FR3095337A1 - KIT FOR BIOPHARMACEUTICAL USE INCLUDING A POCKET 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). Figure for the abstract: Figure 1

Description

SET FOR BIOPHARMACEUTICAL USE INCLUDING POUCH AND FRAME

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

By biopharmaceutical product is meant here 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, powdery form, in one or more phases, homogeneous or not, capable of flowing through a valve, thus being able to be qualified as a 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 with regard to 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 together, for example by a weld. In order to receive the biopharmaceutical product, this type of pocket is able to expand. Once expanded, the pocket has a limited volume. Therefore, this type of pocket is commonly called a “2D pocket” (for “two dimensions”).

A single-use bag is generally made up of a film. More specifically, the walls of the pocket comprise 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 product (in other words, the contact layer is on the side of the internal volume of the pocket). The contact layer is therefore made of a material compatible with the biopharmaceutical product without causing degradation of the film or of the biopharmaceutical product. 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 resistance of the walls of the pocket. To this end, it must be flexible enough to withstand high mechanical stresses, but not be too stretchy 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 pocket must be hermetically sealed in order to avoid, for example, any leakage of product outside the pocket or any contamination of the product contained in the pocket. For this purpose, the walls are usually welded together. However, the materials making up the multilayer film are sometimes difficult to match in terms of welding. Thus, in certain situations, the weld can yield, which leads to the loss of the integrity of the pocket. For example, the weld may yield when excessive forces are applied to the weld, when filling the pouch with a biopharmaceutical product, or in the event of overfilling. The weld can also break during transport or handling of the bag, especially when it is filled with a biopharmaceutical product applying pressure on the weld.

The invention improves the situation.

There is proposed an assembly 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 partly joined together by a weld, the weld defining a welded perimeter of the pocket and delimiting an internal space of the pocket, the frame enclosing the pocket on a continuous path along the along the welded perimeter at least in one area of the weld.

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

The set may further include the features set forth in the following paragraphs which may optionally be implemented independently of each other or in combination with each other:
- the pocket is closed by welding with the exception of the zone comprising the at least one entry/exit port, and the frame encloses the pocket over the entire continuous path along the welded perimeter;
- the frame comprises a first part able to come into contact with the first side wall and a second part able to come into contact with the second side wall, the first part and the second part being fixed to each other by a fixing means of so as to apply reinforcing pressure to the weld;
- the reinforcing pressure applied to the weld is between 10 N/m²and 100 N/m² ;
- The first part of the frame comprises a recess and the second part of the frame comprises a flat 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 capable of receiving one of the pockets;
- the weld extends in a radial direction with respect 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 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 also encloses part of the pocket beyond the weld.

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

Fig. 1

shows a top view assembly according to one embodiment of the invention;

Fig. 2

shows a pocket seen from above according to an embodiment of the invention;

Fig. 3

shows the assembly of Figure 1 seen from below;

Fig. 4

shows the assembly in a sectional view along plane A of Figure 1;

Fig. 5

shows an example of the assembly in a sectional view along plane B of Figure 1;

Fig. 6

shows another example of the assembly in a cross-section along plane B of Figure 1;

Fig. 7

shows a top view assembly according to another embodiment of the invention;

Fig. 8

shows an assembly in a cross-sectional view according to another embodiment of the invention.

Fig. 9

shows an assembly in a cross-sectional view according to another embodiment of the invention.

The drawings and the description below contain, for the most part, certain elements. They may therefore not only be used to better understand the present invention, but also contribute to its definition, if necessary.

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

The pocket 22 is illustrated in more detail in Figure 2. The pocket 22 is rectangular in shape and substantially flat, and extends along a plane P (visible for example in Figure 4 and Figure 5). A pocket as shown is commonly referred to as a 2D pocket. The pocket 22 is a flexible plastic envelope. Pouch 22 includes an inlet/outlet port 27 and first and second side walls 28, 30.

The flexible plastic envelope of the bag 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 pocket 22.

The pocket 22 is further provided with at least one entry/exit port 27. For example, as illustrated, the entry/exit port 27 comprises a single orifice 26. According to other examples not illustrated, the input/output 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 pocket 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 together 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 piece of polyethylene, such as for example a shuttle comprising at least the inlet/outlet port 27, with the first and second walls lateral 28, 30. Said input/output port being for example a connector with a tip of the fir tree type, often called “Hose Barb” in English. According to another variant, the inlet-outlet port 27 is a plastic tube (polyethylene, thermoplastic elastomer polymer) or silicone 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 perimeter 34 of the pocket 22. More specifically, the first side wall 28 and the second side wall 30 are welded together by the weld 32 along the welded perimeter 34. As seen in Figure 2, the welded perimeter 34 extends over the entire circumference 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 adapted 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 inner peripheral edge 37. The weld 32 extends in a radial direction R with respect to the pocket 22. The weld 32 therefore extends radially from the internal space 36 moving away from it. More precisely, the radial direction R is located in the plane P, and extends perpendicular to the tangent T of the internal peripheral edge 37, in the opposite direction to the internal space 36.

Further, 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 along the radial direction R. The width L32 can be between 5 mm and 20 mm. For example, the L32 width is 10 mm.

Figure 1 and Figure 3 illustrate an example of frame 24 according to the invention. 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 to 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 seal 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 material.

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 from pocket 22.

The first part 40 constitutes the upper face of the frame 24. The first part 40 is rectangular and flat. The first part 40 further comprises a rectangular recess 41 in 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 FIG. 40 includes an outer periphery 44 and an inner periphery 43. The outer periphery 44 is rectangular. The inner periphery 43 is rectangular and corresponds to the outline 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 shown in Figure 9, width L40 is 1.5 times width L32. For example, the width L40 is 20 mm.

The second part 42 is illustrated in particular in FIG. 3. The second part 42 constitutes the underside of the frame 24. The second part 42 is rectangular and flat. More specifically, 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 fixing means 45 on the weld 32 is a prestress which must make it possible to prevent the weld 32 from yielding. For example, the prestress applied is between 10 N/m ² and 100 N/m ² . This prestress allows the weld 32 to resist when the pocket 22 is subjected, for example, to a pressure in its internal space 36 of up to 1.5 bars. This is for example the case when the pocket 22 is filled with a biopharmaceutical product. The application of this prestress during the filling makes it possible to protect the weld 32 from a possible rupture. Since the weld 32 is only really subjected to pressure during filling, it may be possible to remove the frame 24 which encloses the pocket 22, once the pocket 22 has been filled. The frame 24 can therefore act as a temporary reinforcement for the weld 32 when the pocket 22 is filled. Alternatively or in addition, the frame 24 can act as a support during use, transport and/or storage. of pocket 22.

The fastening 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 to 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 made of metal, engaging with the first part 40 and the second part 42. These lugs can also comprise a tongue for their positioning around the first and second part 40, 42.

According to the example visible in Figure 5, the frame 24 encloses 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 enclosed between the first part 40 and the second part 42 of the frame 24. The frame 24 thus encloses the weld 32 from the outer peripheral edge 38 towards the inner peripheral edge 37, over the entire width L32. In other words, the weld 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 comes under 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 crushes not only the weld 32 but also a part of the pocket 22. In this configuration, the width L40 can for example represent 1.5 times the width L32. The edge of the internal peripheral 43 of the first part 40 can for example overflow the weld 32, towards the internal space of the pocket 36, by 5 mm.

According to another example, visible in 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 covers the weld 32 sufficiently so that the frame 24 sufficiently reinforces the weld 32 in the event of pressure being applied to the weld 32.

Figure 7 illustrates another 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 recesses 41. In the example illustrated in FIG. 7, the frame 24 receives six pockets 22. Each pocket 22 is arranged at a recess 41.

Figure 8 illustrates another 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 in accordance with 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 of recess 41 and to allow the swelling of the two side walls 28, 30 of the pockets 22 held in the frame 24.

– 20: together
- 22: pocket
- 24: frame
- 26: hole
- 27: input/output port
- 28: first side wall
- 30: second side wall
- 32: welding
- 34: perimeter
- 36: internal space
- 37: internal peripheral edge
- 38: outer peripheral edge
- 40: first part of the frame
- 41: recess
- 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: fastening means
- L32: width of the weld
- L40: width of the edge of the first part of the frame
- R: radial direction
- T: tangent

Claims (13)

Assembly (20) for biopharmaceutical use comprising a pocket (22) adapted to receive a biopharmaceutical product and a frame (24), the pocket (22) being a flexible plastic envelope provided with at least one inlet/outlet 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 partly joined 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 zone of the weld (32). An assembly (20) according to claim 1, wherein the pocket (22) is closed by the weld (32) except for the area including the at least one inlet/outlet port (27), and the frame ( 24) encloses the pocket (22) over the entire continuous path along the welded perimeter (34). Assembly according to Claim 1 or 2, in which the frame (24) comprises a first part (40) able to come into contact with the first side wall (28) and a second part (42) able 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). Assembly according to Claim 3, in which the reinforcing pressure applied to the weld is between 10 N/m ² and 100 N/m ² . An assembly (20) according to claim 4, wherein the first part (40) of the frame (24) comprises a recess (41) and the second part (42) of the frame (24) comprises a flat plate so that the frame ( 24) frames the pocket (22). Assembly (20) according to any one of claims 3 to 5 comprising several pockets (22), the first part (40) of the frame (24) comprising several recesses (41), each recess (41) being capable of receiving one of the pockets (22). An assembly (20) according to any preceding claim, wherein the weld (32) extends in a radial direction (R) relative to the pocket (22). Assembly (20) according to any one of the preceding claims, in which the weld (32) comprises an internal peripheral edge (37) on the side of the internal space (36) of the pocket (22) and an external 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). Assembly (20) according to Claim 8, in which the weld (32) comprises a width (L32) measured between the internal peripheral edge (37) and the external peripheral edge (38), the width (L32) being between 5 mm and 20mm. Assembly (20) according to claim 9 in which the frame (24) encloses the weld (32) from the outer peripheral edge (38) towards the inner peripheral edge (37), over part of the width (L32). An assembly (20) according to claim 9 or 10 and any one of claims 3 to 5 wherein the first portion (40) includes an outer periphery (44) and an inner periphery (43), the outer periphery (44) and the inner periphery (43) being spaced apart by a width (L40), the width (L40) being 1.5 times the width (L32). Assembly (20) according to claim 9 in which the frame (24) encloses the weld (32) from the outer peripheral edge (38) towards the inner peripheral edge (37), over the entire width (L32). An assembly (20) according to claim 12, wherein the frame (24) further encloses a portion of the pocket (22) beyond the weld (32).