CA2440444A1 - Albumin in a flexible polymeric container - Google Patents

Albumin in a flexible polymeric container Download PDF

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Publication number
CA2440444A1
CA2440444A1 CA002440444A CA2440444A CA2440444A1 CA 2440444 A1 CA2440444 A1 CA 2440444A1 CA 002440444 A CA002440444 A CA 002440444A CA 2440444 A CA2440444 A CA 2440444A CA 2440444 A1 CA2440444 A1 CA 2440444A1
Authority
CA
Canada
Prior art keywords
albumin
container
bags
flexible polymeric
interior
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.)
Granted
Application number
CA002440444A
Other languages
French (fr)
Other versions
CA2440444C (en
Inventor
James D. Lewis, Jr.
William Baccia
Josef Schmidt
Johan Vandersande
John Carl Card
Theodor Langer
Georg Habison
Helmut Eder
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.)
Baxalta GmbH
Baxalta Inc
Original Assignee
Individual
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=25188062&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2440444(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2440444A1 publication Critical patent/CA2440444A1/en
Application granted granted Critical
Publication of CA2440444C publication Critical patent/CA2440444C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • B65B39/04—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers having air-escape, or air-withdrawal, passages
    • 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
    • B65B9/00—Enclosing successive articles, or quantities of material, e.g. liquids or semiliquids, in flat, folded, or tubular webs of flexible sheet material; Subdividing filled flexible tubes to form packages
    • B65B9/06—Enclosing successive articles, or quantities of material, in a longitudinally-folded web, or in a web folded into a tube about the articles or quantities of material placed upon it
    • B65B9/08—Enclosing successive articles, or quantities of material, in a longitudinally-folded web, or in a web folded into a tube about the articles or quantities of material placed upon it in a web folded and sealed transversely to form pockets which are subsequently filled and then closed by sealing
    • B65B9/087—Enclosing successive articles, or quantities of material, in a longitudinally-folded web, or in a web folded into a tube about the articles or quantities of material placed upon it in a web folded and sealed transversely to form pockets which are subsequently filled and then closed by sealing the web advancing continuously
    • 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
    • A61J1/14—Details; Accessories therefor
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports

Landscapes

  • 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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Basic Packing Technique (AREA)
  • Packages (AREA)
  • Containers And Plastic Fillers For Packaging (AREA)
  • Supply Of Fluid Materials To The Packaging Location (AREA)
  • Bag Frames (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

A flexible polymeric container for holding albumin. The container (12) is made of a sheet of flexible polymeric film (34) formed into a bag having a cavity enclosed by a first wall, an opposing second wall, and seals about a periphery of the first and second walls. The seals join an interior portion of the opposing first and second walls and create a fluid-tight chamber within the cavity of the container for storing a concentration of the albumin. A method of packaging the albumin protein into a flexible polymeric container is also provided. Therein a flexible polymeric material is converted into bags, the bags are filled with a quantity of albumin by a filler (44), and a seal area of the bags is sealed to enclose the albumin within the bag.

Claims (48)

1. A method of packaging albumin protein, comprising the steps of:
providing a flexible polymeric container having an opening extending from a cavity of the polymeric container;
providing a quantity of a concentration of albumin in a sterile solution;
inserting the albumin under a solution line pressure from about 4 psig. to about 20 psig. into the cavity of the polymeric container through the opening therein; and, sealing the opening to secure the liquid albumin within a fluid-tight chamber of the cavity of the polymeric container.
2. The method of Claim 1, wherein the albumin is maintained at a temperature of about 68°F prior to insertion into the cavity of the container.
3. The method of Claim 1, wherein the albumin is inserted into the cavity of the flexible polymeric container under a solution line pressure from about psig. to about 16 psig.
4. The method of Claim 1, wherein the flexible polymeric container is provided within an aseptic environment of a form-fill-seal packaging machine, wherein the albumin is inserted into the cavity of the flexible polymeric container within the aseptic environment of the form-fill-seal packaging machine, and wherein the opening of the container is sealed within the aseptic environment of the form-fill-seal packaging machine.
5. The method of Claim 1, further comprising the step of providing a filler having a distal tip with first and second adjacent interior passageways, the first interior passageway having a larger cross-sectional area than the second interior passageway, wherein the second interior passageway extending adjacent the first interior passageway to an exterior of the tip, and wherein the albumin is dispersed from the filler through the second interior passageway.
6. The method of Claim 1, further comprising the step of providing a filler having a tip with concentric first and second interior passageways, the first interior passageway having an inside diameter being dimensioned larger than an inside diameter of the second interior passageway, wherein an interface between the first and second interior passageways is interior of an exterior of the tip, wherein the second interior passageway extends to the exterior of the tip, and wherein the albumin exits the filler through the second interior passageway.
7. The method of Claim 1, further comprising the step of providing a sheath exterior a portion adjacent the tip of the filler, the sheath preventing contact between the polymeric container and the filler.
8. The method of Claim 1, wherein the albumin is provided in a 20%
concentration.
9. The method of Claim 1, wherein the albumin is provided in a 25%
concentration.
10. The method of Claim 1, wherein the flexible plastic container is provided having a volume of 50 ml.
11. The method of Claim 1, wherein the flexible plastic container is provided having a volume of 100 ml.
12. The method of Claim 1, further comprising providing a flexible polymeric container comprising a laminate film having an outside layer of linear low density polyethylene, a gas barrier layer, a core layer of polyamide, and an inside layer of linear low density polyethylene, the layers being bonded together by a polyurethane adhesive.
13. A method of packaging albumin protein in a series of flexible polymeric containers, comprising the steps of:
providing a quantity of filtered albumin;
providing a flexible polymeric material;
providing a form-fill-seal packaging machine and converting the flexible polymeric material into a series of bags in the form-fill-seal packaging machine;

filling the bags with a quantity of albumin within the form fill-seal packaging machine; and, sealing a seal area of the bags with the packaging machine to enclose the quantity of the albumin within the bags.
14. The method of Claim 13, wherein adjacent bags in the series of bags are initially connected, and are separated following the filling of each bag.
15. The method of Claim 14, further comprising providing a forming mandrel in the form-fill-seal packaging machine.
16. The method of Claim 15, further comprising forming the flexible polymeric material into a tube with the forming mandrel, and further forming the tube into the series of adjacent bags.
17. The method of Claim 13, wherein the bags are sequentially filled with the quantity of albumin.
18. The method of Claim 13, further comprising heat sealing a periphery of the bags to enclose the quantity of the albumin within the bags.
19. The method of Claim 13, further comprising providing a flexible polymeric container comprising a laminate film having an outside layer of linear low density polyethylene, a gas barrier layer, a core layer of polyamide, and an inside layer of linear low density polyethylene, the layers being bonded together by a polyurethane adhesive.
20. The method of Claim 13, wherein the form-fill-seal packaging machine has an aseptic area, wherein a sterilized flexible polymeric material is provided within the aseptic area, wherein the sterilized flexible polymeric material is formed into a series of adjacent bags within the aseptic area, wherein the albumin is sequentially inserted into the bags in the aseptic area, and wherein the bags are sequentially sealed within the aseptic area to form a fluid-tight container.
21. The method of Claim 13, further comprising the step of providing a repeating filler having a tip with concentric first and second interior passageways, the first interior passageway having a cross-sectional area greater than a cross-sectional area of the second interior passageway, wherein an interface between the first and second interior passageways is interior of an exterior of the tip, wherein the second interior passageway extends to the exterior of the tip, wherein the albumin exits the filler through the second interior passageway, and wherein the albumin is maintained at the interface between the first and second interior passageways during a suspension of filling.
22. The method of Claim 21, further comprising the step of providing a sheath exterior to a portion adjacent the tip of the filler, the sheath limiting contact between the polymeric container and the filler.
23. The method of Claim 21, further comprising the step of providing an exterior sheath concentric with the filler, and an air passageway extending between an interior of the sheath and an exterior of the filler, wherein the sheath limits contact between the polymeric container and the filler, and wherein sterilized air passes through the air passageway and is expelled adjacent the tip of the filler and upstream of the albumin exit.
24. The method of Claim 13, further comprising the step of filtering the albumin through a 0.2 micron filter.
25. A method of packaging albumin protein in a series of flexible polymeric containers, comprising the steps of:
providing a quantity of filtered albumin;
providing a flexible polymeric material;
providing a form-fill-seal packaging machine and converting the flexible polymeric material into a tube with a former in the form-fill-seal packaging machine;
converting the tube into a series of bags in the form-fill-seal packaging machine;

filling the bags, through an opening in the bags, with a quantity of albumin within the form-fill-seal packaging machine; and, sealing a seal area of the opening of the bags with the packaging machine to enclose the quantity of the albumin within the bags.
26. The method of Claim 25, wherein the bags are sequentially filled with the quantity of albumin.
27. The method of Claim 25, further comprising a filler discharging albumin from the filler and into the bag without contacting the seal area of the opening of the bag.
28. A process of packaging albumin in a flexible polymeric container, comprising the steps of:
providing a concentrate of albumin;
providing a packaging machine having a filling assembly and a sealing assembly, the filling and sealing assemblies being located within an interior aseptic environment of the packaging machine;
providing a sterile flexible polymeric container having an opening extending into a cavity;
filling the container with albumin under pressure through the filling assembly within the aseptic area of the packaging machine, the filling assembly having a fill tube exit positioned a distance from a wall of the flexible polymeric container, the fill tube exit directing the albumin into the cavity of the container distal the periphery of the opening of the container, and the fill tube maintaining the albumin in the fill tube a distance from the fill tube exit during filling suspension; and, sealing the opening of the container within the aseptic area of the packaging machine to retain the albumin within the cavity of the container.
29. The method of Claim 28, further comprising the step of providing a sheath exterior to a portion of the filling assembly, the sheath limiting contact between the polymeric container and the filling assembly.
30. A process of packaging albumin in a flexible polymeric container, comprising the steps of:
providing a concentrate of albumin;
providing a packaging machine having a forming assembly, a filling assembly, and a sealing assembly, each of which is located within an interior aseptic environment of the packaging machine;
providing a flexible polymeric film;
forming the flexible polymeric film into an elongated tube with the forming assembly;
sealing a portion of the elongated tube of polymeric film with the sealing assembly, the sealed polymeric film being dimensioned in the shape of a bag having seal areas about a periphery thereof, a cavity located within the bag and between the seal areas, and an opening extending from the cavity to an exterior of the bag;
filling the bag with albumin under a solution line pressure through the filling assembly, the filling assembly having a fill tube extending through the opening of the bag and into the cavity of the bag, and a sheath concentric to an exterior of the fill tube, the fill tube directing the albumin into an interior of the bag a distance away from a periphery of the opening of the bag, and the sheath limiting contact between the fill tube and the bag; and, sealing the opening of the bag to retain the albumin within the cavity of the bag.
31. The process of Claim 30, wherein the seal areas are provided about the entire periphery of the bag except for the opening.
32. The process of Claim 30, further comprising converting the tube into a plurality of adjacent bags.
33. The process of Claim 32, further comprising sealing at least three sides of the bags.
34. The process of Claim 32, further comprising sequentially filling the bags with the quantity of albumin.
35. The process of Claim 34, further comprising sequentially sealing the opening of the bags.
36. The process of Claim 30, wherein the filling step comprises providing a filler having a tip with concentric first and second interior passageways, the first interior passageway having a cross-sectional area greater than a cross-sectional area of the second interior passageway, wherein an interface between the first and second interior passageways is interior of an exterior of the tip, wherein the second interior passageway extends to the exterior of the tip, wherein the albumin exits the filler through the second interior passageway, and wherein the albumin is maintained at the interface between the first and second interior passageways during a suspension of filling.
37. A flexible polymeric container for holding a concentrate of water-soluble albumin, comprising:
a bag made from a sheet of flexible polymeric material initially converted into a tube with a former, the tube being subsequently converted into a series of adjacent bags in an aseptic area of a formfill-seal packaging machine, the bags having a first side member, a second side member peripherally sealed to the first side member, and a cavity between an interior of the first and second side members, wherein a quantity of a concentration of water-soluble albumin is located within the cavity of the bag following sequential filling of the albumin into the cavity of adjacent bags through an opening of the bags with a filler in the aseptic area of the form-fill-seal packaging machine, the opening of the bags being sealed sequentially within the aseptic area of the form-fill-seal packaging machine to create a fluid-tight chamber.
38. The flexible polymeric container of Claim 37, wherein the flexible polymeric sheet material comprises a laminate film having an outside layer of linear low density polyethylene, a gas barrier layer, a core layer of polyamide, and an inside layer of linear low density polyethylene, the layers being bonded together by a polyurethane adhesive.
39. The flexible polymeric container of Claim 38, wherein the gas barrier layer is a polyvinylidene chloride.
40. The flexible polymeric container of Claim 37, wherein the core layer of polyamide is a nylon.
41. The flexible polymeric container of Claim 38, wherein the gas barrier layer is constructed from SARAN.
42. A flexible polymeric container filled with albumin, comprising:
an outer shell made of a flexible polymeric sheet material, the material comprising a laminate film having an outside layer of linear low density polyethylene adhesively bonded together with a polyurethane adhesive to a first side of a polyvinylidene chloride layer, a second side of the polyvinylidene chloride layer being adhesively bonded together to a first side of a layer of SARAN, the second side of the layer of SARAN being adhesively bonded together with a polyurethane adhesive to an inside layer of linear low density polyethylene, the outer shell having a first side and an opposing second side heat sealed together at a periphery of the outer shell, and a cavity located between the first and second sides, the cavity forming a fluid-tight chamber having a concentration of albumin stored therein, wherein a fitment extends from the outer shell, the fitment having a sealed passageway extending into the cavity of the container to allow the albumin to be released from the fluid-tight chamber.
43. A container for holding albumin comprising:
a sheet of flexible polymeric film formed into a bag having a cavity enclosed by a first wall, an opposing second wall, and seals about a periphery of the first and second walls, the seals joining an interior portion of the opposing first and second walls and creating a fluid-tight chamber within the cavity of the container, wherein a concentration of albumin mixed with a solution of sterile water and stabilizers is stored within the fluid-tight chamber.
44. The container of Claim 43, wherein the bag has a plurality of peripheral edges, three of the peripheral edges being sealed with heat, and one of the peripheral edges containing a fold that separates the first wall from the opposing second wall.
45. The container of Claim 44, wherein a fitment is connected to the container adjacent the fold, the fitment having a passageway that cooperates with the fluid-tight chamber of the container.
46. The container of Claim 44, wherein the peripheral edge opposing the fold contains a first longitudinal seal and a second longitudinal seal, the first and second longitudinal seals joining the first and second opposing walls, and wherein an aperture is located between the first longitudinal seal and the second longitudinal seal, the aperture extending through the first and second opposing walls.
47. The container of Claim 45, further comprising at least one chevron seal in the fold.
48. The container of Claim 45, further comprising a chevron seal in the fold on opposing sides of the fitment.
CA2440444A 2001-03-12 2002-03-12 Albumin in a flexible polymeric container Expired - Lifetime CA2440444C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/804,047 2001-03-12
US09/804,047 US20020124526A1 (en) 2001-03-12 2001-03-12 Albumin in a flexible polymeric container
PCT/US2002/007581 WO2002072429A1 (en) 2001-03-12 2002-03-12 Albumin in a flexible polymeric container

Publications (2)

Publication Number Publication Date
CA2440444A1 true CA2440444A1 (en) 2002-09-19
CA2440444C CA2440444C (en) 2010-02-23

Family

ID=25188062

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2440444A Expired - Lifetime CA2440444C (en) 2001-03-12 2002-03-12 Albumin in a flexible polymeric container

Country Status (17)

Country Link
US (1) US20020124526A1 (en)
EP (1) EP1368238B1 (en)
JP (2) JP4636782B2 (en)
CN (1) CN1245310C (en)
AU (2) AU2002254196B2 (en)
BR (2) BRPI0208033B1 (en)
CA (1) CA2440444C (en)
CZ (1) CZ304107B6 (en)
DK (1) DK1368238T3 (en)
ES (1) ES2492890T3 (en)
HU (1) HU228558B1 (en)
MX (1) MXPA03008320A (en)
NZ (1) NZ528791A (en)
PL (1) PL226183B1 (en)
RU (1) RU2287462C2 (en)
SK (1) SK287656B6 (en)
WO (1) WO2002072429A1 (en)

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Also Published As

Publication number Publication date
CZ304107B6 (en) 2013-10-30
AU2002254196B2 (en) 2007-08-23
JP2004532059A (en) 2004-10-21
CN1245310C (en) 2006-03-15
JP2008273631A (en) 2008-11-13
CZ20032779A3 (en) 2004-08-18
AU2007203131B2 (en) 2009-11-26
HUP0303414A2 (en) 2004-03-01
AU2007203131A1 (en) 2007-07-26
RU2287462C2 (en) 2006-11-20
WO2002072429A1 (en) 2002-09-19
EP1368238A1 (en) 2003-12-10
SK287656B6 (en) 2011-05-06
CA2440444C (en) 2010-02-23
MXPA03008320A (en) 2003-12-11
BR0208033A (en) 2004-02-25
JP4636782B2 (en) 2011-02-23
HU228558B1 (en) 2013-03-28
PL364663A1 (en) 2004-12-13
US20020124526A1 (en) 2002-09-12
HUP0303414A3 (en) 2006-03-28
EP1368238B1 (en) 2014-05-07
ES2492890T3 (en) 2014-09-10
BRPI0208033B1 (en) 2018-11-21
SK12702003A3 (en) 2004-06-08
PL226183B1 (en) 2017-06-30
RU2003130086A (en) 2005-02-27
WO2002072429A9 (en) 2002-12-19
DK1368238T3 (en) 2014-06-23
NZ528791A (en) 2005-10-28
CN1541172A (en) 2004-10-27

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