Sealed container comprising a device for releasable connection to a housing

Abstract

The present invention relates to a sealed container (1) comprising a flexible film (2) arranged to define an internal space (3) and a through opening, and a sealed connection device (4) arranged to enable the flexible film (2) to be connected to a complementary connection device of a sterile housing, while ensuring sterile communication between the internal space (3) of the container (1) and the internal space of the housing, characterized in that the connection device (4) comprises a flange to which the flexible film (2) is attached, the flange defining the through opening of the flexible film (2), the flange being constituted by two distinct and separate pieces forming an outer sleeve (5) and an inner sleeve (6), respectively, and the flexible film (2) remains gripped between the outer sleeve (5) and the inner sleeve (6).

Description

Technical Field

[0001] The present invention relates to the field of containers intended to be connected in a sealed manner to a sterile housing so that their respective volumes can be installed in communication without contacting the external environment.

[0002] More specifically, the present invention relates to a sealed container comprising a flexible film arranged to define an internal space, a through-opening enabling the internal space to be installed in communication with the outside of the film, and a sealed connection device arranged to enable the connection of the flexible film to a complementary connection device of a sterilization housing.

[0003] The sealed containers according to the present invention are particularly intended for the transfer of dangerous products such as, but not limited to, certain pharmaceuticals, biotech-related, biological, chemical or radioactive products, the transfer of components such as stoppers, bottles, pistons, syringes, the transfer of environmental control devices such as culture racks, particle counters, the transfer of cleaning systems, the transfer of liquids, powders, tools, the transfer of waste outside the housing, and / or the transfer of any element necessary for the production or maintenance of a production line.

[0004] Prior Art In known systems, the connection of a sealed container to a sterilization housing for the transfer of products, without damaging the connection and the seal, is carried out using two connection devices, one equipped with the container and the other with the housing. Each connection device comprises a flange defining a through-opening in the internal space of the container or the housing, and each of the through-openings is closed by a door. The flange and door of the container are connected to the flange and door of the housing, respectively, by a bayonet connection and can be separated from each other under the action of the rotational movement of the associated flange and door of the container with respect to the flange and door of the housing to which they are attached.

[0005] In the case of a flexible film container, the connecting device and the flexible film are assembled by welding the film to the flange. However, the assembly by welding for this type of container has several drawbacks.

[0006] First, the assembly by welding cannot ensure an optimal seal and cannot eliminate the presence of leakage points. Similarly, a homogeneous weld cannot be guaranteed at all points on the surface of the film. Furthermore, since welding essentially modifies the material on which it is performed, the flexible film can undergo changes during the welding operation, which can then generate brittle points from the perspective of resistance and sealing.

[0007] Second, the joining device has the drawback that it is not removable and thus not recyclable.

[0008] Third, the assembly by welding specifies the materials used for the flange to which the film is welded and the film itself.

[0009] The present invention aims to correct these problems by proposing a sealed container provided with a flexible film that has improved mechanical strength and can be connected to a sterile housing to ensure an optimal seal.

[0010] Another object of the present invention is to provide a sealed container having a flexible film that can be connected to a sterilized housing without the risk of film degradation and contamination and can be manufactured simply and quickly.

[0011] Another object of the present invention is to provide a sealed container having a recyclable flexible film.

[0012] The subject matter of the present invention For this purpose, the present invention proposes a sealed container comprising a flexible film arranged to define an internal space and a through-opening, and a sealing connection device arranged to enable the flexible film to be connected to a complementary connection device of a sterile housing, wherein the connection device comprises a flange to which the flexible film is attached, the flange defining the through-opening of the flexible film, and the container is excellent in that the flange is constituted by two separate pieces respectively forming an outer sleeve and an inner sleeve, and the flexible film continues to be gripped between the outer sleeve and the inner sleeve.

[0013] The present invention also proposes a sealed container comprising a flexible film arranged to define an internal space and a through-opening, a door for closing the through-opening, and a sealing connection device arranged to enable the flexible film to be connected to a complementary connection device of a sterile housing by providing a sterile communication between the internal space of the container and the internal space of the housing, wherein the connection device comprises a flange for assembling the door to the flexible film and means for connection to a complementary connection device of the housing, the assembling flange defining the through-opening of the flexible film, and the container is excellent in that the assembling flange is constituted by two separate pieces respectively forming an outer sleeve and an inner sleeve to which the door is attached, and the flexible film continues to be gripped between the outer sleeve and the inner sleeve.

[0014] According to other advantageous and non-limiting features of the present invention, alone or in any technically practical combination: - The inner sleeve is surrounded at the bottom by the outer sleeve and at the top by a collar arranged to ensure connection to a complementary connection device of the housing, the collar forming said means for connecting the connection device. - The container comprises first means for indexing a connection collar having the inner sleeve. - The container comprises second means for disengaging a door having an inner sleeve. - The outer sleeve is clamped onto the inner sleeve. - The outer sleeve and the inner sleeve are sized relative to each other such that Rib ([[:en]] gadroons also called) provided on the outer sleeve are supported on the inner sleeve. - The connecting means for connection to the complementary connecting device of the housing is formed integrally with the outer sleeve. - The container comprises means for clamping the outer sleeve on the inner sleeve, arranged to grip portions of the outer sleeve and the inner sleeve between which a flexible film is interposed. - The container comprises an annular seal received in an inner peripheral groove of the outer sleeve, and the flexible film extends between the annular seal and the inner sleeve. - The inner sleeve has a face with a support recess located on the opposite side of the peripheral groove of the outer sleeve. - The inner sleeve has a notched zone adjacent to a support recess arranged to cooperate with complementary notches provided on the inner face of the outer sleeve. - The outer sleeve has a lower skirt extending from the lower edge of the outer sleeve and having longitudinal slots evenly distributed around the sleeve, for forming elastic tabs capable of exerting a clamping force on the inner sleeve. - The elastic tabs comprise means associated with the clamping means. - The connecting device comprises a door mounted on the inner sleeve and closing a through opening. - The flange comprises an annular seal having a substantially L-shaped section received within the region defined by the outer sleeve, the inner sleeve, and the door. - The flexible film and the connecting device are made of a bacteriostatic material.

Brief Description of the Drawings

[0015] Other features and advantages of the present invention will become apparent from the following detailed description of the invention, provided with reference to the accompanying drawings:

Figure 1

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[0016] For clarity, the same or similar elements of the various embodiments are denoted by the same reference numerals throughout the drawings.

[0017] "Lower" means that the part constituting the container or the ends of these parts are farthest from the through-opening of the container, and "upper" means that the part constituting the container or the ends of these parts are closest to the through-opening of the container.

Best Mode for Carrying Out the Invention

[0018] With reference to FIGS. 1 to 5, the container 1 will be described according to the first embodiment of the present invention. The illustrated container 1 includes a flexible film 2 arranged to define an internal space 3 and a through-opening that allows the internal space 3 to communicate with the outside of the film. The container also includes a sealing connection device 4 arranged to allow the flexible film 2 to be connected to a complementary connection device of a sterile housing. The connection is made in such a way as to ensure sterile communication between the internal space 3 of the container 1 and the internal space of the housing.

[0019] The connection device 4 includes a flange to which the flexible film is attached, the flange defining the through-opening of the flexible film and comprising means for connecting to the complementary connection device of the housing. According to the present invention, the flange is composed of two separate pieces, a first piece forming a so-called outer sleeve 5 and a second piece forming a so-called inner sleeve 6, between which the flexible film extends.

[0020] The connection device 4 further includes a removable door 7 attached to the flange so as to close the through-opening. Advantageously, the flange and the door 7 are attached to each other by notches and lugs carried by the inner sleeve 6 and the door 7 respectively. Thus, the flange defines an assembly flange of the flexible film with respect to the door.

[0021] In the illustrated embodiment, the inner sleeve 6 includes a notched zone 64 adjacent to a carrying recess 61 arranged to cooperate with a complementary notch 54 provided on the inner surface 50 of the outer sleeve 5.

[0022] According to an advantageous configuration illustrated in FIG. 4, the outer sleeve 5 comprises a lower skirt 10 including longitudinal slots 11 extending from the lower edge of the sleeve. These longitudinal slots 11 are advantageously evenly distributed around the sleeve. Thus, they define elastic tabs 12 that can exert a uniform clamping force over the entire outer periphery of the inner sleeve 6 when the outer sleeve 5 is mounted on the inner sleeve 6. The elastic tabs 12 comprise means for associating the clamping means, described below, with the inner sleeve 6, respectively, in relation to each other. In the illustrated example, the means for associating with the clamping ring consists of a thread 53 and a notch 54. The clamping means are arranged to grip portions of the outer sleeve 5 and the inner sleeve 6 with the flexible film 2 interposed therebetween. In the illustrated example, the clamping means are in the form of an outer clamping ring comprising an inner thread 90 having a shape complementary to the thread 53 provided on the outer surface 52 of the outer sleeve 5.

[0023] In the illustrated example, the outer sleeve 5 comprises, at its upper periphery, an arrangement of lugs forming connection means to complementary connection devices of the housing.

[0024] The container 1 further comprises a first annular seal 8 housed in a peripheral groove 51 formed on the inner surface 50 of the outer sleeve 5 and the outer surface 60 of the inner sleeve 6. As shown in FIG. 3, the flexible film 2 remains gripped between the annular seal 8 and the inner sleeve 6. To improve the retention of the flexible film 2 between the two sleeves forming the assembly flange, the inner sleeve 6 comprises an outer surface provided with a support recess 61 located on the opposite side of the peripheral groove 51 of the outer sleeve 5. Thus, when the outer sleeve 5 is clamped onto the inner sleeve 6, the annular seal 8 presses the flexible film 2 into the support recess 61, ensuring an improved engagement of the flexible film 2.

[0025] Container 1 further comprises a second annular sealing portion 13 carried by the flange. When the door is in the position closing the through-opening, the annular sealing portion 13 is received within the space defined by the outer sleeve 5, the inner sleeve 6, and the door 7. Advantageously, the annular sealing portion 13 has a cross-section of a shape that matches the region in which it is received. In the illustrated embodiment, the annular sealing portion 13 has an L-shaped section.

[0026] Due to the arrangement of the components, the connection device is assembled by simply clamping the elements according to the stack illustrated in FIG. 5. To fabricate the container 1, the portion of the flexible film located on the side of the through-opening is arranged to be installed between the outer sleeve 5 and the inner sleeve 6. The clamping is effected by clamping the ring 9 on the outer sleeve 6, causing the tab 12 to grip against the inner sleeve 6. The flexible film 2 can be disassembled by turning the clamping ring 9 and removing the outer sleeve 5 from the inner sleeve 6.

[0027] In the described embodiment, the outer sleeve 5 jointly ensures the function of holding the flexible film 2 on the inner sleeve 6 and thus maintaining its assembly to the associated door 7, and the function of connection to the connection device fitted to the housing. FIGS. 6 and below show another embodiment of a container according to the invention, in which the connection function to the complementary connection device is ensured not directly by the outer sleeve 5 but by an additional piece described later.

[0028] Similar to the foregoing variant, the assembly flange of the door 7 with respect to the flexible film 2 consists of the outer sleeve 5 and the inner sleeve 6 to which the door 7 is attached, and the flexible film 2 remains gripped between these two sleeves. The outer sleeve 5 having an axial length less than the axial length of the inner sleeve 6 is sized to surround the lower part of the inner sleeve 6.

[0029] Advantageously, the outer sleeve 5 is attached onto the inner sleeve 6 by clamping. To do this, the outer sleeve 5 comprises an annular groove 15 arranged to engage onto first circumferential fins 20 of complementary shape provided on the outer surface of the inner sleeve 6.

[0030] The outer sleeve 5 further comprises a clamping device 16 which cooperates with a complementary imprint made on the inner sleeve 6 when the sleeve is clamped onto the inner sleeve 6 (Figs. 10 and 11). Thus, the clamping device 16, on the one hand, maintains the axial position of the outer sleeve 5 on the inner sleeve 6 and, on the other hand, maintains the angular position of the outer sleeve 5 on the inner sleeve 6. These thus provide the axial and angular indexing of the outer sleeve 5 on the inner sleeve 6.

[0031] On the one hand, to ensure that the film continues to be gripped between the two sleeves 5, 6 and, on the other hand, to ensure the sealing of the outer sleeve 5 having the flexible film 2 gripped between the two sleeves, the outer sleeve 5 has an inner peripheral surface provided with circumferential girdles 14 arranged to define a compression zone of the film portion 20 engaged between the sleeves together with the outer peripheral surface of the inner sleeve 6 (Figs. 8 and 9). The shapes of the outer sleeve 5 and the inner sleeve 6 are nominally defined such that the girdles 14 present on the outer sleeve 5 interfere with the inner sleeve 6. The girdle 16 is pressed and exerts a radial force on the outer peripheral surface of the inner sleeve 6 and functions as a seal. In the illustrated embodiment, the inner annular portion 7 is located at the lower end of the outer sleeve 5 and comprises a single girdle 14 extending over the entire circumference of the inner peripheral surface of the sleeve. Of course, it is obvious that several different girdles can be provided without departing from the scope of the invention.

[0032] In addition to the outer sleeve 5, the inner sleeve 6 is provided at the top with a collar 30 carrying connection means 31 for connection to a complementary connection device of the housing. Thus, the collar 30 forms a so-called connection flange. The collar 30 will then be referred to as a connection collar or flange.

[0033] The connection collar 30 is attached to the upper end of the inner sleeve 6 by joint clamping with the sealing portion 13 and the door 7 (Figs. 8 and 9). The connection collar 30 includes an internal circumferential extension 32 sized to engage forcibly within the cavity of the sealing portion 13. Also preferably, at the lower part, it includes a hollow annular cavity 33 into which the second circumferential fin 22 of the inner sleeve 6 engages.

[0034] Advantageously, the container comprises first indexing means 40 of the connection collar 30 having an inner sleeve 6 illustrated in Figs. 12 and 13, and second indexing means 41 of the door 7 having an inner sleeve 6 illustrated in Figs. 14 and 15. In the illustrated example, the first and second indexing means are radial fingers.

[0035] In this variant, the clamping ring and the associated sealing portion 8 are each no longer necessary to ensure the maintenance of the flexible film 2 and the sealing of the assembly, and these functions are jointly ensured by the outer sleeve 5 and the associated gadroon forcibly attached onto the inner sleeve 6. To reinforce the sealing of the assembly ensured by the gadroon 14, the flexible film 2 is preferably pre-thermoformed on the inner sleeve 6 so as to form an annular contact line sealed on the surface of the inner sleeve 6. The thermoforming is carried out at the limit of welding of the flexible film on the inner sleeve 6 to ensure complete attachment of the film while maintaining the integrity of the film. When the outer sleeve 5 is fitted onto the inner sleeve 6, the contact line is manufactured to be located above the gadroon 14. Thus, during assembly, the flexible film 2 is held and the force is maintained by the elasticity of two rings that are deformed under a force linked to the displacement induced by the interference defined between the gadroon 14 and the inner sleeve 6 and clamped.

[0036] Advantageously, the inner sleeve 6 comprises a conical chamfer 21 made at the lower end of the sleeve (Figs. 8 and 9) to facilitate threading and sliding of the flexible film 2 over the inner sleeve 6. Further, as in the foregoing example, the inner sleeve 6 and the door 7 each comprise a notch 70 and a lug, enabling them to be assembled by clamping.

[0037] The flexible film 2 and the connection device 4 are advantageously made of an antibacterial material. The sealing portions 8 and 13 are made of a silicone material or other material that minimizes residual phenomena. The sealing portions may also be defined to be made of an antibacterial material.

[0038] The present invention is described above by way of example. It will be understood by those skilled in the art that they are thereby in a position to manufacture various modified embodiments of the present invention without departing from the scope thereof.

Claims

1. A sealed container (1), comprising a flexible film (2) arranged to define an internal space (3) and a through-opening, a door (7) for closing the through-opening, and a sealing connection device (4) arranged to enable the flexible film (2) to be connected to a complementary connection device of a sterile housing by providing aseptic communication between the internal space (3) of the sealed container (1) and the internal space of the housing. The sealing connection device (4) comprises a flange for assembling the door (7) to the flexible film and means for connection to the complementary connection device of the housing. The flange for assembling to the flexible film defines the through-opening of the flexible film (2), and the flange is constituted by two separate pieces respectively forming an outer sleeve (5) and an inner sleeve (6) to which the door (7) is attached. The flexible film (2) is continuously held between the outer sleeve (5) and the inner sleeve (6). The outer sleeve (5) carries the means for connection, and the outer sleeve (5) is clamped and attached onto the inner sleeve. The sealed container (1) comprises means for ensuring the seal between the outer sleeve (5) and the flexible film (2) held between the outer sleeve (5) and the inner sleeve (6). The means for ensuring the seal is an annular sealing part (8) accommodated in an internal peripheral groove (51) of the outer sleeve (5). The flexible film (2) is held between the annular sealing part (8) and the inner sleeve (6). The sealed container (1).

2. The sealed container (1) according to claim 1, characterized in that the inner sleeve (6) is surrounded at the lower part by the outer sleeve (5) and at the upper part by a collar arranged to ensure the connection to the complementary connection device of the housing, and the collar forms the means for connection.

3. The sealed container (1) according to claim 2, characterized in that it comprises a first means (40) for indexing a connection collar (30) having said inner sleeve (6).

4. The sealed container (1) according to claim 2 or 3, characterized in that it comprises a second means (41) for indexing said door (7) having said inner sleeve (6).

5. The sealed container (1) according to claim 1, characterized in that the connecting means (31) of said housing to said complementary connecting device are integrally formed with said outer sleeve (5).

6. The sealed container (1) according to any one of claims 1 to 5, characterized in that it comprises means for clamping said outer sleeve (5) on said inner sleeve (6) arranged to grip portions of said outer sleeve (5) and said inner sleeve (6) with said flexible film interposed therebetween.

7. The sealed container (1) according to any one of claims 1 to 6, characterized in that said inner sleeve (6) comprises a surface provided with a supporting recess (61) located on the opposite side of said annular sealing portion (8) housed in said inner peripheral groove (51) of said outer sleeve (5).

8. The sealed container (1) according to claim 7, characterized in that said inner sleeve (6) comprises a notch zone (64) adjacent to said supporting recess (61) arranged to cooperate with complementary notches (54) provided on the inner surface of said outer sleeve (5).

9. The sealed container (1) according to any one of claims 1 to 8, characterized in that said outer sleeve (5) comprises a lower skirt (10) extending from the lower edge of said outer sleeve (5) and having longitudinal slots (11) evenly distributed around said outer sleeve (5) for forming elastic tabs (12) capable of exerting a clamping force on said inner sleeve (6).

10. Means for clamping the outer sleeve (5) on the inner sleeve (6) arranged to grip the portions of the outer sleeve (5) and the inner sleeve (6) between which the flexible film is interposed, the elastic tab (12) comprising means associated with the means for clamping. The sealed container (1) according to claim 9, characterized in that it comprises such means.

11. The flange comprises an annular sealing portion (13) having a substantially L-shaped section housed within the region defined by the outer sleeve (5), the inner sleeve (6), and the door (7). The sealed container (1) according to any one of claims 1 to 10, characterized in that it comprises such an annular sealing portion.

12. The flexible film (2) and the sealing connection device (4) are made of a bacteriostatic material. The sealed container (1) according to any one of claims 1 to 11, characterized in that it is made of such a bacteriostatic material.

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