EP4015400A1 - Füllnadel zur abgabe von flüssigen zusammensetzungen in behälter - Google Patents

Füllnadel zur abgabe von flüssigen zusammensetzungen in behälter Download PDF

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Publication number
EP4015400A1
EP4015400A1 EP20214143.8A EP20214143A EP4015400A1 EP 4015400 A1 EP4015400 A1 EP 4015400A1 EP 20214143 A EP20214143 A EP 20214143A EP 4015400 A1 EP4015400 A1 EP 4015400A1
Authority
EP
European Patent Office
Prior art keywords
needle
filling
filling needle
equal
less
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP20214143.8A
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English (en)
French (fr)
Inventor
Vinko VRABEC
Klemen SMREKAR
Denis JANC
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
KRKA dd
Original Assignee
KRKA dd
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 KRKA dd filed Critical KRKA dd
Priority to EP20214143.8A priority Critical patent/EP4015400A1/de
Publication of EP4015400A1 publication Critical patent/EP4015400A1/de
Pending legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B39/00—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/22—Defoaming liquids in connection with filling

Definitions

  • the present invention relates to a filling needle that is preferably used for filling medicinal liquids having low viscosity and/or low surface tension and/or low density into containers.
  • the filling needle according to the invention is preferably used for filling medicinal pharmaceutical and veterinary liquid compositions that are used in small volumes.
  • Filling needles are used for dispensing or dosing medicinal liquids into containers such as vials, ampules, pipettes, bottles.
  • containers such as vials, ampules, pipettes, bottles.
  • filling needles known in the art that aim to fulfil a number of critical requirements in filling liquid compositions, such as: accurate and reproducible dose volumes; no drip formation, cavitation, or bubble formation during filling; accurate dosing for different surface tensions, densities, and viscosities; precise bottom-up, high-speed filling; a range of needle diameters for small and large volumes; compatibility with existing filling machines; robust and rigid construction; suitability for use according to pharmaceutical good manufacturing practice (GMP) regulations; and compliance with appropriate pharmacopoeia tests
  • GMP pharmaceutical good manufacturing practice
  • Known filling needles - e.g. disclosed in WO 2008/103484 A2 - use several different approaches to deal with above-mentioned requirements.
  • the blunt, straight-end tip, needles are the "standard" needle type provided by most manufacturers.
  • the blunt needle dispenses liquid directly into the bottom of a container. Problems that are likely to occur with blunt tip needles can include dripping, foaming, and wicking - particularly with hydrophobic and low surface tension products.
  • Liquids having low viscosity and low surface tension are found more challenging for filling in accurate and reproducible dose volumes, without dripping and air bubbles formation.
  • needle tip geometry used in the art it was not possible to achieve satisfactory results regarding dripping, inconsistent filling volumes and air bubble formation.
  • the basket tip type needles are used in applications where foaming and dripping occur, usually because a blunt tip needle can't support the fluid column (even when the tubing is properly occluded).
  • a basket tip needle has a larger combined surface area for fluid to exit, reducing the flow rate, but better supporting the fluid column.
  • the basket design directs fluid towards the sides of the container, causing spraying and wetting of the whole wall of the container that result in incomplete sealing of the containers and leaking of the seals.
  • showerhead type needles are constructed to help to prevent foaming and dripping but they are especially helpful with larger fill volumes and usually not feasible with smaller needles.
  • showerhead needles work by directing product flow in as many as six individual streams. In high volume fills, this greatly reduces the fill times of foamy or soapy products, allowing operators to run pumps with product at full speed without issues.
  • the object of the invention is to provide a filling needle, that allows to fill containers both accurately and quickly - especially the filling of liquids having low viscosity, low density and low surface tension.
  • the product loss should be minimized, therefore foaming of product in the container or dripping through the needle should be minimized.
  • the present invention discloses a filling needle having optimized design that solves above-mentioned drawbacks and provides for quick and accurate filling of liquid compositions, without formation of air bubbles, without dripping and leakage of the seals.
  • the invention discloses a filling needle for dispensing liquid compositions into a container; preferably for filling liquids of low viscosities and/or low surface tension and/or low densities.
  • the container is preferably a vial, ampule, pipette, or bottle.
  • the filling needle comprising a connector for connecting a feeding line and a needle pipe leading from the connector to an outlet of the filling needle.
  • the liquid to be filled runs through the feeding line and trough the connector into the needle pipe.
  • the center line of the needle pipe defines a flow direction of the liquid from the connector to the outlet of the filling needle.
  • Low viscosity liquids are preferably characterized by having viscosity of less than 6 mPa ⁇ s at 20 °C.
  • Liquids with low surface tension are preferably characterized by having surface tension of less than 35 mN/m, preferably less than 30 mN/m, more preferably less than 25 mN/m.
  • Low density liquids are preferably characterized by having density at 20 °C of less than 0.95 g/ml, preferably less than 0.9 g/ml.
  • each of the grid-elements have plurality of apertures, each with a micrometer size aperture width w.
  • the aperture width w is greater than or equal to a lower limit and/or less than or equal to an upper limit, wherein the lower limit is 10 micrometers, preferably 20 micrometers, further preferably 100 micrometers; the upper limit is 900 micrometers, preferably 750 micrometers, further preferably 650 micrometers, further preferably 500 micrometers.
  • At least one of the grid-elements is a mesh, preferably a woven mesh, and/or a perforated plate.
  • Both grid-elements can be a mesh or both grid-elements can be a perforated plate or one grid-element can be a mesh and the other one a perforated plate.
  • the aperture width w of the mesh is the mesh size; which is preferably measured perpendicular to the warp or weft wire.
  • the aperture width w of the perforated plate is the diameter of the holes in the plate.
  • At least one of the grid-elements is made of steel, preferably stainless-steel, or copper, or galvanized wire, or brass, or aluminum, or phosphor bronze, or synthetic monofilaments.
  • the inclination angle ⁇ is greater than or equal to a lower limit and/or less than or equal to an upper limit, wherein the lower limit is 100°, preferably 110°, further preferably 120°, further preferably 130°; the upper limit is 170°, preferably 160°, further preferably 150 °, further preferably 140°. Most preferably, the inclination angle ⁇ is 135°.
  • the ratio of the second length to first length is greater than or equal to a lower limit and/or less than or equal to an upper limit, wherein the lower limit is 1:4, preferably 1:3; the upper limit is 1:1, preferably 1:2.
  • an entire length of the filling needle, preferably of the needle pipe plus connector is greater than or equal to a lower limit and/or less than or equal to an upper limit, wherein the lower limit is 100 mm, preferably 150 mm, further preferably 170 mm; the upper limit is 300 mm, preferably 270 mm, further preferably 250 mm.
  • an inner diameter of the filling needle is greater than or equal to a lower limit and/or less than or equal to an upper limit, wherein the lower limit is 4 mm, preferably 6 mm, further preferably 7 mm; the upper limit is 10 mm, preferably 9 mm, further preferably 8 mm.
  • the at least two grid-elements form a plane flow-through layer perpendicular to the flow direction and therefore perpendicular to the center axis of the needle pipe.
  • the filling needle ends at the outlet side with a blunt end.
  • the grid-elements contacts against a blunt front end of needle pipe.
  • the grid-elements are jammed between the front end of the needle pipe and a holding sleeve; the holding sleeve is preferably plugged onto the needle pipe.
  • the needle pipe over its entire lengths from the connector to the outlet is made in one piece or is made of firmly assembled parts that cannot be detached non-destructively.
  • the needle pipe is made of metal, further preferably steel, more preferably stain-lees steal.
  • the filling needle comprises the connector as only "connection”.
  • the filling needle comprises no other connections and/or no other couplings and/or no branches.
  • the curved portion (also: kink or bended portion) with the inclination angle ⁇ is between the connector and the outlet.
  • the invention further discloses a filling device comprising the filling needle and a feeding line connected to the connector.
  • the other end of the feeding line is preferably connected to a pump.
  • the inner surface of the needle pipe preferably also of the connector, is made of a first material and the inner surface of the feeding line is made of a second material different from the first material.
  • the first material is metal, preferably steel, further preferably stainless-steal, and/or the second material is plastic, preferably polytetrafluoroethylene.
  • the invention further discloses the use of the filling needle or of the filling device for filling liquid compositions - preferably medical liquid compositions - into containers. Thereby the used liquid composition
  • each container is filled with a fill volume greater than or equal to a lower limit and/or less than or equal to an upper limit, wherein the lower limit is 0.2 ml, preferably 0.25 ml; the upper limit is 5 ml, preferably 4.5 ml.
  • the filling needle or of the filling device is preferably used to fill at least 60 containers per minute, preferably at least 75 containers per minute.
  • Figures 1 to 6 disclose a filling needle 1 according to present invention and details thereof.
  • the filling needle 1 is used in a filling devise 20 shown in Figure 7 for liquids as defined above.
  • a feeding line 20 connects the filling needle 1 to a pump 21.
  • the filling needle 1 comprising a connector 6 for connecting a feeding line 22. Further the filling needle 1 comprising a needle pipe 2 leading from the connector 6 to an outlet 10 of the filling needle 1, wherein the needle pipe 2 is curved at an inclination angle ⁇ of 135°.
  • the first section 12 starting with the outlet 10 and merging with the inclination angle ⁇ into the second section 13; the second section 13 ending with the connector 6.
  • the first section 12 can be partially covered by an attachment 8.
  • the outlet 10 comprises two grid-elements 3 arranged one behind the other in the flow direction. According to Fig. 5 and 6 the grid-elements 3 each have plurality of apertures 11, each with a micrometer size aperture width w.
  • Fig. 5 shows a woven mesh as the grid-element 3.
  • the aperture width w of the mesh is the mesh size; which is preferably the distance between two adjacent warp or weft wires, measured in the projected plane at the mid positions.
  • the mesh preferably consists of longitudinal wires (warp) and transverse wires (weft), which are intertwined to form apertures 11 of rectangular shape and allow a stable connection.
  • a mesh with one of the following types of weaving is used: canvas, keper, twill, blind weaving in the shape of canvas, and/or blind weaving in the shape of twill.
  • Fig. 6 shows a perforated plate as the grid-element.
  • the aperture width w of the perforated plate is the diameter of the holes/apertures 11 in the plate.
  • the two grid-elements 3 form a plane flow-through layer perpendicular to the flow direction and therefore perpendicular to the center axis of the needle pipe 2.
  • the filling needle 1 ends at the outlet side with a blunt end.
  • the grid-elements 3 at least the inner grid-element 3, contacts against the blunt front end of needle pipe 2.
  • the grid-elements 3 are jammed between the front end of the needle pipe 2 and a tapered portion 5 of a holding sleeve 4.
  • the holding sleeve 4 is plugged onto the needle pipe 2 - and preferably welded onto the needle pipe 2 as shown in Fig. 3 .
  • the connector 6 shown in Fig. 4 comprises a fitting 7 for connecting the feeding line 22 to the filling needle 1. According to the fitting 7, an inner diameter 23 of the feeding line 20 is greater than an inner diameter 9 of the filling needle 1.
  • the gravity of the liquid in the filling needle 1 is reduced - compared to a not curved needle - which results in avoiding dripping and air bubble formation.
  • the filling needle 1 is preferably made of stainless steel but the pipe (feeding line 22) that connects the filling needle 1 and the pump 21 is made of preferably polytetrafluoroethylene (Teflon). Liquid having low viscosity has in the section of the Teflon pipe (feeding line 22) also low surface tension, but in the section of the filling needle 1 the surface tension is higher than in the section of the Teflon pipe (feeding line 22). Therefore, the length (a+b+c) of the filling needle 1 should be in the range from 170 to 200 mm in order to prevent liquid to tear down from the outlet 10.
  • the required height (h1) for keeping laminar flow in a straight filling needle is higher than the required height (h2) in the curved filling needle 1 as shown in Fig. 7 .
  • Fig. 3 shows schematically by horizontal arrows the surface tension of the liquid on the wall of the needle 1 which contribute to prevent dropping of the liquid which is caused by gravity force of the liquid.
  • the gravity force of the liquid is further reduced by "closing" the needle tip (outlet 10) by at least two mesh of micron size - the grid-elements 3. When flow of fluid comes into contact with the mesh the gravity force is reduced.
  • the effect is schematically shown by the vertical arrows in Fig. 3 .
  • Fig. 7 and 8 show the comparison of the influence of the height (sum of the length of the needle 1 and height of the feeding line 22) on the gravity force for the straight needle ( Fig. 8 ) and the curved needle 1 ( Fig. 7 ).
  • h 1 a + b + c + R 1
  • dimension a is part of the needle from the lower edge to the upper part of the needle attachment
  • dimension b is part of the needle from the upper part of the attachment to a distance equal to the distance of the curved part of the needle
  • dimension c is part of the needle from the curved part of the needle to the end of the needle where the Teflon pipe is attached
  • dimension R1 is the radius or half the distance between the needle and the filling pump. The values for this dimensions are know so the height h1 can be calculated.
  • dimension a is part of the filling needle 1 from the lower edge to the upper part of the attachment 8
  • dimension b is part of the filling needle 1 from the upper part of the attachment 8 to the curved part of the filling needle 1
  • dimension c is part of the filling needle 1 from the curved part of the filling needle 1 to the end of the filling needle 1 where the feeding line 22 is attached
  • dimension R1 is the radius or half the distance between the filling needle 1 and the filling pump
  • dimension R2 is the radius from end of curved filling needle 1 to the position of filling pump 21.
  • Dimension R2 is different than dimension R1.
  • Fg ⁇ * g * h * S
  • Fg 1 ⁇ * g * h 1 * S
  • Fg 2 ⁇ * g * h 2 * S
  • F g 2 ⁇ ⁇ g * h 2 * S
  • F g 2 h 2 h 1 ⁇ F g 1
  • the influence of gravity force is lowered for around 66% in the curved needle 1 compared with straight needle when the needle 1 is curved under angle of 135°.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Supply Of Fluid Materials To The Packaging Location (AREA)
EP20214143.8A 2020-12-15 2020-12-15 Füllnadel zur abgabe von flüssigen zusammensetzungen in behälter Pending EP4015400A1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20214143.8A EP4015400A1 (de) 2020-12-15 2020-12-15 Füllnadel zur abgabe von flüssigen zusammensetzungen in behälter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20214143.8A EP4015400A1 (de) 2020-12-15 2020-12-15 Füllnadel zur abgabe von flüssigen zusammensetzungen in behälter

Publications (1)

Publication Number Publication Date
EP4015400A1 true EP4015400A1 (de) 2022-06-22

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Family Applications (1)

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EP20214143.8A Pending EP4015400A1 (de) 2020-12-15 2020-12-15 Füllnadel zur abgabe von flüssigen zusammensetzungen in behälter

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5950691A (en) * 1997-01-08 1999-09-14 Shikoku Kakoki Co., Ltd. High-speed liquid filling machine
US20020040737A1 (en) * 2000-09-12 2002-04-11 Beldham Paul M. Container filling apparatus and methods
WO2008103484A2 (en) 2007-02-23 2008-08-28 Overlook Industries, Inc. Filling needle
US20100024910A1 (en) * 2006-10-27 2010-02-04 Toyo Seikan Kaisha, Ltd. Filling nozzle
JP2015160626A (ja) * 2014-02-27 2015-09-07 大日本印刷株式会社 液体充填ノズル用多孔板および液体充填装置
US20190016484A1 (en) * 2017-07-12 2019-01-17 Vanrx Pharmasystems Inc. Purgeable pharmaceutical fill needle

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5950691A (en) * 1997-01-08 1999-09-14 Shikoku Kakoki Co., Ltd. High-speed liquid filling machine
US20020040737A1 (en) * 2000-09-12 2002-04-11 Beldham Paul M. Container filling apparatus and methods
US20100024910A1 (en) * 2006-10-27 2010-02-04 Toyo Seikan Kaisha, Ltd. Filling nozzle
WO2008103484A2 (en) 2007-02-23 2008-08-28 Overlook Industries, Inc. Filling needle
JP2015160626A (ja) * 2014-02-27 2015-09-07 大日本印刷株式会社 液体充填ノズル用多孔板および液体充填装置
US20190016484A1 (en) * 2017-07-12 2019-01-17 Vanrx Pharmasystems Inc. Purgeable pharmaceutical fill needle

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