EP1368238B1 - Albumin in einem flexiblen polymerischen behälter - Google Patents

Albumin in einem flexiblen polymerischen behälter Download PDF

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Publication number
EP1368238B1
EP1368238B1 EP02723415.2A EP02723415A EP1368238B1 EP 1368238 B1 EP1368238 B1 EP 1368238B1 EP 02723415 A EP02723415 A EP 02723415A EP 1368238 B1 EP1368238 B1 EP 1368238B1
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EP
European Patent Office
Prior art keywords
albumin
container
interior
filler
bags
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.)
Expired - Lifetime
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EP02723415.2A
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English (en)
French (fr)
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EP1368238A1 (de
Inventor
James D. Lewis, Jr.
William Baccia
Josef Schmidt
Johan Vandersande
John Carl Card
Theodor Langer
Georg Habison
Helmut Eder
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Baxter Healthcare SA
Baxter International Inc
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Baxter Healthcare SA
Baxter International Inc
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Application filed by Baxter Healthcare SA, Baxter International Inc filed Critical Baxter Healthcare SA
Publication of EP1368238A1 publication Critical patent/EP1368238A1/de
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    • 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

Definitions

  • the present invention relates generally to the packaging of a protein in a flexible polymeric container, and more specifically to the mass-packaging of albumin in flexible polymeric containers in an aseptic environment of a form-fill-seal packaging machine.
  • peptides and proteins for pharmaceutical or other use are known, including glycoproteins, lipoproteins, imunoglobulins, monoclonal antibodies, enzymes, blood proteins, receptor proteins, and hormones.
  • albumin is a sulfur-containing, water-soluble protein that congeals when heated, and occurs in egg white, milk, blood, and other animal and vegetable tissues and secretions. Albumin is often utilized as a blood expander to assist in maintaining a patient's blood pressure, or sometimes to assist with increasing a patient's blood pressure during blood loss.
  • Proteins such as albumin
  • Adsorption of the protein onto the artificial polymeric surface results in a lowering of the protein content of that solution.
  • Some protein solutions can be adversely affected by protein adsorption onto artificial surfaces through a process called denaturing. Denaturing is a process whereby the protein is not permanently adsorbed onto the polymeric container, but rather the protein molecules are adsorbed onto the container and then released. The adsorption and release can change the shape of the molecule (i.e., denature it). Often, when protein molecules in protein drug solutions have undergone denaturing, there may lose their efficacy and utility.
  • proteins such as albumin have been stored for individual use in glass vials in order to avoid the risk of denaturing. Because of the cost encountered in producing, packaging, boxing, shipping and storing glass vials, as well as the cost and weight of the glass vial, and the ease with which the glass vial may break, a more efficient, inexpensive and user friendly means of packaging proteins such as albumin to possibly eliminate the above drawbacks is desirable.
  • One type of packaging utilized for packaging non-protein pharmaceuticals is polymeric bags formed with a form-fill-seal packaging machine.
  • Form-fill-seal packaging machines are typically utilized to package a product in a flexible container.
  • the form-fill-seal packaging machine provides an apparatus for packaging certain pharmaceuticals and many other products in an inexpensive and efficient manner.
  • the post-packaging step includes placing the sealed package containing the pharmaceutical in an autoclave and steam sterilizing or heating the package and its contents to a required temperature, which is often approximately 121°C (250°F), for a prescribed period of time.
  • This sterilization step operates to kill bacteria and other contaminants found inside the package, whether on the inner layer of film or within the pharmaceutical itself.
  • Certain packaged pharmaceuticals including certain proteins such as albumin, however, generally cannot be sterilized in such a manner. This is because the heat required to kill the bacteria in the autoclaving process destroys or renders useless certain pharmaceuticals. Further, in the case of albumin protein, the heat may operate to congeal the protein.
  • Form-fill-seal packaging may also present other problems beyond sterilization concerns when packaging certain proteins such as albumin.
  • conventional form-fill-seal packaging machinery introduces heat to certain areas of the polymeric material of the package to create seals. If the heat contacts the protein during the sealing process, the protein may congeal or otherwise denature such as during high-temperature sterilization. Further, since certain proteins such as albumin operate as insulators, all seal areas must be free of the protein in order for the polymeric materials to be heat sealed together. If any protein such as albumin is present in the seal area prior to sealing, the integrity of the seal may be jeopardized.
  • EP 0 286 276 discloses an apparatus for removing liquid and residue from a web of film.
  • this document teaches air knives for removing liquid and residue from a web of film in a packaging machine.
  • US 3,286,061 relates to a bag making and liquid filling machine which is particularly adapted for filling thermoplastic film bags with a multigrade or detergent lubricating oil.
  • US 4,692,361 discloses a film laminate for flexible containers 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, all bonded together by a polyurethane adhesive.
  • the flexible polymeric container comprises a sheet of flexible polymeric film formed into a bag.
  • the bag has a cavity enclosed by a first wall and an opposing second wall.
  • the bag further has seals about a periphery of the first and second walls that join an interior portion of the opposing first and second walls to create a fluid-tight chamber within the cavity of the container.
  • a concentration of albumin of at least about 20% is stored mixed with a solution of sterile water and stabilizers within the fluid-tight chamber.
  • the flexible polymeric container for holding a concentrate of water-soluble albumin comprises a sheet of flexible polymeric material that is initially converted into a tube with a former, and is subsequently converted into a series of adjacent bags.
  • the bags have 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.
  • a quantity of a concentration of water-soluble albumin is located within the cavity of the bag.
  • the openings of the bags are subsequently sealed to create a fluid-tight chamber.
  • the container has a plurality of peripheral edges. Three of the peripheral edges are sealed with heat, and one of the peripheral edges contains a fold that separates the first wall or first side member from the opposing second wall or second side member.
  • a fitment is connected to the container adjacent the fold.
  • the fitment extends from the outer shell of the container at the fold and has a sealed passageway that cooperates with the fluid-tight chamber of the container.
  • the sealed passageway extends into the cavity of the container to allow the albumin to be released from the fluid-tight chamber.
  • a chevron may be located a distance from the opposing sides of the fitment, and along the fold, to assist drainage of the albumin from the container.
  • the peripheral edge of the container opposing the fold contains a first seal and a second seal.
  • the first and second seals join the first and second opposing walls.
  • An aperture is located between the first seal and the second seal, and extends through the first and second opposing walls.
  • 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 are bonded together by a polyurethane adhesive.
  • albumin in concentrations of 20% and 25% is packaged in the flexible polymeric container.
  • the flexible polymeric containers may have a volume of 50 ml. or 100 ml.
  • a method of packaging albumin protein comprises 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 providing a filler having 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 opening of the polymeric container and the filler, and wherein sterilized air passes through the air passageway and is expelled adjacent a tip of the filler and upstream of the albumin exit; inserting the albumin under a solution line pressure from about 128.9 KPa (4 psig) to about 239.2 KPa (20 psig) into the cavity of the polymeric container through the opening, and sealing the opening to secure the liquid albumin within a fluid-tight chamber of the cavity of the polymeric container.
  • the filler has a distal tip with adjacent first and second interior passageways.
  • the first interior passageway has a larger cross-sectional area than the second interior passageway.
  • the second interior passageway extends adjacent the first interior passageway to an exterior of the tip, and the albumin is dispersed from the filler through the second interior passageway.
  • the interface between the first and second interior passageways is interior of an exterior of the tip, and the second interior passageway extends to the exterior of the tip.
  • the albumin is maintained at the interface between the first and second interior passageways during a suspension of filling of the bags.
  • albumin is packaged in a series of flexible polymeric containers with a form-fill-seal packaging machine.
  • a quantity of filtered albumin and a flexible polymeric material is provided, and the form-fill-seal packaging machine converts the flexible polymeric material into a series of bags.
  • the bags are filled with a quantity of albumin within the form-fill-seal packaging machine, and a seal area of the bags is sealed with the packaging machine to enclose the quantity of the albumin in the bags.
  • the adjacent bags in the series of bags are initially connected, are sequentially filled with a quantity of albumin, and are separated following the filling of each bag.
  • the form-fill-seal packaging machine has an aseptic area.
  • the sterilized flexible polymeric material is provided within the aseptic area, and is formed into bags within the aseptic area. Additionally, the filtered albumin is inserted into the bags in the aseptic area, and the bags are sealed within the aseptic area to form a fluid-tight container.
  • albumin is packaged in a series of flexible polymeric containers in a form-fill-seal packaging machine with the following process: converting 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; sequentially 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.
  • the bags may be filled with a filler that discharges albumin from the filler and into the bag without contacting the seal area of the opening of the bag.
  • albumin is packaged in a flexible polymeric container with the following process: 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 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 filltube directing the albumin into an interior of the bag a distance away from a
  • a flexible polymeric container for storing albumin made in accordance with the present invention provides an inexpensive, easily manufactured, and efficient package and process which eliminates the drawbacks associated with prior packages and processes for packaging albumin.
  • the breadth of the present disclosure includes the packaging of any type of certain pharmaceutical compounds such as peptides and proteins for pharmaceutical or other use.
  • Such compounds are known and include: glycoproteins, lipoproteins, imunoglobulins, monoclonal antibodies, enzymes, blood proteins, receptor proteins, and hormones.
  • glycoproteins include glycoproteins, lipoproteins, imunoglobulins, monoclonal antibodies, enzymes, blood proteins, receptor proteins, and hormones.
  • the detailed description of the present invention focuses on the packaging of albumin in a flexible polymeric container.
  • a flexible polymeric container 12 holding a concentration of albumin of the present invention is shown a flexible polymeric container 12 holding a concentration of albumin of the present invention.
  • the flexible polymeric container 12 is preferably manufactured by an aseptic form-fill-seal packaging machine 10 as shown in Figure 1 , and utilizing the process schematically illustrated in Figure 2 .
  • the aseptic form-fill-seal packaging machine 10 generally includes an unwind section 14, a film sterilizing section 16, a film drying section 18, an idler roller/dancer roller section 20, a nipped drive roller assembly section (not shown), a forming assembly section 22, a fin seal assembly section 24, a fitment attaching assembly section 26, a filling assembly section 30, an end sealing/cutting assembly section 32, and a delivery section (not shown).
  • Each of these assemblies downstream of the unwind section 14 is contained within the internal aseptic environment of the aseptic form-fill-seal packaging machine 10.
  • the unwind section 14 contains a roll of the flexible polymeric film 34 that is ultimately formed into the container;
  • the film sterilizing section 16 provides a peroxide bath to sterilize the film 34;
  • the film drying section 18 provides a means for drying and cleaning the peroxide from the film 34;
  • the forming assembly 22 provides a forming mandrel 36 to convert the web of film into a tube 38 that ultimately becomes the flexible container or bag 12;
  • the fin seal assembly 24 provides the longitudinal seal 40 on the tube 38 that ultimately becomes the longitudinal seal 40 on the flexible container 12, thereby longitudinally sealing the formed tube 38;
  • the fitment attachment assembly 26 attaches a fitment 42 to the tube 38;
  • the filling assembly 30 includes a filler 44 that fills the flexible containers 12 with a substance, that being a concentration of water-soluble albumin in the present preferred application; and, the end sealing/cutting assembly 32 contains cutting and sealing jaws 46 that form the end seals 76,78 of the flexible polymeric
  • the albumin utilized to be packaged in the flexible polymeric container 12 is either a 20% human albumin or a 25% human albumin.
  • the albumin is typically combined with sterile water and stabilizers.
  • the albumin concentration is pasteurized and stored in large stainless steel holding tanks (not shown) having a volumetric capacity of approximately 500-600 liters, at approximately 2°C to 8°C.
  • the albumin tanks are removed from refrigeration and allowed to equilibrate to the packaging room temperature approximately 20°C (approximately 68°F). It is important to process albumin at temperatures which do not result in denaturing of the protein, approximately below 60° C.
  • the process temperatures 20°C to 25°C (68°F to 77°F). Additionally, the albumin is filtered through a 0.2 micron filter as it enters the packaging machine 10.
  • the flexible polymeric film 34 utilized in the preferred embodiment of the present invention is a linear low density polyethylene laminate. It has been found that such a film with a gas barrier is particularly suitable for housing oxygen labile solutions, such as the identified proteins, including albumin. Specifically, it has been found that this film reduces or eliminates the denaturing process previously associated with placing proteins, such as albumin, in a plastic container. As shown in Figure 9 , in the preferred embodiment the laminate film 34 has an outside layer of linear low density polyethylene (LLDPE) 52, a gas barrier layer 54, a core layer of polyamide 56, and an inside layer of linear low density polyethylene 58, the layers being bonded together by a polyurethane adhesive 60.
  • LLDPE linear low density polyethylene
  • the material requirements of the laminate structure has the following characteristics: a LLDPE layer (approximately 61 ⁇ 10 ⁇ m) 52, a polyurethane adhesive layer 60, a polyvinylidene chloride (PVDC) layer (approximately 19 ⁇ 5 ⁇ m) 54, a polyurethane adhesive layer 60, a nylon layer (approximately 15 ⁇ 5 ⁇ m) 56, a polyurethane adhesive layer 60, and LLDPE layer (approximately 61 ⁇ 10 ⁇ m) 52.
  • the thickness of the film is approximately 160 ⁇ 25 ⁇ m.
  • the PVDC layer 54 is most preferably manufactured by Dow Chemical and sold under the trademark SARAN.
  • the internal aseptic area of the packaging machine Prior to usage, the internal aseptic area of the packaging machine must be sterilized each day. This is accomplished with a hydrogen peroxide fog which is passed through the aseptic area of the packaging machine.
  • the roll of film 34 is located in the unwind section 14 of the packaging machine 10.
  • the film 34 is transferred through a hydrogen peroxide bath 16 to sterilize the film before entering the aseptic area of the packaging machine 10.
  • This sterilization step cleans the web of film so that it can be utilized to create a sterile product. Sterilization and cleansing of the film is critical in the medical industry when one is packaging parenternal or enteral products. This sterilization step is especially critical when the resultant product is not to be terminally sterilized, i.e., when the packaging machine is an aseptic packaging machine.
  • liquid and other residue for example the chemical sterilant or wetting agent such as the hydrogen peroxide typically remains on the film.
  • An air knife a stream of air blown across the web of film so that the liquid contained thereon is blown off the film located in the film drying section 18 is utilized to remove liquid and other residue from the film 34 as the film enters the aseptic area of the packaging machine.
  • the film 34 passes through the dancer roller section 20 and the drive roller section prior to entering the forming assembly section 22.
  • the web of film 34 Before entering the forming assembly 22 the web of film 34 is substantially planar, and has a first surface 62 and a second surface 64.
  • the first surface 62 faces downward as the film enters the forming assembly 22 and ultimately becomes an interior of the container 12, while the second surface 64 faces upward as the film enters the forming assembly 22 and ultimately becomes the outside of the container 12.
  • the film 34 additionally has a theoretical fold-line approximately located about a centerline of the length of the web of film 34.
  • the theoretical fold-line becomes a fold area 67 that separates the first side member 66 or first wall from the second side member 68 or second wall of the container 12.
  • a forming mandrel 36 is located in the forming assembly section 22.
  • the forming mandrel 36 assists in converting the substantially planar web of polymeric material 34 into an elongated and substantially tubular member 38.
  • the elongated tubular member 38, or tube is generally not cylindrical, but rather has an oblong shape as shown in Figure 4 .
  • the first surface 62 of the first side member 66 opposes the first surface 62 of the second side member 68.
  • the tubular member 38 receives a longitudinal seal 40 in the fin seal assembly section 24, and a fitment 42 is connected to the tube 38 in the fitment attachment assembly 26.
  • fitment 42 is attached to and extends from the outer shell of the container 12 at the fold area 67 with the use of a heated assembly to seal the fitment 42 to the fold area 67 of the container 12.
  • the fitment sealer operates at a temperature from about 212.7°C to about 232.2°C (415°F to about 450°F), and with a pressure from about 480.5 kPa to about 583.9 kPa (55 psig to about 70 psig), although any range within these identified ranges is acceptable.
  • the fitment 42 has a sealed passageway that cooperates with the interior of the tube 38. Specifically, the passageway extends into and creates a fluid communication with the cavity 82 of the container to allow the albumin to be released from the fluid-tight chamber. It should be understood that in some embodiments the albumin may be injected into the cavity 82 of the container 12 through the fitment 42.
  • the fin seal assembly 24 introduces heat and pressure to the film 34 to create the longitudinal seal 40 at the peripheral edge of the tube 38 that opposes the fold area 67.
  • the fin seal assembly operates at a temperature from about 176.7°C to about 193.3°C (350°F to about 380°F), and with a pressure from about 377.1 kPa to 652.9 kPa (40 psig to about 80 psig), although any range within these identified ranges is acceptable
  • the longitudinal seal 40 comprises a first longitudinal seal 70 and a second longitudinal seal 72.
  • the first and second longitudinal seals 70,72 join the first surface 62 of the first wall 66 to the opposing first surface 62 of the second wall 68.
  • An aperture 74 typically utilized to hang a formed container 12, is created between the first longitudinal seal 70 and the second longitudinal seal 72. Accordingly, the aperture 74 extends through the first and second opposing walls 66,68.
  • the sealed tubular member 38 traverses from the fin seal assembly 24 to the filling assembly 30 and the end sealing assembly 32.
  • the form-fill-seal packaging machine 10 utilizes heat and pressure to convert the sealed tube 38 into a series of bags 12, also referred to as containers 12.
  • the end sealing assembly operates at a temperature from about 190.5°C to about 207.2°C (375°F to about 405°F), and with a pressure from about 3548.7 kPa (500 psig to about 5961.9 kPa about 850 psig), although any range within these identified ranges is acceptable.
  • the sealed tube 38 first receives a bottom seal 76 to initially form the bag 12 having a cavity 82 located between the first and second sides 66,68 of the container 12 and the bottom seal 76 of the container, and an opening 80 that extends from the cavity 82 of the container 12 to an exterior of the container 12. It should be understood that during the form-fill-seal manufacturing process, the opening 80 extends from the cavity 82 of the container 12 into the center of the tube 38. Once the bottom seal 76 is created, the bag 12 is filled with the albumin through the opening 80, and then the top seal 78 is formed, thus sealing or closing the opening 80 and creating a fluid-tight chamber 82 wherein the albumin is retained.
  • the polymeric film 34 can be said to be dimensioned in the shape of the open bag 12, having seal areas about its periphery (the longitudinal seal 34 opposing the fold area 67, and the bottom seal 76 joining the fold area 67 and the longitudinal seal 40), and having a cavity 82 located within the bag 12 and between the seal areas 40, 76 and the fold area 67.
  • the finished container 12 has sealed areas on three sides of the bag 12: the top seal 78, the bottom seal 76, and the longitudinal seal 40.
  • the longitudinal seal 40 joins the top seal 78 and the bottom seal 76.
  • the top seal 78 of a first bag 12 is formed at the same time as the bottom seal 76 of an adjacent upstream bag 12 with the end sealing assembly 32.
  • adjacent bags 12 in the series of bags 12 are initially connected, both by being part of the tubular member 38 that forms the bags 12, as well as by having end seals that are formed with the same end sealing assembly 32.
  • the containers 12 are filled with the albumin through a filling assembly 30 that extends down the tube 38.
  • the filling assembly 30 thus fills the cavity 82 of the bag 12 through the opening 80 of the in-process three-sided and open bag 12.
  • the filling assembly 30 of the preferred embodiment is illustrated in Figures 5-8 and 10 .
  • the filling assembly 30 comprises a pressurized filler 44 made up of a fill tube 84, and a sheath 86 located concentrically about the perimeter of the fill tube 84.
  • the filler 44 typically operates under a solution line pressure of from about 128.9 kPa to about 239.2 kPa (4 psig. to about 20 psig.), however, any range of pressures within the identified range is acceptable.
  • the filler operates under a solution line pressure of from about 170.3 kPa to about 211.6 kPa (10 psig.
  • the filler 44 of the filling assembly 30 is configured as a tube 86 overa tube 84.
  • the sheath tube 86 is situated concentric about the fill tube 84, with an air passageway 88 extending in the space between the inner diameter of the sheath tube 86 and the outer diameter of the fill tube 84. Sterilized air passes through the air passageway and is expelled adjacent a tip of the fill tube 84, upstream of a fill tube exit 92.
  • the fill tube 84 has a venturi 85 in that it tapers from a first diameter to a second larger diameter about its length.
  • the tip 90 of the fill tube 84 has a first interior passageway 94 concentric with and adjacent a second interior passageway 96.
  • the first interior passageway 94 is generally circular in cross-sectional shape, having a first interior diameter
  • the second interior passageway 96 is generally circular in cross-sectional shape, having a second interior diameter.
  • the interior diameter, and thus the cross-sectional area of the first interior passageway 94 is dimensioned larger than the interior diameter, and thus the cross-sectional area of the second interior passageway 96.
  • An interface 98 connects the first interior passageway 94 and the second interior passageway 96 at a location that is interior of an exterior of exit 92 of the tip 90 of the filler 44.
  • the interface comprises a chamfered step 98 between the first and second interior passageways 94,96 to sharply reduce the diameter from the first interior passageway 94 to the second interior passageway 96.
  • the interface 98 between the first and second passageways 94,96 provides a important function in the operation of the filler.
  • any migration may allow the albumin to be transferred onto an exterior of the filler and contact the film 34.
  • albumin operates as an insulator. If the albumin migrated onto the film it would likely jeopardize the integrity of the top seal area.
  • the configuration of the present invention provides a means for eliminating this drawback. In testing conducted on the seal integrity of the containers 12 of the present invention, 99.90% of the formed containers 12 were above the minimum seal strength value of 239.2 kPa (20 psi) in burst test evaluation.
  • the sheath 86 resides concentrically about a perimeter of the fill tube 84, and an air passageway 88 extends in the space between the inner diameter of the sheath tube 86 and the outer diameter of the fill tube 84. While in the preferred embodiment the distal end portion 100 of the sheath 86 is an adapter that is mounted on the sheath 86, the distal end portion 100 may be manufactured as part of the sheath 86 without destroying the intended function of the sheath 86. As shown in Figures 7 and 8 , the distal end portion 100 of the sheath 86 has a chamfered end 104. A plurality of vent holes 102 are located adjacent the end of the distal end portion 100 of the sheath 86.
  • the sterilized air is dispelled from the air passageway 88 out of the vent holes 102. Since the exit of the vent holes 102 resides at the chamfered end 104 of the sheath 86, the flow pattern of the sterilized air is circumferentially exterior to the flow pattern of the albumin being dispelled from the fill tip so as not to interfere with the flow of the albumin. This decreases the chances of the sterilized air from introducing a turbulent effect to the dispensed albumin. Additionally, since the air flow pattern is exterior to and away from the liquid flow pattern of the albumin, any possible foaming of the albumin that may come in contact with the air is minimized.
  • the benefits uncovered with the flow of the sterilized air are extremely useful. Such a configuration greatly assists in preventing splashing and foaming of the albumin from the exit of the filler. This, prevents contact by the albumin with the portion of the film that is converted into the top seal area, thereby also aiding in continually creating a stronger top seal.
  • the first interior diameter 106 of the distal end portion 100 of the sheath 86 is dimensioned to fit onto the sheath 86 and be secured thereto with a setscrew 110.
  • the second interior diameter 108 of the distal end portion 100 of the sheath 86 is dimensioned to provide the air passageway 88 between the sheath 86 and the fill tube 84.
  • a chamfer 112 is located at the end of the second interior diameter 108 to further reduce the inside diameter of the sheath 86.
  • a reverse chamfer 114 is located at an exterior portion of the end of the sheath 86.
  • the sheath 86 and fill tube 84 are shown as assembled in Figure 10 .
  • the outside diameter of the fill tube 84 is dimensioned to be the same as or slightly less than the reduced inside diameter of the sheath 86 at the chamfer 112.
  • the second interior diameter of the sheath 86 is approximately 0.584 inch, and is decreased at the chamfer 112 to approximately 0.500 inch.
  • the outside diameter of the fill tube 84 of the preferred embodiment of the present invention is approximately 0.500 inch.
  • interface between the chamfer 112 and the fill tube 86 operates to close the air passageway 88 and force the sterilized air out the vent holes 102 located upstream of the exit 92 of the second interior passageway of albumin fill tube 84.
  • the outside diameter of the sheath 86 is larger than the outside diameter of the fill tube 84 protruding past the sheath 86.
  • the tube 38 of film contacts the filling assembly 30.
  • the sheath 86 is exterior to a portion of the fill tube 84, and thus only the sheath 86 can contact the tube 38, thereby preventing contact between the polymeric container and the fill tube 84.
  • the exit 92 of the fill tube 84 is positioned a distance away from the interior wall of the flexible polymeric container 12.
  • the position and size of the sheath 86 in combination with the interior interface 98 of the first and second interior passageways, and the reverse chamfer 114 prevents any albumin from migrating to an exterior of the filling assembly 30 and coming in contact with the seal areas of the tube 38 that ultimately become the top seal 78 of the finished container. Since albumin operates as an insulator, it is necessary to maintain all seal areas free of the protein in order for the polymeric materials to be heat sealed together. If any albumin was present in the seal area prior to sealing, the integrity of the seal may be jeopardized. As such, with the identified configuration, the albumin is discharged from the fill tube 84 and into the bottom of the bag 12 without contacting the seal area of the opening of the bag 12 that ultimately becomes the top seal 78.

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Claims (29)

  1. Verfahren zum Verpacken eines Albuminproteins, das die Schritte umfasst:
    Bereitstellen eines flexiblen polymeren Behälters (12), der eine Öffnung aufweist, die sich von einem Hohlraum (82) des polymeren Behälters (12) erstreckt,
    Bereitstellen einer Menge einer Konzentration von Albumin in einer sterilen Lösung,
    Bereitstellen einer Fülleinrichtung (44), die eine Außenhülle (86), die mit der Fülleinrichtung (44) konzentrisch ist, und einen Luftdurchgang (88) aufweist, der sich zwischen einem Inneren der Hülle (86) und einem Äußeren der Fülleinrichtung (44) erstreckt, wobei die Hülle (86) einen Kontakt zwischen der Öffnung des polymeren Behälters (12) und der Fülleinrichtung (44) begrenzt und wobei sterilisierte Luft durch den Luftdurchgang hindurchtritt und angrenzend an eine Spitze der Fülleinrichtung (44) und stromaufwärts von dem Albuminaustritt ausgestoßen wird,
    Einbringen des Albumins bei einem Lösungsleitungsdruck von etwa 128,9 kPa (4 psig) bis etwa 239,2 kPa (20 psig) in den Hohlraum (82) des polymeren Behälters (12) durch die darin vorliegende Öffnung und
    Verschließen der Öffnung zum Halten des flüssigen Albumins innerhalb einer fluiddichten Kammer des Hohlraums des polymeren Behälters (12).
  2. Verfahren nach Anspruch 1, bei dem das Albumin vor dem Einbringen in den Hohlraum (82) des Behälters (12) bei einer Temperatur von etwa 20 °C (68 °F) gehalten wird.
  3. Verfahren nach Anspruch 1, bei dem das Albumin in den Hohlraum (82) des flexiblen polymeren Behälters (12) bei einem Lösungsleitungsdruck von etwa 184,1 kPa (12 psig) bis etwa 211,6 kPa (16 psig) eingebracht wird.
  4. Verfahren nach Anspruch 1, bei dem der flexible polymere Behälter (12) innerhalb einer aseptischen Umgebung einer Form-Füll-Siegel-Verpackungsmaschine (10) bereitgestellt wird, wobei das Albumin in den Hohlraum (82) des flexiblen polymeren Behälters (12) innerhalb der aseptischen Umgebung der Form-Füll-Siegel-Verpackungsmaschine (10) eingebracht wird und wobei die Öffnung des Behälters (12) innerhalb der aseptischen Umgebung der Form-Füll-Siegel-Verpackungs-maschine (10) verschlossen wird.
  5. Verfahren nach Anspruch 1, bei dem die Spitze der Fülleinrichtung (44) einen ersten und einen zweiten inneren Durchgang (94, 96), die benachbart sind, umfasst, wobei der erste innere Durchgang (94) eine größere Querschnittsfläche aufweist als der zweite innere Durchgang (96), wobei sich der zweite innere Durchgang (96) benachbart zu dem ersten inneren Durchgang (94) zu einem Äußeren der Spitze erstreckt und wobei das Albumin von der Fülleinrichtung (44) durch den zweiten inneren Durchgang (96) abgegeben wird.
  6. Verfahren nach Anspruch 5, bei dem der erste und der zweite innere Durchgang (94, 96) konzentrisch sind, wobei der erste innere Durchgang (94) einen Innendurchmesser aufweist, der größer dimensioniert ist als ein Innendurchmesser des zweiten inneren Durchgangs (96).
  7. Verfahren nach Anspruch 1, bei dem das Albumin in einer Konzentration von 20 % bereitgestellt wird.
  8. Verfahren nach Anspruch 1, bei dem das Albumin in einer Konzentration von 25 % bereitgestellt wird.
  9. Verfahren nach Anspruch 1, bei dem der flexible Kunststoffbehälter so bereitgestellt wird, dass er ein Volumen von 50 ml aufweist.
  10. Verfahren nach Anspruch 1, bei dem der flexible Kunststoffbehälter so bereitgestellt wird, dass er ein Volumen von 100 ml aufweist.
  11. Verfahren nach Anspruch 1, das ferner das Bereitstellen eines flexiblen polymeren Behälters (12) umfasst, der eine Laminatfolie (34) umfasst, die eine Außenschicht aus linearem Polyethylen mit niedriger Dichte, eine Gassperrschicht, eine Kernschicht aus Polyamid und eine Innenschicht aus linearem Polyethylen mit niedriger Dichte aufweist, wobei die Schichten durch ein Polyurethanhaftmittel aneinander gebunden sind.
  12. Verfahren nach Anspruch 1, bei dem ein filtriertes Albuminprotein in einer Reihe von flexiblen polymeren Behältern verpackt wird und bei dem der Schritt des Bereitstellens eines flexiblen polymeren Behälters umfasst:
    Bereitstellen eines flexiblen polymeren Materials (34),
    Bereitstellen einer Form-Füll-Siegel-Verpackungsmaschine (10) und Umwandeln des flexiblen polymeren Materials (34) in eine Reihe von Beuteln (12) in der Form-Füll-Siegel-Verpackungsmaschine, und wobei der Schritt des Einbringens des Albumins umfasst:
    Füllen der Beutel (12) mit einer Menge von Albumin innerhalb der Form-Füll-Siegel-Verpackungsmaschine (10), und wobei der Schritt des Verschließens der Öffnung umfasst:
    Verschließen eines Verschlussbereichs der Beutel mit der Verpackungsmaschine (10) zum Einschließen der Menge von Albumin innerhalb der Beutel (12).
  13. Verfahren nach Anspruch 12, bei dem benachbarte Beutel (12) in der Reihe von Beuteln (12) zunächst verbunden sind und nach dem Füllen jedes Beutels (12) getrennt werden.
  14. Verfahren nach Anspruch 13, das ferner das Bereitstellen eines Formdorns (36) in der Form-Füll-Siegel-Verpackungsmaschine (10) umfasst.
  15. Verfahren nach Anspruch 14, das ferner das Formen des flexiblen polymeren Materials (34) zu einem Schlauch (38) mit dem Formdorn (36) und weiter Formen des Schlauchs (38) zu der Reihe von benachbarten Beuteln (12) umfasst.
  16. Verfahren nach Anspruch 12, bei dem die Beutel (12) nacheinander mit der Menge von Albumin gefüllt werden.
  17. Verfahren nach Anspruch 12, das ferner das Heißsiegeln eines Umfangs der Beutel (12) zum Einschließen der Menge von Albumin innerhalb der Beutel (12) umfasst.
  18. Verfahren nach Anspruch 12, bei dem der flexible polymere Behälter (12) eine Laminatfolie (34) umfasst, die eine Außenschicht aus linearem Polyethylen mit niedriger Dichte, eine Gassperrschicht, eine Kernschicht aus Polyamid und eine Innenschicht aus linearem Polyethylen mit niedriger Dichte aufweist, wobei die Schichten durch ein Polyurethanhaftmittel aneinander gebunden sind.
  19. Verfahren nach Anspruch 12, bei dem die Form-Füll-Siegel-Verpackungsmaschine (10) einen aseptischen Bereich aufweist, wobei das flexible polymere Material (34) innerhalb des aseptischen Bereichs bereitgestellt wird und innerhalb des aseptischen Bereichs zu einer Reihe von benachbarten Beuteln (12) geformt wird, wobei das Albumin in dem aseptischen Bereich aufeinander folgend in die Beutel (12) eingebracht wird und wobei die Beutel (12) innerhalb des aseptischen Bereichs aufeinander folgend verschlossen werden, so dass ein fluiddichter Behälter (12) gebildet wird.
  20. Verfahren nach Anspruch 12, bei dem die Spitze der Fülleinrichtung (44) einen ersten und einen zweiten inneren Durchgang (94, 96), die konzentrisch sind, umfasst, wobei der erste innere Durchgang (94) eine Querschnittsfläche aufweist, die größer ist als eine Querschnittsfläche des zweiten inneren Durchgangs (96), wobei eine Übergangsstelle zwischen dem ersten und dem zweiten inneren Durchgang (94, 96) einwärts von einem Äußeren der Spitze vorliegt, wobei sich der zweite innere Durchgang (96) zu dem Äußeren der Spitze erstreckt, wobei das Albumin durch den zweiten inneren Durchgang (96) aus der Fülleinrichtung (44) austritt, und wobei das Albumin während einer Unterbrechung des Füllens an der Übergangsstelle zwischen dem ersten und dem zweiten inneren Durchgang (94, 96) gehalten wird.
  21. Verfahren nach Anspruch 12, das ferner den Schritt des Filtrierens des Albumins durch ein 0,2 Mikrometer-Filter umfasst.
  22. Verfahren nach Anspruch 1, bei dem Albumin in einem sterilen flexiblen polymeren Behälter (12) verpackt wird, umfassend die Schritte:
    Bereitstellen einer Verpackungsmaschine (10) mit einer Füllanordnung (30) und einer Verschließanordnung (32), wobei sich die Füllanordnung und die Verschließanordnung (30, 32) innerhalb einer inneren aseptischen Umgebung der Verpackungsmaschine (10) befinden,
    und wobei der Schritt des Einbringens des Album ins das Füllen des Behälters (12) mit Albumin unter Druck durch die Füllanordnung (30) innerhalb des aseptischen Bereichs der Verpackungsmaschine (10) umfasst, wobei bei der Füllanordnung (30) der Fülleinrichtungsaustritt in einem Abstand von einer Wand des flexiblen polymeren Behälters (12) angeordnet ist, wobei der Fülleinrichtungsaustritt das Albumin in den Hohlraum (82) des Behälters (12) distal zu dem Umfang der Öffnung des Behälters (12) leitet und die Fülleinrichtung (44) das Albumin in der Fülleinrichtung (44) während einer Unterbrechung des Füllens in einem Abstand von dem Fülleinrichtungsaustritt hält, und wobei der Schritt des Verschließens der Öffnung umfasst:
    Verschließen der Öffnung des Behälters (12) innerhalb des aseptischen Bereichs der Verpackungsmaschine (10) zum Halten des Albumins innerhalb des Hohlraums (82) des Behälters (12).
  23. Verfahren nach Anspruch 1, bei dem der Schritt des Bereitstellens eines flexiblen polymeren Behälters (12) umfasst:
    Bereitstellen einer Verpackungsmaschine (10), die eine Formanordnung (22), eine Füllanordnung (30) und eine Verschließanordnung (32) aufweist, die sich jeweils innerhalb einer inneren aseptischen Umgebung der Verpackungsmaschine (10) befinden,
    Bereitstellen einer flexiblen polymeren Folie (34),
    Formen der flexiblen polymeren Folie (34) zu einem länglichen Schlauch mit der Formanordnung (22),
    Verschließen eines Teils des länglichen Schlauchs aus der polymeren Folie (34) mit der Verschließanordnung (32), wobei die verschlossene polymere Folie in der Gestalt eines Beutels (12) dimensioniert ist, der Verschlussbereiche um einen Umfang davon, einen Hohlraum (82), der sich innerhalb des Beutels (12) und zwischen den Verschlussbereichen befindet, und eine Öffnung aufweist, die sich von dem Hohlraum (82) zu einem Äußeren des Beutels erstreckt, und wobei der Schritt des Füllens des Albumins umfasst:
    Füllen des Beutels (12) mit Albumin bei einem Lösungsleitungsdruck durch die Füllanordnung (30), wobei die Füllanordnung (30) die Fülleinrichtung (44) aufweist, die sich durch die Öffnung des Beutels (12) und in den Hohlraum des Beutels (12) erstreckt, wobei die Fülleinrichtung das Albumin in ein Inneres des Beutels (12) in einem Abstand entfernt von einem Umfang der Öffnung des Beutels (12) leitet, und wobei der Schritt des Verschließens der Öffnung umfasst:
    Verschließen der Öffnung des Beutels (12) zum Halten des Albumins innerhalb des Hohlraums des Beutels (12).
  24. Verfahren nach Anspruch 23, bei dem die Verschlussbereiche um den gesamten Umfang des Beutels (12) mit Ausnahme der Öffnung bereitgestellt sind.
  25. Verfahren nach Anspruch 23, das ferner das Umwandeln des Schlauchs in eine Mehrzahl von benachbarten Beuteln (12) umfasst.
  26. Verfahren nach Anspruch 25, das ferner das Verschließen von mindestens drei Seiten der Beutel (12) umfasst.
  27. Verfahren nach Anspruch 25, das ferner das aufeinander folgende Füllen der Beutel (12) mit der Menge von Albumin umfasst.
  28. Verfahren nach Anspruch 27, das ferner das aufeinander folgende Verschließen der Öffnung der Beutel (12) umfasst.
  29. Verfahren nach Anspruch 23, bei dem die Spitze der Fülleinrichtung einen ersten und einen zweiten inneren Durchgang (94, 96), die konzentrisch sind, umfasst, wobei der erste innere Durchgang (94) eine Querschnittsfläche aufweist, die größer ist als eine Querschnittsfläche des zweiten inneren Durchgangs (96), wobei eine Übergangsstelle zwischen dem ersten und dem zweiten inneren Durchgang (94, 96) einwärts von einem Äußeren der Spitze vorliegt, wobei sich der zweite innere Durchgang (96) zu dem Äußeren der Spitze erstreckt, wobei das Albumin durch den zweiten inneren Durchgang (96) aus der Fülleinrichtung (44) austritt, und wobei das Albumin während einer Unterbrechung des Füllens an der Übergangsstelle zwischen dem ersten und dem zweiten inneren Durchgang (94, 96) gehalten wird.
EP02723415.2A 2001-03-12 2002-03-12 Albumin in einem flexiblen polymerischen behälter Expired - Lifetime EP1368238B1 (de)

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US804047 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

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