EP3691787A1

EP3691787A1 - Tight connection device for the aseptic transfer of a biopharmaceutical product between a chamber and a container

Info

Publication number: EP3691787A1
Application number: EP18785692.7A
Authority: EP
Inventors: Shuai Yl
Original assignee: Sartorius Stedim FMT SAS
Current assignee: Sartorius Stedim FMT SAS
Priority date: 2017-10-03
Filing date: 2018-09-26
Publication date: 2020-08-12
Anticipated expiration: 2038-09-26
Also published as: EP3691787B1; US20200238273A1; KR20200058538A; CN111182969A; US11684913B2; CN111182969B; WO2019068963A1; FR3071725A1; KR102519531B1

Abstract

A tight connection device (40) intended to ensure the aseptic transfer of a biopharmaceutical product between a chamber (10) provided with a removable door (18) and a container (20) provided with a removable cover, comprises: - stationary temporary clamping means (50) capable of keeping the container (20) clamped against the chamber (10) such that the removable cover (28) of the container (20) is hermetically pressed against the removable door (18) of the chamber (10); stationary unlocking means (60) capable of switching the container (20) from an initial locked position in which the removable cover (28) hermetically seals the container (20) to an intermediate unlocked position in which the removable cover (28) is disengaged from the container (20) and held hermetically against the removable door (18) of the chamber (10) so as to ensure aseptic communication between the container (20) and the chamber (10); stationary locking means (70) capable of switching the container (20) from the intermediate unlocked position to an end locked position in which the removable cover (28) hermetically seals the container (20) once more; an annular functional crown (42) capable of being rotated about a geometric axis of rotation (R) in such a way as to actuate the stationary unlocking means (60) and the stationary locking means (70) of the container (20), the stationary unlocking means (60) and the stationary locking means (70) being mechanically linked to the annular functional crown (42) and arranged such that the rotation of the annular functional crown (42) about the geometric axis of rotation (R) results successively in the actuation of the stationary unlocking means (60) ensuring the switch to the intermediate unlocked position of the container (20), then the actuation of the stationary locking means (70) ensuring the switch to the end locked position of the container (20). The device further comprises stationary immobilising/release means (80) capable of preventing the annular functional crown (42) from rotating when the stationary immobilising/release means (80) are in an immobilising position, and capable of allowing the annular functional crown (42) to rotate when the stationary immobilising/release means (80) are in a release position.

Description

SEALED JUNCTION DEVICE FOR ASEPTIC TRANSFER OF A PRODUCT

BIOPHARMACEUTICAL BETWEEN AN ENCLOSURE AND A CONTAINER

The invention relates to the field of aseptic transfer of biopharmaceutical products between a container and a closed container.

More specifically, the invention relates, in a first aspect, to a sealing junction device specifically 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 connection device, a container and a closed enclosure for ensuring the aseptic transfer of biopharmaceutical products between the container and the closed enclosure. The invention further relates, in a third aspect, to a process for aseptic transfer of a biopharmaceutical product between the container and the closed container.

It should be understood here by biopharmaceutical product or biopharmaceutical product, which is related 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 of solid more or less finely divided, 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 conditioning, together more or less complex comprising a plurality of products, etc. - intended to be used inside the closed enclosure.

By convention, the terms "container" or "container" refer to what, in biopharmacy, is fit and intended in its internal space, to contain, enclose or contain a certain biopharmaceutical content or, where appropriate, more than one biopharmaceutical content, more statically or less durable or durable. Such biopharmaceutical content typically consists of one or more biopharmaceutical product (s) as defined previously. Such containers may be rigid or flexible, disposable or reusable, of various sizes and are for example pockets, sheaths, containers, containers, bioreactors or troughs for biopharmaceutical use, this list being not limiting.

There exists in the field of aseptic transfer of biopharmaceutical products the need to communicate a container and a sealed enclosure, in particular for biopharmaceutical product transfers, without sealing against the external environment of the container and / or the enclosure. is broken and does not lead to contamination of the biopharmaceutical products.

To do this, it is known from the state of the art the document FR2978362 which relates to a sealed connection device for ensuring such an aseptic transfer. The device comprises stationary temporary clamping means, able to hold the container against the enclosure of the junction device. At least one magnet is also provided for securing the removable cover of the container against the door of the enclosure during the aseptic transfer. The device also comprises stationary unlocking means for moving the removable cover of the container from a position in which it hermetically closes the container to a position in which it is separated from the container to ensure aseptic communication between the container. and the enclosure. The device also comprises stationary locking means adapted to move the container into a final locking position in which the removable cover again closes the container permanently. The stationary means of temporary clamping, unlocking and final locking are linked to an annular functional ring so that the unidirectional rotation of the annular functional ring causes the actuation of stationary temporary clamping means, and then unlocking and finally locking.

Although this arrangement is quite satisfactory, this device makes it possible to open the door of the enclosure when a container that has already used and in the final locked state is flanged, in particular by breaking the force of attraction of the magnet solidarisant the removable lid of the container on the door of the enclosure. Once the door of the enclosure open, the non-sterile side of the container door is then in contact with the atmosphere of the enclosure, thereby breaking the sterility of the latter

In this context, the present invention improves the situation.

In this regard, the invention proposes a sealed junction device for ensuring the aseptic transfer of a biopharmaceutical product between an enclosure provided with a removable door and a container provided with a removable lid, comprising:

stationary temporary clamping means able to keep the container clamped against the enclosure so that the removable cover of said container is hermetically applied against the removable door of said enclosure;

stationary unlocking means able to move the container from an initial locking position in which the removable cover hermetically seals the container to an intermediate unlocking position in which the removable cover is detached from the container and held tightly against the removable door the enclosure so as to ensure aseptic communication between said container and said enclosure;

stationary locking means capable of moving the container from the intermediate unlocking position to a final locking position in which the said removable cover hermetically seals the container;

- An annular functional ring adapted to move by rotation about a geometric axis of rotation so as to actuate the stationary unlocking means and the stationary locking means of the container, said stationary unlocking means and said stationary locking means being linked. mechanically to the annular functional ring and arranged so that the rotation of said annular functional ring about the axis of rotation geometry successively causes the actuation of the stationary unlocking means ensuring the passage to the intermediate unlocking position of the container, then the actuation of the stationary locking means ensuring the passage to the final locking position of the container, characterized in that the device further comprises stationary locking / unlocking means able to prevent rotation of the annular functional ring when ue the stationary locking / unlocking means are in a locking position, and able to allow rotation of the annular functional ring when the stationary locking / unlocking means are in an unlocking position.

The stationary locking / unlocking means prevent the opening of the enclosure door without a container being clamped and without a container already used therein being clamped. This solution considerably reduces the risk of contamination of the waterproof junction device.

According to one embodiment, the device further comprises stationary opening / closing means adapted to prevent / allow the opening of the removable door of the enclosure and mechanically linked to the annular functional ring so that the rotation of the functional ring annular around the geometric axis rotation successively or simultaneously actuates 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 actuating the stationary locking means of the container ensuring the passage to the final locking position of the container, and simultaneously or successively the operation of the stationary opening / closing means ensuring the locking of the removable door of the enclosure.

According to one embodiment, the stationary unlocking means comprise a rotational displacement unlocking pusher element and an unlocking member capable of being engrained by a portion of the annular functional ring forming a gear so that, during the rotation of the functional ring annular to an intermediate unlocking position, the pusher element moves and moves the container from the initial locking position to the intermediate unlocking position.

According to one embodiment, the stationary locking means comprise a rotary displacement locking pusher element and a locking member capable of being engrained by a portion of the annular functional ring gear so that, during the rotation of the functional ring annular to a final locking position, the pusher element moves and moves the container from the intermediate unlocking position to the final locking position.

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 go from the initial unlocking position to the intermediate position. unlocking.

According to one embodiment, the stationary locking / unlocking means are capable of passing from a locking position to an unlocking position when the container is held flanged against the enclosure, by means of on-board locking / unlocking means arranged on the container. .

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 an extended position in which the finger protrudes out of the sealed junction device, the stationary locking / unlocking means being in a locking position, and to a retracted position in which the finger does not protrude out of the sealed junction device, the stationary locking / unlocking means then being in a release position.

According to one embodiment, the temporary stationary clamping means comprise a clamping element able to rotate about an axis of clamping rotation, so that, during the rotation of the annular functional ring to a locking position initially, the clamping element moves and hermetically holds the container against the removable door of the enclosure.

According to one embodiment, the stationary temporary clamping means comprise a clamping element able to rotate about an axis of clamping rotation, so that when activating a handle causing a rotation of a crown protection element, the clamping element moves and holds the container hermetically against the removable door of the enclosure.

According to one embodiment, the stationary opening / closing means are directly mechanically connected to the unlocking pusher element. According to one embodiment, the device further comprises stationary means for operating the removable door of the enclosure adapted to open and to hermetically close the removable door of the enclosure.

According to one embodiment, the stationary operating means of the removable door of the enclosure are able to move the removable door of the enclosure in a rotary movement about a hinge axis, so that the door does not hinder the passage of the biopharmaceutical product.

In one embodiment, the annular functional ring is rotated by means of a lever.

According to one embodiment, the stationary locking means and the stationary unlocking means are at least 2 in number, preferably 3 in number, preferably 4 in number.

According to one embodiment, the stationary locking means and the stationary unlocking means are structurally merged.

The invention also relates to an assembly comprising an enclosure and a sealing device specially adapted to be associated with a disposable type container provided with a removable cover for the purpose of carrying out the aseptic transfer of a biopharmaceutical product between the enclosure and the container, wherein the enclosure comprises a closed peripheral wall in which is arranged an annular opening hermetically sealed by a removable door and wherein the sealing junction device is made according to the invention, the assembly further comprising a disposable type container with a removable lid.

According to one embodiment, the disposable type container is specially designed 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 adapted to seal the opening of the annular flange;

on-board means for locking / unlocking the annular functional ring;

- Onboard means for locking / unlocking the removable cover on the annular flange; and

a peripheral envelope secured to the annular flange and delimiting a confined interior space capable of receiving the 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 through housing when the removable cover hermetically seals the opening of the annular flange and, secondly, by an internally radially positioned pin and an externally positioned pin may be introduced and blind housing of the removable cover and the recess 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 through housing when the removable cover hermetically seals the opening of the annular flange and, secondly, by an internally radially positioned pin and an externally positioned pin may be introduced and blind housing of the removable cover and the recess housing of the annular flange;

the container being adapted to be in an initial locking position in which, on the one hand, the internally radially positioned pin has an inner functional locking portion arranged in the housing; blind eye of the removable cover and an external functional locking portion arranged in the housing through the annular flange so as to prohibit the relative displacement of the removable cover vis-à-vis the annular flange and, secondly, the positioning pin external radial is at least partially arranged in the recess housing of the annular flange, so that at least one external operative portion of the initial locking of the externally radially positioned pin protrudes out of the through housing;

the container being adapted to be in an intermediate unlocking position in which, on the one hand, the internally radially positioned pin is at least partially arranged in the blind housing of the removable cover and completely excluded from the housing passing through 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 completely excluded from the blind housing of the removable cover so as to allow the relative displacement of the removable cover vis-a-vis the annular flange;

the container being adapted to be in a final locking position in which, on the one hand, the internal radial positioning pin is arranged in the blind housing of the removable cover and, on the other hand, the external radial positioning pin presents a final locking internal functional portion arranged in the blind housing of the removable cover and an outer functional final locking portion arranged in the housing passing through the annular flange so as to prevent the relative displacement of the removable cover with respect to the flange. annular.

The invention also relates to an aseptic transfer process intended to ensure the aseptic transfer of a biopharmaceutical product between a container and an enclosure belonging to an assembly according to the invention, characterized in that it comprises successive stages consisting in:

-install the enclosure, the watertight junction device and the container;

-positioning the container against the peripheral wall of the enclosure by affixing the annular flange against the peripheral wall of the enclosure, so that the stationary locking / unlocking means and the onboard locking / unlocking means are facing each other;

-generate the clamping of the annular flange of the container vis-à-vis the peripheral wall of the enclosure;

passing the stationary locking / unlocking means from a locking position to an unlocking position;

-generate the passage of the container from the initial locking position to the intermediate unlocking position by rotation of the annular functional ring;

simultaneously opening the removable door of the enclosure and the removable lid of the container, the removable lid being hermetically fixed against the removable door;

aseptically transferring one or more biopharmaceutical product (s) between the container and the enclosure;

- Close simultaneously the removable door of the enclosure and the removable lid of the container, the removable cover being hermetically fixed against the removable door;

generating the passage of the container from the intermediate unlocking position to the final locking position by rotation of the annular functional ring;

- Generate the unclamping of the annular flange of the container vis-à-vis the peripheral wall of the enclosure -pass the stationary means of locking / unlocking a release position to a locking position.

Other features and advantages of the invention will emerge from the description which is given below, with reference to the drawings in which: 1 is an overall view, in perspective and in exploded view, of a sealed junction device associated with the peripheral wall of an enclosure;

FIGS. 2a and 2b are two general views, in perspective and in exploded view, from outside the enclosure and from inside the enclosure, of a sealed junction device of FIG. 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;

FIGS. 3a and 3b are two perspective views of the container according to the invention, respectively in an exploded view and in an overall view;

FIGS. 4a to 4c are top views of the sealed junction device of the preceding figures, without protective crown, associated with the container according to the invention, in which FIG. 4a illustrates a sealing junction device and a container in position. FIG. 4b illustrates a sealing junction device and a container in the intermediate unlocking position, and FIG. 4c illustrates a sealing junction device and a container in the final locking position;

FIGS. 5a to 5c are cross-sectional views of only a 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.

Hereinafter a detailed discussion of several embodiments of the invention with examples and reference to the drawings.

FIG. 1 shows 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 may be a room or any other similar facility - is designed to be permanently isolated from the outside environment. Thus, to prevent 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 able to move from a closed position in which the circular opening 16 is obstructed to an open position in which the circular opening 16 is no longer obstructed.

By convention, the terms "internal" and "external" describe in the rest of the description the relative positions of objects vis-à-vis the geometric axis of the annular opening 16. Thus the object described as " internal "or having" internal radial positioning "should be considered to be 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 as placed furthest from the geometric axis of the annular opening 16.

FIGS. 2a and 2b show a container 20 for transporting biopharmaceutical products and ready to be associated with the closed enclosure 10 for performing 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 envelope also comprises an annular opening 26 delimited by an annular flange 30 on which the peripheral envelope is firmly fixed. The container 20 further comprises a removable cover 28 capable of sealing the opening 24 of the annular flange 30 by resting on a seal 22. The container 20 may be made according to different embodiments and, in this regard, have a flexible peripheral envelope and intended for a single use or rigid and intended to be reused after a decontamination procedure well known to those skilled in the art.

With reference to FIGS. 1, 2a and 2b, there is disclosed a seal device 40 for allowing the aseptic transfer of biopharmaceutical products from the container 20 (described later) to the enclosure 10.

The purpose of the watertight junction device 40 is, firstly, to allow the assembly of the enclosure 10 and the container 20, then to allow 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 biopharmaceuticals from one to the other and, finally, to ensure the separation of said enclosure 10 and said container 20.

These successive steps - hereinafter referred to as "aseptic transfer" - must be carried out without there being any communication between the external environment, on the one hand, and the interior spaces 1, 24 of the enclosure 10. and the container 20, on the other hand.

To do this, the sealing junction device 40 according to the embodiment of Figure 1 has a portion formed outside the enclosure 10 and supported by the peripheral wall ^ - or by a support member separate from the wall device 12 but fixed permanently on it - facing the annular opening 16. More specifically, the sealing junction device 40 comprises an annular functional ring 42.

The annular functional ring 42 has an inner circumferential periphery 44INT and an outer circumferential periphery 44EXT inscribed within four bearing ball bearings 46 themselves supported by the outer face of the peripheral wall 12. In this way, the functional crown annular 42 is positioned outside the enclosure 10, which facilitates any maintenance operations. The four bearing ball bearings 46 form a support for the annular functional ring and ensure its rotation around the geometric axis of the annular opening 16. It should be emphasized, however, that the position of the functional annular ring could be maintained in position. by any other similar mechanical element (roller, bearing, etc.).

According to the embodiment of Figure 1, the annular functional ring 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 block of matter. This embodiment has the advantage of simplifying the production of the annular functional ring, at the same time reducing the production costs and ensuring optimal positioning of the functional surfaces of the annular functional ring 42. However, it is understood that the annular functional ring 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.

Referring to Figure 1, it is also possible to provide a protective ring 41, affixed to the annular functional ring, so that the annular functional ring 42 is not accessible. It should be noted that, by convention, the so-called "stationary" objects are part of the watertight junction device 40 and are therefore intended to be linked and permanently fixed on the enclosure 10. On the contrary, the so-called "embedded objects Are intended to be supported by the containers 20 and are therefore mobile with the latter.

The annular functional ring 42 is capable of rotating around the geometric axis of rotation R under the action of a lever 48, for example activated manually. Alternatively, the annular functional ring can be rotated by means of a motor.

According to one embodiment, the protective ring 41 is also able to rotate around the geometric axis of rotation 2 under the action of a joystick 43, for example activated manually by a user.

The sealing junction device 40 comprises temporary stationary clamping means 50.

The stationary temporary clamping means 50 serve to keep the container 20 flanged against the enclosure 10 so that the removable cover 28 of this container 20 is hermetically applied against the removable door 18 of the enclosure 10.

The stationary temporary clamping means 50 are, in 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 drives the actuation of the stationary means. temporary bridle 50.

According to a second embodiment, the temporary stationary clamping means 50 are mechanically linked to the protective ring 41 so that the rotation of the protective ring 41 around the geometric axis of rotation R mechanically drives the actuation of the stationary means of temporary bridle 50.

In the remainder of the description, and by way of nonlimiting example, it is considered that the temporary stationary clamping means 50 are mechanically driven by the rotation of the annular functional ring 42.

According to the embodiment of FIG. 1, the stationary temporary clamping means 50 can be four in number, regularly distributed around the annular functional ring 42. The stationary temporary clamping means 50 are formed by a clamping element 52, able to rotate about an axis of rotation of clamping so as to temporarily clamp the removable cover 28 of the container 20 against the removable door 18 of the enclosure 10.

More specifically, the clamping element 52, after rotation, protrudes radially into the annular opening 16 and abuts against the container 20 so as to prevent disengagement of the removable cover 28 and the removable door 18.

The sealing junction device 40 comprises stationary unlocking means 60.

The stationary unlocking means 60 are intended to move the container 20 from an initial locking position in which the removable cover 28 hermetically closes the container 20 to an intermediate unlocking position in which the removable cover 28 is disengaged from the container and maintained 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 connected to the annular functional ring 42 so that the rotation of the annular functional ring 42 around the geometric axis of rotation R mechanically drives the actuation of the stationary unlocking means 60.

According to the embodiment of Figure 1, the sealed junction 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 ring 42.

Each of the stationary unlocking means comprises a rotational displacement locking element 62 and an unlocking drive member 64 engageable by a portion of the annular functional ring 42 forming a gear so that, during the rotation of the annular functional ring 42 to an intermediate unlocking position, the unlocking pusher element 62, engrained by the unlocking drive member 64, moves around its axis of rotation and moves the container of the initial lock position at the intermediate unlock position.

More specifically, during the rotation of the annular functional ring 42 to an intermediate unlocking position, the relative movement of the annular functional ring 42 relative to the pusher element causes the displacement of the drive member 64 to means of the gear portion. In the intermediate unlocking position, the pusher element 62 for example protrudes radially into the circular opening 16 of the enclosure.

The sealing 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.

As previously, these stationary locking means 70 are mechanically linked to the annular functional ring 42 so that the rotation of this annular functional ring 42 around the geometric axis of rotation R mechanically drives the actuation of the stationary locking means 70. In the same way as before, the relative position of the stationary locking means 70 and the stationary unlocking means 60 around the annular functional ring 42 is such that the actuation of these stationary locking means 70 can only be consecutive to the stopping stationary unlocking means 60.

According to the embodiment of FIGS. 4a to 4c, the sealed junction 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 ring 42.

Each of the stationary locking means 70 comprises a rotational displacement locking member 72 and a lock driving member 74 engageable by a portion of the annular functional ring 42 forming a gear so that, upon rotation from the annular functional ring 42 to a final locking position, the locking pusher 72, under the engagement of the locking driver 74, moves about its axis of rotation and passes the container of the intermediate unlocking position at the final locking position. More precisely, during the rotation of the annular functional ring 42 to a final locking position, the relative movement of the annular functional ring 42 relative 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 for example protrudes radially into the circular opening 16 of the enclosure.

According to the exemplary and nonlimiting embodiment of Figure 1, the stationary unlocking means 60 and the stationary locking means 70 are structurally merged with each other. More precisely, the pushing elements 62 and 72 are combined, as are the drive members 64 and 74.

Conversely, according to an alternative (not shown), the stationary unlocking means 60 and the stationary locking means 70 could possibly be structurally distinct and independent of one another.

The sealing junction device 40 comprises stationary locking / unlocking means 80.

The stationary blocking / unlocking means 80 are able to cause the annular functional ring to pass from a locking position in which the annular functional ring is not able to be rotated, to an unlocking position in which the ring functional annular 42 is adapted to be rotated.

More specifically, the stationary locking / unlocking means 80 are able to prevent the displacement of the pusher elements 62 of the stationary unlocking means 60, so that the sealing junction device 40 is not authorized to move from the initial locking position. at the intermediate position of unlocking.

According to the embodiment of FIGS. 4a to 4c, the sealed junction device comprises four stationary locking / unlocking means 80, although it may comprise less than four or more than four. The stationary blocking / unlocking means 80 are regularly distributed around the annular functional ring 42.

The relative position of the stationary locking / unblocking means 80 and the stationary unlocking means 60 around the annular functional ring 42 is such that the actuation of these stationary unlocking means 60 can only be consecutive to the actuation of the stationary means. blocking / unlocking 80.

More precisely, the stationary locking / unlocking means 80 are actuated by clamping 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 mounted movably 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 The finger 82 is biased by a spring 86 to an extended position in which the finger protrudes out of the sealing junction device 40, so that the pusher member 62 abuts against the finger 82. The finger 82 is movable to meet the biasing of the spring 86 in a retracted position in which the finger 82 does not protrude out of the sealing junction, so that the pusher element 62 can move and thus allow the rotation of the annular functional ring about its axis of rotation R.

The sealing junction device 40 comprises stationary opening means 90.

These stationary opening means 90 are intended to prevent / allow 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 drives the actuation of the stationary opening means 90. More particularly, because of the position of these stationary opening means 90 on the annular functional ring 42, the latter ensure the opening of the removable door 18 of the enclosure 10.

According to the embodiment of Figure 2b, the stationary opening means 90 ensure the opening of the removable door 18 after the actuation of the stationary unlocking means 60 has led to the container 20 in 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 confinement - necessarily more complex to repair within of the enclosure 10 - which could result from an error handling the container 20. Similarly, these stationary opening means 90 are arranged on the annular functional ring 42 to ensure the closure 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. Thus, the displacement 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.

Likewise, the stationary opening means 90 are for example connected to the stationary locking means 70. Thus, the displacement of said stationary locking means towards a final locking position causes the stationary opening means 90 to move to 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 enable the unlocking of the removable door 18 simultaneously with the passage of the container 20 in the intermediate unlocking position, then the locking of this removable door 18 simultaneously with the passage of the container 20. final locking position.

It is also conceivable 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.

The stationary opening means 90, as illustrated in FIG. 2b, comprise, for example, an opening functional rod 92 situated 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 inside of the interior space 14, preventing the opening of the removable door by overlapping of said removable door in the direction of the opening.

The sealing junction device 40 also comprises stationary operating means 100.

These stationary maneuvering means 100 are intended to open and close hermetically the removable door 18 of the enclosure 10.

To do this, the stationary maneuvering means 100 can, according to a first embodiment, be driven mechanically by the annular functional ring 42. In this case, the stationary operating means 100 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 drives the actuation of the stationary operating means 100. More particularly, the position of these stationary operating means 100 on the annular functional ring 42 allows 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.

In a variant, the stationary operating means 100 are driven by an operating motor (not shown) slaved to the displacement of the annular functional ring 42.

The stationary operating means 100 comprise a rotary arm 102 adapted to be rotated about an axis of rotation of a hinge 104. In this way, the stationary maneuvering means 100 allow, thanks to the operating 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.

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 operating means 100 are mechanically linked to the crown. 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 stationary temporary clamping means 50 to maintain the position in position of the container 20 against the enclosure 10, then successively or simultaneously the actuation of the stationary unlocking means 60 ensuring the passage 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 the actuation of the stationary locking / unlocking means 80. Then, the rotation of the annular functional ring 42 around the geometrical axis of rotation R simultaneously or successively causes 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 passage in 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.

According to a second embodiment, the stationary clamping means 50 are mechanically connected to the protective ring 41 and arranged so that the rotation of the protective ring 41 around the geometric axis of rotation R causes the actuation of the stationary means of temporary clamping 50 to maintain the position of the container 20 against the enclosure 10. The stationary unlocking means 60, the stationary locking means 70, the opening means 90 and the operating means 100 are mechanically connected to the annular functional ring 42 and arranged so that the rotation of said annular functional ring 42 around the geometric axis of rotation R causes successively the actuation of the stationary unlocking means 60 ensuring the passage 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 subsequent to the actuation of the stationary blocking / unlocking means 80. Then, the rotation of the annular functional ring 42 around the geometrical axis of rotation R simultaneously or successively drives the actuators stationary opening means 90 locking the removable door 18 of the enclosure 0 and the actuation of the stationary locking means 70 ensuring the passage in the final locking position of the container 20. Finally, the actuation of the protective ring 41 again allows the operation of the stationary temporary clamping means 50 of the container in order to release the container 20.

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 in front of the stationary locking / unlocking means 80.

Stationary positioning elements 110 may be magnets.

It should be pointed out that the rotation of the annular functional ring 42 makes it possible to actuate the stationary unlocking, locking, opening and operating means that this annular functional ring moves in a direction of rotation or else in the other.

It would also be possible to integrate this annular functional ring 42 not outside the enclosure 10 as illustrated by the embodiment of FIG. 1 but directly into the interior space 14 of the enclosure 10. against the inner 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 peripheral wall 12.

Figures 3a and 3b show in more detail an embodiment of a container 20 to be associated with the sealing junction device 40 according to the invention.

However, in this illustration, the peripheral envelope of the container 20 is not shown.

As indicated above, this container 20 is intended to allow the transport and aseptic transfer of biopharmaceutical products from or to an enclosure 10 provided with the sealing junction device 40 according to the invention.

In this regard, the container 20 comprises the annular flange 30 delimiting the annular opening 26, the removable cover 28 adapted to seal the opening 26 of the annular flange 30 and the peripheral envelope integral with the annular flange 30 and defining the confined interior space 24 likely to contain the biopharmaceutical products. In this way, when closed by the removable cover 28 the container 20 is hermetically sealed, which prevents any leakage or introduction of material into the interior space 24. The container 20 may be rigid or flexible and reusable or to single use depending on the case. By way of example and in no way limiting, it may be a container 20 of any size, such as a pocket, a sheath, a container, a bioreactor, a chute, etc.

The container 20 comprises onboard 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 internally radially positioned pin 148 and an externally positioned pin 150, including an end portion functional radial external positioning 152, capable of being introduced and to move inside the blind housing 146 of the removable cover and the through housing 144 of the annular flange 30.

The on-board blocking / unlocking means 140 cooperate with the stationary blocking / unlocking means 80. More specifically, the outer radial position functional end portion 152, in the initial position, protrudes out of the annular flange 30. The functional end portion with positioning external radial 152 bears against the finger 82 stationary blocking / unlocking means 80, so that the finger 82 is moved against the bias of the spring 86 until no longer beyond the sealing junction device.

The container 20 comprises onboard locking / unlocking means 120 of the removable cover 28 on the annular flange 30.

These onboard locking / unlocking means 120 - whose structure is detailed below - have the function of ensuring the maintenance of the container 20 in three distinct positions. The first position is referred to as the initial locking position because the locking / unlocking means 120 prohibit the relative displacement of the removable cover 28 with respect to the annular flange 30. The second position, referred to as the intermediate unlocking position, is intended to intervene when the annular flange 30 of the container 20 is axially clamped against the peripheral wall 12 of the enclosure 10 and allows the relative displacement of the removable cover 28 vis-à-vis the annular flange 30. The third position, qualified position final locking, is assumed to intervene after the aseptic transfer of the biopharmaceutical products between the container 20 and the enclosure 10 and again prohibits the relative displacement of the removable cover 28 vis-à-vis the annular flange 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 locking / unlocking functional arrangements regularly distributed around the annular flange. 28 of the cover 30.

Each onboard locking / unlocking functional arrangement 122 has a through-housing 124 formed in the annular flange 30 and a blind housing 126 formed in the removable cover 28 of the container 20 and in the extension of the through-housing 114.

Each onboard locking / unlocking functional arrangement 122 also includes an internally radially positioned pin 128 and an externally positioned pin 130. These two pin internal radial 128 and outer position 130 have, according to the embodiment of Figures 3a and 5a to 5c, an elongated body of cylindrical shape allowing them to be introduced and move within 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, on the other hand. It should be noted, however, that the dimensional characteristics and the properties of the outer surface of these inner and outer radial positioning pins 128 are such that the latter can not move inside the blind housing 126 and through 124 just because of gravity. In addition, these pins 128 internal radial positioning and 130 external may have a body of different shape - for example, parallelepiped - to achieve the same result.

The through-housing 124, the blind housing 126, the internally-radial pin 128 and the externally-positioned pin 130 are coaxial and oriented in a radial direction relative to the annular flange 30. More precisely, 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.

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 affecting the confinement and handling of the container 20.

When the container 20 is in the initial locking position, as shown in FIG. 5a, the internal radial positioning pin 128 has an initial internal locking functional portion 128INT arranged in the blind housing 126 of the removable cover 28 and a functional portion external locking 128EXT arranged in the through housing 124 of the annular flange 30. Thus, the internal radial positioning pin 128 prohibits the relative displacement of the removable cover 28 vis-à-vis the annular flange 30.

Furthermore, in this same initial locking position, the externally positioned pin 130 is at least partially arranged in the through-housing 124 of the annular flange 30. According to the embodiment shown in FIG. 5a, the pin with radial positioning external 130 may then have a functional end portion with external radial positioning 130ext excluded from the through housing 124. Access to this functional end portion 130ext by the stationary unlocking means 60 or locking 70 is thus facilitated.

When the container 20 is in the initial locking position, the functional end portion with external radial positioning 130ext of the external radial positioning pin 130 abuts against the stationary locking / unlocking means, so as to pass them into a unlocking position permitting rotation of the annular functional ring 42.

More precisely, the functional end portion with external radial positioning 130ext of the externally positioned pin 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 device. junction 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.

When the container 20 is in the intermediate unlocking position, as shown in FIG. 5b, the internal radial positioning pin 128 is at least partially arranged in the blind housing 126 of the removable cover 28 and completely excluded from the through housing 124 of the In this way, this pin with internal radial positioning 128 no longer prohibits the relative displacement of the removable cover 28 with respect to the annular flange 30.

In this intermediate unlocking position, again, the external radial positioning pin 130 is at least partially arranged in the through-housing 124 of the annular flange 30 and completely excluded from the blind housing 126 of the removable cover 28. In this way, the locking pin external radial positioning 130 has no more influence than the pin radial internal positioning 128 on the relative displacement of the removable cover 28 vis-à-vis the annular flange 30 which can freely be detached to allow the aseptic transfer of biopharmaceutical products.

Finally, to place the container 20 in the final locking position, as shown in Figure 5c, it is first necessary to replace the removable cover 28 against the annular flange 30 and then place the onboard locking / unlocking functional arrangement 122 in the proper position.

More particularly, in this position the internal radial positioning pin 128 is entirely arranged inside the blind housing 126 of the removable cover 28 while the external radial positioning pin 130 has a final internal locking functional portion 130INT arranged in the housing blind eye 126 of the removable cover 28 and an outer functional locking portion 130EXT final arranged in the through housing 124 of the annular flange 30. Therefore, the blind housing 126 of the removable cover 28 has a length sufficient to accommodate, on the one hand, the pin with internal radial positioning 128 and secondly, the inner functional portion of final locking 130INT. Thus, the pin with external radial positioning 130 prevents the relative displacement of the removable cover 28 with respect to the annular flange 30.

Such a use of pins 128 internal radial positioning and external 130 to place the container in the initial locking position, intermediate unlocking and final locking allows to have a blind housing 126 and a through housing 124 to achieve in the removable cover 28 and the annular flange 30 by onboard functional locking / unlocking 122, which limits the risk of contamination due to possible production defects. In addition, the manipulation of the locking / unlocking means 120 is facilitated to the extent that it is sufficient to move the inner radial positioning pins 128 128 and outer 130 in a single direction and one and the same direction to pass the container 20 successively from the initial locking position to the intermediate unlocking position, and then to the final locking position. The realization and operation of the sealing junction device are thus simplified.

In addition, once the functional end portion 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 already used. The risk of contamination is thus greatly reduced. It should also be noted that in the embodiment of FIGS. 5a to 5c, the pins with internal radial positioning 128 and external 130 have identical lengths, which makes it possible in particular to simplify the production and assembly of the pins with internal radial positioning 128 and external 130 on the container since it is then not necessary to distinguish the pins with respect to their respective dimensions. However, alternatively, these pins with internal radial 128 and outer 130 positioning could also have different lengths.

It should further be noted that the through-housing 124 and the externally-positioned pin 130 have lengths such that, when the on-board locking / unlocking means 110 are in the provisional unlocking position, the externally-positioned pin 130 presents a functional end portion 130ext 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 external radial positioning pin 130 is accessible without the radial displacement push member 78 having to move to the interior of the through housing 124.

On the other hand, the lengths of the pin with external radial positioning 130 and the through-housing 124 are such that, when the on-board locking / unlocking means 120 are in the final locking position, said externally-positioned pin 130 has an extreme portion. functional 130ext external radial positioning housed inside the through housing. In this way, when the container is placed in the final locking position, the gripping of the external radial positioning pin 130 is made complex and impractical without a suitable gripping tool. This thus makes it possible to raise the level of safety relating to the sealing of the container 20 in the final locking position.

According to one embodiment, the onboard locking / unlocking means 140 and the onboard locking / unlocking means 120 are structurally merged.

According to the embodiment of FIGS. 3a and 3b, the container 20 also comprises onboard partitioning and protection means 134.

The embedded partitioning and protection means 134 are arranged on an outer peripheral portion of the annular flange 30 so as to prevent the unexpected manipulation of the on-board locking / unlocking means carried by the annular flange 30.

The embedded partitioning and protection means 34 are for example enclosures, at least partially or completely surrounding the through-housing 124 so as to prevent the unexpected or deliberate manipulation of the externally-positioned pin 130 when the latter is not fully inserted into the through housing 128 of the annular flange 30. There are as many onboard partitioning and protection means 134 as on-board locking / unlocking means 120 and / or onboard locking / unlocking means 140.

The implementation of the aseptic transfer process according to the invention is now described in detail.

This aseptic transfer process consists, in the first place, of having a closed enclosure 10 as described above and supporting a sealing junction device 40 according to the invention. This transfer process aseptically consists, secondly, to have a container 20 in the initial locking position as described above.

The aseptic transfer process then involves placing the container 20 against the peripheral wall 12 of the enclosure 10 so that the pins belonging to the onboard locking / unlocking means are facing the stationary locking / unlocking means 80.

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 held tightly in position against the outer face of the removable door 18 - at least partially magnetized.

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 ring 42.

According to a first embodiment, the aseptic transfer method then consists in generating the rotation of the annular functional ring 42 in order to actuate the temporary stationary clamping means 50. More specifically, the clamping elements 52 rotate about their axis of rotation. rotation so as to maintain the container 20 against the enclosure 10.

According to a second embodiment, the stationary clamping means 50 are actuated by the rotation of the protective ring 41. More specifically, a user manually actuates for example a handle 43 then rotating the protective ring 41. The clamping elements 52 then rotate about their axis of rotation so as to keep the container 20 against the enclosure 10.

Then, the rotation of the annular functional ring 42 makes it possible to actuate the stationary unlocking means 60. More particularly, the functional ring gear portions cause the displacement of the pusher elements 62 of the stationary unlocking means 60. As the movement proceeds, the pusher elements 62 abut against the pins 128, 130, also displacing them radially in the through and blind housings 124, 126.

At the end of this operation, the internal radial positioning pin 128 is then arranged in the blind housing 126 of the removable cover 28 and completely excluded from the through housing 124 of the annular flange 30 and the external radial positioning pin 130 is arranged in the through housing 124 of the annular flange 30 and completely 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 displacement of the removable cover 28 with respect to 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 ring 42 in order to actuate the stationary opening means 90 to release the removable door 18 of the enclosure 10 .

For this purpose, 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 handled freely. The aseptic transfer process then consists in driving the stationary operating 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 the container 20. .

To do this, the stationary operating means 100 - which can be actuated by the annular functional ring 42 or by a control motor slaved to the position of this annular functional ring 42 - drive in rotation about an axis of rotation. a hinge, then, the removable door 18 of the enclosure 10.

The container 20 being in the intermediate unlocking position, the removable cover 28 is able to move with respect to 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 one another while being hermetically isolated from the outside environment.

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 again the stationary operating means 100 in order to hermetically close the annular openings 16, 26 of the enclosure 10 and the container 20.

As before, the stationary operating means 100 then drive in rotation, about an axis of rotation of a hinge, the removable door 18 of the enclosure 10 as well as the removable cover of the container 20 to put them in the same position than previously.

The enclosure 10 is then sealed again by the removable door 18, both with respect to the exterior and the container 10. And, symmetrically, the container 20 is sealed by the removable cover, so that to the outside only of the enclosure 10.

The aseptic transfer process then consists in generating the rotation of the annular functional ring 42 in order to actuate the stationary opening means 90 to block the removable door 18 of the enclosure 10.

For this purpose, rotation of the unlocking means 60 causes rotation of the functional rod 92 of the stationary opening means 90, and therefore of the body 94, so that the latter covers the outer face of the removable door 18 again. of the enclosure 10. The removable door 18 can then be handled freely.

The aseptic transfer process consists, simultaneously or successively to the preceding step in generating the rotation of the annular functional ring 42 in order to actuate the actuation of the stationary locking means 70. More particularly, the functional ring gear portions cause the pusher elements 72 of the stationary locking means 70 to move. As the displacement proceeds, the pusher elements 72 come to bear against the pins 128, 130, also displacing them radially in the through and blind housings 124, 126.

At the end of this operation, the internally radially located pin 128 is arranged in the blind housing 126 of the removable lid 28 while the externally positioned pin 130 has a final internal locking functional portion 130INT arranged in the blind housing 126. of the removable cover 28 and an outer functional end locking portion 130EXT arranged in the through housing 124 of the annular flange 30. Thus the relative displacement of the removable cover 28 vis-à-vis the annular flange 30 is impossible and the container is then in the final locking position.

The aseptic transfer process therefore consists in generating the rotation of the annular functional ring 42 so that the temporary clamping elements 52 return to their initial position in which the container 20 can be detached from the enclosure 10.

According to a second embodiment, the stationary clamping means 50 are actuated by the rotation of the protective ring 41. More specifically, a user manually actuates for example a handle 43 then rotating the protective ring 41. The clamping elements 52 then rotate about 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 locking position can thus be freely withdrawn from the sealing junction device 40. The locking / unlocking means then pass into a position in which the rotation of the annular functional ring 42 is not authorized, so as to prevent the opening of the watertight connection device without an unused container being secured to it.

Claims

claims

A sealed junction device (40) for aseptically transferring a biopharmaceutical product between an enclosure (10) having a removable door (18) and a container (20) having a removable cover, comprising:

stationary temporary clamping means (50) adapted 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) said enclosure (10);

stationary unlocking means (60) adapted to move 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 disengaged from the container (20) and held tightly against the removable door (18) of the enclosure (10) so as to provide aseptic communication between said container (20) and said enclosure (10);

stationary locking means (70) adapted to move the container (20) from the intermediate unlocking position to a final locking position in which said removable cover (28) hermetically seals the container (20);

an annular functional ring (42) able to move by rotation around a geometrical axis of rotation (R) so as to actuate the stationary unlocking means (60) and the stationary locking means (70) of 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 such that rotation of said annular functional ring (42) about the axis of rotation rotation geometry (R) successively drives the actuation of the stationary unlocking means (60) ensuring the passage to the intermediate unlocking position of the container (20), then the actuation of the stationary locking means (70) ensuring the passage in position final locking device of the container (20) characterized in that the device further comprises stationary locking / unlocking means (80) capable of to prevent the rotation of the annular functional ring (42) when the stationary locking / unlocking means (80) are in a locking position, and able to allow rotation of the annular functional ring (42) when the stationary blocking means / Unblocking (80) are in an unlocking position.

2. Device (40) according to claim 1, further comprising stationary opening / closing means (90) adapted to prevent / allow 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) around the geometrical axis of rotation successively or simultaneously drives the actuation of the stationary unlocking means (60) ensuring the passage in the position of intermediate unlocking of the container (20) and the actuation of the stationary opening / closing means (90) ensuring the unlocking of the removable door (18) of the enclosure (10), then the actuation of the stationary locking means ( 70) of the container (20) ensuring the passage in the final locking position of the container (20), then simultaneously or successively the operation of the stationary opening / closing means (90) ensuring the locking of the removable door (18) of the enclosure (10).

3. Device (40) according to one of claims 1 and 2, wherein the stationary unlocking means (60) comprise a unlocking push member (62) rotational movement and a unlocking member (64) engageable by a portion of the annular functional ring gear (42) so that, upon rotation of the annular functional ring (42) to an intermediate unlocking position, pusher member (62) moves and moves the container (20) from the initial lock position to the intermediate unlocking position.

4. Device (40) according to one of claims 1 to 3, wherein the stationary locking means

Apparatus (70) comprises a rotational displacement locking member (72) and a locking member (74) engageable by a portion of the annular functional ring gear (42) so that, upon rotation of the the annular functional ring (42) to a final locking position, the pusher element (72) moves and moves the container (20) from the intermediate unlocking position to the final locking position.

5. Device (40) according to one of claims 1 to 4, wherein the stationary locking / unlocking means (80) are adapted to prevent the rotation of the pusher element (62) stationary unlocking means (60). so that the container (20) is not allowed to move from the initial unlocking position to the intermediate unlocking position.

6. Device (40) according to one of claims 1 to 5, wherein the stationary locking / unlocking means (80) are adapted to move from a locking position to an unlocking position when the container (20) is held flanged against the enclosure (10), by means of onboard locking / unlocking means (140) arranged on the container (20).

7. Device (40) according to one of claims 1 to 6, wherein the stationary locking / unlocking means (80) comprise a finger (82), movably mounted in a channel (84) extending in a transverse direction in a radial direction, the finger (82) being able to be biased by a spring (86) to an extended position in which the finger (82) protrudes out of the sealing junction device (40), the stationary locking / unlocking means (80) being in a locking position, and to a retracted position in which the finger (82) does not protrude out of the sealing junction (40), the stationary locking / unlocking means (80) then being in a position deblocking.

8. Device (40) according to one of claims 1 to 7, wherein the stationary temporary clamping means (50) comprise a clamping element (52) adapted to rotate about a clamping axis of rotation, so that, upon rotation of the annular functional ring (42) to an initial locking position, the clamping member (52) moves and hermetically holds the container (20) against the removable door (18) of the enclosure (10).

9. Device (40) according to one of claims 1 to 7, wherein the temporary stationary clamping means (50) comprises a clamping element (52) adapted to rotate about a clamping axis of rotation, so that when activating a handle (43) rotating a guard ring (41), the clamping member (52) moves and holds the container (20) against the door removable (18) of the enclosure (10).

10. Device (40) according to one of claims 2 to 9, wherein the stationary opening / closing means (90) are directly mechanically connected to the unlocking pusher element (62).

11. Device (40) according to one of claims 1 to 10, further comprising stationary maneuvering means (100) of the removable door (18) of the enclosure (10) adapted to open and seal the door removable (18) of the enclosure (10).

12. Device (40) according to claim 11, wherein the stationary maneuvering means (100) of the removable door (18) of the enclosure (10) are able to move the removable door (18) of the enclosure ( 10) in a rotational movement about a hinge axis, so that the door does not hinder the passage of the biopharmaceutical product.

13. Device (40) according to one of claims 1 to 12, wherein the annular functional ring (42) is rotated by means of a lever (48).

14. Device (40) according to one of claims 1 to 13, wherein the stationary locking means (70) and the stationary unlocking means (60) are at least 2 in number, preferably 3 in number preferably 4 in number.

15. Device (40) according to one of claims 1 to 14, wherein the stationary locking means (70) and the stationary unlocking means (60) are structurally merged.

16. An assembly comprising an enclosure (10) and a sealing junction (40) specially adapted to be associated with a disposable type container (20) having a removable cover (28) for effecting aseptic transfer a biopharmaceutical product between the enclosure (10) and the container (20), wherein the enclosure (10) comprises a closed peripheral wall (44) in which is arranged an annular opening (26) hermetically closed by a door detachable device (18) and wherein the sealing device (40) is made according to one of claims 1 to 15, the assembly further comprising a disposable type container (20) having a removable cover ( 28).

An assembly according to claim 16, wherein the disposable type container (20) is specially adapted for the transport and aseptic transfer of a product belonging to the biopharmaceutical field and comprises:

an annular flange (30) defining an annular opening (26);

a removable cover (28) adapted to seal the opening of the annular flange (30); onboard locking / unlocking means (140) of the annular functional ring (42); onboard locking / unlocking means (120) of the removable cover (28) on the annular flange (30); and

a peripheral envelope integral with the annular flange (30) and delimiting a confined interior space (24) capable of receiving the products belonging to the biopharmaceutical field;

wherein 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 internally radially positioned pin (148) and an externally positioned pin (150) which can be inserted and moved within the blind housing (146) of the removable cover (28) and the through housing (144); ) the annular flange (30); and in which the on-board locking / unlocking means (120) comprise at least one on-board locking / unlocking functional arrangement (122) formed, on the one hand, by a through-housing (124) formed in the annular flange (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 flange (30) and, on the other hand, by an internally radially positioned pin (128) and an externally positioned pin (130) which can be inserted and moved within the blind housing (126) of the removable cover (28) and the through housing (124); ) the annular flange (30);

the container (20) being adapted to be in an initial locking position in which, on the one hand, the internally radially positioned pin (128) has an internal locking functional portion arranged in the blind housing of the removable lid (28); ) and an external locking functional portion arranged in the through-housing of the annular flange (30) so as to prevent the relative displacement of the removable cover (28) with respect to the annular flange (30) and, on the other hand, on the other hand, the externally-positioned pin is at least partially arranged in the through-housing of the annular flange (30), so that at least one external locking functional portion (130ext) of the externally-positioned pin (130) ) protrudes out of the through housing;

the container (20) being adapted to be in an intermediate unlocking position in which, on the one hand, 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) and, secondly, the externally-positioned pin (130) is at least partially arranged in the through-housing of the annular flange (30) and completely excluded from the blind housing of the removable cover (28) so as to allow the relative displacement of the removable cover (28) vis-à-vis the annular flange (30);

the container (20) being adapted to be in a final locking position in which, on the one hand, the internal radial positioning pin (128) is arranged in the blind housing (126) of the removable cover (28) and, on the other hand, the external radial positioning pin (130) has a final internal locking functional portion arranged in the blind housing (126) of the removable cover (28) and a final locking outer functional portion (130ext) arranged in the housing through the annular flange (30) so as to prohibit the relative displacement of the removable cover (28) vis-à-vis the annular flange (30).

18. A process for aseptic transfer intended to ensure the aseptic transfer of a biopharmaceutical product between a container (20) and an enclosure (10) belonging to an assembly according to one of claims 16 and 17, characterized in that it comprises successive stages of:

arranging the enclosure (10), the sealing junction device (40) and the container (20);

positioning the container (20) against the peripheral wall of the enclosure (10) by affixing the annular flange (30) against the peripheral wall of the enclosure (10), so that the stationary locking / unblocking means (80) ) and the onboard locking / unlocking means (140) are facing each other;

generating the clamping of the annular flange (30) of the container (20) vis-à-vis the peripheral wall of the enclosure (10);

passing the stationary locking / unlocking means (80) from a locking position to an unlocking position;

generating the passage 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 more biopharmaceutical product (s) between the container (20) and the enclosure (10);

simultaneously closing the removable door (18) of the enclosure (10) and the removable lid (28) of the container (20), the removable lid (28) being hermetically fixed against the removable door (18); generating the passage 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 flange (30) of the container (20) vis-à-vis the peripheral wall of the enclosure (10)

passing the stationary locking / unlocking means (80) from an unlocking position to a locking position.