EP3730119A1 - Assembly for biopharmaceutical use comprising a bag and a frame - Google Patents

Abstract

Set (20) for biopharmaceutical use comprising a bag (22) adapted to receive a biopharmaceutical product and a frame (24), the bag (22) being a flexible plastic envelope provided with at least one input / output port (27 ) of biopharmaceutical fluid and comprising a first side wall (28) and a second side wall (30), the first side wall (28) and the second side wall (30) being in part secured by a weld (32), the weld (32) defining a welded periphery (34) of the pocket (22) and delimiting an internal space (36) of the pocket (22), the frame (24) enclosing the pocket (22) on a continuous path along the periphery welded (34) at least in one area of the weld (32).

Description

Technical area

The invention relates to an assembly for biopharmaceutical use comprising a pocket suitable for receiving a biopharmaceutical product and a frame.

Prior art

The term “biopharmaceutical product” here means a product resulting from biotechnology, such as culture media, cell cultures, buffer solutions, artificial nutrition liquids, or a pharmaceutical product or more generally a product intended for use in the medical field. Such a product is in liquid, pasty or powdery form, in one or more phases, homogeneous or not, able to flow through a valve, thus being able to be qualified as fluid. The invention also applies to products other than biopharmaceuticals, according to the definition which has just been given, but which are subject to similar requirements as regards their storage or their treatment. Besides the transfer of a biopharmaceutical product, the bag can be adapted for a bioreactor or a fermenter.

A bag receiving a biopharmaceutical product can for example be a single-use bag. Such a pocket can comprise two walls. The two walls are sealed with each other, for example by welding. In order to receive the biopharmaceutical product, this type of pouch is capable of expanding. Once expanded, the pouch has a limited volume. As a result, this type of pocket is commonly called a “2D pocket” (for “two dimensions”).

A disposable pouch is usually made of a film. More precisely, the walls of the pocket include a multilayer film. The multilayer film comprises, for example, a contact layer, a barrier layer and an outer layer.

The contact layer is intended to be in contact with the biopharmaceutical (in other words, the contact layer is on the volume side inside pocket). The contact layer is therefore made of a material compatible with the biopharmaceutical without causing degradation of the film or the biopharmaceutical. For this purpose, the material of the contact layer is generally selected from polyolefins such as, for example, polyethylene.

The outer layer is intended to be in contact with the external environment. The outer layer contributes to the mechanical strength of the walls of the pocket. To this end, it must be flexible enough to withstand high mechanical stresses, but not be too stretchable in order to prevent any deformation of the bag when it is filled with a biopharmaceutical product.

The barrier layer serves as a barrier to the passage of gases such as oxygen, carbon dioxide and is generally made of ethylene vinyl alcohol.

Technical problem

The walls of the bag must be hermetically closed in order to avoid, for example, any product leakage outside the bag or any contamination of the product contained in the bag. For this purpose, the walls are generally welded to one another. However, the materials composing the multilayer film are sometimes hardly compatible in terms of soldering. Thus, in certain situations, the weld can give way, which leads to the loss of the integrity of the pocket. For example, the weld can give way when too great a force is applied to the weld, when filling the bag with a biopharmaceutical product, or in the event of overfilling. The weld can also fail during transport or handling of the bag, in particular when the latter is filled with a biopharmaceutical product applying pressure to the weld.

Summary of the invention

The invention improves the situation.

Disclosure of the invention

There is proposed a set for biopharmaceutical use comprising a pocket adapted to receive a biopharmaceutical product and a frame, the pocket being a flexible plastic envelope provided with at least one biopharmaceutical fluid inlet / outlet port and comprising a first side wall and a second side wall, the first side wall and the second side wall being partially secured by a weld, the weld defining a welded periphery of the pocket and delimiting an internal space of the pocket, the frame enclosing the pocket on a continuous path along of the welded periphery at least in one area of the weld.

The frame thus makes it possible to overcome the problems of weld failure of the bag while maintaining its geometric characteristics and the materials of which it is made. The frame also makes it possible to reinforce the welding of the pocket, in particular when the pocket is made of materials that are difficult to match for welding together.

• la poche est fermée par la soudure à l'exception de la zone comprenant le au moins un port d'entrée/sortie, et le cadre enserre la poche sur la totalité du parcours continu le long du pourtour soudé ;
• le cadre comprend une première partie apte à venir en contact avec la première paroi latérale et une deuxième partie apte à venir en contact avec la deuxième paroi latérale, la première partie et la deuxième partie étant fixées entre-elles par un moyen de fixation de sorte à appliquer une pression de renfort sur la soudure;
• la pression de renfort appliquée sur la soudure est comprise entre 10 N/m² et 100 N/m²;
• la première partie du cadre comprend un évidement et la deuxième partie du cadre comprend une plaque plane de sorte que le cadre encadre la poche ;
• l'ensemble comprend plusieurs poches et la première partie du cadre comprend plusieurs évidements, chaque évidement étant apte à recevoir une des poches ;
• la soudure s'étend selon une direction radiale par rapport à la poche ;
• la soudure comprend un bord périphérique interne du côté de l'espace interne de la poche et un bord périphérique externe opposé au bord périphérique interne, la soudure étant sensiblement plate entre le bord périphérique interne et le bord périphérique externe ;
• la soudure comprend une largeur mesurée entre le bord périphérique interne et le bord périphérique externe, la largeur étant comprise entre 5 et 20 mm ;
• le cadre enserre la soudure depuis le bord périphérique interne vers le bord périphérique externe, sur une partie de la largeur;
• la première partie comprend une périphérie externe et une périphérie interne, la périphérie externe et la périphérie interne étant espacées l'une de l'autre par une largeur, la largeur représentant 1,5 fois la largeur de la soudure;
• le cadre enserre la soudure depuis le bord périphérique interne vers le bord périphérique externe sur toute la largeur ;
• le cadre enserre en outre une partie de la poche au-delà de la soudure.

The assembly can also include the characteristics set out in the following paragraphs which can optionally be implemented independently of each other or in combination with each other:

• the pocket is closed by the weld except for the area comprising the at least one entry / exit port, and the frame surrounds the pocket over the entire continuous path along the welded periphery;
• the frame comprises a first part adapted to come into contact with the first side wall and a second part adapted to come into contact with the second side wall, the first part and the second part being fixed together by a fixing means so applying reinforcing pressure to the weld;
• the reinforcing pressure applied to the weld is between 10 N / m ² and 100 N / m ² ;
• the first part of the frame comprises a recess and the second part of the frame comprises a planar plate so that the frame frames the pocket;
• the assembly comprises several pockets and the first part of the frame comprises several recesses, each recess being able to receive one of the pockets;
• the weld extends in a radial direction relative to the pocket;
• the weld comprises an internal peripheral edge on the side of the internal space of the pocket and an external peripheral edge opposite the internal peripheral edge, the weld being substantially flat between the internal peripheral edge and the external peripheral edge;
• the weld comprises a width measured between the inner peripheral edge and the outer peripheral edge, the width being between 5 and 20 mm;
• the frame encloses the weld from the inner peripheral edge to the outer peripheral edge, over part of the width;
• the first part comprises an outer periphery and an inner periphery, the outer periphery and the inner periphery being spaced apart from each other by a width, the width being 1.5 times the width of the weld;
• the frame encloses the weld from the inner peripheral edge to the outer peripheral edge over the entire width;
• the frame further encloses part of the pocket beyond the weld.

Brief description of the drawings

• Fig. 1
  [Fig. 1] montre un ensemble vue de dessus selon un mode de réalisation de l'invention ;
• Fig. 2
  [Fig. 2] montre une poche vue de dessus selon un mode de réalisation de l'invention ;
• Fig. 3
  [Fig. 3] montre l'ensemble de la figure 1 vue de dessous ;
• Fig. 4
  [Fig. 4] montre l'ensemble dans une vue en coupe selon le plan A de la figure 1;
• Fig. 5
  [Fig. 5] montre un exemple de l'ensemble dans une vue en coupe selon le plan B de la figure 1;
• Fig. 6
  [Fig. 6] montre un autre exemple de l'ensemble dans une vue en coupe selon le plan B de la figure 1;
• Fig. 7
  [Fig. 7] montre un ensemble vue de dessus selon un autre mode de réalisation de l'invention ;
• Fig. 8
  [Fig. 8] montre un ensemble dans une vue en coupe selon un autre mode de réalisation de l'invention.
• Fig. 9
  [Fig. 9] montre un ensemble dans une vue en coupe selon un autre mode de réalisation de l'invention.

Other characteristics, details and advantages of the invention will become apparent on reading the detailed description below, and on analyzing the appended drawings, in which:

• Fig. 1
  [ Fig. 1 ] shows a top view assembly according to one embodiment of the invention;
• Fig. 2
  [ Fig. 2 ] shows a top view pocket according to one embodiment of the invention;
• Fig. 3
  [ Fig. 3 ] shows the whole figure 1 view from below;
• Fig. 4
  [ Fig. 4 ] shows the assembly in a sectional view along plane A of the figure 1 ;
• Fig. 5
  [ Fig. 5 ] shows an example of the assembly in a sectional view along plane B of the figure 1 ;
• Fig. 6
  [ Fig. 6 ] shows another example of the assembly in a sectional view along plane B of the figure 1 ;
• Fig. 7
  [ Fig. 7 ] shows a top view assembly according to another embodiment of the invention;
• Fig. 8
  [ Fig. 8 ] shows an assembly in a sectional view according to another embodiment of the invention.
• Fig. 9
  [ Fig. 9 ] shows an assembly in a sectional view according to another embodiment of the invention.

Description of embodiments

The drawings and the description below essentially contain elements of a certain nature. They can therefore not only serve to better understand the present invention, but also contribute to its definition, if necessary.

The figure 1 illustrates an assembly 20 for biopharmaceutical use. The set includes a pocket 22 and a frame 24.

Pocket 22 is illustrated in more detail on figure 2 . The pocket 22 is rectangular in shape and substantially flat, and extends along a plane P (visible for example at the figure 4 and at the figure 5 ). A pocket as illustrated is commonly referred to as a 2D pocket. The pocket 22 is a flexible plastic envelope. The pocket 22 includes an entry / exit port 27 and a first and a second side wall 28, 30.

The flexible plastic envelope of the pocket 22 is for example composed of a multilayer film. The multilayer film can for example be composed of polyethylene. Polyethylene is particularly advantageous in terms of compatibility with the biopharmaceutical product intended to be contained in the bag 22.

The pocket 22 is further provided with at least one input / output port 27. For example, as illustrated, the input / output port 27 comprises a single orifice 26. According to other examples not illustrated, the inlet / outlet port 27 may comprise several orifices (for example four) without, however, departing from the scope of the present invention. The inlet / outlet port 27 allows the passage of the biopharmaceutical fluid to the bag 22 or to leave it.

The first side wall 28 and the second side wall 30 form the 2D shape of the pocket 22. The first side wall 28 and the second side wall 30 are joined by a weld 32. In addition, according to a variant, the inlet port / outlet 27 is secured to the first and to the second side wall 28, 30 by direct welding of a polyethylene part, such as for example a shuttle comprising at least the inlet / outlet port 27, with the first and second walls side 28, 30. Said input / output port being for example a connector with a tip of the fir type, often called "Hose Barb" in English. According to another variant, the inlet and outlet port 27 is a plastic (polyethylene, thermoplastic elastomeric polymer) or silicone tube secured directly by welding to the first and to the second side wall 28, 30 of the pocket. More specifically, due to the presence of the entry / exit port 27, the first side wall 28 and the second side wall 30 are not welded together in the region of the entry / exit port 27. The weld 32 defines a welded periphery 34 of the pocket 22. More precisely, the first side wall 28 and the second side wall 30 are welded together by the weld 32 along the welded periphery 34. As visible on the figure figure 2 , the welded periphery 34 extends over the entire periphery of the pocket 22, that is to say over a continuous path all around the pocket 22. The weld 32 further defines an internal space 36 of the pocket 22. The internal space 36 is able to receive the biopharmaceutical product.

The weld 32 comprises an internal peripheral edge 37 on the side of the internal space 36 of the pocket and an external peripheral edge 38 opposite the internal peripheral edge 37. In other words, the internal peripheral edge 37 delimits the internal space 36. of the pocket 22. The weld 32 is substantially flat between the outer peripheral edge 38 and the internal peripheral edge 37. The weld 32 extends in a radial direction R relative to the pocket 22. The weld 32 therefore extends radially from the internal space 36 away from it. More specifically, the radial direction R is located in the plane P, and extends perpendicularly to the tangent T of the internal peripheral edge 37, in the direction opposite to the internal space 36.

Further, the weld 32 includes a width L32. The width L32 is measured between the inner peripheral edge 37 and the outer peripheral edge 38. More precisely, the width L32 is measured in the radial direction R. The width L32 can be between 5 mm and 20 mm. For example, the width L32 is 10 mm.

The figure 1 and the figure 3 illustrate an example of frame 24 according to the invention. The frame 24 is substantially flat and rectangular. The frame 24 is able to receive the pocket 22. The frame 24 constitutes a support for the pocket 22. In addition, the frame 24 applies a reinforcing pressure on the weld 32 of the pocket 22. The material of the frame 24 is chosen from so that the frame 24 does not deform when pressure is applied to the pocket 22, and in particular when the weld 32 of the pocket 22 is subjected to pressure. This pressure on the weld 32 may be due, for example, to the transport or handling of the bag 22, in particular when the latter is filled with a biopharmaceutical product. Therefore, the frame 24 is for example made of plastic.

The frame 24 comprises a first part 40 and a second part 42. The first part 40 is able to come into contact with the first side wall 28 of the pocket 22. The second part 42 is able to come into contact with the second side wall. 30 of pocket 22.

The first part 40 constitutes the upper face of the frame 24. The first part 40 is rectangular and planar. The first part 40 further comprises a rectangular recess 41 at its center. It is through this recess 41 that the pocket 22 can expand. More precisely, the shape of the first part 40 corresponds substantially to the shape of the weld 32 of the pocket 22. As can be seen in figure 1 , the first part 40 comprises an outer periphery 44 and an inner periphery 43. The outer periphery 44 is rectangular. The internal periphery 43 is rectangular and corresponds to the contour of the recess 41. As seen in figure 1 , the outer periphery 44 and the inner periphery 43 are spaced from each other by a width L40. The width L40 is between 1.2 times and 3 times the width of the weld L32. For example, as illustrated on figure 9 , the width L40 represents 1.5 times the width L32. By way of example, the width L40 is 20 mm.

The second part 42 is illustrated in particular in figure 3 . The second part 42 constitutes the lower face of the frame 24. The second part 42 is rectangular and planar. More precisely, the second part 42 is in the form of a flat plate. In this example, the external shape of the second part 42 corresponds to the external shape of the first part 40. In other words, the external dimensions of the second part 42 and of the first part 40 are identical.

The first part 40 and the second part 42 are fixed together by a fixing means 45 so as to apply a reinforcing pressure on the zone of the weld 32 in contact with the first part 40 and the second part 42. The pressure reinforcement applied by the fastening means 45 on the weld 32 is a prestress which must make it possible to prevent the weld 32 from failing. For example, the applied prestress is between 10 N / m ² and 100 N / m ² . This prestress allows the weld 32 to withstand when the pocket 22 is subjected, for example, to a pressure in its internal space 36 up to 1.5 bars. This is for example the case when filling the bag 22 with a biopharmaceutical product. The application of this prestress during filling makes it possible to protect the weld 32 from a possible rupture. As the weld 32 is only really subjected to pressure during filling, it may be possible to remove the frame 24 which surrounds the bag 22, once the bag 22 has been filled. The frame 24 can therefore play a role of temporary reinforcement of the weld 32 when the pocket 22 is being filled. Alternatively or in addition, the frame 24 can play the role of support during use, transport and / or storage. pocket 22.

The fixing means 45 may consist for example of screw-nut assemblies distributed over the periphery of the first part 40 and of the second part 42. The screw-nut assemblies in this case pass through the first part 40 and the second part 42 for join them together. According to another example, the fixing means 45 is a set of rivets, distributed over the periphery of the first part 40 and of the second part 42. Alternatively, the fixing means 45 can be fixing lugs, preferably made of plastic or metal, engaging with the first part 40 and the second part 42. These tabs can in addition to include a tab for their placement around the first and second part 40, 42.

According to the example visible at figure 5 , the frame 24 surrounds the pocket 24 over the entire continuous path along the welded periphery 34. In this example, the frame 24 covers the entire width L32 of the weld 32. More precisely, the width L40 of the first part 40 is greater than the width L32 so that the weld 32 is clamped between the first part 40 and the second part 42 of the frame 24. The frame 24 thus surrounds the weld 32 from the outer peripheral edge 38 towards the inner peripheral edge 37, over any width L32. In other words, the solder 32 is not exposed (that is to say not visible) in the recess 41. For example, the edge of the internal peripheral 43 of the first part 40 faces the internal peripheral edge 37 of the weld 32. According to another example, the edge of the internal periphery 43 of the first part 40 comes beyond the internal peripheral edge 37 of the weld 32. In this case, the weld 32 and a part of the pocket 22 directly in contact with the weld 32 is covered by the first part 40. In other words, the frame 24 not only crushes the weld 32 but also a part of the pocket 22. In this configuration, the width L40 may for example represent 1.5 times the width L32. The edge of the internal peripheral 43 of the first part 40 may for example extend beyond the weld 32, towards the internal space of the pocket 36, by 5 mm.

According to another example, visible at the figure 6 , the frame 24 encloses the pocket 24 over the entire continuous path along the welded periphery 34, but the frame 24 does not cover the entire width L32 of the weld 32. In this example, the frame 24 covers part of the width L32 of the weld. The frame 24 thus encloses the weld 32 from the outer peripheral edge 38 towards the inner peripheral edge 37, over part of the width L32. In other words, the weld 32 is partly exposed (i.e. visible) in the recess 41. However, the length L40 is chosen so that the first part 40 sufficiently covers the weld 32 so that the frame 24 sufficiently reinforces the weld 32 in the event of pressure applied to the weld 32.

The figure 7 illustrates another exemplary embodiment of a frame 24 according to the invention. In this example, the first part 40 of the frame 24 comprises several recesses 41, so that the frame 24 can receive as many pockets 22 as the first part 40 comprises recess 41. In the example illustrated in figure 7 , the frame 24 receives six pockets 22. Each pocket 22 is arranged at a recess 41.

The figure 8 illustrates another exemplary embodiment of a frame 24 according to the invention. In this example, the first part 40 and the second part 42 of the frame each comprise a recess 41. This alternative allows the inflation of the two side walls of the pocket 28, 30.

According to another exemplary embodiment according to the invention, the first part 40 and the second part 42 each comprise several recesses 41. Each recess 41 of the first part 40 is arranged opposite a recess 41 of the second part 42. This alternative makes it possible both to receive as many pockets 22 as the first part 40 or the second part 42 comprises a recess 41 and to allow the inflation of the two side walls 28, 30 of the pockets 22 held in the frame 24.

List of reference signs

• - 20: set
• - 22: pocket
• - 24: frame
• - 26: orifice
• - 27: input / output port
• - 28: first side wall
• - 30: second side wall
• - 32: welding
• - 34: circumference
• - 36: internal space
• - 37: internal peripheral edge
• - 38: outer peripheral edge
• - 40: first part of the frame
• - 41: obviously
• - 42: second part of the frame
• - 43: internal periphery of the first part of the frame
• - 44: outer periphery of the first part of the frame
• - 45: fixing means
• - L32: width of the weld
• - L40: width of the edge of the first part of the frame
• - R: radial direction
• - T: tangent

Claims (11)

Set (20) for biopharmaceutical use comprising a bag (22) adapted to receive a biopharmaceutical product and a frame (24), the bag (22) being a flexible plastic envelope provided with at least one input / output port (27 ) of biopharmaceutical fluid and comprising a first side wall (28) and a second side wall (30), the first side wall (28) and the second side wall (30) being in part secured by a weld (32), the weld (32) defining a welded periphery (34) of the pocket (22) and delimiting an internal space (36) of the pocket (22),
in which the frame (24) - encloses the pocket (22) on a continuous path along the welded periphery (34) at least in one zone of the weld (32), and - comprises a first part (40) adapted to come into contact with the first side wall (28) and a second part (42) adapted to come into contact with the second side wall (30), the first part (40) and the second part (42) being fixed together by a fixing means (45) so as to apply a reinforcing pressure on the weld (32), the reinforcing pressure being between 10 N / m ² and 100 N / m ² . An assembly (20) according to claim 1, wherein the pocket (22) is closed by the weld (32) except for the area comprising the at least one entry / exit port (27), and the frame ( 24) encloses the pocket (22) over the entire continuous path along the welded periphery (34). An assembly (20) according to claim 1 or 2, wherein the first part (40) of the frame (24) comprises a recess (41) and the second part (42) of the frame (24) comprises a planar plate so that the frame (24) surrounds the pocket (22). Assembly (20) according to any one of claims 1 to 3 comprising several pockets (22), the first part (40) of the frame (24) comprising several recesses (41), each recess (41) being able to receive one of the pockets (22). An assembly (20) according to any preceding claim, wherein the weld (32) extends radially from an internal space (36) of the pocket (22) away from it. An assembly (20) according to any preceding claim, wherein the weld (32) comprises an inner peripheral edge (37) on the inner space side (36) of the pocket (22) and an outer peripheral edge ( 38) opposite the inner peripheral edge (37), the weld (32) being substantially flat between the inner peripheral edge (37) and the outer peripheral edge (38). An assembly (20) according to claim 6 wherein the weld (32) comprises a width (L32) measured between the inner peripheral edge (37) and the outer peripheral edge (38), the width (L32) being between 5 mm and 20 mm. An assembly (20) according to claim 7 wherein the frame (24) encloses the weld (32) from the outer peripheral edge (38) to the inner peripheral edge (37), over part of the width (L32). An assembly (20) according to claim 7 or 8 and any one of claims 1 to 3 wherein the first part (40) comprises an outer periphery (44) and an inner periphery (43), the outer periphery (44) and the inner periphery (43) being spaced from each other by a width (L40), the width (L40) being 1.5 times the width (L32). An assembly (20) according to claim 7 wherein the frame (24) encloses the weld (32) from the outer peripheral edge (38) to the inner peripheral edge (37), over the entire width (L32). An assembly (20) according to claim 10, wherein the frame (24) further encircles a portion of the pocket (22) beyond the weld (32).

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