WO2015146338A1 - Préforme cylindrique pour produire des récipients de liquide à usage médical et procédé de production de récipients de liquide à usage médical à l'aide de celle-ci - Google Patents

Préforme cylindrique pour produire des récipients de liquide à usage médical et procédé de production de récipients de liquide à usage médical à l'aide de celle-ci Download PDF

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Publication number
WO2015146338A1
WO2015146338A1 PCT/JP2015/053855 JP2015053855W WO2015146338A1 WO 2015146338 A1 WO2015146338 A1 WO 2015146338A1 JP 2015053855 W JP2015053855 W JP 2015053855W WO 2015146338 A1 WO2015146338 A1 WO 2015146338A1
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WO
WIPO (PCT)
Prior art keywords
preform
cylindrical
thickness
liquid container
medical liquid
Prior art date
Application number
PCT/JP2015/053855
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English (en)
Japanese (ja)
Inventor
美恵 駒形
慎悟 石井
Original Assignee
テルモ株式会社
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Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2016510107A priority Critical patent/JP6442481B2/ja
Publication of WO2015146338A1 publication Critical patent/WO2015146338A1/fr

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    • 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
    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/08—Biaxial stretching during blow-moulding
    • B29C49/10—Biaxial stretching during blow-moulding using mechanical means for prestretching
    • B29C49/14—Clamps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
    • B29B11/00—Making preforms
    • B29B11/14—Making preforms characterised by structure or composition
    • 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
    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/071—Preforms or parisons characterised by their configuration, e.g. geometry, dimensions or physical properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • B29C2949/00—Indexing scheme relating to blow-moulding
    • B29C2949/07—Preforms or parisons characterised by their configuration
    • B29C2949/0715—Preforms or parisons characterised by their configuration the preform having one end closed
    • 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
    • B29C2949/00—Indexing scheme relating to blow-moulding
    • B29C2949/07—Preforms or parisons characterised by their configuration
    • B29C2949/072—Preforms or parisons characterised by their configuration having variable wall thickness
    • B29C2949/0723—Preforms or parisons characterised by their configuration having variable wall thickness at flange portion
    • 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
    • B29C2949/00—Indexing scheme relating to blow-moulding
    • B29C2949/07—Preforms or parisons characterised by their configuration
    • B29C2949/076—Preforms or parisons characterised by their configuration characterised by the shape
    • B29C2949/0768—Preforms or parisons characterised by their configuration characterised by the shape characterised by the shape of specific parts of preform
    • B29C2949/0778—Preforms or parisons characterised by their configuration characterised by the shape characterised by the shape of specific parts of preform characterised by the flange
    • 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
    • B29C2949/00—Indexing scheme relating to blow-moulding
    • B29C2949/07—Preforms or parisons characterised by their configuration
    • B29C2949/076—Preforms or parisons characterised by their configuration characterised by the shape
    • B29C2949/0768—Preforms or parisons characterised by their configuration characterised by the shape characterised by the shape of specific parts of preform
    • B29C2949/078—Preforms or parisons characterised by their configuration characterised by the shape characterised by the shape of specific parts of preform characterised by the bottom
    • 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
    • B29C2949/00—Indexing scheme relating to blow-moulding
    • B29C2949/07—Preforms or parisons characterised by their configuration
    • B29C2949/076—Preforms or parisons characterised by their configuration characterised by the shape
    • B29C2949/0768—Preforms or parisons characterised by their configuration characterised by the shape characterised by the shape of specific parts of preform
    • B29C2949/078—Preforms or parisons characterised by their configuration characterised by the shape characterised by the shape of specific parts of preform characterised by the bottom
    • B29C2949/0781—Preforms or parisons characterised by their configuration characterised by the shape characterised by the shape of specific parts of preform characterised by the bottom characterised by the sprue, i.e. injection mark
    • 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
    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
    • B29C49/06—Injection blow-moulding

Definitions

  • the present invention relates to a cylindrical preform for producing a medical liquid container. Specifically, the present invention relates to a cylindrical preform used for producing a medical liquid container by injection stretch blow molding and a method for producing a medical liquid container using the same.
  • Injection stretch blow molding is a molding method in which a test tubular preform is formed by injection molding, and the preform is stretch blow molded at a temperature equal to or higher than the glass transition point (Tg) of the molding resin. Depending on the difference in the thermal history of the injection-molded preform, the preform is roughly classified into a hot parison method and a cold parison method.
  • the hot parison method is a method in which the preform is not cooled completely and is transferred to a temperature control process, and then stretch blow molding is performed. Preform injection molding and stretch blow molding are continuously performed on the same molding machine. Is called.
  • the cold parison method is a method in which after forming a preform, it is once cooled to room temperature and reheated with a stretch blow molding machine to perform stretch blow molding. Generally, the cold parison method is more productive than the hot parison method because a preform can be molded and stored in advance.
  • Patent Document 2 JP 2011-815 (Patent Document 2) as a prior art related to the preform.
  • drum of a preform is formed in a mortar shape.
  • the bottom is thinner than the barrel and flat at the center of the bottom, and the bottom of the bottle bottom is formed by bending the bottom of the barrel from the height position of the bottom edge of the bottle to the periphery of the center of the bottom, and It consists of an upper bottle bottom edge forming part in contact with the body of the bottle bottom surface forming part, and a curved part at the boundary between the lower part of the bottle bottom surface forming part and the bottom center part.
  • the thickness of the bottle bottom surface forming part is formed to be thicker than the thickness of the body part by building up the inner surface up to the bent part excluding the bottle bottom edge forming part.
  • the thickness of the bottle bottom edge forming portion is formed to be thinner than the thickness of the bottle bottom surface forming portion.
  • the object of the first invention of the present application is medical treatment in which even when a container is formed by performing biaxial stretch blow molding, the thickness of the upper part of the container is small, and the formation of a dead volume during drainage is small.
  • the present invention provides a cylindrical preform for producing a liquid container and a method for producing a medical liquid container using the same.
  • the object of the second invention of the present application is to maintain the upright form of the preform even when the preform is heated to a temperature close to the endothermic peak temperature of the resin, and to produce a medical liquid container by stretch blow molding.
  • the present invention provides a cylindrical preform for producing a medical liquid container and a method for producing a medical liquid container using the same.
  • the first invention of the present application is as follows. It is a medical liquid container for filling a medicine inside, and has a cylindrical discharge part having an opening at a lower end, a lower part continuing upward from the discharge part, and a trunk part continuing upward from the lower part And an upper part continuous upward from the body part, wherein the lower part, the body part and the upper part have a flat shape having a major axis and a minor axis in a horizontal section, and further, the medical liquid container A biaxially stretched blow of a medical liquid container having an inwardly deformable portion in which at least a part of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the lower portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the upper portion of the
  • the invention relating to the first manufacturing method of the present application is as follows.
  • a stretched product molding which performs an arranging step, an axial stretching for stretching the preform in the axial direction of the preform, and an extended stretching for sending air into the preform to create a stretched product and press the preform against the inner surface of the mold
  • the manufacturing method of the medical liquid container which performs a process.
  • the second invention of the present application is as follows.
  • a cylindrical main body part that forms between the upper end part and the lower end part, a lumen that extends from the lower end to the upper end with substantially the same inner diameter, and a vicinity of the lower end of the grasping protruding part of the closed upper end part.
  • a biaxially stretched portion formed between lower ends, and the biaxially stretched portion includes an inner diameter X at a lower portion of the biaxially stretched portion, and a lumen length Y in the biaxially stretched portion.
  • Ratio (X: Y) of 1: 3.5 to 5 6 is a cylindrical preform.
  • the invention relating to the second manufacturing method of the present application is as follows.
  • a stretched product is produced by an arranging step, pulling-up stretching that picks up and pulls the gripping protrusion of the cylindrical preform, and extended stretching that sends air into the preform, and presses against the inner surface of the mold.
  • the manufacturing method of the medical liquid container which performs a stretched material formation process.
  • FIG. 1 is a front view of an embodiment of a cylindrical preform for producing a medical liquid container according to the present invention.
  • FIG. 2 is a plan view of the cylindrical preform shown in FIG.
  • FIG. 3 is a bottom view of the cylindrical preform shown in FIG. 4 is a cross-sectional view taken along line AA in FIG.
  • FIG. 5 is a perspective view of the cylindrical preform shown in FIG. 6 is a front view of an embodiment of a medical liquid container manufactured using the cylindrical preform shown in FIG. 7 is a right side view of the medical liquid container shown in FIG.
  • FIG. 8 is an explanatory view for explaining the method for producing the medical liquid container of the present invention.
  • FIG. 9 is an explanatory view for explaining the method for producing the medical liquid container of the present invention.
  • FIG. 1 is a front view of an embodiment of a cylindrical preform for producing a medical liquid container according to the present invention.
  • FIG. 2 is a plan view of the cylindrical preform shown in FIG.
  • FIG. 3 is
  • FIG. 10 is an explanatory diagram for explaining the method for producing the medical liquid container of the present invention.
  • FIG. 11 is an explanatory view for explaining the method for producing the medical liquid container of the present invention.
  • FIG. 12 is an explanatory diagram for explaining an example of a molding die for molding the cylindrical preform of the present invention.
  • a cylindrical preform for producing a medical liquid container according to the present invention will be described with reference to an embodiment shown in the drawings.
  • a cylindrical preform 1 for forming a medical liquid container according to the first invention of the present application is a medical liquid container 10 for filling a medicine therein, and has a cylindrical shape having an opening 41 at the lower end.
  • the upper portion 13 has a flat shape having a major axis and a minor axis in a horizontal cross section, and further, at least a part of the upper portion 13 of the medical liquid container 10 has a minor axis as the medicine filled therein is discharged.
  • the medical liquid container having an inwardly deformable portion that can be deformed inwardly is formed by biaxial stretch blow molding.
  • the cylindrical preform 1 of this invention is formed by injection-molding a thermoplastic resin.
  • the closed upper end portion 3 includes a wall thickness changing portion 31 that gradually decreases in thickness upward to form an inwardly deformable portion of the medical liquid container 10. .
  • the thickness a at the upper end of the thickness changing portion 31 is 1.3 to 1.6 mm
  • the thickness b at the lower end of the thickness changing portion is 2.5 to 2.5 of the thickness a. It has become 4 times.
  • the upper wall portion of the container 10 is formed from at least a part of the thickness changing portion 31 of the preform.
  • the difference between the wall thickness and the wall thickness of the body 12 is reduced. Therefore, an inwardly deformable portion that can be deformed in the inner direction of the short axis with the discharge of the medicine filled inside can be reliably formed in the upper portion 13 of the container 10, and the container The dead volume in the upper part of 10 is also small.
  • the cylindrical preform for forming the medical liquid container of the second invention of the present application is made of a thermoplastic resin, and is heated for biaxial stretch blow molding after being heated to near the endothermic peak temperature of the thermoplastic resin. This is for forming the liquid container 10.
  • the cylindrical preform 1 of this invention is the lower end part which forms the obstruction
  • the biaxially stretched portion 20 is formed between the lower ends of the cylindrical main body portion, and the biaxially stretched portion 20 includes an inner diameter X below the biaxially stretched portion 20 and a biaxially stretched portion.
  • the ratio (X: Y) with the lumen length Y is 1: 3.5 to 5.6. In this tubular preform 1, the ratio (X: Y) between the inner diameter X and the lumen length Y in the biaxially stretched portion 20 is short because of the above.
  • the tubular preform 1 of the embodiment shown in FIGS. 1 to 4 will be described.
  • the cylindrical preform 1 of this embodiment forms a closed upper end portion 3 having a gripping protruding portion 5 protruding upward, a lower end portion 4 forming a discharge portion 4a, and between the closed upper end portion 3 and the lower end portion 4.
  • the cylindrical main-body part 2 to be provided is provided. Therefore, the cylindrical preform 1 of this embodiment is stretched in the axial direction of the preform by picking and pulling up the gripping protruding portion 5 protruding upward from the upper end of the thickness changing portion at the time of biaxial stretching blow. Is easy.
  • the closed upper end portion 3 has an outer surface and an inner surface formed in a hemispherical shape, and a gripping protruding portion 5 extending outward is formed at the center of the outer surface.
  • the gripping protrusion 5 is a columnar body and has a tapered shape that is slightly reduced in diameter toward the tip.
  • the outer diameter of the gripping protrusion 5 is preferably 3 to 8 mm, and particularly preferably 3.5 to 6 mm.
  • the length (height) of the gripping protrusion 5 is preferably 5 to 20 mm, and particularly preferably 6 to 10 mm. Accordingly, the gripping protrusion 5 can be reliably picked when the gripping protrusion 5 is picked up and pulled up.
  • the gate position mark 51 is provided on the upper surface of the holding projection 5.
  • the length (height) of the closed upper end 3 excluding the gripping protrusion 5 is preferably 8 to 15 mm.
  • the lower end part 4 is a part for forming the discharge part 4a of the medical container 10 manufactured using this preform. And in the preform 1 of this Example, the form of the lower end part 4 transfers to the medical container 10 manufactured substantially as it is, and it is formed so that it may become the discharge part 4a.
  • the lower end portion 4 is a cylindrical portion having an opening 41 at the lower end and extending at substantially the same inner diameter, and further above the flange 43 for connecting the port member attached to the discharge portion 4 and the flange 43.
  • a reinforcing flange 42 formed and a port member mounting portion 44 extending downward from the flange 43 are provided.
  • the flange 42 is also a manufacturing flange used during manufacturing.
  • the cylindrical main body 2 is a cylindrical part that is located between the closed upper end 3 and the lower end 4 and connects them.
  • the cylindrical main body 2 has a predetermined thickness portion (in other words, a uniform thickness portion) 21 that extends for a predetermined length toward the lower end with the same thickness as the thickness at the lower end of the closed upper end 3.
  • the cylindrical main body 2 is provided with a tapered portion 22 at the lower portion where the outer diameter is reduced toward the lower end portion 4 and becomes thinner.
  • the thick portion 21 is the same diameter portion extending at substantially the same outer diameter, and is positioned between the lower end and the lower end portion 4 of the thick portion (same diameter portion) 21.
  • a tapered portion 22 that decreases in diameter toward the lower end portion 4.
  • the length (height) of the thick part (same diameter part) 21 is preferably 40 to 70 mm, and particularly preferably 45 to 60 mm.
  • the outer diameter of the thick portion 21 is preferably 20 to 40 mm, and the thickness of the thick portion 21 is preferably 3.25 to 5.2 mm, particularly 3.5 to 4.5 mm. Is preferred.
  • the length (height) of the tapered portion 22 is preferably 10 to 20 mm, and the outer diameter of the minimum diameter portion (upper end of the lower end portion) of the tapered portion 22 is preferably 13 to 30 mm. It is preferably 18 to 25 mm.
  • the thickness of the minimum diameter portion (the upper end of the lower end portion) of the tapered portion 22 is preferably 1 to 3 mm.
  • the lower end part 4 of the cylindrical preform 1 is formed thinner than the thick part 21 of the cylindrical main body part 2. Specifically, as described above, except for the flange portion of the lower end portion 4, the thickness is the same as the minimum thickness portion of the tapered portion 22. Further, the outer surface of the closed upper end 3 of the cylindrical preform 1 is a substantially hemispherical outer surface having a gripping protrusion 5 at the center of the outer surface.
  • the closed upper end portion 3 is provided with a thickness changing portion 31 that becomes thinner toward the gripping projection portion 5.
  • the thickness a of the minimum thickness portion (the minimum thickness portion at the peripheral edge of the protruding portion 5 of the closed upper end portion 3) in the thickness changing portion 31 of the closed upper end portion 3 is 1.3 to 1.6 mm. preferable.
  • the wall thickness a is smaller than 1.3 mm, distortion tends to occur in the vicinity of the minimum wall thickness portion of the wall thickness changing portion 31 of the injection-molded cylindrical preform 1, resulting in defective molding such as breakage during biaxial stretching blow. There is a fear.
  • the wall thickness a is larger than 1.6 mm, the upper side wall portion of the medical liquid container 10 manufactured using this preform becomes thick and the upper portion of the container 10 is difficult to be crushed. Becomes larger.
  • the thickness b of the maximum thickness portion (the maximum thickness portion of the closed upper end portion 3) of the thickness changing portion 31 of the closed upper end portion 3 is 2.5 to 4 times the thickness a of the minimum thickness portion.
  • the wall thickness b is smaller than 2.5 times the wall thickness a, the upper wall thickness of the medical liquid container 10 manufactured using this preform becomes thick, and the dead volume becomes large.
  • the thickness of the body of the container 10 is reduced, and the water vapor permeability of the container 10 is increased and the drop strength is decreased.
  • the wall thickness b is larger than 4 times the wall thickness a, distortion tends to occur near the minimum wall thickness portion of the wall thickness changing portion 31 of the injection-molded tubular preform 1 and breakage occurs during biaxial stretching blow. This may cause molding defects.
  • the thickness b of the maximum thickness portion is preferably 3.25 to 5.2 mm, and particularly preferably 3.5 to 4.5 mm. Thereby, it can prevent that the thickness of the both ends of the major axis direction of the flat cylindrical trunk
  • the outer diameter of the portion adjacent to the minimum thickness portion of the gripping protrusion 5 is preferably 3 to 8 mm, and particularly preferably 3.5 to 6 mm. Thereby, it becomes difficult to produce distortion in the thickness minimum part vicinity of the thickness change part 31 of the cylindrical preform 1 by which injection molding was carried out.
  • the outer surface of the closed upper end 3 is a substantially hemispherical outer surface having a gripping protrusion at the center of the outer surface.
  • the inner surface of the upper end portion 2 is also a substantially hemispherical inner surface.
  • the center P of the substantially hemispheric inner surface is located on the upper end side of the upper end portion from the center Q of the approximately hemispheric outer surface. For this reason, the thickness changing portion 31 gradually becomes thinner from the lower side (position of the thickness b) toward the upper side (position of the thickness a).
  • the cylindrical preform 1 of this embodiment includes a lumen 7 that extends with substantially the same inner diameter from the lower end to the upper end.
  • the tip of the lumen 7 is a hemispherical end.
  • the lumen 7 has a tapered shape that is slightly reduced in diameter toward the tip.
  • the preform 1 has a biaxially stretched portion 20 formed between the lower end of the cylindrical main body portion from the vicinity of the lower end of the gripping protruding portion 5 of the closed upper end portion 3. In other words, in the preform 1, the portion where the lumen 7 is located except for the lower end portion 4 constitutes the biaxially stretched portion 20.
  • the biaxially stretched portion 20 has a ratio (X: Y) of the inner diameter X of the lower portion of the biaxially stretched portion 20 to the lumen length Y in the biaxially stretched portion. It is 3.5 to 5.6.
  • the ratio (X: Y) of the inner diameter X of the lower portion of the biaxially stretched portion to the lumen length Y in the biaxially stretched portion is 1: 3.7-4. 5 is preferable.
  • the cylindrical preform 1 described above can be manufactured by using, for example, an injection molding apparatus 90 as shown in FIG.
  • the injection molding apparatus 90 includes two split molds 91 and 92, a core pin 93 inserted between the mold 91 and the mold 92, and a gate 94.
  • An injection molding space corresponding to the preform shape shown in FIGS. 1 to 5 is formed between the inner surfaces of the mold 91 and the mold 92 and the outer surface of the core pin 93.
  • the injection molding space has, from the upper side, a gripping protrusion forming part 96, an upper end forming part (closed upper end forming part) 97, a cylindrical main body forming part 95, and a lower end forming part 98.
  • the gate 94 is configured such that the gate opens at the tip of the gripping protrusion forming portion 96 in the injection molding space.
  • the core pin 93 used in the injection molding apparatus 90 has a biaxially stretched portion inner surface forming portion 93a that forms the inner surface of the biaxially stretched portion 20 of the cylindrical preform 1 and is
  • the ratio (D: H) of the outer diameter D of the lower portion of the axially extending portion inner surface forming portion 93a to the length (height) H of the biaxially extending portion inner surface forming portion 93a is 1: 3.5-5. 6
  • D: Y is preferably 1: 3.7 to 4.5.
  • the length of a core pin can be made short, and what the molded product thickness with respect to design thickness has few errors can be manufactured reliably. Furthermore, by doing in this way, when the cylindrical preform 1 is injection-molded, the core pin 93 is not easily tilted by the resin pressure, so that uneven thickness, that is, distortion hardly occurs in the cylindrical preform 1.
  • a thermoplastic synthetic resin is used as a material for forming the cylindrical preform 1.
  • the resin material is not particularly limited, but a polyolefin resin is preferable from the viewpoint of moldability.
  • the polyolefin resin include polyethylene resins such as low density polyethylene (LDPE), medium density polyethylene (MDPE), high density polyethylene (HDPE), and linear low density polyethylene (LLDPE); propylene homopolymer (homo PP) , Propylene-ethylene random copolymer (random copolymer PP), propylene-ethylene block copolymer (block copolymer PP), or propylene and 1-butene, 1-pentene, 1-hexene, 1-octene, 1-heptene Random copolymer, block copolymer with at least one ⁇ -olefin selected from the group consisting of 4-methyl-butene-1, 4-methyl-pentene-1, and 4-methyl-hexene-1 Or polypropylene resins such as graft copoly
  • the polyolefin resin may be a synthetic product or a commercially available product.
  • a polymerization method for synthesizing these polyolefin resins is not particularly limited, and a known method can be used.
  • a high-pressure radical polymerization method for example, a high-pressure radical polymerization method, a medium-low pressure polymerization method, a solution polymerization method, a slurry polymerization method, a bulk polymerization method, Examples thereof include a phase polymerization method.
  • the catalyst used for the polymerization is not particularly limited, and examples thereof include peroxide catalysts, Ziegler-Natta catalysts, metallocene catalysts and the like.
  • Examples of commercially available polyolefin resins include Novatec (registered trademark) PP, Wintec (registered trademark), Wellnex (registered trademark) (manufactured by Nippon Polypro Co., Ltd.), Zelas (registered trademark) (Mitsubishi Chemical Corporation) Company-made).
  • a resin material in which the polyolefin resin and the rubber component as described above are mixed can be suitably used.
  • the rubber component include olefin elastomers such as ethylene-propylene rubber (EPM) and ethylene-propylene-diene rubber (EPDM), styrene butadiene rubber (SBR), styrene-butadiene block copolymer (SB), and styrene.
  • SBS styrene-ethylene-butylene-styrene block copolymer
  • SEBS styrene-ethylene-butylene-styrene block copolymer
  • SI styrene-isoprene block copolymer
  • SIS Styrene elastomers such as styrene-ethylene-propylene-styrene block copolymer (SEPS), acrylonitrile-butadiene-styrene copolymer (ABS), hydrogenated styrene butadiene rubber (HSBR), natural rubber, Purengomu, butyl rubber, nitrile rubber, acrylic rubber, silicone rubber, polyester elastomer, polyurethane elastomer, polybutadiene elastomer, polyvinyl chloride-based elastomer, polyamide-based elastomers, and the like
  • the content of the rubber component in the blend is preferably 5 to 70% by mass, more preferably 10 to 60% by mass, based on 100% by mass of the entire blend.
  • a synthetic product or a commercially available product may be used. It does not restrict
  • Known blending methods include a method of blending a polyolefin resin, a rubber component, and other components such as additives as necessary.
  • Examples of the blending method include a blending method using various mixers such as a Henschel mixer, a tumbler mixer, a single screw extruder, a twin screw extruder, a Banbury mixer, a kneader, and a hot roll.
  • the polymerization type polyolefin-type thermoplastic elastomer manufactured by making ethylene and propylene react directly as a blend can also be used suitably.
  • Examples of commercially available products of the blend include, for example, soft polyolefin manufactured by Nippon Polypro Co., Ltd., and Zeras (registered trademark, manufactured by Mitsubishi Chemical Corporation) which is a polymerization type polyolefin-based thermoplastic elastomer.
  • the resin material used preferably has a flexural modulus of 200 to 1600 MPa, particularly preferably 220 to 1100 MPa, and more preferably 240 from the viewpoint of needle penetration resistance at the container outlet. ⁇ 700 MPa. If it is such, the chemical
  • the flexural modulus is measured by the method described in JIS K7171 “Plastics—How to obtain bending properties” (2008).
  • the forming resin material of the cylindrical preform 1 has a peak temperature (Tm) of an endothermic peak on the highest temperature side observed by DSC measurement in a temperature range of 120 to 180 ° C. If the peak temperature of the endothermic peak on the high temperature side is 120 ° C. or higher, the container will not melt or deform in the autoclave sterilization. Moreover, if peak temperature is 180 degrees C or less, there will not be many hard components in material, and it will have sufficient softness
  • the peak temperature is preferably 125 to 170 ° C, more preferably 130 to 165 ° C.
  • the peak temperature was about 10 mg of the resin material was heated from room temperature (23 ° C.) to 230 ° C. at a rate of 10 ° C./min, then cooled to 40 ° C. at a rate of ⁇ 10 ° C./min, and again 230 It represents the endothermic peak temperature in DSC characteristics obtained when the temperature is raised to 10 ° C. at a rate of 10 ° C./min.
  • the “highest temperature endothermic peak” indicates the endothermic peak on the highest temperature side when there are a plurality of endothermic peaks, and indicates one endothermic peak when there is one endothermic peak.
  • the forming resin material of the cylindrical preform 1 preferably has an MFR measured in the range of 0.3 to 10 g / 10 min at 230 ° C. and a load of 21.2 N (about 2.16 kgf). . If the MFR of the resin material is 0.3 g / 10 min or more, molding by injection or stretch blow does not become difficult. In addition, if it is 10 g / 10 min or less, a certain degree of melt tension is maintained when the preform is heated, so that local elongation does not occur during injection stretch blow molding, and deformation and collapse of PF do not occur. .
  • the MFR is preferably 0.5 to 8 g / 10 minutes, more preferably 1 to 6 g / 10 minutes. In this specification, the MFR is measured by the method described in JIS K7210 “Thermal Plastic Flow Test Method” (1999).
  • the medical liquid container 10 as shown in FIG. 6 and FIG. 7 is created by using the cylindrical preform mentioned above.
  • the medical liquid container 10 of this embodiment has a cylindrical discharge part 4a having an opening at the lower end, a flat cylindrical lower part 14 that is continuous with the discharge part 4a and extends upward, and a flat cylindrical lower part 14 that is continuous with the upper part.
  • a flat cylindrical body 12 that extends upward, and a flat cylindrical upper part 13 that is continuous with the flat cylindrical body 12 and extends upward.
  • the flat cylindrical lower portion 14, the flat cylindrical body portion 12, and the flat cylindrical upper portion 13 have a flat shape having a major axis and a minor axis in a horizontal section, and the biaxially stretched portion 20 of the preform 1 described above. Is formed by extending in the axial direction (longitudinal direction) and the width direction (lateral direction) to form a thin portion.
  • the discharge part 4a is a cylindrical part having substantially the same inner diameter. Cylindrical discharge part 4a is a non-extension part, and maintains the formation form of a cylindrical preform.
  • the discharge portion 4 a includes a lower end opening 41, a port member joining flange 43, a reinforcing flange 42 formed above the flange 43, and a port member mounting portion 44 extending downward from the flange 43.
  • the container 10 has the obstruct
  • the flat cylindrical lower portion 14 of the container 10 has a substantially cylindrical shape at the lower end (upper end of the discharge portion). It is formed to gradually widen. For this reason, the flat cylindrical lower portion 14 changes in a direction in which the major axis length increases suddenly upward, and the minor axis length also changes in a direction in which the minor axis length gradually increases. However, since the change amount of the major axis length is considerably larger than the change amount of the minor axis length, the flat cylindrical lower portion 14 is flattened rapidly from the lower end toward the upper end.
  • the container 10 further includes a flat cylindrical body 12 that is continuous with the upper end of the flat cylindrical lower part 14 and extends upward, and is further continuous with the upper end of the flat cylindrical body 12 and extends upward.
  • the upper part 13 is provided. As shown in FIG. 6, the flat cylindrical upper portion 13 is formed such that the width decreases toward the upper side (upper surface portion 15) and the thickness gradually decreases. For this reason, the flat cylindrical upper portion 13 changes in a decreasing direction in both the major axis length and the minor axis length upward.
  • the method for producing a medical liquid container according to the present invention includes a step of preparing the above-described tubular preform 1, a preform heating step of heating the tubular preform 1 to near the endothermic peak temperature of the thermoplastic resin, and heating.
  • a stretched product is produced by a preform arranging step in which the cylindrical preform is placed in the mold, a pulling up and pulling up the gripping protrusion of the tubular preform, and an extended drawing in which air is fed into the preform. And a stretched product forming step of pressing against the inner surface of the mold.
  • a step of preparing the cylindrical preform 1 is performed.
  • molding apparatus preparation process which prepares the shaping
  • a molding apparatus 80 illustrated in FIGS. 9 to 11 includes two molds 81 and 82, and the entire flat surface side of the medical liquid container 10 is formed on the inner surfaces of the molds 81 and 82, respectively.
  • the concave portions 81a and 82a are provided.
  • the molding apparatus 80 includes a preform standing placement unit 84, an air injection unit 85 for press-fitting air into the preform placed on the standing placement unit 84 in a standing state, and a projection of the preform 8.
  • a preform pulling portion 83 for holding the portion 83 and pulling it upward is provided.
  • the molds 81 and 82 used include a discharge portion forming portion for forming the discharge portion, a cylindrical upper forming portion for forming a cylindrical upper portion having two shoulder side portions, and two trunk side portions.
  • a barrel molding portion that molds the cylindrical barrel portion, a cylindrical lower molding portion that molds a cylindrical lower portion continuous with the upper end of the discharge portion, and a mold center axis that coincides with the vertical axis of the container I have.
  • a preform heating process is performed in which the cylindrical preform 1 is heated near the endothermic peak temperature of the thermoplastic resin.
  • the tubular preform 1 uneven thickness of the tubular preform 1 due to the inclination of the core pin 93 during injection molding is suppressed. For this reason, as shown in FIG. 8, the tubular preform 1 shrinks while maintaining an upright form, and becomes a heated preform 1a.
  • the entire preform 1 is not heated, but at least the cylindrical main body 2 and the closed upper end that are portions excluding the discharge portion 4 and the gripping protrusion 5. 3 is heated.
  • occlusion upper end part 3 become the cylindrical main-body part 2a and the obstruction
  • the method for heating the preform is not particularly limited, and for example, the preform is heated using a heating device such as an infrared heater, a heating plate, a high-temperature oven, or dielectric heating.
  • a heating device such as an infrared heater, a heating plate, a high-temperature oven, or dielectric heating.
  • the lower limit is a temperature at which 35% by mass of the resin material melts with respect to the total mass of the resin material forming the preform 1
  • the upper limit is a temperature 5 ° C. lower than the peak temperature of the endothermic peak on the highest temperature side. It is preferable that
  • positioning process which arrange
  • a stretched product forming step is performed in which a stretched product is produced by pulling up and pulling up the gripping protrusions of the cylindrical preform and by extending stretching in which air is sent into the preform, and pressed against the inner surface of the mold.
  • axial stretching and lateral stretching in a direction perpendicular to the axis are performed. Specifically, as shown in FIG. 10, first, while feeding air into the heating preform 1a, the preform pulling portion 83 holding the protrusion 5 is moved upward, and the heating cylindrical preform 1a is moved. Is stretched in the axial direction (longitudinal direction).
  • the preform 1a becomes the preform axially stretched product 1b stretched to the same length as the entire length of the medical liquid container 10.
  • the heating main body 2a is stretched to become a stretched main body 2b.
  • the axial stretching for stretching the heated cylindrical preform 1a in the direction of the central axis of the mold and the expansion stretching for sending air into the heated cylindrical preform 1a are started almost simultaneously, the heated tubular preform 1a The film is stretched in the axial direction while being stretched to some extent in the transverse direction.
  • stretching main-body part 2b becomes a cylindrical shape extended
  • the molds 81 and 82 are brought into contact with each other while the air is continuously fed into the preform shaft stretched product 1b so that the preform shaft stretched product 1b is accommodated therein. .
  • the outer surface of the central portion of the stretched main body 2b slightly stretched in the lateral direction comes into contact with the inner surfaces of the molds 81 and 82 and is crushed into a flat shape.
  • air is sent from the air injection part 85 into the preform shaft extension product 1b at a higher pressure so that the entire outer surface of the preform shaft extension product 1b is brought into close contact with the inner surfaces (recesses) 81a and 82a of the molds 81 and 82.
  • the stretched body portion 2b of the preform axially stretched product 1b is completely transversely stretched in the direction perpendicular to the axis to form the expanded stretched body portion 2c, and the medical liquid container 1c (10) is manufactured in the mold. Is done.
  • axial stretching for stretching the heated cylindrical preform 1a in the direction of the central axis of the mold and expansion stretching for feeding air into the heated tubular preform 1b are started almost simultaneously, and axial stretching is performed.
  • the medical liquid container 1c (10) is manufactured by continuing the extension and extension after the completion. Then, the medical liquid container 10 can be obtained by separating the molds 81 and 82 and detaching the preform lifting portion 83 and the upright placement portion 84 from the molded product.
  • the draw ratio in the axial direction is preferably 1 to 7 times, more preferably 2 to 5 times.
  • the stretching ratio in the transverse direction (circumferential direction) is preferably 2 to 10 times, more preferably 3 to 6 times.
  • the draw ratio is controlled by the upward moving distance of the preform pulling portion 83, the blowing pressure of a fluid such as air into the preform shaft stretched product 1b, and the like.
  • the pressure of the fluid at the initial stage of stretch blow molding is preferably in the range of 0.01 to 0.3 MPa.
  • the draw ratio of the heated preform 1a in the stretched product forming step is preferably increased from the lower side of the preform toward the center side.
  • the stretching ratio in the lateral direction (circumferential direction) of the preform increases from the upper side and the lower side of the preform toward the center side.
  • the draw ratio of the preform in the stretched product forming step increases from the upper side and the lower side of the preform toward the center side.
  • the stretching ratio in the lateral direction (circumferential direction) of the preform increases from the upper side and the lower side of the preform toward the center side.
  • the draw ratio in the axial direction and the lateral direction (circumferential direction) of the preform is preferably higher from the upper side and the lower side of the preform toward the center side.
  • the cylindrical preform 1 may be heated to such an extent that it can be biaxially stretched, and the cylindrical preform 1 may be heated at a temperature lower than the vicinity of the endothermic peak temperature of the thermoplastic resin. .
  • a stretching rod is inserted from the lower end opening of the discharge portion forming portion 42 of the heated tubular preform 1a, and the upper end closing portion is pushed upward.
  • a stretching method may be used.
  • axial stretching may be performed in which the heated cylindrical preform 1a is stretched in the direction of the center axis of the mold while the molds 81 and 82 are in contact with each other in advance.
  • the medical liquid storage container of the first invention of the present application is as follows. (1) It is a medical liquid container for filling medicine inside, and has a cylindrical discharge part having an opening at a lower end, a lower part continuous upward from the discharge part, and a continuous upper part from the lower part And a lower part, the upper part and the upper part have a flat shape having a major axis and a minor axis in a horizontal section, and the medical At least a part of the upper part of the liquid container for medical use is provided with two medical liquid containers provided with an inwardly deformable portion that enables deformation in the inner direction of the short axis as the medicine filled therein is discharged.
  • a tubular preform for producing by axial stretch blow molding wherein the tubular preform is formed by injection molding of a thermoplastic resin, and a closed upper end portion and a lower end portion forming the discharge portion And the upper end and the lower end A cylindrical main body part connecting the parts, and the upper end part has a thickness changing part whose thickness gradually decreases upward to form the inwardly deformable part of the medical liquid container.
  • the thickness change portion has a thickness a at the minimum thickness portion of the thickness change portion of 1.3 to 1.6 mm, and a thickness b at the maximum thickness portion of the thickness change portion.
  • a cylindrical preform for producing a medical liquid container having a thickness of 2.5 to 4 times the wall thickness a.
  • the tubular preform for producing a medical liquid container according to (1) wherein the thickness b of the thickness changing portion is 3.25 to 5.4 mm.
  • the cylindrical preform has a gripping protrusion that protrudes upward from the upper end of the thickness changing portion, and the cylindrical preform grips the gripping protrusion during biaxial stretching blow.
  • the cylindrical preform for producing a medical liquid container according to the above (1) or (2) which is stretched in the axial direction of the preform by being pulled up.
  • the cylindrical preform for producing a medical liquid container according to (3) wherein the outer surface of the upper end portion is a substantially hemispherical outer surface having the grasping protrusion at the center of the outer surface.
  • the outer surface of the upper end is a substantially hemispherical outer surface having the gripping protrusion at the center of the outer surface, and the inner surface of the upper end is also a substantially hemispherical inner surface,
  • the cylindrical main body portion has a predetermined thickness portion (uniform thickness portion) having a thickness substantially the same as the thickness b of the thickness change portion and extending a predetermined length toward the lower end portion.
  • Preform. (10) The cylindrical preform for producing a medical liquid container according to any one of (1) to (9), wherein the tubular preform includes a lumen extending from the lower end to the lower end of the upper end portion with substantially the same inner diameter. Tubular preform.
  • the invention relating to the first manufacturing method of the present application is as follows.
  • (11) A step of preparing a cylindrical preform for producing a medical liquid container made of the thermoplastic synthetic resin according to any one of the above (1) to (10), and a preform heating for heating the cylindrical preform Stretching by performing a step, a preform arranging step of placing the preform in a mold, an axial stretching of stretching the preform in the axial direction of the preform, and an extending stretching of sending air into the preform.
  • a method for producing a medical liquid container which comprises a stretched product forming step of creating a product and pressing the product against the inner surface of the mold.
  • (12) The method for producing a medical liquid container according to (11), wherein a draw ratio of the preform in the stretched product forming step is increased from a lower side of the preform toward a center side.
  • the medical liquid storage container of the second invention of the present application is as follows. (13) A cylindrical preform comprising a thermoplastic resin for forming a medical liquid container by biaxial stretching blow molding after heating to near the endothermic peak temperature of the thermoplastic resin.
  • the reform is formed by injection molding of a thermoplastic resin, and includes a closed upper end portion having a gripping protruding portion protruding upward, and a lower end portion forming a cylindrical discharge portion having an opening at the lower end of the container.
  • a cylindrical main body that forms between the closed upper end and the lower end; a lumen that extends from the lower end to the upper end with substantially the same inner diameter; and the lower end of the closed upper end from the vicinity of the lower end of the grasping projection.
  • a biaxially stretched portion formed between lower ends of the main body, and the biaxially stretched portion includes an inner diameter X of a lower portion of the biaxially stretched portion and a lumen in the biaxially stretched portion
  • the ratio to the length Y (X: Y) is 1: 3
  • this preform has the above-described configuration, the core pin at the time of preform molding is thick and short, and the core pin does not easily tilt due to the resin pressure, so that the preform is less likely to be uneven. Therefore, even if the preform is heated to a high temperature close to the endothermic peak temperature of the resin, the upright form of the preform can be maintained, and a medical liquid container can be produced satisfactorily by stretch blow molding.
  • the ratio (X: Y) between the inner diameter X of the lower portion of the biaxially stretched portion and the lumen length Y in the biaxially stretched portion is 1: 3.7.
  • the invention relating to the second manufacturing method of the present application is as follows. (21) A step of preparing the cylindrical preform according to any one of (13) to (20) above, and a preform heating step of heating the cylindrical preform near the endothermic peak temperature of the thermoplastic resin, , A preform placement step of placing the tubular preform in a mold, pulling up and pulling up the gripping protrusion of the tubular preform, and extended stretching of feeding air into the preform.
  • a method for producing a medical liquid container comprising producing a stretched product and performing a stretched product forming step of pressing the stretched product against an inner surface of the mold. (22) The method for producing a medical liquid container according to (21), wherein a stretch ratio of the preform in the stretched product forming step is increased from a lower side of the preform toward a center side.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Manufacturing & Machinery (AREA)
  • Physics & Mathematics (AREA)
  • Geometry (AREA)
  • Blow-Moulding Or Thermoforming Of Plastics Or The Like (AREA)

Abstract

La présente invention concerne une préforme cylindrique (1) destinée à produire des récipients de liquide à usage médical, ladite préforme cylindrique (1) étant formée par moulage par injection d'une résine thermoplastique et comprenant une partie (3) d'extrémité supérieure fermée, une partie (4) d'extrémité inférieure formant une partie d'évacuation (44) et une partie (2) corps principal cylindrique reliant la partie (3) d'extrémité supérieure fermée et la partie (4) d'extrémité inférieure ; la partie (3) d'extrémité supérieure fermée étant pourvue d'une partie (31) de changement d'épaisseur de paroi, où l'épaisseur de paroi diminue progressivement vers le haut, afin de former une partie déformable vers l'intérieur d'un récipient (10) de liquide à usage médical. Dans la partie (31) de changement d'épaisseur de paroi, l'épaisseur (a) de la paroi au niveau de l'extrémité supérieure de la partie (31) de changement d'épaisseur de paroi est de 1,3 mm à 1,6 mm et l'épaisseur (b) de la paroi au niveau de l'extrémité inférieure de la partie de changement d'épaisseur de paroi est de 2,5 à 4 fois plus grande que l'épaisseur (a) de la paroi.
PCT/JP2015/053855 2014-03-28 2015-02-12 Préforme cylindrique pour produire des récipients de liquide à usage médical et procédé de production de récipients de liquide à usage médical à l'aide de celle-ci WO2015146338A1 (fr)

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Cited By (1)

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Publication number Priority date Publication date Assignee Title
US20170121047A1 (en) * 2015-10-30 2017-05-04 Pepsico, Inc. Container and preform with neck finish

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JPH04131221A (ja) * 1990-09-21 1992-05-01 Mitsui Petrochem Ind Ltd 吊り下げ用舌片付き容器の製造方法
JPH06285961A (ja) * 1993-03-31 1994-10-11 Yoshino Kogyosho Co Ltd プラスチックボトル成形用プリフォーム及びそれを用いたボトル成形方法
WO2008149819A1 (fr) * 2007-05-31 2008-12-11 Yoshino Kogyosho Co., Ltd. Procédé de moulage d'un corps de bouteille de résine synthétique
JP2012196878A (ja) * 2011-03-22 2012-10-18 Terumo Corp 薬液容器の製造方法および薬液容器

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Publication number Priority date Publication date Assignee Title
JPH04131221A (ja) * 1990-09-21 1992-05-01 Mitsui Petrochem Ind Ltd 吊り下げ用舌片付き容器の製造方法
JPH06285961A (ja) * 1993-03-31 1994-10-11 Yoshino Kogyosho Co Ltd プラスチックボトル成形用プリフォーム及びそれを用いたボトル成形方法
WO2008149819A1 (fr) * 2007-05-31 2008-12-11 Yoshino Kogyosho Co., Ltd. Procédé de moulage d'un corps de bouteille de résine synthétique
JP2012196878A (ja) * 2011-03-22 2012-10-18 Terumo Corp 薬液容器の製造方法および薬液容器

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170121047A1 (en) * 2015-10-30 2017-05-04 Pepsico, Inc. Container and preform with neck finish
CN108602579A (zh) * 2015-10-30 2018-09-28 百事可乐公司 具有颈部瓶口的容器和预成型件
EP3368425A4 (fr) * 2015-10-30 2019-05-15 Pepsico, Inc. Récipient et préforme avec fini de col

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