WO1999043549A1 - Procede et dispositif de fabrication par soufflage d'un contenant thermoplastique rempli - Google Patents

Procede et dispositif de fabrication par soufflage d'un contenant thermoplastique rempli Download PDF

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Publication number
WO1999043549A1
WO1999043549A1 PCT/GB1999/000577 GB9900577W WO9943549A1 WO 1999043549 A1 WO1999043549 A1 WO 1999043549A1 GB 9900577 W GB9900577 W GB 9900577W WO 9943549 A1 WO9943549 A1 WO 9943549A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
outlet opening
product
mandrel
blow moulding
Prior art date
Application number
PCT/GB1999/000577
Other languages
English (en)
Inventor
Martin M. Browne
John SANDØY
Original Assignee
Nycomed Imaging As
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nycomed Imaging As filed Critical Nycomed Imaging As
Priority to JP2000533319A priority Critical patent/JP2002504447A/ja
Priority to AU26326/99A priority patent/AU2632699A/en
Priority to EP99906362A priority patent/EP1058647A1/fr
Publication of WO1999043549A1 publication Critical patent/WO1999043549A1/fr

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/02Machines characterised by the incorporation of means for making the containers or receptacles
    • B65B3/022Making containers by moulding of a thermoplastic material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06Ampoules or carpules
    • A61J1/067Flexible ampoules, the contents of which are expelled by squeezing

Definitions

  • the invention relates to methods and apparatus for 5 making sealed containers from thermoplastic material and containing a product, and to the sealed containers.
  • the neck of the container is formed as a female cone for sealingly receiving the male cone of a syringe, to enable the liquid to be withdrawn directly from the sterile conditions of the container directly
  • the male and female cones are formed to a standard size and conicity and the most widely accepted standard arrangement is known as a Luer fitting.
  • Such fittings may additionally be provided with an arrangement for locking the syringe and the
  • Luer lock fitting 20 container together, known as a Luer lock fitting, and comprising an outwardly directed flange on the outside of the neck for engagement with a screw thread provided on the syringe .
  • the syringe can thus be screwed to the container to form the sealed connection.
  • Thermoplastic unit dose containers are made using the known blow-fill-seal process. This basically
  • thermoplastic material has hardened, all under sterile/ aseptic conditions.
  • a mandrel is lowered into the neck of the container and blow air is
  • the liquid product is then introduced via a fill needle formed with another passage and during filling the blow - 2 - air is exhausted via the air passage.
  • the outer surface of the mandrel at its tip defines a moulding surface to form the female cone where a male syringe cone will later be sealingly received.
  • the outer surface of the mandrel also acts as a moulding surface to form the inside wall of the frangible portion where the cap is later to be broken away.
  • the invention provides a method of making a sealed container of thermoplastic material containing a product and having an outlet opening for sealingly receiving a syringe cone, spike or giving set, or other equivalent fully or partly conic device, the method comprising blow moulding the container, and forming the outlet opening during such blow moulding with no mandrel or other member defining the inside wall of the outlet opening.
  • the invention provides a sealed container of thermoplastic material having an outlet opening for sealingly receiving a syringe cone, spike or giving set, or other equivalent fully or partly conic device, the container having no irregular internal flange or lip at or adjacent to the outlet opening.
  • the invention provides apparatus for making a sealed container of thermoplastic material containing a product and having an outlet opening for sealingly receiving a syringe cone, spike or giving set, or other equivalent fully or partly conic device, the apparatus comprising means for blow moulding the container, and a mould for forming the outlet opening during blow moulding with no mandrel or other member defining the inside wall of the outlet opening.
  • the product contained by the container is preferably a liquid, but the container may also be used for containing a solid, for example in powder or tablet form, or a gas (in which case the gas itself may be used for the blow moulding step, rather than air) .
  • the product will be for medical use and is preferably a pharmaceutical product .
  • the volume of the product contained may be 1 ml to 1000 ml, preferably 1 ml to 500 ml, and most preferably 10 ml, 15 ml, 20 ml, 40 ml, 50 ml, 60 ml, 75 ml, 100 ml, 150 ml, 200 ml or 250 ml.
  • Product may be introduced into the container via a needle or the like passing through the outlet opening but not making contact therewith.
  • a needle or the like passing through the outlet opening but not making contact therewith.
  • Such an arrangement may be suitable for relatively small containers, for example containing less than 50 ml of product.
  • a further problem of the known blow-fill-seal process arises if it is desired to make a container with an outlet opening to fit a standard syringe cone and containing a liquid volume in excess of about 50 ml.
  • the liquid has to be introduced very rapidly to avoid the plastic cooling and losing its ability to form the seal and the final shape of the container. For example, for a fill needle of 2.5 mm internal diameter introducing 50 ml of liquid in a 3 second fill time, the average liquid speed is 3.4 metres per second.
  • the jet of liquid causes splashing, foaming and fog in the container during filling. The liquid tends to follow the exhaust air into the air passage and can build up and clog the passage.
  • product is introduced into the container via an inlet opening separate from the outlet opening for receiving a syringe cone or other equivalent device.
  • inlet opening dimensions can be chosen independently of the outlet opening.
  • the invention provides a method of making a sealed container of thermoplastic material containing a product and having an outlet opening for sealingly receiving a syringe cone, spike or giving set, or other equivalent fully or partly conic device, the method comprising blow moulding the container, and introducing liquid into the container via an inlet opening separate from the outlet opening.
  • the invention provides apparatus for making a sealed container of thermoplastic material containing a product and having an outlet opening for sealingly receiving a syringe cone, spike or giving set, or other equivalent fully or partly conic device, the apparatus comprising means for blow moulding the container, and a mould arranged to form the outlet opening at a location separate from an inlet opening for introducing product into the container.
  • the invention provides a sealed container of thermoplastic material having an outlet opening for sealingly receiving a syringe cone, spike or giving set, or other equivalent fully or partly conic device, wherein the container contains at least 60 ml of product.
  • the container contains at least 70 ml or 75 ml or 80 ml or 90 ml or 100 ml or 150 ml or 200 ml or 250 ml or 1000 ml of product. It is expected that this aspect of the invention will be particularly useful for containers of 100 ml or more of product.
  • the outlet opening could be used during manufacture to introduce and exhaust blow air, with the inlet opening being used to introduce liquid. This could allow very rapid filling. In the presently preferred arrangement, however, the inlet opening is used both for introducing product to the container and for introducing and exhausting blow air.
  • the inlet opening may, for example, be formed in a shoulder of the container, adjacent to the outlet opening, or elsewhere.
  • product is introduced to the container through its base.
  • the container may advantageously be formed and filled upside down.
  • the main mould, defining the shape to which the main container body is blown, may thus also define the top parts of the container, such as the outlet opening and a removable cap. A mandrel for introducing blow air and product and for exhausting the blow air can then operate from above the upside down container.
  • the inlet opening will be sealed closed. This may for example be done by closing two halves of a head mould located above the main mould. The head mould may be heated to ensure a good seal.
  • a nipple or other tooling markings showing that an inlet opening separate from the outlet opening has been used will generally be visible on the filled and sealed container. If a nipple is left on the container, it may for example be used as a means of hanging the container or for locking into a stand.
  • a nipple could be arranged to be pressable inwardly of the container. For example the nipple could project into a concave recess at the base of the container, the concavity being sufficiently deep that the container is able to stand on its base .
  • the container may have a cap removable by breaking a frangible portion, to allow access to the outlet opening, the frangible portion being formed in conventional manner between a mandrel and the blow moulding tooling.
  • this requires accurate positioning of the mandrel relative to the mould, usually within a tolerance of ⁇ 0.1 mm. If the frangible portion is too thin this may cause leakage, and if it is too thick then it is difficult or impossible to remove the cap.
  • a frangible portion is formed during blow moulding with no mandrel or other member defining the inside wall of the frangible portion.
  • the frangible portion may simply be formed by being stretched over a rib on the mould external of the container.
  • the thickness is then dependent on the thickness of the plastic before moulding (which will normally be extruded into the mould) and should consequently be more reliable.
  • the outlet opening could be formed by a mandrel, in the conventional manner, whilst avoiding the - 7 - problems caused by rapid filling through the outlet opening.
  • the outlet opening is formed during blow moulding with no mandrel or other member defining the inside wall of the outlet opening, to minimise the risk of plastic particle generation as discussed above.
  • the outlet opening could be blow moulded as a female cone.
  • the outlet opening is formed as an annular inward projection for sealingly receiving the syringe cone or other equivalent device.
  • the inward projection may define an orifice into which the syringe cone or other equivalent device can be inserted in sealing manner.
  • Polypropylene and most other thermoplastics are strong and elastic and capable, when formed into an annular inward projection, of forming a good seal with a syringe cone or other equivalent device.
  • the annular inward projection can be easily blow moulded, avoiding the use of a mandrel or the like, and thus minimise the risk of particle generation.
  • An annular inward projection formed by blow moulding over a rib in the mould will tend to be thinned where the material is stretched over the rib.
  • the minimum diameter of the outlet opening is preferably less than or equal to 10 mm.
  • the minimum diameter will be the minimum diameter of the cone, whilst in the case of the container having an annular inward projection the minimum diameter will simply be the internal diameter of the orifice which it defines.
  • a minimum diameter of the outlet opening of 10 mm or less will generally be suitable for a conic device in the form of a spike or a giving set .
  • the minimum diameter is preferably less than or equal to 4.3 mm, more preferably 3.8 mm.
  • the invention provides a sealed container of thermoplastic material having an outlet opening for sealingly receiving a syringe cone, spike or giving set, or other equivalent fully or partly conic device, the container comprising an annular inward projection for sealingly receiving the syringe cone or other equivalent device, and a plurality of strengthening ribs arranged outwardly of the annular inward projection.
  • the ribs will be circumferentially spaced, e.g. two ribs 180° apart, and preferably extend longitudinally of the container neck.
  • Figure 1 is a front elevation of a container
  • Figure 2 is a side elevation of the container
  • Figure 3 is a cross-sectional of a container neck and cap, showing on the right hand side a view on lines III-III of Figure 2, and on the left hand side an equivalent view of a prior art container;
  • Figure 4 is a cross-sectional view of the container during manufacture
  • Figure 5 is a cross-sectional view of the container at a later manufacturing stage
  • Figure 6 is a cross-sectional view of the base of the container, with the base pushed in after moulding;
  • Figures 7a and 7b are respective elevation and cross-sectional views of a mandrel; Figures 8a and 8b are respective elevation and cross-sectional views of an alternative form of mandrel; and
  • Figures 9a and 9b are respective elevation and cross-sectional views of another form of mandrel.
  • Figures 1 and 2 show a completed sealed container made of thermoplastic material. This comprises a main body 2 sealed closed by a cap 3 connected to a neck 4 by - 9 - a frangible portion 5.
  • a twist off top 6 is connected to the cap 3 by a web 7 , and to the neck 4 by a pair of frangible webs 8.
  • the frangible webs 8 and the frangible portion 5 tear to allow removal of the cap 3 and thus open the container.
  • a pair of outwardly directed lugs 9 are provided to engage in an internal thread channel of e.g. a syringe, ie. to provide a Luer lock fit.
  • FIG 3 on the right hand side, shows further details of the neck 4 and cap 3 arrangement.
  • the neck 4 is formed with an annular inward projection 10.
  • the wall thickness of the projection is less than that above and below the projection. This thinning occurs during blow moulding as the plastic is stretched over a circumferentially extending rib of an outer mould defining the external shape of the container.
  • the projection 10 is reinforced by a pair of opposed vertical ribs 11, defined by vertical grooves in the mould. The ribs are disposed radially outwardly of the projection.
  • a syringe cone or other equivalent device may be inserted into the neck to form a seal with the orifice formed by the projection 10.
  • FIG. 3 shows the details of a known cap 3 and neck 4 configuration.
  • the inner wall of the neck below the frangible portion 5 is formed as a female Luer cone for sealing engagement with a male syringe cone.
  • the female cone is formed during manufacture between an outer mould member and a central mandrel, with the result that an irregular lip 12 forms at the lower end of the cone.
  • the frangible portion 5 in the known arrangement is formed in an annular space between the - 10 - outer mould and the inner mandrel, so that the positioning of the mandrel is critical to achieving the correct thickness of the frangible portion 5.
  • Figures 4 and 5 show the container 4 being moulded upside down in a blow-fill-seal machine.
  • the mould tooling comprises a main mould 20 in two reciprocatable main mould parts 20a and 20b, a head mould 21 in two reciprocatable head mould parts 21a and 21b and a parison gripper 22 in two reciprocatable parts 22a and 22b.
  • the parison gripper is in a closed position, gripping the parison, the head mould is in an open position and the main mould is in a closed position, defining the shape of the main body of the container.
  • the lower end of the main mould defines the shape of the top part of the upside down container 1, including the neck 4, the cap 3 and the twist-off top 6 (as shown in Figures 1, 2 and 3) .
  • No mandrel or other inner member is used to define the internal shape of the top part of the container.
  • Figure 4 shows the container after its main part 2 and top part have been blown to the required shape by air introduced by a mandrel 23, and filled with liquid 24 also via the mandrel 23.
  • Figure 5 shows the manufacturing process at a later stage, after the mandrel 23 has been removed and the head mould 21 has been closed to seal the container.
  • a nipple 25 is formed by the sealing process and this may be removed at a later process stage, or it could be left to serve as a hanger device or as a lock to fit into a stand.
  • the container could be shaped to allow its base to be pushed in so that the nipple 25 is located in a recess 26, as shown in Figure 6. This allows the container to stand upright on its base, without the nipple 25 having to be removed.
  • Figures 7a, 7b, 8a, 8b, 9a and 9b show various possible constructions of the mandrel 23.
  • the mandrel of Figures 7a and 7b has a generally circular cross- section and is provided with a central passage 30 for - 11 - blow and exhaust air and, arranged radially outwardly of the central passage 30, a plurality (in this case four) liquid passages 31.
  • the passages are arranged in a line across a mandrel having a generally oblong cross-sectional shape.
  • Air passage 30 is provided at one end of the oblong and a plurality of liquid passages 31 are provided at the other end.
  • the separation of air passage 30 from liquid passages 31 is advantageous in that incoming liquid and exhaust air are separated, reducing the risk of clogging.
  • the mandrel is provided in two parts, a first mandrel part 23a having an air passage 30 and a second mandrel part 23b having a plurality of liquid passages 31. Again, the air and liquid passages are advantageously separated from each other.
  • mandrel design is not constrained by having to form a female syringe cone and thus many variations are possible according to requirements .
  • Standard types of male syringe cone to which the containers described herein may make a sealing fit are Luer or Record cones.
  • the female cones to which such male cones normally fit have respective conicities of
  • the containers described herein may equally be used to fit a spike or giving set or other equivalent fully or partly conic device .

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Blow-Moulding Or Thermoforming Of Plastics Or The Like (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne la fabrication d'un contenant (1), scellé, en matériau thermoplastique, renfermant un produit (24) et muni d'un orifice pour recevoir, de manière étanche, un perforateur ou un nécessaire à perfusion, ou des dispositifs entièrement ou partiellement coniques. Le procédé de fabrication comprend le soufflage du contenant (1) dans un moule et la formation de l'ouverture de l'orifice durant le soufflage sans l'utilisation de mandrin ou d'autre élément de détermination de la paroi interne de ladite ouverture.
PCT/GB1999/000577 1998-02-25 1999-02-25 Procede et dispositif de fabrication par soufflage d'un contenant thermoplastique rempli WO1999043549A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2000533319A JP2002504447A (ja) 1998-02-25 1999-02-25 ブロー成形による充填された熱可塑性容器の作成方法および装置
AU26326/99A AU2632699A (en) 1998-02-25 1999-02-25 Method and apparatus for making a filled thermoplastic container by blow-moulding
EP99906362A EP1058647A1 (fr) 1998-02-25 1999-02-25 Procede et dispositif de fabrication par soufflage d'un contenant thermoplastique rempli

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9804005.8 1998-02-25
GBGB9804005.8A GB9804005D0 (en) 1998-02-25 1998-02-25 Container
US9063098P 1998-06-25 1998-06-25

Publications (1)

Publication Number Publication Date
WO1999043549A1 true WO1999043549A1 (fr) 1999-09-02

Family

ID=10827593

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1999/000577 WO1999043549A1 (fr) 1998-02-25 1999-02-25 Procede et dispositif de fabrication par soufflage d'un contenant thermoplastique rempli

Country Status (5)

Country Link
EP (1) EP1058647A1 (fr)
JP (1) JP2002504447A (fr)
AU (1) AU2632699A (fr)
GB (1) GB9804005D0 (fr)
WO (1) WO1999043549A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0960820B1 (fr) * 1998-05-26 2004-03-03 Automatic Liquid Packaging, Inc. Récipient scellé comportant un embout de distribution muni d'un bourrelet d'étanchéité
WO2009101489A1 (fr) * 2008-02-15 2009-08-20 Lalchand Keshrimal Patni Mécanisme pour produire une entrée, sortie systématiques pour piquer un contenant à partie supérieure plate
US9918900B2 (en) 2014-10-29 2018-03-20 R.P. Scherer Technologies, Llc Inverse blow-fill-seal packaging

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1412319A (fr) * 1963-10-29 1965-09-24 Fmc Corp Procédés et dispositifs pour fixer des éléments préformés sur des récipients e nouveaux produits ainsi obtenus
EP0088056A1 (fr) 1982-02-08 1983-09-07 Astra Läkemedel Aktiebolag Flacon à dose unitaire
EP0327397A2 (fr) * 1988-02-03 1989-08-09 Waverley Pharmaceutical Limited Ampoules
DE3916840A1 (de) * 1988-09-21 1990-03-29 Bernd Hansen Ampulle
WO1991008729A1 (fr) 1989-12-11 1991-06-27 Ab Astra Flacon a dosage unitaire

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1412319A (fr) * 1963-10-29 1965-09-24 Fmc Corp Procédés et dispositifs pour fixer des éléments préformés sur des récipients e nouveaux produits ainsi obtenus
EP0088056A1 (fr) 1982-02-08 1983-09-07 Astra Läkemedel Aktiebolag Flacon à dose unitaire
EP0327397A2 (fr) * 1988-02-03 1989-08-09 Waverley Pharmaceutical Limited Ampoules
DE3916840A1 (de) * 1988-09-21 1990-03-29 Bernd Hansen Ampulle
WO1991008729A1 (fr) 1989-12-11 1991-06-27 Ab Astra Flacon a dosage unitaire

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0960820B1 (fr) * 1998-05-26 2004-03-03 Automatic Liquid Packaging, Inc. Récipient scellé comportant un embout de distribution muni d'un bourrelet d'étanchéité
WO2009101489A1 (fr) * 2008-02-15 2009-08-20 Lalchand Keshrimal Patni Mécanisme pour produire une entrée, sortie systématiques pour piquer un contenant à partie supérieure plate
US9918900B2 (en) 2014-10-29 2018-03-20 R.P. Scherer Technologies, Llc Inverse blow-fill-seal packaging

Also Published As

Publication number Publication date
GB9804005D0 (en) 1998-04-22
JP2002504447A (ja) 2002-02-12
AU2632699A (en) 1999-09-15
EP1058647A1 (fr) 2000-12-13

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