Patent Application
20220371011
The invention relates to the field of containers intended to be connected in a sealed manner to sterile enclosures so as to allow their respective volumes to be placed in communication without contact with said external environment.
The invention relates more particularly to a sealed container comprising a container body having a through-hole delimited by a flange and closed off by a removable door mounted on the flange, an annular seal located between the flange and the door, the flange, the door and the seal forming a sealed connection device capable of being connected to a complementary connection device of a sterile enclosure by means of bayonet connection means in order to allow sterile communication between the sealed container and the sterile enclosure.
The sealed container according to the invention is intended in particular, but not exclusively, for the transfer of dangerous products such as certain pharmaceutical, biotechnological, biological, chemical or radioactive products, the transfer of components such as stoppers, bottles, pistons, syringes, etc., the transfer of environmental control devices such as culture medium racks, particle counters, etc., the transfer of cleaning systems, the transfer of liquids, powders, tools, the transfer of waste to the outside of the enclosure and/or the transfer of any element necessary for the production or maintenance of the production line.
In a known manner, the connection of a sealed container to a sterile enclosure for the transfer of products, without breaking the connection and the seal, is carried out using two connection devices, one equipping the container and the other equipping the enclosure. Each connection device comprises a flange respectively delimiting the through-hole in the internal volume of the container or of the enclosure, each of the through-holes being closed off by a door. The flange and the door of the container are capable of being connected respectively to the flange and to the door of the enclosure by a bayonet connection under the action of a rotational movement of the associated flange and door of the container with respect to the flange and door of the enclosure to which they are attached. Thus, the flanges and the doors, respectively, of the container and of the enclosure are respectively provided with notches and with internal or external lugs. During the rotational movement, the container door is uncoupled from the associated flange.
These connection devices are on the whole satisfactory. However, the friction generated during the rotational movement carried out to lock the door to the flange has the drawback of producing particles that are capable of inducing contamination within the enclosed volumes, but also of producing a break in the seal of the connection. Furthermore, the internal lugs of the flange ensuring the grip of the door extend, once the door is disengaged from these lugs, into the through-hole, so that the transfer of the components may sometimes be hampered by these lugs.
The invention aims to remedy these problems by proposing a sealed container limiting the emission of particles liable to generate contamination of the enclosed volumes during the assembly of the door to the associated flange of the container.
Another object of the invention is to provide a sealed container offering an optimized through-hole as well as stable and durable sealing between the container and the enclosure to which it is connected.
To this end, the invention proposes a sealed container comprising a container body having a through-hole delimited by a flange and closed off by a removable door mounted on the flange, an annular seal located between the flange and the door, the flange, the door and the seal forming a sealed connection device capable of being connected to a complementary connection device of a sterile enclosure by means of bayonet connection means in order to allow sterile communication between the sealed container and the sterile enclosure, the container being remarkable in that the container comprises an annular attachment bead for attaching the door to the flange inserted into a notch on the door provided for this purpose.
The door is thus assembled to the flange of the container by simple clipping, and in the same way is disassembled by unclipping.
By thus avoiding the rotational movement imposed by the bayonet connection implemented in the containers of the prior art, the production of contamination-generating particles is avoided. The attachment bead also has the advantage of taking up less space than the lugs of the flanges. This thus makes it possible to offer an increased passage diameter and thus to facilitate the passage of the components and to reduce the risks of damage to the latter during their transfer.
According to a particular embodiment, the annular attachment bead is provided on the inner peripheral circumference of the flange.
According to another embodiment, the annular attachment bead is offset on the seal. Thus, said bead is provided on the inner peripheral circumference of said seal. The attachment of the door on the flange is thus carried out by means of the seal.
Advantageously, the flange consists of two separate coaxial flange bodies, one of the flange bodies defining an external flange body arranged to allow connection of the container body to the complementary enclosure, the other flange body defining an internal flange body, said flange bodies being arranged relative to each other to define therebetween an annular interstitial space in which the seal is housed.
Advantageously, the annular attachment bead is provided on the inner peripheral circumference of the internal flange body. In the case, however, where the annular attachment bead is offset on the seal, the latter and the internal flange body are advantageously arranged so that the attachment bead rests on the front end of the internal flange body.
Advantageously, the container comprises anti-rotation means preventing the rotation of the door (7) on the flange. According to a preferred variant, the bead has a profile arranged to ensure the prevention of the rotation of the door on the flange.
Advantageously, the seal has a notched face portion intended to be in contact with the door.
Advantageously, the seal comprises means of reciprocal association with the flange.
Advantageously, the seal has at least one contact face with at least one of the flange bodies provided with a notching cooperating with a complementary notching provided on the face of said flange body opposite which it is placed, the notching of the contact face of the seal and the complementary notching forming the means of reciprocal association.
Advantageously, the external flange body comprises an internal peripheral rim abutting which the seal is positioned.
Advantageously, the container body is formed by a flexible film fixed to the flange, the flexible film being held in engagement between the external flange body and the internal flange body.
It may also be provided that the external flange body has a lower skirt comprising longitudinal slots extending from the lower end edge of the external flange body and evenly distributed over the periphery of said flange body so as to form elastic tabs capable of exerting a clamping force on the internal flange body. Provision may also be made for the container to comprise a clamping ring for clamping the external flange body on the internal flange body arranged to grip the parts of the external flange body and of the internal flange body between which the flexible film is interposed. Advantageously, the container comprises an additional annular seal housed in a peripheral groove provided on the inner face of the external flange body, the flexible film extending between the additional annular seal and the internal flange body. These features, taken alone or in combination with each other, make it possible to improve the mechanical strength of the container and to ensure optimum sealing. They also allow a container to be produced simply and quickly, without risk of deterioration of the film and contamination of the latter's contents.
Advantageously, all or part of the container is made of a bacteriostatic material.
Other features and advantages of the invention will become apparent from the following detailed description of the invention with reference to the appended figures, in which:
For greater clarity, identical or similar elements of the various embodiments are denoted by identical reference signs in all of the figures.
In relation to
The container also comprises a sealed connection device that is arranged to allow the flexible film 2 to be connected to a complementary connection device of a sterile enclosure. The connection is made in such a way as to ensure sterile communication between the internal volume 3 of said container 1 and that of the enclosure. The connection device comprises a flange on which the flexible film is attached, said flange delimiting the through-hole of the flexible film. It further comprises a removable door 7 attached to the flange so as to close the through-hole.
According to the invention, the flange is constituted by two mutually different pieces, a first piece forming a so-called external flange body and a second piece forming a so-called internal flange body, between which the flexible film extends.
The internal flange body 6 has a notched zone adjacent to the bearing recess arranged to cooperate with a complementary notching provided on the inner face of the external flange body 5.
According to an advantageous configuration illustrated in
The container 1 further comprises a first annular seal 8 housed in a peripheral groove formed on the inner face of the external flange body 5 and the outer face of the internal flange body 6. As shown in
The container 1 comprises a second annular seal 13 that is borne by the flange. It defines a door/flange seal. When the door is in the position closing off the through-hole, the annular seal 13 is housed in the space delimited by the external flange body 5, the internal flange body 6 and the door 7. Advantageously, the annular seal 13 has a cross-section of shape matching the area in which it is housed. In the illustrated embodiment, the annular seal 13 has a substantially triangular section.
As illustrated in
In order to prevent the attachment bead 130 from collapsing, the seal 13 is arranged with the internal flange body 6 so that the attachment bead 130 rests on the front end 65 of the internal flange body 6.
In order to ensure that the seal 130 is held between the external and internal flange bodies 5, 6, the latter comprises means of reciprocal association with the external flange body 5 on the one hand and the internal flange body 6 on the other hand. In the illustrated embodiment, the means of reciprocal association are in the form of notched zones. Thus, the faces of the seal in contact with the external flange body 5 and the external flange body 6 comprise a notching 131, 132 cooperating with a complementary notching formed on the faces of said flange bodies opposite which they are placed. In the example illustrated, the contact face 132 with the internal flange body in particular has a stepped shape in order to ensure reinforced holding of the seal 13 between the external and internal flange bodies 5, 6. Advantageously, the external flange body 5 is provided with an internal peripheral rim 55 abutting which the seal 13 is positioned, thus ensuring axial holding of said seal, in particular when the door 7 is removed. The seal 13 and its assembly with the flange according to the arrangement described above thus allow elimination of any risk of deformation, torsion and displacement of the seal 13 during the production of the connection device as well as during the use of the container.
Advantageously, the attachment bead 130 is arranged to allow docking of a drop system 100 for the component transfer. As illustrated in
Due to the arrangement of its component elements, the connection device is assembled by simple clipping of the elements. To make the container 1, the part of the flexible film located on the side of the through-hole will be arranged so as to be placed between the external flange body 5 and the internal flange body 6. The clamping will be effective by clamping the ring 9 on the external flange body 6, causing the tabs 12 to be gripped against the internal flange body 6. The flexible film 2 may be disassembled by unscrewing the clamping ring 9 and unclipping the external flange body 6 from the internal flange body 7.
The flexible film 2 and the connection device are advantageously made of a bacteriostatic material. The seals 8 and 13 are made of a silicone material or other materials minimizing remanence phenomena. Provision may also be made for the seals to be made of a bacteriostatic material.
The invention is described in the foregoing by way of example. It is understood that a person skilled in the art is in a position to produce various variant embodiments of the invention without thereby departing from the scope of the invention.
| Number | Date | Country | Kind |
|---|---|---|---|
| FR1915376 | Dec 2019 | FR | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/FR2020/052548 | 12/18/2020 | WO |
