Disposable vacuumizing biological culture solution sub-packaging bag

Abstract

The utility model discloses a disposable vacuumized biological culture solution sub-packaging bag which comprises multiple layers of composite films, two pieces of composite films are oppositely connected to form a bag body, a vacuumizing pipe is inserted into the bag body, a stop valve is arranged on the vacuumizing pipe, and the vacuum pipe is connected with the bag body. The multilayer composite film comprises a wear-resistant layer, an upper supporting layer, a barrier layer, a lower supporting layer and an internal culture solution contact layer which are sequentially arranged from top to bottom, and the wear-resistant layer, the upper supporting layer, the barrier layer, the lower supporting layer and the internal culture solution contact layer are bonded through a compatilizer. By means of the mode, the disposable vacuumizing biological culture solution split charging bag has excellent mechanical performance, barrier performance, friction resistance, welding performance and biocompatibility, low production cost and efficient operation flexibility in the production and research and development process are achieved, and the cross infection probability is reduced.

Description

Technical Field

[0001] The utility model relates to the field of bioreactors, in particular to a disposable vacuum-pumpable biological culture liquid packaging bag. Background Art

[0002] Since the late 1990s, disposable bioreactors have had significant advantages in the biopharmaceutical field. They are mainly used for microbial culture and cell culture in pilot-scale and production-scale discontinuous or continuous processes, as well as clinical sample preparation and Good Manufacturing Practice (GMP) production during process development. Currently, the largest use is in seed expansion culture, culture of mammalian cells to produce antibodies and vaccines, large-scale strain screening and recombinant proteins.

[0003] Disposable bioreactors are predominantly ready-to-use, non-reusable culture vessels made from FDA-approved plastic materials (such as polyethylene, ethylene vinyl acetate, and ethylene vinyl alcohol). Compared to traditional stainless steel or glass bioreactors, disposable bioreactors do not require repeated cleaning and sterilization, reducing the need for flushing water systems and maintenance. Furthermore, since they are not used for subsequent operations, they eliminate the possibility of cross-contamination between process runs and avoid the long cycle time of equipment assembly. Due to the reduced complexity of the system, the engineering requirements involved are also reduced, such as lowering the pressure rating of related piping, valve controllers, or containers. Furthermore, the use of disposable bioreactors reduces the complexity of validation, facilitating faster modification for new process operations. Commercial stirred-type disposable bioreactors are available in a wide variety of materials and specifications, with a wide range of working volumes, up to 2000 L.

[0004] The special film for disposable bioreactors is an important component that determines the performance of disposable bioreactors. The special film is a single-layer or multi-layer composite film of polymer. During use, one side is usually in direct contact with the culture liquid, and the other side is in contact with the outside world. It has good gas barrier function and can provide environmental protection for cell growth.

[0005] A key factor influencing the development of single-use bioreactors is the choice of specialized composite film materials. Currently, these materials are primarily imported, such as the Thermo Fisher Scientific™ and GE Cellbag™ products. These materials are not only expensive and require long procurement cycles, increasing costs for domestic users, but also because raw materials and key manufacturing technologies are controlled by foreign countries. This hinders the development of single-use bioreactors in my country and hinders the sustainable development of related downstream industries. Summary of the Invention

[0006] The main technical problem solved by the utility model is to provide a disposable vacuum-evacuable biological culture fluid packaging bag with excellent mechanical properties, barrier properties, friction resistance, welding properties and biocompatibility, so as to achieve low production costs, high efficiency and operational flexibility in the production and R&D process, and reduce the probability of cross infection.

[0007] In order to solve the above technical problems, a technical solution adopted by the utility model is: to provide a disposable vacuumable biological culture fluid packaging bag, including a multi-layer composite film, two sheets of the multi-layer composite film are relatively connected to form a bag body, a vacuum tube is inserted into the bag body, and a stop valve is provided on the vacuum tube. The multi-layer composite film includes a wear-resistant layer, an upper support layer, a barrier layer, a lower support layer and an internal culture fluid contact layer arranged in sequence from top to bottom, and the wear-resistant layer, upper support layer, barrier layer, lower support layer and internal culture fluid contact layer are bonded by a compatibilizer.

[0008] In a preferred embodiment of the present invention, the wear-resistant layer is a non-polar heat-sealable friction-resistant layer made of thermoplastic polyester elastomer.

[0009] In a preferred embodiment of the present invention, the upper support layer and the lower support layer are low-density polyethylene layers.

[0010] In a preferred embodiment of the present invention, the barrier layer is an ethylene-vinyl alcohol copolymer layer.

[0011] In a preferred embodiment of the present invention, the internal culture medium contact layer is a linear low-density polyethylene layer.

[0012] In a preferred embodiment of the present invention, the edges of the two multi-layer composite films are connected by welding to form a bag body, and the vacuum tube is connected to the multi-layer composite film by welding.

[0013] In a preferred embodiment of the present invention, the longitudinal tensile strength of the multilayer composite film is ≥15.0 MPa, the elongation at break is ≥450%, the yield strength is ≥8.5 MPa, and the 2% fixed-point modulus is ≥260 MPa; the transverse tensile strength of the multilayer composite film is ≥15.0 MPa, the elongation at break is ≥450%, the yield strength is ≥8.5 MPa, and the 2% fixed-point modulus is ≥260 MPa, and the welding strength of the multilayer composite film is ≥50 N / cm.

[0014] In a preferred embodiment of the present invention, the oxygen transmission rate of the multi-layer composite film is ≤0.116cc / m 2 / 24h, carbon dioxide transmission rate ≤0.69 cc / m 2 / 24h, water vapor transmission rate ≤0.185 g / m 2 / 24h.

[0015] The beneficial effects of the utility model are as follows: the disposable vacuumable biological culture fluid packaging bag of the utility model is made into a multi-layer composite film by a co-extrusion casting method, so that the composite film has excellent mechanical properties, barrier properties, friction resistance, welding properties and biocompatibility.

[0016] The utility model discloses a disposable vacuumable biological culture fluid dispensing bag. The vacuum tube not only performs vacuuming but also serves as a pipeline for dispensing and discharging culture medium and cell culture fluid, thereby avoiding oxygen contamination of the culture medium and cell culture fluid.

[0017] The utility model discloses a disposable vacuumable biological culture liquid packaging bag, which is formed by welding two layers of multi-layer composite films and a vacuum hose, and has the advantages of simple process, low manufacturing cost and high production efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative work. Among them:

[0019] Figure 1 This is a schematic structural diagram of a disposable vacuum-evacuable biological culture fluid packaging bag of the present invention;

[0020] Figure 2 yes Figure 1 sectional view of

[0021] Figure 3 It is a schematic diagram of the structure of a multilayer composite film;

[0022] The components in the accompanying drawings are marked as follows: 1. Multi-layer composite film, 11. Wear-resistant layer, 12. Upper support layer, 13. Barrier layer, 14. Lower support layer, 15. Internal culture medium contact layer, 2. Vacuum tube, 3. Stop valve. DETAILED DESCRIPTION

[0023] The technical solutions in the embodiments of the present invention will be described clearly and completely below. The structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification so that people familiar with this technology can understand and read them. They are not used to limit the restrictive conditions that can be implemented in this utility model, so they have no technical substantive significance. Any modification of the structure, change in the proportional relationship, or adjustment of the size should still fall within the scope of the technical content disclosed in this utility model without affecting the effect that can be produced by this utility model and the purpose that can be achieved. At the same time, the terms such as "upper", "lower", "left", "right", "middle" etc. cited in this specification are only for the convenience of description and are not used to limit the scope that can be implemented. Changes or adjustments in their relative relationships should also be regarded as the scope that can be implemented in this utility model without substantially changing the technical content.

[0024] See also Figure 1 and Figure 2 A disposable vacuumable biological culture fluid packaging bag comprises a multi-layer composite film 1, two multi-layer composite films 1 are relatively connected to form a bag body, a vacuum tube 2 is inserted into the bag body, and a stop valve 3 is provided on the vacuum tube 2. The edge parts of the two multi-layer composite films 1 are connected by welding to form a bag body, and the vacuum tube 2 is welded to the multi-layer composite film 1. The vacuum tube 2 is made of PE soft rubber tube. After the vacuum tube 2 and the multi-layer composite film 1 are welded to form a bag body, the air in the bag body is discharged by vacuuming, thereby avoiding oxygen contamination of the culture medium and cell culture fluid. When in use, the vacuum tube 2 is used as a pipeline for packaging and discharging culture medium and cell culture fluid, and is suitable for consumables in the fields of biopharmaceuticals and process development such as disposable bioreactors, and meets the needs of students and biopharmaceutical laboratories for further experimental activities on culture medium and cell culture fluid, etc., to achieve low production costs, efficient operation flexibility, and reduced probability of cross infection in the production and R&D process.

[0025] The multilayer composite film 1 includes, from top to bottom, a wear-resistant layer 11, an upper support layer 12, a barrier layer 13, a lower support layer 14, and an internal culture fluid contact layer 15. The wear-resistant layer 11, upper support layer 12, barrier layer 13, lower support layer 14, and internal culture fluid contact layer 15 are bonded together by a compatibilizer. The wear-resistant layer 11 is a non-polar, heat-sealable, friction-resistant layer made of a thermoplastic polyester elastomer. The upper support layer 12 and lower support layer 14 are low-density polyethylene layers. The barrier layer 13 is an ethylene-vinyl alcohol copolymer layer. The internal culture fluid contact layer 15 is a linear low-density polyethylene layer. The multilayer composite film 1 adopts a typical layer structure of a conventional continuous eleven-layer co-extrusion casting method, with a structure of thermoplastic polyester elastomer / compatibilizer / low-density polyethylene / low-density polyethylene / compatibilizer / ethylene-vinyl alcohol copolymer / compatibilizer / low-density polyethylene / low-density polyethylene / linear low-density polyethylene / linear low-density polyethylene.

[0026] The multilayer composite film exhibits excellent mechanical properties, barrier properties, friction resistance, weldability, and biocompatibility. The multilayer composite film has a longitudinal tensile strength of ≥15.0 MPa, an elongation at break of ≥450%, a yield strength of ≥8.5 MPa, and a 2% fixed-point modulus of ≥260 MPa. The multilayer composite film also has a transverse tensile strength of ≥15.0 MPa, an elongation at break of ≥450%, a yield strength of ≥8.5 MPa, and a 2% fixed-point modulus of ≥260 MPa. The weld strength of the multilayer composite film is ≥50 N / cm.

[0027] Physical performance indicators of multi-layer composite films: Oxygen permeability of multi-layer composite films ≤ 0.116cc / m 2 / 24h, carbon dioxide transmission rate ≤0.69 cc / m 2 / 24h, water vapor transmission rate ≤0.185 g / m 2 / 24h. The haze of the multilayer composite film meets the standard as assessed by ASTM D1003. The multilayer composite film has a temperature range of -80 to 60°C and a glass transition temperature of -48°C.

[0028] Biocompatibility performance index of multi-layer composite film products: multi-layer composite film 10 -6 The sterility assurance level (γ ray 50kGy) test and assessment have met the standards; the multi-layer composite film USP Level VI certification USP 88 test and assessment have met the standards; the multi-layer composite film cytotoxicity USP 87 test and assessment have met the standards, with level 0 non-toxicity; the multi-layer composite film endotoxin USP 85 test and assessment have met the standards ≤0.0125Eu / ml; the multi-layer composite film heavy metal, buffering capacity, non-volatile residue, and ignition residue tests USP 661 have met the standards.

[0029] Different from the existing technology, the disposable vacuumable biological culture fluid packaging bag of the utility model has excellent mechanical properties, barrier properties, friction resistance, welding properties and biocompatibility, achieving low production costs, efficient operation flexibility and reduced probability of cross infection in the production and R&D processes.

[0030] The above is a schematic description of the present invention and its embodiments, which is not restrictive. The drawings show only one embodiment of the present invention, and the actual structure is not limited thereto. Therefore, if a person skilled in the art is inspired by this and, without departing from the inventive purpose of the present invention, designs a structure and embodiment similar to the technical solution without inventiveness, they shall fall within the scope of protection of the present invention.

Claims

1. A disposable vacuumable biological culture medium packaging bag, characterized in that: It includes a multi-layer composite film, two of which are relatively connected to form a bag body, a vacuum tube is inserted into the bag body, and a stop valve is provided on the vacuum tube. The multi-layer composite film includes a wear-resistant layer, an upper support layer, a barrier layer, a lower support layer and an internal culture fluid contact layer arranged in sequence from top to bottom, and the wear-resistant layer, upper support layer, barrier layer, lower support layer and internal culture fluid contact layer are bonded by a compatibilizer.

2. The disposable vacuumable biological culture fluid packaging bag according to claim 1, characterized in that: The wear-resistant layer is a non-polar heat-sealed friction-resistant layer made of thermoplastic polyester elastomer.

3. The disposable vacuumable biological culture fluid packaging bag according to claim 1, characterized in that: The upper supporting layer and the lower supporting layer are low-density polyethylene layers.

4. The disposable vacuumable biological culture fluid packaging bag according to claim 1, characterized in that: The barrier layer is an ethylene-vinyl alcohol copolymer layer.

5. The disposable vacuumable biological culture fluid packaging bag according to claim 1, characterized in that: The inner culture solution contact layer is a linear low-density polyethylene layer.

6. The disposable vacuumable biological culture fluid packaging bag according to any one of claims 1 to 5, characterized in that: The edge portions of the two multi-layer composite films are connected by welding to form a bag body.

7. The disposable vacuumable biological culture fluid packaging bag according to claim 6, characterized in that: The multilayer composite film has a longitudinal tensile strength of ≥15.0 MPa, an elongation at break ≥450%, a yield strength ≥8.5 MPa, and a 2% fixed-point modulus ≥260 MPa; the multilayer composite film has a transverse tensile strength of ≥15.0 MPa, an elongation at break ≥450%, a yield strength ≥8.5 MPa, and a 2% fixed-point modulus ≥260 MPa, and a welding strength of ≥50 N / cm.

8. The disposable vacuumable biological culture fluid packaging bag according to claim 7, characterized in that: The oxygen transmission rate of the multi-layer composite film is ≤0.116cc / m 2 / 24h, carbon dioxide permeability ≤0.69cc / m 2 / 24h, water vapor transmission rate ≤0.185g / m 2 / 24h.

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