usually equipped with a mechanical safety mechanism that prevents the Alpha closure unit from opening in the absence of a Beta component.
  • the closure unit formed by the coupled alpha closure unit and beta closure unit
  • the closure unit is pivoted into the isolation area. Since the holding device is arranged on the beta closure unit, it pivots into the isolation area and the held object is accessible without spatial restrictions and can be removed there.
  • a filling system with a sterile isolation area is also provided, wherein a handling device is arranged in the isolation area, which is designed to open the beta closure unit and the alpha closure unit in the coupled state (i.e., as described above, to open the closure unit formed by the coupled beta closure unit and alpha closure unit).
  • the handling device can also be designed to remove the object held in the holding device, in particular the filling needle, from the holding device and/or to place it in the holding device.
  • the opening of the locking unit can be automated via an automated opening mechanism that is separate from the handling device and can be operated from the operating area.
  • the filling system according to the invention allows a biodecontamination cycle to be carried out in a closed isolation area. This creates a germ- and contamination-free environment in the isolation area.
  • the beta component is docked to the alpha port of the transfer system.
  • the closure unit (coupled beta closure unit and alpha closure unit) is then opened, for example, by the handling device, such as the robot arm.
  • the closure unit can also be opened automatically from the outside (e.g., via a manually operated mechanism or with the aid of a motor).
  • the filling system may comprise a detection unit which is configured for machine vision and whose field of view includes at least the transfer system, so that a position of the filling needle can be detected by the detection unit can be detected. This simplifies the handling device's automated handling of the filling needle.
  • the handling device's movement path can be flexibly adjusted depending on the position of the filling needle.
  • the beta closure unit (or the entire closure unit formed by the coupled beta closure unit and alpha closure unit) can be transferred into a fixed open position upon opening, in which its position is defined. This can be achieved, for example, via a stop or a locking device.
  • the beta closure unit and thus the holding device attached to it are located in a predetermined position when opened. This simplifies the removal of the object held in the handling device.
  • the beta component can comprise a casing for the receiving space that can be removed from the beta flange.
  • the casing can be formed, for example, by a flexible plastic bag or a dimensionally stable, sterilizable container.
  • the casing can also be designed as a semi-dimensionally stable bellows unit. A casing designed in this way can be compressible toward the beta flange or variable in its extension, but rigid transversely to it.
  • the hose section located in the receiving space is typically longer than the distance of the transfer system from the filling needle position provided in the insulator. If the sheath is designed to be flexible, e.g., as a plastic bag, the bag itself can be longer than the distance of the transfer system from the filling needle position provided in the insulator. When the filling needle is moved, the bag (sheath) can be moved toward the transfer system, compressed, or folded.
  • the filling needle When shutting down the filling system or when a filling process is interrupted, the filling needle can be returned from the handling device to the holding device.
  • the hose can be returned to the bag, for example, by pulling on the compressed bag (beta bag or beta bag), allowing the beta closure unit to be closed without crushing the hose. This pulling operation can be performed by the operating personnel outside the isolator without having to intervene in the isolator.
  • the invention and its various developments include the avoidance of errors through the possibility of automated setup and increased product safety by eliminating the need for glove interventions. Furthermore, time can be saved when setting up the filling path.
  • the entire filling path i.e. filling needle and hose, including the single-use bag (beta bag) can be disposed of after production. This is particularly advantageous when filling toxic products.
  • the filling path can be upgraded after the biodecontamination cycle and is not exposed to H2O2. In other words, the filling needle and hose are located outside the isolation area during the decontamination cycle.
  • the object is also achieved by a method for operating a filling plant as described in this application.
  • the procedure includes the following steps: Attaching the Beta component to the Alpha port in the partition. During this attachment, the filling needle is positioned in the Beta component's receiving space in the holder.
  • Opening the closure unit i.e., the entire closure unit formed by the coupled Beta closure unit and Alpha closure unit
  • opening is also possible using an opening mechanism integrated, for example, into the Alpha flange.
  • removing the filling needle from the needle holding device of the filling device in particular by means of the handling device;
  • placing the filling needle in the receiving space in particular by means of the handling device, in particular in the holding device.
  • the filling device 18 comprises a needle holding device 19, which is designed to hold a filling needle 20 or in which the filling needle 20 can be arranged to perform filling processes.
  • the needle holding device 19 forms a holder for the filling needle 20.
  • the needle holding device 19 can also be arranged in the filling device 18 in such a way that it is moved by the filling device during the filling processes.
  • the transfer system 22 comprises a replaceable beta component 24 and an alpha port 27 fixedly arranged in the partition wall 16.
  • the filling needle 20 To insert the filling needle 20 into the insulation area 12, it is first arranged in the beta component 24 in the receiving space 36.
  • the filling needle 20 is connected to a hose 43 that extends out of the receiving space 36 and, at its end facing away from the filling needle 20, includes a sterile connector 48 for connection to a storage container 46.
  • a holding device 50 is arranged for the precise positioning of the filling needle 20.
  • the holding device 50 is, as shown in Figures 3 and 4 clearly shown, arranged on the removable beta closure unit 30. If the beta component 24 is coupled to the alpha port 27 and the closure unit 31 is opened, the filling needle 20 held in the holder device 50 is moved into the isolation area 12.
  • the handling device 40 arranged in the isolation area 12 is designed as a robot arm in the present case.
  • the handling device 40 is designed to open the closure unit 31 (alpha closure unit 29 and beta closure unit 30 connected to each other in the coupled state) and to remove the filling needle 20 from the holder device 50 and insert it into the needle holding device 19. After use of the filling needle 20, the filling needle 20 can be moved back into the holder device 50 by means of the handling device 40.
  • the filling system 10 comprises an optional detection unit 42 which is configured for machine vision and whose field of view comprises the transfer system 22 and, in the present case, the needle holding device 19, so that a position of the filling needle 20 can be detected by the detection unit 42 and the handling device 40 can be controlled or regulated accordingly in order to remove the filling needle 20 from the holding device 50 and to place it in the needle holding device 19 and, after use, to transfer it back into the holding device 50.
  • an optional detection unit 42 which is configured for machine vision and whose field of view comprises the transfer system 22 and, in the present case, the needle holding device 19, so that a position of the filling needle 20 can be detected by the detection unit 42 and the handling device 40 can be controlled or regulated accordingly in order to remove the filling needle 20 from the holding device 50 and to place it in the needle holding device 19 and, after use, to transfer it back into the holding device 50.
  • the casing 44 can also be designed as a semi-rigid bellows unit.
  • a casing 44 designed in this way can be compressible in the direction of the beta flange 26 or variable in its extension, but rigid transversely thereto.
  • the locking unit 31 (or the alpha locking unit 29 and the beta locking unit 30 coupled to it) can be transferred into a fixed open position when opened, as shown in Figure 2 In the fixed open position, the alpha locking unit 29 or the entire locking unit 31 and thus also the beta locking unit 30 and the holding device 50 arranged on it are fixed in their position.
  • the filling needle 20 is connected via the hose 43 to the storage container 46 containing the medium 32 by means of the sterile connector 48.
  • the storage container 46 is connected via a container-side sterile connector 52 to a hose section that passes through a peristaltic pump 56.
  • a medium filter 58 is arranged in the connecting hose line between the peristaltic pump 56 and the sterile connector 48 on the filling needle 20 side.

Landscapes

  • Health & Medical Sciences (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Basic Packing Technique (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)

Claims (10)

  1. Composant bêta (24) d'un système de transfert (22) comprenant un espace de réception (36), une bride bêta (26), une enveloppe (44) délimitant l'espace de réception (36), et une unité de fermeture bêta (30), dans lequel l'unité de fermeture bêta (30) est montée de manière à pouvoir être retirée sur la bride bêta (26) pour ouvrir et fermer l'espace de réception (36), et la bride bêta (26) et l'unité de fermeture bêta (30) sont conçues pour être accouplées à une bride alpha (28) et à une unité de fermeture alpha (29) d'un port alpha (27) du système de transfert (22), caractérisé en ce que le composant bêta (24) présente un dispositif de maintien (50) permettant de maintenir un objet (20), en particulier une aiguille de remplissage (20), dans une position et une orientation définies, caractérisé en ce que le dispositif de maintien (50) est disposé sur un côté de l'unité de fermeture bêta (30) orienté vers l'espace de réception (36), en particulier dans lequel une aiguille de remplissage (20) est maintenue par le dispositif de maintien (50).
  2. Zone d'isolation (12) stérile comportant une paroi de séparation (16) au moyen de laquelle elle est séparée d'une zone de service(14) non stérile , dans laquelle la paroi de séparation (16) comprend un port alpha (27) d'un système de transfert (22) pour l'introduction d'objets (24) depuis la zone de service (14) dans la zone d'isolation (12), dans laquelle un dispositif de remplissage (18) est en particulier disposé dans la zone d'isolation (12), lequel est conçu pour remplir des récipients (34) pouvant être fermés d'un milieu (32) au moyen d'une aiguille de remplissage (20), caractérisée en ce qu'un composant bêta (24) selon la revendication 1 est accouplé au port alpha (27), dans laquelle le dispositif de maintien (50) est déplacé à l'intérieur de la zone d'isolation (12) lors de l'ouverture d'une unité de fermeture (31) du système de transfert (22) qui est formée par l'unité de fermeture alpha (29) et l'unité de fermeture bêta (30) accouplées entre elles.
  3. Installation de remplissage (10) comportant une zone d'isolation (12) stérile selon la revendication 2, dans laquelle un dispositif de manipulation (40) est disposé dans la zone d'isolation (12), lequel est conçu pour ouvrir l'unité de fermeture bêta (30) et l'unité de fermeture alpha (29) à l'état accouplé l'une à l'autre et/ou pour retirer l'objet maintenu dans le dispositif de maintien (50), en particulier l'aiguille de remplissage (20), du dispositif de maintien (50) et/ou pour le placer dans celui-ci.
  4. Installation de remplissage (10) selon la revendication 3,
    caractérisée en ce qu'elle comprend une unité de détection (42) qui est configurée pour voir de manière mécanique et dont le champ de vision comprend au moins le système de transfert (22), de sorte qu'une position et/ou une orientation de l'objet, en particulier de l'aiguille de remplissage (20), peuvent être détectées par l'unité de détection (42).
  5. Zone d'isolation (12) stérile ou installation de remplissage (10) selon la revendication 2, caractérisée en ce que l'unité de fermeture (31) qui est formée par l'unité de fermeture alpha (29) et l'unité de fermeture bêta (30) accouplées l'une à l'autre peut être transférée, lors de l'ouverture, dans une position ouverte fixe dans laquelle sa position est déterminée.
  6. Composant bêta (24), zone d'isolation (12) stérile ou installation de remplissage (10) selon l'une des revendications précédentes,
    caractérisé en ce que l'enveloppe (44) de l'espace de réception (36) du composant bêta (24) est réalisée de manière à pouvoir être retirée de la bride bêta (26), en particulier dans lequel l'enveloppe (44) est formée par un sac en matière plastique flexible ou est formée par un récipient pouvant être stérilisé indéformable.
  7. Composant bêta (24), zone d'isolation (12) stérile ou installation de remplissage (10) selon l'une des revendications précédentes,
    caractérisé en ce que l'aiguille de remplissage (20) est reliée à un tuyau (43) qui s'étend hors de l'espace de réception (36), en particulier, et comprend à son extrémité opposée à l'aiguille de remplissage (20) un moyen de liaison stérile (48) pour la liaison avec un récipient de stockage (46).
  8. Composant bêta (24), zone d'isolation (12) stérile ou installation de remplissage (10) selon la revendication précédente, caractérisé en ce que le composant bêta (24) comprend un dispositif de rappel pour le tuyau (43), lequel dispositif de rappel, lors du rappel, c'est-à-dire lors du retour de l'aiguille de remplissage (20) dans l'espace de réception (36), ramène également le tuyau (43) dans l'espace de réception.
  9. Composant bêta (24), zone d'isolation (12) stérile ou installation de remplissage (10) selon l'une des revendications précédentes,
    caractérisé en ce que la bride bêta du composant bêta (24) et la bride alpha (28) du port alpha (22) sont conçues pour être reliées l'une à l'autre au moyen d'une fermeture à baïonnette et l'unité de fermeture bêta (30) et l'unité de fermeture alpha (29) sont conçues pour être reliées l'une à l'autre au moyen d'une fermeture à baïonnette.
  10. Procédé permettant de faire fonctionner une installation de remplissage (10) selon l'une des revendications 3 à 9 précédentes, dans lequel le procédé comprend les étapes consistant à :
    fixer le composant bêta (24) au port alpha (27) dans la paroi de séparation (16), dans lequel l'aiguille de remplissage (20) est disposée dans l'espace de réception (36) du composant bêta (24) dans le dispositif de maintien (50) ;
    exécuter un cycle de décontamination dans la zone d'isolation (12) ;
    caractérisé en ce que le procédé comprend les étapes suivantes :
    ouverture du système de transfert (22) au moyen du dispositif de manipulation (40) ;
    retrait de l'aiguille de remplissage (20) hors du dispositif de maintien (50) au moyen du dispositif de manipulation (40) ;
    placement de l'aiguille de remplissage (20) dans un dispositif de maintien d'aiguille (19) du dispositif de remplissage (18) au moyen du dispositif de manipulation (40) ;
    en particulier, retrait de l'aiguille de remplissage (20) du dispositif de maintien d'aiguille (19) du dispositif de remplissage (18) au moyen du dispositif de manipulation (40) ;
    en particulier, placement de l'aiguille de remplissage (20) dans l'espace de réception (36), en particulier dans le dispositif de maintien (50), au moyen du dispositif de manipulation (40).
EP21778026.1A 2020-09-23 2021-09-16 Composant bêta d'un système de transfert pour une zone d'isolation stérile, zone d'isolation stérile, équipement de remplissage aseptique et procédé de fonctionnement de cet équipement de remplissage Active EP4217111B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020124826.1A DE102020124826A1 (de) 2020-09-23 2020-09-23 Beta-Komponente eines Transfersystems für einen sterilen Isolationsbereich, steriler Isolationsbereich, aseptische Abfüllanlage sowie ein Verfahren zum Betrieb einer derartigen Abfüllanlage
PCT/EP2021/075431 WO2022063667A1 (fr) 2020-09-23 2021-09-16 Composant bêta d'un système de transfert pour une région d'isolation stérile, région d'isolation stérile, système de remplissage aseptique et procédé de fonctionnement d'un tel système de remplissage

Publications (2)

Publication Number Publication Date
EP4217111A1 EP4217111A1 (fr) 2023-08-02
EP4217111B1 true EP4217111B1 (fr) 2025-07-23

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP21778026.1A Active EP4217111B1 (fr) 2020-09-23 2021-09-16 Composant bêta d'un système de transfert pour une zone d'isolation stérile, zone d'isolation stérile, équipement de remplissage aseptique et procédé de fonctionnement de cet équipement de remplissage

Country Status (7)

Country Link
US (1) US20230364619A1 (fr)
EP (1) EP4217111B1 (fr)
CN (1) CN116194214B (fr)
CA (1) CA3192434A1 (fr)
DE (1) DE102020124826A1 (fr)
ES (1) ES3041274T3 (fr)
WO (1) WO2022063667A1 (fr)

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DE102020102765A1 (de) * 2020-02-04 2021-08-05 Groninger & Co. Gmbh Verfahren zum Transferieren zumindest einer Füllnadel einer Anzahl von Füllnadeln in einen aseptischen Isolator
DE102022101820A1 (de) 2022-01-26 2023-07-27 Atec Pharmatechnik Gmbh Transfer-Port zum Übertragen eines Fluides sowie Übertragungs-System
CN117529446A (zh) * 2022-07-20 2024-02-06 浙江健新原力制药有限公司 一种载体液无菌分装系统及其应用
DE102022131808A1 (de) * 2022-11-30 2024-06-06 Groninger & Co. Gmbh Funktionselement, Beta-Behältersystem, Transfersystem und Barrieresystem
DE102023118665A1 (de) * 2023-07-14 2025-01-16 Syntegon Technology Gmbh Befüllungssystem zur Fluidbefüllung von Behältnissen
DE102023122778A1 (de) 2023-08-24 2025-02-27 Syntegon Technology Gmbh Pharmazeutische Anlage und Verfahren zum Betreiben einer pharmazeutischen Anlage
DE102024115999A1 (de) * 2024-06-07 2025-12-11 OPTIMA pharma GmbH System und Verfahren zum Rüsten einer Anlage sowie Anlage

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CN116194214B (zh) 2025-11-25
DE102020124826A1 (de) 2022-03-24
ES3041274T3 (en) 2025-11-11
WO2022063667A1 (fr) 2022-03-31
EP4217111A1 (fr) 2023-08-02
CN116194214A (zh) 2023-05-30
US20230364619A1 (en) 2023-11-16
CA3192434A1 (fr) 2022-03-31

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