EP3049045B1 - Agencement de produit de nutrition - Google Patents

Agencement de produit de nutrition Download PDF

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Publication number
EP3049045B1
EP3049045B1 EP14771339.0A EP14771339A EP3049045B1 EP 3049045 B1 EP3049045 B1 EP 3049045B1 EP 14771339 A EP14771339 A EP 14771339A EP 3049045 B1 EP3049045 B1 EP 3049045B1
Authority
EP
European Patent Office
Prior art keywords
connector
receptacle
container
diaphragm
food
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.)
Active
Application number
EP14771339.0A
Other languages
German (de)
English (en)
Other versions
EP3049045A1 (fr
Inventor
Torsten Brandenburger
Ismael Rahimy
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.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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 Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Priority to EP14771339.0A priority Critical patent/EP3049045B1/fr
Publication of EP3049045A1 publication Critical patent/EP3049045A1/fr
Application granted granted Critical
Publication of EP3049045B1 publication Critical patent/EP3049045B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • A61J1/1443—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
    • 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
    • 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
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
    • 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
    • B65B39/007—Guides or funnels for introducing articles 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
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/08—Sterilising wrappers or receptacles prior to, or during, packaging by irradiation
    • 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
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • 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
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/38—Devices for discharging contents
    • B65D25/40—Nozzles or spouts
    • B65D25/48—Separable nozzles or spouts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D43/00—Lids or covers for rigid or semi-rigid containers
    • B65D43/02—Removable lids or covers
    • B65D43/0235—Removable lids or covers with integral tamper element
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/04—Closures with discharging devices other than pumps
    • B65D47/06—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/04—Closures with discharging devices other than pumps
    • B65D47/06—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages
    • B65D47/10—Closures with discharging devices other than pumps with pouring spouts or tubes; with discharge nozzles or passages having frangible closures
    • B65D47/103—Membranes with a tearing element
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5861—Spouts
    • B65D75/5872—Non-integral spouts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D85/00—Containers, packaging elements or packages, specially adapted for particular articles or materials
    • B65D85/70—Containers, packaging elements or packages, specially adapted for particular articles or materials for materials not otherwise provided for
    • B65D85/72—Containers, packaging elements or packages, specially adapted for particular articles or materials for materials not otherwise provided for for edible or potable liquids, semiliquids, or plastic or pasty materials
    • 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1418—Threaded type

Definitions

  • the present invention relates to the field of a food arrangement comprising a container filled with a liquid nutritional substance for the clinical nutrition and a method for producing and filling such a nutritional arrangement.
  • the container filled with the solution and sealed is subjected to a final steam sterilization.
  • the containers which are provided in particular as a bottle and or bag, heated with the enteral solutions after filling in an autoclave.
  • a fillable after this type and finally, ie after filling, sterilizable food arrangement is in the document EP 0 830 874 B1 described.
  • a connector for medical liquid containing packaging which has a tubular connection part for receiving a spike for the removal of the liquid.
  • the connector is closed with a twist-off tamper-evident closure.
  • a pierceable membrane is arranged in the connection part.
  • the membrane is also closed or intact prior to putting the packaging into use, ie with the tamper-evident closure not yet removed. After removal of the tamper-evident seal, the membrane is only punctured by the spike during liquid withdrawal.
  • the invention has for its object to provide a container for receiving an enteral nutritional solution and a method for producing such a filled container, which reduce or even avoid the above-mentioned disadvantages of the prior art.
  • the present invention is based on the idea of providing a container for an enteral feeding agent, the interior of which is sterile and hermetically sealed from the environment.
  • a sterile enteral nutritional supplement is then filled under aseptic conditions into the sterile interior of the container.
  • the container is sealed under aseptic conditions.
  • the present invention relates to a food arrangement with a container which is filled with a liquid, sterile food, a placed on or in the container connector with a arranged in a filler neck, preferably injected or pre-assembled pierced, for example, opened, membrane; and a closure connected to the connector, here preferably as a tamper-evident closure, which closes the filler neck of the connector, preferably aseptically.
  • the closure or tamper-evident closure is still in its original condition. That is, he has not been removed yet.
  • the container has not been opened yet.
  • the technical advantage is achieved that a germ-free Food arrangement is provided, without a final autoclaving of the entire filled container is required.
  • the membrane Before being filled with a filling nozzle, the membrane is pierced or broken or torn or cut open or cut open by the filling nozzle itself or by a separate component, in particular a separate mandrel, and thereby opened.
  • the membrane remains open after opening and / or filling.
  • the membrane in this embodiment is a non-resealable membrane. Preferably, it is substantially plastically deformable.
  • the membrane is a plastic membrane.
  • the technical advantage is achieved that it can be produced in a simple and energy-saving manner.
  • the membrane is formed integrally with the filler neck.
  • the membrane is injected into the filler neck.
  • the membrane closes after puncturing and / or filling.
  • the membrane is a resealable membrane in this embodiment.
  • this membrane can also be considered the process of piercing.
  • the membrane is substantially elastically deformable, for example a rubber membrane.
  • the membrane may be, for example, a pre-slit membrane. The slot can be continuous or only partially through the Extend membrane. In both variants, the membrane is closed, before and after piercing. The membrane may be inserted into the filler neck or preassembled in the filler neck.
  • the container is a plastic bag.
  • the bag is a stand-up pouch.
  • the connector comprises a welding section for welding the connector to the container.
  • the filler neck comprises a circumferential detent groove for locking the closure.
  • the filler neck may comprise an external thread for unscrewing the closure.
  • the closure is formed by a tamper-evident closure.
  • the technical advantage is achieved that a closure is used, through which the originality of the food can be ensured.
  • a reclosable septum is disposed between the membrane and the closure. As a result, the filler neck is sealed again after removal of the solution and a multiple removal of the solution allows.
  • the reclosable septum may also be referred to as a, preferably further, resealable membrane.
  • the invention relates to a method for producing a food arrangement with a liquid food.
  • the method comprises the following steps: providing a container for a liquid food with a connector inserted into or onto the container, which has a membrane which hermetically seals an interior space formed in the container, the interior of the container being sterile or sterilized, sterilizing at least one outer side of the membrane of the container provided with the sterile or sterilized interior, and in particular an inlet channel of the connector above the membrane, preferably in an aseptic environment, piercing or opening the sterilized membrane in an aseptic environment, filling the container with a sterile food the connector with the sterilized and pierced membrane by means of a filling nozzle in an aseptic environment and closing the filled container by placing a closure, here preferably as originality Closure, on the connector with pierced membrane in one or aseptic environment.
  • a closure here preferably as originality Closure
  • sterile The sterilized or exposed components or areas and / or the steps performed in a sterile environment are referred to as sterile.
  • the aseptic or aseptic or aseptic or germ-free environment is defined as requirements or standards to be met for enteral clinical nutrition. A microbiological safety and a sufficiently long shelf life of the product must be guaranteed. After sterilization, the, preferably substantially all, reproducible microorganisms killed.
  • the aim of aseptic preparation is to preserve the sterility of the food arrangement composed of sterilized components.
  • the pH of the enteral nutrition to be filled is in one embodiment in a range of 6 to 7.
  • the closure cap is provided in a sterile condition in the aseptic environment and then placed on the connector.
  • the aseptic environment may be an aseptic zone closed to the environment in which only the connector or part of the connector of the container to be filled is contained.
  • the container to be provided with the inserted connector is provided as an empty container.
  • An empty container is a container that is not yet filled with the enteral nutrition solution.
  • the container to be provided is provided as a hermetically sealed container. The interior of the container is closed to the environment.
  • the membrane is pierced by the filling nozzle.
  • the technical advantage is achieved, for example, that pierced with the same component, first the membrane and opened and then the container is filled.
  • the membrane can pierced with a mandrel and thus opened and then the container can be filled with the filling nozzle.
  • the step of sterilizing the membrane comprises sterilization by means of a steam pulse and / or by means of hydrogen peroxide.
  • the technical advantage is achieved that particularly suitable means for sterilizing the membrane are used and germs are reliably killed.
  • the membrane is partially or completely sterilized. Together with the membrane also the filler neck, in particular the inner portion of the filler neck is partially or completely sterilized.
  • the inventive method for producing the food arrangement described above and below can be carried out with all method steps in one place.
  • the container can also initially be made in one place and the container interior can be sterilized and then transported to a filling plant at another location.
  • the method therefore comprises the step of producing the container to be provided by connecting, preferably welding, the connector to the container in order to produce a hermetically sealed connection between the connector and the container.
  • the method comprises the step of sterilizing the prepared container to kill germs within the container.
  • the hermetically sealed interior of the container can be provided germ-free.
  • the preparation and the filling of the container can take place at intervals and / or at different locations.
  • the sterilization of the container produced comprises irradiation, preferably by means of ionizing radiation, and / or gassing of the container in order to kill germs within the container.
  • irradiation preferably by means of ionizing radiation
  • gassing of the container in order to kill germs within the container.
  • the invention relates to an empty bag as a container for a previously described inventive Nutrition arrangement and / or for a method described above according to the invention.
  • the empty bag comprises a connector, which is closed with a pierceable and preferably integrally formed with the connector membrane, so that an interior of the empty bag is completed and wherein the interior of the empty bag is germ-free.
  • An empty bag is a bag that is not yet filled with the enteral nutrition solution.
  • the interior of the blank bag is closed to the environment.
  • the outside of the bag can be exposed to the environment, but the interior of the empty bag remains germ-free.
  • such an empty bag may be transported under ambient conditions and without being separately packaged to a filling station located at a different location.
  • the empty bags can be transported, for example, in the folded state with high packing density and thus cost.
  • FIG. 1 shows a still unfilled food arrangement 100 with a connector 103 and a container 101.
  • the section of the container 101 with the inserted connector 103 is shown here photographically, the rest of the container 101, however, is shown schematically.
  • the connector 103 is a connection system which serves, for example, firstly for mechanical connection and connection to a filling device (not shown) for filling the container 101 with a foodstuff and secondly for removing the foodstuff.
  • the connector 103 is liquid-tightly connected to the container 101 for this purpose.
  • the connector 103 serves for placing a closure 109, in order to prevent penetration of germs after filling of the container 101.
  • the connector 103 is formed for example by a plastic molding.
  • the container 101 is shown as a plastic bag.
  • the side edges of the plastic bag 101 are welded.
  • the connector 103 is also welded into the side edges of the plastic bag 101.
  • the container may be constituted by any device capable of containing a liquid food and which may be sterilized from the outside, such as a container, a plastic bottle, a plastic tank or a rubber bag, and in particular the requirements for storage a clinical enteral nutritional product.
  • the container 101 is the liquid food.
  • the liquid nutritional agent is, for example, a solution for enteral nutrition. Contamination of the enteral nutritional agent with germs should therefore be prevented as far as possible in order not to cause infection of a patient.
  • FIG. 2 shows a perspective view of the connector 103.
  • the connector 103 includes a filler neck 105 having a circumferential detent groove 111, a Versch dipabrough 117 and an inner filler neck 113 with spacer wings.
  • the filling nozzle 105 is used to fill the container 101 by means of a filling device 150, not shown here, and / or to remove the food from the container 101 by means of a spike, not shown here.
  • a filling nozzle is guided into the interior of the filler neck 105, through which the food is filled into the container 101.
  • a closure 109 is plugged onto the filler neck 105, which engages in the locking groove 111, so that the connector 103 is hermetically sealed and the food is not contaminated by germs.
  • the filler neck 105 may include an external thread, so that the closure can be screwed.
  • the welding portion 117 serves to weld the connector 103 to the container 101, so that at this point also a hermetically sealed connection is formed, which prevents the ingress of germs.
  • the inner filler neck 113 of the connector 103 is located in the edge region of the container 101 and also serves to introduce the food.
  • the inner filler neck 113 runs in the interior of the welding section 117.
  • the welding section 117 comprises two spacer wings which prevent the container 101, which is formed here for example by a plastic bag, from lying in front of the inner filler neck 113 and blocking it. For this purpose, so-called spacer ribs are arranged on the spacer wings.
  • FIGS. 3.a to 3.e each show a schematic cross-sectional view through the connector 103 in different views and process stages.
  • FIG. 3 shows a cross-sectional view through the in FIG. 2
  • the connector 103 of the connector 103 comprises in its interior a closed membrane 107.
  • the membrane 107 is a separating layer. It closes the filler neck 105. It prevents 103 germs can penetrate into the unfilled container 101 with inserted connector.
  • the membrane 107 is shown here in the embodiment of a plastic membrane.
  • the plastic membrane 107 may be injected into the filler neck 105.
  • the plastic membrane is integrally formed here with the connector 103.
  • the welding portion 117 of the connector 103 is formed around the inner filler neck 113.
  • the inlet channel 119 of the filler neck 105 is narrower in the illustrated example than the outlet channel 115 of the inner filler neck 113 ,
  • the filling nozzle can be guided through the narrower inlet channel 119. Due to the wider outlet channel 115, the liquid food can flow into the container 101 substantially unhindered.
  • the cleaning performed before opening the membrane 107, in particular sterilization is in Figure 3.b shown.
  • a cleaning nozzle 160 is used. From the cleaning nozzle 160 preferably steam and / or hydrogen peroxide flows to sterilize. As a result, a germ-free filling can be ensured. It can also be at least partially cleaned the outer sides of the connector.
  • Figure 3.c shows the connector 103 Figure 3.b with pierced, opened membrane 107 and introduced filling nozzle 150.
  • the membrane 107 is pierced by means of the filling nozzle 150, so that an opening is formed in the membrane 107 or in the connector 103.
  • the membrane 107 is pushed aside. Thereafter, the filling of the container 101 takes place by means of the filling nozzle 150.
  • the filling nozzle 150 has in the front region, which projects into the filler neck 105, an outlet opening 152 for the liquid food.
  • the filling nozzle 150 at least The filling nozzle 150 is here used both for filling the container 101 and for opening the membrane 107, the membrane 107 has, for example, a thickness of 0.05 mm to 0.5 mm, preferably from 0, 1 mm to 0.3 mm. This thickness of the membrane 107 on the one hand provides sufficient tightness. On the other hand, a membrane 107 with such a thickness can still be easily pierced through the filling nozzle 150.
  • the filling nozzle 150 here provides a stop 153 which comes to bear against the end faces of the connector 103. Preferably, the stop 153 is sealingly against the end faces of the connector 103. As a result, the interior of the container 101 is shielded again.
  • the liquid food can be filled with pressure into the container 101, in particular without affecting the environment by the liquid food.
  • FIG. 3d shows the connector 103 with pierced, opened membrane 107 after the filling process.
  • the filling nozzle 150 is removed.
  • the membrane 107 in this embodiment is a non-resealable membrane.
  • the membrane 107 is pierced, broken here. Thereby, a passage is provided in the connector 103. However, the membrane 107 is still connected to the connector 103.
  • the membrane 107 is movably connected to or attached to the filler neck 105.
  • This compound may be, for example, a hinged connection. He can be made a kind of movie hinge.
  • the membrane 107 after removal of the filling nozzle 150 again fold up to the starting position and form a kind of closure.
  • the membrane 107 may be closed again after removal of the filling nozzle 150.
  • the membrane 107 in such an embodiment is a resealable membrane.
  • an aseptic environment may be provided, for example, by clean room conditions and / or a defined atmosphere of a gas, such as nitrogen become.
  • the aseptic environment may be provided in a sealed environment and / or by a defined gas flow.
  • the entire food arrangement 100 or only parts thereof, in particular the connector 103 can be arranged in this aseptic environment. If, for example, only the connector 103 and an adjacent part of the container 101 or only the connector 103 or even only a portion of the connector 103 are arranged in the aseptic environment, a time, space and cost reduced filling can be made possible.
  • the cleaning of the connector 103, the opening of the membrane 107, the filling of the container 101 with the nutritional solution and / or the closing of the connector 103 can take place in the aseptic environment.
  • the closure 109 is a closure cap, which is plugged or turned on the connector 103. Between the connector 103 and the closure 109, a self-sealing resealable septum 120 is disposed.
  • the septum 120 is made of an elastic material.
  • the septum 120 may be provided inside the closure 109, for example.
  • the septum 120 is clamped between the closure cap 109 and the connector 103, in particular the end faces of the connector 103.
  • the septum 120 allows resealing of the connector after opening the closure 109.
  • the septum 120 may be slit at least in sections. In one embodiment, the septum 120 is slit continuously from the outside to the inside.
  • the closure 109 is a tamper-evident closure.
  • the tamper-evident closure is a closure by which the originality and integrity of the nutritional assembly 100 and the nutritional product can be assessed.
  • the tamper-evident closure 109 here comprises, on the one hand, a base part 109b for latching or snapping-in connection with the connector 103.
  • the tamper-evident closure comprises a break-off and / or twist-off part 109a, which has a predetermined breaking point 109c with the breaker Base part 109b is connected. By breaking off and / or twisting off the break off and / or twisting off part 109a, it can be removed from the base part 109b.
  • the septum 120 is uncovered.
  • a fluid connection for example to a Gösitset and / or a gastric or nasal probe, be provided, so that the liquid food can be removed from the bag 101.
  • the distance D between the bottom of the septum 120 and the top of the membrane 107 is sized so that the function of reclosing the septum 120 is not or not substantially impaired. Furthermore, the previously already opened membrane 107, in particular by the restoring force formed by the film hinge, supports the support of the spike through the septum 120.
  • the distance D is in particular in a range of 3 mm to 20 mm, preferably from 5 mm to 10 mm ,
  • the closure 109 may also include a removal device for removing the nutritional agent from the container 101, such as a user operable outlet or faucet.
  • FIG. 4 shows the entire food arrangement 100 after a filling of the container 101 and after the closure 109 is placed on the connector 103. In this state, the penetration of germs into the connector 103 by the shutter 109 can be prevented.
  • the section of the container 101 with the inserted connector 103 and the applied closure 109 is shown here photographically, the rest of the container 101, however, is shown schematically.
  • the closure 109 still has a thread 109d.
  • a removal system such as a transfer system with a spike, can be secured securely by screwing onto the connector 109 or the container 101.
  • FIG. 5 shows a flow chart of a method for aseptically filling the nutritional arrangement 100.
  • a first step S101 of the membrane 107 -containing connector 103 and the container 101 are welded together.
  • the interior of the container 101 is hermetically sealed.
  • the connector 103 is welded to a plastic bag, so that the plastic bag is hermetically sealed.
  • the still empty interior of the container 101 is hermetically sealed.
  • the preparation of the container 101 may take place under non-aseptic conditions. The interior of the container 101 produced is thus initially not germ-free.
  • the empty container 101 is sterilized with a welded-in connector 103 in order to kill or inactivate germs in the interior of the container 101.
  • a radiation sterilization by means of beta and / or gamma rays since these rays penetrate the container 101 and reliably kill the germs on the outside and inside and optionally in the interior of the container 101.
  • a sterilization of the interior of the container 101 via ethylene oxide gas (EtO gas) take place.
  • EtO gas ethylene oxide gas
  • all other sterilization methods capable of killing germs inside the container 101 may also be used.
  • the container 101 is thus sterile in its interior and germ-free. Its outside, however, may come in contact with the environment.
  • the interior of the container 101 is not affected.
  • the container 101 for example, can not be hermetically packed and transported to a filling plant at another location.
  • the containers 101 can be transported, for example, in the folded state with high packing density of the bags and thus cost.
  • the provision of the container 101 for sterilization S103 explained below of the membrane 107 of the container 101 comprises the two aforementioned steps S101 and S102.
  • the containers 101 Prior to feeding the container 101 to the filling device, the containers 101 are unpacked. In particular, the head and the filling area of the connector 103 are exposed unprotected for a short time and can therefore be contaminated.
  • the interior of the container 101 is still airtight or hermetically sealed by the membrane 107 and remains sterile.
  • a third step S103 prior to a filling process, the membrane 107 and the filler neck 105 are externally sterilized. This is done, for example, by treating the membrane 107 and the interior of the filling nozzle 105 with a germicidal agent.
  • a germicidal agent for example, the outer or outer regions of the connector 103 are pretreated by means of a steam pulse or with hydrogen peroxide.
  • all other sterilization methods capable of killing germs inside the filler neck 105 and on the membrane 107 may also be used. Sterilization may be restricted to the mentioned ranges.
  • a fourth step S104 the membrane 107 is pierced before the filling process by means of the filling nozzle 150 in an aseptic environment in order to fill the container 101 can.
  • the aseptic environment may be present at the time of filling or already during sterilization of the container 101 and / or the membrane 107.
  • a fifth step S105 the previously sterilized containers in the filling device are then filled with the feeding agent under aseptic conditions.
  • the enteric nutritional solution is sterilized or provided germ-free and filled in the container in this state.
  • a sixth step S106 the container 101 is closed by applying the closure 109 to the connector 103 under aseptic condition. This can be done, for example, by placing a closure cap, which is at the same time suitable for removing the food from the container 101.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Toxicology (AREA)
  • Basic Packing Technique (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
  • Bag Frames (AREA)

Claims (15)

  1. Agencement de produit de nutrition (100) avec au moins un récipient (101), qui est rempli d'un produit de nutrition liquide stérile; avec un connecteur (103) introduit dans le récipient (101) avec une membrane percée (107) disposée dans un embout de remplissage (105); et avec une fermeture inviolable (109), reliée au connecteur (103), qui ferme l'embout de remplissage (105).
  2. Agencement de produit de nutrition (100) selon la revendication 1, dans lequel la membrane (107) est réalisée d'une seule pièce avec l'embout de remplissage (105).
  3. Agencement de produit de nutrition (100) selon l'une quelconque des revendications précédentes, dans lequel la membrane (107) est injectée ou insérée dans l'embout de remplissage (105).
  4. Agencement de produit de nutrition (100) selon l'une quelconque des revendications précédentes, dans lequel la membrane (107) est une membrane en matière plastique et/ou dans lequel le connecteur (103) est un connecteur en matière plastique et/ou dans lequel le récipient (101) est un sac en matière plastique.
  5. Agencement de produit de nutrition (100) selon l'une quelconque des revendications précédentes, dans lequel le connecteur (103) comprend une partie de soudage (117) pour le soudage du connecteur (103) au récipient (101).
  6. Agencement de produit de nutrition (100) selon l'une quelconque des revendications précédentes, dans lequel l'embout de remplissage (105) comprend une rainure d'encliquetage périphérique (111) pour l'encliquetage de la fermeture inviolable (109) ou dans lequel l'embout de remplissage (105) comporte un filet extérieur pour le vissage de la fermeture inviolable (109).
  7. Agencement de produit de nutrition (100) selon l'une quelconque des revendications précédentes, dans lequel la fermeture inviolable (109) comprend une partie à rompre et/ou à dévisser (109a).
  8. Agencement de produit de nutrition (100) selon l'une quelconque des revendications précédentes, dans lequel un septum pouvant être refermé (120) est disposé entre la membrane (107) et la fermeture inviolable (109).
  9. Procédé de production d'un agencement de produit de nutrition (100) avec un produit de nutrition liquide, comprenant les étapes suivantes:
    préparer (S101, 102) un récipient (101) pour un produit de nutrition liquide avec un connecteur (103) inséré dans le récipient, qui présente une membrane (107) qui ferme hermétiquement un espace intérieur formé dans le récipient (101), dans lequel l'espace intérieur du récipient est stérile,
    stériliser (S103) au moins un côté extérieur de la membrane (107) du récipient (101) préparé avec l'espace intérieur stérile, de préférence dans un environnement aseptisé,
    percer (S104) la membrane stérilisée (107) dans un environnement aseptisé,
    remplir (S105) le récipient (101) avec un produit de nutrition stérile par l'intermédiaire du connecteur (103) avec la membrane stérilisée et percée (107) au moyen d'une buse de remplissage (150) dans un environnement aseptisé, et
    fermer (S106) le récipient rempli (101) en posant une fermeture inviolable (109) sur le connecteur (103) avec la membrane percée (107) dans un environnement aseptisé.
  10. Procédé selon la revendication 9, dans lequel l'étape de stérilisation (S103) de la membrane (107) comprend une stérilisation au moyen d'un jet de vapeur et/ou au moyen de peroxyde d'hydrogène.
  11. Procédé selon la revendication 9 ou 10, dans lequel on perce la membrane (107) au moyen de la buse de remplissage (150).
  12. Procédé selon la revendication 9, 10 ou 11, avec l'étape de production (S101) d'un récipient à préparer (101) par un assemblage, de préférence un soudage, du connecteur (103) avec le récipient (101), afin de produire un assemblage hermétiquement étanche entre le connecteur (103) et le récipient (101).
  13. Procédé selon la revendication 12 avec l'étape de stérilisation (S102) du récipient produit (101), de telle manière que l'espace intérieur du récipient (101) soit exempt de germes.
  14. Procédé selon la revendication 13, dans lequel la stérilisation (S102) du récipient produit (101) comprend une irradiation et/ou un gazage du récipient (101).
  15. Sac vide en tant que récipient (101) pour un agencement de produit de nutrition (100) selon l'une quelconque des revendications précédentes 1 à 8 et/ou pour un procédé selon l'une quelconque des revendications précédentes 9 à 14, comprenant un connecteur (103), qui est fermé avec une membrane (107) perçable et réalisée d'une seule pièce avec le connecteur (103), de telle manière qu'un espace intérieur du sac vide soit clos et dans lequel l'espace intérieur du sac vide soit exempt de germes.
EP14771339.0A 2013-09-25 2014-09-22 Agencement de produit de nutrition Active EP3049045B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP14771339.0A EP3049045B1 (fr) 2013-09-25 2014-09-22 Agencement de produit de nutrition

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13185855 2013-09-25
EP14771339.0A EP3049045B1 (fr) 2013-09-25 2014-09-22 Agencement de produit de nutrition
PCT/EP2014/070134 WO2015044087A1 (fr) 2013-09-25 2014-09-22 Conditionnement de produit nutritionnel

Publications (2)

Publication Number Publication Date
EP3049045A1 EP3049045A1 (fr) 2016-08-03
EP3049045B1 true EP3049045B1 (fr) 2017-08-30

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Country Status (4)

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US (2) US20160242998A1 (fr)
EP (1) EP3049045B1 (fr)
CN (2) CN114246794A (fr)
WO (1) WO2015044087A1 (fr)

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EP3773411A1 (fr) * 2018-04-13 2021-02-17 Fresenius Kabi AB Récipient pour système de mélange, système de mélange pour nutrition parentérale et procédé de mélange
GB202000444D0 (en) 2020-01-13 2020-02-26 Gbuk Group Ltd Tamper evident cap
US11918540B2 (en) * 2020-04-23 2024-03-05 Vonco Products, Llc Cap for spout and modified spout
USD1004428S1 (en) * 2021-11-29 2023-11-14 Kolmar Korea Co., Ltd. Spout for packaging container
CN118647354A (zh) * 2022-02-04 2024-09-13 费森尤斯卡比德国有限公司 输液袋及其制造方法

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Also Published As

Publication number Publication date
CN114246794A (zh) 2022-03-29
US20210401668A1 (en) 2021-12-30
EP3049045A1 (fr) 2016-08-03
US20160242998A1 (en) 2016-08-25
CN105592837A (zh) 2016-05-18
WO2015044087A1 (fr) 2015-04-02

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