EP3049045B1 - Nutrition assembly - Google Patents
Nutrition assembly Download PDFInfo
- 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
Links
- 235000016709 nutrition Nutrition 0.000 title description 24
- 230000035764 nutrition Effects 0.000 title description 9
- 238000011049 filling Methods 0.000 claims description 67
- 235000013305 food Nutrition 0.000 claims description 36
- 230000001954 sterilising effect Effects 0.000 claims description 23
- 238000000034 method Methods 0.000 claims description 20
- 229920003023 plastic Polymers 0.000 claims description 16
- 239000004033 plastic Substances 0.000 claims description 16
- 235000021056 liquid food Nutrition 0.000 claims description 11
- 238000003466 welding Methods 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 9
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims description 8
- 238000004519 manufacturing process Methods 0.000 claims description 8
- 239000007789 gas Substances 0.000 claims description 5
- 230000005855 radiation Effects 0.000 claims description 2
- 239000000463 material Substances 0.000 claims 3
- 238000005304 joining Methods 0.000 claims 1
- 210000004379 membrane Anatomy 0.000 description 92
- 239000012528 membrane Substances 0.000 description 87
- 239000000945 filler Substances 0.000 description 30
- 244000052616 bacterial pathogen Species 0.000 description 15
- 238000004659 sterilization and disinfection Methods 0.000 description 14
- 238000004140 cleaning Methods 0.000 description 7
- 239000003795 chemical substances by application Substances 0.000 description 6
- 238000002360 preparation method Methods 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 125000006850 spacer group Chemical group 0.000 description 4
- 238000005429 filling process Methods 0.000 description 3
- 230000035515 penetration Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 238000012371 Aseptic Filling Methods 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 230000001771 impaired effect Effects 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 238000012856 packing Methods 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 206010053648 Vascular occlusion Diseases 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 235000015872 dietary supplement Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000013013 elastic material Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 230000002070 germicidal effect Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000005865 ionizing radiation Effects 0.000 description 1
- 230000002906 microbiologic effect Effects 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 238000010137 moulding (plastic) Methods 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 238000012859 sterile filling Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
Images
Classifications
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- 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
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- 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
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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- 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
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- 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
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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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
- A61J1/14—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.
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Description
Die vorliegende Erfindung betrifft das Gebiet einer Ernährungsmittelanordnung mit einem Behältnis, das mit einem flüssigen Ernährungsmittel für die klinische Ernährung befüllt ist sowie ein Verfahren zum Herstellen und Befüllen einer solchen Ernährungsmittelanordnung.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.
Bei der Herstellung von flüssigen Ernährungsmittelprodukten für die klinische Ernährung, wie beispielsweise Lösungen für den enteralen Bereich, wird das mit der Lösung befüllte und verschlossene Behältnis einer abschließenden DampfSterilisation unterzogen. Dazu werden die Behältnisse, welche insbesondere als Flasche und oder Beutel bereitgestellt werden, mit den enteralen Lösungen nach dem Abfüllen in einem Autoklaven erhitzt.In the preparation of liquid nutritional products for clinical nutrition, such as solutions for the enteral sector, the container filled with the solution and sealed is subjected to a final steam sterilization. For this purpose, the containers, which are provided in particular as a bottle and or bag, heated with the enteral solutions after filling in an autoclave.
Allerdings sind viele Inhaltstoffe der Ernährungsmittellösungen nicht bei hohen Temperaturen sterilisierbar und/oder werden durch die Erhitzung in ihrer Wirksamkeit, ihren chemischen Eigenschaften und/oder ihrem Geschmack beeinträchtigt. Daneben eignen sich viele Verpackungsmaterialien nicht für die Sterilisation bei hohen Temperaturen und werden in ihren physikalischen, mechanischen und/oder chemischen Eigenschaften beeinträchtigt. Ferner ist das abschließende Autoklavieren zeit-, raum- und kostenintensiv.However, many ingredients of the nutritional solutions are not sterilizable at high temperatures and / or are affected by the heating in their effectiveness, their chemical properties and / or their taste. In addition, many packaging materials are not suitable for sterilization at high temperatures and are impaired in their physical, mechanical and / or chemical properties. Furthermore, the final autoclaving time, space and cost intensive.
Eine nach dieser Art befüllbare und abschließend, d.h. nach dem Befüllen, sterilisierbare Ernährungsmittelanordnung ist in der Druckschrift
Der Erfindung liegt die Aufgabe zugrunde, ein Behältnis zur Aufnahme einer enteralen Ernährungslösung und ein Verfahren zur Herstellung eines solchen befüllten Behältnisses zu schaffen, welche die vorstehend genannten Nachteile des Standes der Technik reduzieren oder sogar vermeiden.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.
Diese Aufgabe wird durch Gegenstände mit den Merkmalen nach den unabhängigen Ansprüchen gelöst. Vorteilhafte Ausführungsformen sind Gegenstand der abhängigen Ansprüche, der Beschreibung sowie der Zeichnungen.This object is achieved by articles having the features according to the independent claims. Advantageous embodiments are the subject of the dependent claims, the description and the drawings.
Allgemein basiert die vorliegende Erfindung auf der Idee, einen Behälter für ein enterales Ernährungsmittel bereitzustellen, dessen Innenraum zum einen steril und zum anderen hermetisch gegenüber der Umgebung abgeschlossen ist. Ein steriles, enterales Ernährungsmittel wird dann unter aseptischen Bedingungen in den sterilen Innenraum des Behälters eingefüllt. Abschließend wird der Behälter unter aseptischen Bedingungen verschlossen. Im Ergebnis wird ein Behälter mit einem keimfreien Ernährungsmittel bereitgestellt, ohne dass das bisher übliche abschließende Autoklavieren des gesamten, gefüllten Behältnisses erforderlich ist.In general, 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. Finally, the container is sealed under aseptic conditions. As a result, a container with a germ-free food preparation is provided without the hitherto customary final autoclaving of the entire, filled container is required.
Gemäß einem ersten Aspekt betrifft die vorliegende Erfindung eine Ernährungsmittelanordnung mit einem Behältnis, das mit einem flüssigen, sterilen Ernährungsmittel befüllt ist, einem an oder in das Behältnis eingebrachten Konnektor mit einer in einem Füllstutzen angeordneten, vorzugsweise eingespritzte oder vormontierte durchstoßenen, beispielsweise geöffneten, Membran; und einem mit dem Konnektor verbundenen Verschluss, hier vorzugsweise als Originalitätsverschluss, welcher den Füllstutzen des Konnektors, vorzugsweise aseptisch, verschließt. Der Verschluss oder Originalitätsverschluss ist noch in seinem ursprünglichen Zustand. D.h. er wurde noch nicht entfernt. Das Behältnis wurde noch nicht geöffnet. Dadurch wird beispielsweise der technische Vorteil erreicht, dass eine keimfreie Ernährungsmittelanordnung bereitgestellt wird, ohne dass ein abschließendes Autoklavieren des gesamten gefüllten Behältnisses erforderlich ist.According to a first aspect, 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. As a result, for example, the technical advantage is achieved that a germ-free Food arrangement is provided, without a final autoclaving of the entire filled container is required.
Die Membran wird vor dem Befüllen mit einer Fülldüse durch die Fülldüse selbst oder durch ein separates Bauteil, insbesondere einen separaten Dorn, durchstoßen oder aufgebrochen oder aufgerissen oder aufgeschnitten und dadurch geöffnet.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.
In einer Ausführungsform bleibt die Membran nach dem Öffnen und/oder dem Befüllen geöffnet. Die Membran ist in dieser Ausgestaltung eine nichtwiederverschließbare Membran. Vorzugsweise ist sie im Wesentlichen plastisch verformbar.In one embodiment, 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.
Gemäß einer Ausführungsform ist die Membran eine Kunststoffmembran. Dadurch wird beispielsweise der technische Vorteil erreicht, dass diese auf einfache und energiesparende Weise hergestellt werden kann.According to one embodiment, the membrane is a plastic membrane. As a result, for example, the technical advantage is achieved that it can be produced in a simple and energy-saving manner.
Gemäß einer weiteren Ausführungsform ist die Membran einstückig mit dem Füllstutzen ausgebildet. Dadurch wird beispielsweise der technische Vorteil erreicht, dass ein Montageschritt erspart und sich die Herstellung der Ernährungsmittelanordnung vereinfacht.According to a further embodiment, the membrane is formed integrally with the filler neck. As a result, for example, the technical advantage is achieved that saves an assembly step and simplifies the production of the food arrangement.
Gemäß einer weiteren Ausführungsform ist die Membran in den Füllstutzen eingespritzt. Dadurch wird beispielsweise der technische Vorteil erreicht, dass sich der Herstellungsprozess des Konnektors vereinfacht.According to a further embodiment, the membrane is injected into the filler neck. As a result, for example, the technical advantage is achieved that simplifies the manufacturing process of the connector.
In einer weiteren, vorzugsweise alternativen, Ausführungsform schließt sich die Membran nach dem Durchstoßen und/oder dem Befüllen. Die Membran ist in dieser Ausgestaltung eine wiederverschließbare Membran. Vorzugsweise kann auch dieser Membran der Vorgang des Durchstoßens angesehen werden. Die Membran ist im Wesentlichen elastisch verformbar, beispielsweise eine Gummimembran. Die Membran kann zum Beispiel eine vorgeschlitzte Membran sein. Der Schlitz kann sich durchgehend oder nur abschnittsweise durch die Membran erstrecken. In beiden Varianten ist die Membran geschlossen, vor und nach dem Durchstoßen. Die Membran kann in den Füllstutzen eingesetzt sein oder in dem Füllstutzen vormontiert sein.In a further, preferably alternative embodiment, the membrane closes after puncturing and / or filling. The membrane is a resealable membrane in this embodiment. Preferably, 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.
Gemäß einer weiteren Ausführungsform ist das Behältnis ein Kunststoffbeutel. Dadurch wird beispielsweise der technische Vorteil erreicht, dass ein flexibler und auf einfache Weise zu handhabender Behälter geschaffen wird. Insbesondere ist der Beutel ein Standbodenbeutel.According to a further embodiment, the container is a plastic bag. As a result, for example, the technical advantage is achieved that a flexible and easy to handle container is created. In particular, the bag is a stand-up pouch.
Gemäß einer weiteren Ausführungsform der Erfindung umfasst der Konnektor einen Verschweißabschnitt zum Verschweißen des Konnektors mit dem Behältnis. Dadurch wird beispielsweise der technische Vorteil erreicht, dass eine besonders zuverlässige und dichte Verbindung zwischen dem Konnektor und dem Behältnis hergestellt werden kann.According to a further embodiment of the invention, the connector comprises a welding section for welding the connector to the container. As a result, for example, the technical advantage is achieved that a particularly reliable and tight connection between the connector and the container can be made.
Gemäß einer weiteren Ausführungsform umfasst der Füllstutzen eine umlaufende Rastnut zum Einrasten des Verschlusses. Dadurch wird beispielsweise der technische Vorteil erreicht, dass durch einfaches Aufsetzen des Verschlusses eine flüssigkeits-, luft- und keimdichte Abdeckung des Füllstutzens erzielt wird.According to a further embodiment, the filler neck comprises a circumferential detent groove for locking the closure. As a result, the technical advantage is achieved, for example, that a liquid, air and germproof cover of the filler neck is achieved by simply placing the closure.
Gemäß einer weiteren Ausführungsform kann der Füllstutzen ein Außengewinde zum Aufdrehen des Verschlusses umfassen. Dadurch wird beispielsweise der technische Vorteil erreicht, dass ein unbeabsichtigtes Lösen des Verschlusses verhindert wird.According to a further embodiment, the filler neck may comprise an external thread for unscrewing the closure. As a result, for example, the technical advantage is achieved that unintentional release of the closure is prevented.
Erfindungsgemäß oder vorzugsweise wird der Verschluss durch einen Originalitätsverschluss gebildet. Dadurch wird beispielsweise der technische Vorteil erreicht, dass ein Verschluss verwendet wird, durch den die Originalität des Ernährungsmittels sichergestellt werden kann.According to the invention or preferably, the closure is formed by a tamper-evident closure. As a result, for example, the technical advantage is achieved that a closure is used, through which the originality of the food can be ensured.
Gemäß einer weiteren Ausführungsform ist ein wiederverschließbares Septum zwischen der Membran und dem Verschluss angeordnet ist. Dadurch wird der Füllstutzen nach der Entnahme der Lösung wieder abgedichtet und eine mehrmalige Entnahme der Lösung ermöglicht. Das wiederverschließbare Septum kann auch als eine, vorzugsweise weitere, wiederverschließbare Membran bezeichnet werden.According to another embodiment, 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.
Gemäß einem zweiten Aspekt betrifft die Erfindung ein Verfahren zum Herstellen einer Ernährungsmittelanordnung mit einem flüssigen Ernährungsmittel. Das Verfahren umfasst die folgenden Schritte: Bereitstellen eines Behältnisses für ein flüssiges Ernährungsmittel mit einem in oder an das Behältnis eingebrachten Konnektor, der eine Membran aufweist, welche einen in dem Behältnis gebildeten Innenraum hermetisch verschließt, wobei der Innenraum des Behältnisses steril oder sterilisiert ist, Sterilisieren wenigstens einer Außenseite der Membran des mit dem sterilen oder sterilisierten Innenraum bereitgestellten Behältnisses, und insbesondere eines Einlasskanals des Konnektors oberhalb der Membran, vorzugsweise in einer aseptischen Umgebung, Durchstoßen oder Öffnen der sterilisierten Membran in einer aseptischen Umgebung, Befüllen des Behältnisses mit einem sterilen Ernährungsmittel über den Konnektor mit der sterilisierten und durchstoßenen Membran mittels einer Fülldüse in einer aseptischen Umgebung und Verschließen des befüllten Behältnisses durch Aufsetzen eines Verschlusses, hier vorzugsweise als Originalitätsverschluss, auf den Konnektor mit der durchstoßenen Membran in einer oder der aseptischen Umgebung. Dadurch wird beispielsweise der technische Vorteil erreicht, dass eine aseptische bzw. sterile Befüllung des Behältnisses auf besonders einfache und energiesparende Weise erreicht und ein Autoklavieren, als ein abschließender Verfahrensschritt, vermieden wird oder werden kann.According to a second aspect, 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. Thereby, for example, the technical advantage is achieved that an aseptic or sterile filling of the container achieved in a particularly simple and energy-saving manner and autoclaving, as a final process step, is avoided or can be.
Die einer Sterilisation unterzogenen oder ausgesetzten Bauteile oder Bereiche und/oder die in einer sterilen Umgebung durchgeführten Verfahrensschritte werden als steril bezeichnet. Vorzugsweise definiert sich der aseptische oder keimfreie Zustand oder die aseptische oder keimfreie Umgebung über für die enterale, klinische Ernährung einzuhaltende Anforderungen oder Standards. Eine mikrobiologische Unbedenklichkeit und eine ausreichend lange Haltbarkeit des Produktes müssen gewährleistet sein. Nach der Sterilisation werden die, vorzugsweise im Wesentlichen alle, vermehrungsfähigen Mikroorganismen abgetötet. Ziel einer aseptischen Herstellung ist, die Sterilität der aus sterilisierten Komponenten zusammengesetzten Ernährungsmittelanordnung zu bewahren.The sterilized or exposed components or areas and / or the steps performed in a sterile environment are referred to as sterile. Preferably, 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.
Der ph-Wert der abzufüllenden enteralen Ernährung liegt in einer Ausgestaltung in einem Bereich von 6 bis 7.The pH of the enteral nutrition to be filled is in one embodiment in a range of 6 to 7.
Vorzugsweise wird die Verschlusskappe in einem sterilen Zustand in der aseptischen Umgebung bereitgestellt und dann auf den Konnektor aufgesetzt. Die aseptische Umgebung kann eine gegenüber der Umgebung abgeschlossene, aseptische Zone sein, in der von dem zu befüllenden Behältnis lediglich der Konnektor oder ein Teil des Konnektors enthalten ist.Preferably, 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.
Das bereitzustellende Behältnis mit dem eingebrachten Konnektor wird als leeres Behältnis bereitgestellt. Ein leeres Behältnis ist ein Behältnis, welches noch nicht mit der enteralen Ernährungslösung befüllt ist. Das bereitzustellende Behältnis wird als hermetisch verschlossenes Behältnis bereitgestellt. Der Innenraum des Behältnisses ist gegenüber der Umgebung abgeschlossen.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.
In einer Ausführungsform wird die Membran durch die Fülldüse durchstoßen. Dadurch wird beispielsweise der technische Vorteil erreicht, dass mit demselben Bauteil zunächst die Membran durchstoßen und geöffnet und dann das Behältnis befüllt wird. In einer alternativen Ausführungsform kann die Membran mit einem Dorn durchstoßen und damit geöffnet und dann das Behältnis mit der Fülldüse befüllt werden.In one embodiment, the membrane is pierced by the filling nozzle. As a result, the technical advantage is achieved, for example, that pierced with the same component, first the membrane and opened and then the container is filled. In an alternative embodiment, the membrane can pierced with a mandrel and thus opened and then the container can be filled with the filling nozzle.
Gemäß einer weiteren Ausführungsform der Erfindung umfasst der Schritt des Sterilisierens der Membran ein Sterilisieren mittels eines Dampfstoßes und/oder mittels Wasserstoffperoxid. Dadurch wird beispielsweise der technische Vorteil erreicht, dass besonders geeignete Mittel zum Sterilisieren der Membran verwendet werden und Keime zuverlässig abgetötet werden. Die Membran wird dabei abschnittsweise oder vollständig sterilisiert. Zusammen mit der Membran wird auch der Füllstutzen, insbesondere der innere Bereich des Füllstutzens abschnittsweise oder vollständig sterilisiert.According to a further embodiment of the invention, the step of sterilizing the membrane comprises sterilization by means of a steam pulse and / or by means of hydrogen peroxide. As a result, for example, 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.
Das vorstehend und nachfolgend beschriebene erfindungsmäße Verfahren zum Herstellen der Ernährungsmittelanordnung kann mit allen Verfahrensschritten an einem Ort durchgeführt werden. Das Behältnis kann auch zunächst an einem Ort hergestellt und der Behältnisinnenraum sterilisiert werden und erst dann zu einer Füllanlage an einem anderen Ort transportiert werden.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.
Gemäß einer weiteren Ausführungsform umfasst das Verfahren daher den Schritt des Herstellens des bereitzustellenden Behältnisses durch ein Verbinden, vorzugsweise Verschweißen, des Konnektors mit dem Behältnis, um eine hermetisch dichte Verbindung zwischen dem Konnektor und dem Behältnis herzustellen. Dadurch wird beispielsweise der technische Vorteil erreicht, dass sich ein Eindringen von Keimen an der Verbindungsstelle zwischen Konnektor und Behältnis besonders wirkungsvoll vermeiden lässt. Der Innenraum des Behältnisses ist hermetisch von der Umgebung abgeschlossen.According to a further embodiment, 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. As a result, the technical advantage is achieved, for example, that can prevent a penetration of germs at the junction between connector and container particularly effective. The interior of the container is hermetically sealed from the environment.
Gemäß einer weiteren Ausführungsform umfasst das Verfahren den Schritt eines Sterilisierens des hergestellten Behältnisses, um Keime innerhalb des Behältnisses abzutöten. Der hermetisch abgeschlossene Innenraum des Behältnisses kann dadurch keimfrei bereitgestellt werden. Die Herstellung und die Befüllung des Behältnisses können in zeitlichem Abstand und/oder an unterschiedlichen Orten stattfinden.According to another embodiment, 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.
In einer möglichen Ausgestaltung umfasst das Sterilisieren des hergestellten Behältnisses ein Bestrahlen, vorzugsweise mittels ionisierender Strahlung, und/oder ein Begasen des Behältnisses, um Keime innerhalb des Behältnisses abzutöten. Dadurch wird beispielsweise der technische Vorteil erreicht, dass Keime besonders effizient und energiesparend abgetötet werden.In one possible embodiment, 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. As a result, for example, the technical advantage is achieved that germs are killed particularly efficient and energy-saving.
Gemäß einem weiteren Aspekt betrifft die Erfindung einen Leerbeutel als Behältnis für eine vorstehend beschriebene, erfindungsgemäße Ernährungsmittelanordnung und/oder für ein vorstehend beschriebenes, erfindungsgemäßes Verfahren. Der Leerbeutel umfasst einen Konnektor, der mit einer durchstechbaren und vorzugsweise mit dem Konnektor einstückig ausgebildeten Membran verschlossen ist, so dass ein Innenraum des Leerbeutels abgeschlossen ist und wobei der Innenraum des Leerbeutels keimfrei ist. Ein Leerbeutel ist ein Beutel, welcher noch nicht mit der enteralen Ernährungslösung befüllt ist. Der Innenraum des Leerbeutels ist gegenüber der Umgebung abgeschlossen. Die Außenseite des Beutels kann der Umgebung ausgesetzt werden, der Innenraum des Leerbeutels bleibt jedoch keimfrei. Ein solcher Leerbeutel kann zum Beispiel unter Umgebungsbedingungen und ohne separat verpackt zu sein, zu einer Füllanlage transportiert werden, welche sich an einen anderen Ort befindet. Die Leerbeutel können zum Beispiel im gefalteten Zustand mit hoher Packungsdichte und somit kostengünstig transportiert werden.According to a further aspect, 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. For example, 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.
Weitere Ausführungsformen werden Bezug nehmend auf die beiliegenden Zeichnungen näher erläutert. Es zeigen:
- Fig. 1
- eine Ansicht eines Behältnisses mit eingesetztem Konnektor;
- Fig. 2
- eine perspektivische Ansicht eines Konnektors;
- Fig. 3.a bis 3.e
- eine schematische Querschnittsansicht durch den Konnektor mit eingespritzter, nicht geöffneter Membran (
Fig. 3.a ), mit noch nicht geöffneter Membran während der Reinigung (Fig. 3.b ), mit durchstoßener, geöffneter Membran und mit eingeführter Fülldüse (Fig. 3.c ), mit durchstoßener, geöffneter Membran und entfernter Fülldüse (Fig. 3.d ) und mit durchstoßener, geöffneter Membran und aufgesetztem Verschluss (Fig. 3.e ); - Fig. 4
- eine Ansicht einer Ernährungsmittelanordnung; und
- Fig. 5
- ein Ablaufdiagramm eines Verfahrens zum aseptischen Befüllen der Ernährungsmittelanordnung.
- Fig. 1
- a view of a container with inserted connector;
- Fig. 2
- a perspective view of a connector;
- Fig. 3.a to 3.e
- 2 a schematic cross-sectional view through the connector with injected, unopened membrane (FIG.
Fig. 3.a ), with membrane still open during cleaning (Fig. 3.b ), with pierced, opened membrane and with inserted filling nozzle (Fig. 3.c ), with pierced, opened membrane and remote filling nozzle (Fig. 3.d ) and pierced, opened membrane and attached closure (Fig. 3.e ); - Fig. 4
- a view of a food arrangement; and
- Fig. 5
- a flow diagram of a method for aseptically filling the food arrangement.
Das Behältnis 101 ist als Kunststoffbeutel dargestellt. Die Seitenränder des Kunststoffbeutels 101 sind verschweißt. Der Konnektor 103 ist auch in die Seitenränder des Kunststoffbeutels 101 eingeschweißt. Im Allgemeinen kann das Behältnis durch jede Vorrichtung gebildet sein, die in der Lage ist, ein flüssiges Ernährungsmittel aufzunehmen und die von außen sterilisiert werden kann, wie beispielsweise ein Container, eine Plastikflasche, ein Kunststofftank oder ein Gummibeutel, und die insbesondere die Anforderungen zur Lagerung eines klinischen enteralen Ernährungsmittels erfüllt. In dem Behältnis 101 befindet sich das flüssige Ernährungsmittel. Das flüssige Ernährungsmittel ist beispielsweise eine Lösung für die enterale Ernährung. Eine Kontamination des enteralen Ernährungsmittels mit Keimen sollte daher möglichst verhindert werden, um keine Infektion eines Patienten zu verursachen.The
Der Füllstutzen 105 dient zum Befüllen des Behältnisses 101 mittels einer hier nicht dargestellten Füllvorrichtung 150 und/oder zum Entnehmen des Ernährungsmittels aus dem Behältnis 101 mittels eines hier nicht dargestellten Spikes. Beim Befüllen wird beispielswiese eine Fülldüse in das Innere des Füllstutzens 105 geführt, über die das Ernährungsmittel in das Behältnis 101 gefüllt wird. Nach dem Befüllen des Behältnisses 101 wird ein Verschluss 109 auf den Füllstutzen 105 aufgesteckt, der in der Rastnut 111 einrastet, so dass der Konnektor 103 hermetisch abgeschlossen ist und das Ernährungsmittel nicht durch Keime verunreinigt wird. In einer anderen, nicht dargestellten Ausführungsform des Konnektors 103 kann der Füllstutzen 105 jedoch ein Außengewinde umfassen, so dass der Verschluss aufgeschraubt werden kann.The filling
Der Verschweißabschnitt 117 dient zum Verschweißen des Konnektors 103 mit dem Behältnis 101, so dass an dieser Stelle ebenfalls eine hermetisch dichte Verbindung entsteht, die das Eindringen von Keimen verhindert.The
Der Innenfüllstutzen 113 des Konnektors 103 liegt im Randbereich des Behältnisses 101 und dient ebenfalls zur Einführung des Ernährungsmittels. Der Innenfüllstutzen 113 verläuft im Inneren des Verschweißabschnitts 117. Der Verschweißabschnitt 117 umfasst zwei Abstandsflügel, die verhindern, dass sich das Behältnis 101, das hier beispielsweise durch einen Kunststoffbeutel gebildet wird, vor den Innenfüllstutzen 113 legt und diesen blockiert. Zu diesem Zweck sind auf den Abstandsflügeln sogenannte Abstandsrippen angeordnet.The
Die
Die Membran 107 ist hier in der Ausführungsform einer Kunststoffmembran dargestellt. Die Kunststoffmembran 107 kann in den Füllstutzen 105 eingespritzt sein. Die Kunststoffmembran ist hier mit dem Konnektor 103 einstückig ausgebildet.The
Der Verschweißabschnitt 117 des Konnektors 103 ist um den Innenfüllstutzen 113 herum gebildet. Die Rastnut 111 befindet sich hier etwa auf der gleichen Höhe wie die Membran 107. Der Einlasskanal 119 des Füllstutzens 105 ist in dem dargestellten Beispiel enger als der Auslasskanal 115 des Innenfüllstutzens 113. Dadurch kann eine Fülldüse leicht und ohne Behinderungen in den Konnektor 103 eingeführt werden. Die Fülldüse kann durch den engeren Einlasskanal 119 geführt werden. Durch den breiteren Auslasskanal 115 kann das flüssige Ernährungsmittel im Wesentlichen ungehindert in den Behälter 101 strömen.The
Das vor dem Öffnen der Membran 107 durchgeführte Reinigen, insbesondere Sterilisieren, ist in
Nach dem Befüllen wird in einer aseptischen Umgebung der Verschluss 109 aufgesetzt. Das ist in
Der Verschluss 109 ist eine Verschlusskappe, welche auf den Konnektor 103 aufgesteckt oder aufgedreht ist. Zwischen dem Konnektor 103 und dem Verschluss 109 ist ein selbstabdichtendes, wiederverschließbares Septum 120 angeordnet. Das Septum 120 ist aus einem elastischen Material gefertigt. Das Septum 120 kann zum Beispiel im Inneren des Verschlusses 109 bereitgestellt werden. Vorzugsweise ist das Septum 120 klemmend zwischen der Verschlusskappe 109 und dem Konnektor 103, insbesondere den Stirnflächen des Konnektors 103 klemmend gehalten. Das Septum 120 ermöglicht ein Wiederverschließen des Konnektors nach dem Öffnen des Verschlusses 109. Um das Öffnen des Septums 120, beispielsweise mittels eines Spikes, zu erleichtern, kann das Septum 120 zumindest abschnittsweise geschlitzt sein. In einer Ausführungsform ist das Septum 120 durchgehend von außen nach innen geschlitzt.The
Vorzugsweise ist der Verschluss 109 ein Originalitätsverschluss. Der Originalitätsverschluss ist ein Verschluss, anhand dessen die Originalität und Unversehrtheit der Ernährungsmittelanordnung 100 und des Ernährungsmittels beurteilt werden kann. Der Originalitätsverschluss 109 umfasst hier zum einen ein Basisteil 109b zur einrastenden oder einschnappenden Verbindung mit dem Konnektor 103. Zum anderen umfasst der Originalitätsverschluss ein Abbrech- und/oder Abdrehteil 109a, welches über eine Sollbruchstelle 109c mit dem Basisteil 109b verbunden ist. Durch ein Abbrechen und/oder Abdrehen des Abbrech- und/oder Abdrehteil 109a kann dieses von dem Basisteil 109b entfernt werden, Dadurch wird das Septum 120 freigelegt. Mittels eines Spikes, der in das Septum 120 eingestochen wird, kann eine Fluidverbindung, zum Beispiel zu einem Überleitset und/oder einer Magen- oder Nasensonde, bereitgestellt werden, so dass das flüssige Ernährungsmittel aus dem Beutel 101 entnommen werden kann.Preferably, the
Der Abstand D zwischen der Unterseite des Septums 120 und der Oberseite der Membran 107 ist so bemessen, dass die Funktion des Wiederverschließens des Septums 120 nicht oder nicht wesentlich beeinträchtigt ist. Weiterhin unterstützt die vorab bereits geöffnete Membran 107, insbesondere durch die durch das Folienscharnier gebildete Rückstellkraft, die Halterung des Spikes durch das Septum 120. Der Abstand D liegt dazu insbesondere in einem Bereich von 3 mm bis 20 mm, vorzugsweise von 5 mm bis 10 mm.The distance D between the bottom of the
Der Verschluss 109 kann zudem eine Entnahmevorrichtung zum Entnehmen des Ernährungsmittels aus dem Behältnis 101 umfassen, beispielsweise einen von einem Benutzer betätigbaren Auslass oder Hahn.The
In einem ersten Schritt S101 werden der die Membran 107 beinhaltende Konnektor 103 und das Behältnis 101 miteinander verschweißt. Durch die im Konnektor 107 vorhandene Membran 103 wird der Innenraum des Behältnisses 101 hermetisch abgedichtet. Beispielsweise wird der Konnektor 103 mit einem Kunststoffbeutel verschweißt, so dass der Kunststoffbeutel hermetisch dicht ist. Der noch leere Innenraum des Behältnisses 101 ist hermetisch abgedichtet. Die Herstellung des Behältnisses 101 kann unter nicht aseptischen Bedingungen erfolgen. Der Innenraum des hergestellten Behältnisses 101 ist somit zunächst nicht keimfrei.In a first step S101 of the membrane 107 -containing
In einem zweiten Schritt S102 wird das leere Behältnis 101 mit eingeschweißtem Konnektor 103 sterilisiert, um Keime im Inneren des Behältnisses 101 abzutöten oder zu inaktivieren. Vorteilhaft ist die Verwendung einer Strahlensterilisation mittels Beta- und/oder Gamma-Strahlen, da diese Strahlen das Behältnis 101 durchdringen und die Keime auf der Außen- und der Innenseite und gegebenenfalls im Innenraum des Behältnisses 101 zuverlässig abtöten. Alternativ oder zusätzlich kann eine Sterilisation des Innenraums des Behältnisses 101 über Ethylenoxid-Gas (EtO-Gas) erfolgen. Im Allgemeinen können jedoch auch alle anderen Sterilisationsverfahren verwendet werden, die in der Lage sind, Keime im Inneren des Behältnisses 101 abzutöten. Das Behältnis 101 ist somit in seinem Inneren steril und keimfrei. Seine Außenseite kann aber mit der Umgebung in Kontakt kommen. Der Innenraum des Behältnisses 101 wird dadurch nicht beeinträchtigt. Das Behältnis 101 kann beispielsweise nicht hermetisch verpackt und zu einer Füllanlage an einen anderen Ort transportiert werden. In der Ausführungsform als Beutel können die Behältnisse 101 zum Beispiel im gefalteten Zustand mit hoher Packungsdichte der Beutel und somit kostengünstig transportiert werden. Das Bereitstellen des Behältnisses 101 zum nachfolgend erläuterten Sterilisieren S103 der Membran 107 des Behältnisses 101 umfasst die zwei vorstehend genannten Schritte S101 und S102.In a second step S102, the
Vor dem Zuführen des Behältnisses 101 zu der Füllvorrichtung werden die Behältnisse 101 ausgepackt. Dabei stehen insbesondere der Kopf- und der Füllbereich des Konnektors 103 kurzeitig ungeschützt offen und können daher kontaminiert werden. Der Innenraum des Behältnisses 101 ist dennoch weiterhin durch die Membran 107 luftdicht oder hermetisch abgeschlossen und bleibt steril.Prior to feeding the
Daher werden in einem dritten Schritt S103 vor einem Füllprozess die Membran 107 und der Füllstutzen 105 von außen sterilisiert. Dies erfolgt beispielsweise dadurch, dass die Membran 107 und das Innere des Füllstutzens 105 mit einem keimabtötenden Mittel behandelt werden. Beispielsweise werden die äußeren oder außenliegenden Bereiche des Konnektors 103 mittels eines Dampfstoßes oder mit Wasserstoffperoxid vorbehandelt. Im Allgemeinen können jedoch auch alle anderen Sterilisationsverfahren verwendet werden, die in der Lage sind, Keime im Inneren des Füllstutzens 105 und auf der Membran 107 abzutöten. Die Sterilisation kann auf die genannten Bereiche beschränkt sein.Therefore, in a third step S103, prior to a filling process, the
In einem vierten Schritt S104 wird die Membran 107 vor dem Füllvorgang mittels der Fülldüse 150 in einer aseptischen Umgebung durchstoßen, um das Behältnis 101 befüllen zu können. Durch das Durchstoßen der Membran 107 mittels der Fülldüse 150 wird der Weg zum Befüllen des Behältnisses 101 freigegeben. Die aseptische Umgebung kann zum Zeitpunkt des Befüllens oder bereits beim Sterilisieren des Behältnisses 101 und/oder der Membran 107 vorliegen.In a fourth step S104, the
In einem fünften Schritt S105 werden dann die zuvor sterilisierten Behältnisse in der Füllvorrichtung unter aseptischer Bedingung mit dem Ernährungsmittel befüllt. Die enterale Ernährungslösung wird sterilisiert oder keimfrei bereitgestellt und in diesem Zustand in den Behälter eingefüllt.In 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.
In einem sechsten Schritt S106 wird das Behältnis 101 durch Aufbringen des Verschlusses 109 auf den Konnektor 103 unter aseptischer Bedingung verschlossen. Dies kann beispielsweise durch Aufsetzen einer Verschlusskappe erfolgen, die sich gleichzeitig zur Entnahme des Ernährungsmittels aus dem Behältnis 101 eignet.In a sixth step S106, the
Durch dieses Verfahren wird eine aseptische Abfüllung des Ernährungsmittels erreicht, ohne dass die Ernährungsmittelanordnung einer abschließenden Dampfsterilisation unterzogen werden muss.By this method, aseptic filling of the nutritional product is achieved without the food arrangement having to undergo a final steam sterilization.
Alle in der Beschreibung erläuterten und den Figuren gezeigten Einzelmerkmale können in unterschiedlicher Weise miteinander kombiniert werden, um gleichzeitig deren vorteilhafte Wirkungen zu realisieren. Die Erfindung ist nicht auf die in Verbindung mit den Zeichnungen erläuterten Ausführungsbeispiele beschränkt, sondern durch den Schutzbereich der Ansprüche gegeben.All the individual features explained in the description and shown in the figures can be combined with one another in different ways in order to simultaneously realize their advantageous effects. The invention is not limited to the embodiments explained in connection with the drawings, but given by the scope of the claims.
- 100100
- ErnährungsmittelanordnungDiet means assembly
- 101101
- Behältniscontainer
- 103103
- Konnektorconnector
- 105105
- Füllstutzenfilling
- 107107
- Membranmembrane
- 109109
- Verschlussshutter
- 109a109a
- Abbrech- oder Abdrehteil des VerschlussesCanceling or Abdrehteil of the closure
- 109b109b
- Basisteil des VerschlussesBase part of the closure
- 109c109c
- Sollbruchstelle zwischen dem Basisteil und dem Abbrech- oder AbdrehteilPredetermined breaking point between the base part and the Abbrech- or Abdrehteil
- 109d109d
- Gewindethread
- 111111
- Rastnutlocking groove
- 113113
- InnenfüllstutzenInnenfüllstutzen
- 115115
- Auslasskanalexhaust port
- 117117
- VerschweißabschnittVerschweißabschnitt
- 119119
- Einlasskanalinlet channel
- 120120
- Septum oder wiederverschließbare MembranSeptum or resealable membrane
- 150150
- Fülldüse oder FüllstutzenFilling nozzle or filler neck
- 151151
- Dorn oder Durchstechelement an der Vorderseite der FülldüseMandrel or piercing element on the front of the filling nozzle
- 152152
- Austrittsöffnung der Fülldüse für das ErnährungsmittelOutlet opening of the filling nozzle for the food
- 153153
- Anschlag der FülldüseStop of the filling nozzle
- 160160
- Reinigungseinrichtung oder ReinigungsdüseCleaning device or cleaning nozzle
- S101S101
- Herstellen des BehältnissesManufacture of the container
- S102S102
- Sterilisieren eines BehältnissesSterilizing a container
- S103S103
- Sterilisieren der MembranSterilize the membrane
- S104S104
- Durchstoßen der Membran zum Befüllen des BehältnissesPiercing the membrane to fill the container
- S105S105
- Befüllen des BehältnissesFilling the container
- S106S106
- Hermetisches Verschließen des Konnektors in einer aseptischen UmgebungHermetically sealing the connector in an aseptic environment
Claims (15)
- Food arrangement (100) having at least
one receptacle (101) which is filled with a liquid, sterile food;
a connector (103), which is inserted into the receptacle (101), with a punctured diaphragm (107) which is arranged in a filling spout (105); and
a tamper-evident closure (109) which is connected to the connector (103) and closes the filling spout (105). - Food arrangement (100) according to Claim 1, wherein the diaphragm (107) is integrally realized with the filling spout (105).
- Food arrangement (100) according to one of the preceding claims, wherein the diaphragm (107) is injected or inserted into the filling spout (105).
- Food arrangement (100) according to one of the preceding claims, wherein the diaphragm (107) is a plastics material diaphragm and/or wherein the connector (103) is a plastics material connector and/or wherein the receptacle (101) is a plastics material pouch.
- Food arrangement (100) according to one of the preceding claims, wherein the connector (103) includes a welding portion (117) for welding the connector (103) to the receptacle (101).
- Food arrangement (100) according to one of the preceding claims, wherein the filling spout (105) includes a circumferential latching groove (111) for latching-in the tamper-evident closure (109) or wherein the filling spout (105) includes an external thread for screwing on the tamper-evident closure (109).
- Food arrangement (100) according to one of the preceding claims, wherein the tamper-evident closure (109) includes a break-off and/or twist-off part (109a).
- Food arrangement (100) according to one of the preceding claims, wherein a reclosable septum (120) is arranged between the diaphragm (107) and the tamper-evident closure (109).
- Method for producing a food arrangement (100) with a liquid food, said method having the steps:provide (S101, 102) a receptacle (101) for a liquid food with a connector (103), which is inserted into the receptacle and comprises a diaphragm (107), which hermetically seals an interior that is formed in the receptacle (101), wherein the interior of the receptacle is sterile,sterilize (S103), preferably in an aseptic environment, at least one outside surface of the diaphragm (107) of the receptacle (101) which is provided with the sterile interior,puncture (S104) the sterilized diaphragm (107) in an aseptic environment,fill (S105) the receptacle (101) with a sterile food by means of the connector (103) with the diaphragm (107) sterilized and punctured by means of a filling nozzle (150) in an aseptic environment andclose (S106) the filled receptacle (101) by fitting a tamper-evident closure (109) onto the connector (103) with the punctured diaphragm (107) in an aseptic environment.
- Method according to Claim 9, wherein the step of sterilizing (S103) the diaphragm (107) includes sterilizing by means of a vapor blast and/or by means of hydrogen peroxide.
- Method according to Claim 9 or 10, wherein the diaphragm (107) is punctured by the filling nozzle (150).
- Method according to Claim 9, 10 or 11, with the step of producing (S101) the receptacle (101) to be provided as a result of joining, preferably welding, the connector (103) to the receptacle (101) in order to generate a hermetically sealed join between the connector (103) and the receptacle (101).
- Method according to Claim 12 with the step of sterilizing (S102) the produced receptacle (101) such that the interior of the receptacle (101) becomes germ-free.
- Method according to Claim 13, wherein the sterilizing (S102) of the produced receptacle (101) includes exposing the receptacle (101) to radiation and/or gas.
- Empty pouch as receptacle (101) for a food arrangement (100) according to one of the preceding Claims 1 to 8 and/or for a method according to one of the preceding Claims 9 to 14, said empty pouch including a connector (103) which is closed by way of a puncturable diaphragm (107) which is integrally realized with the connector (103) such that an interior of the empty pouch is closed and wherein the interior of the empty pouch is germ-free.
Priority Applications (1)
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EP14771339.0A EP3049045B1 (en) | 2013-09-25 | 2014-09-22 | Nutrition assembly |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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EP13185855 | 2013-09-25 | ||
PCT/EP2014/070134 WO2015044087A1 (en) | 2013-09-25 | 2014-09-22 | Food arrangement |
EP14771339.0A EP3049045B1 (en) | 2013-09-25 | 2014-09-22 | Nutrition assembly |
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EP3049045A1 EP3049045A1 (en) | 2016-08-03 |
EP3049045B1 true EP3049045B1 (en) | 2017-08-30 |
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EP (1) | EP3049045B1 (en) |
CN (2) | CN105592837A (en) |
WO (1) | WO2015044087A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102022105832A1 (en) | 2022-03-14 | 2023-09-14 | Ifm Electronic Gmbh | Container for holding a desiccant |
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Publication number | Priority date | Publication date | Assignee | Title |
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WO2019197647A1 (en) * | 2018-04-13 | 2019-10-17 | Fresenius Kabi Ab | Container for a mixing system, mixing system for parenteral nutrition, and method for mixing |
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 |
WO2023148320A1 (en) * | 2022-02-04 | 2023-08-10 | Fresenius Kabi Deutschland Gmbh | Infusion bag, and method for producing same |
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FR2731621B1 (en) * | 1995-03-13 | 1997-09-05 | Clintec Nutrition Co | PERFORATION DEVICE AND CONNECTION ASSEMBLY FOR ENTERAL SUPPLY SYSTEM AND CONNECTION METHOD |
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DE19831235C1 (en) * | 1998-07-11 | 2000-03-16 | Fresenius Ag | Sterile connector for containers containing medical liquids |
DE10223560B4 (en) * | 2002-05-27 | 2006-01-19 | Fresenius Kabi Deutschland Gmbh | Connector for medical fluid containing packaging and packaging for medical fluids |
DE10313760B3 (en) * | 2003-03-27 | 2004-06-03 | Fresenius Kabi Deutschland Gmbh | Connector for a bag containing medical fluids, for e.g. transfusion/infusion, has a connector with a clamp section integrated into the package by an expanded base and without a connection tube |
DE102004033205A1 (en) * | 2004-07-09 | 2006-02-09 | Fresenius Kabi Deutschland Gmbh | Sterile port |
US20130126370A1 (en) * | 2010-06-17 | 2013-05-23 | David DiLiberto | Multi-compartment container with frangible seal and external means for applying opening force between compartments |
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2014
- 2014-09-22 CN CN201480052660.2A patent/CN105592837A/en active Pending
- 2014-09-22 EP EP14771339.0A patent/EP3049045B1/en active Active
- 2014-09-22 CN CN202111612500.7A patent/CN114246794A/en active Pending
- 2014-09-22 US US15/024,924 patent/US20160242998A1/en not_active Abandoned
- 2014-09-22 WO PCT/EP2014/070134 patent/WO2015044087A1/en active Application Filing
-
2021
- 2021-05-10 US US17/315,925 patent/US20210401668A1/en active Pending
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JP2009132431A (en) * | 2007-11-30 | 2009-06-18 | Hosokawa Yoko Co Ltd | Mouth for container, container with the same, sterilized container with content, and its manufacturing method |
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DE102022105832A1 (en) | 2022-03-14 | 2023-09-14 | Ifm Electronic Gmbh | Container for holding a desiccant |
Also Published As
Publication number | Publication date |
---|---|
US20160242998A1 (en) | 2016-08-25 |
CN105592837A (en) | 2016-05-18 |
WO2015044087A1 (en) | 2015-04-02 |
US20210401668A1 (en) | 2021-12-30 |
CN114246794A (en) | 2022-03-29 |
EP3049045A1 (en) | 2016-08-03 |
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