WO2020020116A1 - 一次性生物工艺袋及其制作方法、热熔式环形焊接机 - Google Patents

一次性生物工艺袋及其制作方法、热熔式环形焊接机 Download PDF

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Publication number
WO2020020116A1
WO2020020116A1 PCT/CN2019/097183 CN2019097183W WO2020020116A1 WO 2020020116 A1 WO2020020116 A1 WO 2020020116A1 CN 2019097183 W CN2019097183 W CN 2019097183W WO 2020020116 A1 WO2020020116 A1 WO 2020020116A1
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Prior art keywords
welding
bag
disposable
biotechnology
film material
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PCT/CN2019/097183
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English (en)
French (fr)
Inventor
胡福林
原世平
宋金沛
韩伟
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浙江金仪盛世生物工程有限公司
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Application filed by 浙江金仪盛世生物工程有限公司 filed Critical 浙江金仪盛世生物工程有限公司
Priority to EP19841876.6A priority Critical patent/EP3828257A4/en
Priority to US17/262,712 priority patent/US12036750B2/en
Publication of WO2020020116A1 publication Critical patent/WO2020020116A1/zh

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/84—Specific machine types or machines suitable for specific applications
    • B29C66/851—Bag or container making machines
    • B29C66/8511—Bag making machines
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/48—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding
    • B29C65/4805—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding characterised by the type of adhesives
    • B29C65/481—Non-reactive adhesives, e.g. physically hardening adhesives
    • B29C65/4815—Hot melt adhesives, e.g. thermoplastic adhesives
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00—Making flexible containers, e.g. envelopes or bags
    • B31B70/14—Cutting, e.g. perforating, punching, slitting or trimming
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00—Making flexible containers, e.g. envelopes or bags
    • B31B70/14—Cutting, e.g. perforating, punching, slitting or trimming
    • B31B70/20—Cutting sheets or blanks
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00—Making flexible containers, e.g. envelopes or bags
    • B31B70/60—Uniting opposed surfaces or edges; Taping
    • B31B70/64—Uniting opposed surfaces or edges; Taping by applying heat or pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00—Making flexible containers, e.g. envelopes or bags
    • B31B70/60—Uniting opposed surfaces or edges; Taping
    • B31B70/64—Uniting opposed surfaces or edges; Taping by applying heat or pressure
    • B31B70/642—Uniting opposed surfaces or edges; Taping by applying heat or pressure using sealing jaws or sealing dies
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/007—Flexible bags or containers
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/02—Form or structure of the vessel
    • C12M23/14—Bags
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/28—Constructional details, e.g. recesses, hinges disposable or single use
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2150/00—Flexible containers made from sheets or blanks, e.g. from flattened tubes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2150/00—Flexible containers made from sheets or blanks, e.g. from flattened tubes
    • B31B2150/002—Flexible containers made from sheets or blanks, e.g. from flattened tubes by joining superimposed sheets, e.g. with separate bottom sheets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2150/00—Flexible containers made from sheets or blanks, e.g. from flattened tubes
    • B31B2150/003—Flexible containers made from sheets or blanks, e.g. from flattened tubes made from tubular sheets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2160/00—Shape of flexible containers
    • B31B2160/20—Shape of flexible containers with structural provision for thickness of contents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2160/00—Shape of flexible containers
    • B31B2160/30—Shape of flexible containers pointed or tapered
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2241/00—Making bags or boxes intended for a specific use
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00—Making flexible containers, e.g. envelopes or bags
    • B31B70/02—Feeding or positioning sheets, blanks or webs
    • B31B70/04—Feeding sheets or blanks
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00—Making flexible containers, e.g. envelopes or bags
    • B31B70/74—Auxiliary operations
    • B31B70/81—Forming or attaching accessories, e.g. opening devices, closures or tear strings
    • B31B70/84—Forming or attaching means for filling or dispensing contents, e.g. valves or spouts

Definitions

  • the invention relates to the technical field of biopharmaceuticals, in particular to a disposable biotechnology bag, a manufacturing method thereof, and a hot-melt ring welding machine.
  • the existing disposable biotechnology bags have undergone multiple linear welding during the production process, and there are many overlapping areas at the welding edges.
  • the physical properties of the multiple overlapping areas have significantly decreased, which has increased the rupture of the bag of the disposable biotechnology bags and the leakage of the culture liquid in the bags. risks of.
  • the poor adherence between the existing disposable biotechnology bag and the bioreactor will cause the shape of the culture liquid flow field in the culture system to deviate from the more ideal flow field shape confirmed at the time of design. Affect the final cell culture effect.
  • the embodiment of the present invention provides a disposable biotechnology bag and a manufacturing method thereof, and a hot-melt ring welding machine, which can improve the physical properties of the welding edge of the disposable biotechnology bag, and at the same time improve the attachment of the disposable biotechnology bag and the bioreactor. ⁇ Degree.
  • the present invention provides a method for making a disposable biotechnology bag:
  • the disposable biotechnology bag is used to be placed in a bioreactor.
  • the upper top of the bioreactor is circular, the upper portion is cylindrical, the lower portion is rounded, and the lower bottom is circular.
  • the process bag includes a circular upper top, a column upper part, a rounded lower part and a circular lower bottom.
  • the circular upper top is provided with at least two bag openings;
  • the manufacturing method includes:
  • a first cutting template, a second cutting template, a third cutting template, and a fourth cutting are prepared, respectively.
  • the raw film material is cut according to the first cutting template to obtain a first film material, and the raw film material is cut according to the second cutting template to obtain a second film material.
  • Three cutting templates cut the raw film material to obtain a third film material, and cut the raw film material according to the fourth cutting template to obtain a fourth film material, the fourth film material Directly as the circular bottom;
  • a hot-melt circular welding machine is used to weld the circular upper top, the upper part of the column, the lower part of the round table and the lower round bottom to obtain the disposable biotechnology bag.
  • Type circular welding machine is used for welding circular welding edges.
  • an error between the size of the first film material and the size of the first cutting template is less than or equal to 2 mm
  • the difference between the size of the second film material and the size of the second cutting template is
  • the difference between the size of the third film material and the size of the third cutting template is less than or equal to 2 mm
  • the size of the fourth film material is different from that of the fourth cutting material.
  • the error between the dimensions of the cutting template is less than or equal to 2mm.
  • the process parameters include:
  • the air pressure is 0.5MPa
  • the temperature of the upper mold is 110 ° C ⁇ 2 ° C
  • the temperature of the lower mold is 80 ° C ⁇ 2 ° C
  • the gap between the upper mold and the lower mold is 1.5mm
  • the welding time is 6s ⁇ 8s
  • the width of the welding edge is 8mm.
  • a layer of high-temperature cloth is placed on the non-welded surface of the first film material.
  • the process parameters include:
  • the air pressure is 0.6 MPa
  • the temperature of the upper mold is 135 ° C ⁇ 2 ° C
  • the temperature of the lower mold is 90 ° C ⁇ 2 ° C
  • the gap between the upper mold and the lower mold is 0.6mm
  • the welding time is 6s ⁇ 9s
  • the width of the welding edge is 10mm
  • the thickness of the welding edge is 0.6mm ⁇ 0.1mm.
  • the process parameters include:
  • the air pressure is 0.6 MPa
  • the temperature of the upper mold is 135 ° C ⁇ 2 ° C
  • the temperature of the lower mold is 90 ° C ⁇ 2 ° C
  • the gap between the upper mold and the lower mold is 0.6mm
  • the welding time is 6s ⁇ 9s
  • the width of the welding edge is 10mm
  • the thickness of the welding edge is 0.6mm ⁇ 0.1mm.
  • the process parameters include:
  • the air pressure is 0.6 MPa
  • the temperature of the upper mold is 135 ° C ⁇ 2
  • the welding time is 50s to 55s
  • the width of the welding edge is 10mm.
  • the lower mold is not heated.
  • the manufacturing method of the disposable biotechnology bag further includes: using a hot-melt ring welding machine, placing the circular top, the upper portion of the column, the lower portion of the round table, and the circular bottom During the welding of the bottom, the upper mold and the lower mold of the hot-melt circular welding machine are replaced according to the diameter of the circular upper top and the diameter of the circular lower bottom, respectively.
  • the method for manufacturing the disposable biotechnology bag further includes: after obtaining the disposable biotechnology bag, performing a pressure drop method on the disposable biotechnology bag to perform air tightness detection.
  • the holding pressure process parameters include:
  • the ambient temperature is 26 °C ⁇ 2 °C in summer time, 20 °C ⁇ 2 degrees in winter time, humidity is 40% -60%, and the holding time is 48h;
  • the holding pressure When the volume of the disposable biotechnology bag is 5L, the holding pressure is 4kPa; when the volume of the disposable biotechnology bag is 50L, the holding pressure is 2kPa; when the volume of the disposable biotechnology bag is 300L The holding pressure is 0.6 kPa; when the volume of the disposable biotechnology bag is 1200 L, the holding pressure is 0.3 kPa.
  • the present invention provides a disposable biotechnology bag, which is formed using any one of the manufacturing methods of the disposable biotechnology bag described above.
  • the present invention provides a hot-melt circular welding machine, which includes a base, a bracket, an upper mold, a lower mold, an air cylinder, and a screw guide rail, and the lower mold is detachably connected to the mold.
  • the bracket is fixed to one end of the base
  • the screw guide is fixed on the bracket
  • the cylinder is fixed on the screw guide
  • the upper mold is detachably connected to the cylinder.
  • the upper mold is a circular arc piece
  • the lower mold is a hollow cylinder
  • the upper mold has a built-in heating module
  • the lower mold can be rotated at any angle between 0 and 360 ° along its axial direction. .
  • a silicone plate is laid on the upper surface of the lower mold.
  • the thickness of the silica gel plate is 2 mm.
  • the hot-melt circular welding machine includes two of the cylinders.
  • the position of the screw guide rail overlaps the position of the axis of symmetry of the upper mold, and the two cylinders are along The symmetry axis of the upper mold is arranged symmetrically.
  • the invention provides a disposable biotechnology bag, a manufacturing method thereof, and a hot-melt ring-shaped welding machine.
  • the first film At least two pockets are welded on the material to obtain a round top.
  • the second film is welded to obtain the upper part of the cylinder.
  • the third film is welded to obtain the lower part of the round table.
  • Welding the upper round top, the upper part of the column, the lower part of the round table and the lower round bottom can obtain the disposable biotechnology bag, so that the number of welding times and the number of welding edges are less during the production process of the disposable biotechnology bag.
  • Second, third, and fourth membranes are the first, second, third, and third cutting templates made according to the size and shape of the bioreactor.
  • the cutting template is obtained by cutting the raw material film, which can improve the fit of the disposable biotechnology bag and the bioreactor, and solve the ideal flow that the culture liquid flow field in the culture system deviates from the design confirmation.
  • the problem of field morphology in turn helps to improve the final cell culture effect.
  • FIG. 1 is a schematic structural diagram of a disposable biotechnology bag
  • FIG. 2 is a flowchart of a method for manufacturing a disposable biotechnology bag
  • FIG. 3 is a schematic structural diagram of a first cutting template
  • FIG. 4 is a schematic structural diagram of a second cutting template
  • FIG. 5 is a schematic structural diagram of a third cutting template
  • FIG. 6 is a schematic structural diagram of a fourth cutting template
  • FIG. 7 is a schematic structural diagram of a hot-melt circular welding machine.
  • FIG. 1 is a schematic structural diagram of a disposable biotechnology bag.
  • the disposable biotechnology bag includes a round top 1, a column upper portion 2, a rounded lower portion 3, and a round lower bottom 4.
  • the circular top 1 is provided with at least two pocket openings 11.
  • FIG. 2 is a flowchart of a method for manufacturing a disposable biotechnology bag.
  • the method for manufacturing a disposable biotechnology bag includes:
  • Step S1 A first cutting template, a second cutting template, a third cutting template, and a fourth cutting template are prepared according to the top, top, bottom, and bottom of the bioreactor, respectively.
  • the first cutting template corresponds to the shape and size of the top.
  • FIG. 3 is a schematic diagram of the structure of the first cutting template.
  • the shape of the first cutting template is circular, and its circumference Is the perimeter of the upper top, which has openings corresponding to at least two pocket openings;
  • the second cutting template corresponds to the shape and size of the inner wall of the upper part, as shown in FIG. 4, and
  • FIG. 4 is the second cutting Schematic diagram of the template, the shape of the second cutting template is rectangular, the length of the two opposite sides is the perimeter of the cross section of the upper inner wall, and the length of the other two opposite sides is the height of the upper part;
  • the three cutting templates correspond to the shape and size of the inner wall of the lower part. As shown in FIG.
  • FIG. 5 is a schematic diagram of the third cutting template.
  • the shape of the third cutting template is an inverted trapezoid, and its longer bottom
  • the length of the side is the perimeter of the cross section of the upper inner wall, and the length of the shorter bottom side is the perimeter of the bottom.
  • the fourth cutting template corresponds to the shape and size of the bottom, as shown in Figure 6, 6 is a structural diagram of the fourth cutting template, and the shape of the fourth cutting template Circular, its circumference is the circumference of the lower base.
  • Step S2 cutting the raw film material according to the first cutting template, the second cutting template, the third cutting template, and the fourth cutting template to obtain a first film, a second film, and a third film Material and the fourth film material, and the fourth film material is directly used as the round bottom.
  • the “fourth film material” is to cut the raw film material according to the first cutting template to obtain the first film material, and the raw film material is cut according to the second cutting template to obtain the second film material.
  • the cutting template cuts the raw film material to obtain a third film material, and cuts the raw film material according to the fourth cutting template to obtain a fourth film material.
  • the error between the size of the first film material and the size of the first cutting template is less than or equal to 2 mm
  • the error between the size of the second film material and the size of the second cutting template is less than or equal to 2 mm
  • the third The error between the size of the film material and the size of the third cutting template is less than or equal to 2mm
  • the error between the size of the fourth film material and the size of the fourth cutting template is less than or equal to 2mm, so that the disposable biological process The degree of fit between the bag and the bioreactor is better.
  • the above-mentioned raw material film is a special film suitable for cell culture.
  • the cutting process firstly lay the raw material film on the workbench, and then press the cutting template (collectively referred to as the first cutting template, the second cutting template, the third cutting template and the fourth cutting template)
  • the cutting template (collectively referred to as the first cutting template, the second cutting template, the third cutting template and the fourth cutting template)
  • the cutting template For cutting, if using an automatic cutter, make sure that the cutting template or ruler cannot be displaced to minimize the dimensional error caused during the cutting process.
  • Step S3 Welding at least two pocket openings on the first film material to obtain a round top.
  • the welding on the surface of the first film material and being able to link the pipeline is collectively referred to as a bag mouth.
  • the mouth of the bag may be a sampling port, an air outlet, a liquid outlet, a sensor interface, a spare pipe, an air inlet, a liquid inlet, and the like.
  • a hot-melt bag bag mouth welding machine can be used to weld at least two bag mouths on the first film.
  • the air pressure the downward pressure exerted by the cylinder of the hot-melt welding machine on the upper mold
  • the temperature of the upper mold and the lower Process parameters such as the temperature of the mold, the gap between the upper and lower molds, the welding time, and the width of the welding edge will all affect the welding effect, specifically:
  • the process parameters include: air pressure of 0.5 MPa, the temperature of the upper mold is 110 ° C ⁇ 2 ° C, the temperature of the lower mold is 80 ° C ⁇ 2 ° C, The gap between the mold and the lower mold is 1.5mm, the welding time is 6s to 8s, and the width of the welding edge is 8mm.
  • the specific manner of welding at least two pocket openings on the first film material is as follows: the gap between the upper mold and the lower mold is adjusted to 1.5 mm, and the upper mold heating system in the hot-melt welding machine is used to The mold is heated to 110 ° C ⁇ 2 ° C, and then the upper mold is given a downward pressure of 0.5 MPa by the cylinder, so that the upper mold and the lower mold perform a fixed pressure extrusion on the first film material and the bag mouth, and the welding time is 6s ⁇ 8s, the welding surface will be fully fused after heating, so as to ensure that the sealing edge of the welding edge and heat sealing strength meet the requirements.
  • a layer of high-temperature cloth is placed on the non-welded surface of the first film material to prevent the non-welded surface of the first film material from being damaged during the welding process.
  • Step S4 welding the second film material to obtain the upper part of the pillar.
  • the second film can be welded by using a hot-melt linear welding machine to obtain the upper part of the cylinder.
  • the process parameters include: an air pressure of 0.6 MPa, an upper mold temperature of 135 ° C ⁇ 2 ° C, a lower mold temperature of 90 ° C ⁇ 2 ° C, an upper mold and a lower mold
  • the gap between them is 0.6mm
  • the welding time is 6s-9s
  • the width of the welding edge is 10mm
  • the thickness of the welding edge is 0.6mm ⁇ 0.1mm.
  • step S4 The reason for selecting the process parameters and the specific welding method in step S4 are similar to the specific content in step S3, and will not be repeated here.
  • Step S5 welding the third film material to obtain the lower part of the round table.
  • a hot-melt linear welding machine may be used to weld the third film material to obtain a lower portion of the round table.
  • the process parameters include: an air pressure of 0.6 MPa, an upper mold temperature of 135 ° C ⁇ 2 ° C, a lower mold temperature of 90 ° C ⁇ 2 ° C, an upper mold and a lower mold
  • the gap between them is 0.6mm
  • the welding time is 6s-9s
  • the width of the welding edge is 10mm
  • the thickness of the welding edge is 0.6mm ⁇ 0.1mm.
  • step S5 The reason for selecting the process parameters in step S5 and the specific welding method are similar to those in step S3, and will not be repeated here.
  • Step S6 Use a hot-melt ring welding machine to weld the circular top, the upper part of the column, the lower part of the round table and the lower round bottom to obtain a disposable biotechnology bag.
  • the hot-melt ring welding machine is used to weld the ring. Welding edges.
  • the process parameters include: air pressure is 0.6 MPa, and the temperature of the upper mold is 135 °C ⁇ 2, welding time is 50s ⁇ 55s, and the width of welding side is 10mm.
  • the lower mold is not heated.
  • step S6 The reason for selecting the process parameters in step S6 is similar to the specific content in step S3, and is not repeated here.
  • the specific welding method in step S6 will be described in detail below with reference to the specific structure of the hot-melt circular welding machine.
  • steps S3, S4, and S5 is not limited in this embodiment of the present invention, and the sequence may be step S3, step S4, step S5, or step S3, step S5, step S4, or, Step S4, step S3, step S5, or step S4, step S5, step S3, or step S5, step S4, step S3, or step S5, step S3, step S4, a person skilled in the art can according to actual needs Make your selection.
  • At least two bag openings are welded to the first film material in the process of manufacturing the disposable biotechnology bag using the method for manufacturing the disposable biotechnology bag, and a round top is obtained, and the second film material is processed.
  • a disposable biotechnology bag can be obtained, so that the number of weldings, fewer welding edges, and fewer overlapping areas of the welding edges can be obtained in the production process of the disposable biotechnology bags, which can improve the physical properties of the welding edges of the disposable biotechnology bags.
  • the first film, the second film, the third film and the fourth film are based on the bioreactor
  • the first cutting template, the second cutting template, the third cutting template, and the fourth cutting template made by the different sizes and shapes are obtained by cutting the raw film material, thereby improving the disposable biotechnology.
  • the degree of fit between the art bag and the bioreactor solves the problem that the shape of the flow field of the culture liquid inside the culture system deviates from the more ideal flow field shape confirmed at the design time, which helps to improve the final cell culture effect.
  • the manufacturing method of the disposable biotechnology bag further includes: using a hot-melt ring welding machine to weld the circular top, the upper part of the column, the lower part of the round table and the lower bottom of the circle according to the circle, respectively.
  • the diameter of the upper top and the lower bottom of the circle are used to replace the upper mold and the lower mold of the hot-melt circular welding machine.
  • the manufacturing method of the disposable biotechnology bag further includes: after obtaining the disposable biotechnology bag, performing air-tightness inspection on the disposable biotechnology bag by using a pressure drop method to determine the Whether the airtightness meets the requirements to avoid the application of disposable biotechnology bags such as defective products during the production process that do not meet the airtightness requirements in the bioreactor, resulting in leakage of the culture liquid.
  • the operation method is: fully cool the disposable biotechnology bag obtained after welding, and then seal the multiple bag mouths with a silicone tube, and reserve two bag mouths for pressure leak detection at the same time, in order to quickly and effectively test once
  • the integrity of the biological biotechnology bag needs to be kept constant to avoid temperature fluctuations affecting the pressure inside the disposable biotechnology bag and thus affecting the accuracy of the test results.
  • the actual pressure inside the disposable biotechnology bag is 80% or more of the holding pressure (that is, the pressure inside the disposable bio bag at the start of holding pressure)
  • the airtightness of the disposable biotechnology bag If it is qualified, the airtightness of the disposable biotechnology bag is unqualified.
  • the holding pressure process parameters include: an ambient temperature of 26 ° C. ⁇ 2 ° C. in summer time, 20 ° C. ⁇ 2 ° C. in winter time, a humidity of 40% -60%, and a holding time of 48 h;
  • the holding pressure is 4kPa; when the volume of the disposable biotechnology bag is 50L, the holding pressure is 2kPa; when the volume of the disposable biotechnology bag is 300L, the holding pressure is 0.6 kPa; when the volume of the disposable biotechnology bag is 1200L, the holding pressure is 0.3 kPa.
  • the present invention also relates to a disposable biotechnology bag, which is formed by using the method for manufacturing a disposable biotechnology bag according to any one of the above embodiments.
  • the disposable biotechnology bag includes a circular upper top 1, a cylindrical upper portion 2, a rounded lower portion 3, and a circular lower bottom 4, and at least two bags are provided on the circular upper top 1. Mouth 11.
  • the disposable biotechnology bag is formed by using the method for manufacturing a disposable biotechnology bag according to any one of the above embodiments, there are fewer welded edges and fewer overlapping areas of the welded edges Can improve the physical properties of the welded edge of the disposable biotechnology bag, reduce the risk of the bag body of the disposable biotechnology bag rupture and the leakage of the culture liquid in the bag, and the degree of fit between the disposable biotechnology bag and the bioreactor is relatively Well, it solves the problem that the shape of the flow field of the culture liquid inside the culture system deviates from the more ideal flow field shape confirmed during the design, which helps to improve the final cell culture effect.
  • FIG. 7 is a schematic structural diagram of the hot-melt circular welding machine.
  • the hot-melt circular welding machine includes a base 71, a bracket 72, The upper mold 73, the lower mold 74, the air cylinder 75, and the screw guide rail 76, the lower mold 73 is detachably connected to the base 71, the bracket 72 is fixed to one end of the base 71, the screw guide 76 is fixed to the bracket 72, and the air cylinder 75 is fixed to On the screw guide rail 76, the upper mold 73 is detachably connected to the bottom of the piston of the cylinder 75.
  • the upper mold 73 is a circular arc piece
  • the lower mold 74 is a hollow cylinder
  • the upper mold 73 has a built-in heating module
  • the lower mold 74 can be along its axial direction. Rotate in any direction between 0 and 360 °.
  • the upper mold 73 of the hot-melt circular welding machine is used to heat the upper mold to a set temperature, and the upper mold 73 is provided with a downward direction through the cylinder 75.
  • the pressure causes the upper mold 73 and the lower mold 74 to press the film material at a fixed pressure to perform welding.
  • the lower mold 74 is rotated to rotate the film material on the lower mold 74 to make the hollow cylinder.
  • the film material corresponding to the pillar of the lower mold 74 is located between the lower mold 74 and the upper mold 73 for a certain time, and then is welded, so that the circular welding edge can be welded by the hot-melt circular welding machine.
  • the lower mold 74 can be driven by a motor to rotate, and it can rotate at a constant speed, or it can rotate a certain angle each time.
  • the certain angle is the center angle of the upper mold 73 corresponding to the arc-shaped piece. After rotating, it stays for a certain time and performs welding Until the welding of the ring-shaped welding edge is completed.
  • the selection of the rotation speed and the dwell time of the above uniform rotation should satisfy: the welding time of each position of the welding edge meets the requirements of the welding time in the process parameters of step S6. Those skilled in the art can design reasonably according to this.
  • the lower mold can be rotated 0 to 360 ° along its axial direction, so that the rotation of the lower mold drives the rotation of the film material or structure that needs to be welded, so that the smaller size can be compared with the smaller mold.
  • Welding of large film materials or structures, and welding of various locations of film materials or structures with irregular shapes help to increase the scope of application of hot-melt circular welding machines.
  • a silicone plate is laid on the upper surface of the lower mold, so that the upper mold and the lower mold are uniformly stressed to ensure the uniformity of the welding effect.
  • the inventor found that if the silicone board is too thin, the effect is not good, and if the silicone board is too thick, the cost is too high. Based on this, the thickness of the silicone board is selected to be 2mm.
  • the hot-melt circular welding machine includes two cylinders 75.
  • the position of the screw guide rail 76 and the position of the symmetry axis of the upper mold 73 overlap, and the two cylinders 75
  • the symmetry axis of the upper mold 73 is symmetrically arranged, so that the pressure is applied to the upper mold 73 by two cylinders 75 at the same time, so that the pressure at each position of the upper mold 73 is more uniform, the welding effect is more uniform, and the physical properties of the welding edge are better.
  • a plurality of rollers 77 are provided at the bottom of the base 71 to facilitate the movement of the hot-melt circular welding machine.
  • the invention provides a disposable biotechnology bag, a manufacturing method thereof, and a hot-melt ring-shaped welding machine.
  • the first film At least two pockets are welded on the material to obtain a round top.
  • the second film is welded to obtain the upper part of the cylinder.
  • the third film is welded to obtain the lower part of the round table.
  • Welding the upper round top, the upper part of the column, the lower part of the round table and the lower round bottom can obtain the disposable biotechnology bag, so that the number of welding times and the number of welding edges are less during the production process of the disposable biotechnology bag.
  • Second, third, and fourth membranes are the first, second, third, and third cutting templates made according to the size and shape of the bioreactor.
  • the four cutting templates are obtained by cutting the raw material film, so that the fit of the disposable biotechnology bag and the bioreactor can be improved, and the ideal shape of the culture liquid flow field in the culture system is deviated from the design confirmation. The problem of flow field morphology will help to improve the final cell culture effect.

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Abstract

本发明提供一次性生物工艺袋及其制作方法、热熔式环形焊接机，涉及生物制药技术领域。该制作方法包括：根据生物反应器的上顶、上部、下部和下底，分别制得第一裁切模板至第四裁切模板；根据第一裁切模板至第四裁切模板分别对原料膜材进行裁切，得到第一膜材至第四膜材，第四膜材直接作为圆形下底；在第一膜材上焊接至少两个袋口，得到圆形上顶；对第二膜材进行焊接，得到柱体上部；对第三膜材进行焊接，得到倒圆台下部；使用热熔式环形焊接机，将圆形上顶、柱体上部、倒圆台下部和圆形下底进行焊接，得到一次性生物工艺袋。本发明能够提高一次性生物工艺袋的焊接边的物理性能，且同时提高一次性生物工艺袋与生物反应器的贴合度。

Description

一次性生物工艺袋及其制作方法、热熔式环形焊接机 技术领域
本发明涉及生物制药技术领域，尤其涉及一次性生物工艺袋及其制作方法、热熔式环形焊接机。
背景技术
随着生物制药技术的不断发展，一次性使用系统(Single-use Systems，简称SUS)的使用越来越广泛，一次性生物工艺袋作为一次性使用系统的配套耗材，在实际的生产制作过程和实际应用中还存在很多不足。
现有的一次性生物工艺袋，生产过程经过多次直线焊接，焊接边重合的部位较多，多次重合部位物理性能明显下降，增加了一次性生物工艺袋袋体破裂和袋内培养液体泄漏的风险。同时，在实际应用过程中，现有一次性生物工艺袋与生物反应器的贴合度差，会导致培养系统内部的培养液体流场形态偏离了设计时确认的较为理想的流场形态，从而影响最终的细胞培养效果。
发明内容
本发明实施例提供一次性生物工艺袋及其制作方法、热熔式环形焊接机，可以提高一次性生物工艺袋的焊接边的物理性能，且同时提高一次性生物工艺袋与生物反应器的贴合度。
第一方面，本发明提供一次性生物工艺袋的制作方法：
所述一次性生物工艺袋用于放置于生物反应器中，所述生物反应器的上顶为圆形、上部为圆柱形，下部为倒圆台形，下底为圆形，所述一次性生物工艺袋包括圆形上顶、柱体上部、倒圆台下部和圆形下底，所述圆形上顶上 设置有至少两个袋口；
所述制作方法包括：
根据所述生物反应器的所述上顶、所述上部、所述下部和所述下底，分别制得第一裁切模板、第二裁切模板、第三裁切模板和第四裁切模板；
根据所述第一裁切模板对原料膜材进行裁切，得到第一膜材，根据所述第二裁切模板对所述原料膜材进行裁切，得到第二膜材，根据所述第三裁切模板对所述原料膜材进行裁切，得到第三膜材，根据所述第四裁切模板对所述原料膜材进行裁切，得到第四膜材，所述第四膜材直接作为所述圆形下底；
在所述第一膜材上焊接至少两个袋口，得到所述圆形上顶；
对所述第二膜材进行焊接，得到所述柱体上部；
对所述第三膜材进行焊接，得到所述倒圆台下部；
使用热熔式环形焊接机，将所述圆形上顶、所述柱体上部、所述倒圆台下部和所述圆形下底进行焊接，得到所述一次性生物工艺袋，所述热熔式环形焊接机用于焊接环形的焊接边。
可选地，所述第一膜材的尺寸与所述第一裁切模板的尺寸之间的误差小于或者等于2mm，所述第二膜材的尺寸与所述第二裁切模板的尺寸之间的误差小于或者等于2mm，所述第三膜材的尺寸与所述第三裁切模板的尺寸之间的误差小于或者等于2mm，且所述第四膜材的尺寸与所述第四裁切模板的尺寸之间的误差小于或者等于2mm。
可选地，对所述原料膜材进行裁切时，每次仅对至多两层所述原料膜材进行裁切。
可选地，在所述第一膜材上焊接至少两个袋口时，工艺参数包括：
空气压力为0.5MPa，上模具的温度为110℃±2℃，下模具的温度为80℃±2℃，所述上模具和所述下模具之间的间隙为1.5mm，焊接时间为6s～8s，焊接边的宽度为8mm。
可选地，在所述第一膜材上焊接至少两个袋口时，在所述第一膜材的非 焊接面放置一层高温布。
可选地，对所述第二膜材进行焊接时，工艺参数包括：
空气压力为0.6MPa，上模具的温度为135℃±2℃，下模具的温度为90℃±2℃，所述上模具和所述下模具之间的间隙为0.6mm，焊接时间为6s～9s，焊接边的宽度为10mm，所述焊接边的厚度为0.6mm±0.1mm。
可选地，对所述第三膜材进行焊接时，工艺参数包括：
空气压力为0.6MPa，上模具的温度为135℃±2℃，下模具的温度为90℃±2℃，所述上模具和所述下模具之间的间隙为0.6mm，焊接时间为6s～9s，焊接边的宽度为10mm，所述焊接边的厚度为0.6mm±0.1mm。
可选地，使用热熔式环形焊接机，将所述圆形上顶、所述柱体上部、所述倒圆台下部和所述圆形下底进行焊接时，工艺参数包括：
空气压力为0.6MPa，上模具的温度为135℃±2，焊接时间为50s～55s，焊接边的宽度为10mm。在该实施方式中，下模具不进行加热。
可选地，所述一次性生物工艺袋的制作方法还包括：使用热熔式环形焊接机，将所述圆形上顶、所述柱体上部、所述倒圆台下部和所述圆形下底进行焊接的过程中，分别根据所述圆形上顶的直径和所述圆形下底的直径，对所述热熔式环形焊接机的上模具和下模具进行更换。
可选地，所述一次性生物工艺袋的制作方法还包括：得到所述一次性生物工艺袋之后，采用压降法对所述一次性生物工艺袋进行气密性检测。
可选地，所述压降法中，保压工艺参数包括：
环境温度为夏令时26℃±2℃，冬令时20℃±2度，湿度为40％-60％，保压时间为48h；
所述一次性生物工艺袋的体积为5L时，保压压力为4kPa；所述一次性生物工艺袋的体积为50L时，保压压力为2kPa；所述一次性生物工艺袋的体积为300L时，保压压力为0.6kPa；所述一次性生物工艺袋的体积为1200L时，保压压力为0.3kPa。
第二方面，本发明提供一次性生物工艺袋，所述一次性生物工艺袋使用以上所述的任一种一次性生物工艺袋的制作方法制作形成。
第三方面，本发明提供热熔式环形焊接机，所述热熔式环形焊接机包括：底座、支架、上模具、下模具、气缸和丝杆导轨，所述下模具可拆卸连接于所述底座上，所述支架固定于所述底座的一端，所述丝杆导轨固定于所述支架上，所述气缸固定于所述丝杆导轨上，所述上模具可拆卸连接于所述气缸的活塞底部，所述上模具为圆弧形片，所述下模具为中空圆柱，所述上模具内置加热模块，所述下模具可沿其轴向方向旋转0～360°之间的任一角度。
可选地，所述下模具的上表面上铺设有硅胶板。
可选地，所述硅胶板的厚度为2mm。
可选地，所述热熔式环形焊接机包括两个所述气缸，在竖直方向上，所述丝杆导轨所在位置与所述上模具的对称轴所在位置重叠，两个所述气缸沿所述上模具的对称轴对称设置。
本发明提供了一次性生物工艺袋及其制作方法、热熔式环形焊接机，一方面，由于在使用该一次性生物工艺袋的制作方法制作一次性生物工艺袋的过程中，在第一膜材上焊接至少两个袋口，得到圆形上顶，对第二膜材进行焊接，得到柱体上部，对第三膜材进行焊接，得到倒圆台下部，使用热熔式环形焊接机，将圆形上顶、柱体上部、倒圆台下部和圆形下底进行焊接，即可得到一次性生物工艺袋，从而使得一次性生物工艺袋的制作过程中焊接次数较少，焊接边较少，且焊接边重合的部位较少，可以提高一次性生物工艺袋的焊接边的物理性能，降低一次性生物工艺袋袋体破裂和袋内培养液体泄漏的风险，另一方面，由于第一膜材、第二膜材、第三膜材和第四膜材都是根据生物反应器的尺寸和形状制得的第一裁切模板、第二裁切模板、第三裁切模板和第四裁切模板对原料膜材进行裁切得到的，从而可以提高一次性生物工艺袋与生物反应器的贴合度，解决了培养系统内部的培养液体流场形态偏离设计时确认的较为理想的流场形态的问题，进而有助于改善最终的细胞 培养效果。
附图说明
下述附图用于更清楚地说明实施例，不应理解为对本发明保护范围的限制。
图1为一次性生物工艺袋的结构示意图；
图2为一次性生物工艺袋的制作方法的流程图；
图3为第一裁切模板的结构示意图；
图4为第二裁切模板的结构示意图；
图5为第三裁切模板的结构示意图；
图6为第四裁切模板的结构示意图；
图7为热熔式环形焊接机的结构示意图。
实施例
为了更清楚地说明本发明的技术方案和优点，下面结合附图，对本发明的技术方案进行清楚、完整地描述。所描述的实施例是本发明的一部分实施方式，而不是全部的实施方式，不应理解为对本发明保护范围的限制。
需要说明的是，在不冲突的情况下，本发明实施例中的各技术特征均可以相互结合。
一次性生物工艺袋用于放置于生物反应器中，生物反应器的上顶(即上部的顶端)为圆形，上部为圆柱形，下部为倒圆台形，下底(即下部的底端)为圆形，如图1所示，图1为一次性生物工艺袋的结构示意图，一次性生物工艺袋包括圆形上顶1、柱体上部2、倒圆台下部3和圆形下底4，圆形上顶1上设置有至少两个袋口11。
如图2所示，图2为一次性生物工艺袋的制作方法的流程图，该一次性生物工艺袋的制作方法包括：
步骤S1：根据生物反应器的上顶、上部、下部和下底，分别制得第一裁切模板、第二裁切模板、第三裁切模板和第四裁切模板。
具体地，第一裁切模板与上顶的形状和尺寸相对应，如图3所示，图3为第一裁切模板的结构示意图，第一裁切模板的形状为圆形，其周长为上顶的周长，其上具有与至少两个袋口对应的开口；第二裁切模板与上部的内壁展开的形状和尺寸相对应，如图4所示，图4为第二裁切模板的结构示意图，第二裁切模板的形状为矩形，其相对设置的两个边的长度为上部的内壁的横截面的周长，相对设置的另外两个边的长度为上部的高度；第三裁切模板与下部的内壁展开的形状和尺寸相对应，如图5所示，图5为第三裁切模板的结构示意图，第三裁切模板的形状为倒梯形，其较长的底边的长度为上部的内壁的横截面的周长，较短的底边的长度为下底的周长；第四裁切模板与下底的形状和尺寸相对应，如图6所示，图6为第四裁切模板的结构示意图，第四裁切模板的形状为圆形，其周长为下底的周长。
需要说明的是，图1～图6中仅示出图形，并不表示实际大小关系。
步骤S2：根据第一裁切模板、第二裁切模板、第三裁切模板和第四裁切模板分别对原料膜材进行裁切，得到第一膜材、第二膜材、第三膜材和第四膜材，第四膜材直接作为圆形下底。
“根据第一裁切模板、第二裁切模板、第三裁切模板和第四裁切模板分别对原料膜材进行裁切，得到第一膜材、第二膜材、第三膜材和第四膜材”即，根据第一裁切模板对原料膜材进行裁切，得到第一膜材，根据第二裁切模板对原料膜材进行裁切，得到第二膜材，根据第三裁切模板对原料膜材进行裁切，得到第三膜材，根据第四裁切模板对原料膜材进行裁切，得到第四膜材。
其中，第一膜材的尺寸与第一裁切模板的尺寸之间的误差小于或者等于2mm，第二膜材的尺寸与第二裁切模板的尺寸之间的误差小于或者等于2mm，第三膜材的尺寸与第三裁切模板的尺寸之间的误差小于或者等于 2mm，第四膜材的尺寸与第四裁切模板的尺寸之间的误差小于或者等于2mm，以使一次性生物工艺袋与生物反应器的贴合度较好。
进一步地，为了保证以上小于或者等于2mm的误差，根据生物反应器的尺寸和形状对原料膜材进行裁切时，每次仅对至多两层(例如一层或者两层)原料膜材进行裁切。
示例性地，上述原料膜材为适合细胞培养的专用膜。在裁切过程中，首先将原料膜材平铺在工作台上，然后按裁切模板(第一裁切模板、第二裁切模板、第三裁切模板和第四裁切模板的统称)进行裁切，如果用自动裁切刀裁切时，要确保裁切模板或直尺不能发生位移，以尽量减少裁切过程中造成的尺寸误差。
步骤S3：在第一膜材上焊接至少两个袋口，得到圆形上顶。
其中，焊接在第一膜材表面并能够链接管路的统称为袋口。上述袋口可以为取样口、出气口、出液口、传感器接口、备用管、进气口、进液口等。可以选用热熔液袋袋口焊接机在第一膜材上焊接至少两个袋口。
发明人发现，在使用各种热熔式焊接机对膜材进行焊接的过程中，空气压力(即热熔式焊接机的气缸给上模具施加的向下的压力)、上模具的温度、下模具的温度、上模具和下模具之间的间隙、焊接时间和焊接边的宽度等工艺参数均会对焊接效果产生影响，具体为：
空气压力过小、上模具的温度过低、下模具的温度过低、上模具和下模具之间的间隙过大、焊接时间过短均会导致焊接边不能均匀充分的融合，影响焊接强度；空气压力过大、上模具的温度过高、下模具的温度过高、上模具和下模具之间的间隙过小、焊接时间过长均会破坏膜材内表面结构层，进而会导致焊接边的物理性能的下降以及氧气阻隔层的破坏；焊接边过窄会影响焊接强度，焊接边过宽会造成膜材浪费。
基于此，在第一膜材上焊接至少两个袋口时，工艺参数包括：空气压力为0.5MPa，上模具的温度为110℃±2℃，下模具的温度为80℃±2℃，上模 具和下模具之间的间隙为1.5mm，焊接时间为6s～8s，焊接边的宽度为8mm。
示例性地，在第一膜材上焊接至少两个袋口的具体方式如下：将上模具和下模具之间的间隙调节为1.5mm，使用热熔式焊接机中的上模具加热系统将上模具加热至110℃±2℃，然后通过气缸给上模具一个向下的0.5MPa压力，使上模具和下模具对第一膜材和袋口进行一个固定压力的挤压，焊接时间为6s～8s，使焊接面加热后充分融合，从而保证焊接边的密封性与热合强度符合要求。
可选地，在第一膜材上焊接至少两个袋口时，在第一膜材的非焊接面上放置一层高温布，以避免焊接过程中第一膜材的非焊接面被破坏。
步骤S4：对第二膜材进行焊接，得到柱体上部。
可以选用热熔直线焊接机对第二膜材进行焊接，得到柱体上部。
可选地，对第二膜材进行焊接时，工艺参数包括：空气压力为0.6MPa，上模具的温度为135℃±2℃，下模具的温度为90℃±2℃，上模具和下模具之间的间隙为0.6mm，焊接时间为6s～9s，焊接边的宽度为10mm，所述焊接边的厚度为0.6mm±0.1mm。
步骤S4中工艺参数的选择理由和具体焊接方式均与步骤S3中的具体内容类似，此处不再进行赘述。
步骤S5：对第三膜材进行焊接，得到倒圆台下部。
本发明实施例中可以选用热熔直线焊接机对第三膜材进行焊接，得到倒圆台下部。
可选地，对第三膜材进行焊接时，工艺参数包括：空气压力为0.6MPa，上模具的温度为135℃±2℃，下模具的温度为90℃±2℃，上模具和下模具之间的间隙为0.6mm，焊接时间为6s～9s，焊接边的宽度为10mm，所述焊接边的厚度为0.6mm±0.1mm。
步骤S5中工艺参数的选择理由和具体焊接方式均与步骤S3中的具体内 容类似，此处不再进行赘述。
步骤S6：使用热熔式环形焊接机，将圆形上顶、柱体上部、倒圆台下部和圆形下底进行焊接，得到一次性生物工艺袋，其中热熔式环形焊接机用于焊接环形的焊接边。
可选地，使用热熔式环形焊接机，将圆形上顶、柱体上部、倒圆台下部和圆形下底进行焊接时，工艺参数包括：空气压力为0.6MPa，上模具的温度为135℃±2，焊接时间为50s～55s，焊接边的宽度为10mm。在该实施方式中，下模具不进行加热。
步骤S6中工艺参数的选择理由与步骤S3中的具体内容类似，此处不再进行赘述。步骤S6中的具体焊接方式将会在下面结合热熔式环形焊接机的具体结构进行详细说明。
其中，步骤S3、步骤S4和步骤S5的先后顺序本发明实施例对此不进行限定，其先后顺序可以为步骤S3、步骤S4、步骤S5，或者，步骤S3、步骤S5、步骤S4，或者，步骤S4、步骤S3、步骤S5，或者，步骤S4、步骤S5、步骤S3，或者，步骤S5、步骤S4、步骤S3，或者，步骤S5、步骤S3、步骤S4，本领域技术人员可以根据实际需要进行选择。
一方面，由于在使用该一次性生物工艺袋的制作方法制作一次性生物工艺袋的过程中，在第一膜材上焊接至少两个袋口，得到圆形上顶，对第二膜材进行焊接，得到柱体上部，对第三膜材进行焊接，得到倒圆台下部，使用热熔式环形焊接机，将圆形上顶、柱体上部、倒圆台下部和圆形下底进行焊接，即可得到一次性生物工艺袋，从而使得一次性生物工艺袋的制作过程中焊接次数较少，焊接边较少，且焊接边重合的部位较少，可以提高一次性生物工艺袋的焊接边的物理性能，降低一次性生物工艺袋袋体破裂和袋内培养液体泄漏的风险，另一方面，由于第一膜材、第二膜材、第三膜材和第四膜材都是根据生物反应器的尺寸和形状制得的第一裁切模板、第二裁切模板、第三裁切模板和第四裁切模板对原料膜材进行裁切得到的，从而可以提高一 次性生物工艺袋与生物反应器的贴合度，解决了培养系统内部的培养液体流场形态偏离设计时确认的较为理想的流场形态的问题，进而有助于改善最终的细胞培养效果。
可选地，一次性生物工艺袋的制作方法还包括：使用热熔式环形焊接机，将圆形上顶、柱体上部、倒圆台下部和圆形下底进行焊接的过程中，分别根据圆形上顶的直径和圆形下底的直径，对热熔式环形焊接机的上模具和下模具进行更换。
可选地，一次性生物工艺袋的制作方法还包括：得到一次性生物工艺袋之后，采用压降法对一次性生物工艺袋进行气密性检测，以确定制作所得的一次性生物工艺袋的气密性是否符合需求，以避免将制作过程中的残次品等气密性不符合需求的一次性生物工艺袋应用于生物反应器中，造成培养液体的泄露。
操作方法为：将焊接完成得到的一次性生物工艺袋充分冷却，然后通过硅胶管将其多个袋口封堵，同时预留两个袋口进行保压测漏，为了能够快速有效的测试一次性生物工艺袋的完整性，需保持恒温，以避免温度波动影响一次性生物工艺袋内部的压力从而影响检测结果的准确性。保压时间结束后，若一次性生物工艺袋内部的实际压力为保压压力(即保压开始时一次性生物袋内部的压力)的80％及以上，则该一次性生物工艺袋的气密性合格，反之则该一次性生物工艺袋的气密性不合格。
可选地，在上述压降法中，保压工艺参数包括：环境温度为夏令时26℃±2℃，冬令时20℃±2度，湿度为40％-60％，保压时间为48h；一次性生物工艺袋的体积为5L时，保压压力为4kPa；一次性生物工艺袋的体积为50L时，保压压力为2kPa；一次性生物工艺袋的体积为300L时，保压压力为0.6kPa；一次性生物工艺袋的体积为1200L时，保压压力为0.3kPa。
此外，本发明还涉及一次性生物工艺袋，该一次性生物工艺袋使用以上任一种实施方式所述的一次性生物工艺袋的制作方法制作形成。具体地，如 图1所示，该一次性生物工艺袋包括圆形上顶1、柱体上部2、倒圆台下部3和圆形下底4，圆形上顶1上设置有至少两个袋口11。
由于该一次性生物工艺袋使用以上任一种实施方式所述的一次性生物工艺袋的制作方法制作形成，因此，该一次性生物工艺袋的焊接边较少，且焊接边重合的部位较少，可以提高一次性生物工艺袋的焊接边的物理性能，降低一次性生物工艺袋袋体破裂和袋内培养液体泄漏的风险，且，该一次性生物工艺袋与生物反应器的贴合度较好，解决了培养系统内部的培养液体流场形态偏离设计时确认的较为理想的流场形态的问题，进而有助于改善最终的细胞培养效果。
此外，本发明还涉及热熔式环形焊接机，具体地，如图7所示，图7为热熔式环形焊接机的结构示意图，该热熔式环形焊接机包括：底座71、支架72、上模具73、下模具74、气缸75和丝杆导轨76，下模具73可拆卸连接于底座71上，支架72固定于底座71的一端，丝杆导轨76固定于支架72上，气缸75固定于丝杆导轨76上，上模具73可拆卸连接于气缸75的活塞底部，上模具73为圆弧形片，下模具74为中空圆柱，上模具73内置加热模块，下模具74可沿其轴向方向旋转0～360°之间的任一角度。
使用上述热熔式环形焊接机焊接环形的焊接边时，用热熔式环形焊接机的上模具73内置的加热模块把上模具加热到设定温度，通过气缸75给上模具73一个向下的压力，使上模具73、下模具74对膜材进行一个固定压力的挤压，进行焊接，在焊接的过程中下模具74进行转动，以使下模具74上的膜材发生转动，使得中空圆柱的下模具74的柱体对应的膜材均有一定时间处于下模具74和上模具73之间，进而被焊接，进而使得通过该热熔式环形焊接机可以焊接环形的焊接边。
其中下模具74可以由电机带动其进行转动，其可以匀速转动，也可以每次转动一定角度，该一定角度为圆弧形片的上模具73对应的圆心角，转动之后停留一定时间，进行焊接，直至环形的焊接边焊接完成。以上匀速转动的 转速以及停留时间的选择应该满足：使焊接边的每个位置的焊接时间均满足之前步骤S6的工艺参数中对焊接时间的要求。本领域技术人员可以根据此进行合理设计。
可选地，下模具可沿其轴向方向旋转0～360°，以使得通过下模具的旋转带动需要焊接的膜材或者结构的旋转，进而使得通过尺寸较小的上模具即可对尺寸较大的膜材或者结构进行焊接，以及对形状不规则的膜材或者结构的各个位置进行分别焊接，有助于提高热熔式环形焊接机的适用范围。
可选地，为了保证环形焊接边模具与膜材受力均匀，下模具的上表面上铺设有硅胶板，使其上模具与下模具之间均匀受力，保证焊接效果的均一性。发明人发现，如果硅胶板太薄则效果不好，如果硅胶板太厚则成本过高，基于此，选择硅胶板的厚度为2mm。
可选地，如图7所示，热熔式环形焊接机包括两个气缸75，在竖直方向上，丝杆导轨76所在位置与上模具73的对称轴所在位置重叠，两个气缸75沿上模具73的对称轴对称设置，从而使得通过两个气缸75同时对上模具73施加压力，使得上模具73的各个位置的压力较为均一，焊接效果较为均一，焊接边的物理性能较好。
可选地，底座71的底部设置有多个滚轮77，以使得热熔式环形焊接机的移动方便。
本发明提供了一次性生物工艺袋及其制作方法、热熔式环形焊接机，一方面，由于在使用该一次性生物工艺袋的制作方法制作一次性生物工艺袋的过程中，在第一膜材上焊接至少两个袋口，得到圆形上顶，对第二膜材进行焊接，得到柱体上部，对第三膜材进行焊接，得到倒圆台下部，使用热熔式环形焊接机，将圆形上顶、柱体上部、倒圆台下部和圆形下底进行焊接，即可得到一次性生物工艺袋，从而使得一次性生物工艺袋的制作过程中焊接次数较少，焊接边较少，且焊接边重合的部位较少，可以提高一次性生物工艺袋的焊接边的物理性能，降低一次性生物工艺袋袋体破裂和袋内培养液体泄 漏的风险，另一方面，由于第一膜材、第二膜材、第三膜材和第四膜材都是根据生物反应器的尺寸和形状制得的第一裁切模板、第二裁切模板、第三裁切模板和第四裁切模板对原料膜材进行裁切得到的，从而可以提高一次性生物工艺袋与生物反应器的贴合度，解决了培养系统内部的培养液体流场形态偏离设计时确认的较为理想的流场形态的问题，进而有助于改善最终的细胞培养效果。
最后应说明的是：以上各实施例仅用以说明本发明的技术方案，而非对其限制；尽管参照前述各实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本发明的范围。

Claims (16)

  1. 一次性生物工艺袋的制作方法，其特征在于：
    所述一次性生物工艺袋用于放置于生物反应器中，所述生物反应器的上顶为圆形，上部为圆柱形，下部为倒圆台形，下底为圆形，所述一次性生物工艺袋包括圆形上顶、柱体上部、倒圆台下部和圆形下底，所述圆形上顶上设置有至少两个袋口；
    所述制作方法包括：
    根据所述生物反应器的所述上顶、所述上部、所述下部和所述下底，分别制得第一裁切模板、第二裁切模板、第三裁切模板和第四裁切模板；
    根据所述第一裁切模板对原料膜材进行裁切，得到第一膜材，根据所述第二裁切模板对所述原料膜材进行裁切，得到第二膜材，根据所述第三裁切模板对所述原料膜材进行裁切，得到第三膜材，根据所述第四裁切模板对所述原料膜材进行裁切，得到第四膜材，所述第四膜材直接作为所述圆形下底；
    在所述第一膜材上焊接至少两个袋口，得到所述圆形上顶；
    对所述第二膜材进行焊接，得到所述柱体上部；
    对所述第三膜材进行焊接，得到所述倒圆台下部；
    使用热熔式环形焊接机，将所述圆形上顶、所述柱体上部、所述倒圆台下部和所述圆形下底进行焊接，得到所述一次性生物工艺袋，所述热熔式环形焊接机用于焊接环形的焊接边。
  2. 根据权利要求1所述的一次性生物工艺袋的制作方法，其特征在于，所述第一膜材的尺寸与所述第一裁切模板的尺寸之间的误差小于或者等于2mm，所述第二膜材的尺寸与所述第二裁切模板的尺寸之间的误差小于或者等于2mm，所述第三膜材的尺寸与所述第三裁切模板的尺寸之间的误差小于或者等于2mm，且所述第四膜材的尺寸与所述第四裁切模板的尺寸之间的误差小于或者等于2mm。
  3. 根据权利要求2所述的一次性生物工艺袋的制作方法，其特征在于， 对所述原料膜材进行裁切时，每次仅对至多两层所述原料膜材进行裁切。
  4. 根据权利要求1所述的一次性生物工艺袋的制作方法，其特征在于，在所述第一膜材上焊接至少两个袋口时，工艺参数包括：
    空气压力为0.5MPa，上模具的温度为110℃±2℃，下模具的温度为80℃±2℃，所述上模具和所述下模具之间的间隙为1.5mm，焊接时间为6s～8s，焊接边的宽度为8mm。
  5. 根据权利要求1所述的一次性生物工艺袋的制作方法，其特征在于，在所述第一膜材上焊接至少两个袋口时，在所述第一膜材的非焊接面上放置一层高温布。
  6. 根据权利要求1所述的一次性生物工艺袋的制作方法，其特征在于，对所述第二膜材进行焊接时，工艺参数包括：
    空气压力为0.6MPa，上模具的温度为135℃±2℃，下模具的温度为90℃±2℃，所述上模具和所述下模具之间的间隙为0.6mm，焊接时间为6s～9s，焊接边的宽度为10mm，所述焊接边的厚度为0.6mm±0.1mm。
  7. 根据权利要求1所述的一次性生物工艺袋的制作方法，其特征在于，对所述第三膜材进行焊接时，工艺参数包括：
    空气压力为0.6MPa，上模具的温度为135℃±2℃，下模具的温度为90℃±2℃，所述上模具和所述下模具之间的间隙为0.6mm，焊接时间为6s～9s，焊接边的宽度为10mm，所述焊接边的厚度为0.6mm±0.1mm。
  8. 根据权利要求1所述的一次性生物工艺袋的制作方法，其特征在于，使用热熔式环形焊接机，将所述圆形上顶、所述柱体上部、所述倒圆台下部和所述圆形下底进行焊接时，工艺参数包括：
    空气压力为0.6MPa，上模具的温度为135℃±2，焊接时间为50s～55s，焊接边的宽度为10mm。
  9. 根据权利要求1所述的一次性生物工艺袋的制作方法，其特征在于，所述制作方法还包括：使用热熔式环形焊接机，将所述圆形上顶、所述柱体 上部、所述倒圆台下部和所述圆形下底进行焊接的过程中，分别根据所述圆形上顶的直径和所述圆形下底的直径，对所述热熔式环形焊接机的上模具和下模具进行更换。
  10. 根据权利要求1所述的一次性生物工艺袋的制作方法，其特征在于，所述制作方法还包括：得到所述一次性生物工艺袋之后，采用压降法对所述一次性生物工艺袋进行气密性检测。
  11. 根据权利要求10所述的一次性生物工艺袋的制作方法，其特征在于，所述压降法中，保压工艺参数包括：
    环境温度为夏令时26℃±2℃，冬令时20℃±2度，湿度为40％-60％，保压时间为48h；
    所述一次性生物工艺袋的体积为5L时，保压压力为4kPa；所述一次性生物工艺袋的体积为50L时，保压压力为2kPa；所述一次性生物工艺袋的体积为300L时，保压压力为0.6kPa；所述一次性生物工艺袋的体积为1200L时，保压压力为0.3kPa。
  12. 一次性生物工艺袋，其特征在于，使用如权利要求1～11任一项所述的一次性生物工艺袋的制作方法制作形成。
  13. 热熔式环形焊接机，其特征在于，包括：底座、支架、上模具、下模具、气缸和丝杆导轨，所述下模具可拆卸连接于所述底座上，所述支架固定于所述底座的一端，所述丝杆导轨固定于所述支架上，所述气缸固定于所述丝杆导轨上，所述上模具可拆卸连接于所述气缸的活塞底部，所述上模具为圆弧形片，所述下模具为中空圆柱，所述上模具内置加热模块，所述下模具可沿其轴向方向旋转0～360°之间的任一角度。
  14. 根据权利要求13所述的热熔式环形焊接机，其特征在于，所述下模具的上表面上铺设有硅胶板。
  15. 根据权利要求14所述的热熔式环形焊接机，其特征在于，所述硅胶板的厚度为2mm。
  16. 根据权利要求13所述的热熔式环形焊接机，其特征在于，所述热熔式环形焊接机包括两个所述气缸，在竖直方向上，所述丝杆导轨所在位置与所述上模具的对称轴所在位置重叠，两个所述气缸沿所述上模具的对称轴对称设置。
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