EP3691787B1 - Tight connection device for the aseptic transfer of a biopharmaceutical product between a chamber and a container - Google Patents

Tight connection device for the aseptic transfer of a biopharmaceutical product between a chamber and a container Download PDF

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Publication number
EP3691787B1
EP3691787B1 EP18785692.7A EP18785692A EP3691787B1 EP 3691787 B1 EP3691787 B1 EP 3691787B1 EP 18785692 A EP18785692 A EP 18785692A EP 3691787 B1 EP3691787 B1 EP 3691787B1
Authority
EP
European Patent Office
Prior art keywords
stationary
container
enclosure
annular
unlocking
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
EP18785692.7A
Other languages
German (de)
French (fr)
Other versions
EP3691787A1 (en
Inventor
Shuai Yl
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.)
Sartorius Stedim FMT SAS
Original Assignee
Sartorius Stedim FMT SAS
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Filing date
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Publication of EP3691787A1 publication Critical patent/EP3691787A1/en
Application granted granted Critical
Publication of EP3691787B1 publication Critical patent/EP3691787B1/en
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • 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
    • B01L2200/025—Align devices or objects to ensure defined positions relative to each other
    • 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
    • B01L2300/04—Closures and closing means
    • 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
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • 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
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/043—Hinged closures
    • 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

Definitions

  • the invention relates to the field of the aseptic transfer of biopharmaceutical products between a container and a closed enclosure.
  • the invention relates, according to a first aspect, to a sealed junction device specially intended to ensure the aseptic transfer of a biopharmaceutical product between a container and a closed enclosure.
  • the invention also relates to an assembly comprising such a sealed junction device, a container and a closed enclosure making it possible to ensure the aseptic transfer of biopharmaceutical products between the container and the closed enclosure.
  • the invention further relates, according to a third aspect, to a method for the aseptic transfer of a biopharmaceutical product between the container and the closed enclosure.
  • biopharmaceutical product or biopharmaceutical product which relates to biotechnology, pharmacy and more generally to the medical field.
  • a biopharmaceutical product is a product derived from biotechnology - culture media, cell cultures, buffer solutions, artificial nutrition liquids - or a product intended for use in the pharmaceutical or medical field, at least in part, in the form more or less finely divided solid, in liquid form, or in pasty form or, more generally, a material product - stopper, container, tube or integrated ports, syringe, syringe plunger, functional means of treatment or packaging, more or less complex comprising a plurality of products, etc. - intended for use inside the enclosed enclosure.
  • the terms “container” or “container” designate what, in biopharmaceuticals, is suitable and intended in its interior space, to contain, enclose or contain a certain biopharmaceutical content or, where appropriate, several biopharmaceutical contents, in a static way more or less durable or perennial.
  • a biopharmaceutical content typically consists of one or more biopharmaceutical product(s) as defined above.
  • Such containers can be rigid or flexible, single-use or reusable, of various sizes and are, for example, pockets, sheaths, containers, containers, bioreactors or even chutes for biopharmaceutical use, this list not being not limiting.
  • the device comprises stationary temporary clamping means, able to hold the container against the enclosure of the joining device. At least one magnet is also provided to secure the removable lid of the container against the door of the enclosure during the aseptic transfer.
  • the device also comprises stationary unlocking means making it possible to move the removable lid of the container from a position in which it seals the container hermetically, to a position in which it is detached from the container in order to ensure aseptic communication between the container and the enclosure.
  • the device also comprises stationary locking means capable of causing the container to pass into a final locking position in which the removable lid once again seals the container definitively.
  • the stationary means of temporary clamping, unlocking and final locking are linked to an annular functional crown so that the unidirectional rotation of the annular functional crown causes the actuation of the stationary means of temporary clamping, then of unlocking and then of final locking.
  • this device makes it possible to open the door of the enclosure when a container which has already been used and is in a final locked state is restrained therein, in particular by breaking the force of attraction of the magnet securing the removable lid of the container to the door of the enclosure. Once the enclosure door is opened, the non-sterile side of the container door is then in contact with the atmosphere of the enclosure, thus breaking the sterility of the latter.
  • the present invention improves the situation.
  • the invention proposes a sealing device according to claim 1.
  • the stationary blocking/unblocking means prevent the door of the enclosure from being opened without a container being clamped therein and without a container already in use being clamped therein. This solution considerably reduces the risk of contamination of the tight junction device.
  • the device further comprises stationary opening/closing means capable of preventing/authorizing the opening of the removable door of the enclosure and mechanically linked to the annular functional crown so that the rotation of the functional crown annular around the geometric axis of rotation causes successively or simultaneously the actuation of the stationary unlocking means ensuring the transition to the intermediate unlocking position of the container and the actuation of the stationary opening/closing means ensuring the unlocking of the removable door of the enclosure, then the actuation of the stationary locking means of the container ensuring passage into the final locking position of the container, then simultaneously or successively actuation of the stationary opening/closing means ensuring the blocking of the removable door of the enclosure.
  • the stationary unlocking means comprise an unlocking push-button element with rotary displacement and an unlocking member capable of being engaged by a portion of the annular functional crown forming a gear so that, when the functional crown rotates annular to an intermediate unlocking position, the pusher element moves and moves the container from the initial locking position to the intermediate unlocking position.
  • the stationary locking means comprise a locking pusher element with rotary displacement and a locking member capable of being engaged by a portion of the annular functional crown forming a gear so that, when the functional crown rotates annular to a final locking position, the pusher element moves and moves the container from the intermediate unlocking position to the final locking position.
  • the stationary locking/unlocking means are able to prevent the rotation of the pusher element of the stationary unlocking means, so that the container is not authorized to pass from the initial unlocking position to the intermediate position of unlocking.
  • the stationary locking/unlocking means are able to pass from a locking position to an unlocking position when the container is held clamped against the enclosure, by means of on-board locking/unlocking means arranged on the container. .
  • the stationary locking/unlocking means comprise a finger, movably mounted in a channel extending in a direction transverse to a radial direction, the finger being able to be biased by a spring towards a deployed position in which the finger protrudes out of the tight junction device, the stationary locking/unlocking means being in a locking position, and towards a retracted position in which the finger does not protrude out of the tight junction device, the stationary locking/unlocking means then being in an unlocked position.
  • the stationary temporary clamping means comprise a clamping element able to enter into rotation around a clamping rotation axis, so that, during rotation of the annular functional crown to a locking position initial, the clamping element moves and hermetically holds the container against the removable door of the enclosure.
  • the stationary temporary clamping means comprise a clamping element able to enter into rotation about a clamping rotation axis, so that, when a lever is activated causing a rotation of a crown protection, the clamping element moves and hermetically holds the container against the removable door of the enclosure.
  • the stationary opening/closing means are directly mechanically connected to the unlocking push-button element.
  • the device further comprises stationary means for maneuvering the removable door of the enclosure capable of opening and hermetically closing the removable door of the enclosure.
  • the stationary means for maneuvering the removable door of the enclosure are able to move the removable door of the enclosure according to a rotary movement around a hinge axis, so that the door does not obstruct the passage of the biopharmaceutical product.
  • the annular functional crown is rotated by means of a lever.
  • the stationary locking means as well as the stationary unlocking means are at least 2 in number, preferably 3 in number, preferably 4 in number.
  • the stationary locking means and the stationary unlocking means are structurally coincident.
  • the invention also relates to an assembly comprising an enclosure and a sealed junction device according to claim 13.
  • the invention also relates to an aseptic transfer method according to claim 15.
  • the figure 1 represents a closed enclosure 10 comprising a peripheral wall 12 defining a confined interior space 14 and a circular opening 16 allowing the introduction of biopharmaceutical products (not shown) into the confined interior space 14.
  • the enclosure 10 - which can be a room or any other similar installation - is designed to be permanently isolated from the outside environment.
  • the annular opening 16 is sealed by a removable door 18 positioned in the interior space and capable of passing from a closed position in in which the circular opening 16 is obstructed to an open position in which the circular opening 16 is no longer obstructed.
  • the terms “internal” and “external” qualify in the rest of the description the relative positions of objects with respect to the geometric axis of the annular opening 16.
  • the object qualified as “ internal” or having an “internal radial positioning” should it be considered as placed closest to the geometric axis of the annular opening 16 while the object qualified as “external” or having an “external” radial positioning must, comparatively, be considered to be placed furthest from the geometric axis of the annular opening 16.
  • the figure 2a and 2b represent a container 20 intended to transport biopharmaceutical products and ready to be associated with the closed enclosure 10 to carry out an aseptic transfer of biopharmaceutical products to or from this enclosure 10.
  • the container 20 comprises, in this respect, a peripheral envelope (not shown) defining a confined interior space 24, into which the biopharmaceutical products can be introduced.
  • the peripheral casing also comprises an annular opening 26 delimited by an annular flange 30 to which the peripheral casing is firmly fixed.
  • the container 20 further comprises a removable cover 28 capable of hermetically sealing the opening 24 of the annular flange 30 by resting on a seal 22.
  • the container 20 can be made according to different embodiments and, in this respect, have a flexible peripheral envelope intended for single use or else rigid and intended to be reused after a decontamination procedure well known to those skilled in the art.
  • a tight junction device 40 intended to allow the aseptic transfer of biopharmaceutical products coming from the container 20 (described later) towards the enclosure 10.
  • the purpose of the sealed junction device 40 is therefore, firstly, to allow the assembly of the enclosure 10 and the container 20, then, to authorize the temporary communication of the interior space 14 of this enclosure 10 with the interior space of this container 20 to ensure the transfer of biopharmaceutical products from one to the other and, finally, to ensure the separation of said enclosure 10 and said container 20.
  • the sealed junction device 40 has a part formed on the outside of the enclosure 10 and supported by the peripheral wall 12 - or by a separate support piece from the peripheral wall 12 but fixed permanently on it - facing the annular opening 16. More Specifically, the sealed junction device 40 comprises an annular functional crown 42.
  • the annular functional crown 42 has an inner peripheral perimeter 44 INT and an outer peripheral perimeter 44 EXT inscribed inside four carrier ball bearings 46 themselves supported by the outer face of the peripheral wall 12. In this way, the annular functional crown 42 is positioned outside the enclosure 10, which facilitates any maintenance operations.
  • the four carrier ball bearings 46 form a support for the annular functional crown and ensure its rotation around the geometric axis of the annular opening 16. It should however be emphasized that the maintenance in position of the functional annular crown could be ensured by any other similar mechanical element (roller, bearing, etc.).
  • the annular functional crown 42 which has several portions having distinct mechanical functions (described later) can be made in one piece - by machining, molding, or the like - from a single and unique block of material.
  • This embodiment has the advantage of simplifying the production of the annular functional crown, at the same time reducing production costs and ensuring optimal positioning of the functional surfaces of the annular functional crown 42.
  • the annular functional crown could also, according to other embodiments, be formed from a plurality of separate mechanical parts, assembled together in one piece so that the rotation of one of these mechanical parts around the geometric axis of rotation R between the rotation of all of them.
  • the annular functional crown 42 is capable of entering into rotation around the geometric axis of rotation R under the action of a lever 48, for example activated manually.
  • the annular functional crown can be rotated by means of a motor.
  • the protection ring 41 is also able to enter into rotation around the geometric axis of rotation 2 under the action of a handle 43, for example activated manually by a user.
  • the sealed junction device 40 comprises stationary temporary clamping means 50.
  • the stationary temporary clamping means 50 have the function of keeping the container 20 clamped against the enclosure 10 so that the removable lid 28 of this container 20 is applied hermetically against the removable door 18 of the enclosure 10.
  • the stationary temporary clamping means 50 are, according to a first embodiment, mechanically linked to the annular functional ring 42 so that the rotation of the annular functional ring 42 around the geometric axis of rotation R mechanically causes the stationary means to be actuated. temporary bridle 50.
  • the stationary temporary clamping means 50 are mechanically linked to the protection ring 41 so that the rotation of the protection ring 41 around the geometric axis of rotation R causes the mechanical actuation of the stationary means of temporary bridle 50.
  • the stationary temporary clamping means 50 are mechanically driven by the rotation of the annular functional crown 42.
  • the stationary temporary clamping means 50 can be four in number, distributed regularly around the annular functional crown 42.
  • the stationary temporary clamping means 50 are formed by a clamping element 52, able to perform a rotation around a clamping rotation axis so as to temporarily clamp the removable lid 28 of the container 20 against the removable door 18 of the enclosure 10.
  • the clamping element 52 after rotation, protrudes radially into the annular opening 16 and comes into abutment against the container 20 so as to prevent separation of the removable cover 28 and the removable door 18.
  • the sealed junction device 40 includes stationary unlocking means 60.
  • the stationary unlocking means 60 are intended to move the container 20 from an initial locked position in which the removable lid 28 seals the container 20 hermetically to an intermediate unlocking position in which the removable lid 28 is detached from the container and held hermetically against the door 18 of the enclosure 10 so as to ensure aseptic communication between the container 20 and the enclosure 10.
  • These stationary unlocking means 60 are mechanically linked to the annular functional crown 42 so that the rotation of the annular functional crown 42 around the geometric axis of rotation R mechanically causes the stationary unlocking means 60 to be actuated.
  • the sealing device comprises four stationary unlocking means 60, although it may comprise less than four, or more than four.
  • the stationary unlocking means are regularly distributed around the annular functional crown 42.
  • Each of the stationary unlocking means comprises a locking pusher element 62 with rotary displacement and an unlocking drive member 64 capable of being engrained by a portion of the annular functional crown 42 forming a gear so that, during the rotation of the annular functional crown 42 to an intermediate unlocking position, the unlocking push-button element 62, under meshing of the unlocking drive member 64, moves around its axis of rotation and causes the container to pass from the initial locking position to intermediate unlocking position.
  • the relative movement of the annular functional crown 42 with respect to the pusher element causes the movement of the drive member 64 at the means of the gear portion.
  • the pusher element 62 protrudes for example radially into the circular opening 16 of the enclosure.
  • the sealed junction device 40 comprises stationary locking means 70.
  • the stationary locking means 70 are intended to move the container 20 from the intermediate unlocking position to a final locking position in which said removable cover 28 closes, again, the container 20 hermetically.
  • these stationary locking means 70 are mechanically linked to the annular functional crown 42 so that the rotation of this annular functional crown 42 around the geometric axis of rotation R mechanically causes the stationary locking means 70 to be actuated.
  • the relative position of the stationary locking means 70 and the stationary unlocking means 60 around the annular functional crown 42 is such that the actuation of these stationary locking means 70 can only be consecutive to the stopping the stationary unlocking means 60.
  • the sealing device comprises four stationary locking means, although it may comprise less than four, or more than four.
  • the stationary locking means 70 are regularly distributed around the annular functional crown 42.
  • Each of the stationary locking means 70 comprises a locking pusher element 72 with rotary displacement and a locking drive member 74 capable of being engrained by a portion of the annular functional crown 42 forming a gear so that, during rotation from the annular functional crown 42 to a final locking position, the locking pusher element 72, under meshing of the locking drive member 74, moves around its axis of rotation and causes the container to pass from the intermediate unlocking position to the final locking position.
  • the relative movement of the annular functional crown 42 with respect to the pusher element causes the displacement of the drive member 74 by means of the gear portion.
  • the pusher element 72 protrudes for example radially into the circular opening 16 of the enclosure.
  • the stationary unlocking means 60 and the stationary locking means 70 are structurally coincident with each other. More precisely, the pusher elements 62 and 72 are combined, as well as the drive members 64 and 74.
  • the stationary unlocking means 60 and the stationary locking means 70 could optionally be structurally distinct and independent of each other.
  • the sealed junction device 40 comprises stationary locking/unlocking means 80.
  • the stationary blocking/unblocking means 80 are capable of causing the functional annular crown to pass from a blocking position in which the functional annular crown is not able to be rotated, to an unlocking position in which the crown annular functional 42 is capable of being rotated.
  • the stationary locking/unlocking means 80 are able to prevent the movement of the pusher elements 62 of the stationary unlocking means 60, so that the sealed junction device 40 is not authorized to pass from the initial locking position to the intermediate unlock position.
  • the sealing device comprises four stationary locking/unlocking means 80, although it may comprise less than four, or more than four.
  • the stationary locking/unlocking means 80 are regularly distributed around the annular functional crown 42.
  • the relative position of the stationary locking/unlocking means 80 and the stationary unlocking means 60 around the annular functional crown 42 is such that the actuation of these stationary unlocking means 60 can only be consecutive to the actuation of the stationary means locking/unlocking 80.
  • the stationary locking/unlocking means 80 are actuated by the clamping of the container 20 against the enclosure 10 by the on-board locking/unlocking means 140 of the container 20, as described below.
  • the stationary locking/unlocking means comprise a finger 82, movably mounted in a channel 84.
  • the channel 84 extends in a direction transverse to the radial direction so that the channel 84 is for example parallel to the axis of rotation R
  • Finger 82 is biased by a spring 86 to an extended position in which the finger protrudes out of the sealing device 40, so that the pusher element 62 comes into abutment against the finger 82.
  • the finger 82 is movable at the against the biasing of the spring 86 in a retracted position in which the finger 82 does not protrude out of the sealing device, so that the pusher element 62 can move and thus authorize the rotation of the annular functional crown around its axis of rotation R.
  • the sealed junction device 40 includes stationary opening means 90.
  • These stationary opening means 90 are intended to prevent/authorize the opening of the removable door 18 of the enclosure 10 and are mechanically connected to the annular functional ring 42 so that the rotation of this annular functional ring 42 around the geometric axis of rotation R mechanically causes the stationary opening means 90 to be actuated. removable door 18 of enclosure 10.
  • the stationary opening means 90 open the removable door 18 after the actuation of the stationary unlocking means 60 has caused the container 20 to pass into the intermediate unlocking position.
  • the opening of the removable door 18 of the enclosure 10 is delayed when a problem occurs during the intermediate unlocking of the container 20.
  • these stationary opening means 90 are arranged on the annular functional crown 42 in order to ensure the closing of the removable door 18 of the enclosure 10 before the stationary locking means 70 have been activated to move the container 20 into the final locking position.
  • the stationary opening means 90 are for example connected to the stationary unlocking means 60.
  • the movement of said stationary unlocking means towards an intermediate unlocking position causes the stationary opening means 90 to move into a position in which the means stationary opening 90 allow the opening of the removable door 18.
  • the stationary opening means 90 are for example connected to the stationary locking means 70.
  • the movement of said stationary locking means towards a final locking position causes the stationary opening means 90 to move into a position in which the stationary opening means 90 prevent the opening of the removable door 18.
  • the stationary opening means 90 can be arranged so that the latter ensure the unlocking of the removable door 18 simultaneously with the passage of the container 20 in the intermediate unlocking position, then the blocking of this removable door 18 simultaneously with the passage of the container 20 in final lock position.
  • the stationary opening means 90 ensure, on the one hand, the unlocking of the removable door 18 of the enclosure 10 before the passage of the container 20 in the intermediate unlocking position and , on the other hand, the locking of the removable door 18 of the enclosure 10 after the passage of the container 20 in the final locking position.
  • the stationary opening means 90 include for example a functional opening rod 92 located in the axis of the axis of rotation of the stationary means 60, 70.
  • the functional rod 92 connects for example the stationary means 60, 70 to a body 94 located at the interior of the interior space 14, preventing the opening of the removable door by overlapping said removable door in the direction of opening.
  • the sealed junction device 40 also comprises stationary maneuvering means 100.
  • These stationary operating means 100 are intended to hermetically open and close the removable door 18 of the enclosure 10.
  • the stationary maneuvering means 100 can, according to a first embodiment, be driven mechanically by the annular functional crown 42.
  • the stationary maneuvering means 100 are mechanically connected to the annular functional crown 42 so that the rotation of this annular functional ring 42 around the geometric axis of rotation R mechanically causes the stationary maneuvering means 100 to be actuated.
  • the position of these stationary maneuvering means 100 on the annular functional ring 42 makes it possible to open the removable door 18 of the enclosure 10 after the passage of the container 20 in the unlocked position, then to close the removable door 18 before the passage of the container 20 in the final locking position.
  • the stationary operating means 100 are driven by an operating motor (not shown) slaved to the movement of the annular functional crown 42.
  • the stationary maneuvering means 100 comprise a rotary arm 102 capable of being rotated about an axis of rotation of a hinge 104.
  • the stationary maneuvering means 100 make it possible, thanks to the maneuvering motor, to move the removable door 18 of the enclosure 10, in a direction substantially perpendicular to the axial direction so that the removable door 18 does not hinder the passage of the biopharmaceutical product during their aseptic transfer between the enclosure 10 and the container 20.
  • the stationary clamping means 50, the stationary unlocking means 60, the stationary locking means 70, the opening means 90 and the maneuvering means 100 are mechanically linked to the crown annular functional ring 42 and arranged so that the rotation of said annular functional ring 42 around the geometric axis of rotation R successively causes the stationary temporary clamping means 50 to be actuated to ensure that the container 20 is held in position against the enclosure 10, then successively or simultaneously the actuation of the stationary unlocking means 60 ensuring the transition to the intermediate unlocking position of the container 20 and the actuation of the stationary opening means 90 ensuring the unlocking of the removable door 18 of the enclosure 10
  • the actuation of the stationary unlocking means 60 is only consecutive to the actuation of s stationary locking/unlocking means 80.
  • the rotation of the annular functional crown 42 around the geometric axis of rotation R causes simultaneously or successively the actuation of the stationary opening means 90 ensuring the locking of the removable door 18 of the enclosure 10 and the actuation of the stationary locking means 70 ensuring the transition to the final locking position of the container 20, and again the actuation of the stationary temporary clamping means 50 of the container in order to release the container 20.
  • the stationary clamping means 50 are mechanically linked to the protection ring 41 and arranged so that the rotation of the protection ring 41 around the geometric axis of rotation R causes the stationary means of temporary clamping 50 to maintain the container 20 in position against the enclosure 10.
  • the stationary unlocking means 60, the stationary locking means 70, the opening means 90 and the maneuvering means 100 are mechanically linked to the functional annular crown 42 and arranged so that the rotation of said functional annular crown 42 around the geometric axis of rotation R causes successively the actuation of the stationary unlocking means 60 ensuring the transition to the intermediate unlocking position of the container 20 and the actuation of the stationary opening means 90 ensuring the unlocking of the removable door 18 of the enclosure 10.
  • the actuation of the stationary unlocking means 60 is only consecutive to the actuation of the stationary locking/unlocking means 80. Then, the rotation of the annular functional crown 42 around the geometric axis of rotation R causes simultaneously or successively the actuation of the stationary opening means 90 ensuring the locking of the removable door 18 of the enclosure 10 and the actuation stationary locking means 70 ensuring the transition to the final locking position of the container 20. Finally, the actuation of the protective ring 41 again allows the actuation of the stationary temporary clamping means 50 of the container in order to release the container 20 .
  • stationary positioning elements 110 cooperating with on-board positioning elements arranged on the container, so as to ensure the positioning of the container against the enclosure. These stationary positioning elements ensure in particular the positioning of the onboard locking/unlocking means 140 opposite the stationary locking/unlocking means 80.
  • the stationary positioning elements 110 can be magnets.
  • FIGS. 3a and 3b show in more detail an embodiment of a container 20 intended to be associated with the leaktight junction device 40 according to the invention.
  • this container 20 is intended to allow the aseptic transport and transfer of biopharmaceutical products from or to an enclosure 10 fitted with the leaktight junction device 40 according to the invention.
  • the container 20 comprises the annular flange 30 delimiting the annular opening 26, the removable lid 28 capable of hermetically sealing the opening 26 of the annular flange 30 and the peripheral casing integral with the annular flange 30 and delimiting the confined interior space 24 capable of containing the biopharmaceuticals.
  • the container 20 can be rigid or flexible and reusable or single use depending on the case. By way of example and in no way limiting, it can be a container 20 of any size, such as a bag, a sheath, a container, a bioreactor, a chute, etc.
  • the container 20 includes on-board locking/unlocking means 140.
  • the on-board locking/unlocking means 140 comprise at least one on-board locking/unlocking functional arrangement 142 formed, on the one hand, by a through housing 144 formed in the annular flange 30 and a blind housing 146 formed in the removable cover 28 and in the extension of the through housing 144 when the removable cover 28 hermetically seals the opening of the annular flange 30 and, on the other hand, by an internal radial positioning pin 148 and an external radial positioning pin 150, comprising an end part functional with external radial positioning 152, capable of being introduced and of moving inside the blind housing 146 of the removable cover and the through housing 144 of the annular flange 30.
  • the on-board locking/unlocking means 140 cooperate with the stationary locking/unlocking means 80. More precisely, the functional end part with external radial positioning 152, in the initial position, projects beyond the annular flange 30. The functional end part with external radial positioning outer radial 152 bears against the finger 82 of the stationary locking/unlocking means 80, so that the finger 82 is moved against the bias of the spring 86 until it no longer protrudes outside the sealed junction device.
  • the container 20 includes on-board locking/unlocking means 120 of the removable lid 28 on the annular flange 30.
  • the first position is qualified as the initial locking position because the locking/unlocking means 120 prohibit the relative movement of the removable cover 28 with respect to the annular flange 30.
  • the second position qualified as the intermediate unlocking position, is supposed to intervene when the annular flange 30 of the container 20 is flanged axially against the peripheral wall 12 of the enclosure 10 and allows the relative movement of the removable cover 28 vis-à-vis the annular flange 30.
  • the third position, qualified as position final locking is supposed to occur after the aseptic transfer of the biopharmaceutical products between the container 20 and the enclosure 10 and prohibits, again, the relative movement of the removable lid 28 vis-à-vis the annular flange 30.
  • the on-board locking/unlocking means 120 comprise four on-board functional locking/unlocking arrangements 122 regularly distributed around the annular flange 28 of cover 30.
  • Each on-board locking/unlocking functional arrangement 122 comprises a through housing 124 formed in the annular flange 30 as well as a blind housing 126 formed in the removable lid 28 of the container 20 and in the extension of the through housing 114.
  • Each on-board locking/unlocking functional arrangement 122 also includes an inner radial positioning pin 128 and an outer radial positioning pin 130.
  • These two pins with internal 128 and external 130 radial positioning present, according to the realization of the figure 3a and 5a to 5c , an elongated body of cylindrical shape allowing them to be introduced and to move inside the blind housing 126 formed in the removable cover 28, on the one hand, and the through housing 124 arranged in the annular flange 30, d 'somewhere else.
  • the dimensional characteristics and the properties of the outer surface of these pins with internal 128 and external 130 radial positioning are such that the latter cannot move inside the blind 126 and crossing 124 housings solely because of gravity.
  • these pins with internal 128 and external 130 radial positioning could have a body of different shape - for example, parallelepipedal - in order to achieve the same result.
  • the through housing 124, the blind housing 126, the pin with internal radial positioning 128 and the pin with external radial positioning 130 are coaxial and oriented in a radial direction relative to the annular flange 30. More exactly, according to this embodiment, these various elements extend in a substantially radial direction, oriented towards the geometric axis of revolution R. However, according to an alternative embodiment, said through housing 124, blind housing 126, internal radial positioning pin 128 and external radial positioning pin 130 could also be oriented in a slightly inclined direction and forming an angle ⁇ with respect to a radial direction relative to the annular flange 30.
  • the blind housing 126 can be flush with the through housing 124 but it could also be envisaged to form an intermediate space between the blind housing 126 and the through housing 124 without this affecting the containment and handling of the container 20.
  • the pin with internal radial positioning 128 When the container 20 is in the initial locking position, as illustrated by the figure 5a , the pin with internal radial positioning 128 has an internal functional portion of initial locking 128 INT arranged in the blind housing 126 of the removable cover 28 and an external functional portion of initial locking 128 EXT arranged in the through housing 124 of the annular flange 30.
  • the pin with internal radial positioning 128 prevents the relative movement of the removable cover 28 vis-à-vis the annular flange 30.
  • the pin with external radial positioning 130 is at least partially arranged in the through housing 124 of the annular flange 30. According to the embodiment shown in the figure 5a , the pin with external radial positioning 130 can then have a functional end part with external radial positioning 130ext excluded from the through housing 124. Access to this functional end part 130ext by the stationary unlocking 60 or locking 70 means is thus facilitated.
  • the outer radially positioned functional end part 130ext of the outer radially positioned pin 130 bears against the stationary locking/unlocking means, so as to cause them to pass through a unlocking position allowing rotation of the annular functional crown 42.
  • the functional end part with external radial positioning 130ext of the pin with external radial positioning 130 bears against the finger 82 which is then moved against the bias of the spring 86, until it no longer protrudes out of the junction device 40.
  • the container is then authorized to pass into the intermediate unlocking position, the finger 82 of the stationary locking/unlocking means 80 no longer preventing the movement of the stationary unlocking means 60.
  • the internal radial positioning pin 128 is at least partially arranged in the blind housing 126 of the removable cover 28 and entirely excluded from the through housing 124 of the annular flange 30. In this way, this internal radial positioning pin 128 no longer prohibits the relative movement of the removable cover 28 vis-à-vis the annular flange 30.
  • the pin with external radial positioning 130 is at least partially arranged in the through housing 124 of the annular flange 30 and entirely excluded from the blind housing 126 of the removable cover 28. In this way, the pin with external radial positioning 130 has no more influence than the internal radial positioning pin 128 on the relative movement of the removable cover 28 vis-à-vis the annular flange 30 which can therefore be freely separated to allow the aseptic transfer of the biopharmaceuticals.
  • the pin with internal radial positioning 128 is entirely arranged inside the blind housing 126 of the removable cover 28 while the pin with external radial positioning 130 has an internal functional portion of final locking 130 INT arranged in the blind housing 126 of the removable cover 28 and an external functional final locking portion 130 EXT arranged in the through housing 124 of the annular flange 30. Consequently, the blind housing 126 of the removable cover 28 has a sufficient length to accommodate, from a on the one hand, the pin with internal radial positioning 128 and on the other hand, the internal functional portion of final locking 130 INT .
  • the pin with external radial positioning 130 prevents the relative movement of the removable cover 28 vis-à-vis the annular flange 30.
  • Such use of internal 128 and external 130 radial positioning pins to place the container in the position of initial locking, intermediate unlocking and final locking makes it possible to have only one blind housing 126 and one through housing 124 to be made in the removable cover 28 and the annular flange 30 by on-board functional locking/unlocking arrangement 122, which limits the risks of contamination linked to possible production defects.
  • the manipulation of the locking/unlocking means 120 is facilitated insofar as it suffices to move the pins with internal 128 and external 130 radial positioning in a single and unique direction and a single and same direction to pass the container 20 successively from the initial locking position to the intermediate unlocking position, then to the final locking position.
  • the production and operation of the sealed junction device are thus simplified.
  • the internal 128 and external 130 radial positioning pins have identical lengths, which in particular makes it possible to simplify the production and assembly of the internal 128 and external 130 radial positioning pins on the container since it is then not necessary to distinguish the pins with regard to their respective dimensions.
  • these pins with internal 128 and external 130 radial positioning could also have different lengths.
  • the through housing 124 and the pin with external radial positioning 130 have lengths such that, when the on-board locking/unlocking means 110 are in the provisional unlocking position, the pin with external radial positioning 130 has a functional end part 130ext with external radial positioning excluded from the through housing 124.
  • This positioning facilitates, in particular, the operation performed by the stationary locking means 70 to move the container 20 from the intermediate unlocking position to the final locking position since the outer radial positioning pin 130 is accessible without the radial displacement pusher element 78 having to move into the interior of the through housing 124.
  • the lengths of the pin with external radial positioning 130 and of the through housing 124 are such that, when the on-board locking/unlocking means 120 are in the final locking position, said pin with external radial positioning 130 has an end part functional 130ext with external radial positioning housed inside the through housing.
  • gripping the pin with external radial positioning 130 is made complex and impracticable without a suitable gripping tool. This thus makes it possible to raise the level of security relating to the tightness of the container 20 in the final locking position.
  • the on-board locking/unlocking means 140 and the on-board locking/unlocking means 120 are structurally coincident.
  • the container 20 also includes on-board partitioning and protection means 134.
  • the on-board partitioning and protection means 134 are arranged on an outer peripheral portion of the annular flange 30 so as to prevent inadvertent manipulation of the on-board locking/unlocking means carried by the annular flange 30.
  • the on-board partitioning and protection means 134 are, for example, enclosures, at least partially or completely framing the through housings 124 so as to obstruct unexpected or intentional manipulation of the pin with external radial positioning 130 when the latter does not is not fully inserted into the through housing 128 of the annular flange 30.
  • This aseptic transfer process consists, firstly, in having a closed enclosure 10 as described above and supporting a sealed junction device 40 according to the invention. This transfer process secondly, to have a container 20 in the initial locking position as described above.
  • the aseptic transfer process then involves positioning the container 20 against the peripheral wall 12 of the enclosure 10 so that the pins belonging to the on-board locking/unlocking means face the stationary locking/unlocking means 80.
  • annular flange 30 of the container 20 is positioned against the peripheral wall 12 of the enclosure 10 and the removable cover 28 - for example formed of magnetized stainless steel - is hermetically held in position against the outer face of the removable door. 18 - at least partially magnetized.
  • the on-board locking/unlocking means 140 bear against the stationary locking/unlocking means 80 so as to allow rotation of the annular functional crown 42.
  • the aseptic transfer process then consists in generating the rotation of the annular functional crown 42 in order to actuate the stationary temporary clamping means 50. More precisely, the clamping elements 52 perform a rotation around their axis of rotation so as to hold the container 20 against the enclosure 10.
  • the stationary clamping means 50 are actuated by the rotation of the protection crown 41. More precisely, a user for example manually actuates a handle 43 then rotating the protection crown 41. The clamping elements 52 then perform a rotation around their axis of rotation so as to hold the container 20 against the enclosure 10.
  • the rotation of the annular functional crown 42 makes it possible to actuate the stationary unlocking means 60. More particularly, the functional crown portions forming a gear cause the movement of the pusher elements 62 of the stationary unlocking means 60. As the movement progresses, the pusher elements 62 bear against the pins 128, 130, also displacing them radially in the through and blind housings 124, 126.
  • the pin with internal radial positioning 128 is then arranged in the blind housing 126 of the removable cover 28 and entirely excluded from the through housing 124 of the annular flange 30 and the pin with external radial positioning 130 is arranged in the through housing 124 of the annular flange 30 and entirely excluded from the blind housing 126 of the removable cover 28.
  • the container 20 is in the intermediate unlocking position and the relative movement of the removable cover 28 vis-à-vis the annular flange 30 is possible.
  • the aseptic transfer process also consists, simultaneously or successively in the preceding step, in generating the rotation of the annular functional crown 42 in order to actuate the stationary opening means 90 to release the removable door 18 from the enclosure 10 .
  • the rotation of the unlocking means 60 causes the rotation of the functional rod 92 of the stationary opening means 90, and therefore of the body 94, so that the latter no longer covers the outer face of the removable door 18 of the enclosure 10.
  • the removable door 18 can then be manipulated freely.
  • the aseptic transfer process then consists in driving the stationary maneuvering means 100 to move the removable door 18 of the enclosure 10 and the removable lid of the container in order to release the annular openings 16, 26 of the enclosure 10 and of the container 20 .
  • the stationary operating means 100 - which can be actuated by the annular functional crown 42 or else by an operating motor slaved to the position of this annular functional crown 42 - rotate around an axis of rotation d a hinge, then the removable door 18 of the enclosure 10.
  • the removable cover 28 is able to move vis-à-vis the annular flange 30 and to follow the movements of the removable door 18 of the enclosure 10 due to the magnetic force. connecting them to each other.
  • the enclosure 10 and the container 20 are open to each other while being hermetically isolated from the outside environment.
  • the aseptic transfer of the biopharmaceutical products between the container 20 and the enclosure 10 can then take place.
  • the aseptic transfer process then consists in driving the stationary maneuvering means 100 again in order to hermetically close the annular openings 16, 26 of the enclosure 10 and of the container 20.
  • the stationary maneuvering means 100 then drive in rotation, around an axis of rotation of a hinge, the removable door 18 of the enclosure 10 as well as the removable lid of the container 20 to return them to the same position. than previously.
  • the enclosure 10 is then again hermetically closed by the removable door 18, both vis-à-vis the outside and the container 10. And, symmetrically, the container 20 is closed hermetically by the removable cover, both -à-vis the outside than the enclosure 10.
  • the aseptic transfer process then consists in generating the rotation of the annular functional crown 42 in order to actuate the stationary opening means 90 to block the removable door 18 of the enclosure 10.
  • the rotation of the unlocking means 60 causes the rotation of the functional rod 92 of the stationary opening means 90, and therefore of the body 94, so that the latter again covers the outer face of the removable door 18 of the enclosure 10.
  • the removable door 18 can then be manipulated freely.
  • the aseptic transfer process consists, simultaneously or else successively to the previous step, in generating the rotation of the annular functional crown 42 in order to actuate the actuation of the stationary locking means 70. More particularly, the functional crown portions forming a gear cause the movement of the pusher elements 72 of the stationary locking means 70. As the movement progresses, the pusher elements 72 bear against the pins 128, 130, also moving them radially in the through and blind housings 124, 126.
  • the pin with internal radial positioning 128 is arranged in the blind housing 126 of the removable cover 28 while the pin with external radial positioning 130 has an internal functional portion of final locking 130 INT arranged in the blind housing 126 of the removable cover 28 and an external functional final locking portion 130 EXT arranged in the through housing 124 of the annular flange 30.
  • the aseptic transfer process therefore consists in generating the rotation of the annular functional crown 42 so that the temporary clamping elements 52 return to their initial position in which the container 20 can be separated from the enclosure 10.
  • the stationary clamping means 50 are actuated by the rotation of the protection crown 41. More precisely, a user for example manually actuates a handle 43 then rotating the protection crown 41. The clamping elements 52 then perform a rotation around their axis of rotation so as to return to their initial position in which the container 20 can be detached from the enclosure 10.
  • the container 20 in the final locked position can thus be freely withdrawn from the sealing device 40.
  • the locking/unlocking means then pass into a position in which the rotation of the annular functional crown 42 is not authorized, so as to preventing the sealing device from being opened without an unused container being attached thereto.

Description

L'invention est relative au domaine du transfert aseptique de produits biopharmaceutiques entre un conteneur et une enceinte close.The invention relates to the field of the aseptic transfer of biopharmaceutical products between a container and a closed enclosure.

Plus précisément, l'invention concerne, selon un premier aspect, un dispositif de jonction étanche spécialement destiné à assurer le transfert aseptique d'un produit biopharmaceutique entre un conteneur et une enceinte close. L'invention concerne également un ensemble comprenant un tel dispositif de jonction étanche, un conteneur et une enceinte close permettant d'assurer le transfert aseptique de produits biopharmaceutiques entre le conteneur et l'enceinte close. L'invention concerne en outre, selon un troisième aspect, un procédé de transfert aseptique d'un produit biopharmaceutique entre le conteneur et l'enceinte close.More specifically, the invention relates, according to a first aspect, to a sealed junction device specially intended to ensure the aseptic transfer of a biopharmaceutical product between a container and a closed enclosure. The invention also relates to an assembly comprising such a sealed junction device, a container and a closed enclosure making it possible to ensure the aseptic transfer of biopharmaceutical products between the container and the closed enclosure. The invention further relates, according to a third aspect, to a method for the aseptic transfer of a biopharmaceutical product between the container and the closed enclosure.

Il convient d'entendre ici par produit biopharmaceutique ou produit de biopharmacie, ce qui est relatif à la biotechnologie, à la pharmacie et plus généralement au domaine médical. En particulier, un produit biopharmaceutique est un produit issu de la biotechnologie - milieux de cultures, cultures cellulaires, solutions tampon, liquides de nutrition artificielle - ou un produit destiné à être utilisé dans le domaine pharmaceutique ou médical, au moins pour partie, sous forme solide plus ou moins finement divisé, sous forme liquide, ou sous forme pâteuse ou encore, plus généralement, un produit matériel - bouchon, récipient, tube ou ports intégrés, seringue, piston de seringue, moyen fonctionnel de traitement ou de conditionnement, ensemble plus ou moins complexe comprenant une pluralité de produits, etc. - destiné à être utilisé à l'intérieur de l'enceinte close.It should be understood here by biopharmaceutical product or biopharmaceutical product, which relates to biotechnology, pharmacy and more generally to the medical field. In particular, a biopharmaceutical product is a product derived from biotechnology - culture media, cell cultures, buffer solutions, artificial nutrition liquids - or a product intended for use in the pharmaceutical or medical field, at least in part, in the form more or less finely divided solid, in liquid form, or in pasty form or, more generally, a material product - stopper, container, tube or integrated ports, syringe, syringe plunger, functional means of treatment or packaging, more or less complex comprising a plurality of products, etc. - intended for use inside the enclosed enclosure.

Par convention, les termes « conteneur » ou « contenant » désignent ce qui, en biopharmacie, est apte et destiné dans son espace intérieur, à contenir, enfermer ou renfermer un certain contenu biopharmaceutique ou le cas échéant plusieurs contenus biopharmaceutiques, de façon statique plus ou moins durable ou pérenne. Un tel contenu biopharmaceutique est typiquement constitué par un ou plusieurs produit(s) biopharmaceutique(s) tel(s) que défini(s) précédemment. De tels conteneurs peuvent être rigides ou souples, à usage unique ou bien réutilisables, de tailles variées et sont par exemple des poches, des gaines, des conteneurs, des récipients, des bioréacteurs ou encore des goulottes à usage biopharmaceutique, cette liste n'étant pas limitative.By convention, the terms "container" or "container" designate what, in biopharmaceuticals, is suitable and intended in its interior space, to contain, enclose or contain a certain biopharmaceutical content or, where appropriate, several biopharmaceutical contents, in a static way more or less durable or perennial. Such a biopharmaceutical content typically consists of one or more biopharmaceutical product(s) as defined above. Such containers can be rigid or flexible, single-use or reusable, of various sizes and are, for example, pockets, sheaths, containers, containers, bioreactors or even chutes for biopharmaceutical use, this list not being not limiting.

Il existe dans le domaine du transfert aseptique de produits biopharmaceutiques le besoin de faire communiquer un conteneur et une enceinte étanche, notamment pour des transferts de produits biopharmaceutiques, sans que l'étanchéité par rapport au milieu extérieur du conteneur et/ou de l'enceinte ne soit rompue et n'entraîne une contamination des produits biopharmaceutiques.There is in the field of aseptic transfer of biopharmaceutical products the need to communicate a container and a sealed enclosure, in particular for transfers of biopharmaceutical products, without the sealing with respect to the external environment of the container and/or of the enclosure is broken and leads to contamination of biopharmaceuticals.

Pour ce faire, il est connu de l'état de la technique le document FR2978362 qui se rapporte à un dispositif de jonction étanche permettant d'assurer un tel transfert aseptique. Le dispositif comprend des moyens stationnaires de bridage temporaire, aptes à maintenir le conteneur contre l'enceinte du dispositif de jonction. Au moins un aimant est également prévu pour solidariser le couvercle amovible du conteneur contre la porte de l'enceinte lors du transfert aseptique. Le dispositif comprend également des moyens stationnaires de déverrouillage permettant de faire passer le couvercle amovible du conteneur d'une position dans laquelle il obture hermétiquement le conteneur, à une position dans laquelle il est désolidarisé du conteneur afin d'assurer une communication aseptique entre le conteneur et l'enceinte. Le dispositif comprend également des moyens stationnaires de verrouillage apte à faire passer le conteneur dans une position de verrouillage finale dans laquelle le couvercle amovible obture à nouveau hermétiquement le conteneur de manière définitive. Les moyens stationnaires de bridage temporaire, déverrouillage et verrouillage final sont liés à une couronne fonctionnelle annulaire de sorte que la rotation unidirectionnelle de la couronne fonctionnelle annulaire entraîne l'actionnement des moyens stationnaires de bridage temporaire, puis de déverrouillage puis de verrouillage final.To do this, it is known from the state of the art the document FR2978362 which relates to a tight junction device making it possible to ensure such an aseptic transfer. The device comprises stationary temporary clamping means, able to hold the container against the enclosure of the joining device. At least one magnet is also provided to secure the removable lid of the container against the door of the enclosure during the aseptic transfer. The device also comprises stationary unlocking means making it possible to move the removable lid of the container from a position in which it seals the container hermetically, to a position in which it is detached from the container in order to ensure aseptic communication between the container and the enclosure. The device also comprises stationary locking means capable of causing the container to pass into a final locking position in which the removable lid once again seals the container definitively. The stationary means of temporary clamping, unlocking and final locking are linked to an annular functional crown so that the unidirectional rotation of the annular functional crown causes the actuation of the stationary means of temporary clamping, then of unlocking and then of final locking.

Bien que cet agencement soit tout à fait satisfaisant, ce dispositif rend possible l'ouverture de la porte de l'enceinte lorsqu'un conteneur ayant déjà utilisé et en état de verrouillage final y est bridé, notamment en rompant la force d'attraction de l'aimant solidarisant le couvercle amovible du conteneur sur la porte de l'enceinte. Une fois la porte de l'enceinte ouverte, la face non stérile de la porte du conteneur est alors en contact avec l'atmosphère de l'enceinte, rompant ainsi la stérilité de cette dernièreAlthough this arrangement is entirely satisfactory, this device makes it possible to open the door of the enclosure when a container which has already been used and is in a final locked state is restrained therein, in particular by breaking the force of attraction of the magnet securing the removable lid of the container to the door of the enclosure. Once the enclosure door is opened, the non-sterile side of the container door is then in contact with the atmosphere of the enclosure, thus breaking the sterility of the latter.

Dans ce contexte, la présente invention vient améliorer la situation.In this context, the present invention improves the situation.

A cet égard, l'invention propose un dispositif de jonction étanche selon la revendication 1.In this respect, the invention proposes a sealing device according to claim 1.

Les moyens stationnaires de blocage/déblocage empêchent l'ouverture de la porte de l'enceinte sans qu'un conteneur y soit bridé et sans qu'un conteneur déjà utilisé y soit bridé. Cette solution diminue considérablement le risque de contamination du dispositif de jonction étanche.The stationary blocking/unblocking means prevent the door of the enclosure from being opened without a container being clamped therein and without a container already in use being clamped therein. This solution considerably reduces the risk of contamination of the tight junction device.

Selon une réalisation, le dispositif comprend en outre des moyens stationnaires d'ouverture/fermeture apte à empêcher/autoriser l'ouverture de la porte amovible de l'enceinte et liés mécaniquement à la couronne fonctionnelle annulaire de sorte que la rotation de la couronne fonctionnelle annulaire autour de l'axe géométrique de rotation entraîne successivement ou simultanément l'actionnement des moyens stationnaires de déverrouillage assurant le passage en position de déverrouillage intermédiaire du conteneur et l'actionnement des moyens stationnaires d'ouverture/fermeture assurant le déblocage de la porte amovible de l'enceinte , puis l'actionnement des moyens stationnaires de verrouillage du conteneur assurant le passage en position de verrouillage final du conteneur, puis simultanément ou successivement l'actionnement des moyens stationnaires d'ouverture/fermeture assurant le blocage de la porte amovible de l'enceinte.According to one embodiment, the device further comprises stationary opening/closing means capable of preventing/authorizing the opening of the removable door of the enclosure and mechanically linked to the annular functional crown so that the rotation of the functional crown annular around the geometric axis of rotation causes successively or simultaneously the actuation of the stationary unlocking means ensuring the transition to the intermediate unlocking position of the container and the actuation of the stationary opening/closing means ensuring the unlocking of the removable door of the enclosure, then the actuation of the stationary locking means of the container ensuring passage into the final locking position of the container, then simultaneously or successively actuation of the stationary opening/closing means ensuring the blocking of the removable door of the enclosure.

Selon une réalisation, les moyens stationnaires de déverrouillage comprennent un élément poussoir de déverrouillage à déplacement rotatif et un organe de déverrouillage susceptible d'être engrainé par une portion de la couronne fonctionnelle annulaire formant engrenage de sorte que, lors de la rotation de la couronne fonctionnelle annulaire jusqu'à une position de déverrouillage intermédiaire, l'élément poussoir se déplace et fait passer le conteneur de la position de verrouillage initial à la position de déverrouillage intermédiaire.According to one embodiment, the stationary unlocking means comprise an unlocking push-button element with rotary displacement and an unlocking member capable of being engaged by a portion of the annular functional crown forming a gear so that, when the functional crown rotates annular to an intermediate unlocking position, the pusher element moves and moves the container from the initial locking position to the intermediate unlocking position.

Selon une réalisation, les moyens stationnaires de verrouillage comprennent un élément poussoir de verrouillage à déplacement rotatif et un organe de verrouillage susceptible d'être engrainé par une portion de la couronne fonctionnelle annulaire formant engrenage de sorte que, lors de la rotation de la couronne fonctionnelle annulaire jusqu'à une position de verrouillage final, l'élément poussoir se déplace et fait passer le conteneur de la position de déverrouillage intermédiaire à la position de verrouillage final.According to one embodiment, the stationary locking means comprise a locking pusher element with rotary displacement and a locking member capable of being engaged by a portion of the annular functional crown forming a gear so that, when the functional crown rotates annular to a final locking position, the pusher element moves and moves the container from the intermediate unlocking position to the final locking position.

Selon une réalisation, les moyens stationnaires de blocage/déblocage sont aptes à empêcher la rotation de l'élément poussoir des moyens stationnaires de déverrouillage, de sorte que le conteneur n'est pas autorisé à passer de la position initiale de déverrouillage à la position intermédiaire de déverrouillage.According to one embodiment, the stationary locking/unlocking means are able to prevent the rotation of the pusher element of the stationary unlocking means, so that the container is not authorized to pass from the initial unlocking position to the intermediate position of unlocking.

Selon une réalisation, les moyens stationnaires de blocage/déblocage sont aptes à passer d'une position de blocage à une position de déblocage lorsque le conteneur est maintenu bridé contre l'enceinte, au moyen de moyens embarqués de blocage/déblocage agencés sur le conteneur.According to one embodiment, the stationary locking/unlocking means are able to pass from a locking position to an unlocking position when the container is held clamped against the enclosure, by means of on-board locking/unlocking means arranged on the container. .

Selon une réalisation, les moyens stationnaires de blocage/déblocage comprennent un doigt, monté mobile dans un canal s'étendant dans une direction transversale à une direction radiale, le doigt étant apte à être sollicité par un ressort vers une position déployée dans laquelle le doigt dépasse hors du dispositif de jonction étanche , les moyens stationnaires de blocage/déblocage étant dans une position de blocage, et vers une position escamotée dans laquelle le doigt ne dépasse pas hors du dispositif de jonction étanche, les moyens stationnaires de blocage/déblocage étant alors dans une position de déblocage.According to one embodiment, the stationary locking/unlocking means comprise a finger, movably mounted in a channel extending in a direction transverse to a radial direction, the finger being able to be biased by a spring towards a deployed position in which the finger protrudes out of the tight junction device, the stationary locking/unlocking means being in a locking position, and towards a retracted position in which the finger does not protrude out of the tight junction device, the stationary locking/unlocking means then being in an unlocked position.

Selon une réalisation, les moyens stationnaires de bridage temporaire comprennent un élément de bridage apte à entrer en rotation autour d'un axe de rotation de bridage, de sorte que, lors de la rotation de la couronne fonctionnelle annulaire jusqu'à une position de verrouillage initiale, l'élément de bridage se déplace et maintient hermétiquement le conteneur contre la porte amovible de l'enceinte.According to one embodiment, the stationary temporary clamping means comprise a clamping element able to enter into rotation around a clamping rotation axis, so that, during rotation of the annular functional crown to a locking position initial, the clamping element moves and hermetically holds the container against the removable door of the enclosure.

Selon une réalisation, les moyens stationnaires de bridage temporaire comprennent un élément de bridage apte à entrer en rotation autour d'un axe de rotation de bridage, de sorte que, lors de l'activation d'une manette entraînant une rotation d'une couronne de protection, l'élément de bridage se déplace et maintient hermétiquement le conteneur contre la porte amovible de l'enceinte.According to one embodiment, the stationary temporary clamping means comprise a clamping element able to enter into rotation about a clamping rotation axis, so that, when a lever is activated causing a rotation of a crown protection, the clamping element moves and hermetically holds the container against the removable door of the enclosure.

Selon une réalisation, les moyens stationnaires d'ouverture/fermeture sont directement connectés mécaniquement à l'élément poussoir de déverrouillage.According to one embodiment, the stationary opening/closing means are directly mechanically connected to the unlocking push-button element.

Selon une réalisation, le dispositif comprend en outre des moyens stationnaires de manœuvre de la porte amovible de l'enceinte aptes à ouvrir et à fermer hermétiquement la porte amovible de l'enceinte.According to one embodiment, the device further comprises stationary means for maneuvering the removable door of the enclosure capable of opening and hermetically closing the removable door of the enclosure.

Selon une réalisation, les moyens stationnaires de manœuvre de la porte amovible de l'enceinte sont aptes à déplacer la porte amovible de l'enceinte selon un mouvement rotatif autour d'un axe charnière, de sorte que la porte n'entrave pas le passage du produit biopharmaceutique.According to one embodiment, the stationary means for maneuvering the removable door of the enclosure are able to move the removable door of the enclosure according to a rotary movement around a hinge axis, so that the door does not obstruct the passage of the biopharmaceutical product.

Selon une réalisation, la couronne fonctionnelle annulaire est mise en rotation au moyen d'un levier.According to one embodiment, the annular functional crown is rotated by means of a lever.

Selon une réalisation, les moyens stationnaires de verrouillage ainsi que les moyens stationnaires de déverrouillage sont au moins au nombre de 2, de préférence au nombre de 3, de préférence au nombre de 4.According to one embodiment, the stationary locking means as well as the stationary unlocking means are at least 2 in number, preferably 3 in number, preferably 4 in number.

Selon une réalisation, les moyens stationnaires de verrouillage et les moyens stationnaires de déverrouillage sont structurellement confondus.According to one embodiment, the stationary locking means and the stationary unlocking means are structurally coincident.

L'invention porte aussi sur un ensemble comprenant une enceinte et un dispositif de jonction étanche selon la revendication 13.The invention also relates to an assembly comprising an enclosure and a sealed junction device according to claim 13.

Selon une réalisation, le conteneur de type à usage unique est spécialement destiné à assurer le transport et le transfert aseptique d'un produit appartenant au domaine biopharmaceutique et comprend :

  • une bride annulaire délimitant une ouverture annulaire ;
  • un couvercle amovible apte à obturer hermétiquement l'ouverture de la bride annulaire;
  • des moyens embarqués de blocage/déblocage de la couronne fonctionnelle annulaire ;
  • des moyens embarqués de verrouillage/déverrouillage du couvercle amovible sur la bride annulaire; et
  • une enveloppe périphérique solidaire de la bride annulaire et délimitant un espace intérieur confiné apte à recevoir les produits appartenant au domaine biopharmaceutique ;
  • dans lequel les moyens embarqués de blocage/déblocage comprennent au moins un agencement fonctionnel embarqué de blocage/déblocage formé, d'une part, par un logement traversant formé dans la bride annulaire et un logement borgne formé dans le couvercle amovible et dans le prolongement du logement traversant lorsque le couvercle amovible obture hermétiquement l'ouverture de la bride annulaire et, d'autre part, par une goupille à positionnement radial interne et une goupille à positionnement radial externe susceptibles d'être introduites et de se déplacer à l'intérieur du logement borgne du couvercle amovible et du logement traversant de la bride annulaire ; et
  • dans lequel les moyens embarqués de verrouillage/déverrouillage comprennent au moins un agencement fonctionnel embarqué de verrouillage/déverrouillage formé, d'une part, par un logement traversant formé dans la bride annulaire et un logement borgne formé dans le couvercle amovible et dans le prolongement du logement traversant lorsque le couvercle amovible obture hermétiquement l'ouverture de la bride annulaire et, d'autre part, par une goupille à positionnement radial interne et une goupille à positionnement radial externe susceptibles d'être introduites et de se déplacer à l'intérieur du logement borgne du couvercle amovible et du logement traversant de la bride annulaire;
  • le conteneur étant apte à se trouver dans une position de verrouillage initial dans laquelle, d'une part, la goupille à positionnement radial interne présente une portion fonctionnelle interne de verrouillage agencée dans le logement borgne du couvercle amovible et une portion fonctionnelle externe de verrouillage agencée dans le logement traversant de la bride annulaire de manière à interdire le déplacement relatif du couvercle amovible vis-à-vis de la bride annulaire et, d'autre part, la goupille à positionnement radial externe est au moins partiellement agencée dans le logement traversant de la bride annulaire, de sorte qu'au moins une portion fonctionnelle externe de verrouillage initial de la goupille à positionnement radial externe dépasse hors du logement traversant ;
  • le conteneur étant apte à se trouver dans une position de déverrouillage intermédiaire dans laquelle, d'une part, la goupille à positionnement radial interne est au moins partiellement agencée dans le logement borgne du couvercle amovible et entièrement exclue du logement traversant de la bride annulaire et, d'autre part, la goupille à positionnement radial externe est au moins partiellement agencée dans le logement traversant de la bride annulaire et entièrement exclue du logement borgne du couvercle amovible de sorte à autoriser le déplacement le relatif du couvercle amovible vis-à-vis de la bride annulaire;
  • le conteneur étant apte à se trouver dans une position de verrouillage final dans laquelle, d'une part, la goupille à positionnement radial interne est agencée dans le logement borgne du couvercle amovible et, d'autre part, la goupille à positionnement radial externe présente une portion fonctionnelle interne de verrouillage final agencée dans le logement borgne du couvercle amovible et une portion fonctionnelle externe de verrouillage final agencée dans le logement traversant de la bride annulaire de manière à interdire le déplacement relatif du couvercle amovible vis-à-vis de la bride annulaire.
According to one embodiment, the single-use type container is specially intended to ensure the transport and aseptic transfer of a product belonging to the biopharmaceutical field and comprises:
  • an annular flange delimiting an annular opening;
  • a removable cover able to hermetically close the opening of the annular flange;
  • on-board means for locking/unlocking the annular functional crown;
  • on-board means for locking/unlocking the removable cover on the annular flange; and
  • a peripheral casing integral with the annular flange and delimiting a confined interior space capable of receiving products belonging to the biopharmaceutical field;
  • in which the on-board locking/unlocking means comprise at least one on-board locking/unlocking functional arrangement formed, on the one hand, by a through housing formed in the annular flange and a blind housing formed in the removable cover and in the extension of the housing passing through when the removable cover hermetically closes the opening of the annular flange and, on the other hand, by a pin with internal radial positioning and a pin with external radial positioning capable of being introduced and of moving inside the blind housing of the removable cover and of the through housing of the annular flange; and
  • in which the on-board locking/unlocking means comprise at least one on-board locking/unlocking functional arrangement formed, on the one hand, by a through housing formed in the annular flange and a blind housing formed in the removable cover and in the extension of the housing passing through when the removable cover hermetically closes the opening of the annular flange and, on the other hand, by a pin with internal radial positioning and a pin with external radial positioning capable of being introduced and of moving inside the blind housing of the removable cover and of the through housing of the annular flange;
  • the container being capable of being in an initial locking position in which, on the one hand, the pin with internal radial positioning has an internal functional locking portion arranged in the blind housing of the removable lid and an external functional locking portion arranged in the through housing of the annular flange so as to prevent the relative movement of the removable cover with respect to the annular flange and, on the other hand, the pin with external radial positioning is at least partially arranged in the through housing of the annular flange, so that at least one external functional portion of initial locking of the pin with external radial positioning projects beyond the through-housing;
  • the container being capable of being in an intermediate unlocking position in which, on the one hand, the pin with internal radial positioning is at least partially arranged in the blind housing of the removable cover and entirely excluded from the through housing of the annular flange and , on the other hand, the pin with external radial positioning is at least partially arranged in the through housing of the annular flange and entirely excluded from the blind housing of the removable cover so as to allow the relative movement of the removable cover vis-à-vis ring flange;
  • the container being capable of being in a final locking position in which, on the one hand, the pin with internal radial positioning is arranged in the blind housing of the removable cover and, on the other hand, the pin with external radial positioning has an internal final locking functional portion arranged in the blind housing of the removable cover and an external final locking functional portion arranged in the through housing of the annular flange so as to prevent relative movement of the removable cover vis-à-vis the flange annular.

L'invention vise aussi un procédé de transfert aseptique selon la revendication 15.The invention also relates to an aseptic transfer method according to claim 15.

D'autres caractéristiques et avantages de l'invention ressortiront de la description qui en est faite ci-après, en référence aux dessins dans lesquels :

  • la figure 1 est une vue d'ensemble, en perspective et en vue éclatée, d'un dispositif de jonction étanche associé à la paroi périphérique d'une enceinte ;
  • les figures 2a et 2b sont deux vues d'ensemble, en perspective et en vue éclatée, depuis l'extérieur de l'enceinte et depuis l'intérieur de l'enceinte, d'un dispositif de jonction étanche de la figure 1 installé sur une portion de la paroi périphérique de l'enceinte et prêt à être associé avec la bride annulaire d'un conteneur selon l'invention ;
  • les figures 3a et 3b sont deux vues en perspective du conteneur selon l'invention, respectivement en vue éclatée et en vue d'ensemble ;
  • les figures 4a à 4c sont des vues de dessus du dispositif de jonction étanche des figures précédentes, dépourvu de couronne de protection, associés au conteneur selon l'invention, dans lesquelles la figure 4a illustre un dispositif de jonction étanche et un conteneur en position de verrouillage initial, la figure 4b illustre un dispositif de jonction étanche et un conteneur en position de déverrouillage intermédiaire, et la figure 4c illustre un dispositif de jonction étanche et un conteneur en position de verrouillage final ;
  • les figures 5a à 5c sont des vues en coupe transversale d'une partie seulement du conteneur associé au dispositif de jonction étanche illustrant respectivement une position de verrouillage initial, une position de déverrouillage intermédiaire et une position de verrouillage final.
Other characteristics and advantages of the invention will emerge from the description which is made of it below, with reference to the drawings in which:
  • the figure 1 is an overall view, in perspective and in exploded view, of a sealed junction device associated with the peripheral wall of an enclosure;
  • the figure 2a and 2b are two overall views, in perspective and in exploded view, from the exterior of the enclosure and from the interior of the enclosure, of a device for sealing the figure 1 installed on a portion of the peripheral wall of the enclosure and ready to be associated with the annular flange of a container according to the invention;
  • the figures 3a and 3b are two perspective views of the container according to the invention, respectively in exploded view and in overall view;
  • the figures 4a to 4c are top views of the leaktight junction device of the preceding figures, devoid of a protective crown, associated with the container according to the invention, in which the figure 4a illustrates a sealing device and a container in the initial locking position, the figure 4b illustrates a tight junction device and a container in the intermediate unlocking position, and the figure 4c illustrates a sealing device and a container in the final locking position;
  • the figures 5a to 5c are cross-sectional views of only part of the container associated with the sealed junction device respectively illustrating an initial locking position, an intermediate unlocking position and a final locking position.

Ci-après un exposé détaillé de plusieurs modes de réalisation de l'invention assorti d'exemples et de référence aux dessins.Below is a detailed description of several embodiments of the invention accompanied by examples and reference to the drawings.

La figure 1 représente une enceinte 10 close comportant une paroi périphérique 12 définissant un espace intérieur 14 confiné et une ouverture circulaire 16 autorisant l'introduction de produits biopharmaceutiques (non représentés) dans l'espace intérieur 14 confiné.The figure 1 represents a closed enclosure 10 comprising a peripheral wall 12 defining a confined interior space 14 and a circular opening 16 allowing the introduction of biopharmaceutical products (not shown) into the confined interior space 14.

L'enceinte 10 - qui peut être un local ou toute autre installation analogue - est conçue pour être en permanence isolée du milieu extérieur. Ainsi, pour éviter toute perte d'intégrité et conserver un environnement aseptique dans l'espace intérieur 14, l'ouverture annulaire 16 est obturée hermétiquement par une porte amovible 18 positionnée dans l'espace intérieur et capable de passer d'une position fermée dans laquelle l'ouverture circulaire 16 est obstruée à une position ouverte dans laquelle l'ouverture circulaire 16 n'est plus obstruée.The enclosure 10 - which can be a room or any other similar installation - is designed to be permanently isolated from the outside environment. Thus, to avoid any loss of integrity and maintain an aseptic environment in the interior space 14, the annular opening 16 is sealed by a removable door 18 positioned in the interior space and capable of passing from a closed position in in which the circular opening 16 is obstructed to an open position in which the circular opening 16 is no longer obstructed.

Par convention, les termes « interne » et « externe » qualifient dans la suite de la description les positions relatives d'objets vis-à-vis de l'axe géométrique de l'ouverture annulaire 16. Ainsi l'objet qualifié d' « interne » ou ayant un « positionnement radial interne » doit-il être considéré comme placé au plus proche de l'axe géométrique de l'ouverture annulaire 16 tandis que l'objet qualifié d' « externe » ou ayant un positionnement radial « externe » doit, comparativement, être considéré comme placé au plus loin de l'axe géométrique de l'ouverture annulaire 16.By convention, the terms “internal” and “external” qualify in the rest of the description the relative positions of objects with respect to the geometric axis of the annular opening 16. Thus the object qualified as “ internal" or having an "internal radial positioning" should it be considered as placed closest to the geometric axis of the annular opening 16 while the object qualified as "external" or having an "external" radial positioning must, comparatively, be considered to be placed furthest from the geometric axis of the annular opening 16.

Les figures 2a et 2b représentent un conteneur 20 destiné à transporter des produits biopharmaceutiques et prêt à être associé à l'enceinte 10 close pour réaliser un transfert aseptique de produits biopharmaceutiques vers ou depuis cette enceinte 10.The figure 2a and 2b represent a container 20 intended to transport biopharmaceutical products and ready to be associated with the closed enclosure 10 to carry out an aseptic transfer of biopharmaceutical products to or from this enclosure 10.

Le conteneur 20 comporte, à cet égard, une enveloppe périphérique (non représentée) définissant un espace intérieur 24 confiné, dans lequel peuvent être introduits les produits biopharmaceutiques. L'enveloppe périphérique comporte également une ouverture annulaire 26 délimitée par une bride annulaire 30 sur laquelle est solidairement fixée l'enveloppe périphérique. Le conteneur 20 comporte, en outre, un couvercle amovible 28 capable d'obturer hermétiquement l'ouverture 24 de la bride annulaire 30 en reposant sur un joint d'étanchéité 22.The container 20 comprises, in this respect, a peripheral envelope (not shown) defining a confined interior space 24, into which the biopharmaceutical products can be introduced. The peripheral casing also comprises an annular opening 26 delimited by an annular flange 30 to which the peripheral casing is firmly fixed. The container 20 further comprises a removable cover 28 capable of hermetically sealing the opening 24 of the annular flange 30 by resting on a seal 22.

Le conteneur 20 peut être réalisé selon différents modes de réalisation et, à cet égard, présenter une enveloppe périphérique souple et destinée à un usage unique ou bien rigide et destinée à être réutilisée après une procédure de décontamination bien connue de l'homme du métier.The container 20 can be made according to different embodiments and, in this respect, have a flexible peripheral envelope intended for single use or else rigid and intended to be reused after a decontamination procedure well known to those skilled in the art.

En référence aux figures 1, 2a et 2b, on décrit un dispositif de jonction étanche 40 destiné à permettre le transfert aseptique de produits biopharmaceutiques provenant du conteneur 20 (décrit ultérieurement) vers l'enceinte 10.With reference to figure 1 , 2a and 2b , there is described a tight junction device 40 intended to allow the aseptic transfer of biopharmaceutical products coming from the container 20 (described later) towards the enclosure 10.

Le dispositif de jonction étanche 40 a donc pour objet, d'abord, de permettre l'assemblage de l'enceinte 10 et du conteneur 20, ensuite, d'autoriser la mise en communication temporaire de l'espace intérieur 14 de cette enceinte 10 avec l'espace intérieur de ce conteneur 20 pour assurer le transfert de produits biopharmaceutiques de l'un vers l'autre et, enfin, d'assurer la séparation de ladite enceinte 10 et dudit conteneur 20.The purpose of the sealed junction device 40 is therefore, firstly, to allow the assembly of the enclosure 10 and the container 20, then, to authorize the temporary communication of the interior space 14 of this enclosure 10 with the interior space of this container 20 to ensure the transfer of biopharmaceutical products from one to the other and, finally, to ensure the separation of said enclosure 10 and said container 20.

Ces étapes successives - englobées par la suite sous la qualification de « transfert aseptique » - doivent être réalisées sans qu'il y ait de communication entre le milieu extérieur, d'une part, et les espaces intérieur 14, 24 de l'enceinte 10 et du conteneur 20, d'autre part.These successive steps - subsequently encompassed under the qualification of "aseptic transfer" - must be carried out without there being any communication between the external environment, on the one hand, and the interior spaces 14, 24 of the enclosure 10 and the container 20, on the other hand.

Pour ce faire, le dispositif de jonction étanche 40 selon le mode de réalisation de la figure 1 présente une partie formée à l'extérieure de l'enceinte 10 et supportée par la paroi périphérique 12 - ou par une pièce de support distincte de la paroi périphérique 12 mais fixée à demeure sur elle - en regard de l'ouverture annulaire 16. Plus précisément, le dispositif de jonction étanche 40 comporte une couronne fonctionnelle annulaire 42.To do this, the sealed junction device 40 according to the embodiment of the figure 1 has a part formed on the outside of the enclosure 10 and supported by the peripheral wall 12 - or by a separate support piece from the peripheral wall 12 but fixed permanently on it - facing the annular opening 16. More Specifically, the sealed junction device 40 comprises an annular functional crown 42.

La couronne fonctionnelle annulaire 42 présente un pourtour périphérique interne 44INT et un pourtour périphérique externe 44EXT inscrit à l'intérieur de quatre roulement à billes porteurs 46 eux-mêmes supportés par la face extérieure de la paroi périphérique 12. De cette façon, la couronne fonctionnelle annulaire 42 est positionnée à l'extérieur de l'enceinte 10, ce qui facilite les éventuelles opérations de maintenance. Les quatre roulements à billes porteurs 46 forment un support pour la couronne fonctionnelle annulaire et assurent sa rotation autour de l'axe géométrique de l'ouverture annulaire 16. Il convient cependant de souligner que le maintien en position de la couronne annulaire fonctionnelle pourrait être assuré par tout autre élément mécanique analogue (galet, palier, etc.).The annular functional crown 42 has an inner peripheral perimeter 44 INT and an outer peripheral perimeter 44 EXT inscribed inside four carrier ball bearings 46 themselves supported by the outer face of the peripheral wall 12. In this way, the annular functional crown 42 is positioned outside the enclosure 10, which facilitates any maintenance operations. The four carrier ball bearings 46 form a support for the annular functional crown and ensure its rotation around the geometric axis of the annular opening 16. It should however be emphasized that the maintenance in position of the functional annular crown could be ensured by any other similar mechanical element (roller, bearing, etc.).

Selon l'exemple de réalisation de la figure 1, la couronne fonctionnelle annulaire 42 qui présente plusieurs portions ayant des fonctions mécaniques distinctes (décrites ultérieurement) peut être réalisée d'un seul tenant - par usinage, moulage, ou analogue - à partir d'un seul et unique bloc de matière. Cette réalisation présente l'avantage de simplifier la production de la couronne fonctionnelle annulaire, de diminuer dans le même temps les coûts de production et d'assurer un positionnement optimal des surfaces fonctionnelles de la couronne fonctionnelle annulaire 42. Toutefois, il est entendu que la couronne fonctionnelle annulaire pourrait également, selon d'autre modes de réalisation, être formée à partir d'une pluralité de pièces mécaniques distinctes, assemblées les unes autres d'un seul tenant de sorte que la rotation l'une de ces pièces mécaniques autour de l'axe géométrique de rotation R entre la rotation de l'ensemble d'entre elles.According to the embodiment of the figure 1 , the annular functional crown 42 which has several portions having distinct mechanical functions (described later) can be made in one piece - by machining, molding, or the like - from a single and unique block of material. This embodiment has the advantage of simplifying the production of the annular functional crown, at the same time reducing production costs and ensuring optimal positioning of the functional surfaces of the annular functional crown 42. However, it is understood that the annular functional crown could also, according to other embodiments, be formed from a plurality of separate mechanical parts, assembled together in one piece so that the rotation of one of these mechanical parts around the geometric axis of rotation R between the rotation of all of them.

En référence à la figure 1, on peut également prévoir une couronne de protection 41, apposée sur la couronne fonctionnelle annulaire, de sorte que la couronne fonctionnelle annulaire 42 n'est pas accessible.With reference to the figure 1 , it is also possible to provide a protective crown 41, affixed to the annular functional crown, so that the annular functional crown 42 is not accessible.

Il convient de signaler que, par convention, les objets dits « stationnaires » font parties du dispositif de jonction étanche 40 et sont donc destinés à être liés et fixés à demeure sur l'enceinte 10. À l'inverse, les objets dits « embarqués » sont destinés à être supportés par les conteneurs 20 et sont donc mobiles avec ces derniers.It should be noted that, by convention, the so-called "stationary" objects are part of the sealed junction device 40 and are therefore intended to be linked and permanently fixed to the enclosure 10. Conversely, the so-called "on-board" objects »Are intended to be supported by the containers 20 and are therefore movable with the latter.

La couronne fonctionnelle annulaire 42, est capable d'entrer en rotation autour de l'axe géométrique de rotation R sous l'action d'un levier 48, par exemple activé manuellement. En variante, la couronne fonctionnelle annulaire peut être mise en rotation au moyen d'un moteur.The annular functional crown 42 is capable of entering into rotation around the geometric axis of rotation R under the action of a lever 48, for example activated manually. Alternatively, the annular functional crown can be rotated by means of a motor.

Selon une réalisation, la couronne de protection 41 est également apte à entrer en rotation autour de l'axe géométrique de rotation 2 sous l'action d'une manette 43, par exemple activé manuellement par un utilisateur.According to one embodiment, the protection ring 41 is also able to enter into rotation around the geometric axis of rotation 2 under the action of a handle 43, for example activated manually by a user.

Le dispositif de jonction étanche 40 comporte des moyens stationnaires de bridage temporaire 50.The sealed junction device 40 comprises stationary temporary clamping means 50.

Les moyens stationnaires de bridage temporaire 50 ont pour fonction de maintenir le conteneur 20 bridé contre l'enceinte 10 de sorte que le couvercle amovible 28 de ce conteneur 20 soit appliqué hermétiquement contre la porte amovible 18 de l'enceinte 10.The stationary temporary clamping means 50 have the function of keeping the container 20 clamped against the enclosure 10 so that the removable lid 28 of this container 20 is applied hermetically against the removable door 18 of the enclosure 10.

Les moyens stationnaires de bridage temporaire 50 sont, selon une première réalisation, liés mécaniquement à la couronne fonctionnelle annulaire 42 de sorte que la rotation de la couronne fonctionnelle annulaire 42 autour de l'axe géométrique de rotation R entraîne mécaniquement l'actionnement des moyens stationnaires de bridage temporaire 50.The stationary temporary clamping means 50 are, according to a first embodiment, mechanically linked to the annular functional ring 42 so that the rotation of the annular functional ring 42 around the geometric axis of rotation R mechanically causes the stationary means to be actuated. temporary bridle 50.

Selon une deuxième réalisation, les moyens stationnaires de bridage temporaire 50 sont liés mécaniquement à la couronne de protection 41 de sorte que la rotation de la couronne de protection 41 autour de l'axe géométrique de rotation R entraîne mécanique l'actionnement des moyens stationnaires de bridage temporaire 50.According to a second embodiment, the stationary temporary clamping means 50 are mechanically linked to the protection ring 41 so that the rotation of the protection ring 41 around the geometric axis of rotation R causes the mechanical actuation of the stationary means of temporary bridle 50.

Dans la suite de la description, et à titre d'exemple non limitatif, on considère que les moyens stationnaires de bridage temporaire 50 sont entraînés mécaniquement par la rotation de la couronne fonctionnelle annulaire 42.In the rest of the description, and by way of non-limiting example, it is considered that the stationary temporary clamping means 50 are mechanically driven by the rotation of the annular functional crown 42.

Selon la réalisation des figures 1 et 4a à 4c, les moyens stationnaires de bridage temporaire 50 peuvent être au nombre de quatre, répartis régulièrement autour de la couronne fonctionnelle annulaire 42. Les moyens stationnaires de bridage temporaire 50 sont formés par un élément de bridage 52, apte à effectuer une rotation autour d'un axe de rotation de bridage de manière à brider temporairement le couvercle amovible 28 du conteneur 20 contre la porte amovible 18 de l'enceinte 10.According to the realization of figure 1 and 4a to 4c , the stationary temporary clamping means 50 can be four in number, distributed regularly around the annular functional crown 42. The stationary temporary clamping means 50 are formed by a clamping element 52, able to perform a rotation around a clamping rotation axis so as to temporarily clamp the removable lid 28 of the container 20 against the removable door 18 of the enclosure 10.

Plus précisément, l'élément de bridage 52, après rotation, dépasse radialement dans l'ouverture annulaire 16 et vient en butée contre le conteneur 20 de sorte à empêcher une désolidarisation du couvercle amovible 28 et de la porte amovible 18.More specifically, the clamping element 52, after rotation, protrudes radially into the annular opening 16 and comes into abutment against the container 20 so as to prevent separation of the removable cover 28 and the removable door 18.

Le dispositif de jonction étanche 40 comporte des moyens stationnaires de déverrouillage 60.The sealed junction device 40 includes stationary unlocking means 60.

Les moyens stationnaires de déverrouillage 60 sont destinés à faire passer le conteneur 20 d'une position de verrouillage initial dans laquelle le couvercle amovible 28 obture hermétiquement le conteneur 20 à une position de déverrouillage intermédiaire dans laquelle le couvercle amovible 28 est désolidarisé du conteneur et maintenu hermétiquement contre la porte 18 de l'enceinte 10 de manière à assurer une communication aseptique entre le conteneur 20 et l'enceinte 10.The stationary unlocking means 60 are intended to move the container 20 from an initial locked position in which the removable lid 28 seals the container 20 hermetically to an intermediate unlocking position in which the removable lid 28 is detached from the container and held hermetically against the door 18 of the enclosure 10 so as to ensure aseptic communication between the container 20 and the enclosure 10.

Ces moyens stationnaires de déverrouillage 60 sont liés mécaniquement à la couronne fonctionnelle annulaire 42 de sorte que la rotation de la couronne fonctionnelle annulaire 42 autour de l'axe géométrique de rotation R entraîne mécaniquement l'actionnement des moyens stationnaires de déverrouillage 60.These stationary unlocking means 60 are mechanically linked to the annular functional crown 42 so that the rotation of the annular functional crown 42 around the geometric axis of rotation R mechanically causes the stationary unlocking means 60 to be actuated.

Selon la réalisation de la figure 1, le dispositif de jonction étanche comprend quatre moyens stationnaires de déverrouillage 60, bien qu'il puisse en comprendre moins de quatre, ou plus de quatre. Les moyens stationnaires de déverrouillage sont régulièrement répartis autour de la couronne fonctionnelle annulaire 42.According to the realization of the figure 1 , the sealing device comprises four stationary unlocking means 60, although it may comprise less than four, or more than four. The stationary unlocking means are regularly distributed around the annular functional crown 42.

Chacun des moyens stationnaires de déverrouillage comprend un élément poussoir de verrouillage 62 à déplacement rotatif et un organe d'entraînement de déverrouillage 64 susceptible d'être engrainé par une portion de la couronne fonctionnelle annulaire 42 formant engrenage de sorte que, lors de la rotation de la couronne fonctionnelle annulaire 42 jusqu'à une position de déverrouillage intermédiaire, l'élément poussoir de déverrouillage 62, sous engrainement de l'organe d'entraînement de déverrouillage 64, se déplace autour de son axe de rotation et fait passer le conteneur de la position de verrouillage initial à la position de déverrouillage intermédiaire.Each of the stationary unlocking means comprises a locking pusher element 62 with rotary displacement and an unlocking drive member 64 capable of being engrained by a portion of the annular functional crown 42 forming a gear so that, during the rotation of the annular functional crown 42 to an intermediate unlocking position, the unlocking push-button element 62, under meshing of the unlocking drive member 64, moves around its axis of rotation and causes the container to pass from the initial locking position to intermediate unlocking position.

Plus précisément, lors de la rotation de la couronne fonctionnelle annulaire 42 jusqu'à une position de déverrouillage intermédiaire, le mouvement relatif de la couronne fonctionnelle annulaire 42 par rapport à l'élément poussoir provoque le déplacement de l'organe d'entrainement 64 au moyen de la portion formant engrenage. En position de déverrouillage intermédiaire, l'élément poussoir 62 dépasse par exemple radialement dans l'ouverture circulaire 16 de l'enceinte.More precisely, during the rotation of the annular functional crown 42 to an intermediate unlocking position, the relative movement of the annular functional crown 42 with respect to the pusher element causes the movement of the drive member 64 at the means of the gear portion. In the intermediate unlocking position, the pusher element 62 protrudes for example radially into the circular opening 16 of the enclosure.

Le dispositif de jonction étanche 40 comporte des moyens stationnaires de verrouillage 70.The sealed junction device 40 comprises stationary locking means 70.

Les moyens stationnaires de verrouillage 70 sont destinés à faire passer le conteneur 20 de la position de déverrouillage intermédiaire à une position de verrouillage final dans laquelle ledit couvercle amovible 28 obture, à nouveau, le conteneur 20 de façon hermétique.The stationary locking means 70 are intended to move the container 20 from the intermediate unlocking position to a final locking position in which said removable cover 28 closes, again, the container 20 hermetically.

Comme précédemment, ces moyens stationnaires de verrouillage 70 sont liés mécaniquement à la couronne fonctionnelle annulaire 42 de sorte que la rotation de cette couronne fonctionnelle annulaire 42 autour de l'axe géométrique de rotation R entraîne mécaniquement l'actionnement des moyens stationnaires de verrouillage 70. De la même façon que précédemment, la position relative des moyens stationnaires de verrouillage 70 et des moyens stationnaires de déverrouillage 60 autour de la couronne fonctionnelle annulaire 42 est telle que l'actionnement de ces moyens stationnaires de verrouillage 70 ne peut être que consécutif à l'arrêt des moyens stationnaires de déverrouillage 60.As before, these stationary locking means 70 are mechanically linked to the annular functional crown 42 so that the rotation of this annular functional crown 42 around the geometric axis of rotation R mechanically causes the stationary locking means 70 to be actuated. In the same way as previously, the relative position of the stationary locking means 70 and the stationary unlocking means 60 around the annular functional crown 42 is such that the actuation of these stationary locking means 70 can only be consecutive to the stopping the stationary unlocking means 60.

Selon la réalisation des figures 4a à 4c, le dispositif de jonction étanche comprend quatre moyens stationnaires de verrouillage, bien qu'il puisse en comprendre moins de quatre, ou plus de quatre. Les moyens stationnaires de verrouillage 70 sont régulièrement répartis autour de la couronne fonctionnelle annulaire 42.According to the realization of figures 4a to 4c , the sealing device comprises four stationary locking means, although it may comprise less than four, or more than four. The stationary locking means 70 are regularly distributed around the annular functional crown 42.

Chacun des moyens stationnaires de verrouillage 70 comprend un élément poussoir de verrouillage 72 à déplacement rotatif et un organe d'entraînement de verrouillage 74 susceptible d'être engrainé par une portion de la couronne fonctionnelle annulaire 42 formant engrenage de sorte que, lors de la rotation de la couronne fonctionnelle annulaire 42 jusqu'à une position de verrouillage final, l'élément poussoir de verrouillage 72, sous engrainement de l'organe d'entraînement de verrouillage 74, se déplace autour de son axe de rotation et fait passer le conteneur de la position de déverrouillage intermédiaire à la position de verrouillage final.Each of the stationary locking means 70 comprises a locking pusher element 72 with rotary displacement and a locking drive member 74 capable of being engrained by a portion of the annular functional crown 42 forming a gear so that, during rotation from the annular functional crown 42 to a final locking position, the locking pusher element 72, under meshing of the locking drive member 74, moves around its axis of rotation and causes the container to pass from the intermediate unlocking position to the final locking position.

Plus, précisément, lors de la rotation de la couronne fonctionnelle annulaire 42 jusqu'à une position de verrouillage final, le mouvement relatif de la couronne fonctionnelle annulaire 42 par rapport à l'élément poussoir provoque le déplacement de l'organe d'entrainement 74 au moyen de la portion formant engrenage. En position de verrouillage final, l'élément poussoir 72 dépasse par exemple radialement dans l'ouverture circulaire 16 de l'enceinte.More specifically, during the rotation of the annular functional crown 42 to a final locking position, the relative movement of the annular functional crown 42 with respect to the pusher element causes the displacement of the drive member 74 by means of the gear portion. In the final locking position, the pusher element 72 protrudes for example radially into the circular opening 16 of the enclosure.

Selon le mode de réalisation exemplatif et non limitatif de la figure 1, les moyens stationnaires de déverrouillage 60 et les moyens stationnaires de verrouillage 70 sont structurellement confondus les uns des autres. Plus précisément, les éléments poussoirs 62 et 72 sont confondus, ainsi que les organes d'entraînement 64 et 74.According to the exemplary and non-limiting embodiment of the figure 1 , the stationary unlocking means 60 and the stationary locking means 70 are structurally coincident with each other. More precisely, the pusher elements 62 and 72 are combined, as well as the drive members 64 and 74.

À l'inverse, selon une alternative (non représentée), les moyens stationnaires de déverrouillage 60 et les moyens stationnaires de verrouillage 70 pourraient éventuellement être structurellement distincts et indépendants les uns des autres.Conversely, according to an alternative (not shown), the stationary unlocking means 60 and the stationary locking means 70 could optionally be structurally distinct and independent of each other.

Le dispositif de jonction étanche 40 comporte des moyens stationnaires de blocage/déblocage 80.The sealed junction device 40 comprises stationary locking/unlocking means 80.

Les moyens stationnaires de blocage/déblocage 80 sont aptes à faire faire passer la couronne fonctionnelle annulaire d'une position de blocage dans laquelle la couronne fonctionnelle annulaire n'est pas apte à être mise en rotation, à une position de déblocage dans laquelle la couronne fonctionnelle annulaire 42 est apte à être mise en rotation.The stationary blocking/unblocking means 80 are capable of causing the functional annular crown to pass from a blocking position in which the functional annular crown is not able to be rotated, to an unlocking position in which the crown annular functional 42 is capable of being rotated.

Plus précisément, les moyens stationnaires de blocage/déblocage 80 sont aptes à empêcher le déplacement des éléments poussoirs 62 des moyens stationnaires de déverrouillage 60, de sorte que le dispositif de jonction étanche 40 n'est pas autorisé à passer de la position initiale de verrouillage à la position intermédiaire de déverrouillage.More specifically, the stationary locking/unlocking means 80 are able to prevent the movement of the pusher elements 62 of the stationary unlocking means 60, so that the sealed junction device 40 is not authorized to pass from the initial locking position to the intermediate unlock position.

Selon la réalisation des figures 4a à 4c, le dispositif de jonction étanche comprend quatre moyens stationnaires de blocage/déblocage 80, bien qu'il puisse en comprendre moins de quatre, ou plus de quatre. Les moyens stationnaires de blocage/déblocage 80 sont régulièrement répartis autour de la couronne fonctionnelle annulaire 42.According to the realization of figures 4a to 4c , the sealing device comprises four stationary locking/unlocking means 80, although it may comprise less than four, or more than four. The stationary locking/unlocking means 80 are regularly distributed around the annular functional crown 42.

La position relative des moyens stationnaires de blocage/déblocage 80 et des moyens stationnaires de déverrouillage 60 autour de la couronne fonctionnelle annulaire 42 est telle que l'actionnement de ces moyens stationnaires de déverrouillage 60 ne peut être que consécutif à l'actionnement des moyens stationnaires de blocage/déblocage 80.The relative position of the stationary locking/unlocking means 80 and the stationary unlocking means 60 around the annular functional crown 42 is such that the actuation of these stationary unlocking means 60 can only be consecutive to the actuation of the stationary means locking/unlocking 80.

Plus précisément, les moyens stationnaires de blocage/déblocage 80 sont actionnés par le bridage du conteneur 20 contre l'enceinte 10 par les moyens embarqués de blocage/déblocage 140 du conteneur 20, tel que décrit plus loin.More specifically, the stationary locking/unlocking means 80 are actuated by the clamping of the container 20 against the enclosure 10 by the on-board locking/unlocking means 140 of the container 20, as described below.

Les moyens stationnaires de blocage/déblocage comprennent un doigt 82, monté mobile dans un canal 84. Le canal 84 s'étend dans une direction transversale à la direction radiale de sorte que le canal 84 est par exemple parallèle à l'axe de rotation R. Le doigt 82 est sollicité par un ressort 86 vers une position déployée dans laquelle le doigt dépasse hors du dispositif de jonction étanche 40, de sorte que l'élément poussoir 62 vient en butée contre le doigt 82. Le doigt 82 est déplaçable à l'encontre de la sollicitation du ressort 86 dans une position escamotée dans laquelle le doigt 82 ne dépasse pas hors du dispositif de jonction étanche, de sorte que l'élément poussoir 62 peut se déplacer et autoriser ainsi la rotation de la couronne fonctionnelle annulaire autour de son axe de rotation R.The stationary locking/unlocking means comprise a finger 82, movably mounted in a channel 84. The channel 84 extends in a direction transverse to the radial direction so that the channel 84 is for example parallel to the axis of rotation R Finger 82 is biased by a spring 86 to an extended position in which the finger protrudes out of the sealing device 40, so that the pusher element 62 comes into abutment against the finger 82. The finger 82 is movable at the against the biasing of the spring 86 in a retracted position in which the finger 82 does not protrude out of the sealing device, so that the pusher element 62 can move and thus authorize the rotation of the annular functional crown around its axis of rotation R.

Le dispositif de jonction étanche 40 comporte des moyens stationnaires d'ouverture 90.The sealed junction device 40 includes stationary opening means 90.

Ces moyens stationnaires d'ouverture 90 sont destinés à empêcher/autoriser l'ouverture de la porte amovible 18 de l'enceinte 10 et sont reliés mécaniquement à la couronne fonctionnelle annulaire 42 de sorte que la rotation de cette couronne fonctionnelle annulaire 42 autour de l'axe géométrique de rotation R entraîne mécaniquement l'actionnement des moyens stationnaire d'ouverture 90. Plus particulièrement, du fait de la position de ces moyens stationnaire d'ouverture 90 sur la couronne fonctionnelle annulaire 42, ces derniers assurent l'ouverture de la porte amovible 18 de l'enceinte 10.These stationary opening means 90 are intended to prevent/authorize the opening of the removable door 18 of the enclosure 10 and are mechanically connected to the annular functional ring 42 so that the rotation of this annular functional ring 42 around the geometric axis of rotation R mechanically causes the stationary opening means 90 to be actuated. removable door 18 of enclosure 10.

Selon la réalisation de la figure 2b, les moyens stationnaires d'ouverture 90 assurent l'ouverture de la porte amovible 18 après que l'actionnement des moyens stationnaires de déverrouillage 60 ait conduit à faire passer le conteneur 20 en position de déverrouillage intermédiaire. De cette façon, l'ouverture de la porte amovible 18 de l'enceinte 10 est retardée lorsqu'un problème se produit au cours du déverrouillage intermédiaire du conteneur 20. Cela permet de limiter les problématiques de confinement - nécessairement plus complexe à réparer au sein de l'enceinte 10 - qui pourraient résulter d'une erreur de manipulation du conteneur 20. De façon similaire, ces moyens stationnaires d'ouverture 90 sont agencés sur la couronne fonctionnelle annulaire 42 afin d'assurer la fermeture de la porte amovible 18 de l'enceinte 10 avant que les moyens stationnaires de verrouillage 70 aient été activés pour faire passer le conteneur 20 dans la position de verrouillage final.According to the realization of the figure 2b , the stationary opening means 90 open the removable door 18 after the actuation of the stationary unlocking means 60 has caused the container 20 to pass into the intermediate unlocking position. In this way, the opening of the removable door 18 of the enclosure 10 is delayed when a problem occurs during the intermediate unlocking of the container 20. This makes it possible to limit the problems of containment - necessarily more complex to repair within of the enclosure 10 - which could result from an error in handling the container 20. Similarly, these stationary opening means 90 are arranged on the annular functional crown 42 in order to ensure the closing of the removable door 18 of the enclosure 10 before the stationary locking means 70 have been activated to move the container 20 into the final locking position.

Les moyens stationnaires d'ouverture 90 sont par exemple connectés aux moyens stationnaires de déverrouillage 60. Ainsi, le déplacement desdits moyens stationnaires de déverrouillage vers une position de déverrouillage intermédiaire entraîne un déplacement des moyens stationnaires d'ouverture 90 dans une position dans laquelle les moyens stationnaires d'ouverture 90 autorisent l'ouverture de la porte amovible 18.The stationary opening means 90 are for example connected to the stationary unlocking means 60. Thus, the movement of said stationary unlocking means towards an intermediate unlocking position causes the stationary opening means 90 to move into a position in which the means stationary opening 90 allow the opening of the removable door 18.

De même, les moyens stationnaires d'ouverture 90 sont par exemple connectés aux moyens stationnaires de verrouillage 70. Ainsi, le déplacement desdits moyens stationnaires de verrouillage vers une position de verrouillage final entraîne un déplacement des moyens stationnaires d'ouverture 90 dans une position dans laquelle les moyens stationnaires d'ouverture 90 empêchent l'ouverture de la porte amovible 18.Similarly, the stationary opening means 90 are for example connected to the stationary locking means 70. Thus, the movement of said stationary locking means towards a final locking position causes the stationary opening means 90 to move into a position in which the stationary opening means 90 prevent the opening of the removable door 18.

Les moyens stationnaires d'ouverture 90 peuvent être agencés de sorte que ces derniers assurent le déblocage de la porte amovible 18 simultanément au passage du conteneur 20 en position de déverrouillage intermédiaire, puis le blocage de cette porte amovible 18 simultanément au passage du conteneur 20 en position de verrouillage final.The stationary opening means 90 can be arranged so that the latter ensure the unlocking of the removable door 18 simultaneously with the passage of the container 20 in the intermediate unlocking position, then the blocking of this removable door 18 simultaneously with the passage of the container 20 in final lock position.

Il est également envisageable d'agencer les moyens stationnaires d'ouverture 90 de sorte que ces derniers assurent, d'une part, le déblocage de la porte amovible 18 de l'enceinte 10 avant le passage du conteneur 20 en position de déverrouillage intermédiaire et, d'autre part, le blocage de la porte amovible 18 de l'enceinte 10 après le passage du conteneur 20 en position de verrouillage final.It is also possible to arrange the stationary opening means 90 so that the latter ensure, on the one hand, the unlocking of the removable door 18 of the enclosure 10 before the passage of the container 20 in the intermediate unlocking position and , on the other hand, the locking of the removable door 18 of the enclosure 10 after the passage of the container 20 in the final locking position.

Les moyens stationnaires d'ouverture 90, tels qu'illustrés sur la figure 2b, comprennent par exemple une tige fonctionnelle d'ouverture 92 située dans l'axe de l'axe de rotation des moyens stationnaires 60, 70. La tige fonctionnelle 92 connecte par exemple les moyens stationnaires 60, 70 à un corps 94 situé à l'intérieur de l'espace intérieur 14, empêchant l'ouverture de la porte amovible par chevauchement de ladite porte amovible dans le sens de l'ouverture.The stationary opening means 90, as illustrated in the figure 2b , include for example a functional opening rod 92 located in the axis of the axis of rotation of the stationary means 60, 70. The functional rod 92 connects for example the stationary means 60, 70 to a body 94 located at the interior of the interior space 14, preventing the opening of the removable door by overlapping said removable door in the direction of opening.

Le dispositif de jonction étanche 40 comporte aussi des moyens stationnaires de manœuvre 100.The sealed junction device 40 also comprises stationary maneuvering means 100.

Ces moyens stationnaires de manœuvre 100 sont destinés à ouvrir et refermer hermétiquement la porte amovible 18 de l'enceinte 10.These stationary operating means 100 are intended to hermetically open and close the removable door 18 of the enclosure 10.

Pour ce faire, les moyens stationnaires de manœuvre 100 peuvent, selon un premier mode de réalisation, être entraînés mécaniquement par la couronne fonctionnelle annulaire 42. Dans ce cas de figure, les moyens stationnaires de manœuvre 100 sont reliés mécaniquement à la couronne fonctionnelle annulaire 42 de sorte que la rotation de cette couronne fonctionnelle annulaire 42 autour de l'axe géométrique de rotation R entraîne mécaniquement l'actionnement des moyens stationnaires de manœuvre 100. Plus particulièrement, la position de ces moyens stationnaires de manœuvre 100 sur la couronne fonctionnelle annulaire 42 permet d'ouvrir la porte amovible 18 de l'enceinte 10 après le passage du conteneur 20 en position de déverrouillage, puis de refermer la porte amovible 18 avant le passage du conteneur 20 en position de verrouillage final.To do this, the stationary maneuvering means 100 can, according to a first embodiment, be driven mechanically by the annular functional crown 42. In this case, the stationary maneuvering means 100 are mechanically connected to the annular functional crown 42 so that the rotation of this annular functional ring 42 around the geometric axis of rotation R mechanically causes the stationary maneuvering means 100 to be actuated. More particularly, the position of these stationary maneuvering means 100 on the annular functional ring 42 makes it possible to open the removable door 18 of the enclosure 10 after the passage of the container 20 in the unlocked position, then to close the removable door 18 before the passage of the container 20 in the final locking position.

En variante, les moyens stationnaires de manœuvre 100 sont entraînés par un moteur de manœuvre (non représenté) asservi sur le déplacement de la couronne fonctionnelle annulaire 42.Alternatively, the stationary operating means 100 are driven by an operating motor (not shown) slaved to the movement of the annular functional crown 42.

Les moyens stationnaires de manœuvre 100 comprennent un bras rotatif 102 apte à être mis en rotation autour d'un axe de rotation d'une charnière 104. De cette façon, les moyens stationnaires de manœuvre 100 permettent, grâce au moteur de manoeuvre, de déplacer la porte amovible 18 de l'enceinte 10, dans une direction sensiblement perpendiculaire à la direction axiale de sorte que la porte amovible 18 n'entrave pas le passage du produit biopharmaceutique lors de leur transfert aseptique entre l'enceinte 10 et le conteneur 20.The stationary maneuvering means 100 comprise a rotary arm 102 capable of being rotated about an axis of rotation of a hinge 104. In this way, the stationary maneuvering means 100 make it possible, thanks to the maneuvering motor, to move the removable door 18 of the enclosure 10, in a direction substantially perpendicular to the axial direction so that the removable door 18 does not hinder the passage of the biopharmaceutical product during their aseptic transfer between the enclosure 10 and the container 20.

Il convient de noter que, selon une première réalisation, les moyens stationnaires de bridage 50, les moyens stationnaires de déverrouillage 60, les moyens stationnaires de verrouillage 70, les moyens d'ouverture 90 et les moyens de manœuvre 100 sont liés mécaniquement à la couronne fonctionnelle annulaire 42 et agencés de sorte que la rotation de ladite couronne fonctionnelle annulaire 42 autour de l'axe géométrique de rotation R entraîne successivement l'actionnement des moyens stationnaires de bridage temporaire 50 pour assurer le maintien en position du conteneur 20 contre l'enceinte 10, puis successivement ou simultanément l'actionnement des moyens stationnaires de déverrouillage 60 assurant le passage en position de déverrouillage intermédiaire du conteneur 20 et l'actionnement des moyens stationnaires d'ouverture 90 assurant le déblocage de la porte amovible 18 de l'enceinte 10. L'actionnement des moyens stationnaires de déverrouillage 60 n'est que consécutif à l'actionnement des moyens stationnaires de blocage/déblocage 80. Puis, la rotation de la couronne fonctionnelle annulaire 42 autour de l'axe géométrique de rotation R entraîne simultanément ou successivement l'actionnement des moyens stationnaires d'ouverture 90 assurant le blocage de la porte amovible 18 de l'enceinte 10 et l'actionnement des moyens stationnaires de verrouillage 70 assurant le passage en position de verrouillage final du conteneur 20, et à nouveau l'actionnement des moyens stationnaires de bridage temporaire 50 du conteneur afin de libérer le conteneur 20.It should be noted that, according to a first embodiment, the stationary clamping means 50, the stationary unlocking means 60, the stationary locking means 70, the opening means 90 and the maneuvering means 100 are mechanically linked to the crown annular functional ring 42 and arranged so that the rotation of said annular functional ring 42 around the geometric axis of rotation R successively causes the stationary temporary clamping means 50 to be actuated to ensure that the container 20 is held in position against the enclosure 10, then successively or simultaneously the actuation of the stationary unlocking means 60 ensuring the transition to the intermediate unlocking position of the container 20 and the actuation of the stationary opening means 90 ensuring the unlocking of the removable door 18 of the enclosure 10 The actuation of the stationary unlocking means 60 is only consecutive to the actuation of s stationary locking/unlocking means 80. Then, the rotation of the annular functional crown 42 around the geometric axis of rotation R causes simultaneously or successively the actuation of the stationary opening means 90 ensuring the locking of the removable door 18 of the enclosure 10 and the actuation of the stationary locking means 70 ensuring the transition to the final locking position of the container 20, and again the actuation of the stationary temporary clamping means 50 of the container in order to release the container 20.

Selon une deuxième réalisation, les moyens stationnaires de bridage 50 sont liés mécaniquement à la couronne de protection 41 et agencés de sorte que la rotation de la couronne de protection 41 autour de l'axe géométrique de rotation R entraîne l'actionnement des moyens stationnaires de bridage temporaire 50 pour assurer le maintien en position du conteneur 20 contre l'enceinte 10. Les moyens stationnaires de déverrouillage 60, les moyens stationnaires de verrouillage 70, les moyens d'ouverture 90 et les moyens de manoeuvre 100 sont liés mécaniquement à la couronne fonctionnelle annulaire 42 et agencés de sorte que la rotation de ladite couronne fonctionnelle annulaire 42 autour de l'axe géométrique de rotation R entraîne successivement l'actionnement des moyens stationnaires de déverrouillage 60 assurant le passage en position de déverrouillage intermédiaire du conteneur 20 et l'actionnement des moyens stationnaires d'ouverture 90 assurant le déblocage de la porte amovible 18 de l'enceinte 10. L'actionnement des moyens stationnaires de déverrouillage 60 n'est que consécutif à l'actionnement des moyens stationnaires de blocage/déblocage 80. Puis, la rotation de la couronne fonctionnelle annulaire 42 autour de l'axe géométrique de rotation R entraîne simultanément ou successivement l'actionnement des moyens stationnaires d'ouverture 90 assurant le blocage de la porte amovible 18 de l'enceinte 10 et l'actionnement des moyens stationnaires de verrouillage 70 assurant le passage en position de verrouillage final du conteneur 20. Enfin, l'actionnement de la couronne de protection 41 permet à nouveau l'actionnement des moyens stationnaires de bridage temporaire 50 du conteneur afin de libérer le conteneur 20.According to a second embodiment, the stationary clamping means 50 are mechanically linked to the protection ring 41 and arranged so that the rotation of the protection ring 41 around the geometric axis of rotation R causes the stationary means of temporary clamping 50 to maintain the container 20 in position against the enclosure 10. The stationary unlocking means 60, the stationary locking means 70, the opening means 90 and the maneuvering means 100 are mechanically linked to the functional annular crown 42 and arranged so that the rotation of said functional annular crown 42 around the geometric axis of rotation R causes successively the actuation of the stationary unlocking means 60 ensuring the transition to the intermediate unlocking position of the container 20 and the actuation of the stationary opening means 90 ensuring the unlocking of the removable door 18 of the enclosure 10. The actuation of the stationary unlocking means 60 is only consecutive to the actuation of the stationary locking/unlocking means 80. Then, the rotation of the annular functional crown 42 around the geometric axis of rotation R causes simultaneously or successively the actuation of the stationary opening means 90 ensuring the locking of the removable door 18 of the enclosure 10 and the actuation stationary locking means 70 ensuring the transition to the final locking position of the container 20. Finally, the actuation of the protective ring 41 again allows the actuation of the stationary temporary clamping means 50 of the container in order to release the container 20 .

On peut également prévoir des éléments stationnaires de positionnement 110 coopérant avec des éléments embarqués de positionnement agencés sur le conteneur, de manière à assurer le positionnement du conteneur contre l'enceinte. Ces éléments stationnaires de positionnement assurent notamment le positionnement des moyens embarqués de blocage/déblocage 140 en face des moyens stationnaires de blocage/déblocage 80.It is also possible to provide stationary positioning elements 110 cooperating with on-board positioning elements arranged on the container, so as to ensure the positioning of the container against the enclosure. These stationary positioning elements ensure in particular the positioning of the onboard locking/unlocking means 140 opposite the stationary locking/unlocking means 80.

Les éléments stationnaires de positionnement 110 peuvent être des aimants.The stationary positioning elements 110 can be magnets.

Il convient de signaler que la rotation de la couronne fonctionnelle annulaire 42 permet d'assurer l'actionnement des moyens stationnaires de déverrouillage, de verrouillage, d'ouverture et de manœuvre que cette couronne fonctionnelle annulaire se déplace dans un sens de rotation ou bien dans l'autre.It should be noted that the rotation of the annular functional crown 42 makes it possible to ensure the actuation of the stationary unlocking, locking, opening and maneuvering means whether this annular functional crown moves in a direction of rotation or else in the other.

Il serait, en outre, aussi possible d'intégrer cette couronne fonctionnelle annulaire 42 non pas à l'extérieur de l'enceinte 10 comme illustré par la réalisation de la figure 1 mais directement dans l'espace intérieur 14 de l'enceinte 10, contre la face intérieure de la paroi périphérique 12. Cette réalisation permettrait, notamment, d'éviter l'utilisation de moyens d'ouverture 90 présentant une tige fonctionnelle 92 traversant la paroi périphérique 12.It would also be possible to integrate this annular functional crown 42 not outside the enclosure 10 as illustrated by the realization of the figure 1 but directly in the interior space 14 of the enclosure 10, against the interior face of the peripheral wall 12. This embodiment would make it possible, in particular, to avoid the use of opening means 90 having a functional rod 92 passing through the wall device 12.

Les figures 3a et 3b représentent de manière plus détaillée un mode de réalisation d'un conteneur 20 destiné à être associé au dispositif de jonction étanche 40 selon l'invention.The figures 3a and 3b show in more detail an embodiment of a container 20 intended to be associated with the leaktight junction device 40 according to the invention.

Toutefois, dans cette illustration, l'enveloppe périphérique du conteneur 20 n'est pas représentée.However, in this illustration, the peripheral shell of container 20 is not shown.

Comme indiqué précédemment, ce conteneur 20 est destiné à permettre le transport et le transfert aseptique de produits biopharmaceutiques depuis ou vers une enceinte 10 dotée du dispositif de jonction étanche 40 selon l'invention.As indicated previously, this container 20 is intended to allow the aseptic transport and transfer of biopharmaceutical products from or to an enclosure 10 fitted with the leaktight junction device 40 according to the invention.

À cet égard, le conteneur 20 comprend la bride annulaire 30 délimitant l'ouverture annulaire 26, le couvercle amovible 28 apte à obturer hermétiquement l'ouverture 26 de la bride annulaire 30 et l'enveloppe périphérique solidaire de la bride annulaire 30 et délimitant l'espace intérieur 24 confiné susceptible de contenir les produits biopharmaceutiques. De cette façon, lorsqu'il est fermé par le couvercle amovible 28 le conteneur 20 est hermétiquement clos, ce qui prévient toute fuite ou toute introduction de matière dans l'espace intérieur 24. Le conteneur 20 peut être rigide ou souple et réutilisable ou à usage unique selon les cas de figure. À titre exemplatif et nullement limitatif, il peut s'agir d'un conteneur 20 de toutes tailles, tel qu'une poche, une gaine, un récipient, un bioréacteur, une goulotte, etc.In this respect, the container 20 comprises the annular flange 30 delimiting the annular opening 26, the removable lid 28 capable of hermetically sealing the opening 26 of the annular flange 30 and the peripheral casing integral with the annular flange 30 and delimiting the confined interior space 24 capable of containing the biopharmaceuticals. In this way, when it is closed by the removable cover 28, the container 20 is hermetically sealed, which prevents any leakage or any introduction of material into the interior space 24. The container 20 can be rigid or flexible and reusable or single use depending on the case. By way of example and in no way limiting, it can be a container 20 of any size, such as a bag, a sheath, a container, a bioreactor, a chute, etc.

Le conteneur 20 comprend des moyens embarqués de blocage/déblocage 140.The container 20 includes on-board locking/unlocking means 140.

Les moyens embarqués de blocage/déblocage 140 comprennent au moins un agencement fonctionnel embarqué de blocage/déblocage 142 formé, d'une part, par un logement traversant 144 formé dans la bride annulaire 30 et un logement borgne 146 formé dans le couvercle amovible 28 et dans le prolongement du logement traversant 144 lorsque le couvercle amovible 28 obture hermétiquement l'ouverture de la bride annulaire 30 et, d'autre part, par une goupille à positionnement radial interne 148 et une goupille à positionnement radial externe 150, comprenant une partie extrême fonctionnelle à positionnement radial externe 152, susceptibles d'être introduites et de se déplacer à l'intérieur du logement borgne 146 du couvercle amovible et du logement traversant 144 de la bride annulaire 30.The on-board locking/unlocking means 140 comprise at least one on-board locking/unlocking functional arrangement 142 formed, on the one hand, by a through housing 144 formed in the annular flange 30 and a blind housing 146 formed in the removable cover 28 and in the extension of the through housing 144 when the removable cover 28 hermetically seals the opening of the annular flange 30 and, on the other hand, by an internal radial positioning pin 148 and an external radial positioning pin 150, comprising an end part functional with external radial positioning 152, capable of being introduced and of moving inside the blind housing 146 of the removable cover and the through housing 144 of the annular flange 30.

Les moyens embarqués de blocage/déblocage 140 coopèrent avec les moyens stationnaires de blocage/déblocage 80. Plus précisément, la partie extrême fonctionnelle à positionnement radial externe 152, en position initiale, dépasse hors de la bride annulaire 30. La partie extrême fonctionnelle à positionnement radial externe 152 vient en appui contre le doigt 82 des moyens stationnaires de blocage/déblocage 80, de sorte que le doigt 82 est déplacé à l'encontre de la sollicitation du ressort 86 jusqu'à ne plus dépasser hors du dispositif de jonction étanche.The on-board locking/unlocking means 140 cooperate with the stationary locking/unlocking means 80. More precisely, the functional end part with external radial positioning 152, in the initial position, projects beyond the annular flange 30. The functional end part with external radial positioning outer radial 152 bears against the finger 82 of the stationary locking/unlocking means 80, so that the finger 82 is moved against the bias of the spring 86 until it no longer protrudes outside the sealed junction device.

Le conteneur 20 comprend des moyens embarqués de verrouillage/déverrouillage 120 du couvercle amovible 28 sur la bride annulaire 30.The container 20 includes on-board locking/unlocking means 120 of the removable lid 28 on the annular flange 30.

Ces moyens embarqués de verrouillage/déverrouillage 120 - dont la structure est détaillée ci-après - ont pour fonction d'assurer le maintien du conteneur 20 dans trois positions distinctes. La première position est qualifiée de position de verrouillage initiale car les moyens de verrouillage/déverrouillage 120 interdisent le déplacement relatif du couvercle amovible 28 vis-à-vis de la bride annulaire 30. La deuxième position, qualifiée de position de déverrouillage intermédiaire, est censée intervenir lorsque la bride annulaire 30 du conteneur 20 est bridée axialement contre la paroi périphérique 12 de l'enceinte 10 et autorise le déplacement le relatif du couvercle amovible 28 vis-à-vis de la bride annulaire 30. La troisième position, qualifiée de position de verrouillage final, est supposée intervenir après le transfert aseptique des produits biopharmaceutiques entre le conteneur 20 et l'enceinte 10 et interdit, à nouveau, le déplacement relatif du couvercle amovible 28 vis-à-vis de la bride annulaire 30.These on-board locking/unlocking means 120—the structure of which is detailed below—have the function of maintaining the container 20 in three distinct positions. The first position is qualified as the initial locking position because the locking/unlocking means 120 prohibit the relative movement of the removable cover 28 with respect to the annular flange 30. The second position, qualified as the intermediate unlocking position, is supposed to intervene when the annular flange 30 of the container 20 is flanged axially against the peripheral wall 12 of the enclosure 10 and allows the relative movement of the removable cover 28 vis-à-vis the annular flange 30. The third position, qualified as position final locking, is supposed to occur after the aseptic transfer of the biopharmaceutical products between the container 20 and the enclosure 10 and prohibits, again, the relative movement of the removable lid 28 vis-à-vis the annular flange 30.

Pour assurer ce passage de la position de verrouillage initiale à la position de déverrouillage intermédiaire, puis à la position de verrouillage final, les moyens embarqués de verrouillage/déverrouillage 120 comportent quatre agencements fonctionnels embarqués de verrouillage/déverrouillage 122 régulièrement répartis autour de la bride annulaire 28 du couvercle 30.To ensure this passage from the initial locking position to the intermediate unlocking position, then to the final locking position, the on-board locking/unlocking means 120 comprise four on-board functional locking/unlocking arrangements 122 regularly distributed around the annular flange 28 of cover 30.

Chaque agencement fonctionnel embarqué de verrouillage/déverrouillage 122 comporte un logement traversant 124 formé dans la bride annulaire 30 ainsi qu'un logement borgne 126 formé dans le couvercle amovible 28 du conteneur 20 et dans le prolongement du logement traversant 114.Each on-board locking/unlocking functional arrangement 122 comprises a through housing 124 formed in the annular flange 30 as well as a blind housing 126 formed in the removable lid 28 of the container 20 and in the extension of the through housing 114.

Chaque agencement fonctionnel embarqué de verrouillage/déverrouillage 122 comporte également une goupille à positionnement radial interne 128 et une goupille à positionnement radial externe 130. Ces deux goupilles à positionnement radial interne 128 et externe 130 présentent, selon la réalisation des figures 3a et 5a à 5c, un corps allongé de forme cylindrique leur permettant d'être introduites et de se déplacer à l'intérieur du logement borgne 126 formé dans le couvercle amovible 28, d'une part, et du logement traversant 124 agencé dans la bride annulaire 30, d'autre part. Il convient toutefois de noter que les caractéristiques dimensionnelles et les propriétés de la surface extérieure de ces goupilles à positionnement radial interne 128 et externe 130 sont tels que ces dernières ne peuvent se déplacer à l'intérieur des logements borgne 126 et traversant 124 du seul fait de la gravité. En outre, ces goupilles à positionnement radial interne 128 et externe 130 pourraient présenter un corps de forme différente - par exemple, parallélépipédique - afin de parvenir au même résultat.Each on-board locking/unlocking functional arrangement 122 also includes an inner radial positioning pin 128 and an outer radial positioning pin 130. These two pins with internal 128 and external 130 radial positioning present, according to the realization of the figure 3a and 5a to 5c , an elongated body of cylindrical shape allowing them to be introduced and to move inside the blind housing 126 formed in the removable cover 28, on the one hand, and the through housing 124 arranged in the annular flange 30, d 'somewhere else. It should however be noted that the dimensional characteristics and the properties of the outer surface of these pins with internal 128 and external 130 radial positioning are such that the latter cannot move inside the blind 126 and crossing 124 housings solely because of gravity. Furthermore, these pins with internal 128 and external 130 radial positioning could have a body of different shape - for example, parallelepipedal - in order to achieve the same result.

Le logement traversant 124, le logement borgne 126, la goupille à positionnement radial interne 128 et la goupille à positionnement radial externe 130 sont coaxiaux et orientés dans une direction radiale relative à la bride annulaire 30. Plus exactement, selon cette réalisation, ces différents éléments s'étendent selon une direction sensiblement radiale, orientée vers l'axe géométrique de révolution R. Toutefois, selon une réalisation alternative, lesdits logements traversant 124, logement borgne 126, goupille à positionnement radial interne 128 et goupille à positionnement radial externe 130 pourraient également être orientés dans une direction légèrement inclinée et formant un angle α par rapport par rapport à une direction radiale relative à la bride annulaire 30.The through housing 124, the blind housing 126, the pin with internal radial positioning 128 and the pin with external radial positioning 130 are coaxial and oriented in a radial direction relative to the annular flange 30. More exactly, according to this embodiment, these various elements extend in a substantially radial direction, oriented towards the geometric axis of revolution R. However, according to an alternative embodiment, said through housing 124, blind housing 126, internal radial positioning pin 128 and external radial positioning pin 130 could also be oriented in a slightly inclined direction and forming an angle α with respect to a radial direction relative to the annular flange 30.

D'autre part, le logement borgne 126 peut affleurer le logement traversant 124 mais il pourrait également être envisagé de formé un espace intermédiaire entre le logement borgne 126 et le logement traversant 124 sans que cela nuise au confinement et à la manipulation du conteneur 20.On the other hand, the blind housing 126 can be flush with the through housing 124 but it could also be envisaged to form an intermediate space between the blind housing 126 and the through housing 124 without this affecting the containment and handling of the container 20.

Lorsque le conteneur 20 se trouve dans la position de verrouillage initial, comme illustré par la figure 5a, la goupille à positionnement radial interne 128 présente une portion fonctionnelle interne de verrouillage initial 128INT agencée dans le logement borgne 126 du couvercle amovible 28 et une portion fonctionnelle externe de verrouillage initial 128EXT agencée dans le logement traversant 124 de la bride annulaire 30. Ainsi, la goupille à positionnement radial interne 128 interdit le déplacement relatif du couvercle amovible 28 vis-à-vis de la bride annulaire 30.When the container 20 is in the initial locking position, as illustrated by the figure 5a , the pin with internal radial positioning 128 has an internal functional portion of initial locking 128 INT arranged in the blind housing 126 of the removable cover 28 and an external functional portion of initial locking 128 EXT arranged in the through housing 124 of the annular flange 30. Thus, the pin with internal radial positioning 128 prevents the relative movement of the removable cover 28 vis-à-vis the annular flange 30.

Par ailleurs, dans cette même position de verrouillage initiale, la goupille à positionnement radial externe 130 est au moins partiellement agencée dans le logement traversant 124 de la bride annulaire 30. Selon le mode de réalisation représenté sur la figure 5a, la goupille à positionnement radial externe 130 peut alors présenter une partie extrême fonctionnelle à positionnement radial externe 130ext exclue du logement traversant 124. L'accès à cette partie extrême fonctionnelle 130ext par les moyens stationnaires de déverrouillage 60 ou de verrouillage 70 est ainsi facilité.Moreover, in this same initial locking position, the pin with external radial positioning 130 is at least partially arranged in the through housing 124 of the annular flange 30. According to the embodiment shown in the figure 5a , the pin with external radial positioning 130 can then have a functional end part with external radial positioning 130ext excluded from the through housing 124. Access to this functional end part 130ext by the stationary unlocking 60 or locking 70 means is thus facilitated.

Lors que le conteneur 20 se trouve en position de verrouillage initial, la partie extrême fonctionnelle à positionnement radial externe 130ext de la goupille à positionnement radial externe 130 vient en appui contre les moyens stationnaires de blocage/déblocage, de sorte à les faire passer dans une position de déblocage autorisant une rotation de la couronne fonctionnelle annulaire 42.When the container 20 is in the initial locking position, the outer radially positioned functional end part 130ext of the outer radially positioned pin 130 bears against the stationary locking/unlocking means, so as to cause them to pass through a unlocking position allowing rotation of the annular functional crown 42.

Plus précisément, la partie extrême fonctionnelle à positionnement radial externe 130ext de la goupille à positionnement radial externe 130 vient en appui contre le doigt 82 qui est alors déplacé à l'encontre de la sollicitation du ressort 86, jusqu'à ne plus dépasser hors du dispositif de jonction 40.More precisely, the functional end part with external radial positioning 130ext of the pin with external radial positioning 130 bears against the finger 82 which is then moved against the bias of the spring 86, until it no longer protrudes out of the junction device 40.

Le conteneur est alors autorisé à passer dans la position de déverrouillage intermédiaire, le doigt 82 des moyens stationnaires de blocage/déblocage 80 n'empêchant plus le déplacement des moyens stationnaires de déverrouillage 60.The container is then authorized to pass into the intermediate unlocking position, the finger 82 of the stationary locking/unlocking means 80 no longer preventing the movement of the stationary unlocking means 60.

Lorsque le conteneur 20 se trouve dans la position de déverrouillage intermédiaire, comme illustré par la figure 5b, la goupille à positionnement radial interne 128 est au moins partiellement agencée dans le logement borgne 126 du couvercle amovible 28 et entièrement exclue du logement traversant 124 de la bride annulaire 30. De cette façon, cette goupille à positionnement radial interne 128 n'interdit plus le déplacement relatif du couvercle amovible 28 vis-à-vis de la bride annulaire 30.When the container 20 is in the intermediate unlocking position, as illustrated by the figure 5b , the internal radial positioning pin 128 is at least partially arranged in the blind housing 126 of the removable cover 28 and entirely excluded from the through housing 124 of the annular flange 30. In this way, this internal radial positioning pin 128 no longer prohibits the relative movement of the removable cover 28 vis-à-vis the annular flange 30.

Dans cette position de déverrouillage intermédiaire, toujours, la goupille à positionnement radial externe 130 est au moins partiellement agencée dans le logement traversant 124 de la bride annulaire 30 et entièrement exclue du logement borgne 126 du couvercle amovible 28. De cette façon, la goupille à positionnement radial externe 130 n'a pas plus d'influence que la goupille à positionnement radial interne 128 sur le déplacement relatif du couvercle amovible 28 vis-à-vis de la bride annulaire 30 qui peuvent donc librement être désolidarisé pour autoriser le transfert aseptique des produits biopharmaceutiques.In this intermediate unlocking position, still, the pin with external radial positioning 130 is at least partially arranged in the through housing 124 of the annular flange 30 and entirely excluded from the blind housing 126 of the removable cover 28. In this way, the pin with external radial positioning 130 has no more influence than the internal radial positioning pin 128 on the relative movement of the removable cover 28 vis-à-vis the annular flange 30 which can therefore be freely separated to allow the aseptic transfer of the biopharmaceuticals.

Enfin, pour placer le conteneur 20 dans la position de verrouillage final, comme illustré par la figure 5c, il convient en premier lieu de replacer le couvercle amovible 28 contre la bride annulaire 30 puis de placer l'agencement fonctionnel embarqué de verrouillage/déverrouillage 122 dans la position appropriée.Finally, to place the container 20 in the final locking position, as illustrated by the figure 5c , it is first necessary to replace the removable cover 28 against the annular flange 30 and then to place the on-board functional locking/unlocking arrangement 122 in the appropriate position.

Plus particulièrement, dans cette position la goupille à positionnement radial interne 128 est entièrement agencée à l'intérieur du logement borgne 126 du couvercle amovible 28 tandis que la goupille à positionnement radial externe 130 présente une portion fonctionnelle interne de verrouillage final 130INT agencée dans le logement borgne 126 du couvercle amovible 28 et une portion fonctionnelle externe de verrouillage final 130EXT agencée dans le logement traversant 124 de la bride annulaire 30. Par conséquent, le logement borgne 126 du couvercle amovible 28 présente une longueur suffisante pour accueillir, d'une part, la goupille à positionnement radial interne 128 et d'autre part, la portion fonctionnelle interne de verrouillage final 130INT. Ainsi, la goupille à positionnement radial externe 130 interdit le déplacement relatif du couvercle amovible 28 vis-à-vis de la bride annulaire 30.More particularly, in this position the pin with internal radial positioning 128 is entirely arranged inside the blind housing 126 of the removable cover 28 while the pin with external radial positioning 130 has an internal functional portion of final locking 130 INT arranged in the blind housing 126 of the removable cover 28 and an external functional final locking portion 130 EXT arranged in the through housing 124 of the annular flange 30. Consequently, the blind housing 126 of the removable cover 28 has a sufficient length to accommodate, from a on the one hand, the pin with internal radial positioning 128 and on the other hand, the internal functional portion of final locking 130 INT . Thus, the pin with external radial positioning 130 prevents the relative movement of the removable cover 28 vis-à-vis the annular flange 30.

Une telle utilisation des goupilles à positionnement radial interne 128 et externe 130 pour placer le conteneur en position de verrouillage initial, de déverrouillage intermédiaire et de verrouillage final permet de n'avoir qu'un logement borgne 126 et un logement traversant 124 à réaliser dans le couvercle amovible 28 et la bride annulaire 30 par agencement fonctionnel embarqué de verrouillage/déverrouillage 122, ce qui limite les risques de contamination lié aux éventuels défauts de production. En outre, la manipulation des moyens de verrouillage/déverrouillage 120 est facilitée dans la mesure où il suffit de déplacer les goupilles à positionnement radial interne 128 et externe 130 dans une seule et unique direction et un seul et même sens pour faire passer le conteneur 20 successivement de la position de verrouillage initial à la position de déverrouillage intermédiaire, puis à la position de verrouillage final. La réalisation et le fonctionnement du dispositif de jonction étanche en sont ainsi simplifiés.Such use of internal 128 and external 130 radial positioning pins to place the container in the position of initial locking, intermediate unlocking and final locking makes it possible to have only one blind housing 126 and one through housing 124 to be made in the removable cover 28 and the annular flange 30 by on-board functional locking/unlocking arrangement 122, which limits the risks of contamination linked to possible production defects. In addition, the manipulation of the locking/unlocking means 120 is facilitated insofar as it suffices to move the pins with internal 128 and external 130 radial positioning in a single and unique direction and a single and same direction to pass the container 20 successively from the initial locking position to the intermediate unlocking position, then to the final locking position. The production and operation of the sealed junction device are thus simplified.

De plus, une fois que la partie extrême fonctionnelle à positionnement radial externe 130ext est insérée dans le logement traversant 124, à la position de verrouillage final, il devient impossible d'ouvrir la porte de l'enceinte 10 avec un conteneur 20 déjà utilisé. Le risque de contamination est donc ainsi fortement diminué.Moreover, once the functional end part with external radial positioning 130ext is inserted into the through housing 124, at the final locking position, it becomes impossible to open the door of the enclosure 10 with a container 20 that has already been used. The risk of contamination is therefore greatly reduced.

Il convient également de noter que dans la réalisation des figures 5a à 5c, les goupilles à positionnement radial interne 128 et externe 130 présentent des longueurs identiques, ce qui permet notamment de simplifier la production et l'assemblage des goupilles à positionnement radial interne 128 et externe 130 sur le conteneur puisqu'il n'est alors pas nécessaire de distinguer les goupilles eu égard à leur dimensions respectives. Toutefois, de manière alternative, ces goupilles à positionnement radial interne 128 et externe 130 pourraient également présenter des longueurs différentes.It should also be noted that in carrying out the figures 5a to 5c , the internal 128 and external 130 radial positioning pins have identical lengths, which in particular makes it possible to simplify the production and assembly of the internal 128 and external 130 radial positioning pins on the container since it is then not necessary to distinguish the pins with regard to their respective dimensions. However, alternatively, these pins with internal 128 and external 130 radial positioning could also have different lengths.

Il convient en outre de souligner que le logement traversant 124 et la goupille à positionnement radial externe 130 présentent des longueurs telles que, lorsque les moyens embarqués de verrouillage/déverrouillage 110 sont dans la position de déverrouillage provisoire, la goupille à positionnement radial externe 130 présente une partie extrême fonctionnelle 130ext à positionnement radial externe exclue du logement traversant 124. Ce positionnement facilite, notamment, l'opération effectuée par les moyens stationnaires de verrouillage 70 pour faire passer le conteneur 20 de la position de déverrouillage intermédiaire à la position de verrouillage final puisque la goupille à positionnement radial externe 130 est accessible sans que l'élément poussoir à déplacement radial 78 n'ait à se déplacer jusqu'à l'intérieur du logement traversant 124.It should also be emphasized that the through housing 124 and the pin with external radial positioning 130 have lengths such that, when the on-board locking/unlocking means 110 are in the provisional unlocking position, the pin with external radial positioning 130 has a functional end part 130ext with external radial positioning excluded from the through housing 124. This positioning facilitates, in particular, the operation performed by the stationary locking means 70 to move the container 20 from the intermediate unlocking position to the final locking position since the outer radial positioning pin 130 is accessible without the radial displacement pusher element 78 having to move into the interior of the through housing 124.

En revanche, les longueurs de la goupille à positionnement radial externe 130 et du logement traversant 124 sont telles que, lorsque les moyens embarqués de verrouillage/déverrouillage 120 sont dans la position de verrouillage final, ladite goupille à positionnement radial externe 130 présente une partie extrême fonctionnelle 130ext à positionnement radial externe logée à l'intérieure du logement traversant. De cette façon, lorsque le conteneur est placé en position de verrouillage final, la préhension de la goupille à positionnement radial externe 130 est rendu complexe et irréalisable sans un outil de préhension adapté. Cela permet ainsi d'élever le niveau de sécurité se rapportant à l'étanchéité du conteneur 20 en position de verrouillage final.On the other hand, the lengths of the pin with external radial positioning 130 and of the through housing 124 are such that, when the on-board locking/unlocking means 120 are in the final locking position, said pin with external radial positioning 130 has an end part functional 130ext with external radial positioning housed inside the through housing. In this way, when the container is placed in the final locking position, gripping the pin with external radial positioning 130 is made complex and impracticable without a suitable gripping tool. This thus makes it possible to raise the level of security relating to the tightness of the container 20 in the final locking position.

Selon une réalisation, les moyens embarqués de blocage/déblocage 140 et les moyens embarqués de verrouillage/déverrouillage 120 sont structurellement confondus.According to one embodiment, the on-board locking/unlocking means 140 and the on-board locking/unlocking means 120 are structurally coincident.

Selon la réalisation des figures 3a et 3b, le conteneur 20 comporte également des moyens embarqués de cloisonnement et de protection 134.According to the realization of figures 3a and 3b , the container 20 also includes on-board partitioning and protection means 134.

Les moyens embarqués de cloisonnement et de protection 134 sont agencés sur une portion périphérique externe de la bride annulaire 30 de manière à empêcher la manipulation inopinée des moyens embarqués de verrouillage/déverrouillage portés par la bride annulaire 30.The on-board partitioning and protection means 134 are arranged on an outer peripheral portion of the annular flange 30 so as to prevent inadvertent manipulation of the on-board locking/unlocking means carried by the annular flange 30.

Les moyens embarqués de cloisonnement et de protection 134 sont par exemple des enceintes, encadrant au moins en partie ou complètement les logements traversant 124 de manière à faire obstacle à la manipulation inopinée ou volontaire de la goupille à positionnement radial externe 130 lorsque cette dernière n'est pas entièrement insérée dans le logement traversant 128 de la bride annulaire 30. Il y a autant de moyens embarqués de cloisonnement et de protection 134 que de moyens embarqués de verrouillage/déverrouillage 120 et/ou des moyens embarqués de blocage/déblocage 140.The on-board partitioning and protection means 134 are, for example, enclosures, at least partially or completely framing the through housings 124 so as to obstruct unexpected or intentional manipulation of the pin with external radial positioning 130 when the latter does not is not fully inserted into the through housing 128 of the annular flange 30. There are as many on-board partitioning and protection means 134 as there are on-board locking/unlocking means 120 and/or on-board locking/unlocking means 140.

La mise en œuvre du procédé de transfert aseptique selon l'invention est maintenant décrite en détail.The implementation of the aseptic transfer method according to the invention is now described in detail.

Ce procédé de transfert aseptique consiste, en premier lieu, à disposer d'une enceinte 10 close telle que décrite précédemment et supportant un dispositif de jonction étanche 40 selon l'invention. Ce procédé de transfert aseptique consiste, en deuxième lieu, à disposer d'un conteneur 20 en position de verrouillage initial tel que décrit précédemment.This aseptic transfer process consists, firstly, in having a closed enclosure 10 as described above and supporting a sealed junction device 40 according to the invention. This transfer process secondly, to have a container 20 in the initial locking position as described above.

Le procédé de transfert aseptique implique ensuite de mettre en place le conteneur 20 contre la paroi périphérique 12 de l'enceinte 10 de telle sorte que les goupilles appartenant aux moyens embarqués de verrouillage/déverrouillage sont face aux moyens stationnaires de blocage/déblocage 80.The aseptic transfer process then involves positioning the container 20 against the peripheral wall 12 of the enclosure 10 so that the pins belonging to the on-board locking/unlocking means face the stationary locking/unlocking means 80.

Ce faisant, la bride annulaire 30 du conteneur 20 vient se positionner contre la paroi périphérique 12 de l'enceinte 10 et le couvercle amovible 28 - par exemple formé d'inox magnétisé - est maintenu hermétiquement en position contre la face extérieure de la porte amovible 18 - au moins partiellement aimantée.In doing so, the annular flange 30 of the container 20 is positioned against the peripheral wall 12 of the enclosure 10 and the removable cover 28 - for example formed of magnetized stainless steel - is hermetically held in position against the outer face of the removable door. 18 - at least partially magnetized.

Simultanément à cette opération, les moyens embarqués de blocage/déblocage 140 viennent en appui contre les moyens stationnaires de blocage/déblocage 80 de manière à autoriser la rotation de la couronne fonctionnelle annulaire 42.Simultaneously with this operation, the on-board locking/unlocking means 140 bear against the stationary locking/unlocking means 80 so as to allow rotation of the annular functional crown 42.

Selon une première réalisation, le procédé de transfert aseptique consiste ensuite à générer la rotation de la couronne fonctionnelle annulaire 42 afin d'actionner les moyens stationnaires de bridage temporaire 50. Plus précisément, les éléments de bridage 52 effectuent une rotation autour de leur axe de rotation de manière à maintenir le conteneur 20 contre l'enceinte 10.According to a first embodiment, the aseptic transfer process then consists in generating the rotation of the annular functional crown 42 in order to actuate the stationary temporary clamping means 50. More precisely, the clamping elements 52 perform a rotation around their axis of rotation so as to hold the container 20 against the enclosure 10.

Selon une deuxième réalisation, les moyens stationnaires de bridage 50 sont actionnés par la rotation de la couronne de protection 41. Plus précisément, un utilisateur actionne par exemple manuellement une manette 43 mettant alors en rotation la couronne de protection 41. Les éléments de bridage 52 effectuent alors une rotation autour de leur axe de rotation de manière à maintenir le conteneur 20 contre l'enceinte 10.According to a second embodiment, the stationary clamping means 50 are actuated by the rotation of the protection crown 41. More precisely, a user for example manually actuates a handle 43 then rotating the protection crown 41. The clamping elements 52 then perform a rotation around their axis of rotation so as to hold the container 20 against the enclosure 10.

Puis, la rotation de la couronne fonctionnelle annulaire 42 permet d'actionner les moyens stationnaires de déverrouillage 60. Plus particulièrement, les portions de couronne fonctionnelle formant engrenage entraînent le déplacement des éléments poussoir 62 des moyens stationnaires de déverrouillage 60. A mesure du déplacement, les éléments poussoir 62 viennent en appui contre les goupilles 128, 130, les déplaçant également radialement dans les logements traversant et borgne 124, 126.Then, the rotation of the annular functional crown 42 makes it possible to actuate the stationary unlocking means 60. More particularly, the functional crown portions forming a gear cause the movement of the pusher elements 62 of the stationary unlocking means 60. As the movement progresses, the pusher elements 62 bear against the pins 128, 130, also displacing them radially in the through and blind housings 124, 126.

À l'issue de cette opération, la goupille à positionnement radial interne 128 est alors agencée dans le logement borgne 126 du couvercle amovible 28 et entièrement exclue du logement traversant 124 de la bride annulaire 30 et la goupille à positionnement radial externe 130 est agencée dans le logement traversant 124 de la bride annulaire 30 et entièrement exclue du logement borgne 126 du couvercle amovible 28. De ce fait, le conteneur 20 est en position de déverrouillage intermédiaire et le déplacement le relatif du couvercle amovible 28 vis-à-vis de la bride annulaire 30 est possible.At the end of this operation, the pin with internal radial positioning 128 is then arranged in the blind housing 126 of the removable cover 28 and entirely excluded from the through housing 124 of the annular flange 30 and the pin with external radial positioning 130 is arranged in the through housing 124 of the annular flange 30 and entirely excluded from the blind housing 126 of the removable cover 28. As a result, the container 20 is in the intermediate unlocking position and the relative movement of the removable cover 28 vis-à-vis the annular flange 30 is possible.

Le procédé de transfert aseptique consiste également, simultanément ou successivement à l'étape qui précède, à générer la rotation de la couronne fonctionnelle annulaire 42 afin d'actionner les moyens stationnaires d'ouverture 90 pour libérer la porte amovible 18 de l'enceinte 10.The aseptic transfer process also consists, simultaneously or successively in the preceding step, in generating the rotation of the annular functional crown 42 in order to actuate the stationary opening means 90 to release the removable door 18 from the enclosure 10 .

À cet effet, la rotation des moyens de déverrouillage 60 entraîne la mise en rotation de la tige fonctionnelle 92 des moyens stationnaires d'ouverture 90, et donc du corps 94, pour que ce dernier ne recouvre plus la face extérieure de la porte amovible 18 de l'enceinte 10. La porte amovible 18 peut alors être manipulée librement.To this end, the rotation of the unlocking means 60 causes the rotation of the functional rod 92 of the stationary opening means 90, and therefore of the body 94, so that the latter no longer covers the outer face of the removable door 18 of the enclosure 10. The removable door 18 can then be manipulated freely.

Le procédé de transfert aseptique consiste alors à entraîner les moyens stationnaires de manoeuvre 100 pour déplacer la porte amovible 18 de l'enceinte 10 et le couvercle amovible du conteneur afin de libérer les ouvertures annulaires 16, 26 de l'enceinte 10 et du conteneur 20.The aseptic transfer process then consists in driving the stationary maneuvering means 100 to move the removable door 18 of the enclosure 10 and the removable lid of the container in order to release the annular openings 16, 26 of the enclosure 10 and of the container 20 .

Pour ce faire, les moyens stationnaires de manœuvre 100 - qui peuvent être actionnés par la couronne fonctionnelle annulaire 42 ou bien par un moteur de manœuvre asservis sur la position de cette couronne fonctionnelle annulaire 42 - entraînent en rotation autour d'un axe de rotation d'une charnière, ensuite, la porte amovible 18 de l'enceinte 10.To do this, the stationary operating means 100 - which can be actuated by the annular functional crown 42 or else by an operating motor slaved to the position of this annular functional crown 42 - rotate around an axis of rotation d a hinge, then the removable door 18 of the enclosure 10.

Le conteneur 20 étant en position de déverrouillage intermédiaire, le couvercle amovible 28 est capable de se déplacer vis-à-vis de la bride annulaire 30 et de suivre les mouvements de la porte amovible 18 de l'enceinte 10 du fait de la force magnétique les reliant l'une à l'autre. Ainsi, l'enceinte 10 et le conteneur 20 sont-ils ouverts l'un sur l'autre tout en étant hermétiquement isolé du milieu extérieur.The container 20 being in the intermediate unlocking position, the removable cover 28 is able to move vis-à-vis the annular flange 30 and to follow the movements of the removable door 18 of the enclosure 10 due to the magnetic force. connecting them to each other. Thus, the enclosure 10 and the container 20 are open to each other while being hermetically isolated from the outside environment.

Le transfert aseptique des produits biopharmaceutique entre le conteneur 20 et l'enceinte 10 peut alors s'opérer.The aseptic transfer of the biopharmaceutical products between the container 20 and the enclosure 10 can then take place.

Le procédé de transfert aseptique consiste ensuite à entraîner à nouveau les moyens stationnaires de manœuvre 100 afin de refermer de façon hermétique les ouvertures annulaires 16, 26 de l'enceinte 10 et du conteneur 20.The aseptic transfer process then consists in driving the stationary maneuvering means 100 again in order to hermetically close the annular openings 16, 26 of the enclosure 10 and of the container 20.

Comme précédemment, les moyens stationnaires de manœuvre 100 entraînent alors en rotation, autour d'un axe de rotation d'une charnière, la porte amovible 18 de l'enceinte 10 ainsi que le couvercle amovible du conteneur 20 pour les remettre dans la même position que précédemment.As before, the stationary maneuvering means 100 then drive in rotation, around an axis of rotation of a hinge, the removable door 18 of the enclosure 10 as well as the removable lid of the container 20 to return them to the same position. than previously.

L'enceinte 10 est alors à nouveau obturée hermétiquement par la porte amovible 18, tant vis-à-vis de l'extérieur que du conteneur 10. Et, de façon symétrique, le conteneur 20 est obturé hermétiquement par le couvercle amovible, tant vis-à-vis de l'extérieur que de l'enceinte 10.The enclosure 10 is then again hermetically closed by the removable door 18, both vis-à-vis the outside and the container 10. And, symmetrically, the container 20 is closed hermetically by the removable cover, both -à-vis the outside than the enclosure 10.

Le procédé de transfert aseptique consiste alors à générer la rotation de la couronne fonctionnelle annulaire 42 afin d'actionner les moyens stationnaires d'ouverture 90 pour bloquer la porte amovible 18 de l'enceinte 10.The aseptic transfer process then consists in generating the rotation of the annular functional crown 42 in order to actuate the stationary opening means 90 to block the removable door 18 of the enclosure 10.

À cet effet, la rotation des moyens de déverrouillage 60 entraîne la mise en rotation de la tige fonctionnelle 92 des moyens stationnaires d'ouverture 90, et donc du corps 94, pour que ce dernier recouvre à nouveau la face extérieure de la porte amovible 18 de l'enceinte 10. La porte amovible 18 peut alors être manipulée librement.To this end, the rotation of the unlocking means 60 causes the rotation of the functional rod 92 of the stationary opening means 90, and therefore of the body 94, so that the latter again covers the outer face of the removable door 18 of the enclosure 10. The removable door 18 can then be manipulated freely.

Le procédé de transfert aseptique consiste, simultanément ou bien successivement à l'étape précédent à générer la rotation de la couronne fonctionnelle annulaire 42 afin d'actionner l'actionnement des moyens stationnaires de verrouillage 70. Plus particulièrement, les portions de couronne fonctionnelle formant engrenage entraînent le déplacement des éléments poussoir 72 des moyens stationnaires de verrouillage 70. A mesure du déplacement, les éléments poussoir 72 viennent en appui contre les goupilles 128, 130, les déplaçant également radialement dans les logements traversant et borgne 124, 126.The aseptic transfer process consists, simultaneously or else successively to the previous step, in generating the rotation of the annular functional crown 42 in order to actuate the actuation of the stationary locking means 70. More particularly, the functional crown portions forming a gear cause the movement of the pusher elements 72 of the stationary locking means 70. As the movement progresses, the pusher elements 72 bear against the pins 128, 130, also moving them radially in the through and blind housings 124, 126.

À l'issue de cette opération, la goupille à positionnement radial interne 128 est agencée dans le logement borgne 126 du couvercle amovible 28 tandis que la goupille à positionnement radial externe 130 présente une portion fonctionnelle interne de verrouillage final 130INT agencée dans le logement borgne 126 du couvercle amovible 28 et une portion fonctionnelle externe de verrouillage final 130EXT agencée dans le logement traversant 124 de la bride annulaire 30. Ainsi le déplacement relatif du couvercle amovible 28 vis-à-vis de la bride annulaire 30 est impossible et le conteneur est alors en position de verrouillage final.At the end of this operation, the pin with internal radial positioning 128 is arranged in the blind housing 126 of the removable cover 28 while the pin with external radial positioning 130 has an internal functional portion of final locking 130 INT arranged in the blind housing 126 of the removable cover 28 and an external functional final locking portion 130 EXT arranged in the through housing 124 of the annular flange 30. Thus the relative movement of the removable cover 28 vis-à-vis the annular flange 30 is impossible and the container is then in the final locking position.

Le procédé de transfert aseptique consiste dès lors à générer la rotation de la couronne fonctionnelle annulaire 42 afin que les éléments de bridage temporaire 52 retournent à leur position initiale dans laquelle le conteneur 20 peut être désolidarisé de l'enceinte 10.The aseptic transfer process therefore consists in generating the rotation of the annular functional crown 42 so that the temporary clamping elements 52 return to their initial position in which the container 20 can be separated from the enclosure 10.

Selon une deuxième réalisation, les moyens stationnaires de bridage 50 sont actionnés par la rotation de la couronne de protection 41. Plus précisément, un utilisateur actionne par exemple manuellement une manette 43 mettant alors en rotation la couronne de protection 41. Les éléments de bridage 52 effectuent alors une rotation autour de leur axe de rotation de manière à retourner à leur position initiale dans laquelle le conteneur 20 peut être désolidarisé de l'enceinte 10.According to a second embodiment, the stationary clamping means 50 are actuated by the rotation of the protection crown 41. More precisely, a user for example manually actuates a handle 43 then rotating the protection crown 41. The clamping elements 52 then perform a rotation around their axis of rotation so as to return to their initial position in which the container 20 can be detached from the enclosure 10.

Le conteneur 20 en position de verrouillage finale peut ainsi être librement retiré du dispositif de jonction étanche 40. Les moyens de blocage/déblocage passent alors dans une position dans laquelle la rotation de la couronne fonctionnelle annulaire 42 n'est pas autorisée, de manière à empêcher l'ouverture du dispositif de jonction étanche sans qu'un conteneur non utilisé n'y soit solidarisé.The container 20 in the final locked position can thus be freely withdrawn from the sealing device 40. The locking/unlocking means then pass into a position in which the rotation of the annular functional crown 42 is not authorized, so as to preventing the sealing device from being opened without an unused container being attached thereto.

Claims (15)

  1. A sealed junction device (40), supported by a peripheral wall (12) of an enclosure (10), intended to ensure the aseptic transfer of a biopharmaceutical product between said enclosure (10) provided with a removable door (18) and a container (20) provided with a removable cover, comprising:
    - stationary temporary clamping means (50) able to hold the container (20) clamped against the enclosure (10) so that the removable cover (28) of said container (20) is hermetically applied against the removable door (18) of said enclosure (10);
    - stationary unlocking means (60) able to switch the container (20) from an initial locking position in which the removable cover (28) hermetically seals the container (20) to an intermediate unlocking position in which the removable cover (28) is separated from the container (20) and held hermetically against the removable door (18) of the enclosure (10) so as to ensure aseptic communication between said container (20) and said enclosure (10);
    - stationary locking means (70) able to switch the container (20) from the intermediate unlocking position to a final locking position in which said removable cover (28) again hermetically seals the container (20);
    - an annular functional ring (42) able to move by rotation about a geometric axis of rotation (R) so as to actuate the stationary means for unlocking (60) and the stationary means for locking (70) the container (20), said stationary unlocking means (60) and said stationary locking means (70) being mechanically linked to the annular functional ring (42) and arranged so that the rotation of said annular functional ring (42) about the geometric axis of rotation (R) successively causes the actuation of the stationary unlocking means (60) ensuring the switching to the intermediate unlocking position of the container (20), then the actuation of the stationary locking means (70) ensuring the switching to the final locking position of the container (20), the stationary temporary clamping means (50) being actuated prior to the stationary unlocking means (60),
    the device further comprising stationary blocking/unblocking means (80) able to prevent the rotation of the annular functional ring (42) when the stationary blocking/unblocking means (80) are in a blocking position, and able to authorize a rotation of the annular functional ring (42) when the stationary blocking/unblocking means (80) are in an unblocking position,
    wherein the actuation of the stationary unlocking means (60) is only subsequent to the actuation of the stationary blocking/unblocking means (80) due to the relative position of the stationary blocking/unblocking means (80) and to the stationary unlocking means (60) around the annular functional ring (42),
    characterized in that the stationary blocking/unblocking means (80) are able to switch from a blocking position to an unblocking position, by means of embedded blocking/unblocking means (140) arranged on the container (20), when the container (20) is held clamped against the enclosure (10).
  2. The device (40) according to claim 1, further comprising stationary opening/closing means (90) able to prevent/authorize the opening of the removable door (18) of the enclosure (10) and mechanically linked to the annular functional ring (42) so that the rotation of the annular functional ring (42) about the geometric axis of rotation successively or simultaneously causes the actuation of the stationary unlocking means (60) ensuring the switching to the intermediate unlocking position of the container (20) and the actuation of the stationary opening/closing means (90) ensuring the unblocking of the removable door (18) of the enclosure (10), then the actuation of the stationary means for locking (70) the container (20) ensuring the switching to the final locking position of the container (20), and simultaneously or successively the actuation of the stationary opening/closing means (90) ensuring the blocking of the removable door (18) of the enclosure (10).
  3. The device (40) according to any of claims 1 and 2, wherein the stationary unlocking means (60) comprise an unlocking pusher element (62) with rotary displacement and an unlocking member (64) capable of being meshed by a portion of the annular functional ring (42) forming a gear so that, during the rotation of the annular functional ring (42) up to an intermediate unlocking position, the pusher element (62) moves and switches the container (20) from the initial locking position to the intermediate unlocking position.
  4. The device (40) according to claim 3, wherein the stationary blocking/unblocking means (80) are able to prevent the rotation of the pusher element (62) of the stationary unlocking means (60), so that the container (20) is not authorized to switch from the initial locking position to the intermediate unlocking position.
  5. The device according to claims 2 and 4, wherein the stationary opening/closing means (90) are directly mechanically connected to the unlocking pusher element (62).
  6. The device according to claims 1 to 5, wherein the stationary locking means (70) comprise a locking pusher element (72) with rotary displacement and a locking member (74) capable of being meshed by a portion of the annular functional ring (42) forming a gear so that, upon rotation of the annular functional ring (42) up to a final locking position, the pusher element (72) moves and switches the container (20) from the intermediate unlocking position to the final locking position.
  7. The device (40) according to any of claims 1 to 6, wherein the stationary blocking/unblocking means (80) comprise a finger (82), movably mounted in a channel (84) extending in a direction transverse to a direction parallel to the geometric axis of rotation (R), the finger (82) being able to be biased by a spring (86) towards a deployed position in which the finger (82) protrudes outside the sealed junction device (40), the stationary blocking/unblocking means (80) being in a blocking position, and towards a retracted position in which the finger (82) does not protrude outside the sealed junction device (40), the stationary blocking/unblocking means (80) then being in an unblocking position.
  8. The device (40) according to any of claims 1 to 7, wherein the stationary temporary clamping means (50) comprise a clamping element (52) able to rotate about a clamping axis of rotation, so that, upon rotation of the annular functional ring (42) up to an initial locking position, the clamping element (52) moves and hermetically holds the container (20) against the removable door (18) of the enclosure (10).
  9. The device (40) according to any of claims 1 to 7, wherein the stationary temporary clamping means (50) comprise a clamping element (52) able to rotate about a clamping axis of rotation, so that, upon activation of a handle (43) causing a rotation of a protective ring (41) of the annular functional ring (42), the clamping element (52) moves and hermetically holds the container (20) against the removable door (18) of the enclosure (10).
  10. The device (40) according to any of claims 1 to 9, further comprising stationary means for maneuvering (100) the removable door (18) of the enclosure (10) able to open and hermetically close the removable door (18) of the enclosure (10) .
  11. The device (40) according to claim 10, wherein the stationary means for maneuvering (100) the removable door (18) of the enclosure (10) are able to move the removable door (18) of the enclosure (10) along a rotary movement about a hinge axis, so that the door does not impede the passage of the biopharmaceutical product.
  12. The device (40) according to any of claims 1 to 11, wherein the stationary locking means (70) and the stationary unlocking means (60) are structurally coincident.
  13. An assembly comprising an enclosure (10) and a sealed junction device (40) especially intended to be associated with a single-use container (20) provided with a removable cover (28) in order to carry out the aseptic transfer of a biopharmaceutical product between the enclosure (10) and the container (20), wherein the enclosure (10) comprises a closed peripheral wall (44) in which an annular opening (26) hermetically sealed by a removable door (18) is arranged and wherein the sealed junction device (40) is made according to any of claims 1 to 12, the assembly further comprising a single-use container (20) provided with a removable cover (28).
  14. The assembly according to claim 13, wherein the single-use container (20) is especially intended to ensure the transport and the aseptic transfer of a product belonging to the biopharmaceutical field and comprises:
    - an annular clamp (30) delimiting an annular opening (26) ;
    - a removable cover (28) able to hermetically seal the opening of the annular clamp (30);
    - embedded means for blocking/unblocking (140) the annular functional ring (42);
    - embedded means for locking/unlocking (120) the removable cover (28) on the annular clamp (30); and
    - a peripheral envelope secured to the annular clamp (30) and delimiting a confined interior space (24) able to receive the products belonging to the biopharmaceutical field;
    wherein the embedded blocking/unblocking means (140) comprise at least one embedded functional blocking/unblocking arrangement (142) formed, on the one hand, by a through housing (144) formed in the annular clamp (30) and a blind housing (146) formed in the removable cover (28) and in the extension of the through housing (144) when the removable cover (28) hermetically seals the opening of the annular clamp (30) and, on the other hand, by a radially inward positioned pin (148) and a radially outward positioned pin (150) capable of being introduced and of moving inside the blind housing (146) of the removable cover (28) and of the through housing (144) of the annular clamp (30); and
    wherein the embedded locking/unlocking means (120) comprise at least one embedded functional locking/unlocking arrangement (122) formed, on the one hand, by a through housing (124) formed in the annular clamp (30) and a blind housing (126) formed in the removable cover (28) and in the extension of the through housing (124) when the removable cover (28) hermetically seals the opening of the annular clamp (30) and, on the other hand, by a radially inward positioned pin (128) and a radially outward positioned pin (130) capable of being introduced and of moving inside the blind housing (126) of the removable cover (28) and of the through housing (124) of the annular clamp (30);
    the container (20) being capable of being in an initial locking position in which, on the one hand, the radially inward positioned pin (128) has an inner functional locking portion arranged in the blind housing of the removable cover (28) and an outer functional locking portion arranged in the through housing of the annular clamp (30) so as to prevent the relative displacement of the removable cover (28) with respect to the annular clamp (30) and, on the other hand, the radially outward positioned pin is at least partially arranged in the through housing of the annular clamp (30), so that at least one outer functional portion (130ext) for initially locking the radially outward positioned pin (130) protrudes outside the through housing;
    the container (20) being capable of being in an intermediate unlocking position in which, on the one hand, the radially inward positioned pin (128) is at least partially arranged in the blind housing (126) of the removable cover (28) and entirely excluded from the through housing (124) of the annular clamp (30) and, on the other hand, the radially outward positioned pin (130) is at least partially arranged in the through housing of the annular clamp (30) and entirely excluded from the blind housing of the removable cover (28) so as to authorize the relative displacement of the removable cover (28) with respect to the annular clamp (30);
    the container (20) being capable of being in a final locking position in which, on the one hand, the radially inward positioned pin (128) is arranged in the blind housing (126) of the removable cover (28) and, on the other hand, the radially outward positioned pin (130) has a final inner functional locking portion arranged in the blind housing (126) of the removable cover (28) and a final outer functional locking portion (130ext) arranged in the through housing of the annular clamp (30) so as to prevent the relative displacement of the removable cover (28) with respect to the annular clamp (30).
  15. An aseptic transfer method intended to ensure the aseptic transfer of a biopharmaceutical product between a container (20) and an enclosure (10) belonging to an assembly according to any of claims 13 and 14, characterized in that it comprises the successive steps consisting of:
    - having the enclosure (10), the sealed junction device (40) and the container (20);
    - positioning the container (20) against the peripheral wall of the enclosure (10) by affixing the annular clamp (30) against the peripheral wall of the enclosure (10), so that the stationary blocking/unblocking means (80) and the embedded blocking/unblocking means (140) are facing each other;
    - generating the clamping of the annular clamp (30) of the container (20) with respect to the peripheral wall of the enclosure (10);
    - switching the stationary blocking/unblocking means (80) from a blocking position to an unblocking position;
    - generating the switching of the container (20) from the initial locking position to the intermediate unlocking position by rotation of the annular functional ring (42);
    - simultaneously opening the removable door (18) of the enclosure (10) and the removable cover (28) of the container (20), the removable cover (28) being hermetically fixed against the removable door (18);
    - aseptically transferring one or several biopharmaceutical product(s) between the container (20) and the enclosure (10);
    - simultaneously re-closing the removable door (18) of the enclosure (10) and the removable cover (28) of the container (20), the removable cover (28) being hermetically fixed against the removable door (18);
    - generating the switching of the container (20) from the intermediate unlocking position to the final locking position by rotation of the annular functional ring (42);
    - generating the unclamping of the annular clamp (30) of the container (20) with respect to the peripheral wall of the enclosure (10);
    - switching the stationary blocking/unblocking means (80) from an unblocking position to a blocking position.
EP18785692.7A 2017-10-03 2018-09-26 Tight connection device for the aseptic transfer of a biopharmaceutical product between a chamber and a container Active EP3691787B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1771042A FR3071725A1 (en) 2017-10-03 2017-10-03 SEALED JUNCTION DEVICE FOR ASEPTICALLY TRANSFERRING A BIOPHARMACEUTICAL PRODUCT BETWEEN AN ENCLOSURE AND A CONTAINER
PCT/FR2018/000223 WO2019068963A1 (en) 2017-10-03 2018-09-26 Tight connection device for the aseptic transfer of a biopharmaceutical product between a chamber and a container

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EP3691787A1 EP3691787A1 (en) 2020-08-12
EP3691787B1 true EP3691787B1 (en) 2022-03-16

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EP18785692.7A Active EP3691787B1 (en) 2017-10-03 2018-09-26 Tight connection device for the aseptic transfer of a biopharmaceutical product between a chamber and a container

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US (1) US11684913B2 (en)
EP (1) EP3691787B1 (en)
KR (1) KR102519531B1 (en)
CN (1) CN111182969B (en)
FR (1) FR3071725A1 (en)
WO (1) WO2019068963A1 (en)

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DE102019003317A1 (en) * 2019-05-10 2020-11-12 Atec Pharmatechnik Gmbh Device for the sterile transfer of goods between a container and an isolator

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2721289B1 (en) 1994-06-17 1996-08-30 Idc Isolateur Denominateur Sealed connection device between two enclosures isolated from an external environment.
FR2927464B1 (en) * 2008-02-12 2014-08-15 Jce Biotechnology SEALED CONNECTION DEVICE BETWEEN TWO ENCLOSURES
FR2978362B1 (en) 2011-07-29 2013-09-13 Sartorius Stedim Aseptics SEALED JUNCTION DEVICE FOR ASEPTICALLY TRANSFERRING A BIOPHARMACEUTICAL PRODUCT BETWEEN AN ENCLOSURE AND A CONTAINER.
FR3010118B1 (en) * 2013-09-03 2016-02-26 Getinge La Calhene SEALED SPEAKER HAVING AN OPENING AND CLOSING CONTROL MECHANISM FOR A SEALED CONNECTION DEVICE BETWEEN TWO CLOSED VOLUMES
US10088398B2 (en) * 2015-02-11 2018-10-02 Emd Millipore Corporation Stirred cell and method of using same
JP2018518351A (en) * 2015-03-02 2018-07-12 デラウェア・キャピタル・フォーメイション・インコーポレーテッドＤｅｌａｗａｒｅ Ｃａｐｉｔａｌ Ｆｏｒｍａｔｉｏｎ Ｉｎｃｏｒｐｏｒａｔｅｄ Customizable mounting interface for sealed transfer ports

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CN111182969B (en) 2022-09-23
WO2019068963A1 (en) 2019-04-11
CN111182969A (en) 2020-05-19
FR3071725A1 (en) 2019-04-05
US20200238273A1 (en) 2020-07-30
EP3691787A1 (en) 2020-08-12
KR102519531B1 (en) 2023-04-10
KR20200058538A (en) 2020-05-27
US11684913B2 (en) 2023-06-27

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