A receptacle (1) for biopharmaceutical use comprises a flexible container (2) having a wall (4), an internal space (5) for receiving a liquid or pasty biopharmaceutical content, mixing means (20) adjacent to a given portion (21) of the wall (4), means (22) for rigid and leaktight connection between the mixing means (20) and the given portion (21), the mixing means (20) comprising a sleeve (24), a suction-delivery opening (26), a suction-delivery part (28), a suction-delivery cavity (29), drive means (23) for driving in an alternating forward/backward axial sliding sequence, means (32) for immobilizing the sleeve and the given portion (21), including during the axial sliding movement of the suction-delivery part (28).
The present invention relates to a flexible bag (1) for biopharmaceutical use, including a shell (3) capable of receiving, in the inner space (3a) thereof, a flowable biopharmaceutical product in the general state of a liquid or paste, and comprising flexible walls joined by fixed and sealed rigid-connection areas (4), two opposite walls (5 and 6) of which are connected to each other by the peripheries (7) thereof, at least one inlet port (9) and at least one outlet port (10), a port (9, 10) being combined with a passage of the shell (3) and mounted on said shell by fixed and sealed connection means (15), a plurality n of similar outlet ports (10) suitable for discharging the biopharmaceutical product received in the inner space (3a) and grouped together in a tapping area (12), a tapping wall (5) provided with at least one opening (14) for the passage and mounting of the outlet port (10) for the n similar outlet ports (10), fixed and sealed port-shell (3) connection means (15) which are rigidly, fixedly, and sealingly connected to the tapping wall (5) around the at least one opening (14) for the passage and mounting of the outlet port (10), and an area (8) for folding the two opposite walls (5 and 6).
Une poche (2) comprend : une première enveloppe (1), intérieure, fermée, délimitant un premier espace (6), formant stricto sensu une poche (1) destinée à recevoir le produit ou dispositif biopharmaceutique, une seconde enveloppe (8), extérieure, fermée, délimitant un second espace (9) dans lequel se trouve la première enveloppe / poche stricto sensu (1), des moyens espaceurs (11), au moins un gaz traceur se trouvant dans le premier espace (6) ou dans l'espace intermédiaire (14) à une pression partielle différente de celle de l'espace intermédiaire (14) ou du premier espace (6), au moins une couche de détection colorimétrique (12) responsive à la concentration de gaz traceur qui l'atteint en passant d'une première couleur à une seconde couleur, faisant partie intégrante d'une paroi (3, 4) de la première enveloppe / poche stricto sensu (1) et/ou d'une paroi (13) de la seconde enveloppe (8) et/ou des moyens espaceurs (11).
The invention relates to a device (1), including: a bag (2), a tube section (5) having a wall (10) defining a free longitudinal space (11), and a plastic connector (4), which are all fused together, the wall (10) comprising a contact layer (12) made of a material other than PVC, selected from PE, EVA, PP, ETFE, and PVDF, and a functional layer (13) including at least one basic functional layer (13i) consisting of a material selected for the function thereof (flexibility, sturdiness, handling, opacity or transparence, gas barrier) and selected from the family including PE, PET, a PA, EVA, EVOH, SEBS, PETG, and PVDF, a bag (2), another tube section (5), and/or a connector (4) fused to the biopharmaceutical tube (5) and comprising a contact layer (16) made of a selected material which is capable of being in contact with the biopharmaceutical material, which is capable of being fused onto itself, and which is identical or similar to the material of the contact layer (12) of the biopharmaceutical tube (5). The contact layer (12) of the biopharmaceutical tube (5) is fused to the contact layer (16) of the bag (2), of the other tube section (5), and/or of the biopharmaceutical connector (4), a substantial physical continuity existing between the respective contact layers (12, 16).
B32B 27/00 - Produits stratifiés composés essentiellement de résine synthétique
C12M 1/00 - Appareillage pour l'enzymologie ou la microbiologie
5.
DEVICE FOR SENSING A PARAMETER RELATED TO AN ELECTRICAL PHENOMENON OF A BIOPHARMACEUTICAL CONTENT AND BIOPHARMACEUTICAL CONTAINER COMPRISING SUCH A SENSING DEVICE
The sensing device (12) comprises support and fixing means (13), means (14) for capturing the parameter, fixed rigidly to the support and fixing means (13), comprising a sensing face (14a), situated in a chamber (17), a solid internal chamber end wall (30) disposed transversely, an open part (18) made in the chamber peripheral wall (27), the chamber (17) being a holding chamber (17) able to ensure confinement of the content (C) therein, and being isolated from the inside space (3a) of the container and safeguarded from the agitation prevailing therein, by the internal end wall (30) of the chamber so as to minimize the impact of this agitation on the measurement of the parameter of the content (C) by the sensing face (14a).
The invention relates to a connection part having communication between biopharmaceutical containers and/or conduits, said connection part having a connection sheath (32) and two connection skirts (38a, 38b). The connection sheath (32) and both connection skirts (38a, 38b) have resiliency such that the connection part (30), from the disassembled state, is transversely stretchable, at the site of both connection skirts (38a, 38b) thereof, until transversely widened without loss of integrity so as to be made threadable through both collars (14, 24). Then, due to the resiliency thereof, said connection part contacts, with resilient clamping for support and with sealability, the coupled portion of the outer surface of both collars (14, 24). Moreover, from the assembled state, said connection part is transversely stretchable, at the site of both connection skirts (38a, 38b) thereof, until transversely widened so as to be capable of being unthreaded from both collars (14, 24) and thus be converted to the disassembled state.
F16L 37/04 - Accouplements du type à action rapide dans lesquels l'assemblage est maintenu uniquement par friction des parties assemblées avec partie extérieure élastique pressée contre une partie intérieure de fait de son élasticité
F16L 33/30 - Dispositions d'assemblage des manches avec des organes rigidesRaccords rigides pour manches, p. ex. éléments unitaires s'engageant à la fois dans deux manches comprenant uniquement des pièces disposées à l'intérieur des manches
The invention relates to a sterilizable biopharmaceutical packaging (1) capable of containing biopharmaceutical contents to be sterilized. Specifically, the packaging according to the invention comprises an opening (6) for inserting the biopharmaceutical contents to be sterilized, said opening being separate from the sterilization gas conveyance channel (7) so that the opening (6) for inserting the biopharmaceutical contents to be sterilized can be closed independently and before closing the sterilization gas conveyance channel (7). Additionally, the opening (6) for inserting the biopharmaceutical contents to be sterilized is directly adjacent to the inner space (2) for receiving the biopharmaceutical contents to be sterilized and the sterilized biopharmaceutical contents so that the biopharmaceutical contents to be sterilized are inserted directly into the inner space (2) from outside the packaging (1). The means (12) for controlling the distribution of the sterilization gas is a means (12) for opening/closing the sterilization gas conveyance channel (7) so that the sterilization gas conveyance channel (7) can be opened or closed independently of the opening or closing of the insertion opening (6). Once the sterilization is performed, the outer wall (3), the sterilization gas conveyance channel (7), and the opening/closing means (12) are capable of remaining rigidly connected therebetween so as to form a sterilized biopharmaceutical packaging (1) that contains the sterilized biopharmaceutical contents and can be subjected to one or more integrity tests at any desired time after the sterilization.
A61L 2/20 - Procédés ou appareils de désinfection ou de stérilisation de matériaux ou d'objets autres que les denrées alimentaires ou les lentilles de contactAccessoires à cet effet utilisant des substances chimiques des substances gazeuses, p. ex. des vapeurs
8.
METHOD AND UNIT FOR THE STERILE FILLING OF A FINAL BASIC CONTAINER WITH CONTENT INTENDED FOR THE BIOPHARMACEUTICAL FIELD
The invention relates in particular to a method for the sterile filling of at least one final basic container (cf) with content suitable for being dispensed in a fluid manner and located originally in a source container (CS) in a sterile manner, which comprises: providing at least one sterile chamber (1) having at least one sterile entrance port (2a) and/or (2b) and providing the source container (CS) containing the content, located outside the chamber (1); providing a communication means, a dispensing means (6) and at least one filling member, of the sterile, fluid type, such as to form, when all are assembled, a sterile fluid filling and transfer line (4); inserting at least one final container (cf) into the chamber (1) in a sterile fashion; structurally combining at least one final container (cf) for filling purposes with at least one filling member; in a filling step, content is taken from the source container (CS) and passed into the transfer and filling line (4) and the desired amount is output into said at least one final container (cf); selecting at least the inner members and means (OI) to be of a size that allows said elements to pass through a port (2a, 2b) of the chamber (1) and to be single-use for the planned filling; in a step prior to the filling step, providing inner members and means (OI) in sterile condition, said means and members being located outside the chamber (1); in a subsequent step of inserting the inner means and members (OI) in the chamber (1), also prior to the filling step, inserting the single-use inner means and members (OI) which were previously outside the chamber (1) in the chamber (1) in a sterile manner, such that once filling is carried out, a new filling process can be performed without having to sterilise the inside of the chamber (1).
B65B 3/00 - Emballage de matériaux plastiques, de semi-liquides, de liquides ou de liquides et solides mélangés, dans des réceptacles ou récipients individuels, p. ex. dans des sacs ou sachets, boîtes, cartons, bidons ou pots
B65B 31/02 - Remplissage, fermeture, ou remplissage et fermeture, de réceptacles dans des chambres maintenues en dépression ou en surpression ou contenant une atmosphère spéciale, p. ex. du gaz inerte
9.
MULTILAYER FILM OF A WALL OF A BAG HAVING SEAMS AND INTENDED FOR A BIOPHARMACEUTICAL PRODUCT
The invention relates to a single-layer contact film (8) intended, once secured to a multilayer functional film (9), for forming a final multilayer film (7) of a wall (2) of a bag (1); the bag (1) comprising seams (3) at least on said bag and intended for being filled with a biopharmaceutical product, made of a material selected so as to be suitable for: being used in the formation of a final multilayer film (7) of a wall of a bag; being in contact with the biopharmaceutical product, without damaging the film (7) and the biopharmaceutical product; being sealable on the bag, having a thickness that is less than the thickness of a single contact layer of a final multilayer film (7) of a wall of a bag suitable for the formation of seams of the single contact layer on said layer, one of the surfaces of which has the purpose of providing a securing interface with a first securing interface of the multilayer functional film (9), the other of the surfaces having the ultimate purpose of forming the contact surface between the final multilayer film and the biopharmaceutical product.
B32B 27/08 - Produits stratifiés composés essentiellement de résine synthétique comme seul composant ou composant principal d'une couche adjacente à une autre couche d'une substance spécifique d'une résine synthétique d'une sorte différente
B32B 37/20 - Procédés ou dispositifs pour la stratification, p. ex. par polymérisation ou par liaison à l'aide d'ultrasons caractérisés par les propriétés des couches toutes les couches existant et présentant une cohésion avant la stratification impliquant uniquement l'assemblage de bandes continues
B65D 65/40 - Emploi de stratifiés pour des buts particuliers d'emballage
The invention relates to a method for producing a biopharmaceutical product, consisting in: obtaining a pouch unit (1) including a pouch (2) and at least one port (4) and, where necessary, a functional device (5); filling the pouch (2) with a biopharmaceutical product or components thereof; carrying out the production process and, at at least one moment or step thereof, using or generating a liquid or small solid incident body located inside the biopharmaceutical product; arranging the pouch unit (1) which includes a support and exchange means (6) formed by, or incorporated into the wall (3) of the pouch (2) or into the at least one port (4) or functional device (5), such that this means can be accessed from the internal space (2a) and can be in direct physical contact with the contents of the pouch (2), whereby said means is arranged so that it can be loaded with the incident body and can allow the passage of the body from the support and exchange means (6) into the contents and vice versa, said means being functionally active either permanently or following a dedicated activation operation; and using the pouch unit (1) such that the support and exchange means is in direct physical contact with the contents and such that, when said means is active, the incident body passes from the support and exchange means (6) into the contents and vice versa, and, consequently, the incident body is loaded on the support and exchange means (6) when it is not, or should not be, inside the biopharmaceutical product.
The invention relates to a bag (2) that includes: a first closed inner casing (1) made of at least one non-porous plastic material having a high barrier capacity to gases and delimiting a first space (6) forming stricto sensu a bag (1) capable of receiving the biopharmaceutical material or device, a second closed outer casing (8) made of at least one non-porous plastic material having a high barrier capacity to gases and defining a second space (9) in which the stricto sensu bag (1) is arranged, spacing means (11), at least one selected tracing gas provided in the first space (6) or in the second space (9) outside the stricto sensu bag (1), with a partial pressure higher than that in the second space (9) outside the stricto sensu bag (1) or in the first space (6), at least one colorimetric detector (12) reacting to the concentration of the at least one tracing gas by passing from a first color to a second different color, the at least one colorimetric detector (12) being provided in the second space (9) outside the stricto sensu bag (1) or in the first space (6), respectively.
B65D 77/04 - Objets ou matériaux enfermés dans plusieurs réceptacles disposés les uns dans les autres
B65D 79/02 - Arrangements ou dispositifs pour indiquer un stockage ou un transport incorrects
B65D 81/20 - Réceptacles, éléments d'emballage ou paquets pour contenus présentant des problèmes particuliers de stockage ou de transport ou adaptés pour servir à d'autres fins que l'emballage après avoir été vidés de leur contenu fournissant une ambiance spécifique pour le contenu, p. ex. température supérieure ou inférieure à la température ambiante sous vide ou pression superatmosphérique ou en atmosphère spéciale, p. ex. sous gaz inerte
12.
RIGID CONTAINER FOR A FLEXIBLE POUCH FOR HOLDING A BIOPHARMACEUTICAL FLUID, ASSEMBLY COMPRISING SUCH A FLEXIBLE POUCH AND SUCH A CONTAINER, AND METHOD FOR USING SUCH A CONTAINER
The invention relates to a container (1) including a bottom wall and an erect side wall defining a top opening (6) of a cavity (7) for receiving a flexible pouch (2) holding a biopharmaceutical fluid, and compression means (14) including a compression wall (15), the gap between the peripheral edge thereof and the side wall being limited. The compression wall (15) can be applied against the pouch (2) and be fixedly retained in said position by active-state retaining means (16) which are arranged in the container (1) and are supported by the compression means (14) via a structural and functional combination, being mobile or deformable between an inactive retracted state and an active expanded state, wherein a distal end portion is either spaced apart from the side wall or applied against the same without any possibility for accidental sliding, and being able to be applied at any desired location of an area of the side wall such that the compression wall (15) can be applied and retained against the pouch (2) regardless of the fill level thereof.
The invention relates to a mixing container comprising a flexible container, mixing means and an upper bearing having a rigid flange. Said flange is provided with an insertion passage that fluidically communicates with the inside space on one end and with the outside of the container on the other end. Said flange is fixed in a rigid and sealing manner to the upper part of the wall of the container around an insertion opening, the insertion passage and the insertion opening communicating fluidically. The flange also supports, on the inside thereof, an upper bearing that is arranged inside, adjacent to the insertion passage, without preventing the fluidic communication between the insertion passage and the insertion opening. The mixing container is used to receive a biopharmaceutical content to be mixed.
The invention relates to a piece (1) mounted in a fixed, detachable, and sealed manner, on a rigid, annular collar (8) of a second piece (2) having an end opening (3), the piece (1) comprising an annular peripheral wall (15) having an inner face (15a) that can come into contact with the outer face (10) of the collar (8). Said first piece is designed such that it comprises a transversal wall (14) that can enter the opening (3); and an annular wall forming a skirt (15), the inner face (15a) of said skirt including a part (39a) with a larger diameter, a part (39b) with a smaller diameter and an intermediate part (39c) that can come into contact with the conjugated parts (10a, 10b et 10c) of the outer face (10) by clamping in a holding manner. The transversal wall (14) and the skirt (15) form one component and are made of a material having a high degree of flexibility enabling the piece (1), by a manual external action, to be brought into an intermediate state wherein it is sufficiently enlarged to be slipped over or removed from the second piece (2), while remaining in the field of elastic deformation.
The invention relates to a piece (1) mounted in a fixed and rigid manner on a rigid annular collar (8) of a second piece (2) having an end opening (3). Said piece (1) comprises a transversal wall (14); an annular wall forming a skirt (15), the inner face (15a) of said skirt including a part (39a) having a larger diameter and a part (39b) having a smaller diameter; a holding toric body (45) adjacent to the inner face (15a), deformable between a retracted state and an expanded state, and filled with a swelling medium; and at least one inlet/outlet port (46) for the swelling media, communicating with the holding body (45). The dimensions of the first piece are selected in relation to those of the collar (8), in such a way as to enable the first piece to be able to be slipped onto, or removed from, the second piece (2), when the holding body (45) is in the retracted state, and to be mounted onto the collar (8) in a fixed, rigid and tight manner, when the holding body (45) is in the expanded state.
The invention relates to a method for closing and cutting a collapsible tube, wherein a cutting member (2) and a pinching closing device (1) are provided for cutting into two sections (3a, 3b), each with two portions (4a, 4b, 5a, 5b) having cavities (11 a, 11 b) that can be placed in removable extension by combination means (24a, 24b, 27, 32) and providing a passage (22) with one entrance (26), the pinching closing device (1) for cutting being in the open or closed state in which the sections (3a, 3b) are closed by locking means (25a, 25b) and in which the surfaces (13, 14) form a passage (23) for pinching and closing the tube; the pinching region of the tube is positioned in the cavity (11a) of one section (3a); the other section (3b) is positioned opposite the preceding section and the pinching closing device (1) for cutting is placed in the closed state, with the engagement of locking means (25a, 25b), the tube being positively pinched and closed in two positive pinching areas and maintained as such; the tube is cut between the portions (4a and 5a, 4b and 5b) in the closed state, using the cutting member (2), making said member pass through the passage (22), without interfering with the pinching closing device (1) for cutting, and the portions (4a and 4b, 5a and 5b) are separated.
The invention relates to a pinching device (1) including two sections (3a, 3b), each having a hollow portion (4a and 5a) with male (11b) and female (11b) cavities, and locking means (25a and 25b), the surfaces (13 and 14) of the cavities (11a and 11b) forming a passage (23) for positively pinching the tube. The male cavity (11 b) is U-shaped with a web (37) and two flanges (38a, 38b), the female cavity (11 a) is U-shaped with a web ((35) and two flanges (36a, 36b), and the pinching passage is U-shaped with a web (41) and two flanges (42a, 42b). The two opposing flanges (36a, 38a and 36b, 38b) gradually come closer together towards the ends thereof (43) opposite the webs of the cavities (35 and 37) and each of the two flanges (42a and 42b) of the pinching passage (23) has an opening with a width that decreases towards the end thereof opposite the web (41) of the pinching passage (23). The width of the opening of the pinching passage (23) is at least slightly smaller than twice the thickness of the wall of the collapsible tube to be pinched. The invention intends to constitute a single-use pinching closing device 1, performing a function of closing the tube onto itself in the pinching region, preventing the flow of fluid in the tube.
The invention relates to a mixing process, a spraying and dispersing device and a mixing device for implementing the process. The process of mixing content (C) in a container (2), of the type in which a container (2) is provided which has means for introducing the components and mixing means (14), components of the content (C) are provided, and the components are then introduced into the container (2) and are mixed, is characterized in that on the one hand a mixing facilitator Fm is provided, a spraying and dispersing device (15) which can be joined to a container (2) at one of its introduction means is provided and can be in an active functional state in which it enables a liquid to be sprayed and dispersed into the container (2), and then, in a first phase, the content base (Cb) and then the component to be mixed (Cm) are introduced into the container (2) without filling it and, in a second phase, the mixing facilitator (Fm) is introduced into the container (2) through the introduction means (3) and is sprayed by dispersing it towards the component to be mixed (Cm) by means of said spraying and dispersing device (15) which is placed in the active functional state.
3D CONTAINER WITH RIGID FRAME, DEFORMABLE CONTAINER AND FUNCTIONAL MEANS FOR PROCESSING THE CONTENT AND INCLUDING AN INNER MEMBER FOR BIOPHARMACEUTICAL APPLICATIONS
According to the invention, the frame defines an inner space and comprises a peripherally closed side wall and two transverse openings or one transverse opening and an end transverse wall. The frame is adapted for ensuring the sealed connection of the open free edge of a side wall in the form of a film of an at least partially deformable container. The frame is specially adapted for making a 3D container. The frame can further be used as a bearing for at least one functional port or port for attaching a functional means. The axial size thereof is sufficient for defining a space having dimensions at least equal to the axial overall dimensions of the functional means so that the latter can be entirely housed within the inner space.
The invention relates to providing a bag (1) including at least one side bellow (4) and at least one port (8), a pressurised gas source (10), and a means for measuring the gas pressure; providing two expansion-limiting plates and two spacing plates; placing the bag flat between the two expansion-limiting plates (2a, 2b); inserting between the two small walls of each bellow at least one spacing plate (15a, 15b) in order to prevent these walls from being pressed against each other; connecting the port with the gas source and the pressure measuring means; feeding the pressurised gas into the bag, the bag expansion being limited by the expansion-limiting plates; then comparing the pressure drop in the bag to a predetermined threshold.
G01M 3/32 - Examen de l'étanchéité des structures ou ouvrages vis-à-vis d'un fluide par utilisation d'un fluide ou en faisant le vide par mesure du taux de perte ou de gain d'un fluide, p. ex. avec des dispositifs réagissant à la pression, avec des indicateurs de débit pour récipients, p. ex. radiateurs
The invention relates to a device (1) for connecting to a vessel (2) an accessory having an active portion (9) that comprises a first member (15), a second member (16), a third member (17) and a chamber (18). The function of the first member (15) is to ensure the rigid attachment of the connection device (1) to the vessel (2), to define a passageway, to act as a holder for the second member (16) and as a translation guide between a first distal state and a second proximal state, to contribute as a guide for the third member (17) and to participate in the definition of the chamber (18). The function of the second member (16) is to act as a holder for the third member (17) which is rigidly attached thereon, to define a mobile member capable of sliding between the first distal state and the second proximal state. The function of the third member (17), that comprises a head (14), is to act as a holder for the accessory (3) which is rigidly attached thereon, to define a mobile member capable of sliding between the first distal state and the second proximal state, to ensure in the first distal state the tight closing of the opening (7) using the head (14), to ensure in the second proximal state a protection of the active proximal portion (9) using the head (14), and to participate in the definition of the chamber (18). The chamber (18) is tightly closed in the first distal state and, in the second proximal state, communicates with the inside (4), and the function of the chamber is to house therein or to place at the periphery thereof the active proximal portion (9), to contain a storage liquid, to contain a liquid for adjusting, controlling or calibrating the accessory (3), or to define a tightly closed chamber in which the accessory (3) is placed before being used.
brevets
