A method of making a single-use biocontainer of three-dimensional structure

Abstract

The application provides a manufacturing method of a three-dimensional disposable biological container, which comprises the following steps: firstly, directly extruding and forming through a film blowing machine, and cutting immediately after forming an elliptical structure film to directly obtain an integrally-formed integrated container body without circumferential welding points, so that the whole container body is formed by a continuous structure film, the problem of cross welding of multiple films in a traditional plane film splicing and welding forming mode is effectively solved, the inherent weak area of three film welding junctions is eliminated from the source, and the structural failure risk is fundamentally reduced; and secondly, the lower bottom and the integrated container body are coaxially assembled in a lap joint type to form a continuous transition structure in the connecting area, the welding interface is stable and uniform, the local strength mutation problem caused by spot welding or butt welding is avoided, the sealing stability of the connecting part is improved from the structure connection mode, and the welding crack and micro-leakage risk are effectively reduced.

Description

Technical Field

[0001] This invention relates to the field of disposable biological container technology, specifically a method for manufacturing a three-dimensional disposable biological container. Background Technology

[0002] Disposable biocontainers are widely used in biopharmaceuticals, cell culture, biological sample storage, fermentation processes, bioreaction systems, and aseptic transport. Their structural safety, sealing reliability, and overall strength directly affect the safety of biological samples and the stability of system operation. In existing technologies, three-dimensional disposable biocontainers are typically made from planar plastic films, which are assembled through cutting, splicing, and thermal welding processes to form a container body with a three-dimensional spatial structure.

[0003] In existing molding processes, a common structural form involves using single or multiple layers of planar plastic film, connecting multiple sheet films into a three-dimensional container through multiple welding processes. In this structural system, to form a three-dimensional spatial structure at the bottom, side walls, and top, it is inevitable to cross-weld multiple film sheets in multiple directions. Especially at the corners, edges, and spatial transition areas of the container bottom, there is usually a structure where three or more film sheets converge and are welded at the same location, thus forming a multi-film welding junction structure.

[0004] This type of multi-film welded interface structure exhibits stress concentration under load. Under conditions such as container pressure, liquid load, transport vibration, stacking, or fluid impact, the welded interface area easily becomes a localized stress concentration zone, becoming the weakest point in the overall structure's mechanical properties. Furthermore, because multiple films are stacked at the same weld point, the welding process window is critical, and consistent welding consistency is difficult to maintain. This easily leads to problems such as incomplete welds, weak welds, inclusions, and insufficient welding, thus creating potential leakage risks.

[0005] Furthermore, traditional planar thin-film splicing structures suffer from numerous weld seams and complex weld paths, increasing production complexity and manufacturing costs. They also create multiple potential failure points during use, reducing the overall system's reliability and safety. For bioprocess systems, microleakage can lead to biological sample contamination and biosafety risks, severely impacting system stability and product quality.

[0006] Therefore, the existing disposable biological containers based on the splicing and welding of planar thin films to form a three-dimensional structure are difficult to eliminate the leakage risks and weak strength problems caused by the welding junctions of multiple thin films. It is evident that it is necessary to provide a method for manufacturing a three-dimensional disposable biological container to solve the above problems. Summary of the Invention

[0007] To address the shortcomings of existing technologies, this invention provides a method for manufacturing a three-dimensional disposable biological container, which solves the problems of leakage risks and weak strength caused by the welding joints of multiple thin films in existing disposable biological containers.

[0008] A method for manufacturing a three-dimensional disposable biological container, comprising an integral container body and a bottom disposed at the bottom of the integral container body, the method comprising the following steps: Step 1: Selecting raw materials and adding antistatic agent, anti-aging agent and heat stabilizer to the raw materials, then thoroughly mixing the raw materials and pre-drying them at 60-80℃ for 1-4 hours to reduce the moisture content of the raw materials to below 0.05%; Step 2: Feeding the pre-treated raw materials from Step 1 into a blown film extrusion machine for extrusion molding, forming a columnar film container through extrusion, blowing and traction processes, wherein the temperature of the extruder is controlled at 100-300℃, the die temperature is 100-300℃, and the film thickness is 0.20-10 mm; Step 3: After the columnar film container is formed in Step 2, stopping the blown film operation and immediately cutting it, with the cutting length tolerance controlled within ±1 mm. Within mm; the top and bottom of the cut cylindrical film container are both open, thus obtaining an integrally molded container body with at least a frustum structure at the bottom; Step 4: Prepare the bottom; Step 5: Assemble the bottom opening end of the integral container body and the bottom coaxially, so that the outer periphery of the bottom and the end of the container body form an overlapping structure with an overlap length of 0.1-10cm; the overlapping position is fixed by overlapping heat welding, bonding or clamp connection, while sealing the top opening of the integral container body; Step 6: Test the sealing and strength of the molded disposable biological container, keep it without leakage for 30s under an internal pressure of 10-30 kPa, and test the tensile strength of the weld, which is not less than 15 MPa. At the same time, conduct an appearance inspection to ensure that there are no bubbles, no scorch marks and no false welds. After passing the inspection, the three-dimensional disposable biological container product is obtained.

[0009] Preferably, the top is prepared simultaneously in step four; the operation of sealing the top opening of the integrated container body in step five is as follows: the top opening end of the integrated container body is coaxially aligned and assembled with the top, so that the outer periphery of the top and the end of the container body form an overlapping structure with an overlap length of 0.1 to 10 cm, and then the overlapping part is fixed by overlapping heat welding, bonding or clamp connection.

[0010] Furthermore, both the lower bottom and the upper top are made of the pre-treated raw materials in step one, and are processed into soft circular films by injection molding or compression molding, or both the lower bottom and the upper top are hard plastic discs.

[0011] Furthermore, when the lower bottom and the upper top are soft circular films, when assembling the lower bottom, the upper top and the integrated container body, a disc-shaped positioning fixture is used to engage and position them to ensure the coaxiality of the lower bottom, the upper top and the integrated container body. During the assembly process, the disc-shaped positioning fixture abuts against and supports the outer end faces of the lower bottom and the upper top, and then they are connected and fixed by welding or bonding.

[0012] Furthermore, when both the lower bottom and the upper top are hard plastic discs, the lower bottom and the upper top are directly overlapped on the inner walls of the upper and lower opening ends of the integrated container body. Self-centering coaxial assembly is achieved by relying on the rigidity of the hard plastic discs themselves, and then they are connected and fixed by welding, bonding or clamps.

[0013] Preferably, the top opening of the integrated container body is sealed by butt welding.

[0014] Preferably, the raw material is PE, PVC, EVA, silicone or PP material.

[0015] Preferably, the amount of antistatic agent added is 0.1-0.5% of the total mass of raw materials, the amount of antiaging agent added is 0.05-0.2%, and the amount of heat stabilizer added is 0.1-0.3%.

[0016] Preferably, the columnar film container formed by the blown film machine in step two is a multi-layer co-extruded columnar film container, preferably with 2 to 20 layers.

[0017] Preferably, the columnar film container undergoes directional stretching and heat setting treatment after molding.

[0018] Compared with the prior art, the present invention has the following beneficial effects: This invention provides a method for manufacturing a three-dimensional disposable biological container. First, the invention employs blown film extrusion and blow-inflated traction to directly form a cylindrical thin-film container. After forming, it is immediately cut to obtain a one-piece container body. The container body is a continuous thin-film structure without circumferential welds, eliminating the traditional method of splicing and welding multiple thin films. This fundamentally eliminates the inherent weak point at the weld junction of multiple films, effectively avoiding problems such as stress concentration, weld cracking, and local structural failure, significantly improving the overall structural integrity and mechanical stability of the container body. Second, the lower opening end and the bottom of this invention adopt an overlapping coaxial assembly structure, combined with hot welding, bonding, or clamping for fixation. This creates a continuous and uniform transition structure at the connection area between the container body and the bottom. The connection interface experiences uniform stress and good sealing, effectively avoiding micro-leakage and weld damage caused by sudden changes in local strength, significantly improving the sealing stability and structural fatigue resistance of the container connection. Meanwhile, this invention adds antistatic agents, anti-aging agents and heat stabilizers before raw material processing, and strictly controls the moisture content of raw materials through high-temperature pre-drying, which effectively improves the molding performance of raw materials, making the prepared film container uniform in thickness and stable in material properties, so that the finished product has good antistatic, anti-aging and heat stability capabilities, avoiding defects such as bubbles, false welds and scorch marks during the molding process, and improving the overall quality and safety of the finished product.

[0019] Therefore, this invention solves the problems of weak structure, poor sealing, numerous molding defects, and insufficient stability of traditional spliced ​​and welded biological containers by integrating the blown film forming container body, overlapping sealing connection, and raw material pretreatment. Attached Figure Description

[0020] Figure 1 This is a schematic flowchart illustrating the method for manufacturing a three-dimensional disposable biological container as described in Embodiment 1 of the present invention. Detailed Implementation

[0021] The embodiments described below are merely some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention. Example 1

[0022] See Figure 1 This embodiment 1 provides a method for manufacturing a three-dimensional disposable biological container, which includes an integral container body, an upper top disposed on the top of the integral container body, and a lower bottom disposed at the bottom of the integral container body. Specifically, the method for manufacturing this three-dimensional disposable biological container includes the following steps: Step 1: Raw material pretreatment: Select PE, PVC, EVA, silicone or PP raw materials as the main materials, add 0.1-0.5% of antistatic agent, 0.05-0.2% of anti-aging agent and 0.1-0.3% of heat stabilizer by total mass of raw materials, and stir thoroughly to mix evenly; place the mixed raw materials in an environment of 60-80℃ for 1-4 hours to pre-dry, so that the moisture content of the raw materials is reduced to below 0.05%, and the raw material pretreatment is completed.

[0023] Among them, antistatic agents can reduce static electricity buildup on the film surface, reduce the adsorption of airborne particles, and improve the cleanliness of the bioprocess environment; anti-aging agents can improve the oxidation resistance and UV resistance of the material during long-term storage and use, and prevent film embrittlement; heat stabilizers can inhibit material degradation during high-temperature extrusion and improve melt stability. Pre-drying treatment can effectively remove residual moisture from the raw materials, prevent bubbles, silver streaks, and uneven thickness caused by moisture vaporization during blown film production, thereby improving the subsequent molding quality and welding reliability.

[0024] Step 2: Blow molding of columnar thin film containers: The pretreated raw materials are fed into a blown film machine for extrusion molding. A multi-layered co-extruded columnar film container is prepared through a continuous process of extrusion, blow-blowing, and traction. Preferably, there are 2 to 20 layers. More preferably, there are 3 layers. Specifically, when using 3 layers, the columnar film container includes a compliant structural layer, a supporting structural layer, and an impact-resistant structural layer. The compliant structural layer improves the overall flexibility and folding performance of the container; the supporting structural layer improves the structural stability of the container when carrying liquid; and the impact-resistant structural layer improves the container's resistance to breakage during transportation, handling, and drops.

[0025] The extruder temperature zone is controlled between 100 and 300°C, the die temperature is controlled between 100 and 300°C, and the film thickness is controlled within the range of 0.20 to 10 mm. This ensures that the resin is fully plasticized and maintains a stable flow state, thereby obtaining a tubular film structure with uniform thickness. After the columnar film container is formed, it undergoes further directional stretching and heat setting treatment. Directional stretching causes the film molecular chains to form an orderly arrangement along the axial and circumferential directions, improving the tensile strength, tear strength, and fatigue resistance of the material; heat setting treatment is used to release internal residual stress, improve dimensional stability, and reduce the risk of shrinkage deformation during subsequent liquid storage.

[0026] Step 3: Cutting to form a one-piece container body: Once the cylindrical film container has stabilized and formed, the blown film operation is immediately stopped and the container is quickly cut, with the cutting length tolerance strictly controlled within ±1mm. The resulting cylindrical film container has open ends, forming a one-piece molded container body with a frustum-shaped top and bottom and no circumferential welds. Because the container body is formed integrally by the blown film process, its circumferential sidewalls are continuous, eliminating the longitudinal welds and intersecting weld points formed by splicing multiple film sheets in traditional methods. This eliminates stress concentration problems caused by the intersection of multiple film sheets from the structural source. At the same time, the continuous sidewall structure makes the container more evenly pressurized, improving overall pressure resistance and sealing reliability.

[0027] Step 4: Prepare the top and bottom: Using the pretreated raw materials from step one, the bottom and top of a flexible circular film structure are fabricated through a compression molding process. During compression molding, the thickness of the circular film is controlled to be uniform, ensuring good flexibility and deformation adaptability. The flexible circular film structure can fully fit the container body, forming a uniform and continuous contact interface during welding, which is beneficial for improving welding quality and sealing effect.

[0028] Step 5: Container assembly and sealing: During assembly, a disc-shaped positioning fixture is used to engage and position the lower bottom and upper top with the integrated container body. The fixture rests against the outer end face of the flexible circular membrane supporting the top and bottom. Then, the flexible circular membrane is fitted onto the top and bottom openings of the integrated container body, ensuring coaxiality of the three components. Subsequently, the lower bottom and upper top are coaxially aligned and overlapped with the upper and lower openings of the container body, with the overlap length controlled to be 0.1–10 cm. A longer overlap area increases the welding contact area, improving connection strength and peel resistance.

[0029] Because the flexible circular diaphragm has low rigidity, it is prone to deformation and displacement during assembly. The disc-shaped positioning fixture effectively limits its radial displacement and axial sway, ensuring good coaxiality between the bottom and top of the container and the main body. Simultaneously, lap-type thermal welding is used to seal and fix both overlapping positions, completing the closure of the container's top opening. The lap-type thermal welding forms a continuous annular weld, which, compared to partial spot welding or short weld structures, distributes stress more evenly, effectively reducing stress concentration in the weld area and improving fatigue resistance and sealing stability during long-term use.

[0030] Step Six: Finished Product Inspection The molded biological container is subjected to finished product testing. It is required to maintain pressure for 30 seconds under an internal pressure of 10-30 kPa without leakage, and the tensile strength of the weld is not less than 15 MPa. At the same time, the appearance inspection shows no bubbles, no scorch marks, and no false welds.

[0031] The internal pressure sealing test verifies the overall sealing performance and welding reliability of the container; the weld tensile strength test verifies the structural strength of the connection area; and the visual inspection checks for defects generated during the blown film, molding, and welding processes. The finished container of this embodiment is obtained after passing the inspection.

[0032] It should be noted that the bottom and top can also be connected to the integrated container body by adhesive bonding after being snapped into place. The antistatic agent can be one or more of fatty acid ester antistatic agents, quaternary ammonium salt antistatic agents, and polyether antistatic agents; preferably, glyceryl monostearate (GMS) is used as the antistatic agent. The anti-aging agent can be one or more of hindered phenolic antioxidants, phosphite antioxidants, or ultraviolet absorbers; preferably, a compound system of antioxidant 1010 and antioxidant 168 is used. The heat stabilizer can be one or more of calcium-zinc composite heat stabilizers, organotin heat stabilizers, or epoxidized vegetable oil heat stabilizers; preferably, a calcium-zinc composite heat stabilizer is used.

[0033] The biocontainer prepared in this embodiment uses a flexible circular film as the top and bottom. The material is soft and conforms well, adapting to deformation during liquid storage and making it suitable for flexible biological storage and aseptic transport scenarios. High-precision coaxial assembly is achieved using a disc-shaped positioning fixture, effectively avoiding misalignment issues in the assembly of flexible materials. Simultaneously, a continuous annular lap weld is used for sealing, resulting in uniform, continuous welds and excellent sealing performance. Combining a multi-layer co-extrusion structure and directional stretching process, the container possesses flexibility, pressure resistance, impact resistance, and aging resistance, meeting the requirements for highly reliable disposable biocontainers in biopharmaceutical, cell culture, and biological sample storage and transportation fields. Example 2

[0034] This embodiment 2 is largely the same as embodiment 1, except that the bottom and the top are made of hard plastic discs.

[0035] Specifically, both the lower base and the upper top are prepared by injection molding, using PP or other thermoplastic engineering plastics to form a disc structure with high rigidity and dimensional stability. Compared to the soft circular film structure in Example 1, the hard plastic disc in Example 2 has higher resistance to deformation and load-bearing stiffness.

[0036] During the assembly process, specifically in step five, the bottom and top of the hard plastic disc are coaxially aligned and overlapped with the top and bottom openings of the integrated container body. Because the hard plastic disc has good geometric regularity and edge rigidity, its outer circumference can form a stable fit with the inner wall of the container body, thus achieving self-centering assembly without the need for additional positioning fixtures, effectively improving assembly efficiency and coaxial accuracy.

[0037] Furthermore, the overlap length at the upper and lower ends is controlled to be 0.1–10 cm to ensure sufficient contact area between the hard plastic disc and the integrated container body, thereby enhancing the interfacial bonding strength and improving peel resistance. Subsequently, both the upper and lower overlap positions are fixedly connected using lap-type heat welding, glue connection, or external clamps, forming a continuous annular connection structure between the hard plastic disc and the container body, thus achieving a reliable seal at both ends.

[0038] Due to the high rigidity of rigid plastic discs, they can effectively suppress local deformation during welding or adhesive bonding, resulting in more uniform stress distribution at the connection interface, reducing local stress concentration, and improving the long-term stability and sealing reliability of the connection. Simultaneously, rigid plastic discs can serve as structural reinforcements, supporting the upper and lower ends of the container, enabling it to maintain good shape stability and pressure resistance when filled with liquid or subjected to external impacts.

[0039] Therefore, the three-dimensional disposable biological container prepared in this embodiment 2 significantly improves the structural strength and deformation resistance of the container ends by using hard plastic discs as upper and lower structural components, making it suitable for biological sample storage and transportation scenarios with high pressure resistance requirements or complex transportation environments. Example 3

[0040] This embodiment 3 discloses a three-dimensional disposable biological container with only a bottom, a top opening sealed by butt welding, and no independent top. The specific steps of its manufacturing method are as follows: Step 1: Raw material pretreatment PE, PVC, EVA, silicone or PP raw materials are selected as the main materials. Antistatic agents, anti-aging agents and heat stabilizers are added to the raw materials. Each additive is added in proportion to the total mass of the raw materials and is fully mixed to ensure that it is evenly dispersed in the matrix material.

[0041] Among them, antistatic agents are used to reduce surface charge accumulation, decrease particle adsorption, and improve biocompatibility; anti-aging agents are used to improve the material's antioxidant and UV resistance during long-term storage and use, and delay material performance degradation; heat stabilizers are used to improve the material's thermal stability during high-temperature processing, inhibit molecular chain thermal degradation, and improve melt stability. The mixed raw materials are pre-dried at 60–80℃ for 1–4 hours to reduce the moisture content to below 0.05%, thus avoiding bubbles, silver streaks, or structural defects caused by moisture evaporation during subsequent blown film production, thereby improving molding stability and welding quality.

[0042] Step 2: Forming of cylindrical film containers: Pretreated raw materials are fed into a blown film machine, and multi-layer co-extruded cylindrical film containers are prepared through a continuous process of extrusion, blow-blowing, and traction. The cylindrical film container has a multi-layer co-extruded structure, including a compliant layer, a support layer, and an impact-resistant layer. The compliant layer is used to improve the material's deformation adaptability, the support layer is used to improve the structural load-bearing capacity, and the impact-resistant layer is used to improve the resistance to breakage under transportation and drop conditions.

[0043] During the molding process, the extruder and die temperatures are controlled within the range of 100–300℃ to ensure sufficient plasticization of the material and maintain a stable flow state. The resulting film thickness is controlled within the range of 0.20–10 mm to meet different volume and pressure requirements. After molding, the columnar film container undergoes directional stretching and heat setting treatment to orient the polymer chains along a specific direction, thereby improving the tensile strength, tear resistance, and fatigue resistance of the material. The heat setting treatment is used to eliminate residual internal stress, improve dimensional stability, and prevent shrinkage deformation during subsequent use.

[0044] Step 3: Cutting to form a one-piece container body Immediately after the columnar thin-film container is formed, the blown film is stopped and it is quickly cut, with the cutting length tolerance controlled within ±1mm. After cutting, a one-piece container body with openings at both the top and bottom is obtained, with a frustum-shaped bottom. The whole is formed by continuous blown film molding, with no splicing welds or intersection welds in the circumference, eliminating the weak welding areas in the traditional multi-film splicing structure from the structural source.

[0045] Step 4: Prepare the bottom base Using the raw materials pretreated in step one, the bottom structural component is prepared through injection molding or compression molding. The bottom can be a flexible or semi-rigid structure to adapt to the sealing requirements and assembly methods in different application scenarios. Its shape is a disc structure that matches the container body to form a stable annular overlapping interface. In this embodiment, no top structure is provided; only the bottom is retained as the bottom sealing component.

[0046] Step 5: Assembly and Top Sealing: The lower opening of the integrated container body is coaxially aligned and overlapped with the bottom, with the overlap length controlled between 0.1 and 10 cm to form a stable annular contact interface. The overlap is then sealed and fixed by heat welding, creating a reliable connection between the bottom and the container body.

[0047] Meanwhile, for the top open end of the container body, an independent top structure is no longer provided, but a butt welding process is directly used for sealing. Specifically, the material edges on both sides of the top opening are butted to form a continuous molten weld in a hot-melt state, thereby achieving a completely sealed seal. Compared with the solution where a top structure is provided, this embodiment reduces the number of parts and assembly procedures through the direct butt welding sealing method, and simplifies the manufacturing process.

[0048] Step 6: Finished product inspection Sealing inspection, weld strength inspection and appearance inspection are performed on the molded container. The product is judged as qualified if there is no leakage after holding pressure for 30 seconds under an internal pressure condition of 10 to 30 kPa, the tensile strength of the weld is not less than 15 MPa, and there are no defects such as bubbles, burn marks, cracks and insufficient welding on the surface.

[0049] In this embodiment, the top butt welding sealing method is used to achieve sealing, which makes the overall structure simpler, reduces assembly components and potential leakage interfaces, and still maintains good sealing performance and structural integrity. It is suitable for single-use biocontainer application scenarios with high requirements for cost control and sensitivity to structural complexity.

[0050] What is disclosed above are only several preferred embodiments of the present invention, which certainly cannot limit the scope of claims of the present invention accordingly. Therefore, equivalent variations made in accordance with the claims of the present invention still fall within the scope covered by the present invention.

Claims

1. A method for manufacturing a three-dimensional disposable biological container, used to manufacture a disposable biological container, the disposable biological container comprising an integral container body, an upper top disposed on the top of the integral container body, and a lower bottom disposed on the bottom of the integral container body, characterized in that: The method for manufacturing the three-dimensional disposable biological container includes the following steps: Step 1: Select raw materials and add antistatic agent, anti-aging agent and heat stabilizer to the raw materials. Then mix the raw materials thoroughly and pre-dry them at 60-80℃ for 1-4 hours to reduce the moisture content of the raw materials to below 0.05%. Step 2: The pre-treated raw material from Step 1 is fed into a blown film extrusion machine for extrusion molding. A columnar film container is formed through extrusion, blowing and traction processes. The temperature of the extruder temperature zone is controlled at 100~300℃, the die temperature is 100~300℃, and the film thickness is 0.20~10 mm. Step 3: After the columnar film container is formed in Step 2, stop the film blowing operation and cut it immediately; the top and bottom of the cut columnar film container are open, thus obtaining an integrated container body with at least a frustum structure at the bottom; Step 4: Prepare the bottom base; Step 5: Align and assemble the lower opening end of the one-piece container body with the lower bottom coaxially, so that the outer periphery of the lower bottom and the end of the container body form an overlapping structure with an overlap length of 0.1-10cm; fix the overlapping position by overlapping heat welding, bonding or clamp connection, and at the same time close the top opening of the one-piece container body. Step Six: Perform sealing and strength tests on the molded disposable biological container. Maintain no leakage for 30 seconds under an internal pressure of 10-30 kPa. Perform tensile strength tests on the welds. The tensile strength should not be less than 15 MPa. At the same time, perform visual inspection to ensure that there are no bubbles, no scorch marks, and no false welds. Once qualified, the three-dimensional disposable biological container product is obtained.

2. The method for manufacturing a three-dimensional disposable biological container as described in claim 1, characterized in that, In step four, the top is prepared simultaneously; in step five, the operation of sealing the top opening of the integrated container body is as follows: the top opening end of the integrated container body is coaxially aligned and assembled with the top, so that the outer periphery of the top and the end of the container body form an overlapping structure with an overlap length of 0.1 to 10 cm. Then, the overlapping part is fixed by overlapping heat welding, bonding or clamp connection.

3. The method for manufacturing a three-dimensional disposable biological container as described in claim 2, characterized in that, Both the bottom and the top are made from the pre-treated raw materials in step one, and are processed into soft circular films by injection molding or compression molding, or both the bottom and the top are hard plastic discs.

4. The method for manufacturing a three-dimensional disposable biological container as described in claim 3, characterized in that, When the lower bottom and the upper top are soft circular films, when assembling the lower bottom, the upper top and the integrated container body, a disc-shaped positioning fixture is used to engage and position them to ensure the coaxiality of the lower bottom, the upper top and the integrated container body. During the assembly process, the disc-shaped positioning fixture abuts against and supports the outer end faces of the lower bottom and the upper top, and then they are connected and fixed by welding or bonding.

5. The method for manufacturing a three-dimensional disposable biological container as described in claim 3, characterized in that, When both the lower bottom and the upper top are hard plastic discs, the lower bottom and the upper top are directly overlapped on the inner walls of the upper and lower opening ends of the integrated container body. The self-centering coaxial assembly is achieved by relying on the rigidity of the hard plastic discs themselves, and then they are connected and fixed by welding, bonding or clamps.

6. The method for manufacturing a three-dimensional disposable biological container as described in claim 1, characterized in that, The top opening of the integrated container body is sealed by butt welding.

7. The method for manufacturing a three-dimensional disposable biological container as described in claim 1, characterized in that, The raw materials are PE, PVC, EVA, silicone or PP materials.

8. The method for manufacturing a three-dimensional disposable biological container as described in claim 1, characterized in that, The amount of the antistatic agent added is 0.1 to 0.5% of the total mass of the raw materials, the amount of the anti-aging agent added is 0.05 to 0.2%, and the amount of the heat stabilizer added is 0.1 to 0.3%.

9. The method for manufacturing a three-dimensional disposable biological container as described in claim 1, characterized in that, The columnar film container formed by the blown film machine in step two is a multi-layer co-extruded columnar film container.

10. The method for manufacturing a three-dimensional disposable biological container as described in claim 1, characterized in that, The columnar film container undergoes directional stretching and heat setting after molding.

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