EP2645981A1

EP2645981A1 - Bag for distributing a product for biopharmaceutical use in the general state of a liquid or paste via a plurality of outlet ports

Info

Publication number: EP2645981A1
Application number: EP11801771.4A
Authority: EP
Inventors: Nicolas Mendyk
Original assignee: Sartorius Stedim Biotech SA
Current assignee: Sartorius Stedim FMT SAS
Priority date: 2010-12-01
Filing date: 2011-11-25
Publication date: 2013-10-09
Anticipated expiration: 2031-11-25
Also published as: WO2012072924A1; EP2645981B1; FR2968197A1; US20130319575A1; FR2968197B1; CN103476381B; CN103476381A

Abstract

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).

Description

Distribution pocket via a plurality of output ports of a biopharmaceutical product in the general liquid or pasty state

The invention relates to a dispensing bag via a plurality of output ports of a product for biopharmaceutical use in the general state of liquid or pasty. According to its different aspects, its object is the pocket in question, whether in an unfolded configuration or in a folded configuration, a distribution assembly comprising such a pocket, a method of implementing such a pocket. and finally a method of producing such a pocket. By convention, the term "biopharmaceutical product" is intended to mean a product in the general liquid or pasty state, suitable for flow, derived from biotechnology (culture media, cell cultures, buffer solutions, artificial nutrition liquids) or having a pharmaceutical purpose.

It is known from the state of the art a single-use flexible pouch for dispensing a biopharmaceutical product via a plurality of output ports to receptacles, such as elementary containers. Such a known pouch firstly comprises an envelope adapted to receive in its interior space the biopharmaceutical product and comprising, united by fixed and sealed zones of attachment, flexible walls, of which two opposite walls connected to one another. by their peripheries. It then comprises at least one port of entry through which the interior space can be filled with the biopharmaceutical product. Finally, it comprises a plurality of output ports for the simultaneous distribution by them of the biopharmaceutical product located in the interior space, to receptacles, such as elementary receptacles. Such an input or output port is associated with a passage of the envelope and mounted on it by means of fixed and sealed connection. For a biopharmaceutical use such as typically the development, storage or transport of biopharmaceutical product, we generally know flexible bags for single use whose two walls are directly joined to each other by fixed and sealed zones of attachment, for example folding, gluing or welding, and which, when expanded, have a limited volume, for example 20 liters, and remain relatively thin, which justifies that we often call them pockets "Pillow" or "2D" pockets (D meaning dimensions). Flexible single-use flexible pockets are also known which comprise two walls united and secured by means of two welded lateral gussets, which can be folded extended or unfolded deployed, the volume then being able to be at least 50 liters, up to 3,000 liters or more. Such 3D bags are described for example in WO00 / 04131 or sold under the trademark FLEXEL ^® 3D. These 2D or 3D pockets have fixed and sealed securing zones, at least some of which are of the bonding or welding type, and ports interposed at the location of the fastening zones.

For use such as blood collection and treatment or perfusion or parenteral fluid collection, there are known flexible 2D disposable pouches of smaller volume (e.g., typically 500 ml for blood and 50 ml to 3,000 ml for infusion) having ports of entry and at the location of the joining zones by gluing or welding or at least partly in the end of the extended pocket, as illustrated for example in the documents US 3 1 10 308, US 4 362 158, and US 3 205 889. The invention does not relate to these applications. US 2009/0105683 discloses a disposable container for biological products comprising a unitary sheet of biologically compatible flexible material, an access zone integrally molded into said sheet, at least one port in said access area to allow materials biological fluid to be introduced into said container, said web being folded along said access area such that an upper portion of said sheet is adjacent to a lower portion of said sheet, and adjacent to a lower portion of said sheet a connecting portion of said upper portion to said lower portion.

The document FR 2528801 describes a sachet for the slow flow of a liquid medium such as an infusion, having at one end at least one tubing at the opposite end a suspension opening, welds closing its lateral edges, the tubings being attached to a base which is adherent to the bag along a fold line from which the opposite walls of the bag extend, this line passing substantially through the geometric axis of each of the tubings.

The document US Pat. No. 4,362,158 describes a bag for human blood and its fractions, dialysis solutions, infusion solutions ... constituted in such a way that when it is suspended it allows the complete or total evacuation of its contents, thanks to an active means in the form of a bellows.

The invention relates to a use in which it is a question of filling with a biopharmaceutical product a set of p receptacles, such as similar elementary receptacles of relatively small unit volume, for example of the order of a few milliliters to a few centiliters. under sterile conditions, from the same single-use flexible bag receiving a larger quantity of biopharmaceutical product and having a plurality of n similar output ports, the number p of containers being generally larger, and even much larger, than the number n of output ports. In this case, filling of all the containers is carried out in several passes, each in which filling is simultaneous for a number n of containers. In this case, it is generally sufficient that the interior space of the pocket has a volume of between 2 and 20 liters, this value range being given for information only.

For such use, it is important that during the implementation of the pocket, the distribution of the biopharmaceutical product by the n output ports is done simultaneously and identically for the n output ports, particularly with regard to the quality and the quantity of biopharmaceutical product distributed. It is also important that at the end of the process, the pouch can be emptied completely or substantially completely from the biopharmaceutical it contains. These goals are difficult to achieve, if not are, when the pocket has ports of entry and exit arranged at the location of the joining zones by gluing or welding. This is the context and the problem underlying the invention.

For an application and relative to a context other than those of the invention, the document US 3,554,256 describes an intravenous container allowing the addition of drugs or other ingredients (vitamin example) to the contents of a container. flexible plastic for administration to a patient. This flexible intravenous container has a flexible tubular compression body, each end of which is aseptically sealed. An output connector is provided halfway between the ends to be connected and allows to connect an intravenous tube. The ends of the compression body are adapted to be fixed to a post support so that the compression body can be folded in its middle and its ends easily fixed on the post support, the output connector being disposed at the bottom of the body of contention. At least one additional connector is provided near one of its ends for the addition of drugs or other ingredients. Initially, one end of the tubular compression body is welded and the other end is left open to fill the compression body with liquid intravenously. Then, after this filling, this open end is closed. The container according to US 3,554,256 is not directed to an application and does not relate to a context in which it is necessary to fill a biopharmaceutical product with a plurality of like elementary receptacles of relatively small unit volume from the same disposable flexible pouch receiving a larger quantity of biopharmaceutical product and having a plurality of n similar output ports, the number p of containers being larger, and even much larger, than the number n of output ports. Thus, the container according to the document US Pat. No. 3,554,256, on the one hand, has no input port of its contents other than one or two ports for adding a drug or other ingredient, and on the other hand, has only one and only one output port. Finally, if the container according to the document US Pat. No. 3,554,256 is concerned with the question of filling the container with an addition of drugs or other ingredients, it does not pay any attention to the problem of the distribution of the contents of the container. several ports of exit so that it is done simultaneously and in the same way for the various ports, especially with regard to the quality and the quantity of biopharmaceutical product distributed. He is not more interested in the problem of emptying the entire bag at the end of the process.

There is therefore the unmet need for disposable flexible pouches of the type comprising an envelope adapted to receive in its interior space a biopharmaceutical product and comprising, joined by fixed and sealed securing zones, flexible walls, two walls of which. opposites connected to each other by their peripheries, at least one port of entry through which the inner space can be filled with the biopharmaceutical product, and a plurality of n ports of exit for the distribution of the biopharmaceutical product, such as that during the implementation of the pocket, the distribution of the biopharmaceutical product by the n ports of exit is done simultaneously and in an identical way for the different ports, in particular with regard to the quality and the quantity of product distributed biopharmaceutical and that at the end of the process, the bag can be emptied totally or substantially completely of the biopharmaceutical product it contains.

The invention aims to meet this need.

For this purpose, according to a first aspect, the subject of the invention is a ladle for dispensing a dose of a biopharmaceutical product in the general liquid or pasty state capable of flow, into a set of receptacles, comprising a envelope adapted to receive in its interior space the biopharmaceutical product and comprising, joined by fixed and sealed zones of attachment, flexible walls, of which two opposite walls connected to each other by their peripheries, at least one port of entry through which the interior space can be filled with the biopharmaceutical product, and a plurality of n output ports which are communicatively associated with n external drain / fill tubes, and through which biopharmaceutical product can be discharged from space interior to a plurality of receptacles communicatively associated with the n output ports to fill them with a dose of biopharmaceutical product, a port being associated é to a passage of the envelope and being mounted on it by means of fixed and sealed connection.

This pocket is such that:

^■ the n output ports are grouped and the like, particularly in the vicinity of each other, in a continuous stitching zone and delimited by the outlet ports or nearby located on a stitching wall of one of the two walls , distinct from the zones of joining, linearly extended or surfaciquement extended of area much smaller than the area of the face of the wall of stitching,

^■ the bag comprises a stitching wall provided with at least one passage opening and exit port assembly for the n output ports, and fixed and sealed connection port means / shell secured fixed and sealed to the stitching wall around the at least one exit and exit port opening,

^■ the bag comprises a bending zone of the two walls at or near which is the stitching zone, at the location of which the two walls can be folded on themselves with the face of the wall stitching located outside the fold forming an end edge of the folded pocket at or near the location of the stitching area and the n output ports.

Thus, the pocket may be either in an unfolded configuration with both extended walls, or in a folded configuration with the two walls folded on themselves in the folding zone and the face of the stitching wall outside the fold, and in which the pocket can be filled with biopharmaceutical product, with the end edge disposed and maintained as the lower edge, that when the pocket is implemented in the folded configuration, the evacuation of the biopharmaceutical product is done simultaneously and identically by the n output ports and that the biopharmaceutical product is distributed to the plurality of receptacles in communicating association to fill them with a dose of biopharmaceutical product, that this process can be reiterated with several plurality of receptacles, and that once the set of receptacles filled with a dose of biopharmaceutical product, the bag can be emptied totally or substantially completely of biopharmaceutical product. According to one embodiment, two output ports in the vicinity of each other are spaced apart from each other by a distance chosen so that the flow of the biopharmaceutical product through one of the output ports does not disturb not substantially flow of the biopharmaceutical product through the other output ports. According to possible embodiments, the area of surface-extending stitching has an area less than 1/5 ^th , more particularly less than 1/10 ^th , more particularly still less than 1/20 ^th of the area of the stitching face,

According to one characteristic, the stitching zone is either linearly extended or surface-lengthwise extended along a stitching segment and, in one embodiment, the stitching segment comprises at least one substantially rectilinear section and, in particular, it is substantially straight.

According to one embodiment, the n analog output ports are distributed at least substantially uniformly throughout the quilting zone, and more particularly, are at least substantially regularly spaced from each other.

According to one embodiment, the n analogous output ports are distributed at least substantially uniformly, in particular at least substantially regularly spaced apart from one another, in all of several stitching sub-zones, each stitching sub-zone being continuous. delimited by exit ports or their proximity, and linearly or surface-extended, the plurality of sub-areas of stitching constituting the stitching area being separated by areas without stitching.

According to this embodiment, a stitching sub-zone is either linearly extended or surface-lengthwise extended along a stitching sub-segment, in particular a stitching sub-segment comprising at least one substantially rectilinear section, more especially substantially rectilinear and / or extending at least substantially parallel to the stitching segment.

According to this embodiment, at least some of the stitching sub-segments, in particular all the stitching sub-segments, are situated at least substantially parallel to each other or at least substantially in extension of one another.

According to the embodiments, either at an output port and output port aperture is associated with a port of the plurality of n output ports or an output port gateway and output port is common to a plurality of ports. the plurality of n analog output ports is the pocket has a single common port output and output port aperture to the n similar output ports.

According to one embodiment, an output port comprises communicatively associated a draining / filling tube at its proximal end and a securing plate forming part of the fixed and sealed connection means port / envelope, secured, in particular by gluing or welding, in a fixed and watertight manner at the stitching wall around a passage opening and outlet port opening. According to one embodiment, the emptying / filling tubes are able to be communicatively associated at their distal ends with receptacles for filling them with the biopharmaceutical product, and to be functionally associated with evacuation or withdrawal withdrawal means. / dosing, in particular programmed or ordered. According to one embodiment, either a connection plate is associated with an output port or a connection plate is common to several output ports, or the pocket has a single joint plate common to the n output ports.

According to one embodiment, the pocket has as many fastening plates as stitching sub-zones, each fastening plate being associated with a stitching sub-zone.

In one embodiment, a fastening plate has an internal face shaped to facilitate the emptying, in particular the complete emptying, of the biopharmaceutical product. According to one embodiment, the stitching zone and / or the folding zone is located at or near the central zone of the face of the stitching wall and / or a central axis of the face of the wall. stitching between the opposite periphery sections of the face of the stitching wall.

In one embodiment, no port is located on the face opposite to the face of the stitching wall and / or in the securing zones.

In one embodiment, the at least one input port is located on the stitching wall at or near the stitching area or at a location separate from the stitching area. According to one embodiment, an input port comprises communicatively associated a filling / feeding tube at its proximal end, adapted to be associated in a communicating manner at its distal end to a biopharmaceutical product supply, with in particular interposition of a filter, and able to be associated functionally with means of stopping supply or feeding / dosing, in particular programmed or controlled. In particular, the bag comprises a plurality of input ports, each communicatively associated with a first section of filling / feeding tube at its proximal end, said plurality of first filling / feeding tube sections being associated with each other. communicating manner at their distal ends to the proximal end of a second common section of filling / feeding tube adapted to be associated in a communicating manner at its distal end to the supply of biopharmaceutical product, with in particular the interposition of a common filter, the supply stop or feed / dosing means being associated with the second common section of filling / feeding tube. In one embodiment, the bag further comprises at least one inlet and / or gas outlet port.

According to one embodiment, the areas of the face of the stitching wall and the opposite face spaced apart from the folding zone and the stitching zone form suspension zones of the pocket in its folded configuration, including suspension members, such as holes or projections.

In one embodiment, the bag comprises means able to keep the two opposite walls folded on themselves when the bag is in the folded configuration, including holding members complementary to each other. According to one characteristic, the bag is in an unfolded configuration in which the two opposite walls are extended.

According to another characteristic, the bag is in a folded configuration in which the two opposite walls are folded on themselves in the fold zone with the face of the stitching wall located outside the fold, the pocket in the configuration. folded having, in the fold zone, an end edge at or near the location of the stitching area and the n output ports.

According to a development, the pocket comprises means capable of maintaining a permanent communication between the two inner subspaces located on either side of the folding zone.

According to one characteristic, the bag is a pocket of the 2D type, essentially comprising two flexible walls of the same shape, joined by zones of attachment to their peripheries.

According to one characteristic, the interior space of the pocket has a volume of between 2 liters and 20 liters.

In one embodiment, the pouch is sterilized. According to a second aspect, the subject of the invention is a set of dispensing a dose of a liquid or pasty general flowable biopharmaceutical product, in a set of receptacles, comprising:

^■ a dispensing pouch of a dose of a biopharmaceutical having a folded configuration, in particular a pocket in the state filled with biopharmaceutical product,

^■ means for holding of said own pocket in that the end edge located at or near the bending zone or the lower edge of the pouch, the inner space positioned as above,

^■ of communicatively association means of the distal end of the drain pipes / filling with receptacles for their filling with the biopharmaceutical product in the inner space of the pouch,

^■ means for stopping evacuation or withdrawal / dosing, in particular programmed or controlled, functionally associated with the emptying / filling tubes.

In one embodiment, wherein the bag is such that an inlet port comprises communicatively associated with a filling / feeding tube at its proximal end, the dispensing assembly also comprises connecting means in a communicating manner of the distal end of the filling / feeding tube to the biopharmaceutical product supply, and supply or feed / dosing stop means, in particular programmed or controlled, functionally associated with the filling / feeding tube for filling the pocket internal space with the biopharmaceutical product from the biopharmaceutical product feed.

According to one embodiment, the means for stopping evacuation or withdrawal / metering functionally associated with the emptying / filling tubes comprise a pump, such as a peristaltic pump or a pump known as "RDP" (for Rolling Diaphragm Pump) or a similar pump, structurally associated with each drain / filling tube set for the distribution of successive doses of biopharmaceutical product, and / or the power supply or feed / dosing means associated in a functional manner. to the filling / feeding tube comprise a pump structurally associated with the filling / feeding tube.

According to one embodiment, the distribution assembly also comprises:

^■ overtaking detecting means with a minimum amount and a maximum amount of biopharmaceutical product in the inner space of the pouch,

^■ and means for controlling means for stopping discharge or removal / dosage associated with drain pipes / filling and supply stop means or feeding / dosing associated with the filling tube / power supply, responsive to said overshoot detection means, such that when the amount of biopharmaceutical product in the inner space of the bag reaches the minimum amount, the control means controls the operation of the feed stop means or feeding / dosing associated with the filling / feeding tube to fill the inner space of the pocket with the biopharmaceutical product from the biopharmaceutical product feed and when the amount of biopharmaceutical product in the inner space of the bag reaches the maximum amount, the control means controls the operating the feed stop or feed / dosing means associated with the filling / feeding tube to stop filling the inner space of the bag with the biopharmaceutical product from the biopharmaceutical product feed.

According to one embodiment, the distribution assembly also comprises:

Feed means of a plurality, in particular of n receptacles not yet containing said dose of biopharmaceutical product,

^■ means for discharging a plurality, in particular n, receptacles containing said dose of biopharmaceutical product. In one embodiment, the receptacles are located within an aseptic chamber and the biopharmaceutical product supply is located outside the aseptic chamber, the bag being located either indoors or outdoors of the aseptic chamber, the wall of the aseptic chamber being traversed respectively by the drain / filling tubes or by a filling / feeding tube.

According to a third aspect, the subject of the invention is a dispensing method for the implementation of a pocket for dispensing a dose of a biopharmaceutical product as described, with a view to dispensing the same dose of biopharmaceutical product by the plurality of n output ports in p receptacles, the number p of receptacles being larger, and even much larger, than the number n of output ports, wherein:

^■ one has a flexible bag having a non-folded configuration as described previously,

^■ the biopharmaceutical product is available,

^There are receptacles not yet containing the said dose of biopharmaceutical product,

^■ first, the bag is folded in the bending zone so that the two opposite walls are folded over themselves with the face of the stitching wall located outside the fold forming an edge of end of the folded pocket, at the place where the stitching zone and the n exit ports are situated, and thus the pocket is brought into its folded configuration as described above, and secondly, fills the inner space of the pocket with the biopharmaceutical product, via at least one input port; thirdly, the n output ports are communicatively associated with a first plurality, in particular n, containers not yet containing said dose of biopharmaceutical product, and fourthly, the end edge is disposed and maintained so that it is and remains the top edge of the pocket,

^And then, the evacuation of the biopharmaceutical product through the n exit ports is carried out simultaneously, and the same dose of biopharmaceutical product is distributed in the first plurality of receptacles, so as to obtain a first plurality of receptacles containing said dose of biopharmaceutical product,

^■ then, while the evacuation of the biopharmaceutical product by the n output ports is prevented, said first plurality of receptacles containing said dose of biopharmaceutical product are evacuated, and a second plurality, in particular n, receptacles not yet containing said dose of biopharmaceutical product, and the process is repeated with this second plurality of receptacles, and so on until the receptacles have been filled.

According to the embodiments, firstly the bag is folded and then the inner space of the bag is filled with the biopharmaceutical product, or the inner space of the bag is first filled with the biopharmaceutical product. and then the pocket is folded.

According to one embodiment, there are also means for holding the pocket and in which they are implemented so that the end edge of the pocket located at or near the area of folding is the lower edge of the pocket, the interior space being placed above.

According to one embodiment:

^■ the one hand, is brought by the feeding means, a plurality, particularly of n containers not yet containing said dose of biopharmaceutical product and communicatively one associates the distal end of tube draining / filling said plurality of receptacles,

^■ on the other hand, is discharged by the discharge means, a plurality, in particular n, receptacles containing said dose of biopharmaceutical product.

According to one embodiment:

With the detection means, it is detected that a minimum quantity and a maximum quantity of biopharmaceutical product in the internal space of the pocket have been exceeded,

^■ and, in function of the detection and control means, it controls the discharge stop means or removal / dosage associated with drain pipes / filling and feed shut-off means or feeding / dosing associated with the filling / feeding tube, so that when the quantity of biopharmaceutical product in the inner space of the bag reaches the minimum quantity, the operation of the stop means is controlled. feeding or feeding / dosing associated with the filling / feeding tube to fill the inner space of the bag with the biopharmaceutical product from the biopharmaceutical product feed and that when the quantity of biopharmaceutical product in the biopharmaceutical product internal space of the pocket reaches the maximum quantity, it controls the means of stopping supply or feeding / dosing associated with the filling / feeding tube to stop filling the space inside the pouch with the biopharmaceutical product from the biopharmaceutical product feed. According to a fourth aspect, the subject of the invention is a method for producing a dispensing bag, in which:

^■ there is plastic film capable of being cut and secured to itself and to form flexible pocket walls,

There is at least one input port and a plurality of n output ports,

^■ film cutting means and fastening means are available,

^■ is cut the film to the desired shape of the pocket walls, in particular two opposite walls,

^■ at least one exit and exit port opening aperture for the n output ports is cut in a stitching wall,

^■ and the pocket walls are joined fixedly and sealingly and output ports in the wall of stitching around the at least one passage opening and exit port assembly.

According to one embodiment, there is communicatively associated a drain / filling tube at its proximal end and a securing plate and the securing plate is secured, in particular by gluing or welding, in a fixed and watertight manner. stitching wall around an opening port and outlet port mounting.

According to one embodiment, at an input port, a filling / supply tube is communicatively associated with its proximal end, in particular, the bag comprising a plurality of input ports, one associates with each a first section of filling / feeding tube at its proximal end, and communicatively associating said plurality of first filling / feeding tube sections at their distal ends with the proximal end of a second common section of filling / feeding tube.

Several embodiments of the invention will now be described with the aid of the drawings in which:

FIG. 1 is an elevational view of a flexible disposable 2D dispensing bag according to the invention in the unfolded and empty configuration of a biopharmaceutical product, this pouch comprising here and by way of example only; six analog biopharmaceutical output ports with platens, drain / fill tubes communicatively associated at their proximal ends to the outlet ports and partially depicted, and evacuation or withdrawal / dosing stop means represented here purely symbolically, two input ports, here without filling tube / power supply, located near the quill area of the output ports surfaciquement linearly extended, being closer to the periphery close to the wall of stitching as the output ports, four gas inlet / outlet ports, two hanging holes, the pocket being viewed from the side of the stitching face,

FIG. 2 is an elevational view similar to FIG. 1, the pouch being seen on the side of the face opposite to the stitching face;

FIG. 3 is a view from above of the pocket of FIG. 1,

FIG. 4 is a side view of the pocket of FIGS. 1 and 2, FIG. 5 is an elevational view illustrating a portion of a dispensing assembly according to the invention, comprising the pocket of FIGS. 1 to 4 in the folded configuration with the quilting face situated outside the fold, and suspended such that the bag has an end edge in the stitching area and the like exit ports, the bag being viewed from a first side, the bag being in a position to dispense the biopharmaceutical product to a set of receptacles, here fill a set of p elementary containers, the drain / fill tubes being associated communicatively at their distal ends to these containers and being functionally associated with the discharge stop means or draw / metering represented symbolically, as previously, the figure also showing means for maintaining the pocket adapted so that the end edge located at or near the folding zone is the bottom edge of the pocket and that the inner space of the pocket is placed at the top,

FIG. 6 is a view similar to FIG. 5, the pouch being seen from the second side opposite the first side,

FIG. 7 is a side view of the dispensing assembly and the bag of FIGS. 5 and 6, whereas the bag is in the filled state of a biopharmaceutical product,

FIGS. 8A and 8B are two simplified schematic views of a 2D pocket in the unfolded and empty configuration of a biopharmaceutical product, illustrating different embodiments with respect to analog biopharmaceutical product output ports and input ports, i.e., with respect to FIG. 8A, twelve analogous output ports in two superficial linearly extended sub-areas arranged in close proximity to each other in a parallel manner and a remote input port of the stitching zone but located on the quilting face and, with respect to FIG. 8B, six similar output ports in two superficial extended sub-zones and an entry port situated in the quilting zone between the two sub-zones. - areas of stitching,

FIG. 9 is a sectional view on a larger scale illustrating an exit port with a tube section and at its proximal end a securing plate forming part of the fixed and sealed port / envelope connection means, fixedly secured and tight to the stitching wall around an opening port and outlet port mounting,

FIG. 10 is a diagram illustrating a portion of a dispensing assembly according to the invention including a dispensing bag in the folded configuration and the filled state, as in FIG. 7, the holding means and the receptacles (or containers) not being shown here, the means for stopping discharge or withdrawal / metering, functionally associated with the emptying / filling tubes being represented symbolically, the bag having two input ports with, associated so communicating, a filling / feeding tube at its proximal end, and communicatively connecting means of the distal end of the filling / feeding tube to a supply of biopharmaceutical product, and stop means of feed or feed / dosing system, functionally associated with the filling / feeding tube symbolically represented.

Referring now more specifically to Figures 1 to 7 and 10 which show a dispensing pocket, 2D, flexible as a whole, disposable, especially for use biopharmaceutical for dispensing a biopharmaceutical product into a set of receptacles, such as here a set of elementary receptacles 2. Such a pouch 1 is intended to be part of it being incorporated into a dispensing assembly. The biopharmaceutical product is a product in the general state liquid or pasty, that is to say, able to flow, resulting from biotechnology or having a pharmaceutical purpose.

The pocket 1 comprises an envelope 3 delimiting an interior space 3a able to receive the biopharmaceutical product. This envelope 3 comprises, joined by fixed and sealed zones of attachment 4, two opposite flexible walls 5 and 6, one of which - the wall 5 - is called the stitching wall, the two walls 5 and 6, facing each other. one of the other, being connected to each other by their peripheries 7.

The two walls 5 and 6 are here of the same general shape and of similar size, such that having an outline at least substantially square or rectangular. Such a wall 5 or 6 thus has two pairs of opposite periphery sections, namely the pair of sections 7a extending in their entirety substantially in the same first direction, here forming the short sides (arranged horizontally in the figures), and the pair of sections 7b extending in their entirety substantially in the same second direction orthogonal to the first direction, here forming the long sides (arranged vertically in the figures). The first direction of the sections 7a defines a parallel axis AA which is central on the pocket 1 and which, during the implementation of the pocket 1, is placed horizontally or substantially horizontally, and which is also an axis of a zone of folding 8 of the walls 5 and 6 and the pocket 1. The sections 7b here define a main axis BB of symmetry of the pocket 1 which, during the implementation of the pocket 1, is placed vertically or substantially vertically, and which is also a maintenance axis of the pocket 1 for its implementation.

In one possible embodiment, the two walls 5 and 6 have a dimension of the order of 10 cm to 50 cm for the short side and 15 cm to 60 cm for the long side. The realization of the two walls 5 and 6 which has just been described is only exemplary and not limiting. It is the same for the realization of the envelope 2 in the form of a 2D pocket.

The inner space 3a of the pocket 1 can have a volume of between 2 liters and 20 liters. Such a volume is well adapted, generally, to a use in which it is necessary to fill the biopharmaceutical product the plurality of similar elementary receptacles 2, each relatively small unit volume, for example of the order of a few milliliters to a few cl

Such elementary receptacles 2 may be chosen from the group comprising vials, syringes, vials and bottles, pouches or bag systems for single use or not. Their unit volume is a fraction of the volume of the interior space 3a of the pocket 1. The flexible walls 5 and 6 of the bag 1 are typically made from monolayer or multilayer plastic film, in particular comprising PE, PP, EVOH, etc. They are secured in the bonding zones 4 by bonding. , or possibly gluing or in any other way. These achievements are only exemplary and in no way limiting. Thus, it is possible that on such or such section 7a, 7b of periphery 7, the walls 5 and 6 are connected to one another by a fold.

The pocket 1 also comprises at least one input port 9 and a plurality of n analog output ports 10, capable of emptying the biopharmaceutical product received in the interior space 3a, so as to distribute the biopharmaceutical product from the plurality of output ports 10, especially in the application more specifically targeted, to fill the elementary receptacles 2 whose number p may be equal to the number n of the output ports 10, each elementary container 2 can thus be associated with a port output 10, because the output ports 10 and the containers 2 are put into communication.

In one embodiment, an appropriate number of elementary containers 2 are filled with a single pocket contents 1. In this case, it may be envisaged to close the port of entry 9 once the interior space 3a of the pocket filled with the necessary amount of biopharmaceutical product. According to another embodiment, the desired number of elementary containers 2 are filled with several successive contents of the same pocket 1. In this case, it is intended to adapt the distribution assembly as will be described later in reference to Figure 10.

In the embodiments more particularly targeted by the figures, the pocket 1 may comprise a plurality of at least four output ports 10, more particularly at least eight output ports 10, and more particularly, at least twelve ports. 10. In Figure 10, there are provided ten output ports 10. These digital data are only exemplary and not limiting. They mean that the bag has not only a single output port but a greater or lesser plurality, depending on the application, in particular the number of elementary containers 2 to be filled, at least to be filled at each pass of the filling process. .

In this case, the pocket 1 includes other ports suitable to perform a function other than the emptying and the distribution of the biopharmaceutical product. In the embodiments of Figures 1 to 7, the bag 1 further comprises one or more ports 1 1 input and / or gas outlet.

In the embodiment of FIGS. 1 to 7 and 10, the pocket 1 is constituted, with respect to the output ports 10, of the plurality of n analog output ports 10, except for the input and / or output ports 11 gas. A port 9, 10, 1 1 is associated with an appropriate passage of the envelope 3 and mounted on it by means of fixed and sealed connection.

The ports 10 of the plurality of n analog output ports 10 are grouped in a tapping zone 12. "Grouped" means that the output ports 10, located in the vicinity of each other, are together in the quilting zone 12. Thus, the quilting zone 12 sets the limit in which the output ports 10 are located, this limit being adjacent to the output ports 10 or located at a low, and in particular very low, distance from the ports of Exit 10. Here is meant by "adjacent", which is immediately adjacent or adjoining. Here, the term "located at a short distance" means a distance of the order of one centimeter for walls 5 and 6 having dimensions of the order of 10 cm to 60 cm, as indicated above. It is understood that these numerical data are only exemplary and in no way limiting. They express that the quilting zone 12 does not extend beyond a small distance from the output ports 10. In combination with the preceding arrangement, it is expected that two output ports 10 in the vicinity of one of the the other are, however, spaced apart by a distance such that the flow of the biopharmaceutical through one of the output ports 10 does not substantially disturb, or even not at all, the flow of the biopharmaceutical product through the other of the output ports 10. Thus, the evacuation of the biopharmaceutical product through the different output ports 10, and filling the containers 2, can be done simultaneously and identically.

The quilting zone 12 is continuous and delimited by the output ports 10 or their proximity. It should be understood that the quilting zone 12 sets the limit in which the output ports 10 are located, this limit being adjacent to the output ports 10 or located at low, and in particular very low, distance from the output ports 10. "Adjacent" means immediately adjacent or adjoining. Here, the term "located at a short distance" means a distance of the order of one centimeter for walls 5 and 6 having dimensions of the order of 10 cm to 60 cm, as indicated above. It is understood that these numerical data are only exemplary and in no way limiting. They express that the quilting zone 12 does not extend beyond a small distance from the output ports 10.

The stitching zone 12, thus defined, is not necessarily identified as such on the pocket 1.

The quilting zone 12 is located on the quilting wall 5 being distinct from the fastening zones 4. And therefore the output ports 10 are also located on the quilting wall 5 and no output port 10 is located in the quilting areas 5. In addition, no outlet port 10 is located on the face 4 opposite to the stitching face 5. As a result, the stitching wall 5 is provided with at least one opening for passage and mounting 14 of output port 10, for the n analog output ports 10. In one embodiment, these characteristics of the output ports 10 also apply to the other input ports 9 and gas input / output 1 1.

The quilting zone 12 is linearly extended or surface-surfaced with an area much smaller than the area of the quilting face 5. By "linearly extended" it is meant that the quilting zone is essentially a line or a line , possibly having a certain thickness, which extends along a stitching segment. The term "surface-extended" means that the quilting zone is essentially a surface, as opposed to a line or a line, even having a certain thickness. In one embodiment, the quilting zone 12 is surfacically extended linearly. "Surfacically extended linearly" means that the quilting zone is a surface but that it extends substantially along a line or a line, which itself extends along In the embodiments shown in FIGS. 1 to 7, such a stitching segment 13 is substantially rectilinear. In other embodiments, the stitching segment 13 comprises at least one substantially rectilinear section.

By the fact that the area of the quilting zone 12 is surface-expanded with a "much smaller" area than the area of the quilting face 5, the fact that the area of the quilting zone 12 is less than 1/5 ^th of the area of the stitching face 5, more particularly is less than 1/10 ^th , more particularly is less than 1/20 ^th .

A port 10 is associated with and mounted on the casing 3 by fixed and sealed connection means 15 fixedly and sealingly secured to the stitching wall 5 around the at least one port opening and mounting opening 14. 10. Referring more specifically to Figure 9 which shows that an output port 10 comprises, communicatively associated, a tube 16 for emptying / filling at its proximal end 16a to the casing 3, a platinum of 17, which is part of the fixed and sealed connection means port / envelope 15. The tube 16 of emptying / filling has a distal end 16b. The tube 16 is qualified as "emptying / filling" for the reason that it ensures both the emptying of the interior space 3a and the filling of the containers 2. In the embodiment considered, it is a flexible tube of a kind that, on the one hand, are contour can be made more or less tormented depending on the requirements of the geometry of the space where it is located (see Figure 10) and that, on the other hand, it can be overwritten locally in according to the requirements for cooperating with a stop member such as a clamp (for example a Halkey-Roberts clamp, well known to those skilled in the art), or a drive-dosing device or withdrawal / dosing device , such as a pump, such as a peristaltic pump or a pump known under the RDP anagram for "Rolling Diaphragm Pump" or another functionally similar pump. This organ or device is designated as a whole by the reference 21 and represented in a purely symbolic manner. The fastening plate 17 is fixedly and sealingly secured to the stitching wall 5 around a passage opening and mounting opening 14 of the output port 10. For this purpose, the fastening plate 17 is extended on the wall stitching 5 around a passage opening and mounting 14 of the output port 10 and secured to the stitching wall 5 in a fixed and sealed manner by gluing or welding or by any other means ensuring in combination mechanical strength and sealing, without creating an obstacle to the flow of the biopharmaceutical product. According to the embodiments, the fastening plate 17 is secured by its external face to the internal face of the stitching wall 5 (FIG. 9), the internal face 17a of the fastening plate 17 then being free or, conversely, the plate of 17 is secured by its inner face 17a to the outer face of the stitching wall 5. The words "internal" and "external" refer to what is, respectively, in or turned to the interior space 3a, and out or turned on the opposite side of the interior space 3a. The embodiment more particularly described and shown with regard to the tube 16 of emptying / filling is only indicative and not limiting. The different tubes have the same length or not, the objective being that they deliver the same dose of biopharmaceutical product. Depending on the needs, the tubes 16 of emptying / filling are of a greater or lesser length or more or less small. If the realization by means of flexible tubes is advantageous, in particular for the satisfaction of the objectives of conformation and crushing pinching, it is not exclusive of others, the means associated with the tubes 16 being adapted accordingly, which is to the scope of the skilled person.

The fastening plate 17 has an opening 17b, through, in communication, on the internal side, with the internal space 3a and, on the opposite side, external, with the passage formed by the tube section 16. The fastening plate 17a thus a general annular or pseudo-annular or multi-annular form, if it comprises several openings 17b.

The foregoing embodiments of the fixed and sealed connection means 15 are only exemplary and in no way limiting.

According to the embodiments and the needs, an input port 9 has no associated tube (FIGS. 1 to 6, 8A, 8B) or, like an output port 10, and as illustrated by FIG. is communicatively associated with a filling / feeding tube at its proximal end 25a. The tube 25 is described as "filling / feeding" for the reason that it ensures both filling of the interior space 3a and the supply of biopharmaceutical product. This filling / feeding tube is adapted to be communicatively associated at its distal end 25b with a biopharmaceutical product feed 26, such as a large capacity tank. There may be provided a filter 27 interposed on the filling / feeding tube. It may also be provided that the filling / feeding tube 25 is adapted to be functionally associated, and is functionally associated with, means for stopping feed or supply / dosing 28. These means 28 are represented in such a way that 10 may be, depending on the embodiments, a clamp capable of closing the filling / feeding tube by crushing / clamping or a pump, such as, in particular, a peristaltic pump or RDP pump or other functionally similar pump. Such means 28 may in particular be programmed or controlled. More specifically, in the embodiment of FIG. 10, where the pocket 1 comprises two inlet ports 9, each of them is communicatively associated with a first section 29a of filling / feeding tube 25 at its proximal end 25a. The first two feed / supply pipe sections 29a are communicatively associated at their distal ends 29a with the proximal end 30a of a second common feed / supply pipe section 30 adapted to be associated communicating at its distal end 25b to the supply 26. In this case, the filter 27 and the supply or supply / dosing stop means 28 are, in the example shown in the figure, associated with the second section common 30.

This embodiment of the input port 9 is particularly well suited according to the embodiment already mentioned in which the desired number of elementary containers 2 are filled with several successive contents of the same pocket 1, which is recharged as a biopharmaceutical product at each as necessary when it has been emptied for distribution to receptacles 2.

What has been described and indicated as to the structure of the draining / filling tubes 16 may be transposed to the filling / feeding tube (s).

The pocket 1 also comprises the folding zone 8 of the two opposite walls 5 and 6.

The term "folding zone" means an area where the walls of the pocket 1 can be deformed so as to be folded back on themselves, in order to have two thicknesses of pairs of walls 5 and 6, each thickness comprising both walls 5 and 6. It is understood that the edge 18 of the fold of the folding zone 8 may be more or less marked, ranging from a fairly straight straight line to a simple curvature or curvature, where appropriate with a bulge such as This fold zone 8 is, however, well localized and has a smaller area than the area of the stitching face 5. The term "smaller", less than of the order of 1/4 ^th .

This embodiment of the folding zone 12 is only exemplary and in no way limiting.

The quilting zone 12 is located at or near the folding zone 8. This means that the two zones 8 and 12 overlap, at least substantially, or that the two zones 8 and 12 are adjacent or located at low, and in particular very low, distance from one another. Here we mean "adjacent", which is immediately adjacent or adjoining. Here, the term "located at a short distance" means a distance of the order of one centimeter for walls 5 and 6 having dimensions of the order of 10 cm to 60 cm, as indicated above. It is understood that these numerical data are only exemplary and in no way limiting. They express that the quilting zone 12 is merged with the folding zone 12, although the two zones do not have the same area, or that the two zones are very close to one another. At the location of the folding zone 8, the two opposite walls 5 and 6 can be folded on themselves, in the sense that has been explained above, with the stitching face 5 located outside the fold that The folding edge 18 of the fold zone 12 forms an end edge 18 of the pocket 1 in its folded configuration (FIGS. 5-7).

The stitching zone 12 and the n analog output ports 10 are located at or near the end edge 18. This means that the stitching zone 12 and the exit ports 10 and the edge of the end 18 are superimposed, at least substantially, or they are adjacent or located at low, and in particular very low, distance from one another. Here we mean "adjacent", which is immediately adjacent or adjoining. Here, the term "located at a short distance" means a distance of the order of one centimeter for walls 5 and 6 having dimensions of the order of 10 cm to 60 cm, as indicated above. It is understood that these numerical data are only exemplary and in no way limiting. They express that the stitching zone 12 and the n analogous output ports 10 coincide with the end edge 18 of the pocket 1 in its folded configuration, or that they are very close to one another.

The preceding embodiments of the folding zone 12 are only exemplary and in no way limiting. FIGS. 1 to 7 illustrate a first embodiment, in which the n analogous output ports 10 are distributed at least substantially uniformly and at least substantially regularly spaced apart from each other in the whole of the quilting zone 12.

FIGS. 8A and 8B illustrate a second embodiment, in which the n analog output ports 10 are distributed at least substantially uniformly, not in the whole of the quilting zone 12 as in the first embodiment, but in the entirety of several sub-areas of stitching, in this case two sub-areas 12a and 12b. This embodiment is only exemplary and not limiting, the number of sub-areas 12a, 12b ... may be different. Each tapping sub-zone 12a, 12b ... has the characteristics of the tapping zone 12, namely is continuous, delimited by the output ports 10 or their proximity, and linearly extended (FIG. 8A) or surface-extended (FIG. 8B) and in particular linearly extended or surfacically extended linearly, along a sub-sewing segment 13a, 13b ... (FIG. 8A). In the embodiment shown in FIG. 8A, such sub-sewing segments 13a, 13b are substantially rectilinear. In other embodiments, one or more stitching sub-segments 13a, 13b comprises at least one substantially rectilinear section.

In the embodiment of FIG. 8A, the stitching sub-segments 13a and 13b are located at least substantially parallel to one another. In another embodiment, the stitching sub-segments 13a, 13b ... are at least substantially an extension of each other. Furthermore, in the embodiment of FIG. 8A, the stitching sub-segments 13a and 13b extend at least substantially parallel to the stitching segment 13. In another embodiment, a stitching sub-segment 13a, 13b extends at least substantially parallel to the stitching segment 13.

In the embodiment of FIG. 8B, the two sub-zones 12a and 12b are spaced apart from one another along the segment 13 of the stitching area 12. It may be, for each stitch sub-zone 12a , 12b ..., the characteristics previously described for the folding zone 12. Thus, the output ports 10 may be at least substantially regularly spaced from each other in each sub-zone of stitching 12a, 12b ...

The different sub-areas 12a, 12b ... constituting together the quilting zone 12 are separated from each other by zones without quilting 19. By unpitched zone 19, the fact that in this zone there is no no queuing output port 10, which does not exclude the presence of another port, such as for example an input port 9 as shown in Figure 8A.

Where appropriate, at least some of the stitching sub-areas 12a, 12b ..., in particular all the stitching sub-areas 12a, 12b ..., are located in the vicinity of each other.

In the embodiment of FIG. 8A, there are two sub-zones 12a and 12b that are linearly extended, arranged facing each other, parallel to one another and in the vicinity of each other. . This embodiment makes it possible to interpose the lower end edge 18 of the pocket 1 in its folded configuration between the two sub-zones 12a and 12b, parallel to the sub-sections 13a and 13b.

In the embodiment of FIG. 8A, there are two sub-zones 12a and 12b that are surface-spaced apart from one another along the segment 13 of the quilting zone 12, so as to provide a zone between them. without stitching 19 where is the port of entry 9.

The described achievements are only exemplary and in no way limitative as to the number, shape, relative layout of sub-areas 12a, 12b ..., the number and the relative arrangement in each sub-area of exit 10.

The arrangement of the at least one passage and mounting opening 14 and the output ports 10, in relation to the output ports 10, is now described.

In the embodiment of FIGS. 1 to 7, there is provided a single and single opening for passage and mounting 14 common to the plurality of n analog output ports 10. Such an arrangement The construction is well suited in the case where the n analog output ports 10 are distributed throughout the quilting zone 12, which is in one piece, without sub-zones, in the sense that has been previously described. In another embodiment, it may be provided that a passage and mounting aperture 14 is common not to the plurality of n analog output ports 10, as before, but only to a portion of the output ports 10 of the plurality of n similar output ports 10. Such a constructive arrangement is well suited in the case where the quilting zone 12 has a plurality of stitch sub-zones 12a, 12b ... Thus, it can be provided for as many passage openings and In this case, each exit opening and mounting opening 14 of the output port 10 is associated with a stitch sub-zone 12a, 12b. Thus, in the case of FIGS. 8A and 8B, two passage and mounting openings 14a and 14b corresponding to the two sub-zones 12a and 12b are provided. In the embodiment of FIG. 9, it is provided that at an exit and exit port opening 14 there is associated a single output port 10 of the plurality of n analog output ports 10.

The embodiments described with regard to the arrangement of the opening passage and mounting 14 and the output ports 10 are only exemplary and not limiting.

The arrangement of a securing plate 17 in relation to one or more of the output ports 10 is now described.

In the embodiment of FIGS. 1 to 7, there is provided a single securing plate 17 common to the plurality of n analog output ports 10. Such a constructive arrangement is well suited in the case where the n analog output ports 10 are distributed. in the entire stitching area 12, which is integral, without sub-areas, as previously described.

In another embodiment, it may be provided that a securing plate 17 is common not to the plurality of n analog output ports 10, as above, but only to a portion of the output ports 10 of the plurality of n ports of Analogous output 10. Such a constructive arrangement is well suited in the case where the stitching zone 12 has several stitching sub-zones 12a, 12b ... Thus, it is possible to provide as many fastening plates 17 as of sub-zones. In this case, each fastening plate 17 is associated with a stitching sub-zone 12a, 12b... Thus, in the case of FIGS. 8A and 8B, two fastening plates are provided. 17 corresponding to both sub-areas 12a and 12b.

In the embodiment of FIG. 9, it is provided that a connection plate 17 is associated with a single output port 10 of the plurality of n analog output ports 10. According to the embodiments and according to the arrangement of a securing plate 17 in connection with one or the output ports 10, a securing plate 17 has a single opening 17b for the n analog output ports 10 or a 17b is not common to the plurality of n analog output ports 10, as previously, but only to a portion of the output ports 10 of the plurality of n analog output ports 10 or 17b is associated with a single port of output 10 of the plurality of n analog output ports 10. Where appropriate, the fastening plate may comprise a middle portion in the form of a grid and a solid peripheral portion for the fastening and the fixed and sealed connection. The embodiments described with regard to the arrangement of a securing plate 17 in relation to one or more of the outlet ports 10 and the arrangement of the opening or openings 17a are only exemplary and in no way limiting.

According to one embodiment, the fastening plate 17 has a certain rigidity, which allows a certain holding of the tube section 16. On the other hand, according to another embodiment illustrated in Figure 9, the inner face 17a or the central free portion the inner face 17a around the passage which is provided with the connecting plate 17 is shaped to facilitate the emptying, and in particular the complete emptying, of the biopharmaceutical product. For example, the inner face 17a may be funnel-shaped or comprise drainage channels.

The draining / filling tube 16 is designed to be communicatively associated with its distal end 16b to an elementary container 2 to be filled with the biopharmaceutical product in the bag 1. In one embodiment, the tube 16 for emptying / filling has at its distal end 16b, a nozzle 20 or a similar dispensing member such as filling needles. This combination is designed to be removable, the distal end 16b to be dissociated from the elementary container 2 when filled, then associated with another container 2 to fill and so on.

The dispensing assembly may also comprise means for association / dissociation of the nozzles 20 or analogous distribution members which are filled with the tubes 16 of emptying / filling. These means may be, in whole or in part, manual or mechanized, if necessary programmed in connection with the operation or the programming of filling and the supply and the evacuation of the containers 2. For this purpose, the set of The distribution also comprises, on the one hand, means for feeding a plurality, in particular n, receptacles not yet containing the desired dose of biopharmaceutical product, and, on the other hand, means for evacuating a plurality, in particular n, receptacles containing said dose of biopharmaceutical product. These means may be, in whole or in part, manual or mechanized, if necessary programmed in connection with the operation or programming filling. As already indicated, the dispensing assembly also comprises a stop member (such as a chuck) or a drive-dosing or withdrawal / dosing device (such as a pump, such as a peristaltic pump or an RDP pump or the like functionally) 21 with which cooperates each tube 16 draining / filling. Such means 21 may be programmed or controlled according to the desired filling and the conditions and modalities thereof.

In one embodiment, it is provided that the means 21 are not specific to each of the tubes 16 for emptying / filling but common to several tubes 16.

The embodiments described with regard to the fastening plate 17 and the pipe section 16 are only exemplary and in no way limiting.

The various configurations and states of the flexible distribution bag 1 are now described.

The dispensing bag 1 is, when necessary, in an unfolded configuration (Figures 1 to 4) in which the two opposite walls 5 and 6 are extended. In this configuration, the pocket 1 is, when necessary, either in a vacuum state where the interior space 3a is empty of biopharmaceutical product (FIGS. 1 to 4) - for example once the flexible bag 1 has been made - either in a filled state where the interior space 3a is filled with biopharmaceutical product - for example in a first variant of implementation of the flexible bag 1 -.

The dispensing bag 1 is, when necessary and for its implementation of emptying the biopharmaceutical product located in the interior space 3a, in a folded configuration (FIGS. 5 to 7) in which the two opposite walls 5 and 6 are folded on themselves in the folding zone 8 with the stitching face 5 located outside the fold. In this folded configuration, the dispensing pocket 1 comprises, in the folding zone 8, the end edge 18 at or near the location of the stitching zone 12 and the n analog output ports 10. In when this configuration is folded, the dispensing bag 1 is, when necessary, either in a filled state where the interior space 3a is filled with biopharmaceutical product (FIGS. 5 to 7) - for example at the moment when the bag is to be emptied - or in an empty or emptied state, respectively, where the interior space 3a is empty or emptied, respectively of the biopharmaceutical product - for example before filling the flexible pouch of the biopharmaceutical product in a second variant of implementation or after emptying, respectively - .

The arrangement of the stitching zone 12 and the folding zone 8 on the stitching face 5 is now described.

Therefore, it is important that the stitching zone 12 - which is not necessarily identified as such on the pocket 1 - and the folding zone 8 are located judiciously on the face of In the embodiment of FIGS. 5 to 7, the stitching zone 12 and the folding zone 8 are located at or near the central zone 5b of the stitching face 5. For example, the stitching area stitching 12 and the folding zone 8 are located at or near the central axis AA of the stitching face 5 located equidistant from the two opposite peripheral sections 7a of the stitching face 5. With such an embodiment, the 1 pocket in its folded configuration has a general symmetrical arrangement with respect to a vertical plane of symmetry P (parallel to the plane of Figures 5 and 6 and identified in Figure 7). Thus, the interior space 3a is then subdivided into two interior subspaces 3aa and 3ab, of equal or substantially equal volumes. On the other hand, the two peripheral sections 7a come into coincidence or substantially in coincidence and constitute the upper end edge 22 of the pocket 1 in its folded configuration (Figures 5 to 7).

According to a development, it is expected that the flexible bag 1 comprises means capable of maintaining a permanent communication between the two inner subspaces 3a, 3b. These means may be spacer type or they may consist of allowing the evacuation of gas during the emptying of the bag 1 of the biopharmaceutical product.

These achievements are only exemplary and in no way limiting.

The arrangement of the input port or ports 9 with respect to the envelope 3 is now described.

In the embodiment of FIGS. 1 to 6, provision is made for the flexible bag 1 to have two inlet ports 9 situated on the stitching wall near the stitching zone 12, here being situated on either side of the stitching zone 12. the quilting zone 12 being closer to the large peripheral section 7b close to the stitching wall 5 than the output ports 10.

In the embodiment of FIG. 8B, provision is made for the flexible bag 1 to comprise a single input port 9 situated at the very location of the stitching zone 12, here between the two stitching sub-zones 12a and 12b.

This type of constructive arrangement makes it possible to fill the inner space 3a of the biopharmaceutical product while the flexible bag 1 is in its folded configuration, the biopharmaceutical product being injected into the two inner subspaces 3aa and 3ab, by the lower end. 18 of the bag 1, which avoids the foaming effect that would be obtained with a biopharmaceutical product having a foaming power that is injected into the flexible bag from above.

In the embodiment of FIG. 8A, provision is made for the flexible bag 1 to comprise a single input port 9 located at a place distinct from the stitching zone 12, and more particularly away from the stitching zone 12, for example located in the vicinity or near a securing section close to the peripheral section 7b, while being situated on the stitching wall 5. In the embodiment of Figure 10, there are provided two input ports 2, located at a median height of the pocket in its folded configuration.

These achievements concerning the arrangement - number and layout - of the input port or ports 9 are only exemplary and in no way limiting.

The arrangement of the port (s) 1 1 of gas inlet / outlet is now described.

One or more such ports 1 1 are intended either to allow the introduction from outside the flexible bag 1 in the interior space 3a, above the biopharmaceutical product, a preservative gas of this product or to allow the evacuation of gas from the interior space 3a towards the outside of the flexible bag 1 during the emptying of the latter, which prevents the pocket 1 from tightening on itself, as this may hinder the draining of the biopharmaceutical product. One or more such ports 1 1 are located in a spaced apart, and in particular clearly spaced apart, location of the quilting zone 12, for example are located in the vicinity of or near a securing section close to the peripheral section 7a.

According to the embodiments, such a port January 1 is located on the stitching wall 5 or on the wall 6 opposite the stitching wall 5.

These achievements concerning the arrangement - number and disposition - of the ports 1 1 of gas inlet / outlet are only exemplary and in no way limiting. According to a development, it is provided that the zones 5a and 6a of the quilting face 5 and of the opposite face 6 which are adjacent to the section 7a of the pocket 1 and which, in the flexible pouch 1 in its folded configuration are adjacent to the upper end edge 22 and opposed to the lower end edge 18 form suspension zones of the pocket 1 in its folded configuration. Such suspension zones 5a and 6a may include suspension members 23, such as holes or projections adapted to removably cooperate with complementary suspension members, such as hooks or stems forming part of the machine or the installation in which the pocket is implemented for its emptying and filling of the elementary containers 2. Such a removable suspension embodiment with holes or projections 23 and hooks or brackets 23a is part of the general knowledge of the skilled pockets here considered. According to another embodiment, the suspension members 23 are provided only on one of the faces 5 or 6, provided that means are provided for holding the two opposite walls 5 and 6 folded on themselves when the pocket 1 is in the folded configuration. With suspension means 23 and 23a as described, the flexible bag 1 in its folded configuration is positively maintained so that the end edge 18 of the bag 1 located at or near the folding zone 8 and of the quilting zone 12 is the lower edge of the pocket 1 and the inner space 3a is placed above, of so as to allow the emptying of the biopharmaceutical product from the interior space 3a through the exit ports 10.

Instead of the holding means of the flexible bag 1 thus folded and disposed in the form of the suspension means 23 and 23a described above, there may be provided means for maintaining the equivalent pocket, structurally different but providing the same function. For example, it may be a rigid container having in the lower part at least one passage for the n analog output ports, whose shape corresponds to that of the pocket filled with biopharmaceutical product.This container may incorporate plates lateral pressure on the faces 5 and 6.

The invention includes an assembly comprising a flexible bag 1 as has been described holding means of the flexible bag 1 in its folded configuration so that the end edge 18 is placed horizontally and in the lower position and that the end edge 22 is placed horizontally and in the upper position, the pocket 1 being placed vertically with its vertical plane of symmetry P. Thus, it is possible to ensure the emptying of the biopharmaceutical product by the output ports 10 by simple gravity, or if necessary in a forced and assisted manner by exerting a compression on both sides 5 and 6 of the bag 1. Thus, according to the case, the holding means are suspension means 23b adapted to cooperate with suspension members 23a of the bag or lateral restraining means, such as a rigid container having in the lower part at least one passage for the n analog output ports. These achievements concerning the maintenance and in particular the suspension of the flexible bag 1 are only exemplary and in no way limiting.

According to another development, it is provided that the flexible bag 1 comprises means 24 able to hold the two opposite walls 5 and 6 folded on themselves when the bag 1 is in the folded configuration, so as to prevent the bag from unfolds.

These holding means 24 may be constituted by the suspension members 23 of the bag 1, the suspension of the bag 1 to the complementary suspension members 23a may be such that the two periphery sections 7a of the bag 1 are maintained adjacent or contact each other. This effect is obtained because of the weight of the pocket 1 on the complementary suspension members 23a via the suspension members 23 of the pocket 1. If necessary, the complementary suspension members 23a are provided with notches or protrusions preventing the two periphery sections 7a of the pocket 1 from inadvertently departing. These holding means 24 may be holding members complementary to each other, provided on the casing 3 and in particular on the face 6 which is inside the fold of the pocket 1 in its folded configuration. Such additional holding members are reversibly or irreversibly maintained depending on the intended applications and they may be, for example, in the form of self-gripping strips such as those known under the trademark VELCRO® or buttons type snap .

These achievements concerning the maintenance of the pocket 1 in the folded state are only exemplary and in no way limiting.

A flexible pouch as just described is most often intended to be implemented in a sterile environment and for this reason it is sterile, having rendered sterile by an appropriate treatment such as for example γ radiation. Such pocket sterilization treatment for biopharmaceutical use is part of the general knowledge of those skilled in the art.

The realization of a pocket 1 as it has been described can be deduced from the very structure of the pocket.

In this process, there is a plastic film capable of being cut and secured to itself and to form the flexible pocket walls constituting the envelope 3, in particular the walls 5 and 6.

There are also components for constituting the ports 9 and 1 1 and especially the analog output ports 10.

There are also film cutting means and fastening means, in particular welding means.

Then, the film is cut to the desired shape of the walls of the pocket, in particular the two opposite walls 5 and 6.

The aperture wall and / or apertures 14, 14a, 14b ... are also cut off in the stitching wall 5, for the n similar output ports 10. Then, the walls 5 and 6 are secured in a fixed and sealed manner. between them to form the casing 3 and the outlet ports 10 to the stitching wall 5 around the opening or openings 14, 14a, 14b ...

Thus, a flexible bag 1 as described in its unfolded configuration and in the empty state of biopharmaceutical product is obtained. According to a particular embodiment of the method, at an outlet port 10, a draining / filling tube 16 is communicatively associated at its proximal end 16a and a securing plate 17 and the securing plate 17 is secured to one another. in particular by gluing or welding, in a fixed and sealed manner to the stitching wall 5 around a passage opening and mounting opening 14 of the exit port 10.

According to another embodiment which can be combined with the preceding one, at an input port 9, a filling / feeding tube 25 is communicatively associated with its proximal end 25a. In particular, the pocket 1 comprising a plurality of input ports 9, is associated with each of them a first section 29 tube filling / feeding at its proximal end 25a, and it is associated in a communicating manner the plurality of first sections of filling / feeding tube 29 at their distal ends 29a at the proximal end 30a of a second common section of filling / feeding tube. These embodiments of the method of maintaining the pocket 1 are only exemplary and not limiting.

The invention also relates to the dispensing assembly of a dose of a biopharmaceutical product in a set of receptacles 2, such as containers 2.

This dispensing assembly comprises on the one hand a dispensing pouch 1 as it has been described, this one being for single use and being in particular in the filled state of a biopharmaceutical product. The dispensing assembly also comprises the means for holding the pocket 1, such as the suspension members 23a, or any other device or arrangement providing the same result, namely that the end edge 18 located at the place where close to the folding zone 8 is the lower edge of the pocket 1, the inner space 3a being placed at the top. The dispensing assembly also comprises means for communicatively connecting the distal end 16b of the emptying / filling tubes 16 to the containers 2.

The dispensing assembly also comprises the means of stopping discharge or withdrawal / metering 21 already mentioned. In one possible embodiment, the dispensing assembly may also include means for communicatively connecting the distal end 25b of the or each filling / supply tube to a biopharmaceutical product supply 26.

In this case, the dispensing assembly may comprise supply or feed / dosing stop means 28, in particular programmed or controlled, functionally associated filling / feeding tube (s) for filling the inner space 3a of the bag 1 with the biopharmaceutical product from the biopharmaceutical product feed 26.

As indicated, the means for stopping evacuation or withdrawal / metering 21 may comprise a stop clamp or a pump set for the distribution of successive doses of biopharmaceutical product. On the other hand, the feed stop or feed / metering means 28 may comprise a pump, such as a peristaltic pump or an RDP pump or another functionally similar pump. According to one embodiment, the dispensing assembly adapted to the case where the p containers 2 are filled with several successive contents of pocket 1, the distribution assembly is adapted accordingly and it is expected that it comprises, first instead, means for detecting the exceeding of a minimum quantity and a maximum quantity of biopharmaceutical product in the interior space 3a of the bag 1.

This dispensing assembly comprises, secondly, means for controlling the means for stopping discharge or withdrawal / metering 21 and means for stopping supply or feed / dosing 28 responsive to said means for detecting the exceeded. Thus, when the quantity of biopharmaceutical product in the inner space 3a of the bag 1 reaches the minimum quantity, the control means control the operation of the supply or feed / dosing stop means 28 associated with the tube Filling / feeding to fill the inner space 3a of the bag 1 with the biopharmaceutical product from the feed 26 to a biopharmaceutical product. Whereas, when the amount of biopharmaceutical product in the inner space 3a of the bag 1 reaches the maximum amount, the control means controls the operation of the supply or feed / dosing stop means 28 to stop filling the inner space 3a of the pocket 1 with the biopharmaceutical product from the feed 26 into a biopharmaceutical product.

According to one development, the containers 2 are located respectively inside and outside of an aseptic chamber. Depending on the case and the achievements, the pocket 1, itself, is located either inside or outside this aseptic chamber. The wall of the aseptic chamber is thus traversed respectively by the tubes 16 of emptying / filling or by a tube 25 filling / feeding.

The method for implementing such a flexible bag 1, that is to say the distribution of the biopharmaceutical product, is now described. Indeed, implementation means the fact, starting from a flexible bag 1 in its unfolded configuration and in the empty state of biopharmaceutical product, to distribute biopharmaceutical product by the plurality of n similar output ports 10, in particular to dispense the biopharmaceutical product into the elementary receptacles 2. Initially, there is a flexible bag 1 having an unfolded configuration and in the empty state. The biopharmaceutical product is also available.

There are also containers 2 not yet containing the desired dose of biopharmaceutical product.

Then, in the first place, the pocket is folded in its fold zone 8 so that the two opposite walls 5 and 6 are folded on themselves with the face of the stitching wall 5 located outside the fold. forming an end edge 18 of the folded pocket, at or near the location of the stitching area 12 and the n output ports 10. Thus the pocket is brought into its folded configuration.

In the second place, the inner space 3a of the pocket is filled with the biopharmaceutical product, via the at least one input port 9.

Thirdly, the n output ports 10 are communicatively associated with a first plurality, in particular n, containers 2 not yet containing the desired dose of biopharmaceutical product, in particular by means of the nozzles 20.

Fourthly, the end edge 22 is positioned and maintained so that it is and remains the upper edge of the dispensing pocket 1, thanks to the suspension members 23a, more generally maintaining the pocket 1, implemented so that the end edge 18 of the pocket 1 located at or near the folding zone 8 is its lower edge, the interior space 3a being placed at above.

In this situation, it is possible, at the desired moment, to evacuate the biopharmaceutical product through the n exit ports 10, and the n associated draining / filling tubes 16, simultaneously, and to dispense the same dose of product. biopharmaceutical in the first plurality of containers 2 by the nozzles 20, thanks to the combined effect of gravity and means 21 (in a dosage and drive function). Thus, a first plurality of containers 2 containing said desired dose of biopharmaceutical product is obtained.

Then, while preventing the evacuation of the biopharmaceutical product by the n output ports 10, by means 21 (in a stop function), the first plurality of containers 2 containing at this time the dose of biopharmaceutical product, and it brings a second plurality, in particular of n, containers 2 not yet containing the dose of biopharmaceutical product, through the means of supply and discharge of the dispensing assembly. The process is repeated with this second plurality of containers 2, and so on until the containers (2) have been filled.

According to the embodiments, firstly the bag 1 is folded and then the inner space 3a of the bag 1 is filled with the biopharmaceutical product, first of all the inner space 3a of the bag is filled. 1 with the biopharmaceutical product and then the pouch 1 is folded.

In all cases, the pocket 1 being in the folded configuration and in the filled state the end edge 18 is disposed and maintained horizontally and in the lower position and the end edge 22 placed horizontally and in the upper position, the pocket 1 being placed vertically with its vertical plane of symmetry P.

The process which has just been described has been carried out in the case where it is carried out in several passes, each time for a number n of containers 2, all the p containers 2 concerned being larger, in particular much larger. that n.

Of course, the method can be considered in the case where p = n.

On the other hand, the method may comprise two variants.

According to a first variant, the inner space 3a of the pocket is filled with the quantity necessary to fill all the containers 2. These can therefore be filled with a single pocket contents 1. In this case, a Once the inner space 3a of the pocket 1 has been filled with biopharmaceutical material, there is no need to consider reloading it as a biopharmaceutical product. And that is why the input port 9 can remain closed.

According to a second variant, the inner space 3a of the pocket is filled with an amount which is only a fraction of that necessary to fill all the containers. In this case, it is intended to fill the containers 2 with several successive contents of pocket 1. In a preferred embodiment, it consists of several successive contents of the same pocket 1. In this case, and thanks to the distribution set adapted accordingly, in a first step, with the detection means that comprises the dispensing assembly, it detects the exceeding of a minimum amount and a maximum quantity of biopharmaceutical product in the interior space 3a of the bag 1.

Then, in a second step, depending on the detection carried out and with the control means that the distribution assembly comprises, the means for stopping evacuation or withdrawal / metering associated with the tubes 16 emptying / filling and the supply or feed / dosing stop means 28 associated with the filling / feeding tube (s) so that, when the quantity of biopharmaceutical product in interior space 3a of the bag 1 reaches the minimum quantity, it controls the operation of the supply or feed / dosing stop means 28 associated with the filling / feeding tube (s) to fill the space 3a interior of the pocket 1 with the biopharmaceutical product from the biopharmaceutical product feed and that, when the quantity of biopharmaceutical product in the interior space 3a reaches the maximum quantity, the stop means is controlled feeding or feeding / dosing 28 to stop filling the inner space 3a with the biopharmaceutical product coming from the feed 26.

Claims

1. Pouch (1) for dispensing a dose of a biopharmaceutical product in liquid or pasty general state capable of flow, in a set of receptacles (2), comprising a casing (3) adapted to receive in its inner space (3a) the biopharmaceutical product and comprising, united by fixed and sealed zones of attachment (4), flexible walls, two opposite walls (5 and 6) connected to one another by their peripheries ( 7), at least one input port (9) through which the interior space (3a) can be filled with the biopharmaceutical product, and a plurality of n output ports (10) to which are communicatively associated n outer tubes of emptying / filling, and through which biopharmaceutical product can be discharged from the interior space (3a) to a plurality of receptacles (2) communicatively associated with the n exit ports (10) to fill them with a dose biopharmaceutical product, a port (9, 10) being associated with a passage of the envelope (3) and being mounted on it by means of fixed and sealed connection means (15),

characterized by the fact that:

The n output ports (10) are analogous and grouped, in particular in the vicinity of each other, in a continuous quilting zone (12) delimited by the output ports (10) or their proximity, located on a wall stitching (5) of one of the two walls (5 and 6), distinct from the bonding zones (4), linearly extended or surfacically extended area significantly smaller than the area of the face of the stitching wall (5)

The pocket (1) comprises a stitching wall (5) provided with at least one outlet port opening and mounting opening (14) for the n output ports (10), and fixed and watertight (15) port / casing (3) fixedly fixed and sealed to the stitching wall (5) around the at least one outlet port opening and mounting opening (14),

■ the pocket (1) has a folding zone (8) of the two walls (5 and 6) at or near the location of the quilting zone (12), at which the two walls (5 and 6) can be folded on themselves with the face of the stitching wall (5) located outside the fold forming an end edge (18) of the folded pocket, at the place where near which is located the quilting zone (12) and the n output ports (10).

2. Pouch (1) according to claim 1, characterized in that two output ports (10) in the vicinity of one another are spaced apart from each other by a distance selected so that the flow of the biopharmaceutical product through one of the output ports (10) does not substantially disturb the flow of the biopharmaceutical through the other of the output ports (10).

3. Pocket (1) according to any one of claims 1 and 2, characterized in that the stitching zone (12) surfaciquement extent has an area less than 1/5 ^th of the area of the face of the wall stitching (5), more particularly less than 1/10 ^th , more particularly less than 1/20 ^th .

4. Pouch (1) according to any one of claims 1 to 3, characterized in that the quilting zone (12) is either linearly extended or surface area linearly extended, along a stitching segment (13), in particular a stitching segment (13) comprising at least one substantially rectilinear section, more especially substantially rectilinear.

5. Pouch (1) according to any one of claims 1 to 4, characterized in that the n output ports (10) are distributed at least substantially uniformly throughout the quilting area (12) and in particular are at least substantially evenly spaced from each other.

6. Pouch (1) according to any one of claims 1 to 5, characterized in that the n output ports (10) are distributed at least substantially uniformly, in particular at least substantially regularly spaced from each other in all of a plurality of stitching sub-areas (12a, 12b), each stitching sub-area (12) being continuous, delimited by or near the output ports (10), and linearly or planarly extended, the plurality of stitching sub-areas (12a, 12b) constituting the stitching area (12) being separated by non-stitching areas (19).

7. Pouch (1) according to claim 6, characterized in that a stitching sub-area (12a, 12b) is either linearly extended or surface area linearly extended along a sub-sewing segment (13a, 13b), in particular a stitching sub-segment (13a, 13b) comprising at least one substantially rectilinear section, more especially substantially rectilinear and / or extending at least substantially parallel to the stitching segment (13).

Pocket (1) according to claim 7, characterized in that at least some of the stitching sub-segments (13a, 13b), in particular all the stitching sub-segments (13a, 13b), are located at least substantially parallel to each other or at least substantially in extension of each other.

9. Pouch (1) according to any one of claims 1 to 8, characterized in that either an outlet port and mounting port (14) of output port (10) is associated with an output port (10) of the plurality of n output ports (10) or an output port mounting and port opening (14) is common to a plurality of output ports (10) of the plurality of n output ports (10) .

10. Pouch (1) according to any one of claims 1 to 9, characterized in that an output port (10) comprises communicatively associated with a tube (16) draining / filling at its proximal end (16a). ) and a fastening plate (17) forming part of the fixed and sealed connection means (15) port / envelope (3), secured, in particular by gluing or welding, in a fixed manner and sealed to the stitching wall (5) around a passage opening and mounting (14) of the output port (10).

1 1. Pouch (1) according to claim 10, characterized in that the tubes (16) draining / filling are able to be associated in a communicating manner at their distal ends (16b) to receptacle (2) for filling them with the biopharmaceutical product, and to be functionally associated with means for stopping discharge or withdrawal / metering (21), in particular programmed or controlled.

12. Pouch (1) according to any one of claims 10 and 1 1, characterized in that either a connection plate (17) is associated with an output port (10) is a connecting plate (17) is common to several output ports (10), or the pocket (1) comprises a single connecting plate (17) common to the n output ports (10).

13. Pouch (1) according to any one of claims 10 to 12, characterized in that a fastening plate (17) has an inner face (17a) shaped to facilitate emptying, particularly complete emptying, the biopharmaceutical product.

14. Pouch (1) according to any one of claims 1 to 13 characterized in that the stitching area (12) and / or the folding zone (8) is located at or near the area median (5b) of the face of the stitching wall (5) and / or of a central axis (AA) of the face of the stitching wall (5) between the opposite periphery sections (7a) of the face of the the stitching wall (5).

15. Pouch (1) for dispensing a dose of a biopharmaceutical product according to any one of claims 1 to 14, characterized in that no port is located on the face (6) opposite to the face the stitching wall (5) and / or in the securing zones (4).

16. Pouch (1) according to any one of claims 1 to 15, characterized in that the at least one inlet port (9) is located on the stitching wall (5) at or near the place from the stitching area (12) or at a place distinct from the stitching area (12).

17. Pouch (1) according to any one of claims 1 to 16, characterized in that an inlet port (9) comprises communicatively associated a tube (25) filling / feeding at its proximal end (25a), capable of being associated in a communicating manner at its distal end (25b) with a feed (26) of biopharmaceutical product, with in particular the interposition of a filter (27), and able to be associated functionally with stopping supply or supply / dosing (28), in particular programmed or controlled.

The pouch (1) according to claim 17, comprising a plurality of input ports (9), each communicatively associated with a first section (29) of filling / feeding tube (25) at its proximal end ( 25a), said plurality of first filling / supply tube sections (29) being communicatively associated at their distal ends (29a) with the proximal end (30a) of a second common section (30). tube (25) filling / supply capable of being associated in a communicating manner at its distal end (25b) to the feed (26) biopharmaceutical product, with in particular interposition of a filter (27) common, the means of supply or supply / dosing stop (28) being associated with the second common section (30) of filling / feeding tube (25).

19. Pouch (1) according to any one of claims 1 to 18, characterized in that it further comprises at least one inlet port and / or gas outlet (1 1).

20. Pouch (1) according to any one of claims 1 to 19, characterized in that the areas (5a and 6a) of the face of the stitching wall (5) and the opposite face spaced from the area of folding (8) and the stitching zone (12) form suspension zones of the pocket (1) in its folded configuration, including suspension members (23), such as holes or projections.

21. Pouch (1) according to any one of claims 1 to 20, characterized in that it comprises means (24) adapted to maintain the two opposite walls (5 and 6) folded on themselves when the pocket is in the folded configuration, including holding members complementary to each other.

22. Pouch (1) according to any one of claims 1 to 21, having an unfolded configuration in which the two opposite walls (5 and 6) are extended.

23. Pouch (1) according to any one of claims 1 to 21, having a folded configuration in which the two opposite walls (5 and 6) are folded on themselves in the folding zone (8) with the face of the stitching wall (5) located outside the fold, the pocket in the folded configuration having, in the fold zone (8), an end edge (18) at or near which is located the stitching area (12) and the n output ports (10).

24. A set of dispensing a dose of a flowable liquid or pasty general biopharmaceutical product into a set of receptacles, comprising:

^■ a pocket (1) for dispensing a dose of a biopharmaceutical having a folded configuration according to claim 23, in particular a pocket in the state filled with biopharmaceutical product, ^■ means (23a) for holding said bag (1) adapted so that the end edge (18) located at or near the folding zone (8) is the lower edge of the pocket, the inner space (3a) being placed most above,

^■ means for communicatively associating the distal end (16b) of the tubes (16) for emptying / filling with receptacles (2) for filling them with the biopharmaceutical product in the inner space (3a) the pocket (1),

^■ means for stopping discharge or withdrawal / metering (21), in particular programmed or controlled, functionally associated with the tubes (16) draining / filling.

25. Dispensing assembly according to claim 24, wherein the pocket (1) is such that an inlet port (9) comprises communicatively associated with a tube (25) filling / feeding to its proximal end (25a), also comprising means for communicatively connecting the distal end (25b) of the filling / feeding tube (25) to the biopharmaceutical product feed (26), and means for supply or supply / dosing stop (28), in particular programmed or controlled, operably associated with the filling / supply tube (25) for filling the inner space (3a) of the bag (1) with the biopharmaceutical product from the diet (26) into a biopharmaceutical product.

The dispensing assembly of any one of claims 24 and 25, wherein the venting or withdrawal / dosing stop means (21) operatively associated with the draining / filling tubes (16) comprise a pump structurally associated with each set-up drain / fill tube (16) for the delivery of successive doses of biopharmaceutical product, and / or the supply or feed / dosing stop means (28) operatively associated with the tube ( 25) of filling / feeding comprise a pump structurally associated with the filling / feeding tube.

The dispensing assembly according to any of claims 24 to 26, further comprising:

^■ detecting means exceeding a minimum amount and a maximum amount of biopharmaceutical product in the inner space (3a) of the bag (1),

And means for controlling the evacuation or withdrawal / dosing stop means (21) associated with the emptying / filling tubes (16) and means for stopping supply or supply / dosing (28). associated with the filling / feeding tube (25), responsive to said overshoot detection means, such that when the quantity of biopharmaceutical product in the inner space (3a) of the bag (1) reaches the minimum quantity, the control means controls the operation of the supply or feed / dosing stop means (28) associated with the filling / feeding tube (25) to fill the inner space (3a) of the bag (1) with the biopharmaceutical product from the biopharmaceutical product feed and when the quantity of biopharmaceutical product in the inner space (3a) of the bag (1) reaches the maximum quantity, the control means controls the operation of the means stopping feeding or feeding / dosing (28) associated with the filling / feeding tube (25) to stop filling the inner space (3a) of the bag (1) with the biopharmaceutical product from the feed (26). ) as a biopharmaceutical product.

28. Dispensing assembly according to any one of claims 24 to 27, wherein the receptacles (2) are located inside an aseptic chamber and the supply of biopharmaceutical product is located outside the aseptic chamber, the bag (1) being located either inside or outside the aseptic chamber, the wall of the aseptic chamber being traversed respectively by the tubes (16) of emptying / filling or by a (25) filling / feeding tube.

29. A method of dispensing for the implementation of a pocket (1) for dispensing a dose of a biopharmaceutical product according to any one of claims 1 to 23, for the purpose of dispensing the same dose of biopharmaceutical product by the plurality of n output ports (10) in p receptacles (2), the number p of receptacles being larger, and even much larger, than the number n of output ports (10), wherein:

^■ one has a flexible bag (1) having a non-folded configuration according to claim 22,

^■ the biopharmaceutical product is available,

^■ there are p containers (2) not yet containing said dose of biopharmaceutical product,

In the first place, the pocket (1) is folded into its folding zone (8) so that the two opposite walls (5 and 6) are folded on themselves with the face of the stitching wall (5). ) located outside the fold forming an end edge (18) of the folded pocket at or near the location of the stitching area (12) and the n exit ports (10) and thus, the bag (1) is brought into its folded configuration according to claim 22, and, secondly, the inner space (3a) of the bag (1) is filled with the biopharmaceutical product via at least one port thirdly, the n output ports (10) are communicatively associated to a first plurality, in particular n, receptacles (2) not yet containing said dose of biopharmaceutical product, and fourthly, the end edge (22) is arranged and maintained so that it is and remains the upper edge of the pocket (1),

And then, the biopharmaceutical product is evacuated via the n output ports (10) simultaneously, and the same dose of biopharmaceutical product is dispensed into said first plurality of receptacles (2), so as to obtain a first plurality of receptacles (2) containing said dose of biopharmaceutical product,

^■ then, while the evacuation of the biopharmaceutical product is prevented by the n output ports (10), said first plurality of receptacles (2) containing said dose of biopharmaceutical product is evacuated, and a second plurality, in particular of n, receptacles (2) not yet containing said dose of biopharmaceutical product, and the process is repeated with this second plurality of receptacles (2), and so on until there is fill the receptacles (2).

30. The dispensing method according to claim 29, wherein firstly the bag (1) is folded and then the inner space (3a) of the bag (1) is filled with the biopharmaceutical product either first, the inner space (3a) of the bag (1) is filled with the biopharmaceutical product and then the bag (1) is folded.

31. The dispensing method according to any one of claims 29 and 30, wherein there are furthermore means (23a) for holding the bag (1) and in which they are implemented so that the end edge (18) of the pocket (1) located at or near the folding zone (8) is the lower edge of the pocket (1), the inner space (3a) being placed above.

The dispensing method according to any one of claims 29 to 31, wherein:

^■ with the detection means, the overtaking detecting a minimum amount and a maximum amount of biopharmaceutical product in the inner space (3a) of the bag (1),

And, depending on the detection carried out and with the control means, the means for stopping evacuation or withdrawal / metering (21) associated with the emptying / filling tubes (16) and means for dispensing are met. supply or feed / dosing stop (28) associated with the filling / feeding tube (25), so that when the amount of biopharmaceutical product in the inner space (3a) of the bag (1) ) reaches the minimum quantity, the operation of the supply or feed / dosing stop means (28) associated with the filling / feeding tube (25) is controlled to fill the inner space (3a) of the pocket (1) with the biopharmaceutical product from the feed (26) to the biopharmaceutical product and that when the quantity of biopharmaceutical product in the inner space (3a) of the bag (1) reaches the maximum quantity, the means for stopping feeding or feeding / dosing (28) are controlled associated with the filling / feeding tube (25) to stop filling the inner space (3a) of the bag (1) with the biopharmaceutical product from the feed (26) into a biopharmaceutical product.

33. A method of producing a dispensing pouch (1) according to claim 22, wherein: ^■ there is plastic film capable of being cut and secured to itself and to form flexible pocket walls ,

^■ one has at least one input port (9) and a plurality of n output ports (10),

^■ film cutting means and fastening means are available,

^■ is cut the film to the desired shape of the pocket walls, in particular two opposite walls (5 and 6),

^■ at least one outlet port opening and mounting opening (14) is cut in a stitching wall (5) for the n output ports (10),

^■ and are joined fixedly and sealingly the walls of the bag and the output ports (10) to the stitching wall (5) around the at least one passage opening and assembly (14) port output (10).

34. A production method according to claim 33, in which, at an outlet port (10), a draining / filling tube (16) is communicatively associated at its proximal end with a connecting plate (17). and the fixing plate is secured, in particular by gluing or welding, in a fixed and sealed manner to the stitching wall (5) around an outlet port opening and fitting opening (14) (10). .

35. Production method according to any one of claims 33 and 34, wherein, at an inlet port (9), is communicatively associated a filling / feeding tube at its proximal end, in particular , the pocket (1) comprising a plurality of input ports (9), it is associated with each of them having a first section of filling / feeding tube at its proximal end, and communicating said plurality of first filling / feeding tube sections at their distal ends to the proximal end of a second common section of filling / feeding tube.