EP3939896A1 - Module fonctionnel destiné au rapprochement d'une station de dosage positionnée dans une chambre de processus d'un confinement et procédé correspondant - Google Patents

Module fonctionnel destiné au rapprochement d'une station de dosage positionnée dans une chambre de processus d'un confinement et procédé correspondant Download PDF

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Publication number
EP3939896A1
EP3939896A1 EP20405021.5A EP20405021A EP3939896A1 EP 3939896 A1 EP3939896 A1 EP 3939896A1 EP 20405021 A EP20405021 A EP 20405021A EP 3939896 A1 EP3939896 A1 EP 3939896A1
Authority
EP
European Patent Office
Prior art keywords
element carrier
functional module
functional elements
transfer
medium lines
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.)
Pending
Application number
EP20405021.5A
Other languages
German (de)
English (en)
Inventor
Matteo Giuliani
Andrea Roncarà
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.)
Pharma Integration SRL
Original Assignee
Pharma Integration SRL
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 Pharma Integration SRL filed Critical Pharma Integration SRL
Priority to EP20405021.5A priority Critical patent/EP3939896A1/fr
Priority to CN202180061065.5A priority patent/CN116234753A/zh
Priority to PCT/IB2021/056440 priority patent/WO2022013830A1/fr
Priority to KR1020237005381A priority patent/KR20230038565A/ko
Priority to JP2023501637A priority patent/JP2023534219A/ja
Priority to CA3186113A priority patent/CA3186113A1/en
Priority to US18/014,460 priority patent/US20230257148A1/en
Publication of EP3939896A1 publication Critical patent/EP3939896A1/fr
Pending legal-status Critical Current

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Classifications

    • 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
    • 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
    • B65B3/006—Related operations, e.g. scoring ampoules
    • 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
    • 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 invention relates to a functional module for leading to a dosing station positioned in a process space of a containment and is provided there for the aseptic filling of vessels with a liquid.
  • the containment is intended for placement in an installation room, with the containment and process room being enclosed in a housing.
  • the functional module comprises an element carrier, functional elements intended for installation on the element carrier and medium lines intended for connection to the functional elements.
  • the subject matter of the invention is a method for bringing the conceived functional module to the dosing station.
  • the invention is based on the object of at least reducing manual activities in the process room and thereby making the workflow more efficient in terms of time expenditure, less error-prone, higher quality and with little outlay on equipment.
  • a special device has to be developed and a method using the device has to be proposed.
  • the designed functional module is intended for the introduction to a dosing station positioned in a process room of a containment and there for the aseptic filling of vessels with a liquid.
  • the containment is intended for placement in an installation room, with the containment and process room being enclosed in a housing.
  • the functional module includes an element carrier, functional elements that are intended for installation on the element carrier, and medium lines that are connected to the functional elements.
  • the assembly as an assembly, consisting of element carrier, functional elements accommodated by this and medium lines connected to it, can be moved from a retracted initial position through a transfer port leading into the process space into an extended working position at the dosing station.
  • the function module is used for the aseptic filling of a plurality of vessels, which are combined in a container, with a pharmacological or toxic liquid.
  • a pharmacological or toxic liquid When handling liquids that are sensitive to oxygen, they are overlaid with an inert gas, e.g. nitrogen.
  • the containment housing has a rear wall that delimits the process space as a component.
  • the transfer port is formed by an opening provided in a molding of a flanged joint installed in the back panel.
  • the function module is installed at the transfer port in such a way that it protrudes into a transfer cell adjacent to the process room and can extend into the installation room, or the function module extends completely freely into the installation room.
  • the external connection or the external connections and an actuator for moving the assembly consisting of an element carrier with a front piece, functional elements accommodated by the element carrier and medium lines connected to them, are accessible from the installation room.
  • the transfer cell can be open to the installation room, e.g. due to a wall opening in the outer wall.
  • the assembled subassembly comprising the element carrier, the functional elements held by it and the medium lines connected to it, is in the transfer cell, and a front piece sitting at the forefront on the element carrier is positioned in the transfer port.
  • this assembled assembly is guided like a sled or supported and moved out of the transfer cell to the dosing station until the end piece on the rear of the element carrier hits the transfer port.
  • the assembly is moved out into the working position by pushing it out from the transfer cell or by pulling it out from the process room, e.g. by means of a robot installed in the process room.
  • the functional module according to the invention is described in detail below in two different versions and as a method of the assembly process, the preparation of operational readiness and the use of the functional module.
  • the containment 9 surrounded by a housing 90 here in the form of an isolator standing in the installation room 8 , is shown in its basic structure for the purpose of explaining the internal division of space, the existing walls and the equipment.
  • a transparent pane 911 is usually seated in the front wall 910 , while an interchangeable unit 95 is inserted in the rear wall 912 .
  • the housing 90 further includes the upper roof surface 91 , the lower floor surface 92 , the rear outer wall 900 with the transfer fitting 903 installed therein and the first and second side surfaces 916 , 918 , which together with the front and rear walls 910 , 912 the containment 9 demarcate to the outside.
  • the passage 917 on the inlet side is located in the first side surface 916 , while the second side surface 916 has the passage 919 on the outlet side.
  • the porch 913 extends into the installation space 8, as well as an inclined, downward-sloping intermediate floor 914 towards the lowest area of the rear wall 912 .
  • the horizontal space divider 915 runs from the upper section of the front wall 910 to the rear wall 912 and from there each horizontally, the upper cell wall 901 and the lower cell wall 902 to the rear outer wall 900 .
  • the front area 94 and the rear area 99 are thus formed by the housing 90 and existing walls.
  • the front area 94 is structured into the roof space 98 divided above the space divider 915 , the floor space 97 present below the intermediate floor 914 , and the process space 93 located between the roof space 98 and the floor space 97 .
  • the transfer cell 96 is formed in the rear space 99 between the upper cell wall 901 and the lower cell wall 902 .
  • a transfer fitting 903 advantageously designed as a rapid transfer port (RTP), in the rear outer wall 900 serves to introduce pre-sterilized components into the transfer cell 96 in a protected manner.
  • glove ports 905 are provided, usually in pairs, to perform 96 activities while maintaining the sterile atmosphere in the transfer cell.
  • the equipment of the containment 9 includes a dosing station 3 set up in the process space 93 to which the functional module 2 - here in the first version - is brought from the transfer cell 96 through a transfer port 260 into the working position.
  • the first version of the function module 2 is the subject of the sequence of figures 1A to 5, after their detailed description the practical assembly process and the application of the device are explained.
  • a flange connection 20 installed in a recess in the exchange unit 95 has the transfer port 260 .
  • the function module 2 is fixed but installed on the flange connection 20 so that it can be extended.
  • An essential part of the function module 2 is the element carrier 23 .
  • a robot 1 has the manipulation element 12 guided by its pivotable arm 11 , for example in the form of a gripper.
  • the robot 1 can advantageously be anchored with its foot 10 below the exchangeable unit 95 on the rear wall 912 .
  • this pair of figures illustrates the functional module 2 previously assembled without being equipped with the functional elements 230 and without connected medium lines 231 , which extends out of the transfer port 260 into the process space 93 has approached the dosing station 3 .
  • the front piece 24 fixed to the element carrier 23 is moved forward in the process space 93 and the end piece 25 fills the transfer port 260 , at least partially sealing it.
  • the cover ring 26 rests against the exchange unit 95 on the side of the process space 93 .
  • the assembled functional module 2 can now be seen equipped with the functional elements 230 , but still without the medium lines 231 connected .
  • the medium lines 231 are now also connected to it, specifically in each case directly at the junction with the functional elements 230 .
  • the functional module 2 is in the real working position, ie pulled out of the transfer port 260 into the process chamber 93 at the dosing station 3 and standing with the end piece 25 in the transfer port 260 and at least partially sealing it.
  • the function module 2 according to the second version - currently in the retracted initial position - is not permanently installed on the flange connection 20 , in contrast to the first version , but can be pushed into this dock through wall opening 904 to flanged joint 20 with access through its open transfer port 260.
  • the functional module 2 has a container 28 that is sealed off from the outside, in whose sterile interior 29 the completely equipped element carrier 23 is accommodated in the retracted initial position, pre-sterilized. In the container 28 there is a passage 280 which is closed almost automatically in the initial position and through which the equipped element carrier 23 can be moved out into the extended working position.
  • the element carrier 23 fitted with the functional elements 230 rests in the container 28 and is therefore not at the dosing station 3 .
  • the front piece 24 closes the passage 280 in a gas-tight manner.
  • the excess length of the medium lines 231 connected to the functional elements 230 lie in the interior 29 of the container 28 and lead to the connection 232 .
  • a medium line 231 exiting from the connection 232 could advantageously be divided into the individual functional elements 230 by branching.
  • a separate medium line 231 with excess length to a respective connection 232 will preferably extend to each functional element 230 .
  • the feed part 286 is driven, which means that the front piece 24 is gradually removed from the passage 280 and at the same time the element carrier 23, together with its equipment, moves out of the container 28 , into the processing space 93 , up to the extended working position the dosing station 3 approach.
  • the end piece 25 abuts inside the container 28 in its front area.
  • the previously existing excess length of the medium line 231 is stretched.
  • the liquid to be processed at the dosing station 3 is fed from the outside to the connection 232 , conveyed into the medium line 231 and via it into the functional elements 230 .
  • vessels to be filled are advantageously transported to the dosing station 3 with the manipulation element 12 of the robot 1 .
  • the vials are filled, for example with a pharmacological liquid, by means of the functional elements 230 , which are now also in the dosing station 3 and are held by the element carrier 23 .
  • the cannula-like functional elements 230 dip into the vials, which are open at the top.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Basic Packing Technique (AREA)
  • Manipulator (AREA)
  • External Artificial Organs (AREA)
EP20405021.5A 2020-07-17 2020-07-17 Module fonctionnel destiné au rapprochement d'une station de dosage positionnée dans une chambre de processus d'un confinement et procédé correspondant Pending EP3939896A1 (fr)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP20405021.5A EP3939896A1 (fr) 2020-07-17 2020-07-17 Module fonctionnel destiné au rapprochement d'une station de dosage positionnée dans une chambre de processus d'un confinement et procédé correspondant
CN202180061065.5A CN116234753A (zh) 2020-07-17 2021-07-16 用于移至位于安全壳加工区内配料站的功能模块及其方法
PCT/IB2021/056440 WO2022013830A1 (fr) 2020-07-17 2021-07-16 Module fonctionnel à rapprocher d'un poste de dosage positionné dans une chambre de traitement d'une enceinte de confinement, et procédé associé
KR1020237005381A KR20230038565A (ko) 2020-07-17 2021-07-16 격납용기의 프로세스 챔버에 위치한 계량 스테이션에 접근시키기 위한 기능 모듈 및 관련 방법
JP2023501637A JP2023534219A (ja) 2020-07-17 2021-07-16 格納容器の処理室に配置された投与ステーションに案内するための機能モジュールおよびそのための方法
CA3186113A CA3186113A1 (en) 2020-07-17 2021-07-16 Functional module for moving to a dosing station positioned in a process chamber of a containment system and corresponding method
US18/014,460 US20230257148A1 (en) 2020-07-17 2021-07-16 Functional Module for Moving to a Dosing Station Positioned in a Process Chamber of a Containment System and Corresponding Method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20405021.5A EP3939896A1 (fr) 2020-07-17 2020-07-17 Module fonctionnel destiné au rapprochement d'une station de dosage positionnée dans une chambre de processus d'un confinement et procédé correspondant

Publications (1)

Publication Number Publication Date
EP3939896A1 true EP3939896A1 (fr) 2022-01-19

Family

ID=72046837

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20405021.5A Pending EP3939896A1 (fr) 2020-07-17 2020-07-17 Module fonctionnel destiné au rapprochement d'une station de dosage positionnée dans une chambre de processus d'un confinement et procédé correspondant

Country Status (7)

Country Link
US (1) US20230257148A1 (fr)
EP (1) EP3939896A1 (fr)
JP (1) JP2023534219A (fr)
KR (1) KR20230038565A (fr)
CN (1) CN116234753A (fr)
CA (1) CA3186113A1 (fr)
WO (1) WO2022013830A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2635335A1 (fr) * 2010-11-01 2013-09-11 GE Healthcare UK Limited Dispositif de perçage et de remplissage
EP2976117A1 (fr) * 2013-03-22 2016-01-27 Amgen Inc. Injecteur et procédé d'assemblage
EP3028946A1 (fr) * 2014-12-05 2016-06-08 F. Hoffmann-La Roche AG Préparation d'un conteneur à chambre double
EP3335844A1 (fr) * 2016-12-15 2018-06-20 Pharma Integration S.R.L. Conception d'un confinement destiné à la production automatisée d'article pharmaceutique ou biotechnique
EP3356238A1 (fr) * 2015-09-30 2018-08-08 Muffin Incorporated Systèmes et procédés de remplissage et de scellage de flacons

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2635335A1 (fr) * 2010-11-01 2013-09-11 GE Healthcare UK Limited Dispositif de perçage et de remplissage
EP2976117A1 (fr) * 2013-03-22 2016-01-27 Amgen Inc. Injecteur et procédé d'assemblage
EP3028946A1 (fr) * 2014-12-05 2016-06-08 F. Hoffmann-La Roche AG Préparation d'un conteneur à chambre double
EP3356238A1 (fr) * 2015-09-30 2018-08-08 Muffin Incorporated Systèmes et procédés de remplissage et de scellage de flacons
EP3335844A1 (fr) * 2016-12-15 2018-06-20 Pharma Integration S.R.L. Conception d'un confinement destiné à la production automatisée d'article pharmaceutique ou biotechnique

Also Published As

Publication number Publication date
WO2022013830A1 (fr) 2022-01-20
CN116234753A (zh) 2023-06-06
CA3186113A1 (en) 2022-01-20
KR20230038565A (ko) 2023-03-20
US20230257148A1 (en) 2023-08-17
JP2023534219A (ja) 2023-08-08

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