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

Abstract

A flexible bag for biopharmaceutical use, includes a shell for receiving, in an inner space thereof, a flowable biopharmaceutical product, and flexible walls joined by fixed and sealed rigid-connection areas, two opposite walls being connected to each other by the peripheries thereof, at least one inlet port and one outlet port, a port being combined with a passage of the shell and mounted thereon by fixed and sealed connection elements, a plurality of similar outlet ports grouped together in a tapping area, a tapping wall provided with at least one opening for the passage and assembly of the outlet port for the similar outlet ports, fixed and sealed port-shell connection elements which are rigidly, fixedly, and sealingly connected to the tapping wall around the at least one opening for the passage and assembly of the outlet port, and an area for folding the two opposite walls.

1 - 35 . (canceled) 
     
     
         36 . A bag ( 1 ) for distributing a dose of a flowable biopharmaceutical product in the general state of a liquid or paste, into a set of containers ( 2 ), comprising a shell ( 3 ) able to receive the biopharmaceutical product in its inner space ( 3   a ) and comprising flexible walls joined by fixed and sealed connection areas ( 4 ), of which two opposite walls ( 5  and  6 ) are connected to each other by their peripheries ( 7 ), at least one inlet port ( 9 ) by which the inner space ( 3   a ) can be filled with the biopharmaceutical product, and a plurality of n outlet ports ( 10 ) with which are associated in a communicating manner n external discharge/fill tubes, and by which the biopharmaceutical product can be discharged from the inner space ( 3   a ) into a plurality of containers ( 2 ) associated in a communicating manner with the n outlet ports ( 10 ) in order to fill them with a dose of biopharmaceutical product, a port ( 9 ,  10 ) being associated with a passage in the shell ( 3 ) and being mounted onto it by fixed and sealed connection means ( 15 ), 
       characterized in that:
 the n outlet ports ( 10 ) are similar and grouped, in particular near to one another, in a continuous tapping area ( 12 ) delimited by the outlet ports ( 10 ) or their vicinity, located on a tapping wall ( 5 ) of one of the two walls ( 5  and  6 ), separate from the connection areas ( 4 ), extending linearly or more widely across a surface area distinctly smaller than the area of the face of the tapping wall ( 5 ), 
 the bag ( 1 ) comprises a tapping wall ( 5 ) provided with at least one opening for outlet port passage and assembly ( 14 ) for the n outlet ports ( 10 ), and fixed and sealed port/shell ( 3 ) connection means ( 15 ) attached in a fixed and sealed manner to the tapping wall ( 5 ) around the at least one opening for outlet port passage and assembly ( 14 ), 
 the bag ( 1 ) comprises a folding region ( 8 ) of the two walls ( 5  and  6 ), at or near where the tapping area ( 12 ) is located, where the two walls ( 5  and  6 ) can be folded onto themselves with the face of the tapping wall ( 5 ) being external to the fold while forming an end edge ( 18 ) of the folded bag, at or near where the tapping area ( 12 ) and the n outlet ports ( 10 ) are located. 
 
     
     
         37 . The bag ( 1 ) according to  claim 36 , wherein it has either of the following elements:
 two neighboring outlet ports ( 10 ) are spaced apart from each other by a distance chosen so that the flow of biopharmaceutical product through one of the outlet ports ( 10 ) does not substantially interfere with the flow of biopharmaceutical product through the other of the outlet ports ( 10 ),   the tapping area ( 12 ) extends over a surface area that is less than ⅕th, particularly less than 1/10 th , even more particularly less than 1/20 th , of the area of the face of the tapping wall ( 5 ),   the tapping area ( 12 ) either extends linearly, or linearly but more widely over the surface, along a tapping segment ( 13 ), in particular a tapping segment ( 13 ) comprising at least one substantially rectilinear section, more particularly being substantially rectilinear,   the n outlet ports ( 10 ) are distributed in a manner that is at least substantially uniform manner over the entire tapping area ( 12 ), and in particular are spaced apart from each other in a manner that is at least substantially regular.   
     
     
         38 . The bag ( 1 ) according to  claim 36 , wherein the n outlet ports ( 10 ) are distributed in an at least substantially uniform manner, in particular are spaced apart from each other in an at least substantially regular manner, throughout the entirety of multiple tapping sub-areas ( 12   a ,  12   b ), each tapping sub-area ( 12 ) being continuous, delimited by outlet ports ( 10 ) or their vicinity, and extending linearly or more widely over the surface, the multiple tapping sub-areas ( 12   a ,  12   b ) which constitute the tapping area ( 12 ) being separated by areas without tapping ( 19 ); and optionally wherein a tapping sub-area ( 12   a ,  12   b ) either extends linearly or linearly but more widely over the surface, along a tapping sub-segment ( 13   a ,  13   b ), particularly a tapping sub-segment ( 13   a ,  13   b ) comprising at least one substantially rectilinear section, more particularly being substantially rectilinear and/or extending at least substantially parallel to the tapping segment ( 13 ); and even more optionally wherein at least some of the tapping sub-segments ( 13   a ,  13   b ), in particular all the tapping sub-segments ( 13   a ,  13   b ), are positioned at least substantially parallel to each other or at least substantially as an extension of one another. 
     
     
         39 . The bag ( 1 ) according to  claim 36 , wherein either an opening for outlet port ( 10 ) passage and assembly ( 14 ) is associated with an outlet port ( 10 ) among the plurality of n outlet ports ( 10 ), or an opening for outlet port ( 10 ) passage and assembly ( 14 ) is shared by multiple outlet ports ( 10 ) among the plurality of n outlet ports ( 10 ). 
     
     
         40 . The bag ( 1 ) according to  claim 36 , wherein an outlet port ( 10 ) comprises, associated in a communicating manner, a discharge/fill tube ( 16 ) at its proximal end ( 16   a ) and an attachment plate ( 17 ) which is part of the fixed and sealed port/shell ( 3 ) connection means ( 15 ) and is attached, in particular by adhesive bonding or welding, in a fixed and sealed manner to the tapping wall ( 5 ) around an opening for outlet port ( 10 ) passage and assembly ( 14 ); and wherein it has optionally either of the following elements:
 the discharge/fill tubes ( 16 ) are able to be associated in a communicating manner at their distal ends ( 16   b ) with containers ( 2 ) in order to fill them with the biopharmaceutical product, and to be associated functionally with extraction/regulation or discharge shutoff means ( 21 ), in particular programmed or controlled,   either an attachment plate ( 17 ) is associated with an outlet port ( 10 ), or an attachment plate ( 17 ) is common to multiple outlet ports ( 10 ), or the bag ( 1 ) comprises a single attachment plate ( 17 ) common to the n outlet ports ( 10 ),   an attachment plate ( 17 ) comprises an inside face ( 17   a ) shaped to facilitate emptying, in particular completely emptying, the biopharmaceutical product.   
     
     
         41 . The bag ( 1 ) according to  claim 36 , wherein it has either of the following elements:
 the tapping area ( 12 ) and/or the folding region ( 8 ) is located at or near the middle area ( 5   b ) of the face of the tapping wall ( 5 ) and/or at or near a central axis (AA) of the face of the tapping wall ( 5 ) between the opposite peripheral sections ( 7   a ) of the face of the tapping wall ( 5 );   no port is located on the face ( 6 ) opposite the face of the tapping wall ( 5 ) and/or in the connection areas ( 4 ),   the at least one inlet port ( 9 ) is located on the tapping wall ( 5 ) at or near the tapping area ( 12 ) or at a location separate from the tapping area ( 12 ).   
     
     
         42 . The bag ( 1 ) according to  claim 36 , wherein an inlet port ( 9 ) comprises, associated in a communicating manner, a filing/supply tube ( 25 ) at its proximal end ( 25   a ), able to be associated in a communicating manner at its distal end ( 25   b ) with a biopharmaceutical product supply ( 26 ), in particular with a filter ( 27 ) placed between, and able to be associated functionally with supply/regulation or supply shutoff means ( 28 ), in particular programmed or controlled; and optionally comprising a plurality of inlet ports ( 9 ), each associated in a communicating manner with a first section ( 29 ) of filling/supply tube ( 25 ) at its proximal end ( 25   a ), said plurality of first sections ( 29 ) of filling/supply tube ( 25 ) being associated in a communicating manner at their distal ends ( 29   a ) with the proximal end ( 30   a ) of a second common section ( 30 ) of filling/supply tube ( 25 ) able to be associated in a communicating manner at its distal end ( 25   b ) with the biopharmaceutical product supply ( 26 ), in particular with a common filter ( 27 ) placed between, the supply/regulation or supply shutoff means ( 28 ) being associated with the second common section ( 30 ) of filling/supply tube ( 25 ). 
     
     
         43 . The bag ( 1 ) according to  claim 36 , wherein it has either of the following elements:
 it additionally comprises at least one gas inlet and/or outlet port ( 11 ),   the areas ( 5   a  et  6   a ) of the face of the tapping wall ( 5 ) and of the opposite face, both distanced from the folding region ( 8 ) and from the tapping area ( 12 ), form areas for suspending the bag ( 1 ) in its folded configuration, including suspension elements ( 23 ) such as holes or projections.   
     
     
         44 . The bag ( 1 ) according to  claim 36 , wherein it comprises holding means ( 24 ) able to keep the two opposite walls ( 5  and  6 ) folded onto themselves when the bag is in the folded configuration, including holding elements which complement each other. 
     
     
         45 . The bag ( 1 ) according to  claim 36 , having an unfolded configuration in which the two opposite walls ( 5  and  6 ) are stretched out. 
     
     
         46 . The bag ( 1 ) according to  claim 36 , having a folded configuration in which the two opposite walls ( 5  and  6 ) are folded onto themselves within the folding region ( 8 ), with the face of the tapping wall ( 5 ) being external to the fold, the bag in the folded configuration having, in the folding region ( 8 ), an end edge ( 18 ) at or near where the tapping area ( 12 ) and the n outlet ports ( 10 ) are located. 
     
     
         47 . An assembly for distributing a dose of a flowable biopharmaceutical product in the general state of a liquid or paste, into a set of containers, comprising:
 a bag ( 1 ) for distributing a dose of a biopharmaceutical product, having a folded configuration according to  claim 46 , in particular a bag in the state of having been filled with biopharmaceutical product,   means ( 23   a ) for holding said bag ( 1 ) so that the end edge ( 18 ) located at or near the folding region ( 8 ) is the lower edge of the bag, the inner space ( 3   a ) being placed uppermost,   means for associating, in a communicating manner, the distal end ( 16   b ) of the discharge/fill tubes ( 16 ) with containers ( 2 ) in order to fill them with the biopharmaceutical product located in the inner space ( 3   a ) of the bag ( 1 ),   extraction/regulation or discharge shutoff means ( 21 ), particularly programmed or controlled, associated functionally with the discharge/fill tubes ( 16 ).   
     
     
         48 . The distribution assembly according to  claim 47 , wherein it has in addition either of the following elements:
 the bag ( 1 ) is such that an inlet port ( 9 ) comprises, associated in a communicating manner, a filling/supply tube ( 25 ) at its proximal end ( 25   a ), said assembly also comprising means for associating in a communicating manner the distal end ( 25   b ) of the filling/supply tube ( 25 ) with the biopharmaceutical product supply ( 26 ), and supply/regulation or supply shutoff means ( 28 ), in particular programmed or controlled, associated functionally with the filling/supply tube ( 25 ) in order to fill the inner space ( 3   a ) of the bag ( 1 ) with the pharmaceutical product supplied from the biopharmaceutical product supply ( 26 ),   the extraction/regulation or discharge shutoff means ( 21 ) functionally associated with the discharge/fill tubes ( 16 ) comprise a pump structurally associated with each discharge/fill tube ( 16 ) and regulated to distribute successive doses of biopharmaceutical product, and/or the supply/regulation or supply shutoff means ( 28 ) functionally associated with the filling/supply tube ( 25 ) comprise a pump structurally associated with the filling/supply tube,   the distribution assembly also comprises:   detection means for detecting that a minimum amount and a maximum amount of biopharmaceutical product has been exceeded in the inner space ( 3   a ) of the bag ( 1 ),   and control means for controlling the extraction/regulation or discharge shutoff means ( 21 ) associated with the discharge/fill tubes ( 16 ) and the supply/regulation or supply shutoff means ( 28 ) associated with the filling/supply tube ( 25 ), responding to said detection means so that when the amount of biopharmaceutical product within the inner space ( 3   a ) of the bag ( 1 ) reaches the minimum amount, the control means order the supply/regulation or supply shutoff means ( 28 ) associated with the filling/supply tube ( 25 ) to fill the inner space ( 3   a ) of the bag ( 1 ) with the biopharmaceutical product supplied by the biopharmaceutical product supply, and so that when the amount of biopharmaceutical product within the inner space ( 3   a ) of the bag ( 1 ) reaches the maximum amount, the control means order the supply/regulation or supply shutoff means ( 28 ) associated with the filling/supply tube ( 25 ) to stop filling the inner space ( 3   a ) of the bag ( 1 ) with the biopharmaceutical product supplied by the biopharmaceutical product supply ( 26 ),   the containers ( 2 ) are located inside an aseptic enclosure and the biopharmaceutical product supply is located outside the aseptic enclosure, the bag ( 1 ) being located either inside or outside the aseptic enclosure, the wall of the aseptic enclosure being traversed respectively by either the discharge/fill tubes ( 16 ) or by a filling/supply tube ( 25 ).   
     
     
         49 . A distribution method making use of a bag ( 1 ) for distributing a dose of biopharmaceutical product, for the purposes of distributing a same dose of a biopharmaceutical product through a plurality of n outlet ports ( 10 ) into p containers ( 2 ), the number p of containers being larger, possibly much larger, than the number n of outlet ports ( 10 ), wherein:
 a flexible bag ( 1 ) having an unfolded configuration according to  claim 45  is provided,   the biopharmaceutical product is provided,   p containers ( 2 ) not yet containing said dose of biopharmaceutical product are provided,   firstly, the bag ( 1 ) is folded in its folding region ( 8 ) so that the two opposite walls ( 5  and  6 ) are folded onto themselves with the face of the tapping wall ( 5 ) being external to the fold while forming an end edge ( 18 ) of the folded bag, at or near which the tapping area ( 12 ) and the n outlet ports ( 10 ) are located, and thus the bag ( 1 ) is placed in its folded configuration; secondly, the inner space ( 3   a ) of the bag ( 1 ) is filled with the biopharmaceutical product via at least one inlet port ( 9 ); thirdly, the n outlet ports ( 10 ) are associated in a communicating manner with a first plurality, in particular n, of containers ( 2 ) not yet containing said dose of biopharmaceutical product; and fourthly, the end edge ( 22 ) is and is maintained so that it is and remains the upper edge of the bag ( 1 ),   next, the biopharmaceutical product is discharged through the n outlet ports ( 10 ), simultaneously, and a same dose of biopharmaceutical product is distributed into said first plurality of containers ( 2 ) such that a first plurality of receptacles ( 2 ) containing said dose of biopharmaceutical product is obtained,   then, while preventing the biopharmaceutical product from discharging through the n outlet ports ( 10 ), said first plurality of containers ( 2 ) containing said dose of biopharmaceutical product are removed and a second plurality, in particular n, of containers ( 2 ) not yet containing said dose of biopharmaceutical product are provided and the process is repeated with this second plurality of containers ( 2 ), and so on until the p containers ( 2 ) have been filled, the method comprising optionally either of the following elements:   either the bag ( 1 ) is first folded and then the inner space ( 3   a ) of the bag ( 1 ) is filled with the biopharmaceutical product, or the inner space ( 3   a ) of the bag ( 1 ) is first filled with the biopharmaceutical product and then the bag ( 1 ) is folded,   bag ( 1 ) holding means ( 23   a ) are additionally provided and wherein they put to use so that the end edge ( 18 ) of the bag ( 1 ) located at or near the folding region ( 8 ) is the lower edge of the bag ( 1 ), the inner space ( 3   a ) being positioned above it,   with the detection means, it is detected when a minimum amount and a maximum amount of biopharmaceutical product in the inner space ( 3   a ) of the bag ( 1 ) is exceeded,   and, based on said detection and with the control means, the extraction/regulation or discharge shutoff means ( 21 ) associated with the discharge/fill tubes ( 16 ) and the supply/regulation or supply shutoff means ( 28 ) associated with the filing/supply tube ( 25 ) are controlled so that when the amount of biopharmaceutical product within the inner space ( 3   a ) of the bag ( 1 ) reaches the minimum amount, the supply/regulation or supply shutoff means ( 28 ) associated with the filling/supply tube ( 25 ) are controlled to fill the inner space ( 3   a ) of the bag ( 1 ) with the biopharmaceutical product supplied from the biopharmaceutical product supply ( 26 ), and so that when the amount of biopharmaceutical product within the inner space ( 3   a ) of the bag ( 1 ) reaches the maximum amount, the supply/regulation or supply shutoff means ( 28 ) associated with the filling/supply tube ( 25 ) are controlled to stop filling the inner space ( 3   a ) of the bag ( 1 ) with the biopharmaceutical product supplied from the biopharmaceutical product supply ( 26 ).   
     
     
         50 . A method for creating a distribution bag ( 1 ) according to  claim 45 , wherein:
 a film of plastic material able to be cut up and attached to itself and to form flexible bag walls is provided,   at least one inlet port ( 9 ) and a plurality of n outlet ports ( 10 ) are provided,   film cutting means and attachment means are provided,   the film is cut into the shape desired for the walls of the bag, in particular the two opposite walls ( 5  and  6 ),   at least one opening for outlet port ( 10 ) passage and assembly ( 14 ) is cut in a tapping wall ( 5 ), for the n outlet ports ( 10 ),   and the walls of the bag and the outlet ports ( 10 ) are attached in a fixed and sealed manner to the tapping wall ( 5 ) around the at least one opening for outlet port ( 10 ) passage and assembly ( 14 ); the method of creation comprising optionally either of the following elements:   at an outlet port ( 10 ), a discharge/fill tube ( 16 ) is associated in a communicating manner at its proximal end with an attachment plate ( 17 ) and the attachment plate is attached, in particular by adhesive bonding or welding, in a fixed and sealed manner to the tapping wall ( 5 ) around an opening for outlet port ( 10 ) passage and assembly ( 14 ),   a filling/supply tube is associated in a communicating manner at its proximal end with an inlet port ( 9 ), in particular, the bag ( 1 ) comprising a plurality of inlet ports ( 9 ), each is associated with a first section of filling/supply tube at its proximal end, and said plurality of first sections of filling/supply tube are associated in a communicating manner at their distal ends with the proximal end of a second common section of filling/supply tube.   
     
     
         51 . The bag ( 1 ) according to  claim 37 , wherein the n outlet ports ( 10 ) are distributed in an at least substantially uniform manner, in particular are spaced apart from each other in an at least substantially regular manner, throughout the entirety of multiple tapping sub-areas ( 12   a ,  12   b ), each tapping sub-area ( 12 ) being continuous, delimited by outlet ports ( 10 ) or their vicinity, and extending linearly or more widely over the surface, the multiple tapping sub-areas ( 12   a ,  12   b ) which constitute the tapping area ( 12 ) being separated by areas without tapping ( 19 ); and optionally wherein a tapping sub-area ( 12   a ,  12   b ) either extends linearly or linearly but more widely over the surface, along a tapping sub-segment ( 13   a ,  13   b ), particularly a tapping sub-segment ( 13   a ,  13   b ) comprising at least one substantially rectilinear section, more particularly being substantially rectilinear and/or extending at least substantially parallel to the tapping segment ( 13 ); and even more optionally wherein at least some of the tapping sub-segments ( 13   a ,  13   b ), in particular all the tapping sub-segments ( 13   a ,  13   b ), are positioned at least substantially parallel to each other or at least substantially as an extension of one another. 
     
     
         52 . The bag ( 1 ) according to  claim 37 , wherein either an opening for outlet port ( 10 ) passage and assembly ( 14 ) is associated with an outlet port ( 10 ) among the plurality of n outlet ports ( 10 ), or an opening for outlet port ( 10 ) passage and assembly ( 14 ) is shared by multiple outlet ports ( 10 ) among the plurality of n outlet ports ( 10 ). 
     
     
         53 . The bag ( 1 ) according to  claim 37 , wherein an outlet port ( 10 ) comprises, associated in a communicating manner, a discharge/fill tube ( 16 ) at its proximal end ( 16   a ) and an attachment plate ( 17 ) which is part of the fixed and sealed port/shell ( 3 ) connection means ( 15 ) and is attached, in particular by adhesive bonding or welding, in a fixed and sealed manner to the tapping wall ( 5 ) around an opening for outlet port ( 10 ) passage and assembly ( 14 ); and wherein it has optionally either of the following elements:
 the discharge/fill tubes ( 16 ) are able to be associated in a communicating manner at their distal ends ( 16   b ) with containers ( 2 ) in order to fill them with the biopharmaceutical product, and to be associated functionally with extraction/regulation or discharge shutoff means ( 21 ), in particular programmed or controlled,   either an attachment plate ( 17 ) is associated with an outlet port ( 10 ), or an attachment plate ( 17 ) is common to multiple outlet ports ( 10 ), or the bag ( 1 ) comprises a single attachment plate ( 17 ) common to the n outlet ports ( 10 ),   an attachment plate ( 17 ) comprises an inside face ( 17   a ) shaped to facilitate emptying, in particular completely emptying, the biopharmaceutical product.   
     
     
         54 . The bag ( 1 ) according to  claim 37 , wherein it has either of the following elements:
 the tapping area ( 12 ) and/or the folding region ( 8 ) is located at or near the middle area ( 5   b ) of the face of the tapping wall ( 5 ) and/or at or near a central axis (AA) of the face of the tapping wall ( 5 ) between the opposite peripheral sections ( 7   a ) of the face of the tapping wall ( 5 );   no port is located on the face ( 6 ) opposite the face of the tapping wall ( 5 ) and/or in the connection areas ( 4 ),   the at least one inlet port ( 9 ) is located on the tapping wall ( 5 ) at or near the tapping area ( 12 ) or at a location separate from the tapping area ( 12 ).   
     
     
         55 . The bag ( 1 ) according to  claim 37 , wherein an inlet port ( 9 ) comprises, associated in a communicating manner, a filing/supply tube ( 25 ) at its proximal end ( 25   a ), able to be associated in a communicating manner at its distal end ( 25   b ) with a biopharmaceutical product supply ( 26 ), in particular with a filter ( 27 ) placed between, and able to be associated functionally with supply/regulation or supply shutoff means ( 28 ), in particular programmed or controlled; and optionally comprising a plurality of inlet ports ( 9 ), each associated in a communicating manner with a first section ( 29 ) of filling/supply tube ( 25 ) at its proximal end ( 25   a ), said plurality of first sections ( 29 ) of filling/supply tube ( 25 ) being associated in a communicating manner at their distal ends ( 29   a ) with the proximal end ( 30   a ) of a second common section ( 30 ) of filling/supply tube ( 25 ) able to be associated in a communicating manner at its distal end ( 25   b ) with the biopharmaceutical product supply ( 26 ), in particular with a common filter ( 27 ) placed between, the supply/regulation or supply shutoff means ( 28 ) being associated with the second common section ( 30 ) of filling/supply tube ( 25 ).