US-12624325-B2 - Single-use container with 3D printed functional element, printing method therefor and assembly

US12624325B2US 12624325 B2US12624325 B2US 12624325B2US-12624325-B2

Abstract

A method for producing a single-use container, particularly a single-use bioreactor, an assembly system, and a single-use container particularly a single-use bag such as a single-use bioreactor comprising: a base material; and at least one functional element being at least partially connected with the base material, wherein the functional element is obtained by a three dimensional printing technique from at least one printable material, wherein the printable material is heated during the three dimensional printing thereby at least partly connecting the printed functional element to the base material.

Inventors

Richard Bendall
Jeremy Pullin
Isabelle Gay

Assignees

Sartorius Stedim FMT S.A.S.

Dates

Publication Date: 20260512
Application Date: 20191022
Priority Date: 20181109

Claims (15)

1 . A single-use container for use as a bioreactor, comprising: a base material being a flexible material selected from the group consisting of a two-dimensional film, a stock sheet, a pre-cut bag, a pre-made bag, and a wall element of a bag or container; and at least one functional element being directly and permanently connected to the base material, wherein the at least one functional element comprises at least one printable material that is connected to the base material by heating the at least one printable material and simultaneously heating at least a portion of the base material during three-dimensional printing of the at least one printable material onto a surface of the base material, and wherein the at least one functional element comprises a port that is fused to the base material around an excess portion of the base material, and wherein the base material comprises an opening disposed within an interior region of the port, the opening being formed by removal of the excess portion of the base material after the port is connected.
2 . The single-use container according to claim 1 , wherein the at least one functional element further comprises at least one out of the following: a flange, an inlet and/or outlet point, a sensor holder, a sensor or a part of a sensor, a window or a window frame, a tube holder, a handle, and a connector.
3 . The single-use container according to claim 1 , wherein the at least one functional element further comprises at least one out of the following: a label, a substantially three-dimensional text, and a reference marker or fiducial.
4 . The single-use container according to claim 1 , wherein the at least one functional element further comprises a stabilizing element, stiffening element, and/or a reinforcement element.
5 . The single-use container according to claim 1 , wherein the at least one functional element further comprises an electronic component.
6 . The single-use container according to claim 1 , wherein the base material and/or the at least one functional element comprises at least one of: PE, EVA, ABS, PC, PMMA, PLA, PES, PSU, POM, PEEK, PEI, PPO, PP, PET, PS, PA, PTFE, PU, TPE, silicone, fluoropolymers, copolyesters, acrylic.
7 . The single-use container according to claim 1 , wherein the at least one printable material is printed by a three dimensional printing technique comprising a fused filament fabrication, a drop-by-drop application of the printable material, and/or a layer-by-layer application of the printable material.
8 . The single-use container according to claim 7 , wherein the three dimensional printing technique further comprises printing from one or more of nanoparticle ink, spraying atomized metal, melting a metal powder, and aerosol jetting an electronic component.
9 . A method of producing a single-use container by producing at least one functional element and connecting the at least one functional element with a base material of the container, comprising the steps of: providing the base material, the base material being a flexible material selected from the group consisting of a two-dimensional film, a stock sheet, a pre-cut bag, a pre-made bag, and a wall element of a bag or container; three-dimensional printing of the at least one functional element from a printable material on a surface of the base material; and connecting at least a portion of the at least one functional element with at least a portion of the base material by supplying heat to the printable material and the base material simultaneously to and/or prior to at least an interval of the step of three dimensional printing, wherein the at least one functional element comprises a port that is fused to the base material around an excess portion of the base material, and removing the excess portion after the port is fused to the base material to define an opening within an interior region of the port.
10 . The method according to claim 9 , wherein the step of supplying heat comprises the step of pre-heating the base material.
11 . The method according to claim 9 , wherein the step of three dimensional printing of the at least one functional element comprises a step of printing from printable material, at least one of: acrylics, EVA, ABS, PC, PE, PMMA, PLA, PES, POM, PEEK, PEI, PP, PS, PTFE.
12 . The method according to claim 9 , wherein the step of three dimensional printing comprises the step of printing from a nanoparticle ink and/or spraying atomized metal and/or melting a metal powder and/or aerosol jetting an electronic component.
13 . The method according to claim 9 , further comprising the step of removing a portion of the base material and/or removing an excess portion of the at least one functional element.
14 . The method according to claim 9 , wherein the three-dimensional printing of the at least one functional element comprises a fused filament fabrication, a drop-by-drop application of the printable material, and/or a layer-by-layer application of the printable material.
15 . The method according to claim 9 , further comprising removing excess material from either the at least one functional element and/or the base material; and at least partly recycling the excess material being removed by reusing it in the three dimensional printing step and/or in a step of manufacturing the base material.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This is the U.S. National Stage of International Application No. PCT/EP2019/078722 filed Oct. 22, 2019, which was published in English under PCT Article 21(2), which in turn claims the benefit of European Patent Application No. 18 290 131.4, filed Nov. 9, 2018. The prior applications are incorporated herein by reference in their entirety. The invention relates to a single-use container, for example a single-use bioreactor, a method for producing this container and an assembly for producing items, particularly a single-use container and/or elements thereof. The invention is specifically related to the fields of biotechnology, bioprocessing, chemical and/or biological plant construction, food and beverage processing and/or chemical technology. The invention is particularly related to fluid management in biopharmaceutical industry. In the production of items such as single-use containers, being comprised of single elements which are produced independently from each other, usually a production step of connecting single elements with each other is required, such as welding and/or gluing and/or mounting for example. Typically, elements comprise protruding portions and/or areas which extend from the main body of an element to provide a surface which may be an excess surface to which glue can be applied or at which a step of welding can be performed. In FIG. 1a, an example of a conventional production procedure is illustrated and discussed further below. For example, EP1778828B1 discloses a bioreactor, comprising a reactor vessel embodied as a bag, wherein a receiving port is arranged at an upper side of the reactor bag and is provided with a flange piece tightly sealed to a vessel wall. A sensor piece is to be connected to the flange piece via a tubular connector piece in such a way that the sensor piece reaches into the reactant from above. Further, EP2707694A1 discloses a single-use bag having a flexible wall comprising a fixation flange for fixing a sensor head to the flexible wall of the single-use bag. The fixation flange may be set to the flexible wall by being adhesive-bonded, welded, screwed, clamped or latched thereto. According to an aspect, there is a need for increasing the degree of versatility of a single-use container, a method for producing this container and an assembly for producing items, particularly in view of the number of materials which may be connected and the arrangement of functional elements on a single-use bag. The problem is solved by the independent claims. Preferred embodiments are subject of the dependent claims. The following aspects of the invention provide a single-use container, a method for producing this container and an assembly for producing items, such as a single-use container allowing multiple materials to be combined and/or connected. Further, the structures of the functional elements, as well as the arrangement on a single-use bag may be improved. According to one aspect, there is provided a single-use container, for example a single-use bioreactor, comprising a base material, particularly a wall element and/or a wall and/or skin of the single-use container, particularly of a single-use bioreactor which may be a single-use bag, such as a foil, a thin sheet and/or a stock sheet; andat least one functional element, for example a port, a sensor holder, a sensor part or the like, being at least partially, preferably permanently connected with or to the base material, wherein the functional element is obtained by a three dimensional (3D) printing technique from at least one printable material, wherein the printable material and/or the base material is/are heated during printing thereby (so as to) at least partly connecting the printed functional element to the base material. In other words, a single-use container, which may be a single-use bag, comprises at least two parts: One part, i.e. a base material, such as for example a stock material and/or a pre-made item and/or a pre-made bag or a pre-made part thereof. The base material being connected to or with at least one second part. The at least one second part is a functional element which particularly is produced by being printed directly onto the base material. At least a portion or a part of the functional element may be in direct contact with the base material being directly connected to the base material such that a physical contact is established. The connection of the two parts, i.e. the base material and the at least one functional element, is established during at least a part of time, i.e. a fraction of time or a period, needed for the production of the functional element performed by 3D printing and heating. It should be understood that the functional element may by 3D printed onto the base material in one step or in plural steps or stages particularly being separate in time. In other words, the functional element may be formed by subsequently 3D printing a sub-element on