Disposable container having three-dimensional printed functional elements, printing method for the same, and assembly

Abstract

A method for manufacturing a disposable container, particularly a disposable bioreactor, an assembly system, and a disposable bag such as a disposable container, particularly a disposable bioreactor, comprising: a substrate (2); and at least one functional element (3) - at least partially connected to the base material (2) and obtained by three-dimensional printing technology from at least one printable material (5), wherein the printable material (5) is heated during three-dimensional printing to at least partially connect the printed functional element (3) to the base material (2).

Description

Technology Field

[0001] The present invention relates to disposable containers, e.g., disposable bioreactors, methods and articles for manufacturing such containers, in particular to assemblies for manufacturing disposable containers and / or their elements. The present invention relates specifically to the fields of biotechnology, bioprocessing, chemical and / or biological plant construction, food and beverage processing and / or chemical technology. The present invention relates particularly to fluid management in the biopharmaceutical industry. Background Technology

[0003] In the production of articles such as disposable containers composed of single elements produced independently of each other, production steps are required to connect the single elements together, such as welding and / or gluing and / or mounting. Typically, the elements include protrusions and / or regions extending from the body of the element to provide an excess surface on which an adhesive can be applied or a welding step can be performed. An example of a conventional production process is illustrated in FIG. 1a and is discussed further below.

[0004] For example, EP177882B1 discloses a bioreactor comprising a reactor vessel implemented as a bag, wherein a receiving port is arranged on the upper side of the reactor bag and a flange piece is provided that is tightly sealed to the wall of the vessel, and a sensor piece is connected to the flange piece via a tubular connector piece so as to reach into the reactant from above. Also, EP270769A1 discloses a disposable bag having a flexible wall comprising a fixing flange for securing a sensor head to the flexible wall of the disposable bag. The fixing flange may be installed by bonding, welding, screwing, clamping, or latching to the flexible wall. The problem to be solved

[0006] According to one embodiment, it is necessary to increase the degree of diversity of disposable containers, methods of manufacturing such containers, and assemblies for manufacturing articles, particularly by considering the number of materials that can be connected and the arrangement of functional elements on disposable bags.

[0007] These problems are resolved by independent claims. Preferred embodiments are the subject of dependent claims.

[0008] The following aspects of the present invention provide a disposable container, such as a disposable container that allows a plurality of materials to be combined and / or connected, a method for manufacturing the container, and an assembly for manufacturing articles. Additionally, the structure of functional elements and their arrangement on a disposable bag may be improved.

[0009] According to one embodiment, a disposable container, for example, a disposable bioreactor, is provided, comprising the following.

[0010] - Base material - The base material is particularly a wall element and / or wall and / or skin of a disposable container, the disposable container is a disposable bioreactor that may particularly be a disposable bag, and examples of the base material are foil, thin sheet and / or stock sheet;

[0011] - At least one functional element - The functional element is, for example, a port, a sensor holder, a sensor part, etc., and is at least partially preferably permanently connected to or with the substrate, and the functional element is obtained by three-dimensional (3D) printing technology from at least one printable material, and the printable material and / or the substrate is heated during printing to at least partially connect the printed functional element to the substrate.

[0012] In other words, a disposable container, which may be a disposable bag, is composed of at least two parts. The first part, i.e., the substrate, is, for example, a stock material and / or a pre-manufactured article and / or a pre-manufactured bag or a pre-manufactured part thereof. The substrate is connected to or with at least one second part. The at least one second part is a functional element, which is manufactured particularly by being printed directly onto the substrate. At least a portion or part of the functional element may be directly connected to the substrate to allow for physical contact. The connection between the two parts, i.e., the substrate and at least one functional element, is established for at least a portion or period of time required for the manufacture of the functional element, which is performed by 3D printing and heating. It should be understood that the functional element may be formed by 3D printing on the substrate in one step or, in particular, in multiple steps or stages that are temporally separated. That is, the functional element may be formed by sequentially 3D printing a sub-element onto another sub-element that has previously 3D printed on the substrate.

[0013] In other words, the above-mentioned disposable container comprises at least one functional element obtained from three-dimensional printing of a substrate and a printable material. Since the printable material is heated during three-dimensional printing and the heated printable material can polymerize and / or fuse and / or connect at least a portion of the substrate, it is preferably connected to and / or attached to the substrate, particularly permanently connected to and / or attached to the substrate. The printable material is heated during the three-dimensional printing process, which is referred to as a group of "material extrusions" in printing technologies such as FDM (fused deposition modeling) or FFF (fused filament fabrication).

[0014] To reach an appropriate melting temperature at the interface for proper bonding with the 3D printed element, the substrate may be preheated by external means. Preheating may be performed, for example, by blowing hot air onto the substrate and / or using a heated plate as a conveyor belt and / or providing thermal radiation, such as infrared rays from a thermal radiation source, and then maintaining the heat for the operation time. It is preferable that the substrate be preheated. A permanent connection between the two elements can be achieved by polymer fusion of the two elements at specific locations, such as seams, when the polymeric material is heated. Non-polymeric materials, such as metallic ink, may also be applied to the substrate and heated to establish adhesion between the two elements, namely the substrate and the functional element.

[0015] The fusion between the two parts or elements, namely the substrate and the functional element, can be established, in particular, at the very moment when the first layer of the functional element is printed on the substrate. The temperature or amount of heat supply provided to the printable material and / or substrate can be maintained throughout the entire production time or can be varied as required by the process.

[0016] The disposable container is advantageous because one or more functional elements can be bonded to a substrate and / or a pre-made bag and / or on it in a single step of 3D printing. 3D printing of functional elements replaces multiple production steps typically required in conventional production processes.

[0017] Additionally, the disposable container described herein may be a disposable bag and includes a functional element that does not necessarily require an excess protrusion, area, or surface protruding from the functional element. Generally, when applying conventional joining techniques such as welding steps, the functional element requires an excess and / or protruding surface to be connected to the substrate. Such surfaces, particularly the excess and / or protruding surface protruding from the functional element, can cause damage to the substrate, for example, if the substrate comprises a very thin and sensitive sheet layer. According to the manufacturing method described herein, such excess and / or protruding surfaces protruding from the functional element are typically not required, and thus the possibility of the substrate, such as a thin sheet, being damaged by the functional element is reduced or eliminated. Accordingly, the disposable container may have multiple functional elements positioned in adjacent locations. Furthermore, delicate structures and / or fine structures and / or complex structures may be easily applied as functional element(s), such as supporting ribs or reinforcing structures. The robust connection between the substrate and the functional elements ensures stability and safety, enabling uncomplicated handling in the shipment and transportation of disposable containers. This technology allows for the integration of large functional elements into disposable containers that would be very difficult to weld to thin plastic disposable container walls. Furthermore, this technology enables only the disposable container wall material to remain in contact with the biopharmaceutical solution contained in the bag, while allowing 3D-printed functional elements to be bonded to the outer surface of the container wall.

[0018] As a result, a disposable container can be provided in which the spatial density of functional elements located thereon is increased. That is, unlike those manufactured using conventional technology, functional elements having a smaller distance from each other can be provided on a small area of ​​the substrate.

[0019] In addition, the use and application of adhesive materials, such as adhesives that can chemically harm materials like the substrate, can be prevented. Also, since the connection is unbroken, especially when fused, deterioration of the adhesive joint can be prevented.

[0020] Furthermore, by automating, simplifying, reducing, or avoiding multiple steps of the process to connect parts or elements, disposable containers can be manufactured efficiently, especially cost-effectively, and easily.

[0021] Optionally, multiple functional elements may be manufactured such that a first functional element is connected to a substrate and a second functional element is connected to the first functional element. For example, a reinforcing structure and / or a pad and / or a support layer acting as a first functional element may be printed on the substrate. A handle acting as a second functional element may be printed on the surface of the reinforcing structure and / or the pad and / or the support layer. It is obvious that any two of the disclosed functional elements and / or three or more of the disclosed functional elements may be connected to each other.

[0022] According to another alternative embodiment, a disposable container, e.g., a disposable bioreactor, is provided, comprising the following:

[0023] Substrate - The substrate is particularly a wall element and / or wall and / or skin of a disposable container, the disposable container is a disposable bioreactor that may particularly be a disposable bag, and examples of the substrate are foil, thin sheet and / or stock sheet;

[0024] - At least one functional element - The functional element is, for example, a port, a sensor holder, a sensor part, etc., and is at least partially preferably permanently connected to or with the substrate, and the functional element is obtained by 3D printing technology from at least one printable material, and the printable material is printed on the substrate by material jetting to form the at least one functional element.

[0025] Printing technologies that do not require heating during the printing process are considered to belong to the "material jetting" group of printing technologies. Material jetting technologies may include, for example, polyJet printing, aerosol jetting, and jetting by "VAT polymerization" such as SLA (stereolithography) or DLP (digital light processing).

[0026] Material jetting technology is advantageous because no heat is supplied during the process of printing functional elements onto a substrate. Bonding can be achieved through the polymerization of the components, namely the substrate material and the printable material.

[0027] The above description is preferably one or more of the following: essentially a two-dimensional film, i.e., a very thin layer or film, a stock sheet, a pre-cut bag, a pre-made bag, in particular a disposable bag, a wall element of a bag or container and / or a skin.

[0028] Although the disposable container of the present invention is a very delicate material that can be easily damaged, the disposable container, which essentially comprises a substrate such as a two-dimensional film, stock sheet, pre-cut bag, or pre-made bag, can be easily and reliably connected to a functional element. Since disposable containers can be used for various disposable applications, cost efficiency and flexibility of the container configuration are very important.

[0029] It may be desirable to print very delicate and / or complex and / or fine functional elements on the substrate, and these may also be very delicate and / or sensitive. The disposable containers according to the present embodiment can be manufactured simply, and problems during their manufacturing and connection can be easily handled. Accordingly, the disposable containers of the present embodiment may be composed of very fine structures and materials.

[0030] Providing pre-fabricated substrates, such as bags that serve as SU bags, offers the advantage of completing production simply by printing functional elements onto the substrate. In other words, once the functional elements are printed onto the substrate, the product—specifically the bioreactor, or SU bag—can be ready for use. This possibility enables highly versatile fabrication.

[0031] Preferably, the functional element comprises at least one of the following: a flange, a port, an inlet / outlet point, a sensor holder, a sensor or part of a sensor, a window or window frame, a connector, a label and / or label information, substantially three-dimensional text, e.g., Braille text, a reference marker or fiducial, a three-dimensional structure and / or three-dimensional pattern, in particular a stabilizing and / or stiffening and / or reinforcement element, a tube holder, a handle, a metal element, i.e., a metal element, in particular an electronic component. In particular, the flange may be understood as any interface with a substrate, such as an external or internal ridge and / or rim and / or lip, intended to be connected to other elements, in particular a pipe and / or tube and / or vessel. The port may be understood as a passage into the bag, such as an inlet and / or outlet point, for example.

[0032] To access the interior of a disposable container and / or the interior of a bag, flanges, ports, inlet / outlet points, sensor holders, sensors or parts of sensors, windows or sills, sewer ports, connectors, etc., may be required on the disposable container. This access may be physical and / or optical access. Providing a sensor allows for permanent and / or temporary monitoring of processes within the disposable container. By providing ports, inlet / outlet locations, etc., temporary or permanent access may be established to reach the interior or internal volume of the disposable container.

[0033] Holders, etc., may be advantageous for mounting cables, tubes, sensors, and / or other equipment that can be kept close to a single-use container in order to provide a well-positioned system for easy use.

[0034] Labels and / or label information, reference markers, or starting points may each be provided to record information on the wall of a disposable container or to achieve an indication of the filling status. Reference markers on the substrate may be used to indicate the location where an element is to be positioned and / or printed. Reference lines on the substrate may indicate the location where a cut is to be placed in an additional procedure step. That is, reference markers or starting points may be provided to support and / or assist the step of cutting the stock sheet into patterns that can be 3D printed for accurate assembly.

[0035] The addition of origin markings can increase the accuracy of the placement of configuration and / or functional elements. The application of origin markings can be easily achieved using the 3D printing technology according to the present disclosure compared to the prior art. Applying origin markings via 3D printing can effectively reduce the number of components in the downstream assembly process.

[0036] The label and / or label information may be a 3D printed label. In this case, the migration or creeping problems of ink and / or adhesive material that frequently occur when traditionally attaching labels to the walls of disposable containers can be avoided.

[0037] Three-dimensional structures and / or patterns, particularly stabilizing and / or curing and / or reinforcing elements, can provide improved stability of the substrate. Patterns and / or reinforcing structures and / or pads and / or support sheets can be printed directly onto the substrate. Additional functional elements, such as handles, flanges, or holders for cables and / or sensors and / or tubes, can be printed onto the patterns and / or reinforcing structures and / or pads and / or support sheets. This offers the advantage of providing a structure that is more stable and resistant to deterioration or damage. In particular, if the substrate is very sensitive and / or brittle and / or delicate, or to assist in the installation of disposable containers, it may be helpful to install disposable containers within a stainless steel support container.

[0038] At least one reinforcing structure may also be provided, particularly along the corners of the SU bag or at the bottom of the SU bag, to support stability, particularly in the filled state. Since the SU bag may not maintain its shape in the filled state, a reinforcing structure may be required to provide a stable shape.

[0039] Preferably, the substrate and / or the functional element and / or the printable material, wherein the functional element and / or the substrate constitute at least partially, is composed at least partially of any one of the following: PE (polyethylene), PP (polypropylene), PC (polycarbonate), TPE (thermoplastic elastomer), EVA (ethylene-vinyl acetate), fluoropolymer, PET (polyethylene terephthalate), POM (polyoxymethylene), ABS (acrylonitrile butadiene styrene), PLA (polylactic acid), PA (polyamide), PSU (polysulfone), PES (polyether sulfone), PEEK (polyether ether ketone), copolyester, PMMA (poly(methyl methacrylate)), PEI (polyethyleneimine), PPO (poly(phenylene oxide)), PS (polystyrene), PTFE (polytetrafluoroethylene), PU (polyurethane), silicone, acrylic (e.g., acrylic resin), or a composite resin having a filler (e.g., having glass fiber). PLA), any new material developed and verified for use in medicine, pharmaceutical and biopharmaceutical applications, and composite materials from at least one of the materials mentioned above. Other possible materials are HOPE (high-density polyethylene), LLDPE (linear low-density polyethylene), LDPE (low-density polyethylene), and PVC (polyvinyl chloride).

[0040] Functional elements that do not intend to come into contact with the internal volume of the bag or container and / or the fluid contents of the container, such as external stiffeners, may also be composed of non-medical grade printable materials, i.e., materials that are not medical grade according to the relevant standard(s), for example, materials that are not suitable for sterilization.

[0041] That is, the functional element and / or substrate and / or printable material used to manufacture and / or print the functional element and / or substrate comprises one or more of the said materials. The said materials may be substantially homogeneously blended or used in different and / or separate parts of the functional element and / or substrate.

[0042] The above materials are particularly useful as printable materials. In particular, thermoplastic materials are useful as printable materials. A special advantage is provided because critical materials can be sterilized when used in SU bags, particularly as components and / or compounds in bioreactors. Consequently, the risk of contamination can be reduced, which is important because filling materials, such as biomaterials, can be highly sensitive to contamination.

[0043] The printable material may include metal, particularly metal powder or granulated metal where 3D printing involves the melting of metal. Preferably, the disposable container, SU bag, functional element, substrate and / or one or more components thereof may be sterilized and / or disinfected so that potential contamination of the contents of the disposable container can be prevented.

[0044] Preferably, the three-dimensional printing technology comprises fused filament fabrication (FFF), drop-by-drop application of the printable material and / or layer-by-layer application of the printable material and / or a fused deposition modeling method (FDM).

[0045] The 3D printing process may, in particular, involve so-called Fusion Filament Fabrication (FFF) using a continuous filament, preferably a thermoplastic material, and / or a Fused Deposition Modeling (FDM) method. The filament may be fed from a coil or roll through a moving and heated printer head, which may be a printer extruder head. The melt may be driven and / or forced from the nozzle of the printer head and deposited onto the substrate and the growing functional element. The printer head may be moved, for example, under computer control, to define and realize the desired printed shape of the functional element. Generally, the printer head moves in terms of two-dimensional stacking layers. That is, to start a new layer, it moves along two-dimensional directions to deposit one (preferably horizontal) plane at a time (in particular, corresponding to the plane of the surface of the substrate on which the functional element is to be 3D printed) before moving in a direction perpendicular to the two-dimensional layer (preferably upward). The speed of the printer extruder head can be controlled to stop and start the deposition of printable material and to form a suspended plane without stringing or dribbling between sections.

[0046] Drop-by-drop application of printable materials and / or layer-by-layer application of printable materials are techniques used for particularly efficient and simple 3D printing.

[0047] Preferably, 3D printing technology includes printing from nanoparticle ink and / or spraying atomized metal and / or melting metal powder and / or aerosol jetting electronic components.

[0048] In particular, 3D printing technology may be based on the step of melting metal powder and printing it onto a substrate. In this case, the metal powder can be considered as a printable material. A connection between the substrate and the functional element is formed by the heating, and the functional element may be, for example, an electronic component. Additionally, by heating and melting the metal powder onto the functional element and printing it, a connection between the functional element and the molten powder can be formed simultaneously with the implementation of the functional element. As an example, the functional element may be composed of a thermoplastic material, and an electronic connector may be provided by printing a gold layer on the surface of the thermoplastic material.

[0049] In addition, 3D printing technology—in addition to printing from printable materials and heating them—may also include printing electronic elements from metal compositions such as nanoparticle inks and / or spraying atomized metal and / or aerosol jetting, which may not necessarily require a heat supply.

[0050] The above-mentioned feature related to printing from metal enables the easy implementation of electronic devices, such as electronic connectors, conductive paths, chips, RFID antennas, etc., at least partially on and / or within functional elements. This allows sensors to be easily connected to other electronic elements and / or the contents or elements of disposable containers. Generally, the implementation of electronic elements can be complex, and since multiple steps must be performed during assembly, production may require significant effort. By including and / or adding an electronic element printing step to the 3D printing process, production can be simplified while achieving high product quality. As a result, production costs and the number of production steps can be fundamentally reduced.

[0051] According to another embodiment, a method for producing a disposable container, particularly a flexible or semi-flexible container, is provided based on the steps of producing a functional element and connecting said functional element to said disposable container, particularly a substrate of a bioreactor, said method comprising the following steps:

[0052] - For example, providing pre-manufactured items such as substantially 2D shaped sheets, 3D shaped materials, or pre-manufactured SU bags;

[0053] - For example, a step of three-dimensionally printing a functional element from a printable material on the surface of a substrate, such as the outer surface of a back wall or skin, using a fused filament fabrication (FFF) and / or drop-by-drop printing method and / or layer-by-layer printing method and / or fused deposition modeling (FDM) method; and

[0054] - At least one cycle or interval, i.e., a temporal part of the three-dimensional printing step, heat is simultaneously supplied to the substrate element and / or printable material to connect at least a part and / or area and / or part of the functional element with at least a part and / or area and / or part of the substrate element, in particular to preheat the substrate and the printable material.

[0055] In other words, a substrate on which a functional element is printed is provided. A connection between the functional element and the substrate is established, in particular, by heating the printable material on which the functional element is produced at least temporarily. Additionally, the substrate may also be heated. In particular, when a first layer and / or part of the functional element is printed on the substrate, heat may be supplied so that the first layer and / or part fuses and / or polymerizes and / or connects with at least a part of the contact area of ​​the substrate.

[0056] It is preferable that the printing and heating are performed simultaneously for at least a certain period of time. The heating connects the substrate and the functional element at least partially to each other. The heating may also include preheating of the printable material and / or substrate. Preheating refers to heating prior to the 3D printing step. For example, heating the substrate on a conveyor belt before or during passing through the 3D printer. Another example would be heating the printable material inside an extruder before or during the step of printing the functional element. That is, particularly in the manufacture of disposable bags, the step of printing the functional element onto the substrate includes the step of 3D printing the functional element and at least partially connecting it. 3D printing, preferably Fusion Filament Fabrication (FFF) and / or Fusion Deposition Modeling (FDM) methods, can be used to create or manufacture functional elements having 3D features and functional structures, such as flanges, ports, filling points, sensor holders, sensor components, etc. This new approach has the advantage of providing the possibility to avoid welding steps for connecting separate elements during the manufacturing process.

[0057] In addition, there is an advantage in avoiding separate individual manufacturing steps by simultaneously producing the functional element and connecting it at least partially to the substrate element. That is, the functional element can be printed directly onto a substrate such as a wall element, (stock) sheet, or any other surface that appears useful.

[0058] An additional advantage of this method is supported by the fact that it does not require protrusions and / or extending surfaces, which are often required when individually bonding or welding elements to a surface in the case of conventional manufacturing techniques (e.g., see Fig. 1).

[0059] Consequently, the functional element requires only a space or area on the surface of the substrate, limited only by its own dimensions—that is, limited by the surface provided by the shape of the functional element used to contact the substrate—without the need for additional areas and / or parts and / or surfaces to establish contact. Furthermore, since the functional elements do not protrude excessively from the contours of the functional elements and their distance is limited only by their inherent shapes, sufficient functional elements can be placed close to each other on the surface of the substrate.

[0060] Preferably, the functional element may be 3D printed on the surface of either a substantially two-dimensional (2D) structure or a 3D (3D) pre-fabricated bag chamber representing the substrate. That is, the substrate may be a pre-fabricated bag chamber on which the functional element is 3D printed. The pre-fabricated bag chamber may have a substantially 2D structure or a substantially 3D structure. A substantially 2D structure may be configured to unfold into a 3D structure, and a 3D structure may be configured to fold into a 2D structure. While it is advantageous to print the functional element on a folded, substantially 2D structure, it may also be possible to print the functional element on an unfolded, substantially 3D structure.

[0061] In a preferred embodiment, the step of supplying heat includes preheating the substrate, for example, on a heated conveyor belt and / or by a heat source such as a lamp and / or a hot air gun.

[0062] Heating the substrate is advantageous in terms of reliable polymerization and bonding between the material of the functional element and the substrate. In particular, in addition to the heat provided to melt the printable material, heat is supplied to the substrate.

[0063] Preferably, the three-dimensional printing step of the functional element comprises printing from a thermoplastic material and / or at least one of the following: acrylic (e.g., acrylic resin), EVA, ABS, PC, PE (e.g., HOPE, LDPE, LLDPE), PMMA, PLA, PES, POM, PEEK, PEI, PP, PS, PTFE, TPE.

[0064] Other suitable polymers or materials may be applicable, although less desirable.

[0065] In other words, the printable material from which the functional element is formed, at least partially, may be one or more of the above materials. The materials may be mixed and / or blended as granulated materials, for example, before heating and melting and / or blending and before 3D printing is performed. Alternatively, 3D printing may be performed using different materials at once so that different parts, particularly layers, may be composed of different materials. It is preferable to print the object from a material suitable as a printable material. Other advantages of using such materials have been previously mentioned. The printable material may be provided from stock and may include filaments, granulated and / or fractionated materials, powders and / or bars. In particular, the printable material may be a recycled material that can be obtained by removing and / or cutting excess material from the functional element and / or the substrate. For example, melt filament processing generally requires the supply of a filament of the printable material.

[0066] Preferably, the 3D printing step includes the step of printing from nanoparticle ink and / or spraying atomized metal and / or ceramic material and / or melting metal powder and / or aerosol spraying electronic components.

[0067] That is, the printable material from which the functional element is formed at least partially may include a metal compound, particularly if the melting of metal powder is included in the method. The metal may be used to produce and / or print electronic components on and / or within the functional element. The functional element may be a sensor holder or a sensor port. The functional element may then be provided with an electronic connection and / or ground for connecting the sensor to another potential electronic device.

[0068] It is advantageous to print electronic components onto or within functional elements instead of assembling them manually or automatically. The step of assembling electronic components can be very difficult and cumbersome. However, when printing functional elements—for example, layer-by-layer printing—integrating the steps for producing electronic components is simple, reducing not only the effort but also the number of steps. Furthermore, electronic contacts can be reliably established using printing technology.

[0069] Preferably, the method further comprises the step of removing a portion of the substrate, particularly cutting away, and / or removing an excess portion of the functional element, particularly cutting away. The excess portion may be a portion of the substrate located between a volume essentially enclosed by the substrate and a volume essentially enclosed by the functional element. A fluidic connection may be required between a volume mainly enclosed by the functional element and a volume mainly enclosed by the substrate, such as the internal volume of an SU bag. To provide a fluidic connection between the two volumes, the excess portion of the substrate may be required to be removed at least partially. The excess portion may also be a portion of the surface of the functional element, for example, a rough surface created during coarse layer-by-layer printing. To provide a smooth surface, the rough surface may be smoothed by removing some of its layers.

[0070] Preferably, the 3D printing of the functional element comprises fused filament fabrication, drop-by-drop and / or layer-by-layer application.

[0071] Standard 3D printing methods can be based on fused filament manufacturing, drop-by-drop and / or layer-by-layer application. These methods have proven to be simple and reliable methods for printing 3D structures.

[0072] Preferably, the above method is:

[0073] - Removal of excess material from functional elements and / or substrates, particularly cutting; and

[0074] - A step of at least partially recycling excess material removed by reuse, particularly in a step of manufacturing a 3D printing step and / or a substrate, wherein the recycling preferably comprises collecting and grinding the excess material by a mill and / or a grinder and / or heating the excess material by a heating device and / or producing a filament from the excess material by an extruder and / or supplying the excess material to a 3D printing machine, particularly supplying the filament.

[0075] The step of recycling unused and / or unnecessary and / or discarded materials is particularly advantageous because it can reduce the amount of required materials and the amount of discarded materials, making it environmentally friendly and cost-effective. According to another embodiment, an assembly device for producing a functional element and connecting the functional element to a substrate comprises the following:

[0076] - A 3D printing device for printing functional elements, e.g., flanges, handles, ports, holders, markers, fiducials, etc., on a substrate surface such as the walls and / or skin of an SU bag; and

[0077] - A heating device and / or heater that supplies heat to a functional element prior to and / or during at least one interval of 3D printing and at least partially connects the printed functional element to a substrate, i.e., establishes a connection between at least a part of the functional element and the substrate; and optionally

[0078] - A heating device for preheating materials.

[0079] That is, an assembly device for manufacturing a disposable container or part thereof, in particular an SU bag and / or at least part thereof, comprises a substrate holder, which is a means for holding a substrate such as a conveyor belt; a 3D printer for printing a functional element from a printable material onto a surface of the substrate, such as the outer surface of the wall of the SU bag; and a heater for heating the substrate and / or the functional element and / or the printable material on which the functional element is printed, at least temporarily.

[0080] The assembly device described above has the advantage of being able to create disposable containers from materials that are normally difficult to connect. It can also manufacture disposable containers with a high surface density of functional elements. The assembly device can also be efficient. One or multiple functional elements can be printed onto the surface of a substrate in a single step without requiring cumbersome steps such as bonding, welding, assembly, or arrangement. Additionally, the 3D printer can receive input data defining the design of an item, namely a disposable container, particularly a bioreactor, and / or a functional element. The user may be required to digitally design only the final product, namely a disposable container, particularly a bioreactor, particularly a SU bag, and / or a functional element on a computer. The data can be transmitted to the 3D printer, and based on the information, the 3D printer can print the desired functional elements. Thus, the assembly device can produce a large number of disposable containers, particularly bioreactors, in a very short time without requiring additional steps performed manually or automatically.

[0081] Preferably, the assembly device further comprises means for providing and positioning the substrate, preferably a conveyor belt, and optionally, the assembly device is configured to provide the substrate from a roll.

[0082] Conveyor belts are useful and efficient for transporting materials that may be bulk stock materials, i.e., very long sheets rolled up into rolls. Conveyor belts can pull, / or unfold, and / or unroll materials from stock piles and / or stock rolls in a very efficient and reliable manner. The speed of the conveyor belt can be adjusted to the time required at different locations or production lines. Essentially, most or all production steps, i.e., method steps, can be performed on the conveyor belt.

[0083] Preferably, the assembly device is:

[0084] - Means for removing excess material from functional elements and / or substrates, particularly cutting, particularly a laser cutter or a conventional cutter; and

[0085] - Means for at least partially recycling the removed excess material, particularly, preferably means for heating the removed material, i.e., means for providing the removed excess material, including the cut excess material, to a 3D printing device and / or a system for manufacturing a substrate.

[0086] That is, the assembly device may preferably include a recycling system that collects, in a first step, the removed, particularly cut, excess material of the substrate and / or functional element. The recycling system may optionally include a heater that melts the removed excess material in a subsequent step. Optionally, the recycling system may include a system that regenerates and / or re-feeds the collected removed excess material to a 3D printer. Optionally, the recycling system may include a system such as an extruder capable of producing new substrate material from the removed excess material. The aforementioned single elements of the assembly device may not be dependent on one another and may all optionally be implemented in the assembly device.

[0087] A recycling system for recycling excess material removed from either a functional element and / or a substrate may include heating means configured to heat the removed excess material. Additionally, the means for recycling, i.e., the system for recycling the removed excess material, may also include a system, for example, an extruder that manufactures at least partially a substrate from the excess material removed from either a functional element and / or a substrate. In another embodiment, the means for recycling the excess material does not include a system for manufacturing a substrate.

[0088] That is, the removed sheet back material and / or the material of the removed 3D-printed functional element can be recycled as filament stock and fed back to the 3D printer, for example, as filament. This can be very efficient, and particularly cost-effective and eco-friendly, because waste can be avoided and less material is required.

[0089] According to the embodiments, reliable and / or intimate bonding between plastic components and / or between metal and plastic components can be achieved using a 3D printing process, for example, fused filament fabrication and / or material jetting. Drop-by-drop or layer-by-layer deposition above the melting point of the plastic and / or metal can heat the substrate, for example, vinyl film and / or other plastic surface, to melt its contact surface sufficiently to achieve reliable adhesion without the substrate, for example, film, deteriorating.

[0090] The described embodiments are particularly advantageous for reinforcing bags and can provide bags with markings containing instructions, including trademarks or even Braille warnings. Mounting and positioning functions are added so that, once completed, the bag can be secured in place. Inbuilt features or jig points to aid assembly can be printed on the bag's structure. Features to aid packaging can be added. Increased material thickness at specific locations can be provided to improve welding. Sensors or sensor components can be printed directly (or indirectly) on the bag. Furthermore, the present invention has the effect of not only reducing the number of parts for manufacturing disposable containers but also shortening the manufacturing process, particularly the overall time, so that the assembly process can be carried out efficiently.

[0091] According to another aspect, a reusable vessel comprising the following, for example, a multiple-use bioreactor, is provided.

[0092] - Reusable vessels, particularly substrates for reusable bioreactors, particularly wall elements and / or walls and / or skins; and

[0093] - At least one functional element, such as a port, sensor holder, sensor part, etc., is connected to the substrate or at least partially to the substrate, and the functional element is obtained from at least one printable material by 3D printing technology, and the printable material is heated during printing to connect the printed functional element to the substrate at least partially.

[0094] It is evident that all optional embodiments described for a disposable container according to the above configuration can be combined with a reusable container, unless there is a contradiction.

[0095] Embodiments of the present invention are described in detail below. The features described in specific embodiments may be combined arbitrarily to the extent that they are not excluded from one another. Furthermore, different features provided together in embodiments of the present invention are not to be considered as limiting to the present invention. Brief explanation of the drawing

[0097] FIG. 1a is a schematic diagram showing a conventional technology that connects a functional element and a substrate using welding. FIG. 1b is a schematic diagram showing a three-dimensional printed functional element connected to a substrate according to one embodiment of the present invention. FIG. 2 is a schematic side view of a disposable bioreactor, i.e., a disposable bag, according to one embodiment. FIG. 3 schematically illustrates an assembly device according to one embodiment of the present invention. FIG. 4 is a flowchart illustrating a method for manufacturing a disposable container according to one embodiment of the present invention. FIG. 5 is a schematic perspective view of a 3D printer that prints functional elements onto a substrate according to one embodiment of the present invention. FIG. 6a is a plan view of a pre-manufactured disposable container, i.e., a disposable bag, having functional elements according to an exemplary embodiment, substantially folded into a 2D structure. FIG. 6b is a perspective view of a pre-manufactured disposable container, i.e., a disposable bag, having functional elements according to the embodiment of FIG. 6a, substantially unfolded into a 3D structure. Specific details for implementing the invention

[0098] Hereinafter, the differences between the manufacturing technology of the embodiments and the conventional manufacturing technology are generally explained. A more detailed comparison is provided below with particular reference to FIGS. 1a and 1b.

[0099] Conventional manufacturing technology for disposable containers, etc., typically includes a welding step when it is necessary to connect elements and / or parts, such as functional elements and substrates, to each other. The present embodiments, in particular, include a step of 3D printing functional elements directly onto a substrate and simultaneously connecting them to each other, thereby replacing the conventional welding step.

[0100] Generally, in a typical manufacturing process, components are produced separately and then welded to the back surface in a separate step. The back chamber is often made of a thin mono or multilayer film of plastic and / or synthetic material(s) (typically about 80 pm to about 400 pm). Heat-fusing a plastic part to a back film strongly influences the selection of the part material and the design of the interface to achieve proper melting between the thin back film and the larger part interface. The primary risk is that the film will completely fuse or degrade before the colder part interface reaches a suitable melting point. Advantageously, drop-by-drop or layer-by-layer application above the melting point of the plastic molding compound can sufficiently heat the plastic back film—that is, the substrate surface—to achieve good adhesion between the plastic part and the film without degrading the film. Consequently, the scope of the embodiments described herein can allow for an expansion of the number of possible part materials and design options to better suit the intended function of the part, i.e., the function of the functional element.

[0101] Additionally, materials that are generally difficult or even impossible to use and / or process in such steps requiring welding of assemblies may be used and / or processed by the embodiments described herein. Such materials include, for example, HOPE components (which may be functional elements) connected to an EVA and / or LLDPE film layer (which may be a substrate); and ABS and / or PC components (which may be functional elements) connected to a PE film layer (which may be a substrate). That is, the above material combinations may be realized using methods such as 3D printing according to the present embodiment. However, prior art, particularly techniques involving the step of welding components, may allow little or no combination of said materials.

[0102] The welding process for plastic parts, e.g., SU back films of functional elements, e.g., on a substrate, requires applying pressure to the assembly to achieve reliable contact at the film-part interface during heating, that is, during the time heat is supplied. This can potentially affect the film thickness and / or the resistance of the welded assembly. However, the 3D printing process according to the present embodiment does not apply pressure to the molten interface, thereby providing a gentler and more reliable technique.

[0103] To enable welding, plastic parts, i.e., functional elements, must be designed with a significantly large extension, i.e., an elongated portion, to allow access for a welding tool, i.e., a welding machine. The embodiments described herein essentially allow for the design of more compact parts while still having a suitable bonding surface to achieve target resistance. Potential benefits associated with this include a reduction in bag weight, the possibility of placing more functional elements and functions on a small SU bag surface, and, if necessary, positioning functional elements closer to the edges of the SU bag.

[0104] The location, configuration, and number of functional elements and parts on the SU bag generally depend on the dimensions of the welding machine and the design of the welded parts, particularly the functional elements. Therefore, the final SU bag assembly is designed with a defined set of parts, namely the functional elements, in mind. The welding parameters and the locations on the bag where the functional elements can be applied generally require prior verification. In this regard, the embodiments described herein may also allow for a higher degree of flexibility, particularly in terms of the customization of the SU bag and the late and / or spontaneous and / or individual differentiation of standard bag chambers. Such "late" and / or spontaneous differentiation of bag chambers may be possible when the functional elements are 3D printed onto the bag chambers as well as on film rolls. The term "late" may refer to a later stage where the SU bag has already been produced but the functional elements must be applied to and / or connected to the SU bag. Furthermore, 3D printing opens up significantly expanded design possibilities for parts compared to, for example, injection molding technology.

[0105] 3D can directly print plastic parts, such as functional elements, onto a substrate, such as SU bag film, and can bond plastic parts onto the substrate and / or SU bag surface that require very specific and difficult welding processes as well as custom welding tools, because very large or even massive components, such as functional elements, need to be processed and / or connected. Additionally, components that must be located and / or connected within SU bag areas inaccessible to welding tools can also limit conventional production. For example, if such parts must be located on the outer bag surface that does not include holes and / or openings in the film, a problem may arise where it is difficult to position welding tools inside a pre-fabricated bag chamber. Some examples of (new) applications that can be implemented by some of the embodiments described herein are as follows: strong reinforcement, holders for tubes and components, and the function of placing bags inside hard containers.

[0106] Direct 3D printing of plastic parts, such as functional elements, onto a substrate such as SU bag film can also allow bonding of plastic parts onto the substrate and / or SU bag surface, which would otherwise require very large or even massive functional elements to be processed and / or connected, thereby requiring very special and difficult welding processes as well as customized welding tools. Additionally, parts that must be positioned and / or connected to SU bag areas inaccessible to welding tools may also limit conventional production. For example, if such parts must be positioned on the outer bag surface that does not include holes and / or openings in the film, it may be difficult to position welding tools inside a pre-fabricated bag chamber. Some examples of (new) applications that can be realized in some of the embodiments described herein include strong reinforcing materials, holders for tubes and components, and features for positioning bags in rigid containers.

[0107] Generally, most SU bags need to retain information such as bag volume, product description, branding info, logo, and batch number throughout their lifecycle. In some cases, the outer layer material and surface treatment of the SU bag allow this information to be printed directly onto the SU bag. Otherwise, a label, such as a plastic layer, is applied to the surface of the SU bag. As well as the label, information can be printed onto the surface of the SU bag using 3D printing technology according to the embodiments described herein. However, conventional methods can be risky in terms of the risk of ink migration and / or damage to the SU bag caused by label adhesives, as well as contamination of the contents of the SU bag by the label adhesive through the bag film and possible unwanted chemical reactions and / or interactions with the contents contained within the bag. Therefore, the embodiments described herein are also useful for printing information and / or labels, with or without information, onto the SU bag film or other plastic components using a characterized material that has been verified for biocompatibility with bioprocess fluids.

[0108] Additionally or alternatively, one or more layers of metal may be applied to plastic parts, such as functional elements and / or substrates, without the need for conventional techniques such as bonding, welding, or soldering. Conventionally, it was possible to encapsulate metal parts within plastic by inserting them into plastic injection molds. It is also possible to deposit thin metal layers onto plastic parts using metal coatings. However, this requires the parts to be immersed in a chemical bath or sputtered and / or treated by metal evaporation. In this regard, the embodiments described herein may allow electronic components, particularly thin electronic pathways, to be bonded to plastic parts, such as functional elements and / or substrates, and / or encapsulate small sensors on the surface of a SU bag (inside or outside of the bag) or on plastic parts, such as functional elements.

[0109] In the following, a specific example of a conventional (welding) production technology is discussed with reference to FIG. 1a along with a product according to this technology and is compared with a technology comprising the step of 3D printing a functional element (3) according to an exemplary embodiment of the present invention onto a substrate (2).

[0110] FIG. 1a is a schematic diagram illustrating an example of a conventional manufacturing step. Conventional manufacturing includes a step of connecting a functional element (9) to a substrate (2) and / or the substrate (2) using a welding step. The conventionally manufactured functional element (9) was produced in a separate step prior to the step of connecting the parts together. Possibly, the conventional functional element (9) was even purchased from a manufacturer. To connect the conventional functional element (9) to the substrate (2) and / or the substrate (2), the conventional functional element (9) comprises an elongated portion (9a) having an excess surface (9c) protruding from the body (9b) of the conventional functional element (9), and the elongated portion (9a) is required to provide a surface for the step of welding the parts together, i.e., a substantially excess surface (9c). The elongated portion (9a) may also be referred to as an 'assembly flange' (not to be confused with a 'flange' as defined herein for connecting tubes or tube-like parts to a container).

[0111] Since the welding machine (8) needs to be placed on the body (9b) of the conventional functional element (9) to reach the slender portion (9a), the slender portion (9a) extends over the dimensions of the body (9b) of the conventional functional element (9), so that the welding step can be performed on or near the excess surface, particularly on the contact surface (2a) where the welding machine (8) contacts the substrate (2).

[0112] The substrate (2) includes an opening (2b), through which the main body (9b) of the conventional functional element (9) can be pushed, pulled, or driven, so that the elongated portion (9a) is located at least partially on one surface of the substrate (2), i.e., the lower surface (L) of the substrate (2) in the drawing. The main body (9b) of the conventional functional element (9) is located at least partially on the opposite side of the lower surface (L) of the substrate (2) and extends from the upper surface (U) of the substrate (2).

[0113] A welding machine (8) is placed on the body (9b) of a conventional functional element (9) and comes into contact with at least a portion of the upper surface (U) of the substrate (2). On the surface (2a), a connection is established by the welding machine (8). The welding machine (8) is configured to provide heat to the lower material, that is, the surface (2a) which is part of the upper surface (U) of the substrate (2). The heat travels through the substrate along the layer thickness of the substrate into the upper surface of the slender portion (9a) of the conventional functional element (9), so that fusion and / or a connection can be established. In particular, fusion based on polymerization and / or a polymerization reaction connects the parts.

[0114] The welding step comprises several steps as illustrated. An opening (2b) is required in the substrate (2) and needs to be made before being connected. An arrangement of conventional functional elements (9) for the substrate (2) and the opening (2b) is also required before the connecting step and after the opening (2b) is made. A welding machine (8) must be positioned specifically over the conventional functional elements (9). Only when the above steps are performed can the welding step be performed. Additionally, it may be required to provide and / or adjust the welding machine (8) to the shape of different conventional functional elements (9).

[0115] FIG. 1b is a schematic diagram illustrating an exemplary 3D-printed functional element connected to a substrate according to the present disclosure. The functional element (3) includes a reinforcing structure (3f) connected to the substrate (2) at a surface and / or interface (2a). The body of the functional element (3) is printed on top of the reinforcing structure (3f).

[0116] Alternatively, it may be possible to print the functional element (3) directly onto the substrate (2) without providing a reinforcing structure (3f). Comparing the drawings of FIG. 1a and FIG. 1b, it can be seen that the slender portion (9a) of the conventional functional element (9) is longer than the reinforcing structure (3f). Furthermore, the reinforcing structure (3f) can be implemented to be much shorter and thinner than the slender portion (9a) of the conventional functional element (9), and the 3D-printed functional element (3) can be implemented without the reinforcing structure (3f). The line (L1) in FIG. 1a and FIG. 1b represents the orthogonal projection of the shape of the functional element (3) onto the shading, i.e., the lower plane, i.e., the plane of the substrate (2) in this drawing. When applying the welding step ( FIG. 1a), the slender portion (9a) required in the conventional technique, i.e., the assembly flange, extends over the projection line (L1). The elongated portion (9a) is longer so that the welding machine (8) can apply pressure and heat along the line (L2), which represents the shading, i.e., the lower plane of the shape of the welding machine (8), i.e., basically the projection onto the plane of the substrate (2) in the drawings. That is, the length (d2) of the elongated portion (9a) is required to extend beyond the line (L1) so that the welding machine (8) is long enough to apply pressure and heat to its surface (9c). The length (d2) depends on the structure of the functional element (3), and if the functional element (3) has a large structure in terms of projection / shading onto the plane of the substrate, the elongated portion (9a) also needs to be large. The length of the elongated portion (9a) according to the example shown in FIG. 1b may be shorter than the length (d2) required in conventional (welding) technology. The length of the elongated portion (9a) according to the example illustrated in FIG. 1b may be particularly short so as not to exceed or intersect the line (L1). The elongated portion (9a) provides a surface for contacting the functional element (3) and the substrate (2). Thus, this surface may be reduced according to the example illustrated in FIG. 1b because the functional element (3) is printed directly onto the substrate (2).In particular, the long portion (9a) is welded to the substrate (2) over substantially its entire surface.

[0117] In the following, an example of a desirable SU bag (1) having a functional element (3) is discussed.

[0118] FIG. 2 is a schematic diagram of a bioreactor, i.e., an essentially disposable (SU) bag (1), according to one embodiment of the present invention. The SU bag (1) comprises one or more functional elements (3) 3D printed on a substrate (2), which is a precursor of the SU bag (1), or on an outer surface (2a) of the SU bag wall or skin, and the SU bag may be a pre-manufactured product. Generally, the substrate (2) is a composite material of the SU bag (1) on which the functional elements (3) are printed. Alternatively, the functional elements (3) may also be printed on a pre-manufactured SU bag. The substrate (2), i.e., the precursor of the SU bag, has a surface (2a) which is also the surface (2a) of the SU bag (1), and the functional elements (3) are printed on the surface (2a). In this drawing, this surface (2a) is represented as an outer side of the wall and / or skin of the SU bag (1).

[0119] The SU bag (1) includes a handle (3a) that can be used to hold, lift, hang, and / or transport the SU bag (1). The SU bag (1) further includes a functional element (3) which is a connection part (3b) and / or a flange and / or port for establishing a fluid connection between the tube and the internal volume of the SU bag (1). The connection part (3b) may be threaded to provide a rigid connection between the tube and the SU bag (1). Alternatively, other types of connections, such as plugs and / or brackets, may be provided.

[0120] Additionally, the SU bag (1) includes a port (3c) which may be an optical port including a window, for example, not shown in the drawing. Optical measurements, such as spectroscopic measurements, can be performed through the window. The port (3c) may be configured to host, for example, at least partially, a light sensor. The port (3c) may be 3D printed only partially, for example, the window may be arranged after the 3D printing of the port (3c) is completed. Typically, glass or other materials used as the optical window are not suitable as printable materials, and therefore, it may be required to assemble the window separately. A frame for hosting the window may be printed as a functional element (3). However, a polymer window material may also be printed during the step of 3D printing the port (3c). Alternatively, or additionally, the port (3c) may also include an opening to establish access to the interior of the SU bag (1), but this is not explicitly shown in the drawing.

[0121] The bioreactor (1), i.e., the SU bag according to the present embodiment of FIG. 2, includes a sensor holder (3d) having a sensor (4). The sensor holder (3d) may also be combined with a reinforcing structure not shown in the drawing. For example, a reinforcing or supporting structure may be printed on the wall of the SU bag. The sensor holder (3d) may be printed at least partially on the reinforcing structure. The sensor holder (3d) may also have electronic components not shown in the drawing. The electronic components may be printed and implemented, particularly when 3D printing the sensor holder (3d).

[0122] According to FIG. 2, the sensor holder (3d) at least partially hosts a sensor (4) capable of contacting a medium inside the SU bag (1). In this case, the sensor holder (3d) preferably provides physical access to the internal volume of the SU bag (1). Alternatively, the sensor (4) does not need to contact any medium within the internal volume of the SU bag (1). For example, the sensor (4) may be a temperature sensor that only investigates the temperature on the outer surface (2a) of the wall of the SU bag (1).

[0123] The SU bag (1) further comprises a label (3e), that is, a layer and / or field of material 3D printed on the outer surface of the wall of the SU bag. In this drawing, a barcode is also printed on the label. Alternatively or additionally, the label may include an RFID code having an antenna element (not shown in this drawing). Additionally, the label may include other types of information indicating the contents within the SU bag (1).

[0124] The bioreactor, i.e., essentially the SU bag (1) of FIG. 2, also includes at least one functional element (3) which is a stabilizing and / or reinforcing element (3f) that causes the SU bag (1) to stand upright. The reinforcing element (3f) has the shape of a basket in this case and is basically composed of a filament structure having ribs, for example, a thick / strong filament rib structure in the shape of a basket.

[0125] It is evident that such reinforcing elements (3f) can be applied along corners where support is needed to avoid damage, such as at the bottom of the SU bag (1), or in areas where support is needed to avoid damage. Ribbed reinforcing elements (3f) can also be applied essentially over the entire surface (2a) of the wall or skin of the SU bag (1), for example, to provide particularly strong stability and support.

[0126] Preferably, functional elements (3), such as a handle (3a), a joint (3b), and a sensor holder (3d), have a reinforcing structure not explicitly shown in the drawing. The reinforcing structure may be a 3D printed layer printed on a substrate (2) when printing the functional elements (3), and this printed layer may be a layer printed on the substrate (2) when printing the functional elements (3) to locally reinforce and support the stability of the substrate (2), and may cover the contact area between the functional elements (3), such as the handle (3a), the joint (3b), and the sensor holder (3d), and the substrate, thereby preventing the connection between the functional elements (3) and the substrate (2) from being easily damaged and / or deteriorated.

[0127] FIG. 3 is a schematic diagram of an exemplary assembly device (10) for manufacturing a SU bag (1) or its parts. The assembly device (10) is equipped with means (12) for providing and positioning a substrate (2), namely, in this case, a conveyor belt. A roll (14) of the substrate (2) is unwound in the direction (14a) by the conveyor belt (12).

[0128] An exemplary production line is illustrated in the drawing. A 3D printing device (11), which includes a printer head, which may be a printer extruder head in particular, is positioned over the surface (2a) of a substrate (2) on which a functional element (3) is to be printed. The printer head includes a heater (13) for substantially melting the printable material. The 3D printing device (11), in particular the printer (extruder) head, scans the layer in the xy dimensions indicated by the arrow in the drawing. In other words, the printer head of the 3D printing device (11) scans a horizontal plane (in the xy dimensions) while printing a substantially two-dimensional layer or sheet (3g), i.e., a very thin layer, of the printable material (5) on the surface (2a) or on a stack of already printed layers (3g) or layers (3g). By heating the printable material (5), the material can be deposited on the surface (2a) of the substrate (2), thereby partially melting the substrate (2) to fix the printable material (5) to the substrate (2), and particularly, as if melting together, fusing the printable material (5) and the substrate (2) to unite or blend them as a whole. In other words, by 3D printing the printable material (5) directly onto the surface (2a) of the substrate (2), a separate melting step is not required, and thus it is possible to allow an efficient connection between the functional element (3) to be created and the substrate (2), particularly with a small footprint (e.g., see FIG. 1b) compared to conventional welding (e.g., see FIG. 1a). In such a connection, it may be considered that the substrate (2) can be further heated (e.g., by a heater not shown) to allow for an improved mechanical connection of the functional element (2) printed together with the substrate (2). As a result of the above, the printable material (5) is heated during three-dimensional printing to connect the printed functional element (3) to the substrate (2) (surface (2a)) at least partially or mechanically, particularly in a sealed or fluid-tight manner.

[0129] Once the layer (3g) is completed, the printer head of the 3D printing device (11) moves to a different position in a direction substantially perpendicular to the xy plane. Since the xy-plane is substantially a horizontal plane, the vertical direction is the vertical direction indicated by the arrow and the sign "z".

[0130] Again, the printer head of the 3D printing device (11) scans a horizontal plane (in the xy dimension) and prints an additional substantially two-dimensional layer or sheet (3g) on ​​the previous layer (3g). The described steps may be repeated or can be repeated until the functional element (3) is completed. Instructions on how the functional element (3) can be made and how the method steps should be performed may be computer-controlled and, in particular, provided from a software program running on a computer to which the 3D printer (11) can be connected.

[0131] Preferably, 3D printing is performed using fused filament fabrication (FFF) and / or fused deposition modeling (FDM) and / or layer-by-layer application and / or drop-by-drop application. A filament (5a) of printable material (5) (such as a metal or thermoplastic filament) is supplied to the 3D printing device (11) from a roll (5b). Alternatively, the printable material (5) may be a fractionated and / or ground and / or fragmented material, such as a powder or granules. The printable material (5) may be selected so that the functional element (3) formed therefrom by 3D printing can be pre-sterilized, in particular, by a sterilization process such as gamma irradiation or steam sterilization, together with the substrate (2) (e.g., formed by an SU bioreactor (1)).

[0132] That is, the 3D printing device (11) can directly print a functional element (3) onto the surface (2a) of the substrate (2) using layer-by-layer and / or drop-by-drop technology (e.g., using fused filament manufacturing, FFF, technology and / or fused deposition modeling method (FDM)), thereby mechanically fixing the functional element (3) to the substrate (2). Heat (19) is supplied, for example by a heat supply unit (18), particularly by a heat supply unit of an extruder head, to fuse and / or connect and / or melt the printable material (5) for the functional element (3) to be printed with the material of the substrate (2) and layers (3g) that may already be printed. Typically, the first printed layer (3g) in contact with the surface (2a) is at least partially connected to the surface (2a) of the substrate (2), while the subsequent layer (3g) is at least partially connected to the already printed layer (3g).

[0133] Heat (19) may also be supplied to the substrate (2) by a heat supply means (not shown) which may be any one or more of, for example, a heated conveyor belt, hot air, an infrared radiation source, etc. Heat (19) may be applied to the top (as shown) or to the bottom of the substrate (2). That is, the substrate (2) may be heated permanently during the entire process, or preheated before and / or during the 3D printing process.

[0134] Care must be taken to control the temperature. It is advantageous to reach the melting points of the two materials before one or more layers of the back sheet material are completely melted so that bonding occurs only at the interface. The temperature depends, for example, on the formulation of the substrate sheet, the thickness of the substrate sheet, the target cycle time, and the formulation and thickness of the part material.

[0135] Typically, a 3D printing device (11) can be moved (particularly computer-controlled) in three dimensions (e.g., xyz dimensions) to realize the structure of functional element(s) (3). Thus, the 3D printing device (11) can be guided or controlled by a computer based on data or design inputs provided by a designer (e.g., based on a digital program or software). Thus, the user, as the designer, can virtually and / or digitally construct and / or design the structure of functional element(s) (3) and / or SU bag (1). The data generated therefrom can be transmitted to a 3D printer (11) that implements the functional element(s) (3) according to computer commands. Alternatively or additionally, means (14) for providing and positioning the substrate (2) (not shown in the drawing), particularly a stage and / or conveyor belt, can be configured to move in three dimensions. In this case, the 3D printer (11) does not necessarily need to move during the printing process, but the stage follows commands provided by the computer so that a layer from the 3D printing device (11) is applied to the correct position on the substrate (2).

[0136] The functional element (3) includes parts and / or portions referring to the excess material (7). The 3D printing device (11) may be supplied with a printable material (5), such as a filament, granule, powder, fractionated material, etc. The printable material (5) may also include at least partially the excess material (7a, 7b) or derivatives thereof.

[0137] The next step of the exemplary production line according to the exemplary assembly device (10) is to cut off excess material (7) of the functional element (3) after printing (at least part of it) is completed. Accordingly, the assembly device (10) includes means (15) for removing, particularly cutting off, excess material (7), which may preferably include a laser cutter. In the illustrated example, only excess material (7) from the functional element (3) is removed, but excess material from the substrate (2) may also be removed.

[0138] In a subsequent step of the exemplary production line of FIG. 3, the removed excess material (7a) is collected by means (16) for recirculating the excess material (7a), that is, by a system for recirculating the removed material (7a). A mill and / or grinder (16a) is provided, which grinds and / or pulverizes the fragmented removed excess material (7a). The pulverized excess material (7b) is transferred to a system (17) that provides the removed material (7b) to a 3D printer (11). The system (17) may include an extruder having a heater (18) configured to extrude a filament (5a) from the removed material (7b). Accordingly, a filament (5a) can be manufactured and rolled into a filament roll (5b). The filament roll (5b) can be used to supply a filament (5a) of printable material (5) to a 3D printer (11) for performing 3D printing using a fused filament manufacturing (FFF) and / or fused deposition modeling method (FDM). Optionally, the system can be configured to manufacture a new substrate (2), such as a sheet (not shown), from the excess material (7a, 7b) (alternatively or additionally). Accordingly, the system (16) for recirculating the removed material (7a) may also include a heating means configured to melt the crushed removed material (7a, 7b). The system (16) for recycling the removed material (7a, 7b) is advantageous because waste can be prevented and the amount of material required for production can be reduced.

[0139] Essentially, method steps performed on a production line provided with the assembly device (10) of FIG. 3 are schematically summarized in FIG. 4. The method (100) includes the step (101) of providing a substrate (2), such as a sheet and / or substrate and / or a pre-manufactured bag and / or bag wall and / or bag skin.

[0140] The step of 3D printing (102) a functional element (3) onto the surface of a substrate (2) is separated into two steps that may occur at least partially simultaneously (i.e., not temporally separated). In particular, the separation is intended to describe two different actions taken only during the 3D printing step (102). In step (102a), the 3D printing of the functional element (3) onto the substrate (2) is handled. In step (102b), the supply of heat (19) to either the functional element (3) and / or the substrate (2) is handled to establish a connection and / or fusion between them. In one particular case, the heat (19) is supplied at the time of 3D printing because the printable material (5) is heated and melted to a temperature high enough to fuse with the substrate (2) when it first comes into contact with the surface (2a) of the substrate. In other examples, heat (19) may be supplied (at least partially) as a separate action taken, for example by a separate heater (not shown).

[0141] In summary, a two-dimensional sheet, which may be a single-layer or multi-layer substrate (2), may be directly loaded and / or supplied (e.g., below) to at least one print head or 3D printing device (11) that is held firmly in place, particularly in an optimal environment. The print head may approach (e.g., descend) the surface of the substrate (2), such as a 2D material and / or a pre-manufactured SU bag and / or a sheet and / or a portion of a SU bag film, and deposit a printable material (5) onto the upper surface (2a) of the sheet (2) to form a bond between the two materials or to fuse the two materials, all of which may be mechanically fixed to the substrate (2) to create a functional element (3). This process may be repeated layer by layer to form the 3D shape of the functional element (3).

[0142] When completed features and / or structures and / or shapes (i.e., one or more functional elements (3)) are added to the surface (2a) of the substrate (2), the sheet, i.e., the substrate (2) having the functional elements (3), can be further transported to a second stage where one or more reference marks indicating a cutting line can be read and / or at least one pattern of SU back section(s) can be cut.

[0143] When one or more parts are cut, they may be removed from the conveyor belt and welded into an SU bag. At this stage, waste and / or removed excess material (7a) may be fed to a crushing stage, i.e., a mill (16a) or a crusher, pelletized, and transferred in the form of a filament (5a) to an extruder and / or a system (17) that provides the removed material (7a) in particular to a 3D printer (11). The system (17) may include an extruder. Specifically, the removed, particularly cut, excess material (7a) may be extruded as a filament (5a) and used to supply to a 3D printer (11) for other applications and / or at the beginning of this process and / or to manufacture a new substrate (2).

[0144] An alternative or additional option is to position a pre-fabricated 2D or 3D SU bag chamber representing the substrate (2) corresponding to (e.g., directly below) at least one printing head of the 3D printing device (11). Where preheating of the SU bag surface may be advantageous, this may be done by thermal convection with pulsed high-temperature filtered air and / or infrared radiation, particularly before 3D printing the functional element (3).

[0145] It should be understood that the 3D printing technology disclosed in this specification is not explicitly limited to the SU bag (1) or functional element (3) as described in this specification. Any plastic element may be connected to the substrate using the technology according to the embodiments described in this specification.

[0146] An exemplary method (100) of the manner illustrated in FIG. 4 also includes a step (103) of taking off and / or removing and / or cutting off and / or cutting away excess material (7) from the substrate (2) and / or functional element (3). The removed, particularly cut, excess material (7a) may be processed in a subsequent optional step (not illustrated in this figure) by a recirculation system (16) according to the example illustrated in FIG. 3.

[0147] FIG. 5 is a detailed view of a printing device (11) during the step of 3D printing a functional element (3) on the surface (2a) of a substrate (2), and the substrate (2) is provided from a stock roll (14) that is unwound in a direction (14a) for the step of 3D printing. The 3D printer (11) printed one or more markers (3e) (e.g., reference marks) to guide a cutter required to cut along a guide line, for example. The 3D printer also printed a reinforcing structure (3f) that is in direct contact with the surface (2a) of the substrate (2). The drawing illustrates the moment when the 3D printer (11) attempts to print the functional element (3) on the reinforcing structure (3f). The functional element (3) printed on the reinforcing structure (3f) may not be in direct contact with the surface (2a) of the substrate (2).

[0148] The combination of the reinforcing structure (3f) and the functional element (3) can be considered as a single functional element, wherein the part in contact with the surface (2a) of the substrate (2) is essentially the reinforcing structure (3f). Alternatively, but less intuitively, the reinforcing structure (3f) can instead be considered as the substrate (2) on which the functional element (3) is 3D printed.

[0149] The advantage of providing a reinforcing structure (3f) between the substrate (2) and the functional element (3) is that stability and resistance are improved. As the reinforcing structure (3f) is provided between the two parts, the risk of damaging the substrate (2) when the functional element (3) bends is reduced. The force applied to the functional element (3) can be distributed over a larger area in this particular case. Thus, rupture of the connection area or seam between the functional element (3) and the substrate (2) can be prevented. The reinforcing structure (3f) may be a closed and / or structured support layer of a specific thickness, for example, about 0.01 cm to about 0.4 cm, preferably about 0.02 cm to about 0.1 cm. Prior to the printing step, the substrate (2) may be preheated (19) by a heat supply means (not shown). Alternatively, the substrate (2) may be heated during the 3D printing process. The heat supply means may include a heated conveyor belt, a heat bulb, a hot air gun, an oven and / or an infrared radiation source, etc.

[0150] FIG. 6a is a plan view of an exemplary pre-fabricated SU bag (1) in which a functional element (3) is substantially folded into a two-dimensional (2D) structure. In this configuration, the functional element (3) can preferably be 3D printed onto the SU bag (1). Alternatively or additionally, the functional element (3) is 3D printed onto a substrate (2) which is a precursor of the SU bag (1), and after the functional element (3) is applied to the surface (2a) of the substrate (2), the walls of the SU bag (1) are welded together on a stage.

[0151] In the drawing, the SU bag (1) includes a port (3b), which may have threads for connecting to a pipe and / or tube. Additionally, the SU bag (1) includes a set of holder elements (3d) for holding, for example, tubes, pipes and / or other elements. The holder elements (3d) may be printed on a field that may include at least one reinforcing element. The SU bag (1) also includes a supported bottom having at least one reinforcing structure (3f) to provide stability, particularly when unfolded and filled. The dashed line indicates a pre-folded edge representing the edge of the SU bag (1) in the unfolded state.

[0152] The state of the SU bag (1) shown in FIG. 6a may be the state in which the SU bag (1) is purchased, transported, and / or stored. Preferably, the SU bag (1) is ready for use in this state (especially may have been pre-sterilized) and only needs to be unfolded before use.

[0153] FIG. 6b is a perspective view showing a pre-fabricated SU bag (1) equipped with functional elements according to the example of FIG. 6a, substantially unfolded into a 3D structure. Unfolding can be accomplished, for example, by pulling the edges apart from the layers and / or by pumping a fluid (e.g., air) into the interior of the SU bag (1) through at least one port (3b). A tube (4b) is connected to the port (3b) of the SU bag (1) in FIG. 6b. The tube may be held by one of the holder elements (3d). The drawing shows how the lower part of the SU bag (1) is supported along the edges and bottom surface by a reinforcing structure (3f). The reinforcing structure (3f), the port (3b), and the holder element (3d) are made of a rigid material. The side walls and top walls of the SU bag (1) are made of a flexible material. The combination of these materials makes the SU bag (1) semi-flexible. SU bag (1) is ready for use (especially, pre-sterilized) and can be filled with a medium in its current state.

[0154] In the following, some general considerations are made to provide more possible features that can be combined with any of the exemplary embodiments, in particular.

[0155] The term disposable container (1) is a general expression that includes the meaning of a specific form of bioreactor SU bag (1) or simply SU bag (1). The term bioreactor (1) may also include the meaning of a container for multiple uses, but essentially, this embodiment mainly includes SU bag (1). For this reason, the same reference numeral "1" is used for both bioreactor and SU bag.

[0156] The SU bag (1) and, in particular, the bioreactor (1) may generally be configured for only single use, that is, for a single use of the item (SU bag, in particular the bioreactor (1)), but are not necessarily limited thereto. The disposable bag, in particular the disposable bioreactor, may be used multiple times or over a specific period of time as required by the user. It should be understood that all embodiments disclosed herein may also be implemented in a bioreactor (1) for multiple uses.

[0157] The functional element (3) is a substantially three-dimensional (3D) element that provides a specific function to a container, particularly a disposable bag, for implementing, for example, measurement, chemical and / or physical reaction, and / or processing steps. Generally, the functional element is not a substantially two-dimensional (2D) element.

[0158] More specifically, the functional parts(s), particularly the functional elements(s) (3), may be parts for labeling such as labels (3e) or markers, parts for stability such as stiffeners and / or reinforcing structures and / or pattern(s) (3f), parts for sensors(s) (4) such as sensor ports (3b) or sensor holders (3d), and parts for fluid transfer such as ports (3b) or flanges. Depending on compatibility with film materials depending on fusion parameters and functions, a 3D printable material (5) on which at least a portion of the functional element (3) can be formed may be one or more of the following materials and / or may include: PE (polyethylene), HOPE (high-density polyethylene), LLDPE (linear low-density polyethylene), LDPE (low-density polyethylene), PP (polypropylene), PC (polycarbonate), TPE (thermoplastic elastomer), EVA (ethylene-vinyl acetate), fluoropolymer, PET (polyethylene terephthalate), POM (polyoxymethylene), ABS (acrylonitrile butadiene styrene), PVC (polyvinyl chloride), PLA (polylactic acid), PA (polyamide), PSU (polysulfone), PES (polyether sulfone), PEEK (polyether ether ketone), copolyester, PMMA (poly(methyl methacrylate), PBI (phenylbenzimidazole sulfone), PEI (polyethyleneimine), PPO (poly(phenylene oxide)), PS (polystyrene), FIFE (polytetrafluoroethylene), PU (polyurethane), silicone, acrylic resin, composite resin containing filler (e.g., PLA with glass fiber), any new material developed and verified for use in medicine, pharmaceutical and biopharmaceutical applications, and composite materials from at least one of the materials mentioned above. Other elements of the disposable bag (1), such as the substrate (2), in particular the wall element (2a), may also include at least partially or be composed of the materials of the above list of materials.

[0159] The printable material (5) in which at least a portion of the functional element (3) is 3D printed, i.e., constructed and / or formed, may particularly comprise a thermoplastic material. A plurality of materials, in particular a mixture or blend of said materials, may also be used as the printable material (5). Thus, the functional element (3) may be composed of a blend of at least two substantially different materials. This means that the two materials may be mixed together before the step of printing the functional element (3), and the functional element (3) comprises a blended material that is essentially homogeneously mixed. Alternatively, the functional element (3) may be formed from a portion of the first material and a portion of the other material, and the first and second materials may be pure, blended, or essentially homogeneously mixed. That is, the blend of materials may be a portion or part of the functional element (3) and may be a transition filament that is placed in direct contact with, for example, the substrate (2) and initiates or starts the process of printing the functional element (3). For example, the printing of the functional element (3) may start from a pure material, e.g., LDPE or any other material fused with the substrate (2), and is blended into a second material more suitable therefor to construct other parts or other parts of the functional element (3), e.g., a sensor (4) or a reinforcing agent (3f) or other types of functional elements (3), along the length of the filament and / or functional element (3). Preferably, the functional element (3) having a multi-material filament, i.e., a portion containing different materials, provides different material properties in different regions, particularly with respect to the diameter of the filament, e.g., with respect to the core-sheath, or with respect to the length of the filament.

[0160] Disposable containers may be film-based containers. Film-based containers may be containers that at least partially include walls comprising a thin, substantially 2D sheet.

[0161] The SU bag (1) may be a flexible or semi-rigid bioprocessing vessel often composed of a plastic sheet commonly referred to as a bag chamber film, which may at least partially refer to the substrate (2). The film thickness may be, for example, approximately 40 μm to approximately 800 μm, preferably approximately 80 μm to approximately 400 μm. The film may be composed of a single layer or multiple layers. Typically, the film may comprise at least one of the following: EVA, PE, PET, PA, EVOH (ethylene-vinyl alcohol-copolymer), fluoropolymer, PP, TPE. The SU bag (1), also referred to as a disposable container, may include semi-rigid or rigid disposable plastic containers, SU bags and / or containers for laboratory applications, and SU bags and / or containers for the food and beverage industry.

[0162] Flexible containers are manufactured from flexible materials such as flexible sheets and / or flexible films. Semi-flexible containers are manufactured partially from flexible materials and partially from rigid materials (e.g., one side or part of the side of the container). An example of a semi-flexible container having rigid elements (3b, 3d, 3f) and side walls and a top wall made of flexible materials is shown in FIG. 6b.

[0163] Typical SU containers such as bag (1) may have a size of about 5 mL to about 5000 L, particularly about 1 L to about 2000 L. The container may be particularly for the production, storage, mixing, testing stability, verification, processing, and / or transport of any contents (e.g., biopharmaceutical solutions). The container may be particularly a disposable container, such as a disposable bioreactor for the production of biopharmaceuticals, for example. The disposable container may be at least partially flexible and / or semi-flexible and may have a 2D- and / or 3D-structure. Explanation of the symbols

[0164] 1: Disposable bags and / or disposable containers such as bioreactor disposable bags (disposable bags are sometimes abbreviated as SU bags) 2: A sheet, in particular, which is essentially two-dimensional and / or is the wall of a disposable bag. 2a: Surface of the substrate on which the functional element is printed and / or the adhesive surface 2b: Opening of the material 3: 3D printed functional elements 3a: Handle, a functional element 3b: Joints and / or flanges that are functional elements 3c: Port, a functional element 3d: Sensor holders and / or tube holders with or without sensors, which are functional elements 3e: Functional elements, labels and / or reference markers and / or standards 3f: Structural, pattern, stabilization, and / or reinforcing elements that are functional elements 3g: Printable material layer as part of a functional element 4: Sensor 4a: Tubes and / or pipes 5: Printable materials 5a: Filament 5b: Filament roll 6: Part of the functional element connected to the basic element 7: Excess material of functional elements to be removed / cut 7a: Excess material of functional elements to be removed / cut 7b: Crushed and segmented excess material of functional elements 6: Welding means 9: Conventional functional elements 9a: Slender section / assembly flange of functional element 9b: Body of a conventional functional element 9c: excess surface 10: Assembly device 11: 3D printing device, especially printer (extruder) head 12: Means for providing and maintaining materials, in particular conveyor belts 13: Heating device 14: Roll of the material 14a: Direction in which the roll is released 15: Means for removing excess material of functional elements and / or substrates, e.g., laser cutter 16: Means for recycling removed, especially cut, excess material 16a: Mill for reducing the part size of removed, especially cut, excess material 17: A system for providing removed material, particularly cut excess material, to a 3D printer or manufacturing a new substrate from excess material. 18: Heating means 19:10 100: Method for manufacturing a disposable bioreactor, in particular a disposable bag 101: Step of providing materials 102: 3D printing step 102a: Step of three-dimensionally printing functional elements on the surface of a substrate 102b: Step of connecting functional elements to the surface of a substrate by providing heat 103: Step of removing and / or cutting excess material and / or excess portions of functional elements and / or substrates U: Upper surface of a substrate, particularly the upper surface of a 2D sheet L: When recording, especially when using a 2D sheet L1: A line defining the projection / shading of the functional element shape on the material L2: Line defining the projection / shading of the welding machine geometry onto the material d1: Length of the assembly flange / slender section potentially used in the examples d2: Length of assembly flange / slender section required in the welding step of the conventional technology

Claims

Claim 1 A disposable container comprising: a substrate (2); and at least one functional element (3) - permanently connected to the substrate (2) and obtained directly on the substrate (2) by 3D printing technology from at least one printable material (5); wherein the printable material (5) and the substrate (2) are heated during 3D printing to connect the printed functional element (3) to the substrate (2), and the at least one functional element (3) is a port (3c). Claim 2 In claim 1, the above description (2) is a disposable container that is at least one of a two-dimensional film; a stock sheet; a pre-cut bag; a pre-made bag; a disposable bag; and a wall element of a bag or container. Claim 3 A disposable container according to claim 1, wherein the at least one functional element (3) further comprises at least one of: a flange (3b); an inlet and / or outlet point; a sensor holder (3d); a sensor (4) or part of a sensor; a window or window frame; a connector; a label (3e); label information; substantially three-dimensional text; a reference marker or starting point; a three-dimensional structure; a three-dimensional pattern (3f); a stabilizing element; a hardening element; a reinforcing element; a tube holder; a handle (3a); a metal element; and an electronic component. Claim 4 In claim 1, the substrate (2) and / or functional element (3) and / or printable material (5) 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, fluoropolymer, copolyester, acrylic, disposable container. Claim 5 A disposable container according to claim 1, wherein the three-dimensional printing technology comprises the manufacture of a fused filament, drop-by-drop application of a printable material (5) and / or layer-by-layer application of a printable material (5). Claim 6 A disposable container according to claim 1, wherein the three-dimensional printing technology further comprises one selected from printing from nanoparticle ink, spraying of atomized metal, melting of metal powder, aerosol spraying, or a combination thereof. Claim 7 A method (100) for manufacturing a disposable container (1) by manufacturing a functional element (3) and connecting the functional element (3) to a substrate (2) of a container (1), comprising: a step (101) of providing a substrate (2); a step (102a) of directly printing the functional element (3) in three dimensions onto a surface (2a) of the substrate (2) from a printable material (5); and a step (102b) of connecting the functional element (3) to the substrate (2) by supplying heat (19) to the printable material (5) and the substrate (2) simultaneously with and / or before at least one interval of the three-dimensional printing step (102), wherein the functional element (3) is a port (3c). Claim 8 In claim 7, the step of supplying heat (19) includes the step of preheating the substrate (2), in a method for manufacturing a disposable container. Claim 9 A method for manufacturing a disposable container according to claim 7 or 8, wherein the three-dimensional printing step (102) of the functional element (3) comprises the step of printing from at least one printable material (5) among acrylic, EVA, ABS, PC, PE, PMMA, PLA, PES, POM, PEEK, PEI, PP, PS, PTFE. Claim 10 In claim 7, the three-dimensional printing step (102) comprises any one selected from printing from nanoparticle ink, spraying finely atomized metal, melting metal powder, and spraying aerosol, or any combination thereof, in a method for manufacturing a disposable container. Claim 11 A method for manufacturing a disposable container according to claim 7, further comprising the step (103) of removing a portion of the material and / or the step (103) of removing an excess portion of the functional element (3). Claim 12 In claim 7, the three-dimensional printing of the functional element (3) comprises the manufacturing of a fused filament, drop-by-drop application of a printable material (5), and / or layer-by-layer application of a printable material (5), in a method for manufacturing a disposable container. Claim 13 A method for manufacturing a disposable container according to claim 7, comprising: a step of removing excess material (7) from a functional element (3) and / or a substrate (2); and a step of at least partially recycling the excess material (7a) removed by reusing it in a three-dimensional printing step and / or a step of manufacturing a substrate (2). Claim 14 An assembly device (10) for manufacturing a disposable container by manufacturing a functional element (3) and connecting the functional element (3) to a substrate (2), comprising: a three-dimensional printing device (11) for printing the functional element (3) on the surface (2a) of the substrate (2); and at least one heating device (13) for connecting the printed functional element (3) to the substrate (2) by supplying heat (19) to a printable material (5) and the substrate (2) during three-dimensional printing, wherein the functional element (3) is a port (3c). Claim 15 A disposable container assembly device according to claim 14, further comprising means for providing and positioning the above-mentioned material (2), and optionally configured such that the assembly device (10) provides the above-mentioned material (2) from a roll (14). Claim 16 A disposable container assembly device further comprising: a removal means (15) for removing excess material (7) from a functional element (3) and / or a substrate (2); and a means (17) for heating the removed excess material (7a) and providing it to a system (18) for manufacturing a three-dimensional printing device and / or a substrate (2), and a means (16) for at least partially recycling the removed excess material (7a).

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